Major Topic #5: Liability

Optimally, decisions regarding system or service protocols and procedures, scope of practice of transport personnel, interagency and inter-jurisdictional agreements regarding transfer should be made prior to the need for interfacility transfer. The extent to which this is accomplished will make decisions easier and the IFT process more efficient. Potential liability has a major impact in making these decisions, and it behooves all stakeholders to have a strong working knowledge of the issue. Laws addressing liability and their interpretation vary widely from state to state. Specific information within this document may therefore be of limited use. It behooves those involved in IFT to become familiar with State laws and court decisions impacting liability in the jurisdiction(s) to be served by the IFT service. This major topic contains general information for consideration, including: definitions, delineations of liability for health care providers, regulations that affect liability, and practice guidelines.

Definition of Liability
Liability is generally defined as legal responsibility for one’s acts or omissions. There are two forms:

• Direct Liability - Liability imposed directly on a person because of his or her own negligence, default, or legal undertaking.
  
  
• Indirect Liability - Liability that arises from a legal obligation owed to an injured party to pay damages for another’s failure to perform or negligent act.

Liability of Each Health Care Professional
Every health care professional has a legal duty to exercise that degree of knowledge, care, and skill that is expected of a comparably trained practitioner in the same class in which he or she belongs, acting in the same or similar circumstances. The standard of care is based on laws, administrative orders, regulations, and guidelines established by entities or individuals with the legal authority to do so.

Liability of Direct Care Providers
Each program, hospital, or service employing health care professionals to provide direct care for patients during IFT is responsible for ensuring that policies, procedures, and protocols are in place for the care provided by the transport team. These documents should be consistent with laws, regulations, and administrative rules for the jurisdiction(s) in which IFT occurs. The IFT service should also maintain written policies addressing appropriate licensure and scope of practice for each team member, based upon the local, regional, and/or State laws and/or regulations in the geographical area(s) in which the team provides care and performs transports.

The IFT transfer service/program is responsible for the care rendered during transport. The program should establish written policies/protocols for all procedures, skills, or care the transport team members provide. Written documentation of education, skills, training, demonstrated abilities, initial and/or ongoing education, should be maintained, and all transport personnel should be familiar with program requirements. In addition, the transfer service should establish an ongoing program for quality assurance/quality management, which uses patient and referring facility/physician satisfaction surveys, chart reviews, case reviews, and peer reviews to identify problems or areas needing improvement as well as areas of strength that could serve as models for other IFT services.

The individual caregivers are responsible for the direct care they provide to the patient during transport. It is imperative that these personnel be familiar with the appropriate State practice acts (e.g., Medical Practice Act, Nurse Practice Act, EMS Act), licensing and/or certification regulations, and the limitations and responsibilities of their specific profession’s scope of practice. It is the obligation of each licensed and/or certified professional to know and understand the standard to which he or she will be held. Individuals providing direct care to the patient should not be pressured into functioning beyond their intended role, and must always function within the scope of practice for which they are prepared, trained, and legally authorized. Procedures should be in place that providers can use to handle situations placing them in questionable situations. Direct care providers may or may not choose to carry individual professional malpractice insurance in addition to what is provided by their employers.

Liability of Medical Directors
Medical practice acts vary from State to State as do statutes related to functions that may be performed under a physician’s license. It is particularly important for the prehospital professional who functions under medical direction to understand the purpose of the law in their jurisdiction(s), and to be familiar with their State’s Medical Practice Act, particularly as it pertains to liability and legal responsibilities.

Obtaining Liability Insurance
Physicians and other medical professionals pay insurance premiums to cover payments for awards resulting from lawsuits. They may need liability insurance to practice medicine; in most cases hospitals, physician groups, as well as many State laws require it. The cost of medical liability coverage varies by specialty and location. Physician specialists practicing emergency medicine, neurosurgery, orthopedics, obstetrics, and gynecology often have the highest premiums, because they perform procedures that have more risks of complications or because their patients have more serious illnesses or injuries.

The medical liability crisis is reported to have posed serious challenges to those physicians providing medical oversight, including those involved with IFT. For more extensive information, refer to Appendix D: Obtaining Liability Insurance.

