A new rule from the Centers for Medicare & Medicaid Services (CMS) that overhauls proficiency testing (PT) for clinical laboratories goes into effect on July 11, 2024. According to CMS, these changes bring CLIA regulations in line with current laboratory medicine practices. The updates are necessary because much has changed in terms of accuracy, precision, and commonly used tests since CLIA became law in 1988, with PT rules implemented in 1992.
The rules add more PT challenges and require more samples per challenges, change limits, and require PT for CLIA-licensed labs that may not be accredited by another approved agency. The rule takes effect in July 2024, and it will be implemented for labs and PT providers in January 2025 with the next PT survey cycle.
James Nichols, PhD, DABCC, FADLM, professor of pathology, microbiology, and immunology and medical director of clinical chemistry and POCT at the Vanderbilt University Medical Center, believes that meeting these regulations won’t be an uphill climb for most laboratories, as conversations about these changes have been ongoing for some time.
Laboratories have had “plenty of warning about this, and laboratories that are doing this are subscribing to proficiency surveys anyway,” he said. “They’re not going to be blind sided.”
Here’s what laboratories need to know to make sure they’re not.
UPDATE ON PT WITH NEW ANALYTES
For nonmicrobiology specialties and subspecialities such as chemistry and toxicology, CMS is adding 29 analytes, and removing five identified as unnecessary, obsolete, or excessively burdensome for laboratories.
These changes are “getting rid of old analytes that are rarely used anymore, and bringing on new analytes that are important in terms of modern medicine,” Nichols said. For example, tests for cardiac troponin and HbA1c were not routinely performed in 1992.
None of these changes are a surprise, experts agreed. “Many of us have been concerned about troponins being a nonregulated analyte for some time, and only getting two challenges a year, when it’s one of the most important tests out there,” Nichols said. He also noted that HbA1c tests are routine and necessary for many patients’ care.
CMS went through a “very consensus driven process,” said Brad S. Karon, MD, PhD, FCAP, chair of the College of American Pathologists Council on Scientific Affairs and professor of laboratory medicine and pathology at the Mayo Clinic in Rochester, Minnesota. “I don’t think there were any great surprises in the addition of regulated analytes,” he said.
For microbiology specialties and subspecialities including bacteriology and virology, CMS is finalizing requirements to specify broad categories of tests for which proficiency testing is required. This will also allow flexibility for new technologies currently in use, and those that may be developed and used in the future, according to CMS.
CHANGES IN PT CHALLENGES AND GRADING
The rule also requires three challenges per year, with five samples in each challenge, where before only two challenges may have been required. “In those laboratories that were not accredited and operated under a CLIA certificate, they often would only enroll in PT for regulated analytes,” said Karon. “They now have these additional 29 analytes they’ll have to enroll in.”
Most limits are also changed from standard deviations to percentage-based limits. Fixed concentration units are also added to fixed percentage units to address lower concentrations, with scores based on whichever is more tolerant. For example, for bilirubin, acceptable performance will be ±20% or ±0.4 mg/dL. For thyroid stimulating hormone, it will be ±20% or ±0.2 mIU/L, and for lithium, ±15% or ±0.3 mmol/L.
For microbiology PT challenges, PT programs must attempt to grade using both participant and referee laboratories before determining that the sample is ungradable. Mixed culture requirements have also been lowered from 50% to 25% for bacteriology, mycobacteriology, and mycology. Types of services listed for each micrology subspeciality were removed, and a more general list of organism groups categories were added.
Grading will be standardized among PT providers. All told, these changes are “going to improve patient safety by demanding that labs show greater accuracy for those tests,” Karon said.
Under CLIA, moderate and high-complexity laboratories that also performed waived tests are not required to enroll in PT for waived tests but are held to requirements for testing of PT samples if voluntarily enrolled for waived tests. Waived tests are also not excluded from PT referral prohibitions.
The rules have potential to improve the quality of laboratory testing overall, as CLIA-licensed laboratories will now undergo more strict challenges, Karon said. “For accredited labs, they may have been doing most or all of this additional PT. Now they will be doing more challenges and using grading criteria fixed by regulations,” he said. Nonaccredited labs will have to enroll, too.
“This is going to improve patient care because some laboratories are going to get additional specimens for some tests,” Nichols said. For laboratories that have already been doing proficiency surveys, this rule may help them in terms of improving peer group performance for some tests.
In the rule, however, CMS emphasized that labs should not use acceptance limits as the criteria to establish performance goals. “Proficiency testing is intended to identify laboratories that are not performing with acceptable analytic accuracy; it is not intended, nor suited, to provide goals for analytical accuracy or clinical performance.”
HOW LABORATORIES CAN PREPARE
Laboratories accredited from a deemed accrediting agency have already most likely heard from that agency, said Karon, and have been told “here’s what you have to enroll in based on what you’re telling us.” Laboratories should still check “just to make sure they do have a survey for each of the regulated analytes,” he added.
Nonaccredited labs will have to do this work themselves by looking at the list of regulated analytes and enroll in a PT product.
The main challenge, said Karon, will not necessarily be to laboratories, but to PT providers. The new rule “discourages them from offering low challenges unless the criteria were set with both absolute and fixed percent targets,” he said. “Most were, but a few weren’t.”
In a webinar on preparing laboratories for CLIA 2024 on behalf of ADLM, Bremansu Osa-Andrews, PhD, DABCC, NRCC, medical director of clinical chemistry and clinical assistant professor at the University of Florida College of Medicine, recommended that, to prepare for the first inspection under the final rule, laboratories should be ready for more stringent inspection, review previous PT data for impacted analytes, and re-asses with current acceptance limit. They should also review all validation records for these analytes.
“You don’t have to repeat all the validation necessarily, but you should review them to see if there are some discrepancies,” Osa-Andrews said.
Laboratories should confirm that they are assigned to the correct peer group, mark the shipping dates for proficiency test samples on the calendar, review the checklist, avoid specimen handling and clinical errors, and submit results by the due date. Laboratories should also review the standard deviation index (SDI) data on the evaluation supplied by the proficiency test provider, Osa-Andrews said.
These inspections are “going to be a part of inspections just like you already have been having,” Osa-Andrews said. “The difference is that the first inspection in the year 2025 will take into consideration the CLIA final rule and all the requirements of the rule including the new analytes and new acceptable limits, the updates that have made for microbiology and non-microbiology disciplines.”
If laboratories have not heard from their accrediting agencies or PT providers, they should reach out as soon as possible, he said, in order to be ready for the rule change in July, and then implementation of the rule change in January.
The final rule can be downloaded from the Federal Register, document citation 87 FR 41194, at www.federalregister.gov.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +X: @byJenAMiller.