9.5 Regulatory Framework, Proficiency Testing & Competency Assessment
Key Takeaways
- CLIA '88 is administered by CMS and categorizes testing as waived, provider-performed microscopy, moderate complexity, or high complexity; manual differentials, manual body fluid counts, cytochemical stains, flow cytometry, and bone marrow evaluation are HIGH complexity.
- CAP, The Joint Commission, COLA, and AABB hold CMS deemed status, so their accreditation substitutes for a CMS survey; CLSI documents are consensus guidelines, not regulations.
- Proficiency testing requires three events per year with routine handling by routine personnel; the passing score is 80 percent per analyte per event, but ABO, Rh, and compatibility testing require 100 percent.
- Referring a proficiency testing sample to another laboratory or discussing results before the deadline are the most serious violations and can cost the CLIA certificate; records are retained for two years.
- Competency assessment is performed at six months and twelve months in the first year and annually thereafter, documenting all six required elements for each test system.
Regulatory Framework, Proficiency Testing & Competency Assessment
The Laboratory Operations content area explicitly names regulation, including proficiency testing, competency assessment, and accreditation standards, and the guideline states that regulatory questions on the examination are based on United States sources. Learn the rules as rules, with their numeric thresholds.
1. CLIA '88: The Governing Statute
The Clinical Laboratory Improvement Amendments of 1988 place every United States facility that tests human specimens for health assessment under a single framework administered by the Centers for Medicare and Medicaid Services, with scientific support from the Centers for Disease Control and Prevention and device categorization by the Food and Drug Administration.
Test Complexity Categories
| Category | Description | Hematology Examples |
|---|---|---|
| Waived | Simple, FDA-cleared for home use, negligible risk of erroneous result | Capillary hemoglobin by handheld meter, point-of-care INR meter, spun microhematocrit in some settings |
| Provider-Performed Microscopy | Microscopy performed by a physician, midlevel provider, or dentist on a specimen that is unstable | Wet mounts, fern test (not a hematology bench activity) |
| Moderate complexity | Most automated systems with limited operator judgment | Automated CBC with automated differential |
| High complexity | Substantial operator interpretation and judgment | Manual peripheral blood differentials, manual body fluid counts, cytochemical staining, flow cytometry immunophenotyping, bone marrow evaluation, coagulation factor assays |
The complexity category determines personnel qualifications, quality control obligations, proficiency testing enrollment, and inspection frequency. CLIA certificates correspond to this structure: Certificate of Waiver, Certificate for Provider-Performed Microscopy, Certificate of Registration, Certificate of Compliance (inspected by CMS), and Certificate of Accreditation (inspected by an approved accreditor).
Accrediting Organizations with Deemed Status
The College of American Pathologists (CAP), The Joint Commission, COLA, and AABB hold CMS deemed status, meaning their standards meet or exceed CLIA and their inspection substitutes for a CMS survey. CAP uses a two-year cycle with a self-inspection in the alternate year and unannounced on-site inspections. Standards such as CLSI guidelines are consensus documents, not regulations, but accreditors frequently incorporate them by reference.
2. Proficiency Testing
Proficiency testing is external quality assessment: an approved provider sends unknown specimens, the laboratory analyzes them and reports results, and the provider grades them against peer or definitive values.
The Operating Rules
| Rule | Requirement |
|---|---|
| Enrollment | Required for each regulated analyte performed, with an approved provider |
| Frequency | Three testing events per year, generally five challenges per analyte per event |
| Handling | Samples must be integrated into the routine workflow, tested by personnel who routinely perform the assay, using the laboratory's routine methods |
| No duplicate testing | Samples may not be analyzed in replicate unless patient specimens are routinely run in replicate |
| No referral | Sending a proficiency testing sample to another laboratory is the most serious violation and can trigger revocation of the CLIA certificate |
| No communication | Discussing results with another laboratory before the reporting deadline is prohibited |
| Passing score | 80 percent of challenges correct for each analyte per event; ABO grouping, Rh typing, and compatibility testing require 100 percent |
| Unsuccessful performance | Two consecutive or two of three consecutive unsuccessful events trigger sanctions, including loss of the right to test that analyte |
| Documentation | Attestation, results, evaluation, and corrective action retained for two years |
Alternative performance assessment is required at least twice per year for analytes with no approved proficiency testing program. Acceptable approaches include split-sample exchange with another laboratory, split samples with a reference method, blinded internal replicates, and clinical correlation with an independent method.
3. Competency Assessment
Competency assessment applies to every person who performs nonwaived testing. It is separate from initial training and from continuing education.
Timing
Competency is assessed at the end of the first six months and again at the end of the first twelve months for new testing personnel, and annually thereafter. Reassessment is also required whenever job responsibilities change or performance problems arise.
The Six Required Elements
- Direct observation of routine patient test performance, including specimen handling, processing, and testing.
- Monitoring the recording and reporting of test results.
- Review of intermediate results, quality control records, proficiency testing results, and preventive maintenance records.
- Direct observation of instrument maintenance and function checks.
- Assessment of test performance using previously analyzed specimens, internal blind specimens, or external proficiency testing samples.
- Assessment of problem-solving skills.
All six elements must be documented for each test system, not merely for the department, and the assessor must be qualified at or above the level of the person being assessed. Continuing education, competency assessment, and annual safety training are three distinct obligations and cannot substitute for one another.
A clinical hematology laboratory receives College of American Pathologists (CAP) proficiency testing (PT) survey samples for automated complete blood counts. According to Clinical Laboratory Improvement Amendments (CLIA '88) and CAP regulatory standards, how must the laboratory process, test, and handle these proficiency testing specimens?
Which testing activity is categorized as HIGH complexity under CLIA?
A technologist receives a proficiency testing sample for a coagulation analyte the laboratory rarely runs and is unsure of the result. Which action is permitted?
A medical laboratory scientist has been performing manual differentials for four months. When must formal competency assessment occur, and what must it include?