Accreditation beyond U.S.?
It’s too difficult. It’s too expensive.
It’s punitive. It’s only for Americans.
That’s what some laboratorians in the Middle East have heard about CAP accreditation. “People look to institutions like the American Hospital Dubai [the first CAP-accredited laboratory in the United Arab Emirates], and they say, ‘Oh, that’s wonderful, but there’s no way I could accomplish that,’” says Noel Adachi, CAP vice president of international market development.
For those who say that becoming CAP accredited is impossible, Laila Abdel Wareth, MBBCh, FRCPC, has a few unambiguous words: “There’s nothing impossible about it.”
She should know. Dr. Abdel Wareth, the chair of pathology and laboratory medicine at Sheikh Khalifa Medical City in Abu Dhabi, UAE, took her laboratory through the CAP accreditation process in 2010, making it the first in the emirate and the fourth in the UAE to achieve that milestone.
As her success demonstrates, CAP accreditation is not an ambition marked “For Americans Only.” In 1984, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, received the Middle East’s first CAP accreditation; since then, 41 other labs, including Dr. Abdel Wareth’s, have followed suit. Several others are on their way. In addition, Adachi says, “a significant number of laboratories in the UAE and Saudi Arabia are participating in our proficiency testing program. Many of those labs in the next few years” are likely to pursue CAP accreditation as well.
Still, the rumor persists that CAP accreditation is achievable only at infinite expense and with great trouble. That’s a notion, says CAP Middle East deputy regional commissioner Samir Amr, MD, that pathologists such as Dr. Abdel Wareth are gradually laying to rest. “In the UAE, everybody is looking at her achievements and her ability to get the accreditation for such a large laboratory in relatively record time,” he says. Here’s how she did it.
A down-to-earth woman with an energetic, cheerful demeanor, Dr. Abdel Wareth was born in Egypt and educated at the University of Cairo, receiving her medical degree there in 1989 before heading to Vancouver, Canada, to do her residency at the University of British Columbia. It was there that she was introduced to the notion of accreditation.
As a first-year resident doing a clinical chemistry rotation, Dr. Abdel Wareth was initially more worried about mastering her clinical competencies than anything else. “You want to be able to interpret laboratory results and understand analytical techniques, and not worry too much about the laboratory administration part,” she says. That mindset lasted until her mentor announced, “I’m expecting you to conduct an inspection of another, smaller lab,” using a Canadian accreditation checklist.
“I’ve just started learning about labs, and all of a sudden I’m going to be an inspector?” she remembers thinking. “Wow! What is this?”
It was an introduction to a whole new way of thinking. “I did that inspection with another, more senior pathologist, and it was an eye-opener. From that point on, the notion of quality systems was on my radar screen,” she says. “I became interested in this whole accreditation process. Even if I wasn’t asked to, I would always be looking for these things during any rotation I went through from that point onward.”
Not until several years later, after she had married a UAE citizen and begun working in the laboratory of Mafraq Hospital in Abu Dhabi, did she encounter the CAP and its standards. “When I came to the UAE, in the absence of any laboratory standards here, I started looking,” she says. At a conference, she heard Dr. Amr—now chair of the Department of Pathology and Laboratory Medicine at King Fahad Specialist Hospital, Dammam, Saudi Arabia—speak about the College, and another light bulb went on. “At that time, the checklists were available for free, so I just printed them out and started using them as a reference. Whenever I got stuck with any questions, I would just go and check what the standard said,” she recalls.
In 2006, she became chair of pathology and laboratory medicine at Sheikh Khalifa Medical City, which had in 2005 acquired two other hospitals, increasing its bed capacity from 200 to 570 in a two-week period. “That little laboratory all of a sudden became responsible for all those beds!” Dr. Abdel Wareth laughs. Soon afterward, the hospital went on to acquire several family medicine clinics and a behavioral science pavilion. “Initially we had, obviously, capacity issues,” she says. “We needed to increase the lab capacity. We needed to automate our analyzers. We had to knock out walls and bring in more modern and high-throughput automated systems.” SKMC’s laboratory now processes about 2.4 million tests each year.
At the same time that SKMC was growing its operations, change was coming on an even larger scale. In early 2008, the Abu Dhabi Health Authority began a serious push to improve and modernize health care in the emirate. As part of that effort, “the government began to understand the importance of being accredited,” says Hany Alfy, the CAP’s regional representative for the Middle East. As a result, “it was made obligatory by the government to be accredited.”
