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Based on observation, interview, and policy review, the provider failed to ensure medications (med) had been properly monitored and secured to prevent unauthorized access to them in the following areas:*One of one randomly observed tray containing anesthesia meds in one of one anesthesia office.
-There was no system in place to monitor which staff had accessed those medications, which patients the meds had been used for, or how many meds should have been in the tray.
*Randomly observed sharps containers holding partially used meds in one of four operating rooms (4), random medical unit patient rooms, and one of one outside storage area were handled by unauthorized staff (housekeeping and maintenance) when they were full.
*One of one medication room in the outpatient surgical center contained one of one tote of unidentified medications.
-There was no system in place to identify who had received that tote, when it had been delivered, or who had access to it until it was handled by pharmacy staff.
Findings include:

1a. Observation and interview on 1/30/18 at 2:30 p.m. with the director of surgical services and certified registered nurse anesthetist (CRNA) A in operating room 4 revealed:*A sharps container attached to the anesthesia cart contained partially used syringes and vials of meds.
*They confirmed there were meds in that container that would have been used for anesthesia purposes.
*Once the sharps container were full housekeeping staff was responsible to remove it and replace it with a new one.

b. Observations and interview on 1/31/18 at 1:15 p.m. with housekeeper C on the medical unit revealed:*Housekeeping staff handled the sharps containers in patient rooms when they were full.
*They brought the full containers to an outside area until they were picked up by some other company.
*Housekeeping and maintenance staff had a key to that outside storage area.

c. Observation and interview on 1/31/18 at 1:30 p.m. with housekeeper C and maintenance staff D in the outside storage area revealed:
*The room was used to store the sharps containers and biohazard containers until they were picked up by the vendor.
*There were ten full sharps containers on the second shelf of a rolling metal cart that contained needles, syringes, and vials of partially used meds.
-Those were collected from multiple areas of the hospital.
*On the top shelf of the cart there was a large red sharps container with yellow zip ties on it.
-They stated that one would have been from the operating room area.
*They were unsure if there had been meds in those containers but confirmed they were not authorized personnel to handle meds.
*All housekeeping and maintenance staff had access to the storage area.
*Maintenance staff D stated there had been a change with the process, and it had "been a real mess."
-He had not been trained on what the expectations or process should have been.

Interview on 1/31/18 at 1:40 p.m. with pharmacist B regarding medication disposal in the sharps containers revealed:*Meds should not have been disposed of in the red sharps containers.
-They should have been put into the designated medication disposal containers.
*She confirmed if meds were disposed of in the sharps containers only authorized staff should have had access to them.
-Housekeeping and maintenance were not considered authorized staff.

Observation and interview on 1/31/18 at 1:55 p.m. with the director of the medical unit revealed:*She confirmed nursing staff put partially used vials and syringes containing meds into the sharps containers.
*Housekeeping staff handled the sharps containers when they were full and replaced them with empty ones.
*She confirmed housekeeping or other unauthorized staff should not have had access to meds.

Interview on 1/31/18 at 3:50 p.m. with the director of nursing regarding the meds in the sharps containers revealed:
*Access to meds should have been limited to authorized staff only.
-Housekeeping and maintenance were not considered authorized staff.
*Staff should have been disposing meds according to the provider's policy.

2. Observation and interview on 1/30/18 at 2:45 p.m. with the director of surgical services and CRNA A in the anesthesia office revealed:*On the counter was a large blue plastic tray containing multiple medications used for anesthesia including:-Three syringes and two vials of phenylephrine.
-Two syringes of succinylcholine.
-Five vials of diprivan.
-Five vials of dexamethasone.
-Two vials of naloxone.
*There was no lock or security of the meds in that tray.
*CRNA A stated:
-The CRNAs got those trays out of the automatic medication dispenser and put them into their anesthesia carts in the operating rooms for use during patients' procedures.
-More than one CRNA would have had access to and used those medications.
-Sometimes the tray was only used for one procedure and sometimes it was used for multiple procedures.
-When the CRNAs thought the tray needed refilling they brought it from their anesthesia cart to their office and set it on the counter.
-The tray would then stay in that office until pharmacy staff picked it up for refilling.
*They confirmed the office was designated for the anesthesia staff only, but all the CRNAs and pharmacy staff had access to that office.
-There was no monitoring of who went into that office or when.
*They agreed 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.
-There would have been no way to audit if a med had been missing or diverted.
*In the past they would have gotten a tray out for one patient's procedure only.
*They were unsure why the process had changed or when.

