HospitalInspections.org

Based on observation, interview, record review, and policy review, the provider failed to ensure:
*Access to controlled substances had been monitored and accounted for in one of one medication overflow room.
*Medications had been properly secured and monitored to prevent unauthorized access in:
-One of one pharmacist office.
-One of one pharmacy storage room.
Findings include:

1. Interview on 2/7/22 at 3:00 p.m. with chief executive officer (CEO) H and director of finance/human resources (HR) J regarding their current staffing and situation in the pharmacy department revealed:
*There had been two pharmacists hired for that department as the pharmacy department was open six days a week.
*Pharmacy director I was currently out on medical leave.
*Part-time pharmacist D had been working those extra hours during the director's absence.
*In the interim, the Avera corporation was assisting with pharmacy coverage and the staff could utilize ePharmacy.
*The last audit completed on their controlled substances was on 6/30/20 by the South Dakota (SD) Board of Pharmacy.
-To CEO H's knowledge there had been no other controlled substance audits completed.
*There was no separate pharmacy and therapeutics meeting (P & T).
-That information was reviewed at the monthly med staff meetings and had not supported the completion of any controlled substance audits.

Observation and interview on 2/7/22 at 3:10 p.m. with pharmacist A in the medication overflow room by the nurses' station revealed:
*He had:
-Been an employee for the provider in 2012.
-Been asked to help out that day by the administrator and any upcoming days in the near future.
*The entrance door was locked and pharmacist A was able to enter the room by using a key he took out of his pocket.
*"The pharmacists and nursing staff are the only ones who can get inside this room."
*"There's a key in the Pyxis that the nurses use. That is how they keep track of who goes in and out of the room for them."
*"We [pharmacists] have our own key to go in and out."
*"We don't take these home, they stay here in the pharmacy department."
*There was no tracking of how often the pharmacist went in and out of the overflow room.
*There had been:
-Several cupboards and shelving in the room for storage of legend (require a prescription from the physician) meds, over-the-counter meds, and controlled substances.
-Two of those cupboards required a key to open them.
*He opened the cupboards with a key from the set he had taken out of his pocket.
*Inside of the cupboards had been several controlled substances.
-They had been in the form of pills, transdermal patches, and injectables.
*"They lock-up all controlled meds like your scheduled II, III, IV, and V."
*"All of the meds in this room are used for the hospital and do not come from the retail pharmacy."
*"The Pyxis will let you know when it is running low on a med or when one is outdated."
*"All of these meds are what they keep the Pyxis stocked with."
*There was:
-A narcotic logbook that had been used to keep track of what meds were in the cupboard and how many.
-A separate sheet was used to document each med for when it was added and how many had been removed.
-Meds that would have been removed to fill the Pyxis or when it was outdated.
*To his knowledge those controlled substances were not counted on a regular basis, but only when some were added or removed from the cupboard.
-The pharmacist was the only person who had access to those meds and it was not required for them to have a witness during the process of removing, adding, or destroying them.
*He was not sure:
-How often the pharmacist had completed a straight count on those meds and if a witness was required.
-What their destruction process of the expired meds had been or where they were stored until destroyed.
-What their auditing requirements were outside of the biennial review from the SD Board of Pharmacy.
*"Typically, most facilities complete audits on their controlled substances a minimum of monthly."
*"There's not been a lot of changes in their processes here since I worked in the past."
*The Pyxis would not have told them how many meds to add or remove from the med cell. That process had been at the discretion of the pharmacist.
*There was no direct documentation between the Pyxis and the narcotic cupboards in the overflow room.
-That left a window of opportunity for meds to have been diverted.
*"Maybe it would have been caught with their biennial audits and maybe not."
*"The Board of Pharmacy does not check all of them. They pick random meds to look at and I don't know how they decide that."

