WILLIAM DUNCAN, MD, PH.D., MACP
ASSOCIATE DEPUTY UNDER SECRETARY FOR HEALTH,
QUALITY AND SAFETY VETERANS HEALTH ADMINISTRATION DEPARTMENT OF VETERANS AFFAIRS
HOUSE COMMITTEE OF VETERANS AFFAIRS
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
June 16, 2009
Good morning, Mr. Chairman and Ranking Member. Thank you for the opportunity to testify about what happened and what has changed regarding endoscopy procedures at the Department of Veterans Affairs (VA). Accompanying me today are Dr. James Bagian, Chief Patient Safety Officer; Nevin Weaver, Veterans Integrated Service Network (VISN) 8 Director; Dr. Joseph Pellecchia, Interim Network Chief Medical Officer and Chief of Staff, Huntington VA Medical Center; Lawrence Biro, VISN 7 Director; Dr. John Vara, Chief of Staff at the Miami VA Medical Center; Juan Morales, Director of the Tennessee Valley Healthcare System; Rebecca Wiley, Director of the Charlie Norwood (Augusta) VA Medical Center; and Mary Berrocal, Director of the Bruce W. Carter VA Medical Center.
My testimony today will provide a brief background on endoscopic devices, explain what happened at four of our facilities, describe changes VA instituted at the local level, report on new national policy, and discuss future actions.
The Department of Veterans Affairs’ number one priority is the well being of our Nation’s Veterans. VA deeply regrets these incidents occurred. We are an organization that is accountable to Veterans.
VHA is committed to being people-centric, results-driven, and forward looking to create an organization that is equipped for the 21st Century. We will use this unfortunate experience to understand how we can transform our Department.
Our Veterans were willing to make the ultimate sacrifice and they deserve the best possible care, at every facility that we operate. We have an obligation to provide them a safe environment in which to get medical care. Veterans and their families need to know when they come to VA they are in good hands and that they are being provided the best care in the country and they need not fear the VA health care system, it is one of the best in the Nation. As this incident shows, however, we must never rest on our laurels, and always remain diligent stewards of leading healthcare initiatives and services.
Secretary Shinseki has made accountability and transparency a top priority for VHA and for the entire Department. It is unacceptable that this has happened and the Secretary has insisted that we take aggressive action to inform, test and support our patients. We are a results driven organization that learns from our mistakes. Everyday we need to push ourselves to better treat, serve and provide for our clients – Veterans.
The Secretary has demanded that we continue to rigorously monitor this situation. Our next step is to utilize the findings of these investigations to implement any necessary corrective actions in a firm, but responsible fashion. We must continue to provide an environment that encourages all disclosures that impact the care and safety of our Veterans.
I hope our testimony today will provide the necessary background information to explain what happened at our facilities, describe changes VA has instituted, report on new national policy, and discuss future actions.
In relation to the inadequate processing of endoscopes, that is, those steps taken to disinfect at a high level endoscopic equipment and prepare it for further use, VA has taken local and national actions to better understand how this could happen and to ensure it does not happen again. We are committed to an open and honest assessment of our policies and procedures. While we do not ever want to worry patients unnecessarily, we believe patients have a right to know about important information that could potentially affect their health. VA’s policy requires disclosure to patients of any adverse events related to their health care that causes or may potentially cause harm. VA has notified patients about even those events that may not be obvious or severe or those that pose only a minimal risk to a patient’s health. The probability that anyone was harmed as a result of our inadequate reprocessing at these four facilities is very low.
Because of the quality and patient safety programs VA has built over the past several years, we discovered the problem, identified the patient population at risk, proactively notified them, and began robust testing, counseling and treatment. The reprocessing issues identified at our facilities were identified and announced by VA, not by an outside group. We have kept Veterans Service Organizations, the media, and Congress informed about this issue.
The disclosures we are making to Veterans are based on the very small potential for harm. At present, there is no definitive evidence to suggest that the positive tests we have found so far are the result of inadequate reprocessing of endoscopy equipment. In this country, many adults who are infected with Human Immunodeficiency Virus (HIV), Hepatitis B and C have not been tested and would not be aware that they are infected. In recent weeks VA has been testing many patients who have never been tested before. As a result, we would expect some of these patients would test positive. No matter how low the likelihood that any disease occurred due to suboptimal scope disinfection, VA will care for patients regardless of the source of infection.
