VAOIG Review of Informed Consent for Human Subject Research

Healthcare Inspection Review of Informed Consent in the Department of Veterans Affairs Human Subjects Research 05/16/09. We conducted this review of informed consent procedures and human subject protections in VA research at the request of U.S. Representative Steve Buyer. The study population consisted of all enrollees of human subjects research projects conducted under VA auspices that were active and required informed consent, and had at least one enrollee as of August 20, 2008. The study used a complex, three-stage sample design that included stratification, clustering, and unequal probabilities of selection. From the 102 facilities that had at least one applicable protocol, we statistically randomly selected 30 (29.4 percent) facilities where we conducted onsite inspections. There were 5,993 sampled participants. We found the following: Insufficient IRB documentation for the waiver for 2 of the 33 sampled research protocols that were waived from the required informed consent process. An estimated 1.7 percent of the 367,103 VA research subject consent forms could not be located; we are 95 percent confident that the true percent value is somewhere between 0.6 percent to 4.5 percent. Thirty-one percent of the VA research subjects consent forms on file were estimated to be noncompliant with VHA standards; 97 percent of the noncompliant forms lacked witness signature. One percent of the 110,231 VA noncompliant forms lacked the subject or subject’s authorized representative signature. VAOIG

New From PubMed

Coming home with posttraumatic stress disorder. Westgard E. Am J Nurs. 2009 May;109(5):11. No abstract available. PMID: 19411879

Do older rural and urban veterans experience different rates of unplanned readmission to VA and non-VA hospitals? Weeks WB, Lee RE, Wallace AE, West AN, Bagian JP. J Rural Health. 2009 Winter;25(1):62-9. CONTEXT: Unplanned readmission within 30 days of discharge is an indicator of hospital quality. PURPOSE: We wanted to determine whether older rural veterans who were enrolled in the VA had different rates of unplanned readmission to VA or non-VA hospitals than their urban counterparts. METHODS: We used the combined VA/Medicare dataset to examine 3,513,912 hospital admissions for older veterans that occurred in VA or non-VA hospitals between 1997 and 2004. We calculated 30-day readmission rates and odds ratios for rural and urban veterans, and we performed a logistic regression analysis to determine whether living in a rural setting or initially using the VA for hospitalization were independent risk factors for unplanned 30-day readmission, after adjusting for age, sex, length of stay of the index admission, and morbidity. Findings: Overall, rural veterans had slightly higher 30-day readmission rates than their urban counterparts (17.96% vs 17.86%; OR 1.006, 95% CI: 1.0004, 1.013). For both rural- and urban-dwelling veterans, readmission after using a VA hospital was more common than after using a non-VA hospital (20.7% vs 16.8% for rural veterans, 21.2% vs 16.1% for urban veterans). After adjusting for other variables, readmission was more likely for rural veterans and following admission to a VA hospital. CONCLUSIONS: Our findings suggest that VA should consider using the unplanned readmission rate as a performance metric, using the non-VA experience of veterans as a performance benchmark, and helping rural veterans select higher performing non-VA hospitals. PMID: 19166563

Improving Mental Health Care for Returning Veterans 05/14/09. A substantial number of the 1.7 million military servicemembers returning from the conflicts in Iraq and Afghanistan may face mental health problems. A comprehensive study conducted by RAND in 2008 found that an estimated 18.5 percent of those back from deployment reported symptoms consistent with a diagnosis of post-traumatic stress disorder (PTSD) or depression. The study also examined veterans' access to quality mental health treatment. It identified gaps in the military and veterans health care systems and opportunities for improvement. A large infusion of new funds into the Department of Defense (DoD) and the Veterans Health Administration (VHA) in recent years is supporting their continuing efforts to improve care. However, many returning veterans also seek care in community settings as they reintegrate into civilian life. As part of the Invisible Wounds of War project, a RAND team published additional results identifying key challenges to the provision of mental health care that cut across community, VHA, and DoD health care settings. This fact sheet is based on Burnam MA, Meredith LS, Tanielian T, and Jaycox LH, “Mental Health Care for Iraq and Afghanistan War Veterans,” Health Affairs, Vol. 28, No. 3, May/June 2009, pp. 771–782. RAND

