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Based on interview with the Emergency Department Medical Staff, Chair of the Hospital's Significant Event Assessment Team (SEAT), the attending ED physician, review of SEAT meeting minutes for March 9, 2010 and July 27, 2010, review of the patient's medical record, review of physician peer review for this event, review of the hospital's consulting Pharmacy report to the SEAT, hospital policy: Adverse Clinical Event Reporting, Patient Care Directive (PCD), hospital policy: Significant Event Review Process Interdepartmental Directives and the Medical Examiners report, on September 8-10 and September 13-15, 2010, the governing body failed to be responsible for the conduct of effective and safe hospital operations.

Findings include:

1. The hospital medical staff failed to be responsible for the quality of medical care provided to patients (for further information see Tag A0338).
2. The hospital failed to meet the Emergency Needs of patients in accordance with the acceptable standards of practice (for further information see Tag A1100).
3. The hospital failed to implement and maintain an effective ongoing quality assessment and performance improvement program (for further information see Tag A0263).
4. The hospital failed to have an effective discharge planning process which ensured the health and safety of all patients (for further information see Tag A0799).
5. The hospital failed to take action following concerns raised in a pharmacy report (for further information see Tag A0508).
6. The hospital failed to maintain an accurately written medical record for each patient (for further information see Tag A0438).

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on interview with the Emergency Department Medical Staff, Chair of the Significant Event Assessment Team (SEAT), the attending ED physician, review of SEAT meeting minutes for March 9, 2010 and July 27, 2010, review of the patient's medical record, review of physician peer review for this event, review of the consulting Pharmacy report to the SEAT, hospital policy: Adverse Clinical Event Reporting, Patient Care Directive (PCD), hospital policy: Significant Event Review Process Interdepartmental Directives and the Medical Examiners report, on September 8-10 and September 13-15, 2010, the hospital failed to implement and maintain an effective ongoing quality assessment and performance improvement program that focuses on indicators related to the prevention and reduction of medical errors.

Findings include:

1. A review of the patient's medical record indicated that the patient had surgery performed on February 25, 2010 for removal of a deep implant from patient ' s right tibia. The patient stayed in the hospital overnight due to difficulty with pain control. The patient was discharged in the early afternoon on February 26, 2010.

2. The patient ' s medical record continued that later on February 26, 2010, the patient returned to the hospital and was seen in the Emergency Department (ED) with uncontrolled post-operative pain and was discharged on February 26, 2010 at approximately 2256.

3. The Medical Examiner's report stated that the patient was found dead at the Rehabilitation Center on February 27, 2010 at 1043 AM. An autopsy was performed by the Medical Examiner on February 28, 2010. The Medical Examiner's Final Report was released on September 9, 2010 and indicated the following:

i. Cause of Death: " Combined Opioid (Fentanyl, Oxycodone, and Tramadol) Toxicity "
ii. Manner of death: " Accident " " *Note: The Fentanyl is significantly elevated above therapeutic range. Although the other two opioid medications (Oxycodone and Tramadol) are within therapeutic range, their effects in combination with the Fentanyl cannot be excluded. "
iii. How Injury Occurred: "Combined effects of prescribed/administered opioid drugs."

4. Review of the Hospital ' s " Adverse Clinical Event Reporting, Patient Care Directive (PCD) " specifies that a " Significant Event " as " events include any adverse clinical event that has or could have had significant patient safety consequences. .... "

5. In addition, review of the Hospital ' s Significant Event Review Process Interdepartmental Directives specifies: ... " significant events as described and defined ....will be reviewed by the SEAT. "

6. An e-mail dated March 10, 2010 from the Risk Manager indicated that this event was reviewed by the SEAT.

7. It was documented that the hospital's SEAT met on March 9, 2010. Minutes indicated that the case was discussed and the following recommendations for action were made:
? Medical director of the rehabilitation center will forward a list of medications taken by the patient at the Rehabilitation Center
? The Director of Pharmacy will review the list of medications for drug dosing and possible drug interactions.
? A peer review to be completed for the Orthopedics and Emergency departments

8. Subsequent SEAT minutes dated July 27, 2010 documented that the patient's Rehabilitation Center medication list was completed and forwarded to the Pharmacy Director for review of dosing and possible interactions on March 10, 2010.

