The Clinical Laboratory Program (CLP) conducts laboratory inspections, both for state licensure and Federal certification under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). CLP is responsible for related survey activities and regulatory interpretations.
In addition, CLP provides some technical assistance to facilities and other agencies' policy and procedure development; investigates complaints; validates "deemed" status accrediting agencies; and when appropriate, undertakes enforcement actions. CLP also monitors blood usage by transfusion facilities within the Commonwealth, investigates transfusion reactions, approves Health Promotion Screening events, provides speakers for various scientific organizations, and supports various special projects sponsored by the Federal government and/or the Commonwealth of Massachusetts.
The CLIA Application can be downloaded from the Federal site for all forms, http://www.cms.hhs.gov/CMSForms/CMSForms/list.asp. The form number is CMS 116 Clinical Lab Improvement Amendments (CLIA) Application for Certification.
- Blood Bank
- Specimen Collection
- Clinical Laboratory Improvement Amendment of 1988
- HIV Testing
- Health Promotion Screening
- Circular Letter
- Retention of Records / Reports
Clinical Laboratory Program
99 Chauncy Street
Boston, MA 02111
Pam Waksmonski, MS, MT(ASCP), PMP, CRA