HospitalInspections.org

32355

Based on observation, interview, South Dakota Department of Health (SD DOH) incident report review, job description review, and policy review, the provider failed to ensure pharmacy services provided oversight and monitoring for the security and accountability of:
*Controlled substances (medications that have a high potential for drug diversion) in one of one ambulance department.
*Medications used for anesthesia in two of two operating rooms (OR) (1 and 2) and one of one procedure room (2).
Findings include:

1. Review of the provider's Complaint/Incident Investigation Report submitted to the SD DOH complaint department on 10/17/22 revealed/indicated an alleged diversion within the ambulance service at their facility. On 8/28/22 an unidentified medic had been completing daily medication (med) counts on their controlled substances. During that count he noticed 2 vials of fentanyl (pain reliever) appeared to have an odd appearance. Those vials had been taken to the pharmacy department and were sequestered (locked-up) until the contents were tested. On 9/19/22 the contents were tested and revealed both vials had been filled with normal saline.

Further review of the provider's Complaint/Incident Investigation Report revealed:
*Between 8/31/22 through 9/19/22 pharmacy director B and ambulance director A had been conducting routine checks on the inventory of the controlled substances.
-During that timeframe they had not found any further evidence to support tampering had occurred.
*They had not identified a suspect and as of 10/13/22 the incident remained under investigation with the DCI (Division of Criminal Investigation).
*In response to what physical controls had been implemented the provider stated:
-"The MedVaults [electronic safes] used in the ambulance were in the process of being updated during that time. It is speculated that the person who did the tampering used this opportunity to divert [steal] during the time the doors to the Med Vault were being updated. One additional MedVault door [is] scheduled to be updated [new software] but has been put on hold during the investigation."
-"Having the MedVault door for each ambulance back in place accomplishes the normal security controls. There is a key that allows for an override of the MedVault and it was identified that there may be a need to keep the key in a more secure/controlled setting. Master key has been returned to the possession of the Brookings Health System nursing supervisor to keep with other master keys."
*There were no policies and procedures in place for med security and safe guards from diversion in both the anesthesia and ambulance departments.
*Added information on 10/13/22: "The Department of Criminal Investigation continues to review this incident and we are waiting for a reply from them with next steps."
*Pharmacist director B had completed the online Complaint/Incident Investigation Report.

2. Interview on 11/16/22 at 8:45 a.m. with ambulance director A revealed:
*They had five ambulances and four of them had controlled substances in them.
-The other ambulance carried extra supplies during an emergency crisis or event.
*The meds were kept secured in a MedVault.
-The MedVault was like a safe and required a numbered code to get into it.
-Each of the paramedics and emergency medical technician (EMT) had their own code to open them.
-There was a master key that could open those vaults should the electronics shut off.
-The key had been stored at the ambulance department and everyone had access to it.
-Currently the master key had been left with the nurse supervisor for security purposes.
*The staff worked 24 hours shifts and the meds had been counted daily between the shift change.
-Those counts had been completed independently and without another staff member.
*The MedVaults were 10 years old and required a a software update.
-Three of the four had been completed.
*The MedVault doors had to be removed and sent into the company for updates.
*During that time, the meds had been placed in a locked cabinet inside the ambulances.
-A key was required to open the cabinet and was stored in a designated area in each ambulance.
-Everyone, including the EMTs, had knowledge of where the key was located to open the cabinet.
*There was one ambulance that the MedVault door had not been removed and updated.
-There had been a drug diversion of two fentanyl vials during the process of when the other doors had been removed.
*He was gone on family leave during the time of the diversion and paramedic C had found the suspicious vials.
*The vials had been found on 8/28/22 and were given to the pharmacy department immediately.
*The vials were sequestered (placed in a locked storage) at the pharmacy until testing of the fluid could be completed.
-On 9/19/22 they had obtained a refractometer to test the vials.
-The fluid in the vials had tested positive for normal saline.

