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STATEMENT OF DR. JOHN H. MATHER
ASSISTANT INSPECTOR GENERAL
DEPARTMENT OF VETERANS AFFAIRS
BEFORE THE SUBCOMMITTEE ON HEALTH,
COMMITTEE ON VETERANS' AFFAIRS,
UNITED STATES HOUSE OF REPRESENTATIVES
OVERSIGHT HEARING ON
THE VETERANS HEALTH ADMINISTRATION'S
RISK MANAGEMENT PROGRAM AND
ITS OFFICE OF MEDICAL INSPECTOR
October 8, 1997
Mr. Chairman and Members of the Subcommittee, I appreciate the opportunity to appear today to discuss the Veterans Health Administration's policy and performance in the area of risk management, and the mission, role, and organizational structure of its Office of Medical Inspector (OMI), as it relates to both risk management and the OMI's other responsibilities.
1. Office of Inspector General (OIG) Role
The Office of Inspector General (OIG) has a mandate to provide independent oversight of the Department of Veterans Affairs. The OIG is accountable to both Congress and the Department in carrying out its mission to promote economy, efficiency, and effectiveness in VA operations; to detect and prevent fraud, waste, and abuse in VA programs; and to monitor VA's medical quality-assurance programs. In carrying out its mission, one of the OIG's primary goals is to help management succeed in its effort to reinvent government; that is, to build a government that works better and costs less for the benefit of today's and tomorrow's veterans and taxpayers. This goal speaks to the very essence of the OIG mission--and unites us with Department management and Congress as we strive together to ensure that quality services are delivered to veterans in a cost effective, efficient, and timely manner.
2. OIG Monitoring of Quality Assurance
In the mid-1980s, a perception developed that, at least in the area of having proficiency in the formal implementation of the healthcare quality assurance (QA) process, VA was lagging. The General Accounting Office (GAO) reported, "VA Has Not Fully Implemented Its Health Care Quality Assurance Systems, " in June 1985, followed immediately by a U.S. House of Representatives report entitled "Patients At Risk: A Study Of Deficiencies In the Veterans Administration Medical Quality Assurance Program" Both reports were very critical of VA's formal QA programs and processes.
The GAO similarly criticized the VA Central Office's Office of the Medical Inspector (OMI) established to oversee quasi-legal and quasi-medical aspects of VA, mainly VA's patient injury control program, patient abuse, and practitioner licensing sanctions. VA's Medical Inspector office, which had been established within the Veterans Health Administration (VHA) in response to an apparent lack of effective central oversight and medical investigator capacity, was felt to require substantial revision in the GAO report, "VA's Patient Injury Control Program Not Effective."
It is consistent with the broad charter of VA's IG--mainly the obligation to monitor the economy, efficiency, and effectiveness of the Department's programs and activities--to oversee VA healthcare and QA activities. Nonetheless, after substantial debate, Congress decided to provide emphasis in this area for VA's IG.
The first specific attempt at such a focus through the OIG was in Public Law 99-166, "The Veterans' Administration Health-Care Amendments of 1985," which mandated that "The Inspector General of the Veterans' Administration shall allocate sufficient resources including sufficient personnel with the necessary skills and qualifications to enable the Inspector General to monitor the [healthcare] quality assurance program." Eventually the Congress was to extend this legislation and, in the "Veterans Benefits and Services Act of 1988", Public Law 100-322. It was more fully elaborated that VA should "upgrade and expand the activities of the Veterans' Administration's Office of Inspector General in overseeing, monitoring, and evaluating the operations of the Department of Medicine and Surgery's [VHA's] quality-assurance programs and activities and its Medical Inspector office so as to provide the Chief Medical Director [Under Secretary for Health], the Administrator [Secretary], and the Congress with clear and objective assessments of the effectiveness of those programs and operations, including ensuring such numbers of, and such skills and training on the part of, employees assigned to the Office of Inspector General as are necessary to carry out such oversight, monitoring, and evaluation effectively."
