COLLECTION AND REPORTING OF PATIENT SAFETY DATA WITHIN THE MILITARY HEALTH SYSTEM Report No. D-2001-037 January 29, 2001 Office of the Inspector General Department of Defense Form SF298 Citation Data Report Date Report Type Dates Covered (from... to) ("DD MON YYYY") N/A ("DD MON YYYY") 29Jan2001 Title and Subtitle Contract or Grant Number Collection and Reporting Patient Safety Data Within the Military Health System Program Element Number Authors Project Number Task Number Work Unit Number Performing Organization Name(s) and Address(es) Performing Organization OAIG-AUD (ATTN: AFTS Audit Suggestions) Inspector Number(s) General, Department of Defense 400 Army Navy Drive (Room D-2001-037 801) Arlington, VA 22202-2884 Sponsoring/Monitoring Agency Name(s) and Address(es) Monitoring Agency Acronym Monitoring Agency Report Number(s) Distribution/Availability Statement Approved for public release, distribution unlimited Supplementary Notes Abstract On November 29, 1999, the Institute of Medicine released a report entitled inTo Err is Human, Building a Safer Health System.le The report estimated that as many as 44,000 to 98,000 patients die each year in the United States as a result of medical errors. As a result of the findings in the report, the President issued a memorandum on December 7, 1999, directing the Quality Interagency Coordination Task Force to evaluate the report recommendations. The Assistant Secretary of Defense (Health Affairs) has proposed a centralized, DoD-wide patient safety reporting program to reduce occurrence of medical errors. The program focuses on prevention of medical errors through centralized reporting of patient safety data and sharing the data and lessons learned throughout DoD. The Assistant Secretary of Defense (Health Affairs) requested that we review the proposed patient safety reporting program. Subject Terms Document Classification Classification of SF298 unclassified unclassified Classification of Abstract Limitation of Abstract unclassified unlimited Number of Pages 25 Additional Copies To obtain additional copies of this audit report, visit the Inspector General, DoD, Home Page at www.dodig.osd.mil or contact the Secondary Reports Distribution Unit of the Audit Followup and Technical Support Directorate at (703) 604-8937 (DSN 664-8937) or fax (703) 604-8932. Suggestions for Future Audits To suggest ideas for or to request future audits, contact the Audit Followup and Technical Support Directorate at (703) 604-8940 (DSN 664-8940) or fax (703) 604-8932. Ideas and requests can also be mailed to: OAIG-AUD (ATTN: AFTS Audit Suggestions) Inspector General, Department of Defense 400 Army Navy Drive (Room 801) Arlington, VA 22202-4704 Defense Hotline To report fraud, waste, or abuse, contact the Defense Hotline by calling (800) 424-9098; by sending an electronic message to [email protected]; or by writing to the Defense Hotline, The Pentagon, Washington, DC 20301-1900. The identity of each writer and caller is fully protected. Acronyms AFIP Armed Forces Institute of Pathology IOM Institute of Medicine JCAHO Joint Commission on Accreditation of Healthcare Organizations MHS Military Health System MTF Military Treatment Facility OASD(HA) Office of the Assistant Secretary of Defense (Health Affairs) QuIC Quality Interagency Coordination Task Force VA Department of Veterans Affairs Office of the Inspector General, DoD Report No. D-2001-037 January 29, 2001 (Project No. D2000LF-0195) Collection and Reporting of Patient Safety Data Within the Military Health System Executive Summary Introduction. On November 29, 1999, the Institute of Medicine released a report entitled (cid:147)To Err is Human, Building a Safer Health System.(cid:148) The report estimated that as many as 44,000 to 98,000 patients die each year in the United States as a result of medical errors. As a result of the findings in the report, the President issued a memorandum on December 7, 1999, directing the Quality Interagency Coordination Task Force to evaluate the report recommendations. The Assistant Secretary of Defense (Health Affairs) has proposed a centralized, DoD-wide patient safety reporting program to reduce occurrence of medical errors. The program focuses on prevention of medical errors through centralized reporting of patient safety data and sharing the data and lessons learned throughout DoD. The Assistant Secretary of Defense (Health Affairs) requested that we review the proposed patient safety reporting program. Objectives. Our objective was to evaluate the collection and reporting of quality assurance data within the Military Health System with a focus on the management of events potentially affecting patient safety. We did not evaluate the management controls program because the patient safety reporting program is still in the development phase. Results. Significant effort to collect and report patient safety data is ongoing at the Military Treatment Facility level within the Military Health System. The DoD proposed patient safety reporting program has the potential to improve data consistency and provide a means for sharing the data and lessons learned throughout DoD. To effectively and efficiently implement the proposed patient safety reporting program, an implementation strategy is needed. Without an implementation strategy, the proposed program(cid:146)s potential for improving health care through reduction of medical errors may not be maximized. See the Finding section for a discussion of the audit results. Summary of Recommendations. We recommend the Assistant Secretary of Defense (Health Affairs) develop an implementation strategy for the proposed patient safety reporting program. The implementation strategy should include goals and performance measures, outline a phased approach for reporting adverse events, identify full-time core staffing, require that patient safety personnel successfully complete program training, and use the Department of Veterans Affairs patient safety database software. Management Comments. The Acting Assistant Secretary of Defense (Health Affairs) concurred with the finding and recommendations, stating that an implementation strategy is essential and one will be developed to include our specific recommendations. The strategy will include specific goals and performance measures. The burden of data management will be minimized through streamlined reporting procedures for the low severity adverse events and use of quarterly aggregated reviews for adverse drug events and falls. A management analysis to determine core staffing requirements will be requested. The draft DoD instruction on the Patient Safety Program was revised to include a requirement for patient safety personnel to