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5189 HOSPITAL ROAD

MARIPOSA, CA 95338

INFECTION PREVENT SURVEIL & CONTROL OF HAIs

Tag No.: C1208

Based on observation, interview, and record review, the hospital failed to maintain a clean and sanitary environment in accordance with hospital policy and procedure (P&P) titled, "Infection Prevention and Control Plan," Centers for Disease Control (CDC-a U.S. federal government agency whose mission is to protect public health by preventing and controlling disease, injury, and disability) and clinical standards of practice for infection control when:

1. A linen cart was not covered in the clean supply linen room.

2. A grocery bag full of citrus fruit that appeared to have mold growing on them was left on the floor of the pantry room.

3. The patient refrigerator had approximately two inches (unit of measurement) of ice was built up all around the freezer compartment which prevented the freezer door from closing completely.

4. The clean storage room stored 11 expired central line stabilization kits (device used to keep medical tubing in place so it doesn't get pulled out).

5. The Emergency Department (ED) supply cabinet stored two expired 5.5 mm (millimeters, a unit of measure) endotracheal tubes (ET tube - a plastic tube inserted into the trachea (windpipe) through the mouth or nose to maintain an open airway and facilitate breathing when a patient cannot breathe on their own).

6. The ED supply cabinet stored one expired wound closure strips (adhesive skin closures are used as a non-invasive method to close wounds, including lacerations and surgical incisions) packets were expired in the ED supply cabinet.

These failures resulted in the potential risk of cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) to patients, visitors, and staff which can lead to infection and diseases.

Findings:

1. During a concurrent observation and interview on 3/25/25 at 9:30 a.m. with Nurse Manager (NM), in the clean supply linen room of the medical surgical unit (med/surg - a nursing unit where patients who are not critically ill are cared for), one of one linen cart which stored clean lines was not covered. The NM stated linens should be covered to prevent dust and germs from getting on the linens. The NM stated this is important to avoid spreading infection to patients. The NM stated the linens are used for both med/surg and ED patients.

During an interview on 3/26/25 at 2:30 p.m. with the Infection Preventionist (IP), the IP stated the linen cart should be covered to protect it from dust and sources of cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) which can be transferred to the patient and had the potential of causing harm.

During an interview on 3/26/25 at 2:57 p.m. with the Chief Nursing Officer (CNO), the CNO stated her expectation was for all hospital areas should be monitored frequently, and the linen cart should have been covered to protect the lines from dust and possible sources of cross contamination. The CNO stated dirty linen could harm patients.

During a review of the document titled, "CDC's Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings" retrieved from, https://www.cdc.gov/infection-control/hcp/core-practices/index.html dated 4/12/24, " ... Education and Training of Healthcare Personnel on Infection Prevention ...standard precautions (basic level of infection control that is used in patient care) include: ...hand hygiene ...environmental cleaning and disinfection ... Minimizing Potential Exposures References and resources ...Reprocessing of reusable medical equipment between each patient or when soiled..."

2. During a concurrent observation and interview on 3/25/25 at 9:40 a.m. with the NM on the med/surg unit in the pantry room, a grocery store paper bag full of citrus fruit was found on the floor. Some of the fruit had black substance on it. The NM stated the paper bag with citrus fruits should not be in the pantry due to the mold. The NM had the fruits discarded by placing it in a plastic bag and throwing in the garbage bin outside the facility.

During an interview on 3/26/25 at 2:30 p.m. with the IP, the IP stated the bag of moldy citrus should not be in the pantry. The IP stated the moldy citrus fruits could get wet and attract insects, which could spread infection.

During an interview on 3/26/25 at 2:57 p.m. with the CNO, the CNO stated her expectation was all food in the pantry should be properly contained. The CNO stated any item with mold should be immediately removed because it could harm patients.

During a review of a professional reference titled, "Infection Control and Prevention (ICP)" (undated) by the Agency for Healthcare Research and Quality (AHRQ), the "ICP" indicated, " ... There is a clear separation of clean and dirty work areas. Clean areas are used for storage and preparation of medications and unused supplies; dirty work areas are used for contaminated equipment ...".

