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clinical laboratory improvement amendments

Achieving CLIA, ISO 15189 at Same Time with A2LA

CEO SUMMARY: An interesting milestone for the clinical lab industry is on the horizon. Physicians Choice Laboratory Services in South Carolina will soon become one of the first lab organizations in the United States to earn joint CLIA and ISO 15189 accreditations with the America…

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Public Comment Started on FDA LDT Regulations

CEO SUMMARY: On October 3, the FDA published draft guidelines to regulate laboratory-developed tests (LDTs). Pathologists and lab executives now have 120 days to comment on the guidelines. Several prominent national lab associations have expressed concerns about this additional bureaucrat…

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Labs Working to Release Test Results to Patients

CEO SUMMARY: A new federal requirement requires labs to make test results available to patients beginning this month. What is unknown is how patients will respond to the opportunity to see their lab test results. The effective date for this new requirement was October 6. It is expected th…

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Test Utilization Targeted by UnitedHealth, LabCorp

CEO SUMMARY: Many independent laboratories serving patients in Florida are unhappy about the decision by UnitedHealth (UNH) to initiate a pilot program that calls for LabCorp’s BeaconLBS subsidiary to handle prior authorization for certain lab tests. UNH’s laboratory benefit managemen…

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May 19, 2014 “Intelligence: Late Breaking Lab News”

How about a hospital that doesn’t have a medical laboratory but issues lab test reports to patients? This unusual development happened in India recently. The Free Press Journal of Mumbai, India, reported earlier this month that government health officials had conducted a surprise inspectio…

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2012’s Top Ten Lab Stories Predict More Challenges

CEO SUMMARY: It’s been a year with more lows than highs, when viewed through the lens of THE DARK REPORT’S “Top Ten Lab Stories of 2012.” The end of the TC grandfather clause, new policies for prostate biopsy billing, and a dramatic 52% cut to 88305- TC fees were widely reported. …

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Pathologists Benefit from Hospital Lab Consulting

CEO SUMMARY: Deteriorating finances at many rural hospitals and smaller community hospitals is a growing trend. It is also a new consulting opportunity for local pathologists because financially-strapped hospitals often give their labs inadequate working capital and lack the staff needed …

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NY Lab Director Resigns, Cites Lack of Support

CEO SUMMARY: When the lab director resigned from his post at a clinical lab in a hospital in rural New York, the resignation letter was sent to the hospital administration and copy went to the New York State Department of Health. In the letter, the lab director outlined eight reasons for …

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Louisiana Pathologists ‘Moonlight’ as Consultants

CEO SUMMARY: Few independent pathology groups have developed robust laboratory consulting businesses. But adopting that strategy has brought important benefits to Delta Pathology Group, LLC, of Shreveport, Louisiana. Not only has providing lab consulting services to cash-strapped hospital…

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CLIA PT Enforcement Ensnares Top Labs

CEO SUMMARY: Think it can’t happen to you? Think again. Following self-disclosure of inadvertent referrals of proficiency testing (PT) specimens, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) was visited by officials from the Ohio Department of Health and the Ce…

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