Expert Q&A: Quality, Proficiency, and CLIA Updates

With quality in the spotlight and Clinical Laboratory Improvement Amendments (CLIA) updates incoming,¹ labs need to know what to look for to make sure they’re at the top of their game. That includes personnel qualifications, documentation requirements, proficiency, and much more. Where does the average clinical lab struggle most—and what can they do to make quality and compliance easier? Lab Industry Advisor spoke to Lighthouse Lab Services chief quality officer Anna Hill, PhD, NRCC-TC, to find out. 

Q: What are the main quality areas in which labs fall short?

A: As of early 2024, there are approximately 33,000 non-exempt CLIA laboratories with Certificates of Compliance or Accreditation.² For these lab types, year over year, our experience and data show that proficiency testing (PT) is the area with the largest number of deficiencies in successful participation, documentation, and/or appropriateness of materials.

A close second would be personnel qualifications and responsibilities, with laboratory director roles specifically having the highest number of citations for lack of qualifications or fulfillment of responsibilities.

Q: Do you have any tips for preventing or overcoming these issues?

A: For both areas in which labs are most likely to fall short, we have found a few ways to ensure compliance. First and foremost is understanding the requirements as outlined by the Centers for Medicare & Medicaid Services (CMS) under CLIA for personnel qualifications before hiring. Once the required roles are filled, obtain these documents:

• • credentials (such as licenses, diplomas, or certificates)

• • job descriptions

• • CV or résumé

• • training documents

• competency assessments (initial, six-month, and annually thereafter)

For PT, identify a commercial vendor—or, if not available, an alternative PT source (for example, a split sample comparison with another CLIA laboratory) that is appropriate for the matrix and methodology of your testing. Once PT materials are received, treat proficiency tests as you would treat patient samples, but never refer PT materials to another laboratory for testing.

In terms of paperwork, ensure that you retain all of the following documentation for all surveys for a period of two to three years depending on your state’s requirements:

• • finalized patient reports

• • results form or submission

• • attestation

• • evaluation

• corrective actions for any failures

It can be helpful to implement a secondary review of results entry prior to submission to ensure that no clerical errors were made during transcription. Attestations and evaluations should be reviewed and signed by both testing personnel and the laboratory director or designee. A high number of citations arise from incomplete review of evaluations when results have not been officially graded and require some additional review or commentary on whether the lab’s response was acceptable.

In short, for both personnel and PT, a checklist of the five items above will greatly assist in maintaining proper compliance.

Q: How will the incoming CLIA update affect labs’ quality and proficiency efforts?

A: The 2024 CLIA updates bring in several significant changes regarding fee structures, training and personnel requirements, histocompatibility personnel regulations, alternative sanctions, and proficiency testing updates to enhance regulatory oversight and adapt to technological advancements in clinical laboratories.

With regard to personnel, the update clarifies and strengthens the documentation requirements for training and experience of clinical lab professionals involved in moderate- and high-complexity testing. Additionally, the Doctorate of Clinical Laboratory Science degree is now recognized as a qualification for high-complexity laboratory director roles, ensuring that high-complexity testing remains under the supervision of adequately trained laboratory professionals. CMS has established a separate pathway and educational requirements for individuals with nursing degrees to become moderate-complexity testing personnel, but they will no longer be qualified as laboratory directors.

Updates to PT requirements include additions and deletions of regulated analytes to cover more clinically relevant tests, revision and restructuring of microbiology PT, clarifications on PT referral regulations, acceptance limit changes, and renewed administrative and quality control enhancements. The revised PT criteria will become effective on July 11, 2024; new PT regulations have an implementation date of January 1, 2025 for both vendors and laboratories. For microbiology, updates included restructured PT categories, consistent reporting at the highest level, and more generalized lists of organisms. Overall updates included the addition of 29 new regulated analytes/tests and the removal of five previously regulated analytes/tests.³ Where applicable, acceptance limits were updated or restricted to percentages versus standard deviations.

These updates to the CLIA PT regulations mark the first major changes since 1992 and are aimed at improving the accuracy and reliability of laboratory testing. Anticipated benefits include increased patient safety and more precise clinical diagnostic results, aligning with technological and methodological advancements in the field. However, laboratories may face challenges such as increased costs, resource allocation, technological and logistical issues, and compliance requirements. To ease the transition, CMS provided an extended lead time for implementation, allowing laboratories to adapt without compromising quality or accuracy.

Q: What key things should lab leaders know about the new rules—or about lab quality more generally?

A: In summary, the key takeaways of the new rules are: stricter personnel qualifications, enhanced PT requirements, improved quality control measures, and heightened patient safety and data integrity.

More generally, the adoption of advanced technologies, data integration (laboratory information systems and electronic health records), sustainability, and efficiency are all imperative to the quality, accuracy, and efficacy of the clinical labs of the future.

Each of the CLIA personnel roles plays a part in the success of a clinical laboratory, so ensure that you meet the updated qualification standards for those roles. Ongoing participation in training and professional development to stay current with new regulations and technologies is key; so is actively engaging in PT programs while working to comply with regulatory requirements and maintain lab accreditation.

Q: How do you envision the landscape of clinical lab quality evolving in the near future?

A: The landscape is sure to transform significantly in the coming years, piloted by technological advancements, regulatory updates, and an increasing focus on personalized medicine. These advancements will lead to more accurate, efficient, and personalized diagnostic services—which, in turn, will enhance the quality of patient care.

References:

1. 1. Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance. Federal Register. July 11, 2022. https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to.

1. 1. Centers for Medicare & Medicaid Services. CLIA Division of Clinical Laboratory Improvement and Quality. March 2024. https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/statupda.pdf.

1. 2024 CLIA Proposed Acceptance Limits for Proficiency Testing. Westgard QC. July 11, 2022. https://westgard.com/clia-a-quality/847-2019-clia-requirements.html.