Aaron Han, MD, PhD, chief of pathology at the Amer-ican Hospital Du-bai, agrees that the UAE’s health care sector has achieved a new understanding of the importance of accreditation. “Ten years ago when there were only one or two labs [in the UAE] accredited, it was a differentiator, but now it’s almost a minimum baseline,” he says. “To be doing laboratory work, you need to be accredited now, because the level of quality has risen all around. I tell people it used to be a high bar, and now it’s a low floor that everybody has to be on.”
While awareness of accreditation was growing, says Alfy, “the misconception was that CAP was extremely difficult. When I started representing CAP in the region, I started changing this concept. CAP will make all efforts to make you pass. It is not like you go into an exam, and it is pass or fail. During the preparation period, CAP is here, I am here; we can help you prepare. If anything is not clear, we can answer it for you. All of this helps a lot to minimize the fear.”
In April 2008, the Joint Commission’s international division accredited SKMC. But even as Dr. Abdel Wareth and her team helped prepare for that hospital-wide accreditation, she says, “We were still thinking: We [the laboratory] really need to do CAP.”
Why the CAP, rather than another accrediting body? Because, she says, “when we started reading the CAP standards, we could very much relate to and understand their language. They were written by peers, by laboratory professionals. They were done in a very practical and professional way that we could certainly relate to. They weren’t vague or left to the interpretation of the reader. We found that CAP also had the longest track record in terms of lab accreditation. We figured they knew what they were doing.”
The natural place to start: enlisting the help of Dr. Amr, from whom Dr. Abdel Wareth had first learned about the CAP and its accreditation process. Not only had Dr. Amr been through the accreditation process himself, but as the CAP’s deputy commissioner for the Middle East, he had conducted inspections and trained inspectors in the UAE, Jordan, Kuwait, Saudi Arabia, and other countries. Indeed, after the events of Sept. 11, 2001, when American inspectors were unable to travel to the region for a time, it was Dr. Amr alone who shouldered the region’s inspection duties.
Now Dr. Abdel Wareth needed his help. “She contacted me and said that she was interested in having CAP accreditation,” Dr. Amr says. “I asked her, ‘Did you go through the checklist?’ She said that to the best of her ability, she had.” So, in June 2009, an inspection team flew from Saudi Arabia to Abu Dhabi to per-form a mock inspection of SKMC’s laboratory.
“That was a true eye-opener,” Dr. Abdel Wareth says. “It wasn’t until they came and looked at our laboratory that we really felt the heat. We got a flavor for how detailed the inspectors can be. We were sitting there going, ‘Yeah, yeah, yeah, we do that.’ But when you have to show the evidence to someone, then you start to doubt it: ‘Oh my God, are we really doing it to the letter or not?’ That mock inspection just set us on fire.”
The deficiencies uncovered during the mock inspection weren’t the only things she needed to remedy, Dr. Abdel Wareth discovered. Her usual “rush right in and get things done” outlook needed to be modified, too. “I’m a very enthusiastic and kind of naive person,” she says. “I wanted to do this very quickly. But I remembered Dr. Amr’s advice. He said, ‘Laila, you’ve got to slow down to move forward.’ He said, ‘You have to stop, address the issues, and then take your time to prepare. Don’t just rush into this.’
“I think that was very important advice,” she continues. “If you want to use this tool to truly transform your lab, you ought to give it time. Rushing into it is a useless exercise. We had issues with safety we had to fix, issues with staffing and so forth, and these things take time.”
For example, she found that in her enthusiasm, she had underestimated how complex it would be to validate the laboratory’s molecular test methods. “We had a big menu of tests, and most of them were homebrew methods. Initially, I thought we could validate them all, and I pushed in that direction,” she explains. “Then I was on the team that did the mock inspection of the molecular lab, and at that time, I realized the complexity involved.” Subsequently, she eliminated some of the lower-volume tests or sent them to reference laboratories, focusing mainly on those that were high-volume or required rapid turnaround time.
Other valuable advice came from the Cleveland Clinic, which has managed SKMC’s operations since 2007. Soon after the mock inspection, Dr. Abdel Wareth e-mailed Kandice Kottke-Marchant, MD, PhD, chair of the Cleveland Clinic’s Pathology and Laboratory Medicine Institute, and asked if she could visit, so she could learn more about both the Clinic and the CAP. Certainly, came the reply.
