HospitalInspections.org

The Condition of Participation of Quality Assessment & Performance Improvement Program was not met.

Findings included:

The Hospital failed to identify opportunities for improvement, consider the incidence, prevalence, and severity of problems and implement changes that will lead to improvement for 1 (Patient #1) of 10 patient records reviewed.

Refer to TAG: A-0283

Based on interviews and records reviewed, the Hospital failed to provide implementation of preventative actions to all relevant hospital staff after 1 of 10 medical records reviewed ( Patient #1) was found to have been receiving an inappropriate weight-based dose of Enoxaparin (an injectable blood thinner/anticoagculant) due to significant decrease in weight throughout his/her admission to the Hospital. Patient #1 was found to have been administered 240 toal milligrams of extra Enoxaparen throughout his.her admission prior to his/her death.

Review of the Hospital's Performance Improvement and Patient Safety Plan FY 2021 indicated that the Risk Management Department in collaboration with the involved physicians and staff are responsible for developing and implementing a comprehensive corrective action plan.
Review of the Hospital's Event Investigation: Root Cause Analysis and Critical Incident Review policy, dated 7/1/2016, indicated that the hospital will:
Design and implement risk reduction strategies by:
1. Select the strongest actions possible: strong/weak may be used in combination, but reliance on staff hard work and vigilance rarely prevents re-occurrence.
a. Strong: forcing function, standardize equipment, physical plant changes, remove unnecessary steps.
b. Intermediate: checklist, redundancy, reduce distractions
c. Weak: double checks, training, new policy/procedure
2. See solutions from a wider range of individuals.
3. Involve medical staff and department leadership in finalizing the action plan, assigning responsibility, and assuring timeline for completion.
4. Finally, develop measures of success to monitor the strength and/or effectiveness of strategies.

Review of the Hospital's Calling Physicians: SBAR, Change in Patient Status, Critical Values policy, dated 5/9/2016 indicated that nurses are to promptly report significant patient information to the attending or covering physician, using the SBAR format. Criteria for reporting includes, but is not limited to the following:
1. Significant change in patient status:
a. Vital signs outside of the range of normal for the individual patient.
b. Unexpected deterioration of physical or mental status
c. New onset of unrelieved pain
d. Fall or injury

Patient #1 was admitted to the Hospital in 11/2020 with diagnoses of new onset atrial fibrillation (abnormal heart rhythm) and anasarca (severe edema with subcutaneous tissue swelling throughout the body).
Review of the History and Physical, dated 11/7/20 at 3:30 A.M., indicated that Patient #1 weighed 147.9 kilograms (326 pounds) and was prescribed 100 milligrams of enoxaparin every 12 hours for treatment of atrial fibrillation.
Review of the Hospital's internal investigation indicated that on 11/9/20 a Hospital Pharmacist recommended that the Physician change the Enoxaparin order based on Patient #1 weight being 138.5 kg (305 pounds). When prescribed for treatment vs. prophylaxis, the Enoxaparin dose should have been ordered via the weight-based formula of mg's of Enoxaparin per kg's of weight. The recommendation from the Pharmacist went unanswered by the physician on 11/9/21. On 11/10/20, Physician #1 saw the recommendation and entered the Enoxaparin order in free text at 140 mg's two times a day, instead of entering the order using the electronic health record's weight-based functionality of mg's to kg's which would ask for the patient's current weight and provide the accurate rounded dosed.
On 11/10/21 Patient #1's weight had decreased to 116.4 kilograms. Had Physician #1 ordered the Enoxaparin using the weight-based function, as recommended by the Pharmacist, she would have had to enter the patient's weight at the time of placing the order and the electronic health record would have alerted the Physician that the dose of 140 mg two times a day did not match Patient #1's current weight of 116.4 kg (256 pounds). This was a 22.1 kg loss and a 49-pound weight loss in one day due to diuresis with Lasix.