Interview on 1/30/18 at 4:05 a.m. with pharmacist B regarding the above concern with the anesthesia med trays revealed:*She confirmed there was no process in place to monitor or audit those anesthesia med trays.
*It would have been difficult to track or know if a medication was missing or diverted.
*Some meds in the anesthesia trays would have been considered high risk for drug diversion.
*All meds should have been accounted for with limited access to them.
*The process for those anesthesia trays had changed, but she was unsure why or when that had occurred.

Interview on 1/31/18 at 3:50 p.m. with the director of nursing regarding the anesthesia med trays revealed:*She confirmed all meds should have been accounted for with limited access to them.
*The anesthesia med tray process was not being done properly to prevent potential drug diversion.



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3. Observation and interview on 1/30/18 at 12:25 p.m. with registered nurse (RN) G in the endoscopy surgical center medication (med) room revealed:
*On the counter was a small med dispensing unit.
*Sitting next to the med dispensing unit was a large gray colored tote.
*Underneath of the counter were three opened and empty red colored totes.
*The lid for the gray colored tote had been secured shut with two yellow unnumbered zip ties.
*There was:
-No list available to help identify the contents inside of it.
-No record keeping available for review to support:
--Where the tote came from.
--Who delivered the tote.
--What staff member had accepted the delivery and when.
*RN G:
-Confirmed the tote currently contained meds for the pharmacy department to put inside of the dispensing unit.
-Stated:
--"Those are delivered twice a week and they sit there like that until pharmacy comes over from the hospital and puts them in the Omnicell."
--"I'm not sure when they are delivered or where they come from."
--"A nurse on duty would have had to accept it and put it in here. They are the only ones who have access to this room."
--"Those red totes come with controlled meds in them, and the process is the same."
*The pharmacist would place unnumbered red colored zip ties on the gray totes after placing the meds in the Omnicell.
*She was unaware why the pharmacist sealed it back up with red zip ties.
*To her knowledge there were twelve nurses on staff that currently had access to the med room, herself, and the pharmacy department.
*There was no monitoring systems or cameras in the immediate area to ensure the security of the med room and its contents.
*The only monitoring system in place was through the use of their electronic badges that the nurses had to use for access into the med room.
*She confirmed there was no process in place to monitor or audit those meds.
*She agreed the process above:
-Would not have ensured the security of controlled and uncontrolled meds.
-Allowed for the meds to have been easily accessible for drug diversion by multiple staff members.
*She agreed all meds should have been accounted for with limited access to them.

Interview on 1/30/18 at 4:20 p.m. with pharmacist B regarding the observations above regarding the delivery process and security for all meds located inside of the endoscopy surgical center med room revealed:
*She agreed with the interview with RN G.
*She confirmed there was no process in place to monitor the security of those meds.
*She stated:
-"The meds come from the hospital pharmacy department in Rapid City."
-"A courier delivers medications over there every Tuesday and Thursday."
-"The nurse signs a log for the courier to support delivery only."
-"The list of what meds the totes contain is inside of it for us to sign. Its sent back with that tote and courier."
-"We put red tags on the gray colored totes to let the courier know its ready for pickup."
-"We go over there when we have time and put the medications in the Omnicell."
*She agreed:
-If a med(s) was taken from those totes it would have been difficult to identify when and who took it.
-All meds should have been accounted for with limited access and diversional capabilities.

Interview on 1/31/18 at 4:10 p.m. with the director of nursing regarding the above observation and interviews revealed:
*She was unaware of the process they used at the surgical center for security and delivery of meds.
*She agreed:
-All meds should have been accounted for with limited access to them.
-The process above had created the potential for drug diversion to have occurred.

