Presentation on theme: "NFPA 99 Health Care Facilities Code 2012 Edition"— Presentation transcript:
1 NFPA 99 Health Care Facilities Code 2012 Edition CHANGES IN THE MEDICAL GAS AND VACUUM SYSTEM REQUIREMENTSPresented By:Jonathan C. Willard, CHC, PMP, CMGVCertified Medical Gas Services
2 INTRODUCTION About the Presenter Jonathan Willard, Medical Gas Systems ConsultantExperience in Medical Gas and Healthcare Construction Industry for over 16 YearsASSE 6010, 6015, 6020, 6030, 6040, 6050, & 6055 CertifiedMGPHO Credentialed Medical Gas Verifier (V-0135)Currently serving as Vice President of Legal for the Medical Gas Professional Healthcare Organization Board of DirectorsPrincipal Member of Technical Committee on Medical Gas and Vacuum Piping Systems (NFPA 99) & Technical Committee on Industrial and Medical Gases (NFPA 55)Certified Healthcare Constructor (CHC) & Project Management Professional (PMP) with a Master’s Degree in Business Education
3 INTRODUCTION About Certified Medical Gas Services: Medical Gas System Consulting ServicesCode Compliance Review & Risk AssessmentsMock SurveysComprehensive Operation and Management ProgramsMaintenance, Inspection, and Testing ProgramsBest Practices & RecommendationsEmergency Preparedness & Policy and Procedure DevelopmentMedical Gas System Inspection, Testing, and Verification ServicesMedical Gas System Service and Preventative MaintenanceMedical Gas System Sales & Installation ServicesMedical Gas System Training & CertificationOn-Site Training & CertificationsOn-Line Training & Certifications
4 NFPA DISCLAIMERAlthough Jonathan C. Willard is a principal member of the NFPA Technical Committee on Medical Gas and Vacuum Piping Systems, which is responsible for the applicable sections of NFPA 99: Health Care Facilities Code, and a principal member of the NFPA Technical Committee on Industrial and Medical Gases, responsible for NFPA 55: Compressed Gases and Cryogenic Fluids Code, the views and opinions expressed in this presentation are purely the authors and shall not be considered an official position of the NFPA or any of its Technical Committees and shall not be considered, nor be relied upon as, a Formal Interpretation or promotion of the NFPA. Readers are encouraged to refer to the entire text of all referenced documents.
5 Important Notice and Disclaimer of Liability Concerning the Use of These Materials The information in this presentation should not be confused with Federal, State, Provincial, or Municipal codes, standards, or regulations; insurance requirements; or national safety codes. These materials are to be used on a voluntary basis and should not be considered absolute. Certified Medical Gas Services (CMGS) disclaims liability for any personal injury, property, or other damages of any nature, whatsoever, whether special, indirect, consequential, or compensatory, directly or indirectly resulting from the publication, use, or reliance on these materials. CMGS makes no guarantee or warranty as to the accuracy or completeness of any information contained in this presentation.
7 GENERAL DISCUSSION ITEMS Standard vs. CodeLegislative Process ChangesLevels vs. CategoriesOccupancy-Based vs. Risk-BasedCategory 3 SystemsCategory 3 systems (previously Level 3 systems) has gone through a total rewrite. I encourage you to review.
8 General Anesthesia & Levels of Sedation DEFINITIONSGeneral Anesthesia & Levels of SedationDefinition ChangeImportant for determination of Anesthetizing Locations
9 APPLICABILITY OF THE CODE “Existing Systems” ClauseStill exists for existing systems not in compliance with the 2012 edition of NFPA 99. Unless it is determined that the condition poses a distinct hazard to life.Examples1.) Zone valve without a pressure gauge2.) No Master Alarm Warning System
10 APPLICABILITY OF THE CODE Added Sections –Defines which sections of the code apply to:1.) New Facilities2.) Existing Facilities3.) Both New and Existing Facilities
11 CENTRAL SUPPLY SYSTEM LOCATIONS Cylinder Storage TemperatureMinimum temperature for N2O and CO2 Cylinders is now -29°C (-20°F) or per the manufacturer’s recommendationsBulk Systems (Over 20,000 cu. ft.)- NFPA 55 for Oxygen SystemsCGA P-18 for Inert Gas SystemsCGA G-8.1 for Nitrous Oxide SystemsCGA G-6.1 or G-6.5 for CO2 Systems
12 DESIGN AND CONSTRUCTION Outdoor Locations ( (3))Minimum of 2 entry /exit doors.
13 DESIGN AND CONSTRUCTION Electrical DevicesMust be protected from physical damage. If at or above 5 feet AFF, then OK. If not, can be protected from physical damage.Ventilation RequirementsThis section has moved toChapter
15 188.8.131.52.4.2 has been clarified CYLINDER STORAGE The only time cylinders are allowed to be stored in a room with motor driven equipment is for an instrument air standby header if and only if this is the only equipment in the room. It is prohibited to store cylinder in any other location with motorized equipment.
16 CENTRAL SUPPLY SYSTEM LOCATIONS “Remote” Control Equipment (i.e. Regulators, valves, and gauges) for Central Supply SystemsControl Equipment is allowed to be remote from the source equipment with this new provision ( ).
18 LOCATIONS FOR MEDICAL GASES has been clarifiedMedical gases are only allowed in areas where they will be used under the direction of a licensed medical professional for the following purposes.Direct respiration by patientsClinical application of the gas to a patient.Medical device applications directly related to respirationPower for medical devices used directly on patientsCalibration of medical devices intended for (1) through (4) above
19 CENTRAL SUPPLY SYSTEMS Final Line RegulatorsNow allowed to be constructed of any materials deemed suitable by the manufacturer ( (6))Three-Header ManifoldsThis section has been deleted from the text. This was a rarely used system configuration. Still allowed under the code, but does not have a dedicated section anymore.
20 CENTRAL SUPPLY SYSTEMS Bulk Cryogenic Liquid SystemsMost of this section has been moved to NFPA 55: Compressed Gases and Cryogenic Fluids Code. Some requirements still remain in NFPA 99 mostly dealing with system cascading operations, clearances for maintenance, alarm requirements, and the EOSC & In-Building Reserve requirements.
