Le Health Services and Mental Health Administration BMPS GRART ADMINISTRATION Regional dical Pronrens Service o f Toe ake 7 bo gw teeerae Pg A Tae rs 7 CONTENTS xr J USE AND REVISION OF MARUAL 1-1 rmtroduction 1-2 Procedures for Revision Chapte Chapter II MISSION STATHENT It-1 Miesion Statement, Regional Medical Programs Chapter III TERMINOLOGY Tit-1 Definitions 1ii-2 Abbreviations Chapter IV APPLICATION AND REVIEW Iv-i RMPS Review Process Requirements And Standards 1V¥-2 Review Responsibilities Under The Triennial Review System Iv-3 Review Groups-Structure, Functions, And Authority IV-4 Review Criteria And Rating System IV-5 ENPS Program Analysis Guide LV-6 Site Visit Guidelines Iv-7 Procedures Por Requesting Supplements To RMPS Crants IV-& Guides For Reviey Gf Conwunmity Based Manpover rrogres Froposals Liv-9 Management Surveys ’ Chapter V APPLICATION FCRMS AND INSTRUCTIONS V-1 Grant Application, Regional Medical Program, RMP~34-1 Veo Financial Data Record, RNP-34-1, page 16 y¥-3 Application for Construction, EN!-537 vV-4 ° Application for Health Services Project Grant, HSM- 550-1 Chapter VI ADMINISTRATIVE AND ORGANIZATICHAL REQUIREMENT VI-1 Grant Administration Reguiremints VI-2 Grantee And Regional Advisory Group Responsibilities And Relationships vI-3 Affiliation Agreementa Chapter VIE FINANCIAL MARAGEMGAT VII-1 General Financial Management Principles And Requirements VII-2 Allowable Coste _ VII-3 Indirect Costs . VII-4. Grant Related Income of VII-5 Contracting By Grantees , VII-6 . Payment Systems VII-7 Governing Princizles And Requirements, Discretionary RNP , Funding And Rebudgeting Authority VII-8 Developmental Component Chapter VIII CONSTRUCTION, ALTERATION AND RENOVATION VIII-1 Construction, Alteration And Renovation Chapter IX IX-1 Chapter CIVIL RIGHTS Civil Righte { SPECIAL REQUIREMENTS Use OF Sectien $10 Authority Guidelines ond haview Procedures for Kidney Disease Activities RMP Health Manpower Activities Emergency Medical Services CHAPTER TI USE AND REVISION OF MANUAL I-1 INTRODUCTION I-2 PROCEDURES FOR REVISION CHAPTER TI USE AND REVISION OF MANUAL I-1 INTRODUCTION 1-1 {-1 INTRODUCTION SUMMARY OF CONTENTS This Manual is intended to be used as a resource and reference vork. It has been developed for use by the staff ef the Regional Medical Programs Service, Regional Medical Programs themselves, and grantees. The Manual includes all currently applicable policies of the Regional Medical Programs Service and either includes, cites, or summarizes policies of the Department of Health, Education and Welfare and the Heelth Services and Mental Health Administration when applicable to grants under Title IX of the Public Health Service Act, Public Law 89-239, as amended, In addition to these iters, the Manual also contains (1) copies of necessary forms and instructions, (2) vefercnces to other docu- ments where appropriate, and (3) the text of applicable regulations. AUDIERCE The Chief Executive Officer of every Regional Medical Program, the Chairmen of Regional Advisory Groups and the financial management officials of RMPs should be thoroughly familiar with the contents of this document. In addition, they should keep current with changes as these occur. It is also advisable for the entire professional staffs of Regional Medical Programs and affiliated institutions to be acquainted with the Manual and to have access to a copy as needed for reference. Each member of the professional eteaff of the Regional Medical Programs Service will be furnished with a copy of the Manual. RMPS staff will use the Manual in answering inquires and will follow procedures presecribed therein. STYLE Because the Manual is a compilation, it contains a variety of material developed over a period of time by different offices and individuals. The literary style may therefore vary from chapter to chapter or within chapters. In some places, legislative or regulatory language or Department policy is quoted verbatim in the text. As of the date of issuance, however, the entire text of the Manual is correct and currently applicable. Revisions will be furnished to RMPs, grantees and RMPS staff as they are issued together with instructions for deletion of obsolete sections or pages. The types of material included in the Manual also vary. Most of the Manual is concerned with requirements for applicants and 1-4 J-1L INTRODUCTION grantees. Soma sections, however, are primarily concerned with RUPS intexnal processes. For example, Subchapter IV-3 describes the operation of RMPS review proups. Subchapter IV-4 illustrates the REPS Review Criteria and Rating System. Subchapter IV-6 contains site visit guidelines. While these documents relate primarily to action by Reps etaff and reviewers, they are included in this Henual, rather than a separate document for staff, 80 that applicants and grantees are fully informed about governmental processes which affect them. Users will note that policies contained in the Manuaél do not represent a monolithic position. Some policies clearly delegate authority to RMPs or Regional Advisory Groups. Other polictes specify Federal requirements that must be followed, and still others call for negotiation. These differences are intentional. The Federal Government cannot and should not monitor or approve every trengaction or decision of a grantee nor can it delegate all responsibility or foresee every contingency. Variations in policy such as those noted above, therefore, are designed to identify the locus of decision-making or the method of arriving at a decision on particular matters. ARRANGE, SUT OF MATERTAL The Manual is divided into chapters and subchaptere as indicated in the Table of Contents. The Contents also listsexnibits located throughout the text. These principally illustrate regulations, forms and related instructions. Exhibite are printed on blue paper. Each chapter begins with a face page showing the name of the chapter and listing any subchapters by title and number. The subchapter title appears at the top of each page, and pages are numbered within each subchapter. The latter procedure permits revision of subchapters without renumbering the entire Manual. The numbering system and arrangement of the text is illustrated on the following page. te 1-5 Tel TNPRODUCT EON FIGURE 1 Format ond Numbering of Manual YO KAME OF CHAPTER (appears on Chapter cones title pege only) XXX-1 SUBCHAPTER TITLE 1-1 MAJOR HEADING Text begins here. Items listed within the text are shown as follows: (1) first item, (2) second item, etc. 1-2 MAJOR HEADING A. Minor Heading Text for minor headings begins as shown, B. Minor Heading 1. Subheadins Minor heedings and subheadings are sometimes omitted when items are listed down a page. a. Individual item under a subheading © CROSS REFERENCES It is not always possible to present 4 complete discussion of a single topic in one place under one heading. Therefore, various aspects of e given subject are sometimes discussed in different chapters within the Menual. For example certain requirements relating to civil rights are discussed under the topic of "Assur- ances" in Chapter VI. Other civil rights requirements are covered in Chapter ix, "Civil Rights," and elsewhere in the text in relation to contracts end conetruction. Wherever the discussion of a given topic appears under several headings, cross references have been dneluded. (Citacions are made in accordance wih the heading and numbering system illustrated on this page. This paragraph, for example, would be cited es Subchapter I-l, 1-5.) Ina few places, where it could be done cencisely, previously mentioned material is repeated rather than being cross referenced. 1-6 1-7 1-38 1-9 J-3 TETRODUCTION RELATED MANUALS ARD PUBLICATIONS In addition to this Manuel, other applicable policies areé con- teined in the "HEN Grants Administration Manuel! which may be obtained from the Covernment veinting Office, Washington, D.C, Every RMP and grantee should maintain both manuals. The present publication makes reference fo HEN Grents Administration Manual in a nuwber of places, rather than repeat detailed financtal management policies spelled out in that document. Other references are made,et appropriate points in the text, te publications of the Office of Grants Administration Policy (part of the Office of the Secretary, DUEK) relating to indirect costs and te the quality of grantee management. POLICY REQUIREVENTS ADMINISTERED BY HEN UNITS OTHER THAN REPS Some of the policies applicable to REPS grantees and contained in this Manual are administered by units of the Department of Health, Education, and Welfare other than the Regional Medical Programs Service and HSMHA. For example, payments are made through the ational Institutes of Health, which is also responsible for giving certain approvals relating to research and experimentation , involving human subjects or laboratory animals. The Office of Grants Administration Policy is responsible for negotiating and approving indirect cost rates. Another part of the Office of the Secretary is responsible for handling inventions developed with grant support, etc. Wherever it is necessary for RMPs or grantees ‘to deal with these or other units of the Department besides RHPS, the name and addrees of the appropriate office is given in the text of the Manual. Affiliates should direct communications to RMPS,or any other HEW Agency, only through the RMP cr the grantee for the RMP. , TERMINOLOGY, Terms used in the Hanval are defined in Subchapter LII-1, "Definitions." Some of the defined terms appear frequently throughout the Manual. Otherg may apnoear once or only cecasionally. The definitions in Sub=« chapter Lii-l are identical with the Aet and Regulations for the terns defined therein. Definitions for various cost and budget items are those prescribed by the HSMHA Office of Grants Management. A few definitions are taxen from other standard Govarnment sources, and certain terms euch as “program staff," and “affiliate” are defined specifically in relation to the RMP program. WAIVER The Director, RMPS, may valve any olicy contained in this Manual ’ . . provided thee rhe sfiect of euch waiver is not contrary to law regubaebiony, © a noha j only in except: n xP dyes Lia tanren a Le eo poss or eh boy. Wehvauarse will oe CHAPTER I USE ARD REVISION OF HANUAL [-2 PROCEDURES FOR REVISION 2-1 2-2 T-% PROCEDURES FOR REVISTON POLICY ITSSULECE sat oreo t The Manual is issued in loose leef form so that policy changes can be incorporated easily. Policy will be reviewed periodically by RHPS staff and amended as necessary. Any interested member of the public may submit suggested revisions at any time to the Director, RPS. ALL policy changes will state the entire correct policy, as revised, and _(1} be accompsnied by a covering statement that includes any needed background explanution; (2) explains where to insert the mat LER erial in the Manual; (3) states the effective date of the new policy; and (4) indicate what obsolete material needs to be deleted from the Manual, if any. At least one set of any deleted obsolete materials shovld be retained by the crates of RHP, since audit questions can freauentiy be avoided by referring to the policies | in effect during the jife of the grant,as opposed to those in effect at the tice Crantecs and RMPs are responsible for heeping their Manuals up to date. in order to insure delivery of nev or revised material, all policy issuances will be mailed with a return receipt requested. Policy igssvances will also be consecutively numbered as a check against missing material. Policy will be issued only when approved in writing by the Director, RMPS, and in the form approved by the Director. PROCEDURE FOR REVISING POLICY A. Submission Suggestions and recommendations relating to policy matters may be submitted at any time by RMPs' grantees, affiliates, and RMPS staff, The Director, RMPS, will periodically solicit suggestions for policy changes and for new policy from staff. B. Required Material Policy suggestions submitted to the Director, RMPS, by staff, RMPs, grantees, or affiliates should include: 1. The proposed wording of the policy, and where applicable, how such wordi:2 differs from existing policy (i.e., strike o T-2 PROCEDURES FOR REVISION out deleted wording by using siashes, ////, and underline the proposed new wording to be inserted.) 2. A copy of any other related existing policies or communf- cations. * 3. A brief statement of what the proposed changes are intended to accomplish. 4, If new, @ statement of why the additional policy is needed. 5S. The names, titles and institutional affiliations of 7% individuals with whom the propesed new modified policy has been diccussead. 6. An estimate of how many RMPs will be affected, and how, 7. A proposed effective date or implementation schedule, plus, where appropriate, a resume of any special problems of trensition from the old policy to the new. C pesinee anecs All proposed changes in grant policy will be sent to the HSMHA Office of Grants Management prior to final approval, pursuant to Chapter 1-20 of the HEW Grants Administration Manual. ALL proposed policy issuances approved by the Director, RHFS, will be sent to the Office of the General Counsel, DHEW, for legal review and determination of the need for publication in the Federal Register. THAPTER TT MISSION STATEMENT UI-1 MISSION STATEMENT, REGICNAL MEDICAL PR OGRAMS 1-1 1-2 TI-1l MISSION STATEMENT, REGICNAL MEDICAL PROGRAMS TRERODECTTION AND PURPOST t The initial concept of Regional Medical Programs was to provide a vehicle by which scientific knowledge could be more readily -ransferred to the providers of heelth services and, by so doing, improve the quality of care provided with a strong emphasis on heart disease, cancer, stroke, and related diseases, 2 The. implenente fon and experience of RMP in the past, coupled with the broadening of the init a concept espectally as reflectea in the most recent Vagisleti ston, has clarified the oparation- al premise on which it is based--nane sly, that the providers of care in the private sector, given the opportunities, have both the innate capacity and che will to provide quality care to all Americans. 3 Given —_ premise, the purpose i this statement is to speclfy (1) whet Regional Madical Prog > ave, (2?) what their evolving wission has bacows, and (2) He epasis' 02 | which thoy will be judged. TANTT ONE i ISM REP--! RMP is a functioning and action-oriented consortium of providers responsive to health needs and problems. It is aimed at doing things which must be done to resolve tho ams RMP is a framework or organization witht can come together to mect health nee that cannot be met by individual practitioners, health professionals, hospitals and other institutions acting alone. It also is a structure delib- crately designed to Cake into account local resources, patterns of practice and referrals, and needs. ‘As Such it is a potentially rnp er ant foree for bringing about and assisting with changes in he provision of personal health services and care. n which all providers h RMP also is a way or process in which providers work together in a structure which offers them considerable flexibility and autonomy in determining vhat it is they will do to improve health care for their communitics “and patients, and how-it is to be done. As such, it gives the health providers of this country an opportun- ity to cxert leadership ‘in addressing hea lth problems and needs | and provides them with a means for doing so. RMP places a grea corollary responsibility upon providers for identifying the beaten problems and needs which they must help to meet and which concern and affect all the people. RMP sheres with a private and publi Co AL health groups, institutions, and programs £ y ¥ e c, the broad, overall goals axe, (2) enhancing its quali neing the organization of availability of erating its coste--1 delivery of care more efficient. Among government programs RMP is unique in certain of its salient characteristics and particular epproaches. Specifically: nee to and works through providers, 1. REE is pr s Healt h professionals; this means the imax iy li roticd bie fe 7 ua 3 vwsially is a voluntary approach drawing heavily or 3. Though RMP continues to have a categorical emphasis, to. be effective that eaphasis frequently must be subsume within or wade subservient to broader and more comprehen- Give approucics. Principsl Ob jectives ¥ct is these bread, shared g characteristics and approac RMP on the other, that shape its more specific mission and objectives. the principal of these are to: t the leeal level 1. Promote and demonstrate among providers a both new technnicues and innoverive delivery patterns for improving the accessibility, efficiency, and effectiveness of health care. At this time the letter would ayn for a exanp le, encouraging provider aecepiance of end extending resources supporiive of Heoalth ? cenance Organizations : late and support those -ivities that will both help sting health panpower to Y and better care ill vesult in the more ef: oO ovide mor . ffLective utilization of new r combinations) of health manpover. Further, to that will insure that profe sstonal, scien- tific, and technical activities of kinds (e.g., informational, vraining) do i :¢ load to professional growth and development and are propriately placed within the context of medical practice and the community. At this time emphasis will be on activities which most effectively and invediately lead to provision of care in urban and rural ereas presently underserved, Cc. ft pe tone os 4 pk a9 ao nar cs noe a a wt 7 b — mo en:ble them to initdace ities, manpower, and other ecurege providers ta 7 i vegionaliz ation ar nealth facil resources so that wore appropriate and better care will be accessible and aveileble at the local and regional levels. In fields where there are marked scarcities of resources, puch as kidney disease, nexticular stress wlll be placed on regionaligelion so thst the costs of such care muy be woderated. Identify or ass o develop and facilitate the implemen- tation of new and specific mechanisms that provide quality control and improved standards of care. Such quad Ey guidelines and performance review mechanisms will be re- quired especially in relation to new and more effective comprehensive systems os health services. Intereonency Cocperation Even in its more specific mission and objectives, RMP cannot fune tion in isolation, but only by working with and contributing to related Federal and other efforts at the local, state, and regi Re alt otial levels, particularly state and arcavide Comprehensive “h Planning ectivities. ‘eotive requires that most RiR-sup- Spanclit and Co uod Support Moreaver, to be maximally ef 3 a port support ence initi terminated; thar 2 f 1 ed endeavors weke adequate citieria al Regional ded ] £ gs, there acneral for continuation yeram prank support is be assurance thet wt 5 future operating costs can be absorbed within the regular health i a care i niy in this way can RMP funds be regularly re-invested. financing system within ¢ reasonabi and agreed upon period. 1-4 RMP--THE KEASURE A. Cries ie £ rckl into sccount a veri: erit to (1) intended resuits of ment ceve i. evia For cllows thet the weasure of a Regional Medical Program, ecting as it botn ae es0R an ud mochanion, must take ty of fee my Lo & eria. The criteria by hich | Retls cq s and perfor loped by the Lt and (3) the Struc ‘ Program Criteria eterna renee ea. Criteria relating to a Regional Medical Pr rogram's proposed program, and the inte nuded or anticipated results of iis future activities, will include: b. STAR MERT ‘ne to which they reflect a provider high prio needs and are the overall mission and ob- to which new or improved tech Ceh knowlodge aye to be more broadly so that jarger mumbers of people nive better care. (2) (3) The extent to which the activities will lead to increased utilization and effectiveness of community health facilities and manpower, @s~ pecially new or existing kinds of allied heaith in ways that will alleviate the stribution of health services. personnel, - health maintenance, disease preven- nd early detection activities are 21 components of the action-plan. degree to “a ich expanded am bulatery g and treatment 0 t : oO O $2 4a 2 (6) Whether they will strengthen and impr relationship between primary and secondary care, s iY 2 thus resulting im greater continuity and acces- sibility of care. “There ere, moreover, other program eriteria of a more “gencral character that. also will be used, Specif fieally: (1) the extent to which more jmuediace pay-off in terms ey quality, end cost moderation, eved by the activities proposed. yee to which they link and strongthen ty of multiple health institutions and/or ns (as opposed to single institutions ) to provide care. (3) The extent to which they will tap local, state and otaer funds or, conversely, are des signed to be supportive of other Federal "efforts. erfornmence Criteria ont oem air area th Performance criteria will include: its Vee clry yt hy wunaere previous 5 GE the specific Ge khether | and the degree to which activities stimulated I norted by RMP have been absorbed wi the 2 Pt es _ ot rancing Ss yYSrem. a. The viability and effectiveness of an RNP as a functioning organization, staff, and advisory structure. b. The extent to which all the health releted interests, stitutions and profession of a region are committed : in co and ectively participating in the progyam. c. The degree te which there is an adequate functioning planning crganization and endeavor, developed sep- arately or in conjunction with CHP, at the local (or subregionel) level. . . . ' * waten there Ls a . 2 “4 ana aseesament Yesources; “and how these are bein region's continuously evolving j @é. The adequacy cf the region's owa management and eval- uation processes and efforts to date in terms of feedback de ed to validate, modify, ox eliminate activities. CHAP TEIGLLEOLOGY Titel DEPIRITIONS CHAPTER Tit TERNINGLOGY TlI-1 DEFINITIONS {II-2 ABBREVIATIONS nae CHAPTER IIT TERHTROLOGY YIT-2 ABBREVIATIONS TiT-2 ABBREVIATIONS 2-1 ABLPEVIATIONS ° t Some of the more commonly used abreviations associated with RMPS are ligeted below: DOD - Division of Operations and Development, RMPS DPTD - Division of Professional and Technical Development, REPS pRG - Division of Research Grants, KIH HEW - Department of Health, Education, and Welfare HSMHA-- Heaith, Services and Mental Health Administration ICK -f Indirect Cost Rete LAG Local Advisory Group ( of an RMP) MIS - Manegement Informacion Syatem (ef RNPS) HAC - Hational Advisory Council HIH - Hational Institutes of Health OA - Office of the Administrator, HSHHA OD - Office of the Director, REPS OGAP - Office of Grant Administration Policy, 0S OPPE - Office of Program Planning and Evaluation, RMPS OS - Office of the Secretary RAG ~ Regional Advisory croup RMP - A Regional Medical Program RMPs - Two or more Regicenal Medical Programa RHPS - Regional Medicel Programs Service RO - An HOW Reeional Office oectae oo web Do Fibs awh ee mieview 2avind Tve1 Iv~2 Iv-3 IV-4 tye Iv~-6 Iv-7 IV-8 CHAPTER IV APPLICATION AND REVLEW REPS REVIEW ICESS REQUIREMENTS AND SPANDARDS REVIEW RESPONSIBILITIES INDER THE TRIENNIAL Rev REVIEW GROUPS~STRUCTURE, FURCTIONS, AND AUTHORITY REVIEW CRITERIA AND D RATING SYSTEM REPS PRO OSKAM ANALYSIS GUIDE SITE VISIT. GUIDELINES PROCEDURES FCR Pa SUPPLEMENTS TO RMPS GRANTS oe CUIDES FOR REVIEW OF COMMUNITY BASED MANPOWER PROGRAM { PROPOSAL Ls * aie aVIE N oAND R CATIO PPLICA’ a * i {V-L WP REVIEW PROCESS REQUIREMENTS ARD STANDARDS * L-1 PURPOSE im ta mace a This document sets forth those minimn atancarce which must be met by @ Region for it to mee the final decisions regarding (1) the technical adeauacy of proposed operational activities and (2) which proposed activities are to be funded within the total amount avall- able to it. The document also outlines the general manner and schedule for implementation to be followed. 1-2 REQUEREY na ara ne jon's review precesa y is to be decentrai- The miniwann xcquirerents or standards that @ Reg, must meet if project review and funding authorit ized to it are grouped as follows: . Review Criteria and Program Priorities . Application . Gteff Assistance, Review, and Surveillance CHP Review ond Comment mim Ww hoe . Technical Reviav : 6. Project Ranking snd Funding Determinations 7. Foedback 8. Appeal Procedures A. ‘Weview Criteria and Prograri Priorttics There must be explicit (1) technical review eriterie end (2) program priorities which ave applied to all operational propossis. These criteria and program priorities must be made aveilable to all prospective spplicants and appropriate areavide CHP agencies within the Region 26 well a5 REPS. The review criteria must, a8 & minimun,refleer those factors coneidered in asseseing the technical and intrinsic edequacy of operational proposals (e.g., the feasibiiity of the project, quality of the personnel and facilities, resources to be involved, and adequacy Gf the proposed evaluation). These eriteria must, in fact, be used in the technical review process--for example, these comnittees and other groups with substantive responsibilities for reviewing and vesing recomendations to the Regional Advisory Group as to the techaical adequacy of operational proposals. Program priorities should yeflect regional needs and problems and appropriately cowplement RHPS and other national priorities. Put another way, these things which the Regional Medical Program and its Regional Advisory Group have identified, and perhaps are actively promoting, that warrant particular and t i Adate eheenbten wed goes ota a preasisb elain on Le ; r eetEective July 7, 19713 awejor factor tcken Into account T¥-1 REVIEW REQUIREMENTS ALD STAR + See or + mate ok oe eh A es "4 wey Ch rap BH esc A poy oP ga . ma fern Ce gee ge 2 ond other resources. As such, the progren oriovities ceusthitute tear eke + a approved proposals (1.¢., technically adequate) are to be funded, Phe final reaponsibility for funding determiastions, and thus fhe applicetion of these program priorities, east reside with the Regional Advisery Group. t Application The Region wust have a standardized application form or format (e.g-, instructions and cutline to be followed) that is employed by coseunity hospitals, local medical sochetieas, medical centers, and other applicants in requesting grant funds of it. It would be desirable if the review eviterla and program priorities of the Region were en integral part of the application packege sent to all srospective applicants. Staff Ascistence Review and Surveillance Progrem ataffs must reapond to preliminary applications and aetand prepared to edvise and essist all prospective applicants in a similar or equitable fashion. - mapies of tt ie susegested that progrém gtefis prepare gu proposed projects for the techuical review comnittecs and Regional Advisory Group. Furthermore, where proposals have been substanti- vally reviewed by program etaff, these critiques should be provided to the technical review committees. Similariy, acy suggested substantive changes in the proposal should be trans- mitted to applicants. cA Ca rt pany periodic surveillance or monitoring of funded operational projects by program staff is recuired so as to insure that the original intent and purpose of guch projects are being ful- filled end progress ig satiefectory. One way in which this yequirement might be satiofied would be to assign & program staff wember this respousiblility ee the outset of a project end have him follow that project through to ite completion. It also would be acsirable 1f periodic progress reports on projecte were made to the Regional Advisory Group. CHP Review end Comment P.0.91-515 provides that an RMP application my be epproved at the Federal level only if recomsended by the Regional Advisory Group and only "if opportunity has been proviced, prior to such _yecomsendation, for consideration of the application by each public or nonprofit private agency or organization which has N LIT-1 DEFINITIONS PURPOSE AND THTRODUCTION To facilitate understanding the policies set forth in the Manual, definitions of key terms are Listed alphabetically below. Where applicable, the definitions are identical with chose in the Act and/or Regulations. Ppefinitions of cost and budget categories are those prescribed by Departmental or HSMHA policy. Some of the terms defined below, however, are not defined elsewhere. These are generally those terms specifically associated with the RMP program. . DEFINITIONS © 1. Act (Title IX) Public Lew 89-239, as amended. 9. Administrator eer Hm ete the Acminiscrator of the Health Services and Mental Health Administration (H5HuA). 3. Affiltate; Affiliated Agency; Affilated Institution a public or nonprofit private agency or institution, other than the grantee, which receives RMP grant funds for specific operational activities. 4. Alteration and Renovation the work required to change the interior arrangements of other physical characteristics of an existing facility or installed equipment so that it may be more effectively utilized for ite currently designated purpose, or adapted to a changed use as a result of & programmatic requirement. ‘Alterations and Reno~ i work referred to es improvements, conversion, ion, remodeling or modernization, vations mey rehabilicat 5. AntiLyenhoevte Globulin; AntiLymphocyte Serum products of enimal serum used to prevent rejection of transplanted organs, especially kidneys. 6. Applicant a public or nonprefit corporate organization, inscitution or geeney wader substir a vemuest for funds under the Aet and + ert * fs ht i waetea ft Re RF ‘ oe @paw Rete Yop Waka | DEFINITIONS orb earomgaectrernaticta: oe aT & request for Yederal funds submitted on the prescribed applicetion form (Rie-34- -l for EMPs). 8, Artificial Kicney A total system used for hemodialyets consisting of dialyzer and dialysate delivery system. 9, asic Education educational activities designed principally to qualify the gtudentea for a degree, diploma, or certification. Internships and residency programs are part of basic education. 10. Budget Period the period of time indicated in Item 7 of the Notice of Grant Award, USM-457, for which grant funds are obligated by the Federal Government (usually twelve months). ~ “fAlso, see "Obligation of Federal Funda. “ 11. Built-in Equipment permanently etteched equipment--such as, plumbing and Lighting fixtures, built-in cabinets, etc. 12. Chief Kxecutive Officer (ef an RHP) the pergon vho begins the principal administrative responsibility for the overall coordination of a Regional Medical Pregran. The Chief Executive Officer is frequently called "Coordinator," er "Director." 13. Clinical Research Center an institution (or part of an institution), the primary function of which is research, training of specialists, and demonstra- tions which, in connection therewith, provides specialized, high-quality diagnostic and treatment services for inpatient and outpatients. ~ 14. Commmication Costs those costs incurred for mailing, tetephone, telegrams, radio and television (uged for education, diagnostic, or other pur- poses), etc. nO 16. 17. 18. 19. 20. 21. 22. 23. Core Construction anise Me Rte me Beat. ahs the erection, installation or assembly of a facility, including the expansion, eddition, extension of an exteting facility which provides new floor space, cubeage, or applicable units of weaguremants, total replacement of a facility and/or the phycical relccation‘cf a facility frem one lecation to enether. For buildings and structures, it mey include site preparation, including demolition, excevation, Landfill, utility system counections and extengions, site improvements guch a9 roads, walke, parking areas, lendecaping, and exterior or interior real property and iuetalled (euilt-in) equipment. ‘Consultant Costs ee er nr RP de DI Yhose costs incurred for consultant fees aud supporting costs guch es travel end perdiem in payment of services related to any program element of a Regional Medical Program. Continuation @ request or grant for funding of an additional budget period for which eugsort has been reccomended previcusly by the Hatiousl Advisory Council. Continuing Education those educational endeavors which are above and beyond those normally considered appropriate for gualification or entrance into practice in @ health profession or an occupation in 4 health related field. . Contractual Services specialized services which cannot be provided by the applicent, such as statistical services, special studies, etc. Coordinator See Chief Executive Officer. See "Program Staff" Decremental Furdine ee cence em accnn erm system of phased reduction of the Federal share of the costs of an activity, usually by increased asaumption of coats through earned income and local third-party payments. the Department of Health, Education, and Welfare. 3 . -EEY-1 DEPIRITIONS 24, Derertptors a standard classification echere prescribed by RMPS which is used by grantees to provide RMPS with selected salient charecterietics of individual operational and program staff activities. Speclal forms, RNY Descriptor Activity Reporte (Ree 47-1 and 47-2) are used for classifying activities in accordance with the descriptors. BR tt o Pots cs ay Py Se 2 / precess by which waste products are removed from the blood by diffusion from one fluid compartment to another aeross a ‘semipermeable membrane. In the case of kidney dialysis, blood is one of the fluids and the bath solution or dialysate is the other. (Also, see "Self Dialysis.") 26. Direct Assistance ig Federel assistance “in kind,” in lieu of grant funds. 27. Director, See “Chief Executive Officer." 28, Director, RMPS the Director of the Regional Medical Programs Service, who is responsible, through formal delegations, fer the administration of RMPS, end Title iX of the Public Health Service Act, PL 69-239, as amended. 29. Employee Benefits are allovances and services provided by the institution to its employees as compensation in addition to regular wages and salaries. 30. End-Stage (Renal) Disease that stage of renal impairment which cannot be favorably _ influenced by conservative management and which requires dialygis and/or kidney transplantation to maintain life and health. : 31. End-Steze (Renal) Treatment refers to either dialysis or kidney transplantation or both forms of therapy. La hn 34. 36. 37. 38. 