Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 180.000 - The Operation, Approval And Licensing Of Clinical Laboratories
Section 180.255 - Standard - Laboratory Procedure Manual

Universal Citation: 105 MA Code of Regs 105.180

Current through Register 1531, September 27, 2024

(A) There shall be available at all times, in the immediate bench area, to personnel engaged in examining specimens and performing related procedures within a category (e.g., clinical chemistry, hematology, pathology, etc.), current laboratory manuals or other complete written descriptions and instructions for all automated and manual test procedures which are performed by the laboratory. Procedures shall include:

(1) The analytical methods used by those personnel, properly designated and dated to reflect the most recent supervisory review;

(2) Reagents;

(3) Control and calibration procedures;

(4) Pertinent literature references. Textbooks may be used as supplements to such written descriptions but shall not be used in lieu thereof.

Each procedure shall be reviewed and dated by the technical supervisor at least annually. Written approval shall be given by the director or supervisor of all changes in laboratory procedures.

(B) Procedures which assure a reasonable turnaround time for all test results and provide for alternative testing mechanisms in the event that equipment or methods become inoperable shall be established for each test performed in the laboratory.

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