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Closed pod 2011.rev02.23

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Note, Closed POD presentation is tweaked to highlingt that businesses and corporation are considered "emergency mgt. workers" and therefore have Title 31 immunity

Note, Closed POD presentation is tweaked to highlingt that businesses and corporation are considered "emergency mgt. workers" and therefore have Title 31 immunity

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  • Note that the presentation has ben tweaked to highlight the fact that corporations and businesses are considered 'emergency management workers' to the same extent as individuals and if participating with ADPH as a register closed POD have Title 31 immunity.
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  • We’ll talk about these subjects: Definitions and Authority Dispensing Meds – Who and Under What Authority? Responsibilities – Yours, Mine and Ours Who owns the stuff? Worker’s Comp issues Federally Declared Emergencies State Proclaimed Emergences Volunteer Protections HIPAA
  • Public Health Emergencies Bio-terrorism (anthrax) Pandemic influenza “ End of the world” scenarios Roles in preparedness Local Public Health MUST take care of their population in a public health emergency ADPH coordinates planning, training, and responding to public health emergencies
  • What is a Closed POD? Any facility or business within the city is encouraged to consider a partnership with ADPH to create a Closed POD. This is what becoming a Closed POD entails: Working with the ADPH to develop a Closed POD plan for your facility Training staff within your facility to conduct Closed POD operations Working with ADPH during POD exercises Being ready to accept medication during a public health emergency, and pass that medication along to staff and/or clients. Requirements related to receiving and dispensing medical countermeasures by Closed PODs is time of event only. In the event ,supplies of critical medical items in the state of Alabama will be rapidly depleted. In anticipation of such a situation, the Federal Government established the Strategic National Stockpile (SNS) to augment local supplies of critical medical items. The SNS is managed by the CDC) and contains large quantities of pharmaceuticals and medical supplies needed to respond to a wide range of expected problems or scenarios. Potential scenarios include attacks using nerve, chemical, or biological agents. In the event of an incident requiring widespread prophylaxis to the residents Alabama, Points of Dispensing (POD) could become the focus of the Public Health response. A mass antibiotic-dispensing campaign may employ several methods of dispensing, depending on the nature and scope of the emergency. The Strategic National Stockpile (SNS) is defined by the CDC’s Division of SNS as “A national repository of antibiotics, chemical antidotes, vaccines, antitoxins, antivirals, life-support medications, IV and IV administration sets, airway maintenance supplies, and other medical / surgical items used to augment federal, state and local public health agencies in the event of a terrorist attack or other emergency.”
  • Commercial Pod – Restricted to a particular business, its employees and dependents. An example would be a particular manufacturing plant or commercial enterprise such as Hyundai or Alabama Power Company. We have MOUs with both presently. Non-Commercial Pod – restricted to member of a particular group and their dependents. Examples of this would be a large church, its members and dependents. Both are designed to lighten the burden of the public pods
  • ADPH Responsibilities: Develop guidelines to ensure safe dispensing of medication Assist in development of organization’s Closed POD plan Provide all medication and accompanying information sheets for dispensing Provide training and exercise support Provide tools, templates and ongoing technical assistance
  • Your Responsibilities: Have MOU or on-line registration with ADPH Designate liaisons to coordinate Develop a Closed POD plan Determine dispensing location(s) Develop procedures Activation and recall procedures Security planning Receipt of medication Dispensing procedures Provide professional and support staff Provide non-medical supplies Participate in training and exercise opportunities Operate a Closed POD during an emergency
  • Focus and goal change. In disasters there is a switch from standard medical ethics with the primary focus on Individual autonomy to an ethics of public health with a primary focus on the health of the community . The overarching goal is to minimize morbidity and mortality during the pandemic (according to CDC) Will it be most good or greatest need ? The plan should uses both concepts: Utilitarian approach - Egalitarian methods Most importantly, Plan NOW! See “Bryant’s Rule” Have a Plan Work your plan. Plan for the unexpected. Whatever method is decided upon: It needs to be decided now . Have a plan now. It is a moral failure to put off such a momentous decision until there is no time to reach a good decision.
  • The Plan must include: A medical director, not necessarily on-scene Designation of how supplies would be received, stored in accord with manufacturers specs and distributed Meds labeled according to clinic protocol per medical direction Who would be authorized to dispense Pharmacy might be different rules
  • Ownership of Medical Supplies All SNS medical supplies provided to the entity are the property of the SNS and the federal Department of Health and Human Services (DHHS). DHHS transfers authority for SNS materials to local and state public health officials when those materials are delivered. Upon receipt, the local health agency delivers SNS supplies to the population in accordance with the Cities Readiness Initiative or other emergency distribution plans. Supplies must be tracked and accounted for through distribution of the supplies at the entity. As custodian, the local public health agency has constructive possession of the supplies—meaning that the agency may have actual control even absent physical possession—and is authorized to distribute them according to its emergency distribution plan. Any unused supplies must be returned to the local public health agency, which will in turn deliver them to the SNS.
