Legal Issues Committee
Members
Melanie Allan, BSN, RN, CIC
Cindy Boer
Kathy Kinsman
Michael Leffler
Cara L. Jansma, JD
*Damon Obiden
Marianne Patten
Bruce Rissi
Barb Van Dyke, RN, BSN, CHCR
*Committee chair
Central Michigan Community Hospital
Smith Haughey Rice & Roegge
Spectrum Health
Michigan Attorney General’s Office
Warner Norcross & Judd LLP
Kent County EMS
Gerber Memorial Hospital
Scholten Fant
Spectrum Health
Objectives

Identify credentialing needs.

Identify liability of professional staff working under relaxed standards of care.

Identify liability of health care organizations with relaxed standards of care.

Formalize, in writing, how state and local health departments will address these same issues.
Assumptions
1) Limited availability of police department for security at hospital.
2) Personal physicians would be informed as to system-wide triage.
3) People may magnify symptoms in order to get maximum care.
4) With the declaration of an emergency, the state will request an Emergency Medical Treatment and
Active Labor Act (EMTALA) waiver.
Background
The legal issues surrounding the continuation of essential health care services during an influenza
pandemic are broad and encompass many unique legal aspects, from delegating authority to the creation
and implementation of plans, directives and guidelines at the federal, state and local levels, to liability
protections for planners, volunteers and disaster workers in the preparation for, response to, mitigation of,
and recovery from pandemic illness.
The Legal Issues Committee has been established to gather and review legal documents and plans from
the federal, state and local levels in order to ensure that, ultimately, the plan for the Continuation of
Essential Health Care Services during an Influenza Pandemic meets all statutory requirements. This
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committee also provides legal guidance for other committees during the development of the plan. The plan
is intended to have a broad-reaching influence by directing the response of a community during a time of
overwhelming crisis. Such a plan should be based on sound principals and meet legal requirements. The
goal of this committee is to support the development of a plan that avoids reactionary decision-making
during times of crisis. Decisions that are based on emotion, faulty logic or misinformation may open the
door for liability, and may hinder the provision of quality care to the community at large.
The Legal Issues Committee has worked diligently to locate statutes, plans and case law that help to
determine legal bounds, rights, protections and requirements that might influence the project. This
Committee is comprised of experts from different backgrounds including a representative from the state
Attorney General’s office; three attorneys with expertise in health care compliance and liability; three
hospital representatives with infection control, risk management, and credentialing responsibilities who are
well-versed in hospital issues and standards; and a representative from Emergency Medical Services Medical Control Authority with expertise in disaster preparedness.
The legal research of this committee is based on Michigan statute and case law and, in that respect, is a
uniquely Michigan work.
The Process
The Legal Issues Committee was provided with the aforementioned objectives along with the directive to
investigate any legal issues surrounding this project. At the outset the greatest challenge was to educate
the group on disaster preparedness and what infrastructure, plans, processes and resources were already
in place. This included a review of the Modular Emergency Medical Systems (MEMS) model, the Michigan
Pandemic Influenza Plan, parts of the Public Health Code, the Emergency Management Act, Region 6
plans and resource lists, and a general review of the National Incident Management System (NIMS) and
the National Response Framework.
In order to develop a list of legal issues it was first necessary to determine, in general, which health care
services were essential during a pandemic influenza. Services that were believed to be essential vary
according to the numbers of ill persons and the severity of illness amongst those infected. However, for
brevity, the following were felt to be essential but scalable:





Access to non-influenza emergency care (hospital and EMS)
Access to care for influenza or influenza-like illness
Access to immunization
Access to transportation to receive care and/or immunization
Notification of community of illness progression, means of prophylaxis and how to access care
During our initial meetings a list of known issues was created, and from those core topics many additional
issues were later added. The list of issues summarized in this document includes:
1.
2.
3.
4.
5.
6.
Authority and liability protection for the development of emergency plans
Authority for the activation of plans
Authority to limit gatherings and close schools
Authority to quarantine
Authority to establish mutual aid agreements
Standards of care
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7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
EMTALA
HIPAA and confidentiality
Liability protections for health care providers
Liability protections for volunteers
Disaster credentialing
Delegation and scope of practice
Use of retired physicians
Ambulance transport to alternative destinations
Use of vehicles other than ambulances to transport patients
Pre-emergency department triage
Rationing of medical care and supplies
Allocation and rationing of Personal Protective Equipment (PPE) - MiOSHA
In order to address each of these topic areas, the committee members did independent research and
brought back to the group any reference materials that could be found relating to either the general topics
or any assigned topics. Each topic was independently researched to ensure that available resources and
references were located. Reference materials were reviewed before and during meetings and discussions
were held in order to identify the legal implications and the intent of each reference. Legal references were
attached to each of the topic areas and a brief summary of the implication and any case law interpreting
the statute was subsequently included.
While it would seem that legal issues would be very straightforward and easy to understand, that was
indeed not the case. In many instances one legal document referred to another for inclusion or exclusion
criteria, or for clarification purposes. In several instances, the terms commonly used by the legal profession
and the medical profession seemed similar but had substantially different meanings (e.g., “delegate,”
“standard of care”). Similarly, there were disparities between EMS providers and other licensed health care
providers as they are governed by two distinct and quite different sections of the Public Health Code.
In terms of time and effort spent on individual topic areas, the statutes governing the development and
implementation of disaster plans were relatively easy to locate and were clearly defined. “Standards of
care” and altered standards were more nebulous. In the legal context, the “standard of care” means the
care a similarly trained individual would provide under same or similar circumstances. In the medical field,
“standard of care” often refers to an established policy or protocol that defines an accepted level of
treatment. These protocols are modified to accommodate changing resources or situations. From a legal
perspective, the "standard of care” is a fluid concept and often independent of written policies and
protocols. From a legal perspective, there would be no “altered standard of care” because from a liability
perspective the standard of care will depend upon the circumstances.
The use of volunteers, their scope of practice, and their associated liability protection, or lack thereof, took
a considerable amount of time and discussion largely due to the number of possible permutations of
volunteer type, licensure and utilization. Similarly, rationing of medical equipment involved considerable
discussion that resulted in a concise answer and prompted us to look at already developed, clinicallybased selection criteria.
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Findings by Topic
1.
Authority and liability protection for the development of emergency plans.
Collectively, the following legislation provides for the authority of the Federal Government, the States, and
the local Emergency Managers, Public Health and Medical Control Authorities to create emergency
management plans and protocols for the preparation for, response to, mitigation of, and recovery from
emergencies or disasters. Liability protections for the development of these plans are also contained within
the legislation.
United States Constitution, Section 8: Powers of Congress
 Allocates authority to the Congress to ensure the general welfare of the United States.
HR 3448, 42 USC 201: Public Health Security and Bioterrorism Preparedness and Response Act of 2002
 Establishes broad recommendations for disaster preparedness in terms of plan development,
education, etc. provided the State accepts federal dollars for such programs. As a recipient of
federal funding for such programs, the State of Michigan must comply with the law and supporting
regulations with regard to the development of emergency plans and work cooperatively with the
federal government and other states to develop plans, establish agreements and compacts, and
follow education plans.
 Establishes the foundation on which NIMS education is based, the National Response Framework,
the Strategic National Stockpile, mandatory disease surveillance, and numerous other functions.
 Allows the Secretary to suspend the application of certain federal laws during a disaster or
emergency (such as the Health Insurance Portability and Accountability Act (HIPAA) or the
Emergency Medical Treatment and Active Labor Act (EMTALA).
Michigan Public Health Code (Act 368 of 1978), Michigan Compiled Laws (MCL) §333.1101 et seq.
 Governs licensed health care providers, public health departments and other health facilities such
as hospitals and nursing homes. Individual sections within the Code apply to additional powers of
individuals during epidemic or disaster.
o The EMS section (MCL § 333.20918 - 20919) establishes Medical Control Authorities and
their responsibility to develop protocols relating to pre-hospital care of patients and
immunity for those developing or implementing those plans provided such plans are
approved by the state (MCL § 333.20965(3)).
Michigan Emergency Management Act (Act 390 of 1976), MCL §30.401 et seq.
 Establishes the authority for actions of the Governor in the designation of an emergency or
disaster, establishes authority of the Director of the Michigan State Police for emergency
management, and designates authority for county and local emergency managers to develop and
implement plans.
 Provides broad liability protections for disaster relief workers.
2.
Authority for the activation of plans.
The authority for the activation of plans is contained in the Michigan Public Health Code, MCL §333.1101
et seq. and the Emergency Management Act), MCL 30.401 et seq. Collectively, these two acts empower
state and local governmental agencies to establish plans defining criteria to activate each plan.
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3.
Authority to limit gatherings and close schools.
Emergency Management Act – Act 390 of 1976, MCL §30.401 et seq.
The governor or the director, in implementing an order from the Governor or enforcing the State
Emergency Plan, may
 MCL §30.405(1)(e): “Direct and compel the evacuation of all or part of the population from a
stricken or threatened area within the state if necessary for the preservation of life or other
mitigation, response, or recovery activities.”
 MCL §30.405 (1)(j): “Direct all other actions which are necessary and appropriate under the
circumstances.”
Public Health Code – Act 368 of 1978, MCL §333.1101 et seq.
The State Director of Community Health:
 MCL §333.2251(1): “Upon a determination that an imminent danger to the health or lives of
individuals exists in this state, the director immediately shall inform the individuals affected by the
imminent danger and issue an order… The order may specify action to be taken or prohibit the
presence of individuals in locations or under conditions where the imminent danger exists, except
individuals whose presence is necessary to avoid, correct, or remove the imminent danger.”
 MCL §333.2253 (1): “If the director determines that control of an epidemic is necessary to protect
the public health, the director, by emergency order, may prohibit the gathering of people for any
purpose….”
The local health officer may:
 MCL §333.2451(1): “Upon a determination that an imminent danger to the health or lives of
individuals exists in the area served by the local health department, the local health officer
immediately shall inform the individuals affected by the imminent danger and issue an order …The
order may specify action to be taken or prohibit the presence of individuals in locations or under
conditions where the imminent danger exists, except individuals whose presence is necessary to
avoid, correct, or remove the imminent danger.”
 MCL §333.2453(1): “If the local health officer determines that control of an epidemic is necessary
to protect the public health, the local health officer may issue an emergency order to prohibit the
gathering of people for any purpose….”
4.
Authority to quarantine.
Public Health Code – Act 368 of 1978, MCL §333.1101 et seq.