3. OIG Organizational Focus: Office of Healthcare Inspections
In 1988, VA's IG established a support Division within its Policy, Planning, and Resources Office known as the Quality Assurance Review Division (QARD). This Division was staffed in 1989. In 1991, coincident with the continuing and, indeed, increasing prominence of QA and oversight of health care systems, the QARD was upgraded to a full VA OIG "office," co-equal organizationally with its Office of Audit and Office of Investigations. This Office is named the Office of Healthcare Inspections (OHI).
The OHI fulfills for the IG the primary focus for general oversight and monitoring of VHA's quality-assurance activities and programs, and oversight of the VHA's OMI. These broad responsibilities are ongoing and become most specific as regards program evaluations, Hotline inspections, and the development of a new Quality Program Assistance (QPA) review.
a. General Oversight
i. Oversight of VA's QA Programs
Oversight of VA's QA programs at all levels, particularly its VACO/VHA Quality Assurance Office (now named, Office of Performance and Quality) was specifically mandated by Congress. OHI attempts to meet this mandate in two general ways. In individual case reviews, a facility's QA programs are routinely assessed, and generally commented upon in conjunction with OHI hotline inspections. Second, OHI understands that VACO/VHA coordinates several nationwide QA programs. These include its "Occurrence Screening Program," "The Patient Incident Reporting System," "Tort Claims Analysis," "Patient Satisfaction Survey Program, " "Utilization Management Program," "Cardiac Surgery Review Program," and the "External Peer Review Program."
OHI, in its oversight capacity has reviewed the strengths and weaknesses of many of these programs, such as the "Evaluation of the Veterans Health Administration's Patient Satisfaction Survey Program." This was followed by an "Evaluation of the Veterans Health Administration's Quality Improvement Checklist (QUIC) Program," and "Evaluation Of The Patient Representative Program." Its most recent report of
a VACO/VHA directed QA program is a review of the "External Peer Review Program."
Earlier this year, OHI initiated an evaluation of VHA's quality assurance program at the request of the Senate Veterans' Affairs Committee (SVAC). This review will encompass and conduct:
- A comprehensive evaluation of the VHA's current QA activities, including those at the VACO level the VISN level, and the local VA medical center (VAMC) level.
- Identifying specific guidance provided to field facilities about QA matters,
- Identifying the number of personnel who are assigned QA responsibilities on a full or part-time basis, and determine if they have the resources, authority, and access to ensure veterans receive quality care.
OHI is in the midst of this review which will include a review of VHA's risk management program. It is anticipated that this will be completed early in 1998.
ii.Oversight of the Office of Medical Inspector
VHA's Office of Medical Inspector (OMI) was established in 1980. This office serves as an internal medicolegal oversight office for VHA, and in some sense might be considered a precursor to OHI. However, it is distinguished from the OIG's OHI, in that OMI is internal to VHA. OHI, being an OIG component, is external to the VHA. This distinction, which, unfortunately, has been a repeated cause of confusion, even to those familiar with VA, might be further explained by the analogy that the OMI serves as an internal overseer and "troubleshooter" for VHA and reports to the Under Secretary for Health (USH): while OHI is an external overseer of health care activities, reporting, through the Inspector General, to the Department's Secretary and Congress. These different reporting relationships provide the OHI with the assurance of an independence of its investigations that the OMI cannot always have. VHA's current operating philosophy is that the USH should have the opportunity to have available internal oversight mechanisms as a "troubleshooter" including an office configured as OMI, for a health care system the size of VHA.