  • Dispensing is defined as: to sell, distribute, administer, leave with, give away, dispose of, deliver, or supply a drug or medicine to the ultimate user or their agent. The state pharmacy law says that under normal circumstances dispensing is limited to MDs, pharmacists, and Public Health RNs in limited circumstances. Normally, an RN may only “administer” on the orders of an MD. However Assuming a Proclamation: Any RN or theoretically, Perhaps other qualified persons like EMTs .
  • The Health Officer, as a physician, may issue standing orders under three conditions: May be carried out by RNs under his control Must be “his” patients (IE., ADPH patients) Cannot conflict with state law Thus, the State Heath Officer could hot issue standing orders that would cover closed pods. The personnel are not under his control and supervision The patients are not “his.” Only those allowed by law can dispense: as we have said, MDs, pharmacists and CRNPs. He is not authorized to allow by standing order, an RN to dispense.
  • Workers’ Compensation - An entity may be responsible for workers‘ compensation injuries sustained by an employee while administering a POD. For purposes of workers‘ compensation, an ―employee is any person in the service of an employer subject to the state‘s workers‘ compensation laws. Therefore, employees injured while administering the POD would be eligible for workers‘ compensation benefits as if they were working in any other capacity for the employer. In some circumstances a volunteer or an independent contractor may be deemed an ―employee for purposes of workers‘ compensation. For example, a volunteer who has an interest in the completion of the work may be deemed a ―gratuitous employee and may be entitled to workers‘ compensation benefits if injured.
  • Unit 2 4/05/05 Basic Definitions: Declarations Declaring a disaster or emergency is a public announcement – a statement or declaration that the government recognizes that emergency situation exists and, presumably, intends to do something about it. A Declaration in the context of this course is a legal determination made by an authorized official, in accordance with criteria specified by law Which has the particular effect specified in the governing law: A declaration may trigger special emergency powers Allow expenditure of emergency funds, or expenditure of funds in advance of appropriation or in lieu of appropriation Waives or modifies normal legal requirement Under Alabama law, the term “proclamation” is what the Governor does to initiate a state of emergency. It has similar import to state law as “declaration” has to federal law when declared by the federal authorities.
  • Unit 2 4/05/05 Emergency and Disaster Declarations and Proclamations may be issued: There are many types of Emergency and Disaster declarations and proclamations, each with different purposes, uses and procedures Level of government: local, state, federal Geographic area: part of a city, entire city, county, region, or a state Type of event: Generally, any threat to life, health, safety, property: weather related or terrorism There are also other declarations not covered in this presentation, including USDA Drought Emergency State/Local Drought Emergencies US Department of Energy –Power Emergency State/Local Power Emergencies and loss of infrastructure emergencies DOI’s Bureau of Ocean Energy Management, Regulation and Enforcement or BOE, the successor to the Minerals Management Service (MMS) and FDA close Gulf to Fishing in Oil Spill. (It is interesting to note that after the disaster, the feds changed the name of the Bureau which was supposed to oversee offshore drilling. They didn’t change the program, they just changed the name.)
  • Legal Authority with Declaration of a Public Health Emergency The HHS Secretary is authorized to take the following actions when a Section 319 Public Health Emergency is declared. Consistent with regular authorities: Make grants to State and local agencies Provide awards for expenses Enter into contracts Conduct and support investigations into the cause, treatment, or prevention of the specific disease or disorder Access funds appropriated to the Public Health Emergency Fund (when funds are so appropriated) Grant extensions or waive sanctions related to deadlines for submitting data or reports required under laws administered by the Secretary Mobilize the National Disaster Medical System and the Medical Reserve Corps** Make temporary appointments of personnel (up to one year or the duration of the emergency) to respond to the public health emergency* Declare an emergency, under Section 564 of the Federal Food, Drug, and Cosmetic Act justifying emergency use of an unapproved product or the unapproved use of an approved product such as a drug, biological product, or medical device Request FDA to issue and EUA. An EUA is an emergency Use Authorization. It allows professions to use an approved drug or device in an unapproved manner such as dilute the stretch the supply or to give to children when it is not labeled for use with children. The EUA is issued at the request of the Secretary by the Chairman of the FDC. He has discretion not to issue it.
