Point-by-point checklist for POC testing

December 2007
Originally published in CAP TODAY

Anne Paxton

The point-of-care testing checklist in the Laboratory Accreditation Program is a slightly different breed from the other checklists: It needs to be responsive to non-laboratorians. In general, explains Nancy Yeransian, MT(ASCP), CAP manager of accreditation services, "We don't like to be prescriptive in checklist questions. But in point of care where you usually have a lot of non-laboratory personnel, you find you have to be a little bit more prescriptive."

The checklist changes that took effect this fall, including more detailed notes for proficiency testing and for retention of primary records, and a reworded QC section for nonwaived tests, reflect this difference.

For example, Yeransian says, "Previously the first phase II question just read, 'Is there evidence of evaluation and, if indicated, corrective actions of unacceptable results of proficiency testing?' Then there was a brief note that didn't get into a lot of specifics."

"Now it says, 'Is there ongoing evaluation of PT performance and alternative assessment?' and we actually give examples of compliance to help participants determine what is required for compliance. The four points in the note were not listed before."

Record retention is another area newly addressed. "We get calls not only for point of care but also for the other checklists regarding primary records of PT and alternative assessment, and we've added a requirement that primary records be kept for two years," Yeransian says. "We didn't have a specific time frame listed in there previously." The checklist question specifies that records to be retained include all instrument tapes, work cards, computer printouts, evaluation reports, evidence of review, and documentation of followup/corrective action.

"In point of care, since it's not usually handled by laboratory personnel, the records of instruments or little handheld devices often aren't seen as necessary to be kept like other documents, so this was clarified."

"We tried in the point-of-care testing checklist and some other checklists to put all the requirements for basic QC for nonwaived tests, particularly with respect to when the laboratory can use built-in controls as its only daily QC, as opposed to having to use external controls, into one checklist question and make it easier for the laboratories," says Stephen J. Sarewitz, MD, chair of the Checklists Committee.

For nonwaived tests, daily QC can be limited to internal controls (without external controls) only if all the criteria in the checklist question are met, Dr. Sarewitz says. "One change to the criteria, in the new edition, is that only a single built-in control is required for qualitative tests." Previously, the checklists were a little unclear about this, he says, and most laboratories interpreted it to mean they had to have two internal controls for qualitative tests. "Now only one internal control for qualitative tests is required, but two are still required for quantitative tests."

Another recent change concerns the validation study before implementing protocols for limiting daily controls to internal controls. "It used to be that was entirely at the discretion of the laboratory director," Dr. Sarewitz says. "Now there is one exception: certain devices with cartridges with built-in liquid controls used for QC. If those are part of the controls, then the laboratory needs to run them against external controls for 20 days."

That change was based to a degree on educated guesswork, he says. "One of the major problems is the entire issue of the relationship between internal and external controls and when the former is sensitive enough to replace the latter. There's very limited data available."

This checklist change was suggested during one of the committee discussions as an empirical way to show that the internal liquid controls give equivalent results to external controls, over a reasonable period of time, Dr. Sarewitz explains.

The revised checklists also say that control testing is not necessary on days when patient testing is not performed. "That was another question we often get," Yeransian says, "not only in point of care but for non-hospital settings like doctors' offices where they are not performing testing every day: 'Do we still have to run controls?' It seems obvious, but now it's in writing."

Finally, the provider-performed testing section of the POC checklist now applies to mid-level practitioners as well as physicians.

"The notes of introduction preceding all the questions now say this includes mid-level practitioners, because we wanted to expand it to not only physicians," Yeransian says. "Mid-level practitioners including credentialed physician assistants, nurse practitioners, and certified nurse midwives do perform this testing in facilities, and we wanted to make sure they were also covered."