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Based on interview and document review, the hospital failed to ensure medication policies and procedures were followed when staff failed to properly identify 2 of 10 patients (P1, P2) who both received insulin injections from the same Novolog insulin pen. As a result, the hospital was found out of compliance with the Condition of Participation - Nursing Services at 42 CFR 482.23.

A condition level deficiency was issued.

See A-0405: The hospital failed to ensure medications were administered to the correct patient.

Based on interview and document review, the hospital failed to ensure medication policies and procedures were followed when staff failed to properly identify 2 of 10 patients (P1, P2), who both received insulin injections from the same Novolog insulin pen. This deficient practice resulted in an immediate jeopardy (IJ).

The IJ began on 6/9/21, at approximately 2:10 p.m. when registered nurse (RN)-A failed to acknowledge and investigate two medication system generated alerts following scanning of P1's Novolog insulin pen, and administered a dose of insulin to P2 using P1's pen. The pen was returned to P1's bin in the medication room and subsequently used to administer three additional doses of insulin to P1. This resulted in the exposure of P1 to bloodborne pathogens HIV (human immunodeficiency virus), Hepatitis B & Hepatitis C (liver infection). The hospital Chief Nursing Officer (CNO), the System Program Manager Regulatory and Accreditation, and the System Director Regulatory and Accreditation were notified of the IJ finding on 7/15/21, at 3:26 p.m. The IJ was removed on 7/16/21, at 2:29 p.m. after verification of an acceptable removal plan.

Findings include:

P1's Discharge Summary dated 7/6/21, indicated P1 had a past medical history of chronic biliary pancreatitis, and was admitted to the facility on 6/5/21, with acute hypoxic respiratory failure, acute onset of lower extremity weakness, and altered mental status.

P2's Admission History dated 6/26/21, indicated P2 had diagnoses which included history of HIV, and lab results which confirmed Hepatitis B and Hepatitis C. P2 also had a history of drug abuse, and was admitted for altered mental status thought to be secondary to use of fentanyl patch which improved with Narcan.

On 7/13/21, at 9:49 a.m. registered nurse (RN)-B was interviewed and stated she was covering the unit on 6/30/21, at 8:30 a.m. when she received notification from the pharmacy of a potential insulin pen medication error with risk for exposure. The report identified an alert had been generated by the medication administration system on EPIC (software system designed for hospitals) on 6/29/21, at 2:10 p.m. The alert identified an error in patient identification for the Novolog pen scanned prior to the insulin administration to P2. The alert had been overridden, and a second alert which required documentation of the reason for the override was documented as "bar code not available." The pharmacy immediately retrieved both Novolog insulin pens from the unit on 6/30/21, and replaced with new pens. RN-B verified the insulin pens identified had been replaced by pharmacy, and stated she continued the investigation of the reported incident by interviewing RN-A who was providing care on the identified medical/surgical unit.

RN-B stated RN-A had confirmed she had administered Novolog insulin to P2 at approximately 2:10 p.m. on 6/29/21. RN-A had denied receiving any computer system alerts when she had scanned the Novolog insulin pen and P2's identification band. RN-A stated she had administered P2's insulin and returned the pen to the bin in the medication room. RN-A stated later that shift, she had retrieved P1's Novolog insulin pen, scanned it according to procedure, and administered P1's insulin dose at 4:00 p.m. P1's medication record identified the same Novolog pen was scanned and used to administer P1's Novolog insulin at 4:00 p.m. on 6/29/21, 12:00 midnight and again at 4:00 a.m. on 6/30/21. RN-A stated she had not received any alerts when she administered P2's insulin dose, and stated she had scanned P2's arm band and the Novolog insulin pen according to the facility procedure. RN-A was removed from duty pending investigation of the incident. RN-B initiated the facility procedure for a blood and body fluid exposure, providers were notified, in addition to the contact person for P1. The facility Medical Director for Infection Prevention (MDIP) was consulted, and following review of P1 and P2's medical record and laboratory results, recommended P1 receive HIV and Hepatitis prophylaxis.

