SubChapter D - Laboratories

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Part 54 - Requirements For Self-Defense Spray Devices

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete
Statutory Authority: 
Penal Law, section 265.20(a)

Section 54.1 - Purpose.

Section 54.1 Purpose.

The purpose of this rule is to protect public health, safety and welfare by specifying the type of self-defense spray device that may lawfully be purchased, possessed or used in New York State.
 

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete

Section 54.2 - Definitions.

54.2 Definitions.

(a) Camouflaged means designed to have the appearance of an object other than a self-defense spray device.

(b) Net weight means the weight of the contents of a self- defense spray device.

(c) Oleoresin capsicum means the oleoresin extracted from fruits of plants of the genus Capsicum. The oleoresin contains the active ingredient capsaicin and related compounds classified as capsaicinoids.

(d) Safety device means a self-defense spray device feature that is designed to prevent unintentional discharges.

(e) Self-defense spray device means a pocket-sized spray device which contains and releases a chemical or organic substance which is intended to produce temporary physical discomfort or disability through being vaporized or otherwise dispensed in the air or any like device containing tear gas, pepper or similar disabling agent.
 

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete

Section 54.3 - Requirements.

54.3 Requirements.

Every self-defense spray device which is purchased, possessed or used in New York State shall satisfy all of the following requirements:

(a) Every self-defense spray device shall contain oleoresin capsicum, and no other substance, as the active ingredient.

(b) The contents of every self-defense spray device shall not contain more than 0.7% by weight total capsaicinoids.

(c) The net weight of every self-defense spray device shall not exceed 0.75 ounces.

(d) Every self-defense spray device shall have a safety device.

(e) Every self-defense spray device shall be sold in a sealed, tamper-proof package.

(f) Every self-defense spray device shall not be camouflaged.

(g) Every self-defense spray device shall be accompanied by an insert or inserts which include directions for use, first aid information, safety and storage information and which shall also contain a toll free telephone number for the purpose of allowing any purchaser to call and receive additional information regarding the availability of local courses in self-defense training and safety in the use of a self-defense spray device.

(h) Every self-defense spray device shall bear the following label: "Warning: The use of this substance or device for any purpose other than self-defense is a criminal offense under the law. The contents are dangerous - use with care. This device shall not be sold by anyone other than a licensed or authorized dealer. Possession of this device by a person under the age of eighteen or by anyone who has been convicted of a felony or assault is illegal. Violators may be prosecuted under the law." This label shall appear on the self-defense spray device if the self-defense spray device does not bear the labels required by the California Penal Code pursuant to Section 12403.7(a)(5)(B) and by the United States Consumer Product Safety Commission pursuant to 16 Code of Federal Regulations Section 1500. This label shall appear on self-defense spray device packaging materials or the self-defense spray device if the self-defense spray device bears the labels required by California Penal Code pursuant to Section 12403.7(a)(5)(B) and by the United States Consumer Product Safety Commission pursuant to 16 Code of Federal Regulations Section 1500.

Effective Date: 
Wednesday, May 21, 1997
Doc Status: 
Complete

Part 55 - Approval Of Laboratories

Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 225, 502, 504, Agriculture and Markets Law, Sec. 353

SubPart 55-1 - Approval of Laboratories and Institutions for Use of Living Animals and for Requisition and Allocation of Animals From Pounds

Effective Date: 
Friday, August 21, 2009
Doc Status: 
Complete

Section 55-1.1 - Purposes for which approval may be granted

APPROVAL OF LABORATORIES

Section 55-1.1 Purposes for which approval may be granted.

(a) Approval may be granted laboratories and institutions for the use of living animals in properly performed or conducted scientific tests, experiments or investigations, including educational demonstrations. Living animals include living mammals and birds.

(b) Approval will not be granted to laboratories for the use of living animals unless evidence is presented that the general research or teaching program of the institution or laboratory will contribute to the understanding of the problems of human or animal health.
 

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Section 55-1.2 - Eligibility for approval

55-1.2 Eligibility for approval.

Only laboratories or institutions will be approved in which the use of living animals for the purposes set forth in section 55-1.1 of this Subpart will be under the immediate supervision of persons qualified by training and experience to conduct scientific work.
 

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Section 55-1.3 - Method of approval

55-1.3 Method of approval.

Application for approval shall be made on forms provided by the State Department of Health. Approval will be granted to a laboratory or institution in the name of the person who is the highest level administrator in that laboratory or institution. The certificate of approval is not transferable and the State Department of Health shall be advised promptly if the individual in whose name approval has been granted shall cease to be in charge.
 

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Section 55-1.4 - Responsibility

USE OF ANIMALS

55-1.4 Responsibility.

(a) The individual whose name appears on the certificate of approval shall be responsible for all of the experimentation that involves the use of living animals in the designated laboratory or institution. Such individual shall designate one person to be in charge of animal care. That person shall be responsible for the animals' care regardless of whether that person is physically within or away from the laboratory or institution.

(b) The laboratory or institution shall have an animal care committee which shall be responsible for the review of the propriety of the procedures used and the scientific justification for the use of animals in experiments, tests, and investigations, including educational demonstrations.
 

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Section 55-1.5 - Care and treatment of animals

55-1.5 Care and treatment of animals.

(a) The laboratory or institution shall give careful consideration to the humane treatment of animals wherever located. This includes any off-premises locations which are not considered part of the laboratory or institution. The food given to the animals shall be wholesome and in sufficient quantity for the type of animal and scientific tests. The animals' quarters shall be kept clean, well lighted and ventilated and be maintained at a proper temperature. Quarters or cages of suitable size shall be provided so that each animal may stand, sit and lie in a normal position and turn around with ease. All quarters and cages shall be kept clean, and after they are vacated and before they are reoccupied shall be cleaned by procedures suitable to prevent spread of communicable diseases.

(b) Laboratories and institutions providing transportation for animals must arrange for their humane handling during their transportation to and from the laboratory or institution.

(c) Pain and discomfort shall be minimized by proper use of tranquilizers, analgesics and anesthetics. Exceptions may be made when provisions for maximum comfort, including the use of tranquilizers, analgesics and anesthetics, would defeat the purpose of the experiment. Any exceptions are to be made only after having received the recommendations of the person in charge of animal care.

(d) If animals are to be killed, they must be killed humanely.

(e) Humane methods for killing animals shall include, but not be limited to, the following:

(1) inhalant agents such as carbon dioxide for small rodents;

(2) noninhalant pharmacological agents such as:

(i) barbituric acid derivatives; and

(ii) a combination of chloral hydrate, magnesium sulfate and sodium pentabarbital for large animals;

(3) physical methods such as decapitation for small animals.

(f) Inhumane methods which are prohibited shall include but not limited to the following:

(1) noninhalant pharmacological agents such as:

(i) chloral hydrate alone;

(ii) strychnine;

(iii) magnesium sulfate alone; or

(iv) curariform drugs or agents with curariform activity;

(2) physical methods such as:

(i) drowning; or

(ii) exsanguination without causing prior unconsciousness.
 

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Section 55-1.6 - Interpretation

55-1.6 Interpretation. In meeting the requirements of this Subpart for adequate sanitation, ventilation, food, temperature and space, the standards set out in the latest edition of the Guide for the Care and Use of Laboratory Animals, DHEW Publications No. (NIH) 78-23, published by the U.S. Department of Health and Human Services, shall be used as a guide.
 

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Section 55-1.7 - Applicability

55-1.7 Applicability. This Subpart shall not apply to elementary or secondary schools under the jurisdiction of the State Education Department.
 

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SubPart 55-2 - Approval of Laboratories Performing Environmental Analysis

Effective Date: 
Wednesday, August 21, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, section 502

Section 55-2.1 - Definitions

55-2.1 Definitions. For purposes of this Subpart, unless the context indicates otherwise, the following terms shall have the following meanings:

(a) Environmental laboratory means any facility that examines, or is available for the examination of, samples or specimens, including, but not limited to: air, stack emissions, water, wastewater, surface water, ground water, recreational waters, swimming pools, leachate, land runoff, solid waste, hazardous waste, soil, sediments and vegetation, as well as any substance that could contribute to the pollution of or that could be contaminated by material contained in such samples or specimens. Such examinations shall be limited to qualitative or quantitative determinations of the biological, chemical, radiochemical or physical characteristics of such samples or specimens for the purposes of public or personal health protection, or the protection of the environment or natural resources. Environmental laboratories shall not include facilities or entities that perform non-laboratory chemical testing associated with residential water softeners and residential swimming pools. Environmental laboratories shall include mobile laboratories, as defined in subdivision (c) of this section. (b) Approved laboratory means an environmental laboratory that has demonstrated to the New York State Commissioner of Health that it has met the on-site assessment, technical direction and proficiency testing requirements of this Subpart, and therefore has been issued a certificate of approval. For purposes of this Subpart, accredited shall have the same meaning as approved.
(c) Mobile laboratory means a separate, self-contained mobile facility for the examination of environmental samples or specimens as described in subdivision (a) of this section. A mobile laboratory shall have a fixed address, provided to the department with each application for approval, to which proficiency test samples and other correspondence may be sent, and shall be managed by a responsible person authorized to receive service of process.

(d) Technical director means an individual responsible for the technical and scientific operation of an environmental laboratory,and who meets the minimum qualifications in section 55-2.10 of this Subpart. If an environmental laboratory employs more than one technical director, the laboratory owner(s) shall designate one such individual as the lead technical director.

(e) Approved method means an analytical method, including sample preparation, of proven reliability which has been approved, or given similar recognition by the United States Environmental Protection Agency (EPA) or a New York State regulatory program in environmental or public health protection, for the specific purpose for which the method is to be used. Methods approved by the department pursuant to section 55-2.5 of this Subpart shall be deemed approved methods. The department shall make available a list of approved methods to approved laboratories. (f) Quality system means a structured laboratory management system that meets the standards for a quality system as set forth in the department’s Environmental Laboratory Approval Program Quality System Standards 2002, July 1, 2002 revision, which is hereby incorporated by reference, with the same force and effect as if fully set forth herein. These standards are available for public inspection and copying at the New York State Department of Health, Records Access Office, Corning Tower, Empire State Plaza, Albany, New York 12237.

(g) Analyte means a chemical and/or physical property, element, compound, group of compounds, organism or group of organisms, to be determined in samples examined. Sample and specimen are synonymous terms, and are used interchangeably in this Subpart.

(h) Statistical mean means the arithmetic average of a data set after outlier rejection, or, if transformation is used, the central point of data set distribution after outlier rejection.

(i) Method detection limit means the minimum concentration of an analyte that can be measured and reported with 99-percent confidence that the analyte concentration is greater than zero, as defined or stated in the least sensitive approved method.

(j) Assigned value means the nominal concentration of an analyte, based on sample preparation.

(k) Relative standard deviation means the standard deviation of a data set divided by the statistical mean, expressed as a percentage. Predictive standard deviation means the standard deviation derived from a linear regression equation based on historical data.

(l) Synthetic blank means an artificial sample with contents of known purity and without added analytes.

(m) Natural blank means a sample derived from the environment, for which the concentration of a given analyte or analytes, after repeated analyses, has been determined to be below the method detection limit.

(n) Spiked sample means a sample to which a known amount of an analyte has been added.

(o) Natural sample means a sample collected from the environment, to which no analytes have been added.

(p) Contract Laboratory Protocol (CLP) means a protocol, issued by the New York State Department of Environmental Conservation, for performance of environmental analyses in accordance with specifications describing: the types of samples to be analyzed (such as soil or water); internal sample-handling procedures (such as chain-of-custody or holding times); instrumentation and method of analysis to be used for each analyte; calibration procedures to be implemented (such as numbers of standards, their concentrations and acceptance criteria); quality control samples to be analyzed and the frequency of such analysis; and organization and content of reports to be issued on analytical results obtained.

(q) CLP data package means a collection of documentation whose organization and content are specified by CLPs. A CLP data package shall consist of analytical reports, including, but not limited to, a narrative description of how the analysis was performed, any problems encountered, analytical results for all samples, results for all quality control samples analyzed, copies of instrument printouts, and all logbook pages and laboratory bench sheets.

(r) Department means the New York State Department of Health. (s) Denial means the department’s refusal to approve, in total or in part, an environmental laboratory’s application for approval, including resubmission of an initial or renewal application. (t) Suspension means the department’s temporary removal, in total or in part, of an environmental laboratory’s approval for a defined period of time not exceeding six (6) months, to allow such laboratory time to correct deficiencies or areas of non-compliance. (u) Revocation means the department’s withdrawal, in total or in part, of an environmental laboratory’s approval.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
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Section 55-2.2 - Certificates of approval

55-2.2 Certificates of approval.

(a) Certificates of approval shall be issued to environmental laboratories in one or more categories, including, but not limited to:

(1) examination of potable water, including but not limited to the analytes listed in Part 5 of the New York State Sanitary Code;

(2) examination of nonpotable water, such as wastewater and samples for water quality monitoring of lakes, streams and rivers;

(3) examination of solid waste, soil and sediment, including but not limited to, hazardous wastes (see New York State Environmental Conservation Law Article 27);

(4) examination of air; (5) examination of medical marihuana (see New York State Public Health Law Article 33, Title 5-A); and (6) examination of any sample, specimen or substance listed or otherwise described in section 502 of the Public Health Law. Certificates of approval shall limit approval to specific analytes within one or more of the above categories.

(b) A certificate of approval issued to an environmental laboratory shall set forth: (1) the nature of the approval (interim or full); (2) the approved categories and analytes; (3) the name of the laboratory lead technical director as defined in section 55-2.1 of this Subpart; and (4) the expiration date of the approval, which date shall be no later than one year from the date the certificate of approval is issued, unless an earlier date is set forth on the certificate. (c) All examinations conducted by an environmental laboratory shall employ approved methods, and shall be within the categories listed on the laboratory’s current certificate of approval or on any appendices thereof. A laboratory shall employ only approved methods for which a demonstration of capability has been conducted at the same site where the method is employed. (d) Current certificates of approval and any appendices shall be posted conspicuously in the environmental laboratory, and a copy shall, upon request, be provided by the laboratory to any person or entity requesting the services of the laboratory.

Effective Date: 
Wednesday, April 15, 2015
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Section 55-2.3 - Application for approval

55-2.3 Application for approval.

(a)(1) An application for a certificate of approval shall be submitted to the department by the owner(s) and technical director(s) of an environmental laboratory on a form prescribed by the department. No certificate of approval shall be granted to any laboratory failing to supply all the information requested on the application form.

(2) For each category for which approval is sought, the application for approval shall specify the analytes to be determined, the types of sample(s) to be analyzed (such as soil or water), and the approved methods to be employed for each analyte/sample type.

(3) The department may require additional information regarding the laboratory, including, but not limited to, its ownership, organization, quality system, testing program, premises, qualification of personnel, equipment, method of reporting results of analyses, and number of analyses performed each calendar year.

(b) Upon receipt of such application, the department shall review the laboratory's performance in required proficiency testing, quality system documentation, technical director(s) credentials, previous performance in on-site assessments, if applicable, and any additional materials and/or information requested, and shall determine whether the applicant laboratory qualifies for a certificate of approval, the analytes by category for which approval is to be issued, and the approval fee to be paid. Prior to issuance or renewal of a certificate of approval, the approval fee shall be paid, unless otherwise expressly authorized by the department pursuant to Subpart 55-3 of this Part.

(c) For purposes of the application and approval process, testing facilities housed in separate buildings shall be considered separate environmental laboratories, unless such facilities obtain a waiver for this requisite from the department. The requirements of this subdivision shall not be waived unless the department determines that:

(1) effective supervision of the operation of all such facilities can be exercised by the same technical director(s);

(2) the facilities do not duplicate each other’s analytical, reporting and/or record keeping activities; and

(3) the facilities are owned by the same legal entity.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
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Section 55-2.4 - Approval criteria

55-2.4 Approval criteria.

(a) In such form as may be prescribed by the department, the environmental laboratory owner(s) and technical director(s) shall attest to the following:

(1) the laboratory will be operated in accordance with section 502 of the Public Health Law, the provisions of this Title and/or section 3-0119 of the New York State Environmental Conservation Law;

(2) the laboratory will employ approved methods and will document information pertinent to the approval, demonstration of capability, and use of each method;

(3) records will be maintained for not fewer than five (5) years and shall identify precisely the samples collected, accepted and examined; and procedures used and personnel involved; and shall document test conditions, observations and results of analyses, except that records of chemical analyses related to potable water supplies shall be maintained for not fewer than ten (10) years and records of analyses related to critical agents shall be maintained as required in section 55-2.13 of this Subpart; (4) the technical director(s) will develop, implement and document a quality system as defined in this Subpart; and

(5) the owner shall notify the department if the laboratory is found to be in violation of any federal, state or local law related to the provision of environmental laboratory services or reimbursement for such services, by the federal, state or local agency enforcing that law.

(b) Approval shall be granted to an environmental laboratory for the analytes by categories sought in the application for approval, provided: (1) the laboratory submits a complete application, including the attestation specified in subdivision (a) above and any additional information required by the department to support the application, and remits to the department the approval fee pursuant to Subpart 55-3 of this Part, unless otherwise expressly authorized by the department; (2) each proposed technical director submits documentation of his or her qualifications for evaluation by the department, and the department finds such individual(s) qualified pursuant to section 55-2.10 of this Subpart;
(3) the laboratory provides documentation of a quality system in compliance with this Subpart; (4) pursuant to section 55-2.8, the laboratory participates and performs satisfactorily in proficiency testing for the analytes for which it seeks approval; (5) except as provided in subdivision (c) of this section, the laboratory undergoes an on-site assessment conducted by the department or by a state regulatory program recognized by the department pursuant to section 55-2.9; the findings of the on-site assessment(s) confirm compliance with the staffing, methodological and other requirements of this Subpart; and the laboratory demonstrates effective implementation of its quality system for planning and assessing the work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results; (6) the laboratory provides entry to representatives of the department and/or of a state regulatory program recognized by the department, for on-site assessments during normal business hours; and (7) the department finds the owner(s) and technical director(s) to be of good character and competence after evaluation of factors including, but not limited to:

(i) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the owner or a technical director listed on the application, individually or jointly, or against any laboratory owned or directed by an owner or a technical director listed on the application, or findings by a municipality that a laboratory owned or directed by an owner or technical director listed on the application has violated a local ordinance relating either to collection and analysis of samples, or to reporting of results for the examination and said samples;

(ii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;

(iii) consideration of whether any environmental laboratory directed by the a technical director listed on the application has demonstrated a pattern of repetitive unsatisfactory performance in required proficiency testing in one or more proficiency testing categories, excluding an unsatisfactory score for administrative reasons such as late result submission;

(iv) consideration of whether any laboratory owned or directed by an owner or a technical director listed on the application has misrepresented any material fact pertinent to obtaining or retaining approval including, but not limited to, falsification of any report on or related to laboratory analysis, or submission of any reports on laboratory work, including work both on samples and proficiency testing, actually performed in another laboratory, without disclosing the fact that the examinations or procedures were performed in another laboratory; (v) evidence of aiding and/or abetting in the violation of any of the provision of this Subpart; and

(vi) any other factor having a direct bearing on the ability of the owner(s) and technical director(s) listed on the application to provide, direct or supervise the provision of high quality environmental laboratory services, or to ensure compliance with applicable statutory and regulatory requirements.

(c) Interim approval. (1) A laboratory that has not undergone an on-site assessment may be granted interim approval, for a period not to exceed twelve (12) months, provided all other requirements for approval in subdivision (b) above are met. (2) A laboratory with interim approval shall be granted full approval in the categories and analytes for which it seeks aprpoval provided the findings of on-stie assessment(s) as described in section 55-2.7 of this Subpart confirm compliance with the staffing, methodological and other requirements of this Subpart, and the laboratory demonstrates effective implementation of its quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
Complete

Section 55-2.5 - Department approval of methods

55-2.5 Department approval of methods. Department approval of methods.

(a) A laboratory shall obtain department approval prior to performing a laboratory-developed method, or other method not otherwise approved or given similar recognition as described in section 55-2.1(e) of this Subpart. The department may approve such a method, provided the laboratory submits data and other information as required supporting the technical merit of the method, and demonstrating that that the method’s precision and accuracy are equivalent or superior to that of an approved method. Such data and information shall include, but not be limited to:

(1) a description of the method, including analyte, sample type, working range, reagents and their preparation, equipment specifications, analytical procedures, precision, accuracy, related calculations, intended purpose and pertinent literature citations;

(2) the anticipated date of method implementation;

(3) comparative data, including: sample source(s), dates and times collected, and matrix; whether the sample was spiked, and, if so, the spiking procedure; the approved method used; and analytical results for both the approved method and the method submitted for approval;

(4) data from inter-laboratory comparisons, demonstrating the method’s reproducibility;

(5) demonstration of capability data; and

(6) any other information pertinent to the department’s determination of the method’s technical merit.

(b) Provided all other requirements of subdivision (a) above are met, the department may approve a method for which reproducibility has not been demonstrated by inter-laboratory comparisons if the laboratory demonstrates that its performance of the method is technically acceptable for the intended sample types and analytical purpose. Such approval shall be limited to the laboratory which applied for such approval.

(c) In addition to the requirements of subdivisions (a) and (b) above, the department may require successful completion of on-site demonstration analysis on samples designed to challenge the procedure.

(d) The department shall respond to a laboratory’s request for method approval, notifying the laboratory of method approval, method approval contingent upon approval by the EPA, proposed denial of the request, or the need for further information.\

(e) If the department proposes to deny a request for method approval, it shall advise the laboratory of such proposed denial and the reasons for the denial. A proposed denial shall become final thirty (30) calendar days from the date of notice of proposed denial, unless the laboratory submits, within thirty (30) calendar days of the date of such notice, a written request for reconsideration, including all documentation and rationale in support of such request. Within thirty (30) calendar days of the date the department receives a request for reconsideration, the department shall issue a final determination concerning the request for reconsideration.

(f) Notwithstanding the provisions of this Subpart, the department may conduct an independent review of any approved method to substantiate or refute its technical merit. If the method’s technical merit is found to be lacking, the department shall notify the affected laboratory(ies) of its proposed determination that the method may not be performed under a New York State environmental laboratory certificate of approval, giving the reasons for such determination. Such proposed determination shall become final thirty (30) calendar days from the date of the notice of proposed determination, unless the laboratory(ies) offering such method submits, within thirty (30) calendar days of the date of the notice, a written request for reconsideration, including all documentation and rationale in support of such request. Within thirty (30) calendar days of the date of department receives of a request for reconsideration, the department shall issue a final decision regarding the request for reconsideration.

(g) All information and data pertinent to method approval shall be documented, and be made available for department review upon on-site assessment or upon request for a minimum of two (2) years after the date of the method’s discontinuation.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
Complete

Section 55-2.6 - Denial, suspension and revocation of department approval

55-2.6 Denial, suspension and revocation of department approval.

(a) The department may deny an environmental laboratory’s application for a certificate of approval for the following reasons:

(1) except as provided in section 55-2.4(c), failure to undergo an on-site assessment conducted by the department or by a state program recognized by the department pursuant to section 55-2.9 of this Subpart or failure to demonstrate, during any on-site assessment so conducted: compliance with the staffing, methodological and other requirements of this Subpart; and effective implementation of a quality system for planning and assessing work performed by the laboratory and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(2) failure to participate or perform satisfactorily in proficiency testing pursuant to section 55-2.8 of this Subpart for the analytes for which the laboratory seeks approval;

(3) failure of the laboratory technical director(s) to meet the required qualifications in section 55-2.10 of this Subpart;

(4) misrepresentation of any material fact pertinent to obtaining or retaining approval for any laboratory owned or directed by an owner or technical director listed on the application including, but not limited to, falsification of any report on or related to a laboratory analysis or submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(5) failure to submit a complete approval application, including the attestation required in section 55-2.4(a) of this Subpart, or failure to provide documentation of a quality system as defined in this Subpart or any additional information required by the department to support the application;

(6) failure to remit the required fees;

(7) the owner(s) and/or technical director(s) listed on the application are determined by the department to lack the character and competence necessary to ensure compliance with the applicable laws, rules and regulations after consideration of factors including but not limited to:

(i) evidence of aiding and/or abetting in violation of any of the provisions of this Subpart;

(ii) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services or reimbursement for such services, against the owner or a technical director, individually or jointly, or against any laboratory owned or directed by an owner or technical director listed on the application, or a finding by a municipality that a laboratory has violated a local ordinance related to collection and analysis of samples or specimens, or to reporting of results for examination of said samples or specimens;

(iii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;

(iv) consideration of whether any environmental laboratory directed by a technical director listed on the application has demonstrated a pattern of repetitive unsatisfactory performance in required proficiency testing in one or more proficiency testing categories, excluding an unsatisfactory score for administrative reasons such as late result submission; and/or

(v) any other factor having a direct bearing on the ability of the owner(s) and technical director(s) listed on the application to provide, direct or supervise the provision of high quality environmental laboratory services, or to ensure compliance with applicable statutory and regulatory requirements;

(8) failure to respond to an on-site assessment report with a corrective action plan within the required thirty (30) calendar days after receipt of the report;

(9) failure to respond to an on-site assessment report with an acceptable corrective action plan within the specified timeframe;

(10) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe; and/or

(11) denial of entry to representatives of the department or of a state program recognized by the department pursuant to section 55-2.9 of this Subpart, for on-site assessment during normal business hours.

(b) (1) If the department proposes to deny an environmental laboratory’s application for a certificate of approval, the laboratory shall be given written notice of the proposed denial, stating the reason or reasons for such proposed denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice, unless reconsideration is requested;

(2) if the department gives notice of proposed denial, the laboratory may request reconsideration of the proposed denial by submitting a written request for reconsideration to the department within thirty (30) days of the date of the notice of proposed denial. Submission of a request for reconsideration within thirty (30) days shall stay any action to deny a laboratory's application for a certificate of approval, pending the department’s decision regarding such request for reconsideration;

(3) the written request for reconsideration shall be signed by the owner(s) and technical director(s), and shall include all information the owner(s) and technical director(s) wish to be considered, including any written documentation that would controvert the reason(s) for the denial or disclose that the denial was based upon a mistake of fact;

(4) if the laboratory properly seeks reconsideration of the proposed denial, the department shall review its proposed denial and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke or modify the proposed denial, allow issuance of a certificate of approval conditional on maintenance of corrective action, or require that the laboratory take corrective action. Such determination shall be the final decision of the department.

(c)(1) An environmental laboratory’s certificate of approval shall be suspended automatically upon a change in laboratory ownership, technical direction, or location. However, provided re-application has been made in writing to the department within thirty (30) calendar days of the change, the department may extend an environmental laboratory’s certificate of approval for a period not to exceed ninety (90) calendar days after any change in laboratory ownership, technical direction or location, in order to permit the department to evaluate, as applicable, the character and competence of the new technical director(s) and/or new owner(s) considering requirements in section 55-2.4(b) of this Subpart; the qualifications of the new technical director(s); and/or the effect of the change in location on the environmental laboratory’s ability to produce accurate and reliable analytical data.

(2) An environmental laboratory’s certificate of approval shall be suspended automatically upon failure to remit at least the quarterly payment of the annual approval fee pursuant to Subpart 55-3 of this Part, unless otherwise expressly authorized by the department.

(3) An environmental laboratory’s certificate of approval shall be suspended automatically, in affected analytes and/or categories, for failure to maintain a record of at least two (2) satisfactory proficiency testing (PT) events within the three (3) most recent PT events.

(4) (i) The department may suspend an environmental laboratory’s certificate of approval, in affected analytes and/or categories, for reasons including:

(a) a pattern of deficiencies on on-site assessment or other demonstration that the laboratory lacks an effective quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results; and

(b) failure to notify the department of any change in major analytical instrumentation within thirty (30) calendar days of the change;

(ii) if the department proposes to suspend a laboratory’s certificate of approval, the laboratory shall be given written notice of the proposed suspension, stating the reason or reasons for such proposed suspension. Such notice shall be sent by certified mail and shall be a final determination to be effective ten (10) days from the date of the notice, unless reconsideration is requested. A laboratory may request reconsideration of the proposed suspension by submitting a written request for reconsideration to the department within ten (10) days of the date of the notice of proposed suspension. Submission of a request for reconsideration within ten (10) days shall stay any action to suspend department approval, pending the department’s decision regarding such request for reconsideration. The written request for reconsideration shall be signed by the owner(s) and the technical director(s) designated responsible for the affected category(ies), and shall include all information the owner(s) and technical director(s) wish to be considered, including any written documentation that would controvert the reason(s) for the suspension or disclose that the suspension was based upon a mistake of fact. The department shall review its proposal to suspend approval and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke or modify the proposed suspension, allow retention of the certificate of approval conditional on maintenance of corrective action, or require that the laboratory take corrective action. Such determination shall be the final decision of the department.

(5) An environmental laboratory whose certificate of approval is suspended pursuant to paragraphs (3) or (4) above shall retain approval for the analytes and/or categories for which it continues to meet department requirements. A laboratory so suspended shall discontinue analysis of samples for the analytes and/or categories affected by the suspension, as of the date of the suspension.

(6) The department shall change a laboratory’s certification status from suspended to approved upon receipt of sufficient documentation to permit the department to determine that the conditions meriting suspension no longer exist, and the laboratory meets the criteria for a certificate of approval in section 55-2.4 of this Subpart.

(7) Notwithstanding any of the provisions of this subdivision, the Commissioner of Health may suspend a laboratory's certificate of approval pursuant to the summary action provisions of Public Health Law section 16.

(d)(1) The department may revoke an environmental laboratory’s certificate of approval in affected analytes and/or categories for reasons including:

(i) failure to respond to an on-site assessment report with an acceptable corrective action plan within the specified timeframe;

(ii) a pattern of deficiencies on on-site assessment, or other demonstration that the laboratory lacks an effective quality system for planning and assessing work performed by the laboratory, and for conducting required quality assurance and quality control procedures to promote and maintain the accuracy and reliability of test results;

(iii) failure to implement the responsive actions detailed in the corrective action plan within the specified timeframe;

(iv) failure to correct the deficiencies meriting suspension within six (6) months of the effective date of the suspension; or

(v) for an environmental laboratory suspended pursuant to section 55-2.6(c)(3) of this Subpart, unsatisfactory performance in the next PT event results in three (3) consecutive failed PT events.

(2) An environmental laboratory whose certificate of approval is revoked pursuant to paragraph (1) above shall retain approval for the analytes and/or categories for which it continues to meet department requirements, and may reapply for approval once the deficiencies meriting revocation have been corrected.

(3) The department may revoke an environmental laboratory’s certificate of approval, in total, for reasons including:

(i) failure to respond to an on-site assessment report with a corrective action plan within the required thirty (30) calendar days after receipt of the report;

(ii) failure to participate in a PT program acceptable to the department;

(iii) falsification of any report on or related to a laboratory analysis, including, but not limited to, submission of proficiency test results which were, in fact, generated by a laboratory other than the laboratory to which the samples were distributed;

(iv) misrepresentation of any material fact pertinent to obtaining or maintaining approval;

(v) denial of laboratory entry to representatives of the department or of a state program recognized by the department pursuant to section 55-2.9 of this Subpart for on-site assessment during normal business hours;

(vi) sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of environmental laboratory services, or reimbursement for such services, against the owner(s) or technical director(s), individually or jointly, or against any laboratory owned or directed by such individuals;

(vii) conviction of any crime, including, but not limited to, any offense related to furnishing of, or billing for, environmental laboratory services, which is considered an offense involving theft or fraud;

(viii) failure to remit the annual approval fee, or, for partial fee payments, failure to remit such payments within the timeframes established by the department;

(ix) aiding and/or abetting in the violation of any of the provisions of this Subpart; and/or

(x) a finding by a municipality that the environmental laboratory has violated a local ordinance related either to collection and analysis of samples or specimens, or to reporting of results for examination of such samples or specimens.

(4) If an environmental laboratory’s certificate of approval has been revoked pursuant to paragraph (3) above and the department finds that the violation was willful, or due to recklessness or gross negligence, no application shall be accepted, for a period of time to be determined by the Commissioner of Health or his or her designee, from any person who was an owner or technical director of such laboratory on the date of notification of proposed approval revocation.

(e) No environmental laboratory’s certificate of approval may be revoked without a hearing or an opportunity for a hearing. The environmental laboratory shall be given written notice of proposed revocation, stating the reason(s) for the department’s proposed action. Such notice shall be sent by certified mail and shall be a final determination, to be effective thirty (30) calendar days from the date of the notice, unless a hearing is requested by the laboratory. The environmental laboratory may request a hearing by submitting a written request for a hearing, signed by both the owner(s) and the technical director(s) designated responsible for the affected category(ies), within ten (10) calendar days of the date of the department’s notice of proposed revocation. Approval shall be automatically suspended while any hearing requested is pending, provided the hearing is scheduled to begin within ninety (90) calendar days of the request for such hearing.

(f) An environmental laboratory whose certificate of approval has been revoked shall submit a new application for approval and shall meet all criteria for approval provided in section 55-2.4 of this Subpart to be issued a certificate of approval. The department may conduct an on-site assessment of the environmental laboratory before acting on such application.

Effective Date: 
Wednesday, November 17, 2004
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Section 55-2.7 - Laboratory on-site assessments

55-2.7 Laboratory on-site assessments.

(a) An environmental laboratory seeking or holding a certificate of approval under this Part shall, as a condition of approval, permit on-site assessments to be conducted by the department or by a state program recognized by the department pursuant to section 55-2.9 during the laboratory’s normal business hours.

(b) The factors to be considered during on-site assessments shall include, but not be limited to, the competence and qualifications of staff, adequacy of facilities and equipment, appropriateness of sampling protocols, use of approved methods, and the laboratory’s quality system, including, but not limited to, quality assurance and quality control procedures, and record keeping and reporting practices, as specified in this Subpart.

(c) Each environmental laboratory shall, following each on-site assessment, be furnished with an assessment report which shall set forth the findings of the on-site assessment and any deficiencies to be corrected.

(d) Environmental laboratories located outside of the State of New York shall be assessed the approval fee specified in Subpart 55-3 of this Part, as well as additional expenses incurred by the department in conducting on-site assessments of each laboratory. Such on-site assessments shall not be performed before the department receives payment for such additional costs.

(e) If deficiencies are found during an on-site assessment, the environmental laboratory may be granted a grace period not to exceed ninety (90) calendar days from the date of notification to correct the deficiencies, provided that, within thirty (30) calendar days of such notification, the laboratory submits to the department or recognized state program performing the assessment a written plan of correction to be implemented within ninety (90) calendar days. If, at the end of the grace period, any of the deficiencies found remain uncorrected, the certificate of approval shall be revoked in affected analytes and/or categories pursuant to section 55-2.6 of this Subpart. If the deficiencies found do not necessarily or immediately affect either the accuracy or reliability of results, and if the environmental laboratory demonstrates in writing that corrections of deficiencies have been delayed for reasons beyond its control, the grace period granted pursuant to this subdivision may be extended further for a period not to exceed ninety (90) calendar days. Such extension may not be renewed further.

Effective Date: 
Wednesday, November 17, 2004
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Section 55-2.8 - Proficiency testing

55-2.8 (a) Environmental laboratories shall examine proficiency test samples supplied by the department or by a proficiency testing provider recognized by the department pursuant to subdivision (i) of this section. Laboratories shall conduct the specified examinations and submit the results to the proficiency sample provider for all analytes for which the laboratories are approved or are seeking approval, and for which samples have been supplied.

(1) The department shall announce its schedule for mailed proficiency test sample distribution as soon as practicable after the first day of each approval year. Distribution frequency and dates shall be included in this announcement. The department shall specify, in letters distributed with samples, the department’s test result scoring criteria. Laboratories participating in the department’s proficiency testing program, shall report test results to the department no later than on the dates specified by the department for each manner of result submission (i.e., hardcopy or electronic). No extensions shall be granted. Laboratories whose results are received after the deadline shall be considered to have achieved unsatisfactory performance in the proficiency test event. Laboratories participating in a recognized proficiency testing provider(s)’ proficiency testing program, other than the department’s program, shall arrange with that provider to have test results forwarded to the department.

(2) To obtain or maintain approval for a given analyte, an environmental laboratory shall attain satisfactory performance in at least two (2) of three (3) consecutive scheduled or unscheduled proficiency test events in which it has participated. Such events shall take place at least thirty (30) calendar days apart.

(3) To obtain or maintain approval for the potable water - total coliforms analyte, for which proficiency testing requires qualitative analysis, an environmental laboratory shall maintain a score of at least ninety (90) percent, without reporting a false negative result for at least two (2) of three (3) consecutive scheduled or unscheduled proficiency test events in which it has participated. Such events shall take place at least thirty (30) calendar days apart.

(4) To obtain or maintain approval in contract laboratory protocol (CLP) analyses, an environmental laboratory shall be evaluated on both proficiency testing performance and conformity to the contract requirements of the CLP data package submitted.

(b) Performance in examining an individual chemical or physical analyte shall be evaluated as follows, for a natural blank test sample:

(1) Satisfactory performance shall be a result, reported with or without the term “less than,” and having a value less than or equal to the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(2) Unsatisfactory performance shall be a result, reported with or without the term “less than,” greater than

the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(c) Performance in examining an individual chemical or physical analyte shall be evaluated as follows, for a synthetic blank test sample:

(1) Satisfactory performance shall be a result reported with the term “less than,” and having a value less than or equal to the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(2) Unsatisfactory performance shall be a result reported with or without the term “less than,” and having a value greater than the detection limit specified by the department, or, if no detection limit is specified, the method detection limit.

