GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

United States Government Accountability Office

Washington, DC 20548

August 24, 2012

The Honorable Patty Murray

Chairman

Committee on Veterans’ Affairs

United States Senate

The Honorable Bob Filner

Ranking Member

Committee on Veterans’ Affairs

House of Representatives

Subject: Veterans Health Care: Veterans Health Administration Processes for 

Responding to Reported Adverse Events

The Department of Veterans Affairs’ (VA) Veterans Health Administration (VHA) 

operates one of the largest health care delivery systems in the United States, 

providing care to more than 6 million veterans annually. Organized into 21 Veterans 

Integrated Service Networks, VHA’s health care system includes 152 Veterans 

Affairs medical centers (VAMC) nationwide that offer a variety of outpatient, 

residential, and inpatient services.1 These health care services are delivered by 

physicians, dentists, and other providers and range from routine examinations to 

complex surgical procedures.

During the course of providing health care services, adverse events2—clinical 

incidents that may pose the risk of injury to a patient as the result of a medical 

intervention or lack of an appropriate intervention, such as a missed or delayed 

diagnosis, rather than that patient’s underlying medical condition3—may occur, 

resulting in potential harm to veterans. They are required to be reported to 

appropriate VAMC staff through each facility’s incident reporting system,4

 

1

In addition, VHA provides outpatient care at more than 800 community-based outpatient clinics.

or through 

2

For the purposes of this report, the term “adverse event” includes “close calls.” A close call is an event that 

could have the potential to result in an adverse event, but did not due to chance or timely intervention. Close 

calls receive the same level of scrutiny as adverse events that result in actual patient injury. Adverse events may 

or may not be attributable to an error made by a clinician, such as falls unrelated to patient care.

3

An example of an adverse event is the improper sterilization of medical equipment that was reported at a 

VAMC, which led to veterans potentially being exposed to infectious diseases. VHA also responds to incidents in 

addition to adverse events, such as incidences of reported thefts or conflicts between employees. Such 

incidences are not considered adverse events and are not the subject of this report.

4

Each VAMC maintains its own incident reporting system, which is used by VAMC staff to report information on 

adverse events.
2 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

other channels, such as anonymous phone calls or e-mails to VAMC staff, such as 

the patient safety manager or risk manager, according to officials.

5 VHA policy 

requires that appropriate action be taken to evaluate reported adverse events.6

Once an adverse event has been evaluated, the VAMC may take actions that 

include correcting system or process issues and taking actions against individual 

clinicians when warranted. Specifically, actions taken against individual clinicians 

following adverse events may include adverse actions—ranging from 

admonishments7 to termination of employment; as well as actions taken to limit a 

clinician’s clinical privileges, such as the reduction or revocation of privileges.8 Staff 

remediation activities, such as refresher training and proctoring, can be employed 

when adverse actions or limiting a clinician’s privileges are not deemed necessary.

Recent adverse events have raised questions about the quality of care provided to 

veterans by VAMCs, and whether lessons learned at one VAMC are being 

translated into systemwide improvements. In response, members of Congress have 

raised questions as to the processes VHA has in place to respond to adverse events 

at VAMCs and take appropriate action, when needed, to address problems found 

within the VHA health care system. You asked us to describe how VHA responds to 

reported adverse events within its health care system. In this report, we describe 

VHA’s processes for responding to reported adverse events within its health care 

system. In future work, we will examine the implementation of these processes at 

VAMCs. To describe VHA’s processes for responding to reported adverse events, 

we reviewed and analyzed documentation that contains policy and guidance for 

these processes,9

 

5

When an adverse event results in serious injury or death, or is reasonably expected to result in serious injury, 

VAMCs are required to disclose the event to the affected veteran or their representative through a formal 

process known as institutional disclosure. Institutional disclosure is generally carried out by a member of the 

