September 2011
Feature Story

Anne Paxton

The College’s Laboratory Accreditation Program is celebrating its 50th year this month, but with the latest round of enhancements to the checklists, the program is doing anything but looking backward.

With the new checklists released July 11, the accreditation program not only downsized checklist requirements through reorganization and consolidation, but also introduced the All Common checklist, completed the implementation of the popular ROAD (Read, Observe, Ask, Discover) inspection process, and added one new checklist. Soon, it will offer, for the first time, a customized version of the Laboratory General checklist based on individual laboratories’ needs.

“We think the changes overall will be much more efficient and people will like them very much,” says Gerald Hoeltge, MD, chair of the CAP Checklists Committee.

The general thinking behind this round of revisions was that a comprehensive review of checklist content might allow the content to be pared down but still properly reflective of the program’s standards, which more than 7,000 laboratories meet to earn internationally recognized CAP accreditation. “The practice of laboratory medicine has become more complex, and as we have added more disciplines and areas of subspecialization in the field of pathology, the checklists have steadily grown,” says Frank Rudy, MD, chair of the CAP Commission on Laboratory Accreditation. “And we really thought it was time to take a step back and do a thorough review of the checklists to see if there’s an opportunity to reduce the number of questions, so as to make the checklists both more user-friendly and a bit less bur-densome.”

In their new, sleeker incarnation, the checklists include an extensive roster of changes, says Dr. Hoeltge. There are 500 fewer requirements in all, though many of the changes are not substantive ones. “It’s a combination of some items that have been deleted, some that have been moved, and some combined,” he says. For example, a requirement about centrifuges has been incorporated into a requirement about equipment maintenance. “We think laboratories will like the look and feel of the new checklist, and if you’re an inspector you should find it an easier tool to determine readiness.”

It’s all part of a three-year “diet” program that will slim the checklists down without any meaningful loss of content. “’Diet’ is actually the term we’re using internally,” Dr. Hoeltge says. “People complain that the checklists are too big, there are too many requirements, and what happens when you get big, complicated checklists is that the inspection team needs to be bigger to manage all of that. The inspection teams balloon. Then people complain there are too many people coming to the lab to do the inspection.”

How will consolidation put the checklists on a slimmer base? Dr. Hoeltge gives an example. “There were 65 requirements for lab safety in the 2010 edition. By regrouping these into nine groups—for instance, putting all the requirements for electrical safety together—we produced a 15 percent reduction in the number of safety requirements. So we have exactly the same content, but in a simpler and easier-to-use form.”

But the diet is only two-thirds finished. “It’s an ongoing project, and there is at least one more step that will be conducted for the 2012 checklists,” Dr. Rudy says. That is when requirements considered no longer necessary for a proper accreditation decision will be removed. “The Checklists Committee is now in the process of looking at checklist items that are rarely or almost never cited to ascertain whether those items are essential to maintaining the quality and safety that are inherent components of our gold standard LAP.”

For example, he says, “Some inspectors may spend as much time looking for one expired reagent in the back of a cabinet or refrigerator as they spend looking at QC failures and actions taken attendant to that. It’s important for us to be able to focus inspectors on aspects of the program that are really critical to quality and safety.” This part of the diet will wait until 2012, however, in part for technological reasons. “We need our new, faster computer platform [at the CAP] to make these really big changes,” says Denise Driscoll, MS, MT(ASCP), CAP director of laboratory accreditation and regulatory affairs.

In this revision, and as the members continue to look for redundant or unnecessary requirements, the Checklists Committee is hewing to a few consistent themes in its work, Dr. Hoeltge says. “First of all, we want to maintain any requirements that are regulatory, any that are based on peer-reviewed best practices, and any that are relevant to patient or employee health and safety. The ones likely to be taken out this time and in the future are those that are not evidence-based or regulatory. They may be good ideas, but they are really not supporting an accreditation decision.”

A major structural change is the introduction of the All Common checklist, which groups together requirements for proficiency testing, test method validation, procedure manuals, and critical results. With this new addition, “very similar requirements that were repeated from checklist to checklist to checklist have been pulled and put into a common checklist,” Dr. Hoeltge explains. Some weren’t phrased identically, so standardizing the wording was one of the original goals. “But it became very obvious that the best way to proceed was to come up with an All Common checklist.”

Less paper handling will be one of the advantages. “In many cases the team leader ended up having to copy and hand out some requirements in the Laboratory General checklist. So the All Common checklist will prevent a lot of copying at the Xerox machine, unstapling, re-stapling, and all that nonsense,” Dr. Hoeltge says. There will be other benefits too. With an overall reduction in the number of requirements and possible citations in each section, laboratories will find they need less preparation time in meeting document control guidelines and less time to respond to similar deficiencies within the different disciplines in the same section unit, or department.

Inspections will be simpler and faster too, Dr. Hoeltge notes. “The program identifies systematic issues. Let’s say you had a problem with quality control and that problem was in three different parts of the lab. If those different QC requirements had three different numbers as their identification flags, they may look like three separate issues when you’re going over the results of the inspection. But now they will have exactly the same flag, so it will be obvious there’s a systematic problem that needs to be addressed at some fundamental level.”

The All Common checklist will be of particular advantage to labs that have a single core facility, a rapid response lab for example, and smaller labs where all of the testing in this core lab is under the direction of a single supervisor or manager, Dr. Rudy says. “So an inspector going in and looking at a section with hematology, chemistry, or urinalysis will be able to apply the All Common checklist to that single section, even though there are different types of testing occurring within that section.” Small labs that often don’t require multiple discipline-specific checklists will be able to have one All Common checklist that will incorporate all of these key areas into one checklist.