(d) Performance in examining an individual chemical or physical analyte shall be evaluated as follows, for a spiked or natural test sample:

(1) For data sets examined by the standard statistical procedures described in subdivision (g) of this section and having a relative standard deviation lower than 34 percent:

(i) Satisfactory performance shall be a result within the 99-percent confidence interval about the statistical mean.

(ii) Unsatisfactory performance shall be a result outside the 99-percent confidence interval about the statistical mean.

(2) For data sets examined by the standard statistical procedures described in subdivision (g) of this section but having a relative standard deviation of 34 percent or higher, the relative standard deviation of the data set used for determining the 99-percent confidence interval shall be set at 34 percent, or a value derived from the scientific literature. Satisfactory and unsatisfactory performance shall be as described in paragraph (1) of this subdivision.

(3) For data sets evaluated by using a reference laboratory panel, the statistical mean and 99-percent confidence interval shall be derived from the reference laboratory data set, after standard statistical analysis. Satisfactory and unsatisfactory performance shall be as described in paragraph (1) of this subdivision.

(4) For data sets evaluated using an interval about the assigned value and defined by a fixed percentage of the assigned value, fixed percentages shall be set based on the department’s determination of the reliability, precision and accuracy of the methods used, and:

(i) Satisfactory performance shall be a result within the fixed percentage interval about the assigned value.

(ii) Unsatisfactory performance shall be a result outside the fixed percentage interval about the assigned value.

(5) For data sets evaluated using published linear regression equations to predict the mean and standard deviations:

(i) Satisfactory performance shall be a result within the interval of the predictive mean, plus or minus two (2) predictive standard deviations for potable water analytes, or plus or minus three (3) predictive standard deviations for other matrices.

(ii) Unsatisfactory performance shall be a result outside the interval described in paragraph (i) above.

(e) Performance in examining an individual bacteriological analyte for which quantitation is required shall be evaluated as follows:

(1) For negative coliform and/or standard plate count test samples, including sterile samples, samples containing bacteria not detectable by the method and samples containing bacteria not producing positive reactions with the required verification procedures, satisfactory performance shall be a result reported as a value lower than the method detection limit. Unsatisfactory performance shall be any other result.
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(2) Performance in examining an individual bacteriological analyte for which quantitation is required shall be evaluated as follows, for a positive inoculated test sample:

(i) Satisfactory performance shall be a result within the 99-percent confidence interval about the statistical mean for Most Probable Number (MPN) and Membrane Filter (MF) coliform data, and within the 95-percent confidence interval about the statistical mean for

standard plate count data.

(ii) Unsatisfactory performance shall be a result outside the 99-percent confidence interval about the statistical mean for MPN or MF coliform data, and within the 95-percent confidence interval about the statistical mean for standard plate count data.

(f) The statistical mean and the confidence intervals used to determine satisfactory and unsatisfactory performance for spiked and natural chemical test samples and positive inoculated MF coliform and standard plate count test samples shall be established from statistical analysis of the data set after rejection or weighting of outliers, as described in subdivision (g) of this section. The value assigned to the statistical mean shall be the mean of the resulting data set.

(g) Rejection of outliers in a chemical data set shall be based on the three-standard deviation interval, after eliminating the extreme values in the data set and all values exceeding twice the theoretical value for the test sample. Rejection of outliers in an MF coliform or standard plate count data set shall be based on the three-standard deviation interval, after eliminating the extreme values in the data set. Weighting of outliers, if used in place of rejection of outliers, shall be accomplished using robust analysis. The statistical mean and confidence intervals used to determine satisfactory and unsatisfactory performance for positive inoculated MPN coliform test samples shall be based on the log normal distribution.

(h) Performance in examining potable water bacteriological samples qualitatively shall be evaluated based upon the known presence or absence of total coliform group members of Escherichia coli (E. coli). Satisfactory performance shall be a result correctly indicating the presence or absence of total coliform bacteria, and correctly identifying E. coli, if present. Unsatisfactory performance shall be a result incorrectly identifying the presence or absence of total coliform bacteria or E. coli.

(i) (1) The department may recognize a proficiency testing provider to offer and score results of proficiency testing samples for purposes of obtaining New York State environmental laboratory accreditation pursuant to this Subpart, provided:

(i) the proficiency testing provider has submitted sufficient documentation to enable the department to determine that the provider adheres to standards for design, production, testing, distribution, data analysis and quality assurance that are at least equivalent to, or more stringent than, the department proficiency testing program’s, and applies scoring systems identical to the department’s;

(ii) the proficiency testing provider demonstrates it has policies and procedures in place to protect the integrity of its proficiency testing program and prevent fraud in its administration;

(iii) for analytes and sample types with EPA proficiency testing participation standards, the proficiency testing provider possesses a certificate or other documented approval demonstrating compliance with such EPA standards; and

(iv) the proficiency testing provider agrees to supply the department with test scores, and any such other information and documentation requested to resolve any issues concerning compliance with this Subpart.

(2) The recognition granted to a proficiency testing provider pursuant to this subdivision may be withdrawn at any time if the department finds the provider no longer meets the criteria set forth herein, or has failed to provide the department with sufficient information and documentation to permit determination or demonstration of compliance or noncompliance with this Subpart.

Effective Date: 
Wednesday, November 17, 2004
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Section 55-2.9 - Recognition of other state regulatory programs

55-2.9 Recognition of other state regulatory programs.

(a) An environmental laboratory located in another state may request that the department recognize, for purposes of a New York State certificate of approval, that the requirements of this Subpart for on-site assessment, technical direction, quality systems and/or proficiency testing have been met by the laboratory’s participation in another state’s environmental laboratory approval program. The department may recognize one or more of such requirements as met by participation in another state’s program, provided:

(1) the legal, technical and record keeping requirements of the state regulatory program in which the laboratory is participating are determined by the department to meet or exceed New York State’s requirements;

(2) the laboratory demonstrates good standing in the other state’s program, including successful completion of an on-site assessment and satisfactory performance in required proficiency testing, and documents such good standing to the department;

(3) the laboratory submits to the department a completed application for approval;

(4) the laboratory pays all applicable fees required by Subpart 55-3 of this Part;

(5) the laboratory pays any costs incurred by department representatives traveling outside New York State to perform an on-site assessment pursuant to this Subpart; and

(6) the technical director(s) meet(s) the requirements of section 55-2.10 of this Subpart.

(b) The department may enter into agreements with other state agencies or programs to assist the department in assessing an environmental laboratory’s performance or in determining whether another state’s program meets or exceeds the department’s requirements.

(c) Notwithstanding another state program's equivalency to the department’s program, the department may require an environmental laboratory to participate in the department’s proficiency testing program, on-site assessment, and/or similar evaluations to ensure the laboratory’s full compliance with New York State statutes, regulations and standards for laboratories approved pursuant to this Subpart.

Effective Date: 
Wednesday, November 17, 2004
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Section 55-2.10 - Technical director: qualifications and responsibilities

55-2.10 Technical director: qualifications and responsibilities.

(a) (1) Each environmental laboratory shall appoint one or more technical directors, who shall be full-time members of the laboratory's staff, and who shall exercise actual day-to-day supervision of laboratory operations, including the reporting of results. The designation of a lead technical director shall be documented; and

(2) each technical director shall have the requisite credentials and experience for an area of analysis, such as microbiology, organic chemistry, inorganic chemistry and radiochemical analysis, and shall supervise only the areas of environmental analysis for which he or she meets the qualifications required by this section.

(b) A technical director's responsibilities shall include, but not be limited to, development and implementation of a quality system as defined in section 55-2.1 of this Subpart, including: monitoring standards of performance in quality control and quality assurance; monitoring the validity of analyses performed and data generated to ensure reliable data; ensuring that sufficient numbers of qualified personnel are employed to supervise and perform the work of the laboratory; and providing educational direction to laboratory staff.

(c) An individual meeting the requirements of this section may not be the technical director of more than one approved laboratory without authorization from the department. Circumstances to be considered in the department's decision to grant such authorization may include, but not be limited to, the extent to which the operating hours of the laboratories to be directed overlap, adequacy of supervision in each laboratory, and availability of environmental laboratory services in the area served.

(d) A technical director who is absent for a period of time exceeding fifteen (15) consecutive calendar days shall designate another full-time staff member meeting the qualifications of this Subpart to assume the responsibilities of technical director temporarily. Whenever the term of such temporary direction exceeds sixty-five (65) consecutive calendar days, the department shall be notified in writing.

(e) A technical director of an approved laboratory engaged in chemical analysis shall be:

(1) a person with an earned doctoral degree in the chemical, environmental, physical or biological sciences, or engineering, with at least twenty-four (24) college semester credit hours in chemistry, and at least one year of experience in environmental analysis of representative inorganic and organic analytes for which the laboratory is approved or seeking approval;

(2) a person with a master's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least twenty-four (24) college semester credit hours in chemistry and at least one year of experience in environmental analysis of representative inorganic and organic analytes for which the laboratory is approved or seeking approval; or

(3) a person with a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least twenty-four (24) college semester credit hours in chemistry and at least two (2) years of experience in environmental analysis of representative inorganic and organic analytes for which the laboratory is approved or seeking approval.

(f) A technical director of a laboratory holding or seeking approval for the contract laboratory protocol tier, in addition to meeting the requirements of subdivision (e) of this section, shall have at least three (3) years of experience, at least one year of which shall be in a supervisory capacity.

(g) A technical director of an approved laboratory engaged in, but limited to, inorganic chemical analysis, other than contract laboratory protocol or metals analysis, shall be a person with at least an associate's degree in the chemical, physical or environmental sciences, or two (2) years of equivalent and successful college education, with at least sixteen (16) college semester credit hours in chemistry. In addition, such a person shall have at least two (2) years of experience performing such analysis.

(h) A technical director of an approved laboratory engaged in microbiological and/or biological testing shall be:

(1) a person with an earned doctoral degree or master's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including, for microbiological testing, at least once course having microbiology as a major component, and at least one year of experience in environmental analysis of representative analytes for which the laboratory is approved or seeking approval;

(2) a person with a bachelor's degree in the chemical, environmental, physical or biological sciences, or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including, for microbiological testing, at least one course having microbiology as a major component, and at least two (2) years of experience in environmental analysis of representative analytes for which the laboratory is approved or seeking approval; or

(3) notwithstanding the requirements of paragraphs (1) and (2) of subdivision (h) above, a person with an earned doctoral, master's, bachelor's, or associate's degree in an appropriate field of the sciences or applied sciences, with at least four (4) college semester hours in general microbiology or a biological science course with a major microbiological component, and one year of experience in environmental analysis of representative analytes, may be a technical director of an approved laboratory, provided the laboratory is engaged in microbiological analysis limited to fecal coliform, total coliform and standard plate counts. Two (2) years of equivalent and successful college education, including the microbiology requirement, may be substituted for an associate's degree.

(i) A technical director of an approved laboratory engaged in radiochemical analysis shall be:

(1) a person with an earned doctoral degree in chemistry, physics or engineering, with at least twenty-four (24) college semester hours in chemistry, and at least one year of experience in radiochemical analysis of environmental samples;

(2) a person with a master's degree in chemistry, physics or engineering, with at least twenty-four (24) college semester hours in chemistry, and at least one year of experience in radiochemical analysis of environmental samples; or

(3) a person with a bachelor's degree in chemistry, physics or engineering, with at least twenty-four (24) college semester credit hours in chemistry, and at least two (2) years of experience in radiochemical analysis of environmental samples.

(j) Notwithstanding any other provision of this section, a full-time employee of a drinking water or sewage treatment facility who holds a valid treatment plant operator's certificate appropriate to the nature and size of such facility shall be deemed to meet the educational and experience requirements for serving as the technical director of the approved laboratory devoted exclusively to analysis of environmental samples taken within such a facility. Such approval for a water treatment facility shall be limited to determination of total dissolved solids, pH, temperature, alkalinity, acidity, total coliform organisms and standard plate counts. Such approval for a sewage treatment facility shall be limited to determination of biochemical oxygen demand, total solids, suspended solids, pH, temperature, alkalinity, acidity and fecal coliform organisms. However, such approval for a sewage treatment facility shall be extended to include determination of ammonia, total Kjeldahl nitrogen, nitrate or total phosphorus, provided such full-time employee has successfully completed a specialized course of study in the analysis of these substances, generally recognized by leading authorities in the field.

(k) Notwithstanding any other provision of this section, a full-time employee of an industrial waste treatment facility with at least one year of experience in environmental analysis, under supervision, shall be deemed to meet the requirements for serving as the technical director of an approved laboratory devoted exclusively to analysis of environmental samples taken within such a facility for determination of biochemical oxygen demand, total solids, suspended solids, pH, temperature, alkalinity, acidity and fecal coliform organisms.

(l) A technical director of an approved laboratory engaged in microscopic examination of asbestos and/or airborne fibers shall meet the following requirements:

(1) For procedures requiring use of a transmission electron microscope, a bachelor's degree, successful completion of specialized courses in use of the instrument, and one year of experience, under supervision, in use of the instrument. Such experience shall include identification of minerals.

(2) For procedures requiring use of a polarized light microscope, an associate's degree or two (2) years of equivalent and successful college study, successful completion of formal coursework in polarized light microscopy, and one year of experience, under supervision, in use of the instrument. Such experience shall include identification of minerals.

(3) For procedures requiring use of a phase contrast microscope, as in determination of airborne fibers, an associate's degree or two (2) years of equivalent and successful college study, documentation of successful completion of formal coursework in phase contrast microscopy, and one year of experience, under supervision, in use of the instrument.

(m) A technical director of an approved laboratory engaged in determination of radon in air shall meet the following requirements:

(1) An associate's degree in the physical sciences, or two (2) years of equivalent and successful college education, and one year of experience in radiochemical measurements, including at least six (6) months of experience in measurement of radon and/or radon progeny.

(2) For radon determinations using a direct continuous monitoring device, as in on-site measurement of residential radon levels, at least a high school diploma or high school equivalency diploma, and certification of successful completion of a training course in operation of the instrument, as well as six (6) months of experience, under supervision, in use of the instrument.

(n) A person who meets the experience requirements but not the educational and/or credential requirements of this Subpart, and is functioning in a technical director's capacity on the date the laboratory becomes subject to these regulations, shall qualify as technical director of that laboratory, or any other laboratory approved by the department and performing similar analyses, provided such person can demonstrate the ability to comply with the proficiency testing and quality system requirements of this Subpart.

Effective Date: 
Wednesday, June 16, 2010
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Section 55-2.11 - Quality assurance officer: qualifications and responsibilities

55-2.11 Quality assurance officer: qualifications and responsibilities.

(a) Each environmental laboratory shall appoint a quality assurance officer (however named), who shall exercise oversight of the laboratory’s quality system. The individual so appointed shall have documented training, and/or experience in quality assurance and quality control procedures; be knowledgeable in the required quality system; and possess a general knowledge of analytical methods for which he or she performs data review.

(b) The quality assurance officer (and/or his or her designees) shall:

(1) serve as the focal point for the environmental laboratory’s quality assurance and quality control, and be responsible for monitoring and/or review of quality control data;

(2) evaluate data objectively and perform independent assessments without outside (e.g., managerial) influence;

(3) arrange for or conduct annual internal audits of the laboratory’s entire technical operation; and

(4) notify laboratory management of any deficiencies in the quality system and monitor required corrective actions.

(c) The quality assurance officer shall have direct access to the highest level of management at which decisions are made on laboratory policy or resources, as well as to the technical director(s). The quality assurance officer shall fulfill his or her functions independently from laboratory operations for which he or she maintains quality assurance oversight; provided, however, for laboratories with limited staffing, the quality assurance officer may also be a technical director.

Effective Date: 
Wednesday, November 17, 2004
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Section 55-2.12 - Contract laboratory protocol personnel: qualifications

55-2.12 Contract laboratory protocol personnel: qualifications.

(a) To gain or maintain approval for contract laboratory protocol analyses, an environmental laboratory shall employ full-time employees qualified to perform the following functions, as set forth in the protocol:

(1) Laboratory supervisor in the specialties of gas chromatography/mass spectrometry (GC/MS), gas chromatography (GC), and/or inorganics shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and three (3) years of relevant laboratory experience, including one year in a supervisory capacity.

(2) GC/MS operator shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and one year of experience in operating and maintaining a GC/MS data system. Three (3) years of experience in operating and maintaining a GC/MS data system may be substituted for the educational requirement.

(3) Mass spectral interpretation specialist shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, who has successfully completed a specialized training course in mass spectral interpretation and has at least two (2) years of experience in mass spectral interpretation.

(4) Pesticide residue analysis expert shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and two (2) years of experience in operating and maintaining a gas chromatograph, and interpreting gas chromatograms.

(5) Organic sample preparation supervisor shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and at least three (3) years of organic laboratory experience, including at least one year in a supervisory capacity.

(6) Extraction/concentration expert shall be a person with at least a high school diploma, including one course in chemistry and one year of experience in an analytical chemistry laboratory.

(7) Inductively coupled plasma (ICP) spectroscopist shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, who has successfully completed specialized training courses in ICP spectroscopy and has two (2) years of applied experience in ICP analysis of environmental samples.

(8) ICP operator shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and one year of experience in the operation and maintenance of ICP instrumentation; or, in lieu of the educational requirement, four (4) years of experience in operating and maintaining ICP instrumentation;

(9) Atomic absorption (AA) operator shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and at least one year of experience in operating and maintaining AA instrumentation for flame, graphite furnace and cold vapor techniques; or, in lieu of the educational requirement, three (3) years of experience in operating and maintaining AA instrumentation as described in this paragraph.

(10) Inorganic sample preparation specialist shall be a person with at least a high school diploma, successful completion of a college-level course in general chemistry or its equivalent, and six (6) months of experience in an analytical laboratory.

(11) Classical techniques analyst shall be a person with at least a bachelor’s degree in chemistry or the physical sciences, and six (6) months of experience in classical chemistry laboratory procedures; or, in lieu of the education requirement, two and one-half (2 1/2) years of experience performing classical chemistry analyses.

(b) Each environmental laboratory seeking approval or wishing to maintain approval for contract laboratory protocol analysis shall have sufficient technical staff to provide continuous coverage, as appropriate, for the functions described in subdivision (a) of this section. The person or persons designated as back-up technical staff shall have at least a bachelor’s degree in chemistry or the physical sciences, in addition to the following minimum experience:

(1) for organic chemistry protocols: one year of experience in each of the following areas: GC/MS operation and maintenance, for volatile and semi-volatile analyses; mass spectral interpretation; extraction; and pesticide analyses; or

(2) for inorganic chemistry protocols: one year of experience in each of the following areas: ICP operation and maintenance; AA operation and maintenance; classical chemistry analytical procedures; and sample preparation for inorganic analyses.
Note: Requirements for laboratories engaged in testing for critical agents in environmental samples, set forth in 55-2.13 adopted as an emergency regulation, shall continue in effect as promulgated, repromulgated and/or finally adopted in accordance with the State Administrative Procedure Act.

Effective Date: 
Wednesday, November 17, 2004
Doc Status: 
Complete

Section 55-2.13 - Requirements for laboratories engaged in testing for critical agents in environmental samples

55-2.13 Requirements for laboratories engaged in testing for critical agents in environmental samples.

(a) For purposes of this Subpart,
critical agentshall mean an organism, chemical element or chemical compound, which is recognized as posing a risk to national security and/or requiring special action to protect the public health because the agent: can be disseminated (e.g., in air, water or food) or transmitted person-to-person with ease; causes moderate to high mortality and/or morbidity; and can have a significant public health impact. The term organism includes, but is not limited to, a virus, bacterium, or product or component of an organism (e.g., a toxin).
Critical agentsshall include critical biological and chemical agents, including select agents, specified by the Federal Centers for Disease Control and Prevention (CDC) in published documents, and other such agents as the Commissioner of Health has determined meet the above criteria. The terms chemical element and chemical compound include substances that emit ionizing radiation including alpha, beta, gamma or neutron radiation.

(b) (1) Prior to performing testing for any critical agent in an environmental sample, a laboratory shall submit a request to the department, and receive an initial or revised certificate of approval that includes the specialty of critical agent testing and the approved method(s) the laboratory is authorized to employ as stipulated in sections 55-2.1 and 55-2.5 of this Subpart. The certificate of approval shall also list the specific critical agent(s) included in the approval, the approved method(s), and the types of samples (e.g., surface swipes, powder, air, fluid and bulk material) the laboratory may accept for testing. No laboratory shall examine an environmental sample for a critical biological agent or critical chemical agent without certification of approval specific to each critical agent for which testing is conducted.

(2) The department may withhold or limit its approval if the department is not satisfied that the laboratory has in place adequate policies, procedures, facilities, equipment, instrumentation and trained personnel to ensure that: collection; labeling; accessioning; preparation; analysis; result reporting or, for an autonomous detection system as defined in section 55-2.14(a) of this Subpart, responding to a signal indicating the presence of a critical agent; storage; transportation; shipping; and disposition of all environmental samples, derivatives and related materials shall be performed in a manner that: ensures consistently correct performance of the approved methods; ensures the protection of the health, safety and welfare of the laboratory's employees and the public; and is consistent with the requirements of this Subpart, and all other applicable laws, rules and regulations. The department shall also consider a laboratory's biosafety level facilities, safety practices, and its capability to assume an appropriate role in the public health and safety response(s) to critical agents, in its determination to approve the laboratory for critical agent testing in environmental samples.

(c) In addition to application and attestation requirements found elsewhere in this Subpart, a laboratory seeking approval to perform critical agent testing in environmental samples shall submit:

(1) a standard operating procedure manual documenting laboratory policies, procedures, facilities, equipment, supplies, instrumentation and personnel for critical agent testing, which are designed to ensure that: collection; labeling; accessioning; preparation; analysis; result reporting or, for an autonomous detection system as defined in section 55-2.14(a) of this Subpart, responding to a signal indicating the presence of a critical agent; storage; transportation; shipping; and disposition of all environmental samples, derivatives and related materials shall be performed in a manner that ensures consistently correct performance of the approved methods; ensures the protection of the health, safety and welfare of the laboratory's employees and the public; and is consistent with the requirements of this Subpart, and all other applicable laws, rules and regulations; and

(2) an attestation signed by the owner(s) and director(s) that the laboratory will accept only the type(s) of samples (e.g., surface swipes, powder, air, fluid and bulk material) specified on the laboratory's certificate of approval, and that the owner(s) and director(s) will take whatever action is necessary to ensure that such samples are collected, labeled, accessioned, prepared, analyzed, stored, transported, shipped and disposed of, and all results are reported in a manner consistent with the approved method and with all other documentation submitted to the department.

(d) In addition to meeting the preceding requirements of this Subpart, a laboratory engaged in critical agent testing in environmental samples, through its owner(s) and director(s), shall:

(1) establish, maintain, review periodically, and implement written policies and procedures designed to ensure that: collection; labeling; accessioning; preparation; analysis; result reporting or, for an autonomous detection system as defined in section 55-2.14(a) of this Subpart, responding to a signal indicating the presence of a critical agent; storage; transportation; shipping; and disposition of samples shall be performed in a manner that ensures consistently correct performance of the approved methods, ensures the protection of the health, safety and welfare of laboratory personnel, sample collectors and the public to the extent possible, and is consistent with all applicable laws, rules and regulations, as well as recognized standards of practice designed to minimize the risks associated with potential exposure to similar hazardous substances or critical agents. Such policies and procedures shall include specific procedures for containment, secured storage, decontamination, and/or disposal or destruction of the sample(s), derivatives, and related collection materials, supplies and/or equipment, as necessary and/or appropriate for the relevant suspected critical agent;

(2) have written policies and procedures in place to implement a chain-of-custody protocol whenever required by a law enforcement agency. Such policies and procedures shall be developed in consultation with law enforcement officials or other persons with appropriate experience and training in chain-of-custody issues, and shall at a minimum require an intact continuous record of the physical possession, storage, and disposition of the sample and any derivatives, including the signatures of all persons who access the sample and derivatives, the date of such access and other pertinent information;

(3) (i) ensure that all laboratory employees engaged in collecting and/or transporting environmental samples receive sufficient training in hazardous material handling techniques to ensure they will perform their responsibilities in a safe and reliable manner. Such training shall include, but not be limited to, training in sample collection, packaging, decontamination, transportation, and chain-of-custody policies and procedures established by the laboratory. The laboratory shall maintain documentation of such training for a minimum of three (3) years and take such other action as is necessary to ensure ongoing compliance with such policies and procedures;

(ii) develop and implement sample acceptance criteria designed to protect the health, safety and welfare of laboratory personnel, sample collectors, and the public to the extent feasible. Such criteria shall be consistent with approved methods for sample collection, handling, packaging and decontamination, and shall minimally define conditions under which a sample shall be rejected, and conditions under which a sample shall be tested and results reported with limitations. The laboratory shall make its sample acceptance criteria available to clients;

(4) issue reports of test results in a format and of a content required by the approved method, and necessary for interpretation of the test results or an autonomous detection system signal indicating the presence of a critical agent, including, but not limited to, unambiguous identification of the tested environmental sample, including collection location and time, source and sample type, and limitations of the method. The department may restrict a laboratory's ability to report information concerning a test result whenever confirmatory or supplemental testing is required by the approved method;

(5) report laboratory findings to the department or an authority designated by the department as soon as practicable, but no later than: (i) 24 hours following generation of a test result, via telephone, facsimile and/or electronic transmission, using a number or e-mail address designated by the department or the department's designee; and (ii) as specified in section 55-2.14 of this Subpart for an autonomous detection system, i.e., as soon as practicable but no later than one hour, whenever the findings indicate that an environmental sample contains an organism, its product or component, or a chemical, any of which exhibits characteristics or properties consistent with those of a critical agent. Whenever the department determines that supplemental testing is necessary, the laboratory shall submit all or part of the sample or its derivative(s) to the department or its designee, as directed by the department. For purposes of sections 55-2.13 and 55-2.14 of this Subpart, the term
supplemental testingshall mean performance of analyses following an initial indication that a critical agent has been detected, including, but not limited to, confirmatory testing and technical procedures to identify further the characteristics of a critical agent for public health protection and/or law enforcement purposes. The term
confirmatory testingshall mean supplemental testing that definitively substantiates or refutes the presence of a critical agent;

(6) unless precluded by law enforcement, prosecutorial or homeland security authorities, make available the findings of confirmatory testing conducted in response to an autonomous detection system signal to the approved laboratory operating the autonomous detection system; and

(7) establish and implement a critical agent inventory and tracking system that accounts for all environmental samples and their derivatives suspected or confirmed to contain critical agents. Unless required to demonstrate implementation of chain-of-custody procedures required pursuant to paragraph (2) of this subdivision or required by this paragraph, a laboratory may discontinue inventory and tracking of samples and derivatives, provided laboratory findings have established the absence of a critical agent. Inventory and tracking documentation shall include the identity of all individuals who access such materials and the date and time of access, as well as specific information regarding transfer, disposal or other disposition of the materials. Samples and their derivatives, access records, chain of custody records and records of the analyses performed shall be maintained in a secure manner until the statute of limitations for bringing any related criminal or civil action has expired, and the sample and its derivatives are no longer needed for evidence in any pending legal matter or by law enforcement officials. Access records, chain of custody records and records of the analyses of confirmed positive samples shall be maintained for ten (10) years, or as required above if longer.

(e) For critical biological agents, an environmental laboratory's proficiency testing performance shall be evaluated based on the known presence or absence of the critical agent, or, as applicable, its product or component. Satisfactory performance shall be a result correctly indicating the presence or absence of the critical agent, or, as applicable, its product or component. Unsatisfactory performance shall be a result incorrectly indicating the presence or absence of the critical agent, or, as applicable, its product or component.

(f) Personnel requirements for environmental sample testing for critical biological agents that are organisms shall be as follows:

(1) notwithstanding the requirements of section 55-2.10 of this Subpart, the environmental laboratory shall employ, as director, one of the following:

(i) a person who holds or meets the qualifications for a New York State clinical laboratory director certificate of qualification in the applicable subspecialty of microbiology (such as bacteriology), pursuant to Part 19 of this Title, and, for analyses using technologies other than conventional microbiologic techniques, at least one year of experience in analysis using the specific technology of the device, instrument or system (e.g., nucleic acid detection by the polymerase chain reaction (PCR) technique). For purposes of this subdivision,
conventional microbiologic techniquesshall mean culture, use of differential media, stains and/or biochemical reactions, and morphologic examination of colonies and/or organisms;

(ii) a person with an earned doctoral degree or master's degree in the chemical, environmental, physical or biological sciences or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including: (a) at least one (1) course having microbiology as a major component, and at least one year of experience in analysis using one or more conventional microbiologic techniques for which the laboratory is approved or seeking approval; or (b) at least two years of experience in analysis using the specific technology of the device, instrument or system (e.g., nucleic acid detection by PCR) for which the laboratory is approved or seeking approval; however, one course in the specific technology may be substituted for one year's experience; or

(iii) a person with a bachelor's degree in the chemical, environmental, physical or biological sciences or engineering, with at least sixteen (16) college semester credit hours in the biological sciences, including: (a) at least one (1) course having microbiology as a major component,

and at least two years of experience in analysis using one or more conventional microbiologic techniques for which the laboratory is approved or seeking approval; or (b) at least three years of experience in analysis using the specific technology of the device, instrument or system (e.g., nucleic acid detection by PCR) for which the laboratory is approved or seeking approval; however, one course in the specific technology may be substituted for one year's experience; and

(iv) with respect to environmental laboratories that limit their critical biological agent testing to toxin analysis, any of the following personnel qualifications may be substituted for qualifications set forth above, as follows: a New York State clinical laboratory director certificate of qualification in toxicology may be substituted for the certification in microbiology requirement specified in subparagraph (i) of this paragraph; and coursework consisting of a minimum of sixteen (16) college semester credit hours in the biological and/or chemical sciences including at least (1) one course in biochemistry may be substituted for the coursework requirements, but not the educational degree requirements specified in clauses (ii)(a) and (iii)(a) of this paragraph; and

(2) with the exception of autonomous detection systems, sample preparation, analysis and related responsibilities shall be performed by an analyst who shall have an associate's degree or equivalent, with at least twelve (12) college semester credit hours in the biological sciences, and at least one year of experience in analysis of representative analytes; however, a person with at least three (3) years' experience in the analysis of representative analytes immediately preceding the effective date of this section shall be deemed to have met the requisite qualifications for performing critical agent analysis in the laboratory in which such experience has been obtained. Analysts with critical biological agent testing responsibilities that are limited to toxin sample preparation, analysis and related responsibilities may meet the semester credit hour qualifications set forth in this paragraph by completing a minimum of twelve (12) college semester credit hours in the biological and/or chemical sciences.

(g) This section shall not apply to bacteriologic testing for total and fecal coliform bacteria (i.e., the common form of
Escherichia coli) in potable and non-potable water.

Effective Date: 
Wednesday, June 16, 2010
Doc Status: 
Complete

Section 55-2.14 - Additional requirements for laboratories engaged in testing for critical agents in environmental samples using autonomous detection systems

55-2.14 Additional requirements for laboratories engaged in testing for critical agents in environmental samples using autonomous detection systems.

(a) For purposes of this Subpart

(1) autonomous detection systemshall mean a fixed or portable self-contained analytical system that: automatically, continuously or periodically samples the environment; analyzes sample(s); and triggers an alert that a critical agent, as defined in section 55-2.13 of this Subpart, has been detected. For purposes of Subpart 55-2, signaland alertshall have the same meaning, i.e., a visual and/or audio alert triggered whenever an organism, its product or component, or a chemical, any of which exhibits characteristics or properties consistent with those of a critical agent has been detected by the detection system;

(2) deployand operateshall mean to engage the system in real time collection and analysis of environmental samples for purposes of detecting incidental release of a critical agent as defined in section 55-2.13 of this Subpart;

(3) autonomous detection systemshall not mean a device for environmental sampling and/or analysis of environmental samples deployed for a purpose other than detecting incidental release of a critical agent as defined in section 55-2.13 of this Subpart. Accordingly, the provisions of this Subpart shall not be applicable to;

(i) carbon monoxide detectors;

(ii) radon detectors;

(iii) hand-held detectors, personal dosimeters or Geiger counters designed and intended for use by individuals, or, when used in an academic setting, for instruction or research;

(iv) detectors deployed within hospitals or other health care facilities;

(v) detectors deployed by utility companies or in an industrial setting for the purpose of monitoring internal air quality or detecting leakage of hazardous materials;

(vi) detectors deployed by certified industrial hygienists, labor unions and other individuals or entities responsible for or engaging in testing or monitoring of workplace or environmental safety, including such testing or monitoring in the aftermath of a possible accident or bioterrorism incident involving critical agent(s); and

(vii) an environmental sampling and/or testing device deployed for a purpose other than detecting the incidental release of a critical agent, and determined by the Commissioner of Health to not require department oversight pursuant to Public Health Law Section 502.

(b) In addition to meeting the requirements stipulated elsewhere in this Subpart, including the department's Quality System Standards as referenced in Section 55-2.1(f), a laboratory engaged in the analysis of environmental samples using an autonomous detection system shall:

(1) ensure that the system is operated in a secure and safe manner to prevent accidental or deliberate tampering that could compromise the integrity of its operation;

(2) establish and validate the minimum concentration(s) of specified critical agent(s) that would trigger a signal;

(3) develop a laboratory response plan acceptable to the department, to be immediately implemented whenever a signal is triggered, that at a minimum includes procedures for: notification of a signal to the client(s) on whose property an autonomous detection system is situated;

notification of a signal to state and local public health and emergency preparedness authorities responsible for confirming, responding to and remediating an incident involving critical agent(s); emergency shutdown of any autonomous detection system suspected to be malfunctioning; communication between the laboratory's technical director and authorities responding to a signal; timely verification that any signal triggered was neither a false positive nor false negative signal, including review of results of any supplemental testing; and remediation for any false signal;

(4) retain documentation that the response plan has been developed in collaboration with:

(i) state public health and emergency preparedness authorities, and comparable local authorities whenever applicable, responsible for confirming, responding to and remediating an incident involving critical agent(s); and includes documentation of approval by state and/or local public health and emergency preparedness authorities. Such documentation shall include a valid permit or certificate authorizing deployment of an autonomous detection system within an area under the authority's jurisdiction; and

(ii) the client(s) on whose property an autonomous detection system is situated and other party(ies) situated at or controlling right of access at that location; and includes an attestation of agreement to follow response plan protocols, signed by the client and any party(ies) situated at or controlling right of access at the location at which the autonomous detection system is deployed;

(5) document, in its standard operating procedures manual:

(i) the laboratory's process for selecting locations in which autonomous detection systems are to be situated, or, if a system is portable, a description of the types of locations in which a system may be deployed;

(ii) procedures to ensure adequate oversight by the technical director of each autonomous detection system deployed by the laboratory, including, but not limited to, review of quality assurance and quality control data and, as available, the results of any postsignal confirmatory testing;

(iii) protocols for monitoring multiple systems or monitoring from a remote location;

(iv) protocols for timely communication between the system's operator and the technical director, and between the client and the laboratory; and

(v) the laboratory's response plan.

(6) for each autonomous detection system in operation: maintain records on its location, including street address, and a description of its exact placement within a building or area
;and

(7) whenever the system triggers an alert:

(i) immediately follow procedures prescribed in the laboratory's response plan;

(ii) as soon as practicable, but no later than one hour after a signal has been triggered, notify the department or an authority designated by the department, via telephone using a number designated by the department or the department's designee; and document the date and time of the telephone call, and the name(s) of the responsible person(s) contacted; and

(iii) request for review records of any supplemental testing conducted in response to the triggered signal. Whenever the results of such supplemental testing are inconsistent with the expected reason for a signal, the laboratory shall render inoperable the autonomous detection system that triggered the signal until the cause of the discrepancy is determined and remediated.

(c) The laboratory shall maintain a fixed-base location at which all records required by this Subpart, including but not limited to, calibration, test, quality assurance, quality control, operator training, and client notification protocols and supplemental testing are retained for periods stipulated in this Subpart. The laboratory shall also retain records demonstrating compliance with federal, state, and local rules for registration, use and disposal of any material that meets the definition of a biological or chemical critical agent, including radioactive material, in its possession.

(d) A laboratory may operate one or more autonomous detection systems under the direction of one technical director. Procedures for direct oversight by the technical director of one or more systems and their operator(s) shall be acceptable to the department.

(e) An autonomous detection system, while in operation, shall be continuously monitored by an autonomous detection system operator who functions under the direction of the technical director. The technical director may also serve as the operator. Prior to designating a person as an autonomous detection system operator, the laboratory owner and technical director shall ensure compliance with applicable personnel requirements stipulated in the department's Quality System Standards as referenced in Section 55-2.1(f), as well as ensure that the operator:

(1) receives adequate training specific to the operation of each specific make and model of autonomous detection system in use by the laboratory;

(2) provides written attestation to reading and understanding the general policies and procedures of the laboratory, and those specific to the autonomous detection system(s) in use, including the laboratory's response plan and the operator's responsibilities under that plan; and

(3) undergoes a successful demonstration of capability that includes participation in the mock implementation of each specific response plan for each autonomous detection system deployed by the laboratory.

