CAP Laboratory Accreditation

Assessment for College of American Pathologists (CAP) laboratory accreditation standards for clinical diagnostic laboratories

HealthcareClinical-labPathologyDiagnostics minutes18 questions

1. Personnel Qualifications

Does the laboratory director meet CAP qualifications (MD, DO, or PhD with appropriate certification)?*

CAP requires: Board certification in relevant specialty OR equivalent training/experience documented per checklist

Are all testing personnel competency-assessed annually per CAP requirements?*

Competency assessment: Direct observation, proficiency testing review, worksheets review, problem-solving evaluation

Are personnel qualifications documented and verified (education, training, licensure)?*

Document: Degrees, certifications (ASCP, AMT), state licenses, continuing education records

2. Quality Management System

Is a comprehensive Quality Management System (QMS) documented and implemented?*

QMS: Quality policy, objectives, organization chart, document control, internal audits, management review

Are quality indicators (QI) monitored monthly with documented review and action?*

CAP-required QIs: TAT, critical value notification time, specimen rejection rate, amended report rate

Is a document control system in place with version control and effective date tracking?*

SOPs: Review every 2 years minimum, approval signatures, change history, archived copies

3. Proficiency Testing

Is the laboratory enrolled in CAP-approved proficiency testing (PT) for all analytes?*

PT: 3 samples per event, 5 events/year for most analytes; CAP Surveys or CMS-approved alternatives

Are PT samples tested blindly without conferring with other labs?*

CAP prohibition: No interlaboratory communication before result submission; treat samples as patient specimens

Are PT failures investigated with corrective action documented within 30 days?*

PT failure: Unacceptable score requires root cause analysis, corrective action, director review

4. Test Validation & Verification

Are all tests validated or verified before clinical use per CAP guidelines?*

FDA-cleared: Verification (confirm manufacturer claims). Lab-developed: Full validation (accuracy, precision, reportable range)

Are reference ranges validated for patient population served?*

Reference interval validation: Verify manufacturer ranges with 20 patient samples OR establish with ≥120 reference individuals

Are test modifications revalidated before clinical use?*

Modifications requiring revalidation: Reagent lot change (if significantly different), instrument change, method change

5. Equipment & Maintenance

Are all instruments maintained per manufacturer and CAP schedules with documented records?*

Maintenance logs: Preventive maintenance, repairs, service contracts, calibration verification

Are temperature-controlled devices (refrigerators, freezers, incubators) monitored daily?*

Temperature logs: Daily recording, alarm testing, corrective action for out-of-range, backup power verification

Are pipettes calibrated annually with documented verification?*

Pipette calibration: Gravimetric verification at multiple volumes, accuracy/precision within ±2%, traceable weights

6. Safety & Environment

Is a Chemical Hygiene Plan (CHP) documented and reviewed annually?*

OSHA Lab Standard: CHP with chemical inventory, exposure controls, PPE, spill procedures, waste disposal

Are Safety Data Sheets (SDS) accessible to all personnel with annual training?*

SDS: Readily available (physical or electronic), staff trained on location, hazard communication, GHS labels

Are biological waste disposal procedures compliant with EPA/state regulations?*

Biohazardous waste: Autoclave or contracted disposal, manifests tracked, annual EPA reporting (if large generator)

Please answer all required questions to see your results