HospitalInspections.org

The Condition of Participation: Patient Rights was out of compliance.

Findings included:

Based on interviews and record reviews, the Hospital failed to provide care in a safe setting for one of ten sampled patients (Patient #2), when Patient #2, who was assessed as high-risk of self-harm behaviors and suicide attempts, and required a continuous one-to-one patient safety observer, ingested a cordless phone battery on 9/8/23, which required an x-ray scan and an endoscopic procedure to remove the battery on 9/10/23.

Cross Reference: 482.13(c)(2): Patient Rights: Care in a Safe Setting (144).

Based on interviews and record reviews, the Hospital failed to provide care in a safe setting for one of ten sampled patients (Patient #2), when Patient #2, who was assessed as high-risk of self-harm behaviors and suicide attempts, and required a continuous one-to-one patient safety observer, ingested a cordless phone battery on 9/8/23, which required an x-ray scan and an endoscopic procedure to remove the battery on 9/10/23.

Findings include:

Review of the Hospital's Suicide Risk Assessment and Risk Mitigation policy, dated August 2023, indicated its purpose was to ensure safety of patients who were at risk of suicide on the inpatient psychiatric unit. The policy indicated the one-to-one observer would always keep the patient (especially hands) in direct view, even when toileting.

Review of the Department of Public Health's Health Care Facility Reporting System (HCFRS), dated 9/18/23, indicated the Hospital reported that Patient #2 was admitted to the inpatient pediatric unit in May 2023 for stabilization of nutritional deficiency and transferred to the inpatient psychiatric unit on 6/2/23, for treatment of food refusal in the context of trauma at home with increased flashbacks. The Hospital's report indicated that on 9/10/23 Patient #2 told staff that on 9/8/23 he/she swallowed a cordless phone battery. The report indicated following Patient #2's adverse event, his/her care plan's safety interventions were increased, and Patient #2 underwent an endoscopic removal of the batteries from his/her stomach on 9/10/23.

Further review of the Hospital's report indicated the Hospital was unable to determine if the Patient #2's adverse event, of ingesting a foreign object while under one-to-one safety observation on 9/8/23, was preventable or not due to the complexity of Patient #2's case at the time of the event.

Review of the Hospital's Internal Investigation, dated 9/10/23, indicated that Patient #2 did not disclose ingesting a foreign object until staff confronted him/her about a missing phone battery from a phone he/she used two days earlier. The Investigation indicated that Patient #2 denied swallowing the battery and attempted to refuse the x-ray scan to try to locate battery. The Investigation indicated that just prior to Patient #2's x-ray scan, he/she reported swallowing the battery as a suicide attempt on 9/8/23.

During an interview on 1/8/24 at 12:20 P.M., the Nurse Manager said she assisted with the investigation and review of Patient #2's adverse event on 9/8/23. The Nurse Manager said Patient #2 swallowed the battery while under one-to-one safety observation; however, the missing battery was not identified until two days later. The Nurse Manager said the review of the adverse event did not identify any need systematic changes/staff re-education on safety supervision to improve patient safety on the unit.

During an interview on 1/4/24 at 11:02 A.M., the Director of Clinical Compliance said he was not directly involved in the Investigation/RCA process involving Patient #2's adverse event on 9/8/23; however, he acknowledged the Hospital was unable to determine if the adverse event was preventable or not, and there were no system-wide corrective actions and/or staff re-education resulting from the Hospital's completed review.

The Condition of Participation: Pharmaceutical Services.

Findings included:

Based on record review and interviews the Hospital failed to ensure medication orders were reviewed for appropriateness before the first dose was dispensed to one Patient (#1) out of a total sample of 10 Patients; Patient #1 received a dose of methadone (an opiate medication) intended for another patient and experienced respiratory depression and opiate intoxication requiring naloxone (medication used to treat Narcotic overdose) resuscitation and Intensive Care Unit (ICU) level of care.
resulting in a finding of Immediate Jeopardy.

An Immediate Jeopardy (IJ) event was identified on 1/4/24, regarding the Conditions of Participation (CoP) of Pharmaceutical Services for Patient #1.

The Hospital was notified of the IJ event on 1/4/24. The Hospital presented a completed Removal Plan to the State Agency/CMS on 1/8/24, which was determined to be acceptable. In summary, the IJ event Removal Plan was implemented on 1/5/24.

The IJ event regarding the CoP of Pharmaceutical Services was removed on 1/8/24, when the State Agency/CMS verified by interview with staff, review of all documentation, education attestations, and Patient records that the Removal Plan was fully implemented.

CoP non-compliance for Pharmaceutical Services remains.

Cross reference:
482.25 (b) Pharmaceutical Services: Delivery of Services (A0500)

Based on record review and interviews the Hospital failed to ensure medication orders were reviewed for appropriateness before the first dose was dispensed to one Patient (#1) out of a total sample of 10 Patients; Patient #1 received a dose of methadone (an opiate medication) intended for another patient and experienced respiratory depression and opiate intoxication requiring naloxone (medication used to treat Narcotic overdose) resuscitation and Intensive Care Unit (ICU) level of care.

