closed pod 2011.rev02.23

Alabama Department of Public Health 2011

By John R. WibleGeneral Counsel

Alabama Department of Public Health

Legal Issues SurroundingLegal Issues SurroundingClosed Pods - 2011Closed Pods - 2011


OutlineOutline• 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 ProblemDefining 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?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 PodsClasses 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 ResponsibilitiesClosed 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 ResponsibilitiesYour 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 planningReceipt of medicationDispensing procedures

• Provide professional staff• Provide non-medical supplies• Participate in training and exercise opportunities• Operate a Closed POD during an emergency


Your Plan – You Your Plan – You DoDo Have One? Have One?

Plan NOW! See “Bryant’s Rule”• Have a Plan• Work your plan• Plan for the unexpectedTo Fail to plan is the greatest moral

failure and assures that failure is imminent Coach Paul “Bear” Bryant


Plan Must IncludePlan 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?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?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: DeclarationsBasic 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 Emergency and Disaster Declarations and ProclamationsDeclarations 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 Legal Authority with Declaration of a Public Health EmergencyPublic 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 Principal Declarations and Proclamations for Public Health Proclamations for Public Health

EmergenciesEmergencies• 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 The Public Health Services Act and Closed Podsand 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 PodsP.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 ActStafford ActThe 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 DisasterMajor 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”


EmergencyEmergency

“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.”

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Special Duplication Issue –Special Duplication Issue –Public Health EmergenciesPublic 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 Differences in Public Health and FEMA Attitudes on Declarations and Proclamations 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 HHS Federal Assistance Without DeclarationWithout 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 ActNational 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: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 ManagementEmergency Management

Under Code of Ala.1975, § 31-9-2:o Governor proclaims an “emergency” defined as:

Enemy attack, sabotage or “other hostile action;” Fire, flood and “other natural causes.”

o Definition is broad enough to cover B/T incidents or naturally occurring events like hurricanes and tornadoes.

o Amendments add “Public Health Emergency”


Governor Proclaimed EmergencyGovernor 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 PowersGovernor’s Powers

In addition to those earlier listed, §31-9-6 also provides authority to:

o Make orders, rules and regulations;o To utilize all state employees;o To utilize any state or local officers or agencies,

granting state officer immunity to such, including volunteers.


Governor’s Orders - ConstitutionalityGovernor’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 ProclamationDispensing 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 ProtectionsPersonal Liability ProtectionsCode 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 ProtectionsProperty Protections

§ 31-9-17 provides similar liability protections apply to those permitting the state to use their real property


Licenses- Deemed StatusLicenses- 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


VolunteersVolunteers

• 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 ActThe 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 ActThe Volunteer Service ActThe 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 LandedThe Eagle has Landed


Questions?Questions?


For A Copy of the Presentation

• See “Closed Pods” - downloads on Slideshare ©• http://www.slideshare.net/jwible

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closed pod 2011.rev02.23

Education

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a319 public health emergency

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closed pod operations

closed pod entails

closed pods

state of emergency andpublic