Continued observation on 2/7/22 at 3:20 p.m. of the controlled substances located in the overflow room revealed the following meds:
*Diazepam 5 milligram (mg) tablets.
*Lorazepam .5 mg tablets.
*Midazolam 2 mg/2 ml (milliliter) injectables.
*Tramadol 50 mg tablets.
*Ambien 5 mg tablets.
*Demerol 100 syringes.
*Fentanyl 100 mcg (microgram) transdermal patches.
*Hydrocodone 5 mg/325 mg tablets.
*Oxy IR 5 mg tablets.
*Hydrocodone 10 mg/525 mg tablets.
*Morphine Sulfate 2 mg/ml injectables.
*Morphine Sulfate 4 mg/ml injectables.
*Oxycontin 10 mg tablets.

Observation and interview on 2/7/22 at 3:35 p.m. with pharmacist A and pharmacy technician B of the pharmacy office revealed:
*The office had been in the retail pharmacy area and adjacent to the hallway where the hospital and retail staff had access to it.
*The entrance door:
-Was unlocked and opened for access to have occurred by unauthorized personnel coming into the retail pharmacy.
-Did not have any type of safety or security lock on it.
*There was a window on the outside wall that clients walked pass when entering the retail pharmacy.
-The window was not covered, and anyone could look inside into the office.
*Underneath of the window was a metal desk that had some boxes on it and several med bottles.
-Inside of those bottles and boxes had been controlled substances.
-There were random numbers written on all of them with a black sharpie.
*Neither the pharmacist nor pharmacy technician knew where they had come from.
*Pharmacist A stated: "They were here when I got in this morning and I have no idea where they came from. I started work at nine this morning"
*Pharmacy technician B stated: "I worked last Thursday and Friday and they were not here then. I have no idea where they came from. Unless [name of pharmacist D] was checking them and didn't get done."
*They both agreed the meds:
-Had not been secured and should have been.
-On the desk created a window of opportunity for misappropriation of meds to occur.
*The entrance door to the pharmacy office was always open and not secured from entrance by the retail and hospital staff who entered the area.
*There was no lock on the pharmacy entrance door to secure the room when the door was shut and would have allowed for unauthorized access.

Continued observation and interview on 2/7/22 at 3:40 p.m. with pharmacist A of the unsecured controlled substances in the pharmacy office revealed:
*A sealed box of five Fentanyl 100 microgram transdermal patches.
*Several opened bottles that contained:
-Six Methylphenidate Hydrochloride extended release 27 mg tablets.
-Half a bottle of Dexmethylphenidate HCL extended release 20 mg capsules.
-Twelve Oxycodone HCL 20 mg tablets.
-Forty Dextroamphetamine 10 mg capsules.
-Forty Dextroamphetamine 5 mg capsules.
-Sixty-nine Methylphenidate extended release 30 mg tablets.
-Ten capsules of Temazepam 7.5 mg.
-Ninety-three Methadone Hydrochloride 5 mg tablets.
*He agreed the meds were not secured and created the opportunity for inappropriate handling and drug diversion to have occurred by both authorized and unauthorized staff.

Observation and interview on 2/7/22 at 3:50 p.m. with pharmacist A and pharmacy technician B of the storage room in the hallway outside of the pharmacy office revealed:
*The entrance door was not locked.
*There had been:
-Several shelves in the room that contained pharmaceutical supplies such as empty med bottles, and delivery bags.
-Four open square boxes sitting on the floor underneath the window.
*All four of the boxes had been lined with clear plastic bags.
*One out of the four boxes were empty but had a sign taped to it with the word "Hospital" on it.
*Two out of the four boxes had multiple legend and over-the-counter meds inside of them.
*The pharmacist was not sure, but thought the meds required counting and then placed in a holding container for their N-MAR or take back program.
*Pharmacy technician B confirmed:
-Controlled substances from the hospital and overflow room would have been stored in the box labeled "Hospital" until the pharmacist had time to take care of them.
-The meds had to be counted and either destroyed or taken care of in some manner. She was not entirely sure what the pharmacist did with the controlled substances from the hospital.
-She had access to this room and any meds placed in those boxes.
-It would have been easy for any technician or pharmacist to take meds from those boxes.
-She had not been a witness to the pharmacist destroying or handling controlled substances. She stated: "He took care of the hospital meds and I don't know what his process was." "We did unpack the delivered meds together but there was no counting of the meds he handled." "I have to be double checked, but he didn't." "This room is supposed to be locked. I don't know why it's not."
-The hospital staff would have to go by the room when entering or exiting the pharmacy area.
-With the entrance door unlocked any staff member could have entered the room and taken meds.

