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Based on observation, interview and record review, the facility failed to meet the Condition of Participation for Nursing Services, as follows.

1. The facility failed to ensure Registered Nurse 7 (RN 7) was competent in the hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) emergency termination procedure for one of two sampled patients (Patient 20). (Refer to A 0397)

2. The facility failed to ensure staff followed the facility's policies and procedures, when:

a. A discontinued IV (intravenous, in the vein) fentanyl (a narcotic and a controlled substance [drug or substance with potential for abuse] used to treat severe pain, it is at high risk for addiction and dependence) bag was not wasted as soon as possible for one of 30 sampled patients (Patient 1), and two registered nurses (RN 4 and RN 5) of three sampled nurses were not able to verbalized the correct procedure to waste narcotic medication with tubing attached according to facility's policy and procedure for pharmaceutical waste manage.

b. The daily weights were not taken and documented for hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) patients, as ordered by the physician for two of two patients (Patient 19 and 20). (Refer to A 0398).

3. The facility failed to:

a. Assess pain prior to and/or after administering pain medication (fentanyl, acetaminophen, and hydrocodone-acetaminophen) for three of 30 sampled patients (Patient 1, Patient 19, and Patient 20).

b. Assess the temperature prior to and after administering Tylenol (acetaminophen, a medication used to reduce fever and treat pain) 650 milligram (mg) for one of 30 sampled patients (Patient 12). (Refer to A 0405)

The cumulative effect of these deficient practices resulted in the facility's inability to meet the Conditions of Participation in Nursing Services.

Based on observation, interview and record review, the facility failed to ensure Registered Nurse 7 (RN 7) was competent in the hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) emergency termination procedure for one out of one sample patient (Patient 20).

This failure had the potential to result in inadequate return of blood form the machine to the patient (Patient 20)causing harm or even death during hemodialysis treatment.

Findings:

A review of Patient 20's history and physical (H&P), dated 10/14/2022, indicated that Patient 20 was admitted to the facility on 10/14/2022 due to fluid overload (a condition where a person has too much fluid in the body). Patient 20 had a history of acute renal failure (damage to the kidneys causing a build-up of waste products in the blood) and hemodialysis treatment.

During an observation 10/19/2022, at 2:45 p.m., in Patient 20's room, Patient 20 was observed receiving hemodialysis treatment.

During an interview on 10/19/2022, at 2:50 p.m., with Registered Nurse 7 (RN 7), RN 7 stated Patient 20 was assigned for her to take care. RN 7 was not able to verbalize the hemodialysis emergency termination procedure. RN 7 said she (RN 7) had not been trained on what to do if the hemodialysis nurse becomes incapacitated.

A review of RN 7's "Competency Validation and Evaluation," form, indicated RN 7 did not receive training on "Emergency Termination of Dialysis by Non-Dialysis Staff."

A review of the facility's policy and procedure (P&P) titled, "Emergency Termination of Dialysis by Non-Dialysis Staff," dated 8/2021, indicated in the event of an incapacitated (unable to perform) hemodialysis nurse, the RN shall turn off the hemodialysis machine and clamp the patient's hemodialysis lines to prevent the possibility of a life-threatening air embolism (blood vessel blockage caused by air).

Based on interview and record review, the facility failed to ensure staff followed the facility's policies and procedures, when:

1. A discontinued IV (intravenous, in the vein) fentanyl (a narcotic and a controlled substance [drug or substance with potential for abuse] used to treat severe pain, it is at high risk for addiction and dependence) bag (a plastic container used to administer medication thru an IV) was not wasted (dispose in designated disposal container) as soon as possible for one of 30 sampled patients (Patient 1). The facility also failed when two registered nurses (RN 4 and RN 5) of three sampled nurses were not able to verbalized the correct procedure to waste narcotic medication with a tubing attached according to facility's policy and procedure for pharmaceutical waste manage.

2. The daily weights were not taken and documented for hemodialysis (the process of removing excess fluid and waste from the body of a person whose kidneys are not working correctly) patients, as ordered by the physician for two of two patients (Patient 19 and 20).

These deficient practices had the following potentials:

1. Patient 1's IV fentanyl medication bag was at risk for diversion (a medical concept involving the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit [forbidden by laws, rules, or custom], overdose [OD, ingestion or application of a drug or other substance in quantities much greater than are recommended]) since the IV fentanyl bag was left for unknown amount of hours in Patient 1's room sink by RN 1. The un-wasted narcotic or controlled substance to be left in Patient 1's room sink area was accessible by anyone, including visitors, housekeepers, and any staff.
RN 4 and RN 5 were at risk for not reflecting the accurate remaining amount of narcotic medication left on the tubing.

2. Patient 19 and Patient 20 not having daily weights as order by the physician were at risk for ineffective hemodialysis treatment and possible fluid retention or overload (too much fluid inside the body).

On October 18, 2022, at 6:57 PM, an immediate jeopardy (IJ, non-compliance that makes serious injury, harm, impairment or death likely to occur to one or more recipients if the non-compliance is not corrected) situation was identified and called in the presence of the Senior Vice President (SVP), Regional Leader of Accreditation for Regulatory and Licensure, Chief Nursing Executive/Chief Nursing Officer (CNO), Chief Operating Officer (COO), Quality Director (QD), and the Director of Accreditation and Licensing 1 (DAL). The facility failed to ensure a discontinued infusion bag of IV (intravenous, in the vein) fentanyl (a narcotic and a controlled substance [drug or substance with potential for abuse] used to treat severe pain, it is at high risk for addiction and dependence) 1000 microgram (mcg, unit of measurement)/ 100 milliliter (ml) for Patient 1 was wasted as soon as the infusion was stopped and discontinued, on 10/12/2022. Registered Nurse 1 (RN 1) stopped the administration of the medication (IV Fentanyl bag) at 8:13 AM. RN 1 did not waste the discontinued Patient 1's IV Fentanyl bag. The IV fentanyl bag was found at Patient 1's bedside sink by RN 2. The IV Fentanyl bag was accessible to the patient, visitors, and hospital staff. After RN 1's shift, the incoming nurse (RN 2) took over the care of Patient 1. Patient 1's IV fentanyl bag was still in the bedside sink in Patient 1's room on 10/13/2022 at 4 AM, when police came to investigate the death of RN 1 found inside a locked restroom with an empty syringe next to her.