21 CENTRAL SUPPLY SYSTEMS In-Building Reserve HeadersReinforced wording for sizing of these headers ( ). They must now be sized with consideration of the following:) The minimum allowed cylinders orcontainers.2.) The ability of the supplier to restock thefacility.3.) Access to alternative supplies / suppliers.4.) The facilities plan and ability to cope withan emergency outage.
22 Hydrocarbon Indicator MEDICAL AIR SYSTEMSParticulates AllowedChanged from 5 mg / m3 to 1 mg / m3.Hydrocarbon IndicatorThe requirement for a this pigment indicator has been removed.Liquid Ring Compressors- Must have seal water that is treated.Must be provided with cylinder backup.
24 Medical Air Intake Location MEDICAL AIR SYSTEMSMedical Air Intake LocationThe requirements for locations have now been aligned with the AIA / FGI Guidelines ( ). Now intakes must be 25 ft. from any exhaust or vent and 25 ft. from areas where “noxious fumes may collect”.Medical Air Intake MaterialNow can be made with any material allowed for “vacuum” pipelines.
26 New Medical Air Source System MEDICAL AIR SYSTEMSMedical Air Dew PointThis has been corrected (FINALLY).New Medical Air Source SystemMedical air proportioning systems or “Blenders” are now allowed ( ). These systems create “synthetic” air using Oxygen USP and Nitrogen NF systems to create medical air that meets the requirements of USP. The requirements for redundancy, system monitoring, automatic switching, alarms, etc. have also been added.
27 MEDICAL VACUUM SYSTEMS Vacuum Exhaust MaterialsPiping Material can be anything appropriate for the service as determined by the manufacturer ( (6)).Vacuum Exhaust LocationExhaust locations must now discharge away from “areas of public assembly” ( (2)).
28 WAGD VACUUM SYSTEMSWAGD Systems using oil lubricated pumps (i.e. combined with the medical vacuum system)It is now clearly defined as to the acceptable limits of using the vacuum system for WAGD service ( (2)). The facility must now ensure that an oxygen enriched atmosphere (>23.5% Oxidizing Gases) never reaches the pumps. This would be accomplished with analyzers at the source equipment.
29 ZVB for Anesthetizing Locations ZONE VALVESZVB LocationsIt is now clearly defined that a zone valve shall NOT be located in a room with station outlets and inlets that it controls ( (3)).ZVB for Anesthetizing LocationsNew wording has been added to eliminate the lowest level of sedation from this requirement ( ).
30 Requirements have changed INLINE CHECK VALVESRequirements have changedNow similar in construction to the shutoff ball valves on the pipeline distribution systems. They must have ( ):Brazed extensionsInline serviceabilityNO threaded connectionsProvided with purge ports
31 PRESSURE AND VACUUM INDICATORS Pressure Indicators (Gauges)The scale range for gauges has changed and been more clearly defined. Normal operating range also tightened to middle third of the scale ( ).Digital Gauge AccuracyThe accuracy of the digital gauges has been clearly defined ( ). The accuracy for digital gauges must now be at least +/- 5% of scale.
32 Wiring for sensors, switches, and transducers ALARM WARNING SYSTEMSWiring for sensors, switches, and transducersProtection of wiring as been clearly defined ( (11)). Wiring may be protected by any of the following:ConduitFree AirWireCable TrayRaceways
33 ALARM WARNING SYSTEMS Alarm sensors, switches, and transducers Must be removable ( (15)). To eliminate any confusion (if there was any).Master alarm wiring is clarifiedCommon conductors is now clearly prohibited ( ).Splicing is permitted and clearly defined ( ).Underground master alarm wiringSingle set of wires is permitted ( ).
35 Wiring for sensors, switches, and transducers AREA ALARM SYSTEMSWiring for sensors, switches, and transducersMust now have wiring that is non-interchangeable ( ). Must provide visual and audible indication in the event a mismatch occurs between the transducer and its associated circuit board.
36 PIPELINE DISTRIBUTION SYSTEMS Cutting Copper Tube EndsRoller deburring is now permitted ( ). As long as chips are prevented from entering the copper tubing.Prohibited JointsPush-fit fittings have made there way into this section ( ). They are not allowed.HangersHangers must be properly sized for copper tubing ( ).Additional requirements for damp locations have been added ( ).
37 PIPELINE DISTRIBUTION SYSTEMS Backfill for underground pipingBackfill must be clean from materials that can damage the pipe and must be compacted ( ).Branch TakeoffsNo longer required to be taken off above the centerline of the piping!!!Metallic Flexible ConnectionsThe requirements and conditions for use have been defined ( ).
38 PIPELINE INSTALLATION Qualification of InstallersThe requirements for qualified installers has been reinforced ( ). “All personnel” has been added to the text.“Supervising” non-certified personnel is clearly prohibited now ( ).Breaching or penetrating pipingMethods used to breach or penetrate the piping shall not result in any residual copper particulates or other debris from remaining in the piping ( ).
39 LABELLING AND IDENTIFICATION Riser valve labelingA section for the labeling and identification of riser valves has been added to the text ( ). Labeling is similar to all other shutoff valves.
40 PERFORMANCE CRITERIA AND TESTING Pressure TestingNew Throughout The CodeLeakage shall be tested by means of a leak detectant that is safe for use with oxygen and does not contain ammonia.
41 PERFORMANCE CRITERIA AND TESTING Standing Pressure TestThe 24 hour standing pressure test of the positive pressure system shall be witnessed by the authority having jurisdiction or its designee. A form indicating that this test has been performed shall be provided to the verifier at the start of the tests required in
42 PERFORMANCE CRITERIA AND TESTING Verifier Piping Purity TestThe outlet most remote from the source shall be tested for total non-methane hydrocarbons and compared to the source.If the system gas is used as the source gas, it shall be tested at the source equipment.
43 PERFORMANCE CRITERIA AND TESTING Final Tie-in TestVacuum joints shall be tested using an ultrasonic leak detector or other means that will allow detection of leaks in an active vacuum system.