5.
MCL §333.2453 (2): “A local health department or the department may provide for the involuntary
detention and treatment of individuals with hazardous communicable disease in the manner
prescribed in sections 5201 to 5238.”
Authority to establish mutual aid agreements.
Emergency Management Act – Act 390 of 1976, MCL §30.401 et seq.
The governor’s authority:

MCL §30.404 (2): Upon declaring a state of disaster or a state of emergency, the governor may
seek and accept assistance, either financial or otherwise, from the federal government, pursuant to
federal law or regulation.
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
MCL §30.404 (3) The governor may, with the approval of the state administrative board, enter into
a reciprocal aid agreement or compact with another state, the federal government, or a
neighboring state or province of a foreign country. A reciprocal aid agreement shall be limited to
the furnishing or exchange of food, clothing, medicine, and other supplies; engineering services;
emergency housing; police services; the services of the national guard…; health, medical, and
related services; fire fighting, rescue, transportation, and construction services and equipment;
personnel necessary to provide or conduct these services; and other necessary equipment,
facilities, and services. A reciprocal aid agreement shall specify terms for the reimbursement of
costs and expenses and conditions necessary for activating the agreement. The legislature shall
appropriate funds to implement a reciprocal aid agreement.
The authority of Emergency Managers as representatives of municipalities or counties:
 MCL §30.410(2) For the purpose of providing assistance during a disaster or emergency,
municipalities and counties may enter into mutual aid or reciprocal aid agreements or compacts
with other counties, municipalities, public agencies, federally recognized tribal nations, or private
sector agencies, or all of these entities. A compact entered into pursuant to this subsection is
limited to the exchange of personnel, equipment, and other resources in times of emergency,
disaster, or other serious threats to public health and safety. The arrangements shall be consistent
with the Michigan emergency management plan.
 MCL §30.410(3) The emergency management coordinator may assist in the development or
negotiation, or both, of a mutual aid or reciprocal aid agreement or compact made pursuant to
section 4(3) and shall carry out the agreement or compact.
6.
Standards of care and authority to change those standards as situations change.
Traditional Standard of Care - The term “Standard of Care” is a legal term of art.


For the purpose of establishing liability for malpractice, the applicable standard of care in Michigan
is as follows:
o General Practitioners: Physicians who are “general practioners” are held to the
recognized standard of acceptable professional practice or care in the same or similar
community in which they practice. MCL §600.2912a.(1)(a).
o Specialists: Physicians who are “specialists” are held to the recognized standard of
practice or care within that specialty, as reasonably applied in light of the facilities available
in the community or other facilities reasonably available under the circumstances. MCL
600.2912a (1)(b).
o Non-Physicians: Nurses, therapists, pharmacists, and the like must use the skill and care
ordinarily possessed and exercised by practitioners of the same profession in the same or
similar communities. Cox v. Bd. of Hosp. Managers for City of Flint, 467 Mich. 1, 10; 651
N.W.2d 356 (2002).
The standard of care should be viewed as a flexible and fluid concept which is dependent on the
1
totality of the circumstances facing the health care provider and the resources available.
Altered Standards of Care - Policies and Protocols

Altered standards of care refer to the changes in the standard of care during a prolonged public
health emergency when resources are scarce.
1
Gee v. Volna Clermont, M.D., 2008 WL 1733657 *2-3 (Mich. App. 2008); Smith v. Joy, 2005 WL 2372029 *1-2
(Mich. App. 2005).
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o
o
o

7.
While the traditional focus of standard of care is on providing individual care, altered
2
standards of care shift the focus to allocating limited resources to save the most people.
Altered standards of care include considerations of resources available, quality of care,
flexibility, and equality.
The main goal is to have procedures in place so that, in the event of an influenza
pandemic, health care providers can respond appropriately, efficiently, and effectively with
a minimal risk of liability.
From a practical standpoint, an emergency plan should include events that would trigger altered
standards of care. One example is for the governor of the state to declare a state of emergency or
disaster.
o In Michigan, the governor may declare a state of emergency or disaster. MCL §30.402.
o The medical control authority may establish an emergency protocol necessary to preserve
the health or safety of individuals within its jurisdiction in response to a present medical
emergency or disaster. MCL §333.20919(3) (e); 333.20971.
o Under the Emergency Management Act, MCL §30.402, et seq., the Emergency
Management Division may establish emergency operations centers (EOC) to provide for
the coordination of emergency response and disaster recovery in the state. MCL 30.407a
(4) (g).
EMTALA implications and the relaxation of EMTALA during a disaster.
Emergency Medical Treatment and Labor Act ("EMTALA"), 42 U.S.C. § 1395dd
EMTALA Regulations, 42 CFR § 489.20 et seq.
Social Security Act, Section 1135(b) (42 USC §1320b-5)
The Emergency Medical Treatment and Labor Act (EMTALA) imposes specific obligations on Medicareparticipating hospitals that offer emergency services to provide a medical screening examination (MSE)
when a request is made for examination or treatment for an emergency medical condition (EMC), including
active labor, regardless of an individual's ability to pay. Hospitals are then required to provide stabilizing
treatment for patients with EMCs. An appropriate transfer should be arranged if a hospital is unable to
stabilize a patient within its capability, or if the patient requests.
Section 1135(b) of the Social Security Act provides the circumstances under which the Secretary of the
Department of Health and Human Services has authority to waive EMTALA sanctions for:

The inappropriate transfer of an individual who has not been stabilized where the need to transfer
arises out of the circumstances of the emergency; or

