Witness Testimony of Hon. Robert A. Petzel, M.D., Under Secretary for Health, Veterans Health Administration, U.S. Department of Veterans Affairs
Chairman Miller, Ranking Member Filner, and other Members of the Committee—thank you for the opportunity to discuss the Department of Veterans Affairs’ (VA) patient safety policies and strategies that build trust and ensure the safe and compassionate care of our Veterans. I am accompanied today by Robert Jesse, M.D., Ph.D, Principal Deputy Under Secretary for Health; William Schoenhard, Deputy Under Secretary for Health Operations and Management, George Arana, M.D., Acting Assistant Deputy Under Secretary for Health for Clinical Operations, and Andrea Buck, M.D., Acting Chief Medical Officer.
First and foremost, I would like to apologize on behalf of the Department to those Veterans who have been affected by a lapse in patient safety practices at any of our facilities. The greatest commitment of every VA employee is the well-being of our Veterans. In the Veterans Health Administration (VHA), from the housekeeper, who ensures each patient’s room is clean, to the Under Secretary for Health, we are united in a common mission to protect and provide quality health care for those who served to defend this Nation.
When a lapse in patient safety practices occurs, it is VA’s fundamental belief that we must be open and transparent with regard to our mistakes and any necessary actions that may result. This can result in disclosing medical events even when not a common practice by others in the medical community. For example, in 2010, the New England Journal of Medicine published an article noting that large-scale adverse events in medical settings are not uncommon; the article described in detail VA’s disclosure policies and concluded, “The VHA policy represents a valuable resource for all health care institutions.” We carefully consider the effects of any disclosure, but our practice is to provide more information to our Veterans in an abundance of caution, even if the risk to their health is low.
We are particularly concerned about any event where Veterans are put at risk because we believe we provide excellent care, and we have the data to support that belief. Despite caring for patients that are, on average, sicker, older, and less affluent than the general population, VA’s performance overall exceeds the best U.S health care systems. Our data collection and publication program is unprecedented in U.S. health care, as we report more data about our programs online than anyone else. As the Wall Street Journal observed in March 2011, “This usually comprehensive sort of consumer information on medical outcomes remains largely hidden from the tens of millions of Americans outside the VA system…” Professional publications and the mainstream media have recognized and lauded our accomplishments in providing the best integrated health care in the country. Recently, the New England Journal of Medicine published an article praising our programs to reduce health care-associated infections by methicillin-resistant Staphylococcus aureus (MRSA), a bacteria known to be resistant to most antibiotics. In the words of a New York Times editorial about this study, “If other hospitals could replicate the effort, thousands of patients might be saved from needless infections acquired after they entered the hospital.”
These accomplishments are significant, but they are not, and never will be, enough. We owe it to our Veterans and ourselves to continually strive to be better. We must be the Veteran-centric, results-driven and forward-looking organization the Secretary has called us to be. This means we will continually learn how to do our jobs more effectively, more efficiently, and more compassionately.
My testimony today will provide an overview of our quality and patient safety programs. It will then describe our practices for standardized reprocessing of reusable medical equipment; our systematic approach to limiting the activities of suspect practitioners through rigorous credentialing and privileging, as well as peer review; and risk management and notification processes for Veterans.
VA Quality and Safety Programs
VA is committed to providing the safest and highest quality health care for Veterans. We have established a wide array of innovative and comprehensive programs to measure, analyze, improve and report on all aspects of health care quality and patient safety. We have published an annual report on each facility’s quality and safety performance since 2008, and these reports are available online (http://www1.va.gov/health/HospitalReportCard.asp). The 2010 report includes new metrics, such as medical and surgical outcomes data, as well as a detailed analysis of VA’s safety reports. We have identified six domains in line with the Institute of Medicine’s recommendations for quality in health care: effective, equitable, safe, timely, patient-centered, and efficient. We have been an early adopter of performance measurement and improvement because we at VA have a special responsibility to maintain the trust of the Veterans we serve and the public at large.
All eligible VA facilities and programs have been accredited by The Joint Commission, and over 200 programs were accredited by the Commission on Accreditation of Rehabilitation Facilities. The Joint Commission’s accreditation is nationally recognized as a symbol of quality and is considered one of VA’s major external quality reviews. Joint Commission accreditation confers recognition that VA health care organizations meet certain standards of quality and safety, as well as compliance with health care quality standards of payors. The Commission on Accreditation of Rehabilitation Facilities reviews VA programs designed to provide specialized treatment and quality rehabilitation to Veterans with disabilities. Various specialty programs are also often reviewed and accredited by boards with expertise in those disciplines. We estimate that more than 4,100 site visits occur at VA health care facilities each year to support approximately 2,000 total accreditation reviews and inspections.
