The College is moving forward on a number of fronts in rolling out and playing up new features of its Laboratory Accreditation Program.
As of July 1, pathologists who lead a team of inspectors must receive training
beforehand, and that training is now online; soon to come will be required
training for all team members involved in an inspection. Meanwhile, the College
has pushed ahead with unannounced inspections and strengthened the performance
monitoring of proficiency testing to help ensure labs’ compliance
with accreditation requirements between the biennial inspections. And specialized
user groups have been formed to more thoroughly vet new checklist questions
and changes (Related article: Checklists undergoing
more intensive review).
The online inspector training is available to CAP members and non-members by clicking on the “Education” tab at the top-center of the College’s home page, www.cap.org, then finding the LAP Education Activities section of the course catalog. That catalog includes not only team leader training but also courses for team members and LAP audioconferences and special events.
“It’s very easy to use,” says R. Bruce Williams, MD, chair of the Commission on Laboratory Accreditation. “All team leaders who are assigned to do inspections after [July 1] need to be trained before they go on the inspection. In order to make that widely available to everybody, at their convenience, we’ve developed this online course so they don’t have to travel, they don’t have to take time off work. They can go back and study it as many times as they’d like.”
The CAP Laboratory Accreditation Program has long provided the expertise of practicing pathologists who are steeped in what to watch for because they live with CAP and CLIA rules daily, Dr. Williams says. The online training, which will be required of all team members starting in 2007, takes that to another level, he says.
“What we’re trying to do is better train these individuals, team leaders and team members, in how to become more efficient and effective inspectors,” he says.
“These programs take them through the pre-inspection period of getting the team ready. Then it takes them through the inspection, gives them different hints on how to inspect, techniques on how to ask different questions and find out if the laboratory is meeting the requirements, and then what to do after the inspection is over.”
The largely positive reviews that unannounced inspections received from labs involved in pilot programs earlier this year have been echoed by those who have been inspected since the pilots ended, Dr. Williams says.
“We participated in the [pilot] inspections...and did interviews of [those inspected] before and after the inspection. We got a good handle on how to run one,” he says. “Since then, we have gone to phase two of studying the unannounced inspection process. We have interviewed laboratories that were routinely assigned to the unannounced inspections, and we’ve had very positive results. They’ve stated that, with the exception of a couple things, the unannounced inspection has gone very well. It didn’t cause significant problems.”
Like those involved in the pilot, labs inspected more recently have commented that the inspection proceeded more slowly in the first hour or two because personnel needed to retrieve required manuals and other documentation, and, in some cases, labs have needed to summon a key member of the staff who was not on site that morning, Dr. Williams says.
“In general, that has not hindered the inspection process,” he says. “They were able to have other people answer the questions and, in general, things have gone pretty well.” The only other comment they had: “They asked if it was possible to have a very short window of opportunity, of notice, so that if they need to request additional personnel during the inspection day, so the testing could continue as well as have enough people there to answer questions for the inspection team,” they could do so, Dr. Williams says.
He worries that some laboratories may be keeping key staff from vacationing during the six-month window, and says, “We strongly discourage that.”
Though he has heard talk of labs switching to other agencies like the Joint Commission on Accreditation of Healthcare Organizations to avoid the CAP’s unannounced inspections, he has not seen evidence of that, and, in fact, JCAHO and others also perform unannounced inspections, he says.
“We cannot identify any trend at this point of anybody... leaving the program, or thinking about using another accrediting body,” he says. All accrediting agencies have to accredit to the same standard, which is the Clinical Laboratory Improvement Amendments. “People understand that the CAP program is more stringent than the CLIA standards, but they feel that this increased stringency results in better laboratory practice.” With laboratorians so committed to quality laboratory practice and interested in providing the best service possible, it’s Dr. Williams’ feeling that most labs “will stay with this program.”
Performance monitoring of proficiency testing is moving down two tracks: actively watching PT enrollment on an ongoing basis, and taking a closer look at failures, says Chantal Harrison, MD, chair of the Continuous Compliance Committee.
“Before, [the College] looked at PT enrollment at the inspection and, for selected analytes, when PT results were not received as expected. But those reviews weren’t as comprehensive or timely as the new process”—made possible by programming improvements, she says.
Labs are now receiving notice ahead of time that they’re due to enroll; many labs have missed at least some programs they should have been enrolled in, Dr. Harrison says. Next year, the laboratories should receive that advance notice even earlier since the system will be fully in place.
