Title: 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.