Current through September 9, 2024
Section
19a-36
-A33 provides that a registered laboratory may be given a certificate of
approval for making certain specified public health laboratory examinations,
determinations or tests in a manner conforming with the requirements and
standards required by the state department of health. In accepting approval,
heads of laboratories shall agree to abide by these minimum standards upon
which approval of public health laboratories is based, as follows:
(1) Adequate housing of the laboratory as
determined by inspection before the certificate of approval is issued and by
reinspection at any time.
(2)
Equipment complete and in good order at all times as considered necessary for
making each examination, determination or test for which approval is extended
according to the method or methods which the person in charge has agreed to
follow under subparagraph (b) of subdivision (4).
(3) Operation of the laboratory under the
direct supervision of an individual designated by the owner of the laboratory
to be in charge of the work for which approval is extended.
(4) Agreement on the part of the person, firm
or corporation operating or maintaining the laboratory, or of the duly
authorized agent thereof, that the individual designated by the owner to be in
charge of the laboratory shall:
(a) Conduct
the laboratory strictly in accordance with recognized standards and to carry
out the provisions of the general statutes and of the public health code
pertaining to the performance and reporting of the examinations, determinations
or tests for which approval has been extended;
(b) report no public health laboratory
examination, determination or test unless based upon a method or procedure
which meets the approval of the state department of health and, upon request,
to furnish the state department of health with a complete description of any
method used in making any specified examination, determination or test for
which approval is extended or requested;
(c) notify the state department of health
before undertaking any new type of public health laboratory examination,
determination or test not already included in the list for which approval has
been extended;
(d) assume
responsibility for the reliability of the laboratory findings made by any
person employed in the laboratory, and for any interpretation based upon those
findings.
(5) Agreement
on the part of the person, firm or corporation operating or maintaining the
laboratory, or of the duly authorized agent thereof:
(a) To notify the state department of health
in writing without delay if the person designated by the owner to be in charge
of the laboratory severs or is about to sever connection with the laboratory
and to surrender the certificate of approval on or before the day such person
leaves; to give notice in writing prior to the taking of a leave-of-absence of
more than four weeks' duration by such person; if approval has been conditioned
upon the performance of a given type of test by a specified person, to give
prompt notice in writing when the specified person severs or is about to sever
connection with the laboratory;
(b)
to inform the state department of health without delay and in writing;
(i) Of any change in the amount of time given
to his position by the person designated by the owner to be in charge of the
laboratory;
(ii) of any
contemplated removal of the laboratory to new quarters;
(iii) of any major changes, alterations or
additions to the laboratory quarters;
(iv) of any change in ownership of the
laboratory;
(v) of any changes in
personnel of the laboratory; (c) to permit the use of no statement, made orally
or appearing on any advertising or laboratory forms, which expresses or implies
that approval of the state department of health is extended beyond that
specified on the certificate of approval.