39. the obligation ef @ grantee te return te the Regional Medieal Progress Service the residue or renidual velue ef equipment purchened with grant funds in aeccorccnce with the lew and eppliceble Federal Regulations . Such residue includas as mach of the equingent, cr a Fairy ms met valua thereof, es represented by the preportion of the iwltial cost of the equipment charged to the grant account G. @,, the amount originally charged to Kurs multiplied by the product of the current value divided by the original cost.) FECA Facilities Engineering and Conutruction Agency Feasibility § peueies is the testing of en activity for a specific triel pariod to determine if larger scale long-term or permanent opsretion is desirable (e.g., @ pilot program for development ef an operational activity). Final fudirect Coat Pate ? the indirect cost rate eatablished afcer an ins titution's actual costs fer « given accounting period (normally ite fisesl yeer) ere neon : Onea nen the final indirect cost rate is used as the institution's eu rrent provisional rete. (also, cae UF t Ceat Rate, " “previa ton al Indirect Cost Rate," end Chapter VII-3.) indiz Finsnctal bata Record form. RMP-34-1 Frings Benefits - sec “Yuployee Eenefite” Grantee - _ the agency deaisnated aa the grantee in Item 9 of a Notice of Grant Award, HSM-457. The grantee's responsibilities inelude the management of end accounting for funds awarded in accord~ ance with applicable Pederal policy. Grant Related Income the Federal share of the net income derived by a grantce or — frow fees ov cherges made fu connection with REPS grant support (ine ya bE beet nit tel Bocas e., "publications films, medical or ‘other devices). . 5 . 49, Al. 42, 43. 45S. 46. net PET ONS Denartesnt of Health, Education, and Welfare (alse ebbreviated DUEW). Major agencies of the Pepar nt include: (1) the Health Services and Mental Beelth Administration, HOMHA; S} the Ustionsl Institutes of Health, NIN: 3) the Food sand 4 3 Drug Administration, FDA; (4) the Seclel and ftehabiliteation Service, SRS: (5) thea Social Security Administrations and £ (6) the Office of Education. HEY Begion the States served by an HEW Regional Office (also, see "Regional Office." HES Pectonnal Office ec ae a CAR hE SER CATR see “Regional Office™ Hospital a facility including gencral, or other types of hosvitals end related facilities, such es laboraterics, outpatient 3 yep oe wre ge ye tiem oy ope Ege ryae Braeey et on ers So in . q t z departrents, nursing heine ities, extended care facilities, facilities related to progy for hema health sarvices, salf- care unite, central service facilities operated im connecticn with hospitals. The term “hospital” also includes education or treining facilities for health professions personnel opurating sg anu integral part of a hospital but does not include sny hospital furnishing primarily domictiiary cere. In addition, with respect to Title IX, the term hespital alse includes other health facilities in which local cepability for diggnosis and trestwene is supported and, augmented by the progrem established under the Act. Indirect Costs those costs of an institution which are not readily identifiable with a particular project or activity, but nevertheless are necessary to the general eperation of the inetictution ard the conduct of the activities it performe. (Aiso, see “previsional Indirect Cost Rate," "Pinal Indirect Cost Rate," and Chapter VII-3) indirect. Cost Rate 1. Provigional Indivect Cost Rate a temporary rate established to allow the obligation and payment of funds by an awarding agency until actual indirect costs can be determined and a final rate eatablished. provisiensil rates are subject to adjustment at a future date. 47. 4%, 49. 590. 51. 52. 53. a rete establishe cd the to federally-epat + * OF oy ge. st $end vu Long Term Training oe ae Tet iwnte rina eee “Training.” Maintenance of Effort the principle which appl to a grent, end which rege tot be supplant funds the aie BS ry ALB PES TREPTONS d after an institutioa's actusl costes anount of Indirect ceate applicable sored activities haa been determined. Tite rete is wot gubject to adjuctment. < hye Lite 1€ t e 6 te : LPG@s are all Federal funds paid puréuant thet Federal grant funds will Hn tey (im ys q.. eng eet etnerwige evail i dno or operating a Regionel Nedical Program. {> i Mangeenent Information Syster (HIS} oky Tan ha le for € nis AY ty Sd blish- the system divised for handling within RMPS, program information from applications and other sources and used for review, plan- sg © wy de «< Ons, leeistaci Ve of the Director, RMPS. Management Surve herr a ORIN an gasessvant performed by with the intent of rec CHE i budeeat 4 at. Cperation oc tha ics Office of Syntusa Management (C 9 : 2 neuen pvt fe is the raspois nate { e " va gh 6 *. se{fications, and program Mo ibility ef the SM), which le part of the Office PMPS ataff and Regional Office Pergzonnel to evaluate the internal menagenent of an REP more effective and efficient operation. Medical Center ding constructive action for a a medical scheol er ether madical institution invelved in rn postgraduate medical treining thet is affiliated vith ona more hospitals for teaching, research, and demonstration PULpOsea. Hovable Equisnent or a complete, identifiable, durable item which is not built-in (see “Built-in Equipsent™) and which has am expected service andable items end spare parts life of one yaar or tore. are classed as supplie S. (Exp See “Supplies. ™) National Advisory Council on Regional Medical Programs the body en the ed ant to Seetion 9695 of the Act to advice cee oe BE ee & . 56, 57. 59. 65. 61. 62. LTfeL LOFINITTONS refit Nactonel Ineci ecnstituent « end Welfare mn Kary land O00. stee of Health, RYH is one of the major “hin the marcment of Health, Educath Len, bed at 9 1 Oud Re ockville Fike, Bethesda, Nonprofit Institution (Agency) an inatitution or agency vhich is owned and operated by one or more nonprofit corporations and associations, mo part of the net earnings of which imere, or may lawfully inure to the benefit of any private shareholcer or individual. Hotica of Grent Award form HSN-457 Obligation of funds (by the Federal Government for a grant) the amount shown im item 12, f of a Notice of Grant Award (HSH-457). Wyiication of Funds (by 2 grantee) a cosuilteest or promise to pay for goods, facilities or services whether or noc the goods ox servicca have been received or 4 bill rendered. (Purchase orders, contracts, ¢tc., are evidence of chligation of funds. Och? Office of Grente Administration Policy. OGAP is part of the Office of the Secretary, HFW, and is under the Assistant Secretary Conptroller. The Office of Grant Adainiatration Policy's address is: Department of HEW, 330 Independence Avanue Su, Washington, B.C. Operational Activity (Project) is en activity maneecd and carried eut by other than progres : staff. (See “Program Staff.") Organ Preservs tion maintenence of an organ artes it has been removed from the donor end until it has been transplanted inte a recipient. Organ preservation is an integral part of a kidney trans- plantation progran. Organ Procurement Jane the sureteal removal 76, 7. 7Z. 73. 74, 75. 76. 77. ~, fay ht . eS ee eae > Het Reeloual Medical Freerem (ANP) ation ox group which meete all the require- & nonprofit orgeniest (a) of the Act. weate of Section 902 col Yrecran: Service (RIS) pes ‘tonal Hed the unit of the Health Services and Mental Health Adminis tration which is responsible for the adminiatration of the Aet. Regional Office an HEW Regional Office. (There ‘are 10 KEW Regioral Offices located, respectively, in Boston, New York, Philadelphia, Kangag City, Atlanta, Chicess, Gallea, Renver, Gan Francisco, and Seattle.) (Algo, see “EW Region.) Regional Office Program Director a teavber of th na HEW Regional Office etaff, aesigned to advise, monitor and asais tt the RH@s in the HEV Region. Regulation ; a rule or series of rules, having the force of law, formally promulgated by & Department of the Federal Government. Regulations are published im the ‘eadearal I Register! a and eodified in the “Cade of Fe i Roguivelows. ALL regulat ef the Bepartment of neaith, end Welfare are promlgeted by the Secretary. 4 LORS Review Pracess Verification special site visits and reports by RNBS staff to Insure that R4Ps comply with tha RMPS "Review Procese Re equirexents and Stcndarda." (Also, see Subchapter IV-1.) RH°S TRaview Coma tte a 20 rember advigery committees of non-T Federal, individuala appointed by the Director, RHES, £6 perform initial review of grant applications, under Title IX, prior to coneideration by the Netional Advisory Council. The Conmittee provides the wajor analytic review of each application. (Also, see Subchapter Iv-3, 3-2.) Secretary the Secretary of Health, Education, and Welfare (HEW). &4, 85. 86. 87, YFL-1L Meek Ee LONs Trieunial Application an application for three years of grant support to en RHP. Unenpended balance unobligated funde remaining in the grent account at the end of a budget period. Unlicuidated Oblipation a bill received or obligation incurred, but not paid. f Verification Vioit seo “Review Process Verification." E - REAP TEY POY Y PST Rep oe DT Oe KRIS oe TV-] REVIEW REQULREMERTS AND STASTARDS fan area or 14(b) covering pran for which the developed a comprencngive other lecal srea plan ref any area in which the rez application is made will be located.” C Agencies from which comments must be solicited include: ' 1. Areavide Comprehensive Health Planning agencies receiving Federal assistance under Section 314(b) of the Public Health Service Act es amended (b" agencies). 2. Other organizations meeting the requirements of Section 314(b) and designated as areawide comprehensive health planning asenctes by the appropriate State Comprehensive Health Planning Agency ("A™ agency). Furthermore, each application to RMPS requesting grant Federal support must be accompanied by copies of any "EF aeancy counants received by the Region or in lfeu of such comments, by 4 letter signed by the Chairman of the Regional Advigory Group eerti- fying thet the epplication or materials adequately describing the ectivities proposed application or materials adequately deseribing the activitiae propesed tha applicernioa have been furnished to the appropriate asency ox agencies ; and that, after a partod of 30 days, no comments have bee: reecived. While the signature of the Chaixman of the Regional Advisory Group on the application, among other things,sienifies that eny comments received heave baen taken into consideration by thet group, it would be highiy desivable ££ the application guvmitted to KGS explicitly took cognizance of and spoke to any especially critical and/or negative "B" agency comments. Fm MY fig dt bo Material sent to "BY" agencies fer cormnant should deacribe RMP activities in sufficient detail to enable the "B" agency to make appropriate couments. It ls suggested that such material tio 1. List or cali ettention to all health care facilities or institutions involved in the RMP activities described in the application. 2. Indicate the amount of RMPS funds to be requested for each, 7 3. Summarize any proposed steps to strengthen primary care through cooperative arrengements and regional linkages among health care institutions and providers. 4. Identify any major therapeutic equipment to be acquired or constructed or major alteration or renovation of health care facilities to be undertaken in connection with proposed RHP activities. at AED STARDLRDS ja Me fox 3 Co! Gri cn Oar and davelon- mental well ag operational proposals. Information relating to Program nteff setivities or @« cevelop- rental component must be sent for conssent to ail "p" agencies serving the Region, in whole or in part. information releting to projects whose impact is ¢ confined to & apacifiec ares with- in the regioa, necd te be sent for comment only to those Be agencies dit veothy concerned, Technical Review Each Region must have, im addition to the legisistively required Regional Advisory Croup, technical review committesa or groups These may be either etanding ¢ mittese or ad hoc groupas they may be cubcomnittces of the Regional havieory Group itesté, Linked to it, or quite geparate from it; and they may be eingle or multi-purpose groups (e.g., ad hoe review group, categorical eine and review comuittee). in ‘short, Regions have consid- rable latitude as to how their technical review ie etructured. : Mt The composition of cheese technical review coumitteea, individ- usily and collectively, must be euch thet Bi technica’ ectentific, and vrofersioaéd 1a z : sgnees the scope of its review funetion (e.g., cancer, “manpower, reasearch and evaluation). This may necessitate bringing in addicicnal expertise, possibly from outelde the Region, to provide sdequate technical review of specific proposals from time to time. se for technical geationa from a Tt would be desirable if the celection ee WE Advisory Group. Tt. he yeview committees inciuce acminations variety of sources, including the Regd siso is destreble thet the co the reflect a broad spectrum of hoaltn in sts and ftustitutions, including private practitioners, community hospitals, and aliied health personnel. ese committees Tho wanner in which merbers ava chosen or appo ointed, procedures or practices soverning the froquency and conduct of wmeetinas, and the like. wast be in writing and have the concurrence of the Renional Advisery Group. In addition to enploying expliele review criteria, these committees should always have available he to them and be guided by anyRHPs requirements currently applicable. ‘Summaries of technical review committee findings and recomnenda- tions must be available to the Regional Advisory Group prior to their meeting at which the projects in question will be considered, With respect to technical review committees, the Regional Advisory Group and any other groups taking actions on applica tiene, sity ations dove qo vorential cu nee of interest + vow gee 3 wo gre 4 wopet lps SvGheue as SORES Bae eo ¢ peecens _ nak piles AC LOT. offiitated with net ba @ part of Project Ranking and Funding Determinations Yoherent in Anniversary Heview is the requirener Regie vebliat a priority ordering ex venti “syatem (in woneral). for all project epplicetions for which support ig requested. jnec such ordering or ranking would by definition reflect the veletive position of projects in reletion to stated gesla and priorities of the pregran, the system itself should incorporate regional needs and program objectives, priorities, and policies The specifics of such a project ordering or rerking gystea, however, ace left to each Region to determine, thus, it might provide for either an interval (e.¢., 1-2-3-4+5) or ordinal (e.g., high-medinm- low priority) ranking of projects, or some other suitable means for reflecting pricrities The application of the system mist be the responsib Regional Advisory Group. Final determination must ie en te the relative or camp gitv ordexine eventuai funding. It yanking of ropeoved pre pecna : js anticipated that regional funding decisions (e.g., whether to fund level of funding) gen ee would be guided by each Region's own project priovities Feedback EE Fach Region must have a forral feedback mechanism, Appli- cants and prospective project directors, whose proposals have been disapproved, should be sivan opeoes reasangs why they have been disallowed in terms of technical adequacy and/or regional priorities. Applicants should net have to wait more than four monthe between the tine che april ton is entered into the REP review process and PAG notificsution of its eet ion: Tf & project is approved with conditions, ox has modified as a result of the regional review, there shou of acceptance of such conditions and/or modifi applicant organization and/or project director. id c ations by the Appeal Procedure A formal appeal mechanism must exist in any Region where a proposal may be disapproved by a body other than the Regional Advisory Group (e.g., an executive or steering committee, the board of trustees of a new corporation) without reterence to the PAG in erder te crovies smelieante wish fue oscion of wt 1-4 ean STASTARGS : ‘ aethon, ehould be clearly c / i ve ethed of appoluting the 1 erehdp of these eroups end be made available at the time of site visit oY manegenent assessment view wtb? of this procedure should SCOPE ean nets ‘ The regional review process must not only meat the mindenuia requirements or standards set for above, it algo must encompass or embrace all operational proposals or projects, for project review and funding authority to be decentrelized to the regional level. In addition, it should provide for general Restonal Advisory Group consideration of and concurrence in the overall program staff that share mony characteristics of operational projects (e.g., aisease reristeries, Library services, pilet or experimental ees progrems for new kinds of health personnel) Lt would be desirable 1£ these were subject to the sane kind of review process, an review for technical adecuacy, as those clearly ihentified as cperational proposals. An exception to the decentralization of project review and funding authority Regions are major kidney or renal disease projects-- for exarcle, prepesais for int A Glalveis-trensp last allen ¢ cengars OX proerains or - major constituent @lements thereof,euch as tissu ; typing or orgen procuremsnt. Ail such propoged prajects must cont inue to be submitted to REPS for approval at the national level in accord- ance with procedures specified in Subchapter X~2, DOCUMENTATION The following documentation reflective of a Region's review process and structure must either be rout jinely submitted to RMP as specified eleewnare (e.g., applicatica) and/or bea available for tts review and exsmination: 1. The review criteria end preavam priorities currently aoployed in determining the technical adequacy of proposals and their priority ve eines reepecitvely. 2. The stendar cd applica ‘tion form or format, end instructions being used, a 3. The comments submitted by erea wide CHP (or "B'") agencies. 4 The current nambership of technical review committces. 5. The procedures or prectices governing appointment to and the operations of these comaittees. 6. The minutes, reports, cor summaries of technical review ecormattres etLans and P/O ecetires covering their ds tahe 4 ue we te tat . : 2 3 Wes Bee a Ny pan Ae ow ROL iG Ceverwiniations. Wel REVIEW VR oy ope ge segs an « te bn aw es ee ye aN yl ty a ele ae . Where eppropriate, tre Gaeveptis Gppead POC ears § aed A yt ge a aa EE pe od es <3 ep yey eh ab ep pe det ee TAG pelsutes veflceeting any appgdl aetaans, Any other written materials, including general application review procedures, pertaining to the review of propessls, either generally or specifically, at the. regional or lecal level. ' Implementation Im the transition from national to regional review of operationa activities the agsuuption is being made that the review processes of ail Regional Medical Programs tmaet the requirements set forth herein, or can be wade to do so with certain minimum adaptations. My Actual compliance with the requirements will be vaxified for each REP prior to December 31, 1972. in many cares this will be carried cut throuch special staff visite to eosess the regional review proccss subsequent to gubmigeion and cxaminatioa of the documentation enumerated above in 1-4, In some ingtances, however, assessment of the regional review process will be undertaken in conjunction with regulorly scheduled managemant agsesament visits. Where the verification process indicates that ony Peeton doga not mact the re : S pearl is propared to provide necessary cc to secure compliance. Any Regional Hedical Progran which ig not in substantial compliance with the minimum etandards set forth im this Subchapter by pecember 31, 1972, may forfeit its project review and funding authority. Im addition, regions that are not in substantial compliance will not be eligible for a developrantal component. Furthermore, noncompliance with thesa standards after December 31, 1972 will be brought to the attention of the National Advisery Council. (this deadiine may be waived where verification visits take place , in lete 1972.) LV D REVIEW WIPO TT SUP UN Y | PLP IED INDER UPHE TRIENNTAL REVIEW reecres bo Eas eae T BT eo av J Dat dks ey a ons LEV Dus CUAL CUTTER de wr LO salt Zr} Y COUNCIL, ACTION Under the frien 5 yee eta normally will be by aly once each thi Ea Tt alee the Region as an naceredited™ Dg goneral level of apntas support for the three-year period. Thus, the Council's favor: she recommendation constitutes a time-limited approval for an me as an organization having recognized capabili- | ties, rather than |! a specific set of activities. In addition to veces al level of support, Council ace sao individ include advice to tha arpli- cant Regional Med ifie conditions for the grant. DPTT RELI ‘Pi Prior to review by i reviewed Review Co nN ie CONTE: er emnmae me genie Ay REVIT the Council, each by assigned RMPS staff, a si ommittee. Subchea 4. A The Director, REED , has detorml has reco: to the Council- Deve bs & ra “3 o rie {te visit i ‘ nnial applic j 2afa and the c cer IV-3, 3-1.) PS, will mal : yew activitlh oxt without fy are elly, the Cou wed, or the R a change requested. new a Cp LeU EY > The Director, the Héview Comnaittee, the Region, or member(s) of the Council itself requests Cot uncil xr cation © . il He a L be a + eyes sre Rie oe n mc od Review Cammnittee in the a view. The applicant has failed in a materiel respect to meet the applicable laws, regulations rnd S the requirerants of Program or formally promulgated policie or RNPS. or 4 ~ es of the Department, HSPMA, “Initially approved by the National Acvisory Council, August 1971. Amended and approved by Council, Febr puary 1972, Sie fe A summary Will be ywovided to the Council on each Region a reviewed by staff Lor continuatioa support. This summary will include: l. The findings as determined by the review of the Director scone ex with a stetement of tne ar eviously re the Council fer funding and emount awarded, 2. A list of activities supported during the most recent grant year, identifying those which have been completed and those which have been supported through a develop- mental component 3, A statement cf the Region's response to any advice specified by the Council or limitations upon or conditions of the 4. Identification of any outstanding accomplishments. 5, Ydentification of any outstanding problems. 6. Ann hf ay + BEES S stat the Council.) on request py 4 AE TU CHAPTER TV APPLICATION AND REVIEW JV-3 REVIEW GROUPS--STRECTURE, FUSCTIONS AND AULHORTITY ROU ua 3-1 PUNO?TIONS AND AUPEHORITY PORE ENAS eview Panel (SARP) was established 1O71,-to engble him sed bo him by. the Nation- ertiining second and third year REPS within the amounts previous~ "he delegation is contained in the ct entitled "Review Reepousibiiities Vrneer the ‘Priat aystom.'| Tho statement was initial- ly approved by of. teense 3, 1971, and was modified on February ©, @ greater clarity. (See IV-2.) Duration The Staff Annivers Keview Panel operates at the pleasure ef the Director ni Medical Prograns § fee. The SARP is en ante 5 wan. cb is net o pubiie advisory Oasis iWithea, and isn Lo the ma ® governing establishment and eperation of public advisory bodies. Structure The Staff Anniversary composed of members of the senior professic RE including the four Operations Bratch Chiess, chee of the ae Management Branch, Director, o and Development, mis tor ial end * Director and Deputy Director, Division of Prof echnical Developmaut, Director, Office of Pee ere Planning and Evaluation and The Chief, Office of Systems ragpement. y 7 fhe Director, Division of Crerations d DEN : serves Membors of the Staff Anniversary Review Panel are appointed t Rb The Executive Secretary for the SARP by the Director of the Division of Operations The Staff Anniversary Revi jew Panel meets prior to each RPS Review ‘Gotmas thee naeting (usua lly.a month prior to the Review BF, H mt tee. ead the ed to reves annually ie de OOS Se r a nel de National 3 , This { evaluate crien vital applicaciens and requests from-Kegionad Medical Programs which have not yet been appr oved for three year support. Scope of Review In reviewing requests for Council-~re ecommanded second and third year funding of Regional Medical Programs, the Anniversary Hae saan ector, RYES, on (1) the level of funding, not. yecomnanded level fer the year in a eeeion, (2) whether further review by the RMPS Review Committee may be advisable, and (3) whether Council action is required for any specific request in the application or on any matter deemed important In making thege determinations, the SARP is « nay © pel tha spolacent adations to the pir- ng the Council- ; ee res aian' s : Couue li ox y conditions of FESyunse RMPS, and auard. tn addition, the SARP evalustes the relative merit of each , Reeional Medical Program whica it > through numerical ca 2 ratings in accordance in t¥-4. The SARP's rating is subject to subseguont review and modification by & rs 4 a the Revi mim 2 1 Cou at tho opti £ those bodies. The Director, RMS, is free, of course, to accepr or rejeee any recommendation "of tt A ry, including pro- pose action by the Direc mad the SARP's retiog, is provided SHE — eho Coureil on each Region BE Supperd. reviewed by i} action * Further Committee ne fc the applica i (i) the birector, Program requests sucn re ev Council-approved lev omponent is reques © ew, (2) a change is needed of support, (3) a new developmental (4) the kegion in question has material- 1 ly failed to mect requirements. In all other instanc ces, the summary of the SanP's findings and the proposed action of tac Director will be transmitted to the Committee and Council for their information. i£ they wish, make ation. In oeder to Council Have nad an wpporcuualy to Buusy fae Sate ’s Kecoauenda~ tions and the Director's proposed action. ? B. DB. rs F. JV-+3 REVIEW GROUPS. -STRECTURE, ‘ne Regional Medical Programs Review Comittee was estaolished in June 1966, by the Director, NIH, and later transferred to the Heelth Sexvices and Mental Health Administration when the RMP Peogram became part of that agency. scion Since the RMPS Review Committee is an administratively es- tablished group, its continued dacration ig subject to renewed Departmental approval at two year intervals. seri sckure The Review Committee consists of 20 members, including the Chaixyman, appointed by the Director, Regional Medical Programs Service, for overlapping terms of a years. Members are leaders in the practice or me - 2, other health professions, public health, 1 radical center ad cok istration, hospital adminis- tration, and oth er aseas related to the activities of the ta toon t OD va oye e MecicaL POA Ras en 6 dd + Agpol Intments Members of the Review Committee are ap poiuted by the Director, IMPS, subject to prior elearance by the Office of the Acminis- trator, HSMRA, In making appointments the composition of the Committee with regard to professional fields is les igried ts cover the major areas of endeavor of the program as well as representation of tha public, women and minoricies. ret 4 a No individual may serve on the Conmit years, and no individual may be appoli other public advisory committee of tn iducation and Welfare tee for more than four nted who serves on any e Department of Health, Meetings AN aittee meets on a regularly scheduled basis at least three times per year, usually in January, May an September. Meeting dates are established a year in advance, and meetings are scheduled for two full days. The Review Con Funetions . ’ The Review Committee reviews applications for grants under Title IX and makes recommendations to the National Advisory Council on Regional Medical Programs with respect to their approval and funding. While the Comaittee's recommencations fieallv, the ens from Reploual Madiceal from Regional Medical Programs net yet ay teas bang CS wy the Director, RUPS, fonsl conmsubtet Review Committee regularly Progra ms, appro seton recommended by the addition, the Committee is regularly informe action as well as RM?S At the diserction of the Director, | end makes recommendations to the, Ce evepts or avnlicabiqus for specie when Lunds se available for sect shall be kept fully informed o© an g or requirements established by the Lo Where ad hce review procedures are establish categories of funds they shalt ine lute, to ¢ participation by Review Committesa In discharging their responsibilit participate with RMPS staff and C visits and other site visits as doomed with applicetions. Conmittee members aise bert 5 ial i : s the £ Review Committee considers the activities, and coms sistency with Ries the COnmictee © estabiishes the relative merit of each Regional Medical Program thr eviteris £ eee ete mM Riera ° enplications fer Resional appropriateness of proposed policies. ¢ AOI ough numer3cal ratir “Eh Subeba oP eae NO Ge of support, a no S a at rt - td “ x o> In addition, Committee menm- to evaluate ¢ antee performance om to strengthen x 4 reviews (13 triennial and (2) applications wed for a triennial : Panei on continued funding of grants within en appreved triennium or other approved period of suppore. In of final Council 's advice in connection with applications. ses. ed for special he extent po oy conditions ate advice. want 2S oa Medical Programs, the In addition,. ngs in accordance with itu dieerces end ta accex g Seark Anais VEEP ERG hag k ” woe ee a ae ‘ °. i Yet ey AF A L broughe toe the ettentiow of 1 for 9 t, the Review Comaittes will ii culy in those cases in ‘eetor, RMPS, or the Review a comeern opart Frem the technical c. The Comittee gpecifically will not 7 anaes che wavitea ef any kidmey prosostal nuverieeal retinse for kidney activities W dat whieh the AG, Tomnitces itsel merits of the projec yevies of 4 technica or estab . Activities for which epectal priorities have been establiched shall be imcorporated inte the atandard Rb mS yeview cycie at the carliest possible time consiftent with, Sound program matasement. yes | ART: AQT HGH PES tah Establisi tet sua Hatilonal Advisory Council on Regional Be al Programe was initially est on November 24, 19 by PL. 69-239 section 905 of the Ms LAS Health Gervic amended, and further amenace “515, 42 USC P.L. @1-515 expanded the Council from 16 to 29 members and the Chief Medical Director of the Veterans ' + provided th Adminigtratier . shalt be an ex officio member in addition to q & a uized that the Council include amber who is outstending in the | and 2 who are outstanciig ja the provention these. 4 wepibse kidney of heart soy gtrese. Tt al re et couraging repres tation in the field of he » administration, and wade the Assistant Secretary of Meelth paueats fon and Welfare for Health end Scientific affairs (vather than tne Surgeon Cen- eral of the Public Health Service) the Council's Chairman. Duration 1 Mental Health Adwdniet Pee eo S 3 Acts Snistration the fields oc health care acm 3 of the appointed menber be outstenc: heart . . re an be be practicing pn dy or health care of per a 4 i ct ec i . oF mn a ory ot “4 ae ge a we o th o rh wv ye ‘ hel wn G2 + ts yea outs tanding in “ Care Of persons” in the stucy © one must be o suifering Cxom ay the field of prevention of e kidney disease, and four must be members of the public. x ve of persons n the stucy or heal ease; two must be cuts ere Le in the: £ Yate fTeart ciscase, cancer, stroke, or c Appointr nements . ‘ are appointed by the Secretary of Health, Council me : Education, and Welfare for overlapping terms of four years and are not eligible to serve continuously for more than two terms, full term may be less Chan four years where a Council mem- ber is appointed to a new place, or to €i1l an unsp! ae by a dy mek lye tae pom ae ets oy a ve theduled basis at least year, usu kty spuery, June and Cotober. oo rn rs os 3 ee 4 et rt are established a year in advance, and meetings Functions respect ‘to, meles the Direct or, RlMPs to approval 3 3 for and the amounts of ews (1) trieunial IRS y (2) applications a triennial for special y, the Council regularly rev gs from Regional Medical Prag Programs noc yet pease projects, mt The Council has dele agate’ | to the Director, RMPS,; auth to make grants for third years o ended for trian ‘ Sar. TeCcor third yoar contin Staff Anniversary Director based on the Review Committec, Council for informati GU - 4 ott {2 fe c KECOMmMenNnaacré C “endat ions ofthe i the comments of oresented to the ev, spey make altec- change the 3 % Mf te oO 2 The Council's x ¢ Director with spect to the a i anim ci of support and conditions for any grant. The ni pouever, may make an award for a lesser auount or a shorter period than that recom- mended by Council. tC everded uuder Tithe Ik without the affirmative vocommondation of the Council. Scope of Review 4 “ L . In the case of any bho wane Tig tase rate advice. SPLOPLS ay founcdl ¢ S % and ca ervebio tm at =p CHAPTER TV APPLICATION AND REVIEW IV-4 REVIEW CRITERLTA AND RATING SYSTEM 4-1 &=-2 4-3 IV-4 REVILW CRITERIA AND RATING SYSTEM USES OF THE GRITERIA This Subchapter illustrates the RMPS Review Criteria and Rating System used in evaluating grant applications for Regional Medical Frograxs. A copy of the Criteria themselves, and the Scoring Sheet used by reviewers is attached. Each Region is rated annually. Regions requesting triennial — approval are rated by the RHPS Review Committee. (See Subchapter IV-3, 3-2.) Agplicante for reconmended second or third year support of a triennial grant are rated by the Staff Anniversary Review Panel. (See Subchapter IV-3, 3-1.) , The Criteria are used to provide a relative ranking of RMPs on the basis of numerical scores. About # third of the Regiona are reviewed at each review cycle. Therefore, the relative Btanding of an individual Region may change on completion of any cycle, based on the ratings for the Regions then undr congideration. The scores represent the subjective opinions of reviewers et given time and ere only one of a number of fectors considered by the staff and Director of RMPS in an approved level of determining support. ‘ . THE CRITERIA The Criterie are divided into three greups: (1) “par fernance , (2) "Process," and (3) "Program Proposal." Each criterion is assigned a relative weight. Weights were originally developad on a subjective basis, modified after a trial period and approved by the Review Comaittee and Council. In addition, a series of questiong appear under each criterion. The questions are tot criteria themselves, put are used to illustrate and amplify the kinds of things covered by the individual criteria. Copies of the Criteria ere furnished to the reviewers at each SARP and Review Committee meeting. THE. SCORING SHEET The Scoring Sheet (Figure I) is used by individual reviewers to provide their ratings. Sach column is used to record the reviewer's ratings for an individual Region. The Criteria and the weights for each are shown in the left hand coluwn. Space is also provided on the Scoring Sheet for an overall assessment of the Region (line D), a recormendation for a Revelopmental Component, if requested (line E), IVe4 REVIEW CRITERIA AND RATING SYSTEU and finally for recording the basis for the reviewer's evaluation (lines F, 1-7). The latter is used by RMPS for monitoring and evalueting the reting system itself. The “Basie for Evaluation" lines are for RMPS use oaly and do not effect the numerical scores. Fech reviewer rates each region on a 1-5 scale for each criterion. The reviewers do not sign the sheets. At the end of the meeting, the Scoring Sheets are collected and a computerized composite score for each Region is generated alwost immediately through the RMPS Management Information System. The overall numerical ratings for «ech Region are made available to the Council which may, at its discretion, modify any rating. er ¢ Iv-4 REVIEW CRYSERTA- AND RATING SYSTEM Searing Sheet ei ene te teen emma Lesa nt tepn aan nest rhe Scene ta Gonstnoing, Meo, 3 saiscactere. 