CLIA cheat sheet

CLIA 1988 is administered by CMS; FDA classifies tests, CDC provides CLIA technical and scientific support, and CLIA-exempt states (Washington and New York) are approved by CMS as meeting or exceeding CLIA requirements.

Certificate types: Certificate of Waiver, Certificate for Provider-Performed Microscopy (PPM), Certificate of Compliance, and Certificate of Accreditation. A CLIA number is required before patient testing begins.

Test complexity categories are waived, moderate, and high. A laboratory holding a Certificate of Waiver may perform only waived tests; PPM holders may add a defined list of provider-performed microscopy procedures.

Laboratories performing only waived testing are not subject to routine biennial inspections, but they must follow manufacturer instructions and are subject to complaint investigations and random validation surveys.

CLIA requires laboratories to have a current CLIA certificate, pay certificate fees, notify CMS within 30 days of changes in laboratory ownership, name, location, director, or test menu, and permit inspections.

The laboratory director is responsible for overall operation, including quality assessment, personnel, testing systems, and result reporting, and may delegate specific duties in writing but retains accountability.

Moderate and high complexity laboratories must participate in an approved proficiency testing program for each regulated analyte they perform, unless the analyte is not available from a CMS-approved program.

Sanctions for noncompliance can include directed plans of correction, civil money penalties, suspension, limitation, or revocation of the CLIA certificate, and a one- or two-year ban on owning or operating a laboratory.

CLIA applies to laboratories examining human specimens for health assessment, diagnosis, prevention, or treatment; it does not regulate forensic testing, research not used for patient care, or drug testing under certain federal programs.

Laboratory director qualifications for high complexity testing include a doctoral degree (MD, DO, or PhD in a relevant science) plus documented experience, or board certification, or qualifying experience under a grandfather provision.

Technical supervisor: for high complexity testing, requires a doctoral degree or a master's/ bachelor's degree with specified experience and, for certain specialties, board certification; for moderate complexity, qualifications are set per specialty.

General supervisor for high complexity testing: doctoral degree, or master's/bachelor's degree in a chemical, physical, biological, or clinical laboratory science with required experience, or associate's degree with qualifying experience.

Clinical consultant must be a doctor of medicine or osteopathy, or a qualified doctoral-level individual, and is responsible for consulting on test ordering and interpreting results for patient care.

Testing personnel for moderate complexity testing must have at least an associate's degree in a laboratory science or medical laboratory technology, or equivalent training, with high school diploma plus documented training as permitted.

Testing personnel for high complexity testing must meet the same education/experience standards as moderate complexity testing personnel, and must have documented training for each test system before performing patient testing.

Personnel records must document education, training, experience, and competency assessment; competency must be assessed at least semiannually during the first year and annually thereafter for each individual.

Competency assessment must include direct observation of test performance and result reporting, review of test results and QC records, and assessment of problem-solving and instrument maintenance skills.

The laboratory director must ensure that personnel perform only tests for which they are qualified and that delegation of director duties is documented in writing.

PT must be performed for each regulated analyte the laboratory tests, using a CMS-approved PT program; the laboratory must test PT samples in the same manner as patient samples.

PT samples must not be referred to another laboratory for testing, and the laboratory must not communicate PT results with other laboratories before the PT event's due date.

The laboratory must rotate PT samples among all personnel who routinely perform the test, and the laboratory director must review and sign PT results before submission.

Acceptable PT performance for a test event requires at least 80% of results to be within the acceptable performance limits; failure of two consecutive or two of three consecutive PT events for the same analyte is unsuccessful performance.

Unsatisfactory PT performance triggers a plan of correction and, for repeated failure, may lead to sanctions including suspension of the certificate for the affected specialty or subspecialty.

PT results must be retained for two years; records include the PT program report, the laboratory's results, and evidence of director review.

For tests without a CMS-approved PT program, the laboratory must establish and follow an alternative performance assessment method, such as split-sample testing or comparison with another laboratory.

PT samples must be handled like patient specimens, including the same personnel, methods, and QC, but the laboratory may not use PT samples for calibration or QC purposes.

QC for moderate and high complexity testing must follow the manufacturer's instructions or an established equivalent protocol; for many quantitative tests, at least two control levels per day of testing are required.

The laboratory must establish and document performance specifications for each test system, including accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference intervals.

Quality assessment (QA) is a required ongoing program that monitors and evaluates the quality of testing, including preanalytical, analytical, and postanalytical processes, with documented corrective action.

QC records must be reviewed and signed by the laboratory director or designee, and QC results must be retained for at least two years.

Calibration and calibration verification must be performed at least every six months for many test systems, or more often if specified by the manufacturer, and records must be maintained.

