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INTERVENTIONAL EQUIPMENT:
CRADLE TO GRAVE
INTRODUCTION
A. Comprehensive Quality Improvement
Keith J. Strauss, MSc
Director, Radiology Physics & Engineering
Children’
’s Hospital
Children
Children’s
Harvard Medical School
COMPREHENSIVE QUALITY IMPROVEMENT
A. Cradle to Grave
1.
2.
3.
4.
5.
6.
7.
Identify Clinical Requirements
Justification of Project
Equipment Acquisition Planning
Facility Planning
Acceptance Testing
Staff Training
Routine Testing, Maintenance, and Repair
1. Meet Clinical Objectives
2. Achieve Good Image Quality
3. Reduce Radiation Dose to Patients and
Personnel
4. Manage Costs
IDENTIFY CLINICAL REQUIREMENTS
A. Clinical Stakeholders (end users)
1.
2.
3.
4.
5.
6.
7.
8.
Interventionalists
Technologists
Nurses
Anesthesiologists
Diagnostic Imaging Physicist
Hospital Informational Services
Radiology Administrator
(Oncologist, Therapy Physicist,
Radiation Safety)
IDENTIFY CLINICAL REQUIREMENTS
B. Obstacles
1. “Silo”
Silo” Mentalities: Hospital Politics
2. Points of Confusion:
a. End Users:
Imaging Equipment
Capabilities
b. Vendors:
Vendors:
Unique Clinical
Demands
IDENTIFY CLINICAL REQUIREMENTS
C. Clinical/Technical Project Leader
2. Serve as Interpreter
a.
b.
c.
d.
Clinical Stakeholders
Vendors
Administration
Architects & Construction Managers
3. Promote Exchange of Information
a. Ask Questions
b. Seek Answers
4. Make Recommendations
IDENTIFY CLINICAL REQUIREMENTS
C. Clinical/Technical Project Leader
1. Develop Global UnderUnderstanding of Project
a. Equipment Specifications
Vendor
b. Clinical Requirements
Stakeholders
c. Non technical issues
Administrator
IDENTIFY CLINICAL REQUIREMENTS
C. Serve as Interpreter
IDENTIFY CLINICAL OBJECTIVES
JUSTIFICATION OF THE PROJECT
A. Comprehensive Business Plan
D. End Product
1. Project Scope Tailored to Clinical
Needs
2. Wishes Ignored
a. Vendor’
Vendor’s
b. End User’
User’s
3. Avoid
A. Unfulfilled Clinical Needs
B. Excessive Costs
1. Projected Costs
a. Capital
– Imaging Equipment
– Associated Equipment
– Construction
– Other Infrastructure
– PACS Modifications
– Equipment for Support Spaces
– Test Equipment
JUSTIFICATION OF THE PROJECT
JUSTIFICATION OF THE PROJECT
A. Comprehensive Business Plan
1. Projected Costs
b. Operational Costs
– Salaries
– Supplies
– Equipment Service Costs
A. Comprehensive Business Plan
2. Projected Revenues
a. New Patients
b. Reimbursement Policies
c. Reduced Service Costs
JUSTIFICATION OF THE PROJECT
B. “Non Revenue”
Revenue” Considerations
1.
2.
3.