Continued interview on 11/16/22 at 9:00 a.m. with ambulance director A revealed:
*Since the drug diversion, either him or paramedic C had done daily checks on the meds in all four ambulances.
*Paramedic C was the only staff, other than him, that was aware of the drug diversion.
-She had assisted the director with daily checks when he was gone or unable to.
*They were working with the DCI on the drug diversion and had been directed to keep it to themselves.
*All the daily checks were done without the other ambulance staffs awareness and by themselves.
*He had just gotten back from vacation and during his absence, paramedic C had found a morphine sulphate (MS) injectable that was out of its storage container and a safety seal had been removed.
*The MS injectable was given to pharmacist director B for security.
-The DCI did not want it tested like the vials were and he was not sure why.

3. Observation and interview on 11/16/22 at 9:30 a.m. with ambulance director A and paramedic F of their 911 ambulance revealed:
*There was a MedVault in the ambulance and it required a numbered code to open it and access the contents.
*On the MedVault door was a green colored pull away tab that was numbered.
-When the tab was removed, it allowed access to a key.
-That key would have opened the MedVault door during an electronic shutdown.
*Each paramedic and EMT had their own access code for the MedVault.
*Inside of the MedVault was two clear small plastic containers.
*One of the containers had two fentanyl vials and three MS injectables.
-The daily check sheet supported that count.
*The staff would have done the daily counts/checks of those meds by themselves.
*When they wasted a med was the only time they were required to have a witness.
*The meds were replenished through the Omnicell located in the emergency department.
*The meds had been stored in a locked cabinet when the MedVault doors were removed for software updates.
*During that time:
-A key was placed in a secured area and all the staff had knowledge of that location.
-The key would have opened the locked cabinet to allow access to the meds.
*The meds had not been secured from potential drug diversion with that process.

Interview on 11/16/22 at 10:11 a.m. with paramedic C revealed:
*She had:
-Worked for the ambulance department as a paramedic for approximately 20 years.
-Been the one who found both of the controlled substances that had been tampered with.
*Both times, ambulance director A had been on leave or vacation.
*She confirmed the process for doing daily med checks in the ambulances per interview with paramedic F.
-Each staff was assigned an ambulance and were responsible to complete med checks/counts on their unit.
-Those med checks/counts were completed without another person as a witness.
*She had been helping ambulance director A with the daily checks when no other staff were around.
-That had been the med security process they put in place for now.
-No other med security or counting process had changed since the initial drug diversion.
*She:
-Confirmed the process for the med security that was implemented when all the MedVaults were upgraded.
-Agreed the process was not secure and created the potential for drug diversion to have occurred.
-Stated: "But both times I found the fentanyl and MS when they were locked inside of the MedVault."
*She was not aware of the last time they had education on med security, accountability, and diversion.
*The random drug testing had stopped and she was not sure why.
*She stated:
-"We can do a random test, but no routine tests is how I understood it."
-"So we have not been tested or that I know of anyway. Not supposed to know when someone is tested."
*She was not sure why they had to have two people when destroying meds but not for counting.
*To her knowledge, pharmacist B had not been in their building checking on med processes and security.
*She stated:
-"He might call with discrepancies found on the med sheets. But physically, no, I have not seen him."
-"He could have when I've been out, but I've been here a long time."

Interview on 11/16/22 at 11:00 a.m. with ambulance director A revealed:
*They had not put in other security measures or changed any processes since the drug diversion.
*He stated:
-"Per DCI we are to keep it between us. We want to be able to catch who is doing this so nothing has changed."
-"The only ones that know are myself, [paramedic C's name], [pharmacist B's name], chief nursing officer [CNO] D and [chief executive officer] CEO E at this point."
-"We stopped doing random drug testing a while ago, not sure why. It would be hard to tell even if we did one."
*The pharmacist had not:
-Been aware the MedVault doors had been removed for a software update and should have been.
-Assisted with the security measures or process that he put in place during those MedVault updates.
-Been over to the ambulance department to check on any of their security measures with meds before or after the drug diversion occurred.
*The pharmacy department should have been more involved with the processes and security of their meds at all times.
*There were no policies and procedures in place for the ambulance department to follow on drug diversion, security, and accountability.
-They would have followed the hospital policies.
-There had not been any individualized policies for their department.

