Question

Considering your facility’s risk management policies and procedures, what would be your role in ensuring compliance with these procedures and policies? How are these policies evaluated and what role can a nurse leader play in supporting such policies?

Answer 1

Risk management professionals should not take lightly the complexity associated with providing healthcare services. While regulations, third-party payer requirements, and licensing/accreditation standards contribute to this complexity, formalized policies and procedures can mitigate it by promoting workplace safety, regulatory compliance, and the delivery of safe, high-quality patient care. Moreover, well-written, up-to-date policies and procedures reduce practice variability that my result in substandard care and patient harm.

The operational challenges associated with drafting (and maintaining) comprehensive written policies place heavy demands on healthcare managers. Given increasing financial pressures and the top-priority status that must be given to direct patient care, managers may find it difficult to find time to review or update policies and procedures. Deferring policy and procedure development, however, may result in negative consequences. Policies and procedures may become outdated, and those who adhere to outdated policies may carry out actions that are no longer consistent with industry-recognized practices. Alternatively, they may simply elect to disregard the policy. Either choice may result in patient harm and a malpractice claim. Evidence that caregivers followed outdated policies may hinder defense of an otherwise defensible claim.

The Purpose of Policies and Procedures

Formalized, written policies and procedures fulfill a number of important purposes:

Facilitate adherence with recognized professional practices.

Promote compliance with regulations, statutes, and accreditation requirements (e.g. HIPAA, EMTALA, CMS Conditions of Participation, DNV/Joint Commission).

Reduce practice variation.

Standardize practices across multiple entities within a single a health system.

Serve as a resource for staff, particularly new personnel.

Reduce reliance on memory, which, when overtaxed, has been shown to be a major source of human errors or oversights.

These functions demonstrate how central policies and procedures are to the healthcare system’s patient safety programProblematic Policies

When a domain unknowingly develops a policy or procedure that already exists—perhaps another domain issued a similar policy earlier—there will likely be differences, resulting in confusion as to which policy should be followed. Discrepancies in clinical policies may also result in allegations that leadership allowed “two levels of care” to be provided, thereby increasing the organization’s risk exposure in several ways. First, exposure may be triggered by inconsistency with The Joint Commission’s leadership accreditation standard, LD.04.03.07: Patients with comparable needs receive the same standard of care, treatment, and services throughout the hospital (Schyve, 2009). Second, and perhaps more importantly, if the treatment given in a specific case followed the less rigorous of the two policies, a plaintiff who suffered harm may allege that his/her care “did not fulfill the legal standard of care.”

Allegations may include:

A nurse’s or physician’s failure to adhere to policy.

Corporate negligence on behalf of a hospital that failed to adopt appropriate policies, adequately train the staff with regard to these policies, implement them, or evaluate how they are used (Destache, 2013).

The policy was inconsistent with the standard of care.

Policies the organization had in effect were contradictory to other organizational policies, differed across entities in the same system without a basis for the difference, or were inconsistent with applicable regulations.

Many healthcare organizations seem to misunderstand the purpose of policy statements and burden them with non-value-added or overly broad information. That may invite a plaintiff lawyer to take a statement out of context and allege that it places an obligation on the defendant that was not intended. The following example illustrates problematic and preferred phrasing within a policy statement:Problematic EMTALA policy statement:

The federal government passed the Emergency Medical Treatment and Active Labor Act (EMTALA) in order to require hospitals to offer treatment to all persons who seek care. They also passed this Act in order to prevent “patient dumping”—when a hospital refuses to treat or transfers a patient to another hospital, such as for financial reasons. It is ABC hospital’s policy to provide care to all patients and to refrain from patient dumping.

This description is oversimplified, potentially misleading, and fails to conform tightly to the EMTALA regulations.

Preferred EMTALA policy statement (which precedes a detailed procedure):

The procedure below is intended to promote compliance with the federal Emergency Medical Treatment and Active Labor Act, its amendments, regulations, and reporting requirements. The procedural steps that apply to a given person/case may differ depending on such factors as (but not limited to): the venue to which the prospective patient presents; whether he/she requests a “medical screening examination,” and the confirmation of the presence or absence of an “emergency medical condition” as defined by the Act. Requests to accept patients (with an emergency medical condition) in transfer from another acute care hospital will be handled in accordance with the procedures noted below, with consideration of the hospital’s capabilities and capacity to provide the level and type of care required at the time of the request.

Questions about these procedures shall be directed to the Legal Department or the Administrator-on-Call on a “live time” basis.

Disclaimer Statements

Each policy should include a disclaimer statement to remind staff members that they must use their judgment to determine if all parts of the policy and procedure apply to each situation or whether some type of modification is warranted. The disclaimer may also help the organization defend allegations that a staff member‘s actions failed to follow a policy, when he/she testifies that he/she deemed it appropriate to make adaptations given the presenting circumstances. Typical disclaimer statements include the following (which should be approved by legal counsel):

A policy statement is intended to describe the reason why the associated procedure has been issued and to explain the context for it.

Procedures are resources to assist staff in carrying out specific actions. Procedures do not specify all circumstances to which they apply.

Procedures cannot, in themselves, guarantee safety. Safety is promoted by people being skilled at judging when and how (and when not) to adapt procedures to local circumstances.

Clinical situations may warrant adaptation due to unique patient characteristics.

Extenuating circumstances may also necessitate adaptation.