On October 20, 2022, at 5:15 PM, the immediate jeopardy was removed after verifying an acceptable IJ removal plan. The IJ removal plan included re-education for the storage, handling, and wasting of controlled substances for all nursing staff, an auditing process to ensure proper wasting of controlled substances by the charge nurse of each unit, and a process for Pharmacist to track and follow-up with un-wasted and discontinued controlled substances. The nurse managers of each unit and the pharmacy department will have oversight.

Findings:

1. a. A review of Patient 1's Face Sheet, indicated Patient 1 was admitted to the facility on 10/12/2022.

A review of Patient 1's History and Physical (H&P), dated 10/11/2022, at 1:11 PM, indicated Patient 1 had a chief complaint of abdominal pain.

A review of Patient 1's Order Report, dated 10/12/2022, at 3:49 AM, indicated an order for intravenous Fentanyl in normal saline (NS, a mixture of water and salt) (10 mcg/ml), ordered dose: 50 mcg/hour (hr.) with frequency as continuous at 5 ml/hr. The order was discontinued on 10/12/2022 at 12:20 PM.

A review of Patient 1's Medication Administration Record (MAR), dated 10/12/2022, indicated a new 100 ml bag of fentanyl in (NS 10 mcg/ml) of IV solution was administered to Patient 1 at 7:54 AM, and stopped at 8:13 AM, as per physician by RN 1.

A review of a document titled, "All Devices Event Report," date ranging from 10/12/2022 starting at 12 AM through 10/12/2022 at 11:59 PM, indicated RN 1 removed a 100 ml bag of IV premixed fentanyl citrate (concentration of 1000 mcg/100 ml) at 7:46 AM. The report does not indicate the date or time the medication was wasted.

During an interview on 10/18/2022, at 3:24 PM, with the Compliance Officer (CO), the CO stated he (CO) investigated an incident in which RN 1 was found deceased on the floor in a locked staff restroom, on 10/13/2022, at 4 AM. The CO stated RN 1 worked on the day shift (7 AM - 7:30 PM) of 10/12/2022. The CO said RN 1's family member (FM 1) called the critical care unit (CCU) on 10/12/2022, at 10 PM, to report that RN 1 had not come home. The CO stated that the Charge Nurse 1 (CN 1) reported this (RN 1 not going home) to the House Supervisor (HS) who instructed security personnel to locate RN 1's vehicle in the parking structure, and the vehicle was not found at that time. The CO stated that another Family Member 2 (FM 2) arrived at the facility on 10/13/2022, at 2 AM. FM 2 stated he (FM 2) found RN 1's vehicle in the parking structure. The CO said a room-to-room search was initiated by two security guards (SG 1 and SG 2).

The CO stated that SG 1 and SG 2 found RN 1, face down on the floor, in a locked restroom located in the hallway just outside the CCU, on 10/13/2022, at 4 AM. The CO said that SG 2 sought help from nursing staff from the CCU. The CO stated that registered nurse (RN 3) turned RN 1 face up and reported that RN 1 was "in rigor" (rigor mortis, stiffening of the joints and muscles of a body a few hours after death). The CO said the nursing staff reported a syringe was also found on the floor in the restroom. The CO stated the police department was called and took over and secured the scene. The CO said that concurrently, RN 2, who took over one of RN 1's patients (Patient 1) found IV fentanyl bag in Patient 1's room. The CO further stated IV fentanyl bag (found in Patient 1's room) and the syringe (found on the restroom floor where RN 1 was found) were confiscated by the Police Department (PD).

During an interview on 10/18/2022, at 4:02 PM, with the chief nursing officer (CNO), The CNO stated RN 1 was found deceased in a locked restroom on 10/13/2022 at 4 AM. The CNO stated a physician (MD 1) pronounced RN 1 deceased at the scene, The CNO stated the PD took over the scene and confiscated an empty syringe, that was found on the floor, next to RN 1. The CNO stated RN 2, who took over Patient 1 from RN 1, found a IV fentanyl bag (IV fentanyl bag with NS, amount unknown due to amount not measured and taken by PD) by the sink, in Patient 1's (one of the patients taken care of by RN 1 during the 7 AM shift on 10/12/2022) room, prior to RN 1 being found in the restroom.

The CNO stated the PD indicated they needed Patient 1's IV fentanyl bag and the syringe. The CNO sated the PD confiscated it (Patient 1's IV fentanyl bag and the syringe), as evidence. The CNO stated Patient 1's IV fentanyl bag should not have been left in Patient 1's room sink unattended, it (IV fentanyl bag) should have been wasted by two nurses. The CNO stated that anyone, including visitors, who entered Patient 1's room, could have had access to Patient 1's IV fentanyl bag. The CNO stated fentanyl had a high risk for diversion. The CNO stated the Patient 1's IV fentanyl bag was found on 10/13/2022, at 4 AM. The CNO stated Patient 1's IV fentanyl bag medication had a physician order to discontinue on 10/12/2022, at 12:20 PM, and it (IV fentanyl bag) should have been disposed of by the end of the shift (7:30 PM) on 10/12/2022 by RN 1 and another nurse as a witness. The CNO stated there was no documented evidence that Patient 1's IV fentanyl bag had been wasted.

During an interview on 10/19/2022, at 8:50 AM, with Security Guard 1 (SG 1), SG 1 stated the following:
1. House Supervisor 1 (HS 1) informed SG 1 that RN 1 was missing on 10/13/2022, at 1:31 AM. SG 1 and SG 2 conducted a room to room search to locate RN 1.
2. SG 1 and SG 2 found RN 1 in a locked restroom, located near the CCU, on 10/13/2022, at 4 AM. SG 1 said RN 1 was found, face down with arms bent and hands covering her (RN 1) face. SG 1 stated SG 2 called nursing staff )from the CCU for assistance. Registered nurse (RN) responded to the scene. SG 1 also said the RN 3 touched RN 1 and stated RN 1 felt "cold and rigid." SG 1 said RN 3 picked up an empty syringe from the floor and placed it on the top of the toilet. The PD was called and took over the scene at 4:30 AM on 10/13/2022.

During an interview on 10/19/2022, at 9:23 AM, with Charge Nurse 1 (CN 1), CN 1 stated she (CN 1) worked the night shift of 10/12/2022 to the morning of 10/13/2022 in the CCU and stated the following: She (CN 1) saw RN 1 giving hand-off report for Patient 1 to RN 2, at the change of shift, at approximately 7:30 PM. RN 2 notified CN 1 that an IV fentanyl bag was still in the bedside sink of Patient 1's room at approximately 4 AM. The IV fentanyl bag was still filled fluid inside, with the IV tubing was still attached and clamped. The concentration of IV fentanyl bag was 1000 mcg / 100 ml. CN 1 approximated three-quarter (75 ml) of fluid was left in the IV fentanyl bag. CN 1 informed House Supervisor (HS 1) and placed the IV Fentanyl bag in a biohazard bag and brought the IV Fentanyl bag inside a biohazard bag to the nurse's station. The PD wanted the bag for evidence and confiscated the IV fentanyl bag on a biohazard bag at 6:30 AM.

