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1303 E HERNDON AVE

FRESNO, CA 93710

SECURE STORAGE

Tag No.: A0502

Based on observation, interview and record review, the hospital failed to ensure all drugs were kept in a secured area and locked when appropriate in the pre-operative area.

This failure had the potential to cause patient harm due to a lack of control of the drug supply and unauthorized use.

Findings:

During a concurrent observation and interview, on 12/9/20 at 10:07 a.m., in the pre-operative area, with the Quality Coordinator (QC) and Director of Surgical Services (DSS), a drawer next to the nurses station with intravenous (IV- into the veins) supplies were found to be unlocked. The drawer had an open multi-dose vial of lidocaine (medication used to relive pain and numb the skin) 1%, 200mg/20ml (milligrams/milliliters) with an open date of 11/25/2020. The QC indicated the vial should not have been left in the unlocked drawer. The DSS confirmed the medication should have been discarded at the end of the day on 11/25/2020 and not left in the open unlocked drawer.

During a review of the hospital policy and procedure titled, "Medication Policies," dated July 2019, the policy and procedure indicated, in part, under "POLICY NO 18 - STORAGE OF MEDICATIONS...4. Medications should remain securely stored until the time of administration (i.e., so not carry drugs around in your pocket)." under, "POLICY NO. 10 - DATING OF MULTIDOSE MEDICATION VIALS...5. In the OR/procedural areas, all opened medication vials will be discarded at the end of the day."

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation, interview and record review, the hospital failed to implement their infection prevention and control program to reduce the risk of infectious disease transmission when:

1. A sterile (to be free from bacteria or other living microorganisms) intravenous (IV - meaning within the vein) start kit package was found opened, unattended on a counter top, and available for patient use in the pre-operative area of the hospital;

2. Designated as clean and ready for patient use IV pumps and Patient Controlled Analgesia (PCA-pump that contains a syringe of pain medication as prescribed by a doctor, set to deliver a small, constant flow of pain medication) machines were stored on dirty shelves in a cabinet that had no record of being cleaned and a refrigerator that stored items for patient snacks was unclean, with brown splatter marks and visible dust noted;

3. Multiple head lamps designated as clean and ready for use in the surgical operating room suites were found hanging within the splash zone of the edge of two scrub sinks hung on a peg style rack;

4. Staff did not wear isolation gowns to care for patients who were exposed to COVID (a highly infectious respiratory illness) and were cared for in a non-COVID unit; and

5. A registered nurse caring for patients in the Transfusion Center and also inserting PICC lines (a type of long catheter that is inserted through a peripheral vein, often in the arm, into a larger vein in the body, used when intravenous treatment is required over a long period) for patients in the COVID unit, improperly doffed (removed) PPE (protective equipment worn to minimize exposure and transmission of disease) after inserting PICC lines in the COVID unit.

These failures had the potential to expose patients and staff to disease causing organisms that could lead to illness.

Findings:

1. During a concurrent observation and interview of the pre-operative area of the hospital with the Quality Coordinator (QC) and the Director of Surgical Services (DSS), on 12/9/20, at 9:24 a.m., a sterile IV kit was found open with the tourniquet missing. The kit was left in the area of IV start kits and was available for patient use. The QC indicated the IV kit should not have been left there since it was opened.

During an interview on 12/9/20, at 10:07 a.m., with the DSS, the DSS indicated the package should not have been left there. The DSS indicated it should have been discarded if not used on the patient and that an open kit should not be left in that area.

During a review of the facility's policy and procedure titled, "Cleaning Patient Care Equipment", dated June 2020, indicated in part, "Patients will be provided a safe, clean environment and equipment that shall minimize potential for cross contamination." in the section titled, "PROCEDURE:" , under number, "2. Separation of Clean and Soiled Supplies and Equipment: A. Clean supplies shall not be stored near soiled supplies. Cross contamination can occur. 1. Use separate drawers, cabinets, or areas for clean and soiled supplies and equipment..."

2. During a concurrent observation and interview of the post-operative area of the hospital (PACU), with the DSS on 12/9/20, at 10:15 a.m., a refrigerator was found to have brown splatters and dust accumulated on the bottom grill which was at waist height. The refrigerator held snacks that were available for patient use. The DSS acknowledged the refrigerator grill was not cleaned as it should have been and further indicated the environmental services department (EVS) was responsible for cleaning the refrigerator. The DSS indicated EVS had not done their job.

