Community Hospital

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 47959 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance. A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews, and document review, the facility failed to follow manufacturers’ instructions for use (IFU) and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturers’ IFUs in one of two observations of the instrument reprocessing process.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 47959 Based on observations, interviews, and document reviews, the facility failed to follow manufacturers’ instructions for use (IFU) and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturers’ IFUs in one of two observations of the instrument reprocessing process. Findings include: Facility policy: According to the Sterile Processing policy, to ensure patient safety, standard procedures should be utilized to properly clean and process all contaminated instrumentation and equipment which actually or potentially contacts the patient while monitoring the system for quality and consistency. Decontamination standards, manual cleaning should be performed in conjunction with the mechanical process and according to the manufacturer’s recommendation. References: According to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) Sterile Processing - Knowledge, Skills, Competencies, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little or visible, can prevent disinfectant or sterilant from contacting the surface of an item. The best resource for determining how to best manage an item is the manufacturer’s IFU. The Integra Jarit IFU read, thoroughly rinse instruments by immersing in deionized water. The DePuy Synthes Instructions for Processing Medical Devices read, immerse devices and parts in the detergent solution, and soak for a minimum of five minutes. Rinse all devices by immersion in ambient less than (<) 40° C (104° F) tap water for a minimum of one minute. Completely submerge the devices in an ultrasonic bath for a minimum of 10 minutes. Rinse devices by immersion in ambient < 40° C (104° F) tap water for a minimum of one minute. 1. The facility failed to manually clean surgical instruments in accordance with facility policy and manufacturers’ IFUs. A. Observations i. On 11/19/25 at 9:30 a.m., observations were conducted in the sterile processing department (SPD). Observations revealed orthopedic surgical instruments from a total knee arthroplasty (knee replacement) being cleaned and reprocessed by sterile processing technician (Tech) #1. Tech #1 soaked the instruments in water with enzymatic solution for two minutes, followed by a soak in a second sink of enzymatic solution, while Tech #1 brushed debris from the instruments. Observations revealed the total soak time did not consistently meet the IFU requirements for a minimum five minute soak time. Tech #1 then removed the instruments and placed them in a third sink to rinse the instruments with a tap water spray, followed by a spray with deionized (minerals removed) water (DI water). Observations revealed the time Tech #1 sprayed the instruments varied between five and 15 seconds. After rinsing, the instruments were loaded into an automated washer-disinfector. This was in contrast to the Integra Jarit IFU, which instructed staff to thoroughly rinse instruments by immersing in deionized water. This was also in contrast to the DePuy Synthes Instructions for Processing Medical Devices which read, devices and parts were to be immersed in detergent solution and soaked for a minimum of five minutes. All devices were to be rinsed by immersion in ambient < 40° C (104° F) tap water for a minimum of one minute. The devices were to be completely submerged in an ultrasonic bath and cleaned for a minimum of 10 minutes. Devices were to be rinsed by immersion in ambient < 40° C (104° F) tap water for a minimum of one minute before they were placed in the automated washer-disinfector. Additionally, this was in contrast to the Sterile Processing policy, which instructed staff to decontaminate surgical instruments according to the manufacturer’s IFUs. B. Interviews i. On 11/19/25 at 7:30 a.m., an interview was conducted with Tech #1. Tech #1 stated the IFUs for the Integra Jarit and DePuy Synthes instruments determined which instruments went into the ultrasonic cleaner. Tech #1 stated the IFUs, which provided a specific cleaning time for the ultrasonic, meant the ultrasonic cleaner was required for the cleaning process. Tech #1 stated, if no specific time was provided, the ultrasonic cleaner was optional, even if the IFU listed it as a step in the decontamination process. Tech #1 stated they did not believe spray rinsing the surgical instruments was adequate due to poor water pressure, and did not know the IFUs requirement to rinse the instruments by immersion in water with a specific water temperature. Tech #1 stated when IFUs were not followed, there was ineffective removal of biofilm (blood, tissue, and microorganisms) from the instruments which caused patient infections. ii. On 11/19/25 at 9:21 a.m., an interview was conducted with surgical services director (Director) #2. Director #2 stated a sterilizer vendor instructed the staff that the ultrasonic cleaner was not necessary for orthopedic instruments when staff used the automatic instrument washer to clean instruments. Director #2 stated the orthopedic IFUs did not require ultrasonic cleaning. These interviews were in contrast to the DePuy Synthes Instructions for Processing Medical Devices, automated cleaning instructions, which read, the devices should have been completely submerged in an ultrasonic bath and cleaned for a minimum of 10 minutes before they were placed into the automated washer-disinfector. Additionally, the interviews were in contrast to the ANSI/AAMI Sterile Processing - Knowledge, Skills, Competencies, which read the manufacturer’s IFU was the best resource to determine how to manage instruments.”