News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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DATELINE: San Antonio, Texas—This week, a large and enthusiastic crowd of clinical laboratory managers and pathologists gathered here to participate in the fifth annual Lab Quality Confab, a conference devoted to Lean, Six Sigma, and process improvement in medical laboratories and hospitals.

It was an opportunity to judge the “state of the clinical laboratory testing industry” in regards to how quality management and the tools of Lean and continuous improvement are helping to transform the nation’s more innovative medical laboratory organizations. This is an important trend in laboratory medicine and it is still in its earliest stages.

Tuesday’s opening session gave convincing evidence of the power of these quality management methods and philosophies to boost the performance of clinical laboratories and give them competitive advantage in the marketplace.

Using Quality Management to Deliver Added-Value Lab Testing Services

“There were three powerful strategic case studies,” observed Robert L. Michel, who founded Lab Quality Confab and is the Editor-In-Chief of The Dark Report and Dark Daily. “These are clinical laboratory and pathology organizations that have achieved a market-leading presence in the communities they serve because of their “close to the customer” mindset.

“The success of Grupo Fleury, based in Sao Paulo, Brazil, is a great example,” explained Michel. “This clinical laboratory company describes itself as the ‘Lexus of medical laboratories.’ It rigorously surveys the satisfaction of its patients and physicians and uses lots of quality management methods and tools to continuously add more value.

“Rogerio Rabelo, Ph.D., who is Executive Director at Fleury, fully engaged the audience when he explained how Fleury—in order to add value—has steadily built an integrated diagnostic service,” he noted. “He then showed photos of patient service centers which can collect lab specimens and perform a full range of imaging and diagnostic procedures in one location and on the same patient visit.

“However, the icing on this cake was the integrated diagnostic test reports that Fleury regularly delivers to its referring physicians,” added Michel. “Rabelo showed examples of very sophisticated, full-color reports that bring together clinical lab test data, surgical pathology images and results and relevant images from radiology and other diagnostic procedures. Currently Fleury offers these comprehensive integrated diagnostic reports for 60 different diseases and health conditions.”

Integrated diagnostic reports are one of the innovations that deliver added value to the physician clients of Grupo Fleury, one of Brazil’s largest clinical laboratory companies. Above is a sample of a thyroid investigation that Fleury would send to a physician. It includes all clinical laboratory test results, anatomic pathology images and findings, as well as the relevant information from imaging studies. This example was shown earlier this week at the fifth annual Lab Quality Confab that took place in San Antonio, Texas.

Next to speak was Richard Zarbo, M.D., DMD. He is the Chair of Pathology and Laboratory Medicine at Henry Ford Health System in Detroit, Michigan. “There is probably no single department of pathology in a major academic center which has more thoroughly implemented Lean and quality management into the entire organization,” observed Michel. “Hearing how anatomic pathologists and professors of pathology were embracing the concepts of Lean workflow and continuous improvement was definitely something that caught the full attention of the audience.

Henry Ford Production System Used by Department of Pathology

“Zarbo discussed how the process of engaging physicians and patients to learn about how the laboratory could better meet their expectations was a key step in guiding the performance improvement efforts of the department,” he said. “One approach to reduce lab errors was to create a process that would capture defects each day. Next, cross-functional teams look to identify the sources of defects and rapidly institute fixes to the system. Examples of errors can be wrong patient identification and ‘not enough specimen’ (QNS) for lab testing.

“Another interesting element in this quality management story is how Zarbo and his team engaged the laboratory testing sites and other hospitals and clinics within the Henry Ford Health System to adopt and use Lean and similar methods,” added Michel. “The benefits here are increased standardization of testing activities in ways that support added value to physicians throughout the health system.”

The third quality management case study presented that morning involved the Tampa, Florida, laboratory of Laboratory Corporation of America (NYSE: LH). “This regional division of LabCorp is the first clinical laboratory facility of a public laboratory company in the United States to earn accreditation to CAP 15189 (College of American Pathologists),” commented Michel. “That means LabCorp Tampa has implemented a respected quality management system (QMS) across all the functional areas of its laboratory.

ISO 15189 At LabCorp’s Tampa Regional Laboratory

“During his presentation, Phil Pawlowski, who is Area Vice President of Quality Assurance for the Southeast Division, explained why this executive team decided to adopt the ISO 15189 QMS,” he said. “It was recognized that this QMS would provide the entire laboratory staff with a framework to improve the quality of the laboratory’s testing services in ways that would make a difference for physicians, patients, payers, and even the lab staff.

“Pawlowski shared some specific quality gains that resulted from adoption of ISO 15189,” added Michel. “However, when he put up a slide that indicated how LabCorp Tampa had achieved zero clerical errors on CAP surveys for the entire year of 2011, that earned a spontaneous round of applause from the Lab Quality Confab audience.”

Each short overview of the three case study presentations shared above demonstrate why ever-growing numbers of clinical laboratories and pathology groups are choosing to implement a quality management philosophy and operating culture within their organization. During their respective presentations, the speakers from Grupo Fleury, Henry Ford Health Laboratories, and LabCorp Tampa emphasized that quality management is now the essential cornerstone that allows them to achieve competitive advantage and deliver more value to referring physicians and their patients.

Dark Daily observes that the experience of these three successful laboratory organizations provides a useful insight into the ongoing evolution of the laboratory testing profession. Pathologists and clinical laboratory managers will want to stay abreast of the pace of adoption of this quality management philosophy and its associated management techniques. In fact, on day two of Lab Quality Confab, the role of quality management systems in helping clinical laboratories better meet CLIA and other regulatory requirements. Dark Daily will report on those presentations in an upcoming e-briefing.


Related Information:


Full Agenda of speakers and topics at Lab Quality Confab 2011

To order audio recordings of presentations at Lab Quality 2011 please email

Clinical Pathology Laboratories in the United States Face Tougher Accreditation and CLIA Environment

More U.S. Medical Laboratories Ready to Step up to ISO 15189 Accreditation

ISO 15189 Laboratory Accreditation