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Certified Hospital Emergency Coordinator (CHEC) Training Program
Regulations and Standards
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Objectives Understand the regulatory context in which healthcare facilities/systems operate Identify the current Emergency Management Standards (Joint Commission, CMS, etc) Identify the current standards, frameworks, and key organizations in healthcare management Discuss surge capacity and pandemic flu planning
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Context of Healthcare Emergency Management
These organizations can be grouped into the following categories: Accrediting organizations Regulatory organizations Standard-setting bodies Providers of guidance, grants, and training Governmental agencies Accreditation by an outside organization as meeting the organization’s written standards may appear to be voluntary, but in many cases, it relates back to certification since accreditation is often a requirement for certification. Regulatory agencies can be local, state or federal in their scope; however, most regulatory requirements for individual healthcare facilities are established and enforced at the state and local level. Depending on which set of regulations is the more stringent usually determines which organization’s rules have precedence over the others. Some jurisdictions have specific emergency management provisions, such as evacuation or utility failure plans. Other subject areas related to emergency management include privacy and patient confidentiality protection, worker health and safety and protection of the environment.
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Accreditation Many accrediting bodies exists for all types of health care settings, for example: The Joint Commission (TJC) DNV Healthcare Inc. (DNV) Accreditation Commission for Health Care (ACHC) Health Facilities Accreditation Program (HFAP) Community Health Accreditation Program (CHAP) Why Accreditation is Important (From: Accreditation is regarded as one of the key benchmarks for measuring the quality of an organization, along with its products and services. In the US, standard setting by industry leaders with peer review is widely accepted. Preparing for accreditation will disclose the company’s strengths and weaknesses. This stage of the process provides information for management to make decisions regarding operations, whether they are business or patient-care related, in order to improve effectiveness and efficiency of business performance. In other words, organizational self-examination should result in better planning, implementation and further evaluation of all processes. Accreditation standards provide the catalyst for organizational management strategy. The on-site survey validates the application of those strategies and determines if the company is actually performing according to the goals and objectives it has adopted in its system. Successful accreditation can reap many benefits for the company. The following is a list of typical results of companies becoming accredited: Better business plan Improved policies More effective and efficient operations Stronger risk management strategies Reduction in incidents Enhanced team awareness Credibility with government and third-party payors Marketing edge Greater customer trust Professional self-respect Services/Programs HOME/DURABLE MEDICAL EQUIPMENT HME/DME services are the selection, delivery, set-up and maintenance of medical equipment and/or oxygen as well as patient education regarding the use of this equipment. Assessment and hands-on care of patients, including performance of any tests, is considered clinical services and will be accredited using the Clinical Respiratory Standards. This includes pulse oximetry measurements. CLINICAL RESPIRATORY CARE This service is the care provided by a licensed respiratory care practitioner or respiratory therapist. The care includes the skilled assessment, treatment and education of patients requiring ongoing care. MEDICAL SUPPLY PROVIDER This service is the storage and delivery of supplies used for medical management in the home. These supplies are generally ordered by a physician and are usually disposable or semi-durable such as diabetic supplies. The supplies are normally delivered by mail. COMPLEX REHAB and ASSISTIVE TECHNOLOGY SUPPLIER Rehab tech supplies are equipment that primarily addresses wheeled mobility, seating and alternative positioning, ambulation support and equipment, environmental control, augmented communication and other equipment that assist patients in performing activities of daily living. FITTER SERVICES These services include prosthetic fitting of a variety of products such as diabetic shoes and post- mastectomy breast implants. HOME HEALTH Home Health services are skilled services that are usually provided on a visit basis, as opposed to hourly, for a short duration of time. These services are usually provided by a licensed and /or Medicare certified agency. Home Health services are provided by skilled professionals including nursing; physical, occupational and speech therapy; medical social work and home health aide. INFUSION NURSING This service is the administration of parenteral medications via various accesses and ports by an RN specifically trained in these specialized services. This service can be performed in a variety of settings. HOSPICE Hospice is the care of patients with life limiting illnesses in the home or hospice inpatient facility. End of life care involves a multidisciplinary approach to medical care, pain management and emotional/spiritual care. This team approach will be used in the survey process. ACHC surveys are conducted by a hospice nurse surveyor as well as a clinical support surveyor, such as a medical social worker. An agency that provides inpatient services must adhere to the inpatient standards as well as the primary hospice standards. PRIVATE DUTY NURSING PDN services are usually provided either hourly or by shift and are covered by various payers, but not Medicare. Services can be provided by an RN or LPN. PRIVATE DUTY AIDE Aide services encompass all levels of care provided by a nursing assistant or sitter including Personal Care Services, chore, companion sitters and homemakers. PHARMACY SERVICES Pharmacy Service includes the following: RESPIRATORY NEBULIZER MEDICATION PHARMACY This is a pharmacy that dispenses aerosolized single patient dose respiratory medications. These medications are compounded by the pharmacy and are usually delivered directly to the patient's home. SPECIALTY PHARMACY This is a pharmacy that targets a specific patient population with a chronic disease. Medications are dispensed to patient homes, physician offices or clinics specializing in treating certain diseases. Medications are usually self-injectable. FIRST DOSE PHARMACY This is an organization that provides a limited number of doses of a medication for initial treatment to another organization. INFUSION PHARMACY This is a pharmacy that provides parenteral medications to patients in various settings. The service includes clinical monitoring by a pharmacist. AMBULATORY INFUSION CENTER AICs are centralized locations where a patient receives infusion therapy. The facility is staffed by a nurse and usually a pharmacist. The medications are compounded by a pharmacist and administered by the nurse. Accreditation Accreditation is awarded for a period of three (3) years from the first day following the last day of the survey. Accreditation is contingent upon receipt of total fees, successful completion of ACHC survey and continuing compliance with the Standards and the Accreditation Policies and Procedures. ACHC reserves the right to make unannounced on-site visits at any time during the three (3) year accreditation cycle to determine continuing compliance with standards. If non-compliance with ACHC standards or Medicare Conditions of Participation is confirmed during the accreditation cycle, survey fees/expenses will be billed to the organization. Why ACHC? ACHC is the only national health care accrediting organization started at the grass-roots level by a few home care providers endeavoring to create a