The direction or relocation of an individual to receive a medical screening examination (MSE) at an
alternate location pursuant to an appropriate State emergency preparedness plan or State
pandemic preparedness plan.
See 42 CFR § 489.24(a)(2).
2
U.S. DEPARTMENT OF H EALTH AND H UMAN SERVICES, AGENCY FOR HEALTHCARE RESEARCH & QUALITY (AHRQ),
Altered Standards of Care in Mass Casualty Events: Bioterrorism and Other Public Health Emergencies, AHRQ
Pub. No. 0-0043, 1, 12 (2005), available at www.ahrq.gov/research/altstand/altstand.pdf (last visited June 18, 2009).
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Hospitals will be notified by the CMS Regional Office that the Secretary is permitting an EMTALA waiver,
including the period of time during which hospitals will not be subject to EMTALA sanctions for
inappropriate transfers and redirecting individuals to alternate locations for MSEs once the hospital has
activated its disaster protocol and after the State has activated its pandemic preparedness plan. In the
pandemic scenario, the opening of ACS or NEHC sites and the transfer or directing of patients from an
emergency department to an alternate site may violate EMTALA. A retroactive EMTALA waiver could be
requested in such circumstances.
8.
HIPAA and information-sharing during a disaster – Confidentiality.
The Health Information Portability and Accountability Act ("HIPAA") Privacy Rule provides federal
protections for personal health information by establishing national standards governing the use and
disclosure of such information and affords patients with certain rights with respect to their own information.
In all circumstances, the Privacy Rule allows for information to be disclosed for treatment, payment and
health care operations without an authorization from the individual. However, during an influenza
pandemic, many of the procedural requirements under the Privacy Rule may interfere with informationsharing and negatively impact the provider's ability to respond to the crisis.
Section 1135(b) (7) of the Social Security Act allows the Secretary of the Department of Health and Human
Services to waive certain sanctions and penalties under the HIPAA Privacy Rule following a declaration of
an emergency by the President and a declaration by the Secretary of a public health emergency.
Specifically, the Secretary may waive sanctions and penalties for the following:
1. the requirement to obtain a patient's agreement to speak with family members or friends involved
in the patient’s care (45 CFR 164.510(b))
2. the requirement to honor a patient's request to opt out of the facility directory (45 CFR 164.510(a))
3. the requirement to distribute a notice of privacy practices (45 CFR 164.520)
4. the patient's right to request privacy restrictions (45 CFR 164.522(a))
5. the patient's right to request confidential communications (45 CFR 164.522(b))
If the Secretary issues such a waiver, it only applies:
1. In the emergency area and for the emergency period identified in the public health emergency
declaration.
2. To all patients at hospitals that have instituted a disaster protocol.
When the Presidential or Secretarial declaration terminates, a hospital must comply with all the
requirements of the Privacy Rule for any patient still under its care.
Regardless of the activation of an emergency waiver, the HIPAA Privacy Rule permits disclosures for
treatment purposes and certain disclosures to disaster relief organizations. For instance, the Privacy Rule
allows covered entities to share patient information with the American Red Cross so it can notify family
members of the patient’s location. See 45 CFR 164.510(b) (4).
Michigan’s Medical Records Access Act (PA 47 of 2004 and PA 48 of 2004), MCL §§ 333.26261333.26271 (1979), closely parallels HIPAA and regulates, and details sanctions for violations of, patient
confidentiality. State and local officials in Michigan have authority under state law to potentially waive
requirements of the Medical Records Access Act.
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9.

If the Director of the Department of Community Health (“Director”) determines that control of an
epidemic is necessary to protect the public health, Section 2253 of the Public Health Code
empowers the Director to “establish procedures to be followed during the epidemic to insure
continuation of essential public health services and enforcement of health laws.” MCL §
333.2253(1).

Additionally, section 2453 of the Public Health Code empowers local health officers with this same
authority with respect to their local units upon their determination that control of an epidemic is
necessary to protect public health. MCL § 333.2453(1).

