Department of Veterans Affairs VHA DIRECTIVE 2004-024 Veterans Health Administration Washington, DC 20420 June 10, 2004
NOTIFICATION OF MEDICAL MALPRACTICE (TORT) CLAIMS AGAINST LICENSED PRACTITIONERS
1. PURPOSE: This Veterans Health Administration (VHA) Directive describes the
duty of Department of Veterans Affairs (VA) Medical Center Directors to notify
practitioners whose care is the subject of a claim for medical malpractice.
NOTE: This Directive does not discuss disclosure of adverse events to patients
or their families; that information is found in the National Ethics Committee
(NEC) report on Disclosing Adverse Events to Patients (also see VHA Handbook
1050.1, Patient Safety Improvement).
2. BACKGROUND: Under the provisions of Public Law 99-660, the Health Care
Quality Improvement Act of 1986, which established the National Practitioner
Data Bank (NPDB), and a Memorandum of Understanding (MOU) between the Department
of Veterans Affairs (VA) and the Department of Health and Human Services (HHS),
VHA must report certain malpractice payments and certain clinical privileges
actions to the NPDB and appropriate state licensing boards. VHA’s reporting
requirements are set forth at Title 38 Code of Federal Regulations (CFR) Part
46, and are applicable to all VHA licensed health care practitioners involved in
patient care who are employed, appointed, contracted for, or otherwise utilized
under job titles listed in the NPDB document entitled “Field Licensure Codes.”
These regulations establish a malpractice payment review process, and authorize
licensed practitioners, for whose benefit a claim for medical malpractice was
paid, to submit a written statement for consideration by the review panel.
However, since the regulations concern only the post-payment review process,
many practitioners have asserted that they are unaware that a claim has been
filed until such time as a recommendation to report them to the NPDB has been
made. VHA believes that the notification of licensed practitioners at the time a
claim for medical malpractice has been made helps ensure the fairness of the
claim resolution process. NOTE: This Directive does not discuss the tort claim
post payment review process or reporting required following an adverse action
against a physician or dentist (VHA Handbook 1100.17, National Practitioner Data
Bank Reports).
3. POLICY: It is VHA policy that each medical center Director must provide
written notification to all licensed practitioners, who were assigned to provide
care to a patient, when such care results in a claim for medical malpractice,
within 30 days from the date that a Regional Counsel notifies the Director that
a claim for medical malpractice has been filed under the Federal Tort Claims Act
(FTCA), Title 28 United States Code (U.S.C.) 1346(b), 2671-2680.
4. ACTION: Each medical center Director, or designee, is responsible for
ensuring that:
a. Each licensed practitioner is given written notice when a claim for medical
malpractice is filed with respect to care provided by such practitioner. The
notice will state only the:
(1) Patient’s name;
(2) Date(s) the incident giving rise to the claim occurred;
(3) Incident described in the claim;
(4) Asserted basis of malpractice liability; and
(5) Name and telephone number of the Regional Counsel for the facility where the
event occurred.
b. A copy of the notice is forwarded to the appropriate Regional Counsel office.
5. REFERENCES
a. Title 42 U.S.C. 11101-11152, The Health Care Quality Improvement Act of 1986.
b. Memorandum of Understanding between the Secretary of Veterans Affairs and the
Secretary, Health and Human Services, dated November 19, 1990.
c. Title 38 CFR Part 46, as amended. Policy Regarding Participation in the
National Practitioner Data Bank, 67 Fed. Reg. 19678 (April 23, 2002).
d. VHA Handbook 1050.1, Patient Safety Improvement.
e. VHA Handbook 1100.17, National Practitioner Data Bank Reports.
6. FOLLOW-UP RESPONSIBILITY: The Chief Consultant, Forensic Medicine Strategic
Healthcare Group (11F), is responsible for the contents of this Directive.
7. RECISSIONS: None. This VHA Directive expires June 30, 2009.
S/ Arthur S. Hamerschlag for
Jonathan B. Perlin, MD, PhD, MSHA, FACP
Acting Under Secretary for Health
T-1
Department of Veterans Affairs VHA DIRECTIVE 1402.1
Veterans Health Administration Transmittal Sheet
Washington, DC 20420 October 22, 1999
1. REASON FOR ISSUE: This Veterans Health Administration (VHA) Directive is
issued toauthorize providing trainees (e.g., medical residents, associated health
residents and students, andparticipants in special fellowship programs) in Department of Veterans Affairs
(VA)-sponsored
programs with malpractice liability coverage if the non-VA facility does not
provide thiscoverage.
2. SUMMARY OF CONTENTS: This document defines VHA policy on providing medical
malpractice coverage for trainees in VA-sponsored programs when they are
performing
professional services at a non-VA facility.
3. RELATED ISSUES: None.
4. RESPONSIBLE OFFICE: The Office Academic Affiliations (14) is responsible for
the
contents of this Directive.
5. RESCISSIONS: This directive rescinds M-8, Part II, Chapter 1, paragraph 1.11,
Chapter 2,paragraph 2.17, and Chapter 4, paragraph 4.14, to the extent that they are
inconsistent with thisdirective.
6. RECERTIFICATION: This VHA Directive is scheduled for recertification on or
before thelast working day of October 2004.
S/M . L. Murphy
Thomas L. Garthwaite, M.D.
Acting Under Secretary for Health
Distribution: RPC: 0005
FDPrinting date: 10/99
October 22, 1999 VHA DIRECTIVE 1402.1
1
MALPRACTICE COVERAGE OF TRAINEES IN VA-SPONSORED PROGRAMS
WHEN THEY ARE PERFORMING PROFESSIONAL SERVICES AT A
NON-VA FACILITY
1. PURPOSE: This Veterans Health Administration (VHA) Directive is issued to
authorize providing trainees (e.g., medical residents, associated health
residents and students, and participants in special fellowship programs) in
Department of Veterans Affairs (VA)-sponsored programs with malpractice
liability coverage if the non-VA facility does not provide this coverage.
2. BACKGROUND: The liability protection is that which is provided under the
Federal Employees Liability Reform and Tort Compensation Act, Title 28 United
States Code (U.S.C.)
2679 (b)-(d). This means that VA-sponsored trainees going to non-VA health care
facilities oragencies for required training will be provided the same liability
protections as they would be provided at VA facilities.
3. POLICY: It is VHA policy to see that all VA trainees in a VA-sponsored
program are covered by malpractice insurance. NOTE: If there is any doubt as to
malpractice coverage during the time that trainees are in a VA-sponsored
program, the local Regional Counsel will be consulted.
4. ACTION
a. Typically, non-VA health care facilities will cover VA trainees from
VA-sponsored programs under their malpractice insurance when they are at the
non-VA facility. In that case, Attachment A should be used when signing the
memorandum of affiliation. Attachment A identifies the non-VA health care
facility, or agency, as the responsible party for providing protection of VA
trainees from personal liability while performing professional services at the
non-VA health care facility or agency.
b. If the non-VA health care facility declines to cover the VA trainees in a
VA-sponsored program under its malpractice insurance when they are at its
facility, Attachment B should be used. Attachment B defines the protection of VA
trainees from personal liability while providing professional services covered
by the agreement at the non-VA health care facility or agency.
5. REFERENCES
a. Federal Tort Claims Act, 28 U.S.C. 2679(b)-(d).
b. VHA Manual M-8, Part II, Chapter 1, 2, and 4.
c. Title 38 U.S.C. 7316.
October 22, 1999 VHA DIRECTIVE 1402.1
APPENDIX A
A-1
SAMPLE MEMORANDUM OF AFFILIATION
EDUCATIONAL PROGRAM AGREEMENT
BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS (VA)
AND THE UNDERSIGNED NON-VA HEALTH CARE FACILITY OR AGENCY
VA NETWORK:
______________________________________________________________________________
VA TREATMENT FACILITY (OR FACILITIES):
______________________________________________________________________________
VA-SPONSORED EDUCATIONAL OR TRAINING PROGRAM:
______________________________________________________________________________
NAME OF NON-VA HEALTH CARE FACILITY OR
AGENCY:__________________________________________________________
LOCATION OF NON-VA HEALTH CARE FACILITY OR
AGENCY:__________________________________________________________
It is mutually agreed by the VA and _____(the non-VA health care facility or
agency)__________ that practical experience for trainees in the specified
VA-sponsored program will be provided at the non-VA health care facility, or
agency, identified above. The VA education program director will assume
responsibility for the selection and assignment of VA trainees to the learning
experiences. There will be coordinated planning between the non-VA health care
facility, or agency, and the director of the VA educational or training
program regarding scheduling and work assignments. While at the non-VA health
care facility or agency, VA trainees will conduct themselves in accordance with
the rules and regulations of the non-VA health care facility or agency. The
non-VA health care facility, or agency, will retain full responsibility for the
care of patients and will maintain administrative and professional supervision
of the VA trainees insofar as their presence affects its operation and/or the
direct or indirect care of the patients.
