Effective management of healthcare practices through implementation of thorough policies and procedures, staff training, and competency assessment is crucial to ensure patient satisfaction and prevent adverse events. This case, which concerns a chemotherapy overdose resulting in severe immunosuppression and hospitalization, illustrates what can happen when practice management is lax, administrators fail to document and enforce employee disciplinary actions, and policies and procedures are inadequate or not followed.

Case Details

The patient was a 74-year-old man who had Stage 4 colon cancer with metastasis to the lung, liver, pelvis, and sacrum. On April 6, the patient presented to the cancer center where he had been receiving treatment, and he was set up for infusion of the chemotherapy drug 5-fluorouracil (5-FU). At this visit, the patient saw Nurse A, who had been removed from patient care and put on administrative duties 2 years prior due to being inattentive in the administration of medication. Despite this disciplinary action, Nurse A would “sneak over” to the infusion area and treat patients. Her restriction to administrative duties was communicated verbally, with no written documentation to support it. The cancer center’s administration was aware that Nurse A was continuing to provide patient care, but the behavior was ignored. Nurse A also had previously been on probation with the state board of nursing.

At the cancer center, each patient generally used the same pump for each visit. When turned on, the pumps pulled up the most recent programming; thus, the nurses typically did not need to change the settings on the pumps from one administration to the next. At the April 6 visit, Nurse A couldn’t find the patient’s pump, so she took one from the cabinet — but she did not confirm the pump settings.

The patient’s infusion was supposed to run over a 48-hour period. However, the patient’s pump began to beep within 2 hours of leaving the facility, indicating that all of the medication had been administered. The patient called the cancer center as soon as the pump started beeping. Nurse A went to the patient’s home and claimed that she reset the pump, but the patient later stated that she disconnected it and took everything with her. Nurse A then texted Nurse B that the pump was incorrectly programmed but said that she had fixed it and resumed the administration. She did indicate that it would still finish early. (In reality, the entire infusion had run in 2.5 hours.) Nurse B’s only instructions were to have the patient drink plenty of water.

When the oncologist/hematologist was informed of the incident, he told Nurse B to notify the patient’s son that a pump malfunction had caused the error. No further instructions were given. A question arose during the legal proceedings as to whether the oncologist/hematologist should have ordered uridine triacetate (the antidote to 5-FU overdose), but this claim was not pursued.

Once Nurse A returned the pump to the facility, Nurse B took the pump home for 2 days to “test” it. She did this without the knowledge or consent of the cancer center’s administration. She stated that she ran a test with saline and it worked properly.

On April 7, the patient returned to the facility for blood work but was discharged prior to the return of results. On April 10, the patient presented to a local emergency room with symptoms of gastrointestinal (GI) bleeding and sores around his mouth, down his throat, and throughout his GI tract. His platelet count, red blood count, and white blood count were all extremely low. He was kept in the critical care unit for 9 days. The plaintiff's attorney argued that this resulted in a substantial decrease in life expectancy.

Ultimately, the patient did recover and outlived his life expectancy. The patient’s attorney was able to establish that the pump did not malfunction but was programmed incorrectly. Data from the pump showed that the dose was not set correctly and that the pump had been accessed after the incident.

The cancer center’s protocol required that two professionals check the setting and the mixture before it was administered (as a check and balance). However, the facility often did not do this because adequate personnel was not present and some of the physicians refused to perform such tasks. In this case, Nurse A was the only person who calibrated the pump. She also attempted to cover up the extent of the error by sending an untruthful text to Nurse B. Because of these various issues, the case was settled in the high range on behalf of the cancer center. Additionally, the state board of nursing suspended Nurse A’s license.

Discussion

At first glance, this case seems to involve a simple clinical error, but it actually involves a number of errors that could have been rectified through proper practice management. In fact, the details of this case raise many important issues related to staff management and staff education needs.

First, medical practices need an employee handbook that clearly defines ethical and professional conduct as well as inappropriate conduct that will lead to disciplinary actions — and then they must follow through with those policies. The cancer center’s administration failed to put the restrictions against Nurse A in writing, and then they did not discipline Nurse A when she took on duties that she was prohibited from performing. As a result, the very type of incident they were initially concerned about happened. In addition, if the administrators had been enforcing the restriction on Nurse A, the outcome of the litigation may have been different since the nurse was practicing outside her scope of employment.

Second, having policies and procedures in place is imperative for both clinical and nonclinical aspects of medical practice. Office policies should outline potential issues and provide guidance on how to handle them. All procedures should be evaluated for quality, relevance, and feasibility, and practice leaders should routinely conduct audits to ensure providers and staff members are following procedures.

In this case, we don’t know whether the cancer center had inadequate policies and procedures or whether they simply were not followed. However, a failure occurred for a very foreseeable event — a medication error involving an infusion pump. The facility should have anticipated this type of issue and had procedures for handling it. Additionally, the fact that the patient’s pump wasn’t available raises a question about the adequacy of procedures related to pump accessibility. Implementing a safety checklist for infusion pumps, including how to program them and what actions to take if a pump is unavailable, may have prevented this injury.

Third, staff education and competency assessment are key components of a well-managed medical practice. Employees cannot be expected to follow policies and procedures if they are not aware of them or have not been properly trained. Thus, management should establish a training program for important office policies and procedures. Training can be completed through proper onboarding of new staff, in-service programs, and other continuing education. All staff education and training should be documented and kept in personnel files.

Following training, competencies should be checked on an annual basis or when new technologies or workflows are introduced. Further, administrators should periodically ask staff for feedback about the training program to help identify gaps and areas for improvement.

The final issue in this case involved the response to the improper medication administration. Staff were not trained about sequestering equipment in the face of a potential equipment malfunction. Fortunately, the pump saved all previous infusion information; however, if it had not, the plaintiff could have alleged spoliation, which may have resulted in an even larger settlement payout.

A policy and procedure on disclosing unanticipated outcomes also would have been useful in responding to this medication error. Proper knowledge about the purpose and benefit of disclosure may have mitigated Nurse A’s cover-up text regarding the incorrectly programmed pump and may have changed the physician’s guidance related to telling the patient’s family that the pump malfunctioned.

In Summary

Practice management is not always recognized as an important part of patient safety, but this case makes clear how poor management can lead to patient harm and liability risk. To avoid this type of situation, practice administrators should be diligent in developing policies and procedures that clearly explain expectations related to employee conduct and thoroughly define responsibilities and competencies related to both clinical and nonclinical functions. They also should establish robust education programs to ensure that employees are aware of the practice’s policies and procedures and receive relevant training, particularly for high-risk situations. Doing so can help improve staff morale, increase practice efficiency, improve job competency, and enhance patient satisfaction.