B&B ImFmRmikriom lm^ae MAkm^i3EmEmy 300 @lmoc M=ot=L"m SOULXVARD Ulefoem M.%ItLECRO, MARY"Odo 2077Z 9 USA a 9301) 24@l 10 AIITO!i,@ATIC", tl,',D D- T AND OTil",,R I,IAJO)@, EQLIIP@,L'I\'T ',EDICAL P?\.Or' 1.1 IN A REGIC)'.IAL I ,PA GUIDE TO PROJECT REVIElq An effective Re-ionil I.Icdical Program bases its grant, contract and core staff activities upon continuing objective appraisal of the match betxqcen medical services available to the people of its r\egion.and their needs for care. Unsolicited action proposals, like those originating within the Regional llcdical Procrrai-,i organization, are subjected to rigorous tests of the system analysis iiid planning processes through which they reach ttie stages of initial, continuation, or renewal rC'ViCX,7. Internal or voluntary proposals halt involve P,!,'LP investment in equipment, research, or development for automation are subject to all the tents of necessity and tirpcli,@icss that apply to other activities. Auto- matioii frequently involves high initial costs, rapid obsolescence, and a high prol)nl)ility of failure. Atitc)rLation research and dcvclopii@nt are important concerns of other granting Regional liedical Programs frequently are importuned to r@i@ile major investments in equipment purchase, rental, or timesharing that is oriented toxqard clinical service, or continuing education, rather than research, and may not involve automation. Many such projects share the ri@-l-,s of loss that are attendant upon automation research and development. A partial list of ;rich projects include . . . Medical record and information svstems . . . Medical reference and consultation nL-ti.?orks 2- . . .Television or otliel: continuing education systems . . .Ifulti-pliisic @crecnii-ig projects . . .Mobil emergency care Heart sounds or ECC transmission sys tcrcis . . .Dosimetry iiet@,7orks . . .Special purpose hospital units: radiation therapy, CCU, etc, In addition to the usua@ tests of necessity, timeliness, potential gain and feasibility reviews of any of these -projects requires certain special tests. 1. @IP investment in projects that have research components sliall be confined to: a. Studies of the regioi-ializatioii of clinical procedures, e(ILlipment or systems i-7hose clinical values and economic values are predictable for specified conditions; or b incidental contributions of minor amounts of staff time or other items that also contribute to the RI-,'.P objectives. 2. RIIP investment in automated equipment for any project stiall be: a. Confined to the minimal rental, time-sliarin- or purchase ,i,.iount requS.red to pilot the project; and b. Withheld until it is demonstrated that: 1) the proposed application of automation is feasible within the limitations of available time, funds and talent; and 2) all contributions to any proposed system of automation 3- and all users of its product liive igreecl to any compromise in terminology and technology the system requires; and 3) the initial specifications for the proposed automation have been completed. 3., PI,IP investment in special laboratory, transpc)rtatio n, or communications equipment- sliall. be confined to: a. minimal rental, timesharing or purchase required to pilot a technique or element that is indispensable to the project; and b. non-e>:perinientil equipment of proven capability in the proposed use; and C. procedures that are endorsed by a sufficient number of users having a potential traffic in demonstrably needed transactions to make the planned system economically self-supporting. 4. RIIP investment in piloting projects that require major eqtiipn,:2nt investment i-7ill be confined to projects i.7,-iose plans for disengagement of RII'P @,,upport: a. include commitment for procurement and appropriate imortizeLioil as N,;oll ascperition of all necessary equipment in their plans for full-scale iion-1111-i',t-I operation; and b. Base their plans for post-PIIP operation on realistic projection of need, without reli.ance upon promotion of noii-function@il utilization; and C. Provide that in the event of discontinuance, any equipment purchased wi.tti P\IIP funds will be liquidated with appropriate return to III.IP or the government. -4- BZ'ICI,GI"OU!qD BROADENII.TG TITE QUESTIO,'Z The Council request addressed itself to projects that: include significant elements of automation and research and development. Th-i.s response is somex,?hatbroader, because IZ,',IP investment is other kinds of equipment also appears to I)c, precarious business. The Rj'.,IPS does not have detailed information on requests for an investment i.n major equipment, I-le have information about project t@itles and magnitudes that indicates the kinds of equipment that are most important.' No fi.el.d survey was mide to improve our information It this point, for ti,.,o reasons. Pi.rst, i.