VHA DIRECTIVE 1402.1 October 22, 1999
APPENDIX A
A-2
VA trainees will receive a thorough orientation to the non-VA health care
facility or agency. VA training program director and the non-VA health care
facility or agency staff supervisors will evaluate the trainee’s performance by
mutual consultation according to the guidelines of the training program. The
non-VA health care facility, or agency, complies with Title VI of the Civil
Rights Act of 1964, Title IX of the Education Amendments of 1972, section 504 of
the Rehabilitation Act of1973, Title III of the Older Americans Amendments of
1975, the Americans with Disabilities Act of 1992, and all related regulations,
and assures that it does not, and will not, discriminate against any person on
the basis of race, color, sex, creed, national origin, age or handicap under any
program or activity receiving Federal financial assistance.
Nothing in this agreement is intended to be contrary to State or Federal laws.
In the event of conflict between terms of this agreement and any applicable
State or Federal law, that State or Federal law will supersede the terms of this
agreement. In the event of conflict between State and Federal laws, Federal laws
will govern. When VA trainees are providing professional services covered by
this agreement, their protection from personal liability while at the non-VA
health care facility, or agency, will be the responsibility of the non-VA health
care facility or agency. Nothing in this agreement grants to VA any legal
authority to exercise control over any non- VA health care facility, agency, or
program. Ultimate responsibility for the control and operation of non-VA
facilities and programs rests with the non-VA facility or agency. Periodic
reviews of academic programs and policies will be conducted as necessary under
the
auspices of VA’s Chief Academic Affiliations Officer. This agreement is in force
until further notice; it may be terminated in writing at any time by mutual
consent with due consideration of patient care and educational commitments, or
by written notice by either party 6 months in advance of the next training
experience. The affiliation agreement previously agreed to on ____(Date)____ is
hereby rescinded.
___________________________________ ____________________________________
Name and Title of Responsible Official Network Director, or designee
for the non-VA facility or agency Department of Veterans Affairs
Date: _______________________________ Date: ______________________________
October 22, 1999 VHA DIRECTIVE 1402.1
APPENDIX B
B-1
SAMPLE MEMORANDUM OF AFFILIATION
EDUCATIONAL PROGRAM AGREEMENT
BETWEEN THE DEPARTMENT OF VETERANS AFFAIRS (VA)
AND THE UNDERSIGNED NON-VA HEALTH CARE FACILITY OR AGENCY
VA NETWORK:
______________________________________________________________________________
VA TREATMENT FACILITY (OR FACILITIES):
______________________________________________________________________________
VA-SPONSORED EDUCATIONAL OR TRAINING PROGRAM:
______________________________________________________________________________
NAME OF NON-VA HEALTH CARE FACILITY OR
AGENCY:__________________________________________________________
LOCATION OF NON-VA HEALTH CARE FACILITY OR
AGENCY:__________________________________________________________
It is mutually agreed by the VA and _____(the non-VA health care facility
or agency)__________ that practical experience for trainees in the specified
VA-sponsored program will be provided at the non-VA health care facility, or
agency, identified above. The VA education program director will assume
responsibility for the selection and assignment of VA trainees to the learning
experiences. There will be coordinated planning between the non-VA health care
facility, or agency, and the director of the VA educational or training program
regarding scheduling and work assignments. While at the non-VA health care
facility or agency, VA trainees will conduct themselves in accordance with the
rules and regulations of the non-VA health care facility or agency. The non-VA
health care facility, or agency, will retain full responsibility for the care of
patients and will maintain administrative and professional supervision of the VA
trainees insofar as their presence affects its operation and/or the direct or
indirect care of the patients.
VA trainees will receive a thorough orientation to the non-VA health care
facility or agency. VA training program director and the non-VA health care
facility or agency staff supervisors will evaluate the trainee’s performance by
mutual consultation according to the guidelines of the training program. The
non-VA health care facility or agency complies with Title VI of the Civil Rights
Act of1964, Title IX of the Education Amendments of 1972, section 504 of the
Rehabilitation Act of 1973, Title III of the Older Americans Amendments of 1975,
the Americans with Disabilities Act of 1992, and all related regulations, and
assures that it does not, and will not, discriminate against any person on the
basis of race, color, sex, creed, national origin, age or handicap under any
program or activity receiving Federal financial assistance. Nothing in this
agreement is intended to be contrary to State or Federal laws. In the event of
conflict between terms of this agreement and any applicable State or Federal
law, that State or Federal law will supersede the terms of this agreement. In
the event of conflict between State and Federal laws, Federal laws will govern.
When VA trainees are providing professional services covered by this agreement,
their protection from personal liability while at the non-VA health care
facility or agency will be that which is provided under the Federal Employees
Liability Reform and Tort Compensation Act, 28 U.S.C. 2679 (b)-(d). Nothing in
this agreement grants to VA any legal authority to exercise control over any
non- VA health care facility, agency or program. Ultimate responsibility for the
control and operation of non-VA facilities and programs rests with the non-VA
facility or agency. Periodic reviews of academic programs and policies will be
conducted as necessary under the auspices of VA’s Chief Academic Affiliations
Officer. This agreement is in force until further notice; it may be terminated
in writing at any time by mutual consent with due consideration of patient care
and educational commitments, or by written notice by either party 6 months in
advance of the next training experience. The
affiliation agreement previously agreed to on ____(Date)____ is hereby
rescinded.
________________ ___________________ ____________________________________
Name and Title of Responsible Official Network Director, or designee
for the non-VA facility or agency Department of Veterans Affairs
Date: _______________________________ Date: ______________________________
Department of
Veterans Affairs
VHA DIRECTIVE 2004-054
Veterans Health Administration
Washington, DC 20420
September 29, 2004
PEER REVIEW FOR QUALITY
MANAGEMENT
1. PURPOSE: This Veterans Health Administration (VHA) Directive sets forth the
requirements for initiating, conducting, and documenting peer review for quality
management of care provided by an individual provider in VHA health care
facilities. NOTE: In this Directive the terms “quality management,” “quality
improvement,” and “quality assurance” are used interchangeably.
2. BACKGROUND: The Joint Commission for Accreditation of Healthcare
Organizations (JCAHO) refers to a peer review as a “focused review.” A focused
review involves members of the health care staff in activities to measure,
assess, and improve performance on an organization-wide basis.
a. When conducted systematically and credibly, peer review can result in both
immediate and long-term improvements in patient care by revealing areas for
improvement in individual providers’ practice. This ultimately contributes to
organizational performance and optimal patient outcomes. NOTE: This Directive is
intended to complement other Directives that address areas of quality management
as patient safety improvement.
b. Authority for focused reviews is found in Title 38 United States Code (U.S.C.)
§ 5705, entitled Confidentiality of Medical Quality-Assurance Records and its
implementing regulations. Only documents designated in advance as being
developed consistent with 38 U.S.C. § 5705 are confidential. This type of
advance directive specifying the protected activities must be contained in a
Department of Veterans Affairs (VA) Central Office or Regional Office policy
document or by an advance designation of the activity at the facility level.
c. Peer review, as described in this Directive, is intended to promote
confidential and systematic processes that contribute to quality improvement
efforts at the individual provider level, within a non-punitive context. It can
also be conducted to assess resource utilization issues related to individual
provider decisions. Although organizational issues are sometimes identified, the
primary goal is overall improvement in the care provided to veterans through
review of individual provider decisions. Similar to the Root Cause Analysis
(RCA) process (as described in VHA Handbook 1050.1), it is hoped that protected
peer review done for quality improvement and/or resource utilization purposes
will foster a responsive environment where issues are identified and acted upon
proactively and in ways that continually contribute to the best possible
outcomes and strong organizational performance.
d. Peer review is intended to be an endeavor encompassing multiple disciplines.
Physicians, nurses, and other licensed staff need to be actively involved in
properly-functioning peer review processes.
e. A common approach to peer review has been a single reviewer making a judgment
about the quality of decisions associated with clinical interventions. However,
this approach does not
THIS VHA DIRECTIVE EXPIRES JULY 31, 2009
VHA DIRECTIVE 2004-054
September 29, 2004
2
have well-documented inter-rater reliability. Published evaluations of peer
review processes highlight the limitations of unstructured judgments by a single
reviewer and justify consideration of alternative approaches, such as use of a
committee, subcommittee, or multiple reviewers with discussion to consensus.
f. Criteria for effective and credible peer review processes include
consistency, timeliness, fairness, balance, and usefulness.
g. Definitions
(1) Confidential Documents. The term “confidential documents” includes all
documents or parts of documents produced by or for VA in the process of
conducting systematic health care reviews for the purpose of improving the
quality of health care or improving the utilization of health care resources,
which are considered privileged under 38 U.S.C. § 5705 and its implementing
regulations.
(2) Provider. The term “provider” is defined as anyone credentialed, privileged,
or operating within a professional scope of practice.
(3) Peer. The term “peer” is defined as an individual of similar education,
training, licensure and clinical privileges.
(4) Peer Review. The term “peer review” is defined to include critical reviews
of an episode of care performed by a peer and/or group of peers. All peer review
processes must be in accordance with all applicable laws, regulations, and
current VHA policies, including protection under 38 U.S.C. 5705, and its
implementing regulations. NOTE: Peer reviews for quality improvement cannot be
used to take personnel actions such as reassignment, changes in privileges, and
demotions.