viable option of accreditation sensitive to the needs of small providers. The model was to “ensure a voice for providers". The inception began in 1985 in Raleigh, NC through the efforts of members of the state home care association and a few representatives from four divisions of state government. Incorporation was accomplished in August of 1986, with the first accredited organization being awarded a certificate in January of The company began offering services nationally in 1996. The founders’ design was based upon the following: Standards that would be patient care focused, relevant, realistic and written in easily understood language A self-assessment process that would help applicants identify and organize evidence of compliance Educational and consultative site-visits Customer services with a user-friendly approach From Joint Commission: What is the Joint Commission Our Mission To continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations.Who We Are The Joint Commission is an independent, not-for-profit organization, established more than 50 years ago. We are governed by a board that includes physicians, nurses, and consumers. The Joint Commission sets the standards by which health care quality is measured in America and around the world.What We Do The Joint Commission evaluates the quality and safety of care for more than 15,000 health care organizations. To maintain and earn accreditation, organizations must have an extensive on-site review by a team of Joint Commission health care professionals, at least once every three years. The purpose of the review is to evaluate the organization's performance in areas that affect your care. Accreditation may then be awarded based on how well the organizations met Joint Commission standards. Accreditation Programs Ambulatory Care Assisted Living Behavioral Health Care Critical Access Hospitals Home Care Hospitals Laboratory Services Long Term Care Networks Office-Based Surgery FROM: About the Healthcare Facilities Accreditation Program (HFAP) The Healthcare Facilities Accreditation Program (HFAP), founded by the American Osteopathic Association, has been providing medical facilities with an objective review of their services since The program is recognized nationally by the federal government, state governments, insurance carriers and managed care organizations. An Invitation to Accreditation Excellence The HFAP has been accrediting healthcare facilities for over 60 years and under Medicare since its inception. It is one of the few voluntary accreditation programs in the United States authorized by the Centers for Medicare & Medicaid Services (CMS), formerly HCFA, to survey hospitals under Medicare. In addition, the program is a cost-effective, user friendly means to validate the quality of care provided by a facility. If a healthcare facility is not accredited by the HFAP, we invite you to consider the benefits you would achieve by signing up. FROM: The Leader in Community based Health Care Accreditation The Community Health Accreditation Program, Inc. (CHAP) is the leader in improving the quality of community based health care services in the USA. CHAP is an independent and non-profit accrediting body created in 1965. CHAP's goal is for home care to not only prosper, but gain strength in the overall health care industry. To achieve this, CHAP is devoted to providing consultation of the highest caliber, along with a broad network of professional staff resources.
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Regulation Regulation of healthcare facilities and systems is conducted by overlapping federal, state, and local agencies
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State and Local Standards and Regulations
Most regulatory requirements for individual healthcare facilities are established and enforced at the state and local level State and local agencies have standards and regulations specific to every jurisdiction in the country
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State and Local Standards and Regulations
Some jurisdictions have specific emergency management provisions Some topics related to emergency management include: Privacy and patient protection Worker health and safety Environmental protection Others…
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Some Health Care Regulatory Entities
Food and Drug Administration Centers for Medicare & Medicaid Services (CMS) Occupational Safety and Health Administration (OSHA) Environmental Protection Agency (EPA) Regulatory Agencies FROM: Employment Standards Administration, US Department of Labor largest agency within the DOL, enforces and administers laws governing legally-mandated wages and working conditions, including child labor, minimum wages, overtime and family and medical leave; equal employment opportunity in businesses with federal contracts and subcontracts; workers' compensation for certain employees injured on their jobs; internal union democracy and financial integrity, and union elections, which protect the rights of union members; and other laws and regulations governing employment standards and practices. Equal Employment Opportunity Commission (EEOC) mission is to promote equal opportunity in employment through administrative and judicial enforcement of the federal civil rights laws and through education and technical assistance. The U.S. Equal Employment Opportunity Commission (EEOC) was established by Title VII of the Civil Rights Act of 1964 and began operating on July 2, Enforces the principal federal statutes prohibiting employment discrimination, including: Civil Rights Act of 1964; Age Discrimination in Employment Act of 1967; Equal Pay Act of 1963 (EPA); Americans with Disabilities Act; Civil Rights Act of 1991; and Rehabilitation Act of 1973. Food and Drug Administration (FDA) is charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. Agency can take a number of actions to protect the public health. Legal remedies include product recalls, seizures, sanctions, and prosecutions. Health and Human Services Department has 300 programs including FDA, Medicare/Medicaid, Public Health Service, Indian Health Service, financial assistance for low-income families, child support enforcement, maternal and infant health, Head Start, services for older Americans, including home-delivered meals, among others. HHS Budget, FY $429 billion with 63,100 employees. Health and Human Services Office of Inspector General (OIG) mission is to reduce fraud, waste, and abuse in the Department’s programs (including Medicare, Medicaid, Indian Health Service, FDA, Public Health Service, NIH, CDC, Child and Maternal Health, among others. It has four Offices: (a) Audit, (b) Investigations, (c) Evaluations and Inspections, and (d) Legal Counsel. The OIG has independent investigative and sanctioning authorities. Centers for Medicare & Medicaid Services (CMS) formerly Health Care Financing Administration (HCFA) administers Medicare, Medicaid and the State Children's Health Insurance Program (SCHIP). Provides health insurance for over 74 million Americans. Performs quality-focused activities, including regulation of laboratory testing (CLIA), development of coverage policies, and quality-of-care improvement. Maintains oversight of the survey and certification of nursing homes and continuing care providers (including home health agencies, intermediate care facilities for the mentally retarded, and hospitals). Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is a private, not for profit organization established in 1951 to evaluate health care organizations that voluntarily seek accreditation. JCAHO evaluates/accredits over 18,000 health care organizations in the United States, including 5,100 hospitals, more than 6,200 home care entities, and over 7,000 other health care organizations that provide behavioral health care, laboratory services, ambulatory care, and long term care services. It also evaluates and accredits health plans and health care networks. It is governed by representatives from the American College of Physicians, American College of Surgeons, American Dental Association, American Hospital Association, American Medical Association, an at-large nursing representative, and six public members. US Department of Justice (DOJ) enforces federal law and defends the interests of the United States according to the law, to provide Federal leadership in preventing and controlling crime, to seek just punishment for those guilty of unlawful behavior, to administer and enforce the Nation's immigration laws fairly and effectively, and to ensure fair and impartial administration of justice for all Americans. Their criminal division operates through the United States Attorney Offices. Occupational Safety and Health Administration (OSHA) was created in 1971 to reduce workplace fatalities, occupational injuries and illness rates. OSHA has a staff of 2,370 including 1,170 inspectors and a budget of $426 million. Office of Government Ethics (OGE) is a small agency within the executive branch, was established by the Ethics in Government Act of It exercises leadership in the executive branch to prevent conflicts of interest on the part of Government employees, and to resolve those conflicts of interest that do occur. In partnership with executive branch agencies and departments, OGE fosters high ethical standards for employees and strengthens the public's confidence that the Government's business is conducted with impartiality and integrity. Office of Managed Care, Health Care Financing Administration The Office of Managed Care (OMC), a HCFA office serves as the Departmental focal point to advance the managed care concept under Medicare and Medicaid, and has regulatory authority over Federally-qualified health maintenance organizations (HMOs). Specific activities are carried out in the areas of Federal qualification of HMOs and compliance with provisions of the Public Health Service Act dealing with Federally-qualified HMOs; granting and administration of Medicare contracts between HCFA and Federally-qualified HMOs. United States Sentencing Commission is an independent agency created in 1984 in the judicial branch of government. They developed sentencing guidelines for organizations and entities that went into effect November 1, These guidelines included standards for compliance programs. Workshop on Electronic Data Interchange (WEDI) Not for profit organization that provides a forum for the definition of NFPA NFPA 1 Batterymarch Park Quincy, Massachusetts USA Tel: Sales/Member Services or Fax: The mission of the international nonprofit NFPA, established in 1896, is to reduce the worldwide burden of fire and other hazards on the quality of life by providing and advocating consensus codes and standards, research, training, and education. The world's leading advocate of fire prevention and an authoritative source on public safety, NFPA develops, publishes, and disseminates more than 300 consensus codes and standards intended to minimize the possibility and effects of fire and other risks. Helping to save lives and protect property around the world NFPA develops, publishes, and disseminates more than 300 consensus codes and standards intended to minimize the possibility and effects of fire and other risks. Virtually every building, process, service, design, and installation in society today is affected by NFPA documents. The Office of Regulatory Services (ORS) regulates a variety of health care, long-term care and residential child care facilities and programs. We help ensure that these facilities and programs provide Georgians with care that meets State and other mandatory requirements. Many changes are occurring in the industries we regulate. Whether you are a provider or consumer, ORS continues to implement new initiatives and take actions to protect you and provide Georgians with better services. What We Regulate The Office of Regulatory Services (ORS) inspects, monitors, licenses, registers and certifies a variety of health care, long-term care and residential child care facilities.
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Occupational Safety and Health Administration (OSHA)
Appendix 2-K – ASHE – Roadmap to Healthcare OSHA Compliance Occupational Safety and Health Administration (OSHA) OSHA regulates the safety and health of America's workers by setting and enforcing standards, as well as providing training, outreach, and education Nearly every employee in the US is under OSHA jurisdiction OSHA has three main roles: Regulators, inspectors and enforcement OSHA issues regulations to ensure workplace safety, performs inspections to ensure that regulations are being followed, and hands out punishments and fines for non compliance. Outreach, education and compliance assistance OSHA provides education and compliance assistance to employers to help them meet OSHA guidelines and regulations and to create safe working environments. Assistance includes publications in print and online and workplace safety; health information or assistance for workers is available through a call center at OSHA; and free workplace consultations to help establish safety and health programs and identify/correct workplace hazards. Partnership Programs. OSHA, through the Strategic Partnership Program, enters into long-term cooperative relationships with groups of employers, employees, employee representatives to improve workplace safety and health. OSHA through the Safety and Health Achievement Recognition Program provides incentives and support to employers to develop, implement and continuously improve effective safety and health programs
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OSHA Seeks to establish partnerships and encourage continual improvement in workplace safety and health Publishes guidance on a variety of topics specific to the healthcare community including PPE and respirator use
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OSHA Regulations General Health and Safety
Appendix 2-C – OSHA – 29 CFR Respiratory Protection Appendix 2-D – OSHA – 29 CFR Hazardous Waste Operations and Emergency Response OSHA Regulations General Health and Safety OSHA has many regulations for general worker health and safety including, hazardous materials, privacy, ergonomics, blood-borne pathogens, etc. In an emergency, OSHA is concerned with… 29 Code of Federal Regulations (CFR) Design and construction requirements for exit routes OSHA’s requirements for emergencies are compiled and summarized in: Principal Emergency Response and Preparedness Requirements and Guidance – Occupational Safety and Health Administration (2004)
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OSHA 29 CFR Maintenance, safeguards, and operational features for exit routes 29 CFR Emergency action plans 29 CFR Fire prevention plans 29 CFR Medical services and first aid 29 CFR Portable fire extinguishers 29 CFR Employee alarm systems
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OSHA Regulations Appendix 2-D – OSHA – 29 CFR Hazardous Waste Operations and Emergency Response Hazardous Waste Operations and Emergency Response (HAZWOPER) 29 (CFR) Requires employers, including hospitals, to plan for emergencies if they expect their employees to handle an emergency involving hazardous substances Requires varying levels of training for personnel involved in hazardous material releases or clean-up Additional requirements under HAZWOPER CFR : Medical personnel and decon training requirements First Responder Operations Level (1) EMS personnel and awareness training First Responder Awareness Level (2) ER clinical staff (plus additional staff) and HazMat / PPE requirements Familiarity with plan, training, and participation in drills Ancillary personnel and decon training 29 CFR (q)(11), and MSDSs
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HAZWOPER (cont.) Requires the use of an Incident Command System
Requires developing a written response plan that includes personnel roles, lines of authority and communication, site security and control, medical and emergency alert procedures, and to provide workers with appropriate protective equipment
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Appendix 2-C – OSHA – 29 CFR 1910.134 Respiratory Protection