Under the Michigan Administrative Code, both the Director and local health officers also have
emergency public inspection powers. MCL § 325.181. Confidential medical and epidemiological
information gathered in an investigation may be released for public inspection without consent from
the identified individual if the Director or local health officer determines that inspection is necessary
to protect the public health. MCL § 325.181(2).
Liability protections for health care providers.
Good Samaritan Statutes: Michigan provides immunity to certain health care providers who respond to
emergency situations under specific circumstances.
Outside the Hospital Setting: MCL § 691.1501 provides immunity for certain health care providers
who in good faith render emergency care without compensation at the scene of an emergency,
unless they are guilty of gross negligence or willful and wanton misconduct. There can be no preexisting patient relationship for the immunity to apply. These protected individuals include:
1. Physicians
2. Physician assistants
3. Registered professional nurses
4. Licensed practical nurses
In the Hospital Setting: MCL 691.1502 provides immunity to certain individuals whose actual
hospital duty does not require a response to the emergency situation, if they in good faith respond
to a life threatening emergency or request for emergency assistance within a hospital or other
licensed medical care facility, unless they are guilty of gross negligence or willful and wanton
misconduct. The protected individuals include:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Physicians
Physician's assistants
Dentists
Podiatrists
Interns and residents
Registered nurses
Licensed practical nurses
Registered physical therapists
Clinical laboratory technologists
Inhalation therapists
Certified registered nurse anesthetists
X-ray technicians
Paramedics
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3
EMS Actions, MCL § 333.20965: This statute provides immunity for all EMS actions in the treatment of
patients unless they are the result of gross negligence or willful misconduct.
Emergency Management Act – Act 390 of 1976, MCL 30.411 (Appendix 2) The Act provides broad
immunity to the state and its employees, agents, or representatives from civil liability personal injury or
property damage sustained by any individual engaged in disaster relief activity or as by any individual
injured as a result of that activity.
Individual disaster relief personnel are afforded the same immunity as State employees under the
Governmental Immunity Act, PA 170 of 1964 (MCL §691.1407). This immunity does not extend to acts
involving the provision of “medical care or treatment” (except for search and rescue and tactical operations
4
medical staff). These protections, while expressly ruling out medical care, are important to individuals
supporting medical providers (including general volunteers) and those medical workers who are providing
supportive functions or activities ancillary to the provision of medical care and treatment.
Physicians (MDs and DOs) and other licensed health care professionals providing medical care in a
disaster are afforded immunity from civil liability for injuries sustained as a result of disaster relief services,
unless the injury resulted from willful conduct or gross negligence. MCL §30.411 (4) and (6). The class of
disaster relief workers entitled to such immunity while providing medical care include:
1. Registered nurses
2. Practical nurses
3. Nursing students (supervised by licensed nurse)
4. Dentists
5. Veterinarians
6. Pharmacists
7. Pharmacist interns (supervised by licensed pharmacist)
8. Paramedics
9. Medical residents (training in licensed hospital in Michigan or another
state)
10.
Liability protections for volunteers.
Non-medical volunteers may be utilized within a medical setting to do many non-medical tasks including
general housekeeping duties, restocking and inventory acquisition, data entry, etc. Such individuals are
entitled to the following protections:
Emergency Management Act MCL §30.411 provides the same immunity from tort liability to disaster relief
force workers or private or volunteer personnel engaged in disaster relief activity as provided under the
Governmental Immunity Act, MCL 691.1401 et seq. In general, they are protected unless there is gross
negligence or willful and wanton misconduct. This immunity does not extend to the provision of medical
care or treatment by general (non-licensed) volunteers.
3
EMS providers include medical first responders, emergency medical technicians, emergency medical
technician specialists, and paramedics, medical directors of a medical control authority or his or her
designee, and certain other individuals. See MCL 333.20965(1)
4
For the purposes of MCL 691.1407(4), “medical care” and “treatment” have been defined as “to
administer or apply remedies of or relating to the practice of medicine, by a medical professional, to a
patient for a disease or injury.” Perez v. Oakland County, 2008 WL 5158809 (Mich. App., December 9,
2008). The Perez case is unpublished, and not binding, but illustrates how the courts would define the
term “medical care” and “treatment” for purposes of the exception to governmental immunity found in MCL
691.1407(4)
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Good Samaritan Statute – providing CPR and AED: MCL 691.1504 provides immunity to individuals who,
having no duty to do so, in good faith voluntarily render cardiopulmonary resuscitation (CPR) to or use of
an automated external defibrillator(AED) on another individual, unless guilty of gross negligence or willful
and wanton misconduct.
Federal Volunteer Protection Act, 42 U.S.C. §14503. The Federal Volunteer Protection Act (below)
provides certain immunities for volunteers of nonprofit organizations or governmental entities. In order to
gain these protections, one must volunteer under the auspices of such an organization. Spontaneous
volunteers, not so affiliated, are not afforded liability protections under this legislation. The Act does not
provide immunity to the organization..
42 USC Chapter 139 § 14503 (The Public Health and Welfare, Volunteer Protection, Limitation on
liability of volunteers)
(a) Liability protection for volunteers
Except as provided in subsections (b) and (d) of this section, no volunteer of a nonprofit organization or
governmental entity shall be liable for harm caused by an act or omission of the volunteer on behalf of
the organization or entity if—
(1) the volunteer was acting within the scope of the volunteer’s responsibilities in the nonprofit
organization or governmental entity at the time of the act or omission;
(2) if appropriate or required, the volunteer was properly licensed, certified, or authorized by the
appropriate authorities for the activities or practice in the State in which the harm occurred, where
the activities were or practice was undertaken within the scope of the volunteer’s responsibilities in
the nonprofit organization or governmental entity;
(3) the harm was not caused by willful or criminal misconduct, gross negligence, reckless misconduct,
or a conscious, flagrant indifference to the rights or safety of the individual harmed by the
volunteer; and
(4) the harm was not caused by the volunteer operating a motor vehicle, vessel, aircraft, or other
vehicle for which the State requires the operator or the owner of the vehicle, craft, or vessel to—
(A) possess an operator’s license; or
(B) maintain insurance.
(b) Concerning responsibility of volunteers to organizations and entities, nothing in this section shall be
construed to affect any civil action brought by any nonprofit organization or any governmental entity against
any volunteer of such organization or entity.
(c) No effect on liability of organization or entity: nothing in this section shall be construed to affect the
liability of any nonprofit organization or governmental entity with respect to harm caused to any person.
11.
Disaster credentialing.
Volunteers are likely to play an integral role in responding to pandemics or other public health
emergencies. The use of volunteer medical providers during an emergency raises a number of important
issues for both the individuals who volunteer and the institutions that need to make planning decisions
about the extent to which they can use volunteers in an emergency. Institutions must understand, in
designing response plans, the requirements for using volunteers and the extent to which they may use
volunteers to meet medical demands that exceed the hospital’s response capacity during an emergency.
Volunteers need to know what types of licenses they must have, and to what extent their well-intentioned
actions, in an emergency, may expose them to liability.
Hospitals are required under the Medicare Conditions of Participation and state law to ensure that all
individuals practicing in the hospital are licensed and credentialed. The Joint Commission has adopted
standards of Emergency Management that permit a hospital to rely on volunteer practitioners when it
activates its Emergency Operations Plan in response to a disaster and is unable to meet its immediate
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5
patient needs. During these situations, a hospital is permitted to grant disaster privileges to volunteer
practitioners who are “licensed independent practitioners” and to those who are required by law to have a
6
license, certification, or registration, but are “not licensed independent practitioners.” In both situations,
however, the hospital must have a plan for overseeing volunteers, assigning responsibilities to volunteers,
7
and verifying volunteer identification.
The Joint Commission also lists standards, or Elements of Performance, describing the criteria by which
the Joint Commission evaluates a hospital and its medical staff. Even in disaster situations, safeguards
are necessary to ensure that volunteers provide appropriate care. Specifically, the standards in place
during an emergency uphold two components typically used in ensuring both qualifications and
competence: “(1) [v]erification of licensure, certification, or registration required to practice a profession;
8
[and] (2) [o]versight of the care, treatment, and services provided.” These standards are necessary to
9
ensure that volunteer practitioners provide “safe and adequate care, treatment, or services.” The
