Home >> ALL ISSUES >> 2014 Issues >> Checklist changes put out fire (drills), for starters

Checklist changes put out fire (drills), for starters

image_pdfCreate PDF

Anne Ford

Dr. Hoeltge

Dr. Hoeltge

May 2014—Though pathologists have many talents, precognition—foretelling the future à la Nostradamus or the Amazing Kreskin—isn’t generally thought to be among them. That said, Gerald Hoeltge, MD, chair of the CAP Checklists Committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the Laboratory Accreditation Program checklists, which launch this month.

The change in question? “Fire exit drills will no longer be required,” he says happily, referring to requirement GEN.75400 of the laboratory general checklist’s safety section. “For 40 years, people have had to participate in fire drills on an annual basis, with many institutions doing them at least quarterly. Everybody, every year, has had to show they’ve walked the exit route.

“At the time those drills were instituted,” he explains, “labs were very different places vis-à-vis the quantity of flammable solvents and the use of open-tissue processors and open flames. Now the National Fire Protection Association’s fire code for these settings has changed, and the emphasis has moved to planning, the use of alarms, isolation of the fire, and so forth. Somebody does have to evaluate the escape routes every year, but not everybody has to actually walk them. This is the part where people will pencil in a happy face in the margin of CAP TODAY when they read it.”

Not to kill anyone’s buzz, but don’t be too quick to sketch a smile beside those words. Not all of the checklist changes, as Dr. Hoeltge himself points out, will be so welcome. Take, for example, the changes to the provider-performed testing section of the point-of-care testing checklist. The entire section has been revised to address provider competency and to eliminate credentialing as an acceptable method of establishing this competency. To wit, checklist requirement POC.09500 now says laboratories must document that providers have satisfactorily completed initial training in the performance of specific tests, and that medical staff credentialing is not acceptable documentation of training.

“They have to have their competency assessed just like any other testing personnel,” Dr. Hoeltge explains. “This can be a tough thing if we’re talking about the chairman of the Department of Urology doing a urine microscopic examination. These people are doing something they’ve done since they got out of training, and now they’ve got to have documentation that they’re actually trained to do it. But that’s the way it is. And hey, let’s face it: Sometimes it’s no fun to be the messenger.” He eases the blow a bit by reassuring checklist users that the documentation for this training has to be done only once.

The new edition of the checklists contains changes that are likely to delight, changes that may spark a bit of initial dismay, and changes that will probably fall somewhere midpoint on the emotional spectrum of the average user. Of course, emotions are not the issue here—patient care and patient safety are. As Dr. Hoeltge says of the changes to the provider-performed testing section: “This is important for compliance to federal regulations. It just has to be done.”

Professional competency is also the focus of a new requirement in the surgical pathology quality management section of the anatomic pathology checklist: ANP. 10255, which says, “The laboratory director ensures the professional competency of pathologists who provide interpretive services to the anatomic pathology laboratory,” and which mandates that there be a written policy for assessing this competency.

Dr. Gomez

Dr. Gomez

“This comes,” says Richard R. Gomez, MD, “from a CMS requirement for competency assessment of technical laboratory personnel. Basically, what CMS has decided is that the interpretation of a pathology slide—in other words, the diagnosis—is a laboratory test. So, as part of our CMS-deemed authority for laboratory accreditation, we need to include this to assess pathologists who are interpreting anatomic pathology tests at their facility.” Dr. Gomez is chair of the CAP Council on Accreditation and medical director of the laboratory at St. Francis Health in Topeka, Kan.

Though this change may come as a surprise, Dr. Gomez doubts it will affect checklist users in any significant way. “We’ve always thought that diagnostic interpretation was part of the practice of medicine,” he says. “We never realized that CMS would classify it as a laboratory test.” Astonishment aside, he points out that “most of our members are already doing this.” That is, they’re using quality assurance products from the CAP, such as slides from the Performance Improvement Program in Surgical Pathology. “These products will help pathologists demonstrate, ‘We’re doing this, and our competency is assessed by the laboratory medical director through these functions,’” he says. “We’re pleased that our discussions with CMS regarding this have resulted in requirements for compliance by our members that are not very onerous, and we believe the checklist requirement is very reasonable.”

One change to the personnel section of the laboratory general checklist is the clarification added to the competency assessment requirement GEN.55500 for the qualifications of the individuals who can perform the assessments. “For moderately complex point-of-care testing, the assessment has to be done by somebody who is qualified to be what CLIA calls a technical consultant,” Dr. Hoeltge explains. “For the most part, that means a bachelor’s degree with two years of laboratory experience. And most of the point-of-care testing is done in hospitals in nursing areas, and there aren’t too many senior nurses out there who have two years of lab experience. That is a challenge people are going to have to sort through.”

A lesser challenge but a change worth noting is new requirement GEN.53625, “Performance Assessment of Supervisors/Consultants,” which also appears in the personnel section of the laboratory general checklist, and says: “The performance of section directors/technical supervisors, general supervisors, and technical consultants is assessed and satisfactory.” It’s likely that laboratories have been doing this, but it now needs to be documented.

Dr. Sarewitz

Dr. Sarewitz

One area that has undergone significant change is the predictive markers section of the anatomic pathology checklist. “This isn’t a huge volume of changes,” says Stephen J. Sarewitz, MD, vice chair of the CAP Council on Accreditation and staff pathologist, Valley Medical Center, Renton, Wash. “The basic checklist requirements are the same, but there are certain very important revisions” to the items pertaining to HER2 testing.

The minimum number of samples required to validate HER2 assays has been changed. “The previous requirement was a range of 25 to 100 cases, but that has been changed to 20 positive and 20 negative samples for FDA-approved or -cleared assays. For tests that are not FDA approved or cleared, the requirement is 40 positive and 40 negative samples,” he says. In addition, the new requirement says that samples that give an equivocal result need not be used in a validation study, on the grounds that, Dr. Sarewitz explains, “If they’re not clearly positive or clearly negative, you get into a gray area, and significance of concordance of the samples with a reference method might be uncertain.”

Then, too, the requirement for the time of fixation has changed. The previous requirement called for six to 48 hours in formalin, but “there really wasn’t a lot of good evidence for that upper limit,” Dr. Sarewitz says. “And in fact, the requirement for fixation for estrogen or progesterone receptors was six to 72 hours, so it was a bit difficult for laboratories in that we had different allowable time periods for fixing the sample for two types of tests that are generally performed on the same sample.” The fixation time requirement for HER2 is now the same as that for estrogen or progesterone receptors: six to 72 hours.

A third change affects the scoring system for both immunohistochemistry and in situ hybridization. “Most or all of the FDA-cleared or -approved tests for immunohistochemistry indicate in the manufacturer instructions that if greater than 10 percent of invasive tumor cells have strong staining, the test should be considered HER2 positive,” says Dr. Sarewitz. “However, in the previous [2007] ASCO/CAP guidelines, reflected in the previous edition of the checklist, that criterion was 30 percent, not 10 percent.”

CAP TODAY
X