Effective Date: 
Wednesday, June 16, 2010
Doc Status: 
Complete

Section 55-2.15 - Requirements for laboratories performing testing for medical marihuana

55-2.15 Requirements for laboratories performing testing for medical marihuana.

(a) For purposes of this subpart, the following terms shall have the following meanings:

(1) “medical marihuana” shall mean marihuana as defined in subdivision twenty-one of section thirty-three hundred two of the public health law, intended for a certified medical use, as determined by the commissioner in his or her sole discretion.

(2) “medical marihuana product” shall mean any material produced from medical marihuana prior to its final packaging, e.g, extracts.

(3) “final medical marihuana product” shall mean the final medical marihuana product as dispensed to the patient. Any form of medical marihuana not approved by the commissioner is expressly prohibited.

(4) “registered organization” shall mean a for-profit business entity or not-for-profit corporation organized for the purpose of acquiring, processing manufacturing, selling, delivering, transporting, distributing or dispensing medical marihuana in accordance with the requirements of title 5-A of article 33 of the public health law.

(b) (1) Prior to performing testing for any medical marihuana, medical marihuana product or final medical marihuana product, a laboratory physically located within New York State shall submit a request to the department, and receive an initial or revised certificate of approval that includes the specialty of medical marihuana testing and the approved method(s) the laboratory is authorized to employ as stipulated in sections 55-2.1 and 55-2.5 of this Subpart, in addition to a valid Class 8 Analytical Laboratory license, issued by the department’s Bureau of Narcotic Enforcement. The certificate of approval shall also list the specific subcategories, analytes, and approved methods included in the approval. No laboratory shall examine a sample related to medical marihuana without certification of approval specific to this category and meeting all other provisions within this Subpart; and

(2) the department may withhold or limit its approval if the department is not satisfied that:

(i) the laboratory has in place adequate policies, procedures, and facility security (physical and cyber security) to ensure proper: collection; labeling; accessioning; preparation; analysis; result reporting for; and disposal of and storage of medical marihuana, medical marihuana product or final medical marihuana product as defined in section 55-2.15(a) of this Subpart; or

(ii) the laboratory is able to meet the requirements applicable to it as set forth in title V-A of article 33 of the Public Health Law, and section 1004.14 of this Title.

(c) In addition to application and attestation requirements found elsewhere in this subpart, a laboratory seeking approval to perform medical marihuana, medical marihuana product or final medical marihuana product testing shall submit:

(1) a standard operating procedure manual documenting laboratory policies, procedures, facilities, equipment, supplies, instrumentation and personnel for medical marihuana, medical marihuana product or final medical marihuana product testing, which are designed to ensure proper: collection; labeling; accessioning; preparation; analysis; result reporting or, disposal of and storage of medical marihuana, medical marihuana product or final medical marihuana product as defined in section 55-2.15(a) of this subpart including any validation summaries or data as requested; and

(2) an attestation signed by the owner(s) and director(s) that, in addition to meeting the preceding requirements of this subpart, a laboratory engaged in medical marihuana testing, through its owner(s) and director(s), shall:

(i) confirm that the laboratory shall accept only the type(s) of samples specified on the laboratory’s certificate of approval;

(ii) confirm that the laboratory owner(s) and director(s) is independent of any owner and employee of a registered organization; and

(iii) confirm that the owner(s) and director(s) will ensure that all test results are reported in a manner and form consistent with the approved method and with requirements in title V-A of article thirty-three of the public health law, including but not limited to:

(a) reporting of results, as applicable, including regulated analytes as well as any contaminants listed in section 1004.14(g) of this title to the registered organization and the department using a department approved mechanism; and

(b) reporting of any improprieties regarding the medical marihuana product testing, including but not limited to, theft and the falsification of any data, documentation, or attestation related to the medical marihuana product testing to the department within two (2) business days from the date of learning of the impropriety.

(c) The approval of mobile laboratories is prohibited for the purposes of this section.

Effective Date: 
Wednesday, August 21, 2019
Doc Status: 
Complete

SubPart 55-3 - Environmental Laboratory Approval Fee

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 502(3), (4), (7)

Section 55-3.1 - Definitions

Section 55-3.1 Definitions.

(a) Adjusted volume shall mean the number of tests performed annually on New York State samples for each analyte determined and for which approval is requested, multiplied by the difficulty factor listed in section 55-3.9 of this Subpart.

(b) Analytes shall mean the total number of analytes per category for which an environmental laboratory is approved.

(c) Approval fee shall mean the annual fee charged to an environmental laboratory calculated pursuant to section 55-3.7 of this Subpart.

(d) Approval year shall mean the State fiscal year (April 1st to March 31st).

(e) For purposes of this program:

(1) Environmental testing is defined as laboratory examination of samples of drinking water, wastewater, recreational waters, natural surface water, swimming pools, air, solid waste, hazardous waste, soil or sediment or other matrices to determine the biological, chemical, physical, or radiological qualities, for the purpose of public or personal health protection or protection of the environment and natural resources.

(2) Not included in the definition of testing for purposes of fee computation are quality control testing, proficiency testing, process control testing, testing on samples taken outside New York State and testing for research and development of new methods. Process control testing includes testing for quality control purposes during a manufacturing process or testing of an effluent of waste treatment, in which tests on an analyte are performed in addition to those required to ensure compliance with a relevant discharge requirement. Research and development testing includes tests performed in order to develop alternate testing methods for approval by the department. Process control testing and research and development testing are generally characterized by (i) no reporting of the analytical result to a client or outside the facility, (ii) no charge assessment, and (iii) no advertisement or promotion of the analysis as a service.

(3) All other tests performed in categories, subcategories or analytes for which the laboratory is approved, regardless of the purpose of the testing not otherwise excluded, must he reported for fee computation purposes.

(f) A governmental laboratory is defined as any laboratory operated by the federal government, a State agency, or an authority, county, city, town, village, water district, sewer district or other political subdivision of the State.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.2 - Annual approval fee

55-3.2 Annual approval fee.

An environmental laboratory which is issued a certificate of approval pursuant to Subpart 55-2 of this Part shall pay an annual approval fee.
 

Doc Status: 
Complete

Section 55-3.3 - Annual report

55-3.3 Annual report.

(a) On or before March 1st of each year, each approved laboratory shall report the total number of individual analyte tests for the previous calendar year (January 1st - December 31st) in each category for which approval is given on forms to be provided by the department. If requested by the laboratory, this report shall be deemed confidential and exempt from disclosure under the Freedom of Information Law (article 6 of the Public Officers Law) pursuant to the authority in section 89(5) of the Public Officers Law. Failure to report or reporting falsely shall result in non-renewal of the certificate of approval. Governmental laboratories are exempted from reporting their total adjusted volume.

(b) Thirty days after approval of the State budget, the department shall bill each laboratory for its approval fee and any adjustment due from the previous year and shall advise each laboratory of the total number of analyte tests reported by all laboratories and the total number of analytes approved for all laboratories.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.4 - Method of payment of approval fee

55-3.4 Method of payment of approval fee.

Payment for the approval fee must be made thirty days after billing, except that a laboratory may elect to make four equal payments with the first payment due thirty days after billing (the "first payment date"), the fourth payment due February 15th of the State fiscal year to which the billing relates, and the remaining two payments due on dates equidistant between the first and fourth payment dates. Nothing herein precludes making full payment before these dates.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.5 - Suspension or renewal of certificate of approval

55-3.5 Suspension or renewal of certificate of approval.

Failure to meet at least the quarterly payment requirement shall result in suspension or nonrenewal of the certificate of approval. A laboratory whose approval has been suspended or not renewed pursuant to this section shall be assessed a fee calculated pursuant to section 55-3.7(b) of this Subpart, if it seeks reapproval.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.6 - Annual cost adjustment

55-3.6 Annual cost adjustment.

Prior to calculating fees for the next permit year, the department shall review and finalize the actual annual cost of the environmental laboratory approval program for the previous fiscal year and compare that cost to the fees collected or anticipated to be collected for that previous fiscal year. Any difference will be reflected in an adjustment to the next annual billing.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.7 - Approval fee computation

55-3.7 Approval fee computation.

(a) Except as otherwise provided in this section, the approval fee assessed to each environmental laboratory shall be computed as follows:

(1) The total projected budget of the environmental laboratory approval program for the upcoming State fiscal year (April 1st to March 31st) shall be computed (hereafter "the budget");

(2) The total number of laboratories shall be multiplied by $500 and the product deducted from the budget, resulting in the balance of the program cost;

(3) One-half of the balance of the program cost shall be divided by the sum of the total adjusted volume of all laboratories, excluding governmental laboratories. The resulting number shall be the volume fee constant;

(4) One-half of the balance of the program cost shall be divided by the sum of the analytes for all laboratories, based on the highest number of analytes for which each laboratory held approval during the previous approval year. The resulting number shall be the analyte fee constant.

(5) The approval fee for each laboratory shall be calculated by adding:

(i) $500; and

(ii) the volume fee constant multiplied by the sum of the adjusted volume for the applicant laboratory; and

(iii) the analyte fee constant multiplied by the sum of the analytes for that laboratory.

(6) Governmental laboratories are exempted from paying that portion of the fee based on adjusted volume.

(b) An environmental laboratory, which is applying for a certificate of approval in a category in which it was not conducting tests on New York State samples prior to its application, shall pay for such approval a fee of:

(1) $500 regardless of the number of months remaining in the approval year; and

(2) An amount calculated by multiplying the analyte fee constant described in subdivision (a) by the total number of analytes within each category for which a certificate of approval is sought, prorated for the months remaining in the approval year.

(c) An environmental laboratory, which is applying for a certificate of approval in a category in which it was conducting tests on New York State samples prior to its application, shall pay an initial approval fee computed as an annual fee but prorated for the months remaining in the approval year or $500, whichever is greater. Such laboratory's adjusted volume shall not be used in recalculating a fee constant for the first approval year in which it operates.

(d) Changes in analytes or subcategories during an approval year shall not require payment of additional fees during that approval year.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.8 - Inspection fee

55-3.8 Inspection fee.

(a) Prior to any on-site inspection, an out-of-state laboratory possessing or seeking a certificate of approval shall pay an inspection fee in addition to its approval fee. The purpose of the inspection fee is to offset the additional travel costs incurred by the department in sending inspectors out-of-state. Such fees will be credited to the environmental laboratory approval fee account. The inspection fee shall consist of the following components:

(1) a transportation expense, which shall be either the actual expense if travel is by common carrier, or a mileage expense at the rate negotiated between the State and the union representing the employees scheduled to conduct the inspection; and

(2) a per diem expense as specified by the New York State Comptroller for the inspecting employees, multiplied by the number of days estimated by the department to be necessary for travel and the actual inspection.

(b) In calculating this fee, the department shall estimate the total cost of the components specified in subdivision (a) of this section and divide it equally among the laboratories inspected on any trip.

(c) In the event the department underestimates any of the above expenses, the laboratory shall pay any difference between the estimate and the actual expense.

(d) In the event the department overestimates any of the above expenses, the laboratory shall be notified of the difference between the estimate and the actual expense, and its account shall be credited that amount unless a refund is requested.

(e) Failure to pay the fee for out-of-state inspection shall result in suspension or non-renewal of the laboratory approval.
 

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Section 55-3.9 - Environmental laboratory approval program difficulty factors

55-3.9 Environmental laboratory approval program difficulty factors.

ANALYTE FACTOR

BIOLOGICAL TEST PROCEDURES

Coliform, fecal 0.3

Coliform, Total 0.3

Standard Plate Count 0.3

INORGANIC TEST PROCEDURES

Acidity 0.3

Alkalinity 0.3

Aluminum, Total 0.5

Ammonia (as N) 0.5

Antimony, Total 0.5

Arsenic, Total 0.7

Barium, Total 0.5

Beryllium, Total 0.5

Biochemical Oxygen Demand 0.8

Boron, Total 0.5

Bromide 0.8

Cadmium,Total 0.5

Calcium, Total 0.5

Carbonaceous BOD 0.8

Chemical Oxygen Demand 0.4

Chloride 0.5

Chromium, VI 0.8

Chromium, Total 0.5

Cobalt, Total 0.5

Copper, Total 0.5

Cyanide, Total or amenable to chlorination 0.8

Fluoride, Total 0.5

Gold, Total 0.5

Hardness, Total 0.2

Calcium Hardness 0.2

Hydrogen Ion (pH) 0.1

Iron, Total 0.5

Kjeldahl Nitrogen, Total 0.5

Lead, Total 0.5

Magnesium, Total 0.5

Manganese, Total 0.5

Mercury, Total 0.7

Molybdenum, Total 0.5

Nickel, Total 0.5

Nitrate (as N) 0.5

Nitrite (as N) 0.5

Nitrogen Dioxide 1.5

Nitrogen Oxide 1.5

Oil and Grease, Total Recoverable 0.8

Organic Carbon, Total 0.5

Orthophosphate (as P) 0.5

Palladium,Total 0.5

Percent Sulfur 2.0

Phenols 0.8

Phosphorus, Total 0.5

Platinum, Total 0.5

Potassium, Total 0.5

Selenium, Total 0.7

Silica, Dissolved 0.5

Silver, Total 0.5

Sodium, Total 0.5

Sulfate (as SO4) 0.5

Sulfide (as S) 0.7

Sulfite (as SO3) 0.7

Sulfur Dioxide 1.0

Surfactants 0.6

Thallium, Total 0.5

Tin, Total 0.5

Titanium, Total 0.5

Vanadium, Total 0.5

Zinc, Total 0.5

NON-PESTICIDE ORGANIC COMPOUNDS

Acenaphthene 0.5

Acenaphthylene 0.5

Acetone 0.5

Acrolein 0.5

Acrylonitrile 0.5

Anthracene 0.5

Benzene 0.5

Benzidine 0.5

Benzoic Acid 0.5

Benzo(a)anthracene 0.5

Benzo(a)pyrene 0.5

Benzo(b)fluoranthene 0.5

Benzo(ghi)perylene 0.5

Benzo(k)fluoranthene 0.5

Benzyl Alcohol 0.5

Benzyl Chloride 0.5

Benzyl Butyl Phthalate 0.5

Bis(2-chloroethoxy)methane 0.5

Bis(2-chloroethyl)ether 0.5

Bis(2-ethylhexyl)phthalate 0.5

Bromobenzene 0.5

Bromodichloromethane 0.5

Bromoform 0.5

Bromomethane 0.5

4-Bromophenylphenyl ether 0.5

2-Butanone 0.5

n-Butylbenzene 0.5 sec-Butylbenzene 0.5

tert-Butylbenzene 0.5

Carbon Disulfide 0.5

Carbon Tetrachloride 0.5

4-Chloroaniline 0.5

4-Chloro-3-methylphenol 0.5

Chlorobenzene 0.5

Chloroethane 0.5

2-Chloroethylvinyl ether 0.5

Chloroform 0.5

Chloromethane 0.5

2-Chloronaphthalene 0.5

2-Chlorophenol 0.5

4-Chlorophenylphenyl ether 0.5

2-Chlorotoluene 0.5

4-Chlorotoluene 0.5

Chrysene 0.5

Dibenzo(a,h)anthracene 0.5

Dibenzofuran 10.0

Dibromochloromethane 0.5

1,2-Dibromo-3-chloropropane 0.5

1,2-Dibromoethane 0.5

Dibromomethane 0.5

1,2-Dichlorobenzene 0.5

1,3-Dichlorobenzene 0.5

1,4-Dichlorobenzene 0.5

3,3-Dichlorobenzidine 0.5

Dichlorodifluoromethane 0.5

1,1-Dichloroethane 0.5

1,2-Dichloroethane 0.5

1,1-Dichloroethene 0.5

1,2-Dichloroethene (any isomer or total) 0.5

trans-1,2-Dichloroethene 0.5

2,4-Dichlorophenol 0.5

1,2-Dichloropropane 0.5

1,3-Dichloropropane 0.5

2,2-Dichloropropane 0.5

1,1-Dichloropropene 0.5

cis-1,3-Dichloropropene 0.5

trans-1,3-Dichloropropene 0.5

Diethyl phthalate 0.5

2,4-Dimethylphenol 0.5

Dimethyl phthalate 0.5

Di-n-butyl phthalate 0.5

Di-n-octyl phthalate 0.5

2,4-Dinitro-2-methylphenol 0.5

2,4-Dinitrophenol 0.5

2,4-Dinitrotoluene 0.5

2,6-Dinitrotoluene 0.5

Epichlorohydrin 0.5

Ethylbenzene 0.5

Ethylene Glycol 0.5

Fluoranthene 0.5

Fluorene 0.5

Formaldehyde 0.8

Hexachlorobenzene 0.5

Hexachlorobutadiene 0.5

Hexachloroethane 0.5

2-Hexanone 0.5

Indeno (1,2,3-cd)pyrene 0.5

Isophorone 0.5

Isopropylbenzene 0.5

p-Isopropyltoluene (p-Cymene) 0.5

2-Methylnaphthalene 0.5

Methylene Chloride 0.5

2-Methyl-4,6-Dinitrophenol 0.5

4-Methyl-2-Pentanone 0.5

2-Methylphenol 0.5

4-Methylphenol 0.5

Naphthalene 0.5

2-Nitroaniline 0.5

3-Nitroaniline 0.5

4-Nitroaniline 0.5

2-Nitrophenol 0.5

Nitrobenzene 0.5

4-Nitrophenol 0.5

N-Nitrosodimethylamine 0.5

N-Nitrosodi-n-propylamine 0.5

N-Nitrosodiphenylamine 0.5

2,2-oxybis(1-chloropropane) 0.5

PCB-1016 0.5

PCB-1221 0.5

PCB-1232 0.5

PCB-1242 0.5

PCB-1248 0.5

PCB-1254 0.5

PCB-1260 0.5

Pentachlorophenol 0.5

Phenanthrene 0.5

Phenol 0.5

n-Propylbenzene 0.5

Pyrene 0.5

Styrene 0.5

2,3,7,8-Tetrachlorodibenzo-p-dioxin 10.0

1,1,2,2-Tetrachloroethane 0.5 Tetrachloroethene 0.5

Toluene 0.5

1,2,3-Trichlorobenzene 0.5

l,2,4-Trichlorobenzene 0.5

1,1,1-Trichloroethane 0.5

1,1,2-Trichloroethane 0.5

Trichloroethene 0.5

Trichlorofluoromethane 0.5

2,4,6-Trichlorophenol 0.5

1,2,3-Trichloropropane 0.5

1,2,4-Trimethylbenzene 0.5

1,3,5-Trimethylbenzene 0.5

Vinyl Acetate 0.5

Vinyl Chloride 0.5

Xylene (any isomer or total) 0.5

PESTICIDES

Aldrin 0.5

Atrazine 0.5

Azinphos Methyl 0.5

alpha-BHC 0.5

beta-BHC 0.5

delta-BHC 0.5

Lindane 0.5

Captan 0.5

Carbaryl 0.5

Chlordane (any) 0.5

2,4-D 0.5

4,4'-DDD 0.5

4,4'-DDE 0.5

4,4'-DDT 0.5

Demeton-O 0.5

Demeton-S 0.5

Diazinon 0.5

Dicamba 0.5

Dichloran 0.5

Dicofol 0.5

Dieldrin 0.5

Disulfoton 0.5

Endosulfan I 0.5

Endosulfan II 0.5

Endosulfan sulfate 0.5

Endrin 0.5

Endrin aldehyde 0.5

Endrin ketone 0.5

Heptachlor 0.5

Heptachlor epoxide 0.5

Isodrin 0.5

Malathion 0.5

Methoxychlor 0.5

Mirex 0.5

Parathion methyl 0.5

Parathion ethyl 0.5

PCNB 0.5

Perthane 0.5

Strobane 0.5

2,4,5-T 0.5

2,4,5-TP (Silvex) 0.5

Toxaphene 0.5

Trifluralin 0.5

PHYSICAL TESTS OR PROCEDURES

Asbestos (PLM) 1.5

Asbestos (TEM) 5.0

Calorific Value (BTU) 1.5

Color 0.3

Density 0.3

E.P. Toxicity (extraction only) 0.3

Fibers 1.5

Ignitability 0.6

Particulates 0.3

Percent Solids 0.3

Percent Water 0.3

Reactivity 0.5

Specific Conductance 0.1

Suspended Particulates 0.3

Temperature 0.1

Total Dissolved Solids 0.3

Total Solids 0.3

Total Suspended Solids 0.3

Volatile Content 0.3

RADIOLOGICAL TEST PROCEDURES

Gross Alpha 0.5

Gross Beta 0.5

Photon Emitters 0.5

Cesium-134 0.5

Iodine-131 0.5

Plutonium 0.5

Radium-226 0.5

Radium-228 0.5

Radon (any method) 0.5

Strontium-89 0.5

Strontium-90 0.5

Tritium 0.5

Uranium 0.5

The commissioner may grant certification for additional analytes, if necessary for the protection of public health and the environment, assigning a difficulty factor commensurate with similar analytes.

Effective Date: 
Wednesday, August 8, 1990
Doc Status: 
Complete

Part 57 - Conditions Under Which A Dog Actively Immunized Against Rabies May Be At Large In Designated Areas Certified For Rabies

Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 2140

Section 57.1 - Definitions

Section 57.1 Definitions.

(a) Three-year vaccine is a rabies vaccine for dogs which the Federal government has accepted as providing three-year duration of immunity.

(b) Active Immunization, to permit a dog to be at large,* shall mean the injection of a three-year vaccine which meets the standards prescribed by the United States Department of Agriculture for interstate sale* * and has been administered by a duly licensed veterinarian not later than the expiration date on the package. Vaccines shall be administered following the directions of the manufacturer as approved by the Federal government.

___________________________________________________________________________

* FOOTNOTE: In accordance with section 2140, article 21 of the Public Health Law "at large" means "elsewhere than on the premises of the owner, except it be on the premises of another person with the knowledge and assent of such other person". An opinion from the Attorney General states a dog on leash is not "at large" within the meaning of this statute (1943, Op. Att. Gen. 290). * * FOOTNOTE: Such products have the legend, "U.S. Veterinary License No. – – " printed on all containers.

___________________________________________________________________________

(c) Certified area means an area certified by the State Commissioner of Health in accordance with section 2140 of article 21 of the Public Health Law as one in which, or in the vicinity of which, rabies exists.

(d) Designated area means an area which the State Commissioner of Health has designated as one in which dogs which have been actively immunized against rabies in accordance with the provisions in the rules may be permitted to be at large.
 

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Section 57.2 - Privilege of vaccinated dogs to run at large in a designated area

57.2 Privilege of vaccinated dogs to run at large in a designated area. The privilege of vaccinated dogs to run at large in a designated area shall not apply:

(a) to any dog until 21 days after rabies vaccination;

(b) to any dog after three years from its last vaccination against rabies with a three-year vaccine;

(c) to any dog which has been bitten by or has been in intimate contact with a rabid animal from the date of such bite or exposure until four months later, except that dogs vaccinated with a three-year vaccine within an interval of three weeks to three years prior to exposure shall be permitted to remain at large, providing a booster injection of a three-year vaccine is given within five days of exposure.* * *

(d) to any dog which has bitten a person until 10 days after such bite.* * *

* * * FOOTNOTE: See Chapter I of this Title § 2.14.

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Section 57.3 - Additional conditions to be complied with

57.3 Additional conditions to be complied with.

(a) The veterinarian administering the vaccine shall give to the owner **** of the dog a signed statement which shall give the name and address of owner, and date or dates of vaccination together with the type of vaccine injected, the amount and manner of injection, name of manufacturer, lot number, and expiration date of the vaccine.

___________________________________________________________________________

**** FOOTNOTE: Section 107 of the Agriculture and Markets Law States: "The word 'owner' includes a person harboring or keeping a dog."

___________________________________________________________________________

(b) The owner shall keep this statement readily available for inspection by official agents concerned with the control of rabies.

(c) The veterinarian administering the vaccine shall attach an indestructible tag securely to the collar of the dog indicating that the dog has been vaccinated against rabies, with the date of last vaccination marked on the tag, which shall be worn by the dog at all times, and which shall be of a size plainly visible at a reasonable distance for purposes of inspection by officials concerned, and readily distinguishable from the dog license tag.
 

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Section 57.4 - Requirements for designated area

57.4 Requirements for designated area.

(a) An area may be designated after at least 70 percent of the enumerated dogs have been vaccinated as defined in subdivision (b) of section 57.1 of this Part.

(b) An area may be designated upon receipt of a resolution from the board of supervisors of the county, requesting the State Commissioner of Health to permit all dogs vaccinated against rabies to run at large, whereupon the commissioner may grant such privilege subject to the limitations of section 57.2 of this Part and subject to the following conditions:

(1) that the board of supervisors shall have provided funds and made the necessary arrangements for giving dog owners the opportunity of having their dogs vaccinated;

(2) that every effort shall be made to permit only vaccinated dogs to run at large;

(3) that, if within four months of the date of granting this request, 70 percent or more of the enumerated dog population have not been vaccinated, the commissioner may revoke this privilege.

Designation may be revoked at any time for failure to enforce the provisions of the Public Health Law or Chapter I of this Title.
 

Doc Status: 
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Part 58 - Clinical Laboratories And Blood Banks

Effective Date: 
Wednesday, December 23, 2015
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, sections 574(1), 576; Vehicle and Traffic Law, section 1194

SubPart 58-1 - Clinical Laboratories

Effective Date: 
Wednesday, December 23, 2015
Doc Status: 
Complete

Section 58-1.1 - Permit

Section 58-1.1 Permit.

(a) Permit means a clinical laboratory or blood bank issued by the Commissioner of Health. No clinical laboratory or blood bank shall be issued a permit in a category unless:

(1) its director or assistant director holds a certificate of qualification in the category for which the permit is sought;

(2) the laboratory has been inspected and has corrected any deficiencies found; and

(3) the laboratory has successfully participated in all required proficiency examinations or remedial activities in the categories sought.

(b) A clinical laboratory or blood bank shall perform only those tests that are within the categories stated on its permit. Specimens for all other tests shall be referred to a clinical laboratory with a permit in the appropriate category. Categories of tests shall be designated according to the following procedures or specialties:

(1) one or more of the following subspecialties of microbiology: bacteriology, virology, mycology, parasitology and mycobacteriology;

(2) hematology;

(3) blood services-diagnostic immunohematology collection and/or transfusion;

(4) one or more of the following subspecialties of clinical biochemistry: clinical chemistry, blood pH and gases, endocrinology and therapeutic substance monitoring/quantitative toxicology;

(5) histopathology or one or more of the following subspecialties: dermatopathology and oral pathology;

(6) cytopathology;

(7) urinalysis;

(8) one or more of the following subspecialties of toxicology: drug analysis-qualitative, blood lead and erythrocyte protoporphyrin, forensic toxicology, and chlorinated hydrocarbons;

(9) cytogenetics;

(10) human immunodeficiency virus (HIV) testing:

(11) histocompatibility;

(12) diagnostic immunology;

(13) cellular immunology;

(14) oncofetal antigens; and

(15) other specific tests or procedures as designated by the department.

(c) In performance of laboratory procedures stated on its permit, a blood bank shall meet the appropriate requirements in Subpart 58-2 and sections 58-1.2 through 58-1.6, 58-1.9, 58-1.10 and 58-1.11 of this Subpart.

(d) A provisional permit shall be available which shall be valid for a period determined by the department to be sufficient to enable the department to assess the proficiency or lack of proficiency of the laboratory in the categories sought. The provisional permit may be renewed pending issuance or denial of a permit if initial proficiency test results are inconclusive.

(1) A clinical laboratory or blood bank initially applying for a permit may be issued a provisional permit when the laboratory meets the following conditions:

(i) a valid and complete permit application has been filed; and

(ii) application and reference fees have been paid; and

(iii) the director or assistant director holds a Certificate of Qualification in all categories sought; and

(iv) the laboratory has been inspected by the department and has provided satisfactory evidence of correction of any deficiencies found.

(2) Provisional permits shall not be available in the categories of cytogenetics-general, mycology, mycobacteriology, human immunodeficiency virus screening and/or confirmatory testing or virology.

(3) A clinical laboratory or blood bank which has failed to demonstrate its proficiency in testing specimens in a category may, after successful participation in a remediation program, including proficiency testing, be granted a provisional permit.

(4) If the director or any owner of the laboratory applying for a provisional permit has ever directed or owned a laboratory which has had its permit revoked, suspended, limited or annulled, or which has an enforcement proceeding against it pending at the time of application for a provisional permit, a provisional permit shall not be issued. Owner shall include any individual, corporation, partner or other person holding a 10 percent or more interest in the laboratory.

(5) Provisional permits may be revoked, suspended, limited or annulled, or the holder thereof may be censured, reprimanded or otherwise disciplined in accordance with the Public Health Law, including section 577 thereof.

(6) A provisional permit in a category may be converted to a permit when the laboratory has demonstrated to the satisfaction of the department its proficiency in testing specimens in that category.
 

Effective Date: 
Wednesday, May 29, 1991
Doc Status: 
Complete

Section 58-1.2 - Laboratory director

58-1.2 Laboratory director.

(a) The director shall serve the laboratory full-time, or on a regular part-time basis. Regular part-time basis shall mean assumption of full responsibility for direction and technical operation of the laboratory, including adherence to the department quality control standards and training of personnel performing the testing. If he serves on a regular part-time basis, he shall not serve as director of more than two clinical laboratories, within or outside New York State or more than one clinical laboratory and one blood bank or more than two blood banks. Where a laboratory and a blood bank are on the same premises and are under the supervision of the same director, such laboratory and blood bank shall be deemed one laboratory for the purpose of this subdivision. Notwithstanding the foregoing provisions of this subdivision, if the commissioner finds that more than two laboratories are required to serve the needs of an area and the total volume and the types of laboratory service provided by the several laboratories are not such as to require the services of more than one director, he may authorize an individual to direct more than two laboratories or blood banks or combinations thereof. Such authorization must be renewed at least every two years. The commissioner may also make an exception where the additional directorships involve only blood-holding facilities as defined in section 58-2.1(i) of this Part.

(b) Commensurate with the laboratory workload, scope and complexity of the testing procedures carried out, qualifications of onsite personnel, proximity to another laboratory under identical directorship, and availability of alternate monitoring and communications capabilities, the director shall spend an adequate amount of time in the laboratory to direct and supervise the technical performance of the staff and shall be readily available for personal or telephone consultation. The adequacy of the amount of time a laboratory director is present and in active direction shall be determined by the department based on the factors enumerated above, results of onsite inspections and proficiency testing and documentation of the director's full responsibility for direction and technical operation. Attendance records may be required to document the adequacy of the director's presence.

(c) The director shall be responsible for performance of all tests carried out in the laboratory, adherence to the department's quality assurance standards for such tests, and accurate reporting of the test results.

(d) The director shall be responsible for ensuring the employment of qualified laboratory personnel, evaluation of job performance of such personnel and their in-service training.

(e) If the director's employment terminates or he is temporarily absent, arrangements shall be made for a qualified temporary director, which arrangements must receive the prior approval of the department. An assistant director who holds a certificate of qualification to be a director of a clinical laboratory or blood bank in the appropriate category may act for the director in the director's absence, and at such time shall fully discharge the duties and responsibilities of the director.

When the director's employment terminates, for whatever reason, both the owner and the director of the laboratory, or the chief executive officer of the facility, shall notify the department in writing prior to the termination. In the case of death or physical and/or mental incapacitation of the director, the owner or the chief executive officer must notify the department within 72 hours of each event.
 

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Section 58-1.3 - Clinical laboratory supervision

58-1.3 Clinical laboratory supervision.

(a) A clinical laboratory shall have one or more supervisors who, under the general direction of the laboratory director, supervise technical personnel and reporting of findings, perform tests requiring special scientific skills, and, in the absence of the director, are responsible for the proper performance of all laboratory procedures.

(b) A laboratory director who qualifies pursuant to the provisions of section 19.2 of this Title shall also be deemed qualified as a supervisor.

(c) Depending upon the size and functions of the laboratory, the department may authorize the laboratory director to also serve as the supervisor of the laboratory.

(d) The supervisor shall be on the laboratory premises during all hours in which tests are performed. An exception to the on-premises requirement shall be applicable with respect to the performance of procedures required for emergency purposes; provided, that the person performing the test qualifies as a medical technologist pursuant to the provisions of section 58-1.5(b) of this Subpart, the results of his work are reviewed by the supervisor or director during his or her next duty period, and a record is maintained to reflect the actual review.

(e) An individual who qualifies as a supervisor pursuant to provisions of section 58-1.4(d) of this Subpart, shall supervise technical personnel in the specialty of cytology only.
 

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Section 58-1.4 - Qualifications of laboratory supervisor

58-1.4 Qualifications of laboratory supervisor. The laboratory supervisor must meet one of the following requirements:

(a) The supervisor is a physician licensed to practice medicine or osteopathy in the State of New York or an individual who has earned a doctoral degree from an accredited institution with a chemical, physical or biological science as his major subject (accredited, as used herein, refers to accreditation by a nationally recognized accrediting agency or association, as determined by the United States Commissioner of Education). The supervisor shall, subsequent to graduation, have had at least two years' experience in one of the laboratory specialties in a clinical laboratory or blood bank having a director at the doctoral level. The clinical laboratory or blood bank shall be part of a hospital, a health department, university, medical research institution, or other institution which provides equivalent training.

(b) The supervisor holds a degree of master of arts or master of science from an accredited institution with a major in one of the chemical, physical or biological sciences and, subsequent to graduation, has had at least four years of pertinent laboratory experience of which not less than two years have been spent working in the designated laboratory specialty in a clinical laboratory having a director at the doctoral level. The clinical laboratory or blood bank shall be part of a hospital, a health department, university, medical research institution or other institution which provides equivalent training.

(c) The supervisor is qualified as a medical technologist pursuant to the provisions of section 58-1.5(b) of this Subpart and has had at least six years of pertinent clinical laboratory experience subsequent to qualifying of which at least two years have been spent working in a clinical laboratory having a director at the doctoral level. The clinical laboratory or blood bank shall be part of a hospital, university, health department, medical research institution or other institution which provides equivalent training.

(d) The supervisor is qualified as a cytotechnologist pursuant to the provisions of section 58-1.5(c) of this Subpart and subsequent to qualifying, has had at least four years of pertinent clinical laboratory experience in cytotechnology in a laboratory having a doctoral level director qualified in cytopathology. The clinical laboratory shall be part of a hospital, health department, university, medical research institution, or other institution which provides equivalent training.

(e) With respect to individuals first qualifying prior to April 1, 1972, an exception to the requirements in subdivision (a), (b) or (c) of this section may be made if:

(1) the supervisor was performing the duties of a clinical laboratory supervisor at any time between July 1, 1961 and September 1, 1971; and

(2) the supervisor has had at least 15 years of pertinent clinical laboratory experience prior to September 1, 1971: provided, that a minimum of 30 semester hours of credit toward a bachelor's degree with a chemical, physical or a biological science as his major subject; or 30 semester hours in an approved school of medical technology shall reduce the required years of experience by two years, with any additional hours further reducing the required years of experience at the rate of 15 hours for one year; and

(3) he has performed the duties of a supervisor for at least two years during the qualifying 15 years in:

(i) a clinical laboratory having a director at the doctoral level, of a hospital, university, health department or medical research institution; or

(ii) in a laboratory approved under the Medicare supplementary medical insurance program, provided also, that where qualifying years in a laboratory described in subparagraph (i) of this paragraph are obtained after January 30, 1969, the laboratory meets applicable conditions under the Medicare health insurance program, or, under title 42, Code of Federal Regulations, part 74, the latter being the regulations issued pursuant to the Federal Clinical Laboratories Improvement Act of 1967.
 

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Section 58-1.5 - Duties and qualifications of clinical laboratory technical personnel

58-1.5 Duties and qualifications of clinical laboratory technical personnel.

(a) Duties of technologist. The laboratory shall employ a sufficient number of qualified medical technologists, or where appropriate, cytotechnologists, to perform proficiently under general supervision the clinical laboratory tests which require the exercise of independent judgment as follows:

(1) The medical technologists shall perform tests which require the exercise of independent judgment and responsibility, with a minimal supervision by the director or supervisor, in only those specialties or subspecialties in which they are qualified by education, training and experience.

(2) With respect to specialties in which the medical technologist is not qualified by education, training or experience, he shall function only under direct supervision and perform only tests which require limited technical skill and responsibility.

(3) Clinical laboratory technologists shall be sufficient in number to adequately supervise the work of technicians and trainees.

(4) An individual who qualifies as a cytotechnologist under subdivision (c) of this section may supervise technicians and trainees only in the specialty of cytology.

(b) Qualifications of medical technologist. A medical technologist must meet one of the following requirements:

(1) Successful completion of a full course of study which meets all academic requirements for a bachelor's degree in medical technology from an accredited college or university.

(2) Successful completion of three academic years of study (a minimum of 90 semester hours or equivalent) in an accredited college or university which met the specific requirements for entrance into, and the successful completion of a course of training of at least 12 months in a school of medical technology approved by the Council on Medical Education of the American Medical Association.

(3) Successful completion in an accredited college or university of a course of study which meets all academic requirements for a bachelor's degree in one of the chemical, physical or biological sciences and, in addition, at least one year of pertinent laboratory experience and/or training covering the specialty(ies) or subspecialty(ies) in which he performs tests, provided the combination has given the individual the equivalent in such specialty(ies) or subspecialty(ies) of the education and training described in paragraph (1) or (2) of this subdivision.

