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Tag No.: A0747
Based on observation, staff interview, review of Manufacturer's Instructions for Use (IFU), and review of facility documents, it was determined that the facility failed to ensure: 1). the Point of Care device that is used for multiple patients, was cleaned and disinfected between patient use, in accordance with the Manufacturer's IFU and facility policy (A0749); 2). Environmental cleaners and disinfectants are used in accordance with manufacturer's IFU (A0749); 3). hand hygiene was performed in accordance with Center for Disease Control and Prevention (CDC) and facility policy (A0749); and 4). the Infection Control Professional (ICP) conducts surveillance and collaborates with the State Health Department in reporting of communicable diseases in accordance with the facility's Infection Prevention and Control Program (A0749). This failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patients.
On 6/20/24 at 1:30 PM, an IJ was identifed for the facility's failure to ensure the Glucometer for Point of Care testing was cleaned and disinfected between patient use, per the manufacturer's Instructions for Use (IFU) and facility policy. The facility was made aware of the IJ and the IJ Template was provided to the DON and the Director of Performance Improvement on 6/20/24 at 2:47 PM. The facility provided an acceptable removal plan on 6/24/24 at 11:39 AM, the last day of the survey, and the surveyors verified full implementation at 1:30 PM and the IJ was removed. Verification of implementation was completed through facility policy review, review of staff education, review of both signed attestations of education and review of electronic completion of education, staff interviews, direct observation, and review of facility documents.
Tag No.: A0749
Based on observation, staff interview, review of Manufacturer's Instructions for Use (IFU), and review of facility documents, it was determined that the facility failed to ensure: 1). the Point of Care device that is used for multiple patients was cleaned and disinfected between patient use, in accordance with the Manufacturer's IFU and facility policy; 2). Environmental cleaners and disinfectants are used in accordance with the Manufacturer's IFU; 3). hand hygiene was performed in accordance with the Center for Disease Control and Prevention (CDC) and facility policy; and 4). the Infection Control Professional (ICP) conducts surveillance and collaborates with the State Health Department in reporting communicable diseases in accordance with the facility's Infection Prevention and Control Program.
Findings include:
1. On 6/20/24 at 11:12 AM, during a tour of the Medical Surgical Telemetry 6 Unit, Staff (S) 13, a Clinical Partner (Patient Care Technician), was observed entering a patient room and used a Point of Care Device to obtain a patient's blood sugar. S13 then exited the patient's room, without cleaning and disinfecting the glucometer, and then entered another patient room to obtain that patient's blood sugar. Upon interview, at 11:35 AM, S13 confirmed that he/she failed to clean and disinfect the glucometer between patient use, and stated, "I forgot to clean it."
The Manufacturer's IFU for the Point of Care Device was requested. The Freestyle Precision Pro Glucometer IFU was provided and reviewed, and stated, "...Cleaning the Exterior Surface Cleaning the exterior surface of the Freestyle Precision Pro meter daily is recommended. Follow your facility's policies and procedures for infection control, which may require more frequent cleaning."
The facility policy titled, "Abbott Freestyle Precision Pro Blood Glucose Monitor," Last Reviewed 4/3/2024, stated " ...Cleaning: Clean daily or when visibly soiled ...and each patient use."
S13's personnel file was selected for review and revealed that he/she received education/training on the Freestyle Precision Pro Blood Glucose Monitor on 6/9/2023.
2. On 6/20/24 at 10:26 AM, during a tour of the 3-Tower Unit, S7, an Environmental Service (EVS) employee was observed cleaning and disinfecting a patient-occupied room. While donned in gloves, S7 was observed mopping the floor, he/she then removed the mop head and placed it in the trash, then removed the entire top of the Oxivir Tb disinfectant wipe canister, and proceeded to reach into the canister, with his/her potentially soiled gloves on, to remove multiple wipes. S7 continued cleaning the remainder of the patient room, reaching into the Oxivir Tb canister multiple times, with his/her potentially soiled gloves on.
After each removal of Oxivir Tb wipes, S7 was observed wetting the wipes with water from the faucet. Upon interview, S7 stated, "I wet the wipes to get a good lather."
The Oxivir Tb Manufacturer's IFU was requested. The IFU was reviewed and stated, "...Hospital Grade Disinfectant...Easy to use: Ready to use...Oxivir Tb -Key features: Degrades to oxygen and water. ...Use Instructions ...Wipes 1. Pull towelette from dispenser and wipe surface. ...To remove Oxivir Tb Wipes from canister: Remove lid. ...Pull up corner of first wipe from centre of roll and push 1 to 2 cm [centimeters] through the slit under the lid. Replace lid. Lift lid top and pull up wipes one at a time. ..."
S7's personnel file was selected for review. The file indicated that S7 received EVS orientation and training upon hire in March of 2024.
3. Reference: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states, Recommendations 1. Indications for handwashing and hand antisepsis A. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, wash hands with either a nonantimicrobial soap and water or an antimicrobial soap and water... B. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations described in items 1C-J ... Alternatively, wash hands with an antimicrobial soap and water in all clinical situations described in items 1C-J... I. Decontaminate hands after contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient...J. Decontaminate hands after removing gloves..."
On 6/20/24 at 10:26 AM, during a tour of the 3-Tower Unit, S7 was observed cleaning and disinfecting a patient-occupied room. While donned in gloves, S7 was observed mopping the floor, he/she then removed the dirty mop head and placed it in the trash, then failed to doff his/her gloves and perform hand hygiene prior to cleaning and disinfecting the remainder of the patient room with the same soiled gloves on. S7 then entered the patient bathroom, cleaned the toilet bowl, doffed his/her gloves, then failed to perform hand hygiene prior to reaching into the clean box of gloves to obtain a new pair. At the completion of the room cleaning, S7 doffed his/her gloves and failed to perform hand hygiene, prior to exiting the patient room and going down the hallway.
