Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories › Section 180.042 - Standard - Collection Stations and Satellite Laboratories

Current through Register 1525, July 5, 2024
(A)
Collection
			 Stations
. A clinical laboratory shall not represent or maintain a
			 specimen collection station on behalf of any other clinical laboratory unless
			 such laboratory, if in the Commonwealth, is licensed under M.G.L. c. 111D,
			 § 5 or has been approved as part of a hospital or clinic licensed pursuant
			 to M.G.L. c. 111 § 51 or unless such laboratory, if not in the
			 Commonwealth, has been accredited or is licensed in accordance with federal
			 law. No laboratory testing may be performed at a collection station unless a
			 license or certificate issued pursuant to
			 105 CMR
			 180.030 has been obtained.
(1) Any permanent area other than the actual
			 laboratory facility which is used for the collection of specimens by
			 venipuncture shall be inspected prior to use and a written certificate of
			 approval shall be issued by the Department. The licensee or director of a
			 laboratory shall notify the Department in writing immediately when the
			 operations of an approved blood collection station are about to
			 terminate.
(2) An approved blood
			 collection station shall meet all applicable requirements set forth in
			 Conditions
			 105 CMR
			 180.250 (Management) and
			 105 CMR
			 180.040 (General) and shall possess as a
			 minimum, a blood drawing chair or cot acceptable to the Department, a
			 telephone, adequate hand washing and toilet facilities for employees and
			 patients within the station and a written procedure manual detailing the steps
			 to be followed in the event of an emergency. Approved blood collection stations
			 shall be identified by signs and advertising in a manner which does not suggest
			 that the station is a laboratory. No laboratory examinations shall be performed
			 in a blood collection station other than the separation of plasma and serum and
			 such other preparative procedures as the Department may allow.
(3) The director of the laboratory of which
			 the approved blood collection station is a part shall be responsible for all
			 aspects of the blood collection station, including without limitation, the
			 physical plant, personnel, processing and transport of specimens. The director
			 of the laboratory of which the approved blood collection station is a part (or
			 his/her designee) shall be available to blood collection station personnel at
			 all times during the operation of the station for personal or telephone
			 consultation and shall make periodic personal inspections of the station to
			 insure suitable handling of patients and specimens and to instruct the
			 employees in such matters and in the most recent improvements in technique. The
			 director of the laboratory of which the approved blood collection station is a
			 part (or his/her designee) shall establish protocol for action in cases of
			 emergency which must include, without limitation, the immediate availability of
			 a physician or emergency medical service. Any technical employee of a blood
			 collection station must be proficient in venipuncture, specimen processing as
			 limited by
			 105 CMR 180.000, and
			 emergency procedures required to aid a distressed patient.