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Never say “never events”

By Alan Lembitz, MD

Can we reframe them to support patient safety?

Confusion persists about the conditions commonly referred to as “never events” and those deemed as “nonreimbursable serious hospital-acquired conditions” (HACs) by the Centers for Medicare & Medicaid Services (CMS).

Despite the widespread use and significant appeal of the phrase “never events” in the public arena, the National Quality Forum (NQF) does not officially use the term and refers to these events as “serious reportable events” (SREs) in all of their definitions and references. Both the NQF and CMS lists include common complications and conditions—not all of which are always preventable—specific to orthopaedic surgeons. In addition, the number of conditions listed is likely to increase. This article attempts to clarify these issues for hospitals, physicians, and professional liability insurers and to introduce a more positive approach toward improving safety in medicine.

What is a serious reportable event?
According to the NQF, SREs are serious and costly errors in the provision of healthcare services that should never happen. They include obvious unacceptable errors, such as wrong site/wrong side surgery and discharge of an infant to the wrong person. Table 1 shows the specific conditions defined by the NQF as SREs.

What is a nonreimbursable HAC?
CMS adopted the nonreimbursement policy for certain HACs to motivate hospitals to accelerate improvements in patient safety and to limit hospitals’ ability to bill Medicare for complications. The nonreimbursable conditions apply only to those HACs deemed “reasonably preventable” through the use of evidence-based guidelines (Table 1).

According to Arnold Milstein, MD, a member of the Medicare Payment Advisory Commission (MedPAC), “The new payment approach is actually a relatively small step in a cautious, intermittent, 50-year effort by payors to stimulate U.S. hospitals and clinicians to accelerate improvement in the quality of care and reductions of wasted spending.”

He also notes that Kenneth Kizer, who coined the term “never events,” believes that using the negative term carries an extra psychological charge. Research on “negative framing” suggests that humans are more strongly inclined to take action when the actions in question are labeled so as to convey the loss avoided (rather than the benefit gained) and when the consequences of failing to act are mentally vivid.

Liability concerns and negligence claims
One concern faced by orthopaedic surgeons and their medical liability insurers is the public confusion between the NQFs list of SREs and the CMS list of nonreimbursable HACs. Most of the events on the NQF’s SRE list will likely result in a medical liability payment. Although establishing the amount of compensation may be difficult, few will argue against just compensation for injuries that result from preventable harmful errors as a result of medical care.

Many of the nonreimbursable HACs, however, are not completely preventable, even with the best practice of evidence-based treatment. Patients who experience complications listed as nonreimbursable HACs will be inaccurately told that negligence exists because these complications are “never” events. Soon, trial lawyers will be advertising and openly soliciting patients with conditions deemed “never” and “nonreimbursable.” Although expert reviews still must be used in most litigation venues, physicians may legitimately fear that the simple occurrence of a “never event” will be construed as a res ipsa loquitur finding circumventing and reducing the input of expert specialty matched review.

Falls, infections, DVT
Although many of the events listed by NQF and CMS are preventable, some have generated controversy related to their preventability. Among these are falls, postoperative infections, and the development of deep venous thrombosis (DVT), which are included on the CMS list of nonreimbursable HACs.

A recent editorial in The New England Journal of Medicine by Sharon Inouye, MD, a professor of medicine at the Harvard Medical School and Beth Israel of Deaconess Medical Center, argues that the inclusion of “falls” on both lists is misguided. According to Dr. Inouye, no evidence currently exists showing that hospital falls “can be consistently and effectively prevented through the application of evidence-based guidelines.”

Furthermore, she writes, “The inclusion may have unintended consequences that may cause greater harm than the falls that the initiative is meant to prevent.”

These unintended consequences are likely to include a decrease in patient mobility, an increase in use of physical restraints, and a tendency to focus on measures such as new prevention devices. These can cause reallocation of resources from areas that might have greater impacts on patient safety. According to Dr. Inouye, “Falls are often the result not of medical errors but of disease, impairments, and appropriate uses of medications and other treatments. Falls and injuries can occur even when hospitals provide the best possible care.”

Two other items on the list that have generated controversy include postoperative infection and postoperative deep vein thrombosis (DVT), neither of which can be completely prevented.

For example, it can be argued that vigorous thromboprophylaxis to combat DVT in certain orthopaedic procedures can lead to an increased risk of hematoma and postoperative infection. This has led the AAOS and the American College of Chest Physicians to recommended different prophylaxis regimens.

Physicians may want to exclaim in frustration that “you’re damned if you do, damned if you don’t,” but it helps to clarify that falls, postoperative infection, and DVT are nonreimbursable HACs and not never events. Efforts certainly should be made to reduce these complications as much as possible via evidence-based assessment and treatment.

Documentation of the informed consent process and the risk/benefit analysis underlying the decision is critical to improving the patient’s understanding of the complication and the physician’s ability to defend the care provided.

Strategies to reduce risk
The following strategies may be helpful in improving the defensibility of care for situations that fall under the list of nonpreventable HACs:

• Pretreatment or preadmission documentation of underlying pre-existing conditions, particularly those involving infections, decubiti, altered mental status, hyperglycemia or hypoglycemia, and patients at high risk for DVT

• Hospital outcomes data with identification of care improvements directed at those complications—especially hospital-acquired infections

• Standardized and universally followed approaches to reduce wrong site/wrong patient/wrong level surgery

• Culture-changing training around communication, assertiveness, team training, and the use of briefings and debriefings, particularly in high-acuity patient care areas

• The use of surgical checklists

• Understanding and using clear language in policies and publications regarding the difference between the NQF’s “never events” and the CMS’ list of nonreimbursable serious HACs to avoid claims of negligence

Although simply stated, these bullet points highlight some of the approaches that can be used; readers should recognize that this list merely suggests solutions that can be quite complex.

Taking a more positive approach
Although negative framing may get attention, a more positive approach to patient safety may also be helpful. Hence, the development of the concept of “always events”—evidence-based events or patient safety activities that reduce adverse outcomes. The “always events” concept represents a positive, affirming behavior that can motivate physicians and other healthcare providers to improve patient safety and promote better outcomes.

So what are some examples of “always events”?

• Including patient identification by more than one source

• Having a mandatory read-back of verbal orders for high-alert medications

• Disclosing adverse outcomes and increasing transparency with patients and families

• Implementing strategies to reduce medication errors

• Holding surgical time-outs, briefings, and debriefings

• Using surgical checklists

• Participating with the patient in the informed consent process by discussing and documenting expectations, potential benefits, and risks of a therapy or procedure

• Fostering an open culture of reporting, including “near misses,” so that the system can learn and improve processes to reduce the recurrence of unsafe conditions

• Anesthesia monitoring that is appropriate for the level of sedation

• Tracking critical imaging, lab, and pathology results

• Making critical information available at handoffs or transitions in care

• Involving the patient and the family in postprocedure care and follow-up

If we take these steps, we can turn around the negative and move forward on the path to improved patient safety and better outcomes.

Alan Lembitz, MD, is vice president for patient safety and risk management at COPIC Insurance. He can be reached at alembitz@copic.com

Additional Links
Milstein A. Ending Extra Payment for "Never Events"--Stronger Incentives for Patients' Safety. N Engl J Med 2009; 360:2388-2390

Inouye SK, Brown CJ, Tinetti, ME. Medicare Nonpayment, Hospital Falls, and Unintended Consequences. N Engl J Med 2009; 360:2390-2393

Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science 1981; 211:4481, p. 453-458.

August 2010 Issue