The above notwithstanding, Public Law 100-322 provides OIG with a specific directive to oversee the OMI. This task has been approached in several ways. Initially, case reviews conducted by OMI are reviewed by OHI prior to final closure. In so reviewing the OMI's work, and having the imprimatur of final closure, both the quality and rigor of that Office's case reviews could be assessed, and hence the OMI overseen. Likewise, this means of oversight provided OHI with a sense of the issues and controversies current within VHA. Second, as OHI evolved, the approach of publishing a detailed summary report on the activities, needs, strengths, and weaknesses of OMI was added to OHI's oversight efforts of OMI, and this is discussed later.
b. Specific Oversight
i. Program Evaluations
More under the auspices of the IG Act than under Public Law 100-322 which focuses specifically on VA's quality assurance programs, review of VHA clinical programs other than strictly its QA programs, has been a continuing OHI activity. At the forefront of such program reviews are current critical issues in veterans health care. These include the Department's response to veterans who become ill after service in the Persian Gulf, provision of health care to an ever increasing number of female veterans in a healthcare system largely designed to serve male veterans, and a review of VA's handling of the new, but extremely expensive and, toxic, high surveillance anti-schizophrenic drug clozapine. In addition to the topics receiving medical and public attention, there are ongoing issues in veterans health care for which VA has developed programs, and which OHI inspected. These include VA's programs addressing such issues as homelessness, domiciliary care, ambulatory care, Advance Directives and the impact of downsizing substance abuse rehabilitation programs. It is anticipated that such programmatic reviews will continue, these being perennial health care issues which require oversight, and which are integral to a large health care system.
ii. Hotline Inspections
To fulfill the OIG organizational charge of identifying waste, fraud, and abuse in the agency, VA's OIG, like most Federal OIGs, maintains a "hotline." This "hotline" is an "800 number," and an address which is prominently displayed in VA facilities (medical and non-medical), and listed in local telephone directories and more recently can be accessed on the OIG Internet. On the order of 20,000 hotline contacts yearly are made to VA's OIG. A large portion of these contacts are clinical or QA related and hence OHI has found itself involved in numerous hotline cases. Additionally, Congressional constituent referrals, White House case referrals, and cases prominently highlighted in the media are often assigned hotline status. While the majority of these cases must be referred to VHA for primary review, many are referred to OMI--thus reinforcing the need for OHI oversight of VHA. However, as a means of independent verification of VHA's work, and due to its status as a clinical oversight body independent of VHA, OHI also independently inspects approximately 100 hotline cases yearly. Most of OHI's hotline cases have very high profiles. Through OHI's performance of hotline reviews, oversight data is obtained in the form of independent verification of the quality and rigor of VHA's review of such cases. These inspections often give some insight into the effectiveness of a VAMC's risk management program. OHI is currently conducting a review of all hotline cases for Fiscal Years 1993 through 1995 from which it is expected that some profiles and patterns will emerge.
Also, OHI provides technical assistance to OIG's audit and criminal investigative branches. OHI provides technical assistance in clinical fields such as medicine, nursing, social work, respiratory therapy, nutrition, and clinical pharmacy to auditors and investigators not trained in those areas. OHI technical assistance has led, on occasion, to identification of clinical, i.e., non-audit and non-criminal, quality assurance issues, which may then be reported under OHI cover.
iii. Quality Program Assistance (QPA) Review
It has become apparent that OHI should "inspect" VHA's hospital facilities and inspect individual VAMC's QA programs, on-site, without the crisis atmosphere or adversarial nature that may accompany a hotline inspection. To meet this need, OHI is pioneering a system of proactive review.
OHI hopes to develop and implement a program of comprehensive medical center reviews which includes an assessment of the medical care and provides VHA managers with independent, objective findings which will assist them in improving the efficiency and effectiveness of their operations. The principles guiding the QPA program development are: healthcare remains, at its core, the interaction of professionals (providers) with clients (patients); the program should focus on broad general indicators of healthcare quality; inspections should be direct and consider historic data only secondarily; the process should not be duplicative of other internal or external review programs; the inspections should be undertaken by generalist healthcare inspectors; the process should use standard instruments, which might eventually allow results to be compared from center-to-center; and the process should be cost effective.
