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Based on interview and record review, the hospital failed to ensure a system was in place to monitor and prevent large doses of central nervous system (CNS) medications from being accessed from the automated medication dispensing system (AMDS) by overriding the warnings and prior approval from the pharmacist. This affected 27 (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26 and #27) of 27 patient records reviewed. (A491)

The failure to prevent patients from receiving a large dose of CNS medications resulted in a determination of immediate jeopardy. The facility census was 186.

Based on interview and record review, the hospital failed to ensure a system was in place to monitor and prevent large doses of central nervous system (CNS) medications from being accessed from the automated medication dispensing system (AMDS) by overriding the warnings and prior approval from the pharmacist. This affected 27 (Patients #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11, #12, #13, #14, #15, #16, #17, #18, #19, #20, #21, #22, #23, #24, #25, #26 and #27) of 27 patient records reviewed. This deficient practice had the potential to affect all patients receiving services at the facility. The facility census was 186.

Findings include:

1. Review of a document titled "High Risk CNS Medications", last updated 12/14/18, stated the usual adult dose of Fentanyl was 25 to 100 mcg (micrograms); Dilaudid was one half to four mg (milligrams); and Versed, one half to four mg.

2. Review of the AMDS "override report", undated, provided by Pharmacist D on 01/18/19, revealed 24 of the 27 patients identified had medications dispensed from the AMDS machine with the override function being used.

3. Review of the "Palliative Ventilator Withdrawal-PowerPlan Medication Reference Document", updated 12/14/18, used by the pharmacy revealed the dosage ranges consist of Morphine five to ten mg intravenous (IV) push once, Dilaudid one half to two mg IV push every 15 minutes when needed for shortness of breath, and Versed two mg IV push once as soon as possible. Fentanyl was not listed on this document as a medication to use for palliative ventilator withdrawal.

4. Review of the facility policy titled "Physician Orders" revealed verbal or telephone orders are to be limited and restricted to:

a. emergent situations

b. When clinical situations make it impractical for orders to be entered into the Electronic Health Record (EHR) or written on the appropriate form for the non-EHR cites.

c. Situations when physicians do not have access to remote computer devices or the patient's chart.

5. Review of the facility palliative care policy/procedure, titled "Palliative Ventilator Withdrawal", dated 05/26/17, stated "palliative ventilatory withdrawal is the provision of comfort measures for a seriously ill patient for whom continuing mechanical ventilation has been determined to be clinically inappropriate or unwanted by the patient." Under "Implementation of Symptom Management Medication orders" it stated "symptom management medications will be ordered as medically indicated".

6. During interview on 01/16/19 at 4:10 P.M., Physician B stated there was no current "lock out" on the AMDS machine to prevent staff from continuing to override the system to obtain medications.

7. During interview on 01/17/19 at 3:15 P.M., Pharmacist A (chief pharmacy officer) was unable to offer any information explaining how staff had been able to override the AMDS system for a long period of time to obtain high doses of CNS medications with no pharmacy approval or intervention.

8. Review of the medical record for Patient #1 revealed the patient presented to the facility on 09/10/18 with increasing shortness of breath. Review of Physician A's progress note, dated 09/18/18 at 2:54 A.M., revealed Physician A was called to Patient #1's bedside by nursing staff for code status discussion. Patient #1 stated "I am done and don't want to suffer anymore". Physician A explained the options of aggressive treatment versus comfort measures. Patient #1 clearly stated that he did not want to suffer and wanted to be comfortable. On 09/18/18 at 4:04 A.M., Physician A gave a verbal order for Dilaudid four mg IV push, which was administered at 4:04 A.M. A second verbal order was received for Dilaudid six mg IV push, which was administered at 4:33 A.M. Physician A pronounced Patient #1 dead at 5:00 A.M.

