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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. Healthcare Engineering Consultants. Monitoring Regulatory Requirements.
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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 Healthcare Engineering Consultants
Monitoring Regulatory Requirements 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 atleast 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 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 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 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 cut-off Healthcare Engineering Consultants
Emergency Management 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 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 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 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 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 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 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 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 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 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 facilitiesto 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 Healthcare Engineering Consultants
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 Healthcare Engineering Consultants