(4) Successful completion of three years (90 semester hours or equivalent) in an accredited college or university with a distribution of courses as shown below, and, in addition, successful experience and/or training covering several fields of medical laboratory work of such length (not less than one year), and of such quality that this experience or training, when combined with the education, will have provided the individual with education and training in medical technology equivalent to that described in paragraph (1) or (2) of this subdivision. Distribution of course work: (Where semester hours are stated, it is understood that the equivalent in quarter hours is equally acceptable. The specified courses must have included lecture and laboratory work. Survey courses are not acceptable.)

(i) for those whose training was completed prior to September 15, 1963: At least 24 semester hours in chemistry and biology courses of which not less than nine semester hours must have been in chemistry and must have included at least six semester hours in inorganic chemistry, and not less than 12 semester hours must have been in biology courses pertinent to medical sciences;

(ii) for those whose training was completed after September 15, 1963: 16 semester hours in chemistry courses, which included at least six semester hours in inorganic chemistry and are acceptable toward a major in chemistry; 16 semester hours in biology courses which are pertinent to the medical sciences and are acceptable toward a major in the biological sciences; and three semester hours of mathematics.

(5) With respect to individuals first qualifying prior to April 1, 1972, an exception to the requirements in paragraph (1), (2), (3) or (4) of this subdivision may be made if:

(i) the technologist was performing the duties of a medical technologist at any time between July 1, 1961 and September 1, 1971;

(ii) the technologist has had at least 10 years of pertinent clinical laboratory experience prior to September 1, 1971: provided, that a minimum of 30 semester hours credit toward a bachelor's degree from an accredited institution with a chemical, physical, or a biological science as his major subject; or 30 semester hours in an approved school of medical technology shall reduce the required years of experience by two years, with any additional hours further reducing the required years of experience at the rate of 15 hours for one year; and (iii) he has performed the duties of a clinical laboratory technologist for at least two years during the qualifying 10 years:

(a) in a clinical laboratory having a director at the doctoral level, of a hospital, university, health department or medical research institution; or

(b) in a laboratory approved under the supplementary medical insurance program: Provided also, that where qualifying years in a laboratory described in clause (a) of this subparagraph are obtained after January 30, 1969, the laboratory meets applicable conditions under the Federal health insurance program, or under title 42, Code of Federal Regulations, part 74, the latter being the regulations issued pursuant to the Federal Clinical Laboratories Improvement Act of 1967.

(c) Qualifications of cytotechnologists:

(1) have successfully completed two years in an accredited college or university with at least 12 semester hours in biology courses pertinent to the medical sciences; and:

(i) must have received 12 months of training in a school of cytotechnology approved by the American Medical Association; or

(ii) received six months formal training in a school of cytotechnology approved by the American Medical Association and six months of full-time experience in cytotechnology in a laboratory acceptable to the pathologist who directed such formal six months of training; or

(2) prior to September 1, 1971, shall have been graduated from high school, completed six months of training in cytotechnology in a laboratory directed by a pathologist or other physician recognized as a specialist in cytology, and completed two years of full-time experience in cytotechnology.
 

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Section 58-1.6 - Physical facilities

58-1.6 Physical facilities.

No specimen shall be examined unless the portion of the laboratory premises and the equipment used therein have been approved by the department as adequate for proper performance of the type of tests for which the laboratory is authorized.
 

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Section 58-1.7 - Acceptance of specimens

58-1.7 Acceptance of specimens.

(a) No establishment other than a clinical laboratory under permit shall accept specimens for the purpose of obtaining information for the diagnosis, prevention, or treatment of a disease or the assessment of a health condition. This subdivision shall not be deemed to prohibit the acceptance of specimens solely for teaching and research purposes.

(b) Except as otherwise provided in section 58-1.9 of this Subpart, a clinical laboratory shall examine specimens only at the request of licensed physicians or other persons authorized by law to use the findings of laboratory examinations in their practice or the performance of their official duties.

(1) If the request is oral, the physician or other authorized person shall submit a written request to the laboratory within 48 hours. If the laboratory does not receive the written request within that period, it shall note that fact in the record of daily accession.

(2) Other persons authorized by law to request the examination of specimens shall include but not be limited to:

(i) dentists and podiatrists, provided such examination is within the scope of practice of dentistry or podiatry;

(ii) chiropractors, provided such examination is within the scope of practice of chiropractic, as determined by the executive secretary of the State Board of Chiropractic, Cultural Education Center, Empire State Plaza, Albany, NY 12201;

(iii) physician's assistants, provided such examination is authorized by the supervising physician, and licensed midwives in accordance with their written protocols;

(iv) nurse practitioners, provided such examination is authorized under Article 139 of the State Education Law;

(v) police officers, provided such examination is incident to arrest charges for alcohol or drug impairment; and

(vi) judges ordering paternity tests under the Family Court Act.

(c) (1) A clinical laboratory under permit may operate one or more collecting or transfer stations, provided that it first obtains written approval from the commissioner for each proposed station.

(2) A collecting station is a facility, fixed or mobile, operated by a clinical laboratory under permit, for the collection, drawing and/or temporary storage of materials derived from the human body, until forwarded to the clinical laboratory for testing.

(3) A transfer station is a fixed facility or a mobile courier service, operated by a clinical laboratory under permit, for the acceptance and/or temporary storage and/or transfer of materials derived from the human body, until forwarded to the clinical laboratory for testing.

(4) A temporary collecting station is a one-time, one-site facility, operated by a clinical laboratory under permit, with the prior approval of the department, which collects, draws and/or temporarily stores materials derived from the human body, as part of a health fair, health assessment or health risk reduction program, for the purpose of screening for health risks under a general order from a licensed physician-in-charge.

(5) A temporary collecting station may perform specific tests onsite with the prior approval of the department, including approval for testing, storage, transportation, recordkeeping, and reporting protocols, provided that:

(i) all testing is performed under the active supervision of a clinical laboratory with a permit in the specific category of testing, provided that:

(a) such testing be limited to treatable diseases or those of public health significance and preventable by early detection; and

(b) the risks of erroneous results do not outweigh the benefits of testing.

(ii) the clinical laboratory can document that the testing method/technique is accurate, reliable, reproducible, and suitable for onsite use;

(iii) the clinical laboratory is responsible for adherence to all quality control/quality assurance procedures;

(iv) the physician-in-charge is responsible for assuring that participants with abnormal/at-risk results are counseled appropriately and/or referred to a physician with pertinent materials for test interpretation;

(v) procedures exist to refer for follow-up those participants without a personal physician;

(vi) the screening is conducted to ensure an orderly flow of activities so that discussion of test results, under the direction of the physician-in-charge, takes place in an area suitable for confidential counseling without distraction; and

(vii) suitable procedures for safe collection and disposal of specimens are in place.

(6) Departmental approval to operate a collecting or transfer station must be renewed annually on July 1st in conjunction with the clinical laboratory's permit. Such application for approval must include the name and address of the permit laboratory and a protocol for operation of the station and for ensuring the security and integrity of the specimens collected. The department will conduct annual inspections of collecting stations. (d) A collecting station or temporary collecting station shall:

(1) create and maintain a record of the daily accession of specimens containing the following information, except that a fixed station which accepts specimens from a mobile station may use a copy of the mobile station's accession record in lieu of creating its own for specimens provided by the mobile station:

(i) the name and address of the person from whom the specimen was taken;

(ii) the name and address or other identifier of the licensed physician or other authorized person who requested the test;

(iii) the date and hour when the specimen was taken;

(iv) the date and if the test must be performed within 24 hours, the time the specimen was received in the collecting station;

(v) the type of test requested; and

(vi) the date and hour when each specimen was forwarded to the clinical laboratory for testing;

(2) forward a copy of the accession record to the clinical laboratory together with the specimens.

(e) Collecting stations, temporary collecting stations and transfer stations shall:

(1) have on their premises an operating refrigerator which:

(i) maintains a temperature range of 4 to 10 degrees Centigrade;

(ii) is equipped with an accurate thermometer; and

(iii) shall be used exclusively for the storage of patient specimens for clinical laboratory testing;

(2) store each specimen requiring refrigeration in the refrigerator at all times until removed for forwarding to the clinical laboratory;

(3) store each specimen so as to maintain its original condition as much as possible, and assure that it will not become unsatisfactory as a patient specimen;

(4) forward specimens only to the clinical laboratory by which they are operated;

(5) transport, or arrange for the transportation of, each specimen which requires refrigeration, in a manner that will assure that its temperature will remain at between 4 and 10 degrees Centigrade until it reaches the clinical laboratory;

(6) transport, or arrange for the transportation of, all specimens not requiring refrigeration, so as to maintain their original condition as much as possible, and assure that they will not become unsatisfactory as patient specimens; and

(7) transport, or arrange for the transportation of all specimens in a manner designed to minimize the likelihood of exposing personnel or the public to any source of infection or hazard.

(f) (1) A mobile collecting station shall, in addition to complying with all requirements for fixed facilities, provide the department upon request with a monthly schedule in advance.

(2) A mobile collecting station, temporary collecting station or transfer station may use an alternative system of refrigerating specimens, provided that specimen temperatures are maintained at between 4 and 10 degrees Centigrade and the system's temperature is monitored and recorded periodically whenever in use.

(g) (1) No tests on specimens, whether human, veterinary, environmental or other, shall be performed in a collecting or transfer station, except for:

(i) the screening for glucose and/or ketones in a collecting station, which must be performed prior to the administration of glucose for a glucose tolerance test. If sugar or ketones are present, the physician ordering such a test must be advised and the collection of blood for the tests may not be performed without his or her approval. Such approval must be documented in the accession record; and

(ii) tests performed in temporary collecting stations pursuant to paragraph (c)(4) of this section.

(2) Processing of specimens in a collecting, temporary collecting or transfer station shall be restricted to the preparation of specimens for transport solely to preserve their integrity and reliability. Such preparation shall include, but not be limited to, centrifugation, separation of serum, freezing, refrigeration of specimens, and air drying, fixing and/or freezing of smears.

(h) A clinical laboratory shall, at any time when a collecting station, temporary collection station or transfer station it operates is open, permit the inspection of said station by a representative of the department.

(i) The collecting station, temporary collecting station or transfer station shall be identified by the name of the clinical laboratory. The collection station, temporary collecting station or transfer station must post conspicuously, in the waiting area or other place visible to all visitors, a sign which states:

(1) the services at the site are limited to collection of specimens and/or preparation of the specimens for transport;

(2) the name and address of the laboratory which will test the specimens; and

(3) information on billing practices, including the name and address of the establishment from which bills will originate and to which billing questions can be directed. (j) Collecting stations, temporary collecting stations and transfer stations shall be operated in such a way that no violation of article 38 of the General Business Law takes place.

(k) The aforesaid written approval of the commissioner may be revoked, suspended, limited or annulled as to any or all of the collecting stations, temporary collecting stations or transfer stations operated by a clinical laboratory under permit on proof that any one of said stations has been operated in violation of this Subpart, the Sanitary Code contained in Chapter I of this Title, or article 38 of the General Business Law. The enforcement provisions applicable to laboratory permits in subdivisions 2, 3 and 4 of section 577 of the Public Health Law shall also apply to such proceedings. In addition, in the event of a violation, the laboratory permit of the clinical laboratory operating the collecting station, temporary collecting station or transfer station may be revoked, suspended, limited or annulled pursuant to paragraph (g) of subdivision 1 of section 577 of the Public Health Law.

Effective Date: 
Wednesday, May 31, 2000
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Section 58-1.8 - Results of tests to be reported only to physicians or other authorized persons

58-1.8 Results of tests to be reported only to physicians or other authorized persons. No person shall report the result of any test, examination or analysis of a specimen submitted for evidence of human disease or medical condition except to a physician, his agent, or other person authorized by law to employ the results thereof in the conduct of his practice or in the fulfillment of his official duties. Upon request by a patient or the patient’s personal representative, clinical laboratories may provide a patient access to completed test reports that can be identified as belonging to that patient as provided in section 34-2.11 of this Title.

Effective Date: 
Wednesday, December 23, 2015
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Section 58-1.9 - Testing to be done on premises except in certain instances

58-1.9 Testing to be done on premises except in certain instances. All specimens accepted by a laboratory for specified tests shall be tested on its premises. However, specimens for infrequently performed tests or those not included within specialties or subspecialties stated on its permit or those requiring specialized equipment and skill may be forwarded to and accepted by another laboratory under permit issued by the commissioner or to a laboratory which is operated by a government agency or a nonprofit research institution or to any other laboratory approved by the department. The reports of the results of such tests shall be sent by the testing laboratory to the forwarding laboratory, except that the forwarding laboratory may authorize the testing laboratory to send the report as provided in section 58-1.8 of this Part, in which event the testing laboratory shall send a duplicate of the said report to the forwarding laboratory. Where the results of a test have been reported to it by the testing laboratory, the forwarding laboratory shall send a transcript of such report as provided in section 58-1.8 of this Part and shall indicate thereon the name of the laboratory actually performing the test. 

Effective Date: 
Wednesday, December 23, 2015
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Section 58-1.10 - Specimens: identification and examination

58-1.10 Specimens: identification and examination.

(a) Every specimen received for testing shall be numbered or otherwise appropriately identified and listed in an accession book, or another system acceptable to the department.

(b) Every tissue specimen, shall be examined and reported upon by a qualified pathologist who is certified or eligible for certification for pathologic anatomy by the American Board of Pathology or whose qualifications, in the opinion of the Public Health Council, are equivalent of such certification. Preliminary examination or "screening" of specimens for cytopathology may be made only by an individual who has had special training acceptable to the Department.

(c) A clinical laboratory or blood bank shall at any time during its regular working hours permit the inspection of its premises and records by a representative of the department and shall examine and report promptly on all specimens submitted by the department for the purpose of determining the competency of the laboratory.

(d) If the component to be tested for in a specimen is perishable, labile, or otherwise subject to deterioration, such specimen shall be tested as promptly as possible after collection. If a specimen is transported or stored, it shall be properly preserved, refrigerated, frozen or otherwise appropriately treated to maintain it in as close to its original state as is possible by then current technics.

(e) A specimen received by a laboratory shall not be tested or reported on if:

(1) the apparent condition of the specimen indicates that it is unsatisfactory for testing or that it is inappropriate for the test requested;

(2) it has been collected, labeled, preserved or otherwise handled in such a manner that it has become unsatisfactory or unreliable as a test specimen;

(3) it is perishable and the time lapse between the collection of the specimen and its receipt by the laboratory is of such duration that the test finding may no longer be reliable; or

(4) the date and, in the case of tests specified by the department, the hour when the specimen was taken by the physician or other authorized person is not furnished with the specimen.

(f) When a specimen is not tested for any of the reasons specified in subdivision (e) of this section the laboratory shall promptly notify the sender and give the reason therefor.

(g) All technical procedures employed in a laboratory shall be of proven reliability and generally accepted by leading authorities in the specialties of laboratory medicine and/or approved by the department.
 

Effective Date: 
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Section 58-1.11 - Reports and records

58-1.11 Reports and records.

(a) When requested, a laboratory shall submit reports containing such information and data concerning its technical operation as may be specified by the department. Such reports shall be signed both by the owner and director of the laboratory.

(b) Each clinical laboratory or blood bank shall have records indicating the daily accession of specimens and containing the following information:

(1) The laboratory shall have an accession system which may be a computerized accession system. It shall include:

(i) the accession number or other identification of the specimen;

(ii) the name or other identification of the person from whom the specimen was taken;

(iii) the date the specimen was received in the laboratory;

(iv) the test or tests requested for that specimen;

(v) if the request for the test was oral and, contrary to the requirements of subdivision (b) of section 58-1.7 of this Subpart, the request was not followed by a written request, a statement to that effect, provided that, in the case of a computerized accession system, such a statement may be recorded in a separate accession log;

(vi) in the event a specimen is forwarded to another clinical laboratory for tests, the name of such other laboratory, the date upon which the specimen was forwarded, the date it was tested or the result or results were reported, and the date the report of findings was received from such laboratory, provided that, in the case of a computerized accession system, such information may be recorded in a separate accession log;

(vii) a brief description of the condition of unsatisfactory specimens when received, for example, broken, leaked, hemolyzed, turbid, etc.; provided that, in the case of a computerized accession system such information may be recorded in the laboratory report required by paragraph (2) of this subdivision;

(viii) if the specimen is not received from another laboratory either:

(a) the date the specimen was tested; or

(b) the date the result was reported, provided that the testing date or dates are available upon the request of the originating physician for the same period of time specified in subdivision (c) of this section for the retention of the report, unless the information required by clause (a) or (b) is recorded in the laboratory report required by paragraph (2) of this subdivision;

(ix) the hour, if required, when the specimen was received in the laboratory, unless such information is recorded in the laboratory report required by paragraph (2) of this subdivision;

(x) the name of the licensed physician or other authorized person or clinical laboratory or blood bank submitting the specimen, unless such information is recorded in the laboratory report required by paragraph (2) of this subdivision;

(xi) where a computerized accession system is in use, hard copy (computer generated) accession records shall be available to the laboratory staff or other authorized person in the laboratory for three months from the receipt of the specimen and shall contain all information required by paragraph (1) of this subdivision to be recorded in a computerized accession system.

(2) Each clinical laboratory or blood bank shall produce a laboratory report and shall supply the original of said report to the physician or other authorized person submitting each specimen for analysis. Each laboratory shall retain a duplicate copy of the report. Pathology reports shall utilize an accepted system of disease nomenclature. Each report shall contain the following information:

(i) patient name or other identification and the name of the person or institution referring the specimen;

(ii) the result of the laboratory test or tests;

(iii) the date, and hour if required, when the specimen was originally collected by the physician or other authorized person;

(iv) the name under which the laboratory has been issued a permit and its address;

(v) any information required to be recorded by paragraph (1) of this subdivision;

(vi) reports including numerical results shall include normal values, reference intervals, or similar method for identifying abnormal values. Alternative procedures other than reporting these values on the report may be approved by the department; and

(vii) if the specimen is received from another laboratory, either the date the specimen was tested or the date the result was reported, provided that the testing date or dates are available upon request of the originating physician or forwarding laboratory for the same period of time specified in subdivision (c) of this section.

(c) All records and reports of tests performed including the original or duplicates of original reports received from another laboratory shall be kept on the premises of both laboratories and shall be exhibited to representatives of the department on request. Records listed below shall be retained by the laboratory for at least the period specified. If other New York State or Federal regulations or statutes require retention for different periods of time, the laboratory shall retain the appropriate record for the longest period applicable. Records shall be retained in their original form for a period of three months and may thereafter be stored on microfilm, microfiche, or other photographic record, or as magnetic tapes or other media in an electronic data processing system. Such records shall be adequately protected against destruction, either by archival storage of duplicated photographic or electronic medium or by other suitable means providing equivalent protection. Records which are required to be retained for more than two years may, after two years, be stored off the immediate laboratory premises, provided they can be available to the laboratory staff or other authorized person in the laboratory within 24 hours of a request for records. (1) Requests for tests shall be retained for the same period of time as required for the test results or seven years, whichever is less, except that referral information for cytogenetic cases shall be retained for six years.

(2) Accession records shall be retained for seven years.

(3) Records of quality control results shall be retained for two years.

(4) Preventative maintenance, service and repair records shall be retained for as long as the instrument remains in use, except that records of monitoring of temperature-controlled spaces shall be kept for one year.

(5) The following types of laboratory reports shall be retained for at least the period specified:

(i) tissue pathology including exfoliative cytology--20 years;

(ii) syphilis serology--negative report--two years;

(iii) cytogenetics--25 years; and

(iv) all others--7 years.

(6) Worksheets containing instrument readings and/or personal observations upon which the outcome is based shall be retained for one year.

(d) The following requirements shall apply to the retention and disposition of specimens:

(1) Specimens shall be retained so as to be accessible to the laboratory within 24 hours for at least the period set forth below:

(i) blood film--other than routine--1 year;

(ii) blood film--routine--6 months;

(iii) bacteriology slide on which a diagnosis depends--1 year;

(iv) cytology slide showing any abnormality--7 years;

(v) cytology slide showing no abnormality--3 years;

(vi) tissue block--20 years;

(vii) histopathology block--20 years;

(viii) histopathology slide--20 years;

(ix) bone marrow biopsy--20 years;

(x) cytogenetic slide--6 years;

(xi) photographic slide of cytogenetic karyotype--25 years; and

(xii) recipient blood specimens--1 week stoppered at 6~C.

(2) All specimens shall be disposed of in a manner designed to minimize the likelihood of causing infection to any member of the public or laboratory staff. The laboratory shall have a written protocol which shall be available to the department for inspection, describing its procedures for the disposal of specimens.
 

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Section 58-1.12 - Cytopathology standards and quality assurance

58-1.12 Cytopathology standards and quality assurance.

(a) Definitions.

(1) Examination means the initial review or screening of cytopathology samples by a cytotechnologist to determine if the sample is negative, abnormal or questionable, and shall include the marking of potentially abnormal cells and completion of laboratory records.

(2) Re-examination means the review of slides which have been examined or screened as normal. The selection of these slides must be made based on a protocol, available in the laboratory, which includes patient history, qualifications of the examining cytotechnologist and source of referral.

(3) Facilitating means the preparation and review of non-gynecological slides by a cytotechnologist for diagnosis by a pathologist, and shall include the marking of abnormal cells and selection of representative slides.

(4) Quality control and quality assurance mean those procedures and protocols, including re-examination, in place in the laboratory to assure consistency, reliability, documentation and accuracy of results reported, and shall include corrective actions taken in the event of laboratory error.

(5) Cytotechnologist means a clinical laboratory professional specializing in the analysis of cytopathology samples, including Pap smears, for cervical cancer and other diseases, who meets the qualifications specified by the department in section 58-1.5 of this Subpart. For purposes of the work standard in subdivision (b) below, this shall mean any person who is engaged in the initial examination of cytologic specimens. Cytopathologists who are engaged in initial examination of cytologic specimens need not register, but must maintain workload records and comply with workload standards.

(6) Cytotechnologist work standard means a limitation on the number of Pap smears (also known as gynecologic slides) and non-gynecologic slides which a cytotechnologist may examine or facilitate during a particular time period, or other limitation on the quantity, speed or manner of examination of slides by a cytotechnologist.

(7) Employ means to employ or contract with a cytotechnologist to examine cytological materials, including gynecologic and non-gynecologic slides.

(8) Part-time means working less than a seven-and-one-half or an eight-hour day for a particular employer.

(9) Clinical laboratory means a clinical laboratory licensed by the department of Health of the City of New York or by the New York State department of Health.

(10) Work day means a twenty-four hour period during which a cytotechnologist examines cytological materials for a clinical laboratory.

(11) Work month means a calendar month during which a cytotechnologist examines cytological materials, including gynecologic slides, for a clinical laboratory.

(12) Non-gynecological slide means a slide containing material obtained from other than the cervical-vaginal area. For each non-gynecologic case for which up to three slides are submitted each of the slides shall count as one toward the work standard. For each non-gynecologic case for which more than three slides are submitted, only the first three shall be counted toward the work standard.

(13) Total hours worked means the time spent during each work day at all employers examining slides and performing ancillary duties as defined in section 58-1.12(b)(3) of this Subpart. For part-time cytotechnologists, the denominator shall be based on a seven-and-one-half or an eight-hour day adjusted as described in section 58-1.12(b)(3) and (4) of this Subpart.

(b) Cytotechnologist work standard. (1) No cytotechnologist shall exceed the applicable cytotechnologist work standard. No clinical laboratory shall require, authorize, encourage or permit any cytotechnologist to exceed the applicable cytotechnologist work standard. In determining whether a cytotechnologist exceeds the applicable cytotechnologist work standard, all work performed by the cytotechnologist during a given workday shall be considered, without regard to the clinical laboratory or other person for which it was performed.

(2) Unless otherwise provided, a cytotechnologist may examine no more than eighty one-slide gynecologic cases or fifty two-slide gynecologic cases per workday. If a cytotechnologist also examines non-gynecologic slides in a given workday, the cytotechnologist's workload for gynecologic slides shall be correspondingly reduced, in accordance with written guidelines prepared by the clinical laboratory and filed with the department, so that a cytotechnologist examines no more than a combined total of one-hundred gynecologic and non-gynecologic slides per work day.

(3) If a cytotechnologist spends more than one hour per day at any laboratory performing duties not directly related to examination of slides, such as assisting in fine needle aspirations, staining and preparation of slides, quality control and quality assurance activities, reporting test results, training, continuing education and routine clerical work, the laboratory director must decrease that cytotechnologist's workload and hours spent in screening. (4) When a cytotechnologist works part-time or performs duties other than slide examination, the slide limit must be prorated using one or more of the following formulas:

(i) screening one-slide gynecologic cases:
hours worked on slides x 80 (cases)
total hours worked in a workday

(ii) screening two-slide gynecologic cases:

hours worked on slides x 50 (cases)
total hours worked in a workday

(iii) facilitating non-gynecologic cases (up to three slides):

hours worked on slides x 30 (cases)
total hours worked in a workday

(5) In no case shall the hourly rate of examination exceed 12.5 slides per hour per cytotechnologist, unless the laboratory has the department's approval to exceed this limit.

(6) The laboratory must provide rest periods and breaks as needed by the cytotechnologist.

(7) Exceptions. (i) Each laboratory shall evaluate the performance of each cytotechnologist in its employ, and establish an appropriate examination volume limitation based on the cytotechnologist's experience, documented accuracy and performance in proficiency testing, or on other reasons, including false-negative or false-positive interpretations. Under no circumstances shall this volume be exceeded, even if it is lower than the maximum work standard.

(ii) A cytotechnologist may exceed the work standard by twenty (20) percent, with the written approval of the department. The laboratory director may request such approval based on each cytotechnologist's experience, documented accuracy, including false- negative or false-positive interpretations, and a performance score in proficiency testing of not more than two (2) errors. Documentation of department approval shall be available in the laboratory, and may be revoked by the department with prior notice to the laboratory, based on a cytotechnologist's performance in proficiency testing or other evidence that the cytotechnologist's accuracy is other than acceptable. The laboratory director shall monitor the performance of each cytotechnologist and advise the department whenever approval is to be revoked based on on-the-job performance.

(iii) Cytotechnologists who qualify as supervisors under section 58-1.4 of this Subpart may re-examine up to twenty (20) slides per day in addition to the workload standard, provided the combined total number of slides does not exceed one-hundred (100), as part of the quality assurance program of the laboratory, with the prior approval of the department, based on documented accuracy, including false-negative and false-positive interpretations, and performance in proficiency testing. Such approval may be revoked, with prior notice to the laboratory, based on proficiency testing performance or other evidence that the cytotechnologist's accuracy is other than acceptable. Records shall be maintained to document the examination volume and hours worked by each cytotechnologist. (iv) The department may increase the cytotechnologist work standard beyond the level already authorized elsewhere in this section for cytotechnologists using a federal Food and Drug Administration (FDA)-approved device in the preparation or examination of cytology slides: (a)in determining whether to increase the cytotechnologist work standard with respect to a particular device, the department shall consider the following: the FDA’s approved use of the device; studies of the accuracy, reliability and appropriate use of the device; input from clinical laboratories using the device; recommendations of experts in the field of cytology and/or cytotechnology; and other relevant information as appropriate; (b) (1)the department may require a clinical laboratory wishing to exceed the cytotechnologist work standard set forth elsewhere in this section to request in writing the department’s approval. The department may also require the applicant laboratory to provide, in a form acceptable to the department, some or all of the following information regarding the device in use at the laboratory: the device manufacturer’s recommendations, if any, regarding the quantity (i.e., slide volume), speed or manner of slide examination, and the basis for such recommendations; documentation of training for each cytotechnologist using the device; each cytotechnologist’s experience using the device, including false-negative and false-positive interpretations, workload, and number of hours spent examining slides; each cytotechnologist’s performance on proficiency testing; as well as any other information as determined appropriate by the department to assess device capacity and user capability; and (2)the department shall provide written notice of the authorized work standard established pursuant to this subparagraph. The department may set a work standard in writing that applies to one or more cytotechnologists. (c)laboratories shall maintain documentation of approval pursuant to this subparagraph for a minimum of two (2) years after use of the device is discontinued; (d)if the department determines that a cytotechnologist work standard authorized pursuant to this subparagraph increases the rate of errors or compromises the reliability of results, the department shall adjust the standard as it deems appropriate and shall notify the affected clinical laboratories in writing of such change. Clinical laboratories that find the adjustment unacceptable may request only in writing that the department reconsider its determination; and (e)notwithstanding the foregoing, any cytotechnologist work standard authorized by the department pursuant to this subparagraph shall be at least as stringent as the federal standards promulgated under the federal clinical laboratory improvement amendments of nineteen hundred and eighty-eight (1988) and/or other applicable law(s).

(c) Regularly scheduled education programs, averaging two hours per month, must be provided to the cytotechnologists and records thereof maintained.

(d) Record-keeping. (1) Each clinical laboratory shall maintain records on work standards for three years, in a form approved by the department, which set forth, for each cytotechnologist employed by the clinical laboratory:

(i) the name and registration number of the cytotechnologist;

(ii) the number of hours worked by the cytotechnologist in each work day; and

(iii) the number of one-slide and two-slide gynecologic cases and non-gynecologic cases and slides examined by the cytotechnologist, as well as the total number of slides examined during each workday.

(iv) the actual hours worked, if required by the department, for any cytotechnologist working at more than one employer.

(2) Every cytopathology laboratory shall maintain, and make available to the department upon request, a calendar year workload report containing the following information for every cytotechnologist employed for any period of time during that calendar year.

(i) name of cytotechnologist;

(ii) registration number of cytotechnologist;

(iii) number of days worked and, for part-time cytotechnologists, full-day equivalent number calculated;

(iv) number of one-slide gynecologic cases read by the cytotechnologist;

(v) number of two-slide gynecologic cases read by the cytotechnologist; and

(vi) number of non-gynecologic cases read by the cytotechnologist.

(3) Every cytotechnologist shall maintain, and make available to the department upon request, a calendar year workload report containing the following information for every cytopathology laboratory in which the cytotechnologist performed screening and/or facilitating during that calendar year:

(i) name of laboratory;

(ii) identification number of laboratory;

(iii) number of days worked and, for part-time cytotechnologists, full-day equivalent number calculated;

(iv) number of one-slide gynecologic cases read by the cytotechnologist; (v) number of two-slide gynecologic cases read by the cytotechnologist; and

(vi) number of non-gynecologic cases read by the cytotechnologist.

(4) Each cytotechnologist shall maintain records on work standards for three years, in a form approved by the department, which set forth:

(i) the number of hours worked by the cytotechnologist in each work day;

(ii) the number of one-slide and two-slide gynecologic cases and non- gynecologic cases and slides examined, as well as the total number of slides examined during each work day;

(iii) the name and address of the clinical laboratory(ies) or other person(s) for whom the slides were examined;

(iv) the cytotechnologist registration number assigned by the department; and

(v) the actual hours worked at each employer, if required by the department.

(5) Records required to be maintained by clinical laboratories and cytotechnologists shall be made available for inspection and copying by the department upon request.

(6) Multiple employers. Whenever a cytotechnologist is employed by more than one clinical laboratory or other person during a work day, the cytotechnologist shall advise each clinical laboratory or person of any previous employment during the work day and the amount of work performed, to ensure that the applicable cytotechnologist work standard is not exceeded.

(e) Standards for gynecologic slides. (1) Each laboratory must establish a written protocol defining the standards to be used for determining if a slide is inadequate to test. These standards must be available in the laboratory and must be provided to each ordering physician or other practitioner.

(2) A gynecologic slide or a Pap smear shall not result in a diagnostic report if:

(i) the apparent condition of the specimen indicates that it is unsatisfactory for testing or that it is inappropriate for the test requested;

(ii) it has been collected, labeled, preserved or otherwise handled in such a manner that it has become unsatisfactory or unreliable as a test specimen;

(iii) the slide is broken to such extent that it cannot be repaired adequately so that cells are not obscured or lost; and

(iv) it contains insufficient cells or the cells are obscured by inflammation, blood, or lubricating ointment, so that an accurate diagnosis cannot be made.

(3) The laboratory shall note in the laboratory record and in the report to the physician the reason for the unsatisfactory evaluation. Such records must be available for inspection by the department. The total number of unsatisfactory smears shall be reported to the department at least annually.

(4) If a slide is unsatisfactory under this subdivision, the clinical laboratory shall have an affirmative duty to advise the collecting physician or other practitioner that the slide or specimen is unsatisfactory and request the submission of a new slide. If the inadequacy is due to collection and preservation technique, the laboratory shall offer assistance to the practitioner in collection of adequate samples, free of contamination and foreign material.

(5) As minimum clinical information, the laboratory order form must request the patient's date of onset of last menstrual period, age, previous abnormal cytology, and previous significant history.

(6) If the minimum required clinical information is not included on the order form or is otherwise unavailable, the laboratory must request this information. If the clinical information is not received, the laboratory record must be so noted and the report to the physician must state that the minimum required information was not provided.

(7) Slides from negative cases must be retained for at least five years and slides from cases with abnormalities must be retained for at least 10 years.

(8) Laboratory records must identify the cytotechnologist and/or cytopathologist who diagnosed the case.

(f) Re-examination of slides. (1) Each laboratory must establish a system for targeted re-examination of at least 10 percent of gynecologic slides determined to be not abnormal or questionable. Documentation of this system must be available in the laboratory for inspection by the department and to ordering physicians or other practitioners.

(2) Re-examination shall be based on prior cancer and other history of the patient, results of previous examinations, patient risk status as determined by the clinical physician, source of referral (i.e., practices and/or clinics with high-risk patients or high incidence or from geographical areas with high risk of disease). Re-examination shall also be performed on slides examined by new or inexperienced cytotechnologists and those determined to be in need of remediation based on proficiency testing performance. Records of this rescreening must be maintained for three years.

(3) In addition, laboratories employing more than one cytotechnologist must establish a system, which may be part of re-examination, to ensure the laboratory's consistency in examination of slides by two or more individuals or by the same individual on different occasions. Copies of the results must be maintained for three years and be available for inspection and copying by the department.

(4) All gynecologic cases which have been interpreted by a cytotechnologist as dysplasia, cervical intraepithelial neoplasia (CIN), carcinoma in situ (CIS) or malignancy and all non-gynecologic cases must be reviewed by a pathologist.

(5) Cases with abnormal findings as described in (4) above must be tracked by the laboratory and follow-up information, including results of subsequent biopsies, must be documented and available in the laboratory for twenty years.

(6) Records of recognized false-positive and false-negative cases must be maintained, including copies of subsequent biopsy reports, for twenty years, and be available to the department.

(g) Registration of cytotechnologists. (1) All cytotechnologists, as defined in this Subpart, who are employed by a clinical laboratory must register with the department on the form provided by the department.

(2) The registration application must include the name and home address of the cytotechnologist; the name and address of all locations at which the cytotechnologist is employed as a cytotechnologist, regardless of whether the site or facility is under New York State or New York City permit; the cytotechnologist's working days and hours at each facility or site; the cytotechnologist's education and experience; the cytotechnologist's Social Security number as required under section 5 of the New York State Tax Law; and other information the department may require for enforcement of this Subpart.

(3) Within 30 days of a change in home address, employer or employer address, the cytotechnologist must notify the department on the form provided by the department.

(4) The department shall advise each cytotechnologist of the assigned registration number and provide an identification card to each cytotechnologist. The registration number must be used on all records, as required by the department. The registration card must be kept by the cytotechnologist and a copy must be maintained by each employing laboratory.

(5) No clinical laboratory shall employ a cytotechnologist unless the cytotechnologist is registered under this section. If the cytotechnologist is not registered at the time of hiring, an application for registration must be made within one week of commencing employment. When a cytotechnologist is hired, resigns or otherwise is separated from the laboratory, the laboratory director must so advise the department.

(6) A cytotechnologist's registration may be revoked, denied, suspended, or annulled upon falsification of information on the registration application, falsification of laboratory workload records, termination from a laboratory for cause, or other violation of the law, rules and regulations.

Effective Date: 
Wednesday, August 9, 2006
Doc Status: 
Complete

Section 58-1.13 - General requirements for performance of anatomic pathology and cytopathology procedures

58-1.13 General requirements for performance of anatomic pathology and cytopathology procedures.

(a) Facilities.

(1) Laboratory space: (i) work areas must be clean, well-lighted and well-ventilated;

(ii) utilities (water, gas, suction, electricity) must be available, as needed;

(iii) microscopic work area(s), including space and furniture, must be conducive to high-quality performance;

(iv) cytopreparation area(s) must be separate from screening and clerical/secretarial area(s) so that personnel are protected from hazardous fumes and screening areas are free from distractions;

(v) there must be sufficient space for quality control, administrative, and clerical functions; and

(vi) storage of records and specimens must be in compliance with section 58-1.11 (c) and (d) of this Subpart.

(2) Safety precautions:

(i) health and safety precautions comparable to those required in hospital laboratories must be maintained; and

(ii) universal precautions must be enforced when liquid specimens are handled.

(3) Equipment and reference resources:

(i) there must be an adequate number of high-quality, well-maintained binocular microscopes;

(ii) preventive maintenance of microscopes and other equipment must be performed, as recommended by the manufacturer, and documented in a log book; and

(iii) a core reference library should be conveniently available on the laboratory premises.

(4) Support personnel. There should be adequate clerical and laboratory assistant personnel, whose number and type are dependent on the volume of work.

(5) Salaries. The method of compensation should not adversely affect the quality of performance. Cytotechnologists should be free from quota or other pressures that limit appropriate slide review time.