(5) Protected Peer Reviews
(a) Essential elements of protected peer review include:
1. Determination of the necessity of specific actions recommended by the peer
review process,
2. Evaluation of an episode of care, and
3. Confidential communication back to appropriate providers regarding the
results and actions taken to improve performance.
(b) Peer review, as designated by the Secretary, Department of Veterans Affairs
(conducted for the purpose of improving the quality of health care and/or
improving the utilization of health care resources), is protected by 38 U.S.C. §
5705, and its implementing regulations. Peer review is a traditional
organizational function designed to contribute to improving the quality of care
and/or the appropriate utilization of health care resources.
VHA DIRECTIVE 2004-054
September 29, 2004
3
(c) Protected peer review documents for quality improvement include all reviews
of patient care by an individual provider that are performed for the purpose of
improving the quality of health care and/or improving the utilization of health
care resources. In order for the documents generated by a peer review to be
protected confidential under 38 U.S.C. § 5705, and its implementing regulations,
each peer review must be designated in writing as being conducted and/or
prepared for quality improvement and/or resource utilization purposes prior to
the initiation of the peer review. This designation can be issued by the Under
Secretary for Health (for all VHA facilities), by a Veterans Integrated Services
Network (VISN) Director (for VHA facilities within that VISN), and/or by the
facility Director (for the individual facility).
1. Language mandating protection under 38 U.S.C. § 5705 (such as the language in
following subpar. 2g(5)(c)2) must be clearly and visibly placed on every page of
every document to be made confidential.
2. All documents associated with this activity need to be treated as strictly
confidential, unless determined otherwise after careful review (with
documentation) by qualified VHA personnel. The following statement is
recommended for required documentation:
“The documents, records, and other information contained herein, which resulted
from _____(name of specific quality program or resource utilization
activity)____, are confidential and privileged under the provisions of 38 U.S.C.
§ 5705, and its implementing regulations. This material cannot be disclosed to
anyone without authorization as provided for by that law or its regulations. The
statute provides for fines up to $20,000 for unauthorized disclosures."
3. Information about protected peer review cases may not be disclosed and is to
be conducted as part of a facility’s quality improvement program. For example, a
peer review may be initiated when malpractice claims are filed, so long as the
purpose of the peer review is to identify, evaluate, and, where appropriate,
correct circumstances having the potential to adversely effect the delivery of
care. NOTE: As long as confidentiality is maintained and appropriately
documented, data from protected peer reviews can be aggregated and communicated
to the organized professional staff so that trends are understood and
opportunities for change identified.
4. Peer review findings may be disclosed as long as they are aggregated and
documented in a way that strictly protects the confidentiality of those involved
and are communicated solely for the purposes of promoting organizational
performance (including appropriate resource utilization) and optimal patient
outcomes. Aggregated findings may not be released unless individual provider
confidentiality is strictly protected.
5. Title 38 U.S.C. § 5705 protection does not mean that all documents are
confidential. Aggregated statistical information about multiple cases that does
not implicitly or explicitly identify individual VA patients, VHA employees, or
reviewers involved in quality assurance processes, is not protected. Similarly,
summary documents which only identify study topics, the period of time covered
by the study, criteria, norms, and/or general overall findings (while not
VHA DIRECTIVE 2004-054
September 29, 2004
4
directly or indirectly identifying individual providers or other employees,
patients, or reviews) are not protected.
6. Protected peer review for quality improvement always starts with an “initial
review,” which must be completed within 45 days. The initial peer reviewer uses
the definitions presented in subparagraph 2g(6) to evaluate quality and/or
resource issues related to the care given by an individual provider.
(6) Peer Review Levels
(a) The initial review results in determination of a Level 1, Level 2, or Level
3 (see following subpar. 2g(6)(b)1). Completed initial protected peer reviews
for quality improvement that were conducted by an individual reviewer must be
sent to a multi-disciplinary Peer Review Committee or subcommittee (hereafter
referred to as the Peer Review Committee) chaired by the Chief of Staff, or
designee. NOTE: As appropriate, the Chief Nurse Executive, or other non-nursing
Executives, or designees, will be asked to co-chair the Peer Review Committee.
(b) The Peer Review Committee then reconsiders all protected peer review cases
within the facility completed by the individual initial peer reviewers when the
level of review is determined to be a Level 2 or Level 3 (see following subpar.
2g(6)(b)1). Since the Peer Review Committee oversees all peer reviews, a
sufficient and representative sample of Level 1 peer review cases (at least 30
per year or 20 percent per year, whichever is greater, or all Level 1s if the
total number does not reach 30) need to be reviewed to ensure the validity and
reliability of the findings and to evaluate the peer review process itself.
NOTE: If there are fewer than eight Level 1s per quarter, all Level 1s need to
be reviewed on a quarterly basis.
1. Peer review of quality improvement and/or resource utilization purposes is
associated with the care provided by an individual licensed health care
professional and includes use of the following definitions in assessing the
decisions made by a provider:
a. Level 1. Most experienced, competent practitioners would have managed the
case similarly in all of the aspects listed in following subparagraph
2g(6)(b)1.c.
b. Level 2. Most experienced, competent practitioners might have managed the
case differently in one or more of the aspects listed in following subparagraph
2g(6)(b)1.c.
c. Level 3. Most experienced, competent practitioners would have managed the
case differently in one or more of the aspects listed:
(1) Choice of diagnostic tests and timely ordering of diagnostic tests.
(2) Performance of a procedure and/or treatment.
(3) Addressing abnormal results of diagnostic tests.
(4) Timeliness of diagnosis and appropriateness of diagnosis.
VHA DIRECTIVE 2004-054
September 29, 2004
5
(5) Timing of treatment initiation and appropriateness of treatment.
(6) Adequacy of technique during procedures.
(7) Recognition and communication of critical clues to patient’s condition
during period of clinical deterioration.
(8) Timely initiation of appropriate actions during periods of clinical
deterioration.
(9) Other relevant aspects of care.
(c) In order for documents to be protected as peer review documents conducted
for quality improvement purposes, the documents must meet one of the following
conditions:
1. Identifies, either implicitly or explicitly, individual providers or other
employees, patients, or reviewers.
2. Contains discussions relating to the quality of VA patient care and/or the
utilization of VA resources by health care evaluators during a review of quality
assurance data.
(7) Other than Protected Peer Reviews
(a) Documents that are generated during many other forms of review conducted for
purposes other than protected quality and/or resource utilization improvement
are not confidential and privileged under 38 U.S.C. § 5705 and its implementing
regulations. In addition to management reviews (see following subpar. 2g(7)(c),
examples of unprotected reviews include, but are not limited to:
1. Reviews conducted while considering clinical privileges,
2. Administrative investigations, and
3. Occupational Safety and Health Administration investigations.
NOTE: Malpractice payment reviews undertaken pursuant to Title 38 Code of
Federal Regulations (CFR) Part 46, “Policy Regarding Participation in the
National Practitioner Data Bank,” are not included within the scope of this
Directive (see VHA Handbook 1100.17).
(b) Findings from non-protected reviews may be disclosed.
(c) Management Review. The term “management review” is defined as any review
that is conducted for purposes other than confidential quality improvement
and/or resource utilization related to individual provider decisions. For
example, administrative investigations are a type of management review. Neither
management review processes nor any related documentation are protected by 38
U.S.C. § 5705, and its implementing regulations. The fact that management
VHA DIRECTIVE 2004-054
September 29, 2004
6
review findings are and can be disclosed needs to be clearly understood and
communicated (verbally and in writing) from the onset of a management review.
Management reviews and other non-confidential reviews must, by law, be kept
separate from any protected reviews. Unprotected management review activities
include, but are not limited to:
1. A review of activities of clinical staff to assess and attest to competency
of professional staff for the purpose of considering an adverse clinical
privileging action.
2. A review of activities performed for the purpose of an administrative
investigation.
3. A review of activities performed for the purpose of assisting the United
States in consideration of tort claims or defenses of litigation under the
Federal Tort Claims Act, particularly if the review is done at the request of
the Regional Counsel or the Assistant United States Attorney.
4. A review of activities related to Professional Standards Boards conducted for
the purpose of potentially reducing or removing privileges.
5. Peer recommendation forms used for credentialing and privileging.
3. POLICY: It is VHA policy that each VISN and health care facility must
establish and maintain a program of protected (confidential) peer review for
quality improvement purposes (including resource utilization) relevant to the
care provided by individual practitioners, in support of clinical care programs
and professional services; and must comply with the requirements of those
accrediting and oversight agencies that periodically review VHA health care
facilities, including, but not limited to JCAHO.
4. ACTION
a. VISN Director. The VISN Director is responsible for:
(1) Establishing oversight processes for their health care facilities’ peer
review activities in order to ensure policy development, implementation, and
follow-up on any action items formalized at the completion of a specific
protected peer review.
(2) Conducting periodic inspections of all VISN facilities to ensure that
oversight, compliance, and follow-up procedures are implemented and functioning.
(3) Ensuring that there is an adequate review of the information provided on a
quarterly basis (see subpar.4c(6)).
