The Clinical Laboratory Improvement Act of 1988 (CLIA-88) was passed by Congress with the intent of making clinical laboratory testing site neutral. That is, tests that are performed in a large commercial laboratory, a hospital, a physician’s office, a nursing home, etc. are all subject to the same legal requirements. If you are a Medical Laboratory, Physician, Ambulance Corps, Home Health Agency, Hospital, Nursing Home, or any other health care provider performing laboratory tests, you are subject to these rules in addition to any local State regulations.

Are you a

Medical Laboratory, Physician, Ambulance Corps, Home Health Agency, Hospital, Nursing Home, or any other health care provider performing laboratory tests?

Do you have

• Written procedures for all tests that you perform?
• Quality control and proficiency testing records?
• Methods validation studies?
• A comprehensive Quality Assurance plan covering all aspects of your laboratory services?

A checklist used by Laboratory Consultation Services, Inc. during a “mock inspection” to assess CLIA compliance, may be found here: Checklist for CLIA Compliance

For detailed information on the CLIA-88 rules, click here: CDC: CLIA-88 Rules

Laboratory Consultation Services, Inc. provides consultation services to assist you with your CLIA compliance. Contact Laboratory Consultation Services, Inc. for further information and an evaluation of your specific needs.

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