VAMC’s leadership and involves providing the veteran or their representative with information on how to seek 

compensation. For adverse events that cause less significant harm, VAMCs are required to disclose the event to 

the affected veteran or his or her representative through an informal process known as clinical disclosure.

including VA and VHA directives and handbooks. Specifically, we 

examined processes that enable VAMCs to determine the cause of an adverse 

event and assessed the characteristics of these processes. We also reviewed VHA’s 

processes for taking action to help prevent an adverse event from recurring, such as 

correcting process or system deficiencies, using remediation approaches such as 

retraining and proctoring, and taking adverse actions against clinicians responsible 

for an adverse event. We also interviewed officials from VHA’s Office of Quality, 

6

In addition to identifying and reporting adverse events, VAMCs have a quality management program in place 

that allows them to identify and respond to other quality-of-care issues that may not rise to the level of an 

adverse event.

7

An admonishment is a written statement of censure given to an employee for a minor act of misconduct, such 

as repeated tardiness.

8

Clinical privileges refer to authority granted to a clinician by a VAMC to provide patient care in the facility. Such 

privileges are limited by the individual clinician’s license, experience, and competence. Some clinicians are VA 

employees, who may be employed on a full-time or part-time basis under permanent or temporary appointments, 

and others are contractors. Actions taken against individual clinicians may vary based on the employment status 

of the clinician. For example, for possible incompetence or professional misconduct by a contractor, VA may 

terminate the contract, thereby automatically revoking the contractor’s medical staff appointment and clinical 

privileges, rather than taking adverse action or privileging action as can be done in cases of potential misconduct 

for employees.

9

Both VA and VHA handbooks and directives contain policies and guidance regarding the processes for 

addressing an adverse event.
3 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

Safety, and Value, about issues related to quality, safety, and risk management and 

adverse actions.10 Our review was limited to VHA physicians and dentists, hereafter 

referred to as clinicians, as they are the primary types of licensed clinicians11 that 

practice independently at VAMCs. Furthermore, our review was limited to describing 

VHA’s processes for responding to adverse events, rather than all quality-of-care 

issues, such as those that did not rise to the level of an adverse event.

We conducted this performance audit from April 2012 through August 2012 in 

accordance with generally accepted government auditing standards. Those 

standards require that we plan and perform the audit to obtain sufficient, appropriate 

evidence to provide a reasonable basis for our findings and conclusions based on 

our audit objectives. We believe that the evidence obtained provides a reasonable 

basis for our findings and conclusions based on our audit objectives.

VHA Generally Allows VAMCs Discretion in Responding to Reported Adverse 

Events

Through its policy and guidance, VHA has outlined processes that enable VAMCs to 

respond to reported adverse events that occur.12 VHA generally grants individual 

VAMCs discretion on choosing which process to use. Specifically, VAMCs conduct 

an initial review to determine how best to respond to an adverse event. According to 

VHA officials, if the circumstances that led to an adverse event are clear, based on a 

VAMC’s initial review, VAMCs can take immediate corrective action. If the 

circumstances that led to an adverse event need to be examined further, VAMCs are 

given discretion to use one or more of the following four processes: (1) root cause 

analysis, (2) peer review, (3) clinical care review, and (4) administrative investigation 

board.13

 

10The Office of Quality, Safety, and Value is charged with enhancing the quality, safety, reliability, and value of 

clinical and business systems throughout VA by enabling enterprisewide approaches to compliance, risk 

awareness, and continuous improvement.

Because VAMCs generally have discretion in which of these processes they 

use, different VAMCs that experience similar adverse events may not use the same 

processes to respond to them. Nonetheless, each process has certain purposes and 

limitations. For example, some of these processes may be used to examine a 

clinician’s actions as they relate to an adverse event, while others may be used to 

examine whether a systems or process issue exists. Furthermore, information 

collected through two of these processes—clinical care reviews and administrative 

investigation boards—can be used to inform actions against clinicians; information 

collected using root cause analyses and peer reviews cannot be used to support 

such actions, because information collected under those processes is protected and 

11VA requires its physicians and dentists to possess at least one full, active, current, and unrestricted license to 

practice medicine or dentistry with limited exceptions, such as a state license limited on the basis of not meeting 

state residence requirements or a state-granted institutional license permitting full, unrestricted clinical practice at 

a specific VA health care facility.

