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5301 S CONGRESS AVE

ATLANTIS, FL 33462

MEDICAL STAFF - ACCOUNTABILITY

Tag No.: A0049

Based on document review and staff and physician interviews, the facility failed to ensure the medical staff evaluated the quality of services provided by the physician for 1 of 3 sampled patients (#1).

The findings included:

1. Review of the record revealed Patient #1 presented to this facility for elective Decompressive Laminectomy with Facet Fixation. The patient tolerated the procedure without any intra-operative complications. On post operative day 1, the patient requested an increased dose of Dilaudid. The pain management physician, who was managing this patient's pain, ordered 4 milligrams of Dilaudid intravenously. This was administered by the nurse intravenously. The patient subsequently, approximately 10 minutes later, developed bradycardia and respiratory depression and a Rapid Response was called. Upon responding to the code and entering the room, the Intensive Care Unit physician (resident), found the patient with evidence of peripheral cyanosis and staff was observed giving rescue breaths. The patient was on a telemetry cardiac monitor with a sinus bradycardia rate of 35, and had a weak pulse. A code blue (full code) was called. The patient was intubated and transferred to Cardiovascular Intensive Care Unit for further care.

2. During an interview with the Director of Pharmacy, on 01/15/19 at 2:25 PM, he stated in 2018, they implemented the criteria from Best Practice Dilaudid Administration. This criteria includes an electronic pop up alert to the provider, when the provider orders >2 milligrams of Dilaudid Intravenous. The pop up alert states, "Dilaudid 2 milligrams intravenous is equivalent to Morphine 14 milligrams Intravenous. Doses 2 milligrams or more should be reserved for patients who are opioid tolerant or have had treatment failure at lower doses and require dose titration."

Review of the physician's electronic response for patient #1 was, "Patient is opioid tolerant. Patient failed lower doses and the Dilaudid Intravenous dose is being titrated." The answer to the question to Specify Other Indications was not completed.

The Director of Pharmacy stated an extreme tolerance example of opioid tolerance is a patient that was given 7000 milligrams a day of Morphine. In contrast, an opioid naïve patient would be given .5 milligrams of Dilaudid and/or 5 milligrams of Morphine. He stated that his clinical pharmacist reported to him, the nurse practitioner called him to alert him that she did not want a substitution of Dilaudid from Intravenous to oral. She stated the patient required a high dose of 4 milligrams. He questioned if she was sure that she wanted 4 milligrams. The nurse practitioner said, "Yes, I want 4 milligrams."

The Director of Pharmacy stated he was not sure if the patient was really opioid tolerant or naïve.

3. During an interview with the neurosurgeon, on 01/15/19 at 4:45 PM, he stated Patient #1 contacted him to perform his surgery. He stated the patient and he had an issue and difference in philosophy regarding pain control and he would not agree to order Dilaudid. He told the patient that he would order Morphine for pain, instead of Dilaudid. The patient then initiated contact with a pain management physician to manage his pain medications while he was in the hospital.

4. During an interview with the Pain Management Physician, on 01/15/19 at 4:06 PM, he stated Patient #1, who is a colleague, contacted him 2 days prior to his surgery. The patient asked this physician to manage his medications while in the hospital. He told the Pain Management physician that he was extremely opioid tolerant, specifically Dilaudid. The physician stated that he and the patient had agreed upon a pain management plan that included Dilaudid. He stated the patient called him the day after his surgery and wanted 10 milligrams of Dilaudid in addition to the Dilaudid he was receiving via Patient Controlled Analgesia (PCA); but he would only order 4 milligrams. He stated, "It seems to me the patient lied to me about being opioid tolerant." He did not confirm or verify whether the patient was opioid naïve or tolerant prior to agreeing to manage the patient's pain medications.

5. Review of the medical record for medical clearance failed to reveal evidence the patient was opioid tolerant.

6. Interview with the Director of Patient Safety, on 01/16/19 at 11:30 AM, she stated the facility monitors reactions to Adverse Drug Reactions, Narcan usage and reports this information to the medication safety committee for tracking and trending and development of new initiatives. The new initiatives were not currently in effect but will be introduced in 2019.

7. Interview with the Director of Patient Safety - she stated Risk Management investigated the nurse who administered the medication but did not send this incident report to Peer Review for review of the physician's services. She stated the incident report was referred by Risk Management to Peer Review, Vice President of Quality, and Chief Nursing Officer for review and follow up. She stated, despite the request to send this case to peer review, the Vice President of Quality reviewed the incident report, reviewed the code blue, and noted post operatively it did not meet criteria for peer review. Therefore, the incident was not sent for peer review for follow up .