The program of QPA reviews was begun in early 1995 and after an initial pilot, six facilities were visited to further refine the process through late 1996. After a careful review of the experience gained from those early endeavors, a final prototype was devised with the advice of some VISN clinical managers, and was tested at six VAMCs at the end of fiscal year 1997. If, after a final thorough evaluation, it is concluded that this is a "value added" process, then it is projected that the QPA reviews will become fully operational in 1998.
4. OHI/OIG Oversight of VHA's Risk Management Policy
The general purpose of a risk management policy in healthcare facilities and healthcare systems is to have program and operational requirements, which have a fundamental orientation towards prevention of errors in the provision of personal medical services. Hence it is expected that an effective risk management program will:
- Minimize the likelihood of adverse events (risk) to patients, personnel and visitors;
- Protect resources and prevent loss by accurately identifying, reporting, trending, reviewing, and correcting problems leading to incidents, through risk identification and analysis, and systems improvements;
- Encourage healthcare facilities to view risk management as an overall activity which includes both clinical and administrative services; and
- Ensure that healthcare facilities, within a healthcare system, share information on adverse events which contributes to the systematic identification and assessment of their potentially harmful impacts.
- Both the VHA and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) identify risk management as an integral part of quality improvement activities. VHA has been active in risk management for many years. Two of VHA's many risk management programs are the Occurrence Screening Program (OS) and Patient Incident Reporting (PIR) Program.
- In May 1987, the GAO recommended that VAMCs be required to implement occurrence screening (see footnote 3). This interest resulted in legislation enacted in May 1988, Public Law 100-322, Section 201. Along with expanding and assigning higher priority and greater resources to quality-assurance programs and activities at each medical center, this law required the implementation of the review known as "occurrence screening" throughout all VAMCs. Patients' medical records are reviewed, with the maximum use of the facility's computerized management information system, for adverse events, which may not be the natural or expected consequence of the patient's disease, injury, or treatment. The OS Program was based on a 1977 California Medical Insurance Feasibility Study, which reported that almost 5 percent of hospital admissions were associated with an adverse event that was potentially compensable. In the OS Program, cases are screened against a predetermined list of criteria. Those cases, which involve one or more of the occurrences, are reviewed to identify possible problems in patient care. The PIR Program has long existed in all VA medical centers and in 1974 it became one of the initial programs included under the QA umbrella. The goal of the PIR Program is to identify opportunities for improvement in patient care by monitoring, reporting, analyzing, reviewing, and investigating (if necessary) any unusual, unexpected or unfavorable incident involving a patient during the course of the patient's medical management.
Section 204(a) of Public Law 99-166, passed in 1985, and codified in Title 38 United States Code (U.S.C.) 7311, required VA to establish a comprehensive Quality Assurance Program, of which PIR was a part. In early 1980, VA transferred the program to the Office of Medical Inspector. Then in 1991, the program was transferred to the Office of the Associate Chief Medical Director for Quality Management, now the Office of Performance and Quality.
Both the OS and PIR Programs are automated and operate in the VA's Decentralized Hospital Computer Programs (DHCP). This allows VA to identify opportunities for improvements through local data analysis and the potential national roll-up of information relevant to the VHA healthcare system as a whole.
The VHA guidance on its Risk Management program has, during the last 5 years, changed four times, with the issuance most recently of the Risk Management Directive VHA Directive 105, September 25, 1997, and its accompanying Handbook. Prior to the issuance of this Directive, the most specific general guidance had been contained in VA Manual M-2, Part I, Chapter 35, "Integrated Risk Management Program" (IRMP), issued April 7, 1995. This was replaced with the VHA Directive 97-029, "Risk Management," June 6, 1997. The IRMP, April 7, 1995, had replaced the previous Chapter 35, August 7, 1992, with rescission of several other Directives. VHA guidance in each of these policy revisions has varied considerably in the scope, specificity and assignment of responsibilities at each managerial level in VHA: the VAMC, VISN and VACO.