Mission & Goals
Retention of Quality Staff
Loss/Leader: Patient
Referral Patterns
4. Community Needs
5. Lease vs Direct
Purchase
JUSTIFICATION OF THE PROJECT
C. Benefits of
Justification Step
1. Defined Project
Scope
2. Comprehensive
Budget
3. Project Properly
Funded
EQUIPMENT ACQUSITION
EQUIPMENT ACQUSITION
B. Request for Purchase (RFP)
1. Generic Equipment Requirements
A. Process
1. End User Writes and Distributes a
Request for Purchase (RFP) Document
2. Vendors offer their “bestbest-fit”
fit” product
3. Stakeholders Objectively Choose “bestbestfit”
fit” vendor
4. Purchase Order and Contract Finalized
a. Customer Defines Scope of Equipment
i. Clinical requirements
ii. Component preferences
b. Goals
i. Communicate clinical requirements
ii. Foster competitive bidding
iii. Structured Vendor response allows
objective evaluation
EQUIPMENT ACQUSITION
A. Request for Purchase (RFP)
2. Explicit General Purchase Conditions
a. Customer Defines Contractual
Responsibilities of
i. Vendor
ii. Customer
b. Major Disputes Identified Early in Evaluation
c. Vendor’
Vendor’s Purchase Conditions Modified
EQUIPMENT ACQUSITION
A. Request for Purchase (RFP)
3. Acceptance Testing
a. Customer Defines
i. Testing Methods
ii. Expected Performance Levels
b. Performance Levels Achieved Prior to
First Clinical Use
FACILITY PLANNING
FACILITY PLANNING
Architects
A. Project Management (Planning)
1. Create Controlled Environment
2. Interpreter: Clinical User, Vendor, and Architect
a. Clinical Requirements
b. Requirements of Chosen Equipment
c. Facility & Building Constraints
Rad/Cardiologist
Anesthesiologist
Project Managers
Hospital Planning
Imaging Physicist
Technologist
Engineers
Structural
Electrical
HVAC
Image Vendors
3. Construction Drawings Become Contractual
a. Change Order Economics
b. Get it right the first time!
Nurse
IS/Communication
s
FACILITY PLANNING
B. Site Planning Guides (Equipment Requirements)
1. Initial
a. Generic
b. Use “Worst Case”
Case” Vendor
2. Final
a. Architectural Drawings Submitted to Chosen
Vendor
b. Vendor Issues Site Specific Installation
Drawings
FACILITY PLANNING
D. Space Program
1. Listing of Each Room with
Required Square Footage
2. Determines Total Space Allotted
to Project!
3. Reconcile
a. Space Program Needs that
b. Exceed Available Space
FACILITY PLANNING
C. Interdepartmental
Interdepartmental Adjacencies
1. Clinical Requirements
a. Other Clinical Services
b. Patient Access
2. Facility Constraints
a. Loading Dock
b. Elevators
c. Floor/Ceiling Deck
Loading
d. Floor/Ceiling Deck
Clearances
E
L
E
V
A
T
O
R
FACILITY PLANNING
D. Space Program
4. Primary Clinical Spaces
a. Procedure Rooms
b. Control Rooms
c. Sedation/Recovery Space
d. Nurse’
Nurse’s Station
e. Patient Toilets
f. Changing Rooms
SURGERY
IMAGING
ADMITING
EMERGENCY
FACILITY PLANNING
D. Space Program
5. Secondary Clinical Spaces
a. Brachytherapy Radioactive Sources
b. Lockers
c. Waiting Room
d. Reception Desk
e. Patient Exam/Consultation Rooms
FACILITY PLANNING
E. Floor Plans & Other Drawings
1. Intradepartmental
Intradepartmental Adjacencies
a. Biggest Blocks
Placed First
b. Gaps Filled with
Small Blocks
c. Surround
Procedure Rooms
With Soft Spaces
FACILITY PLANNING
D. Space Program
6. Other Work Spaces
a. Supply Storage
b. Soiled & Clean Utility
Storage
c. Central Computer Room
d. Reading Room
e. Staff Workspaces
i. Offices
ii. Cubicles
ADJACENCIES
Three Interventional
Procedure &
Control Rooms
Left: Rooms Land
Locked
ADJACENCIES
Three Interventional
Procedure &
Control Rooms
Left: Rooms Land
Locked
Right: Room C can
Grow in Length
if Required
FACILITY PLANNING
E. Floor Plans & Other Drawings
3. Floor Plans
a. “Bird’
Bird’s eye view”
view”
b. Locates each object
mounted on floor
i. Table
ii. Stand
iii. Casework
iv. Scrub Sink
v. Equip Closet
FACILITY PLANNING
E. Floor Plans & Other Drawings
2. Attributes of Each Room
a. Electrical Power & Communications
b. HVAC & Mechanical Issues
c. Lighting
d. Medical Gases & Plumbing
e. Storage
f. Surface Treatments & Doors
g. Radiation Shielding
h. Furniture & Auxiliary Equipment
FACILITY PLANNING
E. Floor Plans & Other Drawings
4. Reflected Ceiling Plan
a. View of Ceiling
b. Locates objects
Ceiling Mounted
i. Lights
ii. Vents
iii. Sprinkler
Heads
iv. Unistrut
FACILITY PLANNING
E. Floor Plans & Other Drawings
5. Elevation Drawing (Wall a)
a. View of Each Wall from Center of Room
b. Locates any Wall Mounted Object
FACILITY PLANNING
E. Floor Plans & Other Drawings
5. Elevation Drawing
a. View of Each Wall (Wall b)
FACILITY PLANNING
E. Floor Plans & Other Drawings
5. Elevation Drawing
a. View of (Wall c)
FACILITY PLANNING
E. Floor Plans & Other Drawings
6. Electrical Drawing
a. Floor Plan: “Bird’
Bird’s Eye View
b. Locates
i. Power Outlets
ii. Light Switches
iii. Communication
Jacks
iv. Call Lights
v. Intercom
FACILITY PLANNING
FACILITY PLANNING
F. Functional Systems
2. Electrical Pathways
F. Functional Systems
1. Electrical Power
a. Dedicated
b. 440 vs 480 Volt Imaging Source
of Power?