During an interview on 10/19/2022, at 9:23 AM, with Charge Nurse 1 (CN 1), CN 1 stated the pharmacy was notified of the un-wasted bag of Fentanyl at approximately 7 AM on 10/13/2022. CN 1 stated Patient 1 had an order for fentanyl and RN 1 removed the IV fentanyl bag from the automated dispensing machine (ADM) with another RN as witness. CN 1 stated Patient 1's IV fentanyl bag (amount unknown) should be wasted right away as soon as the order was discontinued. CN 1 stated RN 1 administered Patient 1's IV fentanyl bag, at 7:54 AM, and stopped it at 8:15 AM on 10/12/2022. CN 1 stated IV fentanyl bag should have been wasted as soon as the infusion of the IV fentanyl bag medication was stopped. The IV fentanyl bag should have been taken to the Medication Room and wasted by two nurses, then documented in the ADM. The medication should have been emptied, the contents should have been measured, poured into a napkin, and disposed of in the pharmaceutical waste bin. CN 1 stated fentanyl bags should not be left unattended because they (fentanyl in IV bags) are considered as narcotics. CN 1 stated the Fentanyl bag could have been taken by anyone, including unauthorized staff and visitors. CN 1 stated anyone could have entered the room and taken it (IV fentanyl bag) because it (IV fentanyl bag) was not wasted and left unattended in the sink area of Patient 1's room. CN 1 stated the misuse of fentanyl could cause overdose or death.

During an interview on 10/20/2022, at 8:50 AM, with Registered Nurse 2 (RN 2), RN 2 stated she (RN 2) took over one of RN 1's patients (Patient 1) on 10/12/2022 at 7 PM. RN 2 said she (RN 2) discovered the IV fentanyl bag in the sink area of Patient 1's room, at 4 AM, on 10/13/2022, around the time that RN 1 was found deceased in the restroom. RN 2 stated she (RN 2) informed CN 1 of the IV fentanyl bag. RN 2 stated the IV fentanyl bag was a narcotic and should not be laying around. RN 2 stated the IV fentanyl bag needed to be wasted because there was a risk that anyone, including visitors, who can take it (IV fentanyl bag). RN 2 said fentanyl was medication to treat pain and could cause respiratory and cardiac (heart) issues, and death. RN 2 stated the bag should have been wasted right away with another nurse to serve as a witness.

During an interview on 10/20/2022, at 10 AM, with Registered Nurse 3 (RN 3), RN 3 stated he (RN 3) responded to the call for help by SG 1 on 10/13/2022, at 4 AM, and reported to the scene. RN 3 stated RN 1 was found on the floor, face down and non-responsive in the restroom. RN 3 stated he (RN 3) discovered an empty 3 ml syringe with an 18 gauge (unit of measurement for the size of a needle) attached to it (syringe), on the floor next to the toilet. The needle's safety lock (a built-in safety mechanism to reduce the risk of needlestick injuries) was on. The needle and syringe were inside the syringe's opened plastic packaging. RN 3 stated the needle's plunger was inside, all the way in, the syringe. RN 3 stated he (RN 3) picked up the syringe and placed it (the syringe) on top of the toilet.

RN 3 also stated he (RN 3) saw the IV fentanyl bag discovered by RN 2 in a plastic bio-hazard bag. RN 3 said the PD confiscated the bag to give to the Coroner. RN 3 stated the bag should not have been left in the Patient 1's room because it (IV fentanyl bag) was a narcotic, a controlled substance. RN 3 stated that anyone who entered Patient 1's room could have taken it, including visitors and staff. RN 3 stated the fentanyl can be misused and lead to overdose, and death.

During a concurrent interview and record review of Patient 1's physician orders and medication administration record (MAR) ,on 10/24/2022 at 10:34 AM, with the Nurse Manager (NM 1) and the Registered Nurse Informatics (RN 6), RN 6 stated the IV (intravenous, in the vein) fentanyl bag was ordered by the physician on 10/12/2022, at 3:49 AM. RN 6 said RN 1 administered the medication at 7:54 AM and stopped the medication at 8:13 AM, per communication with the physician. RN 6 stated the IV fentanyl bag order was discontinued, on 10/12/2022 at 12:20 PM.

During a concurrent interview and review record of the facility's document titled, "All Devices Events Report," dated 10/12/2022, on 10/24/2022, at 1:35 PM, the Inpatient Pharmacy Supervisor (IPS 2) verified that there was no documentation indicating RN 1 wasted the Fentanyl infusion bag that was administered to Patient 1.

A review of the facility's policy and procedure (P&P) titled, "Pharmaceutical Waste Management," revision date 8/2021, indicated a controlled substance was a drug or substance with potential for abuse... Examples include narcotic analgesics, sedative / hypnotics, etc. Controlled substances can only be wasted in the pharmaceutical waste container and must be witnessed by two licensed staff. Documentation of wastage will be done in the Pyxis (an automated dispensing machine). Infusion bags and containers (examples may include patient-controlled analgesia (PCA, epidural cassettes (a method of pain relief for women in labor that allows them to control their pain), lorazepam drips (bag of anti-anxiety medication), fentanyl drips, etc.) and tubing must be cut and emptied on absorbent pads and then discarded into the pharmaceutical waste bin.

A review of the facility's policy and procedure (P&P) titled, "Safe Storage and Oversite of Controlled Substances for Patient Care Areas," dated 11/11/2019, indicated in Section 5.9.1 in wastage of controlled substances is documented in the ADM as soon as possible, but before the end of the shift.

