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AVERA ST MARY'S HOSPITAL 801 E SIOUX PIERRE, SD 57501 Dec. 9, 2020
VIOLATION: PHARMACY ADMINISTRATION Tag No: A0491
Based on observation, interview, and policy review, the provider failed to ensure medications (med) had been properly monitored and secured to prevent unauthorized access for five of five anesthesia med boxes in one of one anesthesia room.
-There was no system in place to monitor and secure those meds from misappropriation of use by one of five certified registered nurse anesthetist (CRNA) (F).
Findings include:

1. Review of the provider's 12/1/20 final incident report and investigation submitted to the South Dakota Department of Health (SD DOH) on suspicion of abuse and neglect by CRNA F of controlled substances revealed:
*He had:
-Been employed with the facility since 10/25/05.
-Required disciplinary action on 11/4/20 and was put on a leave of absence for reasonable suspicion of working while under the influence of an unknown substance.
--A co-worker had reported to the interim operating room (OR) director A that CRNA F kept falling asleep while working.
-Been suspected of drug diversion and was terminated on 11/19/20.
*On 11/17/20 his anesthesia box was returned to the pharmacy department for audit/inspection.
*The audit of that box revealed the following meds were missing:
-Eight vials of Fentanyl (pain med) 50 microgram (mcg)/2 milliliter (ml).
-One vial of Fentanyl 250 mcg/5 ml.
-Three vials of Midazolam (used for sedation and relaxation) 1 milligram (mg)/ml.
*The conclusionary summary statement of the facility investigation revealed:
-"On 11/17/20 a phone call was placed to (CRNA F's name) to investigate the location of the missing medications listed above. (CRNA F's name) explained he had used the medications during colonoscopy procedures with medical doctor (MD) (MD G's name) and that he was busy and did not document the usage. When asked about the time frame he was unable to provide a particular date." A more comprehensive investigation of his cases involving (MD G and MD H's names) was completed from 10/1/20 - 11/6/20. There was no further discrepancies found.
-"On 11/18/20 (CNO A's name) and (pharmacist D's name) phoned (CRNA F's name) to ask if he could provide any more information in regards to the missing medications listed above. (CRNA's name) again could not provide any detailed account of a date or patients the medications were documented on."
-"On 11/19/20 the audit was completed and determined that the medications listed above were not able to be located or accounted for. It was determined that these medications were diverted."

Continued review of the provider's 12/1/20 final incident report and investigation conclusion submitted to the SD DOH revealed:
*The CRNA anesthesia boxes are:
-Stored in the locked storage area and ready for use. There was no documentation to support where the locked storage was located.
-Returned to the pharmacy for reconciliation and refill after each use.
-Filled with a minimum amount of medications to provide service for a minimum amount of cases.
-Specific to each CRNA to ensure chain of custody was maintained.
-CRNA specific, locked with a CRNA specific padlock, stored in a lock box within a locked cabinet, and within a locked room.
*The policy for reconciliation of those boxes by the pharmacy department had been updated and increased to two times per month versus monthly.
*No discrepancies had been found during the investigation of the dispensing machines.
*The abuse/neglect allegation for CRNA F was not substantiated since he did not admit to the diversion of those medications.
*There was no documentation that CRNA F had been tested to support he had been working while under the influence of a controlled or mind altering substance.