@e are developing a long ran(-c, information C> system i,?iiich has a higher claim on staff time it present than a onc,-ti-ii-,e -3ctical)le to survey of selected project proposals. Secondly, it appears pr, enunciate a N,7orl,-,-@ble E,,i-tido for equipiient acquisition without a survey. -il types of major equipment systems have figured im,)ort:ently Sevcr, RYLII project proposals They not been confined to projects ,,,itli 3-n major research and development components. Education, clinical reference, and clinical service demonstrations have Involved major communication, mobile unit, and other equipment -systems. TIIE NATUPE OF THE PISKS From past Council discussions, site visits, common sense and day to day observations, PI.IPS has concluded that a high risk of loss may be present in any project proposal. that involves major investment in hardware. -5- A E,'art-Llt of risl@s, than' a single must be cv,-ilti@,t.c@(i or put to rest, iqlic@iiover i major equip,-.icnt investment is part of P proposal. Iforeover, most of the risl@s atticl)e3 to such projects are not inherent in the performance of the hardware itself. Some examples: A proposal. to evaluate screening plans to use cquil).,-Ilent of uiiknoi,,,n performance cliaracteristics.to record tests ,?Iio@c, norms for the subject population group are uncertain. This gives the project three evaluations to iccoril)li.sli - the equipment, the test, and the screening of the population, of which only the latter may be @n basic PI.ip mission. A continuing education proposal plans to eippl.oy television to present materials that require precise representation, to audiences whose attention or even attendance is difficult to hold. This also gives the project problems to overcoiji-2 in four major fields - television, reproduction, audience motivation, and cffecti,,Tcness in chairing behavior, of v@hich only the last named is PI.PI business, A telephoned heart sound or ECG project is proposed for a thinly populated area, to use cqttil)i-..ient -ind diagnosticians whose performance characteristics are l@nox-7n to be satisfactory. Sharp cost-benefi.t analysis'is needed here, to determine how the unit cost for cases in which the system would make a significant difference to the patients x.,,ould compare with the cost of bringing those patients and high performance 6- is diagnosticians t@o@,2tlicr. Tiior""l' also needed to obtain assurance of acceptance by first-line practitioners and their patients. A coiuple>c rledical. record system proposes to provide computerized data baiilm-ing, retrieval and information transmission, tisincl-1. equipment whose performance characteristics and rentability are i-7cll established. Such a proposal presents a coml)le@: problem in co-.t-benefit comparison of alternatives. It also I)rcsents problems of acco ptarce, not only for the functions but for details lil-.e compromises on specifications for data inclusions, terminology, -s. and presentation of the information product All of these studious and negotiations should be completed and sliox,7@- positive results before P.-.one3, is tied up in equipment. A sum@,iiryt)asScei,i made of projects involving iiiijor cqtiil,).,iicnt investments those total project direct cost awards to date total $200,000 or more. The costs of equipiaciit acquisition, rental and timesharing in these projects is no: l@no%.,,n. llo\.7e vcr, the summary provides so,-ac notion of the amount of P\.'rlP investplont x,21iose success depends upon the capabilities and performance of hardware, and on the quality of the judgments, pl.,Iiiniii,, and negotiation that v.,c!re employed in its ipplicati.on. 7 - The large projects in the tal)lc bc,lc)i@ have Iccouiit-,(2cl for more tliziti @24 million in total. direct cost --@,Tir(Is for the 4-year I)criod. Undoul)tcdly there has been a siE,,nificit-it it)vcst;,,iciit in sin,,-Iler projects Lliit I)in,-cd Upon similar 'co,,-isideriLions during this period. l@uAJOP, ACTIVTTILS Il@VOL@7ING AUTO:.,ATEI) TECt@li'D!,Ol@IIES AND OTI'IER 1-1@RCE EQUII"rlE@,T INVES'17i-!El@TTS Total Direct Cost Obligitioiis by Fiscal Years (in $ t[iou,.@-Pds) Classes nllCl of Projoct7.s 1967 19(,S 1969 1970 A. Projects involving automated equipment investments of $50,000 or more. 22 projects, aggregating $14,609,000 2,441 3,451 t@,883 3,834 B. Projects involving ,:ii-i'Lom@,i tcd equipment of unl@,noi..,ii costs. 1.2 I)rojects, 56,500 493 1,350 2,013 C. llc)l)ilc@ unit projects. 6 projects a@,@ $951,.,Or)O 88 386 480 D. Coin-.],,Vtnicatioit i-iet@.7orl@s for continuing education. 