cphrm preparation course - mtpin.org

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Compliance Plus+Healthcare Solutions

CPHRM Preparation Course

Week 5

Regulatory Requirements



Agenda:

Question from Week 4‐Event ReportingLegal and Regulatory EnvironmentConsent

2/17/20

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Patient Safety Rule

• Implementing Regulations for the Patient Safety Act (November 2008)

• Created a Framework for hospitals, doctors and other healthcare providers to voluntarily report information to Patient Safety Organizations (PSOs)

• Privileged and confidential

• For purpose of aggregation and analysis of patient safety events

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Patient Safety Rule

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Finding a PSO

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AHRQ PSNet

• Registration Required

• AHRQ WebM&M

• Allows you to submit cases

• AHRQ PSNet

• Separate registration

Introducing the New AHRQ WebM&M and AHRQ Patient Safety Network (PSNet) | PSNet

page 6Home | PSNet (ahrq.gov)

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The Legal System in the United States

• Federal and state government make, administer, and interpret laws affecting paramedics.

• Three branches of government


Types of Law

• Two types of law govern paramedics in court:

• Civil

• Patient can sue for perceived injury

• Criminal

• State can prosecute for breaking a statute

Courtesy of Oregon State Police.

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Types of Law

• Civil law

• Concerned with establishing liability

• Civil suit is a legal action of this sort

• Most lawsuits result from vehicle crashes.

• Criminal prosecution

• Action taken by government against someone prosecutors believe violated a law


Types of Law• Most suits against healthcare

providers involve negligence.

• Intentional tort claims may also be filed:

• Assault

• Battery

• Libel or slander

• False imprisonment

© Dan Myers

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Legal and Regulatory Environment –Consent and Informed Consent

Consent NOT just a signature on a Form

Informed Consent = Informed Choice

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Recognizing Patient Capacity for Decision‐Making

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Capacity vs. Competency

page 14

• Capacity (medical term)• Ability to make an informed decision

• Overall Comprehension

• Understanding of concept

• Evaluated by a physician• Specific, not global

• Not necessarily a permanent assessment

• Competency (legal term)• Whether a person is legally able to manager their affairs

• Global ability to make decisions

• Decided by a court / judge• Permanent unless overturned

• Guardian or conservator appointed

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What is Lack of Capacity?

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Advance Directives

• Expresses medical care, if any, the patient wants if he or she can no longer articulate personal wishes

• Differs from state to state

• Laws are often very strict.

• Know and follow state laws.

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Living Will and Health Care Power of Attorney

• Types of advance directives

• Related to end‐of‐life medical care

• Sometimes called “durable” powers of attorney

• Various types of powers of attorney

• Not all authorize health care



• Review the power of attorney carefully.

• Contact medical control when in doubt.

• Living wills generally require a precondition.

• Often contains health care power of attorney

• Consult medical control if it does not.

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• Surrogate decision maker

• Has no authority until patient becomes incapable

• Defer to patient whenever possible.

• When unsure, begin care and contact medical control.


DNR Orders

• Describes which life‐sustaining procedures, if any, should be performed

• Laws differ between states.

• May include a physician order or medical jewelry

Courtesy of the MedicAlert Foundation ®. © 2006, All Rights Reserved. MedicAlert ® is a federally registered

trademark and service mark.

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DNR Orders

• Generally, DNRs must:

• Clearly state medical problem

• Have patient/guardian signature

• Have signature of one or more physicians

• You must still provide supportive measures if a patient is not in cardiac arrest.


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EMTALA Risks• Did the patient “Come to the Hospital’s Dedicated Emergency Department”?

• Includes the hospital’s campus

• Physical area immediately adjacent to the main building

• Any noncontiguous buildings located within 250 years of the main building

• Any other structure as determined by CMS on a Case‐by‐Case basis by the regional CMS office

• Request Treatment (Seeking Treatment)

• Patient or someone on their behalf

• Presenting with symptoms obvious enough that a layperson would be able to tell they needed medical assistance

• Medical Screening Exam

• Court cases support that the exam must be of the same type and quality that is used for patients who present with similar symptoms

• More than Triage

• Qualified Medical Professional

• Designated by hospital’s bylaws

• Qualified by state law / license

• Emergency Medical Condition

• Condition of severity (including pain) that in the absence of immediate medical attention could reasonably be expected to result in placing the health of the patient and/or unborn child in serious jeopardy of permanent impairment to bodily function, serious dysfunction of any bodily organ or part, or death

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EMTALA Risks• Stabilization

• Within a reasonable degree of medical probability, no material deterioration of the condition is likely to occur during transfer

• Good faith admission to the hospital generally satisfies “stabilization”

• Transfer

• Any movement away from the hospital

• Benefits of transfer outweigh the risks

• Patient is stabilized to the best of transferring hospital’s capabilities

• Physician certification in writing

• Copy of medical record accompanies the patient

• Transfer utilizes appropriate medical equipment and personnel

• Psychiatric Emergencies

• Involve the capability and capacity of the hospital

• Reporting Violations

• “snitch rule”

• Required within 72 hours

• Other Requirements

• EMTALA Log

• Signage

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Health Insurance Portability and Accountability Act

• HIPAA

• Stringent privacy requirements

• Provides for criminal sanctions and civil penalties

• Information can be disclosed:

• For treatment

• For payment

• When authorized

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Health Insurance Portability and Accountability Act

• Special reporting situations:

• Mandated reporting

• Authorized data collection/research

• Subpoenas

• Privacy officer required

• Ensures PHI is not released illegally


Health Insurance Portability and Accountability Act• Some states have patient confidentiality laws.

