1. Facility Planning Legal & Regulatory Issues Week 3

2. Objectives for Week 3 Legal & Regulatory Issues Examine local, state, and federal legal and regulatory requirements. Develop a plan for waste management, fire and safety, and disaster management

3. Examine Local, State, & Federal legal and regulatory requirements Regulatory considerations Federal International Building Code National Electrical Code Americans with Disabilities Act (ADA) Governs accessibility requirements Details required sizes of patient rooms, bathrooms, etc., for wheelchair accessibility Includes signage requirements Requires and determines grab bar placement Stipulates handicap parking requirements

4. Examine Local, State, & Federal legal and regulatory requirements Federal (con’t) National Fire Protection Association (NFPA) 101 Life Safety Code for Healthcare Occupancies Requirements for fire alarms, emergency lighting, and fire suppression equipment Stipulates distances to exits, fire pull stations, fire extinguishers, etc. Determines fire and smoke ratings required for most aspects of the building and some furnishings, such as wall and floor coverings and some fabrics Governs smoke barrier requirements Dining room elevator requirements Some states, like California, have requirements that are stricter than the federal government

5. Examine Local, State, & Federal legal and regulatory requirements Health Insurance Portability And Accountability Act (HIPAA) governs patient privacy concerns and information security OSHA Requires worker safeguards (may affect equipment selection or design of work areas) Specific policies and procedures must be in place by opening date related to Bloodborne pathogens Confined spaces (elevators) Material Safety Data Sheets (MSDS) – Hazard Communication Plan Electrical safety (lock-out, tag-out) Other worker safety issues

6. Examine Local, State, & Federal legal and regulatory requirements Federal (continued): Clinical Laboratory Improvement Amendments (CLIA) governs clinical laboratories Medicare and Medicaid Conditions of Participation

7. Examine Local, State, & Federal legal and regulatory requirements State State health planning; Certificate of Need (CON) laws still apply in some states State licensing agency (Department of Health, Aging or Senior Services) Must approve architectural/detailed construction plans before construction starts Conducts onsite inspections of the construction in progress State fire codes enforced by the state fire marshall State building codes

8. Examine Local, State, & Federal legal and regulatory requirements Local Planning and zoning laws Local building codes Local fire department and city-specific fire requirements Architectural/detailed construction plans must be approved and a building permit issued before construction begins Conduct periodic surveys of the construction in progress

9. Examine Local, State, & Federal legal and regulatory requirements If the completed project will be accredited (by JCAHO, CARF/CCAC, other), architectural plans should be reviewed to assure compliance with applicable standards.

10. Examine Local, State, & Federal legal and regulatory requirements Licenses and permits required for operating the facility Must be in place before the facility opens Occupancy permit (issued by local authority) License from the state licensing agency (Department of Health, Aging or Senior Services) A local business license may be required

11. Examine Local, State, & Federal legal and regulatory requirements Licenses and permits required for operating the facility Separate business or operating licenses may be required for: Food service departments, restaurants, and cafeterias Barber and beauty shops Gift shop Drug Enforcement Agency permits (for storing and dispensing medications). If selling medications to outpatients, a retail pharmacy license will be required. Clinical Laboratory Improvements Act (CLIA) for clinical laboratory services. LTC facilities will require a CLIA waiver

12. Examine Local, State, & Federal legal and regulatory requirements Licensing, certifying, and opening the new facility: The state licensing agency will conduct a survey of the completed facility. If all requirements are met, the license to operate will be issued Requirements for passing the licensure survey Building and grounds 100% complete All building systems working properly All furnishings, equipment, and supplies in place Required staff hired, trained and some on duty during the licensure survey

13. Examine Local, State, & Federal legal and regulatory requirements Licensing, certifying, and opening the new facility: All policies and procedures finalized Disaster plan complete Waste management plan complete All contracts for any contracted services negotiated and in effect After state operating license has been issued and the first patients have been admitted, Medicare/Medicaid surveyors will arrive to check for compliance with the Medicare and Medicaid Conditions of Participation. If the facility is in substantial compliance, the facility will be certified to receive payment for Medicare and Medicaid patients.

14. Plans for Waste Management, Fire and Safety, and Disaster Management Waste management Regulatory standards for waste management originated with the World Health Organization (WHO) Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) govern many of the U. S. waste management requirements

15. Plans for Waste Management, Fire and Safety, and Disaster Management Waste management The waste management plan must address: Sorting of waste (where it is generated is best) Handling (as little as possible) Interim storage—short term (1 to 2 days) before final disposal Final disposal Solid medical waste Liquid medical waste Contaminated sharps Waste anesthesia gases Radioactive materials Required recordkeeping

16. Plans for Waste Management, Fire and Safety, and Disaster Management Guidelines for disaster planning or emergency management defined by the Department of Homeland Security Sample disaster or emergency management plans and guidance for developing plans are available from many states. An example from Kansas for long-term care facilities is located at: http://www.jocoem.org/documents/Plan_Templates/Adu lt_Care_Homes_Disaster_Plan_Template.pdf http://www.jocoem.org/documents/Plan_Templates/Adu lt_Care_Homes_Disaster_Plan_Template.pdf Should address business continuity planning as well as specific disaster conditions that might occur

17. Plans for Waste Management, Fire and Safety, and Disaster Management Health care facilities should also address their role for providing assistance when disasters occur elsewhere in their community Disaster plan should include a section on responding to fires Key points in business continuity planning Carefully assess how your organization functions and create a business flow chart if none exists Identify operations critical to survival Include emergency payroll, expedited financial decision making, and accounting systems Determine management succession Identify your suppliers, resources, and other business partners

18. Disaster Management Develop additional professional relationships in case primary suppliers are unable to service needs Create a contact list to use in emergencies and keep with emergency supplies at an off-site location Plan what you will do if your building is not accessible Plan for payroll continuity Define crisis management procedures and individual responsibilities in advance Review and update the plan annually Develop a plan for maintaining communication with employees

19. Disaster Management Keep important records like building plans, insurance policies, employee contact and identification information in a safe off-site location Ensure you have employees able to work Supplies Focus first on the basics of fresh water, food, clean air, and warmth. Create a plan for having essential medical supplies on hand or available Create evacuation plans Develop policies and procedures about deciding whether to stay or evacuate Ensure all employees are well trained in the procedures

20. Questions? Next week…….. Individual – Toolwire Model (alternate assignment is a powerpoint –you need a PHOTO of every key element) Team Summary