We are aware there were other facilities identified with potential issues, but we determined that the risk of harm to patients at these facilities was so remote that it did not justify informing patients.
Endoscopes are small diameter devices that allow a physician to see internal organs through external orifices by utilizing a system of optics. There are many different types of flexible and rigid endoscopes. The endoscopes discussed below are inserted either through the nose or mouth to visualize the esophagus, nasal passages, lung, stomach and upper part of the small intestine, or they are inserted through the rectum to visualize the colon. Some of these endoscopes used for colonoscopies have an internal tube that allows the physician to inject a stream of water through the endoscope to flush away any material that might obstruct adequate visualization of the colon.
Flexible endoscopes are complex devices that need to be reprocessed before they can be used again safely. Reprocessing procedures are defined by the endoscope manufacturer and generally involve careful cleaning of the entire external and internal surfaces with an appropriate cleaner, brushing any interior channels, and subjecting the entire scope to high level disinfection or sterilization as recommended in the manufacturer's instructions.
Discovering the Problems
On Monday, December 1, 2008, at the Tennessee Valley Health Care System, Alvin C. York (Murfreesboro) VA Medical Center (VAMC) in Tennessee, VA staff observed during the third endoscopic colonoscopy of the day a discoloration in the tubing that supplies water to flush the colonoscope. They immediately realized that this presented a potential problem to the patient and investigated further. Over the next two days, staff determined they were not using a water irrigation tube with a check valve designed to prevent contaminated fluid from the patient from flowing back into the scope and irrigation water tubing. As they investigated further, the staff discovered the Auxiliary Water Tube (MAJ-855) had been altered with a different connector that was not a one-way valve. In the process of examining the procedures for the use and reprocessing of the colonoscope, the Murfreesboro staff discovered that they were not changing and reprocessing the MAJ-855 in accordance with the manufacturer's instructions.
The Murfreesboro staff reported these problems to the facility Patient Safety staff on December 4, 2008, and the next day, to VA's National Center for Patient Safety (NCPS). NCPS conducted fact finding by evaluating the equipment and procedures used at Murfreesboro and by closely working with the endoscope manufacturer.
Based on this work, a Patient Safety Alert (AL09-07) was issued to the entire VA system on December 22, 2008. This alert requested that all facilities determine they were using the correct valve and also stressed that the manufacturers' instructions for all endoscopes were to be exactly followed regardless of the brand. All facilities were directed to determine if manufacturers' instructions were followed in the use or reprocessing of flexible endoscope tubing and accessories and to report any deviations to VA Central Office by January 7, 2009. As a result of this alert, in early January 2009, 16 additional facilities reported they had in some way not reprocessed their endoscope water flushing systems in accordance with the manufacturers' instructions.
It must be emphasized that failure to follow a manufacturer's instructions does not necessarily result in significant additional risk of cross contamination because the equipment is designed to have redundant safety features. With this in mind, NCPS contacted the manufacturer, which conducted tests to clarify what additional clinical risk might accrue from the failure to follow its instructions. As a result of these clinical and lab based tests, the VHA Clinical Risk Assessment Advisory Board (CRAAB) determined there was no appreciable additional risk of cross-contamination if the only practice was incorrect reprocessing of the MAJ-855 between patients. This determination was made on February 6, 2009, following receipt of results of the manufacturer’s clinical tests. The CRAAB is a multidisciplinary committee that makes recommendations to the Principal Deputy Under Secretary for Health (PDUSH) as to clinical risk and whether large scale notifications (disclosure) should be made to Veterans.
The CRAAB concluded there was a very small risk of cross-contamination if the MAJ-855 was not reprocessed between patients and either (1) the proper check valve was not attached to the MAJ-855; or (2) the clinician did not prime the MAJ-855 with water prior to initiating the examination. Following the February 6, 2009 meeting, the CRAAB, therefore, recommended disclosure only where either of these two circumstances existed in addition to improper reprocessing of the MAJ-855. Of the 17 VAMCs reporting noncompliance with manufacturers' instructions, these circumstances existed only at Murfreesboro and thus, the CRAAB only recommended disclosure to patients at this facility.