  • Unit 2 4/05/05 Principal Declarations and Proclamations for Public Health Emergencies Only those declarations most likely to be relevant in significant emergencies involving public health will be discussed in further detail Before going on to the characteristics of these declarations – Declarations and proclamations provide particular powers to particular governments/officials Multiple declarations or proclamations are common State level: “State of Emergency” and “Public Health Emergency” Federal level: “Public Health Emergency” and Stafford Act Emergency or Major Disaster
  • The Legal authority of the ”Closed Pod” derives from the authority of the Secretary of the US Department of HHS under the Public Health Services Act. Among other things, the PHS Act authorizes the HHS Secretary “to lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Framework; to direct the U.S. PHS and other components of the Department to respond to a public health emergency; to declare a public health emergency (PHE) and take such actions as may be appropriate to respond to the PHE consistent with existing authorities; to assist states in meeting health emergencies; to control communicable diseases ; [and to]to maintain the Strategic National Stockpile” The Secretary may or may not declare a “Section 319 Public Health Emergency.” The PHS Act was amended recently by the Pandemic and All-Hazards Preparedness Act of 2006 (PAHPA) which has broad implications for the Department’s preparedness and response activities. And the Prep Act. Among other things, the PAHPA amended the Public Health Service Act to established within the Department a new Assistant Secretary for Preparedness and Response (ASPR); provided new authorities for a number of programs, including the advanced development and acquisitions of medical countermeasures; and called for the establishment of a quadrennial National Health Security Strategy.
  • Pandemic and All Hazards Preparedness Act . Authorizes the Secretary to issue a declaration providing immunity from tort liability (not willful misconduct) for claims of loss “caused, arising out of, relating to, or resulting from” administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures. A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations. It Provides Tort immunity for health professionals and “additional persons who are qualified persons pursuant to section 319F–3(i)(8)(B) are the following: (1) Any person authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction to prescribe, administer, deliver, distribute or dispense Covered Countermeasures, and their officials, agents, employees, contractors and volunteers, following a declaration of an emergency, and 2) Any person authorized to prescribe, administer, or dispense Covered Countermeasures or who is otherwise authorized under an Emergency Use Authorization.“ It is different from, and not dependent on, other emergency declarations. If there were a PREP act declaration, those operating a closed POD would have its protections as long as they were following label direction or an EUA.
  • Legal Authority When the President Declares a Major Disaster or an Emergency (Stafford Act) Legal Authority When the President Declares a Major Disaster or an Emergency In addition his regular authorities, the HHS Secretary may be authorized or directed to take other actions when the President declares a major disaster or an emergency under the Robert T. Stafford Act or an emergency under the National Emergencies Act The President may declare a major disaster under the Stafford Act when a natural catastrophe (i.e., hurricane, tornado, earthquake, etc.) or, regardless of cause, any fire, flood, or explosion causes damage that in the determination of the President is of  sufficient severity and magnitude to warrant major disaster assistance to supplement the efforts and available resources of States, local governments, and disaster relief organizations in alleviating the damage, loss, hardship, or suffering caused thereby.  The Stafford Act also authorizes the President to declare an emergency when, in the determination of the President, Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe. The Stafford Act authorizes a multitude of Federal agency actions in response to a major disaster or emergency, such as the following: Issuance of warnings Mobilization of emergency support teams Authorization of Federal use of State and local government services and facilities Hiring temporary personnel Distributing food, medicine, and supplies Coordinating with private sector disaster relief organizations Overseeing mass feeding Coordinating hazard mitigation Use, donation, or lending of Federal equipment, supplies, facilities, or personnel to state and local governments Provide crisis counseling (only in response to a major disaster)
  • Definition of “Major Disaster” any natural catastrophe . . . or, regardless of cause, any fire, flood, or explosion, in any part of the United States, which in the determination of the President causes damage of sufficient severity and magnitude to warrant major disaster assistance under this Act to supplement the efforts and available resources of States, local governments, and disaster relief organizations in alleviating the damage, loss, hardship, or suffering caused thereby.”
  • Definition of Emergency: any occasion or instance for which, in the determination of the President, Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.”