During a review of the professional reference titled, "The role of the surface environment in healthcare-associated infections (RS)", dated 8/2013, the "RS" indicated, " ... Hospital surfaces are frequently contaminated with important healthcare-associated pathogens [bacteria]. Contact with the contaminated environment by healthcare personnel is equally as likely as direct contact with a patient to lead to contamination of the healthcare provider's hands or gloves that may result in patient-to-patient transmission of nosocomial [originating from the hospital] pathogens ...".

3. During a concurrent observation and interview on 3/25/25 at 9:50 a.m. with the NM on the med/surg unit pantry room, the patient refrigerator had two inches of ice buildup in the freezer compartment. The ice was blocking the freezer door from closing completely. The NM stated the freezer should not have ice buildup and needed to be defrosted. The NM stated the ice could affect the temperature of the food in the refrigerator, and if it mels, it could contaminate the food below.

During an interview on 3/26/25 at 1:30 p.m. with the Food Services Manager (FSM), the FSM stated there should be no ice buildup in any freezer because ice could change the internal temperature of the refrigerator/freezer. The FSM stated since the food goes directly to the patients, there was a risk of foodborne illness (caused by eating or drinking something that is contaminated with germs [such as bacteria, viruses, or parasites] or chemicals [such as toxins or metals that can make people sick when not properly frozen, thawed, or cooked). The FSM stated the refrigerator was used for all med/surg and ED patients, so all patients could get sick, and their hospital stay extended. The FSM stated there was no policy in place to check the refrigerator for ice buildup.

During an interview on 3/26/25 at 1:45 p.m. with the Director of Facility Operations (DFO), the DFO stated, there was system in place for all staff to enter a "ticket" into the hospital internal maintenance system for broken or defective equipment. The DFO stated there was not a "ticket" for the refrigerator/freezer not working properly. The DFO stated there was no maintenance on the refrigerator/freezer except if a "ticket" is entered into the system and no maintenance personal check the refrigerator/freezer for proper functioning. The DFO stated there was no policy for checking or cleaning the refrigerator/freezer. The DFO stated if the refrigerator/freezer was not working properly, it could affect all patients in the med/surg unit and ED. The DFO stated patients could get sick or sicker if food from the malfunctioning refrigerator/freezer was consumed.
was consumed from a refrigerator/freezer not functionally optimally.

During an interview on 3/26/25 at 2:30 p.m. with the IP, the IP stated the refrigerator/freezer should not have ice buildup. The IP stated ice buildup could change the temperature of the device and lead to foodborne illness if patient ate food that was not properly frozen or thawed.

During an interview on 3/26/25 at 2:57 p.m. with the CNO, the CNO stated her expectation was for all equipment should be working properly. The CMNO stated if equipment was not working, it should be "ticketed" and taken out for service. The CNO stated the refrigerator/freezer should not have ice buildup. The CNO stated food not stored at proper temperatures could be harmful to patients.

During a review of the professional reference retrieved from https://www.fsis.usda.gov/food-safety/safe-food-handling-and-preparation/food-safety-basics/freezing-and-food-safety titled, "Freezing and Food Safety (usda.gov)" undated, the professional reference indicated, " ...Freezing to 0 °F inactivates any microbes-bacteria, yeasts and molds- present in food. Once thawed, however, these microbes can again become active, multiplying under the right conditions to levels that can lead to foodborne illness ...".

During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, "Guidelines for Environmental Infection Control in Health-Care Facilities," dated 7/2019, the professional reference indicated, " ... Infection-control strategies and engineering controls [physical changes to a work area or process that reduce or eliminate the risk of workers coming into contact with hazards], when consistently implemented, are effective in preventing opportunistic [exploiting chances offered by immediate circumstances], environmentally related infections in immunocompromised populations..."

During a review of the professional reference titled "Controlling Hospital-Acquired Infection: Focus on the Role of the Environment and New Technologies for Decontamination", dated 10/27/14, the professional reference indicated, " ... a large number of reports include cleaning as an important control component for outbreaks of norovirus, VRE, C. Difficile, MRSA, and Multidrug-resistant (MDR) Gram-negative bacilli ... Removing visual and invisible dirt from the hospitals of today and for the future requires sufficient trained staff, ongoing monitoring ...".

4. During a concurrent observation and interview on 3/25/25 at 9:30 with NM on the med/surg unit in the clean supply room, 11 central line stabilization kits (device used to keep medical tubing in place so it doesn't get pulled out) was stored, and had an expiration date of 9/28/24. The NM stated the 11 expired central line stabilization kit could pose an infection control risk for patients because they are no longer considered sterile.