c. UPS?
FACILITY PLANNING
F. Functional Systems
3. Heating, Ventilation, Air Conditioning
(HVAC) Can be Costly
a.
b.
c.
d.
e.
f.
Large Heat Gain from Equipment
Temperature
Humidity
Sterility: High Rate of air Exchanges
Source of Chilled Water
Equipment Closets
a. Avoid Clinical Disruption on Other Floors
b. Universal Design
c. Floor Units
i. Sweep Bends
ii. Extend Inch
Above Floor
Deck
FACILITY PLANNING
F. Functional Systems
4. Procedure Room Lighting
a. Fluorescent Lights for Cleaning
b. Dimmable (on Rheostat), Zoned
Ceiling Lights
c. Steerable, “Operating Room”
Room” Light
d. UnderUnder-Cabinet Lights
e. Lighting Interfaced to Fluoroscopy
FACILITY PLANNING & CONSTRUCTION
F. Functional Systems
5. Hallway Lighting
a. Cove Lighting: Wall Mounted
b. Down Fluorescent Lights
i. Unacceptable
ii. Strobe Effect of Alternating Intensities
iii. Rage after Sedation or Anesthesia
FACILITY PLANNING & CONSTRUCTION
F. Functional Systems
6. Mechanical Supports
b. Ceiling Supports Heavy Loads on Rails
i. Imaging Monitors
ii. Frontal or Lateral Imaging Gantry
iii. Patient Table
iv. Auxiliary Equipment
• Injector Heads
• Radiation Shields
• Lights
• Monitors for Physiological Data
FACILITY PLANNING
F. Functional Systems
6. Mechanical Supports
a. Universal Ceiling Scheme
i. Unistrut (yellow)
ii. Perpendicular to Long
Axis of Table
iii. 4’
