oversight

Veterans Health Care: Veterans Health Administration Processes for Responding to Reported Adverse Events

Published by the Government Accountability Office on 2012-08-24.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

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 events 2—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 condition 3—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 or through
           1
            In addition, VHA provides outpatient care at more than 800 community-based outpatient clinics.
           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.



                      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
admonishments 7 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 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,
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.
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.



2          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 clinicians 11 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 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


10
   The 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.
11
  VA 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.
12
  We use the term “processes” to refer to all policies, procedures, and processes governing VHA’s response to
reported adverse events.
13
  Additionally, 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.



3          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 Figure 1 shows VHA’s four
processes for responding to reported adverse events.




14
  Under 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).
15
  For 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.



4          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
manager 16 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


16
  Each VAMC has a patient safety manager whose responsibilities include facilitating the root cause analysis
process.
17
  An 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.
18
  An 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.



5          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.



19
    38 U.S.C. § 5705; 38 C.F.R. §§ 17.500-17.511.
20
  While 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.


6           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 action 23 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 Should

21
  VHA 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.
22
  Each 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.
23
  The 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.
24
    Proctoring refers to an objective evaluation of a clinician's clinical competence by a peer.



7            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.




25
  The 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.
26
  If 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.
27
  Administrative 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).
28
  Some 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.



8          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.




29
  Upon 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.
30
  Although 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.



9         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




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

              Comments from the Department of Veterans Affairs




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


                   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.




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