(b) Laboratory operation. (1) Specimens must be identified properly and must be accompanied by a complete test requisition containing minimal clinical information.

(2) A laboratory procedure manual describing the handling and storage of specimens from origination to final report, including collection, preservation, transportation, rescreening protocol and standards for specimens or slides, must be available in the work area.

(3) Solutions and stains:

(i) solutions and stains must be labelled to indicate concentration, expiration date, and storage requirements;

(ii) stains must be monitored daily and written records thereon maintained;

(iii) cross-contamination of specimens must be avoided. Non-gynecologic specimens must be stained separately from gynecologic specimens. Solutions must be filtered or replaced daily; particular care must be taken to filter solutions after processing body fluid specimens; and

(iv) solutions and stains must be kept covered when not in use and stored at appropriate temperatures.

(4) Microscopy:

(i) all microscopy must be performed on the laboratory premises; and

(ii) cytotechnologist functions should include evaluation of the adequacy of specimens, marking of areas appropriate for further review, and rendering of a provisional interpretation.

(c) Special requirements for histopathology, oral pathology and dermatopathology.

(1) All special stains shall be controlled for intended reactivity by the use of positive tissue sections, processed at the same time as the unknown tissue sections. Acid-fast staining procedures must include both a positive and a negative control slide.

(2) All unprocessed remnants of tissue specimens shall be retained in a fixative solution until the portions submitted for microscopy have been examined and diagnosed by a pathologist.

(3) Stained slides and paraffin blocks shall be retained for a minimum of 20 years from the date of examination.

(4) It is recommended that copies of reports be kept in numeric and alphabetic cross files. A numerical accession record satisfies the numeric file recommendation.

(5) Records must indicate the total number of blocks taken and the name of the pathologist who diagnosed the case.

(6) A duplicate copy of all reports, or the capability to reproduce the same, must be retained by the laboratory for 20 years.

(7) All slides referred for consultation must have the patient's name and other identifiers written on the label.
 

Effective Date: 
Tuesday, January 9, 1990
Doc Status: 
Complete

SubPart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sec. 3121(5)

Section 58-2.1 - Definitions

Section 58-2.1 Definitions. As used in this Subpart:

(a) Blood bank means a facility for the collection, processing, storage or distribution of human blood, human blood components or derivatives, or the performance of reinfusion procedures. A blood bank shall employ a qualified director for administrative purposes and, if blood collection is performed, a qualified medical director.

(b) Blood donation center means a fixed satellite location operated by a blood bank and used for the collection of whole blood and/or blood components.

(c) Donor or blood donor means a person who provides his/her blood or plasma for transfusion of whole blood, blood components or derivatives.

(d) Blood components means those preparations separated from a single donation of whole blood, or collected by apheresis, intended for direct use in transfusion, including, but not limited to plasma, fresh frozen plasma, plasma frozen within 24 hours after phlebotomy (FP24), red blood cells, washed red blood cells, leukocyte-reduced red blood cells, platelets, granulocytes and cryoprecipitate, but does not include lymphocytes collected from a donor of hematopoietic progenitor cells, as defined in Subpart 58-5.

(e) Derivatives means those preparations separated from plasma derived from multiple donors, including but not limited to albumin, immune globulin, plasma protein fraction and clotting factor concentrates.

(f) Blood products means whole blood, blood components or derivatives.

(g) Plasmapheresis means the withdrawal of blood to obtain plasma with subsequent or simultaneous reinfusion into the donor of his/her own red blood cells.

(h) Serial plasmapheresis program means a program of individual donor donations on a regular basis by plasmapheresis yielding three liters or more of plasma per consecutive four-week period.

(i) Cytapheresis means the separation and collection of blood cells or other formed elements by hemapheresis for the purpose of obtaining a transfusable blood component.

(j) Intraoperative blood recovery means recovery of blood from a surgical field and processing of recovered blood for direct reinfusion, storage or infusion into a cardiopulmonary bypass pump. Intraoperative blood recovery does not include performance of perioperative normovolemic hemodilution procedures. Postoperative blood recovery means recovery of blood from a wound following surgery, and processing of recovered blood for direct reinfusion or storage. Intraoperative blood recovery was formerly termed intraoperative blood salvage.

(k) F.D.A.means the Food and Drug Administration of the United States Department of Health and Human Services.

(l) Limited transfusion service means a facility, home care services agency, physician's office, or other entity which administers blood or blood components, and may temporarily store blood or blood components, and distribute them within its own organization, but relies on a blood bank holding a permit in blood services-transfusion to perform laboratory tests required under section 58-2.17 of this Subpart.

(m) Distribution facility means a facility at which blood and blood components are temporarily stored prior to distribution.

(n) Transfusion service means a service that issues blood or blood components for administration into a person, but does not include a limited transfusion service or an ambulance transfusion service.

(o) Institution means a hospital or other facility operating a transfusion service under a permit issued by the department.

(p) Allogeneic collection means the removal and storage of blood or blood components from a donor for transfusion into another person, and includes blood donated for directed donation to another person, or donated for autogeneic use and subsequently crossed-over in whole or in part for use by others. Allogeneic collection was formerly termed homologous collection.

(q) Autogeneic collection means the removal and storage of blood or blood components from a donor for subsequent reinfusion into that same person, and includes preoperative hemodilution procedures if at any time the blood leaves the operating room in which surgery is performed. Autogeneic collection was formerly termed autologous collection.

(r) Directed donation means an allogeneic collection in which blood from a particular donor is designated for use by a specified recipient.

(s) Medical director means a qualified physician who is employed by a blood bank, and is responsible for donor selection and safety.

(t) Department means the New York State Department of Health.

(u) Reinfusion procedure means the withdrawal of blood or a component thereof from a patient, its processing and administration of the product so obtained, in whole or in part, into the same patient for diagnostic or therapeutic purposes. Such processing may include, but is not limited to, separation ( e.g.into platelet-rich plasma or fibrin glue), radioisotopic tagging, and genetic and immunologic manipulation. Reinfusion procedures shall not include presurgical autogeneic collection, normovolemic hemodilution, intraoperative blood recovery or postoperative blood recovery.

(v) Normovolemic hemodilution means the collection of blood prior to surgery, and includes fluid replacement and reinfusion during or after surgery for purposs of reducing red cell loss during surgery.

(w) Limited reinfusionservice means a facility, home care services agency, physician's office or other non-hospital entity that performs reinfusion procedures.

(x) Clinical laboratory technician means a clinical laboratory practitioner who performs clinical laboratory procedures and examinations, pursuant to established and approved protocols of the department, which require limited exercise of independent judgment, and are performed under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory.

(y) Clinical laboratory technologist means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department, performs clinical laboratory procedures and examinations and any other tests or procedures conducted by a clinical laboratory, including maintaining equipment and records, and performing quality assurance activities related to examination performance, which require the exercise of independent judgment and responsibility.

(z) Health care provider, for the purposes of this Subpart, means a physician, physician assistant or nurse practitioner.

(aa) Nurse practitioner means a registered professional nurse licensed and currently registered, under the Laws of the State of New York, to diagnose illness and physical conditions, and perform therapeutic and corrective measures, in accordance with a collaborative agreement with a physician qualified to collaborate in the specialty involved.

(ab) Physician means an allopathic or osteopathic physician licensed and currently registered, under the Laws of the State of New York or in the state of practice, to practice medicine.

(ac) Physician assistant means a person licensed and currently registered, under the Laws of the State of New York, to practice medicine under the supervision of a physician.

(ad) Physician designee means a physician designated by the medical director to be responsible for one or more routine or special tasks.

(ae) Ambulance transfusion service means an ambulance service certified by the department that administers blood components during transport from one hospital to another hospital.

(af) Hospital, for the purposes of this Subpart, means a general hospital.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.2 - Qualifications of donors

58-2.2 Qualifications of donors.

(a) The medical director shall be responsible for the determination that blood may be collected safely from a donor and that the donor's blood is acceptable for collection. This determination shall be made by the medical director or trained staff members under the medical director's supervision on the day of collection of the blood. In addition, autogeneic collections prior to anticipated surgery or other medical procedure shall require the written authorization of the donor's health care provider and written consent of the donor. If autogeneic blood is to be subsequently used for allogeneic transfusion, all requirements in subdivision (f) of this section must be met.

(b) Only those persons may be accepted as donors of blood for allogeneic use who are in good health as indicated by:

(1) freedom from infectious skin lesions at the phlebotomy site and from any infectious skin disease generalized to an extent that creates a risk of contamination of the blood;

(2) freedom from any disease transmissible by blood transfusion, insofar as can be determined by history and examinations required in this Subpart;

(3) freedom from active tuberculosis. A person with a history of tuberculosis may be accepted as a blood donor following completion of drug therapy;

(4) freedom from syphilis. However, blood for plasma fractionation into heat-treated or pathogen-inactivated derivatives may be accepted;

(5) freedom from a history of viral hepatitis for a duration specified by the United States Public Health Service;

(6) freedom from a history of malaria or travel to or residence in malarially endemic areas for periods of time considered to increase risks for malaria exposure, as determined by the United States Public Health Service. However, plasma for transfusion fractionation may be accepted from donors with a history of malaria or travel to a malarially endemic area;

(7) freedom from signs and symptoms of human immunodeficiency virus (HIV) infection; and

(8) freedom from other medical contraindications.

(c) For allogeneic collection, a person may not be accepted as a blood donor:

(1) whose health may be affected adversely by the bleeding;

(2) who has received a transfusion of blood or blood components within the past year, with the exception of autogeneic transfusion;

(3) who is under 17 years of age, except that donors who are 16 years of age may be accepted, if they have presented written permission specific to the occasion from a parent or guardian;

(4) who is 76 years or older, except that donors who are 76 years or older may be accepted after satisfactory case-by-case review of the donor by the medical director or his/her designee;

(5) who is known to use or presents indications of having used illegal injectable drugs;

(6) whose oral temperature exceeds 37.5 degrees Celsius (99.5 degrees Fahrenheit);

(7) whose pulse after resting is faster than 110 or slower than 45 beats per minute, except if the donir is an athlete with high exercise tolerance; or whose pulse exhibits pathologic irregularities;

(8) whose systolic blood pressure exceeds 180 millimeters of mercury, or whose diastolic pressure exceeds 100 millimeters;

(9) whose weight is less than 50 kilograms (110 pounds), except that a donor whose weight is between 40 kilograms (88 pounds) and 50 kilograms (110 pounds) may donate a volume proportionate to the donor's weight, provided that the anticoagulant is proportionately reduced and the container is appropriately labeled;

(10) whose hemoglobin content is less than 12.5 grams per deciliter or whose hematocrit is less than 38%, as determined by techniques found by the department to meet medical standards generally accepted in New York State;

(11) who is known ever to have received pituitary-derived human growth hormone; or

(12) who falls into a category of individuals determined by the United States Public Health Service to be unsuitable for blood donation.

(d) For allogeneic collection:

(1) All donors shall be given educational materials on risk activities for HIV infection and shall be advised that persons at risk for HIV infection should refrain from donating blood.

(2) Each donor shall be provided the opportunity to indicate confidentially, at the time of donation or after donation, that blood collected may be unsuitable for transfusion.

(e) For autogeneic collection only:

(1) There are no age limits.

(2) The hemoglobin concentration of the donor-patient should be no less than 11 grams per deciliter, or the hematocrit, if substituted, should be no less than 33 percent, unless otherwise approved in writing by the medical director of the blood bank or other physician designated by such medical director.

(3) The frequency of phlebotomy for autogeneic transfusion shall be determined by the medical director of the blood bank and the donor-patient's physician. Phlebotomy of the donor-patient within 72 hours of the time of the anticipated surgery or transfusion must be authorized in writing by the medical director or other physician designated by the medical director.

(4) Donation for autogeneic transfusion should not be undertaken if medically contraindicated.

(f) Blood withdrawn for autogeneic transfusion may not be used for allogeneic transfusion unless the donor meets all the criteria set forth in subdivision (b), and paragraphs (c)(2), (5) and (6) of this section, and the unit meets the requirements set forth in section 58-2.3(a) of this Subpart. The minimum hemoglobin concentration for such a unit shall be 12.5 grams per 100 milliliters or a hematocrit of 38 percent, and the minimum volume for such a unit shall be 405 milliliters.

(g) Blood withdrawn in order to promote the health of a donor otherwise qualified under the provisions of this section shall not be used for transfusion unless the container label indicates the donor's disease that necessitated withdrawal of blood, except that, in the case of a donor with hemochromatosis, blood without such labeling may be used for transfusion, provided that the blood bank has demonstrated that therapeutic phlebotomy is available free of charge to hemochromatosis patients and that all other requirements of this Subpart have been met.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.3 - Required laboratory tests for donated blood

58-2.3 Required laboratory tests for donated blood.

(a) For allogeneic collections under New York State permit, approved tests for syphilis; hepatitis B surface antigen (HBsAg); HIV-1 and hepatitis C virus (HCV) nucleic acid; and antibodies to hepatitis B core antigen (anti-HBc), HCV, HIV-1, HIV-2, and human T-lymphotropic virus types I and II (HTLV-I/II) shall be performed in a New York State-permitted laboratory. For autogeneic collections, such testing shall be performed unless the blood is intended for transfusion at the same facility where it is collected and a system is in place to ensure correct disposition of each blood unit, but the testing need not be performed again if already performed within the previous 30 days or if performed on a specimen collected subsequently. Results of a given test run shall not be accepted and reported if results of test kit controls are outside of the predetermined acceptable range. A written report shall be received thereon prior to the release of blood or blood components for transfusion and, if serologic tests are positive, shall preclude release for allogeneic transfusion except as described in section 58-2.9(b) of this Subpart. Until such testing is completed, all blood and blood components shall be stored in a separate refrigerator or prominently labeled separate area of the refrigerator reserved for quarantined units. However, in an emergency requiring release for transfusion prior to receipt of such report, the results shall be recorded subsequently on the recipient’s chart. Any unacceptable blood unit identified, as well as all of its components, shall be removed immediately from the quarantine area and disposed of or moved to a separate area reserved for such units. Units unacceptable for transfusion, which are retained for other purposes, shall be labeled with pertinent test results.

(b) All test runs for required tests for infectious disease markers that generate numeric readings shall include a weakly reactive control . If the results of this weakly reactive control or any other control do not fall within the predetermined acceptable range, results from that run shall not be reported until the run is repeated. Results of all tests shall be verified by a second staff member to preclude errors in transcription or interpretation. In a manual system, examination of the original instrument tape shall be conducted by the second staff member. Except for results of tests performed on samples from autogeneic donors, as specified in section 58-2.23 of this Subpart, incomplete test results shall not be reported to donors, including any initially reactive test results not yet repeated in duplicate. Release of blood units from quarantine shall be based on examination of a signed and verified hard copy, or electronic equivalent, of all test results. The director of the laboratory conducting the testing shall be responsible for ensuring that testing is performed in accordance with this Subpart. The blood bank director shall be responsible for development of algorithms for test result interpretation and shall approve, in writing, the laboratory procedures to be used.

(c) Plasma collected for fractionation purposes only need not be tested for HTLV-I .
(d) If platelets are donated by the infant's mother to an infant with alloimmune neonatal thrombocytopenia, the donor's blood need not be tested as required in subdivision (a) of this section. In such case, the donor requirements specified in section 58-2.2 of this Subpart may also be waived with the written authorization of the medical director of the blood bank or physican designee.
(e) If multiple patient-dedicated blood components are donated by a single donor to support a particular patient, that donor's blood may be screened for all analytes specified in subdivision (a) of this section every 30 days, rather than at each donation. If the clinically useful shelf life of a blood component precludes completion of the required testing prior to component expiration, screening for all analytes specified in subdivision (a) of this section may be performed on a donor blood specimen collected prior to the donation, as permitted by the F.D.A.
(f) For both allogeneic and autogeneic collection, the ABO and Rh groups of every donor shall be determined in accordance with procedures approved by the department. The determination shall be made by:
(1) testing the blood cells with anti-A and anti-B grouping sera; testing the serum or plasma from the blood with known group A and group B red blood cells; and
(2) testing the blood with anti-Rh(o) (anti-D) grouping serum, including, in the case of initially negative testing with anti-Rho (anti-D), a method designed to detect weak D.

(g) For allogeneic collection, required tests for detecting unexpected alloantibodies:
(1) All donor blood shall be tested for unexpected alloantibodies using reagent red blood cells that meet F.D.A. standards and are intended for this purpose.
(2) Methods of testing for alloantibodies shall be those that demonstrate sensitizing and hemolytic antibodies.
(h) Errors or accidents in collecting, testing or processing of donor blood that are not detected prior to distribution and that may affect the safety of any product or health of the donor or recipient shall be reported to the department's Wadsworth Center within seven (7) calendar days of such an error or its discovery and, if required, to federal authorities.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.4 - Collection of blood

58-2.4 Collection of blood.

(a) Collection of blood for transfusion shall be performed under the direction of the medical director. Medical services for emergency care of the donor shall be available. Blood for transfusion shall be collected only on the premises of a blood bank, at a blood donation center approved by the department, in a self-contained blood collection vehicle operated by a blood bank, or at a temporary collection operation conducted by a blood bank. Each blood bank shall inform the department, upon request, of the location of all blood collection activities and the provisions made for the handling of medical emergencies. Prior to collection of blood for testing, a signed form must be obtained from the donor or person legally authorized to consent on behalf of such donor, in which the donor or the person legally authorized to consent acknowledges that he/she has been provided with written materials stating that HIV testing for donor screening purposes shall be performed in conjunction with all donations.

(b) Quantity limitations. Allogeneic and autogeneic donors may give a maximum of 550 milliliters of whole blood in addition to pilot samples sufficient for all testing to be performed.

(c) Frequency limitations. No allogeneic blood donor may donate more than 550 milliliters of whole blood within an eight-week period, unless approved to do so by a physician who examines the potential donor at the time of the proposed second donation. In no event may an allogeneic blood donor donate more than twice within a 16-week period. The foregoing prohibition on donations does not apply to allogeneic blood donors diagnosed with hemochromatosis. For autogeneic collections, the frequency of donation shall be as specified in section 58-2.2(e)(3) of this Subpart. (d) Persons collecting blood for transfusion shall be trained, under the direction of the medical director, to recognize donor reactions. Whenever donor collection procedures are performed, a nurse or other qualified person specially trained to recognize and address donor reactions shall be immediately available, and a physician shall be available by telephone for consultation.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.5 - Sterilization of instruments

58-2.5 Sterilization of instruments.

For both allogeneic and autogeneic transfusions, syringes, needles, lancets, or other blood-letting devices capable of transmitting infection from one person to another, shall either be licensed by the F.D.A. for single use or be heat-sterilized prior to each use. Heat sterilization shall be by autoclaving at 121.5 degrees Celsius for 15 minutes after the chamber of the autoclave has been evacuated and has reached that temperature, or by dry heat for two hours at 170 degrees Celsius or by such other procedure as may be approved by the department.
 

Effective Date: 
Wednesday, October 6, 1993
Doc Status: 
Complete

Section 58-2.6 - Collection and handling of blood for subsequent allogeneic or autogeneic transfusion

58-2.6 Collection and handling of blood for subsequent allogeneic or autogeneic transfusion.

(a) Phlebotomy apparatus and blood containers shall be clean, pyrogen-free and sterile. Anticoagulants shall be placed in containers prior to sterilization.

(b) Phlebotomy sites shall be prepared by a procedure found by the department to meet medical standards generally accepted in New York State.

(c) Blood collection systems shall meet the following minimum requirements:

(1) Blood shall be collected under aseptic conditions using an approved closed system or a vented system if adequately protected against contamination.

(2) Anticoagulant solutions shall be sterile and pyrogen-free. F.D.A.-approved formulae such as anticoagulant citrate dextrose (ACD) (21-day storage), citrate phosphate dextrose (CPD) (21-day storage), trisodium citrate (48-hour storage), heparin (48-hour storage), citrate phosphate dextrose adenine-1 (CPDA-1) (35-day storage), and other safe and effective formulae and storage periods, of such length as to assure the blood's continued effectiveness for transfusion and retention of its safety, purity and potency, as approved by the department, may be employed.
(d) Blood in transit shall be refrigerated at one to 10 degrees Celsius, preferably at four to six degrees Celsius, with the exception of units from which platelets will be separated, which may be stored at room temperature. (e) Labeling requirements. (1) For allogeneic collection, the container and the attached pilot blood specimens shall be legibly labeled at the time of collection with the associated unit’s identification code. The container label shall indicate the date of expiration. As soon as available, the results of ABO and Rh grouping tests shall be affixed to component containers. (2) With the exception of units collected in an operating room which never leave the immediate proximity of the patient, for autogeneic collection, the following information shall appear on a label or tag attached to the blood container: ( i) the identification of the collecting facility; ( ii)the patient's name and if available, the name of the hospital or limited transfusion service where the patient is to be transfused and the patient's birth date or identifier. This tag shall be removed if the unit is subsequently used for allogeneic transfusion; ( iii) ABO and Rh group; ( iv)date of expiration; ( v) if the unit does not qualify for allogeneic transfusion, a prominent label to read “For autologous use only" or similar wording; ( vi) an autogeneic unit from a donor who has tested positive or reactive on any of the tests required in section 58-2.3(a) of this Subpart, with the exception of anti-HBc, within the previous 30 days shall be labeled as a biohazard unless confirmatory testing has been negative. The exterior of the shipping container shall not contain any information identifying the donor; and ( vii) a label bearing the donor classification statement "Autologous donor" shall be permanently affixed to the unit.

(f) The blood shall be collected in the manner appropriate for the container employed. Following collection, the container shall be sealed securely. If a container is opened or entered in any way, the blood component must be transfused within 24 hours or discarded, unless a sterile connecting device which maintains a functionally closed system has been utilized for entry.
(g) Until issued, whole blood and red cell components shall be stored continuously in a refrigerator either with a fan for circulating air, or of a capacity and design to ensure that the proper temperature is maintained throughout, and equipped with automatic temperature recording and an audible alarm. Periodic verification of alarm function, in accordance with the manufacturer’s recommendations, shall be documented. Storage shall be at one to six degrees Celsius. No items other than specimens, tissue, or reagents shall be stored in a refrigerator in which whole blood and red blood cell components are stored. Temperature records shall be available for inspection for at least five years. Autogeneic units shall be stored in a separate, specifically designated portion of the refrigerator.

(h) Until issued, cryoprecipitate, fresh frozen plasma, FP24, and cryoprecipitate-poor plasma shall be stored continuously at a temperature not higher than minus 18 degrees Celsius for up to one year or, with F.D.A. approval, at a temperature not higher than minus 65 degrees Celsius for up to seven years, in a freezer equipped with automatic temperature recording and an audible alarm. Periodic verification of alarm function, in accordance with the manufacturer’s recommendations, shall be documented. Such frozen components shall not be relabeled as different components and released for transfusion, but may be used for fractionation into derivatives. After thawing, plasma shall be transfused immediately or stored at one to six degrees Celsius. Cryoprecipitate intended for factor VIII replacement shall be transfused within six hours after thawing. Freezer temperature records shall be available for inspection for at least five years.

(i) Until issued, platelets shall be stored at 20 to 24 degrees Celsius and shall be continuously rotated on a rotator designed for such use. Temperature records shall be available for inspection for at least five years.

(j) Until issued, frozen red blood cells shall be stored at a temperature not higher than minus 65 degrees Celsius in a freezer equipped with automatic temperature recording and audible alarm, or in liquid nitrogen. Liquid nitrogen levels must be mechanically or visually monitored daily. Periodic verification of alarm function, in accordance with the manufacturer’s recommendations, shall be documented. Storage time shall not exceed ten years. Freezer temperature or liquid nitrogen level records shall be available for inspection for at least five years. After thawing, red blood cells shall be transfused or refrozen within 24 hours or discarded, unless deglycerolized using a closed system that allows a 14-day expiration date, as approved by the F.D.A. If a refrozen unit is subsequently rethawed and deglycerolized, a notation indicating such previous thawing and deglycerolizing shall be made on a label or tag attached to the blood unit, or on accompanying paperwork.

(k) Whenever blood is irradiated, a protocol for such irradiation, , approved by the director of transfusion services or the director of the blood bank, must be followed. Maintenance and operation of blood irradiators must conform to the manufacturer's instructions. Whenever irradiation of blood is medically indicated because of a blood relationship between donor and recipient, such irradiation shall be performed by the blood bank collecting the blood unless the hospital notifies in writing the facility collecting the blood that the hospital will be responsible for irradiation, in which case such blood shall be identified as requiring irradiation on a tag or paperwork accompanying the units. Blood that has been irradiated shall be identified as "Irradiated" on label or tag attached to the unit.

(l) Fresh frozen plasma, cryoprecipitate, FP24 and frozen red blood cells shall be thawed only in a water bath at a temperature not exceeding 38 degrees Celsius, with entry ports protected from water contamination by positioning or a protective overwrap, or in another device specially designed for such thawing. If a water bath is used for thawing, its temperature shall be recorded each day of such use. Temperature records shall be available for inspection for at least five years. Maintenance and operation of all equipment for processing or preparation of blood components shall conform to the manufacturer's instructions and shall follow a protocol approved by the director of transfusion services.
(m) Except for blood recovered intraoperatively or postoperatively, or collected for use in a reinfusion procedure, all blood intended for transfusion shall, upon collection, become the responsibility of the blood collection service. Disposition of blood collected by phlebotomy shall be at the discretion of the director of the collection service until the blood is transferred to a transfusion service, at which time its disposition shall be at the discretion of the director of transfusion services. The director of the blood bank shall ensure that during any transport blood is packed and handled appropriately, and only by authorized individuals. No directed or autogeneic blood unit or component shall be transported to a transfusion service unless the director of the receiving transfusion service or his/her designee has authorized such transport. A transfusion service which has granted standing authorization for receipt of blood shall be given specific notice prior to each shipment. Disposition of blood recovered intraoperatively or postoperatively shall be at the discretion of the intraoperative or postoperative blood collection service, unless the blood is transferred to the hospital blood bank for storage, at which time its disposition shall be at the discretion of the director of transfusion services. Blood banks shall not release blood or blood components intended for transfusion to any site or entity in New York State not holding a department permit as a collection service or transfusion service, or approved by the department as a limited transfusion service or an ambulance transfusion service.

(n) The premises, equipment, procedure manuals, records, circulars of information, and all blood, blood components and derivatives shall be available for inspection, review and approval by the department during normal business hours.
 

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.7 - Immunohematology testing

58-2.7 Immunohematology testing.

(a) Blood specimens intended for pre-transfusion testing shall be labeled at the patient’s side at the time of collection. Such labeling shall include the patient’s name, patient’s identification number, and date of collection. Identification of the person collecting the specimen shall be recorded. (b) All tests, including, but not limited to, ABO and Rho(D) grouping, antibody detection and identification, and compatibility testing, shall employ methods, techniques or procedures which have been approved or recommended for the particular reagent in use by the F.D.A. or the American Association of Blood Banks, and which have been demonstrated to be effective in a manner acceptable to the department in conformance with generally accepted laboratory principles. All grouping antisera, reagents, devices, methods, and procedures for blood unit processing or transfusion-related testing shall be approved by the F.D.A. or conform to the recommended minimum requirements of the F.D.A.

(c) All reagents shall be stored in labeled containers under conditions appropriate for each reagent as directed by the manufacturer and shall be removed from use after their expiration date. The reactivity and specificity of each reagent shall be determined whenever a new lot is employed. All methods shall conform to manufacturers' instructions unless otherwise approved by the department. (d) Negative controls run on each day of use are not required for anti-human globulin and antibody screening cells, provided manufacturers’ instructions are followed. New lots of reagents shall be thoroughly evaluated, but antibody identification cell panels need not be tested with a known antibody. All test procedures to be used shall be determined by the blood bank director and shall be documented in the standard operating procedure manual. If no negative reactions are observed on a given test run, an investigation shall be performed and controls run. All quality control records shall be retained for five years.

(e) Centrifuges used for testing of red blood cell agglutination shall undergo revolutions per minute (RPM) and timer checks quarterly. Functional calibration that determines optimal centrifugation conditions shall be performed prior to initial use, after adjustments or repairs, and at least annually thereafter, and shall be documented. The procedure shall specify the speed and duration of centrifugation to be used. A microscope shall be located in the work area designated for immunohematology testing, if use of a microscope is specified by the facility’s standard operating procedure manual or by a test kit manufacturer’s package insert. Microscopic examination shall be performed for red blood cell agglutination tests whenever indicated for the procedure in use.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.8 - Standard operating procedures

58-2.8 Standard operating procedures.

(a) Current standard operating procedure manuals or other procedural guides specific to the facility shall be available at all times in the immediate work area of personnel engaged inthe collection, processing, testing, storage, distribution and administration of blood, blood components or derivatives for autogeneic or allogeneic use, and for therapeutic, prophylactic or diagnostic purposes. There shall be a written protocol for all procedures performed at the facility. Manuals shall contain a protocol for writing, maintaining and periodic review of standard operating procedures by user personnel and management staff. Procedure manuals shall have the following features:

(1) a standardized format;

(2) a system of numbering and/or entitling individual procedures;

(3) a clearly written description of purpose for each procedure;

(4) a reference section listing appropriate scientific literature;

(5) clearly defined areas of personnel responsibility by title;

(6) documented approval of procedures and procedural modifications by the director, and annual review by the director or authorized supervisor;

(7) instructions for the completion of reports and forms, including examples;

(8) effective date and date of review for each procedure; and

(9) a system of archiving earlier versions of procedures and forms.

Discontinued procedure documents and forms shall be retained and be available for inspection for at least seven years. Dates of initial use and discontinuance shall be recorded.

(b) The standard operating procedure manual shall include a written procedure for documenting errors or accidents in collection, testing, processing, storage or distribution that may affect the safety or purity of any product, or health of the donor or recipient. All such errors and accidents not detected prior to product distribution shall also be reported to the department's Wadsworth Center within seven (7) calendar days of discovery and, if required, to federal authorities.

(c) The standard operating procedure manual shall include written policies and procedures regarding the following, for activities performed at the site:

(1) use and maintenance of blood warming devices;

(2) type of infusion sets and filters for all components;

(3) issuance of components, which must include visual inspection prior to issuance;

(4) type of personnel authorized to issue components;

(5) for collecting facilities, obtaining blood or components from other institutions during emergency situations;

(6) all transfusion-related testing, prenatal testing, and neonatal testing;

(7) prompt evaluation of reported transfusion reactions and other adverse events;

(8) emergency release of uncrossmatched blood, which must include compatibility testing performed after release;

(9) method validation requirements;

(10) professional qualifications of personnel who may collect blood specimens for pretransfusion testing;

(11) specimen and labeling requirements for pretransfusion samples;

(12) release of blood and blood components to limited transfusion services and ambulance transfusion services; and

(13) administration of blood components, including prevention of transfusion reactions.

(d) The policies and procedures specified in the standard operating procedure manual shall be followed at all times. If deviations are identified, appropriate corrective action shall be taken and documented.

(e) The blood bank director or the director of transfusion services shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of standard operating procedures in the performance of blood bank and transfusion service activities. Included in the program shall be a system for designing and implementing corrective action for any problems identified. Quality assurance deficiencies shall be documented, and evidence shall be available that problems are reported to the appropriate individuals in a timely manner and that corrective action is implemented and subsequently followed-up.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.9 - Issuance of blood, blood components and derivatives

58-2.9 Issuance of blood, blood components and derivatives.

(a) Unless they are needed to meet a medical emergency, blood and blood components shall be transported in a leak-resistant, crush-resistant and puncture-resistant container featuring a prominent label which:

(1) identifies the contents as "human blood" or "biomedical product";

(2) describes the contents, the packing agent, if any, and any special precautions necessary in handling such blood; and

(3) contains the name, address and twenty-four hour telephone number of the person or entity to be contacted in the event that the container is found to be leaking or damaged, or to have been misdirected.

(b) Except in an emergency or except as indicated in section 58-2.3(c) or (d) of this Subpart, blood and blood components shall not be made available for allogeneic transfusion, unless a donor blood sample reacts negatively to tests required in section 58-2.3(a) of this Subpart, and testing specified in section 58-2.3(f) of this Subpart has been completed. Untested or incompletely tested blood, including blood from directed donations and cytapheresis collections, shall not be issued if a fully tested blood component is available, except in the case of autogeneic donations, as specified in section 58-2.3(a) of this Subpart. Cytapheresis units for which testing has not been completed may be distributed to a hospital by the facility collecting the units, but such components may not be issued by a transfusion service until testing is complete, except in the case of a life-threatening emergency or when the clinically useful shelf life of the component precludes completion of testing prior to issuance. The release of cytapheresis components from a donor found to have a positive result for anti-HBc may be permitted upon the authorization of the health care provider ordering the transfusion and the written authorization of the medical director or designee who is a physician, provided that such authorization documents the indication and justification for such release. Such components shall be labeled with all positive test results. Blood from a donor whose blood specimen reacts positively in testing for syphilis and is nonreactive in confirmatory testing shall be appropriately labeled and may be used for plasma fractionation. Blood from a donor whose blood specimen reacts positively in testing for anti-HBc shall be appropriately labeled and may be used for plasma fractionation. Blood from a donor whose blood specimen reacts positively in testing for HBsAg, HIV nucleic acid, HCV nucleic acid, or antibodies to HCV, HIV-1, HIV-2, or HTLV-I/II shall be appropriately labeled and may not be used for allogeneic transfusion or for fractionation. Blood from a donor whose blood specimen reacts positively in testing for HBsAg, HIV nucleic acid, HCV nucleic acid, or antibodies to HCV, HIV-1 and/or HIV-2 may not be used for autogeneic transfusion without the written authorization of the patient’s physician and, if drawn by another facility, the director of the transfusion service receiving the unit.

(c) Blood, blood components and derivatives shall be issued only if ordered by a licensed physician or other person authorized by law. Recipients shall receive whole blood of the same ABO group or compatible red blood cells. Rh(o) (D)-negative recipients shall receive Rho (D)-negative blood, except for reasonable exempting circumstances as determined by the director of transfusion services. Rho (D)-positive recipients may receive Rho (D)-positive or Rho (D)-negative whole blood or red blood cells. In an emergency, appropriately documented in the records, blood may be released for transfusion prior to the completion of compatibility tests. Any transfusion service which issues blood components for transfusion by a limited transfusion service or ambulance transfusion service shall perform the required tests on its own premises.

(d) Whole blood, red blood cells, plasma and other blood components shall be inspected visually immediately prior to issuance. If the color or physical appearance is abnormal or there is indication or suspicion of microbial contamination, the unit of whole blood or blood components shall not be issued for transfusion.

(e) Blood, blood components or derivatives may not be made available for transfusion beyond the designated expiration date, except that whole blood may be used to prepare plasma within nine days after the designated expiration date, provided that it meets the inspection standards required in subdivision (d) of this section.

(f) An established protocol for processing or pooling of blood components prior to issuance must be in place.

(g) The director of transfusion services shall establish a written policy that specifies the circumstances under which more than one unit of red blood cells for a particular patient may be issued simultaneously for transfusion within a hospital without documented approval of the director of transfusion services or designee who is a physician.
(h) If an unused, unopened unit is returned to the blood bank, the time, date and condition of the unit must be recorded.

(i) A sample of red cells or whole blood from each red cell product issued for transfusion shall be retained for a minimum of seven days after the transfusion for further testing in the event of an adverse reaction.

(j) After issuance, red blood cells may be stored at room temperature for up to one hour or by refrigerating at one to six degrees Celsius. Red blood cells kept at room temperature for more than one hour may not be returned to the blood bank and later reissued for transfusion unless the temperature of the component is documented not to have risen above ten degrees Celsius. If refrigerated, red blood cells shall be stored in a refrigerator designed for the purpose of storing blood, except that a cooler with suitable coolant may be used for refrigeration, provided that the temperature of the blood is maintained at one to ten degrees Celsius.

(k) Blood or blood components shall not be identified or labeled or preferentially distributed according to the donor's membership in a category based on age, race, color, creed, national origin, sex, marital status or social organization, except for purposes of phenotyping of blood units. The sequence of issuance by a transfusion service of blood donated for designated recipients shall not be based on factors other than medical considerations.

(l) Blood or blood components from a donor who had been determined in the past to be unsuitable for subsequent donation shall not be released for transfusion unless the donor has been approved for reentry into the donor pool by the director of the blood bank. (m) Blood components issued to a limited transfusion service shall be transported in a leak-resistant, crush-resistant and puncture-resistant container that has been validated to maintain the appropriate temperature for the anticipated duration of storage and that has a label indicating the issuing transfusion service. (n) Blood components issued to an ambulance transfusion service shall be transported in a leak-resistant, crush-resistant and puncture-resistant container that has been validated to maintain the appropriate temperature for the anticipated duration of transport and that has a label indicating the intended receiving hospital’s blood bank.
 

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.10 - Required records and confidentiality

58-2.10 Required records and confidentiality.

(a) Complete and accurate records of blood, blood components and derivatives released for allogeneic or autogeneic transfusion shall be kept for seven years or six months after the expiration date of the individual product, whichever is later, by the blood bank preparing the product and by the institution using the product. Such records shall be open to inspection by the department and shall include the information specified in sections 58-2.11 and 58-2.12 of this Subpart. For all collected or distributed blood, blood components and derivatives, the donor's name, address, telephone number, social security number and any other information which would directly or indirectly identify the blood donor of any specific unit shall not be disclosed by the blood bank to any person or entity except upon the written consent of the donor or except to the department and other agencies which issue clinical laboratory and/or blood bank permits to the facility whose records are requested.