10
standards list requirements and responsibilities applicable before and during potential emergencies.
Among other things, the standards require that medical staff identify who will grant or assign disaster
privileges to volunteers, describe how they will oversee the performance of those volunteers, and actually
11
oversee the performance of each volunteer during the emergency. Additionally, the hospital must
determine how it will distinguish volunteers from other practitioners, obtain relevant identification from the
volunteers, and describe how the medical staff will oversee and evaluate the performance of the volunteers
12
during the emergency.
Under certain circumstances, Michigan law permits a board to grant temporary and limited licenses to
13
qualified individuals. It permits a board to “grant a nonrenewable, temporary license to an applicant who
has completed all requirements for licensure except for examination or other required evaluation
procedure,” but the holder of such a temporary license may only practice under the supervision of a
professional “who holds a license in the same health profession, other than a . . . subfield license . . . [or] a
14
limited . . . or temporary license.” A board may also “grant a limited license to an individual if the board
determines that the limitation is consistent with the ability of the individual to practice the health profession
in a safe and competent manner, is necessary to protect the health and safety of patients or clients, or is
15
appropriate to promote the efficient and effective delivery of health care services.”
12.
Delegation and Scope of Practice.
The Public Health Code provides health professionals with broad authority for the delegation and
supervision of certain acts, tasks and functions within the scope of the health professional's license or
registration. MCL 333.16215 allows a health professional who is licensed or registered under Article 15 to
delegate certain acts, tasks or functions within the scope of their license to another individual who is
5
THE JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS, HOSPITAL ACCREDITATION
STANDARDS 60–65 (2009).
6
Id. at 61, 63 (2009). Specifically, Standard EM.02.02.13 of the Hospital Accreditation Standards says
that, “[d]uring disasters, the hospital may grant disaster privileges to volunteer licensed independent
practitioners.” Id. at 61. Standard EM.02.02.15 says that during such an emergency, “the hospital may
assign disaster responsibilities to volunteer practitioners who are not licensed independent practitioners,
but who are required by law and regulation to have a license, certification, or registration.” Id. at 63.
7
Id. at 61–65.
8
Id. at 61.
9
Id.
10
Id. at 61–65.
11
Id..
12
Id.
13
MCL § 333.16181, and MCL § 333.16182.
14
ID. AT (1), (3) (West, Westlaw through 2009 Sess.).
15
MICH. COMP. LAWS. ANN. § 333.16182(1) (West, Westlaw through 2009 Sess.).
Caring for the Community | preparing for an influenza pandemic
12
otherwise qualified by training, education and experience and acting under the licensee's supervision.
However, a physician may delegate the performance of a procedure that requires the use of surgical
instrumentation to a non-licensed individual only under certain circumstances. MCL 333.16215 (3) and
16
(4).
Additionally, Michigan’s Emergency Management Act allows certain licensed health professionals to
administer anesthetics, perform minor surgery, perform intravenous, subcutaneous and intramuscular
procedures, and give oral and topical medications under the general supervision of a member of the
medical staff of a licensed hospital in Michigan, and to assist the staff member in other medical and
surgical proceedings. MCL 30.411(5).
“Delegation” as used in this section means an authorization granted by a licensee [under Article 15 of the
Public Health Code] to a licensed or unlicensed individual to perform selected acts, tasks, or functions that
fall within the scope of practice of the delegator and that are not within the scope of practice of the
delegatee and that, in the absence of the authorization, would constitute illegal practice of a licensed
17
profession.
An EMS provider, licensed under Article 17, may not delegate their practice to another, such that the
person being directed would be functioning outside of their own scope of practice. EMS providers must
function within their scope of practice as defined within their local protocols unless they are acting under
the delegated authority of an individual licensed under article 15.
13.
Use of Retired Physicians.
Retired health care professionals constitute a class of potential volunteers who might no longer hold a
license, but who nevertheless are likely to be able to provide valuable skills during an emergency, such as
a pandemic. Generally, retired medical personal are treated in the same way as other unlicensed
volunteers. Two situations, however, are particularly relevant to retired health care professionals. First,
18
retired health care professionals may hold a special volunteer license. Second, retired health care
professionals are likely to fit the criteria, previously discussed, for practicing medicine without a license
19
during an emergency situation.
Michigan, like many other states, has a special volunteer license for retired physicians. Retired physicians
are able to obtain a special volunteer license in Michigan in order to provide medical and dental care to
20
“medically indigent individual[s]” in underserved areas of the state. Physicians who practice under this
special volunteer license are protected from liability if: (1) the care is provided at a health facility or agency
that provides at least 75% of its care to medically indigent individuals; (2) the physician does not receive
21
compensation for providing the care; and (3) the physician’s actions do not amount to “gross negligence.”
16
Notably, EMS personnel are not licensed under Article 15 and are not authorized to delegate under this
provision. However, licensees could delegate functions that may be outside of EMS protocol to EMS
personnel who are otherwise qualified by training and experience.
17
MICH. COMP. LAWS. ANN. § 333.16215 (West, Westlaw through 2009 Sess.).
18
See MICH. COMP. LAWS ANN. § 333.16184 (West, Westlaw through 2009 Sess.).
19
MICH. COMP. LAWS ANN. § 333.16171(c) (West, Westlaw through 2009 Sess.).
20
MICH. COMP. LAWS ANN. § 333.16184 (West, Westlaw through 2009 Sess.) (providing the opportunity to
obtain a special license to those retired from the active practice of medicine, osteopathic medicine and
surgery, podiatric medicine and surgery, or dentistry). There is no volunteer license for other retired
medical professionals, such as nurses, but some groups have recommended that these medical
professionals be granted similar volunteer licenses. See e.g. MICHIGAN DEPARTMENT OF COMMUNITY
HEALTH TASK FORCE ON N URSING R EGULATION, FINAL
REPORT, 11–12 (2008), available at:
http://www.michigan.gov/documents/mdch/nurseregfinal_228919_7.pdf.
21
MICH. COMP. LAWS ANN. § 333.16184 (West, Westlaw through 2009 Sess.).
Caring for the Community | preparing for an influenza pandemic
13
Presumably, this protection from liability also extends to care given in an emergency as long as the same
criteria are met. The statute, however, does not indicate that the special volunteer license would grant
protection from liability if the volunteer administers the care at facilities or agencies that do not meet the
22
specified criteria.
Some retired physicians will no longer hold any type of license. In an emergency, responders may prefer
to use these retired medical professionals who are skilled, but unlicensed, to perform procedures for which
23
they no longer hold the proper credentials, rather than withhold care. Under Michigan law, many of these
retired medical professionals will be permitted to administer care in a disaster or emergency situation, even
though they do not have a license. In addition, unlicensed retired professionals are likely to meet one of
the previously-discussed licensing exceptions, which permits them to render medical care in the time of a
disaster if they “substantially meet” licensing requirements through their “education, training, or
24
experience.” However, in doing so, they do not benefit from the immunity from liability that is statutorily
25
afforded to licensed medical professionals who perform procedures in an emergency.
14.
Ambulance Transport to Alternative Destinations.
Under normal circumstances, an ambulance may not transport an emergency patient to locations other
than a hospital or a freestanding surgical outpatient facility (as defined in statute) unless a determination is
made that an emergency (for that patient) no longer exists. This is protocol-specific and may vary under
normal circumstances amongst the medical control authorities in the state.
Michigan Administrative Rules: R 325.22112
Patient destination; transporting agencies.
Rule 112. (1) An ambulance operation, both ground and rotary, shall transport an emergency patient
only to an organized emergency department located in and operated by a hospital licensed under part
215 of the code or to a freestanding surgical outpatient facility licensed under part 208 of the code that
operates a service for treating emergency patients 24 hours a day, 7 days a week and complies with
medical control authority protocols.
(2) Subrule (1) of this rule shall not apply when a determination is made that an emergency no longer
exists in accordance with department-approved protocols.
If a disaster plan has a provision for transport to other facilities (such as an Acute Care Site) during a
disaster, and that plan has been approved by the department, then alternative transport would be approved
with the activation of the plan. A Medical Control Authority may also enact an emergency protocol to alter
patient destinations.
MCL 333.20919(e) A medical control authority may establish an emergency protocol necessary to
preserve the health or safety of individuals within its jurisdiction in response to a present medical
emergency or disaster without following the procedures established by the department under this
section for an ordinary protocol. An emergency protocol established under this subdivision is effective
22
Some states have special volunteer licenses for retired physicians that are less restrictive, requiring only