During an interview on 3/26/25 at 2:00 p.m. with the Purchasing Manager and the (PM) the Chief Financial Officer (CFO), in the presence of the NM, The PM stated the purchasing department staff do not check the supply rooms or carts for expired products. The PM stated this was the responsibility of the nursing department. The PM stated when he restocks supplies based on par levels (the number of items that should be stocked for each item on unit) they rotate stock by placing the newest items at the back. The PM stated he does not check every item in the supply room for expiration, only the items being restocked. The CFO stated there was no consistent system for managing outdated supplies, and that this process needs to be fixed.

During an interview on 3/26/25 at 2:30 p.m. with the IP, the IP stated the expired stabilization kits could pose an infection risk. The IP stated these kits were used to hold central intravenous lines in place and are placed near the insertion site, where the tubing enters the patient's body. The IP stated she does monthly rounds in the department to check for outdated supplies, but it was the department managers' responsibility to check for expired items regularly. The IP stated, "If we find something that is outdated during our rounds, we will pull it out of stock, but it is not our responsibility to monitor that." The IP stated, "We shouldn't have expired items. They might not be sterile after the expiration date." The IP stated the supplies might degrade, which could harm to the patient.

During an interview on 3/26/25 at 2:57 p.m. with the CNO, the CNO stated her expectation was all items in supply rooms be fully functional and not expired. The CNO state expired items should be pulled from stock immediately, and the right people should be notified. The CNO stated expired items could harm patient and cause cross contamination. The CNO stated there was no system for checking expired items.

During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, "Guidelines for Environmental Infection Control in Health-Care Facilities," dated 7/2019, the professional reference indicated, " ... Infection-control strategies and engineering controls [physical changes to a work area or process that reduce or eliminate the risk of workers coming into contact with hazards], when consistently implemented, are effective in preventing opportunistic [exploiting chances offered by immediate circumstances], environmentally related infections in immunocompromised populations..."

During a review of the professional reference titled, "Good Storage and Distribution Practices for Medical Products", (retrieved from https://www.who.int/publications/m/item/trs-1025-annex-7) dated 6/17/20, the professional reference indicated, " ...Storage and distribution are important activities in the supply chain management of medical products ... Storage areas should be of sufficient capacity to allow orderly storage of the various categories of medical products ... Storage areas should be appropriately designed, constructed, maintained or adapted. They should be kept clean and there should be sufficient space and lighting ... Materials and medical products should be stored off the floor, away from walls and ceilings, protected from direct sunlight and suitably spaced, to permit ventilation, cleaning and inspection ... Materials and medical products should be handled and stored in such a manner as to prevent contamination, mix-ups and cross-contamination ...".

5. During a concurrent observation and interview on 3/25/25 at 11 a.m. with the NM in the ED, the supply cabinet stored two 5.5 mm (millimeters, a unit of measure) endotracheal tubes (ET tube - a plastic tube inserted into the trachea (windpipe) through the mouth or nose to maintain an open airway and facilitate breathing when a patient cannot breathe on their own) with an expiration date of 2/19/25. The NM stated the ET tubes needed to be removed from stock because they pose an infection risk.

During an interview on 3/26/25 at 2:30 p.m. with the IP, the IP stated the expired ET tubes could pose infection risk to patients because they are used inside the mouth, which was a route for infections to enter. The IP stated the ET tubes should have been removed from the ED supply cabinet.

During a review of a professional reference titled, "Using Expired Supplies for Patient Care Due to Supply Chain Shortages?" dated April 2023, (found at https://www.hceglobal.org/using-expired-supplies-is-this-the-new-normal) the article indicated, " ...Compromising patient care by using products that may be of inferior quality and integrity should not become the new standard of care ...".

During a review of the professional reference titled, "Keeping it Sterile: Fundamentals of Sterile Storage," (retrieved from https://www.ormanager.com/keeping-it-sterile-fundamentals-of-sterile-storage/) dated 7/20/23, the professional reference indicated, " ... Using sterile items ...is a fundamental practice, not a rudimentary one that can or should be taken for granted. Put simply, using unsterile items can result in a patient infection. If sterile storage conditions are not appropriate, the items can become contaminated. Such contamination may go undetected, rendering items unsafe and unusable. Therefore, healthcare facilities must take action to create an environment that properly protects sterile packages. This includes securing a proper sterile storage environment and developing policies and procedures to help ensure sterile packages are safely stored and handled ... Sterile packages should be handled with care and positioned so they are not crushed, bent, compressed, or punctured. Sterile items should never be stored on floors ...".