OSHA Regulations Requires employers including hospitals, to implement a respiratory protection program if they expect to use their employees to handle an emergency involving hazardous substances Medical personnel who will decon victims must be trained to the First Responder Operations Level (1) with emphasis on the use of PPE and decontamination procedures. (Refer to 29 CFR (q)(6)) EMS personnel are often the first on the scene and should be given First Responder Awareness Level (2) training as a minimum. ER clinical staff, plus any employee who might be exposed to hazardous substances during an emergency response incident, should: (1) be familiar with how the hospital intends to respond to hazardous substance incidents, (2) be trained in the appropriate use of PPE, and (3) be required to participate in scheduled drills. If ancillary personnel will be expected to clean up the decontamination area, must be trained in accordance with 29 CFR (q)(11), and have access to Material Safety Data Sheets (MSDSs) for those chemicals that may be used to decontaminate equipment and area. OSHA requirements for healthcare are summarized in “Best Practices for Hospital Based First Receivers from MCI Incidents Involving Release of Hazardous Substances”
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OSHA Program elements: Establishing a Policy
Selection and Use of Respiratory Protection Equipment Medical Approval Employee Training Fitting Cleaning and Disinfecting Routine Inspection
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Environmental Protection Agency (EPA)
Protection of human health and the environment Develop and enforce regulations that implement environmental laws Responsible for research and setting national standards and delegate enforcement to the states
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Some more regulatory agencies
National Fire Protection Agency (NFPA) Department of Health and Human Services
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Appendix 2-G – NFPA 1600 Standard
NFPA Standards NFPA 1: Uniform Fire Code and NFPA 101: Life Safety Code Provides standards for building design elements and materials, fire alarms and suppression, etc. for occupant safety NFPA 70: National Electrical Code Provides standards for design and modification of electric systems and components NFPA 99: Standard for Healthcare Facilities Chapter 12: Health Care Emergency Management provides a brief framework for an emergency management program
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NFPA NFPA 110: Standard for Emergency and Standby Power Systems
Provides standards for the installation and use of generators NFPA 1600: Standard on Disaster/ Emergency Management and Business Continuity Programs Standard establishes a common set of criteria for disaster/emergency management and business continuity
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Basic Planning Requirements
The disaster plans should include at a minimum plans for the following emergency situations: Local and widespread weather emergencies or natural disasters, such as tornadoes, hurricanes, earthquakes, ice or snowstorms, or floods
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Basic Planning Requirements
The disaster plans should include at a minimum plans for the following emergency situations: Manmade disasters such as acts of terrorism and hazardous materials spills
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Basic Planning Requirements
The disaster plans should include: Unanticipated interruption of service of utilities, including water, gas, or electricity, either within the facility or within a local or widespread area
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Basic Planning Requirements
There should be plans to ensure sufficient staffing and supplies to maintain safe patient care during an emergency situation. Photo © Microsoft Corporation
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Basic Planning Requirements
There should be plans for the emergency transport or relocation of all or a portion of the hospital’s patients, in vehicles appropriate to the patient’s condition(s) when possible, including written agreements with any facilities which have agreed to receive the hospital’s patients
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Basic Planning Requirements
Fire drills shall be conducted at irregular intervals throughout the year.
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State X Emergency Management Agency Act Ch. xx, par. xx, Sec. x
State X Emergency Management Agency Act Ch. xx, par. xx, Sec. x.- Emergency Powers of the Governor (a) In the event of a disaster, …the Governor may, by proclamation declare that a disaster exists. Upon such proclamation, the Governor shall have and may exercise the following emergency powers: To suspend the provisions of any regulatory statute prescribing procedures, if strict compliance with the provisions of any statute, order, rule, or regulation would in any way prevent, hinder or delay necessary action, including emergency purchases, by the State Emergency Management Agency, in coping with the disaster. Most states have a clause or act enabling the governor of the state to relax regulator requirements in the aftermath of a disaster.
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Some Standard Setting Bodies in Health Care
Administration on Aging Agency for Healthcare Research and Quality (AHRQ) Drug Enforcement Agency (DEA) United States Pharmacopeia (USP) Medical Specialty Colleges Government Agencies and Non-Government Standard Setting Organizations Administration on Aging (AoA) For over 35 years, the AoA has provided home and community-based services to millions of older persons through the programs funded under the Older Americans Act. You may have heard about our home-delivered meals programs or nutrition services in congregate settings, or transportation, adult day care, legal assistance or health promotion programs. If you have visited a nursing home, you may have talked to one of our Ombudsmen, who provide an on-going presence in long-term care facilities, monitoring care and conditions and providing a voice for those who are unable to speak for themselves. Our National Family Caregiver Support Program provides a variety of services to help people who are caring for family members who are chronically ill or who have disabilities. AoA has developed a strong focus on measurement of program results, including: implementing and strengthening OAA program information reporting from the states, development of new and well-tested performance outcomes measures, national surveys of OAA participants which assess OAA services, a series of past, current, and planned program evaluations and related studies, and compilations of relevant aging population statistics. AoA's success in these activities has been recognized by its Program Assessment Reporting Tool (PART) assessment by the Office of Management and Budget (OMB) and its success in achieving documented OAA program results. These activities are implemented by AoA's Office of Evaluation and other program offices. [OE Status Report Agency for Healthcare Research and Quality* The Agency for Healthcare Research and Quality (AHRQ), is committed to helping the Nation improve our health care system. To fulfill its mission, AHRQ conducts and supports a wide range of health services research. As 1 of 12 agencies within the Department of Health and Human Services (HHS), the Agency for Healthcare Research and Quality (AHRQ) has a mission to improve the quality, safety, efficiency, effectiveness, and cost-effectiveness of health care for all Americans. The Agency works to fulfill this mission by conducting and supporting health services research, both within AHRQ as well as in leading academic institutions, hospitals, physicians' offices, health care systems, and many other settings across the country, that: Reduces the risk of harm from health care services by using evidence-based research and technology to promote the delivery of the best possible care. Transforms research into practice to achieve wider access to effective health care services and reduce unnecessary health care costs. Improves health care outcomes by encouraging providers, consumers, and patients to use evidence-based information to make informed treatment choices/decisions. The Agency's mission helps HHS achieve its strategic