LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
News
The latest regulatory, legal, compliance, and technology news for labs and pathology practices.
Subscribe today for access to
Articles and Reports
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Earning our Spot on the Patient-Centered Care Team
By Jennifer Dawson, MHA, FACHE, CPHQ, LSSBB, DLM(ASCP)SLS, QIHC, QLC bio
There is a lot of talk these days about integrating the laboratory into patient-centered care teams1 and about forming…
Changes in hazardous waste management: the Generator Improvement Rule
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…
When Your Lab Has to Work through a Weather Emergency
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
I read a written Laboratory Emergency Management Plan, and at the end of the document there was a short section called…
Q&A on Lab Waste Management
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Understanding the proper separation and disposal of the various waste types generated in the lab setting is an important piece of managing the…
The Safety Interpretation
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When hospitals were placed on OSHA's list of "high-risk" workplaces, no one had to ask why. OSHA adjusts that list based on the number of injuries that occur on the job…
Changes in laboratory waste management
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
In the past, if a laboratory or a facility generated less than 220 pounds (or 100 kilograms) of hazardous (chemical) waste each month…
How to Avoid a Laboratory Audit
By Sean McSweeney bio
Laboratory audits have a much harder impact on your lab than intended. As detailed by the NCBI, the audit's intent is to review and…
Where’s your lab safety manual?
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
Laboratory leadership should be committed to providing a safe working environment, and they should believe their employees have a right to know…
How to Adjust to the April 2018 Medicare Beneficiary Cards
By Sean McSweeney bio
In a press release on May 30, 2017, the Centers for Medicare & Medicaid Services (CMS) commented regarding their fraud prevention initiative program and their planned changes regarding…
Should You Contract with The Blues?
By Sean McSweeney bio
Should you contract with the Blues? Many BCBS insurers around the country are opening up to paneling laboratories where previously that had not often been possible. They are offering…