VA has a formal process to evaluate clinical risks to patients when a risk, and hence the need for disclosure, is not clear. The CRAAB weighs the nature of the harm, the probability, severity, magnitude and duration of the harm, and courses of action, and balances these factors against the potential medical, social, psychological or economic benefits or burdens to Veterans resulting from the disclosure itself.
On January 26, 2009, the Augusta VAMC informed VA Central Office of a problem it discovered with reprocessing of their Ear, Nose and Throat (ENT) scopes. These scopes are different from the colonoscopes used at Murfreesboro. As a result of a personnel change in January 2008, ENT scopes were not reprocessed in accordance with the manufacturer's instructions. After reviewing the circumstances, the PDUSH decided that potentially exposed patients should be informed.
To ensure all Veterans Health Administration (VHA) facilities were reprocessing endoscopic medical equipment correctly, on January 28, 2009, the Deputy Under Secretary for Health for Operations and Management issued a memorandum requiring all VA medical centers performing any endoscopic procedures to conduct a review of the set up and reprocessing of these devices. On February 9, 2009, the Under Secretary for Health instructed all medical centers to conduct a safety Step-Up Week during March 9 through 13, 2009, to focus facilities on retraining staff on the proper use of all endoscopy equipment, establishing easily tracked accountability chains for instrument cleaning, and training all appropriate staff about standard operating procedures.
On February 24, 2009, Mountain Home VAMC reported that ENT endoscopes were not reprocessed in accordance with manufacturer’s instructions. On February 27, 2009, after reviewing the facts with the facility and a group of experts, the PDUSH decided that disclosure to patients was required. The facility notified its local congressional delegation, local Veterans Service Organizations, and Veterans at potential risk.
On March 4, 2009, in preparation for the Step-Up Week, staff at the Miami VA Medical Center discovered they had erroneously reported in January they were in compliance with the manufacturer’s instructions. Miami staff found that the water irrigation tubing was not correctly reprocessed and that it was not consistently primed and flushed prior to the start of the patient examination. While either one of these omissions by themselves would not have resulted in increased risk to patients, both practices together created a slightly increased potential for cross contamination between patients. The CRAAB recommended disclosure to affected Veterans, and the PDUSH agreed.
The official policy of the Veterans Health Administration is that "VHA facilities and individual VHA providers have an ethical and legal obligation to disclose to patients adverse events that have been sustained in the course of their care, including cases where the adverse event may not be obvious or severe, or where the harm may only be evident in the future."
As a result of increased scrutiny of the reprocessing of medical equipment within VHA, ten VA medical centers, in addition to the 17 originally identified, have found reprocessing practices that were not in compliance with manufacturer's instructions. Each facility where we found a problem, we evaluated the situation to determine if notification was required.
Each of the four medical centers mentioned above took prompt action to notify possibly affected Veterans; to offer testing, counseling and needed treatment; and to identify and implement necessary procedural changes to ensure the issues would not develop again. Other changes varied among medical centers and are discussed below. Specifically, each VAMC:
- Identified Veterans who received endoscopic colonoscopies or esophageal studies during the applicable date range and sent them letters by regular or certified mail, return receipt requested. The letters informed the Veteran they were potentially at risk and offered testing for Hepatitis B, C, and HIV infection. Hepatitis B, C and HIV were identified as the significant viral conditions which have the potential to be transmitted via endoscopic cross-contamination. The letter provided a toll-free telephone number to call to answer questions or schedule testing.
- Established and staffed call centers to respond to questions from Veterans.
- Established systems to track Veterans who were notified and tested.
- Established clinics to provide, on a priority basis, testing and treatment as appropriate.
- Instituted changes in staffing and processes as necessary to ensure endoscopic equipment would be properly reprocessed according to manufacturer's instructions.
At the Murfreesboro campus, staff identified 6,805 Veterans in initial reports as having received colonoscopies between April 2003, when VA first began using the affected equipment, and December 2008, when VA discovered the issue. After conducting an intensive medical record review to ensure all potentially affected Veterans were identified, VA added 418 patients to the list for notification. VA completed certified mailings to the first group by February 13, 2009, while the second group was notified by certified letters sent May 8, 2009. Murfreesboro VAMC continues to search for Veterans whose letters have been returned. The staff is using additional databases and general internet searches. VA is closely monitoring the results of this outreach, and the records will continue to be updated. My oral statement will include the most current information. As part of its participation in the national Step-Up week in March 2009, the Murfreesboro VAMC conducted an intensive review of the procedures for reprocessing of all reusable medical equipment (RME), ensuring they complied with manufacturers' reprocessing instructions. It also conducted a Root Cause Analysis to identify and understand all components of this issue, validated standard operating procedures (SOPs), confirmed training of all clinical and support staff, and verified staff competencies.