During a concurrent observation and interview of the PACU area, with the DSS on 12/9/20, at 10:20 a.m., two tall cabinets designated as clean storage were opened. The cabinets contained 15 PCA pumps, four IV pumps, two [brand name] E+ CO2 pumps, two oxygen wall connectors, one wall suction connector, and three k-pad machines. All of the shelves were dirty with visible dust and debris noted. The top shelf in one cabinet held used binders. The DOPS acknowledged the pumps were designated as clean and ready for use with patients and that the cabinet shelves were not cleaned. When asked who was responsible for cleaning the shelves and when they had last been cleaned, she indicated it was the PACU department's responsibility to clean the shelves and stated, "I don't think they have ever been cleaned."

3. During a concurrent observation and interview of the Operating Room areas of the hospital on 10/9/20, at 10:40 a.m., with the Surgery Department Manager (SDM) and the QC, two scrub sinks were noted in the middle section of the OR rooms. The double scrub sinks faced away from each other. On the far wall there was a rack that was peg-styled, designated to hold surgical head lamps that had been cleaned and were designated as ready for use. The headlamps were hanging on the pegs. The headlamps were within the designated splash zone from the edge of the sinks. The SDM stated they were not in the splash zone of the sink and used the faucet nozzle as her reference point.

During a professional reference review of ICAP's, "Practice Briefs" located at, "https://icap.nebraskamed.com/wp-content/uploads/sites/2/2018/03/Practice-Briefs-splash-zone.pdf", dated 2/3/2018, the professional reference indicated, " ...A splash zone is an area around a sink in which contamination could occur, to objects within that space, from the splash associated with handwashing or other activity being done in the sink. Splashing can occur up to about 3 feet from the sink. A more rigorous hand wash could potentially distribute droplets farther, but for purposes of surveying healthcare facilities, CMS uses 3 feet as their guide..." (ICAP is a cooperative effort of UNMC/Nebraska Medicine and the Nebraska Department of Health and Human Services. "ICAP Practice Briefs" are intended to provide evidence-based guidance on infection prevention issues).

4. During an interview on 12/8/20, at 2 p.m., with the Clinical Manager of a non-COVID unit (CM 1), CM 1 stated that patients in the unit who have an exposure to COVID are moved to a private isolation room, but the staff do not wear isolation gowns when caring for these patients. CM 1 stated, "I think we failed on that." CM 1 also stated that there are two patients on the non-COVID unit at that time, who are in isolation for "COVID exposure".

During a review of a hospital document titled "Testing Guidelines," dated 10/1/20, under the section pertaining to Isolation Guidelines, the document indicated, in part, "Enhanced Airborne & Contact precautions: for all rule-out or COVID positive patients (PPE: N95 & face shield or PAPR, gown and gloves), negative airflow room."

During a review of a memo dated 12/8/20, with the subject being "Urgent: Exposed patients process," the document indicated, in part, ""Full PPE should be worn by all staff entering the room (gown, gloves, N95 and face shield or PAPR."

5. During an interview on 12/9/20, at 11:45 a.m., with the PICC nurse (PICC RN), the PICC RN stated that when he doffs the gown after caring for a COVID patient, the doffing is performed in the hallway after leaving the room. When asked about the proper protocol for doffing inside or outside the room, PICC RN stated, "I didn't realize it made a difference."

During a review of the hospital procedure titled, "Procedure for COVID-19 PPE Donning and Doffing," dated 10/12/20, the document indicated, in part, "If room has an anteroom: perform all doffing there. If no anteroom, start inside the patient room: Remove gloves, in trash, hand hygiene. Remove gown, in linen, hand hygiene."

During a review of the hospital policy & procedure titled, "Management & Control of Possible Outbreak or Cluster of Covid-19," dated December 2020, the policy ad procedure indicated, in part, "3. Exposed roommate(s) of a COVID-19 positive patient:...B. The exposed roommate will be treated as a Person under Investigation (PUI) and staff shall wear full PPE (N95, face shield, gown and gloves) when in the patient's room."