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38 U.S.C. § 7311 — Quality assurance
Federal law — U.S. Code and appendices · legal_authorities
Page 1172
TITLE 38—VETERANS’ BENEFITS
§ 7311
1 See References in Text note below.
residency for women’s health care through the
Women Veterans Health Care Mini-Residency
Program of the Department during the one-
year period preceding the submittal of the re-
port and the number of mini-residency train-
ing slots for such program that are available
during the one-year period following such
date.
(6) The number of designated women’s
health care providers of the Department who
have sufficient women patient loads or case
complexities to retain their competencies and
proficiencies.
(f) ACCESSIBILITY
AND TREATMENT OPTIONS.—
Each report under subsection (a) shall include
an analysis of the accessibility and treatment
options for women veterans, including the fol-
lowing:
(1) An assessment of wheelchair accessibility
of women’s health centers of the Department,
including, with respect to each such center, an
assessment of accessibility for each kind of
treatment provided at the center, including
with respect to radiology and mammography,
that addresses all relevant factors, including
door sizes, hoists, and equipment.
(2) The options for women veterans to access
mental health providers and primary care pro-
viders who are women.
(3) The options for women veterans at med-
ical facilities of the Department with respect
to
clothing
sizes,
including
for
gowns,
drawstring pants, and pajamas.
(g) DEFINITIONS.—In this section:
(1) The term ‘‘appropriate congressional
committees’’ means—
(A) the Committee on Appropriations and
the Committee on Veterans’ Affairs of the
Senate; and
(B) the Committee on Appropriations and
the Committee on Veterans’ Affairs of the
House of Representatives.
(2)
The
term
‘‘gender-specific
services’’
means mammography
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Page 1172
TITLE 38—VETERANS’ BENEFITS
§ 7311
1 See References in Text note below.
residency for women’s health care through the
Women Veterans Health Care Mini-Residency
Program of the Department during the one-
year period preceding the submittal of the re-
port and the number of mini-residency train-
ing slots for such program that are available
during the one-year period following such
date.
(6) The number of designated women’s
health care providers of the Department who
have sufficient women patient loads or case
complexities to retain their competencies and
proficiencies.
(f) ACCESSIBILITY
AND TREATMENT OPTIONS.—
Each report under subsection (a) shall include
an analysis of the accessibility and treatment
options for women veterans, including the fol-
lowing:
(1) An assessment of wheelchair accessibility
of women’s health centers of the Department,
including, with respect to each such center, an
assessment of accessibility for each kind of
treatment provided at the center, including
with respect to radiology and mammography,
that addresses all relevant factors, including
door sizes, hoists, and equipment.
(2) The options for women veterans to access
mental health providers and primary care pro-
viders who are women.
(3) The options for women veterans at med-
ical facilities of the Department with respect
to
clothing
sizes,
including
for
gowns,
drawstring pants, and pajamas.
(g) DEFINITIONS.—In this section:
(1) The term ‘‘appropriate congressional
committees’’ means—
(A) the Committee on Appropriations and
the Committee on Veterans’ Affairs of the
Senate; and
(B) the Committee on Appropriations and
the Committee on Veterans’ Affairs of the
House of Representatives.
(2)
The
term
‘‘gender-specific
services’’
means mammography, obstetric care, gyneco-
logical care, and such other services as the
Secretary determines appropriate.
(Added Pub. L. 116–315, title V, § 5101(b)(1), Jan.
5, 2021, 134 Stat. 5024.)
Statutory Notes and Related Subsidiaries
REFERENCES TO HEALTH CARE AND SERVICES
For references to health care and services in this sec-
tion as references to health care and services included
in medical benefits package provided by the Depart-
ment as in effect on the day before Jan. 5, 2021, see Pub.
L. 116–315, title V, § 5101(b)(2), Jan. 5, 2021, 134 Stat. 5026,
set out as a note under section 7310 of this title.
INITIAL REPORT
Pub. L. 116–315, title V, § 5101(c), Jan. 5, 2021, 134 Stat.
5026, provided that: ‘‘The Chief Officer of Women’s
Health of the Department of Veterans Affairs shall sub-
mit the initial report under section 7310A of title 38,
United States Code, as added by subsection (b), by not
later than one year after the date of the enactment of
this Act [Jan. 5, 2021].’’
SUBCHAPTER II—GENERAL AUTHORITY
AND ADMINISTRATION
Editorial Notes
PRIOR PROVISIONS
A prior subchapter II of this chapter consisting of
sections 4121 to 4124, related to Regional Medical Edu-
cation Centers, prior to repeal by Pub. L. 102–40, title
IV, § 401(a)(3), May 7, 1991, 105 Stat. 210. See Prior Provi-
sions notes set out under section 4114 of this title.