At the Mountain Home VAMC, staff identified 297 Veterans as possibly affected by improper endoscope reprocessing that was not in strict compliance with the manufacturers’ instructions. All laryngoscopes are now reprocessed by the facility's Supply, Processing and Distribution (SPD) program. The facility has updated policies to require better coordination among departments when RME is purchased and SOPs are written. All staff members responsible for handling RME are trained and certified. Training is noted in each competency checklist prior to actual operations. Supervisors are responsible for maintaining competency checklists and periodically validating adherence to standards. All facility SOPs are aligned with the manufacturers' written instructions.
At the Augusta VAMC, staff identified 1,069 Veterans who received ENT procedures between January and November 2008. VA completed an initial mailing of letters to these Veterans by February 10, 2009. Additionally, VA released public service announcements with the help of local media to further increase awareness among Veterans and family members. VA staff called Veterans who had not contacted the VAMC in response to the initial mailing. At the end of March 2009, VA sent 137 certified letters to patients who still had not made contact in response to the initial mailing or who could not be reached by phone. Of those letters, 128 were successfully delivered, one was declined, and six were returned. Of the six returned letters, one was identified as not deliverable because the patient was deceased. As of May 29, 2009, all but five of the 1,069 patients in the risk pool have received mail notification, and we are continuing to attempt to locate these five patients.
Augusta VAMC also conducted a Root Cause Analysis and, based on its findings, took the following steps to improve medical equipment reprocessing. First, reprocessing of RME was consolidated into the SPD function. Construction also began on a new SPD station near the gastrointestinal endoscopy suite. A multidisciplinary task force ensured the ready availability of manufacturers' instructions for reprocessing and that SOP and staff competency checklists matched those instructions, revising where needed. VA re-trained all staff involved in RME reprocessing and evaluated them using competency checklists. Finally, the facility also increased use of the SPD Observational Assessment Tool from once per year, as nationally required, to once a month to ensure continued compliance with all requirements.
At Miami VAMC, VA identified a total of 2,609 Veterans through medical record searches and reviews as having been possibly at risk for cross contamination. VA began mailing notifications to all affected Veterans March 23, 2009. After checking other databases for address updates or changes, the facility sent a second certified mailing to Veterans whose first letters were returned as undeliverable. Miami has a particularly mobile population, so the facility undertook additional efforts to locate Veterans who could not be notified by mail. These measures included searches for alternate addresses on other VA databases and commercial websites and multiple visits to homeless shelters in the Miami area. The facility continues to attempt to locate and notify remaining potentially affected Veterans.
Miami also reorganized its SPD program and realigned executive leadership and line managers to make them accountable for reprocessing activities. The facility added a Clinical Nurse Specialist to enhance clinical knowledge in the line management function. They also reviewed and revised competency definitions for all employees assigned to the gastrointestinal clinic or to SPD to address proper equipment handling, maintenance, use, and cleaning. VA conducted extensive training for gastrointestinal technicians and nurses in proper equipment set-up and pre-cleaning practices. Some of this training was done by manufacturers' representatives, while some was done by sending staff to other VA medical centers. Facility leadership verified the competencies of all SPD staff responsible for endoscope cleaning by April 7, 2009. Beyond this, the facility established a continuing education plan, including professional certification activities. By enhancing quality management committees and establishing a VISN-level team responsible for conducting unannounced inspections, VA continues to exercise effective oversight of facilities and to preserve patient safety.VA's National Response
VA has taken a number of steps nationally to identify and correct shortfalls with the proper set up, use, reprocessing, and maintenance of reusable endoscopy equipment at all other VA medical facilities.
The Safety Step-Up Week and the series of communications to the field (including memos, the patient safety alert, and reminders on national calls and at national meetings) alerted all facilities about potential problems with endoscope processing and training. Facilities have been given an opportunity during national calls to inform other facility leaders about what they have learned concerning the discovery of problems, patient disclosures, or best practices.
