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WILLIAMSPORT REGIONAL MEDICAL CENTER 700 HIGH STREET WILLIAMSPORT, PA 17701 March 21, 2017
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility's Advanced Practice Professional failed to order an appropriate dose of the antiarrhythmic agent, Flecainide (Tambocor), for one of five medical records reviewed for patients receiving Flecainide (MR1).

Findings include:

Review on March 21, 2017, of the facility's "Bylaws of the Medical Staff of Susquehanna Health (Williamsport)," updated March 10, 2017, revealed "... Article II- Responsibilities The Medical Staff has a responsibility for the quality of medical care delivered to patients ..."

Review on March 20, 2017, of MR1 revealed the patient was admitted to the facility on on [DATE], with the diagnosis of unspecified atrial fibrillation. A Cardiology consultation was obtained. Review of the "Discharge Order Summary Report" revealed CF4 ordered and the patient received Flecainide 300 mg on January 23, 2017, at 19:30 and Flecainide 300 mg. on January 24, 2017, at 08:57. The patient was discharged on [DATE], at 16:27 on Flecainide 300 mg. twice a day. The patient returned to the Emergency Department on January 24, 2017, at 22:27 and expired at 23:47. The Clinical Impression was Sinus bradycardia (secondary to medication). Cardiopulmonary Arrest.

Interview on March 20, 2017, with EMP5 revealed the dose of Flecainide ordered by CF4 was not an allowable dose.

Interview on March 20, 2017, at 2:20 PM with EMP6 confirmed there was a peer review of MR1 and interview of CF4. CF4 admitted to the error in the ordered dose of Flecainide.

Cross reference 482.25(b) Delivery of Drugs
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility's pharmacist failed to ensure the antiarrhythmic agent, Flecainide (Tambocor), was properly dispensed for one of five medical records reviewed for patients receiving Flecainide (MR1).

Findings include:

Review on March 20, 2017, of the facility's policy "Viewing Physician Medication Orders Including Advanced Practice Professionals," last revised December 9, 2015, revealed "Purpose: To ensure that orders are accurately received, written, transcribed and implemented for the correct patient. To ensure that proper patient identification is followed throughout the ordering process. ... Responsible Persons: RN, LPN, UC, Respiratory Therapist, Registered/Licensed Dietician, Pharmacist, Physician, Advanced Practice Professionals: {APP/Allied Health Professionals (AHP)} Medication Ordering Guidelines: ... K. Medication Order Clarification 1. The Pharmacist calls the prescriber for order clarification in the following situations: a. non-formulary medications b. question of dose appropriateness ..."

Review on March 20, 2017, of the facility's medication dispensing system (the Pyxis Lexicomp online) revealed "Flecainide ... Pharmacologic Category: Anti arrhythmic Agent, Class lc ... Dosing Adult: ... [DIAGNOSES REDACTED] atrial fibrillation/flutter and [DIAGNOSES REDACTED] supra[DIAGNOSES REDACTED]s (prevention): Oral: initial: 50 mg every 12 hours; increase by 50 mg twice daily at 4 day intervals; maximum total dose; 300 mg..."

Review on March 20, 2017, of MR1 revealed the patient was admitted to the facility on on [DATE], with the diagnosis of [DIAGNOSES REDACTED]. twice a day. The patient returned to the Emergency Department on January 24, 2017, at 22:27 and expired at 23:47. The Clinical Impression was Sinus bradycardia (secondary to medication). Cardiopulmonary Arrest.

Interview on March 21, 2017, with EMP4, confirmed PF7 who dispensed the Flecainide for MR1 was interviewed by the facility. PF7 stated CF4's order for the Flecainide at 300 mg. BID (twice a day) flagged [an alert for the pharmacist dispensing the medication] in the electronic order entry system. PF7 did not follow up with the practitioner for clarification of the medication dose.

Review of the facility's medication error log revealed the event for MR1 is under investigation.

Cross reference 482.13(c)(2) Patient Rights: Care In Safe Setting