(4) Ensuring that Patient Safety Officers and Patient Safety Managers are not
assigned oversight duties related to peer review for quality improvement and/or
resource utilization purposes.
VHA DIRECTIVE 2004-054
September 29, 2004
7
b. Facility Director. The facility Director, or designee, has ultimate
responsibility for peer reviews for quality improvement that are protected and
performed within the facility. The facility Director is responsible for ensuring
that:
(1) A Peer Review Committee is established. The Peer Review Committee must be
multidisciplinary (including non-physician members) and consist of senior
members of key clinical disciplines. NOTE: VISNs and facilities may wish to
establish an independent committee or may choose to create a sub-committee of an
existing group, such as the Medical Executive Committee. For example, the
Executive Committee of the Medical Staff could fulfill this function. Legal
counsel may serve as technical advisor as needed. Communication with Regional
Counsel may also be appropriate. Persons capable of serving as a “peer” of the
provider whose case is being reviewed need to be included as members of the Peer
Review Committee. NOTE: Flexible membership procedures are periodically needed,
such as adding ad hoc members or ad hoc co-chairpersons, or asking another
executive-level clinician to participate on the Peer Review Committee (when a
subordinate is being reviewed), or requesting an executive from another
discipline to be a temporary co-chairperson. For example, if the issue being
reviewed directly involves nursing, then the Chief Nurse Executive, or designee,
needs to be considered as an ad hoc co-chair.
(a) If the activity which generated the document was performed at a VA facility,
it must have been performed by that facility staff, or there must have been
prior written designation of the role of those individuals who are not facility
staff.
(b) No peer reviewer may have direct involvement with the care in question.
(c) The peer reviewers must:
1. Withdraw from a case if determined that the specialized knowledge required
exceeds their expertise or when they feel uncomfortable about judging the care.
2. Abstain from review of cases in which there is a conflict of interest or, for
any other reason, the reviewer is unable to conduct an objective, impartial,
accurate, and informed review. NOTE: In the event that there is no peer at the
facility able or willing to serve as a peer reviewer, the Chief of Staff, or
designee, consults with the VISN Chief Medical Officer to make arrangements to
have the review conducted at another facility. The rationale for moving a peer
review must be documented.
3. Possess the relevant clinical expertise necessary to make accurate judgments
about the decisions being reviewed. To accomplish this, relevant current
standards of care must be considered. The basis for judgment, including use of
clinical experience and opinion, needs to be explicitly documented.
4. Be formally trained regarding the peer review process, their
responsibilities, and the organizations’ legal and ethical requirements. The
peer reviewers must be clearly informed:
a. Of 38 U.S.C. § 5705, and its implementing regulations; and
VHA DIRECTIVE 2004-054
September 29, 2004
8
b. That the information they learn from their review is confidential and cannot
be revealed to anyone outside the protected quality management process.
(2) A facility-level policy for protected peer review is developed and approved
by the VISN Director by March 4, 2005. At a minimum, this policy must require
that protected peer review (conducted for quality improvement purposes,
including resource utilization) occur as described in this Directive. In
addition, this policy must include provisions that state:
(a) Criteria and definition(s) for those circumstances requiring protected peer
review for quality improvement.
(b) Specification of the participants to be involved in the peer review process,
including incorporation of the definition of the term “peer” as defined in this
Directive.
(c) Method(s) for selecting ad hoc reviewers for protected peer reviews and ad
hoc co-chairs (to be dictated by the content to be reviewed).
(d) Time frames for protected peer review activities, including when reviews are
to be conducted and when results are to be reported to all parties concerned,
including the providers whose care is under review and VISN leadership.
(e) That issues related to patient safety, law enforcement, or potential
administrative investigations determined during the peer review process are
documented and referred to the appropriate management, professional, or law
enforcement official in a timely manner utilizing existing routine-use
exceptions involving those issues. For example, routine use 3 in patient medical
records, system of records 24VA136 permits the referral of relevant records to
the appropriate authorities when there is a violation of law, whether criminal,
civil, or regulatory.
(f) The invited participation (during the review) by the individual(s) whose
performance is being reviewed (see subpar. 4c(8)).
(g) The coordination of an outside protected peer review (conducted outside the
facility), when needed.
(h) The formal education of peer reviewers, to include:
1. VHA quality improvement and patient safety activities can generate
confidential documents under 38 U.S.C. § 5705, and its implementing regulations.
2. Protected peer review pertains to matters relevant to quality improvement
and/or resource utilization and must be identified as confidential in writing at
the beginning of the peer review process.
3. Policy for peer review for quality management purposes must specify the
circumstances under which the reviews need to be considered, including the
following:
VHA DIRECTIVE 2004-054
September 29, 2004
9
a. Mortality Review. All deaths must be screened against death review criteria
and exceptions to the death review criteria (see Att. A). Cases that meet the
criteria must be referred for protected peer review for quality improvement.
Mortalities and major morbidities associated with any surgical procedure
(elective or not) or any mortality later during the same hospitalization (or
related to readmission for the same condition within 30 days) need to undergo
morbidity and mortality peer review.
b. Negative Outcomes. Negative Outcomes are events in which a patient has
experienced a negative and/or unexpected outcome that may be related to the care
provided and for which facility management considers peer review the best method
for determining if the care was appropriate.
c. Executive Concerns. Concerns about quality management issues from members of
leadership or service and/or department chiefs may be requested when
specifically related to the provision of patient care by a provider under the
charge of the executive. Each facility must establish a process for initiation
of peer review based on executive concerns.
d. Tort Claims. Initial notification of the filing of a tort claim may generate
an immediate protected peer review for quality improvement to assess the extent
of clinical staff involvement, review the patient’s outcome, as well as to
identify, evaluate and, when appropriate, correct circumstances having the
potential to adversely effect the delivery of care and/or organizational
performance. For this peer review to be protected by 38 U.S.C. § 5705, and its
implementing regulations, it must be done for the preceding purpose (which is
directly related to quality and/or resource utilization issues) and not for the
purpose of assisting the United States in consideration of tort claims or
defense of litigation under the Federal Tort Claims Act.
e. Concerns of other Facility Groups. Organizational groups or functions within
the facility may submit a request for protected peer review for quality
improvement purposes (including resource utilization). Facility groups
interested in this type of peer review are typically interested in reviews of
operative reports, invasive and non-invasive procedures, blood usage, medication
usage, restraint and seclusion, resuscitation, care to high-risk populations,
efficiency of clinical practice patterns, significant departures from
established patterns of clinical practice, and completion of medical records.
Conversely, facility groups may submit reports. On a quarterly basis, the
committee or subcommittee responsible for protected peer review must review
submitted reports from facility groups.
c. Peer Review Committee. The Peer Review Committee is responsible for:
(1) Meeting on a regularly scheduled basis, quarterly. A Chair or Co-Chair may
call ad hoc meetings or add ad hoc members as needed.
(2) Reporting at least quarterly to the Executive Committee of the Medical Staff
and (when appropriate) to the Chief Nurse and other key (non-nursing)
Executives, as needed. NOTE: Executives from across disciplines need to be kept
apprised of peer review activities related to their subordinates (see subpar.
4c(6)).
VHA DIRECTIVE 2004-054
September 29, 2004
10
(3) Coordinating the referral of significant information to appropriate
personnel when the deficiency of care was not met due only to a system (i.e.,
organizational) issue(s). NOTE: Different types of reviews (e.g., protected and
non-protected) can occur parallel to, or before and/or after, each other as long
as protected and non-protected information and processes are kept separate.
(4) Completing the final review of each case within 120 days from the
determination that a peer review is necessary (the initial reviews must to be
completed within 45 days). The exception for a delay, or an extension beyond 120
days, needs to be documented and signed off by the Chief of Staff, who is
responsible for monitoring and reviewing the number of extensions on a
semi-annual basis.
(5) Notifying the Chief of Staff, or designee, and (as appropriate) the Chief
Nurse Executive, or other non-nursing Executives, immediately if the matter
being reviewed raises concerns about the possibility of substandard care,
negligence, or any other competency issue that might impact safety or
privileges.
(a) In consultation with other Executives, the Chief of Staff, or designee,
determines what actions are needed to protect patients and whether or not a
non-protected review is needed in addition to, or instead of, the protected
review.
(b) Provided that information is kept confidential as required, the protected
findings or any other protected information or documentation (which are the
results of 38 U.S.C. § 5705-protected activities) generated by a peer review may
also “trigger” a new investigation that is not 38 U.S.C. § 5705-protected, such
as a management review; or it may trigger an additional protected review, such
as an RCA. Although the protected findings may serve as the trigger for a
non-protected review, these same findings are protected (confidential) and
cannot be disclosed.
(c) Only the initial report (“charging facts”) can be communicated when starting
a non-protected review, which means that a new and separate investigation(s)
must begin.
(d) There are no restrictions on multiple reviews, as long as protected and
non-protected information and processes are kept separate, and as long as only
the initial reporting information is forwarded from those conducting a protected
review to those conducting a non-protected review.
