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401 WEST GLYNN DRIVE

PARKSTON, SD 57366

PATIENT CARE POLICIES

Tag No.: C1016

Based on observation, interview, and policy review, the provider failed to ensure only authorized personnel had access to pharmaceutical/biological waste containers awaiting destruction in:
*One of one switch gear/mechanical room.
*One of one outdoor storage shed.
Findings include:

1. Observation and interview on 7/27/21 at 2:00 p.m. with pharmacist coordinator B regarding the storage for pharmaceutical/biologically hazardous waste awaiting destruction revealed:
*The provider used a pharmaceutical waste service.
-The waste was picked up annually.
*The provider placed non-hazardous and hazardous waste into the black pharmaceutical containers.
*Chemotherapy/cytotoxic waste was stored in yellow waste containers.
*A different black waste container was used for chemotherapy drugs that had more than 3 percent left in the container.
*Other regulated medical waste was collected in red sharps containers.
-Drug enforcement Agency (DEA) controlled medications left in vials were to have been wasted into the Cactus unit (a narcotic waste receptacle that rendered the drugs unpalatable).
-Pharmacist coordinator B was not responsible for the removal and storage of full sharps containers.
-Housekeeping supervisor C had been responsible for the sharps containers.

Observation of the procedure room at the above time with pharmacist coordinator B revealed a large sharps container. That container contained multiple syringes, tubing, and glass vials.

Observation and interview of the pharmaceutical/biohazard storage area on 7/27/21 at 2:45 p.m. with pharmacist coordinator B revealed she:
*Entered the boiler room and the adjoining switch gear room.
-Both rooms had been unlocked.
*Stated:
-She was aware the black biological waste and yellow waste containers had not been stored securely.
-The provider had very little storage area options.
-The boiler room and switch gear doors had not been locked and were not locked at other times.
*Confirmed:
-The black and yellow pharmaceutical waste containers:
--Had been stored in the switch gear room.
--Had been labeled as to when they had been placed in the room.
-That room had a door that opened to the back of the hospital, was locked from the outside, but could be exited from the inside.
-The container openings were covered with a plastic lid, but had not been secured:
--In the room.
--By any locking devices.

Observation of the red sharps container storage area and interview on 7/28/21 at 9:00 a.m. with pharmacy coordinator B, housekeeping supervisor C, and maintenance technician D revealed:
*Maintenance technician D lead the group to a small storage shed outdoors beside the switch gear door and unlocked the door with a key.
-There were four boxes that would have been stored there until Stericycle picked them up.
*Housekeeping supervisor C confirmed:
-She and all other housekeepers were responsible for removing sharps containers when they were full and moving them to the storage shed.
-There was only one key to the shed.
-That key was:
--Kept on a wall in the switch gear room.
--Not secured and would have been accessible to all employees walking into that room.

Interview on 7/28/21 at 1:30 p.m. with nursing service administrator A regarding the unsecured pharmaceutical waste confirmed the pharmaceutical waste awaiting destruction had not been stored securely.

Review of the provider's January 2020 Pharmaceutical Waste Disposal policy revealed:
*Regulated medical waste including infectious sharps such as syringes with needles, anything visibly contaminated with blood or body fluids, were to have been disposed in a red sharps container. "Glass ampules with or without pharmaceuticals left in them should also be treated as a sharp and placed in a sharps container."
*Pharmaceutical waste had included vials that contained more than three percent of the substance, loose tablets or capsules was to have been destroyed in the Cactus system or placed in a black waste container.
*Once the container was full the housekeeping department was contacted to pick it up.
*Housekeeping was to remove the full, closed container and have placed it in the hazardous waste storage room.
*Waste manifests were to have been stored in the office of the quality assurance officer.

INFECTION PREVENT SURVEIL & CONTROL OF HAIs

Tag No.: C1208

Based on observation, interview, and policy review, the provider failed to ensure infection control precautions were maintained in the following areas:
*One of one emergency room.
*One of one operating room.
*One of one labor and delivery room.
Findings include:

1. Observation on 7/26/21 at 2:02 p.m. of the ED room revealed:
*There were two beds in the room, bed A and bed B.
*Bed A had an opened Yankauer suction tubing that had been opened and placed back in the package.
*The Yankauer tubing contained visible moisture.
*The tubing was located on the wall at the head of bed A.
*In the clean supply closet there was:
-An uncovered soiled utility hopper, that contained water.
-An uncovered Bear Hugger machine that was adjacent to the hopper.
-An open shelving unit that contained clean supplies.
-An opened pack of chux pads on top of a closed door cabinet that contained linens and towels.
-A cart that contained casting supplies.
-A fridge that contained clean ice packs used for patients.
*There was no separation between the clean items and the soiled utility hopper.
*There were two partially used rolls of tape and a partially used roll of Coban on a computer cart by the keyboard.

2. Observation on 7/26/21 at 2:30 p.m. of the labor and delivery room revealed:
*There was an opened vaginal delivery kit, laying on top of a cabinet.
*A partially used roll of paper tape on an epidural cart.
*Intravenous (IV) machine with what appeared to be dried blood on the back.
*Two rolls of partially used tape on the computer cart, by the keyboard.