goals to improve the safety, quality, affordability, accessibility of health care; public health promotion and protection, disease prevention, and emergency preparedness; promote the economic and social well-being of individuals, families, and communities; and advance scientific and biomedical research and development related to health and human services. The Agency has a broad research portfolio that touches on nearly every aspect of health care including: Comparative effectiveness. Patient safety/medical errors. Health care quality. Health information technology. Evidence-based medicine. Clinical practice. Outcomes of care and effectiveness. Primary care and care for priority populations. Organization and delivery of care and use of health care resources. Health care costs and financing. Health care system and public health preparedness. California State Board of Pharmacy Drug Enforcement Administration The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets. Of all the major drugs of abuse, only marijuana is available as a natural, harvested product. The others, whether they are illicit drugs such as cocaine, heroin, methamphetamine, or legitimately produced pharmaceuticals, must be produced or manufactured. Many problems associated with drug abuse are the result of legitimately manufactured controlled substances being diverted from their lawful purpose into illicit drug traffic. The DEA's Office of Diversion Control is responsible for two distinct problems: the diversion of controlled pharmaceuticals and the diversion of controlled chemicals. Diversion of Controlled Pharmaceuticals Many of the narcotics, depressants, and stimulants manufactured for legitimate medical use are subject to abuse, and have therefore been brought under legal control. The goal of controls is to ensure that these "controlled substances" are readily available for medical use, while preventing their distribution for illicit sale and abuse. Under federal law, all businesses that manufacture or distribute controlled drugs, all health professionals entitled to dispense, administer or prescribe them, and all pharmacies entitled to fill prescriptions must register with the DEA. Registrants must comply with a series of regulatory requirements relating to drug security, records accountability, and adherence to standards. The DEA is also obligated under international treaties to monitor the movement of licit controlled substances across U.S. borders and to issue import and export permits for that movement. The DEA also devises ways to deal with problems of international drug diversion. Diversion cases involve, but are not limited to, physicians who sell prescriptions to drug dealers or abusers, pharmacists who falsify records and subsequently sell the drugs, employees who steal from inventory and falsify orders to cover illicit sales, prescription forgers, and individuals who commit armed robbery of pharmacies and drug distributors. Diversion of Controlled Chemicals Most of the drugs in the illicit traffic are products of illicit processing or synthesis. Cocaine, for example, can be extracted and converted to its preferred form only by using a tremendous quantity of industrial chemicals. Heroin must be synthesized by using an acetylating agent after the morphine has been extracted from raw, harvested opium. Methamphetamine, PCP, LSD, MDMA and methaqualone are purely synthetic drugs manufactured from chemical precursors. Until recently, there were virtually no legal impediments to obtaining the chemicals necessary to manufacture drugs of abuse, no records required to be maintained for inspection, and no penalties for negligence or willful diversion. The Chemical Diversion and Trafficking Act of 1988 extended the concept of commodity control to those chemicals most often used for the manufacture and synthesis of drugs of abuse. With the support of the State Department, the DEA pursued the same goal on the international level. The result was the incorporation of Article 12 into the U.N. Convention Against Illicit Drug Traffic of 1988 (the Vienna Convention). This provision established similar controls over a list of 22 critical chemicals commonly diverted for the production of the major drugs of abuse. Furthermore, in February 1991, the Anabolic Steroid Control Act was passed by Congress. The act classified 27 named steroids as Schedule III substances under the Controlled Substances Act which DEA administers. In 1993 domestic chemical control was strengthened with enactment of the Domestic Chemical Diversion Control Act, which added a registration requirement for List I chemical handlers, and removed exemptions in order to prevent diversion of methamphetamine precursor chemicals. Subsequently, Congress passed the Comprehensive Methamphetamine Control Act of 1996 and the Methamphetamine Anti-Proliferation Act of 2000 to pointedly address the growing problem of clandestine methamphetamine production and abuse in the United States. The Office of Diversion Control consists of diversion investigators, chemists, pharmacologists, program analysts, and others. The office's activities include: program priorities and field management oversight; coordination of major investigations; drafting and promulgating of regulations; establishment of national drug production quotas; design and execution of diplomatic missions; U.S. obligations under drug control treaties; design and proposal of national legislation; advice and leadership on state legislation/regulation; legal control of drugs and chemicals not previously under federal control; control of imports and exports of drugs and chemicals; computerized monitoring and tracking of the distribution of certain controlled drugs; distribution of intelligence to the states; liaison with industry; and the planning and allocation of program resources. Food and Drug Administration Liaison* Health Resources and Services Administration Maryland State Board of Pharmacy National Association of Boards of Pharmacy (NABP) National Digestive Diseases Information Clearinghouse North Dakota State Board of Pharmacy United States Pharmacopeia (USP)* Who We Are The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP's standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. USP is a non-governmental, not-for-profit public health organization whose independent, volunteer experts work under strict conflict–of–interest rules to set its scientific standards. USP's contributions to public health are enriched by the participation and oversight of volunteers representing pharmacy, medicine, and other health care professions as well as academia, government, the pharmaceutical and food industries, health plans, and consumer organizations. Our Mission To improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. What We Do Product Quality–Standards and Verification USP establishes state–of–the–art documentary and reference standards to ensure quality medicines, food ingredients, and other health care products. Developed through a unique process of public involvement, standards setting is a core activity for USP. USP's documentary standards and reference standards are used by regulatory agencies and manufacturers of pharmaceuticals, over–the–counter drugs, dietary supplements, and food ingredients to ensure that these products are of the appropriate strength, quality, and purity. Prescription and over–the–counter medicines available in the United States must, by federal law, meet USP's public standards, where such standards exist. Many other countries require the use of high–quality standards such as USP's to assure the quality of medicines and related products. USP disseminates its standards for medicines to pharmaceutical manufacturers, pharmacists, and other users through its United States Pharmacopeia–National Formulary (USP–NF) and its standards for food ingredients through the Food Chemicals Codex (FCC), as well as through official USP Reference Standards materials and Pharmacopeial Education courses. USP also conducts verification programs for dietary supplement ingredients and products and pharmaceutical ingredients. These programs involve independent testing and review to verify ingredient and product integrity, purity, and potency