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Based on medical review of record, review of policies and procedures, hospital document review, and staff interview; the hospital administrative staff failed to implement systems that alerted hospital staff to patients with abnormal electrocardiogram (ECG) results showing a prolonged QT interval and drug to drug interactions of medications that cause a further lengthening of the QT interval. The combination of these drugs and a prolonged QT wave resulted in the death of one patient. The following example confirms this determination.

The nursing staff administered Zofran to Patient #1. The ECG at admission showed Patient #1 had a prolonged QT interval. The patient was prescribed Zoloft, Seroquel, and Zofran. The combination of the drugs caused an adverse drug reaction for patient #1 on 8/4/14. The patient was transferred to the intensive care unit and died on 8/6/14.

Patient #2 had a procedure in the hospital's cardiac catheterization lab on 5/29/14. During the procedure, the patient had an adverse drug reaction from the Zofran related to the patient's use of Celexa. Between 5/29/14 and 8/4/14, the hospital failed to implement a system to prevent similar adverse drug interactions or identify patients with prolonged QT intervals prescribed Zofran as part of their care. (refer to A 405)

The cumulative effects of these systemic practices resulted in the failure of the hospital to ensure the hospital promoted and supported the safe and effective delivery of patient care to its patients.

Based on medical record review, policy review, and staff interview, the hospital lacked a system to alert nursing staff to the potential interactions of ordered medications that could potentially produce an abnormal heart rhythm or worsen an pre-existing abnormal heart rhythm. The acute care hospital staff identified 2 patients that experienced an adverse event related to the interaction of medications when Zofran was administered for nausea (Patients #1 and 2). The interaction of the medication Zofran with other drugs used for the patients with a prolonged QT interval produced an abnormal heart rhythm that could result in torsade, a type of ventricular tachycardia that may spontaneously resolve or cause ventricular fibrillation Ventricular tachycardia and ventricular fibrillation are life threatening emergency conditions.


Failure of the hospital have a system in place to alert the nursing staff when a patient has a QT prolongation with the potential for adverse reactions when certain drugs are administered, resulted in Patient #1 experiencing an adverse drug reaction from the use of a medication that increased the risk of further QT prolongation. Patient #1's admission electrocardiogram (ECG) showed the patient had a prolonged QT interval and nursing staff was not alerted to possible drug interactions that placed the patient at an elevated risk due to the types of medications ordered and the use of Zofran. Patient #1 was monitored using pulse oximetry only and had an adverse reaction related to Zofran on 8/4/14. The patient was moved to the Intensive Care Unit and died on 8/6/14.

Patient #2 was in the cardiac cath lab and had an adverse reaction to Zofran while undergoing a procedure in the cardiac cath lab at the hospital on 5/29/14. The hospital staff responded to the situation when the patient developed torsade and were able to treat the problem. The hospital's documents showed that the hospital's pharmacists were aware of patients with prolonged QT intervals on an ECG or cardiac monitoring but had failed to put a system in place to prevent a similar adverse event in the future.

The hospital failed to put a system in place to ensure a process of notifying the nursing staff of the risks of an adverse reaction to patients with QT prolongation to Zofran and the need to monitor the patients as warranted.


Findings include:


1. Review of Patient #1's medical record revealed an admit date of 7/30/14. The patient died at the hospital on 8/6/14.


a. The patient's History and Physical, dated 7/30/14 revealed patient was admitted to the hospital for acute renal failure with nausea and vomiting related to chemotherapy and radiation for laryngeal cancer. The patient had a Creatinine level of 6 (renal lab value with normal value 0.5-1.1 mg/deciliter) and had been struggling with chemotherapy, hypotension and a recent PEG tube (a feeding tube) placement.


b. The patient's current medications included Seroquel (an antipsychotic medication) 50 mg (milligrams) twice a day, and Zoloft (an antidepressant) 100 mg daily. Review of the patient's admission orders dated 7/30/14, revealed orders for an ECG (electrocardiogram) and Zofran (an anti-nausea medication) 4 mg/2ml IV push every 6 hours as needed for nausea. The patient's ECG results on 7/30/14 showed sinus rhythm, with a long QT interval (a measure of time that extends past the end of the T wave in the heart's electrical cycle) resulting in an abnormal ECG.


c. Review of the patient's Medication Administration Record revealed the patient received the following medications.


Seroquel 50 mg was administered twice daily from 7/31/14 to 8/4/14 as ordered.

Zoloft 100 mg was administered daily from 7/31/14 to 8/4/14 as ordered.

Morphine sulfate 4 mg was administered by IV on 8/4/14 at 4:30 PM for pain.

Zofran 4 mg was administered IV push 11 times from 7/31 to 8/4/14 for nausea and the last dose was administered on 8/4/14 at 4:30 PM.


d. A review of the nurse ' s notes revealed the following information. On 8/4/14 at 4:15 PM, the patient requested pain medication "for pain all over and medication for nausea that is awful". On 8/4/14 at 4:30 PM, the patient desaturated (a decrease of the patient's oxygen level in the blood) when removing the humidified trach collar. The patient had been unwilling to wear continuous pulse oximeter to measure the oxygen level. The nurse convinced patient to wear the continuous pulse oximeter so nursing staff staff could monitor the oxygen levels continuously.
The patient agreed and applied the pulse oximeter probe. On 8/4/14 at 4:45 PM, the pulse oximeter monitor at the nurse's desk indicated the oxygen levels in the blood. Staff assessed the probe and made adjustments to the wire. The oxygen saturations were 92% with portable pulse oximeter. The patient was alert and oriented. The oxygen per trach collar was in place.


