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Based on interview and document review, the hospital failed to ensure appropriate measures were implemented to mitigate medication errors when EPIC (facility computer system) medication administration alerts were triggered during medication administration, and a nurse manually overrode the alerts without following policy and/or procedures. This resulted in two of two patients (P5, P11) receiving insulin from the same insulin pen and potentially being exposed to blood borne pathogens. As a result, the hospital was found out of compliance with the Condition of Participation of Nursing Services at 42 CFR 482.23.

A condition-level deficiency was issued.

See A-0405.

Based on interview and document review, the hospital failed to ensure appropriate measures were implemented to mitigate medication errors when EPIC (facility computer system) medication administration alerts were triggered during medication administration and a nurse manually overrode the alerts without following policy and/or procedures. This resulted in two of two patients (P5, P11) receiving insulin from the same insulin pen and potentially being exposed to blood borne pathogens. This had the potential to affect all patients receiving insulin within the hospital.

The IJ began on 3/26/23, when a nurse, who was previously educated on facility expectations related to insulin administration and triggered warning alerts, along with the five rights of medication administration, manually overrode two EPIC triggered insulin administration alerts and administered insulin to P11 using P5's previously used insulin pen. The Vice President (VP)/Chief Nursing Officer (CNO), System Director for Regulatory and Accreditation, two System Program Managers for Regulatory and Accreditation, and a nursing director were notified of the IJ findings on 4/20/23, at 1:26 p.m. The IJ was removed on 4/21/23, at 4:28 p.m. after verification of an acceptable removal plan.

Findings include:

P5's Acute Rehabilitation Unit Daily Progress note dated 3/27/23, identified P5 was admitted to the rehabilitation unit on 3/23/23, after a hospital stay that started on 2/23/23, where he underwent a CABG x4 (coronary artery bypass graft). In addition, the note identified P5 was diagnosed with insulin-dependent type II diabetes mellitus and was ordered aspart (fast acting) insulin three times a day (TID) with meals based on blood sugar readings (sliding scale). An Addendum identified the provider was notified P5 was involved in an error involving the use of an insulin pen on multiple patients in which P5 and another patient were potentially exposed to each other's blood. P5 was updated and P5 consented to blood testing for HIV (human immunodeficiency virus), HBV (hepatitis B), and HCV (hepatitis C). Lab results on 3/28/23, indicated these three labs were negative.

P11's Acute Rehabilitation Unit Daily Progress note, dated 3/27/23, identified P11 was admitted to the rehabilitation unit on 3/23/24, after a hospital stay that started on 12/6/22, where he was found to have bacteremia (bacterial infection in the blood stream). P11 underwent a bone marrow transplant on 2/3/23, due to myelodysplastic syndrome (cancer where blood cells do not mature into healthy cells) and multiple complications with a complex infectious history which included recurrent neutropenic fevers (low levels of white blood cells which increased risk of infection) and fungemia (fungi or yeast infection in the blood). In addition, the note identified P11 was diagnosed with pancytopenia (reduction of almost all blood cells), immunosuppression (partial or complete suppression of the immune system to fight infection), steroid-induced hyperglycemia (high blood sugars), and type II diabetes mellitus. P11 was ordered aspart insulin with meals based on blood sugar readings. The note identified the provider was notified P11 experienced a possible blood borne pathogen exposure in which P11 consented to blood work. Lab results on 3/28/23 for HIV, HBV, and HCV were negative.

Medication Administration records for P5 and P11 identified the following:
-On 3/26/23, at 12:22 p.m. P5 was administered 1 unit of aspart insulin per sliding scale instructions by registered nurse (RN)-A.
-On 3/26/23, at 1:17 p.m., (approximately one hour after P5), P11 was administered 4 units of aspart insulin per sliding scale instructions by RN-A.
-On 3/26/23, at 6:09 p.m., (approximately five hours after P11), P5 was again administered 1 unit of aspart per sliding scale instructions by RN-A.

An HR (human resources) Intake Guide, dated 3/29/23, identified each morning EPIC generated a report that showed wrong patient insulin pen scan alerts from the previous 24 hours. If a patient was identified on this report, it meant an incorrect insulin pen (pen used for a different patient) was scanned and the involved nurse did not rescan a correct pen within 15 minutes. On 3/27/23, pharmacy updated nursing leadership that on 3/26/23, at 1:11 p.m. P5's insulin pen was scanned during P11's insulin administration preparation process, and at that time EPIC provided the nurse with an initial wrong scan alert. Six minutes later, a not scanned alert triggered. RN-A selected "system downtime" as an override reason, and the aspart insulin was documented as administered to P11 at 1:17 p.m. (six minutes after the initial alert). On 3/26/23, at 6:09 p.m. P5 was administered aspart insulin (without any EPIC alerts.) The leadership team determined this indicated a double exposure situation, in addition to a gap in the medication administration policy, despite prior education provided to staff on the rehabilitation unit related to such events. During the facility's interview with RN-A, RN-A was unable to provide a consistent reason for the medication error, initially denied any alerts, and when showed the evidence she was unable to provide an explanation.

On 4/19/23, at approximately 2:30 p.m. the infection prevention manager (IPM)-A was interviewed and stated when the nurse received an alert with medication administration, the nurse should stop what they were doing and alert the charge nurse, especially as there was a risk for infection if the same insulin pen was used on two patients.

