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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

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Closed pod 2011.rev02.23

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

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