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:
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Reviewed/Updated Date: November 10, 2009