HospitalInspections.org

Based on record review and interview, facility staff failed to report an adverse drug reaction for 1 of 1 patient (Patient #1), in a total universe of 10 medical records reviewed.

Findings include:

A review of the facility's policy #9857584 titled, "Anaphylaxis and Hypersensitivity Management," last revised 06/22/2021 revealed, " ...Algorithm for treatment of hypersensitivity reactions/anaphylaxis/infusion reactions ...Complete occurrence report ..."

A review of the facility's policy #7528826 titled, "Event Reporting, AW (Ascension Wisconsin)," last revised on 01/18/2020 revealed, " ...Appropriate actions will be taken following all patient or visitor events, whether they are near misses or have resulted in harm. This includes ...initiating basic follow-up and reporting procedures. The Safety Event Manager (SEM) of the Event Reporting System (ERS) is a confidential electronic system used to gather information and data to identify underlying causes of events so that action can be taken to reduce the frequency and severity of injuries to patients and visitors ...DEFINITIONS ....Events: any happening or occurrence, with or without injury, that is inconsistent with routine operations or that is an adverse event. The potential for injury and/or damage/near miss should be reported. Examples include but are not limited to ...Medication Errors ...PROCEDURE ...Patient Events: Any associate who witnesses, discovers, or is involved in a patient event should first ensure that medical treatment is provided and appropriate steps are taken to minimize the immediate potential for a future events (sic). Entry into the ERS should occur as timely as possible and before the end of an individual's shift ..."

A review of Patient #1's Emergency Department (ED) medical record revealed the following:

Patient #1 presented to the facility's ED on 08/03/2021 at 10:35 AM with a chief complaint of "Cough/Respiratory."

On 08/03/2021 at 10:51 AM, Tessalon Perle 200 mg (milligrams) oral and a DuoNeb 3 ml (milliliters) nebulizer was ordered by Physician G for Patient #1.

Further review of the ED medical record revealed the Tessalon Perle was administered to #1 on 08/03/2021 at 11:00 AM and the DuoNeb was administered at 11:08 AM.

On 08/03/2021 at 11:20 AM, "Follow Up" revealed, "Response: 1 - Awake and alert; Adverse reaction, Physician notified; Adverse reaction, Physician notified and immediately at bedside. pt (sic; Patient) having more DIB (difficulty in breathing), pt reports swelling to lips, pt clutching [his/her] neck ..."

A review of the medication orders and administration documentation revealed #1 received epinephrine 0.5 ml (milliliters) intramuscularly at 11:24 AM, Benadryl (diphenhydramine; an antihistamine) 50 mg (milligrams) intravenously at 11:24 AM, and methylprednisolone (a steroid) 125 mg intravenously at 11:26 AM with subsequent, "Marked relief of symptoms."

The "Physician Documentation" on 08/03/2021 at 4:46 PM revealed, "ED course: Patient appeared to be having bronchospasm with [his/her] repetitive coughing in the room. Albuterol treatment was provided with minimal improvement to [his/her] symptoms. Patient was given Tessalon Perles. I was called by pharmacy 1 to 2 minutes after [s/he] was administered the medication that [s/he] could have a reaction given [his/her] history of anaphylaxis to 'caines'. (sic) Patient at first tolerated the medication but had worsening SOB (shortness of breath) and subjective worsening tongue swelling and lip swelling. On exam, [his/her] breathing pattern was voluntarily staggered, and [his/her] HEENT (head, eyes, ears, nose, throat) exam was unchanged from initial presentation. [S/He] did appear in more distress, so epinephrine/solumedrol/benadryl and famotidine were administered. [His/Her] symptoms, including [his/her] original bronchospasm, improved dramatically ...Patient was appreciative of care provided in the emergency department. [S/He] was stable for discharge home ..."

A review of the facility's listing of adverse events reported for the Emergency Department and Pharmacy between 06/01/2021 and 08/31/2021 revealed no evidence that Patient #1's adverse drug reaction was reported.

A review of the facility's listing of medication-related adverse events between 05/01/2021 and 08/31/2021 revealed no evidence that Patient #1's adverse drug reaction was reported.

During an interview on 08/31/2021 at 1:44 PM, Patient #1's medical record review findings were discussed with and confirmed by ED Manager C. When asked if it would be expected that a safety event report be completed for #1's adverse drug reaction, C stated, "Per policy, there should have been an incident report filled out." C confirmed that there was no safety event completed for Patient #1.

During an interview with Pharmacist D on 09/01/2021 at 8:57 AM, when asked when an adverse event report should be completed, D stated, "Per policy, anytime there is a reaction or adverse reaction, there should be an ERS completed."