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

Universal Citation: 105 MA Code of Regs 105.180

Current through Register 1531, September 27, 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.

(B) Satellite Laboratories

(1) A satellite laboratory must independently meet all the requirements imposed on laboratories by 105 CMR 180.000 except that a satellite laboratory:
(a) may have the same clinical laboratory director and/or technical supervisor as the parent laboratory; and

(b) may store its records at the parent facility.

(2) A satellite laboratory shall have no separate articles of organization, or by-laws or other charter of its own, and no separate governing body, shareholders, members or officers.

(3) A satellite laboratory shall be inspected in conjunction with the licensure inspection of the parent laboratory.

(4) A satellite laboratory may only perform testing in specialties in which the parent laboratory is licensed using the same methodologies as the parent laboratory.

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