44 PERFORMANCE CRITERIA AND TESTING Medical Air Compressor SystemsThe air quality tests shall be conductedafter the medical air source system has been operating normally, but with the source valve closed under a simulated load for an elapsed time of at least 12 hours.The aggregate run time on thecompressors shall not be used to determine the elapsed run time.
45 PERFORMANCE CRITERIA AND TESTING Proportioning Systems for Medical Air USPThere are new performance criteria and testing requirements identified for the medical air proportioning systems in this section.
46 OPERATION AND MANAGEMENT Maintenance of Medical Gas, Vacuum, WAGD, and Medical Support Gas SystemsGeneral. Health care facilities with installed medical gas, vacuum, WAGD, or medical support gas systems, or combinations thereof, shall develop and document periodic maintenance programs for these systems and their subcomponents as appropriate to the equipment installed.
47 OPERATION AND MANAGEMENT Maintenance ProgramsInventories. Inventories of medical gas, vacuum, WAGD, and medical support gas systems shall include at least all source subsystems, control valves, alarms, manufactured assemblies containing patient gases, and outlets.
48 OPERATION AND MANAGEMENT Maintenance ProgramsInspection Schedules. Scheduled inspections for equipment and procedures shall be established through the risk assessment of the facility and developed in consideration of the original equipment manufacturer’s recommendations as required by the authority having jurisdiction.
49 OPERATION AND MANAGEMENT Maintenance ProgramsInspection Procedures. The facility shall be permitted to use an inspection procedure(s) or testing methods established through its own risk assessment.
50 OPERATION AND MANAGEMENT Maintenance ProgramsMaintenance Schedules. Scheduled maintenance for equipment and procedures shall be established through the risk assessment of the facility and developed in consideration of the original equipment manufacturer’s recommendations as required by the authority having jurisdiction.
51 OPERATION AND MANAGEMENT Maintenance ProgramsNote for CMS Certified Providers. Memorandum dated December 12, 2011.Alternative maintenance, inspection, and testing schedules permitted based on risk assessment by qualified personnel.1.) All equipment “critical to patient health andsafety” must follow manufacturer recommendedmaintenance frequencies.2.) Any “new” equipment must followmanufacturer’s recommendations until sufficienthistory is available for risk assessment.
52 OPERATION AND MANAGEMENT QualificationsPersons maintaining these systems shall be qualified to perform these operations. Appropriate qualification shall be demonstrated by any of the following.Training and certification through the health care facility by which such persons are employed to work with specific equipment as installed in the facility.ASSE 6040 Maintenance Personnel CertificationASSE 6030 Verifier Certification
53 INSPECTION & TESTING OPERATIONS (1) Medical Air SourcesRoom TemperatureShaft Seal ConditionFilter ConditionPresence of HydrocarbonsRoom VentilationWater Quality, if so equippedIntake LocationCarbon Monoxide Monitor CalibrationAir PurityDew Point
54 INSPECTION & TESTING OPERATIONS (2) Medical Vacuum SourcesExhaust Location(3) WAGD Sources(4) Instrument Air SourcesFilter Condition(5) Manifold SourcesVentilationEnclosure Labeling
55 INSPECTION & TESTING OPERATIONS (6) Bulk Liquid SourcesIn accordance with NFPA 55: Compressed Gases and Cryogenic Fluids Code(7) Final Line RegulatorsDelivery Pressure(8) ValvesLabeling
56 INSPECTION & TESTING OPERATIONS (9) Alarm Warning SystemsLamp and Audio Operation(10) Alarm Warning SystemsMaster Alarm Signal OperationArea Alarm Signal OperationLocal Alarm Signal Operation
57 INSPECTION & TESTING OPERATIONS (11) Station Outlets and InletsFlowLabelingLatching / DelatchingLeaks
58 INSPECTION & TESTING OPERATIONS Manufactured Assemblies Employing Flexible ConnectionsNon-stationary booms and articulating assemblies, other than headwalls utilizing flexible connectors, shall be tested for leaks, per the manufacturer’s recommendations, every 18 months or at a duration as determined by a risk assessment.
59 INSPECTION & TESTING OPERATIONS Manufactured Assemblies Employing Flexible ConnectionsThe system pressure to non-stationary booms and articulating arms shall be maintained at operating pressure until each joint has been examined for leakage by effective means of leak detection safe for use with oxygen.
60 INSPECTION & TESTING OPERATIONS Manufactured Assemblies Employing Flexible Connections(C) Safe working condition of the flexible assembly shall be confirmed.(D) D.I.S.S. connectors internal o the boom and assemblies shall be checked for leakage.
61 INSPECTION & TESTING OPERATIONS Manufactured Assemblies Employing Flexible Connections(E) Leaks, if any, shall be repaired (if permitted), or the components replaced (if required), and the equipment retested prior to placing the equipment back into service.
62 INSPECTION & TESTING OPERATIONS Manufactured Assemblies Employing Flexible Connections(F) Additional testing of non-stationary booms or articulating assemblies shall be performed at intervals defined by documented performance data.
63 COMPREHENSIVE OPERATION & MANAGEMENT PROGRAMS DEVELOPING AND MAINTAINING A COMPREHENSIVE PLAN FOR YOUR MEDICAL GAS SYSTEMSPresented By:Jonathan C. Willard, CHC, PMP, CMGVCertified Medical Gas Services
64 APPLICATIONPLEASE NOTE: This presentation has been created to assist in the development and implementation of an Operation and Management Program for medical gas systems. It DOES NOT apply to the construction or repair of medical gas systems.
65 BACKGROUND What to expect? Why develop an Comprehensive O&M Program? Improves Patient Safety*Increases the life of the medical gas equipment, as well as, other hospital assetsHelps ensure Regulatory ComplianceMedical gases are FDA regulated pharmaceutical drugsMedical Air is unique in that it is the only FDA regulated drug manufactured onsite at Healthcare FacilitiesProtection from Liability*What to expect?It will take some time to do it correctlyYou will need assistance from other departmentsYou may need assistance from a subject matter expertAssume (2) Categories:Those without a programThose wanting to improve existing programRequirements vs. RecommendationsItalian Case:Incident occurred in 2007, but 30 people are facing charges for the incident.1.) 8 patients died when they were administered Nitrous Oxide instead of Oxygen.2.) The charges were brought, not only against the contractor, but also doctors, anesthetists, technicians, and administrators.Charges against contractor were for manslaughter.But charges against hospital staff included negligence and administrative violations.Reason:Facility had no formal program for maintaining, inspecting, and testing their medical gas systems.
