Biopem2Lecture4_Equipment Procurement and Vendor Management_revised.ppt

7/27/2019 Biopem2Lecture4_Equipment Procurement and Vendor Management_revised.ppt

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Lecture 4: Equipment

Procurement and Vendor

Management

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Outline

Equipment Acquisition Process Definition of Clinical Requirements

Environmental Survey

Survey of Available Equipments

Specifications and Interface control

Solicitation of Proposals Equipment Evaluation

Vendor Selection

Contracts

Purchase Requisitions and Purchase Orders Equipment Acceptance

Control of the Acquisition Process

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Equipment Acquisition ProcessPhysician initiation

Definition of the medical requirements

Assessment of environmental conditions

Survey of available equipment

Buy off-the-shelf?

Preparation of system specification

Solicitation of proposals

Proposal and equipment evaluation

Vendor selection

Issue contract or purchase

order

Equipment acceptance

Iterate

Safety standard

consideration

Literature search

Yes

No

InformationGathering

Process

Decision

Process

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Info Gathering Process: Equipment

Acquisition Process

The first three steps is information gatheringto assure that clinical engineeringdepartment has:

Acquired the proper clinical requirements from themedical and nursing staff

Assessed the safety, user interfaces,environmental impact and conditions under whichthe equipment must operate

Conducted an appropriate survey of the state ofthe technology and the commercially availableequipment

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Info Gathering Process: Equipment

Acquisition Process

Decisionmaking phase begin after the

completion of data gathering and the needs

of medical staffs have been converted to

detailed and quantitative engineeringrequirements

If the decision is to purchase equipment,

purchase order is issued Device is listed in equipment inventory and

maintained in accordance

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Info Gathering Process: Definition of

Medical Requirements

Team

Medical, nursing and clinical engineering representation

Medical staff pertains to the physicians and surgeons. They

are somewhat less interested in the operation of the machine

system. They are strongly interested in the machine orsystem output.

Nursing intimately involved with the knobs and dials used to

obtain the result the doctor requires

Clinical engineer technical representative of the team and

technical liaison to the officer, which assures that the system

is safe to use. They are the ones who will train the user to

use the system and system effectiveness is also assured.

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Each member of the team must

Define the general clinical goals Write statements of the clinical objectives related to the problem

at hand that will serve as a basis for choosing evaluating and

accepting the equipment Clear and precise, comprehensible to all parties (Make it Specific

Measurable Accurate Realistic Time-framed)

Be careful not to make it a wish list

Specify the physiological variables

measured or controlled Physiological to be measured by the equipment must be defined

to achieve the goals

Variables should be directly measurable

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Characterize the likely range of these

variables To determine the type of transducer to be employed, its

dynamic range, and type of signal conditioning that willbe required

If its research in nature, more flexible, adaptable and

expensive equipment to assure experimental success

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Determine the restrictions of a medical

nature Serious attention must be paid to the restrictions

imposed is the patient at risk from infection such that invasive

measures cannot be employed?

are there certain output data which are not

acceptable? how rapidly should a change in a monitored variable

be made known to the medical staff?

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Info Gathering Process:


Gathering the information concerning the

environment in which the equipment will operate

1. Space

2. Power3. Weight

4. Temperature range

5. Vibration and shock

6. Electric and magnetic field7. Explosive and flammable environment

8. Humidity and moisture

9. Applicable standards

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Space

Generally considered a restriction applying only to

large systems

Is a concern essential in institutions wherenegotiations for additional space may take

months and involve highest level of the

organization

For large equipment, dimensions of the accessroute to the proposed location for the equipment

and its transporters should be determined.

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Environmental Survey Power

A survey of the local or power system should be

made

Includes voltage, number of phases, availablecurrent per phase and the presence and type of

emergency power

The availability of compressed air, a form of power

sometimes required in patient-care Existing access to central oxygen, anesthesia,

suction, water and waste disposal services should

be noted as well

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Environmental Survey Weight

Assess the strength and stability of individual instrumentsor small systems on existing wall or floor-mounted supportstructures

For large systems, maximum safe floor loading of the areato be employed, and of the access route for equipmentbeing transported to that area, should be checked.

Temperature range Temperature must be controlled for staff and patients

If operation is not 24 hours, environmental controls may be

disabled at night and on weekends. If large systems or instruments that purposely generate

heat as part of their operating cycle are visualized, theexisting air-conditioning capacity in the space theequipment will occupy should also be determined

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Environmental Survey Vibration and shock

Characteristics of any unusual mechanical

environment to which the equipment will be

subjected should be determined

Electric and magnetic fields

Be particularly careful to note the presence or

proximity of diathermy and electrocautery

devices, radio paging antennas and large electricmotors

Special shielding or relocation of equipment may

be required to cure severe interference problems

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Environmental Survey Explosive and flammable environments

Use of special equipment designed and powered to eliminate thedanger of explosion is advised.