Observation and interview on 12/9/20 at 8:55 a.m. with the CNO A, registered nurse (RN) B, and CRNA E in the anesthesia office and storage room revealed:
*The entrance door was locked and CRNA E was able to enter the room by putting an access code into a punch pad.
-The anesthesia and pharmacy staff were the only individuals with the code to enter the room.
*There were several cupboards and shelving in the room for storage of medical supplies.
*One of the cupboards had a punch pad on it and required the use of an access code to open it by CRNA E.
*Inside of that cupboard was an old and unlocked safe.
*Inside the safe were five small clear plastic type tackle boxes.
*Each of those boxes had:
-Been secured with a small padlock on them. It required a numbered code to open it.
-Each CRNA had a box assigned to them. Their name had been written on the box with a black marker.
*CRNA E reviewed the process for the boxes and stated:
-"Each of us has our own box and code to get into the box."
-"The boxes are used for patients getting a magnetic resonance imaging (MRI) test or CAT Scan (CT Scan)."
-"There isn't a Pixas machine (med dispensing machine) down in that area that is how these were established."
-"So anytime we have to go down there we take our box."
-"No one can get into our box but us."
-"After we use the box, we are supposed to take it down to the pharmacy department for them to reconcile it and refill it."
-"There is a paper log inside the box for us to document the patient and what we used from the box."
-"I'm assuming the pharmacy department can get into these and check them, but I am not sure if they do or how often."
-"For security purposes of the meds we have limited access and reconciliation knowledge on their process."
*CRNA E confirmed:
-The boxes remained in the locked cupboard and safe until one of them needed to use it.
-No one else had access to the boxes.
-The boxes allowed for easy access to the meds at any time of the day.
-After review of that process, there was the potential for misappropriation of the meds to occur.
-The pharmacy department did not know when the boxes were used. They relied on the CRNAs and the honor system for turning them in after each use.
-The anesthesia and pharmacy departments recently had a meeting to review the current process for the anesthesia boxes.
-From the meeting, they determined there needed to be a change to ensure the security of the meds was maintained.
-He had not been informed of the reason for the change, just that it was needed.
*CRNA E stated:
-"I suppose so, if someone didn't turn in their boxes right away like they are supposed to they could take meds without anyone knowing until they are checked."
-"This process has been like this for some time now. It started when we had issues getting meds down in that area."
-"We are looking at trying to put these boxes in the Pixas until we need to use them and either return to the pixas or pharmacy when done."
-"We just haven't finalized a process yet."
-The process for using the anesthesia boxes had remained unchanged until they agreed upon a more secured process.
*He had been employed at the facility for ten years and could not recollect any of his peers working while under the influence of a controlled substance or a drug diversion concern.
-That would have required an instant notification to the direct supervisor.
*They all agreed:
-The current process had created the potential for drug diversion to have occurred.
-The meds stayed in the cupboard and safe until a CRNA was needed to do an MRI or CT Scan. That could be days, weeks, or months before a box was used.
-The process was based on the honor system and the CRNAs would turn them in after each use.

Continued observation on 12/9/20 at 9:20 a.m. of the five anesthesia boxes revealed:
*There was:
-Several dividers inside of the box with multiple vials of highly divertable meds.
-A Daily Narcotics Log just inside of the box was used for medication documentation when meds were used.
-A list of what was inside of the box and how many.
*Those meds were:
-Ten vials of Fentanyl 50 mcg/ml.
-Fifteen vials of Midazolam 1 mg/ml.
-One Vial of Ketamine 100 mg/ml.
-Two vials of Ephedrine 50 mg/ml.
*On the log there was three areas to document and sign for waste of any unused meds.

Interview on 12/9/20 at 9:30 a.m. with CNO A and RN B regarding the above observation and interview revealed:
*The current operating room (OR) director and anesthesia director were both out on personal leave.
-CNO A was currently the interim director for both of them.
*They agreed:
-The accountability process for the anesthesia boxes allowed for misappropriation and improper use by the CRNAs to have occurred.
-Some of those anesthesia meds were considered high-risk for drug diversion and were not being properly accounted for, monitored, or secured with that process.
*They confirmed:
-The incident and final investigative report that had been submitted to the SD DOH on 12/1/20 regarding CRNA F.
-The pharmacy department, anesthesia, and nursing departments had not:
--Recognized a failure with the anesthesia boxes until that investigation on CRNA F had occurred.
--Recognized the immediacy of correcting this process until the interview and review above had occurred with CRNA E.
*CNO A stated:
-"The anesthesia staff know very little due to privacy issues."
-"All they know is that one of their peers is gone and the process for using those boxes needed to be changed."
*They both confirmed no other licensed staff had that kind of access to controlled substances.

