Clinical laboratories in California general acute care hospitals (GACHs) may soon need to meet federal hospital conditions of participation (CoPs) requirements with their quality assessment and performance improvement (QAPI) programs under new hospital licensure regulations, according to a report from the firm McDermott Will & Emery LLP.
Changes proposed by the California Department of Public Health (CDPH), if approved, would mean clinical laboratory QAPI programs must be integrated into the hospital-wide QAPI program; for hospitals that do not have a distinct lab QAPI program, this requirement would entail establishing such a program and integrating it with the hospital-wide program, explained lead author Emily Jane Cook and colleagues in a September 9 blog post.
Greg Fosheim, Partner, McDermott Will & Emery LLP
"California general acute care hospitals are already required to meet federal conditions of participation requirements for their QAPI programs," explained Greg Fosheim, partner at McDermott Will & Emery in Chicago, for LabPulse.com.
"However, federal hospital laboratory conditions of participation do not include a QAPI program requirement. Instead, CLIA rules at 42 CFR 493.1200 require a laboratory to have written policies and procedures that identify, evaluate and resolve problems in the laboratory and ensure continuous improvement of the laboratory’s performance."
Fosheim added that hospitals can look to CMS State Operations Manual Appendix C for helpful guidelines on what is necessary to meet the quality system requirements of the Clinical Laboratory Improvement Amendments (CLIA).
The firm also called out other aspects of CDPH's proposed regulations, such as a measure tying licensure to clinical laboratory directors fulfilling their duties in accordance with CLIA.
CDPH appears to prefer that directors of clinical laboratory services at GACHs be licensed physicians who are board-certified or eligible to be certified in anatomic pathology or clinical pathology, and to fulfill their duties in accordance with federal CLIA, according to Cook and colleagues. Notably, under CLIA rules, a lab director may be, but is not necessarily required to be, a board-certified physician, they said.
"CLIA rules at 42 CFR 493.1351-1495 describe personnel requirements for laboratories performing non-waived testing," Fosheim said. "Depending on the type of tests performed, a laboratory director may be a licensed physician under CLIA rules, but there are other potentially applicable qualifications as well, including sufficient experience plus a PhD in chemical, physical, biological, or clinical laboratory science and board certification by an appropriate certifying board."
The proposed rule obligates a GACH to have a board-certified or board-eligible anatomic pathologist or clinical pathologist as part of the clinical laboratory staff, Fosheim said, adding that the proposed rule appears to indicate a preference that this pathologist serves as the laboratory’s director.
"However, if this person is not available on a full-time or part-time weekly basis, a physician or licensed clinical bioanalyst may serve as the laboratory director," continued Fosheim. "A California licensed clinical laboratory bioanalyst requires a Master’s degree or higher in chemistry, physics, biology, or clinical laboratory science, so although California’s proposed rule is not clearly written, the proposed California standard and the CLIA standards are not discordant."
Other changes may necessitate that general acute-care hospitals renovate existing clinical laboratory space.
"While few of the proposed changes appear to be substantive, the proposal includes changes that could require GACHs in California to materially alter their current operations," the authors said. A public hearing on the proposed rules will be held September 12.
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