Regulations that Affect Liability

EMTALA
Emergency Medical Treatment and Labor Act¹
The Emergency Medical Treatment and Labor Act is a Federal law enacted by Congress in 1986 as part of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 (42 U.S.C. §1395dd). Referred to as the “anti-dumping” law, it was designed to prevent hospitals from refusing to treat patients or transferring them to charity or county hospitals because they were unable to pay or had Medicaid coverage. EMTALA requires hospitals with emergency departments to provide emergency medical care to everyone who needs it, regardless of ability to pay or insurance status. Under the law, patients with similar medical conditions must be treated consistently. The law applies to hospitals that accept Medicare reimbursement, and to all their patients, not just those covered by Medicare. For more information, refer to Appendix E: EMTALA.

Certificate of Transfer²
Certification of necessity for transfer is a requirement for reimbursement by the Centers for Medicare and Medicaid Services. The CMS definition of medical necessity is as follows:
Medical necessity is established when the patient’s condition is such that use of any other method of transportation is contraindicated. In any case, in which some means of transportation other than an ambulance could be used without endangering the individual’s health, whether or not such other transportation is actually available, no payment may be made for ambulance service.
It is possible (but not likely) that a patient may require transfer and not meet the CMS definition of medical necessity. For more information, refer to Appendix F: Certificate of Transfer.

HIPAA
Health Insurance Portability and Accountability Act (HIPAA)³
The Health Insurance Portability and Accountability Act of 1996 is a law enacted to combat fraud, waste, and abuse in health insurance and the delivery of healthcare services; to improve access to long-term care services and coverage, and simplify the administration of health insurance. The program sets standards for the use and disclosure of protected health information along with measures to ensure the secure transmission and storage of medical records and other individually identifiable or demographic information. The regulations protect medical records and other individually identifiable health information, whether it is on paper, in computers or communicated orally. HIPAA regulations have implications for all IFT services transporting and transferring medical records or medical information from one facility to another. For more information on HIPAA, refer to Appendix F: HIPAA.

Federal, State, and Interstate Regulations
IFT providers are well advised to become familiar with any Federal, State, or interstate regulations that may have an impact on IFT service, as well as their relative jurisdictions. While it is not possible to include an exhaustive listing of these regulations, examples may provide illustration of the potential impact of regulations on IFT.

Example #1 – Federal Aviation Administration (FAA)
The FAA strictly governs the operations of aircraft in the United States under Title 14 of the Federal Code of Regulations. There are two Federal Aviation Regulations (FAR) that are applicable to air medical transport, FAR Part 91⁴ and FAR Part 135⁵. FAR Part 91 addresses the “General Operating Flight Rules” and FAR Part 135 deals with “Commuter and On-Demand Operations and Rules Governing Persons on Board Such Aircraft.” Air medical transport programs are most commonly operating under Part 135. All commuter and on demand aircraft transporting passengers are required to comply with all Federal Aviation Regulations contained in Part 135.

Example #2 — State Regulation
EMS services usually derive their authority from State laws or regulations. These may include laws that allow the provision of emergency care. These statutes define scope of practice and frequently address protocols, communication, and medical oversight. There is great variation from State to State in these laws and regulations. Some grant licensure while others do not. It is important to be familiar with the State laws and regulations as they pertain to the practice of IFT within the jurisdiction(s) where IFT services are provided.

In some cases and for certain circumstances, Fed-eral agencies may have jurisdiction (e.g., EMTALA, HIPAA, Federal Aviation Administration regulations on aircraft used as air ambulances). Specific roles and responsibilities in interfacility transfers will vary from State to State; it is impor-tant to understand these responsibilities. In some localities, the functions of IFT providers and/or services are enabled by a specific law or regulation.

Example #3 — Interstate Issues
Because some geographic areas do not have reasonable access to comprehensive or specialty services within their own state, referral patterns may exist that cross State lines. This situation makes it necessary to consider issues of interstate coordination and cooperation. Interstate issues can also arise for metropolitan areas that serve more than one State. In some cases, interested parties can develop official agreements under the auspices of State or local government agencies. In other cases, contractual or informal relationships develop between referral centers and community hospitals and EMS systems.

