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FILE

BEGINS

Dec # //6

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ARYLAND 20772 (3501) 249-5110

 
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AUPOMATION RESEARCH AND DEVELOPMENT
AND OTHER MAJOR EQUIPMENT INVESTMENTS
!
IN A REGIONAL MEDICAL PROGRAM

?
GUIDE TO PROJLCT REVIEW

An effective Regional Medical Program bases its grant, contract and
core staff activities upon continuing objective appraisal of the match
between medical services available to the people of its Region, and their
needs for care, Unsolicited action proposals, like those originating
within the Regional Medical Program organization, are subjected to
rigorous tests of the system analysis and planning processes through

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which they reach the stages of initial, continuation, or renewal review.

Internal or voluntary proposals that involve RMP investment in
equipment, research, or development for automation are subject to all the -
tests of necessity and timeliness that apply to other activities. Auto-
mation frequently involves high initial costs, rapid obsolescence, and
a high probability of failure. Automation xeeearch and devclopment are
important concerns of other granting programs,

| Regional Medical Programs frequently are importuned to make major

investments in equipment purchase, rental, or time-sharing that is oriented ©
toward clinical service, or continuing education, rather than research,

and may not involve automation. Many such projects share the risks of loss
that are attendant upon automation research and development. A partial

’ .
list of such projects include

+ + « Medical record and information systems

-.« » Medical reference and consultation networks

 

 
 

 

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+ « « Television or other continuing education systems
- « « Multi-phasic sereening projects ,
. . . Mobil emergency care :

- + . Heart sounds or ECG transmission systems “

» « . Dosimetry networks

- + « Special purpose hospital units: radiation therapy, CCU, etc,

In addition to the usual tests of necessity, timeliness, potential
gain and feasibility reviews of any of these projects requires certain
special tests.

1, RMP investment in projects-that have research components shall be

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confined to:
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a. Studies of the regionalization of clinical procedures, equipment
or systems whose 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 RHP objectives.
2, RMP investment in automated equipment for any project shall be;
a, ‘Confined to the minimal rental, time-sharing or purchase amount
required to pilot the project; and
b. Withheld until it is demonstrated that:
1) the proposed application of automation is feasible within

ithe limitations of available time, funds and talent; and

2) all contributions to any proposed system of automation

 

 
 

3)

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and all users of its product have agreed to any compromise
in terminology and technology the system requires; and

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the initial specifications for the proposed automation have

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been completed.

3.. RMP investment in special laboratory, transportation, or communications

equipment shall be confined to:

a.

minimal rental, time-sharing or purchase required to pilot a
technique or element that is indispensable to the project; and
non-experimental equipment of proven capability in the proposed
use; and

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, RMP investment in piloting projects that require major equipment

investment will be confined to projects whose plans for disengagement of

RMP support:

a.

Include commitment for procurement and appropriate amortization

as well as cperation of all necessary equipment in their plans

for full-scale non-RMP operation; and
\ . ,
Base their plans for post-RMP operation on realistic projection
of need, without reliance upon promotion of non-functional
‘
utilization; and
Provide that in the event of discontinuance, any equipment

purchased with RMP funds will be liquidated with appropriate

return to RMP or the government.

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“BACKGROUND
BROADENING TIE QUESTION
The Council request addressed itself to projects that include
significant elements of automation and research and development.
This response is somewhat broader, because RMP investment is other
kinds of equipment also appears to be precarious business.

- The RMPS does not have detailed information on requests for an
investment in major cquipment. We have information about project titles
and magnitudes that indicates the kinds of equipment that are most
important. No field survey was made to improve our information at this
point, for two reasons. First, we are developing a long range information
system which has a higher claim on staff time at present than a one-time
survey of selected project proposals. Secondly, it appears practicable to

enunciate a workable guide for equipment acquisition without a detailed

survey.
Several types of major equipment systems have figured Importantly
in RMP project proposals. They have not been confined to projects with
major research and development components. Education, clinical
reference, and clinical service demonstrations have involved na jor

communication, mobile unit, and other equipment systems.

THE NATURE OF THE RISKS | .
%
From past Council discussions, site visits, common scnse and day to

day observations, RMPS has concluded that a high risk of loss may be .

present in any project proposal that involves major investment in hardware.

 
 

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— ~  - A gamut of risks, rather than a single hazard, must be evaluated or
put to rest, whenever a major cquipment investment is part of a proposal.
Moreover, most of the risks attachej to such projects are not inherent in
the performance of the hardware itself. Some examples:
-.. A proposal to evaluate screcning plans to use equipment
of unknown performance characteristics to record tests whose
norms for the subject population group are uncertain.
This gives the project three evaluations to accomplish -~
the equipment, the test, and the screening of the population,
of which only the latter may be a basic RMP mission.
eee A continuing education proposal plans to employ 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 overcoine
in four major fields ~ television, reproduction, audience i
i
. motivation, and effectiveness in changing behavior, of which
only the last named is RMP business.
++. A telephoned heart sound or ECG project is proposed for a

thinly populated area, to use equipment and diagnosticians

whose performance characteristics are known to be satisfactory.

