Healthcare Inspection - Sterile Compounding Environment and Practices, Overton Brooks VA Medical Center, Shreveport, Louisiana

Important mainly because of the people in the conversation.Click to teach Gmail this conversation is not important. for Thursday, 15 June 2017 - Veterans Affairs Office of Inspector General (OIG) in Washington, D.C., United States

Veterans Affairs Office of Inspector General (OIG). Healthcare Inspection Sterile Compounding Environment and Practices, Overton Brooks VA Medical Center, Shreveport, Louisiana OIG conducted a healthcare inspection at the Overton Brooks VA Medical Center, Shreveport, LA (facility) to determine whether deficient conditions in the compounding pharmacy placed patients at risk. We confirmed that the facility did not comply with key elements of United States Pharmacopeia (USP) <797> (which outlines safe sterile compounding requirements and practices) as initially identified in October 2016 by the Louisiana Board of Pharmacy. The Board’s findings included a lack of proper cleaning of the compounding rooms and incomplete air and surface testing and certification in compounding areas. During our January 2017 site visit, we found continuing noncompliance with USP <797> requirements, including: Cleaning logs from September 2016 through January 27, 2017, reflected 4 days where there was no evidence of appropriate cleaning and mopping of floors; Only 18 percent of applicable employees had all the training and competency documentation required as of January 27, 2017; Air and surface testing and certification had not been completed in July 2016 and January 2017 as required. Appropriate air and surface testing was completed on February 1, 2017. Pharmacy managers did not report the Louisiana Board of Pharmacy’s inspection findings to appropriate leaders or committees. Facility leaders learned of the Louisiana Board of Licensing reports after the OIG unannounced January 2017 site visit. In February 2017, Food and Drug Administration (FDA) investigators conducted an extensive and detailed review of the facility’s compliance with FDA guidance on compounded sterile preparations (CSPs). Facility and Veterans Integrated Service Network (VISN) leaders implemented interim measures to assure patient safety that included sending all chemotherapy CSP orders to the Alexandria, LA, VA Medical Center for compounding; outsourcing all routine compounding to a local pharmacy; and limiting CSP activities to immediate use (≤1 hour beyond use date). Facility and VISN officials implemented an extensive action plan to correct the identified USP <797> deficiencies before re-opening the onsite pharmacy compounding areas. We reviewed the electronic health records of hospitalized patients who were administered CSPs and who were diagnosed with selected types of infections subsequent to the CSP administration in FYs 2016–2017 through January 6, 2017. None of the patients developed infections after intravenous infusions or injections of compounded medications. We made two recommendations to the VISN Director focusing on the implementation of corrective actions and processes to fully comply with USP <797> requirements, and communication of external review results to facility leaders. Veterans Affairs Office of Inspector General (OIG). Veterans Affairs Office of Inspector General (OIG) 801 I Street NorthWest Washington, D.C. 20536, United States 800-827-1000

-------

Healthcare Inspection - Sterile Compounding Environment and Practices, Overton Brooks VA Medical Center, Shreveport, Louisiana for Thursday, 15 June 2017 - Veterans Affairs Office of Inspector General (OIG) in Washington, D.C., United States

Veterans Affairs Office of Inspector General (OIG). Healthcare Inspection Sterile Compounding Environment and Practices, Overton Brooks VA Medical Center, Shreveport, Louisiana OIG conducted a healthcare inspection at the Overton Brooks VA Medical Center, Shreveport, LA (facility) to determine whether deficient conditions in the compounding pharmacy placed patients at risk. We confirmed that the facility did not comply with key elements of United States Pharmacopeia (USP) <797> (which outlines safe sterile compounding requirements and practices) as initially identified in October 2016 by the Louisiana Board of Pharmacy. The Board’s findings included a lack of proper cleaning of the compounding rooms and incomplete air and surface testing and certification in compounding areas. During our January 2017 site visit, we found continuing noncompliance with USP <797> requirements, including: Cleaning logs from September 2016 through January 27, 2017, reflected 4 days where there was no evidence of appropriate cleaning and mopping of floors; Only 18 percent of applicable employees had all the training and competency documentation required as of January 27, 2017; Air and surface testing and certification had not been completed in July 2016 and January 2017 as required. Appropriate air and surface testing was completed on February 1, 2017. Pharmacy managers did not report the Louisiana Board of Pharmacy’s inspection findings to appropriate leaders or committees. Facility leaders learned of the Louisiana Board of Licensing reports after the OIG unannounced January 2017 site visit. In February 2017, Food and Drug Administration (FDA) investigators conducted an extensive and detailed review of the facility’s compliance with FDA guidance on compounded sterile preparations (CSPs). Facility and Veterans Integrated Service Network (VISN) leaders implemented interim measures to assure patient safety that included sending all chemotherapy CSP orders to the Alexandria, LA, VA Medical Center for compounding; outsourcing all routine compounding to a local pharmacy; and limiting CSP activities to immediate use (≤1 hour beyond use date). Facility and VISN officials implemented an extensive action plan to correct the identified USP <797> deficiencies before re-opening the onsite pharmacy compounding areas. We reviewed the electronic health records of hospitalized patients who were administered CSPs and who were diagnosed with selected types of infections subsequent to the CSP administration in FYs 2016–2017 through January 6, 2017. None of the patients developed infections after intravenous infusions or injections of compounded medications. We made two recommendations to the VISN Director focusing on the implementation of corrective actions and processes to fully comply with USP <797> requirements, and communication of external review results to facility leaders. Veterans Affairs Office of Inspector General (OIG). Veterans Affairs Office of Inspector General (OIG) 801 I Street NorthWest Washington, D.C. 20536, United States 800-827-1000