12We use the term “processes” to refer to all policies, procedures, and processes governing VHA’s response to 

reported adverse events.

13Additionally, in certain cases, such as when a veteran files a complaint to VA’s Office of Inspector General or 

VHA’s Office of the Medical Inspector, either of these entities may decide to independently investigate the 

adverse event.
4 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

confidential, under federal law.14 Based on the nature of an adverse event and the 

information gleaned through a particular review process, a VAMC may decide to 

conduct multiple types of reviews, as appropriate.15

 

14Under federal law, records and documents created as part of VHA’s medical quality assurance program are 

confidential and privileged and may only be disclosed under limited circumstances. See 38 U.S.C. § 5705; 

38 C.F.R. §§ 17.500-17.511. VHA’s medical quality assurance program consists of systematic healthcare 

reviews carried out by or for VHA for the purposes of improving the quality of medical care or improving the 

utilization of healthcare resources in VHA medical facilities. The root cause analysis and peer review processes 

are part of VHA’s medical quality assurance program, and as such, documents generated through these 

processes are confidential and privileged. 38 U.S.C. § 5705 was enacted out of concern that, unless clinicians 

could be assured that their remarks and assessments about possible problems with the healthcare services they 

deliver or one of their peers delivers to patients would be kept confidential, the necessary level of candor would 

be lost. Additionally, if the negative results from quality assurance activities were publicly available, the clinicians 

under review may be guarded or uncooperative during the review process. See 126 Cong. Rec. S10918 (Aug. 6, 

1980) (excerpting S. Rep. No. 96-876).

Figure 1 shows VHA’s four 

processes for responding to reported adverse events.

15For example, a VAMC may decide to conduct an administrative investigation board and a root cause analysis 

in response to an adverse event to examine both a clinician’s actions and to examine whether a systems or 

process issue exists.
5 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

Figure 1: VHA’s Processes for Responding to Reported Adverse Events at VAMCs

a

If the circumstances that led to an adverse event are clear, based on a VAMC’s initial review, VAMCs can take immediate 

corrective action, without using any of these processes.

Root cause analysis. If the VAMC’s initial review of an adverse event finds that 

there is a risk to the safety of veterans, a root cause analysis may be required by 

VHA policy. To determine if a root cause analysis is required, the patient safety 

manager16 evaluates the event using VHA’s “safety assessment code matrix.” This 

scoring tool measures safety risk based on the severity of an adverse event and its 

likelihood of occurrence on a scale of one (lowest risk) to three (highest risk). For 

example, an adverse event with a score of three is one that has the potential to 

result in death or permanent loss of function regardless of its likelihood of 

occurrence.17 As directed by VHA policy, adverse events with a score of three 

always require a root cause analysis, either individual or aggregated.18

 

16Each VAMC has a patient safety manager whose responsibilities include facilitating the root cause analysis 

process.

17An example of an adverse event with a score of two is one that has the potential to result in the permanent 

impairment of a bodily function which may occur occasionally—that is, several times over a 1- to 2-year period. 

An example of an adverse event with a score of one is one that has the potential to result in an increased length 

of stay for a veteran, which may occur occasionally.