“It was really inspiring to walk into another lab and talk to people who have done it [achieved CAP accreditation],” Dr. Abdel Wareth says. One of the most valuable things to come out of her visit? “They introduced me to a wonderful tool called ‘compliance binders,’” Dr. Abdel Wareth says. “They printed out every single [CAP checklist] question, and behind each page they inserted the evidence that they met that standard. They would divvy up the tasks: ‘You take those questions, I take these,’ and everybody’s responsible for keeping their binders up to date all the time. I thought that was genius. We started preparing compliance binders that way.”
Of the many challenges that the accreditation process brought to the fore—implementing a new LIS, renovating the TB laboratory to meet safety requirements—Dr. Abel Wareth counts staffing as the most difficult. “During the process, there was high turnover,” says Dr. Abdel Wareth. “I’m not sure if that was anxiety created by preparing for this. But we did lose some key people—not that we wanted to lose them, but they wanted to move on.”
As she notes, people react to stress in different ways: “There are the cool guys who don’t care, and those who get very anxious about the whole thing. The over-anxious guys can spread their anxiety to others, and the very cool people, who don’t care, can transmit that. And then there are those who react in the proper way: ‘Am I doing the right thing?’ You say, ‘Yes, you are. Thank you very much,’ and they go away happy.”
Often, she found herself listening to someone who’d stormed into her office to vent, “and I’d just have to sit there and listen and be supportive.” When that happened, she knew it was time to “titrate the heat” by temporarily backing off on the accreditation front: “You have to slow down, the pressure has to come off a bit, and then you increase it a little more.”
On the bright side, new talent popped up from unexpected places. A medical technologist in the microbiology laboratory, for example, stepped into the newly created safety officer position. “Nobody had expected that she would have that potential, and she is just awesome,” she says. “You discover things about your people that you’re not even aware of.” Other new positions that had to be filled were quality officer, point-of-care testing coordinator, and LIS coordinator.
One of the obstacles: document control. “We have about 1,000 procedures in our laboratory, so to get on top of all of these was a bit of a challenge,” Dr. Abdel Wareth says. “We were lucky to have software called Policy Manager, which enabled us to control that in an electronic manner. It made our life a lot easier.”
All the while, she could see that the laboratory’s culture was slowly changing. “The nice thing about CAP is, they let you do interim self-inspection,” she says. “It doesn’t allow the culture to fade.” Having teams from various sections of the laboratory inspect each other, she says, was especially effective in creating a culture of safety and accuracy: “Now you have all these little inspectors preaching to each other. It was really inspiring to see that.”
Finally, in December 2010, about 18 months after the mock inspection, the laboratory passed its final inspection. Of 3,000 CAP requirements, the lab was found to have only 13 deficiencies, six of which were corrected immediately, and seven of which were corrected within 30 days. “Her lab did spectacularly well,” says Dr. Amr, who led the final inspection. (And, of course, he wasted no time in telling Dr. Abdel Wareth, “We need you to be an inspector now.”)
“It was my dream, and it was a challenge, and I loved it,” Dr. Abdel Wareth says of her lab’s journey to CAP accreditation, the credit for which she gives to the effort of the full team and the support of lab director Andrew Turner and quality officer Frank Resch. At CAP TODAY press time, her lab was up for re-accreditation. This time around, the inspection was to include a newly acquired laboratory from a sister hospital, as well as the main hospital’s respiratory therapy department. In addition, SKMC’s blood donor center was to undergo its first inspection by the AABB.
As interest in CAP accreditation grows among laboratories in the Middle East, says Dr. Amr (who is president of the International Academy of Pathology), SKMC’s lab will serve as an example of what can be done by those who put their minds to it. “There are more and more labs interested in getting accreditation, because there is awareness not only by hospital administrators about the value and importance of quality in the lab, but also by people who are looking for labs that have an edge, labs that are following the gold standard,” he says. “Dr. Abdel Wareth is extending her hand to anybody who’s willing to have CAP accreditation, showing them how to document things, how to do the QC, how to participate in proficiency testing, and the like. When a lab has CAP accreditation, it is looked at with respect.”
Anne Ford is a writer in Evanston, Ill.