1. b. During an interview on 10/18/2022, at 1:27 PM, with Registered Nurse 4 (RN 4), RN 4 stated IV infusion bags of fentanyl, morphine sulfate (a narcotic and controlled substance to treat moderate to severe pain), hydromorphone (a narcotic and controlled substance to treat moderate to severe pain), Versed (midazolam, a medication to help one relax usually taken before having a minor procedure), and Ativan (lorazepam, a sedative and controlled substance) were subject to wasting. RN 4 stated the IV infusion bags containing narcotics or controlled substances should be wasted by two nurses. RN 4 stated the actual process included two nurses to physically remove the IV bag from the patient's room and take it the medication room to be wasted. RN 4 said the contents of the bag was removed and measured, then the amount of medication remaining in the tubing was calculated and added to the measured amount, but the medication was not flushed out of the tubing. RN 4 further stated the tubing allowed for 27 ml of medication. RN 4 stated that the medication, the bag, and the tubing (still containing medication) were disposed in the pharmaceutical waste bin located in the medication room.

During an interview on 10/18/2022, at 1:56 PM, with Registered Nurse 5 (RN 5), RN 5 stated unused portions of IV narcotic infusions should be wasted by two nurses. RN 5 stated the contents of the IV bag should be emptied and measured, poured on a napkin, and disposed in the pharmaceutical waste bin. RN 5 said the contents of the tubing was calculated and added to the amount measured, however, the medication was not removed from the tubing, which allowed for approximately 20 ml of medication to remain in the tube. RN 5 stated that the empty bag of IV narcotic infusion and the attached tubing (containing residual medication) was disposed in the pharmaceutical waste bin.

During an interview, on 10/22/2022 at 2:55 PM, CN 3 stated the correct process to was narcotics was by cutting the tubing to ensure all the medication was removed from the tube.

A review of the facility's policy and procedure (P&P) titled, "Pharmaceutical Waste Management," revision date 8/2021, indicated infusion bags, containers (examples may include patient-controlled analgesia (PCA), epidural cassettes, lorazepam drips, fentanyl drips, etc.) and tubing must be cut and emptied on absorbent pads and then discarded in the pharmaceutical waste bin.

2. a. A review of Patient 19's history and physical (H&P), dated 10/14/2022, indicated that Patient 19 was admitted to the facility on 10/14/2022 due to sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues). Patient 19 had a history of end state renal disease (a medical condition in which a person's kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term hemodialysis) and was on hemodialysis treatment.

A review of the Patient 19's physician orders indicated an order to obtain Patient 19's weight, once a day, starting on 10/14/2022.

A review of Patient 19's daily weight record, indicated from 10/14/2022 to 10/24/2022, Patient 19's weight was not documented six (10/15/2022, 10/16/2022, 10/17/2022, 10/18/2022, 10/19/2022, and 10/22/2022) out of ten times.

During an interview on 10/20/2022, at 10:11 AM, with Nurse Manager 1 (NM 1), NM 1 stated the nurses are responsible for implementing physician orders for daily weights. NM 1 stated the importance of the patient's weight will determine the amount of fluid to be removed from the patient's body during hemodialysis treatment.

A review of the facility's policy and procedure (P&P) titled, "Lippincott's Nursing Procedures and Skills Online Reference" (a primary resource used by the facility for step-by-step instructions for nursing skills), dated 10/2021, indicated for patient admitted to the nursing unit, the nurses were to review, verify, and implement physician orders.

2. b. A review of Patient 20's history and physical (H&P), dated 10/14/2022, indicated that Patient 20 was admitted to the facility on 10/14/2022 due to fluid overload (a condition where a person has too much fluid in the body). Patient 20 had a history of acute renal failure (damage to the kidneys causing a build-up of waste products in the blood) and was on hemodialysis treatment.

A review of the Patient 20's physician orders indicated an order to obtain Patient 20's weight, once a day, starting on 10/14/2022.

A review of Patient 20's daily weight record, indicated from 10/14/2022 to 10/20/2022, Patient 20's weight was not documented one (10/17/2022) out of six times.

During an interview on 10/20/2022, at 10:11 AM, with Nurse Manager 1 (NM 1), NM 1 stated the nurses are responsible for implementing physician orders for daily weights. NM 1 stated the importance of the patient's weight will determine the amount of fluid to be removed from the patient's body during hemodialysis treatment.

A review of the facility's policy and procedure (P&P) titled, "Lippincott's Nursing Procedures and Skills Online Reference" (a primary resource used by the facility for step-by-step instructions for nursing skills), dated 10/2021, indicated for patient admitted to the nursing unit, the nurses aware to review, verify, and implement physician orders.












43419

Based on interview and record review the facility failed to:

1. Assess pain prior to and/or after administering pain medication for three of 30 sampled patients (Patient 1, Patient 19, and Patient 20).

2. Assess the temperature prior to and after administering Tylenol 650 mg (acetaminophen, a medication used to reduce fever and treat pain) for one of 30 sampled patients (Patient 12).

These deficient practices had the potential for under medicating and over medicating patients or giving patients unnecessary medications.

Findings:

1. a. A review of Patient 1's Face Sheet, indicated Patient 1 was admitted to the facility on 10/12/2022.

A review of Patient 1's History and Physical (H&P), dated 10/11/2022, at 1:11 PM, indicated Patient 1 had a chief complaint of abdominal pain.

During a concurrent interview with the Registered Nurse Informatics (RN 6) and the Nurse Manager (NM 1), and record review of Patient 1's medication administration record (MAR) and pain assessment, on 10/24/2022, at 10:34 AM, RN 6 stated Patient 1 received 50 microgram (mcg, unit of measurement) of fentanyl, intravenously (IV, in the vein) on 10/12/2022, at 12:22 PM and 3:44 PM. RN 6 reviewed Patient 1's pain assessments and verified that a pain assessment was not documented prior to the administration of the medication at 12:22 PM and after 30 to 60 minutes after administering the medication. RN 6 stated Patient 1 was intubated (when a tube is inserted through a person's mouth, or nose, then down into their airway, so air can get through) and required a pre and post pain assessment which was 30 to 60 minutes after medication administration by using Critical-Care Pain Observation Tool (CPOT-a pain assessment tool used for intubated or non-verbal patients). RN 6 stated Patient 1's pain assessment record had no documented assessment after the medication (fentanyl) was administered at 3:44 PM. RN 6 stated Patient 1 received an additional doses of fentanyl 50 mcg IV, on 10/12/2022, at 9:21 PM, on 10/13/2022 at 2:43 AM, and at 8 AM. RN 6 stated Patient 1 pain assessment had no pain pre-assessment or post assessments documented in the medical record for the additional dose of fentanyl medications.

