Regulatory

Follow the links below to access sources for regulations, standards, and other resources that either directly or indirectly effect our POCT program.

California Business and Professions Code

          Section 1206.5

Clinical Laboratory Improvement Ammendments (CLIA)

          Current CLIA Accreditation

          CLIA – 1967

          CLIA – 1988

          CLIA – 1988 – Part 493

          CLIA – Changes 1988-1997

          CLIA – Changes 1997-2012

          CLIA – Subpart M – INDEX

          CLIA – Subpart M – Personnel for Non-waived Testing Requirements

Centers For Medicare & Medicaid Service

          Assessing Personnel Competency

Code of Federal Regulations

          Public Health – Title 42 – Code of Federal Regulations – revised Oct 2004

          Taking Essential Steps For Testing Act of 2012

Food and Drug Administration

          FDA Modernization Act – 1997

          FDA – Tests Waived by FDA from January 2000 – Present

The Joint Commission

          The Joint Commission Chapter on Waived Testing

          The Joint Commission QSA Chapter on Nonwaived Testing

          National Patient Safety Goals – Laboratory, January 2018

          National Patient Safety Goals – Hospital, January 2018