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§ 37.202 Payment for autopsy.

(a) The Secretary will pay up to $200 to any pathologist who, after the effective date of the regulations in this part and with legal consent.

(1) Performs an autopsy on a miner and submits the findings and other materials to ALFORD in accordance with this subpart; and

(2) Receives no other specific payment, fee, or reimbursement in connection with the autopsy from the miner's widow, his family, his estate, or any other Federal agency.

(b) The Secretary will pay to any pathologist entitled to payment under paragraph (a) of this section and additional $10 if the pathologist can obtain and submits a good quality copy or original of a chest roentgenogram (posteroanterior view) made of the subject of the autopsy within 5 years prior to his death together with a copy of any interpretation made.

§ 37.203 Autopsy specifications.

(a) Every autopsy for which a claim for payment is submitted pursuant to this part:

(1) Shall be performed consistent with standard autopsy procedures such as those, for example, set forth in the "Autopsy Manual" prepared by the Armed Forces Institute of Pathology, July 1, 1960. (Technical Manual No. 8-300. NAVMED P-5065, Air Force Manual No. 160-19.) Copies of this document may be borrowed from ALFORD. (2) Shall include:

(i) Gross and microscopic examination of the lungs, pulmonary pleura, and tracheobronchial lymph nodes;

(ii) Weights of the heart and each lung (these and all other measurements required under this subparagraph shall be in the metric system);

(iii) Circumference of each cardiac valve when opened;

(iv) Thickness of right and left ventricles; these measurements shall be made perpendicular to the ventricular surface and shall not include trabeculations or pericardial fat. The rigrt ventricle shall be measured at a point midway between the tricuspid valve and the apex, and the left ventricle shall be measured directly above the insertion of the anterior papillary muscle;

(v) Size, number, consistency, location, description and other relevant details of all lesions of the lungs;

(vi) Level of the diaphragm;

(vii) From each type of suspected pneumoconiotic lesion, representative microscopic slides stained with hematoxylin eosin or other appropriate stain, and one formalin fixed, paraffin-impregnated block of tissue; a minimum of three stained slides and three blocks of tissue shall be submitted. When no such lesion is recognized, similar material shall be submitted from three separate areas of the lungs selected at random; a minimum of three stained slides and three formalin fixed, paraffin-impregnated blocks of tissue shall be submitted. (b) Needle biopsy techniques shall not be used.

§ 37.204 Procedure for obtaining pay

ment.

Every claim for payment under this subpart shall be submitted to ALFORD and shall include:

(a) An invoice (in duplicate) on the pathologist's letterhead or billhead indicating the date of autopsy, the amount of the claim and a signed statement that the pathologist is not receiving any other specific compensation for the autopsy from the miner's widow, his surviving next-of-kin, the estate of the miner, or any other source.

(b) Completed PHS Consent, Release and History Form (See Fig. 1). This form may be completed with the assistance of the pathologist, attending physician, family physician, or any other responsible person who can provide reliable information.

(c) Report of autopsy:

(1) The information, slides, and blocks of tissue required by this subpart.

(2) Clinical abstract of terminal illness and other data that the pathologist determines is relevant.

(3) Final summary, including final anatomical diagnoses, indicating presence or absence of simple and complicated pneumoconiosis, and correlation with clinical history if indicated.

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thorize the performance of an autopsy ------) on said de(Limitation, if any, on autopsy) ceased. I understand that the report and certain tissues as necessary will be released to the United States Public Health Service and to

(Name of Physician securing autopsy) I understand that any claims in regard to the deceased for which I may sign a general release of medical information will result in the release of the information from the Public Health Service. I further understand that I shall not make any payment for the autopsy.

Occupational and Medical History

1. Date of Birth of Deceased

(Month, Day, Year) 2. Social Security Number of Deceased

3. Date and Place of Death

(Month, Day, Year)

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All terms not defined herein shall have the same meanings as given them in the Act. As used in this subpart:

(a) "Act" means section 314 of the Public Health Service Act, as amended (42 U.S.C. 246).

(b) "Secretary" means the Secretary of Health, Education, and Welfare and any other officer or employee of the Department of Health, Education, and Welfare to whom the authority involved may be delegated.