attend training before participating in the program. The Department of Veterans Affairs patient safety database software is expected to be used beginning in the spring 2001 at the start of the next phase of the program. See the Finding section for a discussion of management comments and the Management Comments section for the complete text of the comments. Audit Response. The Acting Assistant Secretary of Defense (Health Affairs) comments were fully responsive and no additional comments are required. Actions planned to minimize the burden of data management satisfy the intent of the recommendation to implement a phased approach for reporting adverse events. Based on management comments, we deleted the portion of the recommendation to use Department of Veterans Affairs software during the DoD program pilot phase. Throughout the audit we worked closely with the staff in the Office of the Secretary of Defense (Health Affairs), and we commend the staff on their aggressive approach to implementing corrective actions. ii Table of Contents Executive Summary i Introduction Background 1 Objectives 3 Finding Implementing Strategy for Collection and Reporting of Patient Safety Data 4 Appendixes A. Audit Process Scope and Methodology 13 Prior Coverage 14 B. Report Distribution 16 Management Comments Assistant Secretary of Defense (Health Affairs) 17 Background Quality Interagency Coordination Task Force. On March 12, 1998, the Advisory Commission on Consumer Protection and Quality in the Health Care Industry issued a report to the President entitled, (cid:147)Quality First: Better Health Care for all Americans.(cid:148) The report recommends establishing two complementary entities(cid:151)one public and one private(cid:151)to provide ongoing national leadership in health care quality improvement. In response to the recommendation regarding the public entity, the President issued a memorandum on March 13, 1998, which directed the Secretary of Health and Human Services to establish the Quality Interagency Coordination Task Force (QuIC). The President directed the QuIC to ensure better coordination among executive agencies with jurisdiction over health programs. The QuIC is cochaired by the Secretary of Health and Human Services and the Secretary of Labor. The Administrator of the Agency for Healthcare Research and Quality in the Department of Health and Human Services serves as chairman for day-to-day operations. In addition to the Department of Health and Human Services and the Department of Labor, Federal members of the QuIC are the: • Department of Commerce, • Department of Defense, • Department of Veterans Affairs, • Office of Management and Budget, • Office of Personnel Management, • U.S. Coast Guard, • Federal Bureau of Prisons, • Federal Trade Commission, and • National Highway Traffic Safety Administration. Institute of Medicine Report. On November 29, 1999, the Institute of Medicine (IOM)* released a report, (cid:147)To Err is Human, Building a Safer Health System.(cid:148) The report estimated that as many as 44,000 to 98,000 patients in the United States die each year from medical errors. The IOM calculated the estimate by extrapolating the results from two separate studies on patient hospitalizations. One was a 1992 study that reviewed hospitalizations in Colorado and Utah, and the other study reviewed patient admissions from a 1984 New York hospital admissions database. The July 5, 2000, issue of the Journal of the American Medical Association contained two reviews of the IOM *The IOM is an organization that is part of the National Academies. The Federal Government created the National Academies to be advisors on scientific and technological matters. The National Academies are private, non-governmental organizations and do not receive direct Federal appropriations for their work. Studies undertaken for the Government by the National Academies usually are funded by appropriations made available to Federal agencies. 1 report. One review stated the report exaggerated the number of medical errors and the other review stated the report underestimated the number of medical errors. The IOM report provides a strategy for addressing errors that occur in the health system and recommends establishing a national goal to reduce the number of medical errors by 50 percent during the next 5 years. The report outlines a four-tiered approach to reduce medical errors with actions to: • establish a national focus to create leadership, research, tools, and protocols to enhance the knowledge base about safety; • identify and learn from medical errors through both mandatory and voluntary reporting systems; • raise standards and expectations for improvements in safety through the action of oversight organizations, group purchasers, and professional groups; and • implement safe practices at the delivery level. Executive Memorandum. On December 7, 1999, the President directed the QuIC to evaluate the recommendations in the IOM report and provide specific actions that will improve health care outcomes and to prevent medical errors. QuIC Report to the President. The QuIC issued (cid:147)Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact(cid:148) in February 2000. The QuIC agreed with the IOM recommendations and provided the actions that QuIC member agencies will take to address the IOM recommendations. The QuIC report explained that DoD would implement a confidential patient safety reporting system, modeled after a Department of Veterans Affairs (VA) system, in its hospitals and clinics. The proposed reporting system will collect information on adverse events, medication errors, close calls, and other patient safety issues. The intent of the reporting system is to provide health care professionals and facilities with the information necessary to protect patient safety. Other DoD-Wide Patient Safety Initiatives. There are many DoD-wide initiatives that have potential for improving patient safety. For example, DoD is developing a new computerized patient medical record that will include an automated entry order system for pharmaceuticals. The computerized record is being developed to assure that all relevant clinical information on a patient is complete, accurate, and available when and where it is needed. DoD also plans to deploy a pharmacy bar-code system that will scan a patient(cid:146)s military identification card and the medication bar code at the time the medication is delivered. The bar-code system will help ensure that a patient is not given medication intended for someone else and reduce the risk of medication errors. We did not review these initiatives, rather we reviewed the collection and reporting of patient safety data. 2