If the equipment will be used in an oxygen-enriched environment, itshould be noted to address safety issues

Humidity and moisture

If an apparatus or component must operate in especially high orlow relative humidity, this should be noted. Most equipment areoperated in humidity controlled environment where a humiditymeter is used.

Occasionally some equipment may need to operate in anenvironment containing water droplets or standing water, such arequirement should be noted. This leads to the use of a sprinklersystem which can have a deleterious effect on some expensiveelectronic equipment. The presence of workable floor drain shouldbe available to prevent flooding in the use of sprinkler system.

The sprinkler can be replaced by non-aqueous substance.

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Applicable standards

Codes, standards and regulations should be

reviewed.

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Info Gathering Process: Survey of

Available Equipment

Literature search

Vendor contacts

Get a running cost estimate

Iteration

Decision

Combination

State of the art development

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Info Gathering Process: Survey of

Available Equipment Literature Search

Begin among the advertisements carried byvarious publications relating to the intersection ofthe medical or biological fields and engineering or

current industrial periodicals Look into newsletters and information services

Main objective: determine who is carrying outdevelopment work in the particular area of

medical interest, and what instrumentation areused in this effort

Medical libraries and public library systems

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Survey of Available Equipment Vendor Contacts

List potential vendors of the equipment you wish to acquire Get the contact of the local sales representatives of each

manufacturers

Request specific equipment specification sheets

Running Cost Estimate It is a cost estimate which is accumulated and modified as

one gathers technical information about the equipment tobe acquired.

Useful to establish some idea of the cost of thecomponents, or system of the components to be acquired

Dont forget to include the installation cost which is animportant component of the total cost

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Survey of Available Equipment

Iteration Findings should be available in brief but understandable

form to the users: manufacturing data, various

governmental standards

Formal presentation to the users with the important points

Objective: develop discussion and interaction among

committee members

Moment of truth: examining tradeoff between user needs

and cost

Process of maximizing the system cost effectiveness becarried out at the user level, and that out of the process

comes a rationale to support acquisition of the system

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Decision Four major directions for acquisition

Direct purchase

If user needs can be met by commercially availableinstruments or systems

Evaluation of the equipment of competing vendors, andselection of a vendor from those qualified should precedethe actual generation of the purchase order

Contract purchase

In large systems, user needs are usually met only byassembling a number of commercially availablecomponents, properly interfacing these components, anddesigning in the appropriate system control features

Customized

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Combination

An alternative to procurement, the clinical engineeringneed to carry out the component interfacing itself.

Commercial system components are purchased directly

Acquisition of equipments from single vendor and theclinical engineering department will carry out the interfacing

Can result to finger-pointing if problems occur

State-of-the-art development

Required if the commercially available components orsystems cannot meet the users needs

Clinical engineers would develop the machine andinterface which can be funded by government or privatesector

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Specification of Interface Control Specification Format

1. Scope2. Applicable Documents

Precedence

Specification Changes

3. Requirements

Design ObjectivesGeneral System Requirements

Specific System Requirements

4. System Testing and AcceptanceVendor Test Requirements

System Acceptance Testing

Acceptance Criteria5. General

Documentation Requirements

Training

Warranty

Maintenance

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Specification of Interface Control

Scope Brief description of the areas that the specification will

cover

Applicable documents Documents that could assist vendors who respond to the

solicitation of proposals

Address the problem precedence of documents referenced

in the specification Defines the route to be followed for the incorporation of

changes in the specification following the initial issuance

Drawing of the equipment with specification changes

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Specification of Interface Control

Requirements The core of the technical portion of the specification

First part: system motivation, description of the systemdesign objectives,

Second part: general requirements that the system to be

proposed

System Testing and Acceptance

Notifies vendors how the system is proposed to be tested

Describes the criteria to be used to determine acceptability

General Cover details that do not fit other sections

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Sample requirements: cancer monitoring

system

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Sample requirements: cancer monitoring

system

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Equipment Evaluation Quantitative comparison of each vendors proposal

and/or equipment with regards to the followingfactors:

System Performance

Physical Construction Reliability

Maintainability

Safety

Human Factors

Cost

Accuracy

Interchangeability

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System Performance

Quantitative electrical and environmental

parameters from each supplier or vendor or

equipment will be compared = comparison

matrix

Judge the vendor based on the data in thematrix comparing it with the user needs as

well

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Physical Construction

Each vendor should be responsive to any

restrictions your specification placed on the

equipment

Module, subassembly, system size andweight should be evaluated

Comparison matrix can be constructed

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Reliability

Equates to the Mean Time Between Failure or MTBF of theequipment

You can measure it by doing test and gathering data to performstatistical test

Qualitative feel of the equipments reliability through examinationof the component quality, evidence of sound manufacturingprocesses and evidence of mechanical resistance to shock,impact and vibration

Check the judicious sealing of circuitry against dust, dirt andmoisture

Can do consultation with other clinical engineers of hospitalregarding the performance of the equipment

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Decision Process: Solicitation of

Proposals

Request for proposal should list the

enclosures and contain a very brief

discussion of the reason for the request

The final section of the request for proposal

should indicate the approach that will be

used to evaluate the proposal and includesdisclaimer

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Maintainability Refer to the Mean Time To Repair of

equipment

It requires attention to the availability of

quality maintenance documentation, spacing

and ease of removal of components whenthey fail, rapid availability of any vendor-

specific components, availability of a local

vendor supported maintenance facility and

availability of specialized training for the

technicians from the vendor

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Safety

Each vendor adheres to some accepted

specification of safety

Safety in AC power system ground and

patient lead leakage system

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Human Factors

Usability issues in the interface of the

equipment

HCI and User Interface Design

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What is HCI?

Human Computer Interaction

Computer Human Interaction (used in the US)

Replaced Man Machine Interaction (MMI)

Human Machine Interaction (HMI)- might be a better choice

The study of the relationships which existbetween human users and the computersystems they use in the performance of

their various tasks

Faulkner, C., 1998182


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Definition of HCI

Human-computer interaction is a disciplineconcerned with the design, evaluation and

implementation of interactive computer systems

for human use and with the study of majorphenomena surrounding them.

Association of Computing Machinery (ACM)

Special Interest Group in Computer-Human Interaction (SIGCHI),

1992.

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What is HCI?

Understand how user interact with computers todesign easier and more satisfying systems.

User

TasksContext To design system that is:

Transparent

Easy to use

Easily understood

Meet task requirement

Faulkner, C., 1998 184


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Interaction Design

Designing INTERACTIVE PRODUCTS to

SUPPORT people in their everyday and

working lives.

Make GOOD DESIGN and not POORDESIGN.

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A multi-disciplinary design perspective

Psychology

Sociology

Art

Design

Engineering

Computer

Science

Linguistics

Philosophy

Physiology

Anthropology

Ergonomics

A.I

Understanding

The user

Modeling

The userHelp

facilities

EquipmentDesign

Groupware

Aesthetic Appeal

User Interface

Layout

Faster Machines, system

Means of building better UI

Language

For Commands

Physical Capabilities

Creatingconsistency

Users body shape

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Goals of HCI To develop or improve the:

SAFETY

Safe to use; does not cause injury or harm

UTILITY functionality - things that the system can do

EFFECTIVENESS can do what it purports to do accurately and completely

EFFICIENCY can do what it purports to do easily, without too much resourcesor overheads

USABILITY EASY TO USE and EASY TO LEARN, and gives satisfaction

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G l f HCI


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Goals of HCI

The aim of HCI is, therefore, to produce systems

that are both natural and transparent to use.

Above all, the aim of HCI should be to develop

systems that do not involve the user in significant

amount oflearning time or in significant amount oflearning effort.

The systems should be effective, fun and safe to

use.

Faulkner, 1998

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Important Concepts

1. Affordances2. Visibility

3. Feedback

4. Constraints restricting the kind of userinteraction that can take place at a given

moment

5. Mapping layout

6. Consistency

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Visual Affordance

Perceived and actual fundamental propertiesof an object that determine how it could beused

Chair is for sitting Ball is for throwing

Button is for pushing

Refer to an attribute of an object that allows

people to know how to use it

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Usability

Usability is the KEY CONCEPT in HCI

Human Computer Interaction (HCI) is the studyand the practice of usability. It is aboutunderstanding and creating software and othertechnology that people will want to use, will beable to use, and will find effective when used.

John Carroll, 2002

HCI in the new millennium

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Satisfying - rewarding

Fun - support creativity

Enjoyable - emotionally fulfilling

Entertaining and more Helpful

Motivating

Aesthetically pleasing

Motivating

User experience goals

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Measures of Usability

Time to learn: How long does it take for typical members of the user

community to learn how to use the commands relevant toa set of tasks?