Interview on 12/9/20 at 11:00 a.m. with Pharmacist D, CNO A, and RN B regarding the investigation of CRNA F and the process with the anesthesia boxes revealed:
*On 11/4/20 CRNA F:
-Had been scheduled to work that day.
-Kept falling asleep.
--A staff member reported CRNA F's odd behavior to the interim OR director.
-Was questioned about his behavior and he originally stated he had taken some of his wife's meds.
-Denied taking any other meds and a replacement had been called in for him.
-His wife came to pick him up right away.
-Was suspended indefinitely until an investigation was completed regarding his behavior.
*From 11/4/20 through 11/17/20 pharmacist D did a comprehensive review of CRNA F's:
-Procedures he was involved with and the anesthesia reports that he had scanned into the system.
-His review included documentation from 10/1/20 through 11/6/20, since CRNA F did not return to work after 11/4/20.
-The review and investigation on those reports never revealed any med discrepancies in the Pixas machines he had access to.
*They had called CNRA F several times throughout the investigation to give him the opportunity to admit what happened.
*CNRA F was adamant he had not taken any meds.
-His anesthesia box was not checked for misappropriation of use by pharmacist D until 11/17/20. That had been 13 days after CRNA F had been suspended for suspicion of working under the influence.
*Pharmacist D stated:
-"It was human error, I didn't even think to check those boxes."
-"That was when we found the missing meds. He never turned in his box and the sheet inside the box did not support a date for when he used the meds."
-"His box was the only one with missing meds in it."
-"I called him right away on the 17th about those missing meds and why he had not turned in his box after using them."
-"He stated he forgot, and he thought he had used them around 10/30/20 on some colonoscopy procedures with (MD G's name)."
-"That was a Saturday and there were no procedures done that day, but he had done a MRI for the patient identified on the narcotic log."
-"That was his story and he would never admit to taking the missing meds."
-"We gave him multiple times to admit to taking them and he never did."
-"He was terminated on 11/19/20 for suspicion of taking those meds."
-"I knew the process for the boxes needed to change so on 11/24/20 we had a meeting to start that process."
--That had been 20 days after CRNA F was suspended and 7 days after the investigation into the missing meds had occurred.
*The process and system for the CRNAs' to use those meds and anesthesia boxes for MRI and CT Scan procedures was still in place and unchanged as of 12/9/20.
*They:
-Had recognized the process for CRNA access and use of those anesthesia boxes required changing.
-Did not recognize the process required changing immediately.
*He stated:
-"We've had those boxes and process for the CRNAs for as long as I can remember."
-"We only reconcile the boxes when we check for outdates, which is every other month or when they return them to our department."
-"I have it documented that his box was last checked on 8/27/20 and then on 11/17/20." That had been 83 days apart.
*Pharmacist D agreed:
-"You are correct, it was set-up to be used on an honor system."
-"Until now, there was never any issues with it."
*He had:
-Not recognized the immediacy of the situation until this interview and review of the process.
-Agreed there was potential and risk for continued misappropriation and use of those anesthesia boxes with the policy/procedure remaining unchanged.
*The anesthesia, pharmacy, and nursing departments had met on 11/24/20 and 12/7/20 to review the current lock box process and develop a new process.
-As of 12/9/20 the security, monitoring, use of, and reconciliation process remained unchanged. That had been 43 days since CRNA F had been suspended for the suspicion of working while under the influence of a controlled or mind altering substance.
*Pharmacist D stated:
-"After the meeting on the 7th we had agreed that the CRNAs would need to check the boxes out from pharmacy and return at the end of the day. I just have not put the process in place yet and then we will need to do education."

Review of CRNA F's undated Daily Narcotics Log for patient 9 revealed:
*No documentation to support:
-What type of procedure or test she had.
-A date or time of when the test or procedure was performed.
*She had required the use of the following meds during her test/procedure:
-Two of the ten vials of Fentanyl 50 mcg/ml (200 mcg).
-Two of the fifteen vials of Midazolam 1 mg/ml (4 mg).
*The log was reconciled on 11/17/20 at 8:30 a.m.
-None of the ten vials of Fentanyl were returned to the pharmacy department. There should have been eight vials returned.
-Ten of the fifteen vials of Midazolam were returned. There should have been thirteen vials returned.

Review of the provider's September 2020 Controlled Substance Distribution policy revealed:
*"The inventory record for anesthesia procedure boxes containing controlled drugs in schedules II, III, and IV will be verified by a pharmacist and a member of the anesthesia staff at the exchange of each box."
*Theft:
-"Human Resources Officer; Director of Quality, Safety, and Risk Management; and the unit director will meet with the employee and conduct an interview."
-"The employee health nurse or designee will conduct a drug and alcohol screening and test for cause. At this time the employee will be suspended without pay pending further investigation."