Review of the Nutrition Note dated 11/14/20 indicated that Patient #1 continued to lose weight throughout his stay. Patient #1 lost 88 pounds from 11/7/20 - 11/14/20. The patient remained on the higher dose, that wasn't calculated by the 11/10/21 weight because it was ordered without using the appropriate order set by Physician #1. Over the next few days, Patient #1's medical condition continued to deteriorate, and he she/had a final weight of 105.2 kg (231.93 pounds) a total of 43.7 kg and 94.1 pounds) and the Enoxaparin order remained at 140 milligrams bid throughout the admission. This led to an additional to 240 mg Enoxaparin to be administered to Patient #1.

During an interview on 9/23/21 at 11:50 A.M., Physician #2 said that he was following Patient #1's care on a consulting basis and since he didn't order the Enoxaparin and he didn't review the dosing. He said that a lot of times, Enoxaparin is weight based and that when patients are edematous it is harder to manage. Physician #2 said that although he was caring for the patient, he was not involved or invited to any meetings to discuss the dosing error. He said that to avoid medication errors the medication order sets can change in the electronic health record. He said would also ask a pharmacist if he has a question.

During an interview on 9/23/21 at 12:00 P.M., the Clinical Manager of the Pharmacy said that the Hospital doesn't have a policy for ordering weight-based medications. She said that the initial corrective action due to this this medication dosing error would be that the physicians can't order weight-based medications in free text and must utilize the weight-based functionality of the electronic health record. She said that due to clinical reasons, this change was not able to be made. The Clinical Manager of the Pharmacy said that during the review, they were able to identify that the pharmacists cross check all anticoagulant orders daily. The determination was the pharmacy team did not notice this error because: 1. The order was not put in as mg's to kg's and 2. The order was 140 mg and that can look like a standing prophylactic order of 40 mg to the eye, when not ordered using the weight-based functionality. The Clinical Manager of Pharmacy said that she developed a presentation for the pharmacy staff to view and discuss the case during a weekly meeting and that the presentation is recorded and able to be viewed by her staff at any time if they missed the meeting. She said that she did not keep attendance to those who attended the meeting and the meeting/presentation were not considered mandatory education.

During an interview on 9/23/21 at 1:09 P.M., Physician #1, the physician who ordered the 140 mg of Enoxaparin on 11/10/21, said that she remembers receiving emails regarding the dosing error weeks after the event. She said that she doesn't know how to order weight-based medication and relies on the pharmacist's recommendation.

During an interview on 9/23/21 at 2:18 P.M. the Director for Performance Improvement and Quality said that it is the pharmacy's standard practice that all pharmacists receive the email after a weekly meeting, including the power point and meeting information regarding this medication error. She said that there is no way to track who opened the email and/or reviewed the Power Point presentation. She said that there was no sign in sheet for the meeting to identify who was in attendance in real time.

During an interview on 9/24/21 the Chief Nursing Officer said that this medication dosing error was discussed. She said that the communication to physician's policy doesn't identify weight loss as a significant event for reporting to the physician. She said that there was a deterioration in patient's health, but it is not documented that there was a conversation with the physician's and nurses regarding the significant weight loss.

During an interview on 9/24/21 at 11:05 A.M., the Director for Performance Improvement and Quality said that in the end pharmacy is the back stop and that their vigilance missed this dosing error.

During an interview on 9/24/21 at 11:05 A.M., the Manager of Regional Compliance said that the hospital could possibly have the pharmacists look specifically at Enoxaparin orders based on prophylactic vs. treatment-based orders.

During an interview on 9/24/21 at 11:30 A.M., the Director of Pharmacy and the Clinical Manager of the Pharmacy, they said that the education for the order set for weight-based function was provided to the Hospitalist's Medical Director. They were not responsible for the education to all the physicians.
The Clinical Manager of the Pharmacy said that in July 2021, they requested that an alert be added to the electronic health record when a patient has a 10% weight loss so that the weight loss would be identified if a patient lost at least 10% of his/her body weight. This request has not been acted upon at the time of the survey.

The Hospital failed to provide education and corrective actions to prevent a like occurrence from happening again. Patient #1's required a weight-based treatment and his/her weight changes were not documented because the order was written in free text and not using the weight-based function of the electronic health record. The Hospital has identified corrective actions, but they have not been put into place and the staff hasn't been educate