§ 7311. Quality assurance
(a) The Secretary shall—
(1) establish and conduct a comprehensive
program to monitor and evaluate the quality
of health care furnished by the Veterans
Health Administration (hereinafter in this
section referred to as the ‘‘quality-assurance
program’’); and
(2) delineate the responsibilities of the
Under Secretary for Health with respect to the
quality-assurance program, including the du-
ties prescribed in this section.
(b)(1) As part of the quality-assurance pro-
gram, the Under Secretary for Health shall peri-
odically evaluate—
(A) whether there are significant deviations
in mortality and morbidity rates for surgical
procedures performed by the Administration
from prevailing national mortality and mor-
bidity standards for similar procedures; and
(B) if there are such deviations, whether
they indicate deficiencies in the quality of
health care provided by the Administration.
(2) The evaluation under paragraph (1)(A) shall
be made using the information compiled under
subsection (c)(1). The evaluation under para-
graph (1)(B) shall be made taking into account
the factors described in subsection (c)(2)(B).
(3) If, based upon an evaluation under para-
graph (1)(A), the Under Secretary for Health de-
termines that there is a deviation referred to in
that paragraph, the Under Secretary for Health
shall explain the deviation in the report sub-
mitted under subsection (f).1
(4) As part of the quality-assurance program,
the Under Secretary for Health shall establish
mechanisms through which employees of Vet-
erans Health Administration facilities may sub-
mit reports, on a confidential basis, on matters
relating to quality of care in Veterans Health
Administration facilities to the quality manage-
ment officers of such facilities under section
7311A(c) of this title. The mechanisms shall pro-
vide for the prompt and thorough review of any
reports so submitted by the receiving officials.
(c)(1) The Under Secretary for Health shall—
(A) determine the prevailing national mor-
tality and morbidity standards for each type
of surgical procedure performed by the Admin-
istration; and
(B) collect data and other information on
mortality and morbidity rates in the Adminis-
tration for each type of surgical procedure
performed by the Administration and (with re-
spect to each such procedure) compile the data
and other information so collected—
Page 1173
TITLE 38—VETERANS’ BENEFITS
§ 7311
(i) for each medical facility of the Depart-
ment, in the case of cardiac surgery, heart
transplant, and renal transplant programs;
and
(ii) in the aggregate, for each other type of
surgical procedure.
(2) The Under Secretary for Health shall—
(A) compare the mortality and morbidity
rates compiled under paragraph (1)(B) with the
national mortality and morbidity standards
determined under paragraph (1)(A); and
(B) analyze any deviation between such
rates and such standards in terms of the fol-
lowing:
(i) The characteristics of the respective pa-
tient populations.
(ii) The level of risk for the procedure in-
volved, based on—
(I) patient age;
(II) the type and severity of the disease;
(III) the effect of any complicating dis-
eases; and
(IV) the degree of difficulty of the proce-
dure.
(iii) Any other factor that the Under Sec-
retary for Health considers appropriate.
(d) Based on the information compiled and the
comparisons, analyses, evaluations, and expla-
nations made under subsections (b) and (c), the
Under Secretary for Health, in the report under
subsection (f),1 shall make such recommenda-
tions with respect to quality assurance as the
Under Secretary for Health considers appro-
priate.
(e)(1) The Secretary shall allocate sufficient
resources (including sufficient personnel with
the necessary skills and qualifications) to en-
able the Administration to carry out its respon-
sibilities under this section.
(2) The Inspector General of the Department
shall allocate sufficient resources (including suf-
ficient personnel with the necessary skills and
qualifications) to enable the Inspector General
to monitor the quality-assurance program.
(Added Pub. L. 102–40, title IV, § 401(a)(3), May 7,
1991, 105 Stat. 214; amended Pub. L. 102–405, title
III, § 302(c)(1), Oct. 9, 1992, 106 Stat. 1984; Pub. L.
103–446, title XII, § 1201(g)(5), Nov. 2, 1994, 108
Stat. 4687; Pub. L. 111–163, title V, § 505(b), May
5, 2010, 124 Stat. 1159.)
Editorial Notes
REFERENCES IN TEXT
Subsection (f), referred to in subsecs. (b)(3) and (d),
was repealed by Pub. L. 103–446, title XII, § 1201(g)(5),
Nov. 2, 1994, 108 Stat. 4687.