3. Observation on 7/27/21 at 9:00 a.m. of the facility's OR revealed:
*Adjacent to the procedure table was an Olympus Surgical Tower with a Post-It note on top of it.
*There was a Post-It note on the oxygen tank.
*On the anesthesia cart there was:
-Two used patient caps laying on the flat surface of the cart.
-Used single-use tape on the cart.
-Opened oxygen breathing mask and tubing.
-Two pairs of gloves laying on top of the cart.
*On the Pyxis medication cart in the OR there was:
-A laryngoscope in a package that was opened.
-A small laryngoscope that was opened and placed back in a bin.
-A larger laryngoscope that was opened and placed back in a bin.
-Two used rolls of tape.
*A Yankauer suction tubing that had been opened, connected, and placed back in the package.
*On the GlideScope video cart was a basket that contained:
-A pediatric GlideScope laryngoscope in sterile packaging that had been opened.
-An adult GlideScope laryngoscope in sterile packaging that had been opened.

4. Interview on 7/27/21 at 9:24 a.m. with certified registered nurse anesthetist (CRNA) F revealed:
*He confirmed that:
-The opened sterile packages should not have been there, and required re-sterilization.
-They had a case the other night, he was assuming that was why things were opened on the anesthesia cart and had not been thrown away.
-All of the tape should have been thrown away.
-The tape they use is single-use tape.
-Some staff open packages to prep for cases.
-The packages should not be opened ahead of time.
-He noticed the open packages as soon as he walked in the OR.
-They were supposed clean off the anesthesia cart when they are done with a case.
*CRNA F then began cleaning the anesthesia cart and discarding the opened packages.

5. Interview on 7/27/21 at 9:30 a.m. with housekeeping director C revealed:
*They clean the OR after procedures.
*The OR had been cleaned after the last procedure.
*Housekeeping wound not have cleaned the anesthesia cart, the CRNAs do that.
*They would not have handled the opened packages that are found in the OR.

6. Interview on 7/28/21 at 8:20 a.m. with registered nurse (RN) infection preventionist H and nursing services administrator (NSA) A revealed:
*NSA A agreed there should not have been any open packages in the ED or OR.
*They:
-Did not have enough space to have separate clean and dirty utility rooms.
-Agreed clean and dirty items should be separated.
-Had looked at putting plastic over the hopper in the clean storage room.
-Agreed tape should be thrown away after use.
*The staff were supposed to be taking off the amount of Coban they needed with clean hands and place the coban back in a clean space.
-They had not audited this process to ensure it was happening.

7. Review of the provider's April 2021 Maintaining a Sterile Field policy revealed:
*"All individuals involved in surgical intervention must establish and maintain a sterile field. These individuals should maintain aseptic practices preoperatively, intraoperatively, and postoperatively in order to protect patients from injury, minimize would contamination, and reduce patient risks for surgical site infections."
*Items will be inspected for proper packaging, seal, and package container integrity.
*All items introduced to a sterile field are to be opened, dispensed, and transferred to maintain sterility.
*Nonsterile equipment will be covered with a sterile barrier before being brought into the sterile field.

Review of the provider's February 2021 Anesthesia Infection Control policy revealed:
*Anesthesia supply's cleanliness and sterility will be maintained by CRNA staff.
*Anesthesia circuits are to be wiped down between cases.
*All disposable items are discarded after use.

9. Review of the provider's February 2021 Operating Room Personnel Infection Control policy revealed:
*"To provide guidelines for infection control pertaining to anesthesia equipment and personnel in the operating suites. It is designed to protect the patient and employee from infection by promoting prevention, early recognition, and containment of infection."
*All OR personnel were expected to have kept their work areas in a clean and orderly fashion.
*Suction apparatus is changed between each patient.

Review of the provider's February 2019 Infection Control Program policy revealed:
*"Develop, maintain, and evaluate, on an ongoing basis, the effectiveness of the infection prevention activities within the hospital.
*"Evaluation and revision of preventive, surveillance, and control procedures relating to the inanimate hospital environment, including sterilization processes, disinfection practices, central sterile, housekeeping, laundry, engineering and maintenance, food sanitation and waste management."
*"The infection prevention Program has an ongoing, systematic process of monitoring. When important problems related to patient care or opportunities to improve care are identified, actions are taken and the effectiveness of the action is evaluated."


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8. Interview on 7/28/21 at 8:45 a.m. with the head of maintenance I in regard to the climate control system for the operating room revealed:
*The climate control system for the operating room was computer controlled.
*The system was set to keep the humidity below 55 percent.
*The relative humidity in the return air was 52 percent
*The system would not have given any notification or alarmed if the humidity was above the set point.
*The system was not tracking the history of the humidity in the operating room.
*The system was not equipped to add humidity so there was no set point for low humidity.
*They used to track the humidity with a hygrometer in the operating room and write it on a log sheet.
-They were no longer doing that.

Interview on 7/28/21 at 10:15 a.m. with the nursing service administrator A revealed the staff in the operating room were not tracking the humidity in the operating room.

Review of the August 2014 Infection Control in the OR policy revealed:
*"D. Humidity and Temperature:
Persuant to the 2014 AORN [Association of periOperative Registered Nurses] Recommenced Guidelines the Humidity and Temperature control should be to create and maintain a safer physical environment. These guidelines also help perioperative nurses collaborate with infection control preventionists, engineers and other colleagues in establishing and maintaining a safe physical environment.
1. Humidity: AORN recommends daily monitoring is not required. Humidity at 30 - 60 % [percent] should be maintain and monitored on surgical days.
2. Temperature should range between 68 - 73 degrees, but should be adjusted and evaluated to support patient care.
3. Documentation of the Room temperature and humidity will be documented on the OR [operating room] log."