6 projects agrc,,-iting $4,876,000 243 1,074 1,744 1,815 -8 - Atl'fO'.,,ATIO:@!, Ti'l,',, Vie@,,c(-l from a rcslc@ctftil dist@ince the co!i,,I)tit-.ci- field p7-e@ci-its a busy, but apparent].), orecrly landscape. This because most basic computer production is in the hands of giants, i@iio i..Ianopc to i-tinint-lin their o-@.7n equilibrium. The field of or of computer thinking and technology, is ver), different. l@ilicn @een at close range, it is characterized b), disorganization, volatility and speculative turbulence. 1.1-iny factors co-,itributcci to this situation. Anioil- tlici:i are rapid cliaiir-e, lii-li requirc-,P.,,en'u-s for specialization in application, lo-,,7 requirements for entrepreneurial capitE.1, lacl@ of sophistication aric)ng the buyers, and widespread uncoordinated ability of grant and contract support for -,pc-ctil.-tivc development. All of those factors are operatiii- in the development of ,Iutor,.i.,ition for riedic@ql purposes. liere the confusion is li(-,iflitcned bccciiLsL- both suppliers -and users of mechanization ,iiid instrLioetititiOTI traditionally have been small, independent and in their oi-@n ways fiercely competitive units. In medical automation, relatively isolated small or one-system achievements have fired the imaginations of,l)ol)ular writers, physicians, business men and the geiieril ptibli-c. Iie ii-iiigine the world to be populated with benevolent computers, showering blessings upon us. In cold fact, automation has saved us from becoming mired in routine management, business and statistical data. It has made conceivable many 79- specialized eia,@.,nostic @@I)plic;ition,,-, such -i,- ul'L:risc)i7iic incl certain lie,-it and radiation sensing procedures. Auton),Itioii lj,-is rii@ir-le possible ir@ir)rovcd deployment (or utilization) of Iii-lll)' specialized techniques, such as computation of radiotherapy dosagc, Bctx@--en these extreiii@-@. of miss production on the one hand and pinpointed specialization on tlic@ other, is a large area in which success has been highly elusive. It is technologically possible today to automate any operation %.,,c specify. Parenthetically, we must note that for soci il, economic or -other reasons, many operations we can specify slio,,tld not be auto,-,-.atcd.- In i-,icdical care, ipi,)Iication of automation capability has bcc,-,i retarded by difficulties in spccificatio-,i. The program for autor.,iatioii of the me(3ic,il laboratory oL- the I-',.itiotial Institute of General liedi.cal Sciences has found this to be true, In an exariinatioii of tl-ic prol)].eiii in I)rcy,,Irit:ion for a fortlico,.iiin- 3970 publication, they lil%,e found si>, l@c3, aspects of laboratory autorati-oi) that rc@riitiiii iLiidexr--,Ioped: 1. Coinputer control of output q,,iilit)@, 2. 'Positive pitiel-it identification for savipic-s, 3. Development of better rietliods for existing tests as well as neiq tests for chemical and biolo,,,,ic substances as yet unkiio@n or unmeasured, '4. Develop:iient of a reasonable approach to,tlie problem of mass screening, 5. Dcvelol).,iic,.nt of methods for reporting test results which will enable the physician to obtain a knoi-71cO,-e of the patient's condition at a glaiice. (l,speciaII3, true in clinical chemistry.) -lo- 6 Estibli.sl):Iie,,it of iiori,,,,al vnlttes for -ill cliciiiicil age, sex, gcogriplij.c location and rpcc. These problems represent inability to specify what is i-7antecl and lacl,, of agreement on spccifi.c@ition of lioiq results are to be presented. The systems in N.,Iiicli tlicsc problems occur pro@nt tcclinoloi,,ic@il problems also i-n both iutoniatioti and basic process. Solul@-i-ons for these problems are predictable, but there is little reason to attgcl@ tliein i,7]iile the larger difficulties of specification remain i-inr(--solvcd. The medical laboratory already has experienced sii-.Iilar frustrations at a ]eager level of productivity development. Typi-fied bv the continuous fl.oi,7 qi-i,3!yzers, this phase has been one, of mccii,-,tii- zation rather thin full autoi,,iition. Characterized by I,,IC',"@S as "not very, good, not very bad analytical instruments," these devices no@q act as an economic I)raice on @@Lito-@-nation, in @iclclj-tj.oti to f@iciiic, specification probl.c,@-,is of their C)@-711. AI)out.90% of hospital lalioratori.(--s have invested in this fami.ly of devi.ces. To these small businesses such investments ire large. As a rc-sul.t tlil-y tend to be locked into mediocrity unti.1 the investments are amortized, and indeed until operational- pressures force directors and staff to consider re-toolin,- themselves to copo @.7i.tli nex,7 tcclinolo-y. This in turn tends to rarroi-7 the discernible immedi,3te market for true automation,, and to discourage potential producers from investing i.n major devcl.ol)iii,-ntal. efforts. The same I-)robleris that liive eiii,.,@iied t:llc- Lilil-lilIL; v-Lsion of laboratory automation affect the auto".'