9. Review of the SEAT meeting minutes for July 27, 2010 also indicated that the Orthopedic and ED peer reviews were completed by March 25, 2010.

10. In addition, there was an e-mail forwarded from the Hospital Risk Manager to the SEAT Chair from the Rehabilitation Center Director on March 10, 2010 specifying the resumption of home medications and statements from staff regarding the patient ' s condition upon return on February 26, 2010 from the ED. There were also staff concerns stated regarding " the high Fentanyl dose since this patient had been drug free prior to surgery for 6 months. "

11. An E-mail documentation trail also indicates that the completed Pharmacy event related report was forwarded to the Risk Manager on March 17, 2010, and then forwarded to the SEAT Chair also on March 17, 2010. The report stated " There are multiple medications given to [the patient] that could have led to excessive sedation Trazodone, melatonin, Fentanyl. [The patient] received substantial doses of Fentanyl while in the ED. Fentanyl patches have a peak onset of action 8-12 hours after application. This would have occurred while the patient was asleep. [The patient] would have no way of perceiving over-sedation while asleep. Fentanyl patches are intended for the management of chronic pain not acute management. It is also reported that [the patient] received Percocet, Tramadol, Trazodone and melatonin when [the patient] arrived back at the Derek House. All these medication cause sedation! The combination of these medications could have led to excessive sedation with respiratory depression. "

12. There was no documentation or interview to substantiate that the reports submitted by the Medical Director of the Rehabilitation Center or the Pharmacy were reviewed by the SEAT. Although the minutes of the July 27, 2010 SEAT meeting minutes stated that the peer review indicated " Care Appropriate " , the information from the Clinical Pharmacist and the Medical Director of the Rehabilitation Center were only noted as " Completed " .

13. There was no documentation that action was taken through September 8, 2010 on the concerns raised in the Pharmacy event related report. The SEAT meeting minutes for July 27, 2010 noted that this case was still listed as pending the Medical Examiners report.

14. The Chair of the SEAT was asked about the opinion expressed in the hospital ' s Clinical Pharmacist event related report [presented to the Chair prior to the July meeting of the SEAT]. The Chair stated that the pharmacist was not a physician, and the amount of Fentanyl administered in the ED was appropriate. He continued: " I do not agree with the Pharmacist comments, they are not relative or accurate. " When asked about the other medications found in the toxicology report and the medications administered by the rehabilitation center staff, the Chair of the SEAT said that the hospital was not responsible for the actions of the Rehabilitation Center.

15. In addition to the peer review, the ED Medical Director was interviewed on September 9, and 10, 2010 and indicated that the case was discussed and reviewed at an ED medical staff meeting. He/She stated that it was in his/her opinion that the care was appropriate, and that view was shared by the other ED physicians. He/She further stated that the Fentanyl prescribed and administered in the ED was appropriate.


16. Despite that this unanticipated death was referred to the SEAT for review, that an e-mail from the Medical Director of the Rehabilitation Center documented staff concerns, that the hospital's Pharmacy event related report listed multiple concerns, and that the final Medical Examiner's cause of death specified " Combined Opioid Toxicity (Fentanyl, Oxycodone, and Tramadol) " , the SEAT Chair in an interview on September 14, 2010 stated that he still could not identify any system issues: " You must be thinking there are system issues; I am having a hard time coming up with any " .

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on interview with the Emergency Department Medical Staff, Chair of the Hospital's Significant Event Assessment Team (SEAT), the attending ED physician, review of SEAT meeting minutes for March 9, 2010 and July 27, 2010, the hospital ' s Medical Staff Bylaws, review of the patient medical record, review of physician peer review for this event, review of the consulting Pharmacy report to the SEAT and the Medical Examiners report , on September 8-10 and September 13-15, 2010, it was determined that the hospital failed to have a medical staff that is responsible for the quality of medical care provided to patients by the hospital.

Findings Include:

1. A review of the patient's medical record revealed that the patient had surgery performed on February 25, 2010 for removal of a deep implant from the patient ' s right tibia. The patient stayed in the hospital overnight due to difficulty with pain control. The patient was discharged at approximately 1330 on February 26, 2010.

2. The medical record stated that later on February 26, 2010 the patient returned to the hospital Emergency Department (ED) for uncontrolled post-operative pain at 1848 and was discharged on February 26, 2010 at approximately 2256.

