Issue link: https://beckershealthcare.uberflip.com/i/1348345
35 DATA ANALYTICS & INFORMATICS Data gaps will delay FDA's COVID-19 vaccine monitoring system for 'weeks or months' By Jackie Drees W hile more than 35 million Amer- icans have gotten a COVID-19 vaccine as of late February, the monitoring system the FDA is building to catch any dangerous reactions won't be able to analyze safety data for weeks or months, according to a Feb. 12 report in e New York Times. In interviews with the Times, FDA officials acknowledged that the monitoring system, dubbed BEST, is still in developmental stag- es. ey expect it to start analyzing vaccine safety data sometime soon, but likely not un- til aer the Biden administration hits its goal of vaccinating 100 million people, according to the report. "It's the right thing to do, but the fact of the matter is we don't have enough information and we're desperately in need of post-mar- ket information and monitoring," said a high-ranking FDA official who asked to re- main anonymous since he is not authorized to discuss the situation publicly. Public health experts told the publication that funding shortages and "bureaucratic hurdles" were to blame for the slowdown of the new COVID-19 vaccine safety moni- toring system, formally called the Biologics Evaluation Safety Initiative. In the meantime, the government is using a 30-year-old safety monitoring system, known as the Vaccine Adverse Event Report- ing System, or VAERS, that the FDA shares with the CDC and a smartphone app that people who get vaccinated can download and report any reactions they experience. e CDC also manages the Vaccine Safety Datalink, which is a collaboration between the agency and nine health systems that collects vaccine data and EHRs of about 12 million patients. As of late February, VAERS and the smart- phone app have not received reports of any deaths conclusively linked to the vaccines, and it has seen reports of only few serious problems. n Intermountain earns patent for clinical analytics methodology to standardize outcomes By Laura Dyrda S alt Lake City-based Intermountain Healthcare and Empiric Health received a patent for their clinical analytics methodology. Intermountain developed a clinically driven program, ProComp, to focus on reducing outcomes variation for similar surgical proce- dures. The health system's clinicians built the program to make their team more aware of surgical procedure variations and the overall cost of care. The new patent covers methods and pro- cesses to identify clinically similar patient cohorts. Physicians then review the data of similar patients for a better comparison of outcomes, which could improve clinical deci- sion-making and outcomes overall. The patent is licensed to Empiric Health, a clinical analytics company Intermountain formed with Oxeon in 2017 to commercialize the ProComp product. More than 100 hospitals and eight health systems use the technology. n 'This discovery is a little disturbing': Centura Health data reports miss 2,500 COVID-19 hospitalizations since April By Jackie Drees C entennial, Colo.-based Centura Health failed to report almost 2,500 COVID-19 hospitalizations dating back to last April be- cause of a system coding issue, The Journal reported Jan. 8. Five details: 1. The Colorado Department of Public Health and Environment confirmed on Jan. 5 that Centura failed to report 2,450 COVID-19 hospitalizations, most of which happened during October, November and December while cases spiked in the state. 2. Durango, Colo., Mayor Dean Brookie expressed his concern to the publication: "It's disturbing the lack of reporting was during a critical period of time," he said. "I want to trust our healthcare providers, but this discovery is a little disturbing." 3. The Colorado health department said that the missed reporting was the result of "a quality control system established by local public health agencies and the state." The system revealed that some of Centura's hospitalizations weren't making it into the COVID Patient Hospitalization Surveillance because of certain hospital coding is- sues, which have since been fixed. 4. The missing data reports account for almost 13 percent of the state's 19,000 hospitalizations. 5. A Centura Health spokesperson called the coding issue an "over- sight" and said once the system learned of the issue, it quickly resolved it. n