--itiol-I of 11,P@ny other roo(lical service ol)crati-C),-IS. Under contract: i-7i.tli the Nitional Center for Ilealtili Scrvi.ces research -ii(I I)evclopi-@.-,eiit, a I.,Ias.IiiiiZ,,ton,l). C. firm,, Ilcrner and Coiipany, reported on October 1, 19'08 on their survey of computer use in 1,251 Hospitals tllat responded to a questio-La-,ia-i-re mailed to 2,431. institutions.. Among tl)c@ respondents use and i-ioti;u,-ze of cCinl),,itc@rs N-7c@rC' reported as fo I 1 O-,.7s User.c; Non-tisers Tot.-,I Fac-,ility size l@o. Pet. l@o. PC, L. No. over 200 beds 511 ti9.8 515 50.2 1,026 *Under 200 beds 32 14.2 193 85.8 2-25 *Only a 10 percent r@inejo@,i sample of smaller hospitals %.ias aei(.1ressed. In broad tc@ri,,is the computer usincyl instituti.on,,,,reportcd tliit medicil and research functions x@7ere perforated by less than 15% of their co-@,putc-r applications. Class of Full tic)lls AP-P C- Iq t: i 0 No. Pet. Administrative and financial 1,689 66.7 Operational procedures 467 18.4 *Ifedical. and research 378 14.9 *274 of these were in mc-cli.cil record maintenance .;tatistics and indexing. -12 - for Ie of ni c@ dical care and rese,@ cil fLilictio,,lc3 c,f- 'ire that tllc cliffict!!Ly ill useft.il in ciii:i:cnt iii---dicil practice is one of the major c)L)sticic-s to tic, de\,c,loi)i,-,ent of auLc):@,,-.@Lion i.n care @- -,id r cc o, r c li In plp-iii Words, auf-O@litio',l of medical care ill all stac,e of its research and dovelop,.-,.eii@@ I)liise. 'P@o nrr,,s of the Pul)lic C, Ilealtli Servicc, specific rosponsi.l)il,'-ty and oL-i,-oiTi- I)roFran-is for research and developnierit that iiclilecl,-, Iutoinatio@.I. Til-2se Or@r.-,ni@,ati@017,.s are ti-ic- liit:!.onal Center for Health S,--rvi-ces Pcsc-,arcii -in@ Dcvc-lop!-.ieiit, and tlic, Institute of--' General Sci-cl@ICOS. Recic)-,7,,il Pro-rer.,s should to these prograris research @iiie- devel.opi;-,C.?nt in -33. Iul-o-,-.!atio-..i. mecl i c, Fi-o,@ii Ill of tliesc, f@icts, it appear,-, tl-@@gt research @ii-ici invol\,in- autoip,-iLion occup@l.cs a vcr.), ncrroT.@ bar@,J in the .11'ecioi,,l ProE;r,-i;ii spnctru,.:i,. oct. 22 1970/)iD/ili DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE PUBLIC HEALTH SERVICE HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION Date: October 22, 1970 Reply to Aftn of. Projects That Provide Medical Services, Including Coronary Subject: and other Intensive Care TO: National Advisory Council to the Regional Medical Programs 1. Minutes of the last two meetings of the Council record interest in developing guides for use of RMP funds'in two kinds of medical service. a. Item IX, A, 1, page 7, Minutes, March 31 April 1, 1970 ... establishment and continued demonstration of intensive care units:.. b. Item X, A, 3, page 11, Minutes, July 28-29' 1970 ... projects ... for demonstration ... outraining ... (wliic@) ... become ... serv3-ce to patients. 2. Essentially, these are two aspects of the same question: To what extent, for how long, and for what purposes may RMP funds be used to initiate and provide medical services? 3. Examples of services to patients which have been proposed for RMP initiation or support include among others: a. Intensive care, including coronary care units; b. Stroke centers; c. 14ulti-phasic or other screening services; and d. Mobile emergency services. 4. Every mission or project activated by a Regional Medical Program should be a step, logical in direction, format and priority, toward improving the capability of the Region's medical resources to match the needs of its people on a self-sustaining basis. As the Council has noted, further specification of these principles could be helpful. in keeping service projects within their bounds. 5. The following document, Medical Care Services in a Regional Medical Program is presented in two sections. The first, Guide to Project Review, is intended for issuance to Regional Medical Programs as a part of our forthcoming guidance system. The second, headed Background sums up for Council members the staff reasoning which produced the Guide. 2 2. Objective assurance that the proposed medical services: a. If of predictable potential value, will be performed under conditions capable of producing the predicted value; or b. If of uncertain value, will be performed so as to measure the values achieved and identify the conditions that affect results. 