A review of the facility's policy and procedure (P&P) titled, "Pain Assessment and Conversation," dated 12/2020, indicated non-verbal pain scales included CPOT, a critical care pain observation tool was a behavioral pain scale used in detecting the presence of pain, but not the intensity. Reassess pain within one hour of medication administration. The assessment of pain will be based on the patient's self-reporting using pain scales, reports from family and caregivers, and the patient's behavior, i.e., facial expression, body movements, guarding, crying. The initial pain assessment, subsequent pain assessments, and patient response to pain interventions must be documented per Medical Center Wide policies in the HC pain flow sheet.

1. b. A review of Patient 19's History and Physical (H&P), dated 10/14/2022, indicated that Patient 19 was admitted to the facility on 10/14/2022 due to sepsis (a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues).

During a concurrent interview with Nurse Manager 1 (NM 1), and record review of Patient 19's MAR and pain assessment flowsheet, on 10/24/2022, at 9:45 AM, NM 1 stated Patient 19 received acetaminophen IV (a medication to treat pain) seven times for back and leg pain. The pain assessment flowsheet indicated Patient 19's pain re-assessment was not documented four (10/17/2022 2:26 a.m., 10/17/2022 3:58 p.m., 10/18/2022 12:10 a.m., and 10/18/2022 8:40 p.m.)out of seven times. NM 1 stated the nurse must reassess the patient's pain after the medication was given to determine its effectiveness.

1. c. A review of Patient 20's History and Physical (H&P), dated 10/14/2022, indicated that Patient 20 was admitted to the facility on 10/14/2022 due to fluid overload (a condition where a person has too much fluid in the body).

During a concurrent interview with NM 1 and record review of Patient 20's MAR and pain assessment flowsheet, on 10/24/2022, at 9:55 AM, NM 1 stated the MAR indicated Patient 20 received one tablet of hydrocodone-acetaminophen (a medication to treat pain), on 10/17/2022, for neck pain. The pain assessment flowsheet indicated Patient 20's pain re-assessment was not documented. NM 1 stated the nurse must reassess the patient's pain after the pain medication was given to determine its (pain medication) effectiveness.

A review of the facility's policy and procedure (P&P) titled, "Pain Assessment and Conversation," dated 12/2020, indicated reassess pain within one hour of medication administration. The initial pain assessment, subsequent pain assessments, and patient response to pain interventions must be documented per Medical Center Wide policies in the HC pain flow sheet.

2. A review of Patient 12's Face Sheet indicated Patient 12 was admitted to the facility on 10/19/2022.

A review of Patient 12's History & Physical (H&P) examination, dated 10/19/2022, at 4:23 AM, indicated Patient 12 was 37 weeks pregnant and was admitted for a leakage in fluid.

A review of Patient 12's MAR, dated 10/20/2022, indicated Tylenol 650 mg was ordered to be administered by mouth, every four (4) hours for a temperature greater than 38.3 Celsius (C, normal is 37 C) or 100.9 degrees Fahrenheit (F, normal is 98.6). The MAR indicated Patient 12 received 650 mg of Tylenol at 3:40 PM.

A review of Patient 12's Vital Signs, dated 10/20/2022, indicated the following: At 12 PM, Patient 12's temperature was 36.4 degrees (97.6 F). At 4 PM, Patient 12's temperature was 97.6 F (36.4 C).

During a concurrent interview with Registered Nurse Informatics (RN 6) and Nurse Manager 1 (NM 1), and record review of Patient 12's MAR and vital signs ( measurements to assess a patient condition that includes temperature, respiration, pulse, and blood pressure), on 10/24/2022 at 3 PM, RN 6 stated Patient 12's MAR and vital signs were conducted and indicated the following: Patient 12 received Tylenol 650 mg by mouth on 10/20/2022, at 3:40 PM. RN 6 stated Tylenol 650 mg was ordered on 10/20/2022, at 9:58 AM, to be given by mouth, every four (4) hours as needed for a temperature over 38.3 degrees Celsius (C, normal temperature at 37 degrees) or over 100.9 degrees Fahrenheit (F, normal temperature at 98.6 degrees). RN 6 stated the Tylenol was given at 3:40 PM, however, the temperature was taken on 10/20/2022 at 12 PM and at 4 PM, which was outside of the parameters of when the temperatures should have been taken. RN 6 stated the temperature should have been assessed prior to giving the medication, at 3:40 PM, and re-assessed 30 to 60 minutes after giving the medication to determine if the medication was effective. RN 6 stated that in this case, Patient 12's temperature was normal at 12 PM and 4 PM and Patient 12 should not have received the Tylenol which was ordered by the physician to be administered as needed.

A review of the facility's policy and procedure (P&P) titled, "Patient Assessment and Reassessment," dated 10/2021, indicated continuous assessment of patient's condition will be performed throughout the admission and the plan of care will be revised accordingly. Patients are reassessed after treatment, therapy, or educational sessions to determine the effectiveness (extent of improvement) of the interventions undertaken by the health care team.




































43419

Based on interview, and record review, the facility failed to meet the Condition of Participation (CoP) for Pharmaceutical Services, as follows:

1. The facility failed to ensure the inventory count of controlled substances (medications that can cause physical and mental dependence) was done routinely for eleven of twenty-four sampled days, according to the facility's policies and procedures for Automated Dispensing Machine (ADM, a machine that provides secure storage for controlled substances). (Refer to A 0494)

2. The facility failed to provide safe environment for care for one of 33 sampled patients (Patient 1) when:

a. Patient 1's discontinued IV Fentanyl (drug or substance with potential for abuse used to treat severe pain, it is at high risk for addiction and dependence administered via the vein) bag was not disposed according to facility's policy and procedure (P&P). (Refer to A 500).

b. Registered nurse (RN 1) and incoming nurse (RN 2) left Patient 1's discontinued IV fentanyl bag on the sink, inside Patient 1's room unattended that left the IV fentanyl bag accessible for possible diversion (a medical concept involving the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit [forbidden by laws, rules, or custom], overdose [OD, ingestion or application of a drug or other substance in quantities much greater than are recommended]) for patient, staff, and visitors. (Refer to A 500)

c. The pharmacy did not ensure adherence to provisions set forth in this policy for controlled substance storage conditions, removal, administration, wastage, return inventory discrepancy in the care delivery areas. (Refer to A 0500)

3. The facility failed to appropriately dispose a discontinued infusion bag of IV Fentanyl (drug or substance with potential for abuse used to treat severe pain, it is at high risk for addiction and dependence administered via the vein) per facility's policy and procedure for one of 30 sampled patients (Patient 1). (Refer to A 0505)

Based on interview and record review, the facility failed to ensure the inventory count of controlled substances (medications that can cause physical and mental dependence) was done routinely for eleven of twenty-four sampled days, according to the facility's policies and procedures for Automated Dispensing Machine (ADM a machine that provides secure storage for controlled substances).

