What are the requirements for Clinical Laboratory Improvement Amendments (CLIA) waived documentation?

CLIA Waived Documentation Requirements

CLIA waived testing sites must maintain specific documentation to ensure quality testing and comply with regulatory requirements. 1

Core Documentation Requirements

Test Reports

• Test reports for CLIA waived testing must include:
  • Patient name and identification number or unique patient identifier 2
  • Name and address of the laboratory where the test was performed 2
  • Test report date 2
  • Test performed 2
  • Specimen source (when appropriate) 2
  • Test result and any applicable units of measurement or interpretation 2
  • Information regarding specimens that did not meet acceptability criteria 2

Records Retention

• CLIA requires laboratories to retain records of patient testing for a minimum of 2 years, including: 2
  • Test requests and authorizations 2
  • Test procedures 2
  • Analytic systems records 2
  • Records of test system performance specifications 2
  • Proficiency testing records 2
  • Quality system assessment records 2

Test Request Documentation

• Test requests must include:
  • Name and address of the person requesting the test 2
  • Patient name or unique identifier 2
  • Sex and either age or date of birth 2
  • Tests to be performed 2
  • Source of specimen (if appropriate) 2
  • Date and time of specimen collection (if appropriate) 2
  • Any additional information relevant for accurate and timely testing 2

Quality Assurance Documentation

Alternative Performance Assessment

• For tests without available proficiency testing programs, documentation of alternative performance assessment must be maintained, which may include: 2
  • Records of interlaboratory exchanges 2
  • Documentation of testing using externally derived materials 2
  • Records of repeat testing of blinded samples 2
  • Documentation of blind testing of materials with known values 2
  • Records of sample splitting with another instrument or method 2

Performance Tracking

• Documentation must track performance in proficiency testing and alternative performance assessment 2
• Quality improvement assessments must be documented periodically to evaluate performance 2
• Records of investigation of failures or concerns, implementation of corrective actions, and documentation of outcomes must be maintained 2

Special Considerations

Laboratory-Developed Tests

• For laboratory-developed tests using analyte-specific reagents, test reports must include the statement: "This test was developed and its performance characteristics determined by (Laboratory Name). It has not been cleared or approved by the U.S. Food and Drug Administration" 2

Electronic Records

• If maintaining electronic records, laboratories must ensure that: 2
  • Electronic records remain accessible as storage technology evolves 2
  • Primary data from which reports are generated should be kept along with the reports 2
  • Records of tests with normal results are also retained 2

Common Pitfalls and Caveats

• High personnel turnover rates in waived testing sites can lead to documentation errors and quality concerns 1
• Lack of understanding about good laboratory practices and inadequate training contribute to documentation problems 1
• Failure to document quality control procedures is a common deficiency in CLIA waived testing sites 1
• Inadequate specimen handling documentation can compromise test results and patient safety 1
• Sites must comply with both federal CLIA requirements and sometimes more stringent state regulations 3