4. Review of the provider's 2018 Anesthesia Drug Security and Controlled Substances policy revealed:
*"A. Anesthesia carts will be locked, with all medications inside, when anesthesia providers leave the [unidentifiable word on the copy received]."
*"B. The Anesthesia workroom will be locked when the OR is not staffed."
-There was no mention of who had access to it when it was locked.
*"I. Pharmacy caregivers will do checks to verify that drugs are being labeled and properly disposed of according to established policy."
*There was a process identified for controlled medications and kits.
-There was no mention of the trays containing all the other anesthesia meds or what the process for them should have been.

Review of the provider's 2018 Drug Security and Storage policy revealed:
*"A. Only authorized personnel will have access to drug storage areas, machines, cabinets, or carts. Authorized personnel includes staff members providing care and services to patients including, but limited to, medical staff, anesthesia, surgical staff, nursing, pharmacy, respiratory therapy, paramedics, and ancillary support personnel as necessary to perform their assigned duties.
-1. Other staff may request access to drug storage areas.
-2. Staff must have prior approval from the supervising manager and from Pharmacy Director or designee.
-3. Access must be allowed under laws and regulations."
*"H. All medications will be stored securely to prevent unauthorized access."
*"2. Pharmacy personnel will deliver medications to ADS's [automatic dispenser system]. In areas where pharmacy cannot physically deliver medications, they will be sent in secure bags/totes by designated hospital personnel."
-The process for that deliver was not specified.
*"d. Areas with restricted access, such as clinics, pre-op, PACU, surgery, endoscopy and radiology specials may leave block carts and medications unlocked during business hours as long as medications are in areas that prevent unauthorized access. Medications shall be maintained in a locked area after business hours."
*"10. Medications in the nurse's or other caregiver's possession that are not dispensed to a patient may be returned to pharmacy. Those medications can be returned to the ADS return bill, turned back to pharmacy, picked up by pharmacy personnel or other designated hospital personnel in a locked bag/tote, or delivered to main pharmacy by the nurse or designated personnel."
*"11. Pharmacy will determine whether to return the medication to storage or destroy."

Review of the provider's November 2017 Hazardous and Infectious Waste Management Plan policy revealed:*"1. Hazardous waste: At Regional Health Spearfish Hospital hazardous waste includes any characterically hazardous or Environmental Protection Agency P listed or U listed pharmaceutical waste. This includes containers with medications still remaining in containers, not empty containers unless the container held a P listed pharmaceutical such as Coumadin, warfarin or nicotine."
*"2. Infectious waste: Includes but is not limited to the following:
-Pathological and surgical waste.
-Clinical and other biological and laboratory waste.
-Sharps such as used needles, scalpels or blades.
-Patient care items from isolation rooms or other areas where infectious patients have required care."
*Disposal of Hazardous and infectious waste included:
-Infectious waste was placed in "biohazard" labeled containers and sharps containers.
-Each department was responsible for segregating the waste generated at the point of origin in their department.
-"7. Hazardous waste pharmaceuticals include:
--a. Partial vials.
--b. Un-dispensed IV's containing medications.
--c. Pre-filled syringes.
--d. Partial syringes.
--e. Discontinued medications.
--f. Un-administered medications.
--g. Patient prescriptions.
--h. Physician samples."
-"10. Hazardous waste disposal containers are black and must be labeled with facility name, department container start date, container full date, emergency spill response contact, and contact for [unidentifiable word] pick up or issue."

Based on observation, interview, and policy review, the provider failed to ensure:
*Personal care products and linens for the patients had been stored in a sanitary manner in one of two medical supply rooms located on the medical/surgical unit.
*Yankauer suction catheters and tubing remained packaged until used in four of four pre/post-anesthesia care unit rooms (PACU) and two of two procedure rooms located at one of one surgical center .
*The protective vinyl covering on two of two patient exam/treatment chairs remained intact and free from uncleanable surfaces located in the wound care clinic.
Findings include:

1. Observation on 1/29/18 at 3:10 p.m. in a clean supply room located on the medical surgical unit revealed:
*A large covered cart inside of the room.
*The cart contained three shelves of various clean linens and unused personal care products for the patients to use.
*On the bottom shelf there had been two plastic containers.
*Those plastic containers had been:
-Filled with partially used medical and Coban adhesive tape.
-Located next to the clean linens and personal care products.