  • Unit 2 4/05/05 Special Duplication Issue – Public Health Emergencies There are special rules to ensure that there is no duplication of assistance provided by federal government: even if the Secretary declares a Public Health Emergency and the President issues a Stafford Act declaration, a cost will of course only be reimbursed once. There have been differing opinions within DHS/FEMA as to whether the Stafford Act can or should be applied to Public Health Emergencies -Some believe that it is a powerful tool the president can/should use to ensure that all appropriate measures can be taken to protect life, health and property. Other’s believe that since the Secretary of HHS has the authority to declare a “Public Health Emergency” and the appropriate funding/ resources to do so, then the Stafford act should not be used until the other options have been exhausted. As stated earlier, the full and complete authority/responsibility for declaring an Emergency or Disaster under the Stafford act lies with the President of the United States. However, the recommendations which come from DHS/FEMA can very much influence the President’s Decision. Knowing the concerns may help the states address those concerns in their request for declaration. DHS/FEMA tends not to activate Stafford Act authorities when there are specialized statutory provisions for specialized emergency response/ recovery actions Private Chemical or on land Oil spills (Superfund) Federal Aid Highways (DOT Emergency Fund) DOT Regional Motor Carrier Emergency in Gulf Oil Spill; Stafford Act inoperative as private party cost Stafford Act has been used for public health – Emergencies declared for West Nile Encephalitis, to fund spraying of Mosquitoes
  • Unit 2 4/05/05 Importance of Declarations and Proclamations Differs in Public Health and Emergency Mgt Disciplines There will be more detail to follow on the types of declarations most likely to be relevant in significant emergencies involving public health Before going on to the characteristics of these declarations – For Public Health”: Public Health: Declaration is frequently optional Officials have strong powers to act without declaring “public health emergency” “ Public Health Emergency” declarations do not normally trigger availability of significant funds While for Emergency Management: Declaration is critical It is required to “turn on” emergency authorities It is Required to make costs eligible for reimbursement
  • Unit 2 4/05/05 Federal Assistance Without Declaration Both the National Disaster Medical System “NDMS” and the Strategic National Stockpile (SNS) can be deployed without a declaration of a public health emergency The law indicates that they can be deployed to respond to the needs of a “public health emergency (whether or not [so declared]” To be present at locations the Secretary of HHS determines “at risk of a public health emergency” Unfortunately, the ability to deploy these assts without a declaration may be limited by the available funding. A declaration would make additional funding available for the deployment of these assets Note: With a public health emergency declaration, funding for activities may be more substantial – as the Secretary of HHS can use the Public Health Emergency Fund. This is assuming that there is a current appropriation to this fund In many years, this fund does not receive a specific appropriation, and therefore funding is not available 42 USC § 300hh-11 provides The Secretary may activate the National Disaster Medical System to-- (I) provide health services, health-related social services, other appropriate human services, and appropriate auxiliary services to respond to the needs of victims of a public health emergency ); or (ii) be present at locations, and for limited periods of time, specified by the Secretary on the basis that the Secretary has determined that a location is at risk of a public health emergency during the time specified. Once SNS or NDMS is authorized, some other resources, such as those from EPA, DoD or Dept of Veterans affairs may also become available. Additionally some other, less massive resources, such as small teams of CDC personnel and/ or access to Federal Labs may be available without any declaration.
  • The President may also declare a National Emergency under the National Emergencies Act, specifying which statutory authorities available for use in an emergency will be exercised. It was declared by President Obama and used with H1N1 . The National Emergencies Act ( 50 U.S.C. 1601-1651 ) is a United States federal law passed in 1976 to stop open-ended states of national emergency and formalize the power of Congress to provide certain checks and balances on the emergency powers of the President . The act sets a limit of two years on states of national emergency. It also imposes certain "procedural formalities" on the President when invoking such powers. There were 32 declared national emergencies between 1976 and 2001. Most of these were for the purpose of restricting trade with certain foreign entities under the International Emergency Economic Powers Act . The United States has been in a state of national emergency continuously since September 14, 2001, when the Bush administration invoked it premised on the September 11 attacks . In September 2010, President Barack Obama informed Congress that the State of National Emergency in effect since September 14, 2001, will be extended another year. [1] [2] The National Emergencies Act grants various powers to the president during times of emergency, and was intended to prevent a president from declaring a state of emergency of indefinite duration.
  • Unit 2 4/05/05 Declaration Analysis – Ask: At early stages of an event – while it is not clearly out of control --consider whether one is truly needed and whether a declaration will have an adverse impact. Example: Anthrax attacks in Washington DC: District did not declare public health emergency Federal government did not declare a public health emergency Federal government did not declare Stafford Act emergency But Emergency resources were made available. e.g.; In DC during the anthrax crisis resources were made available from the CDC, Public Health Service, and time was donated by Kaiser docs and others.
  • Once the Governor declares the emergency, the world in Alabama changes. Under Code of Ala.1975, § 31-9-2: Governor proclaims an “emergency” defined as: Enemy attack, sabotage or “other hostile action;” Fire, flood and “other natural causes.” Definition is broad enough to cover B/T incidents or naturally occurring events like hurricanes and tornadoes. Under newly passed HB 107, “Public health emergency,” is defined as: “ an occurrence or imminent threat of an illness or health condition, caused by Bioterrorism, epidemic or pandemic disease, or novel and highly fatal infectious agent or biological toxin, that poses a substantial risk of a significant number of human fatalities or incidents of permanent or long-term disability. Such illness or health condition includes, but is not limited to, an illness or health condition resulting from a national disaster.”
