HospitalInspections.org

Based on observation, interview, policy review, and manufacturer's instructions for use (IFU) review, the provider failed to ensure:
*One of one Lifepak 15 defibrillators located outside the operating room (OR) had been checked daily per the manufacturer's IFU.
*Expired supplies were not available for patient use in the OR and obstetrical unit.
Findings include:

1. Observation and interview on 9/10/24 at 10:57 a.m. outside of the OR with surgery supervisor E and certified registered nurse anesthetist (CRNA) K revealed:
*A Lifepak 15 defibrillator had been plugged into the wall on top of a supply cart.
*Surgery supervisor E stated the nurse anesthetists had overseen checking the defibrillator.
*CRNA K stated it had been the responsibility of the OR nursing staff to monitor and check the defibrillator.
*Surgery supervisor E stated, "I'm not sure who brought this equipment in. There was no in-service provided to staff."
*Surgery supervisor E said checking the defibrillator and managing supplies had fallen through the cracks over the years.
*Surgery supervisor E said there had been no maintenance, or an operator's crash cart checklist completed daily.

Observation and interview on 9/10/24 at 11:07 a.m. outside of OR with registered nurse (RN) G revealed:
*She had been waiting for maintenance to fix the test load device (a tool that can be used to test the defibrillator's function and performance) to perform the user test.
*She had not checked the defibrillator in over two years.
*RN G stated, "The defibrillator does still work, we need the test load device to perform the user test."
*The test load device used to perform the user test was located within the side pocket of the defibrillator.
*The manufacturer's IFU and other related resources for the Lifepak 15 defibrillator had not been unsealed from its original packaging for staff reference.

Interview on 9/10/24 at 1:25 p.m. with chief nurse officer (CNO) B revealed:
*They did not have a policy for crash carts or defibrillator checks.
*She stated, "We would follow the manufacturer's IFU."
*She would have expected staff to follow the manufacturer's IFU on the Lifepak 15 defibrillator daily checks.
*She confirmed there had been a daily crash cart checklist developed and should have been used by all departments.

2. Observation and interview on 9/10/24 at 9:22 a.m. in the central supply room with certified surgery technician (CST) F and surgery supervisor E revealed:
*There were 14 expired Alcon intraocular lens implants available for use.
*Surgery technician F stated the nurses were responsible to check the implants monthly.
*Surgery supervisor E stated supplies were checked monthly and any expired items should have been discarded.

Observation and interview on 9/10/24 at 10:57 a.m. outside of the OR with surgery supervisor E revealed:
*One pediatric quick combo defibrillator patch that expired on 7/20/24. It was the only one available for use.
*She confirmed the defibrillator patches should have been replaced.

Observation and interview on 9/10/24 at 1:45 p.m. in the obstetrical unit clean supply room with RN H revealed:
*In the delivery cart, two sterile #8 gloves that expired in June 2024.
*In the hemorrhage cart, one Bakri postpartum balloon device that expired on 9/1/24. It was the only one available for use.
*RN H stated carts and supplies were checked monthly.
*She confirmed the supplies should have been removed from the carts.

Interview with nurse manager D and purchasing director I on 9/12/24 at 9:20 a.m. revealed:
*Nurse manager D confirmed checking for outdated supplies had been done monthly and was the responsibility of everyone.
*Purchasing director I confirmed every department was to check for outdated supplies.
*Confirmed expired products should have been taken back to purchasing.
*Nurse manager D confirmed staff had been educated on the process of checking and handling expired supplies.
*Nurse manager D confirmed they did not have a policy on managing expired supplies.

3. Review of the provider's daily crash cart checklist for defibrillator revealed staff should have:
*Inspected it's physical condition.
*Checked the expiration dates on therapy and electrocardiogram (EKG) pads.
*Checked the battery power.
*Performed a user test.
*Verified a therapy cable check at 200 joules.

4. Review of the manufacturer's 2019 Lifepak 15 Monitor/Defibrillator Operating Instructions for Use (IFU) revealed:
*Daily inspection and testing of the Lifepak 15 monitor/defibrillator was recommended.
*"Complete operator's checklist daily.
-Check quick-combo therapy cable.
-Inspect defibrillator.
-Check all necessary supplies and accessories are present.
*Perform the user test as part of the operator's checklist daily."

5. Review of the obstetrical monthly checklist to restock and check outdates revealed:
*The case cart had not been signed off as completed in July 2024 and August 2024.
*The equipment room had not been signed off as completed in August 2024.
*The supply room had not been signed off as completed in July 2024 and August 2024.

