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Consequences of Underfunding Lab Test Services
By R. Lewis Dark | From the Volume XXVIII No. 11 – August 15, 2011 Issue
HOW LONG CAN IT TAKE FOR A HEALTHCARE SYSTEM to underfund clinical lab testing and anatomic pathology services before this ongoing financial erosion becomes visible in the form of systemic quality problems with lab tests? I believe the United States is now on the path to learning the answer to this …
Destructive Tornado Hits Joplin Hospital, Lab Rebuilds Swiftly
By Robert Michel | From the Volume XVIII No. 10 – July 25, 2011 Issue
CEO Summary: One week after one of the worst storms ever to strike a hospital in the U.S., St. John’s Regional Medical Center in Joplin, Missouri, was back treating patients. Surprisingly, the hospital’s lab was one of the first departments to get up and running again. Within…
Teamsters, UCFW Sue NID, Quest In Racketeering Case
By Robert Michel | From the Volume XVIII No. 9 – July 5, 2011 Issue
CEO SUMMARY: For the second time in recent years, Quest Diagnostics Incorporated and Nichols Institute Diagnostics (NID) face a lawsuit alleging problems with a number of diagnostic test kits that were manufactured and sold by NID going back to 2000. The plaintiffs are two unions…
False Positive STD Tests Get News Coverage in Indy
By Robert Michel | From the Volume XVIII No. 6 – May 2, 2011 Issue
CEO SUMMARY: After going public with the discovery that it had reported false positive lab test results for Chlamydia to eight female patients, Mid America Clinical Laboratories (MACL) found itself the subject of stories broadcast by a local television news program. The news cove…
Analysis of Lab Test Error Offers Lessons for Labs
By Robert Michel | From the Volume XVIII No. 6 – May 2, 2011 Issue
CEO SUMMARY: As happens now and again, a rather typical example of an error in lab testing has made the nightly news in Indianapolis because of one justifiably irate patient who got a false positive test report for an STD. One pathologist, asked by THE DARK REPORT to assess the p…
Office-Based Physicians Want In-Clinic Laboratories
By Joseph Burns | From the Volume XVIII No. 6 – May 2, 2011 Issue
CEO SUMMARY: Interest by office-based physicians in creating an in-clinic medical testing laboratory is on the increase. This has direct consequences for independent commercial labs, hospital lab outreach programs, and anatomic pathology groups, since office- based physicians are…
Putting Centrifuges Into Courier Cars For Mobile Processing
By Robert Michel | From the Volume XVIII No. 2 – February 7, 2011 Issue
CEO SUMMARY: To improve the quality of lab services it provides to more than 300 skilled nursing facilities (SNF) while reducing costs, MuirLab of Concord, California, has created a “mobile specimen processing” solution. It operates a fleet of courier cars with centr…
More IVD Consolidation as Danaher Buys Beckman
By R. Lewis Dark | From the Volume XVIII No. 2 – February 7, 2011 Issue
TODAY IT WAS ANNOUNCED that Danaher Corporation would acquire Beckman Coulter, Inc., in a transaction valued at $5.8 billion. The news was not a surprise, since word had leaked out last December that Beckman’s board of director had engaged Goldman Sachs …
Using Audits to Uncover Bad Data in the Lab
By Robert Michel | From the Volume XVIII No. 2 – February 7, 2011 Issue
CEO SUMMARY: Labs using Lean, Six Sigma, and similar quality management methods are now putting these tools to a new purpose. They are being employed to validate the accuracy of metrics designed to monitor and manage work processes directly related to turnaround times and custome…
Many Questions About FDA Regulation of LDTs
By Robert Michel | From the Volume XVII No. 14 – October 4, 2010 Issue
CEO SUMMARY: Ask most pathologists and laboratory administrators about the FDA’s intent to regulate laboratory-developed tests (LDTs), and they will likely answer that it is to control web-based direct-to-consumer lab testing companies and the rapidly- growing number of proprie…
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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