66 Centers for Medicare and Medicaid Services Other Important Resources REGULATORY OVERVIEWNFPA 99, 2012 EDITIONThe Joint CommissionENVIRONMENT OF CARE STANDARDSPHYSICAL ENVIRONMENTEMERGENCY MANAGEMENTCenters for Medicare and Medicaid ServicesOther Important Resources
67 REGULATORY OVERVIEW NFPA 99, Health Care Facilities Code, 2012 Edition Chapter 5 Requirements:Certification after a “breach” of the systemTesting after repairs or component replacementMaintenance Programs must now include:Equipment InventoriesInspection SchedulesInspection ProceduresMaintenance SchedulesPersons maintaining medical gas systems must be qualified to perform these operations demonstrated by any of the following:ASSE 6040 Medical Gas Systems Maintenance PersonnelASSE 6030 Medical Gas Systems VerifierTraining and certification by the healthcare facility by which they are employed through a documented training program.
68 REGULATORY OVERVIEW NFPA 99, Health Care Facilities Code, 2012 Edition Chapter 11 Requirements:Maintenance Programs and Record KeepingCylinder & Container Storage RequirementsOperation & Management of Cylinders & ContainersStorage, Maintenance, Handling, and Use of OxygenQualification and Training of Personnel (PeriodicContinuing Education for Medical Gases & Cylinders)Chapter 12 Requirements:Emergency management planning for facilities thatintend to provide services during an emergency or disaster situation.Staff education of the emergency management program, including their specific duties and responsibilities (Conducted at time of hire and annually thereafter).Annex Materials: Assistance with further explanations of the requirements.
69 REGULATORY OVERVIEW The Joint Commission Environment of Care Standards*Utility Management (EC & )Medical Gas and Vacuum Systems(EC ) - Top 20 Noted DeficienciesMedical Equipment (EC )Serving Life Support EquipmentPhysical EnvironmentMedical Gases fall into the Joint Commission concern related to the immediate threat to life in the physical environment.Contingency Planning for UtilitiesEmergency ManagementEmergency Operations PlanECThe hospital manages risks associated with its utility systems.2.) The hospital maintains a written inventory of all operating components of life supporting equipment (at a minimum).3.) The hospital identifies inspection and maintenance activities of these systems.4.) The hospital identifies the intervals for inspection, testing, and maintaining these systems.7.) The hospital maps the distribution of utility systems.9.) The hospital has written procedures for responding to utility system disruptions.10.) The hospital’s procedures address shutting off the malfunctioning system and notifying staff in affected areas.11.) The hospital’s procedures address performing emergency clinical interventions during utility system disruptions.12.) The hospital’s procedures address how to obtain emergency repair services.ECThe hospital inspects, tests, and maintains utility systems.1.) The hospital tests utility system components before initial use.2.) The hospital inspects, tests, and maintains life-support utility systems.ECThe hospital inspects, tests, and maintains medical gas and vacuum systems.1.) In time frames defined by the hospital, the hospital inspects, tests, and maintains, the critical components of piped medical gas systems.2.) The hospital tests piped medical gas systems when installed, modified, or repaired. Third-party verification.3.) The hospital makes main supply valves and area supply valves accessible and clearly identifies what the valve controls.EC (Medical Gases Systems are not considered “Medical Equipment”)…BUT!The organization inspects, tests, and maintains medical equipment. These activities are documented.Hospital may use different approaches to maintenance strategy.
70 REGULATORY OVERVIEW Centers for Medicare and Medicaid Services (CMS) Certified Providers:Must meet applicable provisions of NFPA 101, 2000 editionMedical gas storage and administration areas in existing health care facilities must be protected in accordance with 2005 edition of NFPA 99Regulations and Interpretive Guidelines (Operations Manual):Equipment must be maintained to ensure an acceptable level of safety and qualityThus, a qualified individual must conduct a regular, periodic maintenance and testing programAlso, if equipment is likely to be needed in an emergency, adequate provisions must be made to ensure its availability
71 OTHER IMPORTANT RESOURCES ASSE Series 6000Equipment Inspection (Assessment) ChecklistsMaintenance, Inspection, and Testing ProceduresRecommended Frequencies for Maintaining, Inspecting, and Testing EquipmentMaintenance, Inspection, and Testing Qualification StandardsCGA M-1, Guide for Medical Gas Supply Systems at Consumer Sites, 2007 Edition*CGA E-10, Maintenance of Medical Gas and Vacuum Systems in Healthcare Facilities, 2007 Edition*CGA M-1This document addresses the medical gas industry's need to ensure that storage and control systems supplying medical gases in bulk or cylinder form at health care facilities are installed and maintained in a safe and consistent manner in compliance with regulations and current good manufacturing practices (CGMP). This document establishes the minimum requirements for the installation, maintenance, and removal of the medical gas systems supplying piping systems as defined in NFPA 99.CGA E-10Guide to the preparation of a maintenance program regarding piped medical gas/vacuum systems in health care facilities. National codes require health care facilities with these systems to have an effective, documented maintenance program for these systems. Covers inspection and testing related to:Gas/vacuum outletsGas/vacuum alarm systemsCompressed gas manifoldsVacuum pumpsMedical air compressorsSuggested frequency of inspectionTest methodsDocumentation
72 SURVEY EXISTING SYSTEMS Conduct Survey of Existing SystemsCreating an Equipment InventoryDetermine Maintenance StrategiesEstablish an Equipment Spare Parts List
73 SURVEY & INVENTORY Conducting a Survey of Existing Systems All equipment should be surveyed for the following:Current Condition of EquipmentApproximate Life ExpectancyTo assist with Capital PlanningMaintenance HistoryInspection & Testing HistoryEquipment Issues or ProblemsOngoing items should be investigated.Are Operation & Maintenance Manuals Available?Equipment Inventories can be created at the same time the survey is conducted.