2 faite Dpom) Rant wrt Restate tm a des tebe j de ts nonce A fs Prix FL x CEULY Pint Ls Hela CUEIA B, RPPSITACE - 83 Gos. actives & 2, Keres & eu Comes eer Maeoiy intezesis 5 FRELEMOA SIVIES CERES (SRE Ff, FX Gere Sire Visit Frevien Save Visit AIA * * Cae Parser Siok iiraee Ramee Tan o fear Rove Sime Visit we TEE UBS PAE PAUALY GP eT SCORING GET AD INSET US: SEIS PD : CMICE WITH THE CRETERGA SET a Abt Th. PV wet VL SACR TIL ALA OS DLT NTS Ob AE Ft OF CITFid Ff - pt 5, PEO Mal Ce ee WD ME BL VIENER IN 2 EAN ABD BG ASICS AEE TS Ae PD NECLOSAAY ALOT ULL BE EOE bY STATE, sts in Ties 2. OvtPAL TIVULOKT. PF IN YOUR REST QULGET 1415 FLGIOR HAS AOUIESED SUTFICIENT PROGRAY BATURITY ANG STATIS 70 SP AVIUCTETL ptste Fen cet PESECH TE BASIS FOR WOUR EVALUATION, HUEN APPROCREATE. MORE THAN Cre ITEM in STEM F ney Be TRITHES, BPEL TV-4 REVIEW CRIYESTA AND RATING SYSTEH RMPS REVIEW CRITE AGAR A. PERFORMANCE (40) 1. GOALS, OBJECTIVES, AND PRIORITIES (8) a. Have these been developed and explicitly stated? b. Are they understood and accepted by the health providers "and institutions of the Region? oe oS c. Where appropriate, were community and consumer groups also consulted in their formulation? d. Have they generally been followed in the funding of opera- tional activities? e. Do they reflect short-term, specific objectives and priori- ties as well as long-range goals? £, Do they reflect regional needs and problems and realistically take into account available resources? 2. ACCOMPLISHMENTS AND IMPLEMENTATION (15) a. Have core activities resulted in substantive program ac- complisizents and stimulated worthwhile activities? b. Have successful activities been replicated and extended throughout the Region? . c.. Have any original and unique ideas, programs or techniques been generated? : , d. Have activities led to a wider application of new knowledge: and techniques? , e. Have they had any demonstrable effect on moderating costs? f. Have they resulted in any material increase in the availa- bility and accessibility of care through better utilization of manpower and the like? g. Have they significantly improved the quality of care? h. Are other health groups aware of and using the data, expertise, etc., available through RMP? ct i, Do physicians and other provider groups and institutions look to RP for technical and professional assistance, consultation and information? j. If so, does or will such assistance be concerned with quality of care standards, peer review mechanisms, and the like? 3. CONTINUED SUPPORT (10) a. Is there a policy, actively pursued, aimed at developing other sources of funding for successful RMP activities? b. Have successful activities in fact been continued within the regular health care financing system after the withdrawal of RP support? Fffective Deecenper £5, 1971 4.- IV-4 REVIEW CRITERIA AND RATING SYSTEM MINORITY INTERESTS (7) a. b. Do the goals, objectives, and priorities specifically deal with improving health care delivery for underserved minorities? How-have the RMP activities contributed to. significantly increasing the accessibility of primary health care services to underserved minorities in urban and rural areas? How have the RMP activities significantly improved the quality of primary and specialized health services delivered to minority populations; and, have these services been developed with appropriate linkages and referrals among in- patient, out-patient, extended care, and home health services? Have any RMP-supported activities resulted in attracting and training members of minority groups in health occupations? Is this area.included in next year's activities? What steps have been taken by the RMP to assure that minority patients and professionals have equal access to RMP- supported activities? Are minority providers and consumers adequately represented _on the Regional Advisory Group and corollary committee structure; and do they actively participate in the deliber- ations? . Does the core staff include minority professional and supportive employees and does’ it reflect an adequate consideration. of Equal Employment Opportunity? Do organizations, community groups, and institutions which deal primarily with improving health services for minority populations work closely with the RMP core staff? Do they actively participate in RMP activities? What surveys and studies have been done to assess the health needs, problems, and utilization of services of minority groups? , B. PROCESS (35) 1. COORDINATOR (10) a. b. Cc. d. Has the coordinator provided strong leadership? Has he developed program direction and cohesion and established an effectively functioning core staff? Does he relate and work well with the RAG? Does he have an effective deputy in name or fact? CORE STAFF (3) a. Does core staff reflect a broad range of professional and discipline competence and possess adequate administrative and management capability? . IV-4 REVIEW CAYTERLA AND RALIKG SYSTEM CORE STAFF (3) (continued) b. c. Are most core staff essentially full-time? Is there an adequate central core staff (as opposed to institutional components)? REGIONAL ADVISORY GROUP (5) f. g. Are all key health interests, institutions, and groups within the region adequately represented on the RAG (and corollary planning committee structure)? Does the RAG meet as a whole at least 3 or 4 times annually? Are meetings well attended? Are consumers adequately represented on the RAG and corollary committee structure? Do they actively participate in the deliberations? Is the RAG playing an active role in setting program policies, establishing objectives and priorities, and providing overall guidance and direction of core staff activities? Does the RAG have an executive committtee to provide more frequent administrative program guidance to the coordinator and core staff? ; Is that committee also fairly representative? GRANTEE ORGANIZATION: (2) a. b. Does the grantee organization provide adequate administrative and other support to the RMP? Does it permit sufficient: freedom and flexibility, especially "dnsofar as the RAG's policy-making role is concerned? 5. PARTICIPATION (3) ~ 6. a. b. Cc. Are the key health interests, institutions, and groups actively participating in the program? Does it appear to have been captured or co-opted by a major interest? Is the Region's political and economic power complex involved? -LOCAL PLANNING (3) ante eninge seminars a Has RMP in conjunction with CHP helped develop effective local planning groups? . Is there early involvement of these local planning groups in the development of program proposals? - Are there adequate mechanisms for obtaining substantive CHP review and comment? - ASSESSMENT: OF NEEDS AND RESOURCES (3) b. Cc. IV-4 REVIEW CRITERIA AND RATING SYSTEM Is there a systematic, continuing identification of needs, problems, and resources? Does this involve an assessment and analysis based on data? Are identified needs and problens being translated into the Region's evolving plans and priorities? Are they also reflected in the scope and nature of its emerging core and operational activities? MANAGEMENT. (3) Are core activities well coordinated? Is there regular, systematic and adequate monitoring of projects, contracts, and other activities by specifically assigned core staf£? . Are periodic progress and financial reports required? EVALUATION (3) a. b. c. d. Is there a full-time evaluation director and staff? Does evaluation consist of more than mere progress reporting? Ts there feedback on progress .and evaluation results to” program management, RAG, and other appropriate groups? Have negative or unsatisfactory results been converted into program decisions and modifications, specifically have unsuccessful or ineffective activities been promptly phased out? C. PROGRAM PROPOSAL (25) 1. ACTION PLAN (5) g. Have priorities been established? Are they congruent with national goals and objectives, including strengthening of services to underserved areas? Do the activities proposed by the Region relate to its stated priorities, objectives and needs? Are the plan and the proposed activities realistic in view of resources available and Region's past performance? Can the intended results be quantified to any significant degree? ~ Have methods for reporting accomplishments and assessing -results been prcposed? Are priorities periodically reviewed and updated? DISSEMINATION OF KNCWLEDGE (2) a. Have provider groups or institutions that will benefit been targeted? , vend IV-4 REVIEW CRITERIA AND RATING SYSTEM 2. DISSEMINATION OF KNOWLEDGE (2) (continued) b. Have the knowledge, skills, and techniques to be disseminated been identified; are they ready for widespread implementation? Are the health education and rescarch institutions of the Region actively involved? Is better care to more people likely to result? Are they likely to moderate the costs of care? - Are they directed to widely applicable and currently practical techniques rather than care or rare conditions of highly specialized, low volume services? UTILIZATION MANPOWER AND FACILITIES (4) Will existing community health facilities be more fully or effectively utilized?. It is likely productivity of physicians and other health manpower will be increased? Is utilization of allied health personnel, either new kinds or combinations of existing kinds, anticipated? Is this an identified priority area; if so, is it proportion- ‘ately reflected in this aspect of their overall program? Will presently underserved areas or populations benefit significantly as a result? IMPROVEMENT OF CARE (4) a. h. a. , Have RMP or other studies (1) indicated the extent to which ambulatory care might be expanded or (2) .identified problem areas (e.g., geographic, institutional) in this regard? Will current or proposed activities expand it? Are communications, transportation services and the like being exploited so that diagnosis and treatment on an out- patient basis is possible? Have problems of access to care and continuity of care been identified by RMP or others? Will current or proposed activities strengthen primary care » and relationships between specialized and primary care? Will they lead, to improved access to primary care and health services for persons residing in areas presently underserved? Are health maintenance and disease prevention components included in current or proposed. activities? If so, are they realistic in view of present knowledge, _ state-of-the-art, and other factors? SHORT-TERM PAYOFF (3) Is it reasonable to expect that the operational activities proposed will increase the availability of and access to services, enhance the quality of care and/or moderate its costs, within the next 2-3 years? 8 7. TV-4 REVIEW CRITERIA AND RATING SYSTEM SHORT-TERM PAYOFF (3) (continued) b. Is the feedback needed to document actual or prospective pay-offs provided? c. Is it reasonable to expect that RMP support can be withdrawn successfully within 3 years? a REGIONALIZATION (4) a. Are the plan and activities proposed aimed at assisting multiple provider groups. and institutions (as opposed to groups or institutions singly)? b. Is greater sharing of facilities, manpower and other resources envisaged? . . c. Will existing resources and services that are especially scarce and/or expensive, be extended and made available to a larger area and population than presently?’ d, Will new linkages be established (or existing ones strengthened) among health providers and institutions? e. Is the concept of progressive patient care (e.g., OP clinics, hospitals, ECF's, home health services) reflected? OTHER FUNDING (3) a. Is there evidence the Region has or will attract funds other than RMP? . - , b. If not, has it attempted to do so? u c. Will other funds, (private, local, state, or Federal) be available for the activities proposed? d. Conversely, will the activities contribute financially or otherwise to other significant Federally-funded or locally- supported health programs? CHAPTER IV APPLICATION AND REVIEW IV-5 RMPS PROGRAM ANALYSIS GCUIDZ 5-1 IV-5 RMPS PROGRAM ANALYSIS GUIDE em Na The attached RMPS Progren Analysia Guide was developed primarily to eesist NEOS ataff to-develop information on individual REHPa in relation to the RHPS Review Criteria. See Subchapter IV-4.) Regional Medical Programs way also find the document helpful in insuring that the most appropriate information ia conveyed in applications, reporta, RMPS staff contacts, and site vielt presenta- tions. , ‘ The Proaran Analysis Guide consists of two columns, The left hand column lists the Criteria end summarizes the illustrative questions under cach. (The questions are fuliy spelled out in Subchapter IV-4.) The right hand colum shows where information yelating to each question may possibly be found in the application form RMP-34-1, or other sources such as site visit and staff reports or computer outputs from the RUS Management Information System. 7 rer 1A RM 5 é TOGRAM YSES GUIDES (for use in connecticn with, “iRYep Review Criteria’) CRITERL SOURCE OF INFORMATION A. PERFORMANCE lL. Goals, Objectives and Priorit ties (8) -b. understood end accented? ¢. community and: consumers consulted? d. followed in funding operation activities é. short as well eas long term goals , €, realistically reflect needs problems and resources : 2. Accomplishments and Implementation (15) a. worthwhile activities ans substantive accomplishments? RAG Report, Site Visit, Staff Visits $ite Visits, Staff Visits Page 4& (Consumers on RAG) Page 5 (Consumers on appropriate Committ 3) Pages 9 (Relationshi os with any consumer - roups) » Pace 10 (Consultation and Community Reis ions) Pase LL (Consumer related feasibility -— Lanning »tudies) Page l3a (ite oms 5,6 and 7) mo Page 13b (items 8 & 9) ‘ Pare 15 (eap. item 9, Target Groups) Page 16 (Printouts of deseriptors) RAG Report, Site Visit, Steff Visits Site Visit * Pare 8 (Core activities) pee 10 (Comunity Relations & Consultazion) Pace 11 (Feasibility and Planning Studics -- esp. Have any resulted in Operations: Activiti activit " + he we be ¥ a 5 2 cy a ) le studies) ttems mar 2 oO w 0) Ms eg o. os fe PY LATION ry wee ww e re t above com 7 on activities, OS See as c 15 uae t-outs (to determine re il ? i bove above ebove ey rey wt icablé operational activities n (ev 4 nga Pare 8, 10, il Page l4b Same as Sama as "2d" 3 and prograds aque ideas 4 on of new knowledge 2 ty of care? q 1 activit - successtu ed qual der applicat wLoVv < eneration of ua 4 « or ao wi demonstrable. effect on costs? im b. Ce ‘de: e@.. Be. ps) e Relationsht “Tr ¥ a9 (Ccoperatl Page ll (Results of Par “) other health groups u h. arganiza al activities, Items 4, and 11) a : he * 1 Se rative Relationships) der targets, Item 9b) Me Now ways Bere a a = (Operatilor (Coop se 12 (Ce Same as "2d" above Page 15 (Prov Fage 9 assistence on quality of care, etc.? providers use RMP as resource? i. ie CRITERIA 3. Continued Support (10) a. policy to develop other support? b. activities continued efter RMP phase-out? - & Minority Interests (7) -@., goals and objectives relate to minorities? (bd, accessibility of 1° care to minorities? | * c. improved 1° cate quality end linkages? d. attracting minorities to health field? e. minority access to RMP activities? £, minority representation of RAG etc.? RAG Report, Site Visit, Seaff Visits Page 15 Item lle) Page 16 (Budget print out -- other, funding) _RAG Report, Site Visit, Staff Visits relevance activit Descriptor print-out (to determine Page 8 (Applicable Core activities) Page 11 (Applicable studies) Page 15 (Avplicable operations] activitics, Item ¢ Same as "4b" above ;, S, Same as "4b" above . RAG Report, Site Visit, Staff Visits A (Minority representatives on RAG) - Page 4 Pege § (Minorities on advisory groups) Page 7 (Egual enpleyment) Page 9 (Cooperative relationships with coplicable organizations) : Pare 13b (Item 11 Civil Rights assurance by sponsor Page 4 (Minority representatives on RAGS . Page 5 (Minorities on advisory groups) wes. bw * g minorities on core staff? h. ecooneration with community groups servirg - 9 : Coordinator @. strong leadership? d. hes effective Deputy? Core Staff b. most core staff essentially full time c. adequate | central vs. institutional staff£? rd $3 2 {o eholg 3 £3 3 © te te ret td ns er 04 @ © * rd tes 9 (Cooverative relacis 100 (Comnuaity consults: 10 (Co: y consuitetion and Liaivcna) ll (Fe cy studies) 15 (Ap e operstio onal activitius, tt consumer cargets) Be priat- out to deters: > relevant ge 8. Visit, Steff Visits as "La" sbove il as. La" above 6. (Core personnel list) . Visit, Staff Visits . 6 (Core persoanel list) o £f we a ~ he 6 (Core personnel list) 6 (Core personnel list) 8 ("Central Office" and "Field Office" items’ - CRITERIA OF INFORMATION SOURCE me 2 Ge 08 fo oO RAG & Page Pare Page i e G2 rt wm 4 (RAC list) 5 (Advisory groups) Report 5 (advisory groups - “Number of Be. columa) | Visit, Staff Visies, inspection of pe ort. 4 {RAG list) bs) Advisory groups) 7 (ESO - *Plcaning and Advisory GY Visit, Staff Visits i Report, Site Visit, Staff Visits 3a & b cree 2,7,9,16,12,13,16 : 14a (3,4 14b lene 5,5, 7, and 2 at bottc» 4 (286 list - "Steering/Executive check blocks) ° + oe oye A 5 (dvisery groups - "Number of th. column) Visit, Staff Visits, meeting minutc: 4 (RAG list) Visit, Staff Visits. 16 (Print-out of indirect cos st dats) ciags” as fly minutes, is" item) ‘$ tt rs a jad a fo ing fe 3 Qa RMP co-opted by any major interest? vion's political and economic power - complex involved? wing factive local planning groups developed? G to oO 7 © mw Ew % 3 G62 2 & sro hod tS e ¢2 [fe] mS 2 G2 ts Visit, Staff Visits ification visit reports Lu (yee rete and performenc: sites) tcceperat ve Re elationships) (Core studies - “Parcicipacing ¢ocanizatior tomy (Central Services - "Organizatic . Providing ervice" item) (Item 4,.Sponsor; Item 9 Mrarge! soups"; "Or er Programs") t, Staff Visits (RAG list) , ores groups) * * Visit, Sraff Visits ; (R4G list) es - nee disty {bation of operati (Acvisery groups - * Check for Lozal comnitti and frequeacy of meetings) (Core suxaary - "Field Office™ item) (Coogerative relationships) “a 10 (Community relations and liaison} ification visic reports - CRITERTA arly local involvement in proposal develop~ £2? e mechanisms for CHP review and ” 7, Assessment of Needs and Resources d. oO Se w& ct @ Ms és tt pa Qa pte dentification of needs? involves data analysis? identified problems translated into plans and priorities? ‘ reflected in scope and nature of operational activities? &. Management’; a... Core activities well coordinated te oa +h OD td a hg 0? Visit, Staff Visits fication visit report 13. (Item 16) comments (Check for substance and valuc to RMP) Pege 8 (Core activities) Pase 9 (Cooperative relationships - “Dera Collecti: item) Page 11 (Core studies) Sema as "7a". above . *; ‘RAG Report, Site Visit, Staff Visits Reports of actual studies \ RAG Report, Site Visit, Staff Visits Pace 11 (Core Studies "Results" item) Also check previous app plication to see if current > goals have been derived from prior studics . 15 (Operational activities) ch 16 (Descriptor print-out) Visit, Steff Visits | o 6 (Core personnel list - check for Inspection of actual reports to the RMP Verification visit reports ite visit Sraffr Visits rification visit reports te Page 11 (Core studies ~- “Results item 2. “Corpleted" studies) Page 15° ("Progres item for terminated .:iivities) RAG Report Page 13a (Item 5,6 and 7) Site Visit, Staff Visits Applicable NEW, HSISIA & RMPS internal decv .onts (ie statements by Secretary, Administrator, Director Council minutes and highlights, ete?) ae Page 8 (Core summary) Page 10 (Cooperative relationships), Page 11 (Core studies) Page 12 (Central Sarvice Activities) “ to nak Activities) Page 15 (Sperac er ae te SOURCE OF INFORMATION © CRITERIA ad. activities realistic in relation to resources Site Visit and past performance? e. results are quantifiable Pose LL ("Resules" item) Pace 15 (Operational Activities - Itens 1: & 12) £. reporting mechanisms established? Peoes 13a & b Page 15 (Operations Activities - Item 12) culodge or skills identified ow o° * Dieserenation of Knowledgs a. provider. groups have been targeted? b.: svecific a for diss enation? . c. “health education and research institutions | of region involved? better cere to more people will result? hs RAS Re Nn 2 Pave Des 2WOX 15 ape 13a (Items 5,5 and 7) t, Site Visit, ‘Stafe Visits _ (Iten 9,."Provider targe ts") eripter pring-out RAG Revort, Site Visit, Staff Visits Page 11 (Core studies - "Results" item) Paye 15 (Overarionnl Activities - Ttems 32% 125. Pesce 3 (icen ft, Pege 9 (Cooperatt ship ' item) Page 11 (Core studies - ppartieipating Or. atzation teen) , Page 15 (Cperational Activities Tren 43 Site Visit Page 15 (Cperational Activities - especially ftens 10b, 10c and 101) Descriptor print-out oo ‘ec. . improved utilization of allied healt Utilization of Manpower aad Facilities a. comunity fa ellities more effectively cilized b. inerease productivity of physicians and . manpower ? : . d. manpower and facilities utilization iden- tified as priority area? e. underserved population will benefit? Improvement of Care a. need for improved ambalatory care? souncs OF INFORMATION Sara ag "2d" sbove Sener Ps 15 (Ope: 5 a ¥ we ne ara ee Pr on ae ae te Deseriptor peint-out a L Activities. - Item &) rational Activities, especial ty 10d, 10g an 101) Si Page 13a. (Itens age 3 ("Performance sites") ; ace 15 (Operational Activities - Items $2,410 -- especially a, b, h and I, ~~ LL.exd 12) Descriptor print-outs Site Visit, Staff Visits Pege lL (Core studies) Page 13a (Items 5 and 6) : Page 14b (Iten 5 “Evaluations last year yous SOURCE OF INFORMATION hee a. activities will expand anbulatory care? imoroving communication and tran D *S ran services to facilitate oucpatient care? fee access and continuing care problems have been identified? hen primary care? improved access to primary for residents of underserved areas? Health maintenence and prevention incluced? operetional activities will heve visible payoff re access availability and guality within 3 years? necessary feedback is available? sportation Site Visit Paze LL (Core etudies Page 15 (Operational Activities ~ Items & and 12) Beseriptor print-outs ("Non emergency trea portatior RAC Resort, Sice Visit, Staff Visits Pace 1L {Core stucies) Page 15 (Overational Activities -'Items ©| and 12) Descriptor print-out . Same as "4d" above Same as "4d" above = i! a Site Visit a Loo - Site Visit Trem 3, “Evaluation criteria” ..der “Droaran Evaluation’) e 18 (Operational Activities - {tens 2,6, LL an Pace 1l4b ve l4a (item 2, "Pericdic reports") ge 4b (item 5 under "Operational and Core Monitoring") Review of actual progress reports submitt:< to RMP on asplicable operational activities, on fonsibility studies. »® CRITERIA o. worn SOURCE OF INFORMAT Cc. d. co Gther Funding a. RIP support can be phased out within e yoars? t multiple provider groups? % oO ct pt < ety ct fae Q & fe pote r} to fa Fr) A sharing of facilities, manpower. resources? ' d ‘ expanding existing resources mong providers and institutions? progressive patient care? s (3) evidence of other funding? if not RMP has attempted to raise other ~ funds? other funds available for. proposed activities? activities contribute to other Federally or lecaily funded programs? Pege 1b (Core studies a@ member cf the REP evaluation staff 4. Practicing physisian who has had working experience with a Regional Medical Program; ans *An "Operations Officer" in the RMPS Division of Operations and Develop- ment is assigned to each RMP. The Operations Officer for a particular RMP is responsible for coordinating the site visit fer that RMP's eppli- cation. The name and telephone number of the res sponsible Operations Offic- ex appears on the first page of the "Staff Bricfing Docume ent” which is furnished to all RMP site visitors In those cases where a site visit is conducted with respect to special progran priorities or particular techni- cal issues, staff of other RMPS units may be essigned to coordinate the visit. Riad we IV¥V-6 SIVE VISIT GUILELINES 5. Consultants or members of past site visit teams 6. As necessary, appropriate technical experts are included. These might include allied health profes-~- sionals, medical oc nursing educators, persons with backgrounds in community orga nization, and consumer problems, etc. B. RMPS Staff RMPS staff members involved at site visits are as follows 1. Operations Officer responsible for the RMP who coordinates the visit arrangements with all parties concerned. 2. Operations Branch Chief when possible. 3. RMP Regional Office Program Director responsible for the RMP. 4, Wherever possible and as necessary, a staff representative from (1) the Office of Planning and Evaluation, and (2) a staff representative from the Division of Professional and Technical Development. sending on special issues which must be explored by the team, other HSMiA and Regional Office personn nel may be included. , Vn - 6. RMPS staff who are in traialy tg capacity or in orlentation may be included as appropri Late. 6-4 ADVANCE PREPARATION FOR THE SITE VISTR A. Advence Materials to Toam Several weeks in advance of the site visit, the team members are to be provided with copies o Cu it guidelincs o L.. the site vis 2. the application 3. previous site visit ‘report 4. appropriate trip reports from staff** 5. a staff briefing document (or other spectal purpose summary in the case of special projects). : ik RMPS Operations Officers and Regional Office staff visit RMPs regularly throughout the year. 6-5 COR A. . IV-6 SITE VISIT GUIDELINES 6. selected Management Information System printouts 7. the letter to the Coordinator outlining the purpose of the site visit 8. the suggested agenda-format (submitted by the Coordinator) 9. copies of REFS review criteria for RMPs (or other special c¥iteria in the case of applications relating to special - program priorities or special projects) elong with blank criteria forms for use by visitors in noting their ob- servations prior to the visit 16. current, applicable Management Survey Report and/or Review Process Verification Report, if any ll. other documents considered by staff to be pertinent Pre-Site Visit Briefing he site visit team will meet the evening before the designated ay of the site visit to discuss issues, asstgncent of visitors x 7 . “< ev aae a rf Lf sane) for spoetal sections of the report, aadustment o: agenda as ARS x needed beeause cf shifts in schedules, ete. WDUCTING THE SITE VISIT The Site Visit Agenda The site visit itself may teke several forms. A i include a review of the effectiveness of the Regional Group, of program accomplishments, of involvement of Regiona provider and consumer constituencies and plans ior new pro-~ gram developments. The agenda should provide an opportunity for the team to obtain information by which to evaluate the 20 review criteria (See Subchapter IV-4) and specific elements as they relete to the RMP shich is being assessed, The site visit team usually weets the evening after the first day to discuss their findings and their reactions to the re- view ae This provides an opportunity for discussion of those are that need further exploration-and those that have been sufficiently covered. ; Toam Executive Session It is imperative that all the site team members remain for an executive session after the formal visit to clarizy their fintings and priépare recommendations waich will be reported pei te ae aera Tah oT by staff), but the conclusions should represent the team's views. 3 TV-6 SUPE VISTE GUIDELINES Before the site visit ends, team mambers (or the Chairman) provide verbal feedback to the Coordinator with regard to the main. findings of the site visit team, pointing out that their recommend are subject to modificstion by the Review Comaittee and the National Advisor ny Council. 6-6 SITE VISIT REPORTS A. Draft Report The draft report is outlined around the twenty review criteria and conclusions. After completion copies are mailed to all site visitors fer comment, additions, deletions, ete. The final report with any changes should be returned to the co- ordinating Operations Officer within 7 days in order to allow time for preparation of final reports. B. Distribution of Final Report Copies of the final site the menbere cf ‘presents a verbal report on the site ; indings “ion is reviewed by the full Review Commit te Co adept Pp meond he Baviow Govnple ct when the . Sub- applicat i e sequently, copies of the final re eport sare made available to Advisory Council. (Usually the Council member who was at ite visit as Ene primary reviewer and spokesmen for the team at the : Council meeting.) C. Post Council Feedback (to Resions) After the Council hes made its lations, an advice letter is prepared and forwarded over the signature of the Director, RMPS, which embodies the site visit recomnendations and mod ; 3 end accepted by ‘The advice “Lotter to ser ys nt which reflects the atio: endatio muing from the full re- view process. This routine feedback in writing, provides the AMP with casitive disaction besed on an in-depth review of its total program that can be shared by everyone involved in program direction and policy-making. CHAPTER IV PROCEDURES FOR SUPPLEMENTS ‘TO GRANTS ¥ IV-7 PROCEDURES FOR REQUESTING SUPPLEMENTS TO RMPS GRANTS IV-7 PROCEDURES FOR REQUESTING SUPPLEMENTS TO RMPS GRANTS* 7-1 APPLICABILISY The procedures contained in this section relate to submission of requests by Regional Medical Programs for supplementary. funds under Title IX of the Public Health Service Act, and primarily to special procedures which apply when out-of-cycle supplementary requests are authorized by the Director, RMPS. 7-2 DEPINITICN A Regional Medical Program may request supplemental funds to support any activity eligibile for support under Title IX and any future amendments thereto. A supplement is an addition to the direct costs awarded as shown in Item llg. of the most recent "Notice of Grant Award," and/or an addition to the recommended future suppert shown in Item 15 of such : . funds ree ovarded, oppro- priate bes EE > rr ? tf 0 #kxA triennial application, also, may request funds in excess of the prior level of support, but this would not be a supplement. A triennial application seers funds for an additicnal period of continued support, while a supplement is an addition to an existing award. beet 7-4 SNES TO RMPS GRANTS “IV-7 REQUESTING SUPE RMPS in seme cases will permit requests for supplemental funds to be submitted outside of the normal review cycle which has been established individually for each Regional Medical Program. Such out-of-cycle requests, however, may -be submitted only when specif- ieally authorized by the Director, RMPS, in a general announcement to all Regionsl Medical Programs. RMPs should not recuest individual exceptions to their normal review cycles and may not submit out- of-cycle applications in the absence of such an announcement. DURATION OF SUPPORT oe Oo Supplementary funds may be requested for any length of time within the period of support specified in Item 6 of the last Hotice of Grant Award. A single application may request an addition to the amount awarded , for the current budget period (item 1lg.), and if needed, an addition to the recommended future suppore (Item 15), An award of supplementary funds may not include support for any activity beyond the ending date of the period of support shown in Item 6 of the currentHotice of Grant Avwarc Any funds needed to continue activities in the next period of support (beyond that shown in Item 6) may be requested in the normal triennial review cycle. This procedure is designed to channel re- view and funding of activities into the regular review cycle as quickiv as possible. vu cthexviun greet aré.og ocher communieation, it should not be inferred that RMPS requires termina- tion of an activity at the end of the current period shown in Item 6. Regional Medical Programs should, hewever, keep in mind that grant support for any activity generally should be for a limited period. 1 proposals at. WEbOG Ri gue Thus, an important factor in considering supplementa should be the likelihood of the activity cither terminating or be- coming self-sustaining within several years.