9. Review of the medical record for Patient #2 revealed the patient presented to the facility with generalized weakness and confusion on 11/25/17. A physician note dated 12/11/17 at 2:48 A.M. revealed a "code blue" (cardiac/respiratory emergency) was called; Patient #2 was intubated at that time, placed on a ventilator and transferred to the intensive care unit (ICU). Review of Physician A's progress note, dated 12/11/17 at 4:17 A.M., revealed Patient #2 was readmitted to the ICU for cardiac arrest and was intubated during a code blue. Physician A documented the patient's family was updated at the bedside regarding events and decided to withdraw care. At 5:10 A.M., Physician A gave a verbal order for Fentanyl 1,000 mcg IV push. The order was verified by the pharmacist at 5:14 A.M. This medication was dispensed from the AMDS via override and administered at 5:45 A.M. Patient #2 was pronounced dead by Physician A at 6:03 A.M. There was no documentation in the medical record stating when Patient #2 was removed from the ventilator.

10. Review of the medical record for Patient #3 revealed the patient presented to the facility on 03/11/17 with altered mental status. Review of a physician progress note dated 03/11/17 at 1:02 P.M. revealed Patient #3 was intubated in the emergency room with agonal breathing. Physician A's progress note, dated 03/11/17 at 10:58 P.M., revealed a meeting was held at the bedside with the the patient's family and the family wished to withdraw care. Physician A entered an order for Fentanyl 400 mcg IV push for agitation on 03/11/17 at 10:13 P.M. The order was verified by the pharmacist at 10:18 P.M. The medication was dispensed from the AMDS and administered at 10:36 P.M. The physician stated all blood pressure medications were stopped, the patient was extubated and died at 10:50 P.M.

11. Review of the medical record for Patient #4 revealed the patient presented to the facility on 07/18/16 at 6:06 P.M. for cardiac arrest at a long term care facility and was intubated in the field. The nursing progress note dated 07/25/16 at 8:05 P.M. revealed Physician A spoke to the spouse of Patient #4 over the phone about changing the patient's code status to do not resuscitate. A physician progress note dated 07/25/16 at 10:11 P.M. revealed at 9:45 P.M., the patient's spouse made the decision to extubate the patient. At 9:46 A.M., Physician A gave a verbal order for Fentanyl 400 mcg IV push. The AMDS system was overridden and the Fentanyl was administered at 9:46 P.M. At 9:47 P.M., Patient #4 was extubated. At 9:50 P.M., medication to support blood pressure was stopped. Patient #4 was pronounced dead at 10:06 P.M.

12. Review of the medical record for Patient #5 revealed the patient presented to the facility on 02/10/15 for septic shock. Review of Physician A's progress note dated 02/11/15 at 2:32 A.M. revealed Physician A explained the grave situation to Patient #4's family members, and after considering all options, the patient's family decided on "palliative ventilator withdrawal". Physician A ordered Fentanyl 400 mcg IV push and Versed 4 mg IV push at 12:41 A.M. These orders were verified by a pharmacist at 12:42 A.M. The medications were dispensned from the AMDS via override and given at 1:05 A.M. Patient #4 was pronounced dead at 1:07 A.M.

13. Review of the medical record for Patient #6 revealed the patient presented to the facility on 04/22/15 for a seizure. A physician progress note dated 05/10/15 revealed the patient's family decided to withdraw care. On 05/10/15 at 11:23 P.M., Physician A ordered Fentanyl 1,000 mcg IV push. The AMDS system was overridden and the medication was dispensed at 11:24 P.M. The pharmacy verified the order at 11:24 P.M. stating the medication was compliant with standard treatment. The Fentanyl was administered at 11:32 PM. Medications to support blood pressure were stopped and the patient was extubated. Patient #6 was pronounced dead at 11:40 P.M.

14. Review of the medical record for Patient #7 revealed the patient presented to the facility on 04/30/15 for progressive weakness followed by a fall. A nursing progress note dated 05/04/15 stated that at 11:28 P.M., Patient #4's cardiac monitor showed asystole (absence of a heartbeat). At that time, Patient #4 was given Dilaudid 0.5 mg IV push for comfort. Patient #4 still had agonal breathing at which point Physician A ordered Fentanyl 500 mcg IV push. On 05/03/15 at 11:57 P.M. a telephone order for Fentanyl 500 mcg IV push was placed. The medication was dispensed via override and given at 11:57 P.M. The order was verified by a pharmacist at 11:59 P.M. The patient's family arrived at 12:05 A.M. Physician A ordered Fentanyl 400 mcg IV push due to agonal breathing. On 05/04/15 at 12:10 A.M., a telephone order for Fentanyl 400 mcg IV push was placed. The medication was dispensed via override and administered at 12:10 A.M. The order was verified by a pharmacist at 12:22 A.M. Patient #4 was pronounced dead by Physician A at 12:30 A.M.

