CEO SUMMARY: Piedmont Medical Laboratory (PML) could be the only clinical laboratory ever to pursue three quality improvement initiatives simultaneously. Even as it was in the early stages of implementing both Lean and Six Sigma methods, PML also decided to seek ISO 15189:2007 accreditation. Since 2004, the lab has worked diligently to put all three programs in place. The lab is currently preparing for its final assessment that will lead to formal accreditation under ISO 15189:2007.
IN THE NEXT FEW MONTHS, Piedmont Medical Laboratory (PML) of Winchester, Virginia, has a good chance of becoming the nation’s first laboratory to achieve accreditation under ISO 15189:2007 Medical Laboratories.
This month, PML is preparing for the last step in ISO 15189 accreditation: assessment by independent auditors. This comes after the lab’s gap assessment was con- ducted last April and the pre-assessment audit was completed in July. PML is using the College of American Pathologists (CAP) as its accrediting body.
“Achieving accreditation under ISO:15189:2007 is a milestone that caps the quality management strategy initiated here at PML in 2004,” stated Benita Haines, PML’s Quality Management, Compliance and Education Coordinator. “At that time, the decision was made to simultaneously introduce Lean and Six Sigma methods while laying the groundwork for ISO 15189 accreditation.”
The strategy of introducing continuous improvement throughout the laboratory has paid regular dividends for PML. “We see steady gains in productivity, along with comparable improvements in quality, fewer errors, and reduced costs,” noted Haines. “Lean, Six Sigma, and our transition to the ISO 15189:2007 standards have worked in combination to produce these outcomes.”
Piedmont Medical Laboratory is a joint venture, for-profit, independent laboratory located in Virginia’s Shenandoah Valley. Founded in 1991, it is owned by three healthcare systems and two independent pathology groups.
Competitive Strategy
PML launched its quality management pro- gram back in 2004 as a deliberate strategy to improve its ability to compete for outreach business in its region. “Like regional laboratories everywhere, Piedmont Medical Laboratory recognized how managed care companies were taking steps to monitor the quality of services provided by physicians, laboratories and other providers,” noted Joe Skrisson, CEO at PML. “We wanted to be ready to meet tightening payer criteria covering clinical quality, service performance, patient satisfaction, and similar factors.
“Our quality management strategy was specifically crafted to prepare PML to meet payer requirements that could possibly exclude PML and other local laboratories,” continued Skrisson. “Our ISO, Six Sigma, and Lean efforts help us improve quality, sustain high levels of patient and physician satisfaction, and reduce our error rate. These tools are important to make sure that our lab doesn’t get excluded from managed care contracts.
Managed Care Contracts
“Obviously, the largest national labs are very good at helping managed care organizations include criteria in their contracts that could exclude competitors like us,” he explained. “As a regional lab, you have to be on the alert for such criteria and either stay parallel with these national lab competitors or get ahead of them in some way. That’s part of what we’re doing here with our ISO, Six Sigma, and Lean initiatives.”
Many laboratories now use Lean and Six Sigma methods as a way to improve performance and become tougher competitors. But taking on the challenge of an ISO 15189 accreditation remains a rare event. For PML, the decision to become ISO 15189–accredited actually starts in Detroit, a long way from the verdant hills of the Shenandoah Valley.
“Prior to my arrival at Piedmont Medical Laboratory in 2004,” explained Skrisson, “I was at William Beaumont Hospital in Detroit where we were one of the first labs to use ISO 9001 standards. At the time, everyone thought we were crazy to do this.
Employers Recognize ISO
“But Detroit was the perfect environment for a laboratory to pursue ISO accreditation,” he noted. “That’s because the auto companies, the tool and die companies, and other supply firms in Greater Detroit are all ISO-compliant themselves. They recognize the value of pursuing ISO quality standards. Further, as patients, our lab served many employees of these companies. Beaumont lab’s ISO status gave us competitive advantage with employers and payers in this market.
“It’s difficult to explain to some employers what the Joint Commission and CAP (College of American Pathologists) accreditation means to them,” Skrisson explained. “But when your lab is ISO accredited, they immediately know what that means because they may be ISO accredited as well. They understand the terminology and know what we had to achieve to become accredited. It is an international language of quality and competence.”
PML has a staff of 100, including couriers and billing professionals. It serves 13 patient service centers and eight hospitals in the Shenandoah Valley. It also serves 300 physicians and nursing homes in its outreach program. Its core lab in Winchester handles up to 1,300 requisitions daily and about 750,000 billed procedures (about 1 million tests) annually.
Dramatic Results At PML
Skrisson explained that all three quality improvement efforts have produced dramatic results at PML. “Our Lean initiative supports the ISO effort by helping us continually improve efficiency,” he explained. “One example is the change in how we handle specimens. With Lean, we now process specimens in real time, as they arrive in the laboratory. We no longer hold specimens until the afternoon and evening shifts to then test them in batches. This has generated significant improvements in productivity, reduced costs, and faster turnaround times.”
“Work flow analysis using Lean and Six Sigma methods also helped us re-route our couriers to support continuous flow of specimens into the lab,” added Haines. “Lean, Six Sigma, and ISO require us to look more closely and more critically at everything we do. Another example is our introduction of scanning software to aid our staff in looking up requisitions, therefore improving turnaround time in the customer service department.”