for manufacturers who choose to participate. Healthcare Information USP develops authoritative, unbiased information relating to various aspects of drug use and disseminates this information to practitioners, pharmacists, and others who make decisions about health care around the world. Significant among USP's health care information initiatives is the development of a drug classification system that Medicare Prescription Drug Benefit plans may use to develop their formularies. USP also partners with the U.S. Agency for International Development, the World Health Organization, John Snow International, the Bill and Melinda Gates Foundation, and others in worldwide projects that help to assure drug quality and proper drug use in many developing countries. Patient Safety USP operates two programs to promote safer care of patients who take medications and stay in hospitals. The Medication Errors Reporting Program allows healthcare professionals to directly report medication errors to USP. MEDMARX®, an Internet–based medication error and adverse drug reaction reporting program, is designed for use in hospitals and health systems. USP also uses its knowledge base to provide information that supports the healthcare community in the research and development of patient safety initiatives. Drug Quality and Information USP's Drug Quality and Information (USP DQI) Program is a cooperative agreement with the United States Agency for International Development (USAID). The USP DQI program has established a presence in USAID–priority countries on four continents advancing strategies to improve drug quality and the appropriate use of drugs. Four main programs that USP promotes are: ensuring drug quality by imparting its expertise in the field of drug quality by working with local governments, USAID missions, the World Health Organization (WHO), and other partners to evaluate a country's readiness and capacity to provide necessary drug quality assurance, providing continuing education for physicians, pharmacists and nurses in drug information and pharmacovigilance to help improve drug dispensing and ensure competence and accountability, developing and disseminating evidence–based drug and therapeutic information through targeted drug and therapeutic information materials for health care providers based on specific needs, and furnishing technical leadership toward regional and international cooperation through USP's system of open conferences, Internet–based communications, and regular publications.
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Context of Healthcare Emergency Management
Appendix 2-A – Annotated Bibliography of Resources Each healthcare facility/system contends with a multiplicity of different standards, regulations, and requirements prescribed by various state-wide and nation-wide organizations CMS Many organizations offering guidance to healthcare facilities / systems or public health institutions publish this guidance in the form of best practices. These can include lessons learned from previous incidents through the experiences of other organizations and personnel, or may instead utilize detailed medical or management research principles. While standards and regulations can impose on your facility / system effective structures, processes, equipment, and training to assist in emergency management, best practices offer experience-based recommendations that many times go beyond what is required and provide a proactive approach to your facility’s / system’s preparedness. DNV OSHA NFPA Joint Commission EPA
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Healthcare Facility Regulatory Context
Appendix 2-A – Annotated Bibliography of Resources Healthcare Facility Regulatory Context Applicability of these requirements varies greatly and stems from their diverse methods of implementation, for example: Inclusion in Code of Federal Regulations (CFR) Adoption into state laws and local codes Requirements for products and vendors Financial disincentives for non-compliance Code of Federal Regulations (CFR): Main Page The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. Each volume of the CFR is updated once each calendar year and is issued on a quarterly basis.
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Healthcare Facility Regulatory Context
The three most commonly applied standards and regulations to healthcare facilities are: Licensing Certification Accreditation Joint Commission (JC) Accreditation Process: JC’s accreditation process evaluates an organization’s compliance with its standards and other accreditation requirements Why seek accreditation? Strengthens community confidence in the quality and safety of care, treatment and services Provides a competitive edge in the marketplace Improves risk management and risk reduction Helps organize and strengthen patient safety efforts Provides education on good practices to improve business operations Provides professional advice and counsel thereby enhancing staff education Enhances staff recruitment and development Provides deeming authority for Medicare certification Recognized by insurers and other third parties May reduce liability insurance costs
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Licensing, Certification, and Accreditation
Issued by a government regulatory body, typically at the state-level May be required for Medicaid participation Certification Issued by Centers for Medicare and Medicaid Service (CMS) Required for Medicare participation State licensing of healthcare facilities has historically been the trend in the United States, with some exception (e.g. New York City hospitals vs. New York State hospitals). These licensing requirements are implemented in state regulations and typically address a facility’s physical plant and its operations. In addition, there may be additional licenses necessary to function fully (i.e. pharmacy permit, business license, hazardous waste permit, CLIA waiver, plan review approvals, etc.).
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Licensing, Certification, and Accreditation
Theoretically voluntary, but can often be a de facto requirement May fulfill continuing state licensure and/or CMS certification obligations
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Putting the Rules Together
Joint Commission DNV CMS NFPA OSHA EPA State statutes Etc…
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Joint Commission Joint Commission regulations and standards are the cornerstone The process begins with the TJC EM requirements
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TJC Emergency Management Standards
Those outlined in the Emergency Management (EM) Chapter for Hospital Program Accreditation are of most importance The slides that follow review the current Standards
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Emergency Management Standards: The Six Critical Areas
2017 Standard EM Communication EM Resources and Assets EM Safety and Security EM Staff Roles and Responsibilities EM Utilities EM Clinical and Support Activities
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Planning Requirements from TJC
The hospital engages in planning activities prior to developing its written EOP EP #1-hospital’s leaders, including leaders of the medical staff, participate in planning activities prior to developing the EOP 8 Elements of Performance for EM
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EM.02.01.01 2017 Standards The hospital has an EOP
There are 8 Elements of Performance: Leadership must participate There must be a comprehensive EOP 96 hour capabilities must be known Recovery strategies should be included When to initiate and terminate phases Name those in authority to activate the plan ID alternative sites of care If an actual emergency occurs the hospital must implement its procedures related to care, treatment and services for patients 96 hour Rule: The Emergency Operations Plan identifies the hospital’s capabilities and establishes response procedures for when the hospital cannot be supported by the local community in the hospital's efforts to provide communications, resources and assets, security and safety, staff, utilities, or patient care for at least 96 hours.