Interview on 11/15/22 at 1:15 p.m. and again on 11/16/22 at 1:30 p.m. and 5:00 p.m. with CNO D revealed:
*She had been aware of the drug diversion incident on 8/28/22 in the ambulance department.
*She stated:
-"Just recently there was another med that looks like it was tampered with."
-"It was a MS injectable. It was found during their daily checks."
-"[Ambulance director's name] was gone again on vacation when it was found."
--"They think this might be a window of opportunity."
*There was only a few of them that knew about the drug diversion.
*The provider was working with DCI and they were taking any and all direction from them.
*With the partnership with the DCI they were instructed to not let others know or the ambulance staff.
*[Pharmacist B's name] was keeping all the meeting notes and investigation information.
*She was not aware of any master key that would have been used to override the MedVault system when the electronics were down.
*She stated:
-"You would have to check with [pharmacist B's name] about that."
-"Maybe it's with the house nurse supervisor, but that person changes, so I'm not sure."
*She was not able to locate any provider policies and procedures specific to the ambulance department.
*She stated:
-"You probably are not going to get what you are looking for."
-"I can't find any policies or procedures for the ambulance department."
-"Yes, they should have their own because their processes for drug security and accountability are different then the hospitals."

Interview on 11/16/22 at 2:30 p.m. with pharmacy director B revealed:
*He had been aware of the drug diversion activity in the ambulance department and was a part of the investigation process.
*He confirmed:
-The provider was working with DCI on this incident and had been following their direction and lead with this investigation.
-The ambulance director had been gone when both incidents had occurred.
-The same paramedic had found both meds that had been tampered with.
--The first incident was on 8/28/22 of two vials of fentanyl and the second was a MS injectable.
*The MS injectable had not been tested to confirm its contents per the direction of the DCI.
*He was aware the ambulance director, with the help from paramedic C, had been doing daily checks/counts on the controlled substances.
*He was not aware:
-The MedVault doors had been removed for software updates.
-Of what process the ambulance director had put in place for med security while those doors had been removed.
*He stated "[Ambulance director A's name] didn't talk to me about the MedVault doors and a process while they were off."
*To his knowledge, the MedVault door and electronic updates had not been discussed in any of the meetings they both attended.
-He agreed it should have been discussed for everyone's awareness.
*He was aware there was a master key that would override the MedVaults when their electronic system was down.
-He was not sure who had possession of that key since the drug diversion had occurred.
*He was not aware:
-Who had possession of that key since the drug diversion had occurred.
-The process with that master key had changed when updates on the MedVault doors were completed.
-Each MedVault had their own key that was secured to it with a breakaway tab process.
*The ambulance department should have been following the same policies and procedures as the hospital for medication security.
*He was not aware the ambulance director and paramedic C had been doing daily checks/counts on the controlled substances without a witness.
*He confirmed:
-The hospital policy was for all staff to have a witness when counting and destroying controlled substances.
-The ambulance department should have been following that same process.
-The paramedics did a daily check/count of their meds on the ambulance they were assigned to.
-That count had been done without a witness.
*He did not have any policies and procedures specific to the ambulance department.
*He stated:
-"I would have helped in the very beginning stages with developing them, but not after."
-"The directors are responsible for their own policies and reviewing them."
-"You will have to check with [ambulance director A's name] on any policies and procedures they have."
-"Yes, they should have their own policies because the hospitals processes are different."
-"They do not use the Omnicell for drug security and accountability like the hospital, so yes, there should be different policies."
*He:
-Had not been involved with checking on the ambulance departments drug security and accountability process.
-Could not recall the last time he was over there and checked on their processes.
-Had not been to the ambulance department to check on the med security since a drug diversion had been identified on 8/28/22.
-Stated: "Since I don't go over there and did now, the staff would be suspicious because I am never over there."
*He agreed:
-The ambulance department was a part of the hospital system and he had oversight of their med processes as a pharmacist.
-There had been a breakdown in that process.

4. Observation on 11/15/22 at 2:02 p.m. in procedure room 2 revealed:
*There was an unsecured sharps container in the procedure room.
*Inside the sharps container there was:
-Approximately 14 vials of discarded Propofol.
--The vials had a white-milky substance that appeared to be Propofol remaining in the vials.