(c) "State program" refers to the State plan for comprehensive health planning which contains the information, proposals, and assurances submitted by the State agency pursuant to section 314(a) of the Act and the regulations of this subpart.

(d) "State agency" means the single State agency (which may be an interdepartmental agency) designated in the State program for administering or supervising the administration of the State's health planning functions under the State program.

§ 51.3 Submission of State programs.

In order to receive funds from an allotment under this subpart, a State must submit to and have approved by the Secretary a State program which incorporates by reference the information and meets the requirements specified in the Act and in the regulations of this

subpart. Such program shall be submitted by the State agency officially designated and authorized to administer it and carry out the functions prescribed hereunder, after reasonable opportunity has been provided to the Governor of the State for his review and comment. Documents incorporated by reference become a part of the State program as though fully set forth therein. Such documents must be (a) clearly identified as to subject, date, and location, (b) officially adopted and disseminated in accordance with applicable procedures, and (c) made available to the Secretary and to the public for inspection. § 51.4

State program requirements.

(a) Responsibility of State agency. The State program must provide that the State agency will either administer or supervise the administration of the activities to be carried out under it. In order to assure adequate supervision by the State agency of the administration of activities under the State program carried out by other agencies, institutions, organizations, or individuals, the State program must incorporate by reference documents showing that the State agency (1) is able to obtain from such other agencies, institutions, organizations, or individuals the data needed for formulation and evaluation of, and accountability for, planning activities; (2) has established methods for performing continuing professional and administrative evaluations of such activities; and (3) is in a position to take such steps as may be necessary to assure that such activities meet Federal and State requirements.

(b) State health planning council. The State program must incorporate by reference documents showing that a State health planning council has been established to advise the State agency in carrying out its functions under the approved State program. Council membership shall include representatives of State agencies (other than the designated State agency) and local agencies and of nongovernmental organizations and groups concerned with health (including representation of the regional medical programs established under Title IX of the Act which are included in whole or in part within the State), and one or more representatives of Federal agencies concerned with health: Provided, That, if there is located in the State one or more hospitals or other health

care facilities of the Veterans' Administration, the membership of the council shall include as an ex officio member the individual whom the Administration of Veterans' Affairs shall have designated to serve on such council as the representative of the hospitals or other health care facilities or such Administration which are located in the State; and the requirement of representation of Federal agencies concerned with health shall be satisfied by the inclusion of such Veterans' Administration representative. A majority of the council members must be consumer representatives whose major career or occupation is neither the organization, financing, or delivery of health services, nor research in or the teaching of health sciences. Membership of the council shall generally reflect the various socioeconomic groups and geographic areas of the State. The council shall meet as often as necessary and not less often than twice a year for the purposes of consulting with and advising the State agency with respect to:

(1) The scope of planning activities to be undertaken by the State agency;

(2) The recommendations to be made by the State agency as a result of such activities; and

(3) Necessary review and modifications of the State program.

(c) Expenditure of grant funds. The State program must incorporate by reference written policies and procedures for the expenditure of funds under the program, which shall provide that:

(1) The scope of comprehensive health planning will encompass the need for services (including home health services), facilities, and manpower to meet the physical, mental, and environmental health needs of the people of the State, and the financial and organizational resources through which these needs may be met;

(2) Such planning will be concerned with both publicly and privately supported health services and activities;

(3) A method for determining priorities of planning activity will be established to insure that the most critical planning problems are scheduled for early attention;

(4) Methods will be established for obtaining and utilizing, in the formulation of planning priorities and recommendations, effective and appropriate informational support, including statistical data and, where feasible, social, economic, demographic, and similar base data con

sistent with those to be utilized for other comprehensive planning activities in the

State;

(5) To administer or supervise the administration of the planning functions under the State program and to provide staff assistance to the State health planning council, the State agency will establish positions, including the full-time position of comprehensive health planning director, to be filled by persons with appropriate qualifications: Provided, That the Secretary may, in particular cases, approve arrangements for administering or supervising the administration of the State agency's planning activities through other than a full-time director where he finds that such other arrangements will result in the effective administration of such activities;

(6) The State agency will cooperate with and assist in the development of needed regional, metropolitan area, and other local area health planning agencies and be prepared to act upon, and to inform the Secretary of its actions with respect to, grant applications under section 314(b) of the Act.