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2017 Standards EM As part of its Emergency Operations Plan, the hospital prepares for how it will communicate during emergencies. There are 15 EPs on this standard (though they are numbered 1-17, 15 and 16 have been previously omitted) 1st of the 6 critical areas
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2017 Standards EM As part of its Emergency Operations Plan, the hospital prepares for how it will manage resources and assets during emergencies There are 9 Elements of Performance for this standard (though they are numbered 1-12, 7, 8, and 11 have been previously omitted)
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2017 Standards EM As part of its Emergency Operations Plan, the hospital prepares for how it will manage safety and security during an emergency There are 9 EPs for this standard (though they are numbered 1-10, #6 was previously omitted)
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2017 Standards EM As part of its Emergency Operations Plan, the hospital prepares for how it will manage staff during an emergency There are 9 EPs for this standard (though they are numbered 1-10, #1 was previously omitted)
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2017 Standards EM As part of its Emergency Operations Plan, the hospital prepares for how it will manage utilities during an emergency. There are 7 EPs for evaluation on this standard (though they are numbered 1-8, #1 was previously omitted)
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2017 Standards EM As part of its Emergency Operations Plan, the hospital prepares for how it will manage patients during emergencies There are 8 EPs for this standard (though they are numbered 1-17, 1, 9, and 10 were previously omitted) Last of the 6 critical areas
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2017 Standards EM …the hospital may grant disaster privileges to volunteer licensed independent practitioners There are 9 EPs for this standard NOT IN THE SIX CRITICAL AREAS!!!!!!! During disasters, the [organization] may grant disaster privileges to volunteer licensed independent practitioners. Note: A disaster is an emergency that, due to its complexity, scope, or duration, threatens the organization's capabilities and requires outside assistance to sustain [patient] care, safety, or security functions. Standard EM The hospital grants disaster privileges to volunteer licensed independent practitioners only when the Emergency Operations Plan has been activated in response to a disaster and the hospital is unable to meet immediate patient needs.
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2017 Standards EM The hospital evaluates the effectiveness of its emergency management planning activities Some of the Elements of Performance for this standard include: An annual review of hazards, risks, and emergencies Annual review of inventory An annual review of the objectives and scope of the EOP Annual emergency management planning reviews are forwarded to senior hospital leadership for review NEW in 2014
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EM.03.01.03 2017 Standards …evaluates the effectiveness of its EOP
There are 17 EPs for this standard, including: Conducting exercises on the plan at each site included in the plan twice a year One exercise must include an influx of patients (for each site offering emergency services) Monitoring communications, resources, management of safety and security, staff roles and responsibilities, utility systems, and patient clinical and support activities Revised EP 13-input from all levels of staff, including independent practitioners Revised EP 15-all deficiencies and identified opportunities for improvement are comminicated to senior leadership and additional cross references. Revised in 2014
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DNV Healthcare Inc DNV is only the third national hospital accreditor to be approved by CMS Its accreditation program is called NIAHO-National Integrated Accreditation for Healthcare Organizations This is the first new hospital accreditation organization in 30 years.
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Physical Environment (PE) PE.6 Emergency Management System
Standard Requirement (SR).1 The organization must provide a comprehensive Emergency Management System to respond to emergencies in the organization or within the community and region that may impact the organization’s ability to provide services. SR.2 The organization shall meet the requirements set forth in NFPA 99, Chapter 12, Emergency Management. SR.3 The Emergency Management System shall require that the organization conduct a HVA to identify potential emergencies in the organization and the community.
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EP.6 Continued, Standard Regulation 4
SR.4 The Emergency Management System shall establish an emergency process to address the potential hazards to the organization and the community. The hospital shall conduct an organization-wide emergency management exercise, including the triage and disposition of patients. The organization-wide emergency management exercises, shall be conducted at least twice per year SR.4a. Exercises shall test the most threatening hazard(s) from the HVA & tax the resources of the organization. SR.4b. At least every other exercise shall be conducted with the community to evaluate surge capacity, the integration of IC and interoperability of communications. SR.4c. The organization shall formulate an AAR of all exercises to identifying opportunities for improvements and revise its EOP accordingly.
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Standard Regulations 5-7
SR.5 The Emergency Management System processes shall address alternative means to support essential building functions such as electricity, water, ventilation, fuel, medical gas and vacuum systems, and other identified utilities. SR.6 The Emergency Management System shall include memorandums of understanding for utilization of resources (space, personnel, and equipment) with local and regional healthcare facilities and public health agencies in cases of organizational, community, or regional crisis. SR.7 The organization shall have policies, procedures, and decision criteria for the determination of protection in place or evacuation of patients in the event of a disaster.
