Enterprise Risk Management (ERM) Legal & Regulatory

Effective Health Care Policies Mitigate Litigation Risks

Well-crafted health care policies provide a foundation for operational excellence. However, the perils associated with drafting, revising and implementing policies and procedures are often underappreciated. While policies can promote regulatory compliance, standardize practices and provide resources to personnel, they also can heavily impact risk management. Carefully drafted policies reduce clinical errors and mitigate the risk that they can be weaponized against the hospital in litigation. The following addresses writing health care policies while considering implications for litigation.            

Definitions

While the terms policies, procedures, protocols and guidelines may be used synonymously, in this article, they are distinct categories. Policies are general principles that govern behaviors reflecting the organization’s fundamental position on issues.  Procedures are the steps organizations take to implement policies and achieve organizational goals, explaining when and how to act in specific situations, while also allowing discretionary flexibility. Protocols are the mandatory rules, instructions or standards developed based on best practices. Guidelines are recommendations intended to optimize patient care.

Questions to Guide the Crafting of Hospital Policies – The “Poli-Cs”

  • Is it compulsory?

Before generating a new policy, have a clear understanding of the why and whether the policy is needed. Is the policy mandated by the Joint Commission or another regulation, statute or accreditation standard? Or is it proposed merely to serve an internal need? Policy developers should beware of policy proliferation. Unnecessary policies can expose your hospital to undue litigation-related risk. 

  • Is the language clear?

It is imperative to know your audience.  Use plain, easy to understand terms for your target readers. A vague or unclear policy risks confusion, delay and medical errors. Your policy language should be universal and avoid any abbreviations or local slang that newcomers might not recognize. 

  • Is the language concise?

Keep your policies short and simple. Success is when they can be quickly read and the policy substance understood. Time is of the essence for many critical patient circumstances and delayed care due to a cumbersome policy fails the patient and the providers. Consider a two-page limit as a guide. 

  • Is the language clinical?

Clinical language is your friend; critical language is your foe. For instance, a policy might refer to blood pressure that is elevated compared to a target range. The term elevated is clinical, mathematical; it is not pejorative as with dangerous or worrisome. Embrace the more accurate clinical terms in your policy language.

  • Is the policy compliant?

There are increasing numbers of regulations to which health care organizations must adhere, from accreditation standards to federal, state and local regulations. Policies must be compliant with these requirements, but also consistent with the standardized practices of the organization. The review process for policies should include an assessment for updated regulatory, statutory and accreditation standards and compliance. 

  • Is there consensus?

Having those expected to adhere to policies share in the development process yields a more user friendly end product and fosters a sense of shared purpose. Risk managers are encouraged to collaborate with division leaders, oversight committees and subject matter experts during all phases of policy development. Involving appropriate stakeholders promotes organizational support and ensures that the policy conforms to standard practices and procedures.

  • Is the content standardized?

Instituting standardized titles, formats and content for all organizational policies makes it easier for employees to navigate policy resources quickly. While content formats are generally flexible, policies should include the purpose statement, definitions, policy, disclaimer and effective dates. The purpose statement is a concise statement outlining the context, goal or intent of the specific policy. It is the thesis statement of your policy. Refrain from using superlative or aspirational terms in your purpose, such as, “to provide the safest care possible.” If a hospital embraces aspirational outcome-driven goals in its policy, and a patient has a poor outcome, the hospital has arguably failed its own policy. Consider care-driven purpose statements like “…to promote the quality of infection control.…” Do not make your purpose an outcome-driven standard (i.e., “…to avoid hospital-acquired infections…”). 

A clear policy needs unambiguous definitions of terms that may be unfamiliar to the reader or susceptible to various interpretations. A definitions section, such as key definitions at the beginning of the policy, is an invaluable component of effective policies. If terms are not defined in a policy, they are more apt to be misconstrued by staff and later mischaracterized by plaintiffs’ lawyers.

The policy itself is a general statement governing health care provider behavior and sometimes reflecting the hospital’s position on certain issues.

Each policy should also include a disclaimer statement to remind staff members (and plaintiffs’ attorneys) that “clinical presentations or extenuating circumstances may warrant deviations from the policy.” A standard disclaimer statement would advise the reader that the policy is “designed to be a resource and guideline, but it is not intended to establish the standard of care.”  These important provisos are accurate, easy to include and lessen the risk that a policy will be used effectively as a sword against the hospital in litigation. 

Finally, best practice is to note the effective date(s) of policy origin and each subsequent review within the body of the policy. Without clear effective dates, creative plaintiffs’ attorneys may convince a judge that all policies are fair game simply because they were presumably in effect at the time in question. When the effective dates show that a policy was not in effect during the care in question, the defense can typically keep that policy out of evidence. And if your policy was not followed, but your attorney kept that failure out of the evidence based on the effective date that can make a significant difference in how the case is assessed for potential settlement and in the outcome at trial. 

Policies on Trial

Hospital policies are often deemed discoverable in litigation.  If poorly crafted, they can be incredibly damaging to a hospital’s defense and used by plaintiffs’ counsel such as to allege:

  • That the hospital had an institutional expectation that its policy would be followed;
  • That an employee’s failure to follow the hospital policy reflected a breach in the standard of care;
  • That the hospital failed to properly train/supervise staff on its policy;
  • That the policy itself was outdated or otherwise flawed.