(6) Quarterly tracking of peer review activity. This includes the following:
(a) The number of reviews;
(b) The outcome by Level 1, Level 2, and Level 3;
(c) The number of changes from one level to another during the review process
(e.g., the initial reviewer determines a Level 2, but it is changed to a Level 1
by the committee);
VHA DIRECTIVE 2004-054
September 29, 2004
11
(d) Follow-up on action items; and
(e) Recommendations that result from completed peer reviews.
(7) Ensuring that formal discussions about peer review (e.g., occurring during
peer review committee meetings) are recorded in formal meeting minutes.
Documentation relevant to protected peer reviews must be kept by a Peer Review
Committee official in a folder(s) that is not identifiable by provider and
stored in a secure location.
(8) Inviting the provider whose care is under review by the Peer Review
Committee (only Level 2 and Level 3) to submit written comments on issues raised
during the review process and to provide additional substantive documentation if
a Level 2 or Level 3 is assigned following the initial review. When a Level 2 or
Level 3 has been determined, providers must also be allowed, if they choose, to
appear before the Peer Review Committee before a final committee decision is
reached. The responsible Peer Review Committee official must fully document
discussions held with a provider. NOTE: The provider whose care is under review
has the option to appeal based on local policies.
(9) Ensuring that the initial peer review (conducted by an individual) is
accomplished within 45 days. Extensions may be granted in writing only by the
Chief of Staff, or designee. NOTE: The number and reasons for extensions will be
tracked and documented by the Chief of Staff.
(10) Seeking, as necessary, peer reviewers from outside the facility or VISN. If
multiple reviews are required for the same case (for example when the same case
requires both a protected peer review as well as a non-protected review, such as
an administrative investigation), outside assistance from another facility or
VISN may be sought. NOTE: These instances are relatively rare.
(11) Conducting each review through an explicit application of current standards
of care based on accepted practice and analysis of reviewed professional
literature published within the United States health care community.
5. REFERENCES
a. Title 38 U.S.C. § 5705.
b. Title 38 CFR Part 46, “Policy Regarding Participation in the National
Practitioner Data Bank.”
c. Title 38 CFR 17.500-17.511, “Confidentiality of Healthcare Quality Assurance
Review Records.”
d. VHA Handbook 1050.1, VHA National Patient Safety Improvement Handbook.
e. VHA Directive 0700, Administrative Investigations.
VHA DIRECTIVE 2004-054
September 29, 2004
12
f. VA Handbook 0700, Administrative Investigations.
g. VHA Handbook 1100.19, Credentialing and Privileging.
h. VHA Handbook 1100.17, National Practitioner Data Bank Reports.
i. VHA Record Control Schedule 10-1.
j. VHA Directive 2004-036, Mortality Assessment.
k. VHA Directive 2004-051, Quality Management (QM) and Patient Safety Activities
That Can Generate Confidential Documents.
l. VA System of Records, 24VA136.
6. FOLLOW-UP RESPONSIBILITY: The Office of the Deputy Under Secretary for Health
for Operations and Management (10N) and the Office of Quality and Performance
(10Q) are responsible for the contents of this Directive. Questions may be
referred to 202-273-8953.
7. RECISSIONS: None. This VHA Directive expires July 31, 2009.
S/Jonathan B. Perlin, MD, PhD, MSHA, FACP
Acting Under Secretary for Health
DISTRIBUTION:
CO:
E-mailed 9/30/04
FLD:
VISN, MA, DO, OC, OCRO, and 200 – E-mailed 9/30/04
VHA DIRECTIVE 2004-054
September 29, 2004
A-1
ATTACHMENT A
DEATH REVIEW SCREENING CRITERIA
If any of the following criteria is present, Peer Review is required.
1. There is lack of documentation of patient’s deterioration during 48 hours
preceding death.
2. There was a change in patient’s condition with no action taken during 48
hours preceding death.
3. If there was a cardiac or pulmonary arrest, could it have been avoided?
4. There was a lack of concordance between patient’s pre-mortem and post-mortem
diagnoses.
5. It appears there were signs of patient’s deteriorating condition that should
have been noted and/or communicated to the physician, but were not.
6. Death appears to be related to a failure to carry out orders.
7. There is a lack of documentation indicating explanation for the death.
8. There is a lack of documentation indicating that the patient’s death was
expected.
9. Death appears to be related to a hospital-incurred incident or a complication
of treatment.
10. Death within 24 hours of admission (except in cases in which death is
anticipated and clearly documented, such as transfer from hospice care).
11. Death within 72 hours of transfer out of a special care unit (unless the
transfer was made because death expected).
12. Death during or within 30 days of a surgical procedure or (if after 30 days)
death is suspected to be related to the original procedure.
13. Death appears to be related to a medication error or a choice of medication.
14. There is reason to think death may have been preventable.
VHA DIRECTIVE 2004-054
September 29, 2004
B-1
ATTACHMENT B
PEER REVIEW FLOWCHART Need for Peer Review for Quality Improvement Identified.
Identify Peer Review as protected by Title 38 United States Code 5705QM sends
letter to provider requesting written response and inviting provider to meet
with PRC Initial Peer Review completed and Level of Care assigned(1, 2, or 3).
Reviewer sends case to Quality Manager (QM).Level 1's sent to PRC member who
selects casesf or PRC review. All Level 2's and 3's sent to PRC. Identify
provider specialty and forward to peer reviewer. When process/system issues are
identified, include in report to Peer Review Committee (PRC) PRC reviews case
and mayreassign Level of Care assigned in initial peer review. If desired,
provider submits written response to QM (who forwards response to the PRC).
Provider mayalso meet with PRC.PRC reviews case and decides final Level.
Provider has option to appeal, based on local policies. PRC sends final
recommendation to the QMQM sends letter to the service chief, Chief of Staff, or
Chief Medical Officer. Case Returned to QM Director informed as appropriate What
is theLevel assigned? PRC makes quarterly report to appropriate local executive
committees Service chief discusses and documents review with provider. Note:
Peer reviews for QI cannot be used for personnel action. Process or systems
issues present to patient safety staff12 or 3VHA
Directive 2004-054
National Ethics Teleconference
Disclosing Adverse Events to Patients
April 29, 2003
Dr. Berkowitz:
Good day everyone. This is Ken Berkowitz. I am the Chief of the Ethics Consultation Service at the VHA National Center for Ethics in Health Care and a physician at the VA NY Harbor Healthcare system. I am very pleased to welcome you all to today's National Ethics Teleconference. By sponsoring this series of calls, the Center provides an opportunity for regular education and open discussion of important VHA ethics issues. Each call features an educational presentation on an interesting ethics topic followed by an open, moderated discussion of that topic. After the discussion, we reserve the last few minutes of each call for our 'from the field section'. This will be your opportunity to speak up and let us know what is on your mind regarding ethics related topics other than the focus of today's call.
Dr. Berkowitz:
Remember that CME credits are available for listeners of this call. To get yours go to http://vaww.ees.aac.va.gov/ethics.
Ground Rules: Before we proceed with today's discussion on Disclosing Adverse Events to Patients, I need to briefly review the overall ground rules for the National Ethics Teleconferences:
Today's presentation will cover the most recent report of the National Ethics Committee, “Disclosing Adverse Events to Patients.” The National Ethics Committee (NEC) is a standing subcommittee under the Executive Committee of the National Leadership Board. The NEC is made up of an interdisciplinary and broadly representative membership that includes both VHA leaders and staff. The Committee is responsible for providing guidance on difficult ethical issues affecting VHA patients and employees—as well as health care policymakers and interested parties beyond VHA. The Committee accomplishes this task is through the development of reports on timely ethics topics. This report, “Disclosing Adverse Events to Patients,” provides the ethical and legal reasons for disclosing adverse events to patients, and identifies barriers that can prevent practitioners from effectively disclosing adverse events. The report concludes by offering practical recommendations for what adverse events warrant disclosure, who should disclose, when to disclose, and how disclosure should occur. To begin today's presentation I would like to call upon the primary author of this report, Dr. Michael Cantor. Dr. Cantor is both a physician and a lawyer, and is currently the Associate Director of the New England GRECC Boston Site.
Now, I’d like to turn things over to Mike Cantor.
PRESENTATION
Dr. Cantor:
Thank you Ken, and welcome to everyone. First, I’d just like to say that writing a National Ethics Committee report is not a trivial task, and a lot of people worked hard to get this report together. That being said, I’d like to thank the authors who contributed to this report: Paul Barach from the University of Chicago Department of Anesthesiology and Critical Care Medicine; Arthur Derse, Center for the Study of Bioethics, Medical College of Wisconsin, and Chair of the National Ethics Committee; Ginny Hamm, Lexington, KY VAMC, Caryl Lee, National Center for Patient Safety, Claire Maklan of the National Center for Ethics in Health Care; Marta Render, VA Midwest Patient Safety Center of Inquiry, David Weber, Office of Research Compliance and Assurance, Ginger Schaffer Wlody of the Phoenix VAMC; and Ellen Fox, Director of the National Center for Ethics in Health Care.