* Support mey also be requested for Jess than the remainder of the currently approved period. For example, if there were two and one-half years remaining in a Region's triennial period, and ad- ditional funds were being requested for an activity that would be completed in 18 months, the application would only request supplementary funds for the six months remaining in the current budget period (item 7 of the last Notice ef Grant Award) and for the next 12 wouths, and not for the remainder of che trienniva. ‘The National Advisory Council has suggested that ordinarily RMPs should plan to support specific activities for no more than 3 years. Regional Advisory Groups shauld carefully deliberate concerning any possible longer term commitments in order to assure maximum flexi- bility in the use of RMPS grant funds. . Re 7-5 “JV-7 REQUESTING SUPPLEMENTS TO RMPS GRANTS ACCOUNTING AND REPORTING When awarded, supplementary funds may be mingled in appropriate accounts with other RMPS grant funds for the activity or activities in question, Normal accounts should be maintained for specific activities, but it is neither necessary, nor destrable to account for or report expenditures of supplementary funds separately from furds previously awarded. All normal accounting, expenditure and reporting requirements pre- vail with respect to any activity funded in whole or in part through a supplementary award. Progress and expenditure reports for such activities would be submitted in the usual manner, and no special procedures would be required. , ALLOZABLE COSTS When out-of-cycle requests for supplements are authorized by the Director, RMPS, the announcement of such supplements may contain special requirements with respect to costs allowable for the appli- cable activities. Unless specified otherwise in such announcement, the following cost principles apply to both in-cycle and out-of-cycle regueste for supplements, A. Direct Costs Supplementary funds may be requested for any eligibie RHPS direct cost category. Such funds may be requested to'ccver the costs of new or previously unfunded activities, costs of ex- panding existing activities. Supplementary funds may be requésted for core, operational activities, or unanticipated additional costs of existing activities. — B. Indirect Costs When requested, applicable indirect costs will be authorized in connection with an award of supplementary funds. Where the sup- plementary request includes additional funds for an existing activity, indirect costs for the supplement will be calculated on the same basis as the indirect costs for the original grant (i.e., salaries and wages only, or total applicable direct costs) using the currently applicable rate(s) for the institution(s) involved, . C.- Developmental Compenents . Since the amount of any developmental component is calculated aS a percentage of direct costs, it should be noted that the award of supplemental funds for core or operational activities does not automatically authorize an RMP to increase the amount of any previously apvroved Developmental Component. Any such fperense has to ba ccouested snd srecificaily anprsrec, 3 -IV-7 REQUESTING SUPPLEMENTS TO R¥@PS GRANTS 7-7 OUT-OF-CYCLE SUBMISSIONS ‘ 7 A. Authorization and Announcemant In certain circumstances, REPS may from time to time authorize the submission of out of cycle requests for supplementary funds. In such cases, authorization for out-of-cycle submissions will be provided through a general written announcement to all Regional Medical Programs. The announcement will include: 1. deadlines for submission where different from the usual dates for each Council cycle; 2. a general description of any special class or type of activity to be funded; 3. criteria for development of proposals; 4. any necessary special instructions. Application Requirements The announcement by RMPS that supplementary funds are available ao ere toe , 7 : : se ottwaa fet aoplicananoan we etes G@ FUER BPP LiCecvave. A bea Ge Goes pot nosessarily mean that prier to initiating an activity. Unless othervise specified, activities for which it is announced that supplementary funds are available can be funded locally through rebudgeting or through — support beginning in the next budget period. In the latter case, funds to support the activity would be ineluded in the next in-cycle 02, 02 year, or triennial request. Where funds are rée~ budgeted, the normal requirements for reporting such changes apply.* When the availability of supplementary funds is announced, all Regions may apply on equal terms whether in-cycle or out-of-cycle. When it ig announced that supplementary requests will be consid- ered curing a particular review cycle, any Region which is preparing er has already submitted an application for the cycla in ac jane with its regul anniversary date may (1) amend its eppii or (2) submit an additional request, or (3) both, in accord with the deadlines oc any other conditions stated in the REPS 2 Ll re Q ry announcement. ** *See instructions for Page 16, "Financial Data Record," form No. RMP-34-1. *kAS a general rule, an RMP should follow what it considers to be the most sensible course of action under the circumstances, Where there .is any question as to the best procedure, Regions are advisad to contact the appropriate Operations Branch staff. “YV-7 REQUESTING SUPPLEMENTS TO-RMPS GRANTS 1. Example To illustrate the above points, consider the case of a triennial or anniversary application submitted in its normal cycle for the June Council. In accordance with | the usual schedule, the application would be received on March 1 and funded on September 1. If, however, on March 15 (after the regular application was submitted) RiWS were to announce the availability of out-of-cycle supplements, the Rep in the example could prepare a supplementary request for additional funds to cover the last months of its cur- rent budget period. If the Region's in-cycle request were for the 02 or 03 year of a triennium, the supplemental application could include funds necded to continue thesactiv- ities (for which the supplement is requested) for the remainder of the approved period of support, Tten 6 of the lest award. An alternative would be to begin the new activity concur- rently with the next budget period, in which case the regular application could be amended in accordance with whatever special deadline was set for out-of-cycle supplementary re- quests. Method of Review The method of review of out-of-cycle requests for supplemental funds will be determined by the Director, RHPS, in each instance where such requests are authorized. The particular method of , review chosen will depend upon: ° : 1. the nature of programmatic activities for which support is requested; 2. existing Council and RMPS policies; 3, existing delegations of authority by the Council. Review Schedule for Out-Cf-Cvcle Supplementary Resvests Out-of-cycle supplementary requests, when authorized, will be reviewed in accordance with the following schedule, The earliest beginning cates for awards pursuant to such requests are shown in the table below. Later beginning dates, if desired, may be requested in an application. ‘Council Submission . Earliest Review Dates . Deadline Beginning Date February per announcement _. March 1 “June . per announcement July lo ~ October per announcement November 1 ~{V-7 KEQUESTING SUPPLEMENTS TO RMPS GRANTS Local Review by the Regional Medical Progrem and Comprchonsive Health Planning 1. nas RAG Review Like all other applications submitted to Regional Medical Programs, out-of-cycle requests for supplements must first be reviewed by the epplicant RMP in accordance with its established local review processes. No application shall be submitted ro RMPS unless it has been reviewed and recommend-=- ed by the applicant RMP's Regional Advisory Group. CUP Review and Comment Out-of-cycle epplications are also subject to the require- ments of Section 904(b) of the Act relating to opportunity for review and cowrent by Comprehensive Health Planning "RB Agencies."' In any case where special deadlines for sub- HLESTON aiounced by RMPS do not permit the usual 30 days for review end comment required by RMPS and CHP policy, the applicant RMP is responsible for working with the appropriate _ "RB Agencies" to insure that they are afforded an opportunity to comment prior to Regional, Advisory Croup reviey within nt et fae SLGh Gea. inecs.,. 4 -, ety Lee ten fey eed y my tlre deg et tye flak the shorter tire periodg afloriva Oy Lae sie @ "" "9.8 APPLICATIONS AND AWARDS A. Format and Content of Cut-of-cycle Applications Unless otherwise specified in a special announcement, requests for supplemental funds should be submitted on the standarc Regional Medical Program Service Application Form, RMP-34-1, For out-of-cycle applications, only the following pages of the RMP Application Form (RMP-34-1) need to be submitted: 1. Page 1 Submit one Faca Page for the entire application, Show only the additiongl funds needed on line 7a. (I.e., sometimes a supplementary request will involve additional fuads for an existing activity.) Page 2 Submit one Assurances and Certifications page for the entire application. This page should be signed person- ally by the required individuals including the Chairman of the Regional Advisory Group. Actual signatures are needed even though the same individuals may have signed the original application for which the supplementary funds ay IV-7 REQUESTING SUPPLELLRTS TO RMES GRANTS are being requested, ‘In completing this page of ti application, for a supplementary request, show the ‘da on which it is signed, not the dates of the original subinission for the period in question. Page. 3 Submit one Organization and Performance Site Data page for each operational activity-for which supplemental funds are requested. If performance sites are not known at the time of application, indicate this in the first data block under Item 10. Pape 11 Conuplate for any ' gpplicable programa etart ectivities to be e supported with the additional funds, otherwis not submit. Page 12 Same as above for Page ll. Page 15 Submit ene page 15 for each operational activity for which supplemental funds are requested. a. Qut-of-cycle specific activities: ity. Snow the charac- announcement by RMPS. applied. Use how it fulfills teristics e Deseribe how continuation possible. b. Le a moase TE ae page 5. C'rrozre oes” ed covered by ine (Item 11 of wage 15 is left blank if the funds are requested for now activities.) e. All supplementary requeses: _ Complete item 12 on Page 15 for all suppiements requested for operation nal activities. Enter information relating to the approved period of sup- port for which the supplement is being reques sted. In the event that the activity would continue into the next period of support and receive support for less ths ii year during the current period, To would to cube. Ven pence 0 pate: eee at ~IV-7 REQUES STING SUPPLEMENTS TO RHFS GRANTS the next triennium, and to indicate this in the narrative with the dates for the period entered in Ltem 12. 7. Fage 16 a. Funds requested for Program Sten Submit the -Pinancial bata Record form for Program Staff (Core) Activitics where additional funds would be provided for Program Staff through_the proposed supplement. In addition, complete page 16 for each operational activity to be supported in whole or in part with supplementary funds. b. Increased funds for existing Operational Activity: If the proposed supplement invoivés an increase in the budget of an existing activity, show the total budget as revised, not the difference between the original budget and the new request. c. Increase for Paxt of Budget Period: Where the requested supplement for a given activity would begin part way through the current budget period shown in Item 7 of the last Award Notice, complete one page 16 for the next year of the project If it is to be continued even if the next year were in the next tricanium, In the latter case indicate in a footnote that the partic- ular data pertains to the succeeding period of support and is submitted for information oniy. Descriptor Codes Each Regional Medical Program is responsible for insuring that the descriptors for its varicus activitics are kept current Program Staff (Core) planning and feasibility studies as well as operational activities. Where a Deseriptor Coding Sheet has been submitted previously no additional Descriptor Coding Sheet is necessary unless changes have occurred, When any change has occurred, complcte the entire Vescriptor Coding Sheet fer the activity as modified--not just the changes from the previous submission. Submit a Descriptor Coding Sheet for any new core planning or feasibility studies, or operational activitics for which funds are requested. for ~ Awards Awards for supplemerttal funds will be issued in the form of a "Notice of Grant Avard" which incorporates all necessary changes. Such award will supplant any previous "Notice of Grant Award" for the period. 7-9 {V-7 REQUESTING SUPPLEMERTS TO RN?S GRANTS o ATTACHMENTS roe ateminn cei eat A. Notice of Grant Award ‘ B. Operational Activity Summary (RMP 34-1, Page 16) OO HEALTH, EDUCATION, PUBLIC HEALTH SERVICE HEALTH SERVICES NOTICE OF GRANT AWARD Under Authority of Federal Siotutes and Regulations, ond HSMHAL Policy Standords Appliceble to the Following Grant Progrom: ANO WELFARE AD MENTAL HEALTH AOMIMISTRAT {On ec a weer ter ate ttc a. BUPER CED OS AWARD OTIC dAtOd ene ee me ce except thot any conditions of restrictions previously isipote! effect unless specifically rescinded. 3) "PHOITC T IDENTIFICATION NO, . 8. 7. BUDGET PERIOD ADMINISTRATIVE 6. PROJECT PERIOD From * Through From Through 6. TITLE OF PROJECT (OR PROGRAM) (Linit to $3 spaces) 4 9. GRANTEE (Name and Address) 10. DIRECTOR OF PROJECT [PROGRAM OR CENTER OIREC COORDINATOR OR PRINCIPAL INVES TIGATOR) (Name & . € 1. APPROVED BUDGET FOR HSMBA FUNDS SOURCE | OF HSMHA FINANCIAL ASSISTANCE BUDGET CATEGORIES FINANCIAL DIRECT For items identified by ASSISTANCE ASSISTANCE . Asterisk”, see remarks A : B 0. APPROVED BUDGET (11 & Col. A) $ b. inpiIRECT costs . @. PERSONAL SERVICES $ s (RATE % $ — b. PATIENT CARE Bose: $&W—~TADC of $ ) d ¢. EQUIPMENT . TOTAL $ d. CONSTRUC TION 3d. LESS UNOBLIGATED BALANCE FROM $ oe e. OTHER: PRION RPUOGET PERIODS) (Specify) ©. LESS CUMULATIVE: PRIOR AWARD(S) $ FIruS DUOGET PERIOD FL UN LE TH PTY vy oe . {, AMOUNT OF THIS ACTION * $ en : se ALL OTHER ’ “y3. REQUIRED GRANTEE PARTICIPATION (, TRAINEE COSTS (Jiusmitu tional Cost SHARING AGREEMENT / EFFECTIVE DATE g. TOTAL APPROVED (Clinoivinuat GRANT AGREEMENT 3 BUDGET $ (LIMATCHING AGREEMENT . % 14. REMARKS [J orHers (] kone ReQquirneo ° 15. RECOMMENDED FUTURE SUPPORT (Subject to arailadlli . BUDGET FISCAL BUDGET PERIOD TOTAL ORES »~ YEAR YEAR ° ‘ —~ . t : 16, ACCOUNTABILITY FOR EQUIPMENT —~ b : CONDITIONALLY WAIVE 7 NOT ' . CJ DITIC WAIVEO }NoT wAiveo [_j, £7. FIR ANCIAL MANAGEMENT OFFICIAL (Title & Address) 18. RSMHA OF FICIAL (Signature, Name and Title) . 4 tS. . jo. PRS LAS’ NO. va PATE T 2 ETON c. PUELC T ASBISTAS CE FOS a FO a 4 batts [ aieaA CRO. ee : INFORM. , ‘ . C ~_yNGet FY $C | County . Cone. ATION ; ORLY e, ACCOUNTING DATA pce pb t. TITue ‘ . VE vA. UPPORT ] 2. tener. 3. 4. SPOHSOR (Mislitulion/Orgonization) . ‘ [ nusBER Lobes Ss - . {2-12} Prone YUL RR (i3-ta4} | (05-16} vee weer ee AE LL 4.. 8. GEOGRAPHIC AREA SERVED 1S (17-18) 7. OUR ECTOR $, TARGEUT GROUP(S) (25-28) . 8. DISEASE CATEGORY (FES) (23-24) . “A. CONSUMERS AND/OR PATIENTS B. PROVIDERS (29-39) 10. SIGNIFICANT RELATIONSHIPS WITH OTHER FEDERAL PROGRAMS (Check allappiicable) 134) DO CHP-A (35) & O CHP-B (39] GByAN obo (a2) 8B O EXP. HEALTH PLAN. & DELIV. (331 C (J OTHER NCHSR&D (37) G O cHp-€ (41) (32). 4 () mob. Chiles (36) F O crP-c- (40) J () FDA K (1) AFPALACHIA (az) & CU NIH-ASISTITUTES (43) 4 ONT MANPOWER BUREA (44) N 0 OTHER (Specify) CO) Mo PERIOD. FROM (45-43} [ Ho, | Vu, | BO, i I { $1. PROGRESS | WR, A. WHAT VIAS DONE? . B. WHAT ARE THE SIGNIFICANT OUTPUT. DATA? Cc. WHAT ARE THE BENEFITS OR FINDINGS? D. WHAT PROBLEMS WERE ENCOUNTERED (IF ANY)? £. IF RMPS SUPPORT HAS BEEN OR WILL TERMINATE . EXPLAIN WHY AND WHETHER ACTIVITY WILL GS CONTINUED VATH OTHER SUPPORT, THROUGH (45-52] $2, PROPOSAL PERIOD FROM (53-55) THROUGH fs HO, | 7R. | Ho, ¥ | | i A. WHAT ARE THE GENERAL OBJECTIVES? 7 B. WHAT VILL BE DONE IN THE ABOVE PERICD? Cc. WHAT RESOURCES WILL GE EMPLOYED? O. WHAT SPECIFIC RESULTS ARE EXPECTEDIN Tt ABOVE PERIOD? REP-34A-f (PAGE $5] 72 Use nia inote then cue continuation page wore necessary, CHAPTER IV COMMUNITY BASED NANPOSER PROGRAM PROPOSALS + ty ood re ae me my a te zd es es IV-8 GUIDES FOR REVIEW OF COMMUNITY BASED MAN ROGRAM PROPOSALS IV-8 GUIDES FOR REVIEN OF COMMUNITY BASED MANPOWER PROGRAM PROPOSALS * 8-1] APPLICATION ESSENTIALS 1. Proposal is requesting funding in execss of $50,000. 2. Proposal has approval of the Regional Advisory Group. 3. Proposal includes review and comment of the appropriate _ CHP agency, 4£ not, explanation is given. 4, The area to be served is clearly defined and comprises a medical trade area. 5, Names of all institutions and agencies involved. 8-2 DOCUMENTATION OF NEED A. Required Data p whet sources of data have been used for plonaing to cetermine needs for health services? Do these include: 1. Number and characteristics of the population to be served; 1 2, Numbers, distribution, and utilization of health manpover roviding services; 3, Numbers and kinds of institutions, agencies, both private and public, providing health manpower education and training opportunities; numbers and nature of their training programs. 8-3 OBJECTIVES 1. Objectives are stated in clear and measurable terms. 2. Objectives relate to the RMPS concept of the community based manpower programs. , 8-4 PLANNING 1. - The proposal is not in competition with similar efforts within the same -geographical area. 2. Identification of the accredited education institutions, health care provider institutions and community health care and planning interests committed to the advancement of the program. . ES cote wg ba ee yr oe sy fe ” ate met wlan Geeabooten M-% for furtrur diseunsts: 4 YV-8 GUIDES Feu REVIER OF COMMICHITY NASED MANPOWER PROCRAM PROPOSALS 8-5 ORG A. D. £ 3. Identification of the potential membership of a Coordinating/Governing Body group. 4, here is a plan for evaluating the developmental process. 5. An implementation scheme has been developed and L . appropriate sources of funding to support each phase has been identified. AMTIZATTON AND DEVELOPMENT The Coordinating/Governing Body has been formed, its function formalized, and an administrative structure planned for Manageinent purposes. , 1. For established Bodies, by-laws are attached. ‘Such a Coordinating/Governing Body is proposed. — 1. Draft by-laws are attached if available. The Coordinating/Governing Body represents 2 consortium of: 1. At least one fully accredited institution of higher learning. 2. Principal health care provicer groups Or institutions, including appropriate clinical resources. , 3, Consumer interests. 4. Health professional societies. Evidence is provided of the degree of commitment of particip educational institutions, health service institutions, and o appropriate groups. , 8-6 OPERATIONAL A. eer mac nnn The operational phase of the proposal describes which of the are to ba undertcken in tha current pevicd. 1. Setting of priorities based upan continuous appraisal of the relationship between comnuaity heaith service needs and oe production of health manpower. ing oce tions to meet the particular health service needs 2. Designing education for both traditional and new health upa of the area. CHAPTER IV IV-9 MANAGEMENT SURVEYS IV -9 HANAGEMSNT . SURVEYS Organization and Personnel Management The staffing pattern and organizational structure of the RMP is reviewed. In addition, the adequacy and effectiveness of personnel policics are considered. ‘The team ascertains the degree tc which employees understand the policies and their own responsibility and relationships to related elements of the RMP. A review is made of office procedures relating to time and leave records, payroll procedures, and internal cormunication. Development and Monitoring of Activities Although the team makes no judgment on the professional aspects of projects, it inguires into the staff assistance provided in project development, review, and supervision. The team member covering this area is interested in the region's data collection and evaluation, guidelines available to project authors and reviewers, and staff participation in developing realistic project budgets. Under normal circumstances this review and analysis is. the responsibility of the operations ofiicer. Fiscal Controls No effort is made to conduct a deep financial audit. The survey teem instead is concerned with what fiscal controls have heen established, policies relating to disbursements, and fiscal reports vequired of t affiliates. A review is also mace of documentation required of the affiliates to support payment and the written instructions * tc are available to them. If questionable uses of grant pursued until proper action is determined by the team. Purchasing A review is made of the purchasing policies and the controls established to assure that they sre folicwed. in the area of équipment, the team is concerned with inventory records, accountability for equipment and maintenance of it, and what provisions are made for its eventual disposal. The Affiliation Agreement, Articles of Incorporation, and any written documents between the RMP or grantee and affiliates are examined within the limitations of the team to determine if the RMP is adequately protected. 9-4 IPYEYS % ot a SURVEY REPORT Upson returning to RMPS, each team member contributes a written report on his area of responsibility during the survey, and the team leader edits, rewrites, and combines the parts into a single survey report. Copies of the written report are distributed to (1) Director, RMPS (2) Dixector, DOD (3) Chief of responsible operations branch (4) Office of Planning | and Evaluation, RMPS (5) Coordinator , (6) Chairman of Regional Advisory Group (7) Grantee institution (8) Office of Grants Management, "HSMBA (9) Office of Grants Aéministration Policy, DHEW (10) DHEW audit agency Recommendations made in the report are used in working with the rec (3) by the airector inn aking management decisions concerni ng the region, ) (4) as part of the total review process, and (5) as information to be included in the site visit package. Among other things, the findings may result in developing new EMPS policy and may be the basis for special studies by either the Grants Managemen 1%& Branch or some other office in RPS In addition the Office of Grants Adm dnistrati on " Bolicy has used the reports as | basis for reconsideration of indirect cest rates for ment survey Approximately six months after the report has been forwarded to the RMP and its grantee and after their written response CHAPTER VI ADMINISTRATIVE AND ORGANIZATIONAL REQUIREMENTS - “ 2 Vi-1 GRAND ADMINISTRATION REQUIREMENTS VI-2 ORGANIZATIONAL AND STRUCTURA REQUIREMENTS FOR RMPS CHAPTER VI ADMINISTRATIVE AND CRGANIZATIONAL REQUIREMENTS VI-1 GRANT ADMINISTRATION REQUIREMENTS | CHAPTER VI . ADMINISTRATIVE AND ORGANIZATIONAL REQUIREMENTS - VI-2 GRANTEE AND REGIONAL ADVISORY GROUP RESPONSIBILITIES AND RELALTTONSHIPS 2-2 VI-2 GRANTRE ASD REGIONAL ADVISORY GROUP RESPONSIBILITIES AND RELATIONSHIPS IRPRODUCTIOR There are three major components of a Regional Medical Program at the regional level: the grantee organization; the Regional Advisory Croup; and the Chief Executive Officer foften referred to as the RMP Coordinstor) with his (or her) program staff. The responsibilities that each has and how they relate to and interact with one another are important factors in a successful Regional Medical Program. The following outline sets forth a framework for these responsibilities and relationships. GRANTEE A. Responsibilities of the Grantee Institution The grantee organization shall manage the grant of the Regional Medical Program in a manner which will implement the procrem established by the Pegional Advisory Group snd wee with rederal regularions and policies. Tunis in accords shall include: 1, Initially designating a Regional Advisory Group in accordance and conformance with Section 903(b) (4) of the Act, Such designation includes selection of th Chairman until such time as the bylavs of the BRAG have been approved. (This is a responsibility of the appli- cant organization which requests pieuning support for the establishment of an RUT.) 2. Confirming subsequent seicction of RAG Chairmen. 4 Chief Executive Officer on the basis of as tees = Myre at wy es wtp ee tet J te As he Be de eel ee A de he AN ea on Q me tC iving, administering, and acccunting for funds cn enalf of the Regional icdical Progran. 5. Reviewing operational and other activities proposed for RMP funding with respect to: a. their eligibility for aad conformence with REPS and other Federal funding requirements, b. capabilities of affiliates to manage grant funds properly. x r "OST sno RELAPTGRSATYS VT-2 RAG/ CH: 6. Prescribing fiseal and administrative procedures designed to assure compliance with all federal. requirements and to safeguard the grantee against audit liabilities. , 7. Negotiating provisional and/or final indirect cost ‘ rates for affiliates. (See Subchapter VII-3, 3-4 -) 8. Providing the RNP with all administrative and sup- portive services that are included in the grantee's indirect cost rate. (See Subchapter VII-3, 3-1, C, and 3-3.) 3 responsibilities of the Chief Executive Offic As its employee, the Chief Executive Officer the full-time person with day-to-day resp ponsibility for the management t 1 be Tw + +4 oy sear te fon ~ ~ of the RMD is responsible to the crantee; ho is also respon- grote wholes ES CEN.LSaLS proegy an 1. Providing day-to-day administrative dire ction for the program in accordance with the procedures established py the grantee and the program policies established by the Regional Advisory Croup tuaze staff and other support to the Reeienal mt & p and its committees for efrecti ive functiouiug. ‘pe O. a fete cn C2 Oke me Nat OQ ad © e 3. Developing the RHP staff orgen sterf and supervising their act o uf ao GE ODeracionai a 2td jonal and statf ectivii 5. Monitoring grant-supported activities to assure complianc with all Federal requirements. intaining an effective review process a RUPS regulrements. riate relationships and liaison with * Regional Office staff. This shall sominets Jon of en program policies and Group, aac v Pos within tne reg,roi and program Co Rows, - ee RTS hoe Re Ate ‘ VI-2 RAG/GRANTER TE CATIONSHTIS GIONAL ADVISORY GROUP @ 2-3 REG Ae 2-4 IMPLEMENT A. Responsibilities The Regional Advisory Group (RAG) has the responsibility for setting the general direction cf the RMP and Lorisule 4 apAT u program policies, objectives, and priorities. More specifically, RAG responsibilities shall include: 1. Establishing goals and objectives for. the Region's total program; setting priorities for both operational and program staff activities; and evaluating overall program progress and accomplishments : Approving any applications submitted to RMPS. Approving the RMP organizational structere and significant program staff activities. Approving overall budget policy and major. budget allocations, eo CMM: presentation on egional th the Act, RMP regulations, and utinuity; selecting and appointing ‘the chairman); and establishing % fren its own menbersnip to act on an exe utive comaltte Sts behalf between RA Selecting the Chairman for confirmation by the grantee. os Executive Officer for selection by 2, A., 3., above.) Nominating the Chi the grantee. (See nN e ' Developing, : + todi¢esl ly ups tus RAS by have % on seb rir LES ati orities, one ations of authority, including those 9, Approving any dcleg relative to specific budget allocations, to the Chief & Executive Officer, its executive committee, and others. ATION Effective Date roe 7 * on Foe gee eesbhoe ytot der + * Via geen QO Poe (LER RELATLONSHIES - VI-2 RAG/GRAD Implementing Working Documents Individual Regional Medical Programs are responsible for developing and maintaining the working Cccuments necessary for implementing the policy. Such documents estaplisn a basis for the required relationships and serve 4s evidence that the required relationships do, in-fact, exist. Some examples of implementing working documents are: corporate charters; corporate or RAG bylaws; organizational, procedural ‘and policy materials; the Coordinator's job description or contract of employment; and various agreements or contracts among the organizations participating in or involved with the REP. Approvals Although there must be documentary evidence of the required relationships, the written materials do not have to be submi.tted to RMPS unless requested. Regional Medical Prograzas and grantees, ae. aes ve x7 rie: I= je P e - o Tht ay a sfaes however, mey call on RNPS at any tire for advice relative to implementing the policy. ‘Shile routine approval of tae worsing documents by kMPS is nog required, the Director, RMPS , omety review such documents at any time and require. any changes nacessary to assure compliance, Bffect on Existine Acreements : Fixed term contracts or agreasments (e.g., the coordinator has a 3 year employmant contract} in effect 45 of the date of this se with the policy mevied. Gther contycetual issuance shall be ccemed to be in -il the expiration of unt Onur? arrangements affected by the policy should be altered accord- ingly by March 1, 1973. “7 or renewed contractual srrengements reincing to the relatione caverad by the toliey must comply in zil respects. CHAPTER VI ADMINISTRATIVE ARD CR TZATTOUAL REQUIREMENTS - VI-3 AFFILIATION AGGLEMENTS 10. 11. 12, . VI-3 APLILIATION AGREEMENTS - the agency for both direct atd/or indirect costs were not made in compliance with the regulations and policies of the granting or funding agency. Hold the Grantee Institution harmless from any and all claims arising by reason of this agreement. Acknowledge and agree that the ultimate disposition of equipment purchased with Regional Medical Program funds is the responsibility of the Grantee Institution, subject to the concurrence of Regional Medical Programs Service that it will continue to be used to further the objectives of the Public Health Service. Certify that it will comply with Section 601, Title VI of the Civil Rights Act of 1964, 42 U.S.C. 20000d, which forbids discrimination to any individual on the grounds of race, color, or national origin, and also agree that on each construction project it will comply with the requirements of Executive Order 11246, 30 F.R. 12319 and the applicable rules, regulations, and procedures -as prescribed by the Secretary of Labor. (See Subchapter IX-1, and VI-1, 1-2, a 4 tans Swe era my ert &y - meee ty “ye a4 ou ty 8 Assure that it will comply with the samo assurances u ‘agreed to by the grantee with the funding agency, with specific reference to: a. The Protection of Human Subjects Involved in Research Projects (See Subchapter Vi+l, 1-3, A.) , b. Patents and Inventions (See Subchapter VI-1, 1-4, A.) c. Humane Treatment of Research Animals. (See Subchapter VI-i, 1-2,1 Agree that all income generated as a result of RMP grant supported activities will be the property of the grantee, until disposition instructions are received from the funding agency. (See Subchapter VII-4 and VI-1, 1-4) Agree that continuation of this agreement is contingent upon the continund funding of the grantee by the funding agency, and decision by the RAG to continue support of the activity at che affiliated institution. Agree that grant funds received from the grantee institu- tion, will be exvended in accordance with the budget agreed upon with the grantee for support of the approved activity, and that any deviations proposed from the approved budget will be subject to the approval of the grantee. CHAPTER Vil FINANCIAL MANAGEMENT POLICIES VII-1 GENERAL FINANCIAL MANAGEMENT PRINCIPLES AND REQUIREMENTS VII-2 ALLONABLE COSTS VIl-% INDIRECT COSTS VIT-4 GRANT RELATED INCOMES . VII-5 CCNERACTING BY GRANTEES VII-6 PAYMENT SYSTEMS Vil«7 COUFRUING PRINCIPLES AND REQUIREMENTS, DISCRETIONARY RMI FUNDING AND REBUDGETING AUTHORITY cn tour Mulishe FINANCIAL MANAGEMENT POLICIES VII-1 GENERAL FINANCIAL MANAGEMENT PRINCIPLES AND REQUIREMENTS , VIT-1 FINASCIAL MANAGEIGNT REQUIREMELTS 4. Grantees will aiso be responsible for advising the recipients of the proposed equipment that any transfer to such equipment is made conditionally upon compliance by the recipients with the obligation to use the equip- ment for the purposes for which the original grant was made during the entire useful life of the equipment. If the recipient of the proposed equipment does not fulfill this obligation, the Federal Government may exercise its right to recover its proportionate share of the resid- ual value-of said equipment from the so designated recipient. The recipient of said equipment shall label the equipment to distinguish it from all other equipment within its facility, and keep appropriate records of the current status, . location and eventual disposition of said equipment at the completion of its useful life. D. Forns for Transfer ef Equipment Title and Accountability See attachment for suggested forms. meen . RAST RT MAM AEDS en UTT<1 PISANCIAL MANAGEMENT REOUIRE AY PACHMENT } } for 1-10 "Management of and Acc untability’ for Equipment Acquired with RHPS Punds." . Suggested forms to be utilized to transfer title to and account for equipment purchased with RMPS funds. A. Communication from grantee to RMPS requesting transfer B. Communication from grantee to affillate advising of approval of transfer C. Affiliate's certification re: continued use of equipment To cere taper yay 14 peoephewn oper ak Ji } PLRANCIAL MANAGE MEAT EU REUENTS (Affiliated Institution) From Grantec Inet fitution Transfer of title and accountability for the equipment listed has been approved by the Regional Medical Programs Service. 4 ’ 5 are advised that the follewing conditions apply: The equipment will continue to be us sed for the furtherance of REPS activities. The equipment shall be labeled to distinguish i€ from all other equipment within the facility. Aporepriare reeores wilt be kept of Che cuvreab status, location, and eventual disposition of said equipmant at the completion of its useful life. recover The Federal Government may exercise it its prerertionate share of the origin ° ina Lf said equipment of the above three condition Eouly Q G 3 3 a ie ct m pas nm er eI et Q 5 sO & Wh Pe -— as 7 _ 2 ae . “~ *“ The wwe owe mod T.D. he. Deserisbion Purchase pate Crieinal Cost team emis vik : 10° ‘ ~ TY -1 PINSNOTAL ay “i : ae VIE-1 FPISSSCLAL MANAGES ENT ROQUIREMERTS To From (Affiliate) js a The a _ __ seers cane no longer receiving Regional Medical Program operational funding and requests the transfer of title to and accountability for the equip- ment listed. All of this equipment was purchased with RHYS funds 2b008 5 under Grant Number (Project No. and Title) It is hereby certified that all of the equipment listed will continue to be used during its useful life for an activity which is approved by phe Regional Medical Programs Service or supportable under Title IX tho equipment at any ting cecees to bo used, + - ~ What oy es nO “sy te Gt ats Service, Grants wots Hoe From To Craatee Institution The above requested transfer is recommended far approval. Coordinator or Director CHAPTER VII FINANCIAL MANAGEMENT POLICIES VII-2 ALLOWABLE COSTES VII-2 ALLOWABLE COSTS 2-1 GUIDE MAT PERI TALS RELATING TO COSTS 2-2 Allowable costs under thé RMP program are those specified in this Sub-Chapter (VII-2) and in the follewing HEW Guides. 