The laboratory must have a written procedure for corrective action when QC results fall outside acceptable limits, including repeating controls and evaluating patient results affected by the QC failure.

For waived testing, the laboratory must follow the manufacturer's instructions for QC and maintain records of QC and testing personnel training, but is not subject to the full CLIA QC requirements for moderate/high complexity testing.

A quality assessment program must include review of complaints, incident reports, and problems identified in proficiency testing, and must document actions taken to correct identified problems.

A laboratory may perform testing only when ordered by an authorized person, and the order must be documented in the medical record; the laboratory must have a policy for verbal orders and their authentication.

Specimen collection, handling, and processing must follow written procedures that include patient preparation, specimen type, collection method, labeling, storage, and transport conditions.

Specimen labeling must include at least two unique patient identifiers and must be verified at the time of collection; specimens with labeling deficiencies must be rejected or handled under a documented policy.

The laboratory must establish and document reference intervals for each test, and must make them available to the ordering provider.

Results must be reported in a manner that is accurate, timely, and legible; critical values must be reported immediately to the responsible caregiver and the notification must be documented.

The laboratory must have a written policy for reporting results, including how results are reported by telephone or electronic means, and must maintain records of reports for at least two years.

The laboratory must establish a system for identifying and correcting errors in reported results, including notifying the affected provider and documenting the corrected report.

For waived testing, the laboratory must follow manufacturer instructions and have a system for reporting results, but the full CLIA requirements for reference intervals and critical values apply only as applicable to the test system.

OSHA Bloodborne Pathogens Standard requires an exposure control plan, hepatitis B vaccination offered to at-risk employees, and use of universal precautions with all blood and body fluids.

Personal protective equipment, including gloves, gowns, masks, and eye protection, must be provided and used when there is reasonable anticipation of exposure to blood or other potentially infectious material.

Hand hygiene must be performed before and after patient contact, after removing gloves, and after contact with contaminated surfaces; alcohol-based hand rub is acceptable when hands are not visibly soiled.

Laboratories must have written procedures for decontamination, spill cleanup, and waste disposal, and must use appropriate disinfectants effective against bloodborne pathogens.

Sharps must be disposed of in puncture-resistant, closable containers located as close as feasible to the point of use; needles must not be recapped by hand unless a mechanical device or single-handed technique is used.

Chemical hygiene and hazard communication requirements include a chemical inventory, safety data sheets, labeling of secondary containers, and training for employees who handle hazardous chemicals.

The laboratory must have a fire safety plan, emergency evacuation procedures, and appropriate fire extinguishers, and must conduct and document safety training.

Post-exposure evaluation and follow-up must be provided after an occupational exposure, including confidential medical evaluation and documentation, at no cost to the employee.

Laboratories with a Certificate of Compliance are inspected by CMS or a state agency every two years; laboratories with a Certificate of Accreditation are inspected by their accrediting organization.

Inspection findings are cited as deficiencies under the CLIA condition-level or standard-level requirements, and the laboratory must submit a plan of correction within a specified timeframe.

Condition-level deficiencies are more serious and may result in a directed plan of correction, civil money penalties, or suspension of the certificate if not corrected.

The laboratory has the right to appeal certain enforcement actions, and CMS may impose alternative sanctions such as a directed plan of correction, monitoring, or a civil money penalty.

Accrediting organizations approved by CMS include CAP, The Joint Commission, COLA, and others; their standards must be equivalent to or more stringent than CLIA requirements.

During an inspection, the laboratory must provide access to facilities, personnel records, QC records, PT records, and patient test records, and must permit interviews with staff.

A laboratory may be subject to a complaint investigation at any time, including waived laboratories, and must cooperate with the investigation.

Failure to permit an inspection or to provide required records can result in suspension or revocation of the CLIA certificate and civil money penalties.

Waived tests are those classified by FDA as simple, with a low risk of erroneous results, and include many CLIA-waived point-of-care tests such as glucose meters, rapid strep tests, and pregnancy tests.

A laboratory with a Certificate of Waiver must follow the manufacturer's instructions for the test, including storage, QC, and specimen handling, and must not modify the test system.

Waived laboratories must have a current CLIA certificate, permit inspections, and maintain records of testing personnel training and QC for at least two years.

Point-of-care testing must have written policies for operator training and competency, QC, result documentation, and reporting into the patient record.

Waived testing is not subject to routine biennial inspections, but CMS may conduct random validation surveys and complaint investigations.

If a laboratory performs a test that is not waived, it must have the appropriate certificate (PPM, compliance, or accreditation) and meet the corresponding requirements.

For waived tests, the laboratory must still ensure that testing personnel are trained and that results are accurately reported and documented in the patient record.