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The Expectation Triad
Regulatory Compliance:
“Ensuring that all of the required
standards are being met”
Healthcare Engineering Consultants
Monitoring Regulatory Requirements
Regulatory Compliance Dashboard
Description
General Reqs
SC Meetings
Dashboard Rpt
Leadership Rpt
Evaluations
Policy Review
Safety Mgmt
Hospital Surv
Clinic Surv
Security Mgmt
Alarm Tests
Abduction Drills
Hazmat Mgmt
Manifests
Haz Vapor Mon
Permits, Lic
Verify MSDS
Emer Mgmt
Hospital Drills
Clinic Drills
HVA
Fire Prev
Hosp Fire Drills
Clinic Drills
SOC Document
ILSM Measures
Extinguishers
Fire Det Dev
JAN
FEB
X
X
X
MAR
APR
X
X
MAY
JUN
X
X
JUL
AUG
X
X
X
X
SEP
OCT
X
X
NOV
DEC
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
A/R
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
A/R
X
A/R
X
X
A/R
X
A/R
X
A/R
X
X
A/R
X
A/R
X
A/R
X
X
A/R
X
A/R
X
A/R
X
X
Healthcare Engineering Consultants
Comments
Monitoring Regulatory Requirements
Regulatory Compliance Dashboard (continued)
Description
Fire Prev
Water Devices
Fire Pumps
Ver/Hor Doors
F/S Dampers
Med Equipmt
PM LS Eqmt
PM NLS Eqmt
Util Systems
PM LS Sys
PM NLS Sys
Em Gen Tests
Batt Light Test
Water Tests
HVAC Tests
MGAVS Tests
App Environ
PCRA
Miscellaneous
Eyewash units
Showers
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
W
X
W
W
W
X
W
W
W
X
W
W
W
X
NOV
DEC
X
W
W
Comments
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
A/R
A/R
A/R
A/R
A/R
A/R
A/R
A/R
A/R
A/R
A/R
A/R
W
X
W
X
W
X
W
X
W
X
W
X
W
X
W
X
W
X
W
X
W
X
W
X
Key to dashboard symbols:
X – Indicates that action is required during the month indicated; W – Indicates that weekly action is required
A/R – Indicates that action is required when applicable
Key to colored boxes: Red boxes indicate non-compliance (tests were not performed); Yellow boxes indicate partial compliance
(tests have been delayed or not fully completed); Green boxes indicate full compliance (tests satisfactorily completed).
Healthcare Engineering Consultants
Safety Management
Regulatory Standards Include:
 EC.1.10 - Written plan, risk assessment,
policies
 EC.1.20 - Environmental surveillance
 EC.1.30 - Smoking policy
Healthcare Engineering Consultants
Safety Management
EC.1.10 - Management of Safety Risks
 Written management plan
 Safety leadership appointment
 Safety officer intervention authority
 Proactive risk assessments
 Review of safety policies
 Safety recall process
 Grounds and equipment
Healthcare Engineering Consultants
Safety Management
EC.1.10 - Safety Officer Appointment
Appointment letter signed by CEO, CMO
Intervention authority
Position description
“Consultant” to safety committee
Oversees safety management program
Healthcare Engineering Consultants
Safety Management
EC.1.10 - Safety Policies and Procedures
 Staff accessibility (manuals or computer)
 Staff knowledge related to policies
 Reviewed at least every three years
 Do what you say you’re going to do!
Healthcare Engineering Consultants
Safety Management
EC.1.10 - Safety Recall Process
 Product safety recalls
 Durables, disposables, pharmaceuticals,
and nutritionals
 Aggregation of data
 Responsibility?
Healthcare Engineering Consultants
Safety Management
EC.1.10 - Grounds and Equipment
 Policy recommended
 Should describe exterior maintenance of
lawns, landscaping, parking lots, snow
removal, lighting replacement, care of play
areas, jogging trails, etc.
