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Tag No.: C0914
Based on observation, interview, and record review, it was determined that the Critical Access Hospital (CAH) failed to ensure that patient care equipment was maintained in safe operating condition in 2 of 4 outpatient setting visited.
Findings include:
Review on 9/30/25 of the facility's policy titled "Testing and Inspection of Patient and Non-patient Care Equipment, dated March 1, 2022, revealed, "... To provide for the systematical testing and inspection of all clinical patient care and non-patient care equipment... A. All incoming equipment, either patient care equipment or electrical equipment, is inspected and evaluated by the Plan Services Department prior to being used in the Hospital. B. After equipment is inspected and evaluated, it is added to the master inventory list and scheduled for periodic inspections. Patient care equipment inspections intervals are based on [contracted company's name omitted] risk-based testing (6-or 12-month intervals) and 12 month intervals for all other electrical equipment..."
Observation on 9/25/25 at 8:45 a.m. of the Cardiac Rehabilitation area revealed an upper body ergometer and a recumbent bike for the lower body with an upper-body ergometer) that did not have a sticker that they had been inspected and evaluated.
Interview on 9/25/25 at 8:45 a.m. with Staff C (Certified Medical Assistant Practice Manager) confirmed the above findings.
Review on 9/30/25 of a work order for the upper body ergometer revealed it was last inspected 2/4/21.
Review on 9/30/25 of a purchase order for the recumbent bike for the upper and lower body was purchased on 6/10/22. There was no work order that any inspections had been done.
Interview on 9/25/25 at 3:50 p.m. with Staff D (Director of Facilities) confirmed the above two exercise machines should be inspected annually. Staff D was unable to provide documentation that inspections had been done annually for the above equipment.
40522
Review on 9/25/25 of the manufacturer's instruction for the mini-pasteurmatic equipment revealed "...Cleaning Tank...Weekly tank cleaning is recommended. Because some localities have water that is extremely corrosive, they may require that the tank be cleaned more often...Cleaning Procedure The tank should be cleaned at least once a week, or more often if local water conditions results in severe scale buildup...Checking Water Temperature The water temperature at the mid-tank point should be checked every two weeks to verify that the thermistor and heater are functioning properly 1 turn the unit off, then on. The printer will print the current temperature setpoint. 2 Allow the water in the tank to heat completely. The WATER TEMPERATURE display will show the current setpoint. 3 Lower a thermometer to the middle of the tank and verify that the water temperature is at the pasteurization setpoint...".
Observation on 9/23/25 at approximately 11:28 a.m. with Staff E (Clinical Supervisor for Cardiopulmonary) in the sleep medicine department on the third floor revealed a mini-pasteurmatic device ( a machine that provides High-Level Disinfection through pasteurization by submersion in hot water) located in a storage room.
Interview on 9/23/25 at approximately 11:28 a.m. with Staff E confirmed the mini-pasteurmatic device was in use. Staff E revealed the mini-pasteurmatic device was used for cleaning and disinfecting the masks and tubing used for sleep study tests. Further interview with Staff E revealed that for maintenace they empty and replace the water in the mini-pasteurmatic equipment and check water temperature weekly. Staff E was unable to provide documentation of the weekly water temperature checks, chaning the water or cleaning in the mini-pasteurmatic equipment.
Interview on 9/25/25 at 3:50 p.m. with Staff D revealed that he/she was unaware there was a mini-pasteurmatic device in the sleep medicine department. Staff D was unable to provide documentation of annual inspection of the mini-pasteurmatic equipment after 3/2021.
Tag No.: C1206
Based on observation, interview and record review, it was determined that the Critical Access Hospital (CAH) failed to employ methods for disinfecting equipment to prevent the potential transmission of infections in 2 of 4 outpatient settings visited.
Findings include:
Review on 9/24/25 of the Digital Ultrasonic Diagnostic Imagine System User Manual for the above ultrasound machine and probe, provided by the facility, revealed, " ...14.2. Cleaning and Disinfection ... 14.2.2. Probe and Probe Holder Cleaning and Disinfection ... To clean the probes: Disconnect the probe from the system. Wipe off all the gel gently with a soft cloth. Rinse the probe with enough distilled water to remove all visible soap residues. Air dry or dry with a soft cloth ...To disinfect the probe: Disinfection should be performed each time after use: 1. Prepare the disinfectant (2.4% glutaraldehyde or 0.55% ortho-Phthalaldehyde). 2. Place the cleaned and dried probe in contact with the disinfectant ... for the time specified by the disinfectant manufacturer ... 3. After removing from the disinfectant, rinse the probe according to the disinfectant instructions. Flush all residues from the probe and perform air dry ... Proper Use of Probes ... Each time after use, clean and disinfect the probe ..."