The stability of both official and informal arrangements depends on meeting the needs of all the groups involved and on addressing key issues, such as coordination of professional, legal, and regulatory requirements. Neighboring States often differ in such matters as certification and licensing requirements for institutions and practitioners, scopes of practice and guidelines for transfer. Interstate transfer agreements can address some of these differences to ensure that consistent and acceptable levels of care are rendered and that providers do not face liability risks related to differences in practice standards.

Practice Guidelines
Various terms are used to outline the expectations of performance within the EMS community. The terms “standards” and “guidelines” are frequently and erroneously used interchangeably.
The Health Improvement Institute provides a generic definition for these similar terms.⁶ A standard (or protocol) is described as “a basis for comparison; a reference point against which other things can be evaluated; ‘they set the measure for all subsequent work.’” A guideline is explained as “something that is to be preferred, but that does not have the force of a standard.” EMS standards and guidelines can be written to reflect a course of action for clinical as well as operational/management needs. For the purposes of this discussion, standards create an expectation while guidelines are generally thought to be a bit more flexible.

The Institute of Medicine (IOM) defines clinical practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”⁷ Frequently promulgated by relevant professional organizations, societies, health care organizations, or government agencies, standards and guidelines are generally developed using verifiable, systematic literature searches and reviews of existing evidence published in peer-reviewed journals to establish best practice recommendations.

Perceived advantages of establishing clinical practice guidelines for IFT include:

• evidence-based reference for provider practice;
• direct linkage with improvement in patient clinical condition and outcome;
• direct linkage with reduced risk of morbidity and mortality;
• established benchmark for measuring performance;
• direct linkage with enhanced patient safety;
• comparison between agencies easier using similar guidelines;
• provides public and referring physicians/facilities a clearer understanding of the capabilities of any one IFT provider and
• gives provider a clear understanding of expectations and responsibilities.

Perceived disadvantages of establishing clinical practice guidelines for IFT include:

• use by the legal community to argue a breach in the standard of care when litigation ensues following
• negative outcome (whether or not medical negligence actually exists);
• difficult and resource-intensive to develop and maintain;
• minimal flexibility for individual preferences, agency capabilities, changes in patient condition;
• difficult to establish for patients with multiple, complex diagnoses;
• balance between optimal clarity and minimal liability difficult to establish; may be too vague to be useful or too narrow to be legally “safe”;
• might force IFT provider to meet unrealistic expectations regarding equipment, education, and maintenance of skills and
• guidelines do not have the force and effect of the law.

References
1. Emergency Medical Treatment and Labor Act. State Operations Manual. Appendix V – Interpretive Guidelines – Responsibilities of Participating Hospitals in Emergency Cases. (Rev. 1, 05-21-04). Department of Health & Human Services. Centers for Medicare and Medicaid Services. Washington, DC.

2. Certificate of Transfer. Federal Register, June 22, 1994 (59FR32086). Department of Health & Human Services. Centers for Medicare and Medicaid Services. Washington, DC.

3. Health Insurance Portability and Accountability Act. http://www.cms.hhs.gov/hipaa/. Department of Health & Human Services. Centers for Medicare and Medicaid Services. Washington, DC.

4. Code of Federal Regulations, Part 91. General Operating and Flight Rules.
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=c3a8e094742081e734f4dafc1496bf36&tpl=/ecfrbrowse/Title14/14cfr91_main_02.tpl U.S. Government Printing Office. Washington, D.C.

5. Code of Federal Regulations, Part 135. Operating Requirements: Commuter and On Demand Operations and Rules Governing Persons On Board Such Aircraft. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=c3a8e094742081e734f4dafc1496bf36&tpl=/ecfrbrowse/Title14/14cfr135_main_02.tpl. U.S. Government Printing Office. Washington, D.C.

6. Clinical Practice Guidelines: Directions for a New Program, (1990), M.J. Field and K.N. Lohr (editors) Washington, DC: National Academy Press. Page 38.

7. Health Improvement Institute Quality Award. Standards. Definitions and Abbreviations. Health Improvement Institute. http://www.hii.org/index.html