1. “A Guide for Colleges and Universities--Establishing Indirect Cost Rates for Grants and Contracts with the Department of Health, Education, and Welfare." (CASC-1, Revised) 2. “A Guide for Non-Profit Institutions, Cost Principles: and Procedures for Cost Rates for Grants and Contracts with the Department of Health, Education, and Welfare." (OASC-5, Revised) 3. "A Guide for State Government Agencies~-Establishing Cost Allocation Plans and Indirect Cost Rates for Grants and Contracts with the Departrent of Health, Fducation, aod Willere.” (OASC-S) 4. "A Guide for Hospitals--Establishing Indirect Cost Rates for Research Grauts and Contracts with the Department of Health, Education, and Welfare." (OSAC-3) ALLGZARLE COSTS A. Use of List of Allowable and Not Allowable Costs the Lise of allow: le costs furnished in Suce- tion 3B, below, cove frequently cucountered. The stated policies wise specified in a Hetice of Grant Awaz jeation frac Cufasion ef a per Eso onot iat oe tem is either allowable or not allowaale, ; ply ther the omit BR. Allecability of Tres antlu Encountered Cost Catcusrias : : 1. Alteration and Renovation - _ Allowable. (Also see Chapter VII, 1-4, A, 3; Chapter VIT, 43-2, A end Us ard Chanter VITI.) 2. Audiovisual Materials--(See B, 20,"Films and Videotapes.' ‘') s-~Allovable. (See Chapter VII-1, 1-9, "Bonding hee Basic Education (Training) Allowable for student support (tuition, stipends, etc.) and associated costs for training of new types of health personnel. Student support for basic education and training in esteblished medical and allied health professions (including internships and residencies) is not allowable. The training institution may be reimbursed for services rendered to an RMP activity by residents interns or other students. A health. profession is considered established if a Board of Schools of the AMA Council on Medical Education, or some similarly recognized mechanism, has been set up to approveschools, outline standards for admission, curriculum requirements and certification procedures, and/or if definitive formal educational programs in the particular health occupation have already been instituted in the educational and training systems of hospitals, technical schools, junior and senior colleges. Training of new types of health personnel is that training which relates to newly developing technologies or new modalities of diagnosis and treatment for which no standard curriculum is yet recognized, no minimum national standards for certification or licensure are yot established and which is not generally part of the regular offerings of the health-related educational and train- ing system of hospitals and/or technical schools, junior and senior colleges. Bonus Payments -- Not allowable Books and Periodicals -- Allowable Communications . Costs incurred for telephone services, local and long distance telephone calls, telegrams, radiograms, postage and the like, are allowable, provided that such costs are not treated as indirect cos Computers . Allowable. Grant funds may be used to purchase computer time, or if the needs of the program are sufficient, the rental of a conpute as with all other activities, the costs of acquiring computer capability must be measured.against the benefits to be derived. Computer Assisted EKG Analysis Not allowable to implement, equip or operate new computer assisted electrocardiographic systems (CAE). Limited funding is allowable, however, specific organizational phases of CAE system implementatic Such funding may assist in: establishing working relationships bets participants, provision of technical consultation, and evaluation ¢ as 2. 23. 24. 25. VIT-2 ALLOWABLE COSTS ec. The medical personnel of the Uniformed Services of the United States (excepting commissioned officers of the Public Health Service) hired as consultants have prior written authorization from their commanding officers to work on the grant supported activity and to be paid for their efforts. In addition, travél or other Supporting costs but not consultant fees for Federal employees may be paid when con- sultative assistance is required from a Federal program tion from an Office of Education employee, it could pay his travel and subsistence in the event that the OE's travel funds vere limited.) . va) Films and Videctere Allowable provided that the film in question is intended for viewing by restricted audiences. Grant funds may not be used to produce films or videotapes for viewing by the general public without prior approval of the Regional Med- ical Programs Service. While there is no universal rule for determining whether the intended aucience for a: -t .otoY a we tot noe rote tH Slikove enti. 2. yosdrucs 2% ae mee eee ok Pee Be i 5 Bo " . following situations: are routinely considered as in- volving the general public: (See Chapter 3-450 of Gants Administration Manual..) a motion ’ ‘ + - a. Broadcast on commercial or educational public television b. Showing in commercial movie heuses c, Showing in public places such as airports, walting rooms, bus or railrcad depots, vacation resort facilities, ete. when used as a teaching tool in a classroom sotciug), clubs, fraternal organizations, or similar lay groups. d. Showing to civie associations, schools. (except Films and videotapes-produced with RMPS grant funds shall acknowledge grant support and clearly indicate that the material in question does not necessarily represent the ‘wiews of the Federal Governmert. (Also see VI-1, 1-4, B,C, & D.). Poreten Travel-- See; "Travel," this Subchapter. Fringe Benefits ¢ The arantea's shere of fringe penefits, imeludine leave. policies, unirormly charged as a direct cost of aa aciua rather than an estimated basis, and charged in proportion to salary charged to the grant. . 27. 28. 29. Vibes ALLOWABLE COSTS Home Dialysis Training See "Kidney Disease Activities," this Subchapter. (Also see Subchapter X~-2.) Honoraria Not allowable. An honorarium is a payment or reward, the primary intent: of which is to confer distinction on or to symbolize respect, esteem, or admiration for the zecipient. ~ Pete fidney Disease Activities Allowable and not allowable costs of various specific categories of kidney disease activities are outlined below. Kidney disease programs are expected to be fully operational independently from RNPS support after the third year of grant support. (See Subchapter X-2 for further requirements.) a. Dialysis and Transplantation Facilities for Children -- Start-up costs are allowable for pediatric end-stage renal activities in selected areas of need. b. Education ~~ Training and continuing education of physicians postgraduate renal nurses, and other allied health professiona to improve care for patients with end-stage renal disease is + allowable, subject to the requirements and limitations of RMPS policies relating to educational and training activities. (See “Basic Education (Training)," and "Training Costs," this Sub- chapter. Also see "Public Education," below, in this’ Section.) ais c. Home Dialysis Training-- Allowable where there is a demonstrated need.Home dialysis training programs must be affiliated with a transplantation program and provide or have. access to acute dialysis backup. d. Low-overhead Limited-care Dialysis-- Allowable for the develop- ment of home dialysis training programs where there is a demon- Strated need, Such programs -ust be affiliated with a primary care program and have access to-acute medical resources, e. Organ Procurement Activities-- Allowable for start-up of a Region’: organ procurement activities. f£. Organ Procurement and Communication Activities -- Allowable. Such activities must provide optimal use of harvested organs through sharing among many transplant centers serving several areas, These activities should, like other kidney disease activities, become self-sufficient over time as RMPS funding ‘is reduced and eventually withdrawn. It is, however, more difficult for these activities to be financed by third-party carriers, and the costs ‘of mana reine the organ- procurement net- work mav he -47-d ta the Gdusd cost nov hoeen Boece abe eh - _ hee WA ka tLied Suppose fer _ appropriate pub. ic education activities which are clearly related to specific output of the end- stage renal program. + * -VEL~ ~2 ALLOWABLE COSTS 44, Training Costs Allowable. Grant funds may be used for the payment of stipends and other benefits related to training in connection with RM activities. Maximum allowances are set forth in the following schedule: er Annum Dependency... Per Travel Stipend Allowance Dien Conferences and Seminars* 10ne _ none yes. yes Short -Term Training* none “none yes -yes Long-Term Treaining* College level but less than Bachelor's Degree $2,400 $600 none none post Bachelor's, but less than a Doctorate lst year post os: 52,408 on AG. Hoa Zud year post 7 Bachelor's $2,600 $600 none none 3rd year post Bachelor's and : : . beyond $2,800 $609 one none Postdectorate negotiable $600 none none a. Stipends for lnag-term training which is leas than a full twelve moaths are to be calculeted on a prorata basis, and leave snd holiday policies of the grantee institution are to be followed. h. Benendtucy allowances for those long-term trainess, who ere in tratning for a full acad » mes be mucyded an ah not ro ancecd cur for each de pende or et yee DE who would meet the criteria develop- £ trainces - avel policioe amnee thereof, EW travel ne ed by the Internal Revenue Service for dependency. (Consult IRS for details.) c. Bopmburseray for per dien and travel should be wace in accordance with the of the grantee insritucioa, or in the in accordanes with currently effoctive regulations. (See 2, 35, "Travel.") 3 rd 2 ‘IN aa: i VII-3 INDIRECT CO S Cag vs. bookeeping, * the central adeinistrative. mechanisms tutien for such services. For the above reasons, approvr lat of the whereas the usual cusearch grant would rely on grantee insti- then, it will usually be necessary to indirect cost ra te for the grantee determine en @ PRP and each affiliated institution. cost rate determined for be dif corent from of grants. cost rates for: the (a) } The methods Jn addition, the indirect a given institution for RNP will usually indirect cost rate approved for other types for neg notiation and RMP grantees} approval of indirect and (b) affiliated institu- tions receiving FoR GRAS 4 mon ow Aree COST FATES tethod of Necotiation VRE ER mi fede RMP support ie discussed in the following sections. ISTITUTIGNS 2 The Office of Grants Administration Policy, (OGAP), in the Department of Heaith, Education, and We lfiare has the responsi- bility for negotiating indirect cost rates vith each grantee institution requesting indirect costs. Eceh grantee which wishes to ba selroucsas foe iudirect cast must eubadt an annual indirect cost rate progosal yithin six mont iS after the last day of each of the fiscal years for which Each institution's indirect cest rete proposal should ‘propose as many indirect cost rates &3 ate deered necensery for the equiteble allocation of indirect costs to its awards. For exemple, if the grantee conducts RMP activities at several different locations, it may propose separate rates for exch, where cppropeiate (i.@., on-campus rates, off-conpus rates, etc.). should be submitted to: Aduinistration Folicy th, Education, and Velfere Indirect cost rate proposals Division of Cost Policy end Neaetiaticn Cifice ef Grants Cepertment of Hea 320 Tadependence Avenuc Washington, D.C. 20201 Once an indirect cos it will be incorpo setting forth the recults therein the applicable rate for RMPS grants. Provisional and Final Rates 4 oy ye negotiated The indirect cast rate » + ze + eporietaccnd at mF - toate em rate has been negotiated by OGAP, orazed into an official negotiation agreement of the negotiation, indicating by GCAP may be cither 4 VIL-3 INDIRECT COSTS 4 provisional indirect cost rate is a temporary rate established to allow the obligation and payment of funds RUPS grants, until such time as actual indirect costs can be determined and a final indirect cost rate established. Frovisional indirect cost rates are subject to adjustment by OGAP at some future date. A provisional rate is used to compute indirect costs on grant applications and on grant reports. of expenditures. A final indirect cost rate is established after an institution's actual cost for a given accounting period (normally its fiscal year) are knowa.. Once csteblished, a final indirect. cost rate is used as its current provisional rate. -If RMES mskes an award to an institution that has in good faith negotiuted on indirect cost rete with OGAP, that rate will be used on & provisional basis by RHPS, icrespective of the eppli- cability of this rate to RMPS, subject to the finalization by OSAP of an indirect cost rate applicable to the KEMPS grant. 3-4 NECOTIATING INDIRECT COST RATES FOR AFFILIATES A. Gtantee Reavonsibilities 1. Required Grantee Action The grantee institution is respoasible for negotiating indirect cost rates for RNP affiliates when: a. The affiliate has no established indirect cost rate and none is currantly being negotiated with OSAP for any other HEW program. b. an indirect cost rate has been negotiated for specific progrems of the affiliate other than Ri? and is not applicable acrces the board to all HEW support The grantee is also responsible for verifying the appropri- ateness for RMPS supported activities of any indirect cost rates previously negotiated with the affiliate by OGAP. In the case of any discrepancy, the grantee is responsible for informing OGAP and for establishing a special rate for the affiliate's RMPS- supported activities. a 2. Cases in which the Grantee's Negotiation is not Required The graatce is not required to negotiate an indirect cost. rate for an affiliate when; , a. There is an established rate for the affiliated institution which is applicable to all] HEW support and determined by the grantee to be appropriate for RMPS supported activities. VII-3 LNDERECT COSTS b. GAP is fa the process of nevatiating the affiliace's indirect cost rate for other HEW programs (in which ease OCAP will eimiltene sously establish a rate for REPS support). c. The grencee decides at its discretion to reimburse @ll of an affiliate's costae as direct cherges to the serant. Staffing for Indirect Cost Studies by: the Grantee A grantee's pegocitation or verification of indirect cost rates for affiliaces can be carried out by either the grantee's own cinaneial staff or through the employment of qualified geccountants or eccoumting fires 2s consultants. In addition, OGAP may be called upon for advice as necessary. Provisional end Final Rates for Affiliates Where the grantee institution negotiates indirect costs directly with an affiliated institution,it will be the grantee's responsibility to negsotiate both provisional and final indirect cost vates with cach afgiliste feets tution. Gore a Einel rote is agreed upon between the grantee and an affilia be, dt will not be subject to further review or change, and will be con- sidered to be the final rate as if negotiated by OGAP. Before finaliging an indirect cost rate, the & . $ ollowing sters fo must be teken by the grantee to suodert che reasonableness af the finally established indirect cout rate: 1. Review the adequacy of the affiliate‘'s procedures, the reliability of the records, aud the effectiveness of their ‘internal coutrols. Review the cowpletcness of the base used for distributing he overhead cosss, re bes ng om eval ss and applicabi lit sna bese urd labor hours, direct Labo doller: etc and purpose of the project to ohie h app a M Review the pool of indirect expenses for those expenses which may be fully or partially unallowable, based upon their nature or content. Selectively analyze the remaining accounts in the overhead pool for epplicability to the RMP activity. Eliminate from the pool any expenses where similar type expenditures were previously recovered as a direct charge. Do not automati- cally eliminate cverhesd accounts from the pool purely by wae LSTA eayy exrence nemancioture if trees of the eave + - : : . 16, VII~3 ZNBIRECT COSTS gny accounts fren the overhead pool, a review should be made of’ the expenses comprising the seccunt to ascertain if these expensca are really similer to those included as direct charges. ‘the besis for determining the specific areas to be selected for intensive review and testing, and the depth and scope of the review should be determined by ac-review cf @ Listing of the account balances of the various indirect c osts, comparison with prior periods, and with the current year's operating budget. The reviewar - should obtain or prepare 2 schedule of indirect expense accounts fer the period under review and select for thorough anglysis these accounts which are significant in amount, rary from developed trends, or which,on the basis of © nomen lature veview, appear to be sensitive in nature and likely to contain questionable costs. Reconcile the affiliated institucion'’s overhead submission to their general books of account. Ascertain in relation to the nature of the project whether a special overhead rate is warranted for the RMP activity. Where applicable review the reasonableness of the ra utilized for depreciation, and whether th ; Wag based upon aequs ition value or appraised value of the institution's assets. Ascertain if large repair and maintenance expenses have been incurred which may be justi- £iebly reclassified to a capitalization account rather than annually expend & & Ue ed. - Determine whether fringe benefits are included in both the overhead pool and base, and evaluate the reasonableness of this. procedure. os Aseertain whether any income accounts from the "Income Statement" shoulc be an offset to any of the expense accounts in the overhead subvission. When PMP erofect octivitics ere perferned at (off-site locations, determine whether a separate overhead 90 is varrante at this off-site location, TF evuth a studyv io ovuitable, evaluate the reasons tblensss of allocations contained therein. If not, evaluate the reasonableness of the application of the main facility's overhead rate to off-site activities. After elininatin: unallowable items, the remaining total expenditures should be segregated between: (a) expenditures applicable to cverhead functions, and (b) expenditures for all other purposes (direct). Expenditures applicable to an institution's overhead function normally include Administration and General Expooses, House: Linen, Main- tenonce Of Flare. and Provision PRC VII-3 THDIRICT COSTS | 5) When the grantce submits the final SROEAS for 2 particular 4 } budget period, such Report should be annorated as the “final report." vthe final report should also indicate the t i balance of indirect costs claimed on the Report of Ex- penditures submitted for which no adjustment will be requested. Processing of Indirect Cost Adjustments When appropriate, each grantee shall submit a SROEAS to the Office of Finencial Management (NIH) reflecting the necessary adjust- ments in indirect costs to be made by RNPS for each project or activity. Upon receipt of the SROZAS by the OfL ce of Financial Menagement (SIH), a copy will be forvarced to the Grants Panage- ment Brench (4HPS), via the Office of Grants Management, HOMBLA. he KMPS Grants Management Branch Staff will review the informa- tion submitted to determine whether or not the adjustments, 8s reflected, are correct. RMPS will then forward a transmittal memo to the Office of Financial Management, NIH, via che Office of Grants Management, HSMHA, along with the SKOEAS, reflecting any changes that may be necessary. Upon receipt of notification of approval, er exceptions, to the SROEAS submitted by the Office. of Grants Mauagement, HSNHA, the - RIH will institute a payment or collection of funds. A single Treasury check or Billi of Collection will be.forwarded to the grantee reflecting the net total dollars of indirect cost adjust- ments submitted and approved... : CHAPTER VII FINANCIAL MANAGEMENT POLICIES VII-4 GRANT RELATED TNCOME 4-2 : - " VIL-4 GRANT REASON SCOME c. requires a formal set of prerequisite ccurses prior to enrollment. d. is open to all students meeting the necessary pre- requisites, s subject to space evailabllity. 4. Other Common Examples of Grant Related Income xamples of grant related income that may result from REPS supported activities are: a. sale of services such as laboratory tests or computer time. b. payments received from patients or third parties for medical or hospital services. c. fees received for parsonal services performs sd in connection with end during the period of grant suppe d. lease or rental of filles or videotepas and e. rights or royalty payments resulting from patents and copyrights developed or acquired by the RMP in connecticn —_ with RMPS grants. §. Gifts and Donations Grant related income does not include contributions, gifts donations or other grants given to an organization to further an LoPS supperted ectivity. A contribution, gise or constion is distinguished from grant related income if the donor or the grantor neither expects, nor recelves any goods or service in return for his financial support. ? . 6, Investment Incone - Interest or other inceme derived frem investment of grant funds is not trested as crant velated income. ALL invest- ment income must be ren: ro ibe Foderal Government and may not be waived to or reieinosd by @ grantee or affiliate. (See 4-2, below) USE OF NYT RELATED INCOME PS may, and ordinarily will, auchorize the use of grant reiated incone to further the purpeses of the RED. Grant tees, however, a reguices to submit writren request : e a related income. Such recuests should indicate, sufficient de stail, the expected sources and amounts of such ‘revenues and plans for their use. 2 th } is] 2 ‘ io mem Lobe for the ese posses 5 Vhere grant related incete is expected to be generated during a budget period, a prespective plan for the disposition of such income in connection with RMP must be submitted as early as possible, based on estimates of sources and amounts of funds. Grant related income be spent within the budget period in which it is earned. 4-3 4-4 " VII-4 GRANT RELATED INCOME After evaluating such plans, RMPS will advise the grantee of the amounts and authorized uses of grant related income waived to the grantee, and/or the amount to be refunded to the Federal Government, if any. Grant related income can be used (where permission is requested and granted by RMPs) for purposes such asthe following: (1) to assist in phasing-in community support for activities Initiated by an RMP, (2) to expand successful operational or program staff activities, (3) to initiate additional activities within the scope of the program in accordance with Sub-Chapter VII-7, below, and (4) to continue kidney dialysis and transplant activities. Grant related income may be used only for allowable costs. (See VII-2) SPECTAL RULES FOR CALCULATING INCOME FROM PATENTS AND COPYRIGHTS RMPS grentees and affiliates from time to time dervive income from patented or copyrighted materials~-usually films, videotapes, or publications. Special policies apply to the disposition of such income. Any proceeds from the sale of patented or copywrited materials developed with grant funds must be credited to the grant account and returned to BMPS uo to the total amount of direct certs of the grant expended for development of the materials. RMPS cannot waive repayment of the proceeds. of grant developed, patented, or copywrited materials (as it can in the case of other grent related income.) (See 4-2, above) Earnings accruing to the grantee or affiliate from patented cr copywrited materials in excess of the applicable amount of direct costs are not grant related. In the case of a single purpose activity, the sole purpose of which is to produce the patented or copywrited materials in question, the amount expended to develop the material is the total direct cost of the activity. ‘nis is the cost that will be used to determine the maximum repayment in such cases. Where the development of patented or copywrited materials is incidental to a grant awarded primarily for other purposes, the direct costs of developing the item in question should be based upon the time, effort and materials directly attributable, and a reasonable estimate of any other costs. The maximum amount of repayment in such cases will be negotiated on an individual basis. oe ft , REPORTS, RECORDS AND ACCOUNTABILITY The grantee is expected to maintain or require affiliates to maintain adequate records to support the computation of net RMP grant related income. The grantee is accountable to RMPS for itself and all affiliates for ‘the Federal ehere of any grant related income. The Federal + boat whe nen wn oat vente og ft vee . are te eh eee Bee bee Rw CHAPTER VII - FINANCIAL MANAGEMENT POLICIES - VII-5 CONTRACTING BY GRANTEES ViI-5 CONTRACTING BY CRARTRES When completed the Request for Bids can be disseninatced to potential bidders through advertising in appropriate publications or through direct notification by mail. Evaluetion of Bids Bids submitted should be evaluated from (1) a technical and (2) a business standpoint. 1. Technical Evaluation The technical evaluation of bids should be based on the iene criteria contained in the “request" and a ating or weieht should be assigned to esch criterion. red technical rating and the accompanying narrative of evaluation generally should cover: a. The Contractor's understanding of the scope of work as shown by the scientific and technical approach proposed, b. Availability end competence ef experianced scientific and techn ical personnel. c. Availability of necessary facilities. d. Experience or pertinent novél ideas in the specific branch of science involved. e. The contractor's willingness to devote his resources to the proposed work. . £. The contractor's preposed plan for achicving the quality of performance required. he reasonableness of the proposed marhours, validity of subcontracting, and the necessity of proposed travel. ro Ze After the coffers are rated, a narrative statement should be prepared expressing the strength or weaxness ef each _ proposal and any reservations or qua alifications that might bear oa the selection of the source of negotiation or award. Business Evaluation The business evaluation usually centers around cost anatysis and analysis of the contractor's financial strength and ranagement capability. plement considered in cost analysis cenerally include direct material and So pag kasa laber coats. cebtent: financial strengch and management capability include . - Vil-5 COMPRACTING BY GRANTEES organization, pase performance, reputation for reliability, availabi — y of required facilities, cost control, person- nel precti es, financial resourecs, etc. C. Courract Tssucnce 1. Type of Contract , perenne aay erate . Oncé it is decided to issue a contract, a decision should be made by respousible grantee persouncl as to the most effective contract instrument available, fixed price, or cost reimbursement. , The influencing factors in selecting and negotiating a contract are: a. Type and complexity of the product or service. b. Stability of the design. ¢. Prospective period of the contract performance. Ie . : mating end secounting . any wey d. Adesuacy of the contractor's est syeten, e. Urgency of the requirement. f. Degree of the competition. g. Availability of the comparative cost or pricing data, market prices, and wage levels. % ¥ oa h. Administrative cost to both parties. 2. Megottiation a aR omnence be tien and th will usually a. Reaching agreement with a proposed contractor on the technical requirenents--which is included in the vorkscone (if there is a true change in the requirem nts , all offerors must be given an opportunity to revice their proposals.) b. Reaching an agreement on the type of contra act--the objective is to negotiate that type 2 of contract and price which includes a reasonab ble amount of d visk to the contractor, ee HOTS Paar tt wey eB Cost pesporsibiediiw # periciigimec. VIL 5 CORTESAGTING BX GRAND EDS c. Reaching an agreeiveant on the pricing and al}. other provisions which will condition his performance of the contract. , d. Setting forth al} terms and conditions in a mutually acceptable contractual docusent which includes terms and conditions:reduired in. relation to (1) civil richts (See Subchapter Vi-1, 1-2, C, and Chapter IX); and (2) vace rates and related matters as specified in Section 604 of tne Act. (See Subchapter Vi-l, 1-2, 8 4.) e. Justifying and documenting the contract negotiated. Contract Administration Once the contract is issued end performance commences, the grantee institution should assign a project officer to administer the contract. This function will normally entail the following: 1. Monitoring of Performance The protect i should ho. posponsible fer providing technical assistence and monitoring the performance of ; a the contract. It is essential that he monitor a4 con- tractor's progress closely and identify problems that threaten contract performance so that remedial measures may be taken if necessary. The contractor should usually be required to submit periodic progress reports which could be used by the project officer to evaluate con- tractual progress. These reports should provide the project officer with most of the information necassary regarding the progress of the work. @ The terms of the contract govern and they can only be modified by the Project officer arter he has reached an agreement with the contractor. 2. Contract Modifications During the administration of a contract, different types of modifications may be necessary, to incorporate new requirements or to handle contingencies which may develop after contract piacement. The project officer must be careful in distinguishing between 4 modification and a new contract. 3. Property Administration When pronerty 35 provided by 2 grantee to a contractor, , Sf er Phe called upon te advise or a. In determining the necessity for the property to be provided. VIiI-5 CONTRACTING BY GRANTEES b. In determining che kind and quantity of property required end the pertod cf use. c. In ensuring proper utilieation of property. & Inspection and Acventance . The project officer must ensure that the work performed under the contract is measured against the work statement. If performance does not meet contract requirements, it is jneumbent upon the project officer to identify deficiencies, “and plen for remedial action that can be taken. Once final acceptance of the work effort by tha project officer has been accomplished, the contractor is no longer responsible for unsatisfactory effort. This concludes performance by the contractor,-except for administrative details relating to contract closing. 5. Contract Closing A contract is covpleted when‘all services have been rendered, all articles, material, reports ‘cata, exhibits, ete., , have been delivered and accepted; ali administrative actions accomplished; and final payment has been made to the con- tractor. Final Audit and Close-out Upon the physical completion of the contract, action should be taken to provide assurance that: All services have been rendered. All articles have been delivered and accepted. All payments and collections have been accomplish Release from liabilities, obligations, and claims have been executed by the contractor. - 5. All administrative actions have been compl ’ disoates, protests, Mitigation, determinat overhead rates, zelease of funds, etc. Wh ee . 2 * eted, including io on of final Before final payment is made under’ a cost-reimbursement type contract, a represenzative of the grantee institution should verify the allowability and reasonableness of all costs re- imbursed. When appropriate, verification of total costs reimbursed can be obtained from the DHEW audit agency in the form of a final audit report. Similar verification of actual costs must be made for fixed price contracts when costs incentives or price radeterminstion is invalved, “4 CHAPTER VII FINANCIAL MANAGEMENT VII-6 PAYMENT SYSTEMS In an ef the publi related VII-6 PAYMENT SYSTEMS INTRODUCTION t . Fort to minimize the impact of withdrawals on ic debt level and the creation of additional financing costs the U.S. Treasury has issued regulations governing the flow of Federal cash to recipient organizations. These regulations provide that the amount of cash in thé hands of recipient organizations should not at any one time exceed one months funding requirement for support of Federal activities. Grant payments are usually authorized by either (1) letter of credit, or (2) a monthly cash request procedure. The Office of Financial Management, NIH, acts as the centrali zed payment point for authorizing payment for support of PMPS grant activities. LETTER OF CREDIT A "Letter of Credit" is a document which can authorize. "a grantee for an. RMP to submit payment vouchers through its local commercial bank to a Federal Reserve Bank or branch for deposit of cash on an _a grantee's bank account. The letter of credit is a “as needed" basis in commitment, certified to by en official of CHEW, which specifies a dollar amount available to a designated grantee. The Letter of Credit can only be used when a grantee meets the following criteria: 1. Annual aggrecate Federal financing exceed $250,009. Federal and grantee business relationship will exceed one year. ad of The supported program is not a loan or construction project. Reimbursement of actual costs is not a program requirement. until actual disbursements are anticipated. Disburse~ ments and related cash requests or draws can be made during periods subsequent to the close of budget period or the Federal fiscal year as long as the encumbrances, obligations, or accrued expenditures were incurred in accordance with the terms of the grant award. In short, the grantee will not lose funds if actual payments from grant funds are made after the close of the Budget period or Federal fiscal year. REQUESTS FOR INFORMATION AND ASSISTANCE Additional 3 information and/or forms necessary to effect payment may be obtained by contacting the: National Institutes of Health Office of Financial Management Grant Accounting & Financial Reports Branch Westwood Building, Room 550 Bethesda, Maryland 20014 a a Vee pee OT ETT a a0 Ty? woe de OT v Chec: or FEPS ¢rants are iessuecd by NEN not RAPS. in the event of any payment problems. grantees “should contact the Office of Financial Management, WIE, directly. ted CHAPTER VII FINANCIAL MANAGEMENT VII-7 GOVERNING PRInC Sere wea ~ REGU TREMENTES F FUNDING AND REBUDGETING AUTHORITY IPLES AND 7-2 VII-7 GOVERNING PRINCIPLES AND REQUIREMENTS : DISCRETIONARY RMP FUNDING AND REBUDGETING AUTHORITY* APPROVAL AND FUNDING AUTHORITY hn RMP, at its discretion, may fund any eligible. operational or program staff activity (including new activities) ox rebudget funds within the total direct costs awarded subject to the principles and require- ments set forth below. PRINCIPLES The following principles shall be generally applicable in all situations: “ BR. Consonance With Federal Requirements No activity shall be undertaken that is contrary to Title IX of the PHS Act and other applicable legis- lation, regulations, written Departmontal, HSMHA, é ; policies, and/or speciric conditions of B. Applicability of Local RMP Procedures Any activity undertaken pursuant to the authority conferred by this policy shall be subject to the regular review, approval and funding requirements of the particular RMP, the grantee (where different), an@ the Recional Advisory Group. C. Current Regional Advisory Group Approval jonal activity initiated by an RMP within eretionary authority must have current FAG sroval. That is, it must be appreved by the RAG in the budcet period during which it is initiated ately preceding one. If not, the m™ be reapproved by the RAG before it can be undertaken. Likewise, any reapproved program w 3 9 bet oO N QV ocr staff activity must have current RAG approval in accordance with the policies or normal administra~ tive procedures of the RMP. Activities Jointly Funded by Two or More RMPs “Any activity which involves, anticipates, or requires funding by more than one RMP during the total anticipated RMPS support period reouires prior. RMPS approval for such funding (bat not for the technical designs or details of the activity). Obligations of Funds Derived From Grant Related Income No grant related income may be expended without prior REPS approval. Resolution of Questions Regarding piscretionary Funding Authority When. there are any substantive questions or doubts as to the scope and applicability of the discretionary funding and rebudeeting authority, the grantee or the Coordinator on its behalf shall communicate with BMPS for advice and guidance. 