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38 U.S.C. § 7311 — Quality assurance

Federal law — U.S. Code and appendices · legal_authorities

38 U.S.C. § 7311 — Quality assurance

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

38 U.S.C. § 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 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

42 U.S.C. § 263a — Certification of laboratories

**(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

42 U.S.C. § 263a — Certification of laboratories

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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