3. The medical record stated that multiple narcotics were administered during the patient stay on February 25-26, 2010. Review of the patient record indicated the following medications were administered on February 26, 2010 prior to the 1330 in-patient discharge: 5 doses of IV Morphine 2mg, 2 doses of IV Toradol 30mg, 2 doses of PO Percocet 5/325, one dose PO Prozac 80mg and 1 dose of PO Vistaril 25 mg.

4. In addition, review of the ED attending physician ' s " Emergency Department Record " indicated that the physician was aware of medications taken by the patient on February 26, 2010 at the rehabilitation center, after hospital in-patient discharge and prior to ED presentation. Medications taken by the patient at the Rehabilitation Center were: " 1 Percocet, 1 Naprosyn and 1 Tramadol " .

5. Despite the amount of narcotics administered to this patient during her in-patient hospitalization on February 25-26, 2010 and medications taken upon returning to the Rehabilitation Center, the attending physician Emergency Department Record stated " I did consult pharmacy to find out what pain medications (the patient) has had in the hospital and it seems there were very few narcotics " .

6. The patient ' s ED medical record indicated that while in the ED, the patient received a total of 250 mcg of Fentanyl intravenous (IV) for acute post operative pain. At the time of discharge, 2238, the patient ' s pain level was documented by nursing to be 6 out of 10 on the Pain Scale.

7. In addition to the 250 mcg of IV Fentanyl, the attending ED physician ordered and staff administered to the patient at 2115 and 2117 two (2)- 50 mcg Fentanyl transdermal system patches.

8. Review of the patient's ED medication discharge instructions indicated that the ED physician personalized the patient's discharge medication instructions. This was confirmed during an interview with the ED attending physician on September 10, 2010. The discharge instructions for the Emergency Room visit on February 26, 2010 specified the following:

? " Take naproxen Every 12 hours. This is not an as needed medication "
? " You have two Fentanyl 50 mcg patches on. These should last for 3 days. You may continue to take Percocet for breakthrough pain but the patches should decrease your need for the Percocet. If you get too sedated you may remove one or both of the patches. If these do not control your pain, call the center for family medicine. They are on call 24/7 and can help with further pain management. If you are still needing pain control on Monday, they may need to prescribe patches to start Monday night when the ones you have are done. "

9. There was no documentation in the patient ' s medical record to restrict use of any home medications. In fact, the patient's discharge instructions for the Emergency Room visit on February 26, 2010 specified the following: " You should continue your home medications, unless otherwise instructed by the Emergency Department Clinician, that examined you today. "

10. Documentation submitted to the Hospital Risk Manager from the Rehabilitation Center ' s Medical Director on March 10, 2010 stated that upon the patient ' s return to the Rehabilitation Center at 2345 on February 26, 2010, the Staff at the Rehabilitation Center carried out the ED discharge instructions, which stated to take home medications [in addition to the Percocet and Fentanyl]. The Staff administered the patient ' s routine home medications including: 1 tab Percocet, 50mg Tramadol, 100mg Trazodone and 2 tabs Melatonin 3mg.

11. The Medical Examiners report stated that the patient was found dead at the Rehabilitation Center on February 27, 2010 at 1043 AM. An autopsy was performed by the Medical Examiner on February 28, 2010. The Medical Examiner's Final Report was released on September 9, 2010 and indicated the following:

? Cause of Death: " Combined Opioid (Fentanyl, Oxycodone, and Tramadol) Toxicity "
? Manner of death: " Accident " " *Note: The Fentanyl is significantly elevated above therapeutic range. Although the other two opioid medications (Oxycodone and Tramadol) are within therapeutic range, their effects in combination with the Fentanyl cannot be excluded. "
? How Injury Occurred: "Combined effects of prescribed/administered opioid drugs."

12. A review of the hospital ' s SEAT minutes for March 5, 2010 indicated a request for the Medical Director of the Rehabilitation Center to forward a list of medications taken by the patient at the Rehabilitation Center, a request for the Director of Pharmacy to review the list of medications for drug dosing and possible drug interactions and a request for peer review to be completed for the Orthopedics and Emergency departments for this event.