.- Sharp cost-benefit analysis is needed here, to determine
how the unit cost for cases in which the system would make

@ significant difference to the patients would compare :

with the cost of bringing those patients and high performance

 

 
 

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diagnosticians together. Thorough advance negotiation is

also needed to obtain assurance of acceptance by first-line
practitioners and their patients.

A complex medical record system proposes to provide computerized
data banking, retrieval and information transmission, using.
equipment whose perforinance characteristics and reliability

are well established.

Such a proposal presents a complex problem in cost-benefit
comparison of alternatives. It also presents problems of
acceptance, not only for the function, but for details like
compromises on specifications for data inclusions, terminolosy,
and presentation of the information products. All of these

studies and negotiations should be completed and shows

positive results before money is tied up in cquipment.

RMP INVESTMENT

A summary has been made of projects involving major equipment

investments whose total project direct cost awards to date total $200,000

or more. The costs of equipment acquisition, rental and time-sharing in

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these projects is net known. However, the summary provides some notion
of the amount of RMP investment whose success depends upon the capabilities

and performance of hardware, and on the quality of the judgments, planning

and negotiation that were employed in its application,

 
 

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The large projects in the table below have accounted for more than

$24 million.in total direct cost awards for the 4-year period. Undoubtedly

there has been a significant investment in smaller projects that hinged

upon similar considerations during this period.

iAJOR ACTIVITIES INVOLVING AUTOMATED TECHNOLOGIES

AND OTHER LARGE EQUIPMENT INVESTMENTS

Classes and Numbers of Projects
Projects involving automated
equipment investments of $50,090
or more. 22 projects, aggregating
$14,609,000
Projects involving automated
equipment of unknown costs.

12 projects, agererating $3,856,500
Mobile unit projects.

6 projects agerepating: $954,000
Comminieation networks for
continuing education.

6 projects aperepating $4,876,000

Total Direct Cost Obligations by

1967

2,44)

243

Fiscal Years

(in $ thousands)

1968

3,45]

493

88

1,074

1969 -

4,883

1,350

386

1,744

1970

3,834

2,013

480

1,815

 
 

AUTONATION - THE STATE OF HE ART.

 

Viewed from @ respectful distance the computer field presents a
busy, but apparently orderly landscape. This because most basic
computer production is in the hands of giants, who manage to maintain
their own equilibrium, The field of automation, or application of
computer thinking and technology, is very different. When seen at
close range, it is characterized by disorganization, volatility and
speculative turbulence.

Many factors have contributed to this situation. Among them are
rapid technological change, high requirements for specialization in
application, low requirements for entreprencurial capital, lack of
sophistication among the buyers, and widespread uncoordinated avail-
ability of grant and contract support for speculative development.

All of these factors are operating in the development of automation
for medical purposes, Here the confusion is hei phtened because both
suppliers and users of mechanization and instrumentation treditionally
have been small, independent and in their own ways fiercely competitive |
units. '

In medical automation, relatively isolated small or one-system
achievements have fired the imaginations of popular writers, physictans,
business men and the general public. We imagine 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

 
 

 

specialized diagnostic applications, such as ultrasonic and certain heat
and radiation sensing procedures, Automation has made possible improved |
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deployment (or utilization) of highly specialized technigues, such as
computation of radiotherapy dosage. Between these extremes of mass
production on the one hand and pin-pointed specialization on the other,
is a large area in which success has been highly clusive.
It is technologically possible today to automate any operation we
specify. Parenthetically, we must note thet for social, economic or
“other reasons, many operations we can specify should not be automated,
In medical cere, application of automation capability has been retarded
by difficulties in specification, The program for automation of the
medical laboratory of the National Institute of General Nedical Sciences
has found this to be true, In an examination of the problem in preparation
for a forthcoming 1970 publication, they have found six key aspects of
laboratory automation that remain undeveloped:
1. Computer control of output quality,
2. “Positive patient identification for samples,
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3. Development of better nethods for existing tests as well as
new tests for chemical and biologic substances as yet unknown
or unineasured,
4. Development of a reasonable approach to: the problem of mass
. .
screening,

5. Development of methods for reporting test results which will

enable the physician to obtain a knowledge of the patient's

condition at a glance. (Especially true in clinical chemistry.)

 

 
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6. Establishaent of normal values for all chemical paraneters by
age, sex, geographic location and race.

These problems represent inability to specify what is wanted and
lack of agreement on specification of how results are to be presented,
The systems in which these problems occur present technological problems
also in both automation and basic process. Solutions for these_problems
are predictable, but there is little reason to attack them while the
larger difficulties of specification remain unresolved.

The medical laboratory already has experienced somewhat similar
frustrations at a lower level of productivity development. Typified
by the continuous Flow analyzers, this phase has been one of mechani-
zation rather than full automation.