 Other exterior safety-related issues
Healthcare Engineering Consultants
Safety Management
EC.1.20 - Safe Environment
 Hazard surveillance rounds
Patient areas - 2X per year
Non-patient areas - annual
All occupancies, including satellites
 Resolution of identified problems
 Recurring deficiencies
 Prioritization of deficiencies
Healthcare Engineering Consultants
Safety Management
EC.1.30 - Smoking Policy
 Policy must be developed and enforced
 Requirements for indoor patient smoking
 Not permitted in ambulatory settings
 Scoring clarifications (EC News, 9/2001)
 Smoking exceptions
Healthcare Engineering Consultants
Safety Management
EC.1.30 - Smoking Monitoring
 Monitoring to verify compliance with
smoking policy is required
 Strategies to eliminate violations
required
Healthcare Engineering Consultants
Smoking Monitoring
Summary of Smoking Violations
Location of Smoking Violation
Time of Observed Violation
Description of Violator
Area directly outside of Emergency
Center; “B-C” corridor area
Loading dock attached to “B” building
All shifts
Staff, patients, visitors
First and second shift
Staff, vendors
Loading dock attached to “D” building
First and second shift
Staff, vendors
Second level stairway exterior from “B”
building
Main entrance to “A” building (within 50
feet)
Second and third shift
Staff
First shift
Visitors and patients
Summary of Compliance Strategies






New anti-tobacco policy, effective 18 October, 2004
Smoking shelters are on order and will be installed in January, 2005 near the “A” building entrance
Current signage will be replaced with universal “No Smoking” signs in January, 2005
New protocols for staff discipline have been implemented with the new policy
Additional training for all staff regarding smoking policies has been provided
Smoking cessation classes for hospital staff have been implemented; all smokers are encouraged to participate
Healthcare Engineering Consultants
Security Management
Regulatory Standards Include
 Management plan
 Responsibility appointment
 Proactive risk assessment
 Identification policy
 Sensitive area determination, access
 Emergency procedures
 Other security issues
Healthcare Engineering Consultants
Security Management
EC.2.10 - Responsibility Appointment
 Provided by leadership
 Identifies security responsibility
 Security leadership responsible for:
Coordination
Development and implementation
Monitoring
 Contract staff?
Healthcare Engineering Consultants
Security Management
EC.2.10 - Identification Policy
 Applies to patients, staff and visitors
 Must follow hospital policy
 Visitors can be “default” group
 Problem individuals/ groups can include:
Independent practitioners
Clinical consultants
Outside vendors, contractors
Overnight visitors
Healthcare Engineering Consultants
Security Management
EC.2.10 - Security Sensitive Areas
 Risk assessment by security staff
 Expected to include:
ED, OB/ Gyn, Pharmacy
Other areas?
 Terrorist vulnerabilities
 Access control
 Training for staff in sensitive areas
Healthcare Engineering Consultants
Security Management
EC.2.10 - Security Incident Reporting
 Documentation of security incidents
 Monitoring of security trends
 Clear identification of benchmarks
 Use of spreadsheet format
 Reporting to safety committee
Healthcare Engineering Consultants
Security Management
HR.2.10, 20, 30 - Security Staff Training
 Orientation and ongoing training
 Means of force
 Staff in security sensitive areas
 Contract staff
 Staff/ guards with forensic patients
 Staff who assume security duties
Healthcare Engineering Consultants
Security Management
EC.2.10 - Emergency Procedures
 Civil disturbances, including terrorism
 VIP’s (visitors and patients)
 Media relations
 Vehicular ER access, parking policies
 Access control to facility
 Infant or pediatric abduction
Healthcare Engineering Consultants
Security Management
EC.2.10 - Security Implementation
 Follow your policies!
 Special cases:
Use of firearms or other means of force
Mental health areas
Medication security
Access to unauthorized areas
Infant/ child abduction prevention and drills
Cell phones with cameras/ privacy issues
Healthcare Engineering Consultants
Hazardous Materials and Wastes
Regulatory Standards Include:
 Management plan
 Accurate inventory and cradle-to-grave control
 Adequate space, handling and separation
 Hazardous vapor monitoring
 Emergency spill procedures
 Permits and licenses
 Oversight of manifests
 Compliant labeling
Healthcare Engineering Consultants
Hazardous Materials and Wastes
EC.3.10: Cradle-to-Grave Processes
 Accurate inventory and MSD sheets
 Cradle-to-grave processes and control for:
Chemicals
Chemotherapeutics
Radioactive materials
Medical waste and sharps
 Per applicable laws (OSHA, EPA, NRC, DOT)
Healthcare Engineering Consultants
Hazardous Materials and Wastes
EC.3.10: Management of “Hazmat” Risks
 Adequate and compliant storage space
 Appropriate signage
 Effective separation of materials
 Approved handling methods
 Appropriate PPE equipment and training
 Compliant labeling of materials
Healthcare Engineering Consultants
Hazardous Materials and Wastes
EC.3.10: Hazardous Gases and Vapors
Clinical lab: formaldehyde and xylene
Central supply: ethylene oxide
OR’s: nitrous oxide, methyl-methacrylate
Respiratory: glutaraldehyde
Sleep lab: collodion
Monitor and document per OSHA requirements!
