HospitalInspections.org

Bringing transparency to federal inspections

910 EAST 20TH STREET

SIOUX FALLS, SD 57105

SECURE STORAGE

Tag No.: A0502

Based on observation, interview, and policy review, the provider failed to ensure medications had been properly monitored and secured to prevent unauthorized access to them in the following areas:
*One of one observed anesthesia airway medication and supply cart outside of patient room 208.
*One of one randomly observed crash cart in the unstaffed lower level.
*Randomly observed sharp's containers holding partially used medications in 1 of 15 operating rooms (3), random surgical unit patient rooms, and 1 of 1 outside storage area were handled by unauthorized staff (surgical technician, nursing assistants, and unlicensed staff) when they were full.
Findings include:

1. Observation on 5/20/19 at 2:15 p.m. outside of patient room 208 revealed a red six drawer cart and a wheeled vital sign machine with two baskets attached to the pole.

Observation again on 5/20/19 from 4:00 p.m. through 4:30 p.m. revealed the same cart and vital sign machine located by patient room 208.
Upon further investigation it was noted the cart was not locked or secured and revealed:
a. Medications in the cart included:
*Benzocaine 20 percent (%) Topex topical anesthetic metered spray.
*Lidocaine hydrochloride (HCl) oral topical solution 2%, 100 milliliter (ml) viscous.
*Nasal decongestant.
*Lidocaine 1% HCl 10 milligram (mg) per ml, 50 ml vial.
*Four lidocaine 4%, 5 ml ampule.
*Two lidocaine HCl jelly USP 2%.
*Two lidocaine 2% HCl 100 mg (20 mg per ml), 5 ml syringe.
*Two 0.9% sodium chloride 500 ml intravenous solution.
b. Medications in the airway basket attached to the vital sign machine included:
*Two 10 ml vials of succinylcholine 200 mg/10 ml.
*One 10 ml vial of epinephrine 1 mg/10 ml.
*Two 20 ml vials of diprivan 200 mg/20 ml.
*One 10 ml vial of rocuronium bromide 10 mg/ml.
*One 10 ml vial of esmolol HCl 100 mg/10 ml.
*One 10 mg vial of unreconstituted vecuronium bromide.
*One 10 ml vial of phenylephrine HCl 10 mg/ml.
*One 20 ml vial of amidate 40 mg/20 ml with an expiration date of 2/1/19.
*One 5 ml vial of glycopyrrolate 1 mg/5 ml.
*One 20 ml vial of sterile water with an expiration date of 5/1/18.
*One 1 ml vial of ephedrine sulfate 50 mg/ml.

Review of the recovery care airway cart monthly check sheet for 2019 revealed the cart had been checked in January, February, March, and April. The medications and supplies had been checked for expiration dates. A red lock number was documented on the bottom of the sheet. No dates had been documented when those checks or the red lock tag had been applied.

Interview on 5/20/19 at 4:15 p.m. with the director of inpatient services revealed:
*The anesthesia department brought the cart and vital sign machine to the room of any patient that had undergone neck surgery.
*She was not aware the medications in the cart were not secure.
*She agreed there was no red numbered tab on the cart to ensure it had not been opened.
*The vital sign cart should not have had medications in the airway baskets.
*The anesthesia cart had last been checked in April 2019, and the red lock number had been documented at that time. She agreed no date had been documented.
*No documentation was present when the red tag documented in April 2019 had been removed.
*Agreed the cart and vital sign machine was not monitored constantly, and patients, visitors, and staff would have had access to the medications.

Interview on 5/22/19 at 8:20 a.m. with anesthesiologist C confirmed the recovery care airway cart was used when a neck surgery was completed. She was not aware the cart and vital sign machine basket had medications in them that should have been secured.

Surveyor: 29354
2. Observation and interview on 5/21/19 at 2:15 p.m. in the lower level with the chief nursing officer (CNO) revealed:
*A large cart with six drawers.
-There was a red tag attached to the cart securing the items in that cart.
*The CNO removed the red tag with a scissors.
*Inside of the cart:
-Was a clear plastic container secured with a red tag.
-Inside of the clear plastic container were:
--A list of Recovery Care 3 Emergency Drug Tray items along with a tray that included controlled and non-controlled medications.
--There were several medications inside of that clear plastic tray that matched the list above.
*A log on top of the cart had documentation the cart had been checked by pharmacy on 5/10/19.

