College of American Pathologists

  Notification to CAP-Accredited Laboratories in Massachusetts


Posted December 16, 2013

Dear CAP Accreditation Participant:

As a service to CAP-accredited laboratories, the CAP offers compliance alerts to help your laboratory maintain continuous compliance.

The following clarification to the CAP checklist requirements is being provided to laboratories in the Commonwealth of Massachusetts only:

The Commonwealth of Massachusetts Department of Public Health requires procedure manual review annually, as stated in DPH regulation 105 CMR 180.255(4): Standard – Laboratory Procedure Manual. While CAP Checklist requirement COM.10100, Procedure Manual Review, allows laboratories to perform review of all technical policies and procedures every two years, laboratories located in the Commonwealth of Massachusetts must perform this review annually to comply with the more stringent state law.

Please review the regulation below to confirm that your laboratory is meeting the commonwealth’s requirement.

180.255: Standard – Laboratory Procedure Manual
(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:

(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.

Additionally, CAP Checklist requirement GEN.20374, State/Local Regulations, requires laboratories to have a policy ensuring compliance with applicable state and local laws and regulations.

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