• Confidentiality is part of the code of Ethics for Emergency Medical Technicians.

• You must provide patients with a copy of your service’s privacy policy.

• HIPAA also regulates electronic information.

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Mandatory Reporting

• Each state has its own requirements.

• Virtually every state has laws for reporting child and elder abuse.

• Many states have immunity provisions.

• Failure to report is a crime.

• Know reporting requirements in your state.


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Americans with Disabilities Act (ADA)

• Protects qualified persons with disabilities from employment discrimination

• All aspects of employment (hiring, salary, etc.)

• For ADA protection, a person must:

• Have a disability that limits life activities

• Possess the basic qualifications and be able to perform the essential job functions


Americans with Disabilities Act (ADA)

• Employers cannot inquire about disabilities or require a medical exam until after the job offer is made.

• Reasonable accommodations must be provided.

• Employers are not required to give preference to disabled employees.

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Title VII of the Civil Rights Act

• Prohibits discrimination based on race, color, religion, gender, national origin

• Also prohibits sexual harassment

• Applies to all aspects of employment

• Generally, a pattern over time, not single incident


Sexual Harassment

• One of the most common Title VII claims

• Two types:

• Quid pro quo

• Hostile environment

• No precise definition of what is harassment

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Sexual Harassment

• Typically includes:

• Sexual comments

• Display of offensive material

• Unwelcome advances, touching

• Inappropriate personal inquiries

• Employers are obligated to prevent harassment.

• Must investigate all claims promptly

• Must provide training

• Employees must promptly report any harassment.


Additional Federal Laws Dealing With Discrimination

• Pregnancy Discrimination Act

• Equal Pay Act of 1963

• Men and women who perform equal work in the same workplace must receive equal pay.

• Age Discrimination in Employment Act of 1967

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State Laws

• Deal with discrimination in the workplace

• Compared to federal law:

• Address same issues

• Sometimes provide more rights

• Do not usually require 15 or more employees

• Become familiar with laws in your state.


Family Medical Leave Act (FMLA)

• Up to 12 weeks unpaid leave per year

• For eligible employees

• Under certain circumstances

• Some states have their own versions.

• May provide more rights

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Occupational Safety and Health Administration (OSHA)

• Regulates safety in the workplace

• States may enforce regulations tighter.

• Covers all employers

• Additional responsibilities in health care

• Standards are often changing

• Do all you can to avoid injuries.

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The Legal Process

• Begins when a complaint is filed

• Process may take several years

• Discovery period

• Motions

• Settlement process or trial

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Licensure and Certification

• Terms often confused; generally:

• Certification

• Certain levels of credentials

• Criteria met for minimum competency

• Licensure

• Privilege granted by government authority

• Credentialing may also be adopted.


Discipline and Due Process

• Licensing action may be taken if an infarction occurs.

• Paramedic has a right to due process.

• Notice

• Opportunity to be heard

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Medical Practice Act

• Defines minimum qualifications of health service providers

• Defines skills practitioners can use

• Establishes means of licensure/certification

• May also include relicensure requirements


Scope of Practice

• Care paramedic may perform according to the state under its license or certification

• Medical director may not permit paramedic to perform all skills/give all medications.

• Practicing outside scope of practice is negligence or a criminal offense

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Negligence and Protection Against Negligence Claims

• No protection for gross negligence

• Negligence occurs when:

• There was a legal duty to the patient.

• There was a breach of duty.

• The failure to act was the proximate cause of injury.

• Harm resulted.


Negligence and Protection Against Negligence Claims

• Behaving according to established standards and procedures is the best protection.

• Consider insurance coverage.

• “Foreseeability” is one aspect of negligence.

• Negligence is typically divided into three categories:

• Malfeasance

• Misfeasance

• Nonfeasance

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Elements of Negligence

• Duty

• Prescribed by law

• Do no further harm to patient.

• Obligated to respond to calls while working

• Typically, not while off duty

• Make sure appropriate personnel respond.



• Duty (cont’d)• Must perform within a standard of care when providing assistance

• Cannot abandon the patient once care begins

• Must maintain licensure or certification and skills

• EMS systems can be held to a legal duty.

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• Breach of duty

• Standard of care

• What a reasonable paramedic would do in a similar situation

• Some states distinguish between ordinary and gross negligence.

• Re ipsa loquitur or negligence per se may apply.



• Proximate cause

• Improper action or failure to act caused harm

• Harm

• Usually physical injury

• May also include emotional distress, loss of income, loss of spousal consortium, etc.

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Governmental and Qualified Immunity

• Governmental immunity

• Sovereign immunity

• Limits

• Types of lawsuits that can be filed

• Time frames

• Amount of money that can be recovered

• Qualified immunity

• Common complaints:

• Improper restraint

• Excessive force

• Deviation from standard of care

• Only liable when paramedic violated a clearly established law


Thank YouVirginia Gleason

406‐799‐7879

[email protected]

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