74 SURVEY & INVENTORY Medical Gas System Inventory (Utilities Mgmt) Documentation of all equipmentBulk Liquid Oxygen SystemsMotorized Equipment (e.g. Medical Air, Medical Vacuum, & WAGD)Manifold SystemsAlarm Warning Systems (Master Alarms, Area Alarms, Local Alarms)All Critical Control Valves (Source, Zone, Emergency, etc)Station Outlets & InletsDocumentation Information (Standard Forms & Checklists)Equipment Data, Location, Function, and Use (Areas Served)Operation & Maintenance ManualsAre the systems life supporting?
75 SURVEY & INVENTORY Maintenance Strategy Must first understand: How the equipment operatesHow it might fail* (e.g. full system failure vs. single component failure)Clinical impact of different failure scenarios*Types of Maintenance StrategiesInterval-Based MaintenancePredictive MaintenanceReliability-Centered MaintenanceMetered MaintenanceRun-to-Fail or Corrective MaintenanceNot every strategy is appropriate for every piece of equipment*How it might fail?Note: Code compliant equipment allows for a single fault failure to occur and still maintain system operation.Most of the time even repairs can occur without system shutdown.
76 Equipment Spare Parts List SURVEY & INVENTORYEquipment Spare Parts ListMost manufacturer’s provide a recommended spare parts list in their O&M ManualsOther resources are ASSE 6000 and CGA DocumentsOnce spare parts list are established, determine availability of parts from supplierIf readily available, may choose not to keep on handShould be based on past experiences with equipment
77 COMPLIANCE REVIEW AND RISK ASSESSMENT CODE COMPLIANCE REVIEWEXISTING SYSTEMS & COMPONENT REVIEWSAFETY & RISK ASSESSMENTDETERMINE IN-HOUSE PERSONNEL CAPABILITIES
78 COMPLIANCE REVIEW Code Compliance Review Audit: All systems and componentsSource Supply Systems, Alarm Warning Systems, Critical Valves, etc.May want to consider assistance from subject matter expertCan be very time consuming (Annual Inspection)*Should include an audit of existing policies and procedures as wellDocument: All items not in ComplianceDocumentation should include code referencesShould include specifics about compliance issueShould include specific concerns with existing policies and proceduresUpgrades: Any system improvements that will promote patient and/or personnel safetyExample: 20 year old bulk oxygen system with operational issues.
79 WHAT ARE THE WORST CASE SCENARIOS? RISK ASSESSMENTWHAT ARE THE WORST CASE SCENARIOS?Worst Case Scenario:Loss of Oxygen in NICU with infants on ventilators that do not have a backup.Are you prepared for this situation?
80 KEEP IT SIMPLE STRAIGHT - FORWAR D RISK ASSESSMENTKEEP IT SIMPLE STRAIGHT - FORWAR D
81 RISK ASSESSMENT First, determine a “risk ranking” method What are the physical risks associated with equipment use?If equipment fails:What is impact to patient safety?What is impact on clinical processes?What is impact on staff / personnel safety?If Medical Gas Systems are Life Supporting:Should equipment be included in Emergency Management Program?Typically, the oxygen, medical air, and medical-surgical vacuum systems are life supporting and will be included in the EOP.Assess Risks Identified in Code Compliance ReviewOther Outcomes:Emergency Operations Plan and Impact on Medical Equipment
82 RISK ASSESSMENT Risk Ranking Method This method ties to the Joint Commission Levels of Criticality.High Risk / Level 1: Immediate Threat to LifeImmediate Corrective Actions Required (Plan for Improvement)This risk level identifies a finding that has a direct adverse impact on patient health and safety.Findings with this designation are considered to be an immediate threat to life by the Joint Commission and will most likely constitute a distinct hazard to life by the Authority Having Jurisdiction.Generally, if noted during a survey by the Joint Commission, a preliminary denial of accreditation may be issued. These findings are considered Level 1 deficiencies in the physical environment by the Joint Commission.Example: Absence of master alarms for medical gas systems.
83 RISK ASSESSMENT Risk Ranking Method This method ties to the Joint Commission Levels of Criticality.Medium Risk / Level 2: Possible Threat to Patient SafetySituational Decision Rules Apply: May require additional assessment.This risk level identifies a finding that has or may have an adverse impact on patient health and safety.Findings with this designation are considered to have a direct impact on the operation of the medical gas and vacuum systems, which may constitute a distinct hazard to life by the Authority Having Jurisdiction.Generally, if noted during a survey by the Joint Commission, a Requirement for Improvement (RFI) may be required and this finding would need to be corrected within 45 days of the finding.For this level of risk the Joint Commission survey team may recommend a preliminary denial of accreditation (PDA) or contingent accreditation based on the impact of the finding on patient safety.Example: Leaking oxygen zone valve (creating an oxygen enriched atmosphere, which could be a potentially dangerous situation).
84 RISK ASSESSMENT Risk Ranking Method This method ties to the Joint Commission Levels of Criticality.Low Risk / Level 3: Little to No Threat to Patient SafetyThis risk level identifies a finding that has little to no adverse impact on patient health and safety.Findings with this designation may be considered to have a direct impact on the operation of the medical gas and vacuum systems, but do not constitute a distinct hazard to life.However, if noted during a survey by the Joint Commission, a Requirement for Improvement (RFI) may be required, and this finding would need to be corrected within 45 days of the notice.May require review of Authority Having Jurisdiction (For determination)Example: The termination of the vacuum system exhaust is not turned down, with a screen to prevent the entry of precipitation or vermin.
85 RISK ASSESSMENT Risk Ranking Method This method ties to the Joint Commission Levels of Criticality.No Risk / Level 4: No Threat to Patient SafetyIndirect Impact RequirementsOrganizational decision to repair or notThis risk level identifies a finding that has no adverse impact on patient health and safety.Findings with this designation are considered to have an indirect impact on the operation of the medical gas and vacuum systems and do not constitute a distinct hazard to life.However, if noted during a survey by the Joint Commission, a Requirement for Improvement (RFI) may be required, and this finding would need to be corrected within 60 days of the notice.May be placed on capital improvements programExample: No demand check fitting for alarm initiating device/sensor.