Review of the provider's 11/19/19 Drug and Alcohol Free Workplace (provider's name) Administrative policy revealed:
*Purpose: "To provide a safe and alcohol free work environment at all (provider's name) facilities."
*Policy Implementation:
-"Employees are prohibited from being under the influence of an illegal controlled substance at any time while working or performing job duties."
-"If a leader has reasonable suspicion that an employee may have used alcohol or a controlled substance, or is under the influence while on the job they should take the following steps: "The leader will take the employee to Employee Health for assessment to verify if reasonable suspicion exists to warrant further testing."

Review of the provider's January 2020 Pyxis ES policy for medication waste revealed: "CRNA or anesthesiologist controlled substance waste does not require a witness, but is collected by pharmacy staff for analysis."

Review of the provider's CRNA Specific Medication Lock Boxes policy revealed:
*The policy origination date was December 2020 and its next review date had been set for December 2021.
*Purpose: "The purpose of this policy is to describe the use and procedure of CRNA anesthesia specific medication boxes."
*Procedures:
-"All CRNA's will be assigned a specific medication box."
-"CRNA's will be given a specific padlock with an unique combination known only to them and pharmacy."
-"CRNA's will utilize the medication lock box when a Pyxis is not readily available. They will document patient name, date of birth, medications utilized, medication waste on this form."
-"When finished utilizing the box at the end of the day the CRNA will return the box to the pharmacy for medication reconciliation and refill."
-"Pharmacy will reconcile medications and refill the medication box as needed and return to anesthesia workroom."
-"Anesthesia lock boxes will be audited on a regular basis for proper documentation and reconciliation."

Interview on 12/9/20 from 2:00 p.m. through 2:50 p.m. with pharmacist D, RN B, and CNO A regarding the above policy review revealed:
*They had been aware that any employee who was suspected of working while under the influence of a controlled or mind altering substance should have been tested to support that suspicion.
*CNO A stated:
-"He was adamant that he had taken some of his wife's meds and we called her into pick him up. We never took him down to have him tested ."
-"Since we let him leave the building without being tested we could not make him come back."
*They confirmed:
-The current process for the anesthesia boxes never had a policy in place until there was an issue identified.
-That policy was not developed until December 2020.
-There was not a policy put in place for when the pharmacy would have reconciled them.
*They had not been aware the corporate policy allowed the CRNAs to waste any controlled substance without a witness.
*They agreed:
-The CRNAs are licensed professional staff and should be held to the same accountability rules and regulations for controlled substance as all the other licensed professional staff.
-Someone should follow-up with the corporate office regarding that policy.
*RN B:
-Was the director of quality and risk management.
-Stated: "Our committee meets every other month and we have not had a meeting and an opportunity to review this incident yet."

Interview on 12/9/20 at 3:15 p.m. with administrator C regarding the results from the investigation that involved CNRA F revealed he:
*Had been aware of the incident involving CRNA F that resulted in his termination.
*Agreed there were processes and policies that needed review and changing from that incident.
*Was not aware of the corporate policy that allowed CRNAs to waste controlled substances without a witness.
-He agreed that policy had to be reviewed.

Review of CRNA F's 10/28/15 job description revealed:
*"Functions performed: "Maintains professional standards and promotes profession."
*"Specific worker traits: "Knowledge of and respect for drugs."

Review of January 2020 Director of Pharmacy job description revealed:
*"The director of pharmacy: Plans, directs, and oversees the clinical and distributive pharmacy services for (provider's name)."
*Responsibilities, expectations, standards: "Comply with safety principles, laws, regulations, and standards associated with, but not limited to CMS, Joint Commission, and OSHA."
*Essential Functions:
-"Plan, direct, and oversee the clinical and distributive pharmacy services for the hospital and/or related areas to ensure compliance with applicable laws and regulations and to provide optimal patient care."
-"Actively participate in the appropriate system management team to ensure the development of and adherence to system standards and practice."
-"Understand and ensure policies and procedures are in place to adhere to all appropriate legal and accreditation standards to ensure compliance as well as the safety of health-system personnel and patients."
-"Responsible for the coordination of all activities associated with departmental policies and procedures."