7-3. REQUIREMENTS . > A. : RMPs Approved for a Triennial Period . a triennial period must obtain prior Directors BMPS for any. proposed cnal ace ivity involving: La} RMPs approved fo approval from th program or opera cr @ 1. Alterations and renovations in excess of $25,000 total Federal direct costs per activity, or any new constructicn regardless of amount. oe sees 2. Research or other activities involving the use of human subjects. (Programmatic approval by FMPS is required in addition to approval by NIH of an institutional plan for safeguarding the rights and welfcre of human subjects. See Subchapter VI-1,1~-3, A). 3. HMO related feasibility studies. 4. End-stage treatment of kidney disease (e@.g., dialysis, transplantation and supportive facilities and services). See Subchapter X-2, 2-6. 7-4 "5. Other specialized activities as identified by HSMHA/RMPS. B. RMPs not yet Approved for_a Triennial Period “ diseenfort or fxeanie. For cathy, emargency mea disshility cy reduce pe’ STATE C? TRE TECHNOLOGY A. Princteal Technological Caveloprants A multitude of technological aids have become available. Nany of these developed from single purpose sliccations of faderal 'yesearch funds. These grants and coutracte were evarded on the basis of the ecientizic merits of the projects. Their relation to the entire EMS evstem end the economic base has not alvays Se fi "4 peers i Rye « X<4 PERO SCCY PQTCLL BERVECES been considered. Among techuslegical developments are such features as: ‘ 1. telemetric yonttorts ng of Life signs of patients in : medical evrerseucias for phyaietana or other attendants at base hospitals 2. mobile coronary care units, popularly called heart- mobiles, and other eleborately 6 apocielized patient traneportation or | field esre uults centralised rescue veltele and anbulanee dispatch eystens equipped with single eveawide regueet numbers and redio and telephone disesteh natworks to control all patient creneportacicn veliicics &an &. vehicle to dispatch, vehicle te destination hospital and inter-vebicle radio communication 5. helicopter aud fixed wing airlife to supplement ground madicsl, rescue &5 id trenepertation, eematines in aireraft caulpped for adwuinistration Gf medical Cars en penke 6. two way television commu: teation between heapital B. Utiiizction «ef New Tooknolocy oo . Due to the rewantic eppeal of these techn glosieal dev yeLopments and the iuplied prowises with which they are promoted, efforts to make major ieproverancs in coueunity EXS eyetens heve concentrated on tustallat: aa of costly rezeug end embu f{nnovations. tg 2 et ‘ fa poe) 7 mes Technical davelopment in hespitel emargency Toons has bee carried cut larscly for spceicic heopitals under lescersadp of innovative, individunl physicians but hes not produced tue provements easily tre. neferred to other areas. Efforts to improve huspital ENS often have culminated in purchase of underutilized equiprmant and have failed te coordinate the emerncacy capabilities of the separate departmenta within tue hos spical or to improve the coordin- eticon batveen hospitals and medical transportation cervices. Technology clene cay multiply si. expe nditures without gignificent imprevencnt in the outeome for victins of medical emergencies. 4-6 GAT AsnTe aun CuUTRT “y reregt otc en at IE bs BREF ba ett ee ee pt mw Vive wee Pot aes weed organizations (Asendix 4). the. principles of these 4& or ¥3 ett, ~~ wv et By > ee ’ se X-4 » EEERGENCY ie SPECAL, SERVICES tevdarda have been genovelly ¢ accepted throughout che panei Generally, these otate aute are iu agreement ew beaic principles of EMS operatic: st. Appendix A contains a list of the mest widely accepted of these . documents. 4 Soe yr Although they do net cover all aspacte of pee DMS cystea, theee standards have been epplied in a number of furise- élections which have reperted improvement. 7 cur keowlads there are no publ iehed reports that have been brsed on comparisons between emergency hea aith service performance bevore and after application. It sheald be neo ned that cuch comparisons are Very difficult to execute. onversion of any ayeten from non-commlisnce to conplisrea th such etendards ie not accomplished outright. The length of the conversion period, the difficulty of assembling baselines data, cte., put guch evaluction beyoud the reach of many counmunitiea. B. Hodsl Stetute 3 cher of, etentarde, git ber youes moc identical, ére enplicd ae erlteria aiibibilicy in the Macdonald Binhva y Safety Acc. sodel Levs,this ona presgante aifficulcios to ota fe ee the come piezitics of state special ingercets that services in vpensval ¢ end ge 3 8 their non- ewergensy business 2g woll aa tha soaggeney oporations. a ee eee, 4-7 ESOTORT OSG GVESVEILG Medical emerpencies may affect very large numbers ef persons, es in «4 commumity-#2 = how aster, or thiy rosy ceeur fo a single péetient as in 4 heaz tack, The demacing incidents may be gufden iliness, ccck “ones, roisenings, poescenal violence or netural forces. hy definition, each patient needs medical care te control the outeoms cf his emergency. BY definition, the tine from caset to definitive treatment is a factor in the outcome. The precese by which the given emergency victin may be brought te is conkrel may neve pany ateps 2 . RE GULathuy A vec oe vio Unicagd, Lilinoss, cictiy dyidl 5 - X-4 EMERGENCY M2 DCA, SERVICES outlined above. Ia every case, the madics) procecures required are crucial to the outcoua. Tis lepees can determina the medical reouizvement sad the outecne, but medical procedures can alter time tolerances. Boer gency medical services wase be time conselousa, but thay are dominated by the medical options. The most efficient cnergenucy treng- portation ccnoeiwabie je useless for patients who are dead on arrival, or dic waiting for care in a hoapital. Responsibils tice of Providers Providers of medical carve in any community have inescapable responcibilicies related to emexgency medical se aywiecas, They need to work togathes to (1) assure effective functioning of their emergency care, (2) assure that enbuience and ocher ancillary services protect the medical csre options 4s far ae possible for each victiia; aud (3) protect the emargency medical services against unnecessary dewands and other abuses. The providere of uwedical care jointly have other responsibilities for their comauniticse' emergency medical care oystens. fhey are beet qualified to determine the POLE of diminishing Shuts eulag me ee im enorosney m 281 Oa) . ec which additional expenditures for such services will yield lese - benefit jin control of death and injury than would Che seams emounte invested in alternative diseare prevention or control Tor pb ened f wage wee a owe Ae ey ‘services. Their unique situation ereblac vrovidere of radical care to Peraie appraice and moniter existing emergency madical services. ‘Th position permite idertifieation of phasee of heepital energoney systems, trangportation services eerationg and cthar @ieorints of the toetel oysten wail funckioning, Ths reletive priorities cf the vros vted by malfunctions can also be determined by provider: and Fundins rie ities of attacks on these problems election of the most realistic of ¢ They can provide essantial the EMS systern. Financing end Reavletion The wedical functions of emerg gency redicel services eyatens and the requirements imeosed by medical necessity opsrate withia social and eecnonie constraints. mech part of the eystem has its own needs for manpower, facilities, equipment, supplies and supportive servicee. ‘These needs can be satisfied only to an extent commensurate with the funds and options available. l. Public Reeulaticn of Servicas pub l UER ES OM, poet. Lt . at o as . . in Woke we he Swe dete tae See ee owe ant tite! te ie the By foe a Die ce Vee gy & oe hy aa i ae eer He og Be OF an emergency medical service system have rudimentary 6 . Xe& EMERGENCY MEDICAL SERVICES characteristics of oublic utilities. They sre regulated to degreea that vary auong jurdedictions. Ps qualifications, equipment configurations, a and operational practices may be vegulated by ' elmost every atate in which such resulation has beer attempted, only cxbulenee services ox their conivalents are controlled by statutes directed to emergency medical gervices. Hespital emerrency persounel and functions eaployed in ES ara usuaily not afficeted by epecial cmornency mediesl service legislation. In many etates, enfercement of and compliance with the Laws regulating ambulance services have not been ideal. Financing Community subsidization occurs in several. forms. Host obvious are the emarpercy roors of publicly-owned and comamity hespitais. Aubulence services may be operated by come of these hospitals or by such agencies es fire departments or volunteer ambulance and rescue companics. In money-loging proprietory ambulance services, os: gag are paid by the vublic chreueh hicher ori¢ea fer thea services that wske up the owner !é principal businesses. Cost Effectivansza d eres ie ‘ee ambulance phase of rot plece oneal avubsidigation. £ ted effactivensss, sucn i use of costly deviers cf Lins as hear tuobiles aad helicaptere nem introduced ation of thelr econecsic effects. aoyvices too often have been a Bk ft ~ wee cua: sendy oe ryywices fae EOS Ered Bitee roe nh besed | QM SPCR s eplected. beress for hospital budse SRURCE CS. Boo have produced ec ange foe Hospitals have peen led to ) buy and daveion ‘gipuent and facilities tnat are under-utiilzeed. unity. demands heve pushed some hogpitais out of the emergency care business, or, in geome cases, have forced emphasis on emergency services to the detrimant of other cperations. d 3 gate and ctaffing preblens ih In emeypenty roote, Access To Services Many medical emergencies still become th responsibility of the nearest person who will attempt to ure whetever resources aye at hand. X-4 BYEEGERCY MEDICAL SERVICES | | ; Hany population groups feel thet they have speci a problems of acceas to ersrpency medical POEVAGtS: In some areas, this & In of hes, these groups sinply ghere & coumon problem of imedequate cservices, The situation in emergency medical services of all kinds is turbuleat. Tt cannot be solved by unilateral action of the provicers. a 4 UE a Ty Developuent of én adequate commmity emergency medical service 7 at Tenet pe Tt fe estt apt to fiad its inetee gieea in the erray of ceri coneorns when it receives uly eapvesentative and informad etteation. Ciera Try ythe MASI ERAT SNe er rae u. ween aL ana a 3 es ea fhe process by which a ccmaunity assumes and exercises manasgement of its emergency medical services has many elements and may take many forms. The relative emphasia placed on individual elemsate and the order end way in which they are taken may legitimerely vary. Experieuce hag shown, however, that successful wanepement processes have certain essential characteriatics. Successful management of emergency redical services is most likely when thea management process is: A. medical service srea o¢ lecal political uit in © - Xe EMESGENCY NEDICAL SERV YCES Conan ty Powered Led by influenticl "volunteer or lecally appointed groupe ‘with the etrong involvement of redical care prorecsionals, buginess people, public administrators a and legislators. . Com ity Epecifie erably & uich public and professional vadical feelings of unity and respo onsibi lity already exist. Concerned with « defined ares and population, pret shy Informed About 1. Pertinent Legislation and Regulations Elemante of State codes which may affect emergency medical services may include health end gedical, buginess, tax, incorporation, liability, inaurance, treneportation, property and other laws. va a ae on Ft obs ca i Lee nae ge gored ? 9, Cheracter and iopultiu Local desographie, ceccupationsl, geceraphic, climatic, economic, cultural and other charsct teristics tend te individusalize the patterns of disease, aceidant, victense end natural forces that cake up “the workload of emergency medical service reyuirenents in ccch cosmunity , 3. Performance Evalustion Ideally, a couse~srecific and sorvine-srectfie comparisen of untimely death and ¢i t : @ lovest levels of these events tna n 4 by applicetion ef tha bs tt f on e i ‘ 3 rt ft st te © GLac t¢ eES cay. po ot ey nedica @ ft, A te bee fot Be 4. Resources _ All manpover, freilitics and equipment potentially directly yeeful to emergency medical services, cleasified and cross- classified by: e. Activity status b. Deployment c. Effectiveness in terma of patient outcomes for partici- pating resources eter ihe pe Yong x-4 LKEGQCeNCy EODICSL Gan UE d. Gantrol, in teres of cunorahip 7 ne Le @. Kespa ff. Funding (L) Revenue (2) ocher g. Reinforcerent of cannbiiities of neighboring coumunities for massive or specialized needs 5. Relative significance of medical cuergencles Compariseca “between untine ehy death, disability, & COBMELE = with otter health problems end with noi problicns presents Lng cesande on comaunlty fundin D. Explielitly becisive Os 1. Emergency medical cervice pattern desired for local and shared uses Ae Kinds Be mership « a | single type of a mix of types b. herponse 7 e. Guality contre: 3. Yunding patterne desirad (by sources, amounts, snd modes of poyrent of each): ‘ & Revenues b. Other 5 maid £ oe + eee 4, Jdeetifiearton and rok ty * * : fee vadiess) acrvices cnet nege ce éGesived pattern 5. Rel ation whips ¢e ether components of health cere delivery eysterns on 4-10 $1 OLN OF RMP YN COMSTITTY ACTION ON EMPRCNYCY MEDICAL SURyvICk ‘A. Ressons for RNP Tnvelverent Erergency medical sarvice is a highly vielble part of the health cera delivery systerm, Cenmumity deci £5, sions on emargency services inevitably affeet 6h 2 otner Bepac of heaitt h care. ae ee ET a ee ee : aT Ee . the pe riority OL medical cuergencies aioag the “comaunity's responsibilities. 10 . ™y ~ mt oe ws - X-4 ERCENCY MEDICAL SERVIC: nS a Res gional Madical Program hes an wre in emnrgency medical service considers tion exists reesardlecs of the oxigin of the ve on the medical emargency problem. For these reasons, th obligation to tak ations. This cbli community's initl » o pe a o> pS 2 i b # he 7 EMS Resnonsibilities of Ri@es The Regional Madical Program is ree upene Abie for: 1. Meblization of hoalth care providers fully vepresent- ative of the health care delivery systen. Ze Cosper ation with other public and private agereies in agsesbly and presentation of all available and pertinent information, 3. Directing and presenting staff, studies to: a. Demonstrate the medical imperatives of emargency services. b. Relate medical emergencies to other problems of the courunity. c. Coupare feasibility, probable outcomes, and cos dollars, manpower end tine of alternative prope for improvement of exergency medicsi services. t in sel dg. Aseure representation. af a mnigorested segrmantse of the community ond of verwlous plannisg @ganeies In co the decisi maturity and equity in e. Implement ens/or continuing (1) Support for be pL whebad hove gource OF Chis guppe to an evard. ducation plan da compatibie with or part of any Area Health Education Center trogren. (2) The training end continuing € Financial Asaistenesa The Regional Madical Program is the development arm of ‘the community's decisionasking process. In addition to the - types of services represented sbove, the Regional Medical Program may assist in obi ein ag ENGHES or loons to ipsiansnt cocmaunicy Aredrtes¢. fee teccc mm: ent pe bot eka tes ciety parte ctr, ehee he aS boa Li Such essiscance will be confined, however, to requests that have fully informed approve L of the decision meking bedy. The cocwwnity's emergency service plan cannot be considered viable until its discernable incoze and operational requires ments are shown to be in prospective balance by a apecified date. 4-il APPER mee A. lippeypency Medical. Service Standards Cuidelines and Protocols." B. “Federal, Fineneiel, and Other Assistance for res." 12 Req: EMERGENCY MEDICAL SERVICES AEFENDIX A. EMERG SENN I SEDICAL SEUVICE STANDSZDS, GULP: 4S AND PROTOCOLS 1. Averican Acadeny or Orthe nedie Surgeans, Comaittes on Injuries, Emergency Care snd Transportetion of the Sick end Injured, Chicago, Iihinois, 1971 Loe 2. American Medical ‘Association, Commission on 1 Emergency Medical Services, Developing Exvergency Medical Services - Guid elines for Community Councils, Chicago, Illinois, 1970 3. Bullictin, Arerican College of Surgeons, Essential Equipment for Ambulances, Chicago, Illinois, May 1970, pp. 7-13 4. Diviston of Medical Sciences, National Academy of Sclences, National Research Council, Advanced Trainins Program for Euareency Medical . Technician - Ambulance, Washington, D.C., September 1970 5. Bey fstion of Hedical 5 ty Souseil, Enotorent, ” Washingeon, dD. e. i3 6. Givision of Medical Sciences, National Academy of Gclences Research Council, Training of fsbulance ene and for Fourgerey Cave of the Sick and Trenapert, Wesniagton, B.C,, 1958 7. Realth Care Pacilitics ees U.S, Department of ‘Health, Eaucation, and Helfere, Yessital Gutratient Erorzancy Activities = Funerion Prourecuine retin: Rockville, arylanud, August 1971 8. Joint Cormission on Accreditation of Hoe spitals, Accreditation Manual for Hospitals, pp. 69-76, Hospital Exarcency Services, Chicano, Illinois, Becember 1970 9, Hational Highway Traffic Safety Administration, U.S. Department of Gransportation, ~asic Trataine Progrt: for trorcerney Kogleal ‘tech - Arbulance, Course Guide end Ceurse Coordinstozs Orientation Washington, D.C., January 1971 on 10. National Highway Traffic Safety Administration, U.S. Department of Transportation, Posie Tecining Prosrca for Emurrency Medical tcchnician - a Ambulance, Instrvetors' Lescon Plans, Washington, D.C., January 1971 93 & = Ary ryt t r Re MERCH VOY HaDIGAL &§ SERVICES |. APPENDIX A ik. We onal Highway Yreffie Safety Adninigtyarteny U.S, Eepartment aston, D.C, March 19 ‘rannportetion, Refresher trsainje2 for chaieden: « -Avbuiance, Cours Guies, Ve partmenc 12. National Highway Traffic Safety Administrat: ey Maddie of Transpertatiocn, hefresher Sraining broees for es : Mareh 1971 a : al Technielun - Ambulance, Instructors! Lesson Plans, Washiagtoa, D.C., of A 1970 study by the Divielon of Medical Sciences, Vationel Academy Sefonces, Macional Research Council indicat ed that tore ¢ 2 federal agencies have ecue vole and/or vesources for supp porting cone prehensive euargency medical services. Available &u i scope frow limited consultation to substantial finer wial assistance. » upport renges The followings is 2 partic] lise of those agencies; 3. Appalechian Regional Commission Appalachian Regional Health Program Of Fiee “at . . b. Departwant of the army “(1} Directorate of Military Support (2) Office of the Surgeon General Department of Health, Education and Welfare a. Health Services end Vental Health Administration (1) Federe] Health Prorrams Se ' Some O98 YEEMCY neGiLu Service (2) Rational Center for Health Services Research and Revelopment (3) National ene EL ett e@ of Mental Health (4) Offic eslth Planning Bivision of Com many Health Sexvices iensl Hadical Programs Service natitutes of Health sy of Eealth Professions, Education end Manpower Tr D ion of Allied Health Manpower mo of furs) sion of Fayeielan Manpower Instituce of General Medical Sciences Institute of Nevrological Dise acas c. Office of Education (1) VYooational Education and Research Progran (2) Division of Menpower Development and Treining d. Social Security 4 sguistration Departms ment of Labor cues LEVEES LOS wt he (5) Regi b. National (1) Bure m9 m2 ining We eh Department of Trensportsation @. Naticnel Wighvay Traisie Sa Fety Adminiletration (1) Division of Beerzoncy F fadical Programs b. Rational Highway Administration X-4 EMERGENCY MEDICAL SERVICES AFTERDIE % | | ; 6. Office cf Ecorsmic Opportunity 7. Office of Evirgency Preparednesa &. Small Business Administration 9. VYaterans Administration :CHAPTER X SPECIAL REQUIREMENTS X-2 GUIDELINES AND REVIEW PROCEDURES FOR KIDNEY DISEASE ACTIVITIES 2-1° X-2 GUIDELINES AND REVIEW PROCEDURES FOR KIDNEY DISEASE ACTIVITIES BACKGROUND Nowhere in medicine does the same gap-exist between technology and delivery as in the area of treatment of patients with end-stage renal disease. Technological developments in recent years have made possible the rapid expansion of programs to provide patients with hemodialysis in institutional settings. Innovations which allow self-dialysis by the patient in his home, or in a low overhead facility, vastly extend the utilization of delivery resources, and reduce the cost to the patient. Techniques of organ harvesting, preservation, and transplan- tation have made renal homotransplantation a service entity, no longer a research tool. It is estimated that of the approximately 50,000 persons who die each year from kidney disease, 7,000 to 10,000 are suitable candidates for chronic hemodialysis and/or renal transplantation, and that an additional 10,000 to 20,000 might benefit from each treatment. At present, the annual increment of new patients being offered treatment for terminal kidney disease is probably not more than 3,000. CURRENT RMPS PROGRAM EMPHASIS FOR KIDNEY DISEASE PROPOSALS Current program emphasis is aimed at addressing the service delivery problems of kidney disease. It recognizes the fact that a finite amount of funds are available for attacking this problem. The frame- work of this program is based upon a comprehensive regional plan cov- ering the multiple aspects of renal disease. The matrix of the system requires the establishment of primary, secondary, and tertiary. care mechanisms for the identification, referral, and treatment of the patient with kidney disease. The realities of currently available treatment for end-stage renal disease necessitate the establishment of a limited number of tertiary kidney disease centers with the technical expertise and service capabilities to provide comprehensive care to a large number of patients on a regional basis. Studies concerning physical resources and available monies, compared with projected costs and cest effectiveness data, show that any effort aimed at treating end-stage kidney patients must be linked with such tertiary centers in order to provide a complete spectrum of high quality care at a price which can be reasonable borne by the public. Although national priorities for kidney disease programs will be estab- lished and modified over time as appropriate by a panel of renal author- ities, for the present it is necessary to focus on improvement and expansion of the delivery of care to end-stage kidney disease patients. ~2- RMPS is primarily concerned with the development and implementation of kidney disease programs which will provide the therapeutic tertiary- care services of dialysis and transplantation to patients who do not now have access to such life-saving care. A. High Priority Kidney Disease Activities As is further explained in section 2-6, kidney activities will receive RMPS support in the form of "separate" decremental funding which provides less RMPS funding each subsequent year of program operation as developed third-party sources of funds support an increasing share of the program cost. Kidney disease programs are expected to be fully operational and independent from RMPS support after the third year of grant support, or sooner. Separate funds are available for the following program areas: 1. Transplantation — RMPS funds will be provided on a decre- mental basis for establishing programs in transplantation in areas of need. Direct patient-care costs are not appropriate for support. Organ Procurement Activities ~ RMPS will finance the start-up of a region's organ-procurement activities in the framework of decremental RMP funding with assumption of costs by other sources over time. Tissue Typing -— RMPS will pay for start-up costs in this activity provided that the tissue-typing labs are not re- dundant and duplicative. Tissue-typing costs also must be assumed by other sources of funds. Organ Procurement and Communication Activities - These are designed to provide optimal use of harvested organs shared among many transplant centers over several regions. These activities. should also become self-sufficient by the time RMPS seed money is withdrawn. It is, however, more difficult for these activities to be financed by third-party carriers and the costs of managing the organ-procurement network may be added to the individual cost per organ harvested. Home Dialysis Training - RMPS will provide seed money for the development of home dialysis training programs where the need has been demonstrated. Such programs must be affiliated with a transplantation program and provide or have access to acute medical resources. -3- 6. Low Overhead Limited-Care Dialysis - Where documented regional needs exist, RMPS will support the development of low-cost limited-care programs having access to acute medical care resources and affiliated with a tertiary care program. 7. Satellite Dialysis Facilities - Where appropriate, RMPS may support the development of satellite-dialysis resources to serve the backup needs of patients who are geographically removed from the tertiary-care facilities. 8. Dialysis and Transplantation Programs for Children— RMPS will provide the start-up costs for pediatric end-stage renal activities in selected areas of need. Since an esti- mated total of only 600 children each year are believed to be good candidates for dialysis and transplantation, we anticipate providing support for only a few highly centralized pediatric nephrology units. As with adult facilities, pediatric nephrology units must be based on a decremental RMP funding sequence, with assumption of costs by non-RMPS sources in time. 9, Education - RMPS will support, when appropriate to the goals of a comprehensive renal program, training in continuing edu- cation of physicians (excluding fellowships), postgraduate renal nurses, and other allied health professionals aimed at improving care for patients with end-stage renal disease. RMPS is not the appropriate source for support of degree or certificate-oriented programs, such as A.A., R.N., and M.D. programs; internships, residencies, and fellowships also are not suitable for RMP support. 10. Public Education - RMPS will provide limited support for appropriate public education activities which are clearly related to specific output of the end-stage renal program. With respect to-the renal programs initiated prior to issuance of the Guidelines, they should be brought into conformity with these priorities as soon 4s possible. This does not mean that nonconforming activities should be dropped in a precipitous manner, but they should be phased out as RMPS-supported work in an orderly way within,a year. Essential Elements of Kidney Programs The. substance of kidney disease programs includes: 1. Procedures to assure early identification of patients in, or approacning a ters inal stage of renel failure. : 6. C. ~4he . Rapid referral of such patients from the level of primary care (private physician) to tertiary~care facilities for dialysis and transplantation. Early patient classification with regard to tissue type, and other pertinent factors. Dialysis and transplantation facilities which assure treat- ment alternatives to. both the patient and physician. Effective cadaver kidney procurement operations, coupled with rapid kidney donor~recipient matching. Selective short-term training to meet the specific needs of the above program. Outline of Program Characteristics Characteristics of kidney programs include: 1. 2. The patient has access to conservation management before kidney function has ceased. The patient is registered in shared recipient rosters to assure optimum tissue matching, and maximum utlization of harvested cadaver kidneys. The patient can be trained to carry out dialysis at home, or if not eligible for this mode of care delivery, has access to satellite dialysis, or in-center care. Dialysis facilities encompassing all three of the above modes of dialytic treatment will serve, or be an integrated part of a system which serves a population of no less than 500,000. The patient. can gain access to transplantation if such therapy is his choice, with his physician's concurrence. Transplantation programs will serve populations of 2-4 million persons. a. A Transplantation Program has one or more hospitals doing transplantation surgery, one (1) tissue typing facility or contractural agreement, one (1) organ procurement D. 10. 11. -5= and sharing program, linkages to dialysis services (backup and home dialysis training), and should do a minimum of 25 transplants per unit per year and . aim ultimately at 50-100 transplants per year and meeting the Region's needs. Transplantation facilities are centralized to: Limited duplication of high cost facilities and services. Assume maximum utilization of full-time transplantation surgeons. A full-time transplantation surgeon is a surgeon who is committed to the full time vocational conduct of planning, organizing and performing trans- plantation services which will meet the transplantation needs of a large population. Assure availability of complementary backup services required for special patient evaluations and treatment. Provide the coordinating point for patient referral, donor-recipient matching, patient data exchange and organ sharing. Maximum utilization is made of services and facilities for kidney disease patients. ‘ Continued development of third-party payment mechanisms is pursued to support expanding kidney patient-care services. Integration of renal disease patient services with other patient services and facilities is organized at all levels. Pediatric dialysis and transplantation services are coordinated with adult facilities to provide optimal use of services. a. pediatric nephrology services do not necessarily have to be housed and extended within adult nephrology facilities. Maximum utilization should be made of common facilities and staff, however. Program Development The project(s) forwarded for consideration must have been preceded by, or be a part of, a comprehensive renal plan. The comprehensive regional renal plan should not be confused with the grant applica- tion for RMP support of specific projects. The plan provides the b= objectives and overall system; the projects represent successive steps over time to realize the comprehensive program based on the plan. The comprehensive renal plan should identify and describe the: 1. Geographic area to be served. 2. Population area to be served. 3. Estimated or established number of renal patients. a. If only estimated, how will accurate confirmation of this estimate be achieved? b. How will patients gain entrance into the program? Are there any factors concerning minorities or patients with cultural, economic or environmental uniqueness effecting entrance into this system which must be con- sidered? What are the selection criteria of the institutions within the region? 4. Existing personnel and facilities providing care, and the quantity and physical characteristics of the care being delivered by these facilities, such as, in~center dialysis, home- training programs, low overhead limited-care dialysis, transplantation, etc. 5. The proposed resources which are necessary to meet the regional needs identified by the parameters above. 