18An aggregated root cause analysis collects information from multiple similar adverse events to conduct a single 

root cause analysis. An aggregated root cause analysis is required with several types of incidents: patient falls, 

adverse drug events, and missing patients. When not required, VAMCs have discretion to conduct aggregated 

root cause analyses for adverse events that receive a score of one or two.
6 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

To conduct a root cause analysis, a VAMC director convenes a multidisciplinary 

team, which includes appropriate subject matter experts from the VAMC, such as 

clinicians and quality management staff. The team attempts to identify the systemic 

causes for an adverse event by determining what factors contributed to the event 

and why those factors occurred. Furthermore, the team identifies changes that could 

be made in systems and processes, such as through the development of new 

processes that would improve performance and reduce the risk of the adverse event 

recurring. For example, in a case that identified the root causes of a VAMC’s failure 

to properly sterilize a piece of reusable medical equipment, a root cause analysis 

was used to examine whether instructions for cleaning the equipment were clear, 

whether sufficient training was provided to staff, and to develop steps to address 

these root causes. 

Information gleaned through a root cause analysis may be used to make systems or 

process changes within a specific VAMC or VHA’s health care system more broadly. 

The details of a root cause analysis are protected and confidential under federal law, 

meaning that they are protected from disclosure within and outside of VHA and 

cannot be used to take any adverse action or privileging action against clinicians.19

According to officials, the lessons learned from the root cause analysis process may 

be used to provide lessons to the larger healthcare system.

Peer review. If the VAMC’s initial review or a root cause analysis finds there is a

need to determine whether a clinician’s actions associated with an adverse event 

were clinically appropriate—that is, whether another clinician with similar expertise 

would have taken similar action—a VAMC may initiate a peer review.20

During a peer review, the peer reviewer—a clinician or group of clinicians with 

similar expertise to the clinician involved in the incident being reviewed—evaluates 

the actions of the clinician under review to make an initial determination of whether 

the clinician should have taken different action when providing patient care. At the 

conclusion of this evaluation, the peer reviewer preliminarily rates the clinician’s 

actions as one of the following:

• Level 1, at which the most experienced, competent clinician would have 

managed the case in a similar manner;

• Level 2, at which the most experienced, competent clinician might have managed 

the case differently; or

• Level 3, at which the most experienced, competent clinician would have 

managed the case differently.

 

1938 U.S.C. § 5705; 38 C.F.R. §§ 17.500-17.511.

20While VHA policy requires that peer reviews be considered under certain circumstances, such as when a 

VAMC becomes aware of a veteran’s death, each VAMC maintains a facility-specific peer review policy that 

describes the specific circumstances under which a peer review is to be considered or required. 
7 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

If the peer reviewer initially rates the clinician’s actions at Level 2 or 3, the clinician’s 

case is referred to the VAMC’s peer review committee—a multidisciplinary group of 

clinicians and/or other clinical staff members, such as nurses—which reviews the 

clinician’s actions. Clinicians under review are given the opportunity to appear before 

the peer review committee or submit written comments to explain their actions. The 

peer review committee either validates the initial rating or assigns a higher or lower 

final rating of Level 1, 2, or 3.21 The final rating is reported to the clinician’s 

supervisor and, when appropriate, the VAMC director. The clinician’s supervisor 

provides the clinician feedback based on the peer review committee’s findings. 

According to officials, clinicians may be offered training to help them improve clinical 

proficiency, as determined to be appropriate by the supervisor. However, as is the 

case for root cause analyses, information obtained through peer reviews is protected 

and confidential and cannot be used to inform an adverse action or privileging action 

against a clinician.

Clinical care review. According to VHA officials, if the initial review finds there is a 

need to determine whether a clinician’s actions associated with an adverse event 

were clinically appropriate, VAMCs have discretion to conduct a clinical care review. 

Through a clinical care review, a clinician’s competency—his or her ability to provide 

an appropriate standard of care—is reviewed, to determine what type of action, if 

any, should be taken.22 In addition, the peer review process can trigger a 

subsequent clinical care review. Each VAMC is required by VHA to establish its own 

criteria for review, such as triggers—that is, the number of Level 1, 2, and 3 peer 

reviews pertaining to an individual clinician over the course of a designated period of 

time that result in a clinical care review. For example, at one VAMC, three Level 3 

peer reviews within a 6-month period would trigger a clinical care review.