-------

How is the VA using data to improve Veterans' lives? for Thursday, 15 June 2017 - U.S. Department of Veterans Affairs I Washington, D.C., United States

Easier access to information resources means more opportunities to serve.

What is VA Open Data? The VA is working to make information resources easier to find, access and use, while protecting individual personal data. VA's Open Data initiative strives to provide easy access to information that can fuel entrepreneurship, innovation and public policy research, such as: Patterns and comparative rates of health conditions for vulnerable Veteran groups Location information for Veteran gravesites across the U.S. Analysis on the growing number of women Service members and Veterans How can VA data help you? Learn more about how VA information is improving Veteran services and sign up for future updates on VA Open Data: Veterans Affairs.  Please remember the only secure way to ask personal questions is at https://iris.custhelp.com. Explore VA benefits at explore.va.gov

US Department of Veterans Affairs
810 Vermont Avenue, NorthWest
Washington, D.C. 20420, United States 

-------

Healthcare Inspection – Alleged Misdiagnosis and Delay in Treatment, Providence VA Medical Center, Providence, Rhode Island for Thursday, 15 June 2017 - Veterans Affairs Office of Inspector General (OIG) in Washington, D.C., United States

Veterans Affairs Office of Inspector General (OIG). Healthcare Inspection – Alleged Misdiagnosis and Delay in Treatment, Providence VA Medical Center, Providence, Rhode Island OIG conducted a healthcare inspection to evaluate allegations that a provider at the Providence VA Medical Center, (facility) Providence, RI, misdiagnosed a patient’s Achilles tendon rupture (ATR) in 2014 leading to a delay in treatment and further injury to the tendon. We substantiated that, on two occasions, an Emergency Department (ED) provider did not respond to a patient’s complaint that he may have an ATR and misdiagnosed him with a sprained ankle. The provider did not fully assess the patient’s injury (did not conduct a common definitive test used to identify a potential ATR) and is diagnosed the injury as a sprained ankle. We substantiated that the sprained ankle misdiagnosis caused a 16-day delay in treatment of the ATR. We could not substantiate that the misdiagnosis, delay in treatment for the ATR, and the treatment prescribed for a sprained ankle versus an ATR in the ED worsened the injury. A delay in ATR diagnosis or treatment may result in a worse outcome. Providers utilize a combination of ATR-specific clinical assessments and tests to diagnose and determine the extent of an ATR. However, because the ED provider did not document the proper assessments, which would have provided a clinical baseline of the ATR, we could not discern whether the injury became worse during the 16 days the patient was treated for a sprained ankle. Besides the 16-day delay, we identified other timeframes when different treatments affecting optimal outcomes could have occurred. The initial assessment occurred 3 days after injury. The patient was given options for conservative or surgical treatments within 4 weeks of injury and pursued conservative treatment. The patient had complaints of persistent pain after 6 months of conservative treatment and subsequently decided to undergo Achilles tendon surgery. We could not determine the extent to which the 3 day delay in seeking treatment, the 16-day delay in diagnosis, and/or the 6 month delay occasioned by the patient’s initial choice of non-operative treatment contributed to unfavorable healing. We found a peer review was done but documentation of the peer review process was incomplete. We identified that the Chief of Emergency Medicine did not follow up on the patient’s complaint about his first ED visit. We recommended that the Facility Director (a) ensure that peer reviews are completed as required by the Veterans Health Administration and (b) strengthen processes to ensure that patient complaints are resolved in accordance with facility policy. Veterans Affairs Office of Inspector General (OIG). Veterans Affairs Office of Inspector General (OIG) 801 I Street NorthWest Washington, D.C. 20536, United States 800-827-1000

-------

Veterans Affairs YouTube Update for Thursday, 15 June 2017 - U.S. Department of Veterans Affairs in Washington, D.C., United States

Veterans AFFAIRS         VA YouTube   McGuire VA Medical Center 3-D Printing Program 06/15/2017 02:13 AM EDT     Keep updated & let us know how we're doing.     Explore VA benefits at explore.va.gov.   US Department of Veterans Affairs 810 Vermont Avenue, NorthWest Washington, D.C. 20420, United States

