The Revised Infusion Nursing Standards of Practice (INS, 2000) define risk management as “a process that centers on identification, analysis, treatment, and evaluation of real and potential hazards.” Risk assessment is the scientific process of asking how risky something is. It is a process of collecting and analyzing scientific data “to describe the form, dimension, and characteristics of risk.” Risk assessment and risk management are equally important but different processes, with different objectives, infor-mation content, and results.
Risk management concepts include the concerns that organizations face with exposure to losses. Organizations handle the chances of losses or risks by financing, purchasing insurance, or practicing loss control.
Loss control consists of preventive and protective activities that are per-formed before, during, and after losses are incurred. Risk manage-ment involves all medical and facility staff. It provides for the review and analysis of risk and liability sources involving patients, visitors, staff, and facility property. Risk management consists of the following compo-nents:
■ Identification and management of clinical areas of actual and high risk
■ Identification and management of nonclinical (e.g., visitor, staff) areas of actual and high risk
■ Identification and management of probable claims events
■ Management of property loss occurrences
■ Review and analysis of customer surveys and patient com-plaints
■ Review and analysis of risk assessment surveys
■ Operational linkages with hospital quality management, safety, and performance improvement programs
■ Provision of risk management education
■ Compliance with state risk management and applicable federal statutes, including the Safe Medical Devices Act (Clinical Orientation Manual, 1998)
Risk assessment is performed by government agencies such as the U.S. Environmental Protection Agency (EPA). Risk assessment takes dif-ferent approaches depending on available information. Some assessments look back to try to assess effects after an event. They may also look ahead before a new product is approved for use.
JCAHO advocates establishing an integrated risk management and quality assurance program.
Risk management strategies combine the elements of both loss reduc-tion and loss prevenreduc-tion. Risk management strategies that may decrease the risk of potential liability are as follows:
■ Informed consent
■ Unusual occurrence reports
■ Sentinel events
■ Documentation
■ Professional liability insurance
■ Patient relations
■ Quality management (Alexander & Webster, 2001)
Informed Consent
One of the most effective proactive strategies taken in risk management is informed consent. The purpose of informed consent is to provide patients with enough information to enable them to make a rational deci-sion regarding whether to undergo treatment. The focus is on a patient’s understanding the procedure, not just signing consent to have the proce-dure performed.
The right of self-determination provides the basis for informed con-sent and is grounded in the bioethical principles of autonomy. A compe-tent adult (competence to consent) is aware of the consequences of a
decision and has the ability to make reasonable choices about health care, including the right to refuse health care.
There are categories of necessary elements for informed consent and informed refusal. The first category comprises the information elements.
This involves the disclosure of appropriate information. Generally, this disclosure must include benefits and risks of procedure, alternative pro-cedures, benefits and risk of the alternatives, and the qualifications of the provider.
The second category consists of the consent elements. The consent must be voluntary, not coerced. Consent can be manifested by conduct.
For example, the infusion specialist states, “I am going to restart your I.V.
now,” and the patient holds out his or her arm.
There may be limits to consent, such as waiver of consent: the patient must know that options and risks exist even if he or she does not want to know what they are. Other limits to consent include verbal limits; for example, the patient may tell the infusion nurse, “Okay, I will let you try to restart my I.V., but only once.”
The duty to obtain informed consent belongs to the person who will perform the procedure, but also may belong to the licensed person who is aware that the patient has not been informed, does not understand, or did not consent. A breach of this duty may result in discipline for unprofes-sional practice and/or a civil lawsuit for profesunprofes-sional malpractice. If the infusion specialist knows that consent does not exist or the patient is not informed and has not waived that right, the infusion specialist must con-sult with the ordering provider, and go up the chain of command for assistance. Refer to Table 1–2 for elements necessary for informed consent (Collins, 2001).
INS Standard.The patient or a representative legally authorized to act on the patient’s behalf shall be informed of potential compli-cations associated with treatment or therapy. The nurse shall
docu-Table 1–2 ELEMENTS NECESSARY FOR INFORMED CONSENT Information Elements
Benefits and risks of the procedure Alternative procedures
Benefits and risks of the alternatives Qualifications of the provider Consent Elements
Consent form on chart or waiver of consent
Consent is manifest by conduct; it is a voluntary process Limits to consent
Waiver of consent: patient must know that options and risks exist even if he or she does not want to know what they are.
Note: Exceptions to requirement for consent are emergency situations, and other situations such as crimes, public safety, or healthcare worker safety (Collins, 2001).
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ment the information given and patient’s or legally authorized rep-resentative’s response in the patient’s medical record. (INS, 2000, 11)