This failure had the potential to result in diversion (redirected from its intended destination for personal use, sale, or distribution to others) of controlled substances.

Findings:

A review of "Narcotic Count Log," (a document that indicates the inventory count of controlled substances was completed) for automated dispensing machine (ADM - a machine that provides secure storage for controlled substances) on the 4th floor nursing unit, from 1/1/2022 to 10/19/2022, the Narcotic Count Log indicated the inventory count for controlled substances such as fentanyl (pain medication), morphine (pain medication), midazolam (sedative medication), and hydromorphone (pain medication ) was not completed eleven (1/17/2022, 1/25/2022, 1/26/2022, 1/31/2022, 5/29/2022, 7/12/2022, 7/27/2022, 8/29/2022, 9/6/2022, 9/12/2022, and 10/11/2022) of twenty-four days.

An interview on 10/19/2022, at 2:49 PM, with Charge Nurse 4 (CN 4), CN 4 stated the inventory count for controlled substances is done daily during the night shift by two nurses. Both nurses initial the Narcotic Count Log to indicate the task was completed. CN 4 stated if the log was not initialed by the nurses, it (the Narcotic Count Log) probably was not completed.

During an interview, on 10/20/2022 at 12:30 PM, with Inpatient Pharmacy Supervisor 1 (IPS 1), IPS 1 stated the inventory count for controlled substances in the ADM was done at night by two nurses to prevent diversion.

A review of the facility's policy and procedure (P&P) titled, "Automated Dispensing Machine," dated 1/2022, indicated inventory count of controlled substances must be conducted by two licensed staff at least once daily.

Based on interview and record review, the facility failed to provide safe environment for care for one of 33 sampled patients (Patient 1) when:

1. Patient 1's IV fentanyl (drug or substance with potential for abuse used to treat severe pain, it is at high risk for addiction and dependence administered via the vein) bag was not disposed of appropriately per facility's policy and procedure (P&P).

2. Registered nurse (RN 1) and incoming nurse (RN 2) left Patient 1's discontinued IV fentanyl bag on the sink inside Patient 1's room unattended that left the IV fentanyl bag accessible for possible diversion (a medical concept involving the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit [forbidden by laws, rules, or custom], overdose [OD, ingestion or application of a drug or other substance in quantities much greater than are recommended]) for patient, staff, and visitors.

3. The pharmacy did not ensure adherence to provisions set forth in this policy for controlled substance storage conditions, removal, administration, wastage, return inventory discrepancy in the care delivery areas.

This failure had the potential for avoidable medication errors that may affect the patient's health condition and increased the risk of loss, misuse, or diversion of narcotic (fentanyl, morphine, midazolam, and hydromorphone) drugs.

Findings:

1. A review of Patient 1's Face Sheet, indicated Patient 1 was admitted to the facility on 10/12/2022 to the Critical Care Unit (CCU) from the Emergency Department (ED) at 3:54 AM.

A review of Patient 1's History and Physical (H&P), dated 10/11/2022 at 1:11 PM, indicated Patient 1 had a chief complaint of abdominal pain.

A review of Patient 1's Order Report, dated 10/12/2022:

At 3:49 AM, indicated an order for intravenous Fentanyl in normal saline (NS, mixture of salt and water solution) (10 microgram (mcg)/milliliter (ml) with , ordered dose for: 50 mcg/hours (hr.) on, continuous infusion at 5 ml/hr.

At 8:13 AM, RN 1 documented Patient 1's Fentanyl bag was verbally ordered stopped

At 12:20 PM, physician ordered electronically in Patient 1 clinical record to discontinue Fentanyl bag. RN 1 documented that she received and carried out the physician's order to discontinue Patient 1's Fentanyl bag.

A review of Patient 1's Medication Administration Record (MAR), dated 10/12/2022, indicated Registered Nurse (RN 1) documented on the MAR the new bag of Fentanyl in NS 10 mcg/ml of IV solution was administered to Patient 1 at 7:54 AM and stopped at 8:13 AM per verbal physician order. Patient 1's MAR documented the physician later electronically entered an ordered into Patient 1's clinical record for IV Fentanyl infusion to be discontinued on 10/12/2022 at 12:20 PM.

A review of the pharmacist Pyxis machine (automated dispensing machine, ADM) transaction report titled, "All Devices Event Report," date ranging from 10/12/2022 starting at 12:00 AM/midnight (MN) through 10/12/2022 at 11:59 PM, indicated Registered Nurse 1 (RN 1) removed a 100 ml bag of IV premixed Fentanyl (concentration of 1000 mcg/100 ml) at 7:46 AM. There was no documentation on the Pyxis transaction report, titled, "All Device Event Report," to indicate the Fentanyl bag of medication was wasted after the medication was stopped on 10/12/2022 at 8:13 AM or discontinued on 10/12/2022 at 12:20 PM.

On 10/18/2022 at 4:02 PM, during an interview with the Chief Nursing Officer (CNO), CNO stated RN 1 worked on 10/12/2022 from 7 AM to 7 PM. CNO stated RN 1 was found deceased in the bathroom outside of the Critical Care Unit (CCU) on 10/13/2022 at 4:00 AM with an empty syringe next to her body. CNO was also notified by the House Supervisor (HS), that a Registered Nurse (RN 2) found Patient 1's IV fentanyl bag at the sink area inside Patient 1's room. CNO stated that HS was instructed to take the bag to the hospital pharmacist to determine the amount of fentanyl remaining in Patient 1's IV fentanyl bag. CNO stated HS informed her the police department (PD) needed Patient 1's IV fentanyl bag for evidence and confiscated Patient 1's IV fentanyl bag and the syringe found next to RN 1. CNO stated the hospital does not know how much fentanyl medication remained in the IV bag.

A review of the facility's policy and procedure titled, "Safe Storage and Oversite of Controlled Substances for Patient Care Areas", dated 11/11/2019, indicated: Section 5.2, Controlled substance monitoring: Pharmacy has a process in place to monitor adherence to provisions set forth in this policy for controlled substance storage conditions, removal, administration, wastage, return, and inventory discrepancy in the care delivery areas. Section 5.9.1, wastage of controlled substances documentation in the ADM (automated dispensing machine) was to be done as soon as possible, but before the end of the shift.