Observation on 11/15/22 at 2:11 p.m. in OR 1 revealed:
*There was an unsecured sharps container on the side of the anesthesia cart.
-The sharps container was able to be lifted off of the cart.
*Inside the container there was:
-Discarded vials and syringes swimming in a white milky substance.
-The substance had been disposed of inside the container but was not in a vial or a syringe.

Observation on 11/15/22 at 2:19 p.m. in OR 2 revealed:
*There was an unsecured sharps container.
*Inside the sharps container there had been:
-A 20 milliliter(mL) syringe that contained approximately 10 mL of a white-milky substance.
-A vial of Ketamine with medication remaining in the vial.
-Vials of Propofol with medication remaining in the vials.

Interview on 11/16/22 at 7:30 a.m. with director of surgical services H revealed she:
*Had been unaware there was discarded Propofol vials in the ORs and procedure rooms.
*Agreed the medication should have been secured from unauthorized access.

Interview on 11/16/22 at 9:20 a.m. with anesthesia director G revealed:
*Staff should have been disposing the remaining Propofol in the pharmaceutical waste container.
*There was to be no remaining vials of Propofol or medication disposed of in the sharps container.
*Propofol was a highly divertable medication that should have been secured and wasted to prevent unauthorized use.

Interview on 11/16/22 at 3:30 p.m. with director of pharmacy B revealed:
*He had been unaware they were disposing of Propofol and other medications in the sharps containers.
*Propofol could be a highly divertable substance and it should have been properly disposed of.
*Housekeepers and other unauthorized personnel had access to the ORs and procedure rooms.

Interview on 11/17/22 at 8:35 a.m. with the CEO E and CNO D revealed:
*They agreed:
-The sharps containers were expected to have been secured.
-Propofol was to be discarded properly to prevent unauthorized access to the medication.
*They would have expected the pharmacist to:
-Assist with the development and onging updating of the ambulance department's policies and procedures.
-To be aware of the med security process and policies that had been used in the ambulance department.
-Be knowledgeable of any changes occurring in that department in regards to process changes such as the MedVault updates and med security process implemented during those updates.
-Know there was a change with the key access to MedVaults and who currently had the master key.
*They would have expected the ambulance department:
-To follow the hospitals policies on drug accountability and security. That would have required two person witness with controlled substance counts and destruction.
-To also have their own policies as a department because not all of their processes were the same as the hospital.
*They had not been aware:
-The pharmacist had little to no oversight of the med security in the ambulance department.
-The ambulance department had no policies and procedures for the staff to follow to ensure all meds had been accounted for and secured .
*There was a breakdown of communication and oversight by the pharmacy department over the ambulance department and there should not have been.

5. Review of the provider's April 2013 Medication Storage, Handling, Safety, Administration, and Documentation policy revealed:
*"Medication handling and administration are an integral part of healing and patient care. The physicians, nurses, pharmacists, and other care providers must handle medications in a manner that is consistent with safe storage, handling, and administration procedures."
*"This policy applies to any staff that assist with medication handling, delivery, storage, administration, or documentation."
*"Ordering and procuring medications will be the sole responsibility of the Pharmacy Department. All medications used at the [hospital's name] will be ordered, received, and issues by the Pharmacy. The Pharmacy will order only from suppliers that can ensure chain of custody and quality for the medications that are ordered."
*"The Pharmacy will be responsible for receiving, communication, and managing all recalls related to medications..."
*"All medications will be stored in well illuminated and secured areas that prevent access by patients, residents, visitors, or unauthorized individuals."
*"Medications administered by the ambulance personnel will be documented in the ambulance trip report."
*There had been no other documentation in the policy to support how:
-The ambulance department should have distributed, secured, and accounted for their meds in the ambulances.
-All departments should have completed med counts/checks and destruction of controlled substances.

Review of the provider's 3/6/10 Pharmacy Director Job Description revealed the director:
*Was "Responsible for directing, coordinating, and controlling the operation of the Pharmacy Department.
*Ensured compliance with patient care quality standards, directs and controls the purchase and inventory maintenance of all pharmaceuticals and related substance/supplies."