  • This would activate the State Emergency Operations Plan (EOP). Specifically activation of Tab A (Pandemic Influenza) to Incident Annex A (Biological Incident Annex) . Due to the complex nature, the Department of Public Health has developed different operational plans to deal with mass distribution of countermeasures and pandemic influenza. The two plans are the Strategic National Stockpile Plan (SNS Plan) and the Pandemic Influenza Operational Plan (PI Plan).  These plans can be utilized together or separately. They complement each other, and serve as the operational response to a biological incident in the State of Alabama. The Alabama Emergency Management Agency will activate the State Emergency Operations Center for biological incidents as required by following the same process and protocol as for any other disaster impacting the state. A unified command will be established between agencies such as the Alabama Emergency Management Agency, Alabama Department of Public Health, Alabama Department of Homeland Security, Alabama Department of Public Safety, Alabama Department of Agriculture and Industries and/or other agencies as the situation requires. ADPH is responsible for Emergency Support Function (ESF) #8 —Public Health and Medical Services   We would expect the Governor to say: WHEREAS, this outbreak presents an occurrence or imminent threat of an illness or health condition that is believed to be caused by a novel infectious agent which poses a high probability of a large number of deaths in the affected population; a large number of serious or long-term disabilities in the affected population; and/or widespread exposure to an infectious agent that poses a risk of substantial future harm to a large number of people in the affected population; and   WHEREAS, this event has placed will place an extraordinary burden on various state and local governments and non-profit agencies within the state. Because of the event, a state public health emergency exists infecting or exposing a great number of people to virulent disease agents; and   WHEREAS , the widespread nature of the state public health emergency is overwhelming available emergency and medical resources and disrupting public and private infrastructure and services. Such impacts will require extraordinary measures to contain the spread of the disease, treat the victims, protect the public health, investigate criminal acts, apprehend suspects, ensure public safety, render relief, protect the public from further impact, restore vital services and protect the Alabama economy. These current conditions constitute an imminent threat to the safety and welfare of the State, and create a State of Emergency within the meaning of the Alabama Emergency Management Act of 1955, as amended, Under The authority of Title 31, the Governor could proclaim a state of public health emergency.
  • In addition to those earlier listed, §31-9-6 also provides authority to: Make orders, rules and regulations; To utilize all state employees; To utilize any state or local officers or agencies, granting state officer immunity to such, including volunteers.
  • On Sept. 24, 1862, President Abraham Lincoln exercised a similar power when he issued the following proclamation suspending the right to writs of habeas corpus nationwide. BY THE PRESIDENT OF THE UNITED STATES OF AMERICA: A PROCLAMATION That the Writ of Habeas Corpus is suspended in respect to all persons arrested, or who are now, or hereafter during the rebellion shall be, imprisoned in any fort, camp, arsenal, military prison, or other place of confinement by any military authority of by the sentence of any Court Martial or Military Commission. ABRAHAM LINCOLN By the President: In Ex parte Merryman, 17 F. Cas. 144 (C.D.Md. 1861), Chief Justice Taney rejected what was determined to be President Lincoln’s unauthorized suspension of the writ of habeas corpus. . This is not  good precedent for an Alabama Governor issuing an order under his or her executive authority. Nevertheless, the limits are not known
  • We have written a proclamation for the Governor that allows certain others to dispense in a closed pod. He will say: “ I further direct and authorize that the plans for distribution of the items maintained in the closed pods are to be dispensed as directed by the designated persons, or distributed pursuant to any Emergency Use Authorization for prescription medications issued by the Food and Drug Administration.” This presumes that the closed pod has a plan.
  • Section 31-9-16 provides that: Except for willful misconduct, gross negligence or bad faith, any “emergency management worker” is granted state officer immunity. Requirements for licenses to practice do NOT apply “ Emergency worker” is anyone helping out whether paid or not. The business or corp. is also an EMW and therefore has the same immunity as the individuals.
  • § 31-9-17 provides similar liability protections apply to those permitting the state to use their real property
  • Professionals of one state are “deemed” licensed in the site state to the extent they would be licensed in their home state Law enforcement could be brought in for security Health care workers for treatment
  • Commercial Closed Pos will likely not be using volunteers Non-Commercial Pods likely will be using volunteers. Volunteers will have certain immunities Volunteer Service Act Title 31 Immunity
  • § 6-5-336. Volunteers. (a) This section shall be known as "The Volunteer Service Act.“ VOLUNTEER. A person performing services for a nonprofit organization, a nonprofit corporation, a hospital, or a governmental entity without compensation, other than reimbursement for actual expenses incurred. The term includes a volunteer serving as a director, officer, trustee, or direct service volunteer. § 6-5-336. Volunteers Defined. A person performing services for: a nonprofit organization, a nonprofit corporation, a hospital, a governmental entity, without compensation,
  • (d) Any volunteer shall be immune from civil liability in any action on the basis of any act or omission of a volunteer resulting in damage or injury if: (1) The volunteer was acting in good faith and within the scope of such volunteer's official functions and duties for a nonprofit organization, a nonprofit corporation, hospital, or a governmental entity; and (2) The damage or injury was not caused by willful or wanton misconduct by such volunteer. (e) In any suit against a nonprofit organization, nonprofit corporation, or a hospital for civil damages based upon the negligent act or omission of a volunteer, proof of such act or omission shall be sufficient to establish the responsibility of the organization therefor under the doctrine of "respondeat superior," notwithstanding the immunity granted to the volunteer with respect to any act or omission included under subsection (d).
