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Title: Section 58-1.3 - Clinical laboratory and blood bank supervision

Effective Date

05/24/2023

58-1.3 Clinical laboratory and blood bank supervision.

(a) A clinical laboratory or blood bank shall have one or more supervisors who, under the general direction of the laboratory director, supervise technical personnel and the reporting of findings, perform tests or procedures requiring special scientific skills, and, in the absence of the laboratory 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 clinical laboratory or blood bank, the department may authorize the laboratory director to also serve as the supervisor of the clinical laboratory or blood bank.

(d) A supervisor shall be on the laboratory premises during all hours in which tests are performed. An exception to this requirement shall be applicable if all the following conditions have been met:

(i) the clinical laboratory or blood bank has not demonstrated a pattern of noncompliance with fundamental standards of practice, nor have any laboratory practices been identified that could lead to immediate jeopardy of public health;

(ii) the clinical laboratory or blood bank has not demonstrated a pattern of unacceptable and/or unsatisfactory proficiency testing performance;

(iii) the supervisor is immediately accessible by telephone or synchronous two-way electronic audio-visual communication to all testing personnel at all times testing is performed;

(iv) the supervisor is assigned on-site hours as determined by the laboratory director to ensure adequate supervision for the scope, complexity and volume of testing being carried out at each site, which shall not be less than eight hours per week;

(v) documentation is maintained that defines and delegates supervisory responsibilities including whether these responsibilities are performed on-site versus off-site;

(vi) when more than one supervisor is employed by the clinical laboratory or blood bank, documentation is maintained that defines which supervisor is responsible for a specific time period;

(vii) the individual who serves as the supervisor may only serve in this capacity at five clinical laboratories or blood banks; and

(viii) the clinical laboratory or blood bank meets any other requirements prescribed in the clinical laboratory standards of practice related to the proper supervision of testing.

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

Statutory Authority

Public Health Law, Section 576

Volume

VOLUME A-1 (Title 10)

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