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

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