According to the Healthcare Effectiveness Data and Information Set (HEDIS), VA facilities provided high quality outpatient medical care and compared favorably with the top performing health plans in the Nation. When looking at disease-specific health care within inpatient settings, VA also compares favorably with the best hospitals in the Nation on core indicators of quality that are published on Medicare’s Hospital Compare Quality of Care Web site. The rates of hospital-acquired infections at VA were generally low when compared with national averages according to the Centers for Disease Control and Prevention. Many VA facilities report rates that match or are lower than the top 10 percent of reporting hospitals in the country (lower infection rates are better). High quality outpatient care was available to Veterans regardless of where they lived. Women Veterans receive gender-specific care that substantially exceeds care available in non-VA health care systems.
There are several programs that have proven instrumental to VA’s success in overseeing quality care. First, VA’s Surgical Quality Improvement Program (VASQIP) monitors surgical procedures and tracks risk-adjusted surgical outcomes, including complications (morbidity) and mortality rates. VASQIP analyzes aggregate patient data from surgical outcomes of 124 VA facility surgical programs using mathematical models to predict an individual patient’s expected outcome based on the patient’s pre-operative characteristics and the complexity of the surgical procedure being performed. This calculated expected outcome is then compared to an observed outcome on a regular basis. Facilities with an observed adverse outcome that significantly exceeds expected outcomes undergo a quality improvement assessment to identify specific issues that require resolution to enhance patient safety. This kind of monitoring has resulted in reductions in patient morbidity and mortality across the organization. VASQIP was developed more than 15 years ago, and the American College of Surgeons now offers a similar program to private sector hospitals.
Another effort is VA’s National Center for Patient Safety (NCPS), which was established more than 10 years ago to improve the quality and safety of care we provide. One key process that NCPS uses when an adverse event or a “close call” happens is a root cause analysis (RCA) to identify the basic or contributing causal factors. This is an interdisciplinary review process that focuses primarily on systems and processes, rather than individuals, to determine what actually or almost went wrong. These investigations can identify changes that should be made to either redesign or develop our practices and reduce the risk of a similar event in the future. Approximately 40 percent of RCAs are done on events that produced little or no harm to patients. This is a testament to VA’s developed culture of safety, as it reflects the willingness of staff to identify close calls for review and analysis. The five most common subjects for an RCA include falls; delays in treatment, diagnosis, or inpatient surgery; “high alert” adverse drug events; unexpected deaths (other than suicide); and outpatient suicides. Both The Joint Commission and VA require an RCA to be completed within 45 days; as such, we track the timeliness of these investigations, and we have shown continued improvement over the last several years in completing these in a timely manner.
Finally, VA has recently begun publishing detailed quality and safety data online to inform Veterans and the public of the care we provide. These efforts also improve our internal accountability structure. ASPIRE is a Web-based dashboard that documents quality and safety goals for all VA hospitals and reports on how individual hospitals are meeting these standards. The standards identified by ASPIRE are the gold standard and should be the target of every health care organization; for example, we have targeted zero MRSA infections in all of our facilities. We will not necessarily meet these objectives, but they should always be our goal. The Linking Knowledge and Systems (LinKS) dataset is another dashboard that summarizes outcomes in areas such as acute care, safety, intensive care, and other measures. LinKS reports quarterly risk adjusted as well as unadjusted data that shows how well each VA hospital is performing and areas in which each facility can improve. Much of the data in the LINKS and ASPIRE dashboards are simply not available in other health care systems, which limits VA’s ability to compare itself against other health care systems.
Nevertheless, VA has been identified as a leader in the field, and we are setting the bar for other systems to meet. Perhaps most importantly, we are using these quality and safety datasets to inform the performance reviews of senior leadership. A key element of the performance plan for every Veterans Integrated Service Network (VISN) Director and VA Medical Center (VAMC) Director is based on objective performance in health care quality and safety, as measured by independent sources of information pulled from our electronic health record system. VA has also contracted for an external peer review program, which selects a statistically significant random sample of cases for each facility and assesses the care we provided. This assists VA with validating our internal peer review process and helps ensure we are providing the highest quality of care to our Veterans.