Healthcare Engineering Consultants
Hazardous Materials and Wastes
EC.3.10: Emergency Spill Procedures
Spill procedure training for staff
Spill clean-up equipment and PPE
Reporting procedure for spills
Spill data collection and analysis
Healthcare Engineering Consultants
Hazardous Materials and Wastes
EC.3.10: Permits, Licenses and Forms
 Specific state requirements
 Have permits available for surveyor
 DOT requirements on hazmat transport
 Receipt and match of manifest forms
 Waste stream analysis (local and EPA)
 Special cases: incineration, EtO discharge,
running emergency generator
Healthcare Engineering Consultants
Hazardous Materials and Wastes
HR.2.20: Hazardous Materials Training
 Orientation and education
All staff who manage or contact hazardous
waste
OSHA requirements
Other regulatory agency requirements
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
Regulatory Standards Include
 Management plan and disaster manual
 Hazard vulnerability analysis
 M-P-R-R procedures
 Incident command system (ICS)
 Facility evacuation (H, V, T)
 Utility failure procedures
 Decontamination, WMD
 Emergency drills
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Hazard Vulnerability Analysis
 Perform a “global” risk assessment
 Document HVA for all facilities annually
 Assign probability, impact and preparedness
 Calculate overall HVA score
 Prioritize based on score
 Select hazard “cut-off” score
 Develop procedures for hazards above cutoff
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Disaster Manual
 Include procedures for hazards above cut-off
 Consider use of “color codes”
 Consider use of “flip cards” or spreadsheets
 Coordinate code colors with tabs for manual
 Coordinate order of disasters on “flip card”
and
manual
 Focus on response and recovery procedures
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Phases of Emergency Management
Mitigation: Describes what has been done to prevent
or lessen the impact of a disaster
Preparedness: Describes what has been done to
prepare staff to properly respond to a disaster
Response: Describes staff actions that should be
taken during a disaster
Recovery: Describes staff actions that should be
taken to return to normal after the initial phase of the
disaster have passed
Note: Required for each “priority” emergency
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Incident Command System (ICS)
Initiation Procedure: How is ICS initiated during a
disaster?
Organizational Chart: Indicates who has
responsibilities for the ICS in a chart format using
hospital terminology
Job Action Sheets: Provides step-by-step
procedures for every position on the organizational
chart
Command Center: Define location and provide
supplies (vests, clip boards, two-way radios, etc.)
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Additional Emergency
Procedures
 Emergency notification to external authorities
 Activation of internal call list
 Identification and assignment of staff
 Emergency privileges to clinical staff
 Care-related activities (scheduling, etc.)
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Additional Emergency
Procedures (continued)
 Staff and family support (housing, transport)
 Supply logistics and media interaction
 Security-related: crowd, media, traffic control
 News media communication
 Care-related activities (scheduling, etc.)