that the retired physician not be compensated for their services. See PAUL A. HATTIS ET. AL.,
UNDERSTANDING CHARITABLE IMMUNITY LEGISLATION: A VOLUNTEERS IN HEALTH CARE GUIDE 17–19 (2003),
available at: www.ada.org/prof/resources/topics/topics_access_vih_manual.pdf.
23
Sharona Hoffman, Responder’s Responsibility: Liability and Immunity in Public Health Emergencies, 96
GEO. L.J. 1913, 1958–59 (2008).
24
MICH. COMP. LAWS A NN. § 333.16171(c) (West, Westlaw through 2009 Sess.).
25
See MICH. COMP. LAWS ANN. § 30.411(4)–(6) (West, Westlaw through 2009 Sess.); see also 42
U.S.C.A. § 14503 (West, Westlaw through 2009 Sess.) (extending immunity to volunteers of nonprofit
organizations and government entities who are properly licensed or certified); see also Sharona Hoffman,
Responder’s Responsibility: Liability and Immunity in Public Health Emergencies, 96 GEO . L.J. 1913, 1958
(2008).
Caring for the Community | preparing for an influenza pandemic
14
only for a limited time period and does not take permanent effect unless it is approved according to this
subsection.
Transport of a patient to a NEHC would not be inclusive of any emergency patient and would not need an
exception as an emergency (for that patient) no longer exists, even if the request for service came through
911.
15.
Use of vehicles other than ambulances to transport patients.
In an influenza pandemic, it may be necessary to transport patients in alternative vehicles such as buses,
vans, or personal automobiles. MCL 333.20939 permits an EMS responder to transport patients in nonambulance vehicles under “extraordinary circumstances” if this is done without charge or fee.
Any disaster plan that intends to utilize non-ambulance methods of transport should include a provision
that either creates an exception to this statute and is then duly approved by the state, or promptly requests
a waiver from the state from this section, if needed.
R 325.22113 Patient transfers; ground, rotary, aircraft transport.
Rule 113. (1) A person shall not transport a patient by stretcher, cot, litter, or isolette unless it is done
in a licensed ambulance or aircraft transport vehicle. The life support agency transporting the patient
shall require that any applicable department-approved protocols of the medical control authority are
followed in accordance with section 20921 (4) and (5) of the code.
(2) An out-of-state service that is coming to this state to transfer a patient from a Michigan facility to a
facility in another state or country shall be licensed or certified within its own jurisdiction.
MCL 333.20939 Spontaneous use of vehicle under exceptional circumstances; written report. Sec.
20939. If an ambulance operation is unable to respond to an emergency patient within a reasonable
time, this part does not prohibit the spontaneous use of a vehicle under exceptional circumstances to
provide, without charge or fee and as a humane service, transportation for the emergency patient.
Emergency medical personnel who transport or who make the decision to transport an emergency
patient under this section shall file a written report describing the incident with the medical control
authority.
16.
Pre-emergency department triage.
It is the responsibility of the Medical Control Authority for a particular geographical area to establish
protocols directing the appropriate dispatch of license life support agencies and/or departments.
MCL 333. 20919. (1) a local medical control authority shall establish written protocols for the practice
of life support agencies and licensed emergency medical services personnel within its region. The
protocols shall be developed and adopted in accordance with procedures established by the
department and shall include all of the following:
(a) The acts, tasks, or functions that may be performed by each type of emergency medical
services personnel licensed under this part.
(b) Medical protocols to ensure the appropriate dispatching of a life support agency based upon
medical need and the capability of the emergency medical services system.
These protocols may vary amongst the Medical Control Authorities in Michigan. However, by statute, a
licensed EMS service must respond to each request for service. The type of response (lights and siren vs.
none) and the types of responders sent is dependent on the protocols authored by the Medical Control
Authorities and approved by the State.
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15
333.20921 Ambulance operation; duties; prohibitions; occupants of patient compartment;
operation at higher level of life support; applicability of subsection (5).
Sec. 20921. (1) An ambulance operation shall do all of the following:
(a) Provide at least 1 ambulance available for response to requests for emergency assistance on a
24-hour-a-day, 7-day-a-week basis in accordance with local medical control authority
protocols.
(b) Respond or ensure that a response is provided to each request for emergency assistance
originating from within the bounds of its service area.
(c) Operate under the direction of a medical control authority or the medical control authorities with
jurisdiction over the ambulance operation
Based on these two statutes, and the provision within 333.20919 for the Medical Control Authority to enact
emergency protocols to protect the public during a time of emergency (declared or otherwise), it is possible
to create a protocol that limits the sending of ambulances within a dispatch center using a consistent triage
tool. Triage tools should be based on specific and measurable clinical criteria and should avoid all
subjectivity, or potential bias, or discrimination based on anything other than clinical criteria.
Any disaster plan should include a provision that would expressly state that, when such a plan is activated,
the need to send an ambulance to every request for service is waived. Likewise, it would be prudent to
provide direction to callers regarding how to appropriately access health care services (i.e., this will not
always necessitate calling 911 and requesting an ambulance).
17.
Legal considerations for rationing of medical care and supplies.
When rationing medical care, it is appropriate to consider criteria based on an individual’s specific state of
health. It also may be appropriate to prioritize certain groups necessary for maintaining civic order (e.g.
law enforcement, government personnel, and essential health care providers). Criteria that limit access to
health care based on an individual’s race, color, national origin, religion, sex, age, disabilities, height,
weight, and familial or marital status are illegal.
An influenza pandemic will affect a large part of the global population, spanning all age groups and
26
including health care, emergency response, and other essential workforces. The pandemic will create
large numbers of patients that will quickly overwhelm hospitals and will necessitate the allocation of scarce
resources. The supply of antiviral drugs will be inadequate and the development of a vaccine will take a
significant amount of time. There will be a significant shortfall of mechanical ventilators required to treat
27
patients suffering from acute respiratory failure. Health care providers will have to make difficult
decisions regarding the allocation of these scarce resources. These decisions will result in some patients
being denied access to life-saving care.
Should an influenza pandemic arrive in Michigan, protocol should be in place for deciding which patients
will have access to scarce resources. Critical care triage protocols in a pandemic will likely use a formula of
factors to determine which patients should be considered for critical care and which patients should be
28
excluded.
Allocation criteria should be rationally related to the goal of maximizing the use of limited
26
U.S. Department of Health & Human Services, Mass Medical Care with Scarce Resources: A
Community Planning Guide, http://www.ahrq.gov/research/mece/mece1.htm (last visited June 2009).
27
Id.
28
See NYS Workgroup on Ventilator Allocation in an Influenza Pandemic, Allocation of Ventilators in an
Influenza Pandemic, http://www.health.state.ny.us/diseases/communicable/influenza/pandemic/ventilators/
(March 2007). For example, New York is considering a triage protocol that withholds and withdraws
ventilators from patients with the highest probability of mortality to benefit patients with the highest
Caring for the Community | preparing for an influenza pandemic
16
resources to benefit the largest number of individuals. Thus, any allocation criteria should be adopted at
state, regional, or local levels, rather than by individual facilities and agencies.
The state has authority to mandate a rationing protocol that gives priority access to medical resources to
specific groups of people that are essential to maintaining social order in the event of a pandemic
29
disaster. For example, in addition to key government decision makers, priority may be given to
manufactures of vaccine and antiviral medications, health care workers, public safety workers, and utility
30
workers. In an emergency, the State has the duty and authority to take full charge of the administration
31
of health laws, rules, and regulations applicable to the emergency. Under this authority, the State
rationed scarce flu vaccinations in 2004. The same authority would likely be used to ration scarce
resources in an influenza pandemic. Thus the state may mandate that these factors be taken into
consideration when determining who has access to scarce resources.
However, medical rationing criteria based on contributions to society, such as a person’s employment as a
health care provider, should be implemented only under the guidance of Federal, state, or local authority.
Legislators should be encouraged to provide such guidance to health care providers in creating protocols
for rationing medical treatment.
In the case of an influenza pandemic, triage of life-sustaining treatment – specifically, mechanical
ventilation – may well become necessary. While Michigan lacks statewide guidelines regarding the
allocation of mechanical ventilation in a pandemic environment, other states have addressed the issue.
New York and Minnesota have addressed both the need to allocate ventilators in a pandemic environment
and the need to re-allocate them, removing them from patients who do not appear to be improving.


