CEO SUMMARY: For a lab looking to continually improve lab operations, becoming accredited to either ISO 15189 or CAP 15189 is an ideal challenge. After hearing from other lab directors about the benefits of becoming accredited to CAP 15189, the staff at Mercy Medical Center in Canton, Ohio, believed that accreditation to this standard would allow them to move to the ‘next level’ in quality and patient care. Implementation of the quality management system (QMS) as part of the accreditation process has given staff new ways to improve quality across the laboratory.
AS THE COMPETITIVE BAR FOR SERVICE and quality moves ever higher, some hospital lab directors are implementing a quality management system (QMS) to position their laboratory organizations as high-service providers.
It was recognition of the need to stay in front of their competitors in the Greater Canton, Ohio, region that motivated the staff at the Mercy Medical Center to implement the QMS of CAP 15189 last year. For both the laboratory and the staff, this decision has produced important benefits.
Mercy Lab’s QMS Journey
This QMS journey began in 2008. That’s when members of Mercy’s laboratory attended the THE DARK REPORT’S Lab Quality Confab program. This meeting features presentations by labs and pathology groups using Lean, Six Sigma, and process improvement methods in innovative ways. During Lab Quality Confab, the Mercy lab staff members heard about outcomes that early adopters of QMS programs were having.
“We constantly look for ways to improve operations, patient safety, and efficiencies,” explained Mary Ann Burich-Boccia, MBA, MT (ASCP), SBB. She is Administrative Director, Department of Pathology and Laboratory Medicine at Mercy Medical Center. “After attending the conference and hearing from other lab administrators about the outcomes of these early adopters of CAP 15189, we believed that our lab’s accreditation would move us to the ‘next level.’
“In addition, we recognized the importance of looking at the laboratory as one unit and not as a number of different sections,” noted Burich-Boccia. “We wanted to develop a system that enabled us to be more disciplined in practicing continual process improvement. We also wanted to implement steps that would help us prevent problems.”
Mercy Medical Center is part of the Sisters of Charity Health System. This 476-bed hospital serves patients in five counties in Northeast Ohio. In addition to the core lab at the medical center, Mercy provides lab services at Mercy Health Centers in Carroll, Plain, and Tuscarawas counties, and in the towns of Jackson, Lake, Louisville, and North Canton. It also runs Mercy Laboratory Services in Harrisburg and Little Flower. With a full-time staff of 141, including nine managers and a four-person pathology group, the lab did 1.6 million billable tests in 2011.
“Mercy Medical Center is known for having achieved a number of firsts in the region,” observed Burich-Boccia. “We recognized that our accreditation to 15189 would be recognized as another ‘first.’
“Being an early adopter allows us to market ourselves as being first to earn accreditation to CAP 15189 in our region,” she added. “At this time, we believe we are also the only laboratory in our market area that is accredited to CAP 15189.
Widely Known Accreditation
“In the manufacturing community, ISO accreditation is widely recognized—much more so than other accreditations,” noted Burich-Boccia. “Our lab’s accreditation to 15189 sends a strong message about our commitment to having a QMS.
“Within the laboratory community in our region, even though CAP 15189 is not the same as ISO 15189, it is an accreditation that other laboratorians recognize,” she continued. “They know it demonstrates our lab’s continuing commitment to quality patient care and service.
“These are benefits that are distinct from the business advantages that adoption of the QMS is delivering to our laboratory,” stated Burich-Boccia. “We understand that, within our laboratory, every improvement to a process and every gain in efficiency while also reducing rework directly contributes to improvements in patient care and patient satisfaction. When physicians and patients understand this about our laboratory, we believe it encourages them to choose Mercy.
“Of course, one direct economic benefit is our increased ability to lower our costs as a result of having standardized processes that reduce variances,” she said. “This results in lower overall costs.”
Upon their return from the 2008 Lab Quality Confab, the Mercy lab team first had to convince health system administrators that earning accreditation to CAP 15189 and implementing a quality management system would truly deliver all of these benefits—both to the laboratory and its parent health system.
Confidence in the Strategy
“The experiences of other lab directors at the confab gave us confidence that we could persuade the hospital administrators to agree to let us pursue CAP accreditation,” Burich-Boccia said. “We did our homework so that meetings with administration went well.
“First, we explained the process of obtaining accreditation to the requirements of CAP 15189, along with the benefits that would follow,” she noted. “We emphasized that such accreditation is a public demonstration of our lab’s commitment to delivering quality patient care. We called attention to the fact that, once again, this would be one more opportunity for the laboratory to be recognized as a first-mover in the Greater Canton region.
“Of course, the hospital administrators wanted to know how long it would take, what resources were required, and what the cost would be,” said Burich-Boccia. “In fact, the hospital’s chief operating officer requested these specifics on the program.
Estimated Implementation Time
“The only cost was the fee CAP charges facilities for accreditation,” she explained. “We estimated the time would be eight months. In reality, it took 18 months for our lab to earn accreditation to CAP 15189.
“We did not incur other direct costs because we used staff time to get the job done,” commented Burich-Boccia. “It was not necessary to hire anyone nor incur overtime.
“We did not purchase any software programs for document control because we used what resources we had in the lab,” she said. “We did purchase books and some appropriate online courses.”