5. VHA's Risk Management Directives
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The present Risk Management Directive, VHA Directive 105, September 25, 1997, and its accompanying Handbook (hereafter referred to as the RM Directive) contains guidance which satisfactorily addresses several issues that have been of great concern to the OIG. Further this RM Directive encompasses features that make it a much more definitive and comprehensive document than has been heretofore available in VHA. If fully and consistently implemented it has the potential for becoming an effective risk management policy
The issues, until the publication of this RM Directive, that have been outstanding for OHI/OIG are:
a. Recommendations made in OHI program reviews agreed to by VHA, which had not been incorporated into the prior risk management guidance.
b. Understandings reached with VHA concerning the tracking and trending of mortality data to identify unusual and unanticipated deaths.
- c. Ensuring that the guidance to VAMCs, VISNs, and VACO will result in continuing improvements in quality.
The following discussion expands on these three areas:
a. Incorporation of OHI/OIG recommendations.
Three OHI program reviews had made specific recommendations related to VHA's Risk Management Directive:
i. "Oversight Inspection of the Veterans Health Administration's Office of Medical Inspector, Fiscal Year 1994" (Report No. 5HI-A28-039). - Recommendation 1b - Delete the paragraph in the M-2, Part I, Chapter 35 revision draft that deletes OMI's review of VAMC's Boards of Investigation.
This recommendation was implemented through the VHA Directive 97-029 "Risk Management," June 6, 1997. The role for the OMI has been further extended and clarified in the most recent RM Directive.
ii. "Evaluation of VHA's Policies and Practices for Managing Violent or Potentially Violent Psychiatric Patients" (Report no. 6HI-A28-038). - Recommendation 1a.The Under Secretary for Health should ensure that:
1a. All patient-on-patient and patient-on-staff assaults are properly and uniformly entered into the automated PIR program at all VAMCs to ensure accurate counting of assaults, but more important, to ensure that all assaulters are identified and the circumstances of the incidents are trended for use in both local and national VHA planning and monitoring purposes.
The issue of patients assaulting other patients or employees is a serious one. VHA health care facility right-sizing could exacerbate the problem and increase the risk of both types of assaults. When the subject report was issued in March 1996, the USH stated that one of the goals of a Risk Management Program would be to implement a uniform facility-level automated database that could also be accessed in VACO by the individual VISNs. The USH also stated that tracking, trending, and problem solution information could then be shared throughout the VHA. Implementation of such a system would necessitate a change in current regulations or PIR reporting as well as possible technical enhancements to the existing automated system. VHA Directive 97-029, Risk Management, dated June 6, 1997, did not implement these commitments. The most recent RM Directive has now incorporated this important procedure.
iii. Alleged Cover-up of an Unexplained Increase in Deaths, Harry S. Truman VA Medical Center, Columbia, Missouri" (Report No. 5PR-A19-115) - Recommendation 4 - Revise M-2, Part I, Chapter 35 on reporting serious incidents at medical centers to provide clarifying guidance that facility Directors could use to determine if and when to report an incident such as the Columbia Medical Center's unexplained deaths to law enforcement authorities. The guidance in those cases where there is strong suspicion that a serious crime may have been committed, should emphasize both aggressive internal investigations to determine the possible clinical causes as well as simultaneous reporting to law enforcement officials.
This recommendation was implemented through the VHA Directive 97-029, "Risk Management," June 6, 1997, as an improvement upon the previous Manual reference. Even so, OHI did not consider that the guidance was sufficiently specific or strong for a VAMC Director. The latest RM Directive has further clarified the procedures to be followed by VAMCs under these circumstances.
b. Tracking and Trending of Mortality Data
In Title 38 U.S.C. § 7311, "Quality Assurance", it is required that mechanisms for monitoring mortality and morbidity rates for surgical procedures be established. The National Surgical Quality Improvement Program (NSQIP) analyzes data on surgical mortality (within 30 days) and morbidity (presence of 1 or more postoperative morbidities within 30 days). NSQIP allows VHA to monitor surgical outcomes system-wide as well as locally. Data are shared with VAMC directors and surgeons to advise them of the quality of care they are providing and of opportunities for improvement. This system has the potential for monitoring significant fluctuations in mortality.