6. The proposed program or project elements requiring specification are detailed in 2-4C. REVIEW PROCEDURES The openly categorical nature of end-stage kidney disease activities, and the need to effectively coordinate integrated dialysis and trans- plantation systems indicate the need for continued central direction for development of a national program. Thus, applications for kidney activities will be handled in a manner different from other Regional Medical Program applications. A. Policy Preclearance .. Immediately upon an indication of interest in the submission of a kidney proposal by a source within the RMP, the RMP should con- tact the appropriate RMPS Branch in the Division of Operations and Development (DOD). A brief abstract or letter of intent should be submitted, which outlines the nature of the prospective activity, the probable role the proposal would play in the regional program, and the need which will be satisfied within the overall renal ~ ~im disease program of the Region. If a comprehensive regional renal plan has not been forwarded, the letter should indicate the status of its development. The Branch which serves the Region will utilize the Region's written inquiry to confer with staff of the Division of Professional and Technical Development (DPTD). RMPS will advise the Region whether it is desirable to proceed further. The RMP, of course, may accept or reject this advice. Technical Program Review Each application for RMP support of kidney disease activities (including applications for continuation of approved activi- ties) requires a peer review by outside renal experts. Prior to submitting application for a renal disease program, the RMP is expected to obtain a technical review of the proposal by a group which has not participated in the program's develop- ment. The technical review group must be comprised of at least three renal authorities for new activities (or two for continu- ations) from outside the geographic area served by the Region. Payment of the costs of such consultant services will be made by the requesting RMP. : The values of outside consultant review for the Region are multiple. Most importantly, it is designed to give the Region's decision-making body, the RAG, an objective evaluation. of pro- posed or continuing kidney activities. This. should permit the RAG to make sound decisions concerning approval, funding and relationships of these activities. Thoughtful consideration and resolution by the RAG of issues posed in the evaluation, should insure program effectiveness. The review also provides an opportunity for information exchange between the consultants and the Region's principals which should foster appropriate and compatible program development from region to region. This is most important when supraregional and national cooperation becomes an essential part of kidney programs. Timing of Technical Reviews There are three basic circumstances when outside consultation will be requested, two of which are required of renal program sponsors by paragraph B, above. 1. Renal program planning. Before a specific proposal has been developed, a Region may wish assistance in planning its regional program. (Not required, but frequently desirable) 2. A specific project or program has been developed and requires technical review so that the RAG is provided objective information to surport its decision concerning approval or dis- ~8- 3. A project(s) or program will be reviewed annually to ascertain progress. (Required) Consultant~RMP Roles BMPS supplies the Regions with the names of Renal Technical Consultants on request from the Regions. The outside Renal Technical Consultant services are official peer review services provided to the Regional Advisory Group (RAG) of a particular Region. The renal consultant is a private agent responsible for conducting his own negotiation on fee, time and site of consultation with the RMP which requests his services. The negotiated agreements. reached between the consultant and the RMP represent a contractural arrangement between the two parties for consultant personal services. Consultants who assist a Region in planning a program and/or projects should not participate in the technical review or progress assessments. Consultants who review the initial program or project proposals will frequently participate in the annual ptogress assessment. A minimum of three consultants will collabor- ate in the initial technical review; two consultants will perform the progress assessments. Since the consultant's official relationship is with the RAG, a written report of the consultant's program review will be prepared for the RAG and presented to the RMP Coordinator (or Director). The reviewers’ report should address organizational setting of the program, the specificity of outcomes, efficacy of program methodology (including evaluation activities), relationship of proposed to existing facilities or resources, development of other funding sources, and specifices of equipment and personnel. A recommendation section should clearly indicate suggested action, such as approval/ disapproval, funding level, and changes or modifications necessary to merit RAG approval. Reimbursement for Outside Consultant Services Payment for Consultant review services cannot be a part of the renal program grant budget, nor can it be contingent upon successful project funding. The Region should negotiate the fee which it has established for such services, or an otherwise reasonable or mutually agreed-upon amount. RMPS typically pays a fee of $75 per day (of for any part of a day), plus up to $25 per diem, plus tourist-class, round-trip air or other appropriate travel mode.. It is appropriate to pay an extra day's fee for study of a proposal and associated background material when the material to be absorbed is sizable. . 9. Organization of Outside Consultant Reviews Arrangements for renal program review and progress assessment should include: 1. Simultaneous visit to the sponsoring Region by the outside Consultants as a team. 2. A preconference meeting of the Consultants. 3. Joint Region-Consultant agreement on the program-related individuals to be interviewed. 4, Identification of additional program background .information, and its provision as requested by the Consultants. To adequately review program progress after the first and second grant years, technical reviewers will need to be provided with a statement of the program undertaken in the first year, the comments of the initial reviewers, a complete statement on program achieve- ments (including numbers of patients treated, program staff development, costs of treatment services), and related information. Forwarding Proposals Only those proposals which are recommended favorably by the outside Consultants shall be eligible for consideration by RMPS. In addition, an opportunity must be provided prior to consideration ‘of the proposal by the RAG for review and comment by the appro- priate CHP agency(ies) as required by Section 904(b) of the Act. The RAG shall consider any CHP comments and comment on the ability of the RMP to manage the kidney project without hindering the development of the overall RMP program, and the reasonableness and adequacy of the kidney budget proposed. The RAG is responsible also for indicating how major issues raised by the local technical review group will be resolved. ‘ Since kidney proposals are reviewed separately at the national level, the RAG need not give priority ranking to kidney proposals in relation to other nonkidney operational activities. Kidney proposals shall be considered by RMPS in relation to national priorities. The RMP submittal of the renal project report to RMPS must contain, in addition to the Form 15 summary statement and the RAG report, CHP agency comments, and the review comments of the outside technical Consultants. BE. I. J. ~10~ RMPS Staff Review The initial review of kidney applications shall include: 1. Program compliance with RMPS guidelines. 2, The contribution of the project toward kidney program objectives. 3. The completeness and nature of the comments of the RAG (Section 2-3G, above). 4. Comments of CHP agencies. 5. The preferred method of funding. RMPS Review Committee RMPS staff will summarize for the RMPS Review Committee available information as to how each kidney proposal proposes to support the National Kidney Program objectives, and the substantive points developed through local review processes by the Technical Review Committee, the RAG, and the CHP Agency. For those applications for which the RAG: CHP Agency; Director, RMPS, or RMPS Review Committee has indicated a concern apart from the technical merits of the project, the RMPS Review Committee will be asked to make a recommen-~ dation to the National Advisory Council. The RMPS Review Committee specifically will not review on a technical basis the merit of the proposal, or establish formal numerical ratings for individual proposals. Council Review All kidney proposals shall be submitted to the National Advisory Council for final recommendation. In keeping with the categorical nature of the kidney disease program within RMPS, the Council will review and recommend funding levels for kidney proposals separately from the funding level of the specific RMP. Kidney program funding will be. in addition to other RMP program funding. 2~4 PREPARATION OF APPLICATIONS A. When to Submit All kidney proposals must be submitted as part of the RMP's regular annual application in accordance with the Region's assigned anniver-~ sary date. Prior to July 1, 1973, kidney proposals may be submitted in accordance with Subchapter IV-7, Procedures for Requesting aegan, Dyers ght ao Fk THRITE Oy Supplements to BMPS Crante. B. -11- Routing of Proposal Sponsors of applications for support of kidney disease projects should submit them to the appropriate RMP in the format which the RMP prescribes. An application involving two or more RMP's may be submitted where appropriate. In such cases, one RMP should be designated to act as "applicant" and submit a single application. Such applications must be approved by at least one RAG and shall include a description and affidavits of mutually agreed upon arrangements for administration of the project. In view of the preliminary clearances which are called for in these guidelines, it may be helpful to develop and submit a letter of intent to the appropriate RMP's before an application is prepared. ‘Information Required In addition to the summary information to be provided on the forms specified for applications, narrative should address in detail the program elements specified below. Descriptions which are comprised only of generalized narrative will not be acceptable; disease control feeds and the applicability of the proposed program must be presented on the basis of solid data relating to patient populations and distribution, specification of existing services and resources, clearly documented commitments of cooperation and participation from key persons and institutions, and specification of the outcome (quantified, insofar as possible) which the Region intends to achieve. Assistance can be obtained from the program staff of the RMP. Program elements to be addressed are: 1. the magnitude of the renal disease problem. 2. facilities and programs currently in operation and the needs they are meeting. 3. the specific unmet needs which the new proposal will meet and how the program will integrate with existing programs to improve patient-care services without duplication of existing services or facilities. 4, existing and potential sources of third-party payment for care and how these resources will be developed. 5. the commitment of cooperating institutions, groups and health practitioners whose collaboration is essential to insure the success of the program. 2-6 -~12- 6. increments of service increases, or numbers of patients treated which the program is designed to achieve. 7. training, when pertinent to the plan, which is directly related to the projects comprising the plan, or judicious expansion of existing programs. 8. the system or method of program evaluation which will be employed. 9, a decremental rate or proportion of Federal (RMPS) contribution to the program over time. 10. the program's phase-out as an RMP-supported activity. ALLOWABLE COSTS Program costs related to the Federal share of support should normally be identified with personnel and equipment requirements in tertiary- care facilities. RMPS will not fund ALG-related activities. Such funding may be allowed in the future if standardized production and testing is achieved and its efficacy is demonstrated. AWARDS Awards for kidney projects will be issued as a part of the total award to the Regional Medical Program. The amount allocated for the kidney activity will be specified in Item 14, under "Remarks", of the Notice of Grant Award, Form HSM-457. Unexpended balances of funds awarded for kidney activities may be rebudgeted only with prior RMPS approval as specified in Chapter VII, Section 7-3, A.4. In some cases, a kidney proposal may be approved by RMPS but unfunded. An RMP may fund such a kidney project through rebudgeting other RMP funds to the kidney activity. Rebudgeting of this nature should be undertaken only after the RAG has carefully considered the effect of such action on the remainder of the RMP program. Likewise, a kidney project may be expanded as determined by the RAG by rebudgeting of funds to the kidney activity in addition to those specifically indi- cated for kidney in the Notice of Grant Award. PTLeL PLPITLOrS e -63, Operst: sre nen ttn a Rieter Officer a a ns rset mt -¢ comborna of the staff of the Diviston velopent who essist end moniter agsigned ers oor ain . § title umed to desi of Ogerations and Regio fou oo Do - eA ui 64, Practicing Poysicien aa licensed to practice medicine in eccordance able Stete lava end currently engaged in the and treatrent of patients any physi with spp diagnos ie 7 65. Progran Staff (fercerly "Core') Rar perel ” in the etefft exployed by the RHP and their functions as contrasted ON with the ataff aud functions of operational activities. (See et ic FTL en "Oserutional Activity.") 66. Provisional Indirect Coat Rete a provisional indirect cost rate is a temporary rate @es~ . tabliched toa allow the Pgs Sond woveent «f funds 2 grants, witil suck x dudivect casts can be - ; determined end & Final indirect ac rece established. @ ‘ : Provisional indirect cast rates are adjustment by OChY at sowa future date. A proviaional rate is used te cone pute indirect costs on grant erplications and on Beene repoarte of exzendituxes. (Aliso, see Wtndirect Cost Rate,' end Chapter VITI-3,) 67, Publicetion Costs those costs incurred for printing, distribution, promotion and general handling of publications, purchase of books, reprints, pamphlets, brechures, page costa, etc. 68. Region 1. Region « - att individual Regional Medical Program 2, region 8 the area and population gerved by an RMP. (Also, see "HEY Region." 69. Regional Advisory Group (RAG) gy the advisory svoun assien sted te advise am RNP pursuant to @ Aw Qe Section S03¢>) 04> <2 the Aen, a be Te? PES LN LTEONS 78. Self-Dialysis ener ens rnesene dialysis performed by a treined patient at home or in & special facility with or without the assistance of a family mewber or friend. . 79, Short Term Training see “Training.” 80 iy Staff Anniversary Review Panel NOs . . ; Ae CMa interns] RUPS staff committee appointed by the Director, ne RMPS, the primery function of which je to review applications £ gecoud and third year funding of applications and to rate Regionswrecouended for triennial support by the National Advigory Council. (Also, see Subchapter IV-3, 3-1.) - 81. Supplies acne aalineaseemeewnantt expendable items which have an expected service life of less a ‘ a T yet . wy gE bey Cm oT eh Be pa than one year. (CIneludes expendable items end cpere ports.) 82. Tissue Typing laboratory procedure used to determine the degree of com- patebllity between the donor organ and the recipient of a kidney transplant. 83. Treining 1. Training Conferences and Seminars presentations which are planned for full-time partici- pation for periods from one full day to five consecutive days, or intermittently on a regulser basis. 2. Short-Term Training activities which are plenned for full-time participation for more than five consecutive dayg, but not more than a single ecadenic sessiqn (quarter or semester). 3. Long-Term Training activities requiring full-time participation for more than a single academic session (quarter or semester). , _ Iv-9 MANAGEMENT SURVEYS 9-1 INTRODUCTION The Grants Management Branch of the Division of Operations and Development, RMPS is responsible for conducting management surveys. These surveys are conducted by RMPS staff as a service to RMPs for the improvement of management. The survey team identifies and makes recommendations on areas which can be strengthened. Through this in-house type of review, problems can be Ae 4 ..6«COfhe reviews also assist the Regions in maintaining a high level of management capability and performance. The survey's scope includes management practices of both the program staff and the grantee institution. SURVEY PROCEDURES survey Team The survey team usually consists of three people, (1) the team leader who is a member of the RMPS management survey staff, (2) the operations officer for the RMP, and (3) a grants managerent. officer from either RMPS ox the HEW Regional Office Preparation for the Survey ‘In preparing for a survey the team gathers as much information in advance as possible on the RMP. This involves daiscussions with the operations officer, the regional program director, and a review of RMPS files. Of particular value in preparation for the survey is the report on the verification of the R'Ps review process, if such has been completed. Survev Proce.jures Surveys include interviews with RMP staff and review of documents. Selected advisory group menbers are also interviewed. Surveys normally are conducted for wf A. iv-9 JAUAGIMEN? SURVEYS I three full days, beginning with a meeting with the coordinator and program staff and ending with an exit conference on the fourth day. During the initial meeting the coordinator gives the team a very broad overview of the RMP. . The team leader also explains to the coordinator and his staff how the survey will be conducted and each team member's responsibility. Following the meeting each team member goes his own way to begin his part of the survey. Interviews are normally held with RMP employees at their desks rather than having employees come into a team room and appear before the entire team. Throughout the total review of management systems the team members must each be aware of an alert to other signals which they may receive since they also are reviewing internal communication within the RMP and the manner in which RMP business is directed, controlled and coordinated. ‘Fach day throughout the survey the team meets and Giscusses its findings, conclusions, and potential recommendations. On the last morning the team meets with the Coordinator and representatives of the Regional Advisory Group and the grantee institution to present an oral report. -Nothing appears in the final written report of the survey team that has not been Giscussed at this meeting and that the RMP has not hed an opportunity to rebut. SCOPE OF SURVEY Board and Regional Advisory Group omposition and function of the Regional Advisory nd Board cf Directors of the gzartce are examined to ascertain if the responsibilities cf each have been identified, are properly divided, and are t both todies. Committee activities are to determine if, members understand their missions, how well they coordinate relevant activities with other committees, and how effective the committees are. Program staff input in terms of providing . irforration to committees is considered. D by oO arg ey 9 . ‘ IV-9 MANAGEMENT SURVEYS to the report has been received by RMPS either the operations officer or the regional program director conducts a follow-up visit to determine the adequacy of the region's implemention of recommendations. GUIDE MATERIAL The RMPS management survey dctivity is part of an overall department-wide effort to improve the quality of grantee. management. As part of this departmental program, the Office of Grant Administration Policy in the Office of the Secretary has developed two guides for improving the quality of grantee management in financially dependent . or independent organizations. . (A financially dependent ot mote organization is one tnat recféves 89 percentMGE£ its total support from DHEW grants.) Copies of these guides are available upon request from the Office of Grants Administration Policy, DHEW, 330 Independence Avenue , S.W., Washington, D. C. 20201. ee 5 s VI-1 G ANT. ADMINISTRATION REQUIREMENTS 1-1 GENERAL RESPONSIBLILITIES OF THE GRANTEE The grantee is responsible for insuring compliance with all Federal requirements. Specifically every grant must be admin-~ istered in accordance with (1) the Act, (2) the regulations thereunder, (2) other applicable regulations (i.e., Civil Rights), and (4) written Federal policies (e-£-, in this Manual). program staff, participating in an RMI the policies contained Grantecs are also responsible for advising affiliates and all institutions and agencies #P cf the applicable Federal requirements and for instituting procedures to insure compliance. Grantees are urged to safeguard their interests by requiring that institutions and agencies participating in the RMP execute a contract or affiliation agreement regarding the administration of RM?S funds. te include appropriate references to the Act, this Manual, erentee in the evant in conmmection with It would be advisable for such an agreement regulations and and, further, to provide for reimbursement of the - of cudit liabilities incurred by others out the grant. re Ad carrying 3 we : L 1-2 ASSURANCES a, opgher © sulk Ket, . an The signature of the applicant's authorized representative on page 2 of the grant application provices assurance C9 the Faderal Covernment that the grantee will comply with the required assurances discussed below. Section 903 The folloving assurances are specified by Section 903(b) of the Act: »% S t ° Suz 6 hi 1. essurance that Federal funds paid pu ; vant will be used enly for the g aud in accordance with the epplic CG # Act and the regulations thereunder; me or fh ort is pay o E " gy mo Q pent 2 rt rt + Qs vd we 1D 2 2. reasonable assurancethat the applicant will provide for sucn fiscal control and fund accounting procedures as are required »y the Secretary to assure proper dis- bursement of and accounting for such Federal funds; reasonable assurance that the applicant will make such reports in such form and containing such information as the Secretary may from time to time reasonably require,. and will keep such records and afford such access thereto as tne Sac ny find necessary to assure the correct- 7f mit i not f ‘ oom at Poet ake cotp E L . yo bee Vi- 1 Ghe List ALMINIS TRATION REQUIRUMERY $ ‘satisfectory showing that the applicent has designated an advtsory group to advise the applicant (and the insti- tutions and agencies participating in the resulting Regional Medical Progrem) in formulating and carrying out the plan for the establishment and operation of such Regional Madical Program bhich advisory group includes practicing physiciens, medical center officials, naspital administrators, representatives from appropriate medical societies, voluntary health agencies, and representatives from other organizations, institutions and agencies con- cerned with activities of the kind to be carried on under the Program and members of the public familiar with the needs a the services provided under the Program. SCE B. Section 904 The following assurances are specified by Section 904(b): 1. Federal funds paid pursuant to any applicable grant (a) will be used for the purposes for which paid and in accordance with the applicable provisions of Title IX and the regulations. Thexeuncer, and (b) will not: supplant funds thet sre cthervise avetlable fer establishment or Heal Program with respect to & - operation of which the grant is made; the applicant will provide for such fiscal control and fund accounting procedures as are required by the: Sceretary to assure proper disbursement of and accounting for such Federal funds; the applica ill make such reports, ins ueh form and containing s such information as the see “yeata may from time to time reasonably require, and will maep such records and afford such access thereto as the Secretary may find necessary to assure the correctness and verifi- cation of such reports; and any laborer or mechanic employed by any contractor or subcontractor in'the performance of work on any con- struccion aided sy payments pursuant to any grant under this section will be paid wages at rates not less thar those prevailing on similar construction in the locality as determined by the Secretary of Labor in accordance with the Davis-Bacon Act, as amended (40 U.S C. 27€a--276a-5); and. the Secretary of Labor shall have, with respect to the labor standerds specified in this paragraph, the author- ity and functions set forth in Reorganization Plan Numbered 14 of 1950 (15 FR. 3176; 5 US C, 133z2~15) and section 2 of the Act of June 13, 1934, as amended (40 U.S C. 276c). Boca wa Executive Orders, forms, and instructions. 7 sp ANI OR VRE RTT nae vit Mors eee VI-l GRASS ABSMTOISTE. Ve LOR REQUE t Civil Rizhts Assurar A special assurance must be provided in relation to civil rights. Section 601 of the Civil Rights Act of 1964 pro- vides that no person in the United States shall, on the ground of race, color or national origin, be excluded from participation in, be denied the benefits of, or be sub- jected tG discrimination under any program or activity receiving Federal assistance. oe No RMPS funds may’ be expended by or in behalf of any in- stitution or egency which is not in compliance with Section 601. Compliance is signified by completion and submission of form HEW-441 (See Chapter IX.). The form only needs to he aubmitted once ‘by any given organization. The Department maintains a list of organizations that have. already filed a civil rights assurance. , Crantees are responsible for insuring that all affiliates and other institutions participating in the RMP submit HEW-441 where they have not already done so, and comply with the assur- ances given. In addition, all organizations participating in an REP mast comely with Executive Order 1Il46 as amended and el & Ma! BS superceded by Executive Order 31375 and 11478, respectively. Animal Care Assurance A special assurance relating to animal care must be sub- mitted for any RMES program stefi or operational activity which involves the use of anima for research or other purposes. Such activities must be conducted in accordance with Departmental policies relating to animal care. Wo RMPS funds may be used te support any activity involving the use of animals unless the grantee or other appropriate institution has filed a specific written assurance relating to animal care. @ assurance must provide that the institu- tion will eval its animal fecilicies on a continuing basis in xvegard to the re, use, and treatment of animals in a manner consistent with (1) standards established by the Animal Welfare Act (2.L, 89-344, as amanded), (2).th “EEN "Suide for the Care and Use of Laboratory Aniwals,"' and (3) other Department requirements. Where the applicable institution has previously submitced the required animal care assurance, no further action is necessary, since the assurance only needs to be subuitted once. - ry i » hace ¢ er a % oO. c tr 4 Requirements relating to animal care are administered by .the National Institutes of Health, not RMPS. Inquiries, assurances and other communications relating addressed to the Division of at 1 to animal care should he ratehn Grants, NIH, Bechesda, d@ FUPULALAGIS, lek tay Uncen Ogee, erawer beatakivend Gpphi cau 3 ’ Vi-} GRANT ADMYELISTRATION REQUIREMENTS - Rive Me a ee 1-3 POLICIES RELATING TO SAFEGUARDING Or INDIVIDUALS A. Protection of Human Subjects Where applicable to any RMPS supported activity, a plen for the protection of human subjects must be subaitted and approved” in necordance with Chapter 1-40 of the HW Grants - Administration Manual. The plan must be applicable to the institution directly responsible for the activity in question (i.e., the insticution identified as the project sponsor on pages 15 and 16 of an application, RMP-34-1). Where such plan is already in effect as noted in item 6 on page 3 of an application, no further approvals are necessary. (Also see Chapter VII-2, 2-2, B, 25, “Patient Care.") , A plan for the protection of human subjects is required when any individual would be Nat yvisk" — exposed to the possibility of physical, psychological, sociclogical or other harm — a8 a result of RMPS supported activities. No RMPS funds may be expended for such activities unless the required plan has been approved. Plans for the protection of human sproved by the National Inatitures of Peaita, nec His. i > » UES nquiri lating to further requirements and instructions of all correspondence should be sent to RMPS. Ro REPS. funds may be used for any activity involving human subjects, hovever, without pricr RNPS epproval in accordance with Subchapter VII-7. Confidentiality of Tuformation mnorted activities must be con- right to privacy. Clinical informat oO we was obtained, 1-4 GRAKI GENERATED MATERIALS — -- A. Patents and Inventions Patents or inventions made in the course of, or under, any grant must be promptly and fully reported to the Department in accorance with Department regulations (45 CFR, Subtitle A, Parts 6 and 8). No commitments or obligations may exist or be made which confi An invention : saufacture or im- 774 APD aS wok it relates. Grantee ar their ae aud 8 Vue] GRANT ADS ESTRARION REQUIREMENTS The completion of item 5, “Inventions,” on page 3 of a grant application, RMP-34-1, prevides the notice required above. Notice of patents and inventions may also be provided by filing an "Invention Statement," form PHS 3245 (which is attached). The letter should be forwarded to the Grant Application and Document Control Office, ublic Health Service, 9000 Reckville Pike, Bethesda, Maryland 20614, When notice of an invention has been provided either through the application or an Invention Statement, the reporting institution will be sent a "Grantee invention Report” form which mest be completed and returned to the appropriate office ‘in accordance with instructions. tr A final Invention Stetement must be submitted on FHS 3945" for each operational activity after termination of RMBS support. . Publications : Publications relating to RMP activities may be produced without prior review or approval by RPS, provided that the title page incluces an anaes eb of REPS support nd conelusion s do not necessarily Yepresent the views : Gar CALSO See Subchapter VII-2, 2-1, B, "Prints ing and Publicetion Coats. ") and indicates that fin When publications, nat als are developed with RHPS support, et ange for copyright without approval. ials subject to a oyaltv-iree, nonex ad dk ocable license to the Govern- ment to reproduce, ranalate, end publich them, and to authorize others to do so. (Aliso, sea Subcicpter VII-2, 202, B, VFLiea ena 4, D, below.) Videotapes," and Subchapter VI-1, 1- Distribution of Files, Videotanss, and ether Auitevi eudti Ks esiele Tew SARRR SNaaL SE C Preduction Authority 1. & fildeated institutions may produce and distribuc d ual meterials, or contract for such production and di tribution of such audiovisual materiale that have been produced with RMPS funds, provided that such sudfovisual materials include the required acknovledg- ment of RMPS casistance and the disclairer required by Subchapter VI-1, 1-4, B, above. (Also, see VII-2, 2-2, B, "Pilme and Videotapes." 2. Ownership Sadievésust vce oials eradensd Par the orant with Teo fiends this, & einy coltrart enterce isco ior the production and/or distribution of such audiovisual materials would have to be between the grantee and the distributing or producing organization. 5 Viel GRAGT AGHIDISTPRATTION aha hod Derived Jncome Audicv isual materials produced with RMPS funds are copyrightable subject to the provisions of Subchester VI-1, 1-4, C, ebove, regarding the repreductioa and distribue- tion rights of the Federal Government. Grantees should copyrignt audiovisual materials produced through. grants, since the copyright would afford grantees a legal hasis for Eeeekpe of any income derived from the aietrioution of such materidls. All royalties or other fees received by grantees or their affiliated institutions from the use of dis- tribution of audiovisual materials produced with grant funds, up to the amount they charged te the grant for prediction of the » audiovisual materials, must be re- furided to the RPP In this regard, grantees shall be respensibie for maintaining records for the receipt and disposition of the Federal share of income received from the distribution of these audiovisual materials in the same manner as required for the funds provided by the grant which gave rise to this income. Upon notifica-~ - tion from a grantee that income has been generated from Rta af Cais DESL ution of the as . me rials, av. rised as to the dis; sosition of such fur ede Any income received by a grantee or an affiliated insti- tution from distribution ef these audiovisual materials that is over and above the amount that is charged to the grant may be used by the grantee at its discretion. (See Subchapter VII-4, “Grant Related Incone.") m) hae its 4 Will be adv Required Approvals grantees comply with Chapter 1-450 Manual, entitled, "Use of Grant Funds on of Motion Picture Films," which prescribes -8 Which must be followed when motion picture ‘eral grant fuads. RMF tery to all audicvisual this Chact ection with RMFS support. Grant cut prior emproval to produce audiovisu: re intended for viewing by restricted nection with a progrem or project conducted by a grantee or an affiliated institution. Prior RMPS approval is necessary, however, when the intended audience fer the audiovisual materials to ba nreduced «ould be available to general audiences. (See Subchapter VII-2, 2-2, B, "Filns "riims and Videctapes.") Chapter 1-450, does net (1) restrict the distribu- tion of thrsa ‘rrtertals onco praduced in eccordance with tha weties ee gine toewetey ge (2) ts ret anol Te VYE-] GRANT ADMUNTISTRATICN REQUIRES 1-5 RECORD KEEPING AND REPORTING @ A. Accounting Accounting for grant funds will be in accordance with generally accepted principles consistently applied, regardless of the source of funds. Ail supporting re- cords of. project expenditures must be compatible with RMPS reporting requirements. B. Reteneion of Records All grantees and/or their af £filiated institutions are required to maintain grant accounting records, identifi- able by grant number, until audit fyGn behalf of the Department or five years after the enc of the finakBudget period, whichever is less. Accounting records must con- tain adequate references for identifying and locating original documents in support of direct costs. These in- clude invoices, checks, time records, and payrolls, etc. 1-6 PROGRAM CHANGES wetetaa C8 oies¢ RHPS must be notified whenever a new Chief Executive Officer aay © (Coordinator) is appointed for an RME. Such notification must also be given when any. individual is appointed to act 1 jrcsuch capacity when a vacancy exists. B. Cheree of Crantee Institution i. General . - oy ere pct Tf for any reason a grantee proposes to reli nguish re- ne ~ poof sponsibility for Regional Medi coer mm” grant, it must ne one neds scat Pront ass hive he imaediately noti ? LC - o : Coy é Sexvice. A cher . a new nonprofit era a change S grantea is conteupietad ol . aan OP . an RMP. KwHSYe 2. A - and. naw srenteés La ‘ seygete ype OP Ola ie for completing an necessari information, and tor the snocth transfer of responsibilities. 