Characterized by NICHS as “not very good, not very bad analytical
instruments," these devices now ACE és an economic brake on automation,
in addition to facing specification problems of their own,

About.90% of hospital laboratories have invested in this family of
devices. To these small businesses such investments are large. As a

result they tend to be locked into mediocrity until the investments

are amortized, and indeed until operational pressures force directors
and staff to consider re-tooling themselves to cope with new technology.
This in turn tends to narrow the discernible immediate market for true

automation, and to discourage potential producers from investing in

major developmental efforts.

 

 
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The same problems that have dimmed the shining vision of laboratory

automation affect the automation of many other medical service operations.

Under contract with the National Center for Health Services Research and

Development, a Washington, D. C. firm, Herner and Company, reported on
October 1, 1968 on their survey of computer use in 1,251 hospitals that
responded to a questionnaire mailed to 2,431 institutions.

Among the respondents, use and nonzuse of computers were reported as

follows:

 

Users Non-users Total
Faculity size No. Pet. No. Pet, No.
Over 200 beds 511 49.8 ° 515 50.2 1,026 .
*“Under 200 beds 32 14.2 193 85.8 225

*Only a 10 percent random sample of smaller hospitals was eddressed.

in broad terms the computer using institutions reported that medical
‘and research functions were performed by less than 15% of their computer
applications.

Class of Functions ; _ ... Application

No. Pot.
Administrative and financial 1,689 66.7
Operational procedures . 467 18.4

*Medical and research . 378 14.9

*274 of these were in medical record maintenance, statistics and

indexing.

 

 
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Many reasons may be adduced for this minimizing of autonstion in
medical care and research functions of the reporting Lustitutions. it
is certain that the difficulty in specifying computer services that are
useful in current medical practice is one of the mejor obstacles to the
development of automation in medical care and research,

In plain vords, automation of medical care rewains in an early
stape of its research and dove lopment phase, Two arms of the Public
Health Service have specific responsibility and ongoing programs for
research and development that includes automation. These organizations
are the National Center for Health Services Research and Development,
and the National Institute of General Medical Sciences, Regional Medical
Programs should leave to these programs research and developizent in
medical automation,

From all of these facts, it appears that research and development
involving automation occupies a very narrow band in the Regional Medical

Program spectruia,

Oct. 22, 1970/HD/jh

 
Date:

Reply to

Atin of:
Subject:

To:

 

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE
HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION

October 22, 1970

Projects That Provide Medical Services, Including Coronary
and Other Intensive Care

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 ... (which) ... become ... service
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;

¢. Multi-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.

 

 
MEDICAL CARE SERVICES
IN A
REGIONAL MEDICAL PROGRAM

GUIDE TO PROJECT REVIEW

An effective Regional Medical Program bases its solicitation, selection
and scheduling of grant, contract and core staff activities upon the needs
of its service population revealed by continuing objective appraisal of the
medical services available in its region. Unsolicited requests for RMP grants
or contracts, like those invited or originated by the Regional Medical Program
organization, are subjected to the rigorous tests of the system analysis and
the planning process before they are subjected to formal initial, continuation,
or renewal review.

{

Both voluntary and RMP initiated proposals that provide services to
persons or groups are subject to all the tests of necessity and timeliness
that apply to RMP support of other activities. Service projects frequent ly
exhibit escalation of expenditures, stimulate public assumption of vested
interest in subsidization and create distorted public impressions of disease-
categorical needs. Direct medical care services also are important concerns
of other grant-in-aid programs. Therefore, certain tests of approvability
and timeliness are especially important to projects in which RMP support
makes possible direct medical care services. :

1. Objective comp:rison of RMP support of a med*cal service with other

‘conceivable alternative modes of progressing toward the stated

demonstration training or research objective, in terms of cost, time,

effectiveness and other measures;

 

 
 

2. Objective assurance that the proposed medical services:

a.

b.

Lf of predictable potential value, will be performed under
conditions capable of producing the predicted value; or
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 with the proposed

services have been consulted and will:

a.

Assist the service segment of the project in. coordination with

RMP assistance; ‘

Assume responsibility for assisting in deve lopment of any residual
subsidization that may be needed after the scheduled termination of
RMP support; or t |

Will not participate in grant or contract support of the service

functions of the project.

‘ . ‘

“4, Objective appraisal of the probability that successful services provided

by the project will be integrated into the medical care system of the

region, within the schedule planned for disengagement of RMP support,

including:

a.

‘the community;

The extent to which such integration will be more attractive than
continued RMP support in the views of the project leadership and
The project plan's provision for public education on the temporary
role of RMP support and its dedication to stimulation, training

or development; and

 
 

as

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

x

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, RMP's have funded over 100 ICU projects, a large ma jority
of which are coronary care units. Many are requesting RMP support beyond
the periods originally scheduled for disengagement of RMP funds, and beyond
the periods considered necessary to demonstrate their success or failure in

improving regional deployment of medical resources.

~ +,

)

 
 

e

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 and accepted
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 medical 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.

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To a greater extent than is often realized, success or failure of

such projects is predictable. The greatest potential for success is

 

 
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 Limp ing
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 typical of projects that provide patient services
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/nmh