86 REVIEW AND ASSESSMENT Determine In-House Capabilities* Do you have the Guns?What are the capabilities of facility personnel?What is their comfort level with the medical gas systems?What qualifications do facility personnel possess?*Are Personnel Training Programs available and are they adequate?*I like to include a picture of me in my presentation just in case you see me walking around your facility…You will recognize me.Qualifications of facility personnel:If personnel have an ASSE 6010 Installer certification or an ASSE 6040 Maintenance Personnel certification, most maintenance, inspections, and testing can be conducted by the facility personnel.Resource Availability:Will organization invest in testing equipment, etc?
87 POLICIES AND PROCEDURES EXISTING POLICY & PROCEDURE REVIEWGENERAL WORK REQUIREMENTSDEVELOPING & DOCUMENTING MAINTENANCE, INSPECTION, AND TESTING (MIT) PROCEDURESEMERGENCY OPERATIONS PLANNINGSCHEDULED SYSTEMS SHUTDOWN AND TEMPORARY BACK FEED PROCEDURESNEW EQUIPMENT SELECTION PROCEDURERECORD KEEPING
88 POLICIES AND PROCEDURES Existing Policies & Procedures ReviewAre the following items included?Safety ProgramGeneral Work RequirementsNew Employee / Vendor Site Orientation ProcedureProcedures to prevent system cross connectionsMaintenance, Inspection, and Testing Policies & ProceduresEmergency Operations Plan (Contingencies)Scheduled System Shutdown / Temporary Back Feed ProceduresNew Equipment Selection ProcedureRecord Keeping ProceduresReview Training ProgramsIs additional training required to ensure qualified personnel?Other Considerations: What is most cost effective?Are financial resources available?
89 POLICIES AND PROCEDURES General Work RequirementsIncorporate Facility Safety Program*Site Orientation and Equipment OverviewPrior to commencement of any workBoth for new employees and vendorsVerification of vendor credentials (Ask for copy of certifications)Review physical properties and the distinct hazards associated with the use of:Motorized medical gas equipmentHigh pressure cylindersConfined space and/or oxygen enriched/depleted environmentsProcedures to prevent cross connection of systemsShutdown one system at a timeDevelop procedures to ensure tools and parts are kept clean and free from contamination (dust, dirt, grease, or oil).
90 POLICIES AND PROCEDURES Developing & Documenting “MIT” ProceduresIf this work is performed by facility personnel, procedures performed must be documented.Cookbook Style (Step by Step)Make sure they are based on industry accepted proceduresIf more than “Daily Inspections”, additional training should be considered for facility personnelDon’t reinvent…These procedures may be available in the resources discussed.If this work is performed by a contractor, the procedures should be included in their Standard Operating Procedures.Responsibility lies with the organization performing the work, but should be submitted for review prior to commencement of workA Statement of Compliance for outside vendors should be included in Operation & Management Program
91 POLICIES AND PROCEDURES SAMPLE Statement of Compliance “All maintenance, inspections, and testing on the medical gas systems shall be performed per the equipment manufacturer’s recommendations and in accordance with NFPA 99, 2005 edition and industry accepted standard operating procedures. If adherence to these standards is not possible, substitute procedures shall be submitted to the organization for review prior to commencement of any work on the medical gas systems.”
92 POLICIES AND PROCEDURES Testing Procedure (Example)Manifold Inspection & Testing Procedure1.) Start flow of gas from an outlet in the piping system or use vent valve.2.) Close header shutoff or cylinder valves on the primary supply (in-use)side of the manifold.3.) Verify changeover to secondary supply occurs.4.) Check mainline pressure to ensure proper operating pressure.5.) Verify “Empty” light for depleted header has activated.6.) Verify “Secondary in Use” alarm has activated at all master alarmpanels.7.) Silence audible alarm at all master alarm panels.8.) Open valves that were closed in Step 2.9.) Verify “Ready” light is now activated on original header.10.) Verify master alarm panels are back to normal and alarms aredeactivated.11.) Repeat for other side of manifold to ensure both sides operateproperly.
93 POLICIES AND PROCEDURES Emergency Operations PlanningLife Supporting EquipmentOxygen, Medical Air, Vacuum (Potential Systems)How will you ensure systems are available during an emergency?What is the protocol for monitoring systems during the emergency?How will the EOP be activated / deactivated?Will the plan meet the (96) Hour Sustainability Requirement?*Staff must be educated on their specific duties and responsibilities.Some Options for Contingencies:Cylinders available for critical care patientsTemporary back feed of all critical care portions of the systemPortable vacuum systems available for critical care areasSuppliers temporary bulk oxygen trailer (Might not be practical)
94 POLICIES AND PROCEDURES Emergency Operations PlanMust address the four phases of an emergency*Mitigation:Redundancy or duplicationPreparedness:Documented Inventory – Needed SystemsResources & Assets – Replacing supplies consumed during emergencyClinical Support Activities – Administration of medicationsEssential Utilities – Plan for operation of critical systemsResponse:Activation / Deactivation of EOPRecovery:Restore Operational CapacityAccess & Update EOP
95 POLICIES AND PROCEDURES Scheduled Shutdown and Temporary Back Feed ProceduresThe facility should establish a documented procedure for planned interruption and / or temporary back feed of medical gas systems.Who is involved in the shutdown?*What are each individuals responsibilities?Healthcare Facility Personnel Responsibilities (Lockout/Tagout)Shutdown Coordinator ResponsibilitiesInstaller ResponsibilitiesThird-Party Verifier ResponsibilitiesNotification ProceduresWhich departments are affected?Department Heads should be involved in planning process*Utility shutdown “Approval” prior to equipment shutdownsASSE 6000 Series - Annex J & Annex*
96 POLICIES AND PROCEDURES New Equipment Selection ProcedureThe Environment of Care states:The organization must consult with equipment manufacturers prior to acquisition of equipment.The organization must follow an established process for selecting and acquiring equipment.The organization must involve both the individuals who operated the equipment and those who service it.The organization must review how equipment will interface with other existing equipment at facility.The organization should evaluate maintenance requirements and availability of repair parts and repair services.