In a broader context, stemming from situations at VAMC Columbia and other VAMCs in recent years related to unusual mortality occurrences, it has been considered essential that VHA develop more robust mechanisms of monitoring data on mortality. The expectation has been that a RM Directive would delineate tracking, trending, and analysis of specific risk management/quality indicators such as mortality and certain morbidity rates in order to achieve early identification of possibly serious, unacceptable health care practices.
The rates for individual VAMCs, VISNs, and VACO in regard to the data or information to be monitored, collected, reported, analyzed, organized, and "rolled-up" would be specifically defined. Provisions would also be made for VHA's healthcare system to be alerted to unusual or unexpected mortality rates.
The present RM Directive clearly provides an overall strategy to suitably track and trend information and data concerning unexpected deaths at the individual VA facility. The RM Directive's Appendix C clearly defines roles and responsibilities for the VAMC, VISN and VACO. In this same Appendix C, VISN directors are requested to designate from within the VISN a statistical consultant to assist in data analyses for risk management and other quality assurance functions. We consider these actions to fulfill VHA's commitment and should, when fully implemented, provide a vital mechanism for identifying unusual patient deaths from mortality data.
c. Ensuring Continuing Improvements in Quality
The present RM Directive has several features, which can potentially result in improvements to the quality of care for veterans across the VHA healthcare system.
Mr. Chairman, recently you asked me to review VHA's response to the Committee's concerning 18 incidents in which there were patient deaths under allegedly unusual or apparently avoidable circumstances at VAMCs. There were 15 incidents in which there was a confirmed specific misadventure, including deaths from burns, administration of incorrect medications or blood, and so forth.
My personal impressions, as reported to you, were:
- Almost without exception each VAMC seriously engaged with the issues related to the incidents.
- All VAMCs indicated immediate extensive investigation of the incidents, with possibly two exceptions.
- The oversight by the Region/VISNs, OMI and/or OHI have ensured that these untoward incidents are definitively and completely reviewed, with few exceptions.
- Most of the 15 VAMCs with specific incidents have responded by careful in-depth inquiries which have resulted in several local policy changes.
- VAMCs which have reported incidents to external agencies, such as JCAHO and FDA, seem to be most highly motivated to complete more extensive facility-wide performance improvements such as root cause analyses.
- VHA Regions/VISNs and VACO did monitor these incidents, but it is unclear as to whether they have been accurately and consistently recorded on the DHCP data base.
- The OMI and OHI, when inspections have been completed, have generally validated that the incidents were adequately managed, and in several instances confirmed an excellent response by the VAMC.
- The present RM Directive has the potential for ensuring greater accuracy and consistency in resolving these observations. Yet, there is an important question which goes beyond these 15 specific incidents, which is, "What has the corporate" VHA learned and what systematic changes in practices and policies have been promulgated throughout the VA's health care system, especially to all VAMCs, to assist them in preventing and avoiding similar occurrences?
This RM Directive has specific roles for the VISNs and VACO, including a mechanism for monitoring untoward events, with possible standardization of VISN risk management programs. Even so, the assistance role of the VISNs and VACO, capitalizing on the diligence at VAMCs to have effective Risk Management programs, will need to be evident and robust. The "lessons learned" from analyzing the specific incidents should be codified and disseminated in a timely fashion throughout VHA's health care system.