AMENDMENTS
2010—Subsec. (b)(4). Pub. L. 111–163 added par. (4).
1994—Subsecs. (f), (g). Pub. L. 103–446 struck out sub-
secs. (f) and (g) which read as follows:
‘‘(f)(1) Not later than February 1, 1991, the Under Sec-
retary for Health shall submit to the Secretary a re-
port on the experience through the end of the preceding
fiscal year under the quality-assurance program car-
ried out under this section.
‘‘(2) Such report shall include—
‘‘(A) the data and other information compiled and
the comparisons, analyses, and evaluations made
under subsections (b) and (c) with respect to the pe-
riod covered by the report; and
‘‘(B) recommendations under subsection (d).
‘‘(g)(1) Not later than 60 days after receiving such re-
port, the Secretary shall submit to the Committees on
Veterans’ Affairs of the Senate and House of Represent-
atives a copy of the report, together with any comment
concerning the report that the Secretary considers ap-
propriate.
‘‘(2) A report submitted under paragraph (1) shall not
be considered to be a record or document as described
in section 5705(a) of this title.’’
1992—Subsecs. (a) to (d), (f). Pub. L. 102–405 sub-
stituted ‘‘Under Secretary for Health’’ for ‘‘Chief Med-
ical Director’’ wherever appearing.
Statutory Notes and Related Subsidiaries
COMPREHENSIVE POLICY ON PAIN MANAGEMENT
Pub. L. 110–387, title V, § 501, Oct. 10, 2008, 122 Stat.
4130, provided that:
‘‘(a) COMPREHENSIVE
POLICY
REQUIRED.—Not later
than October 1, 2009, the Secretary of Veterans Affairs
shall develop and implement a comprehensive policy on
the management of pain experienced by veterans en-
rolled for health care services provided by the Depart-
ment of Veterans Affairs.
‘‘(b) SCOPE OF POLICY.—The policy required by sub-
section (a) shall cover each of the following:
‘‘(1) The Department-wide management of acute
and chronic pain experienced by veterans.
‘‘(2) The standard of care for pain management to
be used throughout the Department.
‘‘(3) The consistent application of pain assessments
to be used throughout the Department.
‘‘(4) The assurance of prompt and appropriate pain
care treatment and management by the Department,
system-wide, when medically necessary.
‘‘(5) Department programs of research related to
acute and chronic pain suffered by veterans, includ-
ing pain attributable to central and peripheral nerv-
ous system damage characteristic of injuries incurred
in modern warfare.
‘‘(6) Department programs of pain care education
and training for health care personnel of the Depart-
ment.
‘‘(7) Department programs of patient education for
veterans suffering from acute or chronic pain and
their families.
‘‘(c) UPDATES.—The Secretary shall revise the policy
required by subsection (a) on a periodic basis in accord-
ance with experience and evolving best practice guide-
lines.
‘‘(d) CONSULTATION.—The Secretary shall develop the
policy required by subsection (a), and revise such pol-
icy under subsection (c), in consultation with veterans
service organizations and organizations with expertise
in the assessment, diagnosis, treatment, and manage-
ment of pain.
‘‘(e) ANNUAL REPORT.—
‘‘(1) IN GENERAL.—Not later than 180 days after the
date of the completion and initial implementation of
the policy required by subsection (a) and on October
1 of every fiscal year thereafter through fiscal year
2018, the Secretary shall submit to the Committee on
Veterans’ Affairs of the Senate and the Committee on
Veterans’ Affairs of the House of Representatives a
report on the implementation of the policy required
by subsection (a).
‘‘(2) CONTENTS.—The report required by paragraph
(1) shall include the following:
‘‘(A) A description of the policy developed and im-
plemented under subsection (a) and any revisions to
such policy under subsection (c).
‘‘(B) A description of the performance measures
used to determine the effectiveness of such policy
in improving pain care for veterans system-wide.
‘‘(C) An assessment of the adequacy of Depart-
ment pain management services based on a survey
of patients managed in Department clinics.
‘‘(D) An assessment of the research projects of the
Department relevant to the treatment of the types
of acute and chronic pain suffered by veterans.
Page 1174
TITLE 38—VETERANS’ BENEFITS
§ 7311A
‘‘(E) An assessment of the training provided to
Department health care personnel with respect to
the diagnosis, treatment, and management of acute
and chronic pain.
‘‘(F) An assessment of the patient pain care edu-
cation programs of the Department.
‘‘(f) VETERANS SERVICE ORGANIZATION DEFINED.—In
this section, the term ‘veterans service organization’
means any organization recognized by the Secretary
for the representation of veterans under section 5902 of
title 38, United States Code.’’