On 4/19/23, at 3:28 p.m. RN-B (the director of acute rehab unit) and RN-C (the manager of rehab unit) were interviewed. RN-B and RN-C both verified the medication error. RN-C stated if the system triggered alerts, she expected the nurse to notify the charge nurse and not to override the EPIC system to use the incorrect insulin pen for insulin administration. RN-C verified there were no issues with the EPIC system when RN-A administered P11 his oral medications and the insulin. RN-C stated there was a risk for a bloodborne pathogen being spread when the same insulin pen was used on two different patients. RN-C explained RN-A completed all her annual education related to medication administration, along with recent education and participation in beginning of shift huddles. This was due to a similar wrong patient/wrong insulin incident that happened approximately two weeks prior on another unit with a different nurse, which again reviewed medication/insulin administration, expectations related to the 5 Rights of Medication Administration, and EPIC alert processes. RN-C stated RN-A was removed from the schedule pending the investigation and had since returned. She stated the EPIC reports lacked evidence of any further issues when RN-A administered medications/insulin; however, she denied she or other staff personally observed and/or audited RN-A's medication/insulin administration processes to ensure policy/process compliance.

On 4/19/23, at 4:04 p.m. the regulatory and accreditation system program manager (PM)-A was interviewed and stated after the 3/26/23, error occurred "double" reeducation was only provided to RN-A and the acute rehabilitation unit nurses, due to whole house nurse education being provided after the incident two weeks prior and recent annual medication administration education requirements.

On 4/20/23, at 10:38 a.m. P11 was interviewed and stated he was updated "the next day" after an insulin event where he was "stabbed with someone else's needle and got their insulin. They used it on them and then they used it on me and then on the other patient again." P11 explained he underwent a recent transplant, and he was considered immunocompromised thus this incident concerned him greatly. He stated this incident made him feel "not very happy ...that s*** should not happen these days."

On 4/20/32, at 1:32 p.m. VP/CNO stated two nurses [one being RN-A] were recently "reckless" and "intentionally ignored the alert" which placed patients at risk when they chose "not to follow what we have instructed them to follow."

On 4/21/23, at 1:39 p.m. RN-A stated she completed her annual medication/insulin administration earlier this year and attended the unit huddles. RN-A explained her process for insulin administration included the following steps: verify with the medication record the order and administration time, obtain the insulin from the medication room patient bins, double check the order when in the patient's room, scan the patients badge to verify the right patient, scan the medication to ensure the right medication, "do all [5] rights [of medication administration]," and once all verified administer the insulin. In addition, she explained if she scanned the patient or the medication and received an alert, she would stop, read the alert, attempt to identify the issue, and would correct it before she administered the medication. RN-A stated the reason for the alerts was to alert the nurses if something did not match up and identified she was able to override an alert. She denied issues with the scanner in the past few months; however, she explained if there were scanner or EPIC issues, she would try to recalibrate the scanner, restart the computer, and if still could not fix the issue would update the charge nurse. When asked about the incident, she stated there were two patients with the same name that were across the hall from each other; however, she was unsure what may have occurred that day to cause the potential error, or the six-minute delay in scanning and administration, as there was no rememberable events that typical day, and she lacked remembrance of any alerts that triggered for P11. RN-A explained P11 was immunocompromised due to a transplant and if exposed to someone else's blood, it "would be bad" for P11 due to the risk of infection from potential blood swapping: "You do not want to expose anyone to anyone else's bodily fluids."

A copy of the Compass event report was requested; however was not provided.

A Process Title: Insulin Administration using pen Standard Work dated 11/30/21, directed its purpose was to ensure safe administration of insulin using a pen. The process directed the following steps were to be completed prior to insulin administration using a pen: obtain pen from intended patient medication bin, perform the "5 rights - right patient, right drug, right dosage, right routine, right time," ensure the right pen was labeled for the specific patient, scan the patient's identification barcode, scan the medication label, address any alerts that appear in EPIC. The process identified "ALERT: When this wrong pen alert fires, it is telling you the WRONG insulin pen has been scanned for this patient. STOP? DO NOT ADMINISTER INSULIN," and instructed the nurse to close the function, return to the electronic medication administration record, return the pen to the correct patient's bin, or pharmacy bin if appropriate, obtain the correct pen, and re-start the process form the beginning. If the scanner failed to recognize the barcode, pharmacy was to be notified to relabel the pen and if the scanner was broken the manager was to be updated. The process identified, "One Pen, One Patient! Pens are NEVER shared."

The IJ was removed on 4/21/23, at 4:28 p.m. after the following actions were completed: an automatic E-Learning email notification was sent to all employee and agency nurses on 4/20/23, which instructed mandatory education was to be completed prior to the start of their next shift, any staff on leave were required to complete prior to their first shift, and all shift huddles led by nurse managers/supervisors or designee were to include standardized and consistent contact which included notification of the 5 Rights of Medication Administration, appropriate procedures for safely administering insulin via pen device, and procedures if staff received error alerts. If non-completion of the mandatory education was identified, the nurse would be removed from the schedule until the education was completed. This was verified through staff interview and document review.