Mission, Function & Organizational Structure of Clinical Engineering Services

Stephen L. Grimes, FACCE Senior Consultant & Analyst Strategic Health Care Technology Associates www.SHCTA.com

Organizations (Hospitals) Mission

To improve the health of the communities we serve by delivering a broad range of high quality services with sensitivity to the needs of our patients and their families Hospitals Goal: To improve the health of the communities we serve What hospital does: delivers a broad range of high quality services How hospital does it: with sensitivity to the needs of our patients and their families

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Mission
Program Mission
Should be simple Should support & be consistent with organizations mission statement

Organizations Mission

Clinical Engineering Mission

Medical / Clinical Dept Mission

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Other Support Services Mission

Healthcare Technology Program Mission

To support the delivery of healthcare by insuring the availability of safe and effective medical technology in a cooperative effort with other members of the healthcare team Our Goal: To support delivery of healthcare What we do: Provide safe & effective medical technology How we do it: In a cooperative effort with other members of the healthcare team

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Mission Statement
The Office of Engineering Services will apply engineering, technical, and managerial expertise to provide safe, effective, and economical facilities and equipment as needed by University Hospital for patient care, teaching, research, and community service.
Slide 10 of Roles of Supervisors & Managers (Miller ~ Peru 2002)

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Requirements of a Technology Management Program

Program to control & monitor equipment performance
Routine performance testing Initial inspection Preventive maintenance Repair Action reports on device hazards & recalls

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ECRI

Requirements of a Technology Management Program

That accurately and consistently computes and monitors total equipment maintenance costs, including:
In-house costs Manufacturer costs 3rd party service costs

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ECRI

Requirements of a Technology Management Program

Involvement in all aspects of equipment acquisition and replacement decisions, development of new services and planning of new construction and major renovations:

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ECRI

Requirements of a Technology Management Program

Development of training program for all equipment users of patient care equipment and for biomedical technicians

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ECRI

Requirements of a Technology Management Program

A quality assurance program relating to technology use

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ECRI

Requirements of a Technology Management Program

Risk management as it relates to technology

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ECRI

Traditional Roles & Responsibilities

Technical services
Inspection & testing (functional, safety, performance) Calibration Preventive maintenance Repair Scheduled Maintenance Unscheduled Maintenance

Technology management services

Equipment management program (risk analyses, control elements) Evaluation of new technologies prior to acquisition, including life cycle cost analyses Service vendor management Compliance (government, accrediting standards) Education services (equipment users & biomedical equipment technicians) Device tracking (hazards & recalls) Incident reporting & investigation
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Policies & Procedures

Policies Statements of principles and values that guide organizational activities Effective policies are flexible, coordinated, comprehensive, ethical, and clear Procedures Defined courses of established methods used to achieve an objective
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Policies & Procedures

1. Equipment Classification System ~ Criteria for including equipment categories in program 2. Biomedical equipment inventory management ~ Process for adding, deleting 3. Inspection & PM ~ Determining protocols & frequencies 4. Obtaining Equipment Service/Repair 5. Incoming inspection of all medical devices & systems ~ Installation & acceptance testing of all purchased, leased, loaned devices 6. Storing & Retiring medical equipment 7. Medical Device Tracking ~ Dealing with hazards and recalls 8. Education/Training ~ Regarding proper use, testing & troubleshooting 9. Evaluating Healthcare Technology Management Program effectiveness 10. Incident reporting & investigation 11. Reporting to Safety Committee
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Equipment Inventory
C linical En g ine e rin g

0 11 1 7 8

In ven tor y Prin tout

I N VE N T O R Y
I D o r C o n t ro l # D e sc ri p t i o n M a n u f a ct u re r M o d el # S e ri a l # L o ca t i o n / C o st C en te r A c q u i si t i o n D a te / C o st M a i n t e n a n c e r e q ui r em e n t s ( fr eq u e n c y/ s c he d u le )

I D

IN C o n r l o r V E t o N # O R T
a r c u e i # a p l f # t i c o u t n r r e

M n S D d e i r s o a

M r ( A L c o f c i q a

q a n e i u t

i s u e t o

n t i e

o c C / n a

y n o c

/ e D t s

c h a r C

q e t

/ C u d t n

l e o r u i

e ) m t s r

n e

IN V E N T O R Y
I D o r C o n tro l # D e sc r ip tio n M a n u fa c t u r e r M odel # S e r ia l # L o c a tio n / C o s t C e n te r A c q u isitio n D a te/ C o st M a in te n a n c e re q u irem e n ts ( freq u en c y /s c h ed u le )

