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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 Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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” Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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% Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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. Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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 Healthcare Engineering Consultants 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 Healthcare Engineering Consultants Appropriate Environment EC.8.10 - Furnishings and Equipment Proper maintenance Appropriate for patient LTC - “normalize” environment Healthcare Engineering Consultants 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 Healthcare Engineering Consultants Appropriate Environment EC.8.30 - Codes for New Construction AIA document, 2001 edition Applicable local, state or federal guidelines Equivalent design criteria Healthcare Engineering Consultants 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 Healthcare Engineering Consultants Appropriate Environment EC.8.30 - Pre-Construction Risk Assessment Controls include measures to reduce risk and minimize the impact of the construction activities Healthcare Engineering Consultants