VHA developed, published and implemented a national directive (Veterans Health Administration Directive 2009-004, dated February 9, 2009, "Use and Reprocessing of Reusable Medical Equipment (RME) in Veterans Health Administration Facilities"). Cornerstones of the directive are:
- Assigning responsibilities, especially at the front line level with Network and Facility Directors, but also with key staff within each medical facility;
- Requiring oversight programs be established, including unannounced site audits and quality assurance processes;
- Requiring through policy that manufacturers’ instructions for the use, reprocessing, and maintenance of RME must be obtained and followed. These instructions must be used to develop local standard operating procedures and have them available for use by staff; and
- Requiring staff training and assessing staff competency to ensure manufacturers’ instructions are being followed correctly.
VA's national SPD program has developed several training courses to increase the professionalism and education of field SPD employees. For example, VHA has developed a five-day course, which includes a National SPD Certification Test, for new SPD staff, particularly front-line technicians. SPD Chiefs, Assistants and Supervisors can take a three-day seminar, and managers who supervise Chiefs of SPD can take a different three-day class. A new three-day class is available for new SPD Chiefs and Assistant Chiefs. The VHA National Infectious Diseases Program and Employee Education System have produced one educational video for reprocessing endoscopes, distributed it to medical facilities and is completing the production of another video.
Oversight of SPD is accomplished by both internal and external mechanisms. First, a National SPD Self-Evaluation involves each facility analyzing its SPD-related activities twice a year. A facility's performance is judged in part on the results of this evaluation. Second, the National SPD Quality Management Observational Assessment Tool (SPD Tool) was conducted in fiscal years (FY) 2007 and 2008 and is being repeated this fiscal year. VA distributed the SPD Tool to VISNs and facilities in May for completion. The SPD Tool requires a four-person team at each medical facility to directly observe staff members reprocessing cytoscopes, colonoscopes, bronchoscopes, and upper GI endoscopes. Low outliers identified by this SPD Tool are scheduled for special site visits. One of the recommendations of the FY 2008 SPD Tool was to establish and fill Assistant Chief of SPD positions at all Complexity Level 1 facilities.1
All Complexity Level 1 and 2 facilities have been directed to establish these positions, and facilities are working to establish and fill them. These positions will assist with the oversight of reprocessing activities that occur both inside and outside of SPD. Finally, the National SPD Site Review Program also sends a site review team each year to one-third of VHA facilities. Areas reviewed by the site review team include the SPD department and areas outside SPD where medical equipment reprocessing occurs.Future Actions
VA has several initiatives underway to improve SPD and ensure it becomes a high reliability production environment. We are working to make SPD compliant with International Organization for Standardization (ISO) 9001, which is widely considered to be the standard for quality management systems. In addition, a workgroup continues to investigate ways to standardize the brands and models of endoscopes used in a particular facility, which will simplify reprocessing protocols and training needs. The workgroup is also evaluating leasing options that will provide repair, maintenance and training services. VA has issued a request for information (RFI) for a software solution for SOP management that can also be used for competency verification and document control. VA expects such software will facilitate automatically transmitting any changes to the manufacturers' instructions to users and verifying receipt of these changes. We are also developing a new directive that will align SPD at each medical center under the facility Chief of Staff. Standardizing organizational alignment will simplify communication lines from VA Central Office to the field and vice versa. It will also enhance clear lines of authority and responsibility for the SPD function.
To better understand any possible connection between newly discovered chronic blood borne infections and reports of possible improper reprocessing of endoscopy equipment, VA has assembled a team of subject matter experts to conduct a detailed epidemiologic investigation, starting with an extensive review of electronic medical records. The review encompasses all recent and prior testing for HIV, Hepatitis B, and Hepatitis C, as well as other relevant laboratory test results (e.g. liver function tests); medical histories and risk factors for each of the three viral infections; and details of the actual procedures. The team will also review the sequence of patients receiving endoscopic exams, to assess whether a Veteran previously diagnosed with one of the three viruses preceded a newly-diagnosed Veteran on a daily examination schedule. It is very important to note that, even when completed, this study will not be able to demonstrate causality. However, it will be able to answer the following questions:
- Have all positive test results for HIV, Hepatitis B and C been confirmed? Are there any false positives?
