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24 HOSPITAL AVE

DANBURY, CT 06810

MEDICAL RECORD SERVICES

Tag No.: A0431

The Condition of Medical Records has not been met. Based on medical record review and interviews, the Hospital failed to ensure that critical medical information (allergies) known during previous admissions and documented in the inpatient electronic medical record, was available to emergency department (ED) staff in the ED electronic medical record and in the electronic medication system. This failure led to an allegic reaction for a patient with a known medication allergy and resulted in the patient's death.

Please see A449.

CONTENT OF RECORD

Tag No.: A0449

Based on clinical record review and interviews the hosptial failed to ensure that the hosptial record for 1 of 14 patients reviewed (Patient #1) contained the appropriate information. This failure led to an allegic reaction that led to the patient's death. The findings include:

a. Patient (P) #1 had an inpatient admission to Hospital #1 on 11/23/12 and was treated for cellulitis. During the course of this hospitalization it was identified that P#1 had an allergy to Ancef (Cefazolin).

b. On 2/6/13 at 2:50 AM, Patient #1 was brought by ambulance from an assisted living facility to Hospital #1's Emergency Department (ED). Patient #1 presented to the ED awake and alert with symptoms of respiratory distress, fever and lower extremity redness/cellulitis. The interagency referral (W-10) report received from the assisted living facility and ambulance personnel documentation identified P#1 had no known drug allergies.

c. At 3:23 AM a physicians order was written to administer Ancef 2 grams (gm) intravenously (IV). At approximately 3:52 AM Ancef 2 grams IV was initiated. Approximately ten minutes after the Ancef was administered, Patient #1 experienced an anaphylactic reaction that included respiratory arrest, low heart rate, and required intubation. Epinephrine was administered resulting in a return of circulation. P#1 was transferred to the intensive care unit and expired on 2/8/13 with discharge diagnoses of respiratory failure and anoxic brain injury.

d. Interview with Registered Nurse (RN) #1 on 2/22/13 at 9:15 AM identified that upon admission he/she received report from the ambulance personnel, (86 year old, alert and oriented, with fever and leg swelling, identified by ambulance personnel with tight respiratory wheezes, and the patient reported no drug allergies) reviewed the interagency documentation (W-10) and interviewed P#1, all of which indicated P#1 had no known drug allergies (NKDA).

e. RN#1 indicated a physician's order for Ancef was placed in the ED electronic medical record. The ED electronic medical record identified no known drug allergies. RN#1 accessed the electronic medication storage system and entered P#1's name and the ordered Ancef. RN#1 identified that the computerized medication screen did not indicate that Patient #1 had any known drug allergies. RN#1 reviewed the medication (Ancef) and allergies with Patient #1, then administered the Ancef.

f. During a review of the incident involving P#1 with the Vice President of Quality and Safety and the Director of Patient Care Services on 2/20/13 at 10:10 AM, they indicated that the Hospital had two electronic systems used for medical record documentation (ED electronic medical record and inpatient electronic medical record) and one electronic system for medication storage.

Following the incident involving P#1 it was identified that the inpatient electronic medical record did not transfer allergy information to the ED electronic medical record.

Standard-level Tag for Pharmaceutical Service

Tag No.: A0490

The Condition of Pharmacy services has not been met. Based on record review and interview with the Vice President of Quality and Safety, the Director of Patient Care Services, and the Pharmacy Director, the hospital was not aware that allergy information did not transfer from the inpatient electronic medical record to the ED electronic medical record. This failure led to an allegic reaction for a patient with a known medication allergy and resulted in the patient's death.
Please refer to A492.

PHARMACIST RESPONSIBILITIES

Tag No.: A0492

Based on record review and interviews with the Vice President of Quality and Safety, the Director of Patient Care Services, and the Director of Pharmacy, the hospital was not aware that allergy information did not transfer from the inpatient electronic medical record to the ED electronic medical record. This failure led to an allegic reaction that led to the patient's death. The findings include:

a. Patient #1 had an inpatient admission to Hospital #1 on 11/23/12 and was treated for cellulitis. During the course of this hospitalization it was identified that P#1 had an allergy to Ancef (Cefazolin).

b. On 2/6/13 at 2:50 AM, Patient (P)#1 was brought by ambulance from an assisted living facility to Hospital #1's Emergency Department (ED). Patient #1 presented to the ED awake and alert with symptoms of respiratory distress, fever and lower extremity redness/cellulitis.

c. At 3:23 AM a physicians order was written to administer Ancef 2 grams (gm) intravenously (IV). At approximately 3:52 AM Ancef 2 grams IV was initiated. Approximately ten minutes after the Ancef was administered, Patient #1 experienced an anaphylactic reaction that included respiratory arrest, low heart rate, and required intubation. Epinephrine was administered resulting in a return of circulation. P#1 was transferred to the intensive care unit and expired on 2/8/13 with discharge diagnoses of respiratory failure and anoxic brain injury.

d. Interview with Registered Nurse (RN) #1 on 2/22/13 at 9:15 AM identified that upon admission he/she received report from the ambulance personnel, reviewed the interagency documentation (W-10) and interviewed P#1, all of which indicated P#1 had no known drug allergies (NKDA).

e. RN #1 indicated a physician's order for Ancef was placed in the ED electronic medical record which identified no known drug allergies. RN#1 accessed the electronic medication storage system and entered P#1's name and the ordered Ancef. RN#1 identified that the computerized medication screen did not indicate that P#1 had any known drug allergies. RN#1 then administered the Ancef.

f. During a review of the incident involving P#1 with the Vice President of Quality and Safety and the Director of Patient Care Services on 2/20/13 at 10:10 AM, and the Pharmacy Director on 2/22/13 at 1:30 PM, they indicated that the Hospital had two electronic systems used for medical record documentation (ED electronic medical record and inpatient electronic medical record) and one electronic system for medication storage. If a medication was ordered in the ED and it was a stock medication, it would be dispensed from the ED stock medication, and not through the electronic medication system

g. Interview with the Director of Pharmacy on 2/22/13 at 1:30 PM indicated that allergies identified in the inpatient electronic record would transfer to Med select, however, ED stock medications such as IV medications did not interface with the pharmacy's electronic medication system. The Pharmacy Director indicated when a new medication order is placed in the ED electronic medical record, the order is not reviewed by pharmacy. The Director of Pharmacy indicated that retrospective reviews are conducted to monitor ED medications and allergies.

h. The medication administration policy identified that a pharmacist would review all routine medication orders (except in emergency situations and when under an LIP's control which would include the ED) prior to drug administration. The review is critical (in part) to screen for potential allergies.

Following the incident involving P#1 it was identified that the inpatient electronic medical record did not transfer allergy information to the ED electronic medical record.