Based on observation, interview, and policy review, the provider failed to ensure one of two blanket warmers in the operating room (OR) was monitored and recorded in accordance with their policy.
Findings include:

1. Observation and interview on 9/10/24 at 11:34 a.m. outside of the OR with registered nurse (RN) G and surgery supervisor E revealed:
*A small-sized blanket warmer without a digital or internal thermometer to measure the temperature.
*RN G confirmed there had been no device to monitor or record the temperature of the blanket warmer.
*RN G had stated there should have been a thermometer placed inside the blanket warmer to measure the temperature.
*Surgery supervisor E had stated it had been brought into the facility by a physician who used to work there.
*Surgery supervisor E confirmed the blanket warmer's temperatures had never been monitored or recorded on a log and should have been.

Review of the provider's daily log for the OR revealed there had been no documentation of the temperature of the blanket warmer located outside the OR.

Review of the provider's April 2024 policy on Warming Cabinets-Blankets and Solutions revealed:
*"Fluids and linens (e.g., blankets) must be stored in a separate warming cabinets or in cabinets with separate compartments that have independent temperature controls.
*Blanket-warming cabinets temperatures will not exceed 130 F (54.4 C).
*Check and record temperatures of linen and solution cabinets daily during hours of operation.
*If the cabinet does not have an electronic recording device, the warming cabinet temperatures will be documented daily during hours of operation by Surgical Staff on a temperature log."

A. Based on observation, interview, review of manufacturer's instructions for use, and policy review, the provider failed to:
*Follow the reuse period of not more than 30 days for MetriCide OPA Plus solution used for high level disinfection on two of two endocavity (within a body cavity) probes.
*Test for sufficient strength of MetriCide OPA Plus solution between uses for high level disinfection on two of two endocavity probes.
Findings include:

Notice:
Notice of immediate jeopardy was given verbally and in writing on 9/11/24 at 3:47 p.m. to chief executive officer (CEO) A, director of quality assurance C, and radiology supervisor J of the immediate jeopardy related to C1140 when the provider failed to follow the manufacturer's instructions for use for MetriCide OPA Plus solution a high-level disinfectant.

On 9/11/24 at 3:55 p.m. chief executive officer A, director of quality assurance C, and radiology supervisor J were asked for an immediate removal plan.

Removal Plan:
"Plan of Correction for C-1140 Noncompliance
Effective immediately, the solution for cleaning the two endocavity ultrasound probes has changed from MetriCide OPA Plus to Revital-Ox RESERT, which will be used to clean both probes after each and every use.

The temperature and concentration of the high-level disinfectant will be tested by the radiology technician performing the ultrasound prior to every use and documented on a log (see attached), which the Radiology Director will turn into the Quality Director every week for review and reported monthly to the QAPI Committee.

When a radiology technician opens a new disinfectant container, it will be clearly labeled with the opening date and the expiration date. The disinfectant, once opened, will be stored per manufacturer's recommendations for up to 90 days, provided the 90 days does not extend past the manufacturer's expiration date on the container. The radiology technician will label the solution in the secondary container upon fill with the fill date and the expiration date. The solution in the secondary solution can be used for a period of up to 21 days, or sooner as dictated by the results of the solution test strip.

The applicable guiding policy (Endocavity Probe Cleaning & GUS (disinfection soak stations for general purpose and endocavity probes) Instructions - see attached) has been updated to reflect these changes and all Radiology Department staff will go through education of the policy and competency training in the steps of high-level disinfection according to the manufacturer's instructions for use by 9/13/2024.

The Revital-OX RESERT Solution Test Strips will be clearly labeled by the radiology technician with the open date and expiration date. The test strips expire 180 days after opening, or at the manufacturer's expiration date. All chemicals and supplies will be appropriately disposed of and replaced when expired.

New quality measures have been added to the Radiology Department's QAPI plan to ensure that prior to every use of Revital-Ox RESERT, the solution concentration, temperature, and expiration date is checked (see attached). If, after 6 months, all steps are being correctly completed on 100% of the patients, the Radiology Director will move from weekly reporting to the Quality Director to monthly reporting."
On 9/12/247 at 10:35 a.m. CEO A provided their final plan for the removal of the immediate jeopardy.

On 9/12/24 at 11:40 a.m. the provider's removal plan was reviewed and accepted by the survey team.

On 9/12/24 at 11:41 a.m. the survey team reviewed the provider's documentation for the removal of the immediate jeopardy and determined the immediacy was removed.

Current census was zero.