 Back-up emergency communications
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Facility Evacuation
 Horizontal staff and patient movement
 Vertical staff and patient movement
 Total facility evacuation
 Total evacuation logistics include:
Alternate site, patient transportation
Staffing, medications and equipment
Medical records
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Sharing Among Organizations
Command structures
Control center locations
Incident command staff names, phone #
Sharing resources, assets
Patient and victim identification
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.10 - Patient Decontamination
 Procedures
Radiation contamination
Chemical and biological contamination
Weapons of mass destruction (WMD)
 Appropriate Facilities and Equipment
 Staff Training
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
EC.4.20 - Emergency Drills
 Two drills per year, separated by 4 to 8 months
 One drill per year in “business occupancies”
 At least one influx drill per year (if considered a
“disaster receiving station”)
 At least one community-wide drill per year
(tabletop permitted beyond two required drills)
 Drill evaluation and documentation required
Healthcare Engineering Consultants
Emergency Management
EMERGENCY
HR.2.20 - Emergency Management Training
 Orientation and education to include:
All affected personnel, including physicians
Specific roles and responsibilities
Recognition of specific patient complaints
Emergency skills and use of equipment
Incident command system
Healthcare Engineering Consultants
Fire Prevention
Regulatory Requirements Include:
EC.5.10 - Management plan and policies
EC.5.20 - Life Safety Code compliance
EC.5.30 - Fire drills
EC.5.40 - Fire system tests
EC.5.50 - Interim life safety measures
Healthcare Engineering Consultants
Fire Prevention
EC.5.10 - Management Plan and Policies
 Written fire prevention management plan
 Policies for fire system tests
 Fire response plan
(hospital-wide and department-specific)
 Acquisitions policy
 Decorations policy
 Policy for candles, portable heating devices
Healthcare Engineering Consultants
Fire Prevention
EC.5.20 - Life Safety Code Compliance
 Facility in compliance with 2000 LSC
 Statement of Condition (SOC) completed
BBI: Basic Building Information form
LSA: Life Safety Assessment
PFI: Plan for Improvement
 Equivalencies must be approved by the
JCAHO (including FSES)
Healthcare Engineering Consultants
Fire Prevention
EC.5.20 - Statement of Condition Document
 BBI Form: Should be completed for all facilities to
indicate occupancy classification
 LSA Form: Must be completed for healthcare and
ambulatory facilities (Note: CMS definition)
 PFI Form: Should include non-operational
deficiencies that have not been resolved
Note 1: Be sure the surveyor signs the PFI!
Note 2: Get a JCAHO delay letter if the PFI is late!
Healthcare Engineering Consultants
Fire Prevention
EC.5.20 - Building Maintenance Program
 Voluntary, but should include:
 A policy describing the program
 A method to measure and document
“effectiveness”
 Program effectiveness of at least 95%
Healthcare Engineering Consultants
Building Maintenance Program
Building Maintenance Program Data Collection Sheet
Description
Fire Doors – Positive latches
Magnetic closers
Door/ frame rating
Door gap (<1/8 inch)
Undercut (<3/4 inch)
Door integrity
Smoke Barrier Doors – Closers
Door rating
Door gap (<1/8 inch)
Undercut (<3/4 inch)
Door integrity
Corridor Doors – Positive latches
Undercut (<1 inch average)
Door integrity
Linen Trash Chutes – Self-closing
Positive latches
Smoke Barrier Wall - Penetrations
Total unsealed penetrations
Corridor Wall – Penetrations
Total unsealed penetrations
Egress Illumination Devices
Exit Signs
Exits free from Ice and Snow
Maintenance for – Exhaust hoods
Exhaust duct systems
Grease removal devices
Location 1
Result
Location 2
Result
Location 3
Healthcare Engineering Consultants
Result
Location 4
Result
Fire Prevention
EC.5.30 - Fire Drills
 Healthcare and ambulatory:
1 drill per shift per quarter
 Business occupancy:
1 drill per shift per year
 Drill monitoring as defined in the plan
 Evaluate effectiveness annually
Healthcare Engineering Consultants
Fire Prevention
EC.5.30 - Fire Drills
 Drill knowledge requires evaluation of:
1. Use of fire alarms
2. Fire alarm audibility
3. Smoke and fire containment
4. Transfer to refuge areas
5. Use of fire extinguishers
6. Specific fire duties
7. Preparation for evacuation
Healthcare Engineering Consultants
Fire Prevention
EC.5.40 - Fire Component Tests
 Include fire detection/ suppression systems
 Aggregate in-house and vendor data
 Organize documentation effectively
 Verify and track regulatory compliance
 Must meet local/ state codes beyond JCAHO
 Refer to specific NFPA 99 requirements
Healthcare Engineering Consultants
Fire Component Tests
Fire System Component Test Schedule
Device Description
Test Frequency Code Reference
Supervisory signal devices
Quarterly
Valve tamper switches
Water flow devices
Duct detectors
Magnetic releasing devices
Heat detectors
Smoke detectors
Fire alarm pull boxes
Audible devices (speakers)
Visible devices (strobes)
Off-site transmission eqmt.
