Sec.19a-36-D31. Examination of specimens

(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.

(Adopted effective June 4, 1996)