Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D31 - Examination of specimens

Current through July 10, 2024
(a) No specimen
				shall be examined if unsuitable for testing because of improper collection,
				improper preservation, apparent spoilage, excessive time lapse between
				collection and examination when applicable, or other reasons sufficient to
				render the findings of doubtful validity.
(b) No specimen of excised tissue shall be
				subjected to pathological examination except by a physician who is licensed to
				practice medicine in the state in which the laboratory is located and is
				certified in anatomic pathology by the American Board of Pathology or the
				American Osteopathic Board of Pathology or meets all of the education, training
				or experience requirements to take the examination but has not actually taken
				and successfully completed the examination. Physicians qualified under these
				requirements may delegate the responsibility for examination and interpretation
				of histopathology specimens to an individual who is a resident in a training
				program leading to certification in anatomic pathology.
(c) No specimen of exfoliated tissue or cells
				shall be examined except under the supervision and review of a physician who is
				licensed to practice medicine in the state in which the laboratory is located
				and meets the personnel qualification standards specified in the CLIA
				regulations, Title 42 part 493 of the code of federal regulations, as
				applicable. The Commissioner or the Commissioner's designee may deem a
				Connecticut licensed physician who is not certified in anatomic pathology to be
				qualified if said physician possesses qualifications that are equivalent to
				those required for such certification.
(d) There shall be available at all times, in
				the immediate bench area of personnel engaged in examining specimens and
				performing related procedures within a specialty (e.g., clinical chemistry,
				hematology, bacteriology) current laboratory manuals or other complete written
				descriptions and instructions relating to the analytical methods used by those
				personnel, properly designated and dated to reflect the most recent supervisory
				reviews. Such manuals shall also contain information concerning preparation and
				storage of reagents, control and calibration procedures, and pertinent
				literature references. Textbooks may be used as supplements to such written
				descriptions but may not be used in lieu thereof. Technical procedures employed
				in the laboratory for the processing and examination of specimens shall be
				performed according to directions detailed in the laboratory manual. Each
				laboratory shall verify or establish performance specifications for any new
				test method being utilized including accuracy, precision, reportable range or
				any other performance characteristic requirements for test performance. If the
				department deems it necessary, it shall review the laboratory's verification or
				performance specifications on new methodology to ensure its accuracy,
				precision, reportable range or other performance characteristic requirements
				for test performance.