15. Review of the medical record for Patient #8 revealed the patient presented to the facility on 02/28/15 with a change in mental status. The patient was diagnosed with a multi-embolic stroke with brain stem involvement. While in the emergency room, Patient #8 went into respiratory arrest and was intubated. Physician A's progress note dated 03/01/15 at 12:47 A.M. stated the family wished to pursue "palliative ventilator withdrawal". The patient had a physician order dated 03/01/15 at 12:11 A.M. for Fentanyl 800 mcg IV push. The AMDS system was overridden and the medication was administered at 12:11 A.M. The patient was extubated at 12:11 A.M. and Patient #8 was pronounced dead at 12:42 A.M. The pharmacy verified the order at 1:19 A.M.

16. Review of the medical record for Patient #9 revealed the patient presented to the facility on 09/30/17 for suspected chronic heart failure and had been intubated in the ICU that same day. On 10/09/17 at 8:24 P.M., a telephone order from Physician A was obtained for Fentanyl 1,000 mcg. A pharmacy note stated Physician A entered an order for 1,000 mcg of Fentanyl IV push for a morbidly obese patient that had been on high dose narcotic drips on whom care was being withdrawn. The pharmacist discussed with Physician A that Fentanyl was on shortage and recommended a dose of 500 mcg. The physician agreed. The nursing note stated the patient was taken off the ventilator on 10/09/17 at 9:00 P.M. with the patient's family at the bedside. Fentanyl 500 mcg was dispensed from the AMDS system via override and given at 9:03 P.M. Physician A's progress note documented Patient #9 died at 9:10 P.M.

17. Review of the medical record for Patient #10 revealed the patient presented to the facility on 10/02/17 due to a coughing spell that lead to finding of probable bronchogenic cancer. The discharge summary documented the patient had a liver biopsy done on 10/09/17. Shortly after the biopsy, the patient developed a small hematoma. In a few hours, the patient's blood pressure dropped and the patient went into cardiac arrest. Patient #10 was intubated and transferred to the ICU. On 01/09/17 at 10:22 P.M. a telephone order was placed for Fentanyl 500 mcg IV push and Versed four mg IV push. The nursing progress note documented the patient was removed from the ventilator at 11:20 P.M. Review of the medication administration record revealed both medications were dispensed from the AMDS via override and administered at 11:34 P.M. Review of the physician progress note revealed the patient died at 11:34 P.M.

18. Review of the medical record for Patient #11 revealed the patient presented to the facility on 10/06/17 due to acute brain swelling and respiratory failure. The patient required emergency intubation. On 10/11/17 at 4:01 A.M., a verbal order was obtained for Fentanyl 500 mcg IV push. At 4:02 A.M., the AMDS system was overridden and the Fentanyl was dispensed. On 10/11/17 at 4:05 A.M. Versed six mg was dispensed from the AMDS system via override. The physician didn't enter the order until 4:11 A.M. The medication administration record documented the Versed was administered at 4:11 A.M. and the Fentanyl was administered at 4:12 A.M. Patient #11 was extubated at 4:12 A.M. and was pronounced dead at 4:19 A.M.

19. Review of the medical record for Patient #12 revealed the patient presented to the facility on 11/12/18 due to sepsis. On 11/20/17 at 8:13 P.M., a physician n order for Fentanyl 500 mcg IV push was entered into the system. The order was verified by the pharmacy at 8:22 P.M. and dispensed from the AMDS system at 8:23 P.M. The medication administration record documented the medication was given at 8:28 P.M. The patient was extubated at 8:34 P.M. Patient #12 died at 10:40 P.M.

