Legal issues of infection control practices (1)

BASIC PRINCIPLES
• In general, the law is made up of a series of rules that govern the behavior of
individuals.
• These rules may be in the form of constitutions, statutes, administrative law,
and written court decisions.
• When written statutes do not apply in a particular case, or when there is no
precedent, the court will decide what the law is.
• Common law is the law created when there is no statute governing a particular
situation at hand.
• In general, for a person to bring a cause of action against another, the following
elements must exist:
✓ The plaintiff must have an interest that is protected by law.
✓ There must be a legal duty.
✓ A breach of duty by the defendant must be proved.
✓ An injury must be shown damage to the protected interest.
✓ It must be proved that the breach caused the injury.

Malpractice/NegIigence
• Malpractice is defined as professional misconduct or failing to meet the
standard of care of a professional that results in harm to another person.
• Clearly, the issue of malpractice threatens the overall accessibility, affordability,
and quality of healthcare.
• Negligence, the most common allegation in medical malpractice cases, is
defined as an unintentional omission or commission of an act that a reasonably
prudent person would or would not do under a given circumstance.
Omission of an act may include such acts as:
✓ Failing to administer medications
✓ Failing to order diagnostic tests
✓ Failing to follow up on abnormal test results
Commission may include such acts as:
• Administering the wrong medication to a patient
• Administering medication to the wrong patient
• Performing a surgical procedure without a patient or family consent
✓ Negligence is a form of heedlessness or carelessness that constitutes a
departure from the standard of care generally imposed on members of
society.
✓ There are four elements that must be present for a plaintiff to recover
damages caused by negligence.
These elements are:
1. Duty: an obligation to conform to a recognized standard of care
2. Breach: a deviation from the recognized standard of care
3. Causation: an act or conduct in departing from the recognized standard of
care caused the injury
4. Injury: that either heedlessness or carelessness results in damages
To illustrate negligence, consider an example of a patient that acquires an
infection during his hospital stay. The patient must establish:
1. He or she contracted the infection in the hospital.
2. The hospital breached its duty to the patient through an act of negligence.
3. This negligence caused the infection (with no healing).
4. The patient's wound did not heal completely because of the infection.
The test for negligence in this example may be to determine the answer to the
questions:
o Was the hospital care or lack of care in some way responsible for the infection?
and
o Did the hospital act in a reasonable and prudent manner to recognize, report,
and try to control the infection?
Causation, Damages, and Liability
➢ To prevail in a negligence action, the patient must prove that a hospital's
failure to exercise a required standard of care directly or approximately caused
the plaintiff's injury.
➢ If a patient can establish that he or she suffered injury due to an infection
resulting from the hospital or staff negligence, the hospital or its staff may be
liable.
• Liability is not established on mere proof that a patient developed an
infection.
• Because HAIs are common, unpredictable, and sometimes difficult to
prevent, courts have recognized that such infections may occur despite
reasonable care.
Hospital employees, therefore, must be alert to infections and immediately
report suspected infections to the physician.
• A provider may not be liable for infection sustained by a patient that is
more susceptible to infection than the average patient.
• For example, a leukemia patient died of an infection.
➢ The patient's family alleged that the patient contracted the infection due to the
negligence of a hospital worker who did not adhere to the hospital's IC policies.
The jury found, however, that the defendant did not act negligently.
Duty to Provide Care
•The first requirement in establishing negligence is for the plaintiff to prove that
he has a relationship with the defendant.
•Duty refers to an obligation of care or performance. Duty may arise from the
relationship that exists between the doctor and the patient or the nursing staff
and the patient to protect the patient from harm or injury.
•In the healthcare context, a duty translates to a standard of care. Once patients
place themselves under a healthcare practitioner's care, the practitioner then has
a duty to provide the patient with reasonable care.
•A duty of care is associated with a corresponding responsibility not only to
provide care but also to provide it in an acceptable manner.
•To prove negligence, the patient must establish that the hospital failed to meet a
standard of care.
•The standard of care depends, in turn, on the circumstances of the particular
case.
•Often, plaintiffs and attorneys find that confusion arises when determining the
applicable standard of reasonable care in a specific situation and whether the staff
member or the hospital failed to meet the standard of care.
•This approach is based on the assumption that there should be one prevailing
level of care.
•Experts frequently disagree, however, as to what constitutes appropriate care in
specific situations. Hence, a variety of approaches may be considered to define the
standard of care for a given clinical situation.
Standard of care in HAI cases
• The hospital, however, must realize that it can be liable for a patient's infection if
the infection was caused by the negligence of any of its employees.
• The standard of care that must be implemented within the institution is to
monitor the patient outcomes of the medical care provided.
• This monitoring includes conducting quality assurance activities such as
(1) performing IC surveillance,
(2) reviewing and revising IC policies and procedures,
(3) providing in service training sessions for staff about appropriate IC
practices, and
(4) adhering to the Patient Safety Goals
• If a patient establishes that he acquired an infection at a hospital, the hospital
may have to prove that IP&C policies and practices were in place and that, when
the infection occurred, the physician and staff took immediate and appropriate
interventions to treat and minimize the patient's infection.
• To ensure that the hospital meets its standard of care, the hospital should
continuously evaluate how the staff uses aseptic technique and IP&C procedures
and should monitor daily staff performance to validate that proper procedures are
being followed.
• The hospital should be very observant and make sure that all members of the
healthcare team follow IP&C regulations, accreditation standards and practices
and procedures.
• In addition to requiring staff compliance with IP&C practices, hospitals should
establish clear, useful internal practice manuals that are readily available to all
staff members.
• These requirements vary considerably from country to another hence, hospital
administrators and legal counsel should consult their own regulations.
Establishing the Standard of Care
• When a person alleges that a healthcare provider fails to meet a standard of
care, the person must first establish the standard and then prove that it was
breached.
• This proof is normally accomplished by the use of expert testimony.
• Alternatives to expert testimony include the use of medical texts journals, laws
regulations, and guidelines, protocols, and practice parameters.
Practice Parameters
• Practice parameters, or protocols, are "medical guidelines encompass a broad
range of strategies designed to assist practitioners in the clinical decision making
process." More specifically, they are "standardized specifications for care
developed by a formal process that incorporates the best scientific evidence of
effectiveness with expert opinion."
• These guidelines are set by specific areas of the medical profession to advise
members of the recommended standard of care to be used in a given situation.
• One of the applications of practice guidelines is to assist healthcare facilities in
meeting national quality indicators, thus improving patient care, patient
outcomes, and quality of life.
• Practice parameters — also referred to as clinical pathways, or care maps — are
tools that guide a practitioner in the care of a particular condition and often
include strategies to meet the quality indicator.
• Practice parameters are not absolute rules of conduct.