"(c) A license issued by the Secretary under this section may be applicable to all laboratory procedures or only to specified laboratory procedures or categories of laboratory procedures. “(d)(1) A license shall not be issued in the case of any clinical laboratory unless (A) the application therefor contains or is accompanied by such information and assurances as the Secretary finds necessary, and (B) the applicant agrees and the Secretary determines that such laboratory will be operated in accordance with standards found necessary by the Secretary to carry out the purposes of this section. "(2) A license issued under this section shall be valid for a period of three years, or such shorter period as the Secretary may establish for any clinical laboratory or any class or classes thereof; and may be renewed in such manner as the Secretary may prescribe. "(3) The Secretary may, if he deems it appropriate, require payment of fees for the issuance and renewal of licenses, but the amount of such fees shall not exceed such sum (which in no event may be more than the sum determined by him to be necessary on the average to provide, maintain, and equip an adequate service for the purpose) as the Secretary may by regulation prescribe from time to time. "(e) A laboratory license may be revoked, suspended, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory "(1) has been guilty of misrepresentation in obtaining the license; "(2) has engaged or attempted to engage or represented himself as entitled to perform any laboratory procedure or category of procedures not authorized in the license; "(3) has failed to comply with the standards with respect to laboratories and laboratory personnel prescribed by the Secretary pursuant to this section; "(4) has failed to comply with reasonable requests of the Secretary for any information or materials, or work on materials, he deems necessary to determine the laboratory's continued eligibility for its license hereunder or continued compliance with the Secretary's standards hereunder; "(5) has refused a request of the Secretary or any Federal officer or employee duly designated by him for permission to inspect the laboratory and its operations and pertinent records at any reasonable time; or "(6) has violated or aided and abetted in the violation of any provisions of this section or of any rule or regulation promulgated thereunder. "(f) The license of any laboratory under this section may be temporarily suspended without a hearing for a period of not to exceed 60 days if the Secretary determines that the public safety or welfare would otherwise be in imminent danger. "(g) (1) Any party aggrieved by any final action taken under this section may at any time within sixty days after the date of such action file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for judicial review of such action. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record on which the action of the Secretary is based, as provided in section 2112 of title 28, United States Code. "(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendations, if any, for the modification or setting aside of his original action, with the return of such additional evidence. "(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the atcion, or to set it aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive. "(4) The judgment of the court affirming or setting aside, in whole or in part, any such action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28, United States Code. "(h) Any person who violates any provision of this section or any rule or regulation promulgated thereunder shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine. "(i) The provisions of this section shall not apply to any clinical laboratory operated by a licensed physician, osteopath, or podiatrist who performs laboratory tests or procedures, personally or through his employees, solely as an adjunct to the treatment of his own patients. "(j) In carrying out this functions under this section, the Secretary is authorized, pursuant to agreement, to utilize the services or facilities of any Federal or State or local public agency or nonprofit private agency or organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as he may determine. "(k) Nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with the provisions of this section or with the rules and regulations issued under this section." (b) The amendment made by subsection (a) shall become effective on the first day of the thirteenth month after the month in which it is enacted, except that the Secretary of Health, Education, and Welfare may postpone such effective date for such additional period as he finds necessary, but not beyond the the first day of the 19th month after such month in which the amendment is enacted. (c) This section may be cited as the "Clinical Laboratories Improvement Act of 1967". VOLUNTEER SERVICES SEC. 6. Title II of the Public Health Service Act is amended by adding after section 222 (42 U.S.C. 217a) the following new section: "VOLUNTEER SERVICES "SEC. 223. Subject to regulations, volunteer and uncompensated services may be accepted by the Secretary, or by any other officer or employee of the Department of Health, Education, and Welfare designated by him, for use in the operation of any health care facility or in the provision of health care." COOPERATION AS TO MEDICAL CARE FACILITIES AND RESOURCES SEC. 7. Part C of title III of the Public Health Service Act is amended by adding after section 327 (42 U.S.C. 254) the following new section: "SHARING OF MEDICAL CARE FACILITIES AND RESOURCES "SEC. 328. (a) For purposes of this section "(1) the term 'specialized health resources' means health care resources (whether equipment, space, or personnel) which, because of cost, limited availability, or unusual nature, are either unique in the health care community or are subject to maximum utilization only through mutual use; "(2) the term 'hospital', unless otherwise specified, includes (in addition