Further interview at that time with the CNO revealed:
*No one staffed that area.
*They had patients in the area until January then patients were moved up to the second floor.
*The old crash cart had been left behind.
*They "Kind of forgot about the cart."
*They had gotten a new crash cart on second floor.
*She felt the crash cart would be unsecured if someone had broken the red tag lock.

Interview on 5/21/19 at 2:45 p.m. with the director of pharmacy regarding the above revealed:
*He felt the crash cart was secured.
*When the cart was not in use it was secured with the red tag.
*Pharmacy checked the crash cart monthly.

Review of the provider's undated Floor Stock Medication Location Of policy revealed:
*Policy:
-"Will store all medications appropriately and in the designated areas."
*Procedure:
-"A. The following areas are designated for the storage of medications:
--5. Recovery Care Center (Lower Level, 2nd Level, and 3rd Level).
-C. All drug storage areas listed in Procedure A and the Central Pharmacy will be secured and locked such that these areas are inaccessible to visitors, patients, and unauthorized staff."



29354

3. Observation and interview on 5/21/19 from 7:40 a.m. through 8:10 a.m. in surgical suite three with certified registered nurse anesthetist (CRNA) A and registered nurse (RN) B regarding the sharp's containers revealed:
*A large sharp's container on the floor and a smaller sharp's container on the CRNA's cart.
*During that time both of them had discarded items into the sharp's containers.

Interview with CRNA A and RN B during the above time revealed:
*Narcotics not used were returned to the pharmacy for destruction.
*Unused medications, vials, and syringes were discarded into both of the sharp's containers.
*When the sharp's containers were full they were brought by a surgical technician to the Biohazard room in the basement.

Observation and interview on 5/21/19 at 2:00 p.m. with the CNO and RN B regarding the sharp's containers revealed:
*The nursing assistants or unlicensed staff took the sharp's containers from the surgical suites to the Biohazard room in the lower level when they were full.
*If the unlicensed staff were unable to take the sharp's containers to the Biohazard room then the CRNAs would do it.
*The sharp's containers contained unused non-narcotic medications left in the vials or syringes including lidocaine.
*The sharp's containers were not secured to the walls in the surgical suites.
*The Biohazard room was on the lower level by the loading dock.
*The sharp's containers in the peri-operative, pre-operative, and the post-anesthesia care unit (PACU) areas were secured to the wall.
*The key for the sharp's container in the peri-operative area was in a desk drawer behind the nurses station.
-Everyone had access to that key.
*Nursing assistants in the peri-operative, pre-operative, and PACU areas took the sharp's containers to the Biohazard area.
*The sharp's containers did snap shut after they were full.

Observation and interview on 5/21/19 at 2:10 p.m. with the CNO in the lower level revealed:
*The door leading into the loading dock area was not secured.
*Inside of that room:-Was an unlocked, unsecured door that had two large red barrels in it.
--Inside one of the barrels was a small sharp's container with the lid secured.
--On the floor next to the above barrel was a large sharp's container with the lid secured.
--There was not any information on the two sharp's containers indicating they were biohazard medical waste.
*All staff had access to that area.

Interview on 5/21/19 at 2:28 p.m. with the director of inpatient services regarding the second and third floor sharp's containers revealed:
*She was in charge of the second and third floor patient rooms.
*When the sharp's containers were three-fourths full the "tech [technician]" would remove the containers from the walls and take it to the risk management area.
-That person was not a licensed nurse.

Interview on 5/21/19 at 2:45 p.m. with the director of pharmacy regarding the security of the sharp's containers revealed he had not felt there was a security issue.

