CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Anne Paxton
August 2017—There was no trip to the spa. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last year’s checklists. A microbiology section that is shorter by eight pages, fewer Individualized Quality Control Plan reporting requirements, and a new section addressing chain of custody once again reflect the hard work of the Checklists Committee and scientific resource committees to achieve conciseness and clarity.
Molecular microbiology is one part of the checklist that is noticeably slimmer and lighter than last year’s model; the section is now only about two-thirds its previous length. “This is by far the biggest revamp we’ve done of the microbiology checklist,” says D. Jane Hata, PhD, D(ABMM), a member of the Microbiology Resource Committee (MRC). “Concerns about individual checklist requirements certainly come up at every MRC meeting, but I think this was a much bigger project.”
Dr. Procop
The requirements themselves were refined very little. Instead, the formerly separate sections for FDA-approved or -cleared, modified FDA-approved or -cleared, and laboratory-developed tests have been combined into one. “This was largely an extensive reorganization and clarification initiative,” says Gary W. Procop, MD, MS, medical director of molecular microbiology, virology, mycology, and parasitology labs at Cleveland Clinic and past chair of and now advisor to the MRC. Other items that were already in the all common checklist were removed, while the number of requirements in the molecular section of the microbiology checklist was reduced from 71 to 56 because of all the combinations that were made.
Feedback to the accreditation program spurred this consolidation. “Participants reported that the former version of the checklist, particularly the molecular microbiology portion, was confusing. Some participants were unsure which of the sections to use, given the various subdivisions, and there were several duplications between the various sections,” Dr. Procop says. “The subspecialty experts of the MRC worked to clarify and label each part of the checklist, so that users would clearly understand which sections were applicable to their tests. Duplicative information was consolidated, whenever possible.”
The reorganized checklist now includes subsections for electrophoresis, microbial in situ hybridization, and sequencing.
The Microbiology Resource Committee believes laboratories will find the revised checklist clearer and more user-friendly. “The essence of the requirements hasn’t really changed,” says Susan E. Sharp, PhD, D(ABMM), a member of the MRC and director of microbiology, Kaiser Permanente Northwest Region Laboratory. “We basically have just reorganized and eliminated redundancy. Regardless of the type of testing you’re doing, you have had to perform validation and verification studies, so why not bring everything together?”
The change doesn’t affect the inspection process, Dr. Sharp adds. “But it will make it easier for laboratories to know they are in compliance.”
As a result of the consolidation project, the committee opted to remove a chart that had appeared at the front of the microbiology section and was meant to be helpful, but was not. “Laboratories had difficulty interpreting the chart. They were confused when tests they were performing were not listed, and they didn’t know which part of the checklist to use for that particular test. Once we reorganized the checklist, the chart was found to be unnecessary and was eliminated,” Dr. Sharp says.
Dr. Sharp
Other changes were more minor. For example, the MRC agreed to replace the term “sample” with “specimen” in the assay validation and verification section (MIC.64770). “This requirement specifically refers to when you are going to use a specimen that is different from the specimen type cleared by the FDA. It just seems more clear to refer to these as specimens rather than as samples,” Dr. Sharp explains.
“There are still several checklist requirements for assay validation and verification in the microbiology section. Part of these requirements indicate you need to have records showing that the appropriate validation and verification studies were done,” she notes. The all common checklist also contains further information on validation and verification testing.
To make the language more consistent in MIC.65140 and other checklist requirements, the MRC changed the term “non-FDA-cleared/approved test” to “laboratory-developed test.” “They’re really the same thing, so we are trying to label them the same way,” says Dr. Hata, director of clinical microbiology and serology labs at Mayo Clinic in Florida.
The small but significant word “written,” pertaining to criteria for calibration verification, was added to MIC.65150. “When you walk into a lab, the lab might say, ‘Well, yes, of course we do this.’ But without written documentation it’s very difficult to justify a finding that best practices are being followed,” Dr. Hata notes.
Few changes were made in the instruments section of the molecular microbiology checklist. “These testing methods change rapidly, and we went through these specific requirements to make sure they were technologically accurate,” Dr. Hata says. Most were found to be fine and needed no change. But MIC.65580, Group B Screening, was clarified to note that it relates to screening done by non-amplified DNA probe. “There are specific tests for Group B that use non-amplified technology, and they don’t fit neatly into one of the categories we’ve delineated in this section, so we wanted to set that off” from MIC.65590 (Group B Screening-Amplified Method).
In the results reporting section, the MRC opted to change “ASR Report” (in MIC.66120) to “ASR Disclaimer” to employ current terminology. “We know the definition of ASR [analyte-specific reagent] is continually changing, and I’ll say in advance that we’ll probably be changing this again as the definition changes. These checklists are always in flux,” Dr. Hata says.
New language in MIC.66120 also adds that “The laboratory may put a single ASR disclaimer on the patient report for all microbiology studies collectively used in a particular case. Separately tracking each reagent used for a case and selectively applying the disclaimer to only the class I ASRs is unnecessary.” This change will lighten laboratories’ reporting, Dr. Hata explains. “Some labs would put four or five instances of this particular disclaimer on a single patient report, making it messy and difficult to read. We were trying to help labs by indicating you only need to do it once.”
Dr. Hata
Particularly in this round of changes, the MRC has often sought to follow the concept of less is more. But, as Dr. Hata suggests, “less” is not always easier to achieve. “As these checklists evolve, it’s easy to add items, especially when it becomes apparent specific needs should be addressed. Granted, it can be more work to go back and clean up redundancies, but it is necessary.”
Checklist changes can sometimes be unnerving for laboratories, Dr. Hata admits, but she believes once labs read through the revised molecular microbiology requirements, they will find the items to be much clearer. The committee counts on accreditation program participants to help with the process, she says. “We have a very smart membership. They bring up valid points, and I think it’s always good to continually go back and review these checklists to make sure they’re doing what we need them to do.”
In the all common checklist’s section on Individualized Quality Control Plans, the Checklists Committee made mostly housekeeping changes rather than anything sweeping, says Accreditation Committee member Deborah Perry, MD, a past chair of the Point-of-Care Testing Committee and medical director of pathology at Methodist and Children’s hospitals in Omaha, Neb. “There are some good updates now that we’ve had time to use the checklist and develop IQCP.”
The biggest change is that there will only be one form to complete because the committee eliminated the IQCP summary form. In 2016, the CAP implemented two different forms, explains William W. West, MD, of Physicians Laboratory Services, Omaha, Neb., and chair of the Checklists Committee. “One was an IQCP list of the IQCPs you had in the lab; the other was a summary form that asked for details on how you set up IQCPs in the first place. People said on the summary form that they were often just listing what was already on the IQCP documentation in the lab itself; it was duplicative. As we looked at it, we thought we could eliminate the summary form by including a few other details on the list form. So we cut the number of forms from two to one by doing that.”