Standardized Reprocessing of Reusable Medical Equipment
VA has made significant progress in standardizing sterile processing techniques across the Department. We have worked with the International Association of Healthcare Central Service Material Management, an internationally recognized organization in sterile processing, to provide supply, processing and distribution training. We have also obtained a national contract to ensure all facilities are supplied with up-to-date manufacturers’ instructions for sterile processing. New standard operating procedures for reprocessing are currently in place. Beyond standardizing processes, VA seeks to set the standard for effective and safe sterile processing techniques nationwide. We have been soliciting proposals from the private sector to automate sterile processing techniques to reduce the opportunities for human error, and VA is internally pursuing innovations to improve the safety, efficiency, and effectiveness of sterile processing.
Between January 1 and September 30, 2010, VA’s Office of Inspector General (OIG) Combined Assessment Program reviewed 45 VA facilities to evaluate reusable medical equipment practices (RME) to determine if facilities complied with VA standards for RME sterilization and high level disinfection, provided documentation for annual training, and assessed and documented annual competencies for employees who perform RME reprocessing activities. OIG identified six areas where compliance with RME requirements needs to improve. We appreciate their assessment and their recommendations. We have concurred with their recommendations, and we have either already completed these improvements or we will do so within the next 6 months. Specifically, the OIG recommended that VA senior managers (at the national, network, and local levels) ensure that:
- Standard operating procedures (SOPs) are current, consistent with manufacturers’ instructions, and located within the reprocessing areas;
- Employees consistently follow SOPs, supervisors monitor compliance, and annual training and competency assessments are completed and documented;
- Flash sterilization is used only in emergent situations, supervisors monitor compliance, and managers assess and document annual competencies for employees who perform flash sterilization;
- Appropriate personal protective equipment is donned before entering and is worn in decontamination areas;
- Ventilation systems are inspected and filters are changed quarterly in all reprocessing areas and that temperature and humidity are monitored and maintained within acceptable ranges in sterile storage areas; and
- Processes for consistent internal oversight of RME activities are established to ensure senior management involvement.
In response to these recommendations, VA has modified inspection processes at the network and facility level to ensure that employees consistently follow SOPs and that training and competency assessments are complete and documented. Staff from VA’s Sterile Processing Departments (SPDs) will perform site visits to provide additional oversight to ensure that annual training and competency assessments are complete as well. We developed and deployed a standardized template as of February 14, 2011, that requires facilities to conduct six inspections of SPD per year, and for VISN staff to conduct three unannounced inspections each year. We will track and review the results of these inspections nationally to refine our oversight methods. VA has developed a national action plan to specifically address RME concerns throughout its entire health care system. When VA Central Office learns of an adverse event, we immediately activate a fact finding team of appropriate subject matter experts to assess the event for Veteran risk. Depending on this team’s determinations, VA may convene a Clinical Review Board (CRB) to determine if disclosure to patients should occur. We have also realigned our organization to create a national SPD office that will provide guidance and oversight for our experts in the field.
We believe Veterans should be encouraged by the results of the OIG’s inspection. While the report identifies areas for improvement, it also commends VA facilities for recognizing the importance of maintaining consistent RME practices to ensure patient safety. VA’s policy is to cooperate with all reviews and investigations, from the OIG and others, that have been designed to improve service and develop better practices for health care. Our facilities have been increasingly vigilant in monitoring, self-identifying, and investigating any inconsistencies in procedures for cleaning RME, and our facilities are conducting frequent and repeated reviews of their patient care areas to ensure that procedures are clear and followed.
The Government Accountability Office (GAO) has also reviewed selected VA facilities to assess the purchasing, tracking, and reprocessing requirements for RME. GAO specifically looked at relevant VA policies, as well as two purchasing, two tracking, and two reprocessing requirements. These requirements were instituted following patient safety incidents at the Palo Alto VAMC, the Miami VAMC, and the Augusta and Murfreesboro VAMCs, respectively. GAO did not identify any inadequacies in the purchasing requirements they selected for review in the context of patient safety. In the area of tracking requirements, GAO found VA has a limited ability to identify equipment on which there are alerts or recalls and maintaining inventory, and that it also experiences challenges developing required training in this area. For reprocessing requirements, GAO found VA did not adequately specify the types of RME that require device-specific training and that there is conflicting guidance on the development of RME reprocessing training.