8 The Chief Medical Officer, on 01/17/19 at 10:50 AM, stated he was not available to be interviewed.

9. Interview with the Vice President of Quality, on 01/17/19 at 1:45 PM, she agreed the physician failed to verify or confirm the patient was opioid tolerant and the case was not sent for peer review.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on document review, staff interviews, and policy and procedure review, the facility failed to ensure the nurse monitored the patient's respirations while administering 4 milligrams of Dilaudid intravenously, when there is a high risk of respiratory depression in 1 of 3 sampled patients (#1).

The findings included:

1. Review of the record revealed Patient #1 presented to this facility for elective Decompressive Laminectomy with Facet Fixation. The patient tolerated the procedure without any intra-operative complications. On postoperative day 1, the patient requested an increased dose of Dilaudid.

2. Review of the nurse's documentation on 05/10/2019 revealed, "family and patient requesting more pain meds and asked if the Patient Controlled Analgesia (PCA) dose could be raised to 6 milligrams an hour and other meds". The physician and nurse practitioner visited the patient in his room and placed orders for 4 milligrams Dilaudid Intravenous push stat and to increase the dose on the Patient Controlled Analgesia Dilaudid pump. The patient was given 4 milligrams intravenously of Hydromorphone/Dilaudid at the bedside at 3:47 PM. The patient became unresponsive shortly after and a rapid response was called. The doses on the Patient Controlled Analgesia pump were not increased. Cardiopulmonary Resuscitation was performed in the patient's room by the hospital code team.

3. Review of record failed to reveal the patient's respirations were monitored prior to, during, or after the 4 milligrams of Dilaudid were administered intravenously. Review of the Rapid Response Team Record revealed the nurse who administered the Dilaudid documented the patient became unresponsive 10 minutes after 4 milligrams of Dilaudid was given intravenously. The rapid response was called at 4:00 PM. The assessment at 4:00 PM revealed the blood sugar 124, blood pressure 90/50, and heart rate 35. The assessment at 4:00 PM failed to reveal the respirations or the reading on the Pulse Oximeter.

4. Review of the Medication Discharge Summary revealed the 4 milligrams of Dilaudid was given into the patient's left Jugular line at 3:47 PM.

5. An interview was requested with the nurse who administered the Dilaudid. The legal counsel for the nurse who administered the Dilaudid to patient #1, advised the nurse to decline an interview. In lieu of an interview, they provided the nurse's written statement.

Review of the nurse's statement revealed the nurse recalls some discussion regarding the dose of Dilaudid that was ordered by pain management and she deferred to the pain management physician for the appropriate dosing. She and the other staff felt comfortable with what was ordered, as a pain management physician ordered it, and the pharmacist and nurse practitioner discussed the dose and it was noted that the patient was opioid tolerant. The nurse stayed at the patient's bedside for an ample amount of time after giving the patient the Dilaudid and only left the patient's room when she was comfortable with the patient's condition and vital signs. The patient was bradycardic and unresponsive when found by the nurse approximately ten minutes later. A rapid response was initially called overhead at 4:00 PM, pulseless electrical activity was recognized shortly thereafter on cardiac monitoring despite Epinephrine, Atropine and Narcan administration, as well as chest compressions. A code blue was announced at approximately 4:10 PM.

6. During an interview with the Vice President of Quality, on 01/16/19 at 11:02 AM, she stated an event report was not generated until eight days post occurrence, by the Director of the Neuro Telemetry Unit.

7. During an interview with the Director of Patient Safety, on 01/16/19 at 11:30 AM, she stated the occurrence was referred by Risk Management to Peer Review, Vice President of Quality, and Chief Nursing Officer for review and follow up. The Vice President of Quality reviewed the incident report, reviewed the code blue, and noted post operatively it did not meet criteria for peer review. Therefore, the incident was not sent for peer review.

She stated they investigated the order and determined there was a valid order, the nurse administered it as ordered, and had appropriate responses to the patient's condition. She confirmed the nurse failed to monitor and document the patient's respirations while administering the 4 milligrams of Dilaudid and immediately following the administration. She stated there was no further investigation.


8. During an interview with the Vice President of Quality, on 01/17/19 at 1:40 PM, she agreed that Risk Management reviewed the actions of the nurse but failed to have the physician's actions reviewed by the medical staff. She agreed the nurse failed to follow the standard of care and monitor/document the patient's respirations while administering 4 milligrams of Dilaudid intravenously, when there is a high risk of respiratory depression.