13. During interviews on September 9-10, 2010 with the ED Medical Director, who performed the peer review, the Director stated that it was his/her opinion that the patient probably took additional un-prescribed narcotics. At the time of these interviews, the ED Medical Director knew the results of the Medical Examiner ' s opinion and the post-mortem toxicology results. The ED Medical Director expressed the opinion that these findings were a result of the patient taking un-prescribed Fentanyl, obtained illicitly which resulted in the patient ' s death. He/she also stated that the other medications found in the toxicology were evidence that the patient had
been taking medications but had not informed the ED staff. The ED Medical Director was not aware that these medications were listed in the patient ' s medical record. He/she stated that patients had to take personal responsibility for their actions and it could not be the responsibility of the ED to control the actions of patients when they are discharged.

14. During an interview on September 14, 2010, the Chair of the SEAT was asked about the opinion expressed in the hospital ' s Clinical Pharmacist event report, completed and presented to the Chair prior to the July meeting of the SEAT. The Chair stated that the pharmacist was not a physician, and the amount of Fentanyl administered in the ED was appropriate. He continued: " I do not agree with the Pharmacist comments, they are not relative or accurate" (see Tag A508 for further information).

15. In spite of the hospital ' s discharge instructions which directed the patient to " continue your home medications " the Chair of the SEAT on September 14, 2010 stated that the hospital was not responsible for the actions of the Rehabilitation Center including the administration of medications.

16. In addition, during the interview conducted with the Chair of the SEAT on September 14, 2010, he/she acknowledged that he/she had reviewed the Medical Examiner ' s report, and other pertinent findings. The SEAT Chair said that the purpose of the committee is to identify system issues, not peer review. He/she said that it was in his/her opinion that the peer review had been adequate, and that the committee did not identify any system issues. He/she further stated that despite the Medical Examiner ' s report he/she still could not identify any system issues. He/she stated: " You must be thinking there are system issues; I am having a hard time coming up with any " .


The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.

Based on interviews with the Medical Director of the Emergency Department and the attending ED physician, and review of the patient ' s clinical record on September 8-10 and September 13-15, 2010, it was determined that the hospital failed to maintain an accurately written medical record for each in-patient.

Findings include:

1. The patient ' s " Emergency Service Standard Order Sheet " on February 26, 2010 revealed a hand written ED physician order for Fentanyl 50mg IV had hand drawn lines through the order with no error statement or initials.

2. All medication orders in the Emergency Service Standard Order Sheet for the patient on February 26, 2010 failed to include date and time. Additionally one order for " Fentanyl 50mcg prn pain x2 " failed to include route of administration.

3. Documentation in the patient ' s medical record for February 25-26, 2010 in-patient and ED visits demonstrated inconsistent information regarding the patient ' s surgical site.
? The " Eastern Maine Surgical Office Visit " dated January 27, 2010 (Note: this document was included in the patient ' s chart for the February 25-26, 2010 visit.) stated " We will plan on hardware removal from the right leg ... " .
? The " Orthopedic Operative Report " dated February 25, 2010 stated: " Removal of deep implant from left tibia .... " . Additionally, this report states " this patient is status post a right tibial fracture compartment syndrome ... " .
? The February 26, 2010 In-patient " Discharge Orders/Summary " listed the " Procedures " as " Left tibia hardware removal " .
? The " Eastern Maine Surgical Office Visit " dated February 26, 2010, stated " Status post a left tibial nail removal. [he/she] is in the Emergency Department at this time .... " .
? Finally, the " Emergency Department Record " dated February 26, 2010 stated " On February 25 of this year, [he/she] had the hardware in [his/her] right knee removed. "
? The Medical Examiners report stated: " there is a suture stapled vertical surgical incision of the anterior right knee. "

Based on interviews with the Medical Director of the Emergency Department and the attending ED physician, review of the patient ' s medical record and the Pharmacist event related report on September 8-10 and September 13-15, 2010, it was determined that the hospital failed to take action following concerns raised in a Pharmacy report.

Findings include:

1. A review of the patient medical record revealed that the patient had surgery performed on February 25, 2010 for removal of a deep implant from patient ' s right tibia. The patient stayed in the hospital overnight due to difficulty with pain control. The patient was discharged in the early afternoon on February 26, 2010. The patient was seen in the Emergency Department (ED) on February 26, 2010 for uncontrolled post-operative pain and was discharged on February 26, 2010 at approximately 2256. (for further information see Tag A1100.)

