Nebula Genomics Offers Anonymous Sequencing to Increase Privacy and Transparency in Genetic Testing

By offering a way for customers to have their DNA sequenced without any fear of being identified, Nebula Genomics hopes to revive interest in personal genetics Nebula Genomics is introducing a new model for genetic sequencing that emphasizes privacy and consumer ownership of data. It does this by allowing customers to anonymously submit their DNA and pay for sequencing without including any personally identifiable information. In a twist that will interest medical laboratory professionals,...

As Accreditation Inspections of Clinical Laboratories Become Tougher, Innovative Labs Use Internal Audits and Continuous Quality Improvements to Help Prevent Deficiencies

Savvy medical laboratory managers conduct internal audits of processes involved in deficiency citations so they can uncover how deficiencies occur and help eliminate recurrences One trend that places clinical laboratories at risk involves increased regulation of lab processes, along with more thorough accreditation inspections. Compared to past years, both developments mean more ways for lab assessors to find greater numbers of deficiencies. However, leading laboratory accreditation and...

Preparing Clinical Laboratories for Invasive Federal Enforcement of Fraud and Abuse Laws, Increased Scrutiny by Private Payers, New Education Audits, and More

Medical laboratory leaders need to take opportunities to stay abreast of government and payer activity, particularly as payer audits become tougher, say legal experts Even compliant clinical laboratories and anatomic pathology groups are reporting tougher audits and closer scrutiny of the medical lab test claims they submit for payment. This is an unwelcome development at a time when falling lab test prices, narrowing networks, and more prior-authorization requirements are already making it...

17 Former Employees Accuse Orig3n of Clinical Laboratory Test Inaccuracies, Contamination, and Fabricated Test Results

This is not the first time genetic-testing company Orig3n has been scrutinized by state and federal investigators over its business practices It’s not often that multiple employees of a clinical laboratory company go public with criticism about the quality of their lab company’s tests. But that is what is happening at Orig3n. Problems at the Boston-based genetic testing company were the subject of an investigative report published by Bloomberg Businessweek (Bloomberg). In September, Bloomberg...

Pathologist, Neurosurgeon, and Critical Care Specialist Face Criminal Charges in the Deaths of Dozens of Patients

Could local and federal prosecutors ask clinical laboratories to disclose information on their client physicians’ test-ordering activities when investigating medical errors? Are physicians facing greater risk of criminal indictments when one of their patients dies, and investigators find that physician impairment or inappropriate medical treatments contributed to the patient’s death? Could clinical laboratories be drawn into federal investigations of their client physicians? The healthcare...

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...