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Clinical Laboratory Program laws, regulations, and circular letters

Regulations governing the Clinical Laboratory Program

Note: DPH guidance memo, April 7, 2020: Massachusetts Clinical Laboratory Program – Changes to Exempt Test List and Definition of Physician .  This replaces #15-11-645 Addition of CLIA-Waived Blood Lead Testing to Exempt Test List 10/4/2015.

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Clinical Laboratory laws and regulations

Massachusetts General Laws Chapter 111D: Clinical Laboratories
105 CMR 180.00: The operation, approval and licensing of clinical laboratories

Blood Bank laws and regulations

Massachusetts General Law Chapter 111, Section 184B
105 CMR 135.00: Use of blood, blood components and derivatives for the purpose of transfusion

Circular letters

DPH Memo, November 17, 2025: Changes to Requirements for Clinical Laboratory Directors, Open PDF file, 208.32 KB (English, PDF 208.32 KB)
DPH Memo, November 17, 2025: Changes to Requirements for Clinical Laboratory Directors, Open DOCX file, 35.78 KB (English, DOCX 35.78 KB)
DPH Memo, October 24, 2022: Notice of Changes for Clinical Laboratory Licensure
DPH Memo, April 7, 2020: Changes to Exempt Test List and Definition of Physician, Open PDF file, 241.25 KB (English, PDF 241.25 KB)
DPH Memo, April 7, 2020: Changes to Exempt Test List and Definition of Physician, Open DOCX file, 13.93 KB (English, DOCX 13.93 KB)
#15-12-649 Guidance Regarding Implementation of Individualized Quality Control Plans 12/8/2015, Open PDF file, 238.87 KB (English, PDF 238.87 KB)
#15-12-649 Guidance Regarding Implementation of Individualized Quality Control Plans 12/8/2015, Open DOC file, 70.5 KB (English, DOC 70.5 KB)
#12-10-575 Electronic Transmission of Correspondence ListServ - 10/1/2012, Open PDF file, 24.38 KB (English, PDF 24.38 KB)
#12-10-575 Electronic Transmission of Correspondence ListServ - 10/1/2012, Open RTF file, 35.5 KB (English, RTF 35.5 KB)

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