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…)
Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label
Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.
UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
Aug 29, 2014 | Coding, Billing, and Collections, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Uncategorized
In both the hospital market and the ambulatory market, Epic has the best-selling electronic health records system, according to data issued by ONCHIT
Across the nation, clinical laboratories and pathology groups are busy interfacing their laboratory information (LIS) systems to the electronic health record (EHR) systems of their client hospitals and physicians. Yet, few lab managers know which EHR systems are dominating the market and which EHR systems are barely surviving.
In fact, it can be a challenge to understand market share by vendor. That is because market share can be determined in multiple ways. Dark Daily found three different rankings of EHR vendors. Each was based on slightly different sets of data. (more…)
Jul 11, 2014 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
The majority of the nation’s hospitals and physicians now use electronic health records and most of these EHR users are already exchanging clinical data with regional HIEs
Pathologists tracking the adoption of EHR systems by hospitals and physicians will be interested to learn that, according to the federal government, more than 80% of hospitals and 50% of physicians now use these products. It is also reported that growing numbers of providers are exchanging data with health information exchanges.
Clinical laboratories and anatomic pathology groups have a big stake in these developments. Medical laboratory test data is an essential component to every patient’s permanent health record, which is why it is important for every lab to have interfaces with the HIEs serving their communities and regions.
(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…)