Interview on 2/8/22 at 2:15 p.m. with pharmacist D revealed:
*Usually he worked one to two days a week but had been filling in for the pharmacy director.
*He had been working for the provider approximately three years now and mostly on the retail side.
*The process reviewed above with pharmacist A of the overflow room meds and Pyxis medstation.
*The Pyxis medstation would have informed the staff when a med was getting low or close to the expiration date.
*"The Pyxis won't tell you how many meds to replace or put in it. Just if it's low or expired."
*"It doesn't do a perpetual log of what we put in it. There is a window of opportunity there for meds to be taken."
*"Nobody monitors the pharmacist taking meds out of the room or putting in the Pyxis."
*"We have our own key to get in the overflow room. The nurses are the ones tracked going in and out of that room. They have to get a key out of the Pyxis."
*He had:
-Placed the scheduled II meds on the desk in the pharmacy office.
-Found them just sitting on the counter by the sink in the retail area.
-Not been sure what to do with them so he had placed them on the desk.
*"I'm not sure what his destruction process is for those and put them there for now."
*"The pharmacy office is not secured to prevent someone from taking them."
*"The door is always open, hospital and retail staff come and go all the time."
*He was not aware the storage room door was unlocked but had knowledge of the med boxes.
*"The hospital box is where the overflow room meds go."
*"Not sure how he handles them, but they do go in there."
*"I'm not sure how the audits are done either. He [pharmacy director I] handled all of that."

Review of the monthly med staff meeting minutes from 7/13/21 through 1/18/22 revealed:
*Pharmacy director I had not attended the meetings.
*There had been no P & T reports for the months of August, September, and November.
*There had been a policy review on Controlled Substance Record in October 2021.
*There was no documentation to support how frequently the controlled substances had been accounted for in the hospital.

Interview on 2/8/22 at 4:45 p.m. with CEO H regarding the above observations and interviews revealed:
*She was not aware of all the opportunities for misappropriation of controlled substances observed above.
*"To be honest, I don't know their protocols. They [pharmacists] pretty much do their own thing."
*"Except for the biennial survey, I know about that."
*"With that survey everything checked out okay so there was nothing left to question."
*There were processes and policies that needed reviewed and changed to ensure the security of controlled substances occurred.



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2. Observation and interview on 2/7/22 at 3:00 p.m. with registered nurse (RN) C in the medication room revealed:
*Cabinets and drawers that held patient supplies and a handwashing sink.
*A Pyxis medstation with an attached locked medication refrigerator.
*The Pyxis medstation contained legend, over-the-counter, and controlled medications.
*RN C stated each time a controlled medication was removed from the Pyxis medstation it had to be documented how many pills of that type were left in the bin.
*The pharmacist refilled the Pyxis medstation.
*The room next door to the medication room was called the overflow room.
*It contained medications that were used to stock the Pyxis medstation and controlled medication cabinets.
*The key to access the overflow room was in the Pyxis medstation so it would be known who had gone in the overflow room.
*The pharmacists had their own key to access the overflow room and a the key to the controlled medication cabinets in the overflow room.
*Observation of the overflow room revealed legend and over-the-counter medications on the shelves, two locked cabinets, and a plastic tote labeled "Transport Tote."
*RN C stated the two locked cabinets had the controlled medications and only the pharmacist could access them.
*That tote had a small padlock on it.
*RN C stated that tote was not used anymore. She was not sure what medications or supplies, if any, were in it.