20. Review of the medical record for Patient #13 revealed the patient presented to the facility on 12/05/17 at 12:15 P.M. due to unresponsiveness related to having low blood pressure. In the emergency room, Patient #13 was intubated and placed on a ventilator. On 12/05/17 at 9:23 P.M., a physician order for Fentanyl 1,000 mcg IV push was entered and at 9:40 P.M., an order for Dilaudid 2 mg IV push was entered. At 9:40 P.M., a verbal order for Versed four mg IV push was entered. Fentanyl 1,000 mcg was dispensed from the AMDS with override at 9:27 P.M.; Dilaudid 2 mg was dispensed with override at 9:35 P.M.; and Versed was dispensed with override at 9:34 P.M. The medication administration record documented the Fentanyl was administered to the patient at 9:37 P.M. Patient #13 was extubated at 9:39 P.M. Dilaudid and Versed were administered at 9:40 P.M. Physician A's progress note revealed Patient #13 was pronounced dead at 9:41 P.M.

21. Review of the medical record for Patient #14 revealed the patient presented to the facility on 12/10/17 at 5:47 P.M. due to altered mental status related to a history of cancer. Physician A's progress note dated 12/10/17 at 8:52 P.M. stated that the decision to intubate was made to hyperventilate Patient #14 to compensate for extreme acid base imbalance of the blood. Physician A's progress note dated 12/10/17 at 11:11 P.M. stated the patient's grim prognosis was discussed with the family at the bedside and the family agreed to withdraw care. Review of the physician orders revealed telephone phone orders entered by nursing staff on 12/10/17 at 10:34 P.M. for Fentanyl 500 mcg and Versed four mg IC push. The medications were dispensed from the AMDS system with override at 10:12 P.M. The medication administration record documented the Fentanyl was administered at 10:36 P.M. and the Versed was administered at 10:36 P.M. Patient #14 was pronounced dead at 10:41 P.M. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

22. Review of the medical record for Patient #15 revealed the patient presented to the facility on 11/15/18 due to difficulty breathing. On 11/19/18, the patient was transferred to the ICU for further monitoring. On 11/20/18 at 8:11 P.M., the patient was intubated and placed on a ventilator. The nursing progress note dated 11/20/18 at 11:15 P.M. documented the patient's family requested "palliative ventilator withdrawal" at 11:48 P.M. Fentanyl 1,000 mcg was dispensed from the AMDS via override at 11:28 P.M. and 11:30 P.M. and Versed 10 mg had been dispensed via override at 11:29 P.M. Review of the physician orders revealed orders at 11:48 P.M. for Fentanyl 2,000 mcg IV push and Versed 10 mg. The medication administration record documented Fentanyl 2,000 mcg IV push was administered at 11:48 P.M. and Versed 10 mg IV push was administered at 11:49 P.M. Patient #15 was pronounced dead at 11:53 P.M. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

23. Review of the medical record for Patient #16 revealed the patient presented to the facility on 11/13/18 due to increased difficulty breathing. After a cardiac catheterization on 11/15/18, the patient developed an enlarging right groin blood clot. The patient was transferred to the ICU and intubated on 11/16/18 related to low blood oxygen levels. Review of the physician orders revealed on 11/19/18 at 12:54 A.M., Physician A ordered Fentanyl 1,000 mcg and Versed 10 mg IV push. The Fentanyl was dispensed from the AMDS at 12:55 A.M. and the Versed was dispensed at 12:56 P.M., both via override. The medication administration record documented both the Fentanyl and the Versed were administered at 1:26 A.M. Patient #16 was pronounced dead at 1:32 A.M. Physician A's progress note, dated 11/19/18 at 1:51 A.M., revealed the patient's family was called to the bedside to discuss the patient's condition and agreed to not resuscitate and provide comfort care. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

24. Review of the medical record for Patient #17 revealed the patient presented to the facility on 11/10/18 due to cardiac arrest. The patient was intubated with increasing seizure activity. Nursing progress notes stated Patient #17 was extubated on 11/13/18 at 4:42 P.M. On 11/13/18, Fentanyl 1000 mcg was dispensed from the AMDS at 10:39 P.M. and Versed 10 mg was dispensed at 10:40 P.M., both via override, prior to the physician order. On 11/13/18 at 10:57 P.M., Physician A ordered Fentanyl 1,000 mcg IV push and at 10:58 P.M., ordered Versed 10 mg IV push. The medication administration record documented the Fentanyl was administered at 10:57 P.M. and the Versed was administered at 10:58 P.M. Patient #17 was pronounced dead at 11:20 P.M. by Physician A.