This change will affect the reporting of deficiencies in a positive way, Dr. Hoeltge points out. “Labs will respond to deficiencies once per section unit. Previously, when they had chemistry, hematology, and microbiology in the same unit, if they were cited, the lab had to respond three separate times. Now they will have to respond only once. That will be a huge relief to labs, who really don’t want to explain to hospital administration that ‘We had 18 deficiencies but six were the same thing.’”

The CAP has begun to ask laboratories to send an update of their Laboratory General activities and scope of services, which will allow each lab to receive a shorter, streamlined, and customized Laboratory General checklist. The checklist requirements that are relevant will depend, Driscoll says, on how laboratories’ computer systems are set up (whether their LIS is off site or on site), how integrated the laboratories are, whether they are autoverifying, whether they perform direct-to-consumer testing, and so on. Dr. Hoeltge says: “If you’re a large lab that does every test, the regular General checklist is appropriate. But for affiliated labs doing a much smaller scope of tests, we can provide you savings in on-site efforts that I think you will appreciate. It’s a total win-win for labs, depending on how much you want to shorten the Laboratory General checklist.”

This year’s revisions also complete the accreditation program’s implementation of the ROAD (Read, Observe, Ask, Discover) inspection process. “In 2010, ROAD was in about half the checklists, and, as promised, now we are adding it to all the checklists,” says Driscoll, who believes laboratories will applaud the completed adoption of this process.

The ROAD process, a formalization of the best practices of experienced inspectors, focuses on groups of related requirements. It asks inspectors, when they’ve identified an area of concern, to drill down to more specific requirements and review more details outlined in the evidence-of-compliance statements. Inspectors read or review documents, observe laboratory practices to note any deviation from documented policies and procedures, ask open-ended, probing questions, and discover or follow a representative specimen through the lab from collection to reporting. “Both ROAD and the evidence-of-compliance components are intended to increase inspectors’ effectiveness on site and to allow labs to better understand examples of what will prove they are in compliance with the checklist items,” Dr. Rudy says.

Finally, one new element of the 2011 changes, the Clinical Biochemical Genetics checklist, brings the total number of checklists to 19. “The Clinical Biochemical Genetics checklist is specific for those labs that are taking care of patients with inborn errors of metabolism,” Dr. Hoeltge explains. “There are not many of them, and they’re virtually all in pediatric hospitals.”

Tests for diagnosing and managing such patients include the analysis of amino acids, organic acids, enzymes involved in intermediary metabolism, carnitine and acylcarnitines, acylglycines, CSF neurotransmitters, sugars, glycosaminoglycans, and glycoproteins. “There are special techniques and obviously small sample requirements that set these labs apart from most chemistry labs, so the Biochemical and Molecular Genetics Resource Committee decided a new checklist was the best way to meet their needs, and the accreditation program certainly agreed,” Dr. Hoeltge says of the CAP and American College of Medical Genetics joint committee. This new checklist is now available. Says Driscoll: “We don’t know how many laboratories might be interested in using it. But based on proficiency testing participation, we estimate about 60 to 100.”

“The LAP needs to be able to keep up with a rapidly expanding, burgeoning field of practice,” Dr. Rudy says, “particularly in the areas of molecular pathology and molecular genetics, and we are doing this by developing new checklists.” The committee is exploring the development of a checklist for whole genome sequencing.

The 2011 revisions illustrate how user feed-back drives checklist changes, Dr. Hoeltge says. “The College is always asking for people to send back comments about the accreditation process, and there are ways to mine that information for quality improvement purposes.” This year, the accreditation program decided to eliminate a checklist requirement that had been added in the 2010 edition, having to do with special handling of cerebrospinal fluid specimens from patients suspected of having Creutzfeldt-Jakob disease.

“A lot of people took the College to task on that requirement,” Dr. Hoeltge says. “They asked ‘what special handling are you recommending?’ or ‘how do you know if CJD is suspected?’ In reviewing that particular requirement, the committee agreed there were no special handling requirements the College could endorse, and that the majority of these specimens were coming from patients who might have CJD but it wasn’t diagnosed yet.” So the requirement was removed.

No laboratory has yet been subject to the revised checklists because of the time lag between reapplication and inspection. “The reapplication is sent out about 150 days ahead of time, and the checklists you get are the ones current on the particular date you reapply,” Dr. Hoeltge explains. So it is likely to be November or December before the first laboratories are subject to the 2011 changes.

“With all the changes we’re undertaking,” Dr. Rudy says, “it’s still our goal to maintain the program as the gold standard of laboratory accreditation programs. So that aspect will not be sacrificed in any of our initiatives. We want to improve processes to ensure thorough and consistent inspections that can be performed efficiently and effectively, for the benefit of both inspectors as well as laboratories.”

Dr. Hoeltge recommends that the checklists be downloaded at the first opportunity, along with the list of the most important changes. Both are available online at www.cap.org. “And stay tuned; there will be more changes in 2012,” he says. “Not just the technical content, but also the organization of the checklist will continue to evolve. The checklist is a document that will never stay the same because the science keeps changing, and it reflects all the wonderful things that are happening in laboratory medicine.”

Related Links

• Learn more about advanced education available through the CAP Laboratory Medical Director Advanced Practical Pathology Program (LMD AP³)