Lab Equipment Requirements: When Manufacturer and Joint Commission Guidelines Differ

Abstract

What should you do when a manufacturer’s maintenance guidelines for equipment differ from compliance requirements published by the Joint Commission (JC)? While some assert that JC standards should be followed, others contend that manufacturers’ or other accreditation agencies’ recommendations—such as those of the AABB (formerly the American Association of Blood Banks)—are more important. Take, for example, blood warmers and the proper intervals at which their calibration and alarm activation checks should be performed. Navigating the maze of regulations and agencies can be a challenge. Paul Kelley, CBET, manager of biomedical engineering at Washington Hospital in Fremont, CA, says that his facility conducts quarterly calibration checks for blood warmers even though manufacturer instructions stipulate such checks need only be performed annually. “At the time—six years ago—we had a very hard time getting clarification on the AABB requirement, so we went with the most conservative recommendation we had,” says Kelley. Arif Subhan, CCE, senior clinical engineer at Masterplan, cites the 2009 Joint Commission Laboratory Accreditation Standard EC.6.20 EP12 and the Clinical Lab Improvement Act (CLIA) regulations, specifically 42 CFR 493.1254. Subhan says it is his understanding that both Joint Commission and CLIA affirm that maintenance checks be conducted on laboratory equipment, instruments, or test systems according to manufacturer recommendations. A JC lab accreditation program must meet CLIA regulations, which stipulate that lab equipment must at least be tested according to manufacturers’ recommendations. However, the JC has given the flexibility under the hospital accreditation program to the hospitals to come up with their own testing intervals based on criteria such as risk, organizational experience, and manufacturers’ recommendations (EC.02.04.01 EP 4). Subhan refers to subtle differences in the accreditation standards for laboratories and hospitals. While most biomedical equipment technicians (BMETs) know that when working in a hospital they must follow that hospital’s accreditation program, Subhan adds, “The lab has to follow JC laboratory standards. They’re almost the same as the hospital standards, but there are subtle differences.” Megan Sawchuk, associate director of the JC’s Standards Interpretation Group, says lab workers must consider the following three sources for compliance when establishing their equipment maintenance practices, particularly for blood transfusion equipment: 1) the CLIA regulations, which are reflected in the JC standards 2) the AABB standards, which are included in the JC’s lab accreditation process 3) the manufacturer’s stated recommendations Like Subhan, Sawchuk also cites CLIA’s CFR 493.1254 as the “go-to” reference for maintenance and function checks for lab equipment and notes that section 493.1252 also has requirements pertaining to protecting equipment from electrical fluctuations. During a JC survey, Sawchuk says a hospital should provide a copy of the manufacturer’s instructions and, if they plan to do something different from those, they should explain why. And when there’s a difference in requirements among the manufacturer, JC laboratory or Lab Equipment Requirements: When Manufacturer and Joint Commission Guidelines Differ