25. Review of the medical record for Patient #18 revealed the patient presented to the facility on 05/24/18 due to septic shock. On 05/28/18, the patient was transferred to ICU, intubated and placed on a ventilator. On 05/28/18 at 10:59 P.M., Fentanyl 1,000 mcg and Versed six mg were dispensed from the AMDS via override, prior to the physician order. On 05/28/18 at 11:20 P.M., the physician ordered Fentanyl 1,000 mcg and Versed six mg IV push. The medication administration record revealed the Fentanyl 1,000 mcg and the Versed 6 mg were administered on 05/28/18 at 11:20 P.M. Patient #18 was pronounced dead by Physician A at 11:40 P.M. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

26. Review of the medical record for Patient #19 revealed the patient presented to the facility on 04/02/17 at 2:54 A.M. due to cardiac arrest. Patient #19 was intubated before arriving in the ICU. Fentanyl 2,000 mcg was dispensed from the AMDS via override; 20 vials were removed at 10:44 P.M., five vials removed at 11:02 PM, three vials were removed at 11:03 P.M. and four vials were removed at 11:05 P.M. Versed 2 mg was dispensed from the AMDS via override; five vials at 10:45 P.M. and five more vials at 11:02 P.M. Dilaudid 10 mg dosages were dispensed from the AMDS via override, one at 10:45 P.M. and one at 11:02 P.M. Review of the physician orders revealed two orders for Fentanyl 1,000 mcg IV push, one at 10:53 P.M. and one at 11:15 P.M.; Dilaudid 10 mg IV push were ordered, one at 10:53 P.M. and one at 11:15 P.M.; and two orders for Versed 10 mg IV push, one at 10:53 P.M. and 11:15 P.M. The medication administration record documented Fentanyl was administered at 10:57 P.M. and 11:16 P.M.; Dilaudid was administered at 10:57 P.M. and 11:16 P.M.; and Versed 10 mg IV push was administered at 10:57 P.M. and 11:16 P.M. Patient #19 was pronounced dead by Physician A at 11:30 P.M. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

27. Review of the medical record for Patient #20 revealed the patient presented to the facility on 10/22/18 due to altered mental status related to drug abuse. Patient #20 was intubated before arriving in the ICU. Review of Physician A's progress note revealed overnight Patient #20 remained on maximal doses of medication to sustain blood pressure. The family was updated at the bedside and decided to withdraw treatment. Fentanyl 800 mcg was dispensed from the AMDS at 2:34 A.M. and 200 mcg was dispensed at 2:35 A.M. override; Versed 10 mg was dispensed at 2:33 A.M. and 2:52 A.M. via override; and Dilaudid 10 mg was dispensed at 2:54 A.M. via override, prior to the physician order. Review of the physician orders revealed Fentanyl 1,000 mcg IV push was ordered on 10/24/18 at 3:00 A.M., Dilaudid 10 mg IV push was ordered at 3:05 A.M. and two doses of Versed 10 mg IV push was ordered at 3:00 A.M. and 3:23 A.M. The medication administration record revealed Fentanyl and one dose of Versed were administered at 3:00 A.M.; Dilaudid at 3:05 A.M.; and the second dose of Versed was administered at 3:05 A.M. Patient #20 was pronounced dead at 3:13 A.M. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

28. Review of the medical record for Patient #21 revealed the patient presented to the facility on 09/30/18 at 9:04 P.M. due to a collapsed lung. The patient was intubated and chest tubes were placed in the emergency room. On 09/30/18 at 11:10 P.M., the physician ordered Fentanyl 600 mcg IV push and Versed six mg IV push. Both these dosages of medications were dispensed from the AMDS with override at 11:12 P.M. The medication administration record documented both medications were administered at 11:22 P.M.. The patient was extubated and taken off the ventilator at at 11:30 P.M. Patient #21 was pronounced dead at 11:53 A.M.

