N.Y. Comp. Codes R. & Regs. Tit. 10 § 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.
Notes
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