32
The New York model calls for a purely objective method of allocation and withdrawal of
ventilators, using a scoring system to make determinations about which patients are entitled to
access and/or continued access to ventilators. The New York model does not allow subjective
comparisons between patients.
33
The Minnesota model uses a primarily objective system as well, but adds the ability to compare
the medical prospects of two patients to one another.
Both the Minnesota model and the New York model endorse the use of a scoring system to determine
whether a patient will be allowed ventilator access. These models would suggest that an objective system
of medical evaluation, adopted at a statewide level, would be best. By all indications, a subjective system
of evaluation could expose a hospital to significant ethical and legal pitfalls. The New York and the
Minnesota models also suggest that any equipment triage and re-allocation plan be adopted at a statewide or at least regional level, rather than on an institutional basis; leaving triage and re-allocation
decisions to each individual institution appears to expose individual institutions to more liability. Further, it
may be beneficial to allocate equipment according to clinical criteria for a trial period. At the end of the trial
period the individual would be reassessed, based on measurable physiological responses, in order to
determine if the patient would be eligible for continued critical equipment use.
likelihood of survival. Triage scores derive from the sepsis-related organ failure assessment system, which
assigns points based on function in 6 basic medical domains.
29
See Public Health Code, MCL 333.2251 (1978).
30
HHS Pandemic Influenza Plan, http://www.hhs.gov/pandemicflu/plan/appendixd.html (last visited June 2009)
31
Public Health Code, MCL 333.2251 (1978).
32
New York State Workgroup on Ventilator Allocation in an Influenza Pandemic, Allocation of Ventilators in an
Influenza Pandemic 2 (Mar. 15, 2007) (draft for public comment, available at http://www.health.state.ny.us/
diseases/communicable/influenza/pandemic/ventilators/docs/ventilator_guidance.pdf).
33
John L. Hick & Daniel T. O’Laughlin, Concept of Operations for Triage of Mechanical Ventilation in an Epidemic,
13 J. ACAD. EMERGENCY MED., 2006, at 225.
Caring for the Community | preparing for an influenza pandemic
17
18.
Workplace safety considerations.
The Michigan Administrative Code contains rules enacted under MiOSHA that require personal protective
equipment (PPE) be used in certain situations including respiratory protection and protection form
bloodborne pathogens. Requirements also exist with all health care facilities for internal plans and
procedures that reflect these standards and requirements. In the event of a pandemic, it is likely that there
will be a shortage of PPE, specifically N95 masks, surgical masks and gloves.
Current guidance from CDC and state and federal agencies has encouraged health care agencies to
create a stockpile of necessary PPE. With a prolonged event and with diversion of supplies from hospitals
and EMS services, it is possible that PPE supplies may be depleted. Given that there will be significant
demand for such supplies nationally and internationally, it may be difficult if not impossible to replenish
supplies. In that case, it would be likely that sharing arrangements could be utilized including, but not
limited to, requesting supplies from the strategic national stockpile.
Should all avenues for the acquisition of standard PPE be exhausted, one would expect that an employer
would make efforts to follow existing CDC guidelines for appropriate non-typical protections such as
doubled-up cravats, etc. It is unlikely that the MiOSHA standard would be waived until such time as there
was a measurable shortage of available PPE.
It would be imprudent to develop a disaster plan that attempted to waive MiOSHA or OSHA standards at
the onset of a pandemic as these are often the measure most successful in slowing the progression of the
disease. However, as an event progressed, a request could be made to the state or at the federal level to
the Secretary of Health and Human Services to waive or relax the standards and the sanctions for noncompliance.
Regardless of whether or not the standards are relaxed, it seems incumbent on employers as well as
individuals to seek out appropriate protections in the absence of standard PPE.
Caring for the Community | preparing for an influenza pandemic
18
APPENDICES
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19
APPENDIX 1
AUTHORITY TO WAIVE REQUIREMENTS DURING NATIONAL EMERGENCIES
Sec. 1135. [42 U.S.C. 1320b–5] (a) Purpose.—The purpose of this section is to enable the Secretary to
ensure to the maximum extent feasible, in any emergency area and during an emergency period (as
defined in subsection (g)(1))—
(1) that sufficient health care items and services are available to meet the needs of individuals in such area
enrolled in the programs under titles XVIII, XIX, and XXI; and
(2) that health care providers (as defined in subsection (g)(2)) that furnish such items and services in good
faith, but that are unable to comply with one or more requirements described in subsection (b), may be
reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any
determination of fraud or abuse.
(b) Secretarial Authority.—To the extent necessary to accomplish the purpose specified in subsection (a),
the Secretary is authorized, subject to the provisions of this section, to temporarily waive or modify the
application of, with respect to health care items and services furnished by a health care provider (or
classes of health care providers) in any emergency area (or portion of such an area) during any portion of
an emergency period, the requirements of titles XVIII, XIX, or XXI, or any regulation thereunder (and the
requirements of this title other than this section, and regulations thereunder, insofar as they relate to such
titles), pertaining to—
(1)(A) conditions of participation or other certification requirements for an individual health care provider or
types of providers,
(B) program participation and similar requirements for an individual health care provider or types of
providers, and
(C) pre-approval requirements;
(2) requirements that physicians and other health care professionals be licensed in the State in which they
provide such services, if they have equivalent licensing in another State and are not affirmatively excluded
from practice in that State or in any State a part of which is included in the emergency area;
(3) actions under section 1867 (relating to examination and treatment for emergency medical conditions
and women in labor) for—
(A) a transfer of an individual who has not been stabilized in violation of subsection (c) of such section if
the transfer arises out of the circumstances of the emergency;
(B) the direction or relocation of an individual to receive medical screening in an alternative location—
(i) pursuant to an appropriate State emergency preparedness plan; or
(ii) in the case of a public health emergency described in subsection (g)(1)(B) that involves a pandemic
infectious disease, pursuant to a State pandemic preparedness plan or a plan referred to in clause (i),
whichever is applicable in the State;
(4) sanctions under section 1877(g) (relating to limitations on physician referral);
(5) deadlines and timetables for performance of required activities, except that such deadlines and
timetables may only be modified, not waived;
Caring for the Community | preparing for an influenza pandemic
20
(6) limitations on payments under section 1851(i) for health care items and services furnished to individuals
enrolled in a Medicare+Choice plan by health care professionals or facilities not included under such plan;
and
(7) sanctions and penalties that arise from the noncompliance with the following requirements (as
promulgated under the authority of section 264(c) of the Health Insurance Portability and Accountability Act
[67]
of 1996 (42 U.S. C. 1320d-2 note)—
(A) section 164.510 of title 45, Code of Federal Regulations, relating to—
(i) requirements to obtain a patient's agreement to speak with family members or friends; and
(ii) the requirement to honor a request to opt out of the facility directory;
(B) section 164.520 of such title, relating to the requirement to distribute a notice; or
(C) section 164.522 of such title, relating to—
(i) the patient's right to request privacy restrictions; and
(ii) the patient's right to request confidential communications.
Insofar as the Secretary exercises authority under paragraph (6) with respect to individuals enrolled in a
Medicare+Choice plan, to the extent possible given the circumstances, the Secretary shall reconcile
payments made on behalf of such enrollees to ensure that the enrollees do not pay more than would be
required had they received services from providers within the network of the plan and may reconcile
payments to the organization offering the plan to ensure that such organization pays for services for which
payment is included in the capitation payment it receives under part C of title XVIII. A waiver or
modification provided for under paragraph (3) or (7) shall only be in effect if such actions are taken in a
manner that does not discriminate among individuals on the basis of their source of payment or of their
ability to pay, and, except in the case of a waiver or modification to which the fifth sentence of this
subsection applies, shall be limited to a 72-hour period beginning upon implementation of a hospital
disaster protocol. A waiver or modification under such paragraph (7) shall be withdrawn after such period
and the provider shall comply with the requirements under such paragraph for any patient still under the
care of the provider. If a public health emergency described in subsection (g)(1)(B) involves a pandemic
infectious disease (such as pandemic influenza), the duration of a waiver or modification under paragraph
(3) shall be determined in accordance with subsection (e) as such subsection applies to public health
emergencies.
(c) Authority for Retroactive Waiver.—A waiver or modification of requirements pursuant to this section
may, at the Secretary's discretion, be made retroactive to the beginning of the emergency period or any
subsequent date in such period specified by the Secretary.
(d) Certification to Congress.—The Secretary shall provide a certification and advance written notice to the
Congress at least two days before exercising the authority under this section with respect to an emergency
area. Such a certification and notice shall include—
(1) a description of—
(A) the specific provisions that will be waived or modified;
(B) the health care providers to whom the waiver or modification will apply;
(C) the geographic area in which the waiver or modification will apply; and
(D) the period of time for which the waiver or modification will be in effect; and
Caring for the Community | preparing for an influenza pandemic
21
(2) a certification that the waiver or modification is necessary to carry out the purpose specified in
subsection (a).
(e) Duration of Waiver.—
(1) In general.—A waiver or modification of requirements pursuant to this section terminates upon—
(A) the termination of the applicable declaration of emergency or disaster described in subsection (g)(1)(A);
(B) the termination of the applicable declaration of public health emergency described in subsection
(g)(1)(B); or
(C) subject to paragraph (2), the termination of a period of 60 days from the date the waiver or modification
is first published (or, if applicable, the date of extension of the waiver or modification under paragraph (2)).
(2) Extension of 60-day periods.—The Secretary may, by notice, provide for an extension of a 60-day
period described in paragraph (1)(C) (or an additional period provided under this paragraph) for additional
period or periods (not to exceed, except as subsequently provided under this paragraph, 60 days each),
but any such extension shall not affect or prevent the termination of a waiver or modification under
subparagraph (A) or (B) of paragraph (1).
(f) Report to Congress.—Within one year after the end of the emergency period in an emergency area in
which the Secretary exercised the authority provided under this section, the Secretary shall report to the
Congress regarding the approaches used to accomplish the purposes described in subsection (a),