On 7/14/21, at 10:34 a.m. RN-A was interviewed and stated she had administered Novolog insulin to P2 on 6/29/21, at 2:10 p.m. with a Novolog Insulin pen dispensed for P1. RN-A stated she was not aware she had the incorrect pen, and stated she had obtained it from P2's bin located on the counter of the medication room, which was beside P1's bin. RN-A stated she did not recall checking the label on the pen, but had taken it to P2's room, scanned both the pen and P2's identification bracelet, and had not received an alert. RN-A stated she then administered the Novolog insulin dose, and returned the pen to the bin in the medication room. RN-A stated she had not received an alert on the system. RN-A stated she was able to document the administration in P2's medication administration record.

On 7/13/21, at 1:23 p.m. RN-C was interviewed and confirmed she had been informed of the incident, had reviewed with pharmacy who confirmed the alert had "fired" (having displayed on medication administration screen for P2). RN-C stated she would expect staff would do an immediate stop in the attempted administration of a medication, and reassess the medication label, review the 5 Rights of medication administration (right medication, right route, right time, right dose, and right patient). RN-C stated implementation of this system would have identified the incorrect medication to the incorrect patient and would have prevented the medication error.

On 7/14/21 at 2:01 p.m. P1's family member (FM)-A was interviewed and stated she had been notified of the medication error on 6/30/21, when she had arrived at the facility. FM-A stated this was very upsetting to her, as P1 had been in the facility for 25 days with his hospitalization and she had frequently observed the process of medication administration with scanning of both the medication and patient bracelet. FM-A stated if the process had been followed, she did not know how this incident had been able to happen.

On 7/14/21 at 3:41 p.m. the MDIP was interviewed. MDIP stated she was not notified about the medication error until 6/30/21, when the hospital infection preventionist had contacted her for recommendations on how to proceed. MDIP stated following review of the medical records and discovery that P2 had a diagnosis of Hepatitis B & C in addition to HIV, she had contacted the hospitalist and recommended expedited treatment due to P1's potential exposure to three separate potential infections. MDIP stated she also recommended protocol for follow up testing. MDIP stated she felt nursing leadership was responsible for insuring the medication administration process was followed. MDIP stated the pharmacy had developed the alert system as a safety measure to prevent this type of medication error from occurring.

On 7/14/21, at 4:05 p.m. the chief nursing officer (CNO) was interviewed with the supervisor of regulatory compliance in attendance. CNO stated an SBAR (SBAR is an easy-to-remember, concrete mechanism useful for framing any conversation, especially critical ones, requiring a clinician's immediate attention and action) had been developed and emailed to the unit supervisors and managers, with direction to educate their staff. CNO stated the email message had been resent on 7/14/21, in the afternoon. CNO stated there was not a method used to identify or track when or if the information had been passed on to staff working on the units.

Review of the SBAR document: Insulin Safety: One Pen, One Patient
S: Recent Blood and Body fluid exposure due to one patient's insulin pen used to deliver insulin to a second patient.
B: Each RN receives education regarding one pen, one patient, and the process of insulin delivery during orientation and competency.
A: Any time an RN scans an insulin pen an alert will fire if it is the wrong patient's pen. If the alert fires, the RN must acknowledge this and stop. The RN had bypassed bar-coding with the stated reason the bar code was not recognized. This practice is not safe or acceptable.
R: Insulin Administration: Obtain patient's pen from medication room and bin. Take to bedside and conduct 5 Rs, Scan patient's armband, Scan the insulin pen. Any pen that doesn't have the patient bar code on it needs to be relabeled by pharmacy. Never carry two patients' pens (or other medication) with you.

The facility policy Medication Administration dated 5/20, directed medications will be administered in a safe and effective manner consistent with best practice, scope of practice and regulatory requirements. Each individual is accountable for medications administered within their scope of practice. Responsibility includes knowing the effect(s), usual dosage, side effects/precautions and calculations (where required) before administration. Any question regarding medication order will be clarified with the prescriber prior to administration. Five (5) Rights of Medication will be followed - Patient, Drug, Route, Dose and Time. Bedside barcode scanning of patient and medication will be done according to the Barcoding and Medication Administration policy.

The IJ was removed on 7/16/21, at 2:29 p.m. when it was verified through staff interviews and document review the hospital had submitted and implemented an acceptable removal plan, education and training was provided to all RN nursing staff with review and acceptance of the facility policy and procedure documented.