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Based on observation, record review and interview the facility failed to supervise and evaluate the nursing care for 2 (P#s 6 & 7) of 10 patient records reviewed. This deficient practice has the potential to result in adverse outcomes including but not limited to death for patients in the facility. The findings are:

A. Record review of P#6's Cardiac Catherization (procedure used to diagnose and treat certain cardiovascular conditions) Order dated 08/23/19 revealed 86-year-old female with a history of chronic atrial fibrillation/flutter (is a type of heart arrhythmia that causes the top chambers of your heart, the atria, to quiver and beat irregularly). She was admitted on 08/23/19 at 6:58 am. P#6 was 86 years old, weighed 135 pounds (61 kg) (kilogram (abbreviation, kg) is the Standard International (SI) System of Units unit of mass), and was admitted to the CVL (cardiovascular lab) for a right and left heart catheterization (radiology procedure to visualize blood vessels supplying blood to the heart).

B. Record review of P#6's CVL (Cardio Vascular Lab) Intra-Procedure Administered Meds from 08/23/19 09:08 am to 08/23/19 09:55 am, revealed fentanyl (medication used for treating severe pain) 50 mcg (microgram- metric unit weight of medication dosage) was administered by S#22 Cardio Invasive Spec II at 09:25 am, 09:28 am, 09:36 am, and 09:47 am.

C. On 12/04/19 at 12:05 pm during interview, S#19 Interim Director of CVL confirmed, S#22 Cardio Invasive Spec II was accessing medical records and documenting medication administration during and after a surgical procedure was completed and updating medical records to indicate additional medications were given to patients when in fact they were not.

D. Record review of P#7's CVL Intra-Operative Procedure Administered Meds from 09/05/19 1242 to 09/05/19 1430 (12:42 pm to 2:30 pm) revealed patient received Fentanyl 50 mcg/mL (megalitre or megaliter, a unit of capacity), at 1:11 pm, 1:12 pm, 1:20 pm, 1:23 pm, 1:25 pm, 1:28 pm, 1:30 pm, 1:34 pm, 1:45 pm, 1:55 pm, 2:10 pm, and 2:17 pm (totaling 650 mcg).

E. On 12/04/19 at 12:10 pm during interview, S#19 Interim Director of CVL confirmed, S#22 Cardio Invasive Spec II was accessing medical records and documenting medication administration during and after a surgical procedure was completed and updating medical records to indicate additional medications were given to patients when in fact they were not.

F. Record review of Fentanyl package insert undated, revealed, "for moderate sedation patients could receive 0.5 mcg/kg".

G. Record review of "Medical News Today" undated revealed, "Fentanyl is much more potent than heroin, there is a hugely increased risk of overdose and death."

H. On 12/04/19 at 1:00 pm during interview, S#19 Interim Director of CVL confirmed:
1. Interventional cardiologist's documentation revealed the physicians ordered excessive amounts of Fentanyl and later confirmed that the excessive amounts were not appropriate and not ordered for P#6 & P#7.
2. S#19 confirmed no written policy could be provided which outlined the verbal order sign off process in the CVL lab, but the accepted practice was physicians signed off their verbal orders for Fentanyl (and other medications used for pain and conscious sedation) via the preliminary report outlining the procedure performed at the time the patient was leaving/being discharged from the CVL lab to the recovery floor.
3. S#19 confirmed the medication (Fentanyl) was possibly being diverted (removing and possibly theft of medication) by a cardiovascular technician working in the CVL lab from November 2018 to September 2019.

I. On 12/04/19 at 1:15 pm during interview, S#19 Interim Director of CVL confirmed S#22 Cardio Invasive Specialist (Spec) II had access to five pyxis med-stations (secure medication cart where medication can be pulled by authorized personnel) at the main hospital as this is part of their responsibilities.

J. On 12/04/19 at 1:30 pm during interview, S#19 Interim Director of CVL confirmed, the Pyxis med-station at the satellite hospital is in the corner making it possible for an employee to take additional medications when accessing Pyxis med-station while a procedure is being conducted because the employee is not in plain sight and no one can see what medications are being pulled.

K. On 12/04/19 at 1:45 pm during observation in the CVL at the satellite hospital, the Pyxis med-station was in the corner of the procedure room. If someone was standing facing the med-station it would be difficult to view what medications the employee was removing during a CVL/surgical procedure. The CVL procedure table was behind the staff performing the procedure would be the Medical Doctor and Surgical Technician (part of the team delivering surgical care).

L. On 12/04/19 at 3:58 pm during interview, S#21 Director of Compliance provided a list of all patients who had medications (including fentanyl) charted by S#22 after the case ended. For the satellite hospital there was a total of 5 (P#8, P#12, P#13, P#14 & P#15) and at the main hospital there was a total of 17 patients (P#6, P#7, P#9, & P#16- P#29) who received medication after the procedure was completed.

M. On 12/04/19 at 5:00 pm during interview, S#19 Interim Director of CVL and S#21 Director of Compliance Pharmacy confirmed, there was a total 96 vials of fentanyl that were tampered or diverted.