According to VHA officials, to the extent that concerns about a clinician’s 

competency are verified through a clinical care review, VAMCs may decide to initiate 

a focused professional practice evaluation or pursue privileging action23 against the 

clinician. According to VHA officials, through a focused professional practice 

evaluation, a clinician is given an opportunity to improve his or her clinical 

competence over a period of time as determined by the VAMC director. At the 

discretion of the VAMC director, this evaluation can include progressive training or 

proctoring aimed at helping the clinician improve clinical competence.24

 

21VHA policy also requires the peer review committee to provide a secondary review of a representative sample 

of Level 1 peer reviews as a way to evaluate the peer review process in general.

Should 

22Each VAMC determines under which circumstances a clinical care review is appropriate and how it is to be 

conducted. For example, during a clinical care review, a clinician’s supervisor may select a number of cases to 

review to help determine whether the clinician provided an appropriate standard of care.

23The VAMC director is the final authority for all privileging decisions. This decision must be based on the 

recommendations of the appropriate service chief(s), chief of staff, and/or the Executive Committee of the 

Medical Staff. Clinicians are given the right to reply to a proposed privileging action prior to a final action. Once 

the VAMC director makes a final determination on a privileging action, the clinician is entitled to a fair hearing by 

a panel of peers. If a privileging action is sustained following a fair hearing, clinicians have the right to appeal the 

decision to the network director, who may ultimately sustain or reverse the privileging action. In addition, adverse 

action, such as termination of employment, may be taken in conjunction with, or instead of privileging action, 

depending on the nature of the adverse event.

24Proctoring refers to an objective evaluation of a clinician's clinical competence by a peer.
8 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

concerns about clinical competence remain at the conclusion of a focused 

professional practice evaluation, a VAMC may then pursue privileging action against 

the clinician. VA policy affords clinicians due process prior to any privileging action. 

VAMCs are required to report physicians and dentists whose privileges are reduced, 

revoked, or surrendered while under investigation to the National Practitioner Data 

Bank,25 which tracks information including privileging actions, as well as to report to 

appropriate state licensing boards, which may use this information to take action 

against the clinicians’ medical licenses, including revoking, restricting, or suspending 

the license.26

Administrative investigation board. If the initial review finds that an investigation 

is warranted to determine whether an adverse event was the result of a clinician’s 

professional misconduct or potential systemic deficiencies related to VHA policies or 

procedures, a VAMC director may convene an administrative investigation board.27

A VAMC director also may choose to convene an administrative investigation board 

if a root cause analysis or peer review indicates an adverse event may have been 

the result of a clinician’s professional misconduct. If this occurs, any ongoing root 

cause analysis or peer review is terminated or suspended until the administrative 

investigation board is concluded. Furthermore, the same individuals involved in

conducting a root cause analysis or peer review may not be members of 

administrative investigation boards examining the same issues. Because any 

information collected through a root cause analysis or peer review is protected and 

confidential under federal law and cannot be used to take adverse action, 

information must be recollected when convening an administrative investigation 

board—that is, the board cannot use information collected and reviewed during the 

root cause analysis or peer review in its investigation.

Once an administrative investigation board is convened, it collects and analyzes 

evidence, such as sworn witness testimony and documentation, related to the 

allegation under investigation. Additionally, the board may obtain all available 

documents, records, and other information that are material to the scope of the 

investigation, including VHA policies, employee personnel records, and e-mail 

correspondence.28 The board analyzes the collected evidence and develops the 

findings and conclusions of the investigation, including whether any allegations 

investigated were substantiated. 

 

25The National Practitioner Data Bank is an information clearinghouse that collects and releases all licensure 

actions or other negative actions taken against clinicians, including malpractice payments.

26If a clinician resigns or retires prior to privileging action being taken, VHA policy requires that he or she be 

reported to the National Practitioner Data Bank and appropriate state licensing boards.