29. Review of the medical record for Patient #22 revealed the patient presented to the facility on 09/17/18 due to abdominal pain and fevers. The patient suffered a cardiac arrest on 09/25/18, was intubated and put on a ventilator. Review of the physician orders revealed Fentanyl 500 mcg IV push and Versed six mg IV push was ordered on 09/25/18 at 8:00 P.M. Both dosages of these medications were dispensed by the AMDS system via override at 8:02 P.M. The medication administration record documented both medications were administered at 8:25 P.M. Patient #22 was pronounced dead at 9:25 P.M. by Physician A. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

30. Review of the medical record for Patient #23 revealed the patient presented to the facility on 07/15/18 time due to cardiac arrest. The patient was intubated before arriving in the ICU. Review of the physician orders revealed Fentanyl 1,000 mcg IV push was ordered on 07/15/18 at 1:25 A.M. Fentanyl was dispensed from the AMDS system via override at 1:17 A.M. The medication administration record revealed the medication was administered at 1:25 A.M. Patient #23 was pronounced dead at 1:28 A.M. by Physician A. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

31. Review of the medical record for Patient #24 revealed the patient presented to the facility on 04/01/18 at 8:20 P.M. due to cardiopulmonary arrest. The patient was intubated before arriving in the ICU. The Versed was dispensed from the AMDS system at 9:29 P.M. and the Fentanyl was dispensed at 9:30 P.M. both via override, prior to the physician order. Review of the physician orders revealed Fentanyl 800 mcg IV push was ordered on 04/01/18 at 9:35 P.M. and Versed six mg IV push was ordered at 9:36 P.M. The medication administration record revealed Fentanyl was administered at 9:35 P.M. and Versed was administered at 9:36 P.M. Patient #24 was pronounced dead at 9:41 P.M. by Physician A. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

32. Review of the medical record for Patient #25 revealed the patient presented to the facility on 03/23/18 due to cardiac arrest. Patient #25 was intubated before arriving at the facility. On 03/25/18, the physician ordered Fentanyl 500 mcg IV push at 9:20 P.M. and Versed six mg IV push at 9:21 P.M. Versed was dispensed from the AMDS at 9:23 P.M. and Fentanyl was dispensed at 9::25 P.M. via override and after pharmacy review. The medication administration record documented the Versed was administered at 9:29 P.M. and the Fentanyl was administered at 9:30 P.M. Patient #25 was extubated and pronounced dead at 9:45 P.M. by Physician A.

33. Review of the medical record for Patient #26 revealed the patient presented to the facility on 01/11/18 due to increased liver enzymes. On 01/14/18 at 7:00 A.M., the patient arrested and was intubated. On 01/14/18 at 9:30 P.M., the physician ordered Versed six mg IV push and at 9:31 P.M., Fentanyl 1,000 mcg was ordered IV push. Fentanyl was dispensed from the AMDS at 9:33 P.M. and the Versed was dispensed at 9:34 P.M., both via override. The medication administration record revealed the medications were administered at 9:51 P.M. Patient #26 was pronounced dead at 10:05 P.M. by Physician A. There was no documentation in the medical record stating when the patient was extubated and taken off the ventilator.

34. Review of the medical record for Patient #27 revealed the patient presented to the facility on 01/13/18 at 5:52 P. M due to a brain bleed. Patient #27 was intubated in the emergency room before being transferred to ICU. Fentanyl was dispensed from the AMDS on 01/13/18 at 11:47 P.M. with override. The physician ordered Fentanyl 1,000 mcg IV push on 01/14/18 at 12:02 A.M. The medication administration record documented the medication was administered on 01/14/18 at 12:02 A.M. Patient #27 was extubated at 12:03 A.M. Physician A pronounced Patient #27 dead at 12:19 AM.

During interview on 01/18/19 between 10:00 A.M. and 2:00 P.M., all findings were confirmed by Nurse G, H, and M.