Where inspectors err
Inspectors commonly make errors on two checklist questions—one in point-of-care testing and the other in chemistry.
First, from the point-of-care testing checklist, is question 30:0380. It asks, "In the absence of a designated on-site supervisor, are the results of tests performed by personnel reviewed by the POCT director, laboratory supervisor, nursing supervisor, or the person in charge of the POCT section on the next routine working shift?"
Inspectors often interpret this to mean that a supervisor must review all point-of-care testing results. "In fact, this business of having the supervisor review results applies only to high-complexity tests. It doesn’t apply to moderately complex and waived tests," Dr. Ruhlen says.
Further, the supervisor can be anyone who meets the CLIA qualifications of a general supervisor, including a nursing supervisor.
The second incorrectly cited question, 03:2786 from the chemistry checklist, asks, "Are recent instrument maintenance, service, and repair records (or copies) promptly available to, and usable by, all technical staff operating the equipment on all shifts?"
"The point isn’t that the records have to be right there physically," Dr. Ruhlen says. "It’s just that they need to be available." If they are off site, rapid access through a computer or by fax is acceptable.