Facility policy titled, "Hand Hygiene," Last Revised 2/15/2022, stated, "Policy: (name of facility) personnel will perform hand washing and hand hygiene in accordance with the Center for Disease Control and Prevention (CDC) guidelines. ..."
Upon making S2, the Vice President of Patient Care Services and Chief Nursing Officer, aware of the identified hand hygiene issues with the EVS employees, he/she stated, "we need to relook at our processes because gloves are overutilized."
4. During an interview with S18, a Healthcare-Associated Infections and Antimicrobial Resistance Epidemiologist with the Infection Control, Healthcare, & Environmental Epidemiology Program within the New Jersey Communicable Disease Service (CDS), he/she indicated that he/she had been trying to reach out to the facility since April of 2023 regarding the reporting of several cases of Multidrug-Resistant Organisms (MDRO) identified at the facility. S18 stated that he/she and his/her colleagues have sent multiple emails to the facility's Infection Control Professional and the Director of Performance Improvement, requesting the completion of the New Jersey Department of Health Multidrug Resistant Organism Case Report form (NJDOH MDRO Case Report form) for several patients. CDS was requesting the MDRO Case Report form for several patients from April 2023 to June 2024. S18 stated they were communicating with the facility and then all communication ceased. S18 confirmed that the NJDOH MDRO Case Report Forms were never received.
On 6/20/24 at 12:16 PM, an interview was conducted with S5, the ICP. S5 confirmed that in the past few months, the facility had patients with both Candida auris (C. auris, a type of yeast that is resistant to antifungal medications and can cause severe illness and spreads among patients in healthcare facilities) and CRAB (Carbapenem-resistant Acinetobacter baumannii, a bacteria resistant to nearly all antibiotics that is difficult to remove from the environment and can cause deadly infections and large outbreaks).
On 6/24/24, S5 explained that all the specimens for microbiology testing are sent out to an outside lab. S5 explained that the outside lab sends an email daily with results from the previous 24 hours. The email is sent to the ICP and the microbiology supervisor. S5 stated that he/she reviews the results every morning. S5 stated that he/she communicates with S16, the Infectious Disease Physician, and S17, the Epidemiologist regarding the results.
On 6/20/24 at 11:17 AM, medical records were reviewed with S3, Education Manager and S4, Educator, and the following was revealed:
On 12/7/23, Patient (P) 7 was admitted from an LTAC (Long Term Acute Care) facility, and a blood culture was collected on 12/12/2023 and resulted on 12/18/2023 growing Candida auris.
On 1/11/2024, P2 was admitted from a rehabilitation facility and a sputum culture was collected on 1/15/2024 and resulted on 1/22/2024 and indicated the MDRO Acinetobacter baumannii.
On 2/8/2024, P3 was admitted from a Long-Term Care (LTC) facility, and a wound culture was obtained on 2/9/2024 and indicated the MDRO Acinetobacter baumannii.
On 3/21/2024, P4 was admitted from home. A specimen of the sacrum was collected on 3/23/2024 and resulted on 3/24/2024 and indicated the MDRO Acinetobacter baumannii.
On 5/16/2024, P5 was admitted from a rehabilitation facility. The 5/16/2024 "Consult Note" stated, " ...Assessment: ...MDR-UTI+VE KLEIBSIELLA PNEUMONIA [sic] (CRE)-Urine culture 5/15/2024 at SAR [Subacute Rehab]."
On 5/16/2024, P6 was admitted from a LTC facility. A urine culture was collected on 5/16/24. On 5/23/24 the result of the urine culture indicated "MDRO." At 12:22 PM, S6 showed evidence that the NJDOH MDRO Case Report Form was completed and provided to the New Jersey Department of Health.
On 6/20/24 when asked if the cases were reported to the NJDOH Communicable Disease Service, S5 stated, "yes, I reported them." When a request was made to S5 for the completed NJDOH MDRO Case Report forms for P2 through P7, S5 stated, "I don't keep a copy." At 12:22 PM, S6 provided evidence that the NJDOH MDRO Case Report form was completed and submitted for one patient, P6. At 12:55 PM, when asked about the case reports for the other patients, S5 stated "I will fill them out when I get the opportunity." S5 and S6 confirmed that the requested forms were not filled out for the other patients.
The facility Infection Prevention and Control Program dated, 2024 stated, "...I. Surveillance- Managing Critical Data ...2. Tracks and trends patient cultures to determine trends, clusters, unusual organisms, ...L. Program Planning/Evaluation and Data Sharing...1. Data Sharing/Analysis Reporting: ...Six times per year to IC committee members (more frequently if needed). ...M. Regulatory Accreditation and Compliance...IC [Infection Control] collaborates with and provides information as requested to appropriate local and state health departments, CMS [Center for Medicaid Service] and other regulatory agencies for reporting of communicable diseases and related conditions, ...and specific MDRO to assist with control of infectious diseases and Community/State-wide infectious disease disaster preparedness."
When asked if S5 investigated the cases of C. auris and CRAB, he/she responded "yes." A request was made for S5's surveillance information and it was not received. S5 stated that the Infection Control Committee meets 6 times a year. The infection control meeting minutes dated February 28, 2024, and April 24, 2024, were reviewed. The meeting minutes lacked evidence that the C. auris and CRAB cases were discussed.
The facility failed to provide evidence of surveillance tracking, data sharing with the IC committee, and reporting of communicable diseases, in accordance with the facility's Infection Prevention and Control Program.