Sec.19a-36-D38. Minimum standards for the operation of private clinical laboratories

(a) The laboratory shall be operated in compliance with all applicable state and federal laws and regulations, including but not necessarily limited to CLIA Title 42 Part 493 of the code of federal regulations and with all reasonable administrative directives pursuant thereto.

(b) Quarters in which laboratory work is performed or specimens collected shall be kept free from filth, excessive dirt or litter or other objectionable condition, shall be adequately lighted and ventilated, shall be equipped with utilities adequate for the work, shall be of adequate size and arrangement for the proper conduct of the work and shall be free from unnecessary safety hazards. Smoking and the consumption of food or beverages shall be prohibited in those areas where the examination of specimens is being carried out. No food or beverage shall be stored in a refrigerator or freezer used for storing patient specimens or potentially infectious materials.

(c) Equipment shall be adequate and in good order at all times as considered necessary for the proper handling of work for which licensure may be granted.

(d) The laboratory shall at all times be operated under the supervision of a director or other qualified person acceptable to the department.

(e) No misrepresentation of the scope of laboratory services or of the qualifications or special abilities of persons associated with the laboratory shall be permitted.

(Adopted effective June 4, 1996)