Quality Assurance

Proficiency Testing (PT)

External quality assessment programs that evaluate a laboratory's testing accuracy by comparing results against peer laboratories and reference values.

What is Proficiency Testing?

Proficiency Testing
Proficiency Testing (PT) is an external quality assessment program where laboratories analyze unknown samples and submit their results for comparison against established reference values or peer group consensus. PT programs are mandatory for CLIA-certified laboratories and are essential for demonstrating analytical competency and maintaining accreditation.

How PT Programs Work

1

Sample Distribution

PT provider sends unknown samples to participating laboratories

2

Testing

Laboratory analyzes samples using routine methods and personnel

3

Result Submission

Results submitted to PT provider by specified deadline

4

Evaluation

Results compared to reference values or peer group mean

5

Reporting

Laboratory receives performance report with scores

6

Corrective Action

Failures trigger investigation and corrective action

Major PT Providers

CAP Surveys

College of American Pathologists proficiency testing

ARUP PT

Comprehensive clinical laboratory PT programs

API

American Proficiency Institute programs

AAB PT

American Association of Bioanalysts

EQAS

External Quality Assessment Schemes (international)

WSLH

Wisconsin State Laboratory of Hygiene PT

CLIA PT Requirements

Regulatory Mandate

CLIA requires laboratories to successfully participate in an approved PT program for each regulated analyte. Key requirements include:

  • Enrollment in CMS-approved PT program for each specialty
  • Three testing events per year minimum
  • Five samples per testing event
  • Testing under routine conditions with regular staff
  • Documentation of all PT testing activities
  • Prohibition of inter-laboratory communication about PT samples

Consequences of PT Failure

Unsatisfactory Event

Score below 80% for a single testing event - requires investigation

Unsuccessful Performance

Two consecutive or two of three unsatisfactory events - triggers sanctions

Referral PT

Intentional referral of PT samples - immediate sanctions possible

LIMS PT Management

Modern LIMS systems can track PT sample receipt, testing, and results. Features include PT event scheduling, result entry, automatic comparison to previous events, corrective action tracking, and generation of PT attestation forms for regulatory compliance.

Need Help Managing PT Programs?

By submitting, you agree to receive communication from Gistia.