FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Lab Compliance Advisor
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
Subscribe today for access to
Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Lean Six Sigma is Not Quality
By Jennifer Dawson, MHA, LSSBB, DLM(ASCP) bio
Now before the entire industry lynches me for the sacrilege of the title of this article, let me explain what I mean. I have known Lean Six Sigma skeptics and outright haters and trust me…
Consortium Releases New Interoperability Standard for Lab IT Systems
From - G2 Compliance Advisor
With the release of a new information technology (IT) standard, the dream of true interoperability of electronic health care information has gotten…
OIG Switches from Semi-Annual to Monthly Work Plan Strategy
From - G2 Compliance Advisor
New OIG Work Plans every six months are a thing of the past. In June, the agency announced plans to update its Work Plan website monthly. The self-proclaimed…
By the Numbers: Lab Injury and Exposure Data
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Finding information about the number of Laboratory Acquired Infections (LAIs) and other laboratory injuries in the United States is difficult…
Theranos and Walgreens Bury the Hatchet—For Now
From - G2 Compliance Advisor
It all looked so promising back in 2015. Privately-held Theranos was poised to usher in a new era of diagnostics with its revolutionary fingerprick technology for…
Employment Law Update for August 2017
By Mike O'Brien bio
Here is my periodic update prepared for interested HR professionals trying to deal with the complex American employment laws…
Help Your Lab Brace for Key Medicare Outpatient Reimbursement Changes
From - G2 Compliance Advisor
With the 2018 Clinical Laboratory Fee Schedule (CLFS) still in the works, CMS proposed changes to the Hospital Outpatient Prospective Payment System (HOPPS) rules on…
The 5 Things You Should Never Say to an OSHA Inspector
From - G2 Compliance Advisor
The way you handle an OSHA inspection can have as much impact on the outcome as the actual health and safety condition of your lab. More precisely…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Health System Pays $6.5 Million to Settle Urine Test Upcoding Charges
Case: A lab director filed a whistleblower suit claiming that…