  • Privacy (HIPAA Privacy Rule and State Privacy Law Compliance) Personal information obtained in the process of administering a POD may be subject to federal and state information privacy laws. Generally, medical records are privileged and confidential. Entity personnel should only disclose identifiable information as allowed pursuant to federal or state law. An entity operating a POD may be subject to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, which applies to covered entities or business associates who electronically retain or transmit individually identifiable health information. Under the HIPAA Privacy Rule, all identifiable health information retained or transmitted by a covered entity or business associate is ―protected health information. Subject to potential limited waivers or exceptions in declared emergencies, the Privacy Rule (and other similar state or local laws) requires entities to disclose only the minimum information necessary to accomplish the purpose of the disclosure, which will often be dictated by state reporting statutes. Forget about it! See 45 CFR § 164, et seq. provides a special exception for public health work There will be no billing – thus not “covered entity” under HIPAA. However, if you are already a covered entity such as a hospital or other heath care provider, you may be covered for the closed pod as under HIPAA, once you are covered for any activity, you are covered for all. Nevertheless, good confidentiality practices should be followed Possibility of suit for breach of privacy
  • The Eagle has finally landed.
  • Questions?
  • See “Closed Pods” - downloads on Slideshare © http://www.slideshare.net/jwible

Closed pod 2011.rev02.23 Closed pod 2011.rev02.23 Presentation Transcript

  • By John R. Wible General Counsel Alabama Department of Public Health Legal Issues Surrounding Closed Pods - 2011
  • Outline
    • Definitions and Authority
    • Dispensing Meds – Who and What Authority?
    • Responsibilities – Yours, Mine and Ours
    • Who Owns the Stuff?
    • Worker’s Comp
    • Declared and Proclaimed Emergences/disasters
    • Volunteer Protections
    • HIPAA
  • Defining the Problem
    • Public Health Emergencies
      • Bio-terrorism (anthrax)
      • Pandemic influenza
      • “ End of the world” scenarios
    • Roles in preparedness
      • Local Public Health MUST take care of their population in a public health emergency
      • ADPH coordinates planning, training, and responding to public health emergencies
  • What is a Closed Pod?
    • Any facility or business can be a Closed POD.
    • This is what becoming a Closed POD entails:
    • Working with ADPH to develop a Closed POD plan for your facility
    • Training staff within your facility to conduct Closed POD operations
    • Working with ADPH during POD exercises
    • Being ready to accept medication during a public health emergency, and pass that medication along to staff, employees and/or dependents
  • Classes of Pods
    • Commercial Pod – Restricted to a particular business, its employees and dependents
    • Non-Commercial Pod – restricted to member of a particular group and their dependents
    • Both designed to lighten the burden of the public pods
  • Closed Pod ADPH Responsibilities
    • Develop guidelines to ensure safe dispensing of medication
    • Assist in development of organization’s Closed POD plan
    • Provide all medication and accompanying information sheets for dispensing
    • Provide training and exercise support
    • Provide tools, templates and ongoing technical assistance
  • Your Responsibilities
    • Have MOU or on-line registration with ADPH
    • Designate liaisons to coordinate
    • Develop a Closed POD plan
      • Determine dispensing location(s)
      • Develop procedures
        • Activation and recall procedures
        • Security planning
        • Receipt of medication
        • Dispensing procedures
    • Provide professional staff
    • Provide non-medical supplies
    • Participate in training and exercise opportunities
    • Operate a Closed POD during an emergency
  • Your Plan – You Do Have One?
    • Plan NOW! See “Bryant’s Rule”
    • Have a Plan
    • Work your plan
    • Plan for the unexpected
    • To Fail to plan is the greatest moral failure and assures that failure is imminent
    Coach Paul “Bear” Bryant
  • Plan Must Include
    • A medical director, not necessarily on-scene
    • Designation of how supplies would be received, stored in accord with manufacturers specs and distributed
    • Meds labeled according to clinic protocol per medical direction
    • Who would be authorized to dispense
    • Pharmacy might be different rules
  • Who “Owns” The Stuff?
