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38 U.S.C. § 7311A — Quality management officers

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

38 U.S.C. § 7311A — Quality management officers

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 PERFOR

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Stable record: federal_law:legal_authorities:usc2024-998246f2d8909f8919c91558
Source file: Laws/federal/codes/united-states-code-2024/title-38/section-7311a-quality-management-officers--575898afcc.md
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Source location: USCODE-2024-title38-partV-chap73-subchapII-sec7311A.pdf

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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 Page 1175 TITLE 38—VETERANS’ BENEFITS § 7313 to the Regional Director of the Veterans Inte- grated Services Network, and to the National Quality Management Officer, regarding the dis- charge of the responsibilities and duties of the officer under this section. (3) The quality management officer for a Vet- erans Integrated Services Network shall— (A) direct the quality management office in the Network; and (B) coordinate, monitor, and oversee the quality management programs and activities of the Administration medical facilities in the Network in order to ensure the thorough and uniform discharge of quality management re- quirements under such programs and activi- ties throughout such facilities. (c) QUALITY MANAGEMENT OFFICERS FOR MED- ICAL FACILITIES.—(1) The director of each Vet- erans Health Administration medical facility shall appoint a quality management officer for that facility. (2) The quality management officer for a facil- ity shall report directly to the director of the fa- cility, and to the quality management officer of the Veterans Integrated Services Network in which the facility is located, regarding the dis- charge of the responsibilities and duties of the quality management officer under this section. (3) The quality management officer for a facil- ity shall be responsible for designing, dissemi- nating, and implementing quality management programs and activities for the facility that meet the requirements established by the Na- tional Quality Management Officer under sub- section (a). (d) AUTHORIZATION OF APPROPRIATIONS.—(1) Except as provided in paragraph (2), there are authorized to be appropriated such sums as may be necessary to carry out this section. (2) There is authorized to be appropriated to carry out the provisions of subparagraphs (B), (C), and (D) of subsection (a)(3), $25,000,000 for the two-year period of fiscal years beginning after the date of the enactment of this section. (Added Pub. L. 111–163, title V, § 505(a)(1), May 5, 2010, 124 Stat. 1158.) Editorial Notes REFERENCES IN TEXT The date of the enactment of this section, referred to in subsec. (d)(2), is the date of enactment of Pub. L. 111–163, which was approved May 5, 2010. § 7312. Special medical advisory group (a) The Secretary shall establish an advisory committee to be known as the special medical advisory group. The advisory group shall advise the Secretary, through the Under Secretary for Health, and the Under Secretary for Health di- rectly, relative to the care and treatment of dis- abled veterans and other matters pertinent to the Administration. (b) Members of the special medical advisory group shall be appointed by the Secretary upon the recommendation of the Under Secretary for Health. The special medical advisory group shall be composed of— (1) members of the medical, dental, podiatric, optometric, and allied scientific professions; (2) other individuals considered by the Under Secretary for Health to have experience perti- nent to the mission of the Administration; and (3) a disabled veteran. (c) The special medical advisory group shall meet on a regular basis as prescribed by the Sec- retary. The number, terms of service, pay, and allowances of members of the advisory group shall be prescribed in accordance with existing law and regulations. (d) Not later than February 1 of each year, the special medical advisory group shall submit to the Secretary and the Congress a report on the activities of the advisory group during the pre- ceding fiscal year. No report shall be required under this subsection after December 31, 2004. (Added Pub. L. 102–40, title IV, § 401(a)(3), May 7, 1991, 105 Stat. 215; amended Pub. L. 102–405, title III, § 302(c)(1), Oct. 9, 1992, 106 Stat. 1984; Pub. L. 103–446, title XII, § 1201(e)(20), Nov. 2, 1994, 108 Stat. 4686; Pub. L. 106–419, title IV, § 403(c)(5), Nov. 1, 2000, 114 Stat. 1864.) Editorial Notes AMENDMENTS 2000—Subsec. (d). Pub. L. 106–419 inserted at end ‘‘No report shall be required under this subsection after De- cember 31, 2004.’’ 1994—Subsec. (d). Pub. L. 103–446 substituted ‘‘the ac- tivities of the advisory group’’ for ‘‘the advisory groups activities’’. 1992—Subsecs. (a), (b). Pub. L. 102–405 substituted ‘‘Under Secretary for Health’’ for ‘‘Chief Medical Direc- tor’’ wherever appearing. § 7313. Advisory committees: affiliated institu- tions (a) In each case where the Secretary has a con- tract or agreement with any school, institution of higher learning, medical center, hospital, or other public or nonprofit agency, institution, or organization for the training or education of health personnel, the Secretary shall establish an advisory committee to advise the Secretary and the Under Secretary for Health with respect to policy matters arising in connection with, and the operation of, the program with respect to which it was appointed. Such a committee may be a dean’s committee, a medical advisory committee, or the like. (b) Any such advisory committee may be es- tablished on an institution-wide, multi-discipli- nary basis or on a regional basis whenever estab- lishment on such a basis is found to be feasible. (c) Members of each such advisory committee shall be appointed by the Secretary and shall in- clude personnel of the Department (including appropriate representation from the full-time staff) and of the entity with which the Secretary has entered into the contract or agreement. The number of members, and terms of members, of each advisory committee shall be prescribed by the Secretary. (d) The Secretary shall require that the Chief of the Nursing Service (or the designee of the Chief) at each Department health-care facility be included in the membership of each policy- making committee at that facility. Such com- mittees include: (1) committees relating to mat- ters such as budget, education, position manage-

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

38 U.S.C. § 7311A — Quality management officers

**(a) National Quality Management Officer.—** (1) The Under Secretary for Health shall designate an official of the Veterans Health Administration to act as the principal quality management officer for the quality-assurance program required by [section 7311 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section7311&num=0&edition=prelim). 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 Officer”). (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 responsibility, the Officer shall be responsible for the following: (A) Establishing and enforcing the requirements of the program referred to in paragraph (1). (B) Developing an aggregate quality metric from existing data sources, such as the Inpatient Evaluation Center of the Department, the National Surgical Quality Improvement Program, and the External Peer Review Program of the Veterans Health Administration, that could be used to assess reliably the quality of care provided at individual Department medical centers and associated community based outpatient clinics. (C) Ensuring that existing measures of quality, including measures from the Inpatient Evaluation Center, the National Surgical Quality Improvement Program, System-Wide Ongoing Assessment and Review reports of the Department, and

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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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