Once it had gained approval by administration, the Mercy lab team took steps to keep administrators informed about the progress being made toward accreditation to CAP 15189. They also wanted to make administrators aware of the specific improvements that could be identified, along with the patient care and cost benefits that could be measured.
“We decided to advise the COO about our progress by inviting him to our regular laboratory meetings,” Burrich-Boccia explained. “We also involved him each time we gave a summation to the CAP 15189 surveyors.
“We regularly discussed the goals we had established for this project with the hospital administrators,” she noted. “We explained that we wanted a more robust QMS that crossed all functional areas of the laboratory. It was equally important to gain buy-in and the participation of all lab personnel.
Lab Planned Next Steps
“When we had the approvals to begin the process of getting accredited, I asked Gayle Brown, MT(ASCP)SH, Lab Quality Systems Coordinator, to head up the project,” Burich-Boccia said. “By taking the lead, Gayle kept us all on track. She began working on the accreditation project at about the beginning of 2009 and worked throughout that year to put everything in place. She drove us to succeed.”
By November 2009, the lab was ready to submit its application to CAP. “We had a desk assessment in January 2010,” stated Brown. “At that point we thought we were getting close to meeting all the accreditation criteria.”
That mindset changed when the first gap assessment was conducted. “It was March 2010 when the gap assessment took place,” recalled Brown. “The important insight that came from this process was that we needed to involve the entire laboratory staff in this effort. Up to this point, only a few people had actively worked on this project.
“We were learning some of the secrets to being successful with accreditation to CAP 15189,” Brown said. “One of those secrets is that it is smart to engage the full commitment of everyone working within the laboratory.”
Selecting Internal Auditors
Another essential step in preparing for accreditation is to develop and train internal auditors. “We identified internal auditors from our pool of laboratory medical technologists,” explained Burich-Boccia. “We selected several newly-graduated med techs for this role.
“It was our view that, as internal auditors, it would give these med techs a deeper understanding of the other side of laboratory operations.” she commented. “We wanted them to become familiar with the non-technical side, because then they would understand how the entire lab operates.”
Brown agreed. “Today, the staff has an entirely different perspective on what it takes to run the laboratory,” she observed. “It is significant that the entire staff of our laboratories have a new mindset about deficiencies. Let me explain why.
Root Cause Analysis
“In the past, when we had a problem within the laboratory, we would just fix it and move on,” noted Brown. “But today, when there is a problem within one department of our lab, we conduct a root cause analysis. This allows us to fix the systemic cause of errors and/or unacceptable quality. Equally important, the findings of the root cause analysis allows us to determine if this same problem occurs in other departments. If it does, we can take corrective action, as appropriate.”
Looking back, Brown said there are some steps she would do differently. “When we started this process we didn’t know what to expect,” she recalled. “Also, there was a limited amount of information available, particularly about how to implement and sustain a quality management system in a clinical laboratory organization. If doing this today, we would take full advantage of all the educational material specific to CAP 15189 and to ISO 15189.
“Another thing we would do differently is to contact other lab facilities that have gone through the 15189 accreditation process to get their opinions on the experience,” continued Brown. “It would have better prepared us for the time required to prepare the laboratory for its first gap assessment, for example.”
Brown noted that input from other 15189-accredited laboratories would have been helpful in another way. “We would have understood that the implementation process—when done correctly—takes time and we should not be discouraged when our artificial timelines were not met,” she said.
“Achieving accreditation to CAP 15189 has been a great experience for the management staff, in particular,” stated Brown. “They now ‘speak 15189’ and live it more so than ever. Each individual within the lab organization takes a different length of time to become aware of the process and incorporate it into daily actions. But as they ‘get it’, there is enthusiasm and motivation to apply these methods to improve quality and patient care in all aspects of what we do.”
THE DARK REPORT observes that the number of laboratories taking steps to implement a quality management system is increasing steadily. This is a trend which directly benefits both the lab testing profession and patients.
List of 15189-Accredited Laboratories Is Growing
WHEN A LABORATORY DECIDES TO PURSUE accreditation to ISO 15189 or CAP 15189, it still must meet the requirements of the federal Clinical Laboratory Improvement Act (CLIA). Here is a list of laboratory organizations which have met CAP 15189 accreditation requirements.
- Advanced Diagnostic Laboratories at National Jewish Health, Denver, CO
- Avera McKennan Hospital & University Health Center Main Laboratory, Sioux Falls, SD
- Blanchard Valley Hospital Laboratory, Findlay, OH
- Esoterix Genetic Laboratories, Monrovia, CA
- Esoterix Genetic Laboratories, Phoenix, AZ
- Laboratory Corporation of America, Tampa, FL
- Laboratory Corporation of America-Center For Molecular Biology and Pathology, Research Triangle Park, NC
- Mercy Medical Center-Pathology & Laboratory Medicine, Canton, OH
- National Medical Services, Inc. dba NMS Labs, Willow Grove, PA
- ProMedica Laboratories, Toledo, OH
- Quest Diagnostics Clinical Trials Laboratory, Valencia, CA
- Quintiles Laboratories Limited, Marietta, GA
- Quintiles Laboratories Limited, Edinburgh, Scotland
- TPMG (The Permanente Medical Group) Regional Laboratory Marina Way South, Richmond, CA
- TPMG Kaiser Regional Laboratories, Berkeley, CA
- TriCore Reference Laboratories, Albuquerque, NM