    • CDC “Owns” it throughout the process
    • “ Custody” is transferred to the State
    • Then “possession” is transferred to the POD sites
    • The stuff is “tracked” throughout the system
    • Unused “stuff” must be turned in after it’s all over
  • The Big Que: Who Can Dispense?
    • Dispensing : “sell, distribute, administer, leave with, give away, dispose of, deliver, or supply a drug or med. to the ultimate user or agent”
    • Assuming no Governor’s Proclamation:
      • MDs
      • Pharmacists
      • Public Health RNs in limited situations
    • Assuming a Proclamation:
      • Any RN
      • Perhaps other qualified persons
  • Standing Orders of Health Officer?
    • The Health Officer, as a physician, may issue standing orders under three conditions:
      • May be carried out by RNs under his control
      • Must be “his” patients (IE., ADPH patients)
      • Cannot conflict with state law
    • Won’t Work with Closed Pods
  • Worker’s Comp Issues
    • If you are a commercial entity, you have worker’s comp
    • Employees injured in the course of executing the plan are covered under your worker’s comp
    • Theoretically could include contractors and “gratuitous employees, IE., volunteers
  • Basic Definitions: Declarations
    • Public announcements recognizing an unusual event, usually:
      • Federal uses the term “Declaration”
      • State uses “Proclamation”
    • Legal determinations
      • Made by an authorized government official
      • Triggering special emergency powers
      • Allowing expenditure of emergency funds
  • Emergency and Disaster Declarations and Proclamations
    • Different levels of government - local, state, federal
    • Different Geographic Area -part of a city, entire city, county, region, or a state
    • Different Type of Event – Examples of responding agencies:
      • Generally, any threat to life, health, safety, property: weather related or terrorism – DHS (w/w/o FEMA) and States
      • Specific threat: public health, drought, fire, insurrection, loss of power or other infrastructure
      • DOE – Power emergency
      • DOI – Wildfire Emergency
      • DOI (BOEMRE) and FDA close Gulf to Fishing in Oil Spill
  • Legal Authority with Declaration of a Public Health Emergency
    • The HHS Secretary is authorized to take the following actions when a § 319 Public Health Emergency is declared.
    • Make grants to State and local agencies
    • Provide awards for expenses
    • Enter into contracts
    • Conduct and support investigations into the cause, treatment, or prevention of the specific disease
    • Request FDA to issue an EUA
  • Principal Declarations and Proclamations for Public Health Emergencies
    • Declarations or proclamations provide particular powers to governments or officials
    • Multiple declarations are common
      • State level: “State of Emergency” and “Public Health Emergency”
      • Federal level: “Public Health Emergency” and Stafford Act Emergency or Major Disaster
  • The Public Health Services Act and Closed Pods
    • Closed Pod is under the SNS
    • SNS is a function of the Secretary of US HHS
    • The Secretary functions under the Public Health Services Act
    • May or may not have a federal declaration of an “emergency” to send the push pack
  • P.R.E.P. Act and Closed Pods  
    • The Public Readiness and Preparedness Act (PREP) authorizes the Secretary to issue a declaration providing immunity from tort liability (not willful misconduct) for claims of loss “caused, arising out of, relating to, or resulting from” administration or use of countermeasures
    • A PREP Act declaration is specifically for the purpose of providing immunity from tort liability, and is different from, and not dependent on, other emergency declarations.
    • The PREP Act declaration stands alone
  • Stafford Act
    • The President may declare a major disaster for:
    • Natural catastrophe (i.e., hurricane, tornado, earthquake, etc.)
    • Fire, flood, or explosion causing severe damage that in the determination of the President is of:
    • Sufficient severity and magnitude to warrant major disaster assistance to
      • supplement state and local resources of States and
      • disaster relief organizations
  • Major Disaster
    • “ any natural catastrophe . . . or, regardless of cause, any fire, flood, or explosion, in any part of the United States, which in the determination of the President causes damage of sufficient severity and magnitude to warrant major disaster assistance . . . to supplement the efforts and . . . resources of States, local governments, and disaster relief organizations in alleviating the damage, loss, hardship, or suffering caused thereby”
  • Emergency
    • “ any occasion or instance for which, in the determination of the President, Federal assistance is needed to supplement State and local efforts and capabilities to save lives and to protect property and public health and safety, or to lessen or avert the threat of a catastrophe in any part of the United States.”