6. Oversight of VHA's Office of the Medical Inspector
Almost 2½ years ago, OHI filed a report on its oversight of the OMI. The recommendations to the USH were:
A. Either provide additional staffing to the Office of Medical Inspector such that clinical staffing is increased sufficiently to perform its legislatively mandated function. This should result in an increase of at least four registered nurses and at least one senior physician; or
1. Submit a legislative proposal through the Office of the Secretary of Veterans Affairs to amend Public Law 100-322 to recognize the reduction in OMI's capability to conduct proper clinical evaluations; or
2. Since the capability for independent oversight overall within VHA is seriously limited, initiate action to transfer the OMI's resources to OIG.
B. Delete the paragraph in the M-2, Part I, Chapter 35 revision draft that deletes OMI's review of VAMCs' Boards of Investigation; and
C. Authorize the OMI to continue development of the self-assessment instruments in order to assist VAMCs to strengthen known program weaknesses.
Since then, only Recommendation B has been implemented through the recent RM Directive.
In response to the report on the OMI, the USH concurred with Recommendation C, but indicated that he wanted to defer decisions on Recommendations A and B, until a new VACO organization has been completed. This was agreed to as an interim measure by the OIG. Now, Recommendation A remains unimplemented and Recommendation C has recently moved into a non-concur status.
In May 1996, Dr. James McManus joined VHA as the new Director of OMI, i.e. the Medical Inspector, which brought the staffing level up to eight. Since then, the OMI lost its Deputy and one of its clinicians while adding a senior nurse located in Iowa City and, recently, another nurse in VACO. The OMI is currently recruiting for a physician Deputy. The staffing level will then be 9, which is far short of the OMI's initial more adequate 20 FTE staffing level.
The OHI and OMI offices have always coordinated their hotline inspection activities. The OHI has generally assumed responsibility for inquiries originating in Congress and complex issues that may or may not involve the OIG's Investigation office. The cooperation between all these offices continues. However, one of the impacts on OHI, from limited OMI staffing has been that OHI has had to assume more of this workload, leaving OHI with constraints on its resources to perform its other healthcare oversight activities, described earlier.
Just prior to Dr. McManus assuming the directorate of OMI, a VHA Directive 96-021, March 20, 1996, "Cooperation with the Medical Inspector" was issued. The role of the OMI was stated to be:
"The Medical Inspector serves as an investigative arm of the Office of the Under Secretary for Health (USH). When issues arise requiring further investigation, the USH, or designee, may ask the Medical Inspector to develop a factual analysis. In addition, the Medical Inspector may undertake investigation on behalf of the USH when requested to do so by veterans, VHA employees, the Inspector General, member of Congress or other stakeholders."
Late last year the USH responded to OIG follow-up inquiries as to the staffing and any modifications to the role of OMI. While the USH indicated additional FTE would be provided he also indicated that a contract would be awarded to an independent entity to study the structure and functioning of the OMI. This contract was awarded to Abt Associates, Inc., on May 6, 1997, with a broadly defined scope of work involving its assessment of the role, functions, and staffing of the OMI. The contractor's report is likely to be available in early November, according to VHA.
Until this past month, we had understood the implementation of Recommendation C was only dependent on OMI having sufficient staff to develop self-assessment instruments. We were informed by VHA that it now will discontinue the development of self-assessment instruments. Rather, VHA will replace the original commitment through the activities of VHA's Office of Special Projects' "Lessons Learned" initiative. The "Lessons Learned" initiative is a reactive process that is instigated after a serious or catastrophic event has occurred. The self-assessment instruments are designed and intended to help prevent incidents from occurring in the first place. Presently, OIG is seeking from VHA a substantive explanation for its apparent change of direction, and an indication as to its vision regarding how its revised approach will be effectively assist in preventing serious adverse incidents in the future
Hence, the OIG considers the issues raised in its report on the OMI to be mostly unresolved.