(b) Blood banks and transfusion services shall file a Blood Services Activity Report annually with the department.

(c) Records shall be maintained of all tests, controls, reagents and current procedures, in a manner acceptable to the department in conformance with generally accepted laboratory principles.

Effective Date: 
Wednesday, March 11, 1998
Doc Status: 
Complete

Section 58-2.11 - Records to be kept when blood is collected for autogeneic or allogeneic transfusion

58-2.11 Records to be kept when blood is collected for autogeneic or allogeneic transfusion.

(a) Every blood bank shall maintain records of each container of blood or blood components collected or prepared therein. The records shall contain the following information:

(1) donor's full name, address, age, sex and identifying code;

(2) date and amount of blood collected;

(3) any adverse reaction of the donor;

(4) signature of or other unique identifier provided by the phlebotomist;

(5) results of all tests performed on a sample from the donor or a unit;

(6) disposition of the blood or blood components;

(7) for autogeneic donation, documentation of written or verbal consent of the donor-patient's health care provider if donation takes place prior to anticipated surgery or medical procedure, of the physician responsible for collection or his/her designee, and of the donor-patient. If the blood is to be considered for allogeneic use, the donor shall sign a consent form giving consent for such use, specifying procedures for release of the unit by the health care provider, and stating that to the best of the donor’s knowledge, the blood is safe for use by others; and

(8) if a donor is determined to be unsuitable for donation based on donor history, laboratory test results or implication in a case of transfusion-transmitted disease according to the protocol of the blood collection service, a record of the donor's name and identifying information. Blood from such a donor shall not be released, even if results of testing on subsequent donations are negative, unless the donor has been approved for reentry into the donor pool by the director of the blood bank or designee who is a physician .
 

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.12 - Records to be kept when blood, blood components or derivatives are issued for allogeneic or autogeneic transfusion

58-2.12 Records to be kept when blood, blood components or derivatives are issued for allogeneic or autogeneic transfusion. (a) For blood and blood components, records of the following information, as applicable, shall be kept in the blood bank and made available to the department for inspection:

(1) source;

(2) unit identification code upon receipt and, if different, upon issuance;

(3) unit ABO and Rh groups;

(4) expiration date;

(5) results of all pretransfusion testing;

(6) disposition of the unit, including remote storage location, if any, and intended recipient's name or, if the name is unknown, identification code;

(7) identification of the station code or person taking possession of the unit;

(8) documentation of visual inspection; (9) date and time of issuance; and

(10) results of all tests associated with the investigation of all transfusion reactions, with the conclusions reached and the report signed, or approved by electronic equivalent, by the director of the blood bank or a qualified physician designated by the director of the blood bank.

(b) For coagulation factor concentrates, logbook records of the following information shall be kept and made available to the department for inspection:

(1) manufacturer;

(2) lot number;

(3) expiration date;

(4) disposition, including recipient's name if administered; and (5) date of issue.

(c) For all derivatives, records associated with the investigation of all by electronic equivalent, by the director of the blood bank or a qualified physician designated by the director of the blood bank, shall be kept and made available to the department for inspection.

(d) These recordkeeping requirements shall also apply to blood components issued to limited transfusion services and to blood components issued to ambulance transfusion services.
 

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.13 - Distribution facilities

58-2.13 Distribution facilities.

A blood bank may operate a distribution facility, provided the department is notified, in advance, of the location and activities to be performed at the site.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.14 - Serial plasmapheresis

58-2.14 Serial plasmapheresis.

(a) The standards that apply to whole blood collection and processing shall apply to serial plasmapheresis except as otherwise specified. Whenever the plasma is not intended for transfusion, or for the preparation of fractions for transfusion, the criteria for donor selection may be limited to those designed for the safety of the donor. In such instances, the plasma unit shall be prominently labeled, "NOT FOR TRANSFUSION", or similar language.

(b) Direction. The director of a serial plasmapheresis program shall be a physician who must demonstrate satisfactory training in all aspects of hemapheresis, including a minimum of two years' experience.

(c) Informed consent.The consent of a prospective serial plasmapheresis donor shall be obtained in writing after a licensed physician explains the hazards of the procedure to the donor in such a manner that he/she is offered an opportunity to refuse consent. The donor shall be told of the risks of serial plasmapheresis, including the possibility of a hemolytic transfusion reaction if he/she is given someone else's red cells, risk of any medications or sedimenting agents to be used, and, if he/she is to be immunized or hyperimmunized, of the hazards involved. For example, in the case of immunization with human blood components, the donor shall be told specifically about the risk of viral hepatitis, as well as about the increased risk of receiving incompatible blood if he/she ever needs a transfusion. A prospective donor who is to be deliberately exposed to an antigen shall also be given a general description of the immunization program, including the nature of the material to be injected. All of this information shall also be given to each prospective donor in written form, and the donor's consent shall be signed and witnessed on a form approved by the department.

(d) Donor qualification. A donor may not be accepted for serial plasmapheresis unless the criteria in section 58-2.2(b) and (c) of this Subpart, with the exception of sections 58-2.2(b)(5) and (7), and 58-2.2(c)(10) and (11), are met.

(e) Care of serial plasmapheresis donors. A qualified, licensed physician shall be available within fifteen minutes' travel time of the premises, at which serial plasmapheresis is performed, immediately available for personal or telephone consultation in the treatment of a donor who manifests an adverse reaction, and responsible for all phases of plasmapheresis conducted. A physician or a registered nurse designated by the medical director shall be available on the premises at all times. The floor supervisor shall be a registered nurse, physician assistant, or person with at least two years' experience performing plasmapheresis procedures, and shall have completed a plasmapheresis training program that includes documented satisfactory performance of donor plasmapheresis procedures. Persons performing manual plasmapheresis procedures shall be licensed practical nurses, registered nurses, clinical laboratory technologists, physician assistants, or persons with at least two years' experience performing manual plasmapheresis procedures. Persons performing automated plasmapheresis procedures shall be licensed practical nurses, registered nurses, clinical laboratory technologists, clinical laboratory technicians or physician assistants, or persons with at least six months' experience in collecting whole blood for transfusion. All persons performing plasmapheresis procedures shall have one year's experience performing plasmapheresis procedures or shall have completed a training program in plasmapheresis procedure technique. The training program must include training in donor screening, venipuncture techniques, instrument operation, prevention of an initially addressing donor reactions, and proper documentation of all completed procedures. At the end of the training program, each plasmapheresis operator must be able to: (1) safely and effectively operate the cell separator systems in use at the facility;

(2) harvest plasma which meets quality standards;

(3) manage fluid volumes safely;

(4) prevent, and when necessary, initially address adverse reactions;

(5) develop the ability to work independently, utilizing the floor supervisor as a resource when necessary; and

(6) provide support to the donor while maintaining control of the operation of the instrument.
The director shall establish an agreement with an accredited hospital in the vicinity of the plasmapheresis center for the admission of donors who sustain adverse reactions and require hospital care.

(f) Laboratory testing. A serologic test for syphilis shall be performed within 24 hours on a specimen collected at the time of the first donation and at four-month intervals thereafter. A donor with a reactive serologic test for syphilis shall not be plasmapheresed again until the donor's serum is nonreactive in confirmatory testing, except that donors with reactive tests for syphilis may be plasmapheresed to obtain plasma to be used for manufacturing control serum for serologic tests for syphilis. Approved tests for HBsAg and antibodies to HCV, HIV-1 and HIV-2 shall be performed on the retained plasma or on a specimen obtained from the donor at the time of donation. If the plasma is intended for transfusion, all tests required in section 58-2.3(a) of this Subpart shall be performed.
(g) Return of red blood cells to donor. If it is not possible to return red blood cells to a plasmapheresis donor, or if whole blood is donated, the donor shall not be plasmapheresed again for eight weeks, unless the donor's extracorporeal red blood cell volume during the procedure is not expected to exceed 100 milliliters.

(h) Manual plasmapheresis procedures. Containers and anticoagulants shall meet the standards for whole blood. Before the blood container is separated from the donor for processing, it shall bear two separate and independent means of identification to enable both the donor and the phlebotomist to determine without doubt that the contents originate from the donor. Plasmapheresis shall be performed aseptically under conditions that avoid air embolism. During their separation, the red blood cells shall be maintained at a temperature not exceeding 37 degrees Celsius and under conditions known to assure the sterility and viability of these cells upon their return to the donor. The identity of the donor and the container shall be confirmed by at least two technical staff members prior to reinfusion of the red blood cells. Red blood cells shall be returned to the donor within two hours of the phlebotomy. If plasmapheresis is to be performed using equipment dissimilar to blood bags used for the collection of blood so that the standards for containers and anticoagulants for whole blood do not apply, specific approval from the department is required.

(i) Automated plasmapheresis procedures. Plasmapheresis shall be performed aseptically under conditions that avoid air embolism and maintain sterile technique. If plasmapheresis is to be performed using equipment dissimilar to blood bags used for the collection of blood so that the standards for containers and anticoagulants for whole blood do not apply, specific approval from the department is required.

(j) Records. All institutions performing plasmapheresis shall maintain records of all plasmaphereses performed, and the clinical and laboratory information pertinent thereto. These records shall include complete information on each donor, signed consent of the donor, his/her identification code, and the amount of plasma removed. When immunizations are performed, the antigen and the procedures employed shall be identified and recorded, and the donor shall give specific consent for the immunization. These records shall be available for inspection for at least seven years after each plasmapheresis.

Effective Date: 
Tuesday, October 23, 2007
Doc Status: 
Complete

Section 58-2.15 - Collection of blood components by apheresis

58-2.15 Collection of blood components by apheresis.

(a) Selection of donors. The standards that apply to whole blood donation shall apply in the selection and care of the donor for apheresis, unless otherwise specified.

(b) Informed consent. The consent of a prospective donor shall be obtained in writing after a qualified and specially trained individual explains the hazards of the procedure in such a manner that the donor is offered an opportunity to refuse consent. The donor shall be informed of the risks of apheresis and the risks of any sedimenting agents or medications to be used.

(c) Qualifications and care of the donor. (1) Only those persons may be accepted as blood donors for apheresis who are in good health as indicated by the qualifications of a whole blood donor specified in section 58-2.2 of this Subpart, with the following exceptions:

(i) Ingestion of aspirin-containing medications within three days of donation shall preclude donation of platelets.

(ii) Cytapheresis of donors who do not meet the requirements of this subsection shall be performed only if the harvested cells are expected to be of particular value to an intended recipient, and only if the supervising physician has confirmed in writing the particular value of these cells and has certified that the donor's health permits cytapheresis.

(iii) Medications or sedimenting agents to facilitate cytapheresis shall not be used in donors whose medical history suggests that these may exacerbate previous or intercurrent disease. Guidelines for use of such agents shall be established by the medical director.

(2) The medical director, who must demonstrate satisfactory training in all aspects of apheresis, including one year of experience, shall be responsible for all phases of apheresis conducted. Persons performing apheresis procedures shall be registered nurses, licensed practical nurses, clinical laboratory technologists, clinical laboratory technicians or physician assistants, or persons with at least six months' experience collecting blood for transfusion. All persons performing apheresis procedures shall have at least one year's experience performing apheresis procedures or shall have completed a training program in apheresis procedure technique. The training program must include training in donor screening, venipuncture techniques, instrument operation, prevention of an initially addressing donor reactions, and proper documentation of all completed procedures. At the end of the training program, each apheresis operator must be able to:

(i) safely and effectively operate the cell separator systems in use at the facility;

(ii) harvest blood components which meet quality standards;

(iii) manage fluid volumes safely;

(iv) prevent, and when necessary, initially address adverse reactions;

(v) develop the ability to work independently, utilizing the floor supervisor as a resource when necessary; and

(vi) provide support to the donor while maintaining control of the operation of the instrument. (3) The floor supervisor shall be a: (i) registered nurse; (ii) physician assistant; (iii) person with at least two years' experience performing apheresis procedures; or (iv) person with at least one year of experience supervising allogeneic blood collection. (4) The floor supervisor shall have completed an apheresis training program that includes documented satisfactory performance of donor apheresis procedures. (5) A person specifically trained in recognizing and addressing reactions that may occur in association with the procedures being performed shall be immediately available on the premises at all times during an apheresis procedure. A qualified licensed physician shall be immediately available, at least for telephone consultation, during all procedures.
(d) Volume and frequency of apheresis. Extracorporeal blood volume shall not exceed 15 percent of the donor's estimated blood volume. No more than 12.0 liters of plasma shall be removed per year from a donor weighing 175 pounds or less, and no more than 14.4 liters shall be removed per year from a donor weighing more than 175 pounds. The interval between procedures shall be at least 48 hours. The above volume and frequency requirements may be waived upon written authorization of the supervising physician, provided the donor meets all other eligibility requirements. Red blood cells shall not exceed 300 milliliters per eight weeks, unless the following requirements are met: (1) for male donors, the donor's weight is at least 130 pounds; (2) for female allogeneic donors, the donor's weight is at least 150 pounds; (3) for female autogeneic donors, the donor's weight is at least 130 pounds; (4) the allogeneic donor's hemoglobin content is 12.5 grams per deciliter or greater, or hematocrit is 38 percent or greater, and the donor meets the hemoglobin/hematocrit and weight requirements for use of the apheresis device, as approved by the F.D.A.; (5) the autogeneic donor's hemoglobin content is 11.0 grams per deciliter or greater, or hematocrit is 33 percent or greater, and the donor meets the hemoglobin/hematocrit and weight requirements for use of the apheresis device, as approved by the F.D.A.; (6) the volume of packed red blood cells removed does not exceed 550 milliliters; and (7) the volume removed is replaced with at least 225 milliliters of normal saline. Following a red cell apheresis procedure in which red blood cell loss exceeds 300 milliliters, the allogeneic donor shall not donate whole blood or undergo another apheresis procedure for a minimum of 16 weeks. For autogeneic donors, frequency and volume to be removed shall be determined by the medical director of the blood bank in conformance with recommendations of the manufacturer of the apheresis device.
(e) Return of red blood cells to donor. If it is not possible to return red blood cells to a donor, or if whole blood is donated, the donor shall not undergo apheresis again for eight weeks, unless the donor's extracorporeal red blood cells volume during the procedure will not exceed 100 milliliters.

(f) Procedures for collection of blood components by apheresis and their processing.Such procedures shall follow a written protocol approved by the medical director. Containers and anticoagulants shall meet the standards for whole blood. Apheresis shall be performed aseptically under conditions that prevent air embolism, and assure sterility and viability of cells returned to the donor. (g) Required records.All facilities performing apheresis shall maintain records of all such procedures performed, and the clinical and laboratory information pertinent thereto. These records shall include complete information on the donor, volume of blood removed, anticoagulants used, duration of the procedure, volume of components obtained, medications and sedimenting agents used, including manufacturer, lot number, expiration date and amount administered, and any adverse reactions and their management. These records shall be available to the department for inspection for at least seven years after each procedure.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.16 - Required standards for transfusion

58-2.16 Required standards for transfusions.

(a) Transfusion services. Every institution which performs transfusions or supplies blood to a limited transfusion service or ambulance transfusion service shall designate a physician who is a member of the staff as director of transfusion services. Such physician must be licensed and currently registered in New York State. The premises, equipment, procedure manuals, records, and all blood, blood components and derivatives shall be available for inspection by the department.

(1) It shall be the responsibility of the chief executive officer or other person in charge of each institution and of the director of transfusion services to determine that:

(i) the rules and regulations of the Council on Human Blood and Transfusion Services and the Administrative Rules and Regulations of the department and related requirements are complied with;

(ii) attending and other staff members and nurses are properly instructed regarding all required procedures;

(iii) records required by the aforesaid rules and regulations are maintained;

(iv) serious unexpected reactions and incidents involving blood components that have been issued by the transfusion service are reported to the department's Wadsworth Center, with sufficient detail to facilitate evaluation and investigation, within seven (7) calendar days of the reaction or incident, or its discovery and, if required, to federal authorities; and

(v) a written policy exists regarding use of blood components negative for cytomegalovirus antibody, irradiated components, leukocyte-reduced components and other specialty components. Such a policy shall include recommended indications for component use and a protocol for component processing and issuance. There shall also be a written policy on recommended indications for transfusion of whole blood, fresh frozen plasma and platelets.

(2) The institution shall report annually to the department the name(s) of the physician(s) in charge of the transfusion service.

(3) If blood componets are issued to a limited transfusion service or an ambulance transfusion service, the director of transfusion services of the issuing facility and the director of the limited transfusion service or an ambulance transfusion service performing the transfusion shall ensure compliance with all requirements of this Part.

(b) Each institution that performs transfusions or supplies blood to a limited transfusion service and/or an ambulance transfusion service shall have a transfusion committee that meets at least quarterly. The committee shall:

(1) be composed of at least five members;

(2) include members with expertise in clinical medicine and/or transfusion medicine and who are qualified to review the appropriateness and technical aspects of a transfusion; and

(3) review all or a representative sample of transfusions of all categories of blood and blood products issued by the facility for administration at any location, including all intraoperative and postoperative recovery procedures.

(c) Each institution, through its transfusion committee, shall establish guidelines for reservation (compatibility or crossmatching) of blood for each elective surgical procedure which has been performed there more than five times in the preceding calendar year and shall set the maximum number of hours that crossmatched blood will be held on reserve.

(d) Whole blood, red blood cells, plasma, or other components and derivatives shall be prepared and administered by methods generally accepted by the F.D.A. or American Association of Blood Banks and/or by other methods approved by the department as in conformance with generally accepted laboratory principles. No medications except physiologic saline for intravenous use shall be added to, mixed with, or administered in the same line with a blood component unless approved for this use by F.D.A. and there is documentation available to show that the addition is safe and does not adversely affect the blood component. A filter meeting F.D.A. requirements shall be incorporated into the intravenous administration set to be used for blood or blood component transfusions.

(e) In a health care setting, the person initiating transfusion of blood or blood components shall be a: (1) physician; (2) registered nurse; (3) physician assistant; (4) nurse practitioner; (5) board-certified cardiovascular perfusionist (intraoperatively); or (6) licensed practical nurse who has completed a transfusion training program meeting criteria specified by the department and by the New York State Education Department, when supervised by a registered nurse, physician assistant, or a physician who is immediately available on site.

(f) In a health care setting, following comparison of the unit's label with all accompanying information, the person initiating transfusion of a blood component shall, at the patient’s side, immediately prior to initiating the transfusion, positively identify the recipient and the blood component to be transfused, using the patient’s name and a unique numerical or alphanumerical identifier. One additional person, authorized to initiate transfusion, and who is not a licensed practical nurse if the person initiating the transfusion is a licensed practical nurse, shall also so identify the recipient and the blood component, unless another procedure to ensure accurate identification is used, in which case a single identification shall be sufficient. Each identification procedure shall be documented in writing by each participant. Two persons authorized to initiate blood transfusions shall be immediately available during a blood component transfusion and for 30 minutes afterward, except for transfusion of a patient enrolled in a chronic transfusion program who has no history of adverse reactions. A blood component recipient’s vital signs shall be serially recorded, in accordance with written policies and procedures. If the person recording the vital signs is a licensed practical nurse, all measurements outside of established parameters shall be reported to a registered nurse, physician, physician assistant, or nurse practitioner for assessment and action. Such notification shall be documented. (g) For transfusions outside a health care setting, including those in a patient's home, but not including those in an ambulance, the person initiating the transfusion and monitoring the patient shall be a physician, registered nurse, physician assistant, or nurse practitioner. Following comparison of the blood product label with all accompanying information, this person shall, at the patient’s side, immediately prior to initiating the transfusion, positively identify the recipient and the blood product to be transfused or infused, using the patient’s name and a unique numerical or alphanumerical identifier. Each such identification procedure shall be documented in writing. A person authorized to monitor transfusions and another competent adult, other than the recipient, shall be immediately available at all times during a transfusion. Both persons shall be available for 30 minutes afterwards, except for transfusions of patients enrolled in a chronic transfusion program who have no history of adverse reactions. The recipient’s vital signs shall be monitored serially and documented, in accordance with written policies and procedures. (h) Transfusions during transport between hospitals may be administered only by a registered nurse, nurse practitioner, physician assistant, physician, or emergency medical technician certified at the critical care or paramedic level, provided such emergency medical technician has received training in blood administration in accordance with requirements established by the department and is performing these services as part of an ambulance transfusion service approved by the department. Blood components to be issued to an ambulance transfusion service must be ordered by a health care provider caring for the patient using a standard order form approved by the department. The transfusion service issuing the blood components shall be made aware that the blood is intended for possible administration during transport between hospitals and shall be informed of the destination hospital. Blood components intended for possible administration during transport shall be packed in a suitable container validated to maintain the appropriate temperature for the anticipated duration of transport. Prior to departure, the identification of the patient and of any blood components to be transported for possible administration during transport shall be verified in accordance with subdivision (f) of this section. In addition, a registered nurse, physician assistant, nurse practitioner, or physician shall verify, at the patient’s side, the identification of the patient and all blood units, with the qualified person who will be caring for the patient during transport. (i) Every facility or limited transfusion service performing transfusions shall provide 24-hour-a-day post-transfusion patient coverage by telephone as necessary.
(j) Each institution, through its transfusion committee, shall develop and implement procedures to encourage the use of autogeneic blood whenever medically indicated. These procedures shall include a mechanism for informing staff physicians of the risks and benefits of autogeneic blood and the options for autogeneic blood transfusion available at the institution, including, but not limited to, intraoperative blood recovery, isovolemic hemodilution and presurgical deposit, as applicable. These procedures shall also include a mechanism to encourage physicians to inform their patients of such options whenever medically indicated. (k) If blood is warmed prior to transfusion, the warming system shall be equipped with a visible thermometer and an alarm to ensure that the blood is not warmed above the temperature specified by the director of the blood bank, in conformance with the system manufacturer’s instructions. Blood warmer temperature shall be monitored and recorded on each day of use, and such records shall be available for inspection for at least five years. Maintenance and operation of blood warmers must conform to the manufacturer’s instructions.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.17 - Laboratory tests to be performed prior to allogeneic or autogeneic transfusion

58-2.17 Laboratory tests to be performed prior to allogeneic or autogeneic transfusion.

(a) Tests shall be performed to determine the ABO and Rho (D) groups of each recipient in accordance with procedures approved by the department pursuant to this Subpart. ABO grouping tests shall include both forward and reverse grouping, except that reverse grouping is not required for infants under four months of age. Prior to transfusion, the ABO group of all units of whole blood and red blood cell components, as well as the Rh group of all such units labeled as Rh-negative, shall be confirmed using a sample obtained from an attached segment. Any discrepancies shall be reported in writing to the collecting facility and resolved prior to issuance of the blood for transfusion purposes.

(b) Serum or plasma from each recipient or, in the case of an infant under four months of age, the infant’s mother, shall be tested for unexpected alloantibodies using reagent red blood cells that meet F.D.A. standards, are intended for this purpose and are not pooled. Methods of testing for unexpected alloantibodies shall demonstrate sensitizing and hemolytic antibodies.

(c) Except in cases necessitating emergency release of group-compatible blood, or in the case of transfusion of a volume of blood or blood components exceeding the recipient's expected normal blood volume in a 24-hour period, compatibility between recipient and donor blood shall be determined. If a clinically significant antibody has been detected, or if there is a history of presence of such an antibody, compatibility testing shall include an antiglobulin phase crossmatch. If no clinically significant antibody has been detected, and there is no known history or presence of such an antibody, the crossmatching procedure to be used may be determined by the director of transfusion services, but shall, at minimum, consist of an immediate spin test or use of a validated computer system, except that crossmatching is not required for infants under four months of age.

(d) In the case of patients requiring repeated blood transfusions, or those pregnant or transfused with allogeneic red blood cell-containing components within the previous three months, fresh blood specimens shall be drawn for compatibility testing and antibody screening at intervals of not more than three days prior to the day of transfusion, except for neonates, to whom no time limits apply.

(e) A pre-transfusion sample of recipient blood, including serum or plasma, shall be retained for seven days after each transfusion for further testing in the event of an adverse reaction.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.18 - Records to be kept when blood or blood component transfusions are performed

58-2.18 Records to be kept when blood or blood component transfusions are performed. The following information shall be included on the recipient's chart or in records maintained in the blood bank:

(a) date of the transfusion;

(b) name(s) of the person(s) who performed the transfusion and who attended the recipient during the transfusion;

(c) for each unit:

(1) blood component transfused;

(2) unit identification code;

(3) unit ABO and Rh groups;

(4) start time and completion time; and

(5) description of any adverse reaction and the results of related investigation.

(d) in the case of emergency issuance of uncrossmatched blood, the signature of the physician authorizing such emergency release.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.19 - Records to be kept when derivatives are infused

58-2.19 Records to be kept when derivatives are infused. The following information shall be included on the recipient's chart or in records maintained in the blood bank or pharmacy:
(a) product name, manufacturer, lot number, and expiration date;

(b) documentation of visual inspection prior to infusion;

(c) name of person administering the product;

(d) documentation of identification of the recipient;

(e) date of infusion and quantity of material infused; and

(f) description of any adverse reaction and the results of related investigation.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.20 - Ambulance Transfusion Services

58-2.20 Ambulance Transfusion Services

(a) No person shall own or operate an ambulance transfusion service in New York State unless approved by the department. An inspection may be conducted prior to departmental approval. Ambulance transfusion services shall comply with the provisions in this Part governing transfusions in general.

(b) Ambulance transfusion services shall have a written agreement with all hospitals issuing blood components to the ambulance transfusion service for possible administration during transport to another hospital, except in cases when no ground or air, as needed, ambulance transfusion service with an agreement in place is available. The agreement shall be subject to the prior approval of the department. The agreement shall:

(1) specify the division of responsibilities for ensuring compliance with the provisions of this Subpart;

(2) include a statement that ambulance transfusion service personnel will have adequately completed training in administering blood components according to a curriculum approved by the department; and

(3) include the written approval of the issuing facility's director of transfusion services and the director of the ambulance transfusion service.

(c) A qualified licensed physician shall provide general supervision of ambulance transfusion service personnel continuing and/or initiating transfusions and shall be responsible for ensuring that such personnel have adequate training and experience.

(d) Any order for a transfusion to be continued and/or initiated in an ambulance shall be documented on an order form approved by the department, and shall specify:

(1) the blood component(s) to be transfused;

(2) the number of units to be transfused;

(3) the rate of infusion;

(4) any special instructions; and

(5) any actions, including transfusion of additional units, to be taken based on circumstances that may arise.

(e) Every transfusion administered in an ambulance must be documented on a transfusion record approved by the department. Such documentation must include:

(1) date of the transfusion;

(2) name of the person who performed the transfusion and who attended the recipient during the transfusion.

(3) for each unit:

(i) blood component transfused;

(ii) unit identification code;

(iii) unit ABO and Rh groups; and

(iv) start time and completion time.

(f) Any adverse reaction shall be documented on a prehospital care report. Such documentation shall include a description of the adverse reaction and actions taken in response.

(g) Any ambulance in which a transfusion is performed by an ambulance transfusion service shall maintain an inventory of isotonic saline and any supplies needed for blood administration and for monitoring transfusion recipients, and have a means to communicate with medical control. All medications, equipment and supplies necessary for the management of adverse reactions shall be immediately available. Medical waste disposal must be undertaken, in collaboration with the receiving hospital, using containers and procedures found acceptable to the department pursuant to Part 70 of this Title.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.21 - Limited transfusion services

58-2.21 Limited transfusion services.

(a) No person shall own or operate a limited transfusion service in New York State unless approved by the department. An inspection may be conducted prior to departmental approval. Limited transfusion services shall comply with the provisions in this Part governing transfusions in general.

(b) Limited transfusion services shall have a written agreement with an issuing facility holding a permit in blood services-transfusion. The agreement shall specify the division of responsibilities for ensuring compliance with the provisions of this Part. The agreement shall be subject to the prior approval of the department. The agreement must include:

(1) the written approval of the issuing facility's director of transfusion services and the director of the limited transfusion service;

(2) the procedures for transport and storage of blood and means to ensure compliance with such procedures;

(3) a description of the transfusion committee of the issuing facility, its responsibilities and composition;

(4) procedures for training of personnel at the limited transfusion service;

(5) requirements for handling adverse reactions, including training of personnel, availability of a physician, 24-hour coverage, and reporting and investigation of such reactions;

(6) procedures for administration of transfusions, including staffing requirements; and

(7) recordkeeping procedures as required in sections 58-2.18 and 58-2.19 of this Subpart, clearly describing responsibilities for maintenance of records and their location.

(c) Transfusions may be performed outside of hospitals only if the patient is cooperative, is able to respond to verbal commands and give informed consent and does not have a history of hemolytic or anaphylactic reactions. The initial transfusion for a given patient shall not be performed in the home setting, and subsequent transfusions may be performed in a patient's home only if physican limitations or hardships exist which would impede transportation to or transfusion in a hospital or ambulatory care setting.

(d) A qualified licensed physician must supervise personnel administering transfusions by limited transfusion services and must be responsible for ensuring that such personnel have adequate training and experience.

(e) A licensed physician, physician assistant, or nurse practitioner must be immediately available for personal or telephone consultation during the transfusion and for 30 minutes afterward.

(f) Any site at which a transfusion is performed by a limited transfusion service must have available an accessible working telephone to allow communication in case of an adverse reaction. All medications, equipment and supplies necessary for the management of adverse reactions must be immediately available on the premises. Infectious waste disposal must be undertaken using containers and procedures found acceptable by the department pursuant to Part 70 of this Title.

(g) Referral of a patient for out-of-hospital transfusion therapy must be approved by the director of the limited transfusion service or his/her designee. Each such transfusion must be ordered by a licensed physician, physician assistant, or nurse practitioner, and a copy of the order must be provided to both the limited transfusion service and the facility issuing the blood.

Effective Date: 
Sunday, September 27, 2015
Doc Status: 
Complete

Section 58-2.22 Reserved

Effective Date: 
Sunday, September 27, 2015

Section 58-2.23 - HIV-1 and HIV-2 antibody testing results

58-2.23 HIV-1 and HIV-2 antibody testing results.

No blood bank shall inform any blood or plasma donor or his/her health care provider of the results of HIV-1, HIV-2 or HIV-1/HIV-2 combination antibody screening tests unless such results are negative, with the exception of autogeneic donors, whose health care provider may be informed of screening test results if there is insufficient time prior to surgery for completion of supplemental testing, provided that such health care provider is instructed that the donor may not be informed that he or she is positive for HIV-1 or HIV-2 antibodies based based on the incomplete results. Initial reactive screening tests shall be repeated in duplicate. If two of three screening tests are reactive, the sample shall be considered repeatedly reactive, and supplemental testing shall be performed. Notification that a donor is positive shall be made only if the results have been reactive for more than one screening test, and the supplemental HIV antibody test result has been unequivocally positive. Appropriate counseling of donors regarding the significance of all test results must be available. HIV results must be reported to donors if the results are substantiated as positive, or upon supplemental testing show an increased likelihood of representing seroconversion to positive, as determined by the director of the laboratory performing the supplemental testing. This report must be made in person unless repeated efforts to encourage a donor to come in have failed, in which case notification may be made by certified restricted delivery mail. HIV results that are substantiated as negative, or upon supplemental testing are indeterminate but do not show an increased likelihood of representing seroconversion to positive, as determined by the director of the laboratory performing the supplemental testing, may be reported to donors by mail, provided that such donors are not informed that they are seropositive. Any notification of HIV results to donors who were repeatedly reactive on initial screening tests, regardless of the results of supplemental testing, must include an offer of appropriate counseling.

Effective Date: 
Tuesday, October 23, 2007
Doc Status: 
Complete

Section 58-2.24 - Disposal of untransfused and expired blood units

58-2.24 Disposal of untransfused and expired blood units. Units deemed unsuitable for transfusion, those not transfused for any reason, and those designated for disposal for any reason, shall be disposed of by an appropriate method in accordance with all applicable regulations and requirements. All expired blood components shall be transferred to a separate storage location within 24 hours of expiration. All such components shall be destroyed, discarded, or removed for non-transfusion purposes within 72 hours of expiration, or returned to the collection facility within one week of expiration.
 

Effective Date: 
Wednesday, August 31, 1994
Doc Status: 
Complete

Section 58-2.25 - Intraoperative and postoperative blood recovery and normovolemic hemodilution

58-2.25 Intraoperative and postoperative blood recovery and normovolemic hemodilution.

(a) Blood recovered intraoperatively or postoperatively from a person or collected for normovolemic hemodilution shall not be transfused into another person.

(b) Methods for intraoperative or postoperative recovery of blood and for normovolemic hemodilution shall be safe and aseptic and shall ensure accurate identification of all blood collected. The equipment used shall be operated according to the manufacturer's instructions, shall be pyrogen-free, shall include a filter capable of retaining particles potentially harmful to the recipient, and shall prevent air embolism. If the blood is warmed prior to reinfusion, the warming system shall be equipped with a visible thermometer and an alarm to ensure that the blood is not warmed above the temperature specified in a written protocol, in conformance with the system manufacturer’s instructions.

(c) A complete written protocol for collection and processing of recovered blood and for normovolemic hemodilution, approved by the director of transfusion services, shall be maintained and followed. The protocol shall include criteria for selection of suitable patients and determination of dosage of ancillary agents used, as well as procedures for prevention and management of adverse reactions.

(d) If recovered blood or blood collected for normovolemic hemodilution is removed from the immediate premises for processing or storage, identification procedures shall be in place to ensure its transfusion into the intended recipient.

(e) If not immediately transfused, recovered blood shall be stored under one of the following conditions:

(1) at one to 24 degrees Celsius for up to six hours after initiating the collection; or

(2) at one to six degrees Celsius under monitored conditions for up to 24 hours, provided storage at one to six degrees Celsius is begun within six hours of initiating the collection and the blood is washed under sterile conditions.

(f) Blood collected for normovolemic hemodilution shall be stored under one of the following conditions prior to initiation of transfusion:

(1) at one to 24 degrees Celsius for up to eight hours after initiating the collection; or

(2) at one to six degrees Celsius under monitored conditions for up to 24 hours, provided that storage at one to six degrees Celsius is begun within eight hours of initiating the collection.

(g) Untested recovered blood and blood collected for normovolemic hemodilution which are kept in the blood bank shall be stored in a specially designated area separate from other units and prominently labeled with the patient's name and a label "Caution: Untested Blood" or similar wording.

(h) Transfusion of blood recovered postoperatively or from post-traumatic patients shall commence within six hours of the initiation of the collection, or if not, the blood shall be discarded.

(i) All records of transfusions of blood recovered intraoperatively or postoperatively shall be available to the department for inspection for at least seven years after each transfusion. Summary records, listing the patient's name, the medical record number and procedures performed, shall be kept of all such procedures, separate from the patient's chart.
 

Effective Date: 
Tuesday, October 23, 2007
Doc Status: 
Complete

Section 58-2.26 - Exceptions

58-2.26 Exceptions.

(a) When, for indications generally accepted by the medical community, an allogeneic donor who would not otherwise qualify to donate blood or blood components is found to be uniquely suited to meet a given patient's needs, exceptions may be made to the requirements in sections 58-2.2(b) and (c), 58-2.3(a), 58-2.4(c), and 58-2.15(c), (d) and (e) of this Subpart. Such exceptions shall be approved in writing by both the medical director of the blood bank collecting the blood or his/her physician designee, and the director of the transfusion service transfusing the blood or his/her physician designee. If donation under such circumstances presents an increased risk to the donor's health or safety, the donor shall be informed of the risk and must consent in writing to such donation. If the donation presents an increased risk to the recipient's health or safety, the written authorizations of the recipient's health care provider and the recipient or person legally authorized to consent on behalf of the recipient are also required. All such exceptions granted shall be reported to the department annually in a format designated by the department.

(b) Exceptions to the requirements of this Subpart, other than the exception specified in subdivision (a) of this section, may be granted by the department on a case-by-case basis and for a limited time only, if necessitated by a medical emergency or special medical conditions. Persons seeking an exception shall apply to the department as soon as possible and shall describe the nature of the emergency or special medical conditions and the exception requested. All such emergencies or special medical conditions must be documented in the medical record, and any action taken in response which is contrary to the requirements of this Subpart must be approved by the director of transfusion services. If it is not possible to request an exception in advance or if the department has not responded before an action contrary to the requirements of this Subpart had to be taken, the director of transfusion services must report the action taken to the department as soon as possible thereafter but not later than the end of the next business day after the action was taken.
 

Effective Date: 
Tuesday, October 23, 2007
Doc Status: 
Complete

Section 58-2.27 - Reinfusion procedures

58-2.27 Reinfusion procedures.

(a) All entities performing reinfusion procedures or any part thereof shall hold a valid department permit in the category of blood services – transfusion or be approved by the department as a limited reinfusion service. Such limited reinfusion services are subject to inspection by the department. (b) All reinfusion procedures shall comply with written protocols approved by the director of transfusion services and the transfusion committee of the facility where the reinfusion is to be performed, the director of the hospital department where the product is reinfused, and the hospital department or facility where processing for the reinfusion procedure is performed, if different. These protocols shall include procedures for collection, labeling, handling, processing and reinfusion of the product. All reinfusion procedures performed in hospitals shall be reviewed by the hospital transfusion committee.