The more careful watch on laboratory testing failures means that even though one incident does not trigger regulatory action, the College will be urging labs to assume one incident could lead to a second and to take action voluntarily, Dr. Harrison says.
“We are in the process of becoming a little bit tougher on laboratories that have repeated failures,” she says. Under CLIA, “if you’re unsatisfactory in two out of three successive events, you’re called unsuccessful. We’re becoming very strict in that if a laboratory doesn’t have a program to fix their problem, they will be told to cease testing.”
The College will send a letter to that effect, which is a harder line than taken in the past, Dr. Harrison says. “They must have a program put into place that is looked at very carefully,” she says. “The committee will look at the responses from the laboratory [and] make a decision about whether this is a real program or just words that try to explain away things.”
The committee will not prescribe a course of action, such as performing a root-cause analysis, but it might make suggestions, Dr. Harrison says. “We have put together some advice on how to look at the failure in the letter we send, trying to wake them up and say it’s serious,” she says, “and here are some ideas on how to approach the problem.”
This tougher approach to proficiency testing did not come about because the College believed its procedures were inadequate, says Paul Valenstein, MD, member of the Continuous Compliance Committee and the Council on Accreditation. In fact, a recent Government Accounting Office report showed that CAP-inspected labs had the lowest percentage of PT failures, compared with those inspected by COLA, JCAHO, and state agencies (Related article: Percentage
of labs with proficiency testing failures).
“We believe CAP-accredited labs are the best in the industry,” Dr. Valenstein says. “Yet we know we can do better. Some unsatisfactory PT events are the result of innocent clerical or transcription errors that don’t reflect any problems testing patient specimens. But some PT failures reflect real problems with an assay the lab is performing.”
The purpose of the tougher approach to proficiency testing is to protect patients and keep laboratories out of regulatory trouble, Dr. Valenstein says. “We’re asking laboratory management to treat their very first unsatisfactory PT event as a signal that something is amiss,” he says. “We want management to do more than explain the problem. We want laboratories to investigate and correct the cause of the problem, and to document what they have done.”
The College’s statistics show that 93 percent of laboratories that have an unsatisfactory event go on to have two subsequent satisfactory events, which means CLIA sanctions are not triggered. “But playing these odds can be dangerous for patients and puts a laboratory at regulatory risk,” Dr. Valenstein says. “Too often we have seen laboratory managers ignore a PT problem in the hope that it will not recur.” If a PT failure recurs, and there is no record of the laboratory launching a credible investigation after the first unsatisfactory PT event, regulators may require the laboratory to shut the assay down and refer specimens elsewhere. “This is an embarrassment everyone in our industry would like to avoid,” he says.
Promoting high-quality, safe care for patients, “is, as always, the goal of the CAP program,” he says. The CAP accreditation program will “stimulate laboratories to seriously investigate” the cause of poor PT performance after the first unsatisfactory PT event, before the laboratory runs afoul of CLIA’s minimum performance expectations.
The College’s objective is not punitive, but more of a “tough love” approach, Dr. Valenstein adds. “We really want labs to succeed,” he says. “We will be sending an educational circular to labs with an unsatisfactory PT event that will help them troubleshoot their problem and take steps to keep it from recurring.”
Dr. Valenstein emphasizes that while the bulk of unsatisfactory PT events are due to one-of-a-kind clerical errors or other problems that are nonrecurring or promptly corrected, laboratories should never take a chance when quality is at stake. “We want laboratories to take their first unsatisfactory PT event seriously, investigate it with vigor, and undertake remedial action,” he says.
“The College’s tougher approach to unsatisfactory PT events has not been adopted in response to any sort of new government mandate,” he adds. “The CLIA standards have not changed. What we have come to appreciate is that some laboratories do not begin to get serious about a PT problem until their second unsatisfactory PT event, when an assay is at risk of being shut down by regulators. We realized we needed to create tension sooner, so that problems would be resolved with more haste.”
The goal of this program is to reduce the proportion of unsatisfactory PT events that recur. Today, seven percent of unsatisfactory PT events are followed by another unsatisfactory event in one of the next two mailings. “I’d like to see that number closer to zero,” Dr. Valenstein says.
“This initiative should result in fewer laboratories reaching the CLIA ‘unsuccessful’ stage, fewer regulatory sanctions, and better care for patients.”
Ed Finkel is a writer in Evanston, Ill.