N. On 12/05/19 at 5:15 pm during phone interview with complainant confirmed:
1. There was total of 74 vials of fentanyl missing or tampered (replaced with an unknown substance), one vial of morphine (medication is used to help relieve moderate to severe pain) and one vial of midazolam (medication used for anesthesia, procedural sedation, trouble sleeping, and severe agitation).
2. The vials were sent to the lab for analysis and the tampering was confirmed.
3. The vials were sent to a secondary lab to attempt to identify what the vials were replaced with and the results came back inconclusive.
4. The complainant stated, "A google search was completed for the alleged perpetrator's name and individual with the same name and spelling came up with being court marshaled in Washington DC in 2018 for drug related offenses".

O. On 12/05/19 at 9:30 am during interview, S#19 Interim Director of CVL confirmed, failure to oversee medication retrieval (personnel enter pin number to unlock Pyxis to retrieve medication) by management was the reason S#22 Cardio Invasive Spec II was able to go into the Pyxis med-station after/or during procedures and tamper, divert, or take the vials. There was no system in place to establish excess amounts of medication being removed from the Pyxis machine at the hospital at the time. S#19 Interim Director of CVL confirmed, S#22 Cardio Invasive Spec II was using canceled transactions and replacing medication with other vials.

P. On 12/05/19 at 9:48 am during interview, S#21 Director of Compliance Pharmacy confirmed, this is what triggered the internal investigation regarding diversion of medications.

Based on record review and interview, the facility failed to have a process in place to monitor and limit verbal orders for Fentanyl (opioid pain medication) administration for patients undergoing procedures in the Cardiac Catherization (procedure used to diagnose and treat certain cardiovascular conditions) lab for 2 (P#6 and 7) of 10 patient records reviewed. This deficient practice has the potential to result in transcribed orders which are not correct and can result in significant medication administration and treatment errors and narcotic diversion (removing and possibly theft of medication). The findings are:

A. Record review of P#6's Patient Information dated 08/23/19 revealed P#6 was 86 years old, weighed 135 pounds (61 kg) (kilogram (abbreviation, kg) is the Standard International (SI) System of Units unit of mass) and was admitted to the CVL (cardiovascular lab) for a right and left heart catheterization (radiology procedure to visualize blood vessels supplying blood to the heart).

B. Record review of P#6's CVL (Cardio Vascular Lab) Intra-Procedure Administered Meds from 08/23/19 09:08 am to 08/23/19 09:55 am, revealed fentanyl (medication used for treating severe pain) 50 mcg (microgram- metric unit weight of medication dosage) was administered by S#22 Cardio Invasive Spec II at 09:25 am, 09:28 am, 09:36 am, and 09:47 am.

C. On 12/04/19 at 12:05 pm during interview, S#19 Interim Director of CVL confirmed, S#22 Cardio Invasive Spec II was accessing medical records and documenting medication administration during and after a surgical procedure was completed and updating medical records to indicate additional medications were given to patients when in fact they were not.

D. Record review of P#7 Patient Information revealed patient was 85 years old, weighed 133 pounds (60.7 kg) and was admitted to the CVL lab for a pacemaker implant (device used to control abnormal heart rhythms).

E. Record review of P#7's CVL Intra-Operative Procedure Administered Meds from 09/05/19 1242 to 09/05/19 1430 (12:42 pm to 2:30 pm) revealed patient received Fentanyl 50 mcg/mL at 1:11 pm, 1:12 pm, 1:20 pm, 1:23 pm, 1:25 pm, 1:28 pm, 1:30 pm, 1:34 pm, 1:45 pm, 1:55 pm, 2:10 pm, and 2:17 pm (totaling 650 mcg).

F. On 12/04/19 at 12:10 pm during interview, S#19 Interim Director of CVL confirmed, S#22 Cardio Invasive Spec II was accessing medical records and documenting medication administration during and after a surgical procedure was completed and updating medical records to indicate additional medications were given to patients when in fact they were not.

G. Record review of Fentanyl package insert undated, revealed, "for moderate sedation patients could receive 0.5 mcg/kg.

H. Record review of P#6's initial dose recommendation prescribed by the cardiology physician would have been 30 mcg. P#6's maximum dose per hour would have been 122 mcg (it was documented that P#6 received 200 mcg in 22 minutes.

I. Record review of P#7's initial dose recommendation would have been 30 mcg of Fentanyl and maximum dose would have been approximately 180 mcg (it was documented that P#7 received 650 mcg in 1.75 hr.).

J. On 12/04/19 at 1:00 pm during interview, S#19 Interim Director of CVL confirmed:
1. Interventional cardiologist's documentation revealed the physicians ordered excessive amounts of Fentanyl and later confirmed that the excessive amounts were not appropriate and not ordered for P#6 & P#7.
2. No written policy could be provided which outlined the verbal order sign off process in the CVL lab, but the accepted practice was physicians signed off their verbal orders for Fentanyl (and other medications used for pain and conscious sedation) via the preliminary report outlining the procedure performed at the time the patient was leaving/being discharged from the CVL lab to the recovery floor.
3. The medication (Fentanyl) was possibly being diverted (removing and possibly theft of medication) by a cardiovascular technician working in the CVL lab from November 2018 to September 2019




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