to other hospitals) any Federal hospital. "(b) For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide a professional environment therein which will help to attract and retain highly qualified and talented health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and hospitals and other health facilities in the health care community, and to promote the full utilization of hospitals and other health facilities and resources, the Secretary may "(1) enter into agreements or arrangements with schools of medicine, and with other health schools, agencies, or institutions, for such interchange or cooperative use of facilities and services on a reciprocal or reimbursable basis, as will be of benefit to the training or research programs of the participating agencies; and 66 "(2) enter into agreements or arrangements with hospitals and other health care facilities for the mutual use or the exchange of use of specialized health resources, and providing for reciprocal reimbursement. Any reimbursement pursuant to any such agreement or arrangement shall be based on charges covering the reasonable cost of such utilization, including normal depreciation and amortization costs of equipment. Any proceeds to the Government under this subsection shall be credited to the applicable appropriation of the Public Health Service for the year in which such proceeds are received." PROGRAM EVALUATION SEC. 8. (a) Paragraph (1) of section 314 (d) of the Public Health Service Act is amended by inserting before the period at the end thereof the following: ", except that, for any fiscal year ending after June 30, 1968, such portion of such sums as the Secretary may determine, but not exceeding 1 per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the programs authorized by this subsection and the amount available for allotments hereunder shall be reduced accordingly". (b) Section 314 (e) of such Act is amended by inserting at the end thereof the following new sentence: "For any fiscal year ending after June 30, 1968, such portion of the appropriations for grants under this subsection as the Secretary may determine, but not exceeding one per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the program authorized by this subsection." (c) Section 309 (c) of such Act is amended by inserting "(1)" after "except that" and by inserting before the period at the end thereof the following: ", and (2) for any fiscal year ending after June 30, 1968, such portions of the funds made available under this subsection as the Secretary may determine, but not exceeding 1 per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the program authorized by this subsection". RESEARCH CONTRACT AUTHORITY SEC. 9. Paragraph (h) of section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by striking out "during the fiscal year ending June 30, 1966, and each of the two succeeding fiscal years". MEDICAL CARE FOR FEDERAL EMPLOYEES AT REMOTE STATIONS OF THE SERVICE SEC. 10. (a) Section 324 of the Public Health Service Act (42 U.S.C. 251) is amended by inserting “(a)" immediately after "SEC. 324." and by redesignating clauses (a) through (d) of such section, and references thereto, as clauses (1) through (4). (b) Section 324 of such Act is further amended by adding at the end thereof the following new subsection: "(b) At remote medical facilities of the Public Health Service where other medical care and treatment are not available, the Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization for Federal employees (as defined in section 8901 (1) of title 5 of the United States Code) and their dependents. Such employees and their dependents who are not entitled to this care and treatment under any other provision of law shall be charged for it at rates established by the Secretary to reflect the reasonable cost of providing the care and treatment. Any payments pursuant to the preceding sentence shall be credited to the applicable appropriation to the Public Health Service for the year in which such payments are received." (c) Subsection (a) of section 322 of such Act is amended by striking out paragraph (7) and by renumbering paragraph (8) as paragraph (7). MINOR OR TECHNICAL AMENDMENTS SEC. 11. (a) Section 806 (c) (1) of the Public Health Service Act (42 U.S.C. 296e (c) (1)) is amended by inserting after "from a loan fund established pursuant to section 822" the following: "or from sums paid by the Secretary from the revolving fund created by section 827 (d)". (b) The second sentence of section 312 of such Act (42 U.S.C. 244) is amended by inserting "and officials of other State or local public or private agencies, institutions, or organizations" after" such health authorities". (c) Section 725 (a) of such Act (42 U.S.C. 293e (a)) is amended by striking out "sixteen" and inserting in lieu thereof "seventeen" and by striking out "twelve" and inserting in lieu thereof "thirteen". (d) Section 314 (f) of such Act is amended by (1) inserting "for" before "the expenses of travel" in paragraph (5); (2) striking out "Service" and inserting in lieu thereof "Department" in paragraphs (6) and (8). (e) The amendment made by subsection (a) shall be effective as of November 3, 1966. ACCREDITATION OF NURSES EDUCATION PROGRAM SEC. 12. Section 843 (f) of the Public Health Service Act (42 U.S.C. 298b (f)) is amended by striking out "or a program accredited for the program of this Act by the Commissioner of Education,". MEANING OF SECRETARY SEC. 13. As used in the amendments made by this Act, the term "Secretary" means the Secretary of Health, Education, and Welfare. EXECUTIVE OFFICE OF THE PRESIDENT, Hon. HARLEY O. STAGGERS, BUREAU OF THE BUDGET, Washington, D.C., May 5, 1967. Chairman, Committee on Interstate and Foreign Commerce, House of Representatives, Rayburn House Office Building, Washington, D.C. DEAR MR. CHAIRMAN: This is in response to your request for the views of the Bureau of the Budget on H.R. 6418, a bill cited as the "Partnership for Health Amendments of 1967." The bill authorizes the