HospitalInspections.org

Based on policy review, record review, and staff interview, it has been determined that the hospital failed to meet the Condition of Participation: Pharmaceutical Services relative to the hospital's failure to prevent a medication error caused by the administration of a NSAID (non-steroidal anti-inflammatory drug) medication to a patient with an identified severe ibuprofen allergy, causing them to have an anaphylactic reaction requiring additional clinical interventions.

Findings are as follows:

The hospital failed to follow its own policy titled, "Medication Management- Adult Patients" relative to reviewing the medication order for patient allergies or potential sensitivities as well as, clarifying concerns, issues, or questions with the prescribing provider prior to dispensing and administering the medication, (Refer A-0500).

Based on record review and staff interview the hospital failed to follow its own policy "Medication Management- Adult Patients" relative to the reviewing of the medication order for patient allergies or potential, as well as clarifying concerns, issues, or questions with the prescribing provider prior to dispensing and administering the medication. This resulted in a medication error that required additional clinical interventions for Patient ID #1.

Findings are as follows:

On 1/3/2025, the hospital submitted an incident report to the Rhode Island Department of Health which indicated that on 12/29/2024 Patient ID #1 received a dose of Toradol (a non-steroidal anti-inflammatory medication used to treat pain) when it was documented in the patient's electronic medical record that they had a severe allergic reaction to Ibuprofen which is classified as an non-steroidal anti-inflammatory medication. The report states shortly after administration of the medication, Patient ID #1 experienced an anaphylactic reaction which necessitated additional clinical interventions other than monitoring.

The following hospital policy was reviewed:

1). The hospital's policy titled, "Medication Management" last reviewed 3/11/2022 states in part,

"...IV. Procedure all patient clinical information is readily accessible to personnel involved in the medication management system.
- The patient's allergies and sensitivities ..."


"...Procedure
...#26. The Pharmacist reviews all medication orders for the following:
...* Patient allergies or potential sensitivities

#27. Concerns, issues, or questions are clarified with the prescriber prior to verifying the order and dispensing the medication..."

#28. Pharmacists' clarifications and interventions are documented electronically in the patients' electronic medical record ...

#44. Before administering a medication, the practitioner administering the medication performs the following:
...Verifying that there are no contraindications (including allergies) for administering the medications ..."

Review of the medical record revealed that Patient ID #1, is a 43 year old who presented to the hospital's Emergency Room on 12/29/2024, with a chief complaint of rectal pain. CT imaging revealed perianal inflammatory stranding with a fluid collection along the right gluteal cleft measuring 2.5 X 2.3 cm without tracking gas. A surgery consult was completed, and the decision was made to admit the patient with a plan for surgery in the morning.

Review of the medical record revealed an order written by the Surgical Physician Assistant (PA), Staff A for ketorolac (Toradol), 15 (milligrams) mg IV push every six hours, 0n 12/29/2024 at 6:41 PM. The order was electronically submitted to the hospital's pharmacy and was acknowledged and reviewed by Registered Pharmacist, Staff B on 12/29/2024 at 6:46 PM.

The record further revealed that the medication was administered to the patient by Registered Nurse, Staff C on 12/29/2024 at 6:41 PM prior to the pharmacy verification.

Review of the medical record revealed a list of the patient's allergies which included Ibuprofen,with a response of Anaphylaxis (A severe potentially life threatening allergic reaction).

Review of an Acute Event Note dated 12/29/2024 revealed that a Rapid Response was initiated at 7:52 PM after the patient was noted to be flushed and vomiting. The patient was complaining of tingling lips, along with Gastrointestinal symptoms. The Emergency Room attending physician responded immediately and the patient was administered 0.3 mg of epinephrine ( medication used to treat severe allergic reactions) prior to the arrival of the Rapid Response Team.

Review of the Rapid Response Note revealed, Patient ID #1, appeared flushed, with mild duskiness to his/her legs and appeared uncomfortable. She/he was without stridor, or wheezes and the lungs were clear. The patient complained of feeling like his/her throat was closing.

During the event the patient received the following additional medications:
- Solumedrol 60 mg IV
- 2 doses of Epinephrine
- Benadryl IV

During a surveyor interview with the Surgical PA, Staff A and Chief of Surgery, on 1/9/2025 at 9:00 AM, the PA stated that he completed the History and Physical and admission orders for Patient ID #1. When asked if he was aware of the patient's allergies, he remembered seeing the allergy alert pop up while he was placing the orders and said that he saw so many pop up warnings that he could have "blown by" the ibuprofen allergy alert.

During a surveyor interview with Pharmacist, Staff B on 1/9/2025 at 11:00AM, he revealed that he was the pharmacist that checked the patient's medication orders. He then stated that when he checked the orders, he did not remember seeing the alert pop up identifying the allergy to Ibuprofen. The pharmacist acknowledged that the patient's medical record contained the information that the patient was allergic to Ibuprofen, and it was listed as a severe allergy/anaphylaxis. The pharmacist then stated that he takes full responsibility of the event.

During a surveyor interview with the Clinical Pharmacy Manager. Staff D, on 1/9/2025, she stated that it is her expectation that the pharmacist would have investigated the order further. She explained that when the provider chooses to defer to provider it is the pharmacist's responsibility to validate that the issue has been addressed and it is ok to sign off the medication so that it can be administered.

During a surveyor interview with RN, Staff C, on 1/9/2025 at 12 noon, she explained the process of medication administration stating that the process includes reviewing the medication, identifying the patient, asking about allergies, and scanning the medication. The RN was then asked if the patient had an allergy band on at the time she was administering the medications. She then replied that she could not remember, stating that she usually asks the patient if they are allergic to any medications when she is medicating them and this time she did not, acknowledging that she did not follow the hospital's policy.

During a surveyor interview with the Risk Manager's on 1/8/2025 at 11:00 AM, they confirmed that the both the physician and the pharmacist received a warning alert notifying them that the patient has a severe allergy, listing Ibuprofen/anaphylaxis when the Toradol was entered. The warning alert requires a response by entering a reason to override the medication in a drop down box. According to the documentation provided by the Risk Managers the PA chose Defer to Provider to override the warning. The pharmacist then verified the order after responding to the allergy override as Pharmacist Consulted without contacting the PA for clarification.