EVALUATION OF DEPARTMENT OF VETERANS AFFAIRS
NURSE MANAGED CLINICS
Pub. L. 107–135, title I, § 123, Jan. 23, 2002, 115 Stat.
2451, required the Secretary of Veterans Affairs to
evaluate the efficacy of the nurse managed health care
clinics of the Department of Veterans Affairs and sub-
mit to Congress a report on the evaluation not later
than 18 months after Jan. 23, 2002.
QUALITY ASSURANCE ACTIVITIES
Pub. L. 102–405, title I, § 104, Oct. 9, 1992, 106 Stat. 1975,
provided that: ‘‘Effective on October 1, 1992, programs
and activities which (1) the Secretary carries out pur-
suant to section 7311(a) of title 38, United States Code,
or (2) are described in sections 201(a)(1) and 201(a)(3) of
Public Law 100–322 [formerly set out as a note under
former section 4151 of this title] (102 Stat. 508) shall be
deemed to be part of the operation of hospitals, nursing
homes, and domiciliary facilities of the Department of
Veterans Affairs, without regard to the location of the
duty stations of employees carrying out those pro-
grams and activities.’’
REGULATIONS FOR STANDARDS OF PERFORMANCE IN
LABORATORIES
Pub. L. 102–139, title I, § 101, Oct. 28, 1991, 105 Stat. 742,
provided that:
‘‘(a) REGULATIONS FOR STANDARDS OF PERFORMANCE IN
DEPARTMENT OF VETERANS AFFAIRS LABORATORIES.—(1)
Within the 120-day period beginning on the date on
which the Secretary of Health and Human Services pro-
mulgates final regulations to implement the standards
required by section 353 of the Public Health Service Act
(42 U.S.C. 263a), the Secretary of Veterans Affairs, in
accordance with the Secretary’s authority under title
38, United States Code, shall prescribe regulations to
assure consistent performance by medical facility lab-
oratories under the jurisdiction of the Secretary of
valid and reliable laboratory examinations and other
procedures. Such regulations shall be prescribed in con-
sultation with the Secretary of Health and Human
Services and shall establish standards equal to that ap-
plicable to other medical facility laboratories in ac-
cordance with the requirements of section 353(f) of the
Public Health Service Act.
‘‘(2) Such regulations—
‘‘(A) may include appropriate provisions respecting
waivers described in section 353(d) of such Act and ac-
creditations described in section 353(e) of such Act;
and
‘‘(B) shall include appropriate provisions respecting
compliance with such requirements.
‘‘(b) REPORT.—Within the 180-day period beginning on
the date on which the Secretary of Veterans Affairs
prescribes regulations required by subsection (a), the
Secretary shall submit to the appropriate committees
of the Congress a report on those regulations.
‘‘(c) DEFINITION.—As used in this section, the term
‘medical facility laboratories’ means facilities for the
biological,
micro-biological,
serological,
chemical,
immunohematological,
hematological,
biophysical,
cytological, pathological, or other physical examina-
tion of materials derived from the human body for the
purpose of providing information for the diagnosis, pre-
vention, or treatment of any disease or impairment of,
or the assessment of the health of, human beings.’’
§ 7311A. Quality management officers
(a) NATIONAL QUALITY MANAGEMENT OFFICER.—
(1) The Under Secretary for Health shall des-
ignate an official of the Veterans Health Admin-
istration to act as the principal quality manage-
ment officer for the quality-assurance program
required by section 7311 of this title. The official
so designated may be known as the ‘‘National
Quality Management Officer of the Veterans
Health Administration’’ (in this section referred
to as the ‘‘National Quality Management Offi-
cer’’).
(2) The National Quality Management Officer
shall report directly to the Under Secretary for
Health in the discharge of responsibilities and
duties of the Officer under this section.
(3) The National Quality Management Officer
shall be the official within the Veterans Health
Administration who is principally responsible
for the quality-assurance program referred to in
paragraph (1). In carrying out that responsi-
bility, the Officer shall be responsible for the
following:
(A) Establishing and enforcing the require-
ments of the program referred to in paragraph
(1).
(B) Developing an aggregate quality metric
from existing data sources, such as the Inpa-
tient Evaluation Center of the Department,
the National Surgical Quality Improvement
Program, and the External Peer Review Pro-
gram of the Veterans Health Administration,
that could be used to assess reliably the qual-
ity of care provided at individual Department
medical centers and associated community
based outpatient clinics.