  • Special Duplication Issue – Public Health Emergencies
    • DHS/FEMA tends not to activate Stafford Act authorities when there are specialized statutory provisions for specialized emergency response/ recovery actions
      • Private Chemical or on land Oil spills (Superfund)
      • Federal Aid Highways (DOT Emergency Fund)
      • DOT Regional Motor Carrier Emergency in Gulf Oil Spill; Stafford Act inoperative as private party cost
    • Stafford Act has been used for public health –
      • Emergencies declared for West Nile Encephalitis to fund spraying of Mosquitoes
  • Differences in Public Health and FEMA Attitudes on Declarations and Proclamations
    • Public Health:
      • Declaration is frequently optional
      • Officials have strong powers to act without declaring “public health emergency”
      • “ Public Health Emergency” declarations do not normally trigger availability of significant funds
    • Emergency Management:
      • Declaration is usually critical Required to “turn on” emergency authorities and aid
      • Required to make costs eligible for reimbursement
  • HHS Federal Assistance Without Declaration
    • Federal pubic health resources may be available even without federal emergency declaration:
    • National Disaster Medical System “NDMS”
    • Strategic National Stockpile (SNS or “Push pack”)
    • CDC assistance in epidemiological investigations
    • CDC Personnel and labs
  • National Emergencies Act
    • The President may also declare a National Emergency under the National Emergencies Act, specifying which statutory authorities available for use in an emergency will be exercised
    • Used with H1N1
  • Declaration Analysis – Ask:
    • Is the emergency current or merely threatened?
    • What resources are needed to address this?
      • Can they be obtained without declaration?
      • Would a declaration trigger them?
    • Why avoid the declaration?
      • Media impact of declaration?
      • Public panic?
      • Credibility: perception of crying “wolf”
    • Why request a declaration?
      • Need financial assistance or special authority?
  • Emergency Management
    • Under Code of Ala.1975, § 31-9-2:
    • Governor proclaims an “emergency” defined as:
      • Enemy attack, sabotage
      • or “other hostile action;”
      • Fire, flood and “other natural causes.”
    • Definition is broad enough to cover B/T incidents or naturally occurring events like hurricanes and tornadoes.
    • Amendments add “Public Health Emergency”
  • Governor Proclaimed Emergency
    • Activation of State EOP
    • Tab A (Pandemic Influenza) to Incident Annex A (Biological Incident Annex) A
    • ADPH is responsible for ESF #8 Public Health and Medical Services
  • Governor’s Powers
    • In addition to those earlier listed, §31-9-6 also provides authority to:
    • Make orders, rules and regulations;
    • To utilize all state employees;
    • To utilize any state or local officers or agencies, granting state officer immunity to such, including volunteers.
  • Governor’s Orders - Constitutionality
    • What do you think of the constitutionality of such orders?
    • What is the limit of the Governor’s power?
    • The Constitution? Is it supreme or is self-preservation a higher law?
    • How about Ex. parte Merryman, 17 F. Cas. 144 (C.D.Md. 1861)
  • Dispensing Under a Proclamation
    • “ I further direct and authorize that the plans for distribution of the items maintained in the closed pods are to be dispensed as directed by the designated persons, or distributed pursuant to any Emergency Use Authorization for prescription medications issued by the Food and Drug Administration”
  • Personal Liability Protections
    • Code of Ala, 1975 § 31-9-16 provides that:
    • Except for willful misconduct, gross negligence or bad faith, any “emergency management worker” (WMW)is granted state officer immunity.
    • Requirements for licenses to practice do NOT apply
    • “ Emergency worker” is anyone helping out whether paid or not
    • The business or corp. is also an EMW
  • Property Protections
    • § 31-9-17 provides similar liability protections apply to those permitting the state to use their real property
  • Licenses- Deemed Status
    • Professionals of one state are “deemed” licensed in the site state to the extent they would be licensed in their home state
    • Law enforcement could be brought in for security
    • Health care workers for treatment
  • Volunteers
    • Commercial Closed Pods will likely not be using volunteers
    • Non-Commercial Pods likely will be using volunteers.
    • Volunteers will have certain immunities
      • Volunteer Service Act
      • Title 31 Immunity
  • The Volunteer Service Act
    • § 6-5-336. Volunteers Defined.
    • A person performing services for:
      • a nonprofit organization
      • a nonprofit corporation
      • a hospital
      • a governmental entity
      • without compensation
    “ Minuteman”
  • The Volunteer Service Act
    • The volunteer is immune from civil liability
    • in any action on the basis of any act or omission
    • resulting in damage or injury if:
      • acting in good faith and within the scope of duties;
      • for a covered organization; and
      • damage or injury was not caused by:
        • willful misconduct;
        • or wanton misconduct by the volunteer
    • Does NOT immunize the organization, however
  • What About HIPAA?
    • Generally, forget about it!
      • See 45 CFR § 164, et seq.
      • Special exception for public health work
    • There will be no billing – thus not “covered entity” under HIPAA, unless already covered
    • Nevertheless, good confidentiality practices should be followed
    • Possibility of suit for breach of privacy .
  • The Eagle has Landed
  • Questions?
  • For A Copy of the Presentation
    • See “Closed Pods” - downloads on Slideshare ©
    • http://www.slideshare.net/jwible
    Slideshare 7 ©