4’ 2” On Center
iv. Large Grid
FACILITY PLANNING
F. Functional Systems
6. Mechanical Supports
c. Safe Attachments
i. Bolt Through
above Preferred
ii. Anchor Below
Left Preferred
iii. Avoid Anchor
Orientation
Below Right
d. Maintenance
FACILITY PLANNING
F. Functional Systems
8. Equipment Closets
a. Independent HVAC
b. Surface Mounted
Electrical Pathways
c. Lifetime Reduced
Installation Cost
ACCEPTANCE TESTING
A. Foundation of Equipment Performance Testing
1. Elimination of
Installation Errors
2. Elimination of Substandard
Components
3. Compliance with Regulations
a. Federal
b State
4. Contracted Performance?
5. Baseline Data of Equipment Performance
FACILITY CONSTRUCTION
A. Project Management (Construction)
1. Monitor Construction Progress
2. Interpreter: Clinical User and Contractor
a. Clinical Requirements
b. Requirements of Chosen Equipment
c. Facility & Building Constraints
3. Minimize Construction Delays Due to
Changes
ACCEPTANCE TESTING
B. Request for Purchase (RFP)
1. Customer Proposes
a. Testing Methods
b. Expected Performance
Levels
2. Vendor May
a. Take Exception
b. Propose Alternate
3. Compromise Performance Levels
Achieved Prior to First Clinical Use
ACCEPTANCE TESTING
ACCEPTANCE TESTING
C. Test Equipment
2. Digital Readout Only Non Invasive
kVp Meter is Unacceptable
C. Test Equipment
1. Limitations
25 msec Rise Time
a. Must be Understood by Physicist
b. May Affect Measured
Performance Levels
ACCEPTANCE TESTING
D. Why Necessary Today?
ACCEPTANCE TESTING
D. Why Necessary Today?
2000
1970
1987
1. Hardware failures infrequent
2. Human calibration errors eliminated by
automated algorithms
TRAINING OF STAFF
ACCEPTANCE TESTING
D. Why Necessary Today?
E. Exercise system with test exposures.
a. Complete functional testing
b. Identify software errors
3. Check configuration of machine
a. Factory APR Settings for Adults
b. Develop APR Settings for Children
c. Functional Testing of Image Routing
(PACS)
A. Comprehensive Training Fosters
1. Full Utilization of Equipment Design
2. Optimum
Image
Quality
3. Reduce
Radiation
Dose
TRAINING OF STAFF
B. Types of Training
1. Core Knowledge Provided at Regular InInServices
a.
b.
c.
d.
Basic Imaging Principles
Quality Control Responsibilities
Radiation Protection Principles
Equipment Care & Maintenance
2. Credentialing Programs of Fluoroscopists
TRAINING OF STAFF
B. Types of Training
2. “Buttonology”
Buttonology”: Unique Operational
Features
Establish Lead Operators
a.
b.
c.
d.
Other clinical sites
Vendor’
Vendor’s headquarters
Phantom Imaging on Site
First patients
EQUIPMENT MAINTENANCE
AND REPAIR
A. Equipment is Only as Good as its Support
B. Planned, Periodic Maintenance Program
1. Eliminate problems prior to clinical Impact
2. Scheduled installation of Replacement Parts
C. Prompt Repair of Failed Equipment
D. Include Mechanical and Electrical Safety
Issues
EQUIPMENT MAINTENANCE
AND REPAIR
F. Types of Coverage
1. OEM Provided: COST
a.
b.
c.
Fix Costs @ 8 - 10% of Purchase Price
Periodic Maintenance?
Maintenance?
Best Trained Staff
EQUIPMENT MAINTENANCE
AND REPAIR
E. Type of Coverage Selected Affects
1. End user control
2. Degree of SelfSelf-Insurance
3. Savings Realized
EQUIPMENT MAINTENANCE
AND REPAIR
F. Types of Coverage
2. Third Party: Not Recommended
a.
b.
c.
d.
Savings?
Periodic Maintenance?
Training of Staff?
Availability of Parts?
EQUIPMENT MAINTENANCE
AND REPAIR
F. Types of Coverage
3. Departmental or Institutional Coverage by
1 Vendor: Not Recommended
a. OEM Coverage on own Equipment
b. Third Party Coverage on Other Equipment
c. Cut Throat Pricing:
i. Scheduled Maintenance?
ii. Quality of Repair Parts?
d. “Conflict of Interest”
Interest”
EQUIPMENT MAINTENANCE
AND REPAIR
EQUIPMENT MAINTENANCE
AND REPAIR
F. Types of Coverage
4. Third Party Insurance Coverage: Not
Recommended
a. Same Issues as #2 & #3 above
b. Disputes on Remedial Action
i. OEM vs Third Party Parts
ii. “Institutional”
Institutional” Leverage
iii. Must be settled prior to repair
CONCLUSIONS
F. Types of Coverage
5. InIn-House Service Organization
a. Start Up Costs
i. Qualified Personnel
ii. Ongoing Training of Staff
iii. Spare Parts Inventories
iv. Tools & Test Equipment
v. Space
b. Managed as a Business
c. Can Reduce Costs 25 - 30%
A. Comprehensive Quality Improvement
Requires Active Equipment Management
from Concept to Decommissioning
1. Acceptance Testing Still Required
CONCLUSIONS
B. Imaging Physicist Must Understand
1. Design Limitations of Purchased
Equipment
2. Design Limitations of Test Equipment
3. Reasonable Performance Expectations
CONCLUSIONS
B. Project Leader (Imaging Physicist)
1. Clinical Needs of End Users
2. “Environmental”
Environmental” Needs of Selected
Equipment
3. Building and Construction Limitations
4. Consensus Building