1. Observation, interview, and review of the manufacturer's instructions for use on 9/11/24 at 12:15 p.m. with radiology supervisor J revealed:
*They used MetriCide OPA Plus solution as a high-level disinfectant for the two endocavity probes.
*She thought the reuse period was 75 days for the in-use solution based on the information on the label.
*She was not aware of the manufacturer's instructions for use.
*She was not aware that the reuse period for MetriCide OPA Plus solution was not to exceed 30 days.
*She was not aware that each time the MetriCide OPA Plus solution was used it should have been tested for sufficient strength.
*She was not aware the 75 days was for how long the solution was good in an opened bottle.
*They did not have test strips for testing MetriCide OPA Plus solution.
*They had been using MetriCide OPA Plus solution as a high-level disinfectant for up to 75 days.
*They had been discarding every 30 days up to September of 2023 when they changed and went to 75 days before discarding.

Review of the manufacturer's instructions for use for MetriCide OPA Plus revealed:
*"The reuse period for MetriCide OPA Plus solution was not to exceed thirty days in manual reprocessing."
*"Concentration of MetriCide OPA Plus solution during reuse life must be verified by the MetriCide OPA Plus solution test strip prior to each use to determine that the solution concentration was above the minimum recommended concentration."

Review of the providers endocavity probe cleaning and GUS (disinfection soak stations for general purpose and endocavity probes) instructions policy dated June 2019 revealed:
*"The disinfectant should be changed according to the disinfectant's recommendations."
*The policy did not mention testing of the disinfectant.

Interview on 9/12/24 at 10:50 a.m. with radiology supervisor J revealed:
*Her and the other four technicians who performed high level disinfection had been trained by the previous radiology supervisor.
-She had been trained in 2019.
*She had assumed they were trained correctly and was not aware they were not performing high level disinfection according to the manufacturer's instructions for use.



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B. Based on observation, interview, policy review, and manufacturer's instructions review for use (IFU) the provider failed to ensure:
*Proper concentration of two of two enzymatic detergents and water had been measured per manufacturer's IFU.
*The water temperature of the Empower Multi-enzymatic detergent used for pre-cleaning of surgical instruments and endoscopes had been monitored per manufacturer's IFU.
*Staff who performed sterilization and high-level disinfection (HLD) tasks had received education and training.
Findings include:

1. Observation and interview on 9/10/24 at 9:43 a.m. in the operating room (OR) decontamination room with certified surgery technician (CST) F revealed:
*Two large sinks with a sticker inside each of the sinks that indicated a fill line.
*CST F confirmed she would fill the water to the fill line in both sinks and add three pumps of Empower multi-enzymatic detergent to the right side of the sink and three pumps of Virex II 256 enzymatic detergent on the left side of the sink.
*She was unsure of how many gallons of water each sink held when filled to the fill line.
*She was unsure of the ounces (oz) yielded to one pump of enzymatic detergent.
*She confirmed they had not been monitoring the temperature of the water after putting the Empower multi-enzymatic detergent in.
*She determined with a one-gallon bucket that each sink held about 10 gallons of water at the fill line.
*CST F confirmed staff had not been measuring the concentration of the enzymatic detergents to gallons of water as instructed by the manufacturer's IFU.

Interview on 9/11/24 at 11:45 a.m. with surgery supervisor E revealed:
*The water fill line in each sink was to be used when cleaning scopes not instruments.
*She confirmed staff were not measuring the water temperature of the sink and should have been when using Empower multi-enzymatic detergent.
*She confirmed staff had not been measuring the proper concentration of the enzymatic solutions and water per the manufacturer's IFU.

Interview on 9/12/24 at 11:05 a.m. with chief nurse officer (CNO) B regarding CST F's education and training revealed:
*There was no standard form for education or a competency checklist related to high level disinfection and sterilization competencies for surgical staff documented.
*Confirmed CST F received education on 9/29/22 on the Sterrad velocity system (steam sterilizer).
*Confirmed she could not locate documentation if CST F had received training for the OER-pro (machine used to process endoscopes).
*She would have expected education, training, and competencies to have been completed and documented prior to staff performing the skill.

Review of the provider's April 2024 High Level Disinfection policy revealed:
*"Follow manufacturer's written instructions for use when preparing and using disinfectant solutions.
*Perioperative personnel processing medical devices using HLD for use in the perioperative setting will receive education and compete competency verification activities on the principals and processes of processing medical devices using HLD."

Review of the provider's April 2024 Sterilization-All Methods policy revealed:
*"Items to be sterilized will be cleaned, decontaminated, inspected packaged, sterilized, and stored in a controlled environment and in accordance with the device manufacturer's written instructions for use.
*Perioperative personnel who sterilize items for use in the perioperative setting will receive education and complete competency verification activities on the principals and processes pertinent to all methods of sterilization."

Review of the 2024 EmPower Multi-enzymatic solution detergent revealed, "Add 1 fl. oz (30 ml) (1 pump yields 1 fl. oz) of concentrate to one gallon of warm water (68 F-104 F)."

Review of the 2018 Virex II 265 disinfectant revealed to "Add the product at ½ oz per gallon of water (1:256)."