6. During a concurrent observation and interview on 3/25/25 at 11:10 a.m. with NM in the ED, the ED supply cabinet stored one wound closure strips packets ready for patients use with an expiration date of 2/29/24. The NM stated the expired wound closure strips could pose a risk of infection to patients. The NM stated the wound closure strips should have been removed from the supply cabinet.

During an interview on 3/26/25 at 2:30 p.m. with the IP, the IP stated the expired wound closure strips could pose a risk of infection to patients. The IP stated the wound closure strips risk are used for holding open wounds or lacerations in place which was a route for infection. The IP stated the expired wound closure strips should have been removed from the supply cabinet.

During a review of hospital policy titled Infection Prevention and Control Plan Dated 05/21/2020 indicated, "POLICY: A. (Hospital name) Infection Prevention and Control Plan ensures that this organization develops, implements and maintains an active, organization-wide program for the prevention, control and investigation of infections and communicable diseases in order to reduce the risks of endemic and epidemic infections in patients, visitors and healthcare workers, and to optimize use of resources ...GOALS: ... 1. Preventing healthcare associated infections. 2. Limiting unprotected exposure to pathogens ...4. Preventing the transmission of infections associated with the use of medical equipment, devices, and supplies. Examples include cleaning, disinfection and sterilization of equipment and utilization of sterile supplies. 5. Ensuring policies and procedures follow current infection prevention guidelines and recommendations ... 7. Ensuring that a sanitary environment for patients, visitors and employees is maintained ...IV. INFECTION PREVENTION AND CONTROL ACTIVITIES/ACTION PLANS: A. Implementation of the DISTRICT's Infection Prevention and Control Plan requires: 1. The development, review and revision of infection prevention and control policies and procedures 2. Ensuring that the infection prevention and control policies and procedures are followed by all staff, patients and visitors 3. Annual competencies with patient care staff in each department. B. Prevention: 1. Educating patients and staff about infection prevention and control guidelines 2. Policy and procedure review and evaluation ... C. Clinical Controls: ...2.Implementation of appropriate infection control measures ...4. Communicating responsibilities about preventing and controlling infection including hand hygiene and respiratory hygiene practices to all staff, medical staff, patients, families, and visitors ...3. Department managers shall enforce infection prevention policies and ensure that all personnel in their department are competent to participate in infection prevention and control activities. V. EVALUATION: A. Performance Improvement: B. The Infection Preventionist, in coordination with department managers and supervisors, shall continuously review and evaluate infection control practices. C. An evaluation of the organization's Infection Prevention and Control Plan shall be conducted at least on an annual basis and whenever risks significantly change. D. The evaluation shall review: a. Infection prevention and control goals b. Implementation of infection control and prevention activities 4. Performance improvement findings and recommendations shall be provided to staff. 5. Information from the Infection Prevention and Control Program will be reported every quarter to the Medical Staff by the Chair of the Infection Prevention Committee."

During a review of a professional reference titled, "Quick Safety: Managing packaged sterile supplies and devices (QS)," dated June 2022, (found at https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-65/#:~:text=Managing%20commercially%20prepared%20sterile%20supplies,on%20or%20with%20their%20devices.), the QS indicated, " ...In order to protect patients from infection and other potential harm from expired or compromised supplies and devices, organizations must identify the best location to store the supplies so that staff can readily access them, ensure the supplies are being stocked to the most optimal par levels, and that items have not passed their expiration dates. The purpose of this Quick Safety is to provide guidance for managing and storing packaged sterile supplies within your facility with the goal to keep patients safe from infection and other potential harm from expired or compromised supplies and devices..."

During a professional reference review retrieved from https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines-P.pdf titled, "Guidelines for Environmental Infection Control in Health-Care Facilities," dated 7/2019, the professional reference indicated, " ... Infection-control strategies and engineering controls [physical changes to a work area or process that reduce or eliminate the risk of workers coming into contact with hazards], when consistently implemented, are effective in preventing opportunistic [exploiting chances offered by immediate circumstances], environmentally related infections in immunocompromised populations..."