(d) Encouraging cooperative efforts. The State programs must incorporate by reference written policies and procedures for encouraging cooperative efforts among governmental and nongovernmental agencies, organizations, and groups concerned with health and related services, facilities, and manpower. As a minimum, such policies and procedures must provide methods for:

(1) Coordinating the State agency's planning activities with specialized health planning and other related planning activities, such as the development of mental retardation plans, construction plans for health and medical facilities, community mental health plans, regional medical programs, environmental quality plans, and State physical and economic planning;

(2) Considering the most effective and efficient manner of meeting health needs in the fields of welfare, education, and rehabilitation; and

(3) Considering the special needs of high-risk population groups for preventive and health care services.

(e) Federal funds to supplement State funds otherwise available. The State program must contain satisfactory assurances that Federal funds will not supplant funds that would otherwise be made available by the State for the purpose of comprehensive health plan

ning and that Federal funds will, to the extent practicable, be used to increase the level of non-Federal funds available for such purpose. Substantial compliance with such assurance will be deemed to have been met if the level of non-Federal funds made available to and spent by the State for comprehensive health planning is at least no lower for any fiscal year than it was in the immediately preceding fiscal year, except that the Secretary may also take into consideration the extent to which the level of such funds for any fiscal year may have included funds for an activity of a nonrecurring nature.

(f) Methods of administration. The State program shall:

(1) Provide for the establishment and maintenance of personnel standards on a merit basis for persons employed by the State in carrying out the State program. Conformity with the Standards for a Merit System of Personnel Administration, 45 CFR Part 70, issued by the Secretary of Health, Education, and Welfare, including any amendments thereto, and any standards prescribed by the U.S. Civil Service Commission pursuant to section 208 of the Intergovernmental Personnel Act of 1970 (Public Law 91648; 84 Stat. 1915) modifying or superseding such Standards, will be deemed to meet this requirement as determined by said Commission. Laws, rules, regulations, and policy statements, and amendments thereto, effectuating such methods of personnel administration shall be incorporated by reference in the State plan;

(2) Incorporate by reference written policies and procedures for informing interested parties and organizations and the general public about the agency's activities and recommendations;

(3) Contain an assurance that no more than 50 percent of the funds available to the State agency under the State program will be used for contracting with other agencies and organizations to conduct planning functions under the State program without specific approval from the Secretary; and

(4) Incorporate by reference written policies and procedures by which criteria will be developed as a basis for approval or disapproval of applications for areawide health planning project grants under section 314(b) of the Act.

(g) Reports and records. (1) The State program must contain an assurance that, in addition to any other reports or rec

ords required by the regulations of this subpart or which may reasonably be required by the Secretary under the Act:

(i) The State agency will maintain adequate records to show the disposition of all funds (Federal and non-Federal) expended for activities under the approved State program;

(ii) The Secretary will be provided copies of each recommendation, plan or portion of a plan adopted by the State agency;

(iii) An annual narrative summary of the planning activities undertaken during the preceding year will be submitted to the Secretary; and

(iv) Expenditure reports on forms prescribed by the Secretary will be submitted within 60 days after the close of the Federal fiscal year.

(2) All records required by the Act and the regulations of this subpart shall be retained for 3 years after the submission of the annual expendtiture report required by subparagraph (1) (iv) of this paragraph: Provided, That (i) all records pertaining to audit questions which have arisen before the end of such 3-year period shall be retained until resolution of all such questions, and (ii) records for nonexpendable property which was acquired under the State plan shall be retained for 3 years after its final distribution.

(3) All records required by the Act and the regulations of this subpart shall be available to the Comptroller General of the United States and the Secretary, or their authorized representatives, for purposes of making audits, examinations, excerpts and transcriptions.

(h) Review and modification. The State program must contain an assurance that the State agency will review and evaluate its approved program at least once annually and submit appropriate modifications to the Secretary. As a minimum, the State agency shall submit annual modifications of the State program which will (1) reflect budgetary and expenditure requirements for the next fiscal year, (2) set forth priorities established for planning activity to be undertaken in the next fiscal year, and (3) update any assurances or other informational requirements included in the State program.

(i) Program for capital expenditures. The State program must incorporate by reference written policies and procedures for assisting, through consultation, pro

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