including an evaluation of such approaches and recommendations for improved approaches should the
need for such emergency authority arise in the future.
(g) Definitions.—for purposes of this section:
(1) Emergency area; emergency period.—An “emergency area” is a geographical area in which, and an
“emergency period” is the period during which, there exists—
[68]
(A) an emergency or disaster declared by the President pursuant to the National Emergencies Act
[69]
Robert T. Stafford Disaster Relief and Emergency Assistance Act ; and
or the
(B) a public health emergency declared by the Secretary pursuant to section 319 of the Public Health
Service Act.
(2) Health care provider.—The term “health care provider” means any entity that furnishes health care
items or services, and includes a hospital or other provider of services, a physician or other health care
practitioner or professional, a health care facility, or a supplier of health care items or services.
[67]
See Vol. II, P.L. 104-191, §264(c).
[68]
P.L. 94-412.
[69]
P.L. 93-288.
Caring for the Community | preparing for an influenza pandemic
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APPENDIX 2
MCL 30.411 Powers and duties of personnel of disaster relief forces; liability for personal injury or property
damage; right to benefits or compensation; disaster relief workers; immunity; liability and legal obligation of
persons owning or controlling real estate or other premises used for shelter; "gross negligence" defined.
Sec. 11.
(1) Personnel of disaster relief forces while on duty are subject to all of the following provisions:
(a) If they are employees of this state, they have the powers, duties, rights, privileges, and immunities of
and receive the compensation incidental to their employment.
(b) If they are employees of a political subdivision of this state, regardless of where serving, they have the
powers, duties, rights, privileges, and immunities and receive the compensation incidental to their
employment.
(c) If they are not employees of this state or a political subdivision of this state, they are entitled to the
same rights and immunities as provided by law for the employees of this state. All personnel of disaster
relief forces shall, while on duty, be subject to the operational control of the authority in charge of disaster
relief activities in the area in which they are serving, and shall be reimbursed for all actual and necessary
travel and subsistence expenses.
(2) This state, any political subdivision of this state, or the employees, agents, or representatives of this
state or any political subdivision of this state are not liable for personal injury or property damage sustained
by any person appointed or acting as a member of disaster relief forces. This act does not affect the right
of a person to receive benefits or compensation to which he or she may otherwise be entitled to under the
worker's disability compensation act of 1969, 1969 PA 317, MCL 418.101 to 418.941, any pension law, or
any act of congress.
(3) This state or a political subdivision of this state engaged in disaster relief activity is not liable for the
death of or injury to a person or persons, or for damage to property, as a result of that activity. The
employees, agents, or representatives of this state or a political subdivision of this state and
nongovernmental disaster relief force workers or private or volunteer personnel engaged in disaster relief
activity are immune from tort liability to the extent provided under section 7 of 1964 PA 170, MCL
691.1407. As used in this section, "disaster relief activity" includes training for or responding to an actual,
impending, mock, or practice disaster or emergency.
(4) A person licensed to practice medicine or osteopathic medicine and surgery or a licensed hospital,
whether licensed in this or another state or by the federal government or a branch of the armed forces of
the United States, or an individual listed in subsection (6), who renders services during a state of disaster
declared by the governor and at the express or implied request of a state official or agency or county or
local coordinator or executive body, is considered an authorized disaster relief worker or facility and is not
liable for an injury sustained by a person by reason of those services, regardless of how or under what
circumstances or by what cause those injuries are sustained. The immunity granted by this subsection
does not apply in the event of an act or omission that is willful or gross negligence. If a civil action for
malpractice is filed alleging an act or omission that is willful or gross negligence resulting in injuries, the
services rendered that resulted in those injuries shall be judged according to the standards required of
persons licensed in this state to perform those services.
(5) An individual listed in subsection (6), during a state of disaster declared by the governor, may practice,
in addition to the authority granted by other statutes of this state, the administration of anesthetics; minor
surgery; intravenous, subcutaneous, or intramuscular procedure; or oral and topical medication; or a
combination of these under the supervision of a member of the medical staff of a licensed hospital of this
state, and may assist the staff member in other medical and surgical proceedings.
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(6) Subsections (4) and (5) apply to all of the following individuals:
(a) Any of the following, if licensed in this or another state or by the federal government or a branch of the
armed forces of the United States:
(i) A registered nurse.
(ii) A practical nurse.
(iii) A nursing student acting under the supervision of a licensed nurse.
(iv) A dentist.
(v) A veterinarian.
(vi) A pharmacist.
(vii) A pharmacist intern acting under the supervision of a licensed pharmacist.
(viii) A paramedic.
(b) A medical resident undergoing training in a licensed hospital in this or another state.
(7) A person owning or controlling real estate or other premises who voluntarily and without compensation
grants to this state or a political subdivision of this state a license or privilege, or otherwise permits this
state or a political subdivision of this state to inspect, designate, and use the whole or any part or parts of
the real estate or other premises for the purpose of sheltering persons during an actual, impending, mock,
or practice disaster, together with his or her successors in interest, if any, is not civilly liable for negligently
causing the death of or injury to any person on or about the real estate or premises under the license,
privilege, or permission or for loss or damage to the property of the person.
(8) A person owning or controlling real estate or other premises who has gratuitously granted the use of the
real estate or other premises for the purposes stated in this section is legally obligated to make known to
the licensee any hidden dangers or safety hazards that are known to the owner or occupant of the real
estate or premises that might possibly result in the death or injury or loss of property to a person using the
real estate or premises.
(9) As used in this section, "gross negligence" means conduct so reckless as to demonstrate a substantial
lack of concern for whether an injury results.
History: 1976, Act 390, Imd. Eff. Dec. 30, 1976 ;-- Am. 1990, Act 50, Imd. Eff. Apr. 6, 1990 ;-- Am. 2002,
Act 132, Eff. May 1, 2002 ;-- Am. 2005, Act 321, Imd. Eff. Dec. 27, 2005
Admin Rule: R 30.1 et seq. of the Michigan Administrative Code.
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Appendix 3
333.16215 Delegation of acts, tasks, or functions to licensed or unlicensed individual; supervision; rules;
immunity; third party reimbursement or worker's compensation benefits.
Sec. 16215.
(1) Subject to subsections (2) to (6), a licensee who holds a license other than a health profession subfield
license may delegate to a licensed or unlicensed individual who is otherwise qualified by education,
training, or experience the performance of selected acts, tasks, or functions where the acts, tasks, or
functions fall within the scope of practice of the licensee's profession and will be performed under the
licensee's supervision. A licensee shall not delegate an act, task, or function under this section if the act,
task, or function, under standards of acceptable and prevailing practices, requires the level of education,
skill, and judgment required of the licensee under this article.
(2) Subject to subsection (1) and except as otherwise provided in this subsection and subsections (3) and
(4), a licensee who is an allopathic physician or osteopathic physician and surgeon shall delegate an act,
task, or function that involves the performance of a procedure that requires the use of surgical
instrumentation only to an individual who is licensed under this article. A licensee who is an allopathic
physician or osteopathic physician and surgeon may delegate an act, task, or function described in this
subsection to an individual who is not licensed under this article if the unlicensed individual is 1 or more of
the following and if the procedure is directly supervised by a licensed allopathic physician or osteopathic
physician and surgeon who is physically present during the performance of the procedure:
(a) A student enrolled in a school of medicine or osteopathic medicine approved by the Michigan board of
medicine or the Michigan board of osteopathic medicine and surgery.
(b) A student enrolled in a physician's assistant training program approved by the joint physician's assistant
task force created under part 170.
(3) Subject to subsection (1), a licensee who is an allopathic physician or osteopathic physician and
surgeon may delegate an act, task, or function described in subsection (2) to an individual who is not
licensed under this article and who is 1 of the following:
(a) Performing acupuncture.
(b) Surgically removing only bone, skin, blood vessels, cartilage, dura mater, ligaments, tendons,
pericardial tissue, or heart valves only from a deceased individual for transplantation, implantation,
infusion, injection, or other medical or scientific purpose.
(4) Subject to subsection (1), a licensee who is an allopathic physician or osteopathic physician and
surgeon may delegate an act, task, or function described in subsection (2) to an individual who is not
licensed under this article if the procedure is directly supervised by a licensed allopathic physician or
osteopathic physician and surgeon who is physically present during the performance of the procedure, the
delegation of such procedure is not prohibited or otherwise restricted by the board or that health facility or
agency, and the delegation of that act, task, or function is specifically authorized by that health facility or
agency to be delegated and performed by either of the following unlicensed individuals:
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(a) A surgical technologist who meets the qualifications established by the health facility or agency with
which he or she is employed or under contract with.
(b) A surgical first assistant who meets the qualifications established by the health facility or agency with
which he or she is employed or under contract with.
(5) A board may promulgate rules to further prohibit or otherwise restrict delegation of specific acts, tasks,
or functions to a licensed or unlicensed individual if the board determines that the delegation constitutes or
may constitute a danger to the health, safety, or welfare of the patient or public.
(6) To promote safe and competent practice, a board may promulgate rules to specify conditions under
which, and categories and types of licensed and unlicensed individuals for whom, closer supervision may
be required for acts, tasks, and functions delegated under this section.
(7) An individual who performs acts, tasks, or functions delegated pursuant to this section does not violate
the part that regulates the scope of practice of that health profession.
(8) The amendatory act that added this subsection does not require new or additional third party
reimbursement or mandated worker's compensation benefits for services rendered by an individual
authorized to perform those services under subsection (4).
History: 1978, Act 368, Eff. Sept. 30, 1978 ;-- Am. 1990, Act 279, Eff. Mar. 28, 1991 ;-- Am. 1999, Act 60,
Eff. Sept. 1, 1999 ;-- Am. 2005, Act 211, Imd. Eff. Nov. 17, 2005
Popular Name: Act 368
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