7. An Analysis and Present Status
VHA, along with most of the healthcare professionals it employs, has long had policies that are directed towards ensuring veterans receive safe, effective personal healthcare in VAMCs with an assurance that their risk of incurring inadvertent actions that threaten disability and cause avoidable deaths is minimal. VAMCs have long had in place and have applied policies to use appropriate screening mechanisms, confidential reporting mechanisms and investigative processes to accurately monitor, identify, evaluate and correct harmful and potentially harmful healthcare circumstances. These procedures, when consistently and properly applied, help to prevent injury and avoid harm.
VHA has a broad approach to quality assurance, including a risk management program, focused on achieving effective operations in the VAMCs, augmented by various oversight and investigative procedures. Over the past several years, it appears that when there are critical inadvertent and unusual adverse consequences to veterans in the course of receiving their healthcare through the VA, whether disability or death, VAMCs have for the most part taken the situations very seriously. In dealing with their own situations, VAMCs employees have conducted in-depth investigations, determined the nature of the error, assigned culpability, if needed, devised mechanisms to prevent similar incidents and filed reports with senior management. Unlike private sector healthcare providers, VAMC managers inform patients and families if they make serious errors, and explain their prerogatives for redress
In providing VAMCs with policies and guidance for its Risk Management program, VHA has, over the past five years, provided a series of four Directives. The most recent RM Directive was published this past September 25th and constitutes a strong and comprehensive policy, which fully addresses criticisms the OIG/OHI had previously raised concerning omissions and weaknesses in prior RM Directives, particularly the one published this past June. The current RM Directive has the potential to strengthen and enhance VHA's present mechanisms for conducting an effective risk management program.
In all previous RM guidance there have been VAMC reporting requirements and defined procedures for oversight by the Regions, (now replaced with 22 VISNs), and VACO. Within the past two years the VISNs have steadily been staffed, and the VACO offices have gained new leadership. During this time period it is evident that issues related to resource allocation, strategic planning and the implementation of a performance measurement system have been dominant on VHA's agenda. As a consequence, little or no attention has been given to reviewing information on the Patient Incident Reporting (PIR) program either in the VISNs or in VACO. The recently published RM Directive seeks to remedy this deficiency by assigning more definitive roles to the VISNs and VACO. It is essential that VISN programs be appropriately standardized to ensure that comparable data and information is collected and available for review. The RM Directive has given some broad guidance in this regard although appointment of a statistician in each VISN can assist in ensuring some consistency in this regard.
Once data and information on risk management is collected it is essential that it be tracked and routinely examined for trends. This requires assignment of clear roles and responsibilities in the VISNs and for VACO components. The RM Directive provides the clearest guidance so far in this area with the establishment of an Adverse Event Registry and the establishment in VACO of a Risk Management Oversight committee. The OMI is included on this committee but its participation is likely to be compromised as long as questions persist about its role, responsibilities and functions, and the staffing level in the office remains restrained. Without resolving these issues very soon, it is difficult to envisage how the OMI can significantly and effectively contribute to this activity. A regular and systematic review of the Adverse Event Registry, with the identification of relevant information that must be prompt in its dissemination to all VAMCs, is necessary. This communication is an essential feature of a Risk Management program for a healthcare system as large and complex as VHA. It provides the critical step in the sequence of an effective risk management program which, uses the broad dissemination of what has been learned from inadvertent event(s), to assist in the prevention of a similar occurrence at the same or other VAMCs.
8. Conclusion
The OHI is a QA oversight office, unlike any other in government, including the rest of the OIG community. It has direct clinical and QA oversight responsibilities under law. The task of monitoring a health system's effectiveness and overseeing its QA activities has proved to be most challenging in an era of shrinking government yet continuing increases in health care expenditures for veterans in VHA.
In fulfilling its mandate to oversee VHA's quality assurance activities and the OMI, the OHI/OIG has generally viewed VHA's need to address its risk management policies as paramount. VHA has made significant progress in this area with the possible notable exception of clarifying the OMI's role, function, and staffing. OIG will continue to monitor the implementation and effectiveness of VHA's recently published Risk Management Directive.
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