A review of the facility's policy and procedure titled, "Pharmaceutical Waste Management," revision date 8/2021, indicated a controlled substance is a drug or substance with potential for abuse... Examples include narcotic analgesics (pain medication), sedative / hypnotics (medication to help for sleep), etc. Controlled substances can only be wasted in the pharmaceutical waste container located in CCU and must be witnessed by two licensed staff. Documentation of wastage will be done in the Pyxis (an automated dispensing machine).

2. On 10/18/2022 at 4:02 PM, during an interview with the CNO, CNO stated, the nurse (RN 2) that found the fentanyl bag inside Patient 1's room was not the nurse (RN 1) that had removed the IV fentanyl bag from the Pyxis. CNO stated the IV Fentanyl bag was documented in the Pyxis to have been removed and administered to Patient 1 on 10/12/2022 at 7:42 AM and was found un-hung in the sink area of Patient 1's room the next day on 10/13/2022 at 4 AM. CNO stated Patient 1's IV fentanyl bag should have been wasted with two nurses per facility policy.

On 10/18/2022 at 4:24 PM, during an interview with CNO, CNO stated there was a gap in getting Patient 1's discontinued IV fentanyl bag to the pharmacy, and Patient 1's discontinued IV fentanyl bad was left in Patient 1's room. CNO stated there was a high risk for drug diversion. CNO stated the unsecured bag of Fentanyl was accessible to anyone including visitors to Patient 1's room. CNO stated inappropriate use of the Fentanyl could cause harm, abuse, or death.

A review of the facility's policy and procedure titled, "Pharmaceutical Waste Management," revision date 8/2021, indicated a controlled substance is a drug or substance with potential for abuse... Examples include narcotic analgesics, sedative / hypnotics, etc. Controlled substances can only be wasted in the pharmaceutical waste container and must be witnessed by two licensed staff. Documentation of wastage will be done in the Pyxis (an automated dispensing machine).

3. On 10/18/2022 at 2:39 PM., during an interview with Inpatient Pharmacy Director (IPD) and Inpatient Pharmacy Supervisor (IPS) 1, IPS 1 stated the hospital computerized system for tracking narcotic waste and disposal did not track IV narcotic (fentanyl, morphine, midazolam, and hydromorphone) infusion bags wastage or disposal. IPS 1 stated the hospital do not have a process to capture the wasting of discontinued IV narcotic infusion bags of medication that was removed from the hospital's Pyxis machines.

On 10/19/2022 at 3:35 PM., during an interview with IPD and IPS 2, IPS 2 stated hospital pharmacist are not actively monitoring the wastage of controlled IV drips and staff (RNs) may wait a few hours before wasting. IPS 2 stated waiting up to seven days to resolve a discrepancy with a controlled medication was too long. IPD stated controlled substances that are removed from the Pyxis and unaccounted for over a longer period of time could increase the risk for abuse, diversion, and ultimately not providing the best patient care which could lead to harm or loss of life. IPD stated the hospital did not have a process in place to track and review the wastage of controlled IV infusion bags removed from the Pyxis throughout the hospital that include but not limited to critical care unit (CCU), emergency department (ED), medical surgical unit (Med/Surg), and gastrointestinal lab (GI Lab).

A review of the facility's policy and procedure titled, "Safe Storage and Oversite of Controlled Substances for Patient Care Areas," dated 11/11/2019, indicated in: Section 5.2, Controlled substance monitoring: Pharmacy has a process in place to monitor adherence to provisions set forth in this policy for controlled substance storage conditions, removal, administration, wastage, return, and inventory discrepancy in the care delivery areas. Section 5.9.1, wastage of controlled substances was documented in the ADM (automated dispensing machine) as soon as possible, but before the end of the shift.

Based on interview and record review, the facility failed to appropriately dispose a discontinued infusion bag of IV Fentanyl (drug or substance with potential for abuse used to treat severe pain, it is at high risk for addiction and dependence administered via the vein) per facility's policy and procedure for one of 30 sampled patients (Patient 1).

This failure had the potential for medication diversion (redirected from its intended destination for personal use, sale, or distribution to others) and misuse which could have likely been used as a cause of death for one RN seen dead in a restroom with an empty syringe beside the body.

Findings:

A review of Patient 1's Face Sheet, indicated Patient 1 was admitted to the facility on 10/12/2022.

A review of Patient 1's History and Physical (H&P), dated 10/11/2022 at 1:11 PM, indicated Patient 1 had a chief complaint of abdominal pain.

A review of Patient 1's Order Report, dated 10/12/2022 at 3:49 AM, indicated an order for intravenous Fentanyl in normal saline (NS, mixture of salt and water solution) 10 microgram (mcg)/milliliter (ml) with ordered dose for 50 mcg/hour (hr.) on continuous infusion at 5 ml/hr. The order was discontinued on 10/12/2022 at 12:20 PM.

On 10/18/2022 at 2:46 PM, during an interview with Inpatient Pharmacy Supervisor (IPS 1), IPS 1 stated that he received notice of an IV fentanyl bag (Patient 1's IV fentanyl bag) was found in a patient's room in the sink area and a nurse had passed away in a bathroom next to Critical Care Unit (CCU). IPS 1 stated, the IV fentanyl bag medication (Patient 1's IV fentanyl bag) should have been secured and not left in the patient care area. IPS 1, stated at no time should controlled medication (fentanyl) be accessible to people (other patients, visitors, and staffs) that should not have access. IPS 1 stated, there was a chain of custody (a sequence of controlling or transferring) in which the staff (RNs) must know where the controlled medication was at all times.

A review of Patient 1's Medication Administration Record (MAR), dated 10/12/2022, indicated Registered Nurse (RN 1) documented on the MAR the new bag of fentanyl in NS 10 mcg/ml of IV solution was administered to Patient 1 at 7:54 AM and stopped at 8:13 AM per physician order. Patient 1's MAR documented the physician later discontinued the IV Fentanyl infusion on 10/12/2022 at 12:20 PM.

A review of the pharmacist Pyxis transaction report titled, "All Devices Event Report," date ranging from 10/12/2022 starting at 12:00 AM/midnight (MN) through 10/12/2022 at 11:59 PM, indicated Registered Nurse 1 (RN 1) removed a 100 ml bag of IV premixed fentanyl (concentration of 1000 mcg/100 ml) at 7:46 AM. There was no documentation on the Pyxis transaction report, titled, "All Device Event Report," to indicate Patient 1's discontinued IV fentanyl bag medication was wasted after the medication (Patient 1's IV fentanyl bag) was stopped on 10/12/2022 at 8:13 AM or discontinued on 10/12/2022 at 12:20 PM.