3. Evidence that all other granting agencies concerned wit@ the proposed services have been consulted and will: a. Assist the service segment of the project in-coordination w ith RMP assistance; b. Assume responsibility for assisting' in development of any residual subsidization that may be needed after the scheduled termination of RNP support; or c. Will not participate in grant or contract support of the service functions of the project. Objective appraisal of the probability that successful serv' ices provided by the project will be integrated into the medical care system of the region, within the schedule planned for disengagement of @IP support, including: a. The extent to which such integration will be more attractive than continued RMP support in the.views of the proje'ct leadership and .the community; b. The project plan's provision for public education on the temporary role of RMP support and its dedication to stimulation, training or development; and 3 c. Where the patient care services are highly specialized and costly, the credibility of long-range plans for their efficient deployment and utilization as they are integrated into the medical service system of the community and region. 5. Evidence that the project will recover revenue appropriate to the services rendered and the economic status of the persons or groups served, and will utilize and account for that revenue in compliance with applicable grant law and regulation 6. Evidence that the proposed service, selection of clientele, and mode of operation are compatible with the objectives of the Comprehensive Health Planning agencies of the area, and with national objectives. BACKGROUND At the March-April, 1970 meeting, the Council expressed a need for guidelines to the funding of intensive care units and stroke centers. In July the Council expressed a need for guidelines to RMP support 'of patient care in demonstration and training projects. The draft of a guide presented above is intended to respond to both needs.. At present, RIQ's have funded over 100 ICU projects, a.large majority of which are coronary care units.- Many are requesting PIIP support beyond the periods originally scheduled for disengagement of @EP funds, and beyond the periods considered necessary to demonstrate their success or failure in improving regional deployment of medical resources. A CCU staffed with personnel well qualified to perform or learn its special functions, and to maintain the necessary discipline has a high possibility of developing capability to improve both morbidity and mortality secondary to infarction. An appropriately placed andlaccepted CCU can improve deployment and regionalization of services in its area. The location of small ICU's in outlying hospitals with strong teaching ties to a large central institution also has proven merit. Such services also are potentially self-supporting and once established should readily integrate themselves into the med'ical care systems of their communities and regions. units set up in hospitals that cannot provide trained personnel and disciplined performance will not provide successful patient care. units located so that they may compete for patients in a given area or operate at low levels of service are likely to dilute both the regional- ization and effectiveness of patient care in their areas. They.are also likely to prove incapable of integrating themselves on a self-supporting basis into the medical system. All of these characteristics are found in other costly, specialized services that require high levels of training and operational discipline as well as major start-up investments in equipment. in any clinical class of such projects, it is likely to be the failures that press for extension of grant assistance beyond the periods of their original plans. To a greater extent than is often realized, success or failure of such projects is predictable. The greatest potential for success is 5 achieved by identifying potential locations systematically from a thorough knowledge of the needs and resources of the area, before any applications are entertained, and then requesting competing applications from suitable facilities. The same technique is advisable in correcting a system of limping projects that resulted from one-by-one consideration of unsolicited requests for support. Fully detailed knowledge of need, resources and potential in the entire area, as well as in the applicant institutions, is the most reliable guide to recognition of viability. Recent short-term performance is important, but it is sensitive to many factors that need not signifi- cantly affect long-term expectations. Stroke centers are t pical of projects that provide patient services y of highly speculative clinical value. Sixteen such centers supported by the National Institute of Neurological Disease and Stroke and eighteen acute stroke units supported by RMPS are evaluating.specific modalities of stroke therapy. Until we know the potential values of these modalities and the conditions under which specific levels of success can be achieved, their contributions to regionalization will remain doubtful. Revised 10/29/70/HD/uhh