(c) The syringe, tube, bag, or other container into which the blood or component thereof is collected for reinfusion, shall be labeled at the time of collection with two forms of identification, one of which shall be the patient's name. The person drawing the blood or component shall initial or sign the records pertaining to the collection and certify that the identification on the blood or component and on the pertinent records is correct.

(d) During shipment, processing and storage, reinfusion products shall be maintained at a temperature between one and 38 degrees Celsius, except as otherwise required in a protocol approved by the director of the service performing the reinfusion. Red cell reinfusion products shall not be exposed to a temperature above six degrees Celsius for more than six hours. While in transit, the container and shipping box for such products shall be appropriately labeled as containing human blood products.

(e) Any container into which the blood or component is transferred from another container during reinfusion processing shall be labeled prior to the transfer with two forms of identification, one of which shall be the patient's name or identification code. The person performing the transfer shall initial or sign the records pertaining to reinfusion processing of the blood or component and shall certify that the container identification was transcribed correctly. All final containers shall be labeled with the patient's name, description of the contents, expiration date and dosage, if applicable.

(f) No reinfusion of a processed product shall be performed unless two individuals other than the patient have confirmed the identity of the recipient and the product to be reinfused as matching in name and in at least one additional identifier. This confirmation shall be documented in writing.

(g) All errors or accidents during processing or reinfusion procedures, that may pose a substantial risk to the patient shall be reported to the department's Wadsworth Center, with sufficient detail to facilitate evaluation and investigation, within seven (7) calendar days of the error or accident, or its discovery.

(h) All records pertaining to reinfusion procedures shall be retained for a minimum of seven years.
 

Effective Date: 
Sunday, September 27, 2015
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SubPart 58-3 - Clinical Laboratory Inspection and Reference Fees

Effective Date: 
Monday, December 23, 1985
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Statutory Authority: 
Public Health Law, Section 576(4)

Section 58-3.1 - Definitions

Section 58-3.1 Definitions.

(a) Gross annual receipts for clinical laboratories able to segregate income. For independent laboratories or laboratories operated within facilities which can segregate their laboratory income from total facility income, gross annual receipts shall mean the total income of the laboratory from all sources for all clinical laboratory tests performed pursuant to its permit, less any amounts paid to reference laboratories for such tests which are referred.

(b) Gross annual receipts for clinical laboratories unable to segregate laboratory income.

(1) For laboratories operated by health maintenance organizations, facilities with operating certificates issued pursuant to section 2805 of the Public Health Law, and other similar facilities which are reimbursed by third-party payors for laboratory services as part of an all inclusive facility per diem rate and which cannot segregate laboratory income from total facility income, gross annual receipts shall mean the amount computed by multiplying the total annual cost of the laboratory, by a fraction, the numerator of which is the gross revenue of the facility and the denominator of which is the gross cost of operating the facility. This amount must be further adjusted by subtracting any amounts paid to reference laboratories for such tests which are referred. Laboratories must obtain prior department approval to use this method by documenting that they are unable to segregate income.

(2) For all other clinical laboratories unable to segregate their annual income from tests performed pursuant to their New York State permit, gross annual receipts shall mean the amount the laboratory would have received had it billed the prevailing rate for these services. The prevailing rate shall mean the fee schedule for clinical laboratory services as listed on pages 5-1 through 5-14 of the Medicaid Management Information System Provider Manual for Laboratories, March 1982 edition, as published by the New York State Department of Social Services. Copies of this publication are available from the Department of Social Services, 40 North Pearl Street, Albany, NY 12243, and a copy is available for inspection and copying from the records access officer of the Department of Health, Corning Tower, Empire State Plaza, Albany, NY 12237. Laboratories must obtain prior department approval to use this method by documenting that they are unable to identify laboratory income.

(c) Inspection and reference fee shall mean the fee charged to a clinical laboratory calculated by multiplying the total operating expenses of the clinical laboratory evaluation program of the Department of Health by a fraction, the numerator of which is the gross annual receipts of such laboratory and the denominator of which is the total gross annual receipts of all laboratories issued permits.

(d) Permit year shall mean July 1st to June 30th.
 

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Section 58-3.2 - Laboratory inspection and reference fee

58-3.2 Laboratory inspection and reference fee. Each laboratory issued a permit by the department pursuant to section 575 of the Public Health Law shall be charged an annual laboratory inspection and reference fee.
 

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Section 58-3.3 - Reporting

58-3.3 Reporting.

(a) On or before May 1st of each State fiscal year (April 1st to March 31st), the department will advise each laboratory of the total estimated cost of the cl1nical laboratory improvement program for the previous State fiscal year.

(b) On or before May 15th, each laboratory will certify and report its gross annual receipts for the previous calendar year on forms to be provided by the department. If requested by the laboratory, this report shall be deemed confidential and exempt from disclosure under the Freedom of Information Law (article 6 of the Public Officers Law), pursuant to the authority in section 89(5) of the Public Officers Law. Knowing and/or willful failure to report or inaccurate reporting shall result in nonrenewal of the laboratory permit.

(c) On or before June 1st, the department shall bill each laboratory for its inspection and reference fee and shall advise each laboratory of the total gross receipts reported by all laboratories.
 

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Section 58-3.4 - Quarterly payments

58-3.4 Quarterly payments. At least quarterly payments must be made. If the laboratory elects to make quarterly payments, equal quarterly payments must be made by June 30th, September 30th, December 31st and March 10th of the State fiscal year to which the billing relates. Nothing herein precludes full payment from being made before these dates.
 

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Section 58-3.5 - Suspension or nonrenewal of laboratory permit

58-3.5 Suspension or nonrenewal of laboratory permit. Knowing and/or willful failure to meet the quarterly payment requirement will result in suspension or nonrenewal of the laboratory permit.
 

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Section 58-3.6 - Fees

58-3.6 Fees. On or before September 15th, the department will review the annual cost of the clinical laboratory inspection program as initially estimated. Fees will be adjusted when any change results in an increase or decrease in fees of more than $100 per laboratory. If an adjustment is required, the department shall notify the laboratories of any additional fees or credits by October 15th. Any additional fees are payable not later than 30 days after the date of the notification statement. Credits shall be applied to the next regular payment.

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Section 58-3.7 - Gross annual receipts

58-3.7 Gross annual receipts.

(a) A laboratory which has no gross annual receipts because it did not operate in New York State the previous permit year shall pay a first year accreditation fee of $1,000 regardless of the number of months remaining in the permit year. When applying for renewal of that permit, the laboratory shall report its gross receipts for the calendar months in which it operated and these receipts shall be projected to a 12-month basis for the purpose of computing gross annual receipts.

(b) A laboratory which has no permit, but accepted business which required it to have a New York State permit, had gross annual receipts in the previous permit year, and applies for a permit after commencement of the permit year shall pay a fee computed as an annual fee but prorated for the months remaining in the permit year, or $1,000, whichever is greater.
 

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Section 58-3.8 - Out-of-state laboratory seeking permit

58-3.8 Out-of-state laboratory seeking permit.

(a) Prior to any onsite inspection, an out-of-state laboratory possessing or seeking a New York State permit shall pay to the department, by certified check, bank check, teller's check or money order, a fee calculated by the department and consisting of the following components:

(1) a transportation expense, which shall be either the actual travel expense if travel is by common carrier, or a mileage expense at the rate negotiated between the State and the union representing the employees scheduled to conduct the inspection; and

(2) a per diem expense as specified by the New York State Comptroller for the inspecting employees, multiplied by the number of additional days estimated by the department to be necessary for travel and the actual inspection.

(b) In calculating this fee, the department shall estimate the total cost of the components specified in paragraph (a)(1) of this section and divide it equally among the laboratories inspected on any trip.

(c) In the event the department underestimates any of the above expenses, the laboratory shall pay any difference between the estimate and the actual expense.

(d) Fees collected shall be credited to the Clinical Laboratory Reference Fee Account. In the event the department overestimates any of the above expenses, the laboratory shall be notified of the difference between the estimate and the actual expense, and its account shall be credited that amount unless a refund is requested.

(e) Failure to pay the fee for out-of-state inspection will result in suspension or nonrenewal of the laboratory permit.
 

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Section 58-3.9 - Effective dates

58-3.9 Effective dates.

(a) Until March 31, 1986, the following dates shall have the following meanings:

(1) In section 58-3.3(a), May 1st shall mean the effective date of this regulation.

(2) In section 58-3.3(b), May 15th shall mean a date 10 days after the effective date of this regulation.

(3) In section 58-3.3(c), June 1st shall mean a date 45 days after the effective date of this regulation.

(4) In section 58-3.4, June 30th, September 30th, December 31st and March 10th shall mean dates to be negotiated by the department and each laboratory for the payment of quarterly installments of the 1985-86 fee; provided, however, that full payment must be made by March 10, 1986.

(b) The provisions of this section shall expire on March 31, 1986.
 

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SubPart 58-5 - Hematopoietic Progenitor Cell Banks

Effective Date: 
Wednesday, October 13, 1999
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Section 58-5.1 - Definitions

58-5.1 Definitions. As used in this Part:

(a) Bone marrow means the human tissue filling cavities of bone, consisting of fully mature and precursor hematopoietic cells intended for transplantation.

(b) Hematopoietic progenitor cells means human precursor hematopoietic cells derived from bone marrow, peripheral blood or other tissue sources, such as cord blood obtained from the placenta or umbilical cord. (c) Hematopoietic progenitor cell bank means hematopoietic progenitor cell procurement service, hematopoietic progenitor cell processing facility or hematopoietic progenitor cell transplantation facility.

(d) Hematopoietic progenitor cell procurement service means a facility which performs donor selection and bone marrow aspiration or other hematopoietic progenitor cell collection, and pre-processing storage of hematopoietic progenitor cells from autogeneic and/or allogeneic donors.

(e) Hematopoietic progenitor cell processing facility means a facility which processes bone marrow or other hematopoietic progenitor cell samples, including purging, storage, and distribution of hematopoietic progenitor cells from autogeneic and/or allogeneic donors. (f) Hematopoietic progenitor cell transplantation facility means a facility which temporarily stores and transplants hematopoietic progenitor cells, and includes facilities which infuse autogeneic hematopoietic progenitor cells and bone marrow transplantation services approved by the commissioner pursuant to section 709.8 of this Title. (g) Hematopoietic progenitor cell transplantation service means a specific unit conducting hematopoietic progenitor cell transplantation within a hematopoietic progenitor cell transplantation facility. Such a service shall be independently supervised by a qualified director.

(h) Department means the New York State Department of Health. (i) Commissioner means the Commissioner of the New York State Department of Health.

Effective Date: 
Wednesday, October 13, 1999
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Section 58-5.2 - General requirements.

58-5.2 General requirements.

(a) A hematopoietic progenitor cell procurement service shall possess a license issued under Subpart 52-2 of this Title in the category of either limited tissue procurement service or comprehensive tissue procurement service, and operate under standards established by this Subpart, Subpart 52-2 except section 52-2.9, and one or more licensed hematopoietic progenitor cell transplantation facilities. Unless the procurement service and the transplantation facility are operated by the same institution, a hematopoietic progenitor cell procurement service shall have a written agreement with the transplantation facility, which specifies that hematopoietic progenitor cells collected and stored by the hematopoietic progenitor cell collection procurement service are acceptable for transplantation by the hematopoietic progenitor cell transplantation facility. Collection of hematopoietic progenitor cells performed at facilities outside New York State shall follow policies and procedures consistent with this Subpart. Documentation of such policies and procedures shall be maintained by each associated hematopoietic progenitor cell transplantation facility. Hematoietic progenitor cells collected outside New York State shall be approved for use in New York State, in writing, by the director of the hematopoietic progenitor cell transplantation facility or by a physician designated by the director.

(b) A hematopoietic progenitor cell processing facility shall possess a license issued under Subpart 52-2 of this Title in the category of tissue processing facility, and be associated with and operating under standards established by one or more hematopoietic progenitor cell transplantation services. (c) Hematopoietic progenitor cell transplantation facility shall possess a license under Subpart 52-2 of this Title in the category of tissue transplantation facility.

(d) Hematopoietic progenitor cell procurement services, hematopoietic progenitor cell processing facilities and hematopoietic progenitor cell transplantation facilities may operate independently, or together as part of the same organization.

(e) The director of a hematopoietic progenitor cell procurement service and/or processing facility shall ensure the development and implementation of policies and procedures consistent with this Subpart for the operation of the service and the appointment of the medical director and a medical advisory committee. (1) The director of a hematopoietic progenitor cell procurement service collecting hematopoietic cells from peripheral blood shall be a physician and have at least one year's experience in apheresis, including or supplemented by experience in the performance or supervision of at least twenty-five (25) peripheral blood hematopoietic progenitor cell collection procedures. The director of a hematopoietic progenitor cell procurement service collecting bone marrow shall be a physician and have at least one year's experience in bone marrow collection, including or supplemented by experience in the performance or supervision of at least twelve(12) bone marrow collection procedures. The director of a hematopoietic progenitor cell procurement service collecting cord blood only shall be a physician and have at least one year's experience in hematopoietic progenitor cell collection, including or supplemented by experience in the performance or supervision of at least twenty-five (25) hematopoietic progenitor cell collection procedures. Such director shall also demonstrate satisfactory knowledge in the area of hematopoietic cell collection, with particular emphasis on the unique characteristics of cord blood collection. A person who has been approved by the department to direct a hematopoietic progenitor cell procurement service as of the effective date of these amendments shall be deemed to qualify as director. (2) The director of a hematopoietic progenitor cell processing facility shall possess a doctoral degree in the biological sciences and have at least three (3) years' laboratory experience, including at least six (6) months' experience in a clinical laboratory or blood bank. In addition, the director of a hematopoietic progenitor cell processing facility shall have one year's experience in hematopoietic progenitor cell processing, including or supplemented by experience in the performance or supervision of at least twenty-five (25) hematopoietic progenitor cell processing procedures. A person who has been approved by the department to direct a hematopoietic progenitor cell processing facility as of the effective date of these amendments shall be deemed to qualify as director.
(f) Medical direction of a hematopoietic progenitor cell procurement service and/or processing facility shall be provided by a physician in consultation with the medical advisory committee. Such physician shall be licensed and currently registered with the New York State Education Department or in the state or jurisdiction of practice. The medical director of a hematopoietic progenitor cell procurement service shall have two (2) years' experience or training in clinical hematology/oncology that includes experience in bone marrow transplantation or two (2) years' experience in transfusion medicine, in addition to either one year's experience in hematopoietic progenitor cell collection, or performance or supervision of at least twenty-five (25) hematopoietic progenitor cell collection procedures for each anatomic site (bone marrow, peripheral blood, cord blood or other site) to be used as a source of hematopoietic progenitor cells. The medical director of a hematopoietic progenitor cell processing facility shall have two (2) years' experience in clinical hematology/oncology that includes bone marrow transplantation experience, or two (2) years' experience in training in laboratory medicine or transfusion medicine, in addition to either one year's experience in hematopoietic progenitor cell processing, or experience in the performance or supervision of at least twenty-five (25) hematopoietic progenitor cell processing procedures. A person who has been approved by the department as medical director of a hematopoietic progenitor cell bank as of the effective date of these amendments shall be deemed to qualify as medical director. (g) The hematopoietic progenitor cell transplantation service director shall be a physician who shall be responsible for compliance with section 52-2.8 of this Title, and shall monitor the medical efficacy of the hematopoietic progenitor cell transplantation program. (h) The medical advisory committee, which may be the in-house transfusion committee or transplantation committee, shall include experts in the areas of infectious disease, hematology, oncology, histocompatibility and transfusion medicine, as well as physicians representing associated hematopoietic progenitor cell transplantation facilities. The committee shall meet at least annually. (i) The medical director of a hematopoietic progenitor cell procurement service, in consultation with the medical advisory committee shall monitor the medical efficacy of the program, and in conjunction with the associated hematopoietic progenitor cell transplantation facility shall, as a minimum, develop medical criteria for donor participation.

(j) The medical director of a hematopoietic progenitor cell procurement service shall be responsible for all aspects of donor qualification, as described in section 58-5.4 of this Subpart.

(k) The director of a hematopoietic progenitor cell procurement service and/or processing facility shall be responsible for the technical and scientific operation of the facility, and shall develop quality standards for hematopoietic progenitor cells.

Effective Date: 
Wednesday, July 21, 2004
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Section 58-5.3 - Hematopoietic progenitor cell procurement

58-5.3 Hematopoietic progenitor cell procurement.

(a) Facilities where allogeneic or autogeneic hematopoietic progenitor cells are collected shall be adequately lighted, ventilated and equipped, and be operated in a manner which conforms to current medical standards generally accepted by leading authorities in transplantation medicine.

(b) Each hematopoietic progenitor cell procurement service, except for such facilities collecting cord blood only, shall document association with a hematopoietic progenitor cell transplantation facility and compliance with the procedures, protocols and recordkeeping requirements for collection as established by the transplantation facility, as well as all requirements of this Subpart.

(c) All required clinical laboratory testing shall meet the standards of Article 5 Title V of the Public Health Law.

(d) For bone marrow harvesting procedures, adequate facilities shall be available for the administration of anesthesia and for emergency resuscitation. A qualified anesthesiologist shall be on the premises at all times during harvesting procedures.

(e) Emergency services shall be immediately available to any donor who manifests an adverse reaction.

(f) A physician shall explain the hazards of the donation procedure to the donor in such a manner that the donor is offered an opportunity to refuse consent. The donor shall be advised of the risks of hematopoietic progenitor cell donation and of the anesthesia method to be used, the potential need for transfusional support and possible side effects of each procedure, and options for disposition of hematopoietic progenitor cells no longer needed by the intended recipient. All this information shall be provided to each prospective donor in written form. The written informed consent of the prospective donor shall then be obtained. Autogeneic donors shall also be informed of the risks associated with hematopoietic progenitor cell collection. (g) Informed consent for collection of cord blood shall be obtained from the donor's mother before stem cells are placed in inventory. In all cases of in utero cord blood collection, consent shall be obtained prior to collection. (h) Hematopoietic progenitor cells from autogeneic donors shall not be destroyed or released for purposes other than infusion into the intended patient without written authorization from the director of the facility storing the hematopoietic progenitor cells and; (1) if the donor/patient is deceased, written documentation of death; or (2) if the donor/patient is living, written authorization from the physician currently responsible for treating the patient for the underlying disorder for which the hematopoietic progenitor cells were collected; and documented informed consent from the donor/patient or donor/patient's guardian, unless it is documented that no response was received within sixty (60) days to at least two (2) written requests for such consent sent at least thirty (30) days apart. Documentation of such written requests shall be maintained. (i) Hematopoietic progenitor cells from allogeneic donors shall not be destroyed or released for purposes other than transplantation into the originally intended recipient without the written authorization of the intended recipient's physician and documentation that the intended recipient, if living, has been notified that the cells will not be available.

Effective Date: 
Wednesday, July 21, 2004
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Section 58-5.4 - Donor qualifications.

58-5.4 Donor qualifications.

(a) Except in the case of an autogeneic donation, a complete donor history shall be obtained prior to hematopoietic progenitor cell donation. A summary of the donor history obtained by a hematopoietic progenitor cell procurement service shall be provided to the physician performing the transplant for a determination of the cell's suitability for transplantation. The donor history, or in the case of cord blood donation, the history of the donor's biologic mother and, if available, the donor's biologic father, shall include, but not be limited to, information concerning:

(1) any acute respiratory disease;

(2) any infectious skin disease that creates a risk of contamination of the hematopoietic progenitor cells;

(3) any disease transmissible by hematopoietic progenitor cells insofar as can be determined by donor history;

(4) active tuberculosis or history of therapy therefor;

(5) history of malaria or travel to or residence in malarially endemic areas for periods of time considered to bear increased risks for malaria exposure, as determined by criteria established by the procurement or collection facility, consistent with criteria developed by the United States Public Health Service;
(6) known coagulation or platelet disorders;

(7) any medical condition which may be affected adversely by the collection procedure;

(8) any medical condition, including a malignancy,that would adversely affect the quality of the hematopoietic progenitor cells collected; (9) receipt of an organ transplant or a transfusion of blood or blood components within the past twelve (12) months;

(10) indications of drug or alcohol abuse; and

(11) other medical conditions or circumstances as determined by the medical advisory committee and medical director of the procurement service.

(b) Except in the case of an autogeneic donation or cord blood donation, a complete physical examination of the donor shall be performed by the medical director of the procurement service or another qualified physician.

(c) For autogeneic donations, testing for syphilis, hepatitis B surface antigen (HBsAg), antibody to human immunodeficiency virus type 1 (anti-HIV-1) and antibody to human immunodeficiency virus type 2 (anti-HIV-2) shall be performed, unless already performed within the previous thirty (30) days, or unless the hematopoietic progenitor cells are collected, processed and transfused at the same facility and a system is in place to ensure disposition to the intended recipient. (d) For allogeneic hematopoietic progenitor cell donations in New York State, specimens of blood shall be collected from the donor, or in the case of umbilical cord blood, from the donor's mother, and the following tests shall be performed in a clinical laboratory under permit by the department. For out-of-state donations, all required clinical laboratory testing shall be performed by a laboratory which is approved by the regulatory authority in the state or jurisdiction where the laboratory is located, or by the department: (1) within thirty (30) days prior to or seventy-two (72) hours after donation, and prior to initiation of the transplant conditioning regimen in the recipient: (i) direct tests for indicators of infection with syphilis and cytomegalovirus CMV); (ii) HBsAg; (iii) antibody to hepatitis B core antigen (anti-HBc), antibody to hepatitis C virus (anti-HCV), anti-HIV-1, anti-HIV-2 and antibody to human T-cell lymphotropic virus type 1 (anti-HTLV-I; and (iv) except for cord blood donation, peripheral blood cell enumeration (red, white and platelet) and differential blood smear evaluation. (2) prior to ablation of the recipient, major histocompatibility antigens (HLA-A, B and DR and other minor histocompatibility antigens, including mixed lymphocyte culture or DNA typing,m as indicated. (e) Except for allogeneic donors confirmed positive for any indicator of HIV infection, the decision as to the acceptability of hematopoietic progenitor cells shall be made by the hematopoietic progenitor cell transplantation service director. Hematopoietic progenitor cells from allogeneic donors confirmed positive for any indicator of HIV infection may not be used in any case.

Effective Date: 
Wednesday, July 21, 2004
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Section 58-5.5 - Sterilization of instruments

58-5.5 Sterilization of instruments. Syringes, needles, lancets, or other phlebotomy or hematopoietic progenitor cell collection devices capable of transmitting infection from one person to another and licensed for single use by the Food and Drug Administration shall be appropriately discarded after such use. Reusable devices shall be heat-sterilized prior to each use. Heat sterilization shall be by autoclaving at 121.5 degrees Celsius for fifteen (15) minutes after the chamber of the autoclave has been evacuated and has reached that temperature, or by dry heat for two (2) hours at 170 degrees Celsius, or by such other similarly acceptable procedure in accordance with current medical standards generally accepted by leading authorities in transplantation medicine.

Effective Date: 
Wednesday, October 13, 1999
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Section 58-5.6 - Collection and handling of hematopoietic progenitor cells

58-5.6 Collection and handling of hematopoietic progenitor cells.

(a) All hematopoietic progenitor cell specimens obtained by bone marrow aspiration shall be collected by the medical director of the procurement service or other qualified physician, physician's assistant, or a nurse practitioner under the supervision of the medical director. Hematopoietic progenitor cells obtained by peripheral blood apheresis shall be collected by an individual trained in pheresis in accordance with the requirements of section 58-2.15 of this Part. Cord blood collection shall be performed by staff with documented training, experience and proficiency in the techniques utilized.

(b) Hematopoietic progenitor cell collection apparatus and containers shall be clean, pyrogen-free and sterile.

(c) Phlebotomy and bone marrow aspiration puncture sites shall be prepared by a procedure which conforms to current medical standards generally accepted by leading authorities in transplantation medicine.
(d) Hematopoietic progenitor cell collection systems shall meet the following minimum requirements:

(1) hematopoietic progenitor cells shall be collected under aseptic conditions using an approved system adequately protected against contamination;

(2) additives shall be used as required to ensure the continued suitability of hematopoietic progenitor cells for transplantation and retention of viability. All changes in additives shall be validated on-site, and such validation shall be documented;

(3) each container shall be legibly labeled or tagged at the time of collection with:

(i) the donor's identification code and date of collection; and

(ii) if known, the recipient/patient's name, the name of the hospital where the patient is to be transplanted, and the patient's hospital registration number or, if unavailable, Social Security number, birthdate, or similar identifying information; (4) each final container shall be legibly labeled or tagged at the time of issuance with:

(i) if performed, the results of laboratory tests for syphilis, HBsAg, and antibodies to HBV, HCV, HIV-1, HIV-2, HTLV-I and CMV, unless the results were forwarded to the hematopoietic progenitor cell transplantation service in advance or included in records accompanying the hematopoietic progenitor cells; and

(ii) a biohazard label, if the donor has tested reactive or positive for any of the tests required in section 58-5.4(c) or (d)(1) of this Subpart; and

(5) if microbial culturing is performed, suspected contamination shall be reported to the transplantation service. (e) Prior to collection of cord blood, an access agreement/ acknowledgment shall be consummated between the administration of the hospital or other collection site and the licensed cord blood bank.

Effective Date: 
Wednesday, July 21, 2004
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Complete

Section 58-5.7 - Hematopoietic progenitor cell processing facilities

58-5.7 Hematopoietic progenitor cell processing facilities.

(a) If hematopoietic progenitor cells are to be frozen, the following requirements apply:

(1) unless otherwise specifically authorized in writing by the director of the hematopoietic progenitor cell processing facility, hematopoietic progenitor cells shall be frozen within forty-eight (48) hours of collection, using cryopreservation techniques generally accepted by experts in transplantation medicine and meeting the requirements of this Subpart;

(2) until used, hematopoietic progenitor cells shall be stored continuously within a temperature range of minus 196 degrees Celsius to minus 80 degrees Celsius, under one of the following conditions: (i) in a mechanical freezer reserved for hematopoietic progenitor cells, equipped with an automatic temperature recording device, an audible alarm and a back-up system in the event of unexpected mechanical failure; or (ii) in a liquid nitrogen freezer reserved for hematopoietic progenitor cells, equipped with an automatic liquid nitrogen level monitor, an audible alarm and a back-up system in the event of unexpected liquid nitrogen loss; (3) frozen hematopoietic progenitor cells in transit from a processing facility to a transplantation facility or other facility shall be:

(i) maintained, at a minimum, on dry ice or in a liquid nitrogen dry shipper. Storage/transport procedures for the frozen hematopoietic progenitor cells shall be validated, and such validation shall be documented;

(ii) transported as fast as reasonably possible and without any unnecessary delay; and
(iii) used immediately upon arrival or stored as required in paragraph (2) of this subdivision until thawed for use; and

(4) hematopoietic progenitor cell specimens shall be inspected visually at the time of freezing and thawing. If the color or physical appearance is abnormal or there is indication or suspicion of microbial contamination, the cells shall not be released for transplantation unless authorized, in writing, by the transplantation service director.
(b) Hematopoietic progenitor cells stored in the liquid state shall be maintained at a temperature and for a period of time specified in a protocol approved by the director of the hematopoietic progenitor cell procurement service and/or processing facility.
(c) Storage temperature records for hematopoietic progenitor cells shall be maintained as required in section 58-5.8(c) and (d) of this Subpart, and be made available for inspection by the department for the entire period of storage and for one year afterward. (d) Unless needed to meet a medical emergency, hematopoietic progenitor cells shall be transported in a leak-resistant, crush-resistant and puncture-resistant container featuring a prominent label which: (1) identifies the contents as "human blood", "human hematopoietic progenitor cells" or "human bone marrow"; (2) describes the contents, the packing agent, if any, and any special precautions necessary in handling such contents; and (3) contains the name, address and twenty-four (24) hour telephone number of the person or entity to be contacted in the event that the container is found leaking or damaged, or is misdirected.

Effective Date: 
Wednesday, July 21, 2004
Doc Status: 
Complete

Section 58-5.8 - Required records.

58-5.8 Required records.

(a) Complete and accurate records of hematopoietic progenitor cells released for transplantation shall be kept for seven (7) years by the hematopoietic progenitor cell procurement service, processing facility and transplantation service using the sample. Such records shall be open to inspection by the department. For all donated hematopoietic progenitor cells, the donor's name, address, and any other information that would directly or indirectly identify the donor shall not be disclosed or released by the bank to any person or entity, except upon the written consent of the donor or the person authorized by law to make the donation, or to authorized employees of the department, or as permitted by law,. The recipient's name, address, and any other information that would directly or indirectly identify the recipient shall not be disclosed or released by the hematopoietic progenitor cell bank to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law.

(b) Records to be kept by the hematopoietic progenitor cell procurement service shall include, but not be limited to, the following information:

(1) donor's full name, address, age, sex, and identification code, as well as documentation of donor or donor's mother informed consent;

(2) date and volume of hematopoietic progenitor cells collected;

(3) any adverse reaction of the donor and its outcome;

(4) medical history and results of all required clinical laboratory tests and of the physical examination performed;

(5) disposition of hematopoietic progenitor cells;

(6) documentation of sterility testing, and viability and recovery checks, if performed; and
(7) medical director's authorization for the collection.

(c) Records to be kept by the hematopoietic progenitor cell processing facility shall include, but not be limited to, the following information:

(1) donor's identification code, date and amount of cells collected;

(2) results of all clinical laboratory tests performed; (3) methods used for processing, preserving storage and transport of the hematopoietic progenitor cells, including manufacturer's name and lot numbers of all reagents used in processing or preserving the cells; (4) temperature records of the storage chamber;

(5) records of visual inspection of the hematopoietic progenitor cell specimens at the time of freezing and thawing;

(6) specimen location in the storage chamber;

(7) methods used for hematopoietic progenitor cell preservation, storage and transport; and

(8) disposition of the cells.

(d) Whenever hematopoietic progenitor cells are released for transplantation, the following records shall be maintained by the hematopoietic progenitor cell transplantation facility:

(1) name of the hematopoietic progenitor cell bank providing the cells, description of the specimen, and condition of the cells and shipping container upon receipt, including any loss noted of liquid nitrogen, dry ice or other coolant; (2) if applicable, any extenuating circumstances that warrant acceptance of hematopoietic progenitor cells from donors who test positive;

(3) medical history and results of all tests, and of the physical examination performed on the donor, if applicable;
(4) disposition of the hematopoietic progenitor cells, including date and time released, and name of recipient; (5) outcome of the transplantation procedure, including, but not limited to, any adverse outcome or infectious disease in the recipient; and (6) if applicable, records documenting storage and temperature monitoring of hematopoietic progenitor cells, in accordance with the requirements in section 58-5.7 of this Subpart.

Effective Date: 
Wednesday, July 21, 2004
Doc Status: 
Complete

Section 58-5.9 - Quality assurance and safety requirements

58-5.9 Quality assurance and safety requirements.

(a) Quality assurance. (1) The hematopoietic progenitor cell procurement service and hematopoietic progenitor cell processing facility shall keep records which indicate that a quality assurance program is maintained in the following areas:

(i) preventive maintenance, periodic inspections and testing for proper operation of equipment;

(ii) monitoring of all temperature-controlled spaces and equipment to ensure proper performance;

(iii) validation of microprocessor-controlled equipment and associated software, including test plan protocols, results of parallel testing and supervisory review; and

(iv) validation of hematopoietic progenitor cell processing and testing methodologies.

(2) Hematopoietic progenitor cell processing, laboratory and storage facilities shall be maintained in a clean and orderly manner, and shall be of suitable size, construction and location to assure product and personnel safety.

(3) All reagents and solutions shall be in-date, stored properly and labeled to indicate identity and, as appropriate, titer, strength or concentration, recommended storage requirements, preparation and/or expiration date, and other pertinent information. All such materials shall be removed from use on the expiration date. Materials of substandard reactivity and deteriorated materials shall be discarded regardless of expiration date.

(4) All specimens accompanying the collected hematopoietic progenitor cells shall be sufficiently stable to provide accurate and precise test results suitable for clinical interpretation. The hematopoietic progenitor cell procurement service shall ensure that specimens are collected, preserved and transported to the laboratory in such a manner as to meet this requirement. Specimens for analysis shall be identified fully and accessioned in a log book. The accessioning system shall be designed to allow tracing of the hematopoietic progenitor cells to a specific donor, and to identify the date and, if applicable, the time of retrieval.

(5) Current standard operating procedure manuals specific to the facility shall be available at all times in the immediate work area of personnel engaged in retrieval, processing, testing, storage, distribution or other hematopoietic progenitor cell procurement activity. There shall be a written protocol for all procedures performed. Manuals shall contain a protocol for development, maintenance and periodic review of standard operating procedures by facility personnel and management staff. Procedure manuals shall have the following features:

(i) a standardized format for procedures;

(ii) a system of numbering and/or titling individual procedures;

(iii) a clearly written description of purpose for each procedure;

(iv) a reference section listing appropriate scientific literature and industry and/or corporate standards espoused by the hematopoietic progenitor cell procurement servuce and/or processing facility;

(v) clearly defined areas of employee or technical staff responsibility by position/title;

(vi) documented approval of procedures and procedural modifications, including annual review by the director of the hematopoietic cell procurement service and/or processing facility, or authorized supervisor;

(vii) instructions for the completion of reports and forms, including examples;

(viii) effective date and date of review for each procedure; and
(ix) a system for archiving earlier versions of procedures and forms. (6) The policies and procedures specified in the procedure manual shall be followed at all times. If deviations or deficiencies are identified, appropriate corrective action shall be taken and documented.

(7) The director of the hematopoietic progenitor cell procurement service and/or processing facility shall establish and maintain a planned and periodic internal review program for monitoring and evaluating the quality and appropriateness of the hematopoietic progenitor cell banking services. Included in the program shall be systems for evaluating errors, and designing, implementing and documenting corrective action for any deficiencies identified. Quality assurance deficiencies shall be documented, and evidence shall be available that any operational or procedural problems are reported to supervisory personnel in a timely manner, and that corrective action is implemented, documented and subsequently followed-up. (8) The director of the hematopoietic progenitor cell procurement service and/or hematopoietic progenitor cell processing facility shall be responsible for developing policies, procedures and/or standards for the qualifications, training, certification and continuing education of technical staff. Documentation of compliance with this requirement and with the policies developed shall be maintained. (b) Safety. (1) The hematopoietic progenitor cell procurement service and/or processing facility shall implement written safety and infection control policies and procedures to ensure protection from unnecessary physical, chemical and biological hazards, as follows:

(i) Decontamination and disposal techniques for regulated medical waste shall be utilized. All hazardous and regulated medical waste materials shall be handled, stored and discarded pursuant to Part 70 of this Title.

(ii) If sterilization equipment is used, the pressure, temperature and duration of each cycle shall be recorded and such records maintained for one year. For each run, these parameters shall be within the manufacturer's recommended operating standards. If any one or more of these parameters fall(s) outside the manufacturer's standards, all material shall be resterilized. Chemical, biological and physical detection systems should be used in conjunction with these other measurements of performance.

(iii) Eating, drinking, smoking or the application of cosmetics or contact lenses shall not be permitted in the work areas. Refrigerators or freezers used for storing specimens or reagents shall not be used for any other purpose. (iv) Gloves and laboratory coats, gowns or other protective clothing shall be worn as necessary while handling blood specimens or hematopoietic progenitor cell tissue. Such protective clothing shall not be worn outside the work area and shall be disposed of in an appropriate receptacle.

(2) The hematopoietic progenitor cell procurement service and/or processing facility shall have written policies and procedures in the following areas:

(i) infection control;

(ii) biosafety;

(iii) chemical and radiological safety;

(iv) emergency response to worksite accidents; and

(v) medical waste disposal.

(3) The safe collection of peripheral blood hematopoietic progenitor cells by apheresis shall be the responsibility of the medical director of the apheresis service. Collection shall be performed in full compliance with section 58-2.15 of this Part. (4) Hematopoietic progenitor cell transplantation facilities shall report suspected cases of infectious disease transmission in recipients to the hematopoietic progenitor cell bank providing the tissue. (5) The hematopoietic progenitor cell bank shall have a written procedure for documenting any errors or accidents in retrieval, testing, processing, storage or disposition of hematopoietic progenitor cells that may affect the safety of the cells, and for reporting such errors or accidents to the medical advisory committee of the bank. If the error or accident is detected after issuance of the cells, the error or accident shall be reported to the receiving facility immediately upon detection by the distributing facility. All errors with the potential for serious adverse effects on the recipient shall also be reported to the department's Wadsworth Center within seven (7) calendar days of discovery.

Effective Date: 
Wednesday, July 21, 2004
Doc Status: 
Complete

Section 58-5.10 - Compliance with standards

58-5.10 Compliance with standards.

(a) Hematopoietic progenitor cell procurement services and/or processing facilities shall allow admission to representatives of the department for the purpose of inspecting the premises and evaluating operating procedures, equipment and records, including financial records and lists of physicians or facilities to whom or to which hematopoietic progenitor cells are released, to determine compliance with the standards in this Subpart. If the commissioner determines that a significant likelihood exists that adequate safeguards are not implemented, the department may require that cells not be released pending a hearing. Such hearing shall commence within fifteen (15) days of any suspension pursuant to this section.

(b) Whenever requested, a hematopoietic progenitor cell bank shall submit to the department reports containing such information and and data concerning the bank's activities as may be required by this Subpart. Such reports shall be signed by the director of the hematopoietic progenitor cell bank.