97 POLICIES AND PROCEDURES Record KeepingMaintenance, Inspection, & Testing ResultsAll results should be documentedAll sections of forms should be filled out (“Not Tested”)Any scheduled shutdowns or “Breaches” of the system should be documented*Verifiers report will sufficeUtility Shutdown Approvals / Notice of Restoration to ServiceIncident Reporting for Medical Equipment per the Safe Medical Devices Act of 1990SMDA has a broader definition than the Joint CommissionIf equipment is suspected to have caused or contributed to the death, serious injury, or serious illness of individual (Reporting is Required).
98 ACTIVITIES SCHEDULES REVIEW OF THE FOLLOWING INFORMATION: REGULATORY REQUIREMENTSMANUFACTURER’S RECOMMENDATIONSACCEPTED INDUSTRY PRACTICESORGANIZATION’S PAST EXPERIENCESESTABLISHING FREQUENCIES AND ACTIVITIES SCHEDULESREQUIRED VS. RECOMMENDED FREQUENCIES AND SCHEDULES
99 ACTIVITIES SCHEDULES Maintenance, Inspection, & Testing Requirements RegulatoryReview local requirementsEC states that the hospital must test, inspect, and maintain the critical components of the piped medical gas systemsNFPA 99 states that a maintenance program shall be developed for the source supply systems in accordance with Manufacturer’s RecommendationsNFPA 99 also requires annual inspections of central supply systemsManufacturer’s Recommendations: Good Starting Point!*Accepted Industry Practices & Procedures (ASSE & CGA)Review Organization’s Past Experiences*Bottom Line…Must follow a “Documented Procedure”Starting Point:Most Standards point to this as a minimum requirement for frequency of maintenance and testing.Bottom Line:As simple as “The organization conducts an annual inspection of our medical gas systems and maintains the equipment per the manufacturer’s recommendations”
100 ACTIVITIES SCHEDULES Establishing Frequencies & Schedules After completing document reviewWhat will be maintained, frequency of task?What will be inspected and tested, frequency of task?The organization determines frequency of maintenance, inspection, and testing of systems.Develop a schedule for these tasksAs simple as an Excel spreadsheetAs complex as a Work Order Management ProgramWho is responsible for each task?Someone should be identified with responsibility
101 ACTIVITIES SCHEDULES Maintenance Schedules* Maintenance of Motorized Equipment*Medical Air Compressors and Vacuum Pumps need ongoing maintenanceDo you change the oil in your car regularly? So, why not the vacuum pumps.Liquid Ring Systems are a unique animal. Water Quality is Critical!Periodic maintenance should be at least as often as recommended in equipment manufacturer’s guidelines.Additional maintenance is recommended for older equipment and/or equipment used excessively.Maintenance of Non-Motorized Equipment*As required (e.g. station outlet repair)Maintenance and repairs based on inspection and testing resultsMaintenance vs. Testing & InspectionsMaintenance is performing routine actions that keep equipment in good working order.Inspections are conducted to confirm that certain characteristics meet a given standard or requirement.Oil:Change every 3000 miles…Vac pumps are usually every 500 hours or so.As required:Don’t have to change O-rings in the station outlets or inlets every (6) months…You just have to know that the life of the O-rings is about 3-5 years and plan on repairing when needed or listed as a deficiency during your inspections.
102 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Required) Based on:NFPA 99, 2012 Edition:Maintenance & Record Keeping RequirementsNFPA 55, 2010 Edition:Medical Cryogenic System Inspection RequirementsThe Joint Commission:Environment of Care StandardsCenters for Medicare and Medicaid:Requirements for Certified ProvidersJoint Commission Survey Experiences
103 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Required) Annual InspectionsMaster & Area Alarm PanelsInspect audible and visual signals function properly (Push Button Test)Test function of all alarm initiating devicesBulk Liquid Oxygen System*Annual inspection of system required by NFPA 55. This testing should be conducted by a qualified representative of the gas supplier.Source Supply SystemsInspect for proper operation and performanceTest control (automatic) pressure switches to ensure proper operation and settingsVisual inspection of flexible connectors and cylinder pigtails for physical damage, excessive wear, or expirationTest and calibrate carbon monoxide monitors (Medical Air Systems)Bulk Inspections:Good opportunity for ongoing training.
104 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Required) Periodic InspectionsAudible and Visual Alarm Indicators (1-3 Years)Test for proper operationStation Outlets & Inlets (1-3 Years) – Vacuum at least annually.Inspect and test for proper location, labeling, operation, and performance.Inspect for leakageArticulating Booms and Manufactured Assemblies (18 Months)*Inspect and test for leakage of flexible connectors (hoses)Visual inspection of flexible connectors for physical damage or excessive wearInspection of Flex Connectors:Inspect DISS connections as well…Check connections to the pipeline above the ceiling.These can loosen over time with swinging of booms.
106 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Best Practices) Daily InspectionsSource Supply System Operating Pressures (Main-line Gauges)Inspect and confirm all main-line pressures are within acceptable limits (+/- 5%)Medical Air SystemsInspect moisture removal system and drain as necessary (e.g. aftercoolers, receivers, dryer drains, sight glass, etc.)*Inspect dew point & carbon monoxide monitors for proper operation and readings are within acceptable limitsMedical-Surgical Vacuum & WAGD SystemsVisual inspection of receiver sight glass for water accumulation (drain if necessary)Bulk Liquid Oxygen SystemInspect all main tank and reserve system pressuresInspect tank contents (order as needed); If applicable, ensure Telemetry System is operating properly*Inspect for unusual icing and system leakage*Many of these tasks only take a few minutes to complete, but are invaluable in:1.) Ensuring patient safety.2.) Identifying minor issues before they become major issues.3.) Assistance with troubleshooting problems.Source Equipment Reserve:Example…Liquid x Liquid Manifold with the required HP cylinder reserve header.Inspect header for contents.
