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CLIA ’88 for Physician Office Laboratories

Certificate selection, quality control, proficiency testing and survey readiness for waived and moderate complexity testing.

What the standard covers

Key topics your practice must document

Members get the full manual inside the portal. Here is what the programme addresses.

SECTION 1: REGULATIONS

CLIA ’88 scope, certificate types and the complexity categories that determine your requirements.

  • Certificate of Waiver - waived tests only.
  • Certificate for Provider-Performed Microscopy (PPM).
  • Certificate of Registration / Compliance - moderate or high complexity, surveyed by CMS.

SECTION 2: QUALITY ASSESSMENT

The ongoing QA program covering the pre-analytic, analytic and post-analytic phases.

  • Written policies covering all three testing phases, reviewed at least annually.
  • Monitoring of patient test management, quality control, proficiency testing and personnel competency.
  • Documented corrective action whenever a problem is identified, including its effect on patient results.

SECTION 3: SPECIMEN COLLECTION

Patient identification, collection, labelling, handling and rejection criteria.

  • Verify patient identity with two identifiers before collection.
  • Label specimens at the bedside/point of collection with patient name, second identifier, date, time and collector initials.
  • Follow order of draw and correct tube additives; observe fill volumes.

SECTION 4: QUALITY CONTROL

Running, evaluating and documenting internal QC, and handling out-of-range control results.

  • Follow the manufacturer instructions at minimum; for non-waived tests, at least two levels of control each day of testing.
  • Record lot numbers and expiration dates of controls and reagents.
  • An Individualized Quality Control Plan (IQCP) may substitute where a risk assessment supports it.

SECTION 5: MAINTENANCE

Instrument maintenance, function checks, calibration and environmental monitoring.

  • Perform and record daily, weekly, monthly and annual maintenance exactly as specified by the manufacturer.
  • Calibrate at the frequency specified, after major service, and when QC indicates drift.
  • Retain maintenance and service records for at least two years.

SECTION 6: TEST PROCEDURES

The procedure manual: content, approval, review and version control.

  • Purpose and principle, specimen requirements, reagents, calibration, QC, step-by-step procedure.
  • Reportable range, reference intervals, critical values and the action required when they occur.
  • Limitations of the method and the procedure to follow when the system is inoperable.

Members read the complete manual online

Sign in to the member portal for every section, plus the annual safety test.

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