I hope that most of our audience had a chance to read the National Ethics Committee report that we’ll be discussing today, “Disclosing Adverse Events to Patients.” The subject of disclosing adverse events to patients is often a controversial one. Many practitioners feel that disclosing adverse events to patients would open the door to civil lawsuits and liability, and there is a real fear among clinicians and institutions over litigation costs, higher malpractice premiums, and loss of patients. Add to this the emotional toll that lawsuits have on clinicians, and there is a strong incentive not to disclose adverse events. However, we feel that the disclosure of adverse events is ethically warranted, and that part of the controversy over disclosing adverse events stems from the confused definitions that surround it.
For this report, the National Ethics Committee we favor the definition of adverse events already found in VHA policy. VHA defines an adverse event as:
untoward incidents, therapeutic misadventures, iatrogenic injuries, or other adverse occurrences directly associated with care of services provided within the jurisdiction of a medical center, outpatient clinic, or other VHA facility. Adverse Events may result from acts of commission or omission (e.g., administration of the wrong medication, failure to make a timely diagnosis or institute the appropriate therapeutic intervention, adverse reactions or negative outcomes of treatment). Some examples of more common Adverse Events include: patient falls, adverse drug events, procedure errors and/or complications, completed suicides, parasuicidal behavior (attempts, gestures, and/or threats), and missing patient events.
The report focuses on a subset of adverse events covered by this broad definition, namely, those that are potentially preventable.
This definition is the starting point of our ethical analysis of disclosing adverse events to patients.
Dr. Berkowitz:
Thanks Mike. We'll get back to you in a few minutes to talk about the report's recommendations, but let’s first consider the ethics of disclosing adverse events. For that, I'd like to call on Leland Saunders. Leland works for the Center, his background is in philosophy and health care ethics. Leland…
Mr. Saunders:
Thank you Ken. There are really four ethical arguments that favor the disclosure of adverse events to patients.
v The first is based in utilitarian ethics, which places the highest value on actions that produce the greatest balance of benefit over harm for all persons affected by the action. This argument favors disclosure because there is anecdotal evidence to suggest that patients, clinicians, and organizations benefit from disclosure.
o Patients benefit because timely disclosure of an adverse event makes it possible to start remedial care, which may restore health, or at least minimize the harm. Similarly, if a patient suspects that something has gone wrong, that suspicion can cause more harm than disclosure of the adverse event, and patients who have been informed of an adverse event are more likely to cooperate with future treatment.
o Practitioners benefit from disclosure of adverse events because it lifts the emotional burden that they carry after causing or contributing to an adverse event. When a practitioner is involved in an adverse event, the emotional toll can be heavy; especially for physicians whose profession values perfection, and whose prime directive is do no harm. Disclosing the adverse event can help alleviate that emotional burden. Also, in one study, house officers who disclosed mistakes said that the disclosure helped them learn from errors and improve their practice.
o Organizations benefit because encouraging the disclosure of adverse events may help reduce the likelihood that similar events will happen in the future, and thereby improve the overall culture of safety within an organization. Organizations that lack support or incentives to disclose adverse events are usually also organizations where disciplinary action is expected, competition among clinicians is keen, and job security is lacking.
v The second ethical argument favoring disclosure is based in a duty-based ethic. A duty-based ethic hold that health care professionals have a duty to be truthful to their patients, and by extension, a duty to disclose adverse events. There are three main sources for the professional duty of truth-telling.
o First, respect for patient autonomy requires that patients be provided with the information they need to make a health care decision.
o Second, truth-telling is part of an implicit promise practitioners make to patients to act in the patient’s best interests.
o Third, truth-telling is important in establishing and maintaining patient trust.
v The third ethical argument favoring disclosure is derived from professional ethics standards. Professional ethics standards are the defined norms or expectations for the conduct of members. The ethics standards of the American Medical Association, American College of Physicians/American Society of Internal Medicine (ACP-ASIM), and the American Nurses Association[MDC1] all support the disclosure of adverse events. For example, here’s a quote from the ACP/ASIM Ethics Manual: “In addition, physicians should disclose to patients information about procedural or judgment errors made in the course of care if such information is material to the patient’s well-being. Errors do not necessarily constitute improper, negligent, or unethical behavior, but failure to disclose them may.” Other professional codes do not explicitly discuss adverse events, but they do include provisions for honesty and integrity. And, as of July 2001 the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) began requiring acute care hospitals to have policies in place to ensure that “patients and, when appropriate, their families are informed about the outcomes of care, including unanticipated outcomes.”
v And the final ethical argument favoring disclosure of adverse events had to do with health care organization mission statements or statements of corporate values. VHA’s core values of trust, respect, commitment, compassion, and excellence influenced policymakers’ decision to require the disclosure of adverse events to patients that are harmed.
Dr. Berkowitz:
Thanks Leland, thinking about the ethical obligation of disclosure from several angles helps keep its importance in perspective. Now lets turn back to Mike Cantor to go over the Committee’s recommendations for disclosing adverse events to patients.
Dr. Cantor:
Thanks Ken. If you have a copy of the report, the recommendations begin on page 7.
v The recommendations of the Committee deal with what adverse events need to be disclosed. Our recommendations do go further than both VHA Patient Safety policy and the JCAHO standards, but we believe that there are good ethical and legal reasons to disclose in the following circumstances:
o Whenever an adverse event has a perceptible effect on the patient that was not discussed in advance as a known risk. The question on this recommendation is: who has to perceive the effect in order to warrant disclosure? We believe that disclosure is warranted even in instances where only the clinician is aware of the effect, as well as when the patient or family perceives the effect. Another question this recommendation brings up is what level of effect, or what level of harm necessary to warrant disclosure. The committee recommends that even if there is no harmful effect, disclosure should occur whenever the adverse event has had a perceptible effect on the patient, regardless of whether the effect is physical, psychological or both. Whether the effect is actual or anticipated, disclosure is warranted.
o Disclosure is also warranted whenever an adverse event necessitates a change in the patient’s care. And this can be a small change or an extreme change. Either way, the patient should be told the reason that the care plan has changed.
o Disclosure is called for when the adverse even potentially poses a significant risk to the patient’s future health. And again, this could be any risk, large or small. The patient needs to be aware and informed of anything that could be potentially harmful.
o And lastly, disclosure is called for whenever a treatment or procedure is provided without the patient’s consent. This recommendation is really a way to protect a patient’s fundamental right to be informed.
o For an adverse event that does not fall into one of these categories, disclosure is discretionary.
v The Committee also made recommendations about who should disclose an adverse event to a patient.
o When an adverse event results in no harm or only minor harm, the clinician responsible for the patient’s care needs to disclose.
o If an adverse event results in serious injury or death, or involves potential legal liability, a multi-step process is best. First would the “clinical disclosure”, where members of the clinical team provide preliminary information, express concern for the patient’s welfare, and reassure the patient that steps are being taken to investigate the situation. This would be followed by an “institutional disclosure”, where the patient and/or family would be invited to meet with institutional leadership and risk management. An apology would be made, and discussions about compensation are initiated. When an adverse event involves a house officer, facilities and residency programs should provide them with specific instructions on how to respond to the adverse event.
v The Committee also recommends that disclosure take place in a timely manner. Delays in disclosure should only be long enough to give staff members time to collect preliminary information and plan the best way to disclose. Facilities should develop more specific timeframes for disclosure.
v And lastly, the Committee recommends that disclosures should occur in a proper setting, and follow accepted methods for “breaking bad news.” The location should be private, quite, and suitable for discussion, with adequate time set aside. Social workers or Chaplains should be present to help the patient and/or family cope. The explanation should be thorough, and if it is known that the adverse event was the result of substandard care, an apology should be made. Clinicians should not be defensive, and should expect emotional and even angry responses.
Dr. Berkowitz:
I think one thing that’s also worth mentioning here before we move on is the distinction between disclosing an adverse event and discussing an adverse event. Many times adverse events will be discussed with patients, lots of adverse events are already apparent to the patient, or are caused by progression of the underlying disease or other non-preventable factors, and disclosure is not warranted in these circumstances. Even though there may not be a formal disclosure, all adverse events need to be discussed. So the report is not intended to limit disclosure or discussion, but to clarify when things must be disclosed to patients.
Now, there are obviously some very strong ethical reasons to disclose adverse events to patients, but my experience is that most people are very reluctant to do it. Even if they know it’s the right thing to do, it’s uncomfortable and just easier not to. Could you talk a little bit about why people might try to avoid disclosing adverse events, even if they think it’s the right thing to do?
Dr. Cantor:
It’s interesting that you bring that up. A couple of recent studies really drive this point home. For example, in one study researchers posed a series of hypothetical scenarios to clinicians and recorded their responses. In one hypothetical case a drug error led to a patient’s death. One-third of the clinicians studied said they would disclose only incomplete or inaccurate information to the patient’s family. Similarly, a study of house officer’s attitudes showed that they seldom disclose adverse events, especially if they believe the institution will be judgmental.
A couple of really big barriers to disclosure are legal and financial concerns. Some of these concerns are legitimate, but others are simply unfounded. At the same time, there are some pretty basic psychological and cultural factors that make people want to keep quiet about “bad news”.
Dr. Berkowitz:
A statement you made just now made my ears perk up a bit, and that was when you mentioned potential legal liability surrounding disclosure. I think a lot of practitioners fear getting sued when something bad happens, whether it was the result of a medical error or not. And it used to be that the legal wisdom was always to admit to nothing. Does the law protect practitioners who are open and honest about adverse events, or does it open the door for litigation?