2. Approval UA —_—_ 7 In the absence of anysignificant changes in program the MPS way approve a change of grantees. The aE Director, i ax Director, however, may request approval of the National 3 AA, : C ce Advisory Council when, in his Jucgsent, such action Is necessary. Where there ts a change ef granted, a new . wnt = em Eh ws yn ’ - : seyeey Doo be - owen Jf to wettea wf Syent vrercowilt be fecun? po bho nes erante. . VI-1 GRANT ADMINISTRATION REQUIREMENTS 3. Required Materials @ the following materials must be submitted to carry out - a change of grantee: a. Articles of Incorporation b. Corporate By-Laws c. Listing of the Board of Direttors d. Listing of Officers of the Corporation e. Policy statements regarding Personnel, Staff Benefits and Travel Fractices (as these are developed, in the case cf a newly orgavized nonprofit corporation) f. Policy statements regarding fiscal and other handling, taxes, direct taxes, indirect costs, etc. (as these are developed, in the case of a new nonprofit corporation) g. Evidence of nonprofit status with the Internal Revenue Service h. DIEX Form 441 (Assurance of Compliance/Title VI of Civil Rights Act of 1964 if not previously submitted @ : by the now Granteo institution, See Chapter IX, Civil Rights.) i. List of Members of the Regional Advisory Group: (1£ different) : j. Regional Advisory Group By-Laws oa Cet k. G83 Circular A-9! whe, cotpet setion for a planning grant 1 . lette £ in the change From the law . «A letter of concurrence ° terminating grantec m. A final report cf ex grancce on form AM?- + termination date oa n. A final Invention Statement from the terminating grantee on form FHS-3945 within 120 days of the termination dete (See Subchapter Vi-l, 1-4, A.) o. Where applicable, a plan for the protection of human. subjects covering the new grantee (See Subchapter VI- 1, 1-3, A.) ad & jee ald te Med Cc. 1. AGHINE : Viel GRANT uranee relating to grantee (See VI-1, 1-2, D) aGs Uheare applicable animal care covering’ the new an bond for no less than vayable to the United States of America-DUEV-PHS-RMPS A formal application signed by an authorized official of the new grantee and including the following: . (1) A new page 1 and 2 of RMP-34-1 including the signature of an authorized representa~ tive of the new grantee Institution on page 2. (2) A statement adopting the application of the original grantee and agreeing to any conditions of the award with'respect to those activities to be assumed by the new grantee and clearly indicating which activities, if any, will not be undertaken (i.e., in some cases, new RMPs have split off from an existing RMP and divid- ed the activities berveen than) OF Ths Tar oing - riate pages of the application revised as necessary to reflect any significant changes from the original application submitted by the old grantee | 1 (3) Appyop : mote. Ravised Budgets eo by the new grantee 4 + (4) current budget period ind any revision of amounts eStimzted to be required for future periods ar Sugnded auppeort as shovn in item 15 of the Notice of Grant Award issued to the original grantee Ss. Payments to the new Grant A system of payment for the new corporation : established wiih the Office of Financial : National Institutes of Health, prior to processi ing any Notice of Grant Awarded to the New corporation, (See Subchapter VII-6.) must puut ha Karly Termination of Grant By the Grantee may be terminated or cancelled at any time by the upon written nok ttieateen to the Director, Regional Frograne Service, stating the reasons for, and ef- mp eerny Soke bee Mere Soa “A grant grantee Medical VIe1 GRANT ADMINISTRATION REQUIREMENTS Bt gh 2. By RMPS A grant, in whole or in part, may be revoked or term- inated by the Director, RMPS, et any time within the program period whenever it is determined that the grantee has failed in a material respect to comply with the terms and conditions of the grant. fed Hepa Foclive —_ 10 Je do “Wedel " + Cheage \ VI-3 AFFILIATION AGREEMENTS 3-1] NEED FOR AGREEMENTS an RMP will involve a number of different institu- ations, and agencies in additien to the grantee. ‘In order to ure accountability for Federal funds and conform- ance te cther requirerents, and to protect the grantee against audit liabilithes py these additional agencies, an Agreement of e bh ‘Lliation be concluded between each affiliating institution " (or agency) and the RMP grantee. Such an agreement will not be 1 Qien wy. required nor appropriate in the conduct of business with (1) z or, (2) where direct ities or for service ning organization byCsubcentract, Zor the usé PaeL profiten Ke (ee i= co bé rigde Le rendered on behalf of the Regional Medical Program. A minimal, type of agreement is illustrated below. A. Model Affi iiation Agreement That an Affiliated Institution, for and in consideration of mutual benefits, lle and comply wi tle "Ix of the Fublic Hea e he Latent and purpose of ¥ eae t. forth in Sections 903 and 904 of the Act or any philosophy ame endwents thereto. oe ; 2. Administer all erant fends veceived through the Grantee astitution of the Regional Medical Frogram in accordance with the regulations and policies of the grenting or funding Agency. 3. Comply with all rules, regulations, or policies as may be ad @ thea 34 Advisory integral Pa c Ss r a 4, rantee inscitution or the Coordinator to administer the grant properly. rr = {> 3 program for reimburse oney a sum ct money penditures disalloved, t ing agency or an authorized ag y orul ugh aud exception or some ether appropriate means, that expenditures ellocated to Lat rot C nia det (PL. 91-513 Ug 1-1 1+2 1-3 VIE-1 GENERAL FINANCIAL MANAGEMENT PRINCIPLES AND REQUIREMENTS APPLICABILITY OF POLICIES In the cbserice of any contrary provisions of the Law, regulations, or written and announced Federal policies, the policies of the grantce institution or the affiliate dre applicable whichever is more restrictive. UNTEORM TREATMENT OF GRANES AND INSTITUTIONAL FUNDS Institutional policies applied to the management of grant funds must apply equally to all institutional activities irrespective of the source of funds. This means that the institution must have the same policies for expenditures from grants as for ex- penditures for non-Federally supported activities. UNIFORM TREATMENT OF SALARY SCHEDULES No supplementation of normal salarics in accordance with insti- : 2 weeadbtae reD eens won neg mnid pos Pye MO gtd Pps cee f tt tubicaal policles is peraittes Ler qr yloysns a grants. (See Subchapter VII-2, 2-2, B, "Salaries and Wages.") 4 PRIOR APPROVALS A. Vhen Required The following cost categories and types of activities require prior approval by RM?S before such costs may be incurred for the purposes indicated: 1. Foreign Travel Too 2, Certein caterories of printing (Sce details under Subchapter Vil- Drugs Allowable. Grantees are encouraged to adopt policies aad procedures which will ensure the most economical af drecs end erocaliture of funds for the acquisition of a) biologicals for research, training, or patient care, consistent with acceptable standards of identity, strength, safety, quality, purity, and effectiveness. When not contraindicated, drugs should be purchased under their nonproprietary or generic names. (See Chapter 1-50 cf Grants Administration Manual.) mpgs Funds shalt not be used without prior approval to purchase drug products classified “ineffective” or — "possibly effective’ by FDA. Lists of drug products that have been declared “ineffective” and “possibly effective" are available from the Office of Grents wenacement, HSE, Parklawn Building, Rockviile, . if: ¢ alec yt oy MATA Praretileestone 28 fri ores s Covernment Printing Office, Washington, D.C. 20402. @VGULLaDLE Livan Ue SUE Dae Tee ° ViI-2 ALLOWABLE COSTS 18. bues, Institutional - 18 Costs of the grartee or affiliate institution's member~ ship in civic, business, technical, and professional organizations ..are allowable. + e 19, Dues Personal bues, 1c ‘Costs of personal memberships in civic, business, tech- nical and professional organizations are allowable only to the extent that they are (1) limited to one individual per headquarters or major field installation of the Region- al Medical Program; (2) can be purchased at a lower price than iastitutional membership; (3) are required to ob- tain publications necessary to the program. 20. Entertainment Costs of amusements, social activities, entertainment, or incidental costs related thereto are not allowable. 9L, Enubroont @ Rental and purchase of equipment, including diagnostic and hab A 7 _ treatment equipment, for the planning or implementation of ; ave df, a program is allowable. When acquiring major items of rain £ QA equipment, consideration of the relative advantages of Lay on, od lease versus purchase should be considered, (see Subchapter Ws eae pued VII-1, 1-10.) | | & 22, Federal Employee Compensation Grant funds may generally not be. used to pay fees and supperting eests to U.S. Governnent employees regarclass of their employment or pay status, except that grant funds may be used to pay consultant fees to U.S. Government employees when: a. These employees are medical personnel of the Uniformed Services of the United States ‘(excepting commissioned officers of the Public Health Service)- qualified to provide the kind, type, and extent of medical services approved in the grant award. b. Adequate numbers of qualified civilian medical per- sonnel are not available to provide the kind, type, . and extent of medical services approved in the grant @ ; avard mud medical personnel of the Unifoarred Sey - . ts Pome a . - . din addition tc those qualified civilian medical per- sonnel, if any, who are available. Vil-2 ALLOWABLE COSTS h. Satellite Dialysis Facilities -- Allowable where appropriete @ to serve the backup needs of patients who are geographically . removed from tertiary care facilities. i. Tissue Typing -- Allowable for start-up costs provided that the tissue typing labs are not redundant and duplicative. j. Transplantation «~~ Allowable for establishment of transplant~ ation programs in areas of need. Direct patient care costs are not allowable. ~ . 30. Legal Fees 0 -e Allowable when separately incurred specifically for a A eal poe grant-related purpose, such as establishsient of a new : ssc ace” Corporation to administer the EMP or the develepment of \ ge “ew nonprofit educational consortia. Where legal fees g < ¢ . ZC are incurred by the grantee or. affiliate on a "retainer x . t : Kae basis," however, they may be reimbursed only through the ¢ wer indirect cest allowance and may not be charged directly we 2g pars ; of to the grant. : . CS fate peer a. Low-overhead Limited-care Dialysis c eo V/ . See "Kidney Disease Activities," this Subchapter (Also see Subchapter X-2.) " Patient Care : . and /ox other care of esearch, demonstration nt shall be furnished é at any facility unless ed to such fectlicy by a procticin tt {0 pe > ri chapter VIl-l, 1#6, A.) 33, Insurance ability insurance to cover tly conmected with the program. 34. Yeals aleoholic beverage: or enterteinment may be charged to the grant account. Meals may not be charged separately where per diem is paid. . 35. 36. 37. 38. 39. 40. frraranad er ad pregr aman 2% . VIie2 ALLOWABLE COSTS Organ Procurement See Kidney Disease Activities," this Subchapter. (4lso see Subchapter X-2.) Organ Procurement and Communication Activities ‘ . See "Kidney Disease Activities," this Subchapter. (Also see Subchapter X-2) Printing and Publication Costs Allowable, except that any grant activity which would require printing in excess of 5,000 units of one page or 25,000 units in the aggregate of multiple pages must be considered as print- ing substantially for the Government and must be done through regular Government channels. (See Grants Administration Manual Chapter 1-463. Also see Subchapter Vi-l, 1-4, B and C.) Recruitment Costs (for recruiting staff for RMP activities) Allowable only for full-time employment on RMPS supported activ- ities, if payment of such costs is normally made by the grantee, or affiliate, regardiess of source of funds. Costs may include moving the individual, his family, dependents, and a Sods.) Costs of relocating an employee must be credited to the AE account when the employee resigns within 12 months after employment for reasons within his control. Not allowable for individuals recruited for part-time or temporary employment. Recruitment, Health Careers (as a program staff or operational activity) ay Not allowable for direct recruitment of individuals into health careers. RMP program staff activities related to stimulating, planning and coordinating health careers recruitment by appropriate institutions and agencies in the area served by the RHP, however, is alloxsble. RMPs are encouraged to use staff assistance to stim- ulate cooperative efforts between professional assocations, clinical resources, educational institutions and other eporopriate agencies to provide new opportunities for recruitment into health careers and to plan health careers recruitment activities as part of and coordinated with the overall manpower strategy for the area served. Rental of Space alicsable when charges are made in conformance with ner- sss of the sources of funds. for space owned or controlled - mal grantee polici No rentel char ca ox hy nn affilie , * ae pl teem Te 4 int indirect cost. Also, when an organization transfers a facility to a third party through sale, lease, or otherwise, VII-2 ALLOWABLE COSTS and then leases the facility back from that third party, the léase costs which may be charged to the grant may not 1 exceed the equivalent of the "cost of ownership” 41. Salaries and Wages Allowable for time spent on a.grant-supported activity. ts See Chapter VIT, 1-8, “Salary Comparability Studies." No supplementation of base salary is permitted. (See B, 9, “Consultant Fees," above.) Salary and wage rates must be in conformity with those permitted by institu- tional wage and salary scales. and policies. RMP program staff salaries should be reasonable and not exceed the salories of full-time personnel with equivelent respons iol ities in major medical institutions in the Region. Direct charges for professionals must be supported by either: 1. FS a. An adcquate appointment and workload distribution system, accompanied by monthly reviews performed by responsible officials and a reporting of any significant change in wowrlord distribuston of ecch professionel (1.9., on SRCH pat, EEperta ag vpeoeay oF b. A monthly after-the-fact certification system which will require persons in supervisory positions having f the services performed to ge 4 a4 evtwn firsthand knovie report the distribution of effort (i.8., a positive reporting system). Such reports must eccount for the totel salaried effort nersons covered, A systen which previ applicable to acceptable, ceting only of effort activities is not c. sr Vaeded and : =e 4 rte . An omplovse or consultant muy receive atlittonsdl . = : Lat compensation for services performed for an ANP, where T ; BCH services are performed Gith)the individuel's Wh,” - €yll-timre work week. (See B,o, "Consultant Fees," Vite above.) The grant may be charged in proportion to the per- centage of tine or effort an individual devotes to the grant within his full-time work week. 42, Satellite Dialvsis Factlit 2 LoS “ : - - . eset plo. we ye ew eet SUCH a pled ares; . 43. Stipends 45. 46. 47. Vil-2 ALLOWABLE COSTS {Transplantation See "Kidney Disease Activities," this Subchapter. (Also see Subchapter X-2.) Taxes Allowable only fot those taxes which an organization is required to pay in connection with employment, services, travel, renting, or supplies. Travel Allowable when travel is required in connection with RMP activities. No foreign travel may be charged to an RMPS grant without prior approval by RMPS ON Institu- Efonal policies will govern travel expenditures and reimbursement of individuals for travel, except that less than first class air travel must be used when available. In the absence of institutional travel policies the HEW travel regulations apply. Tuition and Related Costs for Employees of RYMPs and Affiliates Allowable for employees of a Federally supportad ackivi- ty when such employecs can contribute more effectively to the conduct of the activity by oebtaining training re- lated to the purpose of the activity. 3 Tuition is not allowable for training courses taken by an RMP employee to acquire basic skills unless provided as an institutional fringe benefit, or as part of an institutional program to upgrede the skills or knowlecge of employees with econemically or educationally dis~ advantaged backgrounds. VII-3 INDIRECT COSTS 3-1 MATURE OF INDIRECT COSTS A. Definition and Elaborations Indirect costs are those costs of an institution which are not readily identifiable with a‘parcticular project or activity, but neverthless are necessary to the general operation of the institution and the conduct of the activities it performs. Indirect costs are not peculiar to government sponsored activi-~ ‘ties, as they sre generated to some extent by all business vencuree. Indirect costs are norwally calculated as a per~ centage of either (a) dizect salaries and wages, or (b) total direct costs exclusive of capital expenditures. Indirect costs Sum t® the institution and may be used for general institutional purposes without further accounting to the Federal Government. (Also, see Subchapter VII-1, 1-6, C.) Exasples of Usual Types of Indirect Costs (Also see Chapter VII,1-6,C) The following type expenses of an institution cre normally , considered a3 indirect costs, and are reimbursed to an institu- tion by means of an indirect cost rate: 1. ‘The cost of operating and maintaining buildings and ecuip- ment--which usually includes: heating, airy conditioning, lighting, eervice cleaning and maintenance contracts, and minor repairs. . 2. Deprecistion--which usually includes writing off the cost of buildings and equipsent over their estimated useful life. 3. Salaries of administrative officials concerned with general management of the institution--veually include the poarson- nel esployed in central executive offices, the purchasing office, the public relations office, and the accounting and finance departments. 4. General telephone expenses--which usually include the monthly rental end usage charge for all telephone and _ long distance calls by the administrative staff. 5. General travel, supplies, and other expenses--which usually include all travel by the central administrative staff (not program staff), all supplies necessary for the operation and maintenance of the building,as well as the offices and facilities within the building,and the insurance, payroll taxes, other teres, and any other fringe benefits, sensrated ’ a Liem ty - Leet ag wee hegay oeauters Ds ot Pew PEELE, 5 CU te tyre rial it, VIL{~-3 PNDIRECT COSTS C. Yneurrence of Indirect Cost Where any of the above types of costs or other central service costs ere used by 4 grantee or affiliated institution to justi- fy an indirect cost rate in counsction with RMP supported activities, the services for which the costs are incurved must actually be provided to the grant supported activity. (@.3+, if all equipment and supplies for an activity are purchased by the EMP program etaff, an affiliated ingtitution sponsoring the activity could not include the costs of its central pur- chasing department as pare of the justification for its indirect cost rate.) , 3-2 PACTORS APFECTING DETERMINATION OF BMP THDINECT COST RATES A. Guices for Institutions Indirect cost rate is simply a device for determining fairly end expeditiously what proportion of an institution's over- head expenses should be charged to grent-supported projects or activities. The Department has issued separate guides for educational institutions, hospitals, State povernment agencies, and nonprofit inseitucions which see Forth waifern principles for the establishment of indirect cost rates. (See Chapter Vil- 2, - Z-1.) The cost principles set forth in the guide covering in tos the specific type of institution receiving nMeS funds will be @ used as the basis for computing a submission for a proposed indirect cost rate. . ) B. Special Indirect Cost Rates for PMPs Because of the complex organizational structure of RMPs, 4 single ICR applicable to all RMP-supported activities will ordinarily not be able to be developed. In some RMPs, program staff is employed by more than one institution and operational activities are carried on by various institutions which change over time as old activities are phased cut and replaced by new activitles under different sponsorship. Fer these reasons, RMP indirect cost rates, when requested, will have to be determined separately for the grantee institution and for each affiliate which receives REPS funds either for support of program staff or operational activities. : ro While many RMP grantees and affiliates have approved indirect cost rates applicable to biomedical research projects, different indirect cost rates specifically applicable to RHPS~-supported © functions may have to be developed. In the case of RMP, many S ¥pes of expensé& ordinarily treated as general administration costs by the grantee for other types of grants are charged as direct césts to RMP. For example, many Rifs provide for their own purchasing, persons) administration, financial manssenene and VII-3 INDIRECT COSTS lL. To obtain an indirect cost rate, the tetal amount of direct costs is divided by the totel amount of indirect costs (after the exclusion of unallovable items). The resulting percentage is the indirect cast rate. 12. The resulting rate should be applied to the direct costs cf the project to arrive at the allowable amount of indirect costs. Full documentation of the above steps should be retained by the granteé institution as evidence that requized procedures. have been carried out. ae TTS 3-5 PROCKPURE FOR EPPECTING SETTLEMENT OF DIFFERERCES BETWEEN FROVISTOCEAL ABD PIFAL YIRECT COOT RATES A. Sumeary Report of Expenditure Adjustment Sheet Chapter 1-80, of the DHEW Grants Administration Manual entitled, “Award and Payment of Indirect Costs on Project Grants," relates to the award end payment of indirect costs on grants and the method for effecting settlement of claims for unrecovered indirect ent ef final nesotiated rates. Chapter 1-30 specifies that “A-Surnary Report of Exponditure Adjustwent Sheet (SROZAS) shall be subuitted by each grantee to the Office of Financial Management (NIU) reflecting the nec- essary adjustment (upward or downward) ia the indirect costs grant by operating agency and appropriation.” SROEAS is illustrated in Chapter 1-0. ~e a eb te day ey Soe ee wh. yet eoniy pT e¢esis resulting from the estaols a Whenever the Grantee for a Regional Medical Program submits a Report of Expenditures, using provisional indirect cost rates, for either their own or an affiliated organization, and a final rate is subsequently established by the Office of Grants 7 tration Policy, for /€@ither Aheir cwn or an affiliated organization, RNPS will expe ‘Re grantee to initiate @ SROEAS fo process any adjustments resulting from the difference between provisional and final indirect cost rates. As indiceted in 3-4, above, grantees are responsible for negotiat- ing final as well as provisional indirect cost rates for affiliated inetitutions, that do not have an OGAP established indirect cost rate. When establishing final indirect cost rates for affiliates, RMPS grantees shall report the difference between the final and provisional indirect cost rates in accordance with procedures specified in 3-5, below. AN SROFAS must be submitted to reflect vO —Frnal tates thet sre lower then the. provisional rate, as well as those that are higher. ~ When a final rate is establ ecesgary to revise any eroviousiy submitted ished that is different from the provis- jonal vate, it fa nc-necass B. VELI-3 UNDIRECT COSTS expenditure reports which include an amount for indirect ased on the provisional rate. All adjustments n the amount of. indirect cost paid will be made @ basis of the SROEAS. Since the Office of Grants Administration Policy reminds the grantee, or affiliated institutions as appropriate, with its covering letter transmitting the executed indirect cost negoti- ation agreement, upward adjustuents for increased indirect is co) costs will not be considered if a SROEAS is not submitted within this time limitation. RMPS shall consider that the date of this one year grace period shall start with the effective date of the earliest negotiation agreement processed by the Office of Grants Administration Policy, which establishes a final indirect cost rate for the applicable budget period, for an institution participating in the grant. Special Requirements for RMPs In addition to the requirements imposed by Chapter 1-80 of the Grants Administration Manual, there are additional require- ments thet must be followed by Grantees for a Regional Medical Program when preparing a SROZAS. These are: (L) The SROEAS must reflect indirect cost adjustements to the RMP grant, separately from those indirect cost adjust- ments applicable to all other grants of the grantee institution. (2) The initial SROZAS submitted for a particular budget period snould reflect as many adjustments €S are neem essary, and can be processed within the one year grace period. (3) When appropriate, addenda to a SRORAS should be processed for those institutions whose indirect cost rates were not finalized at the time of submission of the initial SROEA for a particular budget period. (4) The grantee should indicate on the initial SROEAS submitted, how many of their affiliates. were reimbursed indirect costs, based on either an indirect cost rate established by their ‘own. organization or the Office of Grants Administration Policy. This will serve to inform Rurs (a) as to which affiliates’ indirect costs adjustments were included on the initial SROEAS submitted and which affiliates’ indirect cost adjustments would be expected to be processed on addenda to the initial SROZAS, and (b) inform RMPS as to when the total amount of indirect cost adiustments were processed by the . a & VII-4 GRANT RELATED INCOME 4-1 COMPONENTS GF GRANT RELATED INCOME A. Definition and Elaboration , Grant related income is the Federal share of the net income derived by a grantee or affiliate from fees or charges made in Connection with activities supported in whole,or in part, by an RMPS grant, or, where applicable, derived from the sale of items developed with RMPS. grant support (e.g., publi- cations, films, medical or other devices). (See 4-4, below) Net income is iacome derived from an RMPS supported activity less any direct or administrative cost relating to the generation of such income. WSK Credits or receipts (e.g., refunds, rebates, discounts, adjust- ments, and other allowances) which offset or reduce an expense chargeable to a grant do not constitué grant related income. B. Treatment of Commonly Ceocuring Items ef income 1. Income from Construction Where RMPS funds are avarded for construction of a facility, the income derived from the eperation of the completed facility does not constitute grant-related inceme except where the income is generated through specific RMPS supported activities carried on in the facility. 2. Income from Government Agcacics Income recieved from other RMPs or from Federal or other governmental acencies ca joinely-cupported projects is net grant related income. inecce derived fren foes,or charges, or sales (as discussed in @-1, A, above) to such agencies, however, would constitute grant related inccm:. $ ‘a 3. Income from Educational Programs e - ° Normally, tuition and related fees received by an educational institution for a regularly offered course are not considered to be grant relazed incone. Tuition and related fees, however, received by an educational institution must be treated as grant related income when the course of instruction develop- ed, sponsored, and supported by an RMP is not a regularly offered course. A regularly offered course is a course that: * Lon peer Pec ee 6-2 “to avoid audit problems. VII-5 CONTRACTING BY GRANTEES INTRODUCTION In general, contracts may, be used by grantee institutions for (1) awards to affiliates and/or, (2) purchases of equipment, ‘supplies or services. The purpose of this Sub-Chapter is to outline recommended contracting procedures which will help The Sub-Chapter covers suggested procedures for both com- petitive bidding and for sole source contracts. Discussion of competitive bidding is necessarily more extensive than that relecing to sole source contracts. {It should not be inferred, however, that RMPS necessarily prefers or requires competitive bidding where contracts are used. : In making contracts, the grantee should follow its own institu- tional policies. Where the grantee has no formal contracting policies or where such policies are not 48 extensive as those outined below, it is recommended than the procedures discussed in this Sub-Chapter be followed. USE GF CONTRACTS BY RMPS GRANTEES | is generally well a mecheantom for allecating gations for carrying out § While the use of contracts for purchasin understood, their use by RMPS grantces a grant funds te affiliates or other orgen the purposes of the grant requires some “+ A. Distinction Between Affiliation Agreements and Coliretion of Fonds Most RMPS grantees have some form of written affiliation apgree- ment with the other institutions carrying out program staff and operational activities. In most cases, au affiliation agreement cana be regirded as a memorandum of uvcerstanding be- tween the grantee andj other parties, but is is not an avard or obligations of funds. It usually does not comnit specific amounts of #rant funis to the efiiliate, and the agreement usually has an indeterminate life for the duration of the affiliate's participation in the RMP progran...- “ * s B. Obligation of Funds to Profit-making Organizations While an affiliate rust always be nonprofit, the grantee may make use of the services of profit making firms. Profit making firms may be naid from grant funds for the use of facilities, the purcaase of equipment and supplies, and for services veniere- Clogsa genoa wo axtenges era normally “4 c. not necessarily rec: . VII- 9 CONTRACTING BY GRARTEES Required Allocations Through Gontracts Grantees can allocate funds to affiliates or others through either a contract or other instrument of commitment (i.e., a letter, a special purpose form, ete.) Contracts, however, must be used to allocate grant funds when: 1,. The funds are provided to a profit making firm. 2.. Material having a security classification is involved. 3. Payment of an amount in excess of actual costs (i.e., a profit or fee) is contemplated. Choice of Methods for Allocation of Funds by Grantees Except where contracts are reuqired as indicated in 6-2, C, above, the choice of whether grantees should allocate funds through contracts or other instruments is up to the grantee institution. Small purchases will usually be made through purchase orders in accordance with institutional policy. In general, a contract is considered to be the most desirable mechanism for allecating funds tan: 1. ‘The funds are to be used for the purchase of a specified service 2. The funds are to be used for the purchase of a particular end product, such as a publication, report, or device. 3. Considerable direction and control by the grantee is required with respect to the manner of performance or timing of the work. &. The funds must be formally obligated within a specific time period. Ree ee experience indicates that most grantees do not use formal ontracts in allocating funds to affiliates to carry out specific activities, Usually, Ictters or other at ssuec by the grantee indicating the amounts, pure period for which funds are allocated, and the grsat on the understandirgs in the offiliation agreement to insure proper use of funds and compliance with federal and grantee requiresents. Dealing with affiliates ia this manner pro- vides greater financial flexibility than the usual contract and enhances the RMPS concept of "cooperative arrangements" among the institutions participating in a Regional Medical Program. The source of a propssal shovld not necessarily influence the choice of in avard mechanism. For example, a contract is ute the {initiative for an activity fee fo opet a, geile tise VIT-5 CONTRACTING e GRANTEES ® E. ‘Types of Contracts Where contracts are used, these may be of two types, (1) fixed price, (2) cost-reimbursement. A fined price contract may be used where a definite cost can be established in advance. A. cost-rejmbursement contract, therefore, specifies an estimated Yather than an actuakh cost. ' F. Oblications and Expenditures All contracts (and purchase orders) by grantees for RHP purposes constitute obligations of grant funds for Federal accounting purposes. Federal auditors have taken the position that other forms of allocations do not constitute obligations Where a grantee makes a contract which continues beyond the fiscal year of the grant, the funds are obligated ime diately (even though actually paid out later) and would be shown in the entire amount of the contract on the expenditure report for the fiscal year in which the contract was initiated. Adjustments for any unexpended balance expenditure report for the subsequent fiscal year in which the contract terminated. 6-3 RECOMIIUDED CONTRACTING PROCEDURES » It is recommended that grantees follow the procedures recommended below when making contracts involving RMPS funds. A. hequests for Bids Where competitive bidding is used, the grantee must prepare a "Request for Bids" to inform potential contractors, The "request for Bids" should include the following information, as applicable: 1. A “scope of work" statement which includes (1) a broad, pon-technical deseription of the werk to be dcone or items er services to be purchased, (2) stazes ef work, technical specifications, reports, drawings and publications. 2. ‘the peried of performance. 3. The quanticy needed. 4&.