2. A hospital Pharmacist, when requested by the Hospital's Significant Event Assessment Team (SEAT), reviewed the dosing and possible interactions of medications administered to the patient. The event related report completed on March 17, 2010 stated " There are multiple medications given to [the patient] that could have led to excessive sedation Trazodone, melatonin, Fentanyl. [The patient] received substantial doses of Fentanyl while in the ED. Fentanyl patches have a peak onset of action 8-12 hours after application. This would have occurred while the patient was asleep. [The patient] would have no way of perceiving over-sedation while asleep. Fentanyl patches are intended for the management of chronic pain not acute management. It is also reported that [the patient] received Percocet, Tramadol, Trazodone and melatonin when [the patient] arrived back at the Derek House. All these medication cause sedation! The combination of these medications could have led to excessive sedation with respiratory depression. "

3. There was no documentation or interview to substantiate that the report submitted by the Pharmacy was reviewed by the SEAT. The SEAT minutes of July 27, 2010 stated the Clinical Pharmacist report was only noted as " Completed " .

4. There was no documentation that action was taken through September 8, 2010 on the concerns raised in the Pharmacy's event related report. The SEAT meeting minutes for July 27, 2010 note that this case was still listed as pending the Medical Examiners report.

5. The Chair of the SEAT was asked about the opinion expressed in the hospital ' s Clinical Pharmacist report presented to the Chair prior to the July meeting of the SEAT. The Chair stated that the pharmacist was not a physician, and the amount of Fentanyl administered in the ED was appropriate. He continued: " I do not agree with the Pharmacist comments, they are not relative or accurate. "

6. Despite that this unanticipated death was referred to the SEAT for review, the Pharmacy event related report listed multiple concerns, and the final Medical Examiners cause of death specified " Combined Opioid Toxicity (Fentanyl, Oxycodone, and Tramadol) " , the SEAT Chair in an interview on September 14, 2010 stated that he still could not identify any system issues. He stated: " You must be thinking there are system issues; I am having a hard time coming up with any " .

Based on interviews with the Medical Director of the Emergency Department and the attending ED physician, review of the patient ' s medical record on September 8-10 and September 13-15, 2010, and review of the Food and Drug Administration (FDA) for Duragesic (Fentanyl Transdermal System), it was determined that the hospital failed to meet the Emergency needs of patients in accordance with acceptable standards of practice.

Findings include:

1. A review of the patient medical record revealed that the patient had surgery performed on February 25, 2010 for removal of a deep implant from patient ' s right tibia. The patient stayed in the hospital overnight due to difficulty with pain control. The patient was discharged in the early afternoon on February 26, 2010. The patient was seen in the Emergency Department (ED) on February 26, 2010 for uncontrolled post-operative pain and was discharged on February 26, 2010 at approximately 2256.

2. The medical record stated that multiple narcotics were administered during the patient stay on February 25-26, 2010. Review of the patient record indicated the following medications were administered on February 26, 2010 prior to the 1330 in-patient discharge: 5 doses of IV Morphine 2mg, 2 doses of IV Toradol 30mg, 2 doses of PO Percocet 5/325, one dose PO Prozac 80mg and 1 dose of PO Vistaril 25 mg.

3. Despite the amount of narcotics administered to this patient during the patient in-patient hospitalization on February 25-26, 2010 and medications taken upon returning to the Rehabilitation Center, the attending physician Emergency Department Record stated " I did consult pharmacy to find out what pain medications (the patient) has had in the hospital and it seems there were very few narcotics " .

4. The patient ' s ED medical record indicated that while in the ED the patient received a total of 250 mcg of Fentanyl intravenous (IV) for acute post operative pain. At time of discharge the patient ' s pain level was documented by nursing to be 6 out of 10 on the Pain Scale at 2238.

5. The patient ' s ED medical record also indicated that while in the ED the patient also received a total of 100 mcg of transdermal Fentanyl. The attending ED physician ordered and staff administered a 50 mcg transdermal Fentanyl patch at 2115 and another 50 mcg transdermal Fentanyl patch at 2117.