On 10/18/2022 at 1:02 PM, during an interview with the Charge Nurse (CN) 2 of the Critical Care Unit, CN 2 stated no second nurse as a witness was needed to remove a narcotic (Fentanyl) IV drip from the Pyxis machines (automated dispensing machine, ADM). CN 2 stated a second nurse as a witness was required to hang, start, and to waste a narcotic (fentanyl) IV infusion bag and document the amount wasted in the Pyxis.

On 10/18/2022 at 1:27 PM, during an interview, on CCU with a registered nurse (RN) 4, RN 4 stated the facility's policy for wasting discontinued IV narcotic (that include, fentanyl, morphine [pain medication], midazolam [sedative], or hydromorphone [pain medication]) infusion bags included two nurses entering the patient's room to verify the physician's discontinued orders and disconnect the IV fentanyl bag. The two nurses will walk together to the medication room. The two nurses will observe the draining of the medication to measure the fentanyl bag liquid amount, and document the amount wasted into the Pyxis. The two nurses will observe the disposal of the medication waste into a blue waste bin inside the medication room. RN 4 stated the hospital have visitors that walk about the unit and discontinued narcotic medication should not be left in a patient's room. RN 4 stated best practice, narcotic medications should be wasted as soon as possible after receiving an order to discontinue the medication and not wait until the end of the nurse's shift.

On 10/18/2022 at 1:57 PM, during an interview with RN 5, RN 5 stated, he was informed an IV fentanyl bag was found on the sink inside Patient 1's room, and the IV fentanyl bag found on the sink inside Patient 1's room was not wasted appropriately. RN 5 stated, Patient 1 had two visitors in the room, on 10/12/2022 between 1:00 PM or 2:00 PM, and they stayed until 5:00 PM. RN 5 stated as soon as the order to discontinue a medication was received the nurse should discontinue and waste the medication.

On 10/18/2022 at 2:26 PM, during an interview with the Inpatient Pharmacy Director (IPD) and the Inpatient Pharmacy Supervisor 1 (IPS 1), IPD and IPS 1 stated they were both notified on 10/13/2022 between 7:30 AM to 8 AM that an unsecured IV fentanyl bag was discovered in Patient 1's room in the sink area on 10/13/2022 at 4:00 a.m. Concurrently, on 10/13/2022 at 4 AM, RN 1, who cared for Patient 1 on 10/12/2022 was found deceased on the floor in a locked restroom, with an empty syringe lying next to her. IPS 1 stated discontinued IV narcotic infusion bags should be disposed of as soon as possible, no later than the end of the nurse's shift.

On 10/18/2022 at 2:39 PM, during an interview with IPD and IPS 1, IPS 1 stated the hospital computerized system for tracking narcotic waste and disposal did not track IV narcotic (fentanyl, morphine, midazolam, and hydromorphone) infusion bags waste or disposal. IPS 1 stated the hospital do not have a process to capture the wasting of IV narcotic infusion bags of medication. IPS 1 stated narcotic medications should be secured if not wasted immediately. IPS 1 stated he did not know where a controlled medication could be stored securely on the nursing unit if the nurse waited until the end of the nurse's shift to dispose of the discontinued controlled medication. IPD also stated the discontinued IV fentanyl infusion bag should not have been accessible in a patient care area are available to people that should not have access to controlled medications. IPS 1 stated the IV fentanyl bag found in Patient 1's room, increased the risk for diversion, medication to be taken or used inappropriately. IPS 1 stated the inappropriately stored IV fentanyl bag had the potential to be used personally by hospital staff or visitors entering Patient 1's room, with the risk of exposing patient, staff, or visitors to harmful effects of fentanyl that include respiratory depression (slowed and shallow breathing) or death.

On 10/18/2022 at 3:24 PM, during an interview, the Compliance Officer (CO) stated he investigated an incident in which a registered nurse (RN 1) was found deceased on the floor in a staff restroom, on 10/13/2022 at 4 AM. The CO stated RN 1 worked on the day shift (7 AM - 7:30 PM) of 10/12/2022. CO stated he was notified about the unsecured IV bag of Fentanyl left in the sink area of RN 1's patient's (Patient 1) room. CO stated the police was notified and on 10/13/2022 at 6:30 AM the police confiscated the Fentanyl bag and the syringe that was found next to RN 1 in the bathroom.

On 10/24/2022 at 10:34 AM, during a concurrent interview and record review of Patient 1's physician orders and MAR with the Nurse Manager (NM 1) and the Registered Nurse Informatics (RN 6). Patient 1's physician order for IV Fentanyl was reviewed. Patient 1's physician ordered IV Fentanyl on 10/12/2022 at 3:49 AM. Patient's 1 MAR documentation indicated Patient 1's IV Fentanyl was started on 10/12/2022 at 7:54 AM, verbally ordered stopped at 8:13 AM, and later electronically ordered discontinued by the physician at 12:20 PM. RN 6 reviewed Patient 1's physician orders and MAR. RN 6 stated Patient 1's IV Fentanyl order was documented to have been discontinued on 10/12/2022 at 12:20 PM.

On 10/24/2022 at 1:35 PM, during an interview and review of a document titled, "All Devices Events Report," dated 10/12/2022 with Inpatient Pharmacy Supervisor (IPS 2), the IPS 2 reviewed the Pyxis transaction wastage report and stated that there was no documentation indicating RN 1 wasted the Fentanyl infusion bag that was administered to Patient 1.

A review of the facility's policy and procedure titled, "Safe Storage and Oversite of Controlled Substances for Patient Care Areas", dated 11/11/2019, indicated: Section 5.2, Controlled substance monitoring: Pharmacy has a process in place to monitor adherence to provisions set forth in this policy for controlled substance storage conditions, removal, administration, wastage, return, and inventory discrepancy in the care delivery areas. Section 5.9.1, wastage of controlled substances documentation in the ADM (automated dispensing machine) was to be done as soon as possible, but before the end of the shift.

A review of the facility's policy and procedure titled, "Pharmaceutical Waste Management," revision date 8/2021, indicated a controlled substance is a drug or substance with potential for abuse... Examples include narcotic analgesics, sedative / hypnotics, etc. Controlled substances can only be wasted in the pharmaceutical waste container and must be witnessed by two licensed staff. Documentation of wastage will be done in the Pyxis (an automated dispensing machine).