CEO SUMMARY: Clinical laboratories often promote themselves as being able to deliver quality results. But simply saying so is not the same as having an outside organization audit the laboratory to accredit its analytical processes and its other operational activities. NMS Labs in Willow Grove, Pennsylvania, pursued accreditation to ISO 15189 Medical Laboratories to gain this outside recognition as well as to benefit from implementation of the ISO quality management system (QMS).
WHEN THE DECISION WAS MADE to pursue accreditation to ISO 15819 Medical Laboratories, leaders at NMS Labs of Willow Grove, Pennsylvania, wanted to put down a marker that would differentiate their laboratory from competitors.
“For us, the most important reason to earn accreditation to ISO 15189 was that it certifies that our laboratory delivers quality results consistently in a manner that is recognized immediately by anyone who understands ISO certification and accreditation,” commented Robert A. Middleberg, Ph.D., who serves as Vice President, Quality Assurance, and as Laboratory Director and Forensic Toxicologist for NMS Labs.
“The inspection of our laboratory and its work processes by outside auditors is quite rigorous,,” noted Middleberg. “Every laboratory can claim quality, but having a credible ISO accreditation team come into your organization and validate the quality of your processes is a major benefit for us. It definitely helps our laboratory to stand out in the competitive marketplace.”
NMS earned its ISO 15189 accreditation late in 2010 and used the College of American Pathologists (CAP) as the accreditation organization. One major benefit to the laboratory came with the adoption of the quality management system (QMS) that is embedded in the ISO 15189 standards.
Benefit Of QMS Adoption
“What sets accreditation to ISO 15189 apart from the existing laboratory certification, licensure, and accreditation programs in the United States is how it requires the lab to implement a QMS,” noted Middleberg. “We knew we were a good laboratory, but we had never integrated our management systems to the degree required by ISO 15189.
“Let me explain,” he continued. “As we mapped our existing management and operational procedures to the requirements of ISO 15189, we realized that adopting the quality management system of ISO 15189 would require us to bring more consistency to all our work processes, ranging from courier, accessioning, and analytical to accounting, IT, purchasing, and maintenance.
“ISO and its QMS involves a review of each process in the laboratory, along with the documentation for that process,” said Middleberg. “Prior to adopting ISO 15189, we never had to integrate all the activities that make up our laboratory organization.
Effect On Patient Care
“But the standards of ISO 15189 require that we look at how everything affects our operation,” he added. “Most importantly, each of these areas must be considered as to how it can adversely affect patient care.”
NMS Labs was founded in 1970. “Our lab has a staff of 205 and no pathologists,” noted Middleberg. “We offer about 3,500 different tests.
“Each year, we process about 300,000 to 400,000 requisitions for the clinical lab marketplace and about 50,000 requisitions for the forensics market,” he said. “However, because each forensics requisition requires many more tests than a clinical requisition, the number of forensic tests we perform annually is about equal to the number of clinical tests,” he explained.
“What makes NMS Labs unique is that, not only do we provide clinical testing for many reference laboratories, but we also have a big role in serving the justice system, both civil and criminal,” stated Middleberg.
Demonstrating High Quality
“Earning our ISO 15189 accreditation is part of our goal to raise the public profile of NMS Labs while also demonstrating the high quality of its testing services,” he added. “ISO 15189 accreditation is recognized internationally and we see that as a benefit for our laboratory as it continues to expand into new markets.”
NMS Labs had earlier established a Lean program and its lab team was regularly implementing process improvement projects. “This knowledge base came in handy when we made the decision to pursue ISO 15189 accreditation,” stated Middleberg.
“Our first step was to assemble a team that was built around eight individuals with experience in Lean methods,” he continued. “It was their job to spread the knowledge of ISO, its QMS, and other requirements throughout the laboratory staff.
“The team used kaizen events and worked hard to provide information to every staff member,” noted Middleberg. “This is important because, when the ISO auditors come in during their inspection, they will interact with each individual in the company.
“Further, one important aspect of ISO 15189 is that it does require buy-in and compliance from everyone in the company,” he continued. “ISO 15189’s quality management system instills a strong consistency in how every staff member executes their daily duties.”
“The only way any clinical laboratory can actually prove to the world that it is a quality lab is through its accreditations and certifications, along with having laboratory scientists who are credentialed and certified,” observed Middleberg. “For NMS Labs, we consider our ISO 15189 accreditation to be one way our laboratory company can gain recognition as a high-quality laboratory.
“At the same time, our ISO 15189 accreditation process has given us a very different perspective on our laboratory organization and what is required to delivery top quality on every test every day,” he continued. “Our work flow is more consistent and we can see how the QMS has helped us achieve a tighter integration of all the various functions and activities that happen every day and on every shift in our laboratory.”