ISO 15189 is a quality management system  specifically designed for the needs of medical laboratories

Use of quality management systems (QMS) by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.

Going the Extra Mile to Improve Quality Could Be Strategic Opportunity

On all fronts of laboratory medicine, requirements are becoming more stringent. Each year, labs find themselves held to higher standards for compliance with both Clinical Laboratory Improvement Act (CLIA) requirements and Medicare accreditation guidelines. This situation will become further complicated as clinical labs face the need to also meet the requirements of accountable care organizations (ACOs) and similar models of integrated clinical care. Early adopters are responding to these marketplace dynamics by making strategic use of a QMS to boost the performance of their clinical laboratory organizations. As they do, they often gain a competitive advantage.

Many pathologists and clinical laboratory managers are unfamiliar with the QMS and its definition, which is a system by which an organization aims to reduce and eventually eliminate nonconformance to specifications, standards, and customer expectations in the most cost effective and efficient manner. Mayo Medical Laboratories is an example of a clinical laboratory organization that recognizes the value of a QMS. “Operating within a quality system allows us to meet and exceed the requirements of regulatory/accreditation agencies and facilitates service satisfaction for our customers,” Mayo officials declared on their Framework for Quality web page.

Industry giant Laboratory Corporation of America (NYSE: LH) currently has five CAP 15189 clinical laboratory facilities. “The [CAP 15189] QMS requirements gave us a more balanced approach to quality systems across our labs that is consistent with developing global standards,” stated Kathy McCloy, Quality Assurance Director at LabCorp. McCloy spoke at a recent Lab Quality Confab in San Antonio. (See Dark Daily, “Innovative Clinical Pathology Laboratories Use Quality Management Systems (QMS) to Deliver Added Value to Physicians.”)

QMS Provides Flexible Structure for Evolving Best Practices

Quality standards and guidelines act as a basis for laboratories to develop their own standard operating procedures, according to the Clinical and Laboratory Standards Institute (CLSI) website. By implementing such a QMS, labs align their daily activities of operations and processes in a manner that saves costs, improves quality, and paves the way for meeting licensure and accreditation requirements.

It is regularly noted by lab experts that CLIA is considered as a set of minimum guidelines for quality that all clinical laboratories in the United States must meet in order to continue operation and to receive reimbursement from the Medicare and Medicaid programs. However, there are clinical laboratories that work to achieve the highest possible levels of testing proficiency and standardization. These medical labs organizations take their quality efforts beyond threshold accreditation and licensure standards. Increasingly, the tool these labs use to drive this higher level of performance is implementation of a QMS.

One way clinical laboratories and anatomic pathology groups can better meet the requirements of both CLIA and Medicare conditions of participation is to implement a quality management system (QMS). The special report pictured above contains information about the benefits of using a QMS with a medical laboratory, along with insights about specific ways that a recognized QMS intersects and reinforces the standards defined by CLIA and the Medicare programs.

Generally speaking, it is possible for medical laboratories to align the components of a QMS to fit the complicated patchwork of state and federal standards. Quality improvement methodologies, such as Lean and Six Sigma emphasize continuous improvement. A QMS such as defined by CLSI or ISO 15189 provides a proven framework for sustaining improvements achieved through Lean and Six Sigma-type efforts.

Whether a clinical laboratory chooses to pursue either CLSI or ISO 15189 accreditation depends on a number of variables, according to Glen Fine, currently CEO of CLSI. He was quoted in a story published by the American Association for Clinical Chemistry’s Clinical Laboratory News.

“The CLSI system is easily understood and it’s something you can take and layer into your CLIA requirement,” Fine observed. For this reason, he noted, many U.S. labs will likely identify with the CLSI model more readily than that of the ISO.

Special Report Covers QMS as a ‘Key to Survival’ for Clinical Laboratories

Experts agree that quality management systems are an essential cornerstone for diagnostic laboratories seeking a competitive advantage. “In the worst case, organizations don’t want to be left behind,” cautioned Fine. “In the best case, they want to be early adopters.”

Cordelia E. Sever, M.D., CAP 15189 Committee member, put it even more strongly. “With the enormous cost pressures in medicine, anybody who wants to truly survive or gain further improvements has to implement [a quality management system],” Sever declared in a story published by CAP Today.

“Stars of the clinical diagnostic industry will be those labs that create a culture of continual quality improvement,” confirmed Judith A. Yost, M.A., MT (ASCP), Director, Division of Laboratory Services, CMS.

Yost gave a presentation titled “Understanding How Laboratory Certification and Licensure Intersects with the Essentials of Quality Management Systems” at a recent Lab Quality Confab. Following the presentation, a roundtable discussion took place on the related topic, “Great Debate: Should Labs Complement CMS and CLIA Requirements with a Quality Management System?”

Lucia Berte, MA, MT (ASCP), CMQ/OE(ASQ), President of Laboratories Made Better! P.C., moderated that panel discussion. Joining Yost and Berte were James H. Nichols, Ph.D., DABCC, FACB, Medical Director of Baystate Health; Elissa Passiment, Ed.M., CLS(NCA), Executive Vice-President of the American Society for Clinical Laboratory Science; Christine D. Flaherty, MHA, MT(ASCP), CPHQ, Regional Laboratory Director of Sutter Health; and Leo Serrano, FACHE DLM(ASCP), then Director of Laboratory Services for the Avera McKennan Hospital & University Health Center.

Because of the recognized value of a QMS for today’s pathologists and clinical laboratory managers, Dark Daily has distilled these two important sessions into a Special Report. Titled Quality Management Systems’ Growing Role in Clinical Laboratory Accreditation and Licensure: How labs can better meet CMS and CLIA Requirements, the report is available for purchase at http://darkdaily.com/special-report-the-growing-role-of-quality-management-systems-in-clinical-laboratory-accreditation-and-licensure .

Get more information and order the Special Report here.

—Pamela Scherer McLeod

Related Information:

SPECIAL REPORT: The Growing Role of Quality Management Systems In Clinical Laboratory Accreditation and Licensure

SPECIAL REPORT Press Release

Innovative Clinical Pathology Laboratories Use Quality Management Systems (QMS) to Deliver Added Value to Physicians

Labs on the brink of ISO 15189 approval

ISO Accreditation Comes to America

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