Dr. Cantor:
The fears that you mentioned about civil lawsuits and liability claims are cited by numerous sources as the single most significant reason why clinicians are reluctant to disclose. And not without some legitimate reasons. Studies show that threatened or actual malpractice suites lead to psychological trauma, job strain, shame, and self-doubt. And clinicians who actually experience a malpractice suit are more likely to consider retiring from practice.
However, despite these fears, legal and regulatory systems often encourage disclosure, and under some circumstances, may even require it. And some attorneys and legal commentators are the strongest proponents of disclosure. There’s some interesting legal history here, but one case is really worth mentioning here.
The Simcuski v. Saeli case was tried in New York, and the patient successfully sued his surgeon for failing to admit an error that might have been mitigated by prompt treatment, but instead resulted in permanent disability. What was so important about this case is that the plaintiff sued for fraud, not for negligence. And fraud, unlike negligence, exposes a person to potential punitive damages, which can increase the size of the award, and is often not covered by liability insurance.
Even with cases like this on the books, evidence suggests that when practitioners disclose adverse events to patients, they are much less likely to sue. For example, since the Lexington VA Medical Center implemented a policy to disclose all adverse events that result in harm to patients, they have witnessed a drop in total liability payments resulting from lawsuits. All this suggests that the best way for a practitioner to avoid being sued is to disclose adverse events openly and honestly.
DISCUSSION
Dr. Berkowitz:
Has anyone had experience doing this? Any success? Any barriers? How is the disclosure process incorporated into the patient safety and risk management programs at your facility?
Dale Smith, Regional Counsel, San Francisco:
The point you made about disclosure verses discussion is really important. What we found in some cases is that there’s a tendency to prematurely discuss something that really hasn’t been ascertained. We do not exactly know the cause of what happened, but people are guessing at it because they want to give an answer to the patient/family.
I do not think that is a very good idea at all. We have to tell them exactly what happened and in as factual terms as possible. I get very nervous out here in California when staff say, “We made a terrible, terrible mistake,” which is what some people advocated doing. You can tell them that an error was made. In fact, there are very good legal reasons to tell them an error was made. The statute of limitations for tort claims is 2 years. However, there is case law that states the clock does not start to run until the patient knows or should have known about the facts.
So if we do not disclose we could have that 2 years statute almost forever, extending until they do find out. And then your chances are a lot greater of being sued. I think we have to be truly factual about what we tell the patients. And if we do not know what happened, tell them “We are not quite sure yet what happened.” That’s a perfectly good answer, and we let them know when we find out. I really advocate for adhering strictly to the facts of the case.
We’ve also had some cases where doctors have commented on care given by other practitioners, assuming that certain things are the case, when they really aren’t. That could be a problem too. There are some pitfalls here legally but I think so far it’s an excellent policy. But stick to the facts and that’s the best way to stay safe.
Dr. Berkowitz:
Well, thank you Dale for your comments. Two really important points, the one that may have been hidden in there a little bit is that by documenting disclosure you start the clock on the statue of limitations. . Which may, from a legal standpoint, actually work out in your favor.
But your main point, I think was the tendency to prematurely discuss things or to speculate or to assume certain things in these discussions. Mike, you probably want to comment on this but I would imagine that having clear, transparent and consistent polices and processes to follow would really minimize that.
Dr. Cantor:
Absolutely. I think in the report we talk about the difference between the clinical disclosure versus the institutional disclosure. The idea in the clinical disclosure is that you say what happened and you tell the patient we are looking into this and we are going to figure out the causes behind what happened. Then we’ll get back to you with formal and full disclosure.
In Lexington, where Ginny works, that’s where they have the longest experience that I am aware of in VHA. That’s what they do and it works out very well. They have a committee that is set up with people from multiple disciplines including leadership of the facility; the Chief of Staff is very involved in all of the disclosures. Steve Kraman is involved in personally making disclosures on behalf of the institution.
They make sure that when they work with their clinicians they tell them not to say anything that they are not 100% sure of. Now that we have the whole National Patient Safety program in place with new processes and lot’s of investigations going on. It makes sense for us to wait until those processes are concluded before making determinations about what the causes were, who was involved and who was responsible.
Lester Jones, MD Greater Los Angeles Healthcare System:
A couple of years ago I met with the people from Lexington and we actually adapted that very same policy here in our VISN. We have been using this system for approximately two years, and have had quite good success with it. It’s really a testimony to Ginny Hamm and Steve Kraman for putting that project together. It definitely does work. We have seen our claims actually diminish substantially. I wish our Regional Council, Ken La Faso, is listening, I would love to have him respond to this also. Ken and I have been spearheading that through the Los Angeles Healthcare System and we have had pretty good success with this.
Dr. Cantor:
You said that your liability cost had dropped. I think that the other major benefit that is important is that the relationship between the patients and the facility, and the clinicians and the facility improved as a result of this openness and the idea that people are sort of holding it together. Is that something that you have noticed?
Dr. Jones:
Yes, I have. I could tell you from my own personal experience being involved with this. The few case that have involved disclosing, we have offered these individuals an opportunity to file administrative tort which is one of our responsibilities, and if we feel that it is in the best interest to do so. We have had several people who have backed away and not filed a tort claim against the institution, which I thought a little surprising. But it just goes to show you that if you are honest with people, people just want to know what the truth is.
William Nelson, National Center for Ethics in Health Care:
I just want to follow up on Mike’s comment to you. Success is not only in terms of decreased liability or payouts, but also just in terms of patient-provider or patient-institution relationships. I was wondering have people in West LA done any type of formal survey, such as a patient satisfaction or a follow up with patients that you have worked with in terms of empirically collecting information about their reactions?
Dr. Jones:
Well we haven’t done that as of yet. That is one of the things we want to do. We want to be able to demonstrate from an objective standpoint that the full disclosure process as produced by the Lexington VA actually does work and be able to show at some point, empirically, that we have evidence to prove it.
Fran Cecere, RN Syracuse NY VAMC:
We do have a program but I do have a question about this full disclosure. Hypothetically, let’s just say you have a patient that’s in a hospital for an extravasation of chemotherapy that really causes a kind of gross looking wound. You want to tell the family about it, but they cannot see it because it’s under a dressing or it’s under a cover or whatever. Those people, who do full disclosure, do you offer to show it to the family? What if they do not want to see it? That’s my question. How do you deal with that?
Dr. Cantor:
I think disclosure doesn’t necessarily mean complete demonstration. It depends a lot on the nature of the wound, and the family member, and the patients themselves. The first thing I think you have to do is talk to the patient about it. Obviously they are in significant pain or discomfort from this wound. You need to ask the patient what they understand about what is going on, and explain what happened and then tell the patient and family member why this happened. I do not think you have to flash the wound in the face of the family, which could be a traumatic and shocking event. Instead, you should communicate to them that something has happened, that you are doing everything possible to prevent it from getting worse, and that you are going to take steps to manage the pain. And answer their questions and try to figure out why this happened. In a case like this, you’d probably know, but that you’d get back to them once things are clear and the situation has calmed down.
Ms. Cecere:
There may also be a situation where a decubitus ulcer develops and the patient is not even aware of it. You would have to deal with the family, and what if they are a visual family? They might want to see it. And then again they might not want to see it, if they are squeamish and couldn’t look at it.
Dr. Cantor:
The whole objective is to communicate effectively to the patient, or the family in the case of patient who cannot participate in the discussion, sort of what’s going on with the patient’s health care and what’s being done to mitigate it. What happened, what’s being done to prevent further harm and how it’s going to be treated so patient can be made whole again?
And I think that’s part of common sense for good patient care. And you have to use your judgment when dealing with the family and say; “we know that the patient now has this decubitus ulcer in the sacral area. You can look at it if you’d like, or we could tell you what it looks like.” Effective or non-effective, you have to give the basic facts or leave it up to the family to decide how much they really want to know, and how much they want to see. Is that helpful?
Tia Powell, MD, National Center for Ethics in Health Care:
I am wondering if you could comment on the rights and obligations of trainees. I am thinking about a very distressing incident that occurred when I was a medical student. There was a medical error and the attending surgeon declined to inform the patient about the mistake. It was extremely distressing for the house staff and for me as a student. What can you say about the freedom of trainees, medical students and residents to disclosed events?
Dr. Cantor:
I think that that is a very difficult set of circumstances. One of the biggest challenges we face in our educational system is how to educate people and trainees of all kinds, from all disciplines, to think about patient safety and the systems problem, and what to do in terms of how to report adverse events. ,
Given the existing medical culture, it’s really about our culture changing away from the traditional hierarchical medical system where you have the surgeon and attending physician at the top, and everyone else below that person. For safety it really should not matter whether or not the person who is identifying the problem and suggesting how to fix it is a medical student, nursing student, technician, physician or whoever. Unfortunately, I do not think we are at the point where we have succeeded in many institutions in accomplishing that objective of flattening out the hierarchy so they all are working toward the same goal, ensuring the patient’s safety.