107 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Best Practices) Monthly Inspections*Alarm Warning Systems (Master, Area, & Local Alarms)Inspect audible and visual signals function properly (Push Button Test)Area Alarm PanelsInspect and confirm pressure readouts are within acceptable limitsMedical Air SystemsCalibrate carbon monoxide monitor (Calibration kit required)Source Equipment Reserve SystemsInspect for adequate supply (How long will it last if needed?)*
108 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Best Practices) Quarterly InspectionsMedical Air SystemsInspect medical air intake location for changes in condition, debris, and clearancesTest function of automatic alternating controlsTest control (automatic) pressure switches to ensure proper operation and settings*Inspect filters for performanceInspect compressor hours meter for required maintenanceMedical-Surgical Vacuum & WAGD SystemsInspect vacuum exhaust location for changes in condition, debris, and clearancesTest control pressure switches to ensure proper operation and settingsInspect pump hours meter for required maintenanceOne facility called and said…1.) We get a high carbon monoxide every once in a while.2.) usually around the time our second shift comes in.3.) What do you think?So, we visit the site to check it out…Sure enough at about 4:00PM the alarm goes off and it shows about PPM on the monitor.We take a walk up the roof to see the medical air intake and as we approach the intake, I see a freeway with truck after truck of shipping containers lined up idling in rush hour traffic…I think we found the problem!Ended up relocating to an area that was more protected and better prevailing wind direction.Test Control Switches:Ensure compressors engage / disengage when they are supposed to.
109 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Best Practices) Semi-Annual InspectionsManifold SystemsInspect for leakage (Manifold components, valves, pigtails, etc.)*Visual inspection of cylinder pigtails for physical damage or excessive wearTest function of automatic alternating controls (Secondary in Use)Area Alarm SystemsTest function of alarm sensors*Zone ValvesInspect zone valves for proper labeling, configuration, cleanliness, and accessInspect for leakage*Inspect and confirm gauge pressures are within acceptable limitsStation Outlets & InletsInspect and test critical care areas for proper gas flows, terminal leakage, and proper operation*Manifolds:Pull covers off the manifold.Couple of ways to test for leakage:1.) Ultrasonic Leak Detector2.) Leak Detector Solution (Oxygen Safe)3.) Pressure Test (May be considered a shutdown depending on how it is conducted)Area Alarms:Consider where the sensors are located (In alarm panel or somewhere above the ceiling?)If sensors can be removed, they can be tested with a hand pump.Zone Valves:Leakage same as other method.Do gauges work properly?Station Outlets & Inlets:This is an ASSE recommendation.May choose to test annually with all other outlets and inlets…And that’s fine.
110 ACTIVITIES SCHEDULES Inspection & Testing Schedules (Best Practices) Additional Annual InspectionsAll Central Supply (Source) SystemsInspect locations for proper design, construction, and ventilation requirements*Inspect pressure gauges to ensure proper operation and calibrationTest local alarms for proper operationMedical Air Quality MonitoringRecalibrate dew point sensor (usually sent off-site for recalibration)Test medical air for conformance to USP and NFPA 99 standardsAll Critical Valves (Source, Riser, Mainline, and Service Valves)Inspect valves for proper labeling, configuration, cleanliness, and accessInspect for leakageMedical Gas PipelineTest each patient use system for conformance to USP and NFPA 99 StandardsTest pipeline of each patient use system for particulates and puritySource Locations:Inspect locations for proper labeling and signage.“Caution…Medical Gases”“Room may have insufficient oxygen…Open door and allow room to ventilate before entering”
111 PERSONNEL QUALIFICATIONS WHO WILL BE PERFORMING THE WORK?ADOPTING QUALIFICATION STANDARDSTOOLS & TESTINGEQUIPMENTREQUIREMENTS- Accuracy, reading,and calibrationstandards.
112 PERSONNEL QUALIFICATIONS Who do you want performing the work?Will scheduled activities be performed by facility personnel or vendor performed?What qualifications are you goingto require for those performingthe work?If in-house, is additional trainingrequired to ensure qualifiedpersonnel?Other Considerations:If in-house personnel, isorganization committed tocontinuing education of personnel?We have the guns alright!
113 QUALIFICATION STANDARDS Maintenance, inspections, and testing should be conducted by individuals technically competent and experienced with medical gas systemsQualifications to Consider:Maintenance PersonnelDocumented Training (Manufacturer, Online Courses, etc.)ASSE 6040 Medical Gas Systems Maintenance PersonnelInspections & TestingASSE 6020 Medical Gas Systems InspectorASSE 6030 Medical Gas Systems VerifierMGPHO Credentialed Medical Gas Verifier (CMGV™)
114 QUALIFICATION STANDARDS Tools and Testing Equipment RequirementsTools should be clean, free of oils, and acceptable for use with oxygen service*Testing equipment should meet the requirements of NFPA 99 and ASSE 6000 Series, as well as, other applicable standardsTesting equipment should be National Institute of Standards and Technology (NIST) TraceableAll equipment calibrations should be current andup-to-dateMay want to develop a “Testing Equipment Specification”
115 FACILITY PERSONNEL TRAINING ENVIRONMENT OF CARE STATES:Organizations must provide adequate training of personnelOrganizations must ensure competency of individuals for the operations that they performOrganizations must provide continuing education to minimize physical risks to patients and personnelFDA (21 CFR ):NFPA 99, 2005 edition:*
116 FACILITY PERSONNEL TRAINING Organization should document all personnel training and continuing educationKeep documentation in employee personnel filesCan be a simple “Memo” with pertinent informationContinuing Education Options:Manufacturer TrainingBulk Supplier TrainingOnline TrainingSubject Matter CoursesCode Update Courses
117 CONCLUSION Compliance Review & Risk Assessment PROGRAM DELIVERABLESInventory of Equipment and Critical ComponentsCompliance Review & Risk AssessmentNew / Updated Policies & ProceduresActivities SchedulesQualification StandardsBoth In-House Personnel and VendorsFacility Personnel Training ProgramFinal Product:A Site Specific Operation & Management Program for your Medical Gas Systems
118 ENSURING PATIENT SAFETY Remember:Patients rely on health care organizations to ensure that their safety and well-being are continuously protected.This is an ongoing process, not a one time procedure.Developing a comprehensive Medical Gas Systems Operation & Management Program is the best way to ensure these systems remain safe and reliable.