Effective Date: 
Wednesday, July 21, 2004
Doc Status: 
Complete

Section 58-5.11 - Licensure

58-5.11 Licensure.

No person shall own or operate a hematopoietic progenitor cell procurement service, processing facility or transplantation facility in New York State unless licensed by the department under Subpart 52-2 of this Title. All provisions of Subpart 52-2 of this Title shall apply to a hematopoietic progenitor cell procurement service, processing facility and/or transplantation facility, except for the record keeping requirements contained in section 52-2.9 of this Title.

Effective Date: 
Wednesday, October 13, 1999
Doc Status: 
Complete

Section 58-5.12 - Special circumstances

58-5.12 Special circumstances.

(a) The department may exempt a hematopoietic progenitor cell bank from a specific standard contained in this Subpart, provided:

(1) the hematopoietic progenitor cell bank has requested an exemption under limited circumstances prior to the noncompliance with the standard; and

(2) the hematopoietic progenitor cell bank has demonstrated to the department that application of the standard to such bank under the limited circumstances for which the exemption is sought:

(i) is inconsistent with the provision of the particular service, as documented in properly conducted current medical or scientific research, or current scientific literature;

(ii) is incompatible with a requirement imposed by a federal or other state's government unit which is similar to the standard for which the exemption is sought, and the department determines that the requirement imposed by the federal or other state's governmental unit adequately protects the public health, safety and welfare, based upon commonly accepted medical standards, properly conducted medical or scientific research, or current scientific literature; or

(iii) would prevent or impair the provision of services necessitated by a medical emergency or special medical condition. Hematopoietic progenitor cell banks seeking an exemption pursuant to this subparagraph shall describe the nature of the emergency or special medical condition and the exemption requested, for review on a case-by-case basis by the department. All such emergencies or special medical conditions shall be documented in the medical record, and any action taken in response which is contrary to the requirements of this Subpart shall be approved by the director of the hematopoietic progenitor cell transplantation service.

(b) A copy of the department's approval for an exemption shall be maintained by the hematopoietic progenitor cell transplantation facility and the hematopoietic progenitor cell bank releasing the cells.

Effective Date: 
Wednesday, October 13, 1999
Doc Status: 
Complete

SubPart 58-6 - Repealed

Effective Date: 
Wednesday, July 21, 1993

SubPart 58-7 - Repealed

Effective Date: 
Wednesday, March 12, 1997

SubPart 58-8 - Human Immunodeficiency Virus (HIV) Testing

Effective Date: 
Wednesday, December 23, 2015
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, section 576

Section 58-8.1 - Definitions

Section 58-8.1 Definitions. For the purposes of this Subpart, unless the context indicates otherwise, the terms below shall have the following meanings:

(a) Department means the New York State Department of Health.

(b) Donor means a human being, living or dead, who is the source or potential source of a body, organ, tissue or fluid for transfusion, transplantation, transfer, artificial insemination or implantation.

(c) FDA means the Food and Drug Administration of the United States Department of Health and Human Services.

(d) HIV antibody screening means the performance of tests to detect HIV antibodies, which tests are not sufficiently specific to ensure definitive evidence of HIV infection.

(e) HIV identification testing means the performance of tests to detect or characterize HIV or HIV viral components, including, but not limited to, HIV protein and HIV nucleic acid. HIV identification testing shall also include cultivation of the infectious virus.

(f) HIV confirmatory testing means the performance of one or more supplemental tests to substantiate or refute results of HIV testing procedures that are not sufficiently specific to ensure definitive evidence of HIV infection.

(g) HIV diagnostic testing means the performance of HIV tests for purposes of diagnosing, assessing or monitoring HIV infection in persons who may have been exposed to HIV, are at risk of exposure to HIV, or are known to be HIV infected, but shall not include testing of donors. HIV testing of individuals in conjunction with an application for insurance shall be considered HIV diagnostic testing whenever test results are communicated to the applicant or his/her medical provider by the insurance company's medical director or a consulting physician or a physician under the medical director's supervision. (h) Preliminary finding of HIV infection means results of antibody screening that have been neither substantiated nor refuted by HIV confirmatory testing.

Effective Date: 
Wednesday, August 13, 2003
Doc Status: 
Complete

Section 58-8.2 - HIV testing and record keeping requirements

58-8.2 HIV testing and record keeping requirements. In addition to other applicable requirements in this Part, and Parts 52 and 63 of this Title, clinical laboratories, blood banks and tissue banks with a New York State clinical laboratory permit to perform HIV testing shall meet the following requirements:

(a) Specimens for testing patients, donors and insurance applicants shall be only of the type approved by the FDA or acceptable to the department for use with the particular method or test kit.

(b) All tests shall employ reagents, methods, techniques and procedures approved by the FDA or acceptable to the department in conformance with generally accepted laboratory principles.

(c) If the test result is to be communicated to the test subject or other person legally authorized to receive the result, results for specimens found reactive in accordance with the test manufacturer's interpretation of HIV antibody screening test results shall be confirmed with HIV confirmatory testing.

(d) Confirmatory testing shall be performed as soon as practicable in all cases when notification of a preliminary finding of HIV infection is made.

(e) A standard operating procedure manual (SOPM) shall be developed and maintained current, and shall include, in addition to documentation required elsewhere in this Part and Part 52 of this Title, algorithms for use of each HIV test method or test kit, and policies and processes for accepting specimens, reporting results, and ensuring compliance with confidentiality requirements and, as applicable, reporting requirements of Article 21, Title III and Article 27-F of the Public Health Law and New York State Insurance Law section 2611(c).

Effective Date: 
Wednesday, August 13, 2003
Doc Status: 
Complete

Section 58-8.3 - Confidentiality

58-8.3 Confidentiality.

Each clinical laboratory, blood bank, tissue bank or organ procurement organization performing, or causing the performance or receiving the results of HIV testing shall establish and implement procedures for confidentiality, disclosure and re-disclosure consistent with applicable federal and state law and regulations, including Article 27-F of the Public Health Law and New York State Insurance Law section 2611(c). No bill, claim for reimbursement or invoice issued by a clinical laboratory, blood or tissue bank or its agent shall disclose the nature of the service rendered to a named individual by using the acronym HIV, or the words human immunodeficiency virus or similar identifying words, unless disclosure is authorized by law and the intended recipient of the bill, claim or invoice is an entity subject to New York State or federal confidentiality, disclosure and re-disclosure requirements.

Effective Date: 
Wednesday, August 13, 2003
Doc Status: 
Complete

Section 58-8.4 - HIV result reporting requirements

58-8.4 HIV result reporting requirements. 

(a) No clinical laboratory shall notify a physician or other person legally authorized to receive the result that an HIV test is positive solely on the basis of HIV antibody screening, except that a clinical laboratory may report a preliminary finding of HIV infection as provided in section 58-1.8 of this Part. Results for specimens found non-reactive by HIV antibody screening may be reported to the physician who ordered the testing or other person legally authorized to receive the result. 

(b) For HIV diagnostic testing, a report of preliminary finding of HIV infection shall prominently and clearly state that the finding is preliminary, that results of confirmatory testing will follow, and that such confirmatory results must be considered in making a diagnosis related to HIV infection.

(c) No blood, tissue or organ donor, or consenting next of kin shall be notified that an HIV test result is positive solely on the basis of HIV antibody screening.

Effective Date: 
Wednesday, December 23, 2015
Doc Status: 
Complete

Part 59 - Chemical Analyses of Blood, Urine, Breath or Saliva for Alcoholic Content

Effective Date: 
Wednesday, December 7, 2011
Doc Status: 
Complete
Statutory Authority: 
Environmental Conservation Law, § 11-1205(6); Vehicle and Traffic Law, §§ 1194(4)(c), 1198(6)

Section 59.1 - Definitions

Section 59.1 Definitions.

(a) Techniques and methods means the collection, processing and determination of the alcoholic content of body fluids such as human blood, saliva or urine, and of breath or alveolar air by protocols and/or instruments determined by the commissioner to be acceptable.

(b) Per centum by weight of alcohol as used in the Vehicle and Traffic Law and the Environmental Conservation Law means percent weight per volume, that is, grams of alcohol per 100 milliliters of whole blood.

(c) Chemical tests/analyses include breath tests conducted on breath analysis instruments approved by the commissioner in accordance with section 59.4 of this Part.

(d) Training agency or agencies means the Office of Public Safety of the Division of Criminal Justice Services, the Division of State Police, the Nassau County Police Department, the Suffolk County Police Department, and/or the New York City Police Department.

(e) Commissioner means the New York State Commissioner of Health.

(f) Department means the New York State Department of Health.

(g) Ignition interlock device means any blood alcohol concentration equivalence measuring device which connects to a motor vehicle ignition system and prevents a motor vehicle from being started without first determining through a deep lung breath sample that the operator's equivalent blood alcohol level does not exceed the calibrated setting on the device as required by standards in this Part.

(h) Blood alcohol concentration (BAC) means the weight amount of alcohol contained in a unit volume of blood, measured as grams ethanol/100ml blood and expressed as %, grams %, % weight/volume (w/v), and % BAC. Blood alcohol concentration in this Part shall be designated as % BAC.

(i) Testing laboratory means a nationally recognized, independent materials testing laboratory that is not affiliated with, and operates autonomously from, any ignition interlock device manufacturer, is properly equipped and staffed to carry out test procedures required by this Part, and is independently accredited in accordance with requirements for the competence of testing and calibration laboratories promulgated as a standard by the International Organization for Standardization (ISO), or other commensurate standard acceptable to the department. (j) Breath analysis instrument means a device that complies with section 59.4 of this Part. (k) Saliva means oral fluid. (l) Calibration means the activity of verifying that a value generated by the instrument is in acceptable agreement with the assigned value for a traceable and/or certified reference standard, including any adjustment to the instrument to bring it into acceptable agreement.

Effective Date: 
Wednesday, December 7, 2011
Doc Status: 
Complete

Section 59.2 - Techniques and methods for determining blood and urine alcohol

59.2 Techniques and methods for determining blood and urine alcohol.

(a) All blood and urine alcohol determinations shall be made by quantitative methods and reported as whole blood alcohol concentration (BAC) to the second decimal place as found; for example, 0.137 percent found shall be reported as 0.13 percent weight per volume. If specimens other than whole blood are analyzed, the following conversions shall apply:

(1) three fourths of the determined concentration of alcohol in the urine shall be equivalent to the corresponding BAC; and

(2) nine tenths of the determined concentration of alcohol in the serum or plasma shall be equivalent to the corresponding BAC.

(b) Analytical procedures for blood and urine alcohol analysis shall include the following controls in conjunction with any sample or series of 10 samples analyzed sequentially or simultaneously:

(1) a blank analysis as appropriate; and

(2) analysis of a suitable reference sample of known alcoholic content greater than or equal to 0.08 percent weight per volume, the result of which analysis shall agree with the reference sample value within the limits of plus or minus 0.01 percent weight per volume or such limits as specified by the commissioner.

(c) An analysis of urine shall be made upon two specimens collected at least 30 minutes apart. (d) If a blood specimen is to be collected for analysis, an aqueous solution of a nonvolatile antiseptic shall be used on the skin. Alcohol or phenol shall not be used as a skin antiseptic. (e) Specimens shall be clearly identified at the time of collection.

Effective Date: 
Wednesday, December 7, 2011
Doc Status: 
Complete

Section 59.3 - Blood, urine and saliva alcohol analysis; permits

59.3 Blood, urine and saliva alcohol analysis; permits.

(a) Individuals performing chemical analyses for blood, urine and saliva alcohol content may apply to the commissioner for a permit.

(b) A permit for the performance of chemical analyses for blood, urine and saliva alcohol content shall be issued by the commissioner to an applicant who:

(1) is a high school graduate and has one year of laboratory experience acceptable to the commissioner; or

(2) has satisfactorily completed two years of college study and has six months of laboratory experience acceptable to the commissioner; and

(3) demonstrates to the satisfaction of the commissioner proficiency in the chemical analyses of the alcoholic content of blood and any other sample type that the commissioner requires; and

(4) has access to appropriate laboratory facilities for the performance of such analyses.

(c) The applicant shall demonstrate proficiency in the techniques and methods of analysis by correctly analyzing and reporting results, within limits of accuracy established by the commissioner, for 75 percent of the samples for each set of proficiency tests issued by the commissioner.

(d) A permit shall be issued for a period of one year and may be renewed annually thereafter. A permit shall not be issued or renewed if, for two consecutive sets of proficiency tests; the applicant or permit holder:

(1) does not meet the proficiency requirements of this section; or

(2) fails to report proficiency test results; or

(3) reports results after three weeks from the date of distribution of proficiency test samples, except that the commissioner, for good cause, may extend such time on request made during such three-week period.
 

Effective Date: 
Wednesday, December 7, 2011
Doc Status: 
Complete

Section 59.4 - Breath analysis instruments

59.4 Breath analysis instruments.

(a) The commissioner approves, for use in New York State, breath analysis instruments found on the Conforming Products List of Evidential Breath Alcohol Measurement Devices as established by the U.S. Department of Transportation/National Highway Traffic Safety Administration (NHTSA), published in the Federal Register on March 11, 2010 (75 Fed. Reg. 11624-11627, available for public inspection and copying at the Department of Health Records Access Office, Corning Tower, Empire State Plaza, Albany, NY 12237). A facsimile of that list is set forth in subdivision (b) of this section. At the request of a training agency, the commissioner may approve a breath analysis instrument that has been accepted by NHTSA but is not on the Conforming Products List published in the Federal Register on March 11, 2010, if the commissioner determines that approval of such instrument is appropriate.

(b) Conforming Products List of Evidential Breath Measurement Devices

Federal Register/ Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices

Conforming Products List of Evidential Breath Measurement Devices

 

Manufacturer and model

Mobile

Nonmobile

 

 

 

Alcohol Countermeasure Systems Corp., Mississauga, Ontario, Canada:

 

 

     Alert J3AD *

X

X

     Alert J4X.ec

X

X

     PBA3000C

X

X

BAC Systems, Inc., Ontario, Canada:

 

 

     Breath Analysis Computer *

X

X

CAMEC Ltd., North Shields, Tyne and Ware, England:

 

 

     IR Breath Analyzer *

X

X

CMI, Inc., Owensboro, Kentucky:

 

 

     Intoxilyzer Model:

 

 

          200

X

X

          200D

X

X

          240 (aka: Lion Alcolmeter 400+ outside the U.S.)

X

X

          300

X

X

          400

X

X

          400PA

X

X

          1400

X

X

          4011 *

X

X

          4011A *

X

X

          4011AS *

X

X

          4011AS–A *

X

X

          4011AS–AQ *

X

X

          4011 AW *

X

X

          4011A27–10100 *

X

X

          4011A27–10100 with filter *

X

X

          5000

X

X

          5000 (w/Cal. Vapor Re-Circ.)

X

X

          5000 (w/3/18" ID Hose option)

X

X

          5000CD

X

X

          5000CD/FG5

X

X

          5000EN

X

X

          5000 (CAL DOJ)

X

X

          5000VA

X

X

          8000

X

X

          PAC 1200 *

X

X

          S–D2

X

X

          S–D5 (aka: Lion Alcolmeter SD–5 outside the U.S.)

X

X

Draeger Safety, Inc. (aka: National Draeger) Irving, Texas:

 

 

     Alcotest Model:

 

 

          6510

X

X

          6810

X

X

          7010 *

X

X

          7110 *

X

X

          7110 MKIII

X

X

          7110 MKIII-C

X

X

          7410

X

X

          7410 Plus

X

X

          7510

X

X

          9510

X

X

     Breathalyzer Model:

 

 

          900

X

X

          900A *

X

X

          900BG *

X

X

          7410

X

X

          7410–II

X

X

EnviteC by Honeywell GmbH, Fond du Lac, Wisconsin:

 

 

     AlcoQuant 6020

X

X

Gall's Inc., Lexington, Kentucky:

 

 

     Alcohol Detection System-A.D.S. 500

X

X

Guth Laboratories, Inc., Harrisburg, Pennsylvania:

 

 

     Alcotector BAC–100

X

X

     Alcotector C2H5OH

X

X

Intoximeters, Inc., St. Louis, Missouri:

 

 

     Photo Electric Intoximeter *

 

X

     GC Intoximeter MK II *

X

X

     GC Intoximeter MK IV *

X

X

     Auto Intoximeter *

X

X

     Intoximeter Model:

 

 

          3000

X

X

          3000 (rev B1) *

X

X

          3000 (rev B2) *

X

X

          3000 (rev B2A) *

X

X

          3000 (rev B2A) w/FM option *

X

X

          3000 (Fuel Cell) *

X

X

          3000 D *

X

X

          3000 DFC *

X

X

          Alcomonitor

 

X

          Alcomonitor CC

X

X

          Alco-Sensor III

X

X

          Alco-Sensor III (Enhanced with Serial Numbers above 1,200,000)

X

X

          Alco-Sensor IV

X

X

          Alco-Sensor IV XL

X

X

          Alco-Sensor V

X

X

          Alco-Sensor AZ

X

X

          Alco-Sensor FST

X

X

          Intox EC/IR

X

X

          Intox EC/IR II

X

X

          Intox EC/IR II (Enhanced with serial number 10,000 or higher)

 

X

          Portable Intox EC/IR

X

X

          RBT–AZ

X

X

          RBT–III

X

X

          RBT III–A

X

X

          RBT IV

X

X

          RBT IV with CEM (cell enhancement module)

X

X

Komyo Kitagawa, Kogyo, K.K., Japan:

 

 

     Alcolyzer DPA–2 *

X

X

     Breath Alcohol Meter PAM 101B *

X

X

Lifeloc Technologies, Inc., (formerly Lifeloc, Inc.), Wheat Ridge, Colorado:

 

 

     PBA 3000B

X

X

     PBA 3000-P *

X

X

     PBA 3000C

X

X

     Alcohol Data Sensor

X

X

     Phoenix

X

X

     Phoenix 6.0

X

X

     EV 30

X

X

     FC 10

X

X

     FC 20

X

X

Lion Laboratories, Ltd., Cardiff, Wales, United Kingdom:

 

 

     Alcolmeter Model:

 

 

          300

X

X

          400

X

X

          400+ (aka: Intoxilyzer 240 in the U.S.)

X

X

          SD–2 *

X

X

          SD–5 (aka: S–D5 in the U.S.)

X

X

          EBA*

X

X

     Intoxilyzer Model:

 

 

           200

X

X

           200D

X

X

           1400

X

X

           5000 CD/FG5

X

X

           5000 EN

X

X

Luckey Laboratories, San Bernardino, California:

 

 

     Alco-Analyzer Model:

 

 

           1000 *

 

X

           2000 *

 

X

Nanopuls AB, Uppsala, Sweden:

 

 

      Evidenzer

X

X

National Patent Analytical Systems, Inc., Mansfield, Ohio:

 

 

     BAC DataMaster (with or without the Delta-1 accessory):

 

 

          BAC Verifier DataMaster (w/or without the Delta-1

          accessory)

X

X

          DataMaster cdm (w/or without the Delta-1 accessory)

X

X

          DataMaster DMT

X

X

Omicron Systems, Palo Alto, California:

 

 

     Intoxilyzer Model:

 

 

          4011 *

X

X

          4011AW *

X

X

PAS International, Fredericksburg, Virginia:

 

 

     Mark V Alcovisor

X

X

Plus 4 Engineering, Minturn, Colorado:

 

 

     5000 Plus 4 *

X

X

Seres, Paris, France:

 

 

     Alco Master

X

X

     Alcopro

X

X

Siemans-Allis, Cherry Hill, New Jersey:

 

 

     Alcomat *

X

X

     Alcomat F *

X

X

Smith and Wesson Electronics, Springfield, Massachusetts:

 

 

     Breathalyzer Model:

 

 

          900 *

X

X

          900A *

X

X

          1000 *

X

X

          2000 *

X

X

          2000 (non-Humidity Sensor) *

X

X

Sound-Off, Inc., Hudsonville, Michigan:

 

 

     AlcoData

X

X

     Seres Alco Master

X

X

     Seres Alcopro

X

X

Stephenson Corp.:

 

 

     Breathalyzer 900 *

X

X

Tokai-Denshi Inc., Tokyo, Japan:

 

 

     ALC–PRO II (US)

X

X

U.S. Alcohol Testing, Inc./Protection Devices, Inc., Rancho Cucamonga, California:

 

 

     Alco-Analyzer 1000

 

X

     Alco-Analyzer 2000

 

X

     Alco-Analyzer 2100

X

X

Verax Systems, Inc., Fairport, New York:

 

 

     BAC Verifier *

X

X

     BAC Verifier Datamaster

X

X

     BAC Verifier Datamaster II *

X

X

 

* Instruments marked with an asterisk (*) meet the Model Specifications detailed in 49 FR 48854 (December 14, 1984) (i.e., instruments tested at 0.000, 0.050, 0.101, and 0.151 BAC.) Instruments not marked with an asterisk meet the Model Specifications detailed in 58 FR 48705 (September 17, 1993), and were tested at BACs = 0.000, 0.020, 0.040, 0.080, and 0.160. All instruments that meet the Model Specifications currently in effect (dated September 17, 1993) also meet the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

(c) No law enforcement agency shall use a breath analysis instrument unless the training agency has verified that representative samples of the specific make and model perform properly. Maintenance shall be conducted as specified by the training agency, and shall include, but shall not be limited to, calibration at a frequency as recommended by the device manufacturer or, minimally, annually.

(d) Training agencies shall be responsible for maintaining records pertaining to verification and maintenance (including calibration) of breath analysis instruments and standards; provided, however, that record keeping maintenance may be delegated, in whole or in part, to the law enforcement agency using the breath analysis instrument(s).

Effective Date: 
Wednesday, December 7, 2011
Doc Status: 
Complete

Section 59.5 - Breath analysis; techniques and methods

59.5 Breath analysis; techniques and methods. The following breath analysis techniques and methods shall be a component of breath analysis instrument operator training provided by training agencies and shall be used by operators performing breath analysis for evidentiary purposes:

(a) A breath sample shall be collected at the direction and to the satisfaction of a police officer and shall be analyzed with breath analysis instruments meeting the criteria set forth in section 59.4 of this Part.

(b) The subject shall be observed for at least 15 minutes prior to the collection of the breath sample, during which period the subject must not have ingested alcoholic beverages or other fluids, regurgitated, vomited, eaten, or smoked, or have placed anything in his/her mouth; if the subject should regurgitate, vomit, smoke or place anything in his/her mouth, an additional 15-minute waiting period shall be required.

(c) A system purge shall precede both the testing of each subject and the analysis of the reference standard.

(d) The result of an analysis of a reference standard with an alcoholic content greater than or equal to 0.08 percent must agree with the reference standard value within the limits of plus or minus 0.01 percent weight per volume, or such limits as set by the commissioner. An analysis of the reference standard shall precede or follow the analysis of the breath of the subject in accordance with the test sequence established by the training agency. Readings for the reference standard, a blank and the subject's breath, shall be recorded.

(e) Results of an analysis of breath for alcohol shall be expressed in terms of percent weight per volume, to the second decimal place as found; for example, 0.237 percent found shall be reported as 0.23 percent.

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Section 59.6 - Breath analysis permit program

59.6 Breath analysis permit program. Training agencies shall submit an application for approval of a breath analysis permit program or a training program for breath analysis to the commissioner. Other agencies seeking approval of such programs shall submit an application to the commissioner through the Office of Public Safety of the Division of Criminal Justice Services. The application shall include:

(a) a description of the techniques and methods to be utilized;

(b) the make and model of the breath analysis instruments used;

(c) an outline of the material presented in the breath analysis instrument operator and technical supervisor training program;

(d) the name of the individual primarily responsible for each training program and for the breath analysis program;

(e) the name and qualifications of one or more individuals meeting the requirements for technical supervisor under section 59.9 of this Part; and

(f) such other information as the commissioner shall require.
 

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Section 59.7 - Breath analysis operator permits

59.7 Breath analyzer operator permits.

(a) A permit valid for two years shall be issued by the commissioner to breath analysis instrument operators who have completed an approved program based upon standards acceptable to the training agency and certified by the commissioner. Such program shall consist of a minimum of 24 hours of instruction and training with identified learning objectives, supervised by one or more individuals certified as technical supervisors, and shall include:

(1) three hours of instruction on the effects of alcohol on the human body;

(2) five hours of instruction on operational principles of the selected techniques and methods, including a functional description and a detailed operational description of the breath analysis instrument(s) with a demonstration;

(3) five hours of instruction on the legal aspects of chemical tests generally, and of the particular techniques and methods to be employed;

(4) three hours of instruction on supplemental information to include nomenclature appropriate to the field of chemical tests for alcohol;

(5) six hours of laboratory participation using approved breath analysis instruments and simulators, or other reference standards;

(6) a passing score on a one-hour formal examination designed to evaluate whether the operator has met the course learning objectives; and

(7) a demonstration of analytical proficiency on each breath analysis instrument for which the operator is seeking certification.

(b) A permit as a breath analysis instrument operator shall be renewed for a two-year period, provided that, within the 120 calendar days preceding the permit's expiration date, the operator: completes a retraining program that minimally includes an instructional course in breath analysis designed to refresh and update the operator's knowledge in areas described in subdivision (a) of this section; satisfactorily meets the course's learning objectives as determined by a technical supervisor; demonstrates analytical proficiency on each breath analysis instrument for which the operator is seeking permit renewal; and attains a passing score on a formal examination; or, in lieu of such formal retraining, with the concurrence of the responsible training agency, provided that the operator and his/her superior officer submits to the training agency, a written declaration that the operator has performed six or more breath analyses on subjects in accordance with this Part on each breath analysis instrument for which the operator is seeking permit renewal during the 24 months preceding permit expiration. Notwithstanding such a submission, every four years all operators shall participate successfully in the retraining course described in this subdivision. (c)(1) Whenever a breath analysis instrument operator's permit is not renewed prior to the expiration date, the commissioner may extend such expiration date for 30 calendar days, provided that the training agency and operator jointly submit a written request for such extension, describing the reasons for the failure to renew in a timely manner. The operator's permit shall remain valid during the 30-day extension period. (2) If the operator fails to meet the conditions for permit renewal pursuant to subdivision (b) of this section within the extension period authorized pursuant to paragraph (1) of this subdivision, the permit shall become void and not renewable; an operator whose permit becomes void may apply for a new permit by repeating the requirements of subdivision (a) of this section; and the effective date of any such new permit shall be the date of commissioner approval, without back dating to the date on which the prior permit became void. (d) A training agency shall submit to the commissioner documentation of breath analysis instrument operator training for initial issuance and renewal of a permit in a format designated by the commissioner.
 

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Section 59.8 - Revocation or suspension of permits

59.8 Revocation or suspension of permits.

(a) The commissioner or the training agencies may at any time and from time to time require breath analysis instrument operators or technical supervisors to demonstrate their ability to operate properly the breath analysis instrument(s) for which they hold a permit.

(b) The operator's permit may be revoked by the commissioner based on information acquired by the commissioner, or a training agency, that the operator does not conduct breath tests in accordance with techniques and methods as instructed by the training agency, that the operator's performance is unreliable, or the operator is incompetent. Upon revocation, the operator shall return any and all permits to the commissioner.

(c) The training agency may suspend the permit of any operator under its supervision when, in its judgment, the operator does not conduct breath tests in accordance with techniques and methods as established by the training agency, the operator's performance is unreliable or the operator is incompetent. The training agency shall immediately notify the commissioner in writing of any such suspension and furnish a copy of such notice to the suspended operator, who shall not be permitted to operate the breath analysis instrument until such time as the suspension is removed.

(d) An operator whose permit has been suspended by the training agency may appeal to the commissioner who shall decide whether suspension shall be affirmed or set aside. The commissioner may reinstate the permit of the operator making such appeal under such conditions as the commissioner deems necessary.

(e) An operator whose permit has been revoked shall not be eligible for a new permit within 12 months from the date of revocation or at such other time as may be determined by the commissioner.
 

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Section 59.9 - Technical supervisor; qualifications and certification

59.9 Technical supervisor; qualifications and certification.

(a) The commissioner may authorize certification of an applicant as technical supervisor for a period of four years, provided such applicant submits satisfactory evidence through the training agency that he/she meets the following qualifications:

(1) thirty semester hours of college credits, including eight semester hours of chemistry;

(2) certification as an operator of the breath analysis instrument(s) to be supervised, or possession of equivalent experience or training to qualify as an operator; and

(3) satisfactory completion of a technical supervisor's course, the content of which shall include:

(i) advanced survey of current information concerning alcohol and its effect on the human body (one hour);

(ii) operational principles and theories applicable to the program (two hours);

(iii) breath analysis instrument maintenance and calibration (two hours);

(iv) legal aspects of chemical testing (one hour); and

(v) principles of instruction (two hours); or

(4) training and experience equivalent to a technical supervisor's course and acceptable to the commissioner.

(b) A technical supervisor's certificate may be terminated by the commissioner based on documented evidence that the technical supervisor's performance is not in keeping with the best interests of the breath alcohol testing program.

(c) A technical supervisor shall have responsibility for:

(1) breath analysis instrument operator training, competency evaluation, and periodic examination to ensure maintenance of technical knowledge and proficiency;

(2) maintenance, including calibration of breath analysis instruments and equipment under his/her supervision and preparation and standardization of chemicals used for testing and/or evaluation of such chemicals, by direct performance of such tasks or by delegating performance to another person with demonstrated competency, but who need not be qualified as a technical supervisor; provided, however, whenever such tasks are so delegated, the technical supervisor shall review the work product to ensure that the assigned designee's performance meets expectations; and

(3) periodic inspection of breath analysis instrument performance.

(d) A technical supervisor's certificate may be renewed for a period of four years upon submission of a written application and statement that he/she has carried out his/her duties in accordance with this Part. Suspension or revocation pursuant to section 59.8 of this Part of a breath analysis instrument operator's permit held by a technical supervisor shall result in suspension or revocation, respectively, of the individual's certification as a technical supervisor.
 

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Section 59.10 - Certification criteria for ignition interlock devices

59.10 Certification criteria for ignition interlock devices.

(a) A manufacturer of ignition interlock devices shall apply to the department to certify a device for use in New York State. The application shall be on a form or format specified by the department with documents appended as necessary to provide the requisite information, and shall include, but not be limited to:

(1) name and address of the manufacturer, and contact information, including identification of a person to respond to department inquiries;

(2) name and model of the ignition interlock device;

(3) a detailed description of the ignition interlock device, including: instructions for its installation and operation; technical specifications, including, but not limited to, accuracy; calibration stability; data security; and capability for data collection and recording, tamper detection, and retesting; and unsupervised operation in a range of environmental conditions;

(4) the manufacturer's statement that all ignition interlock devices of the same make and model sold or offered for sale or lease, for which certification is sought, meet the requirements of this Part; and

(5) a certificate or other document from an insurance carrier licensed in New York State demonstrating that the manufacturer holds product liability insurance with minimum liability limits of one million dollars per occurrence and three million dollars aggregate. The documentation shall include the issuing company's statement that at least thirty (30) days notice will be provided to the department whenever the issuing company intends to cancel the insurance before the policy's expiration date. Liability coverage shall include defects in product design and materials, as well as in manufacture, calibration, installation and removal of devices.

(b) The manufacturer shall provide the testing laboratory with:

(1) six representative instruments of each ignition interlock device model for which certification is sought, from which the testing laboratory shall select at least two for testing;

(2) instructions for device installation and operation; and

(3) a description of the device's capabilities, including, but not limited to: security; data collection and recording; tamper detection; circumvention prevention; retesting; and unsupervised operation in a range of environmental conditions.

(c) At the request of a manufacturer of ignition interlock devices, the commissioner shall certify the ignition interlock device for use in New York State, provided the manufacturer:

(1) demonstrates, through arrangements with a testing laboratory, that the model meets or exceeds the model specifications for breath alcohol ignition interlock devices adopted by NHTSA and published in the Federal Register on April 7, 1992 (57 Fed. Reg. 11772 - 11787, available for public inspection and copying at the Department of Health Records Access Office, Corning Tower, Empire State Plaza, Albany, NY 12237);

(2) demonstrates, through arrangements with a testing laboratory, that the device meets the model specifications specified in paragraph (1) of this subdivision when calibrated to a set point of 0.025% BAC;

(3) has requested certification for a device that employs fuel cell technology or another technology with demonstrated comparable accuracy and specificity;

(4) has demonstrated that the certified device can and would be installed to allow normal operation of the vehicle after it is started, except as specifically approved by the department; and

(5) has demonstrated compliance with all the requirements of this Part.

(d) Certification shall be effective as of the date of its issuance.

(e) Certified ignition interlock devices installed in vehicles shall be uniquely serial-numbered.

(f) Each certification shall cover only one model of ignition interlock device. Modifications to a model of a device, without regard to the manufacturer's assigning a new model number, shall be reported to the department as required in section 59.12 of this Part.

(g) The department may deny, suspend or revoke the certification of an ignition interlock device for reasons including:

(1) the device does not meet the requirements for certification specified in this Part, including but not limited to, the commissioner's determination that the testing laboratory misrepresented a device's meeting such requirements;

(2) the manufacturer has failed to comply with any requirement of this Part or of Part 358 of Title 9 of the Official Compilation of Codes, Rules and Regulations of the State of New York;

(3) substantial evidence exists that devices manufactured, sold, leased, offered for sale or leased, or installed in vehicles do not function in accordance with the specifications in this Part or are easily circumvented or tampered with;

(4) substantial evidence exists that the manufacturer has not made adequate provision for effective and timely maintenance, inspection, calibration and repair of installed devices;

(5) the manufacturer is no longer in the business of manufacturing devices;

(6) the manufacturer fails to retain the required product liability insurance, including through cancellation or non-renewal;

(7) the manufacturer has been convicted of a crime or offense related to fraud; or

(8) the ignition interlock device does not meet federal model specifications for breath alcohol ignition interlock devices adopted by NHTSA after the specifications referred to in paragraph (1) of subdivision (c) of this section are adopted.

(h) Notice of an ignition interlock device’s certification, discontinuation, suspension and revocation shall be published in the State Register, and shall be provided promptly to the Division of Probation and Correctional Alternatives. The commissioner shall make available a list of certified ignition interlock devices upon request.

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Section 59.11 - Testing of ignition interlock devices

59.11 Testing of ignition interlock devices.

(a) The department may require a testing laboratory, as defined in section 59.1 of this part, to submit its credentials for department review prior to accepting any report submitted by the testing laboratory in support of an ignition interlock device manufacturer's application for certification.

(b) The testing laboratory shall provide, directly to the department, a detailed report of test data and findings of the ignition interlock device’s performance on each standard, generated by the testing laboratory, documenting that at least two representative instruments of an ignition interlock device model have successfully met the requirements of subdivision (c) of section 59.10 of this Part.

(c) The testing laboratory's report shall minimally include: a description of tests performed; data and findings for each test conducted, with numerical readouts as appropriate; a description of the effectiveness of the ignition interlock device's security provisions, if any, for detection and recording of attempted tampering and preventing circumvention; the reliability of the device's data recording features; and a description of the effectiveness of the device over a range of environmental conditions. The report shall include a dated and signed attestation by the person supervising such testing that identifies the ignition interlock device model and manufacturer, and states that all tests on the named device model were conducted in accordance with NHTSA specifications.

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Section 59.12 - Continued ignition interlock device certification

59.12 Continued ignition interlock device certification.

(a) An ignition interlock device certification shall remain in effect until:

(1) the manufacturer files a written request for discontinuance;

(2) the department issues to the manufacturer a written notice of suspension or revocation of approval; or

(3) the manufacturer modifies the device so that it does not meet the federal model specifications for breath alcohol ignition interlock devices in effect when it was certified.

(b) No manufacturer who makes an operational modification to a model of an ignition interlock device that has been certified pursuant to this Part shall release the modified device for use pursuant to Vehicle and Traffic Law Section 1198 without having obtained the express approval of the department. Manufacturers shall submit to the department a description of the intended operational modification(s),

and the commissioner shall determine either that the existing certification shall continue in effect for the ignition interlock device as modified or that the manufacturer must apply for separate certification for the modified device. For purposes of this section, "operational modification" means any change to product design or function that would or could affect the device's anti-circumvention, anti-tampering or analytical features, as determined by the department.

(c) A manufacturer shall ensure that the department is provided with documentation of current insurance by notifying the department in writing of each renewal of coverage, each change of issuing company, and each change in liability limits.

(d) The department may require manufacturers whose devices are certified pursuant to this Part to periodically renew the certifications. Information required for renewal of certification shall minimally include:

(1) verification that information on file with the department, including, but not limited to, manufacturer's address and contact person, is current;

(2) an attestation that the department has been notified of any operational modification made to the certified model, or that no modification was made; and

(3) documentation of current insurance coverage.

(e) Each device shall be provided with a supply of disposable spit-trap mouthpieces, and the manufacturer shall ensure availability of additional mouthpieces.

(f) A manufacturer shall provide to installation/service providers that install its certified device(s) a sufficient number of labels to label each device installed and replace labels as needed. The label shall contain a notice printed in at least 10-point boldface type, reading as follows: "WARNING – ANY PERSON TAMPERING, CIRCUMVENTING OR OTHERWISE MISUSING THE DEVICE IS GUILTY OF A MISDEMEANOR AND MAY BE SUBJECT TO CIVIL LIABILITY."

Effective Date: 
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