Observation on 9/24/25 at 11:25 a.m. of the outpatient obstetrics/gynecology department revealed an ultrasound machine with an ultrasound transducer (a transvaginal probe) attached to it.
Interview on 9/24/25 at 11:25 a.m. with Staff A (Certified Medical Assistant) revealed that the probe was used for internal vaginal ultrasound during exams and that Staff A cleaned the probe after use with germicidal wipes.
Interview on 9/24/25 at 2:25 p.m. with Staff A confirmed they did disinfect the transvaginal probe with 2.4% glutaraldehyde or 0.55% ortho-Phthalaldehyde according to manufacturer's instructions.
Review on 9/25/25 of the CAH's policy for the facility Surgical Associates titled "Infection Control Policy" dated May 9, 2025, revealed, "Purpose: To establish guidelines to minimize and prevent the spread of infection ... 5. Medical instruments or equipment must be cleaned and the either disinfected or sterilized after each use according to manufacturer's instructions ..."
Review on 9/25/25 of the CAH's policy for the Imaging Service Department titled "Infection Control Policy" dated November 1, 2022, revealed, " ...d. Disinfection, anti-sepsis, and pertinent environmental controls ... ii. Ultrasound transducers are to be disinfected between patients using the Trophon high level disinfection unit ...".
40522
Review on 9/25/25 of the manufacturer's instruction for the mini-pasteurmatic equipment revealed "...Operation CAUTION Before using the Mini-Pasteurmatic, read and be familiar with the entire manual, including warnings, cautions, and notes...Intended Use The Mini-Pasteurmatic is intended for high level disinfection of respiratory and anesthesia parts; it is used in a healthcare setting by health-care workers....What Parts can be Pasteurized? Reusable respiratory therapy and anesthesia breathing circuit parts can tolerate pasteurization without harm..CAUTION All parts should be inspected after processing for normal wear and/or damage...Pasteurizing Temperature Definitions Minimum Pasteurizing Temperature: 158 [degrees] F [Fahrenheit]...for 30 minutes...Maximum Pasteurizing Temperature: 170 [degrees] F...for 30 minutes Above this temperature some plastics may be damaged...Pasteurizing Set Temperature: Nominally 166 [degrees] F [plus or minus] 2 [degrees] F The pasteurizing temperature of Mini-Pasteurmatic is preset...Start Pasteurizing Cycle With basket submerged, press START CYCLE...to begin a pasteurizing cycle. The CYCLE ON light illuminates and the CYCLE TIME REMAINING display shows "30" and the timer begins counting down the 30-minute pasteurizing cycle. In addition, the printer prints "PASTEURIZATION START" followed by the date, time, and water temperature...The printer continues to print the date, time, and water temperature at five-minute intervals throughout the pasteurization cycle. Complete Pasteurization Cycle At the end of the pasteurization cycle, an audible signal sounds, the CYCLE TIME REMAINING display goes blank, and the print out shows "Elapsed time = [equals] 30 minutes PASTEURIZATION COMPLETE." Press Advance to expose the signature line...before tearing off the printout...".
Observation on 9/23/25 at approximately 11:28 a.m. with Staff E (Clinical Supervisor for Cardiopulmonary) in the sleep medicine department on the third floor revealed a mini-pasteurmatic device ( a machine that provides High-Level Disinfection through pasteurization by submersion in hot water) in a storage room.
Interview on 9/23/25 at approximately 11:28 a.m. with Staff E revealed the mini-pasteurmatic device was used for cleaning and disinfecting the masks and tubing used for the sleep study tests. Staff E was unable to provide documentation of the results of pasteurization cycle to validate high level disinfection of the masks and tuning disinfected using the mini-pasteurmatic equipment.
Review on 9/25/25 of the CAH's policy titled, Disinfection of Masks, Tubing, and Humidifiers Using Mini-Pasteurmatic, dated 1/30/24, revealed "...The Mini-Pasteurmatic is intended for the high-level disinfection of sleep and respiratory parts...Parts (masks, tubing, and humidifiers) are loaded in the perforated baskets and submerged in the water that is maintained at the pasteurizing set temperature of 166 [degrees] F [Fahrenheit]...The cycle is complete when the CYCLE ON indicator dims, an audible sound emits, and the printer documents the cycle has been competed...".
Interview on 9/29/25 at approximately 1:15 p.m. with Staff E confirmed that they failed to document the results of the pasteurization cycle to validate high level disinfection when using the mini-pasteurmatic equipment.