(C) Ensuring that existing measures of qual-
ity, including measures from the Inpatient
Evaluation Center, the National Surgical
Quality Improvement Program, System-Wide
Ongoing Assessment and Review reports of the
Department, and Combined Assessment Pro-
gram reviews of the Office of Inspector Gen-
eral of the Department, are monitored rou-
tinely and analyzed in a manner that ensures
the timely detection of quality of care issues.
(D) Encouraging research and development
in the area of quality metrics for the purposes
of improving how the Department measures
quality in individual facilities.
(E) Carrying out such other responsibilities
and duties relating to quality management in
the Veterans Health Administration as the
Under Secretary for Health shall specify.
(4) The requirements under paragraph (3) shall
include requirements regarding the following:
(A) A confidential system for the submittal
of reports by Veterans Health Administration
personnel regarding quality management at
Department facilities.
(B) Mechanisms for the peer review of the
actions of individuals appointed in the Vet-
erans Health Administration in the position of
physician.
(b)
QUALITY
MANAGEMENT
OFFICERS
FOR
VISNS.—(1) The Regional Director of each Vet-
erans Integrated Services Network shall appoint
an official of the Network to act as the quality
management officer of the Network.
(2) The quality management officer for a Vet-
erans Integrated Services Network shall report
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** The Secretary shall—
(1) establish and conduct a comprehensive program to monitor and evaluate the quality of health care furnished by the Veterans Health Administration (hereinafter in this section referred to as the “quality-assurance program”); and
(2) delineate the responsibilities of the Under Secretary for Health with respect to the quality-assurance program, including the duties prescribed in this section.
**(b)**
(1) As part of the quality-assurance program, the Under Secretary for Health shall periodically evaluate—
(A) whether there are significant deviations in mortality and morbidity rates for surgical procedures performed by the Administration from prevailing national mortality and morbidity standards for similar procedures; and
(B) if there are such deviations, whether they indicate deficiencies in the quality of health care provided by the Administration.
(2) The evaluation under paragraph (1)(A) shall be made using the information compiled under subsection (c)(1). The evaluation under paragraph (1)(B) shall be made taking into account the factors described in subsection (c)(2)(B).
(3) If, based upon an evaluation under paragraph (1)(A), the Under Secretary for Health determines that there is a deviation referred to in that paragraph, the Under Secretary for Health shall explain the deviation in the report submitted under subsection (f).11 See References in Text note below.
(4) As part of the quality-assurance program, the Under Secretary for Health shall establish mechanisms through which employees of Veterans Health Administration facilities may submit reports, on a confidential basis, on matters relating to quality of care in Veterans Health Administration facilities to the quality management officers of such facilities under [sect
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Federal law — U.S. Code and appendices · legal_authorities
**(a) “Laboratory” or “clinical laboratory” defined** As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
**(b) Certificate requirement** No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.
**(c) Issuance and renewal of certificates**
(1) **In general** — The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d).
(2) **Term** — A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.
**(d) Requirements for certificates**
(1) **In general** — A laboratory may be issued a certificate or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application—
(i) in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—
(I) the number and types of laboratory examinations and other procedures
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Federal law — U.S. Code and appendices · legal_authorities
Page 477
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 263a
(B) information related to development
programs for biological products, including
biosimilar biological products and inter-
changeable biosimilar biological products
and relevant clinical considerations for pre-
scribers, which may include, as appropriate
and applicable, information related to the
comparability of such biological products;
(C) an explanation of the process for re-
porting adverse events for biological prod-
ucts, including biosimilar biological prod-
ucts and interchangeable biosimilar biologi-
cal products; and
(D) an explanation of the relationship be-
tween biosimilar biological products and
interchangeable biosimilar biological prod-
ucts licensed under section 262(k) of this
title and reference products (as defined in
section 262(i) of this title), including the
standards for review and licensing of each
such type of biological product.
(3) Format
The educational materials provided under
paragraph (1) may be—
(A) in formats such as webinars, con-
tinuing education modules, videos, fact
sheets, infographics, stakeholder toolkits, or
other formats as appropriate and applicable;
and
(B) tailored for the unique needs of health
care providers, patients, caregivers, and
other audiences, as the Secretary deter-
mines appropriate.
(4) Other information
In addition to the information described in
paragraph (2), the Secretary shall continue to
publish—
(A) the action package of each biological
product licensed under subsection (a) or (k)
of section 262 of this title; or
(B) the summary review of each biological
product licensed under subsection (a) or (k)
of section 262 of this title.
(5) Confidential and trade secret information
This subsection does not authorize the di
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