We greatly appreciate the work of the GAO in helping VA ensure our programs are providing the quality of care our Veterans deserve. We have already begun instituting changes to address these concerns and are ahead of the timeline we outlined for GAO. We are analyzing information on non-compliance by specific VA medical centers and are overseeing the development of corrective action plans. We are also developing a systematic approach to analyzing information to identify areas of non-compliance across the nation, with particular focus on those that occur frequently, pose high risks to Veterans’ safety, or that have gone unaddressed. VA has drafted a new handbook that will replace all existing sterile processing policies; this handbook will be reviewed by experts from the field before publication to ensure its requirements are consistent with best practices and capable of implementation. To reduce the variation in equipment and accompanying processes, VA has established national product specifications and criteria for selecting standardized endoscopic equipment. Similarly, an Integrated Product Team for Endoscopes has been charged with developing recommendations for gastrointestinal (GI) endoscopic equipment. As part of our ongoing effort to standardize the reprocessing of RME, we have secured a national contract that supplies up-to-date manufacturers’ instructions to all VA facilities. These efforts will enhance patient safety and quality, realize economic value, and reduce variability for set up and reprocessing this equipment.
In addition, VA is partnering with local communities to provide state-of-the-art training to those responsible for providing oversight of VA’s SPD. For example, in Phoenix, Arizona, VA has entered into a first-of-its-kind agreement with a local technical college to provide VISN SPD boards with a laboratory environment for hands-on training in the reprocessing of RME. The first of these courses will begin in June. By training the trainers and those responsible for oversight within the Department, as well as providing support to community training efforts, VA is setting the standard for excellence in the reprocessing of RME nationwide.
Credentialing, Privileging, and Peer Review
Credentialing, privileging, and peer review are essential components of our quality and safety program as they assess who is competent to perform what types of procedures and how well they perform. Credentialing refers to the systematic process of screening and evaluating qualifications and other credentials, including licensure, required education, relevant training and experience, current competence and health status. Clinical privileging is a process by which a practitioner, licensed for independent practice, is permitted by law and the facility to practice independently, to provide specified medical or other patient care services within the scope of the individual’s license, based on the individual’s clinical competence as determined by peer references, professional experience, health status, education, training, and licensure. Privileging is both facility- and provider-specific.
All VA health care providers who are permitted by law and the facility to provide patient care independently must be credentialed and privileged to do so. VetPro is VA’s electronic credentialing system and must be used for credentialing of all providers who are granted clinical privileges or are credentialed for other reasons. This system helps reduce the chance for human error and improves the care we deliver at VA. All candidates must submit an application to VetPro providing information regarding malpractice, adverse actions against licensure, privileges, hospital membership, research, and other factors. We do not allow an offer of employment to be made to providers until the credentialing process is complete. This process entails screening the candidate through the appropriate State Licensing Board, the Federation of State Medical Boards, and the National Practitioner Data Base (NPDB). The NPDB is a secondary flagging system intended to support a comprehensive review of health care practitioners’ professional credentials by identifying any malpractice payments or adverse actions against clinical privileges. NPDB screening is required before an applicant’s appointment; VA then monitors appointed practitioners through the NPDB’s continuous query program for as long as they maintain an appointment at a VA medical facility. The information we receive from NPDB offers further insight into the provider’s history as a clinician and is considered with other relevant data in evaluating a practitioner’s credentials. VA oversees this program at the national, network and facility level to ensure compliance.
Applicants for VA positions are required to respond to questions concerning clinical privileges at VA and non-VA facilities. Privileges are valid for a period not to exceed two years. To approve privileges for a provider, VA requires evidence of current licensure, relevant training and experience, current competence, and information associated with the person’s health status as it relates to the individual’s ability to perform the requested clinical privileges. We also require information related to malpractice allegations or judgments, loss of medical staff membership, loss or reduction of clinical privileges, or challenges to licensure. At the facility level, each service chief is responsible for developing additional criteria consistent with the needs of the patient population at the facility. We continue to monitor privileges based upon quality and performance data on an ongoing basis, and we provide numerous training opportunities to ensure that those responsible for assessing and validating credentialing and privileging standards have the resources they need to help ensure quality patient care.
VA also maintains a robust peer review program to oversee quality and accountability for care. Peer review is a process carried out by an individual health care professional or a select committee of professionals to evaluate the performance of other providers. When conducted systematically and credibly, as is VA’s process, peer review can result in both immediate and long-term improvements in patient care by revealing areas for improvement in the practice of one or more providers, which contributes to organizational improvement and better patient outcomes. Peer review is intended to be a comprehensive, confidential and non-punitive process that contributes to overall quality improvement efforts and to the improvement of care for Veterans.
Peer reviews are conducted by internal and external parties. For internal reviews, it is VA policy that each VISN and health care facility must establish and maintain a program of peer review for quality management purposes relevant to the care provided. Our facilities must comply with the requirements of all applicable accrediting and oversight agencies that review VA health care facilities, including The Joint Commission. We have established criteria that indicate who can serve as a peer reviewer to ensure these individuals provide competent and accurate information to other providers. VHA Directive 2010-025 provides clear guidelines for which clinical events require a peer review for quality management purposes. As mentioned earlier, VA maintains an external peer review program to gather and validate information related to outcomes and processes for each of our medical facilities. This provides an important, independent assessment of the care we offer and provides an additional source of validation for our internal processes.