Fire pump churn test
Fire pump discharge test
Water tank level alarms
Water tank low level alarm
(cold weather only)
Riser main drain tests
Outside fire department
connection inspection
Automatic kitchen systems
Carbon dioxide systems
Portable fire extinguishers
Semiannually
Semiannually
Annually
Annually
Annually
Annually
Annually
Annually
Annually
Quarterly
Weekly
Annually
Semiannually
Monthly during
cold weather
Annually
Quarterly
Occupant hoses
Fire and smoke dampers
Air-handling smoke shutdown
Horizontal/ vertical fire doors
Semiannually
Annually
Monthly check,
Annual test
Five years after
purchase, three
years thereafter
Every four years
Annually
Annually
Responsibility
NFPA 72, table
7-3.2
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 72
NFPA 25
NFPA 25
NFPA 25
NFPA 25
NFPA 25
NFPA 25
NFPA 10, 1-6,
4-3, 4-4
NFPA 25
NFPA 90, 3-4.7
NFPA 90, 4-4.1
NFPA 80, 15-2.4
Healthcare Engineering Consultants
Fire Prevention
EC.5.50 - Interim Life Safety
 A policy must describe the program
 Document whether ILSM is or is not required
 Document which measures are applicable
 Document required inspections
 Failure to meet ILSM provisions: CON04!
Healthcare Engineering Consultants
Medical Equipment Management
Elements of Performance
 Management plan
 Inventory criteria
 Maintenance strategies, test intervals
 Recall, hazard, SMDA process
 Equipment failure procedures
 Accurate inventory
 Completion of required tests
 Patient safety goals
Healthcare Engineering Consultants
Medical Equipment Management
EC.6.10 - Inventory Criteria
Is voluntary*
Can be used to define program inventory
Consider function, risk and device history
Don’t use to determine test interval
Document results of criteria assessment
Can be numerical or qualitative
*If not used, must include all devices!
Healthcare Engineering Consultants
Medical Equipment Management
EC.6.10 - Medical Device Incidents
 Hazard Recalls
Must address all device recalls
Clearly define responsibility
“Close loop” on device resolution
Aggregate durables and disposables
 Safe Medical Device Act
Define incident procedure
SMDA reporting responsibility
Healthcare Engineering Consultants
Medical Equipment Management
EC.6.20 - Medical Equipment Testing
 Current, accurate, separate inventory
 Initial testing for all program
equipment
 PM strategies for life support devices
 PM strategies for non-life devices
Healthcare Engineering Consultants
Medical Equipment Management
EC.6.20 - Medical Equipment Testing
 100% PM completion for “life support”
devices, based on scoring (A)
 90% PM completion for “non-life
support” devices (C)
 Determine test interval by “PM
effectiveness” and MTBF data
 Test tags with due dates
recommended
Ongoing PM
vs. initial
test only?
Healthcare
Engineering
Consultants
Medical Equipment Management
EC.6.20 - Medical Equipment Testing
Test documentation for sterilizers
Tests for water used in dialysis
Chemical tests
Biological tests
Other tests, based on policies?
Reporting test results to IC?
Healthcare Engineering Consultants
Medical Equipment Management
HR.2.20 - Equipment User and
Maintainer Training
Equipment users
Must be trained to use equipment
Must understand equipment test status
Equipment maintainers
Competency assessment for “in-house”
staff and vendors (not required for OEM’s)
Healthcare Engineering Consultants
Medical Equipment Management
Other Medical Equipment Issues
Patient-owned equipment
Rental devices
Demo and loaner and trial equipment
Radio-frequency interference
Healthcare Engineering Consultants
Medical Equipment Management
Patient Safety Initiatives - 2006
Goal #5: Infusion Pumps (eliminated)
Verification of free-flow protection
Clinical staff explanation
Goal #6: Clinical Alarms
Not a patient safety goal for 2006
for hospitals, but will still be scored
under EC.6
Healthcare Engineering Consultants
Medical Equipment Management
Clinical Alarm Expectations
1. Define and list “critical clinical alarms”
2. Define alarm verification responsibilities
3. Perform audibility assessment
4. Verify clinical response to alarms
Healthcare Engineering Consultants
Medical Equipment Management
Step 1 - Critical Clinical Alarm Risk Assessment
Device Description
Ventilator
Blood Warmer
Infant Warmer
Anesthesia Unit
Apnea Monitor
Bipap Unit
Chair Occupancy Alarm
Defibrillator
Electrosurgical Unit
Feeding Pump
Hypo/Hyperthermia Unit
Infusion Pump
Injector
Intra-aortic Balloon Pump
Bedside Physiological Monitor
Heart Rate Monitor
NIBP Unit
Pulse Oximeter
SCD
Tourniquet
Bathroom Emergency Call
Code Blue Call
Infant Abduction Alarm
Nurse Call
Medical Gas Alarm
Line Isolation Monitor
Severity Probability of
Rating
Inappropriate
(SR)
Response (P)
5
2
4
2
3
3
5
1
5
2
2
3
4
4
5
1
3
2
2
3
3
3
4
3
2
2
5
2
5
3
5
3
2
3
3
3
2
3
3
2
4
3
5
2
3
3
3
4
3
3
2
3
Total
Score
10
8
9
5
10
6
16
5
6
6
9
12
4
10
15
15
6
9
6
6
12
10
9
12
9
6
Inclusion as
Critical Clinical
Alarm?
