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       Headlines - February 2, 2009
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R. Lewis Dark: Lab Test Methodology and Widespread EMR Use

IN BIRMINGHAM, ENGLAND, LAST WEEK to participate at the Frontiers in Laboratory Medicine (FiLM) conference, Editor Robert Michel picked up an interesting theme that connects to current laboratory events here in the United States.

"General practice (GP) clinics in England are establishing electronic medical record (EMR) systems as a preliminary step toward the goal of a national patient health record (PHR)," explained Michel. "Consequently, pathologists and clinical biochemists who run the nation's laboratories are beginning to foresee how one longstanding practice in laboratory medicine has the potential to create confusion among physicians and patients.

"In each city across the country, individual laboratories have always selected their test methodology, then used specimens collected from local residents to validate the test and develop reporting ranges," he continued. "Now, some lab professionals realize that,when a national patient health record becomes a reality, the individual patient's record will contain lab test data produced by several different labs. Because of different methodologies and different reporting ranges for the same test, they can foresee how physicians and patients, as they consult the individual's electronic medical record, will find the presentation of these cumulative lab test results to be confusing and not easy to understand. This realization by forward thinkers in the laboratory profession is causing some to predict that greater standardization of testmethodology and reporting guidelines across all laboratory sites will need to occur as a consequence of a single national system of electronic medical records."

Michel's observation about this development in the United Kingdom has a parallel here in the United States. Wider adoption of a universal patient health record that is transportable across different providers, hospitals, and health insurers will raise the same issue in this country. The explosion of interest in Vitamin 25(OH) D testing may provide our health system with a first example of the problem generated by the use of different test methodologies. Today, different labs are using different methodologies to test for Vitamin 25(OH) D. They use locally-collected specimens to establish reporting ranges. This means that clinicians and patients, looking at Vitamin D results from different labs, cannot automatically assume that one lab's result means the same as another lab's result. Evidence exists that this situation has caused confusion among some physicians and patients during the past two years-a time when interest in Vitamin D testing grew dramatically.



When Does Cost Cutting Affect a Lab's Quality?

Pathologists understand that any lab's quality and performance requires a careful balancing act

CEO SUMMARY: Many lab professionals note the irony that a laboratory so publicly committed to Six Sigma quality management methods is now identified with the single largest episode of systemic failure in lab test accuracy. Looking in from the outside, some pathologists suggest that a decade of aggressive cost cutting and the current campaign to remove another $500 million of costs in 36 months,may be a contributing factor in the 18-month period of systemic deficiencies.




Laboratory Industry Has "Elephant in the Room"

In January, a major lab failure was national news, but the story went unremarked by most lab sources

CEO SUMMARY: In almost every laboratory across the United States and in several countries around the globe, one much-discussed topic in recent weeks has been the Vitamin D testing program deficiencies at Quest Diagnostics Incorporated. Yet, even as rank and file laboratorians actively talked to each other about what this story means, the lab industry's professional associations, societies, and publications were silent on this matter, with few exceptions.



Quest's Deficiencies Trigger QA/QC Questions

Problems in test accuracy should be studied and relevant lessons shared with lab industry

CEO SUMMARY: Experts in laboratory QA/QC and proficiency testing (PT) are following the news that Quest Diagnostics admitted to an 18-month problem with lab test accuracy in its home brew Vitamin 25(OH) D assay. It is recognized as a major failure in the existing system of laboratory licensure, accreditation, and proficiency testing. However, to improve current lab quality standards, more needs to be known about how quality systems failed at Quest Diagnostics.




Got a Lab Test Question? Call an ASCLS Lab Guru!

ASCLS service gets 115 queries every day, almost 42,000 a year—and patients love it!

CEO SUMMARY: Each year since its launch in 2001, the ASCLS Consumer Response Team serves increasing numbers of patients and physicians. Clinical Laboratory Scientist volunteers from the American Society for Clinical Laboratory Science provide answers and help patients understand the meaning of their lab test results. After sending a question by e-mail, these patients get answers within 24 hours. This non-commercial, peer-reviewed, patient-centered site is helping fill a gap in care delivery.





Staunch Laboratory Advocate Retires After 31 Years of Service

Joe Boone, Ph.D., stepped down last month from his position at CDC’s Division of Lab Services





Denver's UniPath Sells Its Histo Labs to APP

UniPath and American Pathology Partners announce a two-part business agreement

CEO SUMMARY: UniPath ended a long search for a business partner with ample capital and resources to help it continue its aggressive rates of growth in specimen volume, market share, and revenue. UniPath announced the sale of its technical laboratories to American Pathology Partners of Brentwood, Tennessee, along with a business agreement to provide pathology professional services. The agreement leaves UniPath in full control of its professional corporation.




Did CMS Err in Issuing New Anti-Markup Rules?

CMS commentary creates uncertainty about whether technical component supervision is needed>

CEO SUMMARY: In the latest anti-markup rules that took effect on January 1, CMS may have unintentionally stated that the anti-markup rule doesn't apply when a pathologist is reviewing histology slides. While the rule itself is unclear, the commentary that accompanies the rule says that supervision is not required. This ambiguity has been noticed by experts. It means that patholologists, lab directors, and their attorneys must act carefully to ensure compliance.



INTELLIGENCE: Late & Latent

NHS BRANDED AS "AGEIST" BY CRITICS

MORE ON: UK's NHS

 

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