extension and expansion of the landmark Partnership for Health legislation enacted by the 89th Congress. As the President said in his Health Message, this legislation "is designed to strengthen State and local programs and to encourage broad-gauge planning in health. It gives the States new flexibility to use Federal funds by freeing them from tightly compartmentalized grant programs." It establishes for a number of health programs a single set of requirements, a single authorization, and a single appropriation. H.R. 6418 increases the dollar authorizations for 1968, and extends the program for four additional years with the provisions that such sums as may be necessary would be authorized for appropriation after 1968. The bill also authorizes the Secretary of Health, Education, and Welfare to embark upon a broadened and coordinated program of research, experiments, and demonstrations relating to the development, coordination, and delivery of improved health services. This provision is in accord with the President's directive that the Secretary of Health, Education, and Welfare establish a National Center for Health Services Research and Development. Its aim is the application of the research techniques, which have brought us new knowledge in health and medicine, to the effort of bringing low cost, quality health care to our citizens. A third major provision of the proposed legislation relates to the licensing of clinical laboratories. Such licenses should be issued upon the applicant's agreeing to operate the laboratory in conformance with standards established by the Secretary. The aim of this provision is to improve the performance of clinical laboratories engaged in interstate commerce. Additionally, the bill authorizes the Secretary to enter into agreements with health schools, hospitals, and other health care training facilities to provide for the interchange or cooperative use of personnel, facilities, services, and information, on a reciprocal or reimbursable basis. This provision is designed to increase cooperative activities between the Public Health Service's hospitals and community health facilities and will result in better utilization of scarce professional personnel and expensive facilities. The Bureau of the Budget favors action on H.R. 6418, which is in accord with the President's program. Sincerely yours, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Hon. HARLEY O. STAGGERS, Chairman, Committee on Interstate and Foreign Commerce, DEAR MR. CHAIRMAN: This letter is in response to your request of March 13, 1967, for a report on H.R. 6418, a bill to amend the Public Health Service Act to extend and expand the authorizations for grants for comprehensive health planning and services, to broaden and improve the authorization for research and demonstrations relating to the delivery of health services, to improve the performance of clinical laboratories, and to authorize cooperative activities between the Public Health Service hospitals and community facilities, and for other purposes. This bill, to be cited as the "Partnership for Health Amendments of 1967,” would 1. Extend through fiscal year 1972, with some modifications, the authorizations for comprehensive health planning and public health services grants and for grants to schools of public health which were enacted last year in P.L. 89-749. 2. Broaden, improve, and consolidate the authorizations now contained in sections 314(e)(3) and 624 of the Public Health Service Act for grant and contract support of research, experiments, and demonstrations relating to the development, utilization, quality, organization, and financing of health services and facilities. 3. Authorize the Secretary to cooperate with States and localities in emergency health planning and in providing temporary assistance on a reimbursable basis to meet health emergencies which warrant Federal assistance. 4. Provide for the improvement of clinical laboratory services through the establishment of a Federal licensing program for such laboratories which engage in interstate commerce. 5. Authorize the Secretary to accept volunteer and uncompensated service in the operation of any health care facility or in the provision of health care. 6. Authorize cooperative agreements or arrangements on a reciprocal or reimbursable basis between hospitals and facilities of the Public Health Service and community hospitals and other health care and educational facilities. 7. Provide that not exceeding one percent of the funds appropriated for grants under Sections 314 (d), 314(e), 304 and 309(e) of the Public Health Service Act shall be available to the Secretary for evaluation of the respective programs authorized by such subsections. 8. Extend without time limitation the current authorization in Section 301 (h) of the Public Health Service Act with respect to research contracts. 9. Delete the current eligibility of employees and noncommissioned officers in the field service of the Public Health Service for medical, surgical, dental, and hospital care at Public Health Service facilities when injured or taken sick in line of duty, and provide that the Secretary is authorized to provide such care on a reimbursable basis for Federal employees and their dependents at remote medical facilities of the Public Health Service where other medical care and treatment are not available. 10. Delete the provision in Section 843 (f) of the Public Health Service Act which currently authorizes the Commissioner of Education to accredit schools of nursing for purposes of participation in programs under the Nurse Training Act. H.R. 6418 embodies the provisions of a draft bill transmitted by this Department to the Congress to implement a number of recommendations by the President relating to public health. We strongly recommend early enactment of the bill. We are advised by the Bureau of the Budget that enactment of this proposed legislation would be in accord with the program of the President. Sincerely, WILBUR J. COHEN, Under Secretary. |