Yes
No
Yes
No
Yes
No
Yes
No
No
No
Yes
Yes
No
Yes
Yes
Yes
No
Yes
No
No
Yes
Yes
Yes
Yes
Yes
No
Healthcare Engineering Consultants
Utility Systems Management
EC.7.10 - Elements of Performance
 Management Plan
 Inventory criteria and maintenance strategies
 Utility diagrams and system failure procedures
 Water and Airborne pathogen programs
 Utility system testing program
 Emergency power system tests
 Medical gas and vacuum system test program
Healthcare Engineering Consultants
Utility Systems Management
EC.7.10 - Inventory Criteria
 Voluntary, but requires all systems if not used
 Consider life support, IC and environment
 Evaluation can be qualitative or quantitative
 Criteria evaluation should be documented
 Cannot be used to delete “life support” systems
(examples: emergency generator, oxygen system)
Healthcare Engineering Consultants
Utility Systems Management
Utility Diagrams and Failure Procedures
Utility drawings must include:
1. Accurate one-line diagrams for systems
2. Valve chart lists and diagrams, as applicable
Failure procedures should include:
1. Written utility failure instructions
2. Intended for “non-specialist” on-call staff
Healthcare Engineering Consultants
Utility Systems Management
Utility System Labeling Must Include:
 Labels for medical gas and vacuum system
components, especially piping and valves
 Labels for electrical switchgear, motor starters
and disconnects
 Breaker panel labels
 Utility shut-off, zone and isolation valves
Healthcare Engineering Consultants
Utility Systems Management
EC.7.10 - Waterborne Pathogens Program
Waterborne pathogens policy must include:
 Patient risk assessment for pathogen
vulnerability
 Operational description of measures to
reduce
waterborne pathogens
 Remediation procedures if hospital-acquired
waterborne infection is determined
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Utility Systems Management
EC.7.10 - Airborne Pathogens Program
Airborne pathogens policy must describe:
Air filter maintenance, room air exchange rate and
pressure relationships for operating rooms, delivery
rooms, special procedure rooms, patient isolation rooms,
clinical laboratories, sterile supply rooms and pharmacies
USP 797 - JCAHO requirement deadlines:
 Gap analysis, renovation plan - January, 2005
 Interim safety measures in place - July, 2005
 Renovation completion - January, 2008
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Utility Systems Management
EC.7.30 - Utility System Test Requirements
 Current, accurate inventory must be maintained
 Written test procedures must be available
 “Critical” components must include:
Life support components
Infection control components
Non-life support components
 “Non-critical”
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Utility Systems Management
EC.7.30 - Utility System Test Requirements
 All devices included in the utility systems
management program must be at least initially tested
 Items within policy discretion include:
1) Which components are included in the program
2) What test intervals (if any) are required
3) How much time is permitted to perform the tests
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Utility Systems Management
EC.7.30 - Utility System Test Requirements
 All devices included in the utility systems
management program must be at least initially tested
 Expected PM completion rate for “critical life
support” and “critical infection control” components
based on “A” scoring: 100%
 Expected PM completion rate for “critical non-life
support” and “non-critical” components based on
“C” scoring: 90%
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Utility Systems Management
EC.7.40 - Emergency Power Type I Systems
Testing requires:
 Weekly visual and monthly load test
 20 to 40 days between monthly load test
 Load at least 30% of nameplate full-load rating
 All critical and life safety transfer switches tested monthly
 Manifold temperature or load bank requirements, if
applicable
Note: Refer to NFPA 99 and NFPA 110 for more information
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Utility Systems Management
EC.7.40 - Emergency Power Type 3 Systems
 Battery egress lighting and exit signs
 Battery lights required in anesthetizing locations
(grandfathering still permitted)
 Monthly push-to-test and annual discharge test
 Annual discharge test exception for battery
change
Note: Refer to NFPA 99 and NFPA 111 for more
information
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Utility Systems Management
EC.7.40 - Emergency Power UPS Systems
 Levels of UPS systems (1, 2 or 3)
 Test requirements for level 1 (life support,
permanently installed) systems