Professional Associations’ Practice Guidelines

When developing or updating clinical policies, the first step is usually to identify whether pertinent professional associations have published practice guidelines on the subject. For example, when writing a policy that pertains to the delivery of patient care in an emergency department, reviewing guidelines issued by the American College of Emergency Physicians and the Emergency Nurses Association would be a logical first step. Such guidelines are thoroughly researched and vetted by the issuing association before release. These practice guidelines are often introduced as evidence of the standard of care in a malpractice case.

Professional association recommendations lack the authority of statutes or regulations, making them advisory rather than mandatory. It is important to remember, however, that if a hospital’s procedures differ from those outlined in a professional association-issued guideline on the same subject, without a bona fide reason, that disparity may be called into question. For instance, ABC hospital’s surgical count procedures did not require instrument counts, as specified in the Association of periOperative Registered Nurses (AORN) practice standards (2013, p. 311). If a surgical operation at ABC hospital results in a retained instrument and becomes a claim, the plaintiff counsel will likely allege that the perioperative counts procedure was substandard because it was less rigorous than those recommended by AORN.

Implementing New or Revised Policies

The organization has a duty to inform all affected personnel prior to the effective date of a new or revised policy. Failure to do so may cause a staff member to follow an outdated policy, possibly comprising patient care as well as potential allegations of corporate negligence. To protect the organization from corporate negligence claims, documentation that affirms all affected workers—including floating, part-time, and traveling employees—have reviewed the new or revised policy prior to its effective date should be collected and kept on file.

By allowing a period of time between the approval date of a policy and its effective date managers have time for associated training. Legal counsel should determine the length of time documentation of this type of training should be maintained, factoring in applicable statutes of limitations.

When a new policy or procedure pertains to the use of a new medical device, pharmaceutical agent, or clinical procedure, hands-on training may be warranted, in addition to sharing information about the written policies. Although such training may be provided by the manufacturer/vendor or someone in the organization (e.g.. a nurse educator), the manager for each unit or department should be assigned responsibility for: a) assuring that all staff members working in his/her unit/department have received training in the designated timeframe and attained a passing score on the competency verification test or observations and b) collecting and retaining associated training records.Red Rules’

Frustrated by continued reports of noncompliance with important patient safety rules, some healthcare organizations have classified selected requirements as “red rules.” Doing so, they believe, gives greater emphasis to their importance and is intended to make staff pause and reconsider before they choose to act in a way that differs from the red rule.

When choosing which practices to designate as red rules, leaders must first determine that the practice must be performed without fail, in every case, without exception. Next, they must empower all staff to intercede in real time and “stop the line” if they witness a red rule violation, since non-adherence poses a significant risk of patient harm. Red rule violations are subject to discipline in many organizations, unless the party involved can provide legitimate reasons why that step was skipped.

Leaders who choose to designate key safety practices as red rules should do so thoughtfully; having too many red rules is difficult to manage and may be counterproductive. The Institute for Safe Medication Practices (2008) supports the use of red rules and emphasizes that they should be “few, well-understood, and memorable.”

Practices worthy of classification as red rules may include:

Performing a time-out before an invasive procedure.

Performing instrument, sponge, and needle reconciliation counts during an invasive procedure.

Verifying a patient’s identity using two identifiers.

Requiring two nurses to independently verify the patient’s identity and the intended blood product’s labeling prior to beginning a transfusion.

Before implementing red rules, a multidisciplinary team with representatives from senior leadership, the medical staff, and risk management, should carefully consider each suggested rule to determine if it meets the criteria outlined above.

Standardizing Policies across the System

When there are multiple hospitals within a health system, there is little justification for allowing each hospital to independently develop its own policies. Disparate policies can expose organizations to risk because a plaintiff lawyer may allege that one entity’s policy was less comprehensive than the other’s and thereby represented a lower standard of care. Policies and procedures of the following types lend themselves to being “system” policies:

Those designed to promote compliance with federal regulations (i.e., CMS Conditions of Participation, EMTALA, HIPAA, ADA, Safe Medical Device Act) or accreditation requirements (Joint Commission, DNV);

Those that describe specific patient-care related practices (i.e. induction of labor, patient triage in the ED, specimen collection);

Clinical practice guidelines approved by the medical staff for defined situations or cases.

In the event a specific policy does not apply to one entity in the system (i.e., Hospital X does not have an emergency or OB department so EMTALA may not apply), the system policy can specify that it does not apply to Hospital X.

Electronic Policy Libraries

Most healthcare organizations have replaced paper policy and procedure manuals with electronic policy libraries available on the organization’s intranet, which greatly enhances access. To optimize the usefulness of electronic libraries:

Provide indices by policy name, subject, and sponsoring domain (administration, nursing, pharmacy, etc.)

Incorporate “word search” functionality in order to facilitate searches for pertinent policies irrespective of their issuing domains. Without such a search function, staff may have difficulty locating the policy they are seeking.

Do not prohibit access to policies of one domain to personnel in other domains. There may be legitimate reasons why persons in other departments may need to refer to those documents.

Immediately remove a policy that has been officially retired or replaced from the “active” database and transfer it in the designated archives.

Create an electronic archive for storing “retired” or prior versions of policies. This will facilitate access in response to legal discovery requests. Check with your corporate compliance office regarding organizational document retention policies.

PLEASE DO LIKE?