Following decades-long lab staffing shortages that reached crisis levels during the COVID-19 pandemic and a wave of retirements, a new white paper from the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) suggests updating CLIA regulations to better reflect current technology.
The white paper also recommends reserving high-complexity testing for staff with medical laboratory scientist (MLS) credentials, assigning technicians to run other assays, developing alternate career entry points for nonlaboratorians, and better highlighting the value of laboratory medicine.
Despite ADLM and other organizations working with accredited college programs to train new laboratorians, troublesome vacancy rates persist. Results include greater workloads and more overtime for existing staff, reduced numbers of tests available in-house, and greater use of reference labs, said Erika Deaton-Mohney MT(ASCP), CPP, a coauthor of the white paper. She is a point-of-care and compliance coordinator at Bronson Healthcare in Kalamazoo, Michigan. This situation “has a negative impact on patient care. Laboratory results are taking longer and sometimes are unavailable to providers when they need them,” Deaton-Mohney added.
DETAILING THE PROBLEM
The white paper points to staff shortages prior to and during the COVID-19 pandemic. A 2018 American Society for Clinical Pathology (ASCP) study found average vacancy rates of 7–11% in clinical labs, with vacancy rates as high as 25% in some areas. Meanwhile, a 2020 ASCP vacancy survey showed an average 5-year retirement rate of 12.3%. Also in 2020, the Bureau of Labor Statistics projected that lab technologist and technician positions would increase by 11% by 2030. A 2022 Health Resources and Service Administration report projected an increase in demand for technologists of 22% between 2012 and 2025.
A key problem is that some CLIA provisions are outdated, the paper maintains. CLIA aims to enhance patient safety, but requirements for personnel performing moderate- and high- complexity testing have changed little since 1988, when Congress passed the law. At that time, clinical laboratories had no computers, total lab automation in chemistry and microbiology was generally unavailable, the human genome had not been sequenced, and PCR was new.
In contrast, today labs have automation of the preanalytic, analytic, and postanalytic steps of testing and smart instruments that manage and perform quality control, maintenance, and calibration verification to reduce the likelihood of analytical errors. Middleware ensures results’ accuracy by creating rules for acceptance before reporting them. Laboratory information system rules also reduce the likelihood of error and patient risk. However, CLIA has not addressed these improvements, the paper notes.
CLIA currently stipulates who can perform tests based on tests’ risk and complexity, training and experience of the staff performing tests, circumstances surrounding use of reagents, necessary operational steps, availability of QC material, and complexity of interpreting results. This framework “may overestimate the potential risk to the patients and unnecessarily place testing in the high-complexity category,” the white paper states
It recommends revamping complexity designations based in part on the ease or difficulty of performing testing. Assays currently considered high complexity that may warrant reclassification include those for which middleware automatically performs calculations, manual but relatively simple ELISA tests, and modified FDA-cleared tests, according to the white paper.
Modified FDA-cleared tests have been subject to minor changes by labs to enhance their utility, explained Christopher Farnsworth, PhD, white paper coauthor and associate professor in the pathology and immunology section, head of clinical chemistry at Washington University School of Medicine in St. Louis. “They are the same tests, but they work just a little bit differently.” The paper notes that modifications do not affect manufacturers’ claims.
“It’s clear the complexity model for testing methods is antiquated,” Deaton-Mohney said.
RECOMMENDATIONS
The white paper suggests laboratory test reclassification based on performance complexity. Reclassification should entail moving those tests currently designated as high-complexity, but with relatively simple analytical requirements into the moderate- complexity testing category, while applying the existing personnel requirements.
“We’ve had all these new technologies introduced into the laboratory; things we use daily. A lot of the steps performed [when CLIA took effect] are no longer done,” Farnsworth said. “Nobody’s mixing their own reagents anymore for standard laboratory tests, for example. The system for designating who can perform testing and the assays’ complexity should be based at least in part on the difficulty of required to operate instruments.”
As many tests become simpler to perform, labs also have seen an explosion in the use of molecular assays, especially PCR testing, during the COVID-19 pandemic. Such tests require highly trained laboratorians. For this reason, the white paper also recommends changes to the CLIA complexity model that recognize the value of the MLS certification and require it for performing high- complexity tests.
Another key recommendation is developing educational programs that provide alternate career entry points for nonlaboratorians. At the same time, labs should provide a separate track for those with MLS credentials to advance within the lab and broader healthcare community.
The paper also calls for better recognition of lab staff as crucial members of the healthcare team. Deaton-Mohney said that the profession should better promote itself as a “solid career, with solid pay, professional growth, and career advancement opportunities.”
DOCUMENTING THE VALUE OF LAB MEDICINE
Jon Harol, president and founder of Lighthouse Lab Services, said he agrees with the white paper’s call for more stratification of skill sets. With a dearth of lab staff, “we need to create workflows and adjust regulations to allow the more automated and simpler tests to be performed by lower-level lab staff while still falling underneath the guidance of a qualified medical lab director,” he added.
Harol also agrees that labs should better advocate for the value of laboratory medicine by highlighting the importance of lab results in healthcare. The Medicare MolDx program, which involves labs in roughly half of states, already asks labs to do so, he noted.
The MolDx program determines coverage, coding, and pricing of molecular pathology services. It assigns a “Z code” to laboratory-developed tests before labs can get reimbursement for them. To get reimbursed, labs must demonstrate tests’ analytical validity, clinical validity, and clinical utility.
Harol predicts that commercial payers will implement similar requirements. “Labs need to get better at quantifying the impact of clinical lab testing,” he said.
Demonstrating clinical utility is a huge challenge, Harol noted. It requires showing that a test drives long-term health benefits. Unlike clinicians, laboratorians do not have long-term relationships with patients. Harol suggested that labs team up with providers and other stakeholders to extract clinical utility data.
To alleviate the shortage of lower-level technicians, Harol suggests labs look to phlebotomists. Labs could offer phlebotomists on-the-job training, or the profession could develop a certification program for them. But first labs must solve the larger problem of job dissatisfaction, especially for less experienced staff, Harol emphasized.
He cited Lighthouse’s 2022 Wage and Morale Survey, which found that, among its 1,112 respondents, lab staff with 5 or fewer years of experience were less satisfied than their more experienced peers, with 41% of the less experienced staff reporting they are moderately or extremely unsatisfied. Notably, the ADLM white paper emphasizes that recruitment efforts should be done in a diverse, equitable, and inclusive manner.
Farnsworth noted that the white paper’s recommendations are not set in stone. Rather, they are intended as a starting point for finding solutions. “If there are folks that are really interested in engaging in this problem, join the discussion. This is a problem that’s plaguing us all,” he said.
Deborah Levenson is a freelance writer in College Park, Maryland. +Email: [email protected]