Risk Management and Notification Processes
VA has an ethical and legal obligation to disclose to patients adverse events they experienced during the course of their care, including when the adverse event may not be obvious or severe, or where the harm may only manifest in the future. Disclosure of these events is consistent with our core values of trust, respect, excellence, commitment and compassion. Facility Directors are responsible for ensuring that health care providers communicate these events to patients or the patients’ representative and to support staff members who are involved. It is VA policy to notify our patients of their rights under section 1151 of title 38 United States Code and the Federal Tort Claims Act, including information about procedures available to request compensation as well as where and how to obtain assistance in filing claims.
One of my chief priorities is to ensure VA is a learning organization, and I have emphasized the importance of this philosophy to all of our health care employees. If an error or an adverse event occurs, we must determine if this was the result of a lack of training, or some deeper problem. I believe in holding our providers accountable, but accountability can take many forms and needs to be evaluated on a case-by-case basis. Sometimes disciplinary action is warranted, and in a number of situations, we have taken these necessary steps by convening Administrative Investigation Boards (AIB) to determine the proper response which can and has included administrative action. Recommendations from all AIBs are shared and discussed with VHA leadership for awareness and as a learning opportunity to understand how to deal with any potential future adverse event within their facilities.
In terms of notifications, any events that may require large scale patient disclosures must be documented and communicated to VA Central Office. When we learn of a potential adverse event, we convene a fact finding team of subject matter experts from a range of disciplines to assess the situation. At the conclusion of the fact finding review, a Clinical Review Board (CRB) may be convened. The CRB is made up of appropriate representatives from a range of disciplines and include experts on quality and safety, public health, ethics, operations and management, patient care, and VHA leadership. The CRB considers factors such as the population at risk, the potential severity of outcomes, the probability of those outcomes, and other factors relevant to the population at risk. VHA Directive 2008-002 provides specific guidance regarding what adverse events warrant disclosure, when disclosure should occur, and how adverse events should be communicated.
We are also keenly aware of the need to disclose in a manner that does not exacerbate problems and unduly worry our Veterans or their families. We have convened a working group that is developing common guidance and templates for disclosures, and we expect to have results from this group this summer.
Our primary mission at VA is to serve our Nation’s Veterans. In terms of health care, this means providing Veteran-centered care that focuses on improving the lives and well-being of our patients. VA is more transparent and makes available to the public more information about our entire system than any other health care provider in the country. Our initiative in this area earned the Department the Annual Leadership Award from the American College of Medical Quality. We subject our facilities to greater scrutiny through both external commissions and accreditation organizations as well as internal reviews from the facility, network and national level, including from the Office of the Inspector General and GAO. We welcome these assessments because they provide us with learning opportunities that will produce even better health care systems and outcomes. And we welcome Congressional oversight, as we work together to serve our Veterans.
At VA, our fundamental belief is that our health care system is designed to serve Veterans, and that to do so, Veterans must be an equal partner in their health care decisions. For this partnership to work, we must make sure they have access to the data they need to make an informed decision, and that they must trust us to provide them this information. We understand that disclosures can raise concerns among the public, but we believe that Veterans will have greater confidence in a system that errs on the side of providing more information to them, even when their health risk is low.
Thank you for inviting me here to testify today to discuss our efforts in these vital areas. My colleagues and I look forward to any questions you may have, and we welcome this discussion.
 Denise M. Dudzinski, Philip C. Hébert, Mary Beth Foglia, and Thomas H. Gallagher. “The Disclosure Dilemma—Large Scale Adverse Events.” The New England Journal of Medicine. Vol. 363, no. 10. September 2, 2010. P. 978-986, p. 984.
 Thomas M. Burton. “Data Spur Changes in VA Care.” The Wall Street Journal. March 29, 2011. Available online: http://online.wsj.com/article/SB10001424052748703512404576208812390820304.html.
 Rajiv Jain, et al. “Veterans Affairs Initiative to Prevent Methicillin-Resistant Staphylococcus aureus Infections.” The New England Journal of Medicine. Vol. 364, no. 15. April 14, 2011. P. 1419-1430.
 The New York Times. “Hospitals Shouldn’t Make You Sicker.” April 17, 2011. Available online: http://www.nytimes.com/2011/04/18/opinion/18mon3.html.