Interview on 1/29/18 at 3:20 p.m. with patient care health technician (tech) E regarding the above observation revealed:
*She confirmed:
-Between patients the staff would have restocked the patient rooms with those clean linens and personal care products.
-The tape was:
--Not considered clean and had been used for various reasons on the patients.
--Removed from the patient rooms after they had been discharged.
*She stated:
-"I'm not sure what they do with it after its been removed."
-"I think the staff take it home."
*She agreed the tape was not considered clean and should not have been stored on that cart with those clean items.

Random observation on 1/29/18 from 3:50 p.m. through 4:10 p.m. of six empty patient rooms revealed:
*They had been cleaned and were ready for a new patient.
*There had been a cabinet with one top drawer in each of the rooms.
*Inside each of those top drawers had been several rolls of partially used medical and Coban adhesive tapes.

Interview on 1/31/18 at 1:55 p.m. with registered nurse (RN) F regarding the above observations revealed:
*She was unaware the staff had been storing tape that had been used for various patients on the clean supply cart.
*She confirmed the empty rooms had been terminally cleaned and were ready for new admissions.
*She was unaware there was partially used tape available in those rooms for patient use.
*She agreed:
-The tape was not considered clean and should not have been stored with the clean supplies.
-Any tape used for a patient during their stay in the facility should have been disposed of after they were discharged.
-The above observations were unsanitary and created the potential for germs to have been spread from one patient to another.

Interview on 1/31/18 at 3:50 p.m. with the director of nursing (DON) regarding the above observations further supported the
interview with RN F.

2. Observation on 1/30/18 from 11:45 a.m. through 12:10 p.m. of the surgical center revealed:
*Four PACU rooms had Yankauer suction catheters and tubing that had been opened, were ready-for-use, were attached, and were hanging on the suction wall units.
*Two procedure rooms revealed the same Yankauer suction catheter and tubing observation as in the PACU rooms.

Interview on 1/30/18 with RN G at the time of the above observation revealed:
*She was unaware the Yankauer suction catheters and tubing were opened and ready-for-use in those rooms.
*She confirmed those items were considered single-use equipment and should have been kept free of potential contamination until used.
*Single-use supplies should not have been opened prior to use.

Interview on 1/31/18 at 3:55 p.m. with the DON regarding the above observations revealed:
*She was unaware the Yankauer suction catheters and tubing were opened and ready-for use in those rooms at the surgical center.
*She agreed there was potential risk of contamination to those items when they had not remained sealed in their packages.

Review of the provider's July 2017 Storage and Distribution of Supplies policy revealed "Storage of supplies shall be done under conditions, which tend to preserve, not threaten the integrity of the packaging."

3. Observation on 1/31/18 at 10:50 a.m. of the wound care clinic revealed:
*There had been three treatment rooms within that area.
*Two of the rooms had reclining treatment/examination chairs that were covered with a vinyl type material.
*The foot rest on one of the chairs had:
-Two small holes where the vinyl material was missing.
-A one inch by one inch area where the vinyl material had been toren open.
*The head rest on the other chair had two opened areas on the right top corner that exposed the foam cushion.
*All the areas observed on those chairs had been covered with a clear adhesive protective dressing.
-That type of dressing would have been used on patient wounds.

Interview on 1/31/18 at the time of the above observation with RN H revealed she:
*Had been aware both of the chairs had areas where the vinyl was no longer intact.
*Was aware:
-Those surfaces would not have been considered cleanable.
-The protective dressing covering those areas was also not considered cleanable.
*Stated:
-"The manufacturer had been in to fix those areas a while ago but the repair did not help."
-"So we covered them with tegaderm."

Interview on 1/31/18 at 4:00 p.m. with the DON regarding the above observations in the wound care clinic revealed:
*She was unaware the two vinyl covered chairs had areas that were not considered cleanable.
*She agreed:
-The protective dressing the staff had covered those areas with was also not cleanable.
-The process above had not been sanitary and created the potential for germs to spread from one patient to another.