6. In addition , " The Food and Drug Administration (FDA) drug safety full prescribing information [the black box warning] for Duragesic fentanyl transdermal system specifies the following:

I. " Duragesic is indicated for the management of persistent, moderate severe chronic pain that:

? requires continuous, around the clock opioid administration for an extended period of time, and
? Cannot be managed by other means such as non-steroidal analgesics opioid combination product, or immediate -release opioids. "

II. " Duragesic should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC 25 mcg/h. Patients who are considered opioid tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. "

III. " Because serious or life-threatening hypoventilation could occur,
DURAGESIC (fentanyl transdermal system) is contraindicated:

? In patients who are not opioid-tolerant
? In the management of acute pain or in patients who require opioid
analgesia for a short period of time
? In the management of post-operative pain, including use after out-
patient or day surgeries (e.g. tonsillectomies) ... ... ... ... "

7. The patient ' s Emergency Department Record completed by the attending ED physician stated in the Past Medical History: [the patient was] " ...sober for 5 months. "

8. In spite of documentation that the patient had been sober for 5 months and the FDA warnings regarding contraindications in the use of Fentanyl patches in patients who are " not opioid-tolerant " and " in the management of post-operative pain " , the ED medical record stated that the patient was discharged with two 50 mcg transdermal Fentanyl patches having been administered.

9. During a telephone interview on September 10, 2010, the attending ED physician stated " I was not aware of the [Fentanyl transdermal patch] Black box warning " .

10. In addition, review of the patients ED medication discharge instructions indicated that the ED physician personalized the patients discharge medication instructions. Review of the discharge instructions for the Emergency Room visit on February 26, 2010 specified the following:

? " Take naproxen Every 12 hours. This is not an as needed medication "
? " You have two Fentanyl 50 mcg patches on. These should last for 3 days. You may continue to take Percocet for breakthrough pain but the patches should decrease your need for the Percocet. If you get too sedated you may remove one or both of the patches. If these do not control your pain, call the center for family medicine. They are on call 24/7 and can help with further pain management. If you are still needing pain control on Monday, they may need to prescribe patches to start Monday night when the ones you have are done. "

11. There was no documentation in the patient ' s medical record to restrict use of any home medications. In fact, the discharge instructions for the Emergency Room visit on February 26, 2010 specified the following: " You should continue your home medications, unless otherwise instructed by the Emergency Department Clinician, that examined you today. "

12. After being instructed to take home medications [in addition to the new prescription for Percocet and the discharge instructions regarding the Fentanyl patches], at 2345 staff at the Rehabilitation Center administered the patient ' s routine home medications including: 1 tab Percocet, 50mg Tramadol, 100mg Trazodone and 2 tabs Melatonin 3mg. This information is verified in documentation submitted to the Hospital Risk Manager from the Rehabilitation Center ' s Medical Director on March 10, 2010.

13. A hospital Pharmacist, when requested by the Hospital's Significant Event Assessment Team (SEAT), reviewed the dosing and possible interactions of medications administered to the patient. The report completed on March 17, 2010 stated " There are multiple medications given to [the patient] that could have led to excessive sedation Trazodone, melatonin, Fentanyl. [The patient] received substantial doses of Fentanyl while in the ED. Fentanyl patches have a peak onset of action 8-12 hours after application. This would have occurred while the patient was asleep. [The patient] would have no way of perceiving over-sedation while asleep. Fentanyl patches are intended for the management of chronic pain not acute management. It is also reported that [the patient] received Percocet, Tramadol, Trazodone and melatonin when [the patient] arrived back at the Derek House. All these medication cause sedation! The combination of these medications could have led to excessive sedation with respiratory depression. "

14. The Medical Examiner's report stated that the patient was found dead at the Rehabilitation Center on February 27, 2010 at 1043 AM. An autopsy was performed by the Medical Examiner on February 28, 2010. The Medical Examiners Final Report was released on September 9, 2010 and indicated the following:
a. Cause of Death: " Combined Opioid (Fentanyl, Oxycodone, and Tramadol) Toxicity "
b. Manner of death: " Accident " " *Note: The Fentanyl is significantly elevated above therapeutic range. Although the other two opioid medications (Oxycodone and Tramadol) are within therapeutic range, their effects in combination with the Fentanyl cannot be excluded. "
c. How Injury Occurred: "Combined effects of prescribed/administered opioid drugs. "

The cumulative effect of these deficient practices resulted in this Condition of Participation being out of compliance.