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NIAHO Interpretive Guidelines
Assuring the safety of patients would include developing and implementing appropriate EOPs and capabilities. The organization must develop and implement a comprehensive plan to ensure that the safety of patients are assured during emergency situations. The organization must coordinate with Federal, State, regional, and local emergency preparedness and health authorities to identify likely risks for their area (using an all-hazards approach) and develop appropriate responses for patient safety. The following issues should be considered when developing the plans(s): The differing needs of each location where the certified hospital operates; The special needs of patient populations treated at the; Security of patients and walk-in patients; Security of supplies from misappropriation; Pharmaceuticals, food, other supplies and equipment that may be needed during emergency/disaster situations; Communication to external entities if telephones and computers are not operating or become overloaded (e.g., ham radio operators, etc.); Communication among staff within the hospital itself; Qualifications and training needed by personnel, to implement and carry out emergency procedures
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NIAHO Surveyor Guidance:
Review and verify that the hospital has developed and implemented a comprehensive plan to ensure the safety of patients is assured during an emergency. This plan must address the elements listed within the Interpretive Guidelines. Review and validate that the hospital has conducted a HVA to identify potential emergencies in the organization and the community. Determine the method used to prioritize and made preparations to address the potential hazards to the organization and community. Review and validate: That the organization has conducted appropriate and timely exercises. That AARs identified opportunities for improvements That the organization revised its EOP according to the identified opportunities for improvement
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The CMS Emergency Preparedness Final Rule
42 CFR
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The Basics Draft rule first published in the Federal Register on December 27, 2013 Final Rule published in the Federal Register on September 16, (pg. 64,028) Becomes “Surveyable” on September 16, 2017 (Lisa Parker, Director of Institutional Quality Standards, Center for Clinical Standards and Quality, CMS) Applies to 17 Medicare and Medicaid providers and suppliers
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The 17 Provider/Supplier Types
Hospitals Religious Nonmedical healthcare Institutions (RNHCI’s) Ambulatory Surgical Centers (ASC’s) Hospices Psychiatric Residential Treatment Facilities (PRTF’s) All-Inclusive Care for the Elderly (PACE) Transplant Centers Long Term Care Facilities (LTC) Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF/IID) Home Health Agencies (HHA’s) Critical Access Hospitals (CAH’s) Comprehensive Outpatient Rehabilitation Facilities (CORF’s) Clinics, Rehabilitation Agencies, & Public Health Agencies as Providers of Outpatient Physical Therapy & Speech-Language Pathology Services Community Mental Health Centers (CMHC’s) Organ Procurement Organizations (OPO’s) Rural Health Clinics (RHC’s) & Federally Qualified Health Centers FQHC’s) End Stage Renal Disease (ESRD) Facilities
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Good Rules of Thumb Do you already have to comply with other Conditions of Participation (e.g.: life safety, EOC, governing body, medication management, medical records? Do you participate as a facility in Medicare? That is, do you seek out Medicare beneficiaries as clients and accept Medicare payment? If so, it is highly likely this rule applies to your organization.
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CMS’ Goals Address Systemic Gaps Establish Consistency
Encourage Coordination Rooted in numerous GAO and OIG reports that address healthcare’s state of preparedness and response capabilities in the wake of Hurricane Katrina and other major disasters. CHAOS! Regulatory framework that is tailored for individual provider types and their specific needs and circumstances as well as the needs of the patients they serve. Encourages participation in Healthcare Coalitions. Emphasizes the benefits of collaboration, such as the use of mutual risk assessments, standardized tools, plans, and process; and also sharing of training, exercise, and resources.
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Four Provisions For All Provider Types
Risk Assessment & Planning Policies & Procedures Emergency Preparedness Program EM , EP:2 EM , EP’s 5 & 6 Communications Plan Training & Testing EM EM
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Risk Assessment & Planning
Develop an emergency plan based on a risk assessment Perform risk assessment using an “all-hazards” approach that focuses on capacities and capabilities Update emergency plan at least annually
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Policies & Procedures Develop and implement policies and procedures based on the emergency plan and risk assessment. Policies and procedures must address a range of issues including subsistence needs, evacuation plans, procedures for sheltering in place, tracking patents and staff during an emergency. Policies and procedures must be reviewed and updated at least annually.
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Communications Plan Develop a communications plan that complies with both federal and state laws. Coordinate patient care within the facility, across healthcare providers, and with state and local public health departments and emergency management systems. Review and update plan at least annually.
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Training and Testing Program
Develop and maintain training and testing programs, including initial training in policies and procedures. Demonstrate knowledge of emergency procedures and provide training at least annually Drills and exercises to test the emergency plan
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The Exercise Requirements
One community based full scale exercise A second exercise of the provider’s choice. It appears at this writing that CMS will accept a tabletop for the second exercise An actual emergency that activates the Emergency Operations Plan will exempt the provider from the FSE for one year.
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CMS’ Definition of “Full Scale Exercise”
The simulation of an anticipated response to an emergency involving actual operations and the community. This would involve the creation of scenarios, the engagement and education of personnel, and mock victims/patients. It would also involve participation from other providers, suppliers, and community emergency response agencies. (Ronisha Blackstone, Emergency Preparedness Team, Center for Clinical Standards and Quality, CMS)
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CMS’ Definition of “Full Scale Exercise”
CMS does reference the U.S. Department of Homeland Security definition of a Full Scale Exercise: A multi-agency, multi-jurisdictional, multi-discipline exercise that involves both functional and “boots on the ground” responses.
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FSE Exception If a community based exercise is not feasible, the requirement does allow providers to conduct a testing exercise that is based on the individual facility. (Ronisha Blackstone, Emergency Preparedness Team, Center for Clinical Standards and Quality, CMS)
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Emergency and Standby Power Systems
Specific requirements for hospitals, critical access hospitals, & long-term care facilities. Generators must be located in accordance with the Healthcare Facilities Code (NFPA 110) and the Life Safety Code. Testing, inspection, and maintenance must comply with the Healthcare Facilities Code (NFPA 110) and the Life Safety Code. Maintain sufficient fuel to sustain power during an emergency.
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Healthcare Systems A health care system consisting of multiple separately certified health care facilities may elect to have one unified and integrated emergency preparedness program across the system. The integrated emergency plan and policies and procedures must be developed in a manner that takes into account each separately certified facility’s unique circumstances, patient populations, and services offered. In addition, a risk assessment must be conducted for each separately certified facility in the system. Each separately certified facility must meet the Conditions of Participation on its own.
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Resources The Final Rule: CMS Video Presentation: Transcript:
CMS Video Presentation: Transcript: CMS/TJC Crosswalk
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Regulations and Laws Review
Remember: all agencies, organizations, and standard-setting bodies should be kept in mind during the planning process Check local and state regulations to ensure EOP is compliant Consult legal department if available
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Your Hospital and Accreditation
If your hospital does not meet the required guidelines, it may not receive accreditation from their regulating body (i.e.-TJC, DNV), licensure from the state, or reimbursements from CMS. (Box appears on click)
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Certified Hospital Emergency Coordinator (CHEC) Training Program
Regulations and Standards Questions?
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