Findings include:

Review of the Hospital Policy titled "Pharmacist Medication Order Evaluation, Intervention, and Verification Process", dated 8/2023, indicated the following:
-A pharmacist reviews the appropriateness of medication orders for medications to be dispensed in the Hospital prior to dispensing of the medication.
-The Pharmacist intervenes upon medication orders that are incomplete, illegible, or unclear or that require clarification due to accuracy or appropriateness of order.
-The Pharmacist reviews medication order for accuracy and appropriateness by considering: patient allergies or sensitivities, patient measurements, existing or potential interactions between medication and contaminant medications and/or food, indication, appropriateness of dose, frequency, and route of administration, appropriateness of therapy with consideration to pertinent laboratory values, therapeutic duplication, contraindications to therapy, relevant hospital guidelines.
-If all elements are considered acceptable, the pharmacist verifies the medication orders.

Patient #1 presented to the Hospital Emergency Department (ED) on 10/17/23 with chills, leg pain, and congestion.

Review of Patient #1's medical record indicated the Patient was evaluated by a Physician on 10/17/23 at 8:09 A.M. Patient #1's chief complaint was chills, and Patient #1 was evaluated to have symptoms of an Upper Respiratory Infection (URI) and subsequently diagnosed to have a COVID-19 infection. On 10/17/23, at 9:16 A.M., Physician Assistant (PA) #1 entered orders for Methadone 110 Milligrams (mg) orally to be administered to Patient #1. The order was reviewed by Pharmacist #1 and verified. At 9:40 A.M., RN #1 administered 110 mg of methadone orally to Patient #1.

At 12:00 P.M. Patient #1 was documented as being somnolent (excessively sleepy) and after a Physician's evaluation, found to be in acute opioid intoxication secondary to Methadone administration. The Physician documented the methadone was intended for another patient and not Patient #1. At 12:17 PM, Patient #1 was administered Narcan (naloxone) 0.4 mg intravenous (IV). Patient #1 continued to remain minimally responsive to examination and at 12:27 P.M., was administered a continuous Narcan IV infusion 1.2mg/hr. At 4:16 P.M, Patient #1 was transferred to the ICU for further care. Patient #1 was somnolent on arrival to the ICU. During the evening of 10/17/23, Patient #1 became more apneic with respiratory rates under 10 causing respiratory acidosis and required an increase in Narcan infusion rate with additional boluses of Narcan. On 10/18/23 at 3:46 A.M., Patient #1 required a Levophed infusion to be started to manage his/her hypotension (drop in blood pressure) due to shock likely caused by his/her methadone overdose.

Further review of Patient #1's medical record failed to indicate any history, diagnosis, or indication of Patient #1 having a history of substance use or opiate use disorder, nor was there any history of Patient #1 ever receiving any controlled substances prior to his/her admission on 10/17/23 to the Hospital.

During an interview with the Chair of Quality and Safety for Emergency Medicine on 1/4/24 at 1:10 P.M., he said on 10/17/23 PA #1 was caring for multiple patients in the ED including Patient #1. He said PA #1 obtained all the information from the other patient's clinic for his/her methadone dose but had Patient #1's chart open in the electronic medical record and entered the methadone order for Patient #1. He said the Pharmacist (Pharmacist #1) then verified the order. He said PA #1 was reviewing Patient #1's medical record later on 10/27/23 and realized the methadone had been incorrectly ordered for the Patient and notified the attending physician. The Patient was then evaluated and moved to a more urgent care area in the ED at that time. He said he did counsel PA #1 after the event and meetings were held after the event and initial investigation to explore how to prevent this incident from occurring again. He said at this time, no clear interventions have been put in place.

During an interview with Pharmacist #1 on 1/4/24 at 2:30 P.M., she said a provider must enter information for Patient's utilizing methadone for substance use disorder such as the clinic attended, diagnosis, usual dose prescribed, and last dose taken. She said on 10/17/23 PA #1 entered all the necessary information for the methadone order in Patient #1's medical record. She said when she reviewed the order for methadone for Patient #1 on 10/17/23, she reviewed the ED notes for the Patient. She said during the record review for Patient #1 that while there was no history of methadone/opiate use for Patient #1, he/she did come to the ED with chills, and it is not uncommon for patients to have started opiate use/methadone use outside of the Hospital. She said it is challenging to patients for substance abuse. She said when pharmacists at the Hospital review medication orders for verification so that medications can be administered to patients, the review process depends on the type of medication; she did not reference the Hospital's policy for medication verification, which lists criteria by which all medications must be reviewed.

During an interview with the Pharmacy Director of Med use Safety, Policy, Compliance, and Informatics on 1/4/24 at 2:15 P.M., she said any changes or interventions related to the incident with Patient #1's medication error on 10/17/23 are still pending the interdisciplinary team's collaboration.

The Hospital failed to ensure Patient #1's order for methadone was reviewed for appropriateness, resulting in medication error and subsequent methadone overdose, respiratory suppression, shock, and ICU transfer for Patient #1.