Title: Section 58-1.12 - Cytopathology standards and quality assurance

Effective Date

08/09/2006

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.

Volume

VOLUME A-1 (Title 10)

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