On 8/4/14 at 5:13 PM, the monitor at the desk indicated there were problems reading pulse oximeter at the nurse's station. The nurse sent the certified Nurse Aide (CNA) to check on the patient. The CNA notified nurse patient was not responding. The nurse ran to the room to assess the patient. The oxygen was no no longer applied to the trach collar and the patient had no pulse or respirations. A code blue (a call to alert additional help to come to the room to help resuscitate the patient) was called.

Hospital documentation revealed the pharmacy staff was not alerted about the patient's prolonged QT interval by the ECG technician.


2. Review of the policy titled, "Medication Management: Prescribing and Ordering of Medications", dated 4/2013 stated in part ...C. Identification of any potential for allergic reaction, therapeutic duplication, significant food-drug interaction which cannot be avoided, significant drug-drug interaction which cannot be avoided, or other adverse medication-related event will be brought to the attention of the prescriber for clarification and/or change of drug therapy as appropriate...


Review of the policy titled, "Medication Administration: Administering and Documenting", dated 3/2001, revealed it lacked information related to medication administration and potential adverse drug to drug reactions.


3. The administrative staff verified the hospital lacked a policy or a system that ensured and established when ECG interpretations required immediate notification to the physicians, mid-level practitioners, pharmacy staff, and the nursing staff involved in the care of patients with an abnormal ECG or a history of an abnormal ECG. This is important when there are ordered medications that may result in adverse drug interactions.


4. The following interviews were conducted during the complaint investigation.

a. During an interview on 10/7/14 at 8:25 AM, Staff B, a Pharmacist, reported the hospital staff thought the Zofran caused an interaction with the Seroquel and Zoloft and caused a drug to drug interaction to occur for Patient #1. This could have been the cause of the code blue that occurred for Patient #1 on 8/4/14.

b. During an interview on 10/7/14 at 3:40 PM, Staff A, RN, reported giving the patient Morphine for pain and Zofran for nausea at 4:30 PM on 8/4/14. The patient received Zofran previously during the hospitalization and had tolerated it well. Staff A stated she was unaware the patient had a prolonged QT wave on the ECG completed at the time of the hospital admission.


c. During an interview on 10/8/14 at 8:00 AM, Practitioner C, MD Family Practice, reported ordering the Zofran for the patient ' s nausea on 7/31/14. He did not know the patient had a long QT wave on the admission ECG. Practitioner C he did not know the patient was on Seroquel and Zoloft. He said he was aware the combination of these medications could cause a drug to drug interaction if the patient had a prolong QT wave. The pharmacist notifies physicians if these interactions could cause an adverse reaction.


d. During an interview on 10/8/14 at 8:15 AM, Practitioner B, a Cardiologist, reported he was consulted on 8/4/14 when Patient #1 coded. Practitioner B said the patient was given Zofran at 4:30 PM on 8/4/14. Staff entered the patient ' s room at approximately 5:10 PM, and found her in a code situation. When Practitioner B evaluated the patient in the ICU after the code he did not identify any arrhythmia on the cardiac monitor at that time. The patient started Torsade (an abnormal rhythm associated with a prolonged QT interval) about 12 hours later in the ICU. Torsade is ventricular tachycardia with long QT wave that can change to ventricular fibrillation. The ECG at the time of admission on 7/30/14 showed sinus rhythm with a prolonged QT wave of 458, that is high in women. After reviewing the patient ' s medical record, the patient had received Seroquel, Zoloft and Zofran. The prolonged QT wave should have been identified on admit and communicated to all staff involved in the patient's care. Zofran could cause an adverse effect due to the interactions of the medications.


e. During an interview on 10/8/14 at 9:00 AM, Practitioner A, a Family Practice Physician, reported he was the admitting physician for Patient #1. He reviewed Patient #1's medical record and recalled the patient had a prolonged QT wave on the admission ECG. Practitioner A acknowledged the patient was on Seroquel and Zoloft at the time of admission to the hospital. When asked if Practitioner A should have notified other staff of the patient ' s prolonged QT wave and medications, he said " I don ' t know how to answer the question if I should have notified staff of these findings."

f. During an interview on 1/8/14 at 10:00 AM, Staff C, Pharmacist, stated he took an order on 7/31/14 for Zofran to treat Patient #1's nausea. When he processed the order, he did not know the patient had an admission ECG showing a prolonged QT interval. Staff C reported if he would have been aware if the prolonged QT interval, he would have called the ordering physician to clarify the Zofran order.



5. A review of hospital documents revealed the hospital staff was aware of a previous patient that had a similar adverse drug reaction involving Zofran. Patient #2 was admitted as an inpatient of the hospital on 5/28/14 in the intensive care unit. On 5/29/14, the patient was in the cardiac cath lab for a procedure. The patient was on Celexa, an antidepressant, and had received a dose of Zofran prior to the start of the cardiac catheterization. Patient #2 experienced the QT prolongation and an episode of Torsades and was treated with Magnesium and Amiodarone. The patient's Celexa was discontinued and added to the patient's list of allergies.


6. Hospital documents showed the adverse reaction to Zofran by Patient #2 was reported. The hospital failed to make any changes in their system to alert staff of the potential adverse drug interactions when administering Zofran to patients with a prolonged QT interval since the problem was identified with Patient #2 at the end of May.