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Centralized Documentation System

Servic e Rep o rts
O p era tor s & Serv ice M a nua ls

C linical E n gine e rin g

0 11 1 7 8

In spec tio n Form s

Recalls & Hazard Reports

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Operators Manual

S ervice M an ua l

Incoming Inspection of Biomedical Equipment

Purcha sed, Lea sed D em o or Loa ner Eq uipm ent

C linica l Eng inee r

Bio m ed ic a l Eq uip m e n t Tec h n ic ia n (BM ET)

G EN TECH

0 11 1 7 8

C entra lized B io m ed ica l E q uipm e nt Do cum enta tio n

G EN TEC H
D ate: ______ By : _______

Eq u ip m e n t In ve n to ry & EM C la ssific a tio n

In spe c tio n Fo rm

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Equipment Management Program Risk-based Classifications

Equipm e nt Ca tegorie s

In clu de d in pro gram

GEN TEC H
Da te: ______ By : _______

GEN TEC H

E quipm e nt M anagem ent (E M) Category Cla ssific ation P olicy/Proce dure A pplication + Risk + M a in ten ance R equirem en ts + History =Total E M Rating/Score

H ig h EM R a ting/S core

Da te: ______ By : _______

G EN TEC H
G EN TEC H

Low EM Rating/S core

Exe mp t from p rogram

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Biomedical Inspection/PM Program

Insp e c tio n Sc h e d u le
M a rc h
Sunda y 00 00 M o nd a y 00 00 Tue sd ay 00 00 We d n esd a y Thursda y 00 00 00 00 Frid ay 00 00 Sa turd ay 00 00

Bio m e dic a l Equ ip m e n t Inv en to r y

S unda y 00 00

Insp e c tio n Pro c e du re s & Fo rm s

G EN TEC H
Date: ______ By : _______

00 Sund a y 00 00 M o nd ay 00 00 00 00 00 00 00

Feb ru a r y
00 00 00 Tue sd a y 00 00 00 00 00 W ed n e sda y Thursd a y 00 00 00 00 00 00 00 00 00 00 00

00 Frid a y 00 00

00 Sa turd a y 00 00 00

00

00

00 00

00

00

Ja n ua r y
Tue sda y 00 00 00 00 00 00 00

G EN TEC H
Date: ______ By : _______

M o nd a y 00 00 00

We dn esd a y Thursda y 00 00 00 00

Frid ay 00 00 00

Sa turda y 00 00 00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

00

G EN TEC H
Date: ______ By : _______

00

00

00

00

00

00

00

C e n tra lize d B iom e d ica l Eq uip m e nt D o c u m e n tatio n

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Biomedical Equipment Tagging System

Inve n to r y Ta g
Inspe c tion Ta g
Exem pt Ta g
C lin ic a l E n g in e e r in g

0 11 1 78

N O T IC E
O p e ra to r W arn in g Tag

C LIN ICA L E NG IN EE RIN G S E RVI CE S

D ate: ______ By : _______

D O NO T R EM O V E LA BE L

CL INI CA L E NG IN EE RI NG S ERV IC ES B ased on crite ria ad op ted by the sa fety com mitte e, this de vice is e xe mp t fro m the org an izatio ns E qu ip m ent Ma na gm en t P rogra m. S ervice records a re o n file in B io me dical En gine ering.

Sto ra ge Ta g

C lin ic al E n g in e e r in g
This e quipment has bee n p laced in storage. C on ta ct Biomed ica /Clinical E ngineering be fo re using

D EFEC TIVE D o N o t U se
C om m ents: __ ____ _____ ___ ____ ____ ____ ____ __ ___ ____ ____ ____ ____ __ ___ ____ ____ ____ ____ __
D ATE : _______ BY: _______

Red (Re m o ve fro m Ser vic e ) Tag

C lin ic a l En g ine erin g

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Biomedical Equipment Service/Repair

E q u ip m en t U ser
DEFEC TIVE Do No t Use

Se rvice Re que st

C linica l E ng in e e rin g

GEN TECH

Biom ed ica l Eq u ip m e nt Tech n icia n (BM E T)

C e ntra lized Bio m ed ica l E quip m e nt D o cum entation

- Or er fa c tu r M a n u S e rv ic e a ir R ep

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Biomedical Equipment Storage/Retirement

C lin ic al E n g in ee r in g
This equipment h as b een placed in storage. C on tact Bio me dica/Clinical E ngin eering b efo re u sing