Interview on 2/7/22 at 3:30 p.m. with pharmacist D revealed:
*He worked only one to two days a week and covered both the hospital and retail pharmacy.
*The pharmacists had their own key to the overflow room and the controlled medication cabinets.
*Was not aware of what the transport tote was or what it contained.

Observation and interview on 2/7/22 at 4:00 p.m. with director of nursing G of the transport box revealed:*The transport box had been used very rarely when a nurse was available to ride with a patient in the ambulance.
*She was not sure what the transport box contained.
*She retrieved the key from the Pyxis medstation and opened the box.
*There was no list inside of the box of what it contained.
*The list was located at the nurses station.
*She was not aware the box contained injectable morphine sulfate.

Review of the provider's daily narcotic count sheets from 10/1/21 through 2/6/22 revealed:
*The Pyxis count, narcotic drawer #1 count, and key count areas for documentation.
*There were two signatures for the Pyxis count, a line drawn through the narcotic drawer #1 count, and 3 for the key count.
*There were missing signatures on 10/11/21, 10/12/21

Review of the provider's Transport Box monthly inspection sheet for 2021 revealed:
*It contained medications that included ten morphine sulfate 4 milligram per milliliter carpujects (syringes).
*Each month the box had been checked for contents and expiration dates by the nurses.

Review of the provider's revised February 2021 Pharmacy Keys in Pyxis policy revealed:
*Pharmacy keys would have restricted access via the Pyxis to ensure control and maintain security of pharmacy medications.
*The main pharmacy access key, the key to unlock the controlled substance cabinet doors, the transfer box key, and the medication locked drawer key would be stored in different cubbies in the Pyxis machine.

Review of the provider's revised March 2021 Pyxis ES Landmann-Jungman Memorial Hospital specific information policy revealed:
*The pharmacy keys would be stored in the Pyxis medstation. Those keys included the pharmacy, pharmacy control (for controlled substance), medication room locked drawer, and the transfer box.
*Those keys would only be accessible by logging into the Pyxis medstation and selecting the correct key.
*The pharmacy key should be returned to the Pyxis medstation immediately after each use.
*Pharmacy staff would periodically empty the return bin.
*Controlled substances emptied from the return bin would be reconciled within the provider's CII safe by pharmacy personnel.
*Controlled substance inventory and discrepancies required a blind count and a witness.
*Controlled substances in the Pyxis medstation would be inventoried monthly. Those inventories would take place during the fourth week of the month by two staff members from nursing or pharmacy.
*Monthly inventory counts would be audited by pharmacy staff for completion and discrepancies.

Review of the provider's revised July 2021 ACLS (advanced cardiac life support) Transfer Tote policy revealed:*Emergency medications for emergency medical system (EMS) transports would be kept in a tote.
*The tote would be stored in the locked pharmacy. The locked pharmacy and transfer tote keys would be located in the Pyxis medstation.
*Items in the tote were checked monthly for outdated medications and supplies by nursing.

Review of the provider's March 2019 Controlled Substances Inventory policy revealed:
*"An inventory is a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant as determined by an actual physical count for schedule II, III, IV, or V controlled substances."
*"The inventory will be taken once a year as to comply with State Board of Pharmacy Regulations. The pharmacy personnel are responsible for the inventory process."

Review of the provider's March 2021 Hospital Drug Storage and Safekeeping policy revealed:
*"The pharmacy will be locked at all times. Access to the pharmacy is limited to pharmacists, pharmacy staff under the direct supervision of a pharmacist, providers, and registered nurses on duty."
*"In addition to the pharmacy, drugs are stocked in the medication room, transfer box, and emergency carts. The pharmacy and therapeutics committee is responsible for determining which drugs are stocked in the respective areas of the hospital."
-No documentation to support the stocked process for the overflow room.
*"All controlled drugs will be stored in locked cabinets or in the Pyxis machine. Only licensed personnel or authorized personnel under the direct supervision of licensed personnel