C&P Site Visit Audit

Audit of Veterans Benefits Administration Compensation and Pension Site Visit Program 05/13/09. The VA Office of Inspector General (OIG) conducted this audit to determine whether the Veterans Benefits Administration’s (VBA) Compensation and Pension (C&P) Site Visit program effectively monitors and evaluates Veteran Service Center (VSC) operations. We assessed the effectiveness of Site Visit planning, their ability to identify and report operational issues and best practices, and the disposition of actions requiring attention. We conducted our work from July to November 2008. While the C&P Site Visit program provides centralized oversight and technical assistance to VSC operations, the program lacks the adequate infrastructure and management strategy to meet its mission and goals. Improvements are needed in staffing and staff independence to ensure all VAROs are visited within the agency’s stated goal of 3 years, which includes initial reporting and follow-up. Unless enhancements and comprehensive changes are made to the C&P Site Visit program’s design and execution, the C&P Service is likely to miss opportunities to improve performance across its regional office field structure. VAOIG

Review of Veterans Service Center's Claims Processing Policy in Pittsburg, PA

Review of Alleged Claim Processing Delays to Receive Monetary Performance Awards at VA Regional Office Pittsburgh, PA 05/12/09. The Office of Inspector General (OIG) reviewed an October 21, 2008, anonymous allegation that Veterans Service Center (VSC) managers at VA Regional Office (VARO) Pittsburgh instructed Veterans Service Representatives (VSR) to delay the processing of Global War On Terror (GWOT) claims that were ready for a rating decision to meet incentive goals and receive performance award money. We did not substantiate the allegation but found that VSC managers and VSRs differed in their understanding about how to meet an April/May 2008 incremental incentive offered by the Veterans Benefits Administration (VBA) Office of Field Operations (OFO) to have zero GWOT claims pending that were awaiting a rating decision for more than 7 days by May 31, 2008. VAOIG

Review of Muskogee, OK VA

Combined Assessment Program Review of the Jack C. Montgomery VA Medical Center Muskogee, Oklahoma 05/12/09. The purpose of the review was to evaluate selected operations, focusing on patient care administration and quality management (QM). During the review, we provided fraud and integrity awareness training to 527 employees. The review covered seven operational activities. The medical center complied with selected standards in the following three activities: (1) coordination of care, (2) suicide prevention program, and (3) survey of healthcare experiences of patients. We identified dental service consultation completion as an organizational strength. We made recommendations for improvement in the following four activities: QM. Medication management. Environment of care. Emergency/urgent care operations. VAOIG

Miami VA Comments on Contamination

Miami VA: Steps taken to prevent contamination 05/12/09. Mary D. Berrocal, director of the Miami VA Healthcare System, told The Associated Press she has hired someone in Miami to supervise training, make sure biomedical equipment works properly there and ensure the problems aren't repeated. "We have truly scrutinized our systems to ensure that doesn't happen," she said. "We truly, truly are on it ... We've really, really, really expended every effort possible to make sure that this is an isolated situation." But she declined to discuss specifics about the contamination problems or say how they went undetected for so long. Associated Press via PhysOrg.com

2010 VA Budget

President Obama’s 2010 Spending Plan Initiates Transformation for VA Services 05/11/09. The President’s vision for the Department of Veterans Affairs (VA) is to transform VA into a 21st Century organization that is Veteran–centric, results–driven, and forward–looking. The Department’s resource request for 2010 is nearly $113 billion–up $15.1 billion, or 15 percent, from the 2009 enacted budget. This is the largest one–year percentage increase for VA requested by a President in over 30 years. VA’s budget request for 2010 provides the resources critical to achieving the President’s vision. VA

Single Site for Veterans' Medical & Benefits Records

Single Web site key for vets' combined medical, benefits record 05/11/09. The Veterans Affairs Department said in its proposed fiscal 2010 budget released on May 7 that it has placed a high priority on building a virtual lifetime electronic record, which will follow soldiers from active duty through their retirement, an initiative that the yet-to-be-confirmed VA chief information officer said last week will be supported by a single Web site. NextGov