TAG:
quality laboratory
Court Dismisses ACLA Claims in PAMA Case
CEO SUMMARY: While acknowledging that the American Clinical Laboratory Association raises important questions in its case against the federal Department of Health and Human Services, a district court judge ruled that the court cannot resolve the dispute and dismissed the ACLA’s claims f…
FDA Issues Response to Draft Legislation to Regulate LDTs
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA…
ProMedica, Sonic Form Lab Outreach Joint Venture
CEO SUMMARY: Fast-growing ProMedica Health System of Toledo, Ohio, agreed to a laboratory joint venture with Sonic Healthcare USA. As lab budgets and prices for lab tests are squeezed downward, ProMedica sees opportunity to add volume to this new core lab facility to improve efficiency an…
Can Fee Cuts Be Delayed? Courts Are One Option
CEO SUMMARY: Some lab companies may be prepared to challenge in court the methodology CMS used in setting the requirements of the Protecting Access to Medicare Act of 2014 to conduct a study of private payer market prices for lab tests and use that data to propose new prices for the Part …
PeaceHealth Labs Sold To Quest Diagnostics
CEO SUMMARY: In Oregon, one of the nation’s more successful and long-established health system outreach laboratories will cease to exist following its sale to Quest Diagnostics Incorporated. The seller explained that the Medicare Part B price cuts coming as a result of the PAMA market p…
Brooklyn Toxicology Lab Suspended for 30 Days by NY Department of Health
IN BROOKLYN, N.Y., a toxicology laboratory has been shut down temporarily since Sept. 9 by order of the New York State Department of Health. The lab was cited for failing to perform calibration and quality control procedures properly, The lab company is Advanced Clinical Laboratory Solutions…
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…
NY Hospital Closed Due to Deficiencies in Lab
CEO SUMMARY: Lab executives and pathologists have long read about the deteriorating finances at many rural hospitals, along with their struggles to recruit and retain enough skilled laboratory staff. Now the closure of the laboratory at 37-bed E.J. Noble Hospital in Gouverneur, N…
Mid America Clinical Laboratories Discusses Recent Lab Errors
IN FOLLOWING UP THE DISCOVERY of false positive results for Chlamydia tests it had performed on a limited number of patients, Mid America Clinical Laboratories (MACL) found itself the subject of news coverage. This included interviews with an irate patient who told one television ne…
Pennsylvania Lab Earns ISO 15189 Accreditation
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 G…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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