NEW YORK (360Dx) – Lab industry groups are hoping the US Centers for Medicare & Medicaid Services' request for information on potential changes to lab rules established under the Clinical Lab Improvement Amendment of 1988 will reopen discussions about requirements for lab personnel who perform complex lab tests.
CMS published a request for information Tuesday seeking public comments related to CLIA personnel requirements and histocompatibility requirements, as well as comments on appropriate lab sanctions and CMS lab fees. With minor exceptions, CLIA rules have not been modified since 1992, according to CMS.
Several lab groups have been anticipating this request for information since 2016, when CMS changed requirements for lab personnel that allowed employees with bachelor's degrees in nursing to perform complex lab tests, according to Jim Flanigan, executive vice president of the American Society for Clinical Lab Science. Specifically, the 2016 personnel requirement changes stated that a bachelor's degree in nursing is equivalent to a bachelor's degree in biological science for high-complexity testing personnel, and an associate's degree in nursing is equivalent to an associate's degree in biological science for moderate-complexity testing personnel.
Several lab industry groups tried unsuccessfully to persuade CMS to change those nursing equivalency rules when they were first introduced.
"CMS didn't agree with us, but that is why this is coming back, and to the credit of the agency, this is something they are putting forward that needs to be addressed," Flanigan said.
ASCLS and the American Society of Clinical Pathology, with which it partners on the Board of Certification, along with six other associations, sent a letter to CMS in 2016 pointing out that the requirements of a biology degree and a nursing degree are very different, Flanigan said. At the University of Maryland, for example, students obtaining bachelor of sciences degrees in biological science must complete 63 hours of natural science, while students obtaining nursing degrees are only required to complete 16 hours of natural sciences, according to the letter.
"ASCLS is representative of laboratorians and the lab profession, so personnel regulations, training, and education requirements are all very important to us, but ultimately it comes down to what's best for patients and what is best for improving healthcare in the US," Flanigan said.
American Medical Technologists is looking at the CMS request for information as an opportunity to revisit the nursing equivalency decision as well, according to Michael McCarty, legal and legislative counsel to the group.
"Pursuing the inquiry through a formal rulemaking process will allow stakeholders to submit evidence on the record, and will require CMS to justify its ultimate decision based on the evidence on the record," McCarty said in an email.
McCarty said that AMT is still reviewing how it plans to fully respond to CMS's request for information, but the association also plans to reiterate its long-held position that CMS "should recognize established private-sector certifications for testing personnel and general supervisors in clinical laboratories performing high and moderate complexity."
McCarty noted that certification organizations for generalist lab personnel, including AMT and ASCP-BOC, have standards that exceed minimum CLIA qualifications and include mandatory continuing competency requirements.
"Recognizing private certifications of lab personnel would streamline CLIA surveyors' job of verifying that personnel meet the education and training requirements in the CLIA regulations," McCarty said.
Quest Diagnostics said that the company plans to submit comments to the RFI but is not yet prepared to share its response. Laboratory Corporation of America declined to comment, and several other lab companies did not return calls by press time.
While lab organizations were expecting CMS to request comment on CLIA personnel issues, the RFI that CMS published is broader than expected, Flanigan said.
In addition to requesting comment on CLIA personnel and histocompatibility regulations, the RFI seeks comment regarding sanctions for proficiency testing referral. CMS generally considers it improper when a lab sends the samples it receives as part of a proficiency testing program to another lab, with different degrees of sanctions, depending on the type of referral. The most severe sanctions are for labs that pass off another lab's PT results as its own.
In 2014, CMS implemented the Taking Essential Steps for Testing (TEST) Act, which included three tiers of sanctions for PT referral, based on the severity of the violation, according to R. Bruce Williams, president of the College of American Pathologists. CAP strongly advocated for TEST, because prior to its implementation "laboratories faced draconian sactions for inadvertent PT referrals," Williams said in an email. CAP plans to provide comment to CMS prior to the March deadline.
CMS is also seeking public comment on updating a variety of compliance-related fees.
Flanigan said ASCLS is viewing the request for information on CLIA rules as an opportunity to evaluate the type of regulations that the industry will need in the future.
"If CLIA regulations are 26 years old, there are a fair amount of changes potentially that need to be made to address medical practice in the modern age, and they also should be sufficiently forward-looking to accommodate what we anticipate the practice of medicine and the needs of clinicians and patients might be in the next 25 years," he said.
Issues that the association would like to review include the increasing complexity of lab testing, and how more complex tests lab are managed, according to Flanigan.
"Increasingly the kind of tests that the FDA would have called moderate or high-complexity testing are being put in a category called waived testing," which are considered lower risk and require less specialized skills, he said.
In addition, while ASCLS is opposed to the CMS nursing equivalency rules, Flanigan acknowledged that a shortage of qualified lab personnel is a challenge to the industry that is expected to grow.
"We are likely to experience over the course of the next 10, 20 years workforce shortages and that will drive somewhat how laboratory tests are performed and the interfaces between laboratories and clinicians," he said. ASCLS is working on advocacy programs aimed at expanding the number of graduates from medical laboratory scientist and medical laboratory technician programs, he added.