Oct 23, 2015 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
One new federal law forbids health IT vendors and providers from deliberately blocking information-sharing with competing EHR systems
Several years deep into its effort to get physicians and hospitals to use electronic health record (EHR) systems, the federal government has yet to come up with a way to improve interoperability—the ability of EHRs to interface and communicate with other systems.
Stage one and stage two Meaningful Use guidelines have failed to successfully address the barriers preventing interoperability. Of course, clinical laboratories and pathology groups encounter this problem daily. That’s because they must build interfaces between their laboratory information systems (LIS) and the EHRs of their client physicians. The cost of creating workable LIS-to-EHR interfaces continues to be a huge burden on medical laboratories and that is why they support improved interoperability. But labs also contribute to the lack of interoperability when they enact restrictions on how lab test data can be shared with other providers and competing labs who are serving the same physicians and patients. (more…)
Mar 23, 2015 | Compliance, Legal, and Malpractice, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways
Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015.
Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the research and development of new diagnostic tests that are designed to aid physicians in their practice of precision medicine.
The big question is how to pay for this initiative. President Obama proposed budgeting $215 million to fund this effort. But such funding must be approved by a Congress that is at odds with the President on nearly every issue. Additionally, The American Clinical Laboratory Association (ACLA) warns that the Food and Drug administration’s (FDA) 2014 announcement to regulate laboratory developed testing services (LDTs) is in conflict with the President’s initiative. (more…)
Dec 26, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules
Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device.
The primary goal of the new regulation is to have specified providers report patient deaths that involved high-risk medical devices, such as stents and heart valves, for example. Specified facilities include hospitals, ambulatory surgery centers, and nursing homes. Manufacturers must also report adverse patient events involving their Class III medical devices.
All Class III in vitro diagnostic systems used by clinical laboratories and pathology groups here in the United States will now have a UDI label. (more…)
Dec 3, 2014 | Coding, Billing, and Collections, Laboratory Hiring & Human Resources, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing
Researchers at the University of California San Francisco revealed that the cost for a simple cholesterol test ranged from as little as $10 to as much as $10,169!
Clinical laboratories owned by hospitals and health systems should take note of a public study of hospital laboratory test prices that was conducted by researchers at the University of California at San Francisco (UCSF). It was published this summer and showed a remarkable range of prices for medical laboratory tests charged by California hospitals.
How about a charge of $10,169 for a routine blood cholesterol test? This was one finding a study discussed in the August 2014 issue of the British Medical Journal Open blog. The study was led by Renee Hsia, M.D.. She is an associate professor of Emergency Medicine and Health Policy at the UCSF Medical School. Hsia and her colleagues compared charges for 10 common clinical laboratory tests that were reported in 2011 by all non-federal California hospitals. (more…)
Apr 11, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Uncategorized
Although most clinical laboratories and pathology groups do not use EHR systems, the OIG’s finding should alert them to possible problems with audit integrity of their clients’ EHRs
Electronic Health Record (EHR) systems were supposed to prevent fraud, but a recent report from one federal agency states that the fraud safeguards built into EHR systems are not in engaged by a majority of users.
Pathologists and clinical laboratory managers with the responsibility to maintain security of software systems used in their medical laboratories may be interested to read “Not All Recommended Fraud Safeguards Have Been Implemented in Hospital EHR Technology,” a report issued by the Health and Human Services’ (HHS) Office of the Inspector General (OIG). (more…)