 Inspected monthly, exercised quarterly
Note: Refer to NFPA 111 for more information
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Utility Systems Management
EC.7.50 - Medical Gas and Vacuum Systems
 Preventive maintenance program required
 Must include testing for gas sources, alarm panels,
source and zone valves, pressure switches and outlets
 NFPA 99, chapter 5 requires certification of installers
and verifiers per ASSE 6000 series
 Reference NFPA 99, appendix C for recommended
test intervals
 Medical air quality must meet USP and FDA
requirements
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Utility Systems Management
Medical Gas System Preventive Maintenance Recommendations
Component Description
Gas cylinder manifold pressure
Gas cylinder manifold changeover signal
Liquid cylinder manifold pressure
Liquid cylinder manifold changeover signal
Liquid cylinder reserve/ in-use signal
Bulk liquid system contents gauge
Bulk system pressure gauges
Bulk system master signal
Medical air intake location
Medical air pressure gauge
Medical air high level water sensor
Medical air receiver drain
Medical compressed air alarms
Medical air compressors/ vacuum pumps
Dew point sensor/ CO monitor
Shut-off valve leak test
Outlet leakage and flow
Medical air purity
Recommended Test Frequency
Daily
Daily
Daily
Daily
Annually
Daily
“Regularly” (weekly)
“Periodically” (monthly)
Quarterly
Annually
Annually
Daily
Annually
Per manufacturer specifications
Annually
Annually
Annually
As determined by facility
Note: These recommendations are from Appendix C of NFPA 99, the 2002 edition, and
therefore represent only suggested (not required!) preventive maintenance test intervals
for piped medical gas and vacuum systems. The test requirements for newly installed
and modified systems are provided in chapter 5 of the same document.
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Utility Systems Management
Medical Air Quality Requirements
Definition of Medical Air Quality from NFPA 99, section 5.1.3.5.1, 2002
edition:
Medical air shall be required to have the following characteristics:
1. Be supplied from cylinders, bulk containers, medical air compressor sources
or be reconstituted from oxygen USP and oil-free, dry Nitrogen NF.
2. Meet the requirements of medical air USP
3. Have no detectable liquid hydrocarbons
4. Have less than 25 ppm gaseous hydrocarbons
5. Have equal to or less than 5 mg/cubic meter of permanent particulates sized
1 micron or larger in the air at normal atmospheric pressure
Medical air requirements from the United States Pharmacopeia (USP):
1. Grade “N” air
2. 19.5% to 23.5% oxygen, with predominant balance nitrogen
3. Condensed oil at NTP: None
4. Carbon monoxide: < 10 ppm
5. Odor: None
6. Carbon dioxide: < 500 ppm
7. Nitrogen dioxide: < 2.5 ppm
8. Nitric oxide: < 2.5 ppm
9. Sulfur dioxide: < 5 ppm
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Utility Systems Management
HR.2.20 - Utility Training and Orientation
 Training for utility system “users” includes:
Emergency procedures for utility failures
Depends on staff interaction with utility systems
 Training for utility system “maintainers” includes:
Annual competency assessment
Vendor competency documentation, except for OEM’s
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Appropriate Environment
EC.8.10 - Interior Spaces
 Appropriate to patient care
 Closet and drawer space
 Compliant with USP 797 (drug prep rooms)
 Long-term care accommodations
Equipment
Activities
Rehabilitation
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Appropriate Environment
EC.8.10 - Furnishings and Equipment
 Proper maintenance
 Appropriate for patient
 LTC - “normalize” environment
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Appropriate Environment
EC.8.10 - Other Requirements
 Outdoor areas for LTC
 Safe environment
 Suitable lighting and ventilation
 Locks and restraints per regulation
 emergency access for locked spaces
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Appropriate Environment
EC.8.30 - Codes for New Construction
 AIA document, 2001 edition
 Applicable local, state or federal
guidelines
 Equivalent design criteria
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Appropriate Environment
EC.8.30 - Pre-Construction Risk Assessment
 Evaluation must include:
Noise
Vibration
Air quality
Infection control
Emergency procedures
Utility failures
Interim life safety measures
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Appropriate Environment
EC.8.30 - Pre-Construction Risk
Assessment
Controls include measures to reduce risk and
minimize the impact of the construction
activities
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