- Te m p o ra rily rem ov ed fro m se rvic e

m ent E q u ipa g e to r S

rv Se C om m ents: __ ____ ____ _ m ___ __ ____ ____ ____o____ fr __ ____ ____ ____ ____ ___ ove e m __ ____ ____ ____ ____ ___ R e ispos &d D ATE : _ ___ ___ BY: _______

D EFEC TIVE D o N o t U se

ic e

- O b so le te o r - Re p air no t c o st-e ffe c tive

C lin ic a l En g ine erin g

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Acquisition of Biomedical Equipment

1. 2. Assess Need ~ Determine Specifications Compare available manufacturers & models. Assess ease of use, ease of maintenance, operating & life cycle costs Make selection & prepare purchase order with specifications including operator & service manuals, user & service training, warranty, etc. Acceptance/payment conditional on passing incoming technical inspection, inclusion of manuals, provision of user & service training, adequate warranty

3.

4.

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Equipment Hazard/Recall Program

M an u fa c tu re r Re ca lls & A lerts
F D A E nfo rc e m e n t Re p o rts

EC R I/He a lth D e vic e s A le rts

C e ntra lized B io m ed ica l E q uip m e nt D o cum enta tion

A c tio n Re po rts

C linic al En g in e e r

Bio m e d ic a l Eq u ipm e n t Inv e n to r y

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Equipment Program Education

Clinical Staff
Basic operation & proper use Basic Troubleshooting Potential hazards Equipment management (dealing with obtaining equipment service, equipment related incidents Professional (mission, ethics, conduct) Codes & standards Technical (troubleshooting & use of equipment) Clinical equipment operation & inspection procedures Policies, procedures & documentation
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Clinical engineering staff

Equipment Related Incident Investigation

1. 2. 3. 4. 5. 6. 7. Minimize further injury to patients & personnel Minimize any damage to equipment & facilities Impound all equipment, supplies, disposables, wrappers, etc. Identify witnesses Notify Risk manager, clinical engineering Complete incident report Notify authorities H A ZA R D O U S
E N V IR O N M E N T

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Equipment Management Program Benchmarking

Safety Committee How to measure program performance & effectiveness? Establish Goal & Compare with Actual For example:
User related equipment problems Scheduled vs Actual inspections Percent of inspections with problems found

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Typical Organization Chart Healthcare Technology Program

Dir of Engineering Dir. Of Information Technology Safety Committee

Healthcare Technology Management Program Manager

Clinical Engineers

Biomedical Equipment Technicians

Inspection Preventive Maintenance Calibration Repair

Administrative Staff

Technology Consultation Pre-purchase evaluation, life cycle cost analysis Education of users, technicians Compliance (government, accrediting authorities) Device Tracking (Hazards, Recalls) Incident Investigation Contract/vendor management

Bookkeeping
Accounts Payable & Receivable Payroll & Benefits Management

Correspondence Filing Data entry Reporting

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Organizational Reporting
Reports directly to
Director of Engineering (a traditional approach) Director of Information Technology (the trend) Other (e.g., Administrator of Support Services)

Also reports indirectly to

Safety Committee (interdisciplinary group responsible for hospital safety including technology management elements)

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Safety Committee
Purpose
To bring members of the healthcare team together in an nonadversarial environment to: identify issues affecting patient & staff safety and formulate an effective approach toward the resolution of those issues reviews and approves elements of technology management program that impact on safety of patients & staff

Membership must be interdisciplinary to be effective

Typically includes representatives of
administration nursing/clinical staffs personnel engineering risk management medical staff education purchasing security clinical engineering

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Staff Qualifications
Biomedical Equipment Technicians (BMET)
Associate Degree in Technology (AA) or higher, Military or Manufacturer Training Certified Biomedical Equipment Technician (CBET) Specialties: General Biomedical, Laboratory, Medical Imaging Rankings: Level I, II, III higher level reflects more experience, education and/or specialization

Clinical Engineers (CE)

Batchelor or Masters of Science Degree in Engineering Certified Clinical Engineer (CCE)

Manager
Clinical Engineer Masters in Business Administration or business education
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Organization Chart for Small Clinical Engineering Program

Typical 300-500 bed hospital 1500 device inventory

BMET Supervisor

Clerk

BMET Level I

BMET Level I

BMET Level II

Capable of providing basic service on majority of general biomedical devices 3rd parties provide most sophisticated technical services 3rd party provides clinical engineering consultation & related services
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Organization Chart for Medium Clinical Engineering Program