Here are some appropriate disclaimer statements that can take the sting out of such attacks. 

This policy is a resource and general guideline, but it is not intended to establish the standard of care.”

Variations in the applications of this policy may be appropriate based on clinical judgment.”

Clinical circumstances or other extenuating circumstances may warrant variation.”

Litigation can painfully highlight subtle wording flaws in a policy.  For instance, an ICU policy requiring “documented neurological evaluations every hour” may at first seem benign, so long as the checks are done as required. But if the nurses are doing timely checks, yet not completing their documentation until the end of shift, a plaintiffs’ lawyer who obtains an audit trail can prove that neuro checks were not actually “documented” in the prescribed frequency. Nurses who complete their documentation at the end of shift, despite timely neuro checks, would have failed to follow hospital policy. 

Policy litigation can entail not just the substantive policy, but seemingly collateral aspects such as the purpose statement.  For instance, consider purpose statement #1: This policy is designed to avoid infections… Compare that with purpose statement #2: This policy is designed to promote an environment that decreases infection risk.  If a litigant sues over her devastating infection, and purpose statement #1 is in the policy, she can rightly argue to the jury that the hospital failed at its own goal – “to avoid infections.” But if purpose statement #2 is in the policy, the patient’s jury argument is much less effective.   The hospital could offer abundant evidence of its infection control measures and argue that its goal of seeking to decrease infection risks is an acknowledgement that infection is always a risk, even with comprehensive mitigation measures. 

Other litigation headaches can come from policy items that are best avoided in the text of the policy itself, unless required, like medical references and other cross-referenced hospital policies on related matters. It is important and expected that a medical policy would be based on appropriate medical literature. These resources, however, can do damage if they are listed in the policy itself. When references are included, a plaintiffs’ attorney could pull those references to evaluate whether they were interpreted correctly, whether they should have been updated or even whether those references contain harmful information that undermines the hospital’s defenses in other ways. To avoid a policy’s references being wielded against you, keep those references out of the formal policy, perhaps in a separate resource reference list, indexed by policy. That list would allow policy review committees to access appropriate medical resources when reviewing and updating policies, without inviting scrutiny of those references when the policy itself is produced to opposing counsel.

Likewise, don’t include cross references to other hospital policies, unless required. Opposing counsel may seek production of and possible testimony about those other policies, generating more challenges for the defense over if there is any evidence that they were not followed precisely

Conclusion

Well-crafted policies are essential to high-quality patient care, hospital accreditation and regulatory compliance. The challenge for health care organizations is to craft effective policies that meet those needs yet avoid giving future plaintiffs additional ammunition in litigation. Following the Poli-Cs and anticipating in the drafting stage how policy language could be used against the defense helps limit the risk that a given policy might harm the defense in trial.

REFERENCES

Irving, A.V. (2014). Policies and Procedures for Healthcare Organizations:  A Risk Management Perspective. Patient Safety & Quality Healthcare, October 13, 2014. Retrieved from http://www.psqh.com/analysis/policies-and-procedures-for-healthcare-organizations-a-risk-management-perspective/

O’Donnell, J., & Vogenberg, F. R. (2012). Policies and procedures: enhancing pharmacy practice and limiting risk. P & T: a peer-reviewed journal for formulary management, 37(6), 341–344.

Authors

Jessica Ayd is an associate at Goodell, DeVries, Leech & Dann, LLP in Baltimore, Maryland. Her practice is focused primarily on defending health care providers and health care institutions in medical malpractice claims before the Health Care Alternative Dispute Office of Maryland, the Circuit Courts of Maryland, the Superior Court of Washington, D.C., and the United States District Courts for Maryland and Washington, D.C. 

Sherri Hobbs, MSM, MSN, RN, CPHQ, CPPS currently serves University of Maryland Shore Regional Health as vice president, Chief Quality Officer. In this role, she has responsibility for strategy and outcomes surrounding high reliability organizing, patient experience, patient safety, quality, performance improvement, and infection prevention. A nurse by background, she has worked in health care quality roles since 2008 and in quality leadership roles since 2012. Sherri also teaches quality improvement at the baccalaureate level and serves on the education commission for the National Association for Healthcare Quality. 

Heather Joyce-Byers, MSJ, BS, RN, CCRN-K, CPHRM is a regional director for Maryland Medicine Comprehensive Insurance Program, as well as the past president for the Maryland-DC Society for Healthcare Risk Management. She has been active in the local chapter for many years and continues to serve the ASHRM New Member Taskforce. She has also presented at the ASHRM National Conference on the power of collaboratives and standardizing practice and their role in mitigating risk within a healthcare system.

Shannon M. Madden is a partner at Goodell, DeVries, Leech & Dann, LLP in Baltimore, Maryland. She is a long-standing member of the Maryland-District of Columbia Association for Healthcare Risk Management (MD-DC-SHRM), and is a member of its Education Committee.  She has also served as a presenter to MD-DC-SHRM on damages in medical malpractice cases, and the impact of a hospital’s policies on its defense in malpractice litigation.  Her practice is devoted to defending health care providers in litigation in both state and federal courts. 

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Authors