- Is there evidence that any Veteran with a positive post-endoscope test was infected prior to their endoscopic procedure, but never diagnosed?
- Can we identify whether a patient who was previously diagnosed with HIV or Hepatitis had an endoscope procedure the same day as a Veteran who is now newly diagnosed with these viruses?
It is expected that the first phase of this investigation will take several weeks, to permit review of relevant charts and completion of any additional blood work. We will share the results with the Committee when it is available. Additional analyses will need to be performed after the remaining patients exposed have been tested.
Very limited information exists in the medical literature that could elaborate or quantify the known risks associated with reprocessing of endoscopy equipment. One long-term review (1970 through 2003) examined health care associated infections related to gastrointestinal endoscopy and found 281 transmitted infections.2
Major reasons for endoscope-related infections from this study were inadequate cleaning, improper selection of a disinfecting agent, failure to follow recommended cleaning and disinfection procedures, and flaws in endoscope design or automated endoscope reprocessors. Failure to follow established reprocessing guidelines has continued to result in infections associated with gastrointestinal endoscopes.3
Flexible endoscopes are particularly difficult to disinfect and easy to damage because of their intricate design and delicate materials. Meticulous cleaning must precede any sterilization or high level disinfections of these instruments. Failure to perform thorough cleaning can result in sterilization or disinfection failure, and outbreaks of infection can occur.4
Because of the large variety of types and models of endoscopic equipment, a single, standard process for reprocessing all reusable endoscope equipment does not exist. This equipment is also constantly being updated, improved, and changed. Our responsibility for effective maintenance and disinfection is further complicated by the growing plethora of equipment, as each type of equipment or each piece and component requires unique reprocessing techniques. The leasing option described above is one approach to improving SPD and should help address this concern.
A recent article summarized the information available in the scientific literature about endoscopy-related exogenous infections (an infection having a cause from outside the body) or pseudo-infections (where patients may have a positive test result but do not develop clinical symptoms). The article identified 140 outbreaks during the period 1974 through 2004, roughly half of which occurred in the United States and half elsewhere.5
Overall, the risk of infection due to inadequate endoscope reprocessing is reported as very low.6Conclusion
In conclusion, I would like to say that I know we have not answered all your questions, but we have come here today to be open, honest and to report on an issue of grave importance to us. Although the risk of cross contamination and exposure to infections is exceptionally low, we are notifying all potentially affected Veterans and treating those testing positive regardless of cause.
When we identified a problem related to the reprocessing of endoscopy equipment, we took aggressive actions and voluntarily disclosed the information. From the start, our intention has been to do what is best for the Veterans. We know that we have made a mistake and necessary corrective actions will be taken.
VHA is committed to being a Veteran-centric organization that continues to improve the services we provide the men and woman who have sacrificed for our country. Our sole purpose is to make sure that we put Veterans and their care first.
We are proud of the fact that VA health care is widely regarded as among the best in the country, but we know that we are not perfect and have many things we can improve.
By the end of fiscal year 2008, more than 7.8 million Veterans were enrolled for care and almost 5.6 million of them were receiving care. VA provided more than 67 million outpatient visits last fiscal year alone. Our aim is to ensure every encounter is a positive and safe one for our patients. It is our duty and honor to serve America’s Veterans and provide them the highest quality health care.
Thank you again for the opportunity to testify. My colleagues and I are prepared to answer your questions.
1 There are five levels of Complexity: 1a, 1b, 1c, 2 and 3, in descending order of complexity. VA determines facility complexity based upon a formula that considers the patient population, the patient risk, the level of intensive care unit and complex clinical programs, as well as education and research indices.
2 Seoane-Vazquez E. et al. (2007). Endoscopy-related infections and toxic reactions: an international comparison. Endoscopy 39(8): 742-78.
3 See ibid.
4 See Seoane-Vazquez E., Rodriguez-Monguio R. (2008). Endoscopy-related infection: relic of the past?. Curr Opin Infect Dis; 21(4): 362-6. 9
5 See ibid.
6 See nn 2, 4, ibid; also Schembre D.B. (2000) Infectious Complications Associated with Gastrointestinal Endoscopy. Gastrointestinal Endoscopy Clinics of North America; 10(2) 215-231.