27Administrative investigation boards also may be convened by authorities senior to a VAMC director within the 

network or VHA. Administrative investigation boards also are used to investigate matters besides adverse 

events, such as allegations of wrongdoing that involve nonclinical matters or matters involving potential systems 

deficiencies related to a VHA policy or procedure. See GAO, VA Administrative Investigations: Improvements 

Needed in Collecting and Sharing Information, GAO-12-483 (Washington, D.C.: Apr. 30, 2012). 

28Some information relevant to an investigation, such as patient medical records, may not be available to the 

board, or may be subject to specific restrictions on disclosure or use.
9 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

The board documents results—evidence, findings, conclusions, and any 

recommendations—in an investigation report that is forwarded to the VAMC director, 

who reviews the report to verify that the board sufficiently investigated the matter.29

The VAMC director may accept the report or may ask the board to further investigate 

the matter, clarify the information in the investigation report, or both. VA considers 

an investigation to be complete once the VAMC director certifies the investigation 

report.

VAMC directors may use administrative investigation boards’ findings to inform their 

decisions of whether to take adverse action against a clinician and, if so, which type 

of action to pursue.30 Although VA policy provides guidance on the type of adverse 

action that should be taken in the case of certain offenses, the VAMC director has 

discretion over what adverse action, if any, to pursue. If adverse action is taken 

against a clinician, a standardized process for taking such action must be followed, 

which is defined by VA policy and is dependent on the type of action being taken. In 

addition to, or instead of, taking adverse action against an individual clinician, action 

may be taken to address systemic deficiencies related to policy or procedure found 

to have contributed to adverse events identified through an administrative 

investigation board. Furthermore, a VAMC director may decide to take nonadverse 

action, such as counseling or training, to expand a clinician’s knowledge about VHA 

policies and procedures or clinical standards. 

Agency Comments

VA provided us with comments on a draft of this report, which we have reprinted in 

enclosure I. In its comments, VA expressed concerns about specific language in the 

draft report that the department believed was either incomplete or could mislead the 

reader, and provided technical comments to address its concerns. We maintain that 

the draft report accurately described VHA’s processes for responding to reported 

adverse events as explicitly described in VA and VHA policies and communicated to 

us by VHA officials. We have incorporated VA’s technical comments as appropriate.

However, because these technical comments did not require material changes to the 

draft report, we did not reprint them.

– – – – – 

We are sending copies of this report to the Secretary of Veterans Affairs and 

interested congressional committees. In addition, the report is available at no charge 

on the GAO website at http://www.gao.gov. 

 

29Upon convening an administrative investigation board, the VAMC director may authorize the board to provide 

recommendations for corrective actions. However, the board is prohibited from recommending a specific level or 

type of adverse action, such as termination or suspension. Although an administrative investigation board may 

provide recommendations for corrective actions, the VAMC director is not required to implement them. 

30Although an administrative investigation board’s findings may be used by a VAMC director to inform adverse 

actions, the board is not involved in determining such actions.
10 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

If you or your staff have any questions about this report, please contact me at 

(202) 512-7114 or draperd@gao.gov. Contact points for our Offices of 

Congressional Relations and Public Affairs may be found on the last page of this 

report. GAO staff members who made key contributions to this report are listed in 

enclosure II.

Debra A. Draper

Director, Health Care

Enclosures – 2 
Enclosure I 

11 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

Comments from the Department of Veterans Affairs
Enclosure II

12 GAO-12-827R Veterans Health Administration Response to Reported Adverse Events

GAO Contact and Staff Acknowledgments

GAO Contact

Debra A. Draper, (202) 512-7114 or draperd@gao.gov

Staff Acknowledgments

In addition to the contact named above, Mary Ann Curran, Assistant Director; Jennie 

Apter; Ashley Dixon; Kaitlin McConnell; Lisa Motley; and Michael Zose made key 

contributions to this report.

(291023)
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