Having said that, what does that mean for trainees who are put in these circumstances where the attending tells them to lie, or intimidates them to be silent? There is an article in Health Affairs that describes exactly that circumstance, where a trainee becomes part of the professional code of silence. And obviously that’s not right. What trainees need to do is to work around the attending physician. By that I do not think they should go ahead and disclose, but they need to get in touch with the leadership of their training program and their supervisors, and let them know what happened from their perspective, and to alert them to the potential of an adverse event that occurred that wasn’t being disclosed, or may not have been reported. And now, of course, the event has to be reported within VHA. It is a very difficult situation right now. Hopefully, over time, we will we evolve and move towards a system that is more open and transparent and honest, and allows people of all disciplines and all levels with their training and expertise to speak out and not worry about being punished for their honesty.
Dr. Berkowitz:
The answer is that there really has to be a culture change. People have to recognize that this is right; this is the way we do it and be empowered to participate in it. And obviously, it has to cut across all professions as you say for example. Could you talk a little bit about maybe the role of a nurse or pharmacist say if there was a medication error?
Dr. Cantor:
This is really a difficult problem because each discipline has it’s own code, if you will, in terms of how they think things should be managed. I think the attorney from San Francisco mentioned how physician have interpreted the actions of other people which turn out not to be accurate. I was at a conference about disclosing adverse events where a nurse got up and talked about being put in “Nursing Jail,” where she was basically shunned by her colleagues because she had admitted that she caused an adverse event, and was punished for this. I think it is very hard to know exactly what the right thing to do is.
But I think as far as an individual clinician, they need to understand the system within which they are working. Hopefully, if they are in an organization where patient safety is encouraged, disclosing and reporting adverse events is encouraged, then physicians, nurses, pharmacist, social workers will feel confident that when they are involved in a proposed problem, they can report it and that it will be managed by the institution and by the patient safety group within that institution. That’s what we are working towards and figuring out how to strengthen the team approach to managing adverse events. Again something that we are still working on.
Dr. Haque, Detroit VAMC:
I had a question related to the previous caller who was asking a question about demonstrating a wound and other things of that nature to the family. We had a situation a few years ago where the family actually wanted not only to see the wounds but to actually photograph them for other family members.
Dr. Cantor:
If you are going to live in total honest disclosure then if the family wants to take pictures of the wound, and have permission of the patient or their proxy or the surrogate for the patient, then certainly they should be allowed to take the picture. Is the picture going to be harmful if used in litigation the issue about how much information is that picture going to provide? And who are the people who really look at it. Lots of wounds look ugly, but that doesn’t necessarily mean that they were caused by an adverse event, or that they are a result of a medical mistake, or that they are the result of something, which is potentially circumstance where a practitioner could become liable in a court of law. So I think people really want to be sort of adversarial and sort of pushing the clinician and think it’s OK to use there judgment to decide, most times it’s probably OK to take the picture. It an issue that sort of raises the specter of liability and if you really believe that honest full disclosure reduces liability, and leads to better outcomes, then the picture isn’t going to make any difference.
Dr. Berkowitz:
Another way to think about it Mike, is to turn it around and to think why wouldn’t you honor that request, assuming that it was from the patient or an authorized surrogate. And if really the only answer is to some how limit the disclosure, then it’s hard to reconcile that with the spirit of the disclosure. I am not sure, but depending on the specific circumstances you may want to swing back the other way and offer to help them take the picture. And maybe make it part of the medical record. So there is really different ways to approach that from one end of the spectrum all the way to the other. But it really goes back to the basics of disclosure.
Douglas Devine, Tomah WI VAMC:
My question has to do with consent for disclosure and the HIPAA and OPTI NOTE. A patient who may have been competent and made known he did not want any information provided to anybody or never made any arrangements one way or the other, who now is incapable of giving consent for disclosure.
Dr. Berkowitz:
I guess what you are asking if we need consent to disclose to a family member when the patient lacks capacity to give permission.
Dr. Cantor:
Well I am not an expert in HIPAA, nor am I giving a legal opinion but I guess in a case where a patient said, I do not want anything disclosed and then loses his capacity to make decisions, the question quickly arises about who is going to make medical decisions on behalf of that patient. And if you allow HIPAA to interfere with the more basic right of autonomy that allows someone make decisions on your behalf who you know and trust to make those decisions, then you’re going to end up with a lot more problems.
If the family members are empowered to be surrogates, then that means they are entitled to all the health care information from the provider that would have been provided to the patient if they were capable of making decisions about their own health care. And that, I think, would include disclosing adverse events in order to permit you to make remediation or to offer additional treatment to prevent further harm.
In most cases where there is a surrogate involved, they do have the right to get that information because of their status as surrogate. I think that would be ethically more important than the HIPAA regulation. Although these HIPAA regulations are relatively new, and I am not an expert in HIPAA, so I am not sure how HIPAA experts might respond.
Dr. Berkowitz:
Well I certainly think Mike your point is well taken that there is nothing in HIPAA that is intended to be a barrier to care. The way I understand it, though this isn’t a legal opinion is that if any of these disclosure are giving people information that would be part of an informed consent discussion, or part of information that they would need to know to make healthcare decision, then, there is nothing that would prevent you from doing what you need to do to assure that the patient gets the proper care.
But the real question is whether there are certain parts of disclosing adverse events that go beyond what is relevant to the care of the patient. Not in all circumstances, but there are sometimes where disclosure is beyond the care. I guess unless someone is really willing to comment on it further I think it well to say that it is a really good question as to how that is going to play out in terms of the specter of privacy, and how the disclosure bumps up against the privacy regulations for non-care related matters. I guess that is something we are going to keep our eye on.
Dr. Cantor:
Even before HIPAA, certain types of health care information, such as treatment for substance abuse, sickle cell anemia, and HIV disease, was protected, and the patient had to give specific consent for disclosure of that information to outside parties. I think that is a very tricky situation, and consulting with local counsel is very important because you do need legal guidance on how to balance these concerns.
Dr. Berkowitz:
I guess it’s very difficult to comment on a hypothetical case, and we try hard not to do that, but I could envision a case where a patient says, “look I do not want this, I do not want anything about my health care discussed with my family.” There might be circumstances if the patient lost the ability to understand what was going on, you certainly would take into consideration their previously expresses wishes when you are going to consider your communications with the family, whether it is for disclosure or other things.
Dr. Jones:
Can I briefly just tell you a little bit about our process here? Maybe I can make it a little bit clearer. We encourage everyone within the institution to fill out an incident report on anything that they feel may be potentially harmful to the patient, so we have an incident report in process. An incident report comes to our morning session, and we listen to all of the incidents that happened the previous day
Based upon that we have a team that meets three times a week, which is known as the Patient Safety Assessment Committee, to look at the incidents that have come down and review them and do what is known as fact finding. We can find out information to make it a little clearer. If there is something that we feel that is either going to be a Root Cause Analysis (RCA), or a board of investigations, then we make the decision to go in those directions.
If we have an incident that is disclosed as a potential problem that has occurred during the performance of a procedure, then it goes to our RIF management committee which is where we do our full disclosure process. So it’s a process we try to do in a standard fashion.
Jim McCormick, Lexington, KY VAMC:
I can comment on some of it the way we do it here. An example might be one of the cases that I think Steve Kraman wrote up about a patient who had a problem with pulmonary embolism that might have been related to a wrong concentration of heparin that was given out by the pharmacy. I can mention this because it was published. When the patient came in, I became aware of this. I sat down with the family and told them what I believed had happened. We went over the data on this and I showed them that this had indeed been an error, which contributed to a serious illness that led to his death. Then I referred the case to risk management. My notes in the chart reflected that discussion because I was very sure of what I was telling them, and I had the data in hand to do that. From there it went to risk management, and the family knew what had happened already, because I disclosed it to them. They knew already what was going on and then the hospital dealt with them after that.
Dr. Berkowitz:
Well, as usual, we did not expect to conclude this discussion in the time allotted, and unfortunately we are out of time for today's discussion. We do make provisions to continue our discussions in an electronic form on our Web board, which can be accessed through the VA National Center for Ethics in Health Care Web site. We also post on our Web site a very detailed summary of each National Ethics Teleconference. So please visit our Web site to review or continue today's discussion.
I will be sending a follow up email for this call that will include the links to the appropriate web addresses for the call summary, the Web board discussion, the CME credits, and the references referred to.
Final Thoughts
· I would like to thank everyone who has worked hard on the conception, planning, and implementation of this call. It’s never a trivial task and I appreciate everyone's efforts, especially Mike Cantor, Leland Saunders, and the folks in our Seattle office for today's presentation, and other members of the Ethics Center and EES staff who support these calls.
·
Death & Seriously Ill Patients Policy
GAO Patient Safety at VA 2004 Report
Correct Operative Procedure Standards
Informed Consent For Treatment and Procedures
Resident Supervision Policy 2004
VA Policy for Reporting Medical Practitioners & Malpractice to State Licensing Boards
VA Same Day Surgery Guidelines
VA Spinal Cord Disorder Guidelines
VA Nuclear Medicine Guidelines
VA Laboratory & Pathology Standards
VA Request For and Authorization to Release Medical Records
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