CMS Releases Revision to State Operations Manual Special Procedures for Laboratories

Presenters at the 13th Annual Lab Quality Confab 2019 discussed the negative impact of disparities between medical laboratory processes and SOPs ATLANTA, Oct. 18, 2019—Several weeks ago, the Centers for Medicare and Medicaid Services (CMS) quietly released QSO-19-20-CLIA: Revisions to State Operations Manual (SOM), Chapter 6—Special Procedures for Laboratories. The release, which went to all State Survey Agency Directors, includes a “comprehensive revision to establish quality laboratory...

Federal Advisory Committee Seeks Public Comments on Revising CLIA Regulations, says Keynote Speaker at 13th Annual Lab Quality Confab in Atlanta

At The Dark Report’s annual Lab Quality Confab for clinical laboratory administrators, managers, and quality team members, experts outline how disruption in healthcare requires labs to improve processes and cut costs ATLANTA, Oct. 15, 2019—Clinical laboratory professionals have a chance to advise the federal Centers for Disease Control and Prevention (CDC) on how the federal government could revise the regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). That’s...

Clinical Laboratory Leaders Agree: Showing Value Is More Important than Ever as Healthcare Transitions Away from Fee-for Service Reimbursement

How medical laboratories can show value through process improvement methods and analytics will be among many key topics presented at the upcoming Lab Quality Confab conference Quality management is the clinical laboratory’s best strategy for surviving and thriving in this era of shrinking lab budgets, PAMA price cuts, and value-based payment. In fact, the actions laboratories take in the next few months will set the course for their path to clinical success and financial sustainability in 2020...

University of Washington and Microsoft Research Encode Data into DNA, Demonstrating Potential New Use for Genetic Sequences

The proof-of-concept experiment showed data can be encoded in DNA and retrieved using automated systems, a development that may have positive significance for clinical laboratories It may seem far-fetched, but computer scientists and research groups have worked for years to discover if it is possible to store data on Deoxyribonucleic acid (DNA). Now, Microsoft Research (MR) and the University of Washington (UW) have achieved just that, and the implications of their success could be...

Did The Joint Commission Omit Misdiagnosis from Its Lists of Top 10 Sentinel Events for 2018 and 2019?

Though data on delays in treatment due to misdiagnosis have been collected by TJC since 2015, misdiagnosis is not listed among the reported top 10 sentinel events Accurate diagnosis could be the most critical aspect of all healthcare. Without accurate diagnoses, doctors may be delayed in starting treatment for their patients. In other cases, ordering inappropriate clinical laboratory tests might contribute to a misdiagnosis. Healthcare experts know that misdiagnoses take place far too often....

Senior Citizens on Medicare Are Particularly Vulnerable to New Scams Involving Fraudulent Genetic Test Orders

Medical fraudsters are targeting Medicare recipients with schemes to persuade them to agree to genetic tests advertised as informing them if they are predisposed to specific chronic diseases or cancer Medicare scams involving orders for unnecessary, expensive testing are not new. However, clinical laboratory managers and anatomic pathologists need to be aware—particularly those working in hospital and health system labs—that an entirely new wave of fraud involving medical laboratory testing is...