ISO was a key part of PML’s quality improvement program from the very start. “As we launched implementation in December 2004, our lab had no quality manual,” recalled Haines. “With the help of a consultant, we produced our first quality manual by cross-referencing the lab’s policies to ISO 15189:2003 standards. That was a huge education for our staff!”
“In fact, one of the biggest insights from this effort has been to better under- stand the wide variance in how individual employees perform work,” she continued.
“It’s been a major effort to standardize all work processes, document each practice, then help staff perform their duties using these standard work practices. This all happened as a direct result of the document control portion of the ISO standard. Our motto here now is: “Say what you do and do what you say.”
Moving Forward With Lean
“Then we introduced other initiatives such as Lean and Six Sigma,” continued Haines. “Staff attended classes to become certified as Six Sigma green belts and black belts and to learn about Lean methodologies.
“Overall, it is a challenging and rewarding process that is helping us significantly improve our work processes, quality, and productivity,” Haines concluded. “Two important lessons we’ve learned are, one, the value of standardizing work practices and, two, the documentation of processes and procedures.”
ISO Provides Framework
Skrisson agreed, saying, “If your lab has implemented a process improvement program, then ISO accreditation supports that effort very well. It gives the laboratory a framework that gets people at the bench level involved, particularly because they understand these procedures and how it guides their work.
“In fact, during the assessment process, ISO auditors don’t spend much time with directors like me,” added Skrisson. “They focus on the technicians to confirm that they are following protocols and using standard work. From that perspective, ISO is good for the staff because it reinforces process improvement while helping the lab create a system and culture that guides everyone in their work.”
Three Improvement Initiatives
THE DARK REPORT observes that PML is an uncommon example for other labs installing quality improvement models. By introducing three initiatives at the same time (Lean, Six Sigma, and ISO 15189), PML shows what is possible when seeking to improve processes. It also demonstrates that ISO 15189:2007 accreditation supports these other quality improvement initiatives while simultaneously preparing a lab to compete more effectively in its own market and in the increasingly global healthcare market.
Another noteworthy aspect to the quality improvement effort at Piedmont Medical Laboratory is that it demonstrates how even regional laboratories and smaller hospital lab outreach programs can successfully implement quality management programs like Lean, Six Sigma, and ISO 15189:2007. Once the commitment is made to introduce these quality methods, laboratories can quickly generate improved productivity while lowering operational costs. These savings can be then reinvested into further support for ongoing deployment of Lean, Six Sigma, and ISO 15189.
ISO 15189 Accreditation Typically Requires Two Years and Nine Performance Steps
IN THE UNITED STATES, the College of American Pathologists (CAP) of Northfield, Illinois, offers a lab accreditation program based on the International Organization for Standardization (ISO) 15189:2007 standard for medical laboratories. CAP advises laboratories that the accreditation process involves the following nine basic steps and typically requires two years to complete:
- One: Gain support from key executives, including senior administrators and medical officers, among others.
- Two: Read an official copy of the ISO 15189:2007 standards. A laboratory must purchase an official copy of the standards to become accredited from www.ISO.org or www.ANSI.org.
- Three: Assign appropriate roles for conducting an internal audit. This step may involve updating the organizational chart with key personnel. Those who would be involved in directing the effort would include the laboratory director, all supervisors, all internal auditors, and the quality manager.
- Four: Apply for 15189:2007 accreditation through CAP.
- Five: For organizations that may be unfamiliar with ISO, CAP recommends a gap assessment done 90 days in advance of an accreditation assessment. This assessment will provide a detailed review to the standards to determine areas of strengths and weaknesses. A pre-assessment is a dry-run assessment that is a high level review for degree of conformity to the standards and will take place within 90 days of the accreditation assessment.
- Six: Conduct an internal audit to ISO 15189, document the findings, perform a root cause analysis, take corrective actions as needed, and continue auditing and taking corrective actions until all major nonconformance issues are resolved.
- Seven: Document participation in external quality assessment schemes and proficiency testing programs for all tests and evidence of participation over the preceding two years.
- Eight: Update the lab’s quality manual, including the quality policy and any supporting documentation.
- Nine: After correcting all nonconformance issues identified in the internal audit, schedule an accreditation assessment.
Piedmont’s Timetable for ISO 15189 Accreditation
EXPECTATIONS ARE THAT Piedmont Medical Laboratory (PML) will receive its accreditation under ISO 15189:2007 Medical Laboratories by year end.
“In April, our lab completed its gap assessment,” stated Benita Haines, PML’s Quality Management, Compliance and Education Coordinator. “Next, in July, our pre-assessment was conducted.
“Now we are preparing for the auditors to conduct our true assessment,” she said. “That is scheduled for this week (September 9 to 11). Following this assessment, on September 11, there will be a summation meeting with the auditors. If the laboratory has no nonconformance issues to address, the auditors will submit that information to the accrediting body.
“Should any nonconformance issues be identified, we have 30 days to submit corrective actions. Assessors then have 30 days to submit that information to the accrediting body,” noted Haines. “We expect to learn the outcomes of this assessment and our accreditation status anytime between the middle of October and the end of the year.”