McGuire VA Medical Center 3-D Printing Program

-------

Army supporting clinical trial testing hemorrhage control foam for Thursday, 15 June 2017 - Military Health System in Washington, D.C., United States

Army supporting clinical trial testing hemorrhage control foam Exsanguination, or bleeding to death, remains the most common cause of potentially survivable death to wounded warfighters. The Army is looking at this device as a potential stop-gap for patients awaiting surgical care. It could be a 'bridge to surgery,' keeping the patient alive long enough to give them a fighting chance at survival. The device resembles a caulk gun that contains expandable foam designed to be injected into a patient by a trauma surgeon. (U.S. Navy phot by Lt. j.g. Haraz Ghanbari) The U.S. Army Medical Materiel Agency, a subordinate organization of the U.S. Army Medical Research and Materiel Command, is supporting a pivotal clinical trial to test the safety and effectiveness of a self-expanding foam device to stop massive intracavitary abdominal bleeding. The device received an Investigational Device Exemption in early 2017 from the U.S. Food and Drug Administration. Throughout the next year, the device developer will select the clinical trial sites and complete pre-study approvals. The U.S. Army Medical Materiel Development Activity, which is also part of USAMRMC, will provide regulatory support for the project. The anticipated start date of the pivotal clinical trial is 2018. "Right now, we are looking at this device as a potential stop-gap for patients awaiting surgical care," said Leigh Anne Alexander, USAMMA product manager. "This is not going to repair the injury but it could be a 'bridge to surgery,' keeping the patient alive long enough to give them a fighting chance at survival." The device resembles a caulk gun that contains expandable foam designed to be injected into a patient by a trauma surgeon. The injector allows two separate chemicals to mix, causing the product's material to rapidly expand inside the abdomen to about 35 times its original volume. The foam is designed to expand around the patient's internal organs to stop bleeding and can be left inside the patient for up to three hours. Army Medicine is focused on identifying and transitioning solutions currently in research and development that reduce the number of hemorrhage deaths in the military. Exsanguination, or bleeding to death, remains the most common cause of potentially survivable death to wounded warfighters. A study published in the Journal of Trauma and Acute Care Surgery in 2012 reviewed nearly 5,000 battlefield fatalities from 2001-2011, categorizing them into two groups – non-survivable and potentially survivable. Of those that were considered potentially survivable deaths, more than 90 percent were related to hemorrhage. Of those deaths, more than 67 percent were related to truncal hemorrhage. The wound stasis program began in 2010 at the Defense Advanced Research Project Agency. Under that program, DARPA collaborated with a private vendor, along with the Massachusetts General Hospital and the Harvard Medical School, to develop a novel, self-expanding polyurethane foam that rapidly compresses major abdominal bleeding due to trauma. The project transitioned to the Army in 2015 after promising animal study results. "We are optimistic that this study will provide meaningful data and pave the way for future research," Alexander said. Disclaimer: Re-published content may have been edited for length and clarity. Read original post.  Read More ...

---

Questions for MHS? Contact Us

STAY CONNECTED:

---

Military Health System The Pentagon Washington, D.C. 20301, United States

-------

U.S. Department of Veterans Affairs CMV - Research Update for Thursday, 15 June 2017 - U.S. Department of Veterans Affairs I Washington, D.C., United States

Dear Veteran/Supporter, The Center for Minority Veterans (CMV) is sharing information about recently published research related to minority Veterans on a monthly basis. You can access additional minority Veteran research information on the CMV Research webpage. PubMed.gov is a resource that comprises more than 26 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher websites. Please contact your local library to obtain the full-text of any of these references. Thank you for your service and support, Barbara Ward Director, Center for Minority Veterans Effects of Post-traumatic Stress Disorder on Pregnancy among US Military Veterans: Lessons for ... Misra DP, Giurgescu C. Effects of Post-traumatic Stress Disorder on Pregnancy among US Military Veterans: Lessons for Research on Stress and Racial Disparities. Paediatr Perinat Epidemiol. 2017 May;31(3):195-197. doi: 10.1111/ppe.12361. PMID: 28444992 Racial & Ethnic Disparities Persist At Veterans Health Administration Patient-Centered Medical Homes Washington DL, Steers WN, Huynh AK, Frayne SM, Uchendu US, Riopelle D, Yano EM, Saechao FS, Hoggatt KJ. Racial And Ethnic Disparities Persist At Veterans Health Administration Patient-Centered Medical Homes. Health Aff (Millwood). 2017 Jun 1;36(6):1086-1094. doi: 10.1377/hlthaff.2017.0029. PMID: 28583968 Keep updated & let us know how we're doing. Veterans Affairs.  Please remember the only secure way to ask personal questions is at https://iris.custhelp.com. Explore VA benefits at explore.va.gov US Department of Veterans Affairs 810 Vermont Avenue, NorthWest Washington, D.C. 20420, United States

-------