Regulations/Legal

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January 2019
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FDA launches app for EHR data collection

Editor's Note The Food & Drug Administration (FDA) recently launched a new app to help streamline electronic health record (EHR) data collection for researchers, The November 7 EHR Intelligence reports. Using the MyStudies app, researchers can access patient-generated health data, EHR patient data, and claims and billing information for use in…

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By: Judy Mathias
November 13, 2018
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Success in efforts to prevent HAPUs may depend on data sources

Editor's Note Transitioning from administrative data to chart-based surveillance review to measure hospital-acquired pressure ulcers (HAPUs) and accounting for HAPU severity could improve the validity of measures for assessing the clinical and financial impact of value-based purchasing interventions, this study finds. Assessing HAPU incidence, severity, and trends using administrative data…

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By: Judy Mathias
November 8, 2018
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Joint Commission announces new requirement for THKR certification

Editor's Note The Joint Commission on November 7 announced a new requirement of participation in a national joint replacement registry for its advanced Total Hip and Total Knee Replacement (THKR) certification, effective July 1, 2019. The Disease Specific Care Performance Measurement (DSPM) standard DSPM.4, element of performance (EP) 2 will…

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By: Judy Mathias
November 8, 2018
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DVN GL announces first US sterile processing certification

Editor's Note Healthcare accreditation organization DNV GL Healthcare on November 7 launched the first sterile processing program certification in the US. The program recognizes excellence in an organization’s sterile processing department within the scope of infection prevention and control, surgical services, endoscopic services, and related departments. An important part of…

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By: Judy Mathias
November 8, 2018
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Voters reject Massachusetts ballot Question 1 on nurse-patient ratios

Editor's Note The Massachusetts ballot Question 1 that would have set strict limits on the number of hospital patients a nurse could care for at one time went down in defeat on November 6, the November 7 Boston Globe reports. Hospitals spent nearly $25 million to defeat the measure, more…

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By: Judy Mathias
November 7, 2018
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Joint Commission recognizes nine hospitals for eCQM evolution, utilization

Editor's Note The Joint Commission on November 6 released “Pioneers in Quality eCQM Proven Practices Collection: Recognizing Success 2017-2018.” The publication recognizes healthcare organizations that have successfully leveraged electronic clinical quality measures (eCQMs) and health information technology to drive quality improvement. Nine hospitals are featured:  BayCare Health System, Inc, Clearwater,…

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By: Judy Mathias
November 7, 2018
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FDA guidance updates UDI compliance policy

Editor's Note The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately. The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes…

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By: Judy Mathias
November 6, 2018
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FDA: Class I recall of Cardiosave Hybrid and Rescue IABPs

Editor's Note The Food & Drug Administration on November 2 identified the recall by Maquet Datascope Corp/Getinge Group’s Cardiosave Hybrid and Cardiosave Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the potential for the autofill process to malfunction or fail during…

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By: Judy Mathias
November 5, 2018
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CDC reports decline in hospital infections

Editor's Note The Centers for Disease Control and infection (CDC) on October 31 reported that the risk of hospital patients having healthcare-associated infections was 16% lower in 2015 than in 2011, largely because of declines in surgical site and urinary tract infections. The percentage of patients having surgical site and…

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By: Judy Mathias
November 1, 2018
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AAAHC launches 3-year Advanced Orthopaedic Certification program

Editor's Note The Accreditation Association for Ambulatory Health Care (AAAHC) announced on October 25 that it has launched an Advanced Orthopaedic Certification program for ambulatory surgery centers (ASCs) performing total joints and spine procedures. The 3-year certification program was designed by an expert panel of practicing orthopaedic and spine professionals…

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By: Judy Mathias
October 30, 2018
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