Interview on 5/22/19 at 9:00 a.m. with the director of environmental services, the director of plant operations, and the CNO regarding the security of the sharp's containers revealed:
*The techs put the full sharp's containers by the main floor trash chute.
-The door leading into that area was not secured.
-Anyone had access to that area.
*Maintenance staff would take the full sharp's containers to the Biohazard area.
*The door leading into the Biohazard area from the patient room area in the lower level was not secured.
*The door on the outside of the building and the door leading into the patient room area on the lower level were secured.
-However any staff with a badge had access to that lower level.
--That included housekeeping staff and unlicensed staff.
*They did not track how many sharp's containers were in the Biohazard room or how many were sent out with the contracted waste management company.
-They would receive a sheet from the contracted waste management company on how many totes or boxes were picked-up.
*There was always someone in the lower level area.
*The director of environmental services felt it would be an inconvenience to secure the sharp's containers.
-He felt the sharp's containers were secured.
*The loading dock area had twenty-four hour surveillance camera.
*The CNO confirmed there were vials of non-narcotic medications in the sharp's containers in the Biohazard room.

Review of the provider's undated Needle and Sharp Safety policy revealed:
*Purpose:
-"To provide guidelines to the staff concerning proper handling of sharp's devices to avoid injuries and possible exposure to HIV, Hepatitis B, Hepatitis C and other potentially infectious materials (OPIM)."
*Guidelines:
-"A. Appropriate Use and Disposal of Sharp's:
--2. Sharp's containers shall be replaced routinely when the fill line is reached and prior to becoming over full."
*There was no information on how to secure the sharp's containers after they were full.

Review of the provider's 2/11/19 Regulated Medical Waste Handling Protocol policy revealed:
*Policy:
-"Medical waste will be disposed in a way that minimizes employee contact and complies with local and state regulations."
*Procedure:
-"A. Sharp's Containers:
--Waste items listed are to be placed in the special containers provided.
--Do not place any of these items in the regular trash or receptacles.
---1. Needles.
---2. Disposable syringes (used and unused).
---3. Glass objects.
---4. Any sharp object that can penetrate the skin.
---5. Large Duraprep devices."
*There was no accountability of who was responsible for monitoring the sharp's containers.

VENTILATION, LIGHT, TEMPERATURE CONTROLS

Tag No.: A0726

Based on observation, interview, record review, and policy review, the provider failed to monitor appropriate levels of humidity and maintain appropriate temperatures within safe parameters in all fifteen operating rooms (OR). Findings include:

1. Observation on 5/21/19 from 7:30 a.m. through 11:30 a.m. of OR's 5 and 10 revealed only temperature monitors were noted.

Review of the provider's daily OR checklists for April 2019 and May 2019 revealed:
*For each day checks were to have been done for the:
-Refrigerator temperature.
-Warmer 1 temperature.
-Warmer 2 temperature.
-Humidity level.
-OR temperature.
*There was a number for each day the ORs were in use with a downward pointing arrow in that column and an employee's initials.
*There was no indication which area that number was for.
*There was no indication if the number was a temperature or a humidity reading.
*There was only one area to document the humidity level and OR temperature.
*There were fifteen surgical suites.

Review of the provider's temperature zone log for ORs 1 through 15 from 5/16/19 through 5/21/19 revealed:
*The log had documentation the temperatures were between 59 degrees Fahrenheit (F) and 68 degrees F.
*Temperatures logged for each OR were never above 68 degrees F.

Interview on 5/22/19 at 9:00 a.m. with the assistant director of operative service revealed:
*The humidity levels for each OR was checked each day.
*She agreed there was no documentation that supported that task.
*The temperature and humidity parameters were to have been followed according to the Association of periOperative Registered Nurses (AORN) recommendations.

Interview on 5/22/19 at 9:25 a.m. with the director of plant operations and the director of environmental services revealed:
*The temperature ranges in each OR were out of the recommended parameters of 68 to 75 degrees F.
*The surgeons liked the temperatures lower in the ORs, so they had been set lower.
*They had not been aware of the parameters required for temperature and humidity for each OR.

Review of the provider's undated Temperature and Humidity/OR policy revealed:*"The temperature range in a restricted area (operating room) should be between 68 - 75 degrees F."
*"The relative humidity in a restricted area (operating room) should be maintained within a range of 20-60%."
*"The temperature will be monitored daily and recorded if any problems."
*"Humidity level will be monitored daily in OR rooms."
*"For any readings outside of the recommended parameters, staff will contact the Maintenance Department."
*"The OR will maintain records of temperature and humidity for the OR Department."