Director, Clinical Engineering Typical 500-700 bed hospital 2000 device inventory Clinical Engineer Supervisor, CE Supervisor, BMET Administrative Assistant

BMET Level III

BMET Level II

BMET Level II

BMET Level II

Capable of providing basic to mid-level services on all but most sophisticated medical devices (e.g., lab, imaging) in inventory Capable of providing basic clinical engineering services 3rd party provides most sophisticated technical services (e.g., lab, imaging) 3rd party provides high-level clinical engineer services
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Organization Chart for Large Clinical Engineering Program

Typical 1000-1500 bed hospital 4000 device inventory Supervisor, CE Supervisor, BMET Director, Clinical Engineering Supervisor, Lab BMET Supervisor, Imaging BMET Administrative Assistant

Senior CE

BMET Level III

BMET Level II

BMET Level II

BMET Level III

BMET Level III

Clerk

Clinical Engineer

BMET Level II

BMET Level 1

BMET Level 1

Capable of providing basic to high-level services on almost all medical devices on inventory (including imaging, lab) Capable of providing basic to high-level clinical engineering services 3rd party provides sophisticated technical services on few devices 3rd party provides audit of clinical engineer services
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Clinical Engineering Center

2,200 Sq Ft

Meeting/ Training Supervisor & Sr Tech Library Copy, Fax, Print Technicians Test Equip Parts Manager

Outgoing

Incoming
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Admin Asst

Equipment & Other Resources

Test & Repair equipment
Oscilloscope Digital multimeter Electronic thermometer Electronic pressure/vacuum gauge Spirometer Flowmeters ECG analyzer Defibrillator analyzer Electrosurgical unit analyzer Gas analyzer Electrical safety analyzer Pacemaker analyzer Hand tools

Library
reference books equipment manuals, reference guides, subscriptions to journals, services Workbenches Desks Chairs Stools Tables File cabinets Shelving units Storage cabinets

Office furnishings

Office equipment
Computers, printers Photocopiers, Facsimile

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Logistic Models for Service Delivery

Service Delivery Models
Centralized (dispatch or depot)
less duplication, easier management

Distributed
Better response time (therefore less downtime) Generally less efficient use of resources (more costly)

Issues affecting decision on which model is best for situation

Nature (method) & quality of communications Geography of service area (i.e., travel distances) Nature (method) & quality of transportation available Response time necessary
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Mixed Approach toward Service Delivery

Use resident or in-house services for basics Use centralized or ISO services for more technically specialized needs

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Centralized Model for Service Delivery

Central Technology Management Office and Service Center

Client Hospitals
HH HH HH HH

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Central Dispatch Model for Service Delivery

In this scenario Cost = 3 hours labor Downtime = 3 hours
M an u fa R e p a c tu r e r ir S e rv ic e

1 hour travel H
Technical Service Center

1 hour labor 1 hour travel

r er fa c tu M a n u S e rv ic e p a ir Re

Necessary if equipment is not portable speed to restore is critical

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Central Depot Model for Service Delivery

In this scenario: Cost = 1 hour labor plus shipping Equipment Downtime = 2-3 days

1 day ship out H H 1 hour labor 1 day return ship

Technical Service Center

OK if there is redundant capacity & equipment is portable

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Distributed (Resident) Model for Service Delivery

Central Office for Technology Management

Hospital-based Resident Programs

HH HH HH HH

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Centralized
Technician Schedule Location Hospital #1 Hospital #2 Hospital #3 Hospital #4 Hospital #5 Hospital #6 Hospital #7 Depot Total 1530 Beds 500 350 200 170 150 100 50 1 2 9 2 9 2 9 Mon 2 1 1 1 1 1 Tues 2 2 1 1 Wed 3 1 1 1 1

Thu 2 2 1 1

Fri 3 2 1 1

1 2 9 2 9

Important that clients can rely on a firm schedule there will be fewer emergencies
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Advantages/Disadvantages of Sourcing Options

In-house (e.g., hospital owned & based)
Less expensive in organizations with larger workload Hospital can exercise more control over process

Independent Service Organization (ISO)

Less expensive in organizations with smaller workloads Usually a more efficient use of resources Shared resources with other clients (program development, management, specialized technical expertise & equipment) Access to resources (specialized expertise, equipment) that couldnt be afforded on own
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Questions?
Thank You!
Stephen L. Grimes, FACCE slgrimes@shcta.com www.shcta.com

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