Speed of performance: How long does it take to carry out the benchmark tasks?

Rate of errors by users?

How many and what kinds of errors do people make incarrying out the benchmark tasks?

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Retention over time?

How well do users maintain their knowledge after an hour,

a day, a week? Retention linked to time to learn and

frequency of use

Subjective satisfaction

How much did users like the different aspects of the

system?

Measures of Usability

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Difference between UI and HCI

User Interface:

Medium through which user communicate with computer.

Human Computer Interaction:

Discipline concerned with the design, evaluation,

implementation of interaction computing systems for human use,and with the study of major phenomena surrounding them

ACM SIGCHI 1992

Concern with ALL aspects that relate to the interaction between

user and computer

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Example of Bad Design

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Accuracy

Measure of the devices ability to provide

measured values within an acceptable range

of some known standard

Accuracy should be evaluated and toleranceestablished

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Equipment Evaluation

Clinical Evaluation

Involves hands-on use of the submitted

equipment by the medical staff. With respect with

the following factors:

Quality of in-service training

Clinical Performance

Human factors evaluation

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Vendor Selection

a memorandum of justification of the reasons

for vendor recommendation should be

prepared, which consists of:

Engineering evaluation and ranking Clinical evaluation and ranking

Cost evaluation

Additional information

Recommended vendor

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Contracts Prepare contracts for the chosen vendor,

which consists of: Cover/signature sheet

Schedule of work

A brief description of the following A list of applicable documents

Statement of work

Terms of delivery and acceptance

Work schedule

Cost and terms of payments

Warranty and service

Set of general provisions

Covers the legal rights of both parties

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Purchase Requisitions and Purchase

Orders

If equipment survey results a decision to buy off-

the-shelf

Purchase requisitions A multi-copy form containing the information to be

prepared by the purchasing department for a purchase

order

Purchase Order

Contains information transferred directly from the purchase

requisitions

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Purchase

Requisition

Form

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Purchase

Contract

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Equipment Acceptance

Subsystem and system tests should be madeto assure that all system components and theoverall system complies with the specification

Three sources of information, useful forpreparing the required test procedure The specification

Vendor data sheets on off-the-shelf components Vendor-supplied test procedures, a deliverable

contract item

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Equipment Acceptance

Test at the subsystem level first, and the

system level, in order to assure that the

overall system to be tested is made up of

properly performing subassemblies

Information contained in test procedures and

data sheets will form the basis for equipmentacceptance as well as equipment control

program

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Test Procedure

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T t P d D t Sh t


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Test Procedure: Data Sheet

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C t l f th A i iti


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Control of the Acquisition

Process Coordination Responsibility and Payment

Clinical engineers must be able to effectivelycommunicate with clinical users, the purchasingdepartment, contract office, accounting

department, and the vendor

Clinical engineers must assure the hospital,through equipment quality assurance program

that the equipment received meet its technicalspecification and that vendor payment is thereforein order

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Control of the Acquisition

Process Establish policy agreements between clinical

engineering and both the purchasing and

accounting department to provide the control

required for an effective equipmentacquisition system

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Mini-Case

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List the steps involved in the equipment

acquisition process and break down into two

phase

Phase 1: Information gathering process

Phase 2: Decision making process

Analyze the phase 1 and phase 2 by

identifying the problems and weakness andmake recommendations as well.

Mini-Case: select a hospital and

do the following:

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For Phase 2: How do they get vendor

contacts and ask them to bid in procuring

medical equipment?

For Phase 2: Get a sample purchasecontract and describe the major items in the

contract. Analyze and compare the concepts

learned in vendor contract


do the following:

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In the equipment acquisition process, what

considerations are most important to the

physician? To the nurse? To the clinical

engineer? To the administrator? In the equipment acquisition process, what

HCI concerns do the users have? Identify

these concerns. If the concerns are not metby the equipment, what do the hospital

management do?


do the following:

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Mini Case select a hospital and


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Get the steps carried out in an environmental

survey regarding medical equipment procurement.

How do the hospital get the running cost estimate,

during equipment acquisition? Identify the hospital process as well in system

testing and acceptance testing. Get a sample of

test data sheet analyze the information: are all

information relevant and needed? What changescan be done to be more efficient?


do the following:

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Reference


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Reference

Bronzino, J.D. (Ed.). (1992). Management of

medical technology: a primer for clinical

engineers. Boston: Butterworth-Heinemann

Webster, J.G. & Cook, A.M. (Ed.). (1979).

Clinical engineering: principles and practices.

Englewood Cliffs, N.J..: Prentice-Hall, Inc.

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