Madison Regional Health System

“SURGICAL SERVICES CFR(s): If a CAH provides surgical services, surgical procedures must be performed in a safe manner by qualified practitioners who have been granted clinical privileges by the governing body, or responsible individual, of the CAH in accordance with the designation requirements under paragraph (a) of this section. This Condition is not met as evidenced by: 18559 Based on observation, record review, interview, manufacturer’s instructions for use (IFU) review, and policy review, the provider failed to: *Follow manufacturer’s IFU for Revital-Ox Resert High Level Disinfectant used for high level disinfection for three of three endocavity (within the body) vaginal probes. *Document the disinfection time, solution temperature, vaginal probe number, and patient information when Revital-Ox Resert High Level Disinfectant had been used. *Test for the concentration of the Revital-Ox Resert High Level Disinfectant between each vaginal probe cleaning. *Ensure multiple surgical instruments that had been wrapped with surgical tape were free from cracks, rips, tears, and discoloration. *Ensure multiple surgical instruments had surgical tape wrapped 1.5 times around the instrument, applied flat, and without gaps per the manufacturer’s IFU. Findings include: 1. Observation and interview on 12/3/25 at 9:14 a.m. of the ultrasound room with sonographer F and sonographer G revealed: *Three endocavity vaginal probes were stored in the room. *A Trophon Sonex-HL (automated system to disinfect ultrasound probes) was located on the counter. *They stated the Trophon was used to disinfect the probes. *They have had to use a different disinfectant when the Trophon was not working. *They stated they believed Cidex (a brand name for a disinfectant) was the disinfectant that was used but would check with supply chain manager H. *When the vaginal probes were disinfected in the Trophon, they would have documented patient information on a log. *They would document Cidex used and the dates used when the Trophon was not working. Review of the provider’s Trophon 2 High Level Disinfection (HLD) log revealed: *There was documentation that Cidex (a brand of disinfectant) had been used to clean vaginal probes from 6/1/25 to 9/1/25. *There was no documentation Revital-Ox had been used by the provider. *The was no documentation for the amount of time the probe was in the Revital-Ox. *The temperature of the Revital-Ox was not documented. *There was no documentation of test strips being used to test the minimum effective concentration of the HLD. *There was no documentation of how often Revital-Ox solution was used. *There had not been a log to document patient information, vaginal probe that was used, and if HLD parameters had been met. *She thought director of quality and IC B had trained them on using Revital-Ox but was not sure when. Review of the undated Revital-Ox Resert High Level Disinfectant IFU label revealed: *The probe should have been in the solution for eight minutes and the soak time should have been tracked with a timer. *Minimum temperature of the solution should have been 68 degrees Fahrenheit (F). *Tests strips should have been used prior to each disinfection to test if the minimum recommended concentration was met. *The solution should have been discarded after 21 days. Interview on 12/3/25 at 9:40 a.m. with supply chain manager H revealed the provider had been using Revital-Ox Resert HLD prior to June of 2025. Interview on 12/3/25 at 10:35 a.m. with sonographer F revealed: *She confirmed they had used Revital-Ox instead of Cidex when the Trophon was down. *Documentation of the Cidex being used was incorrect. *They had not created a separate log for the Revital-Ox HLD. *She was not aware of the manufacturer’s IFU’s. *She was not aware they should have used test strips prior to the disinfection process to ensure the solution was at the required concentration level. *She was not aware they need to use a log to document the submersion time and solution temperature. *She thought the director of quality and infection control (IC) B had trained them. Interview on 12/4/25 at 10:32 a.m. with director of quality and IC B revealed: *The sonographers were not doing the HLD procedure correctly when the Trophon was not working. *Test strips should have been used. *She was not aware of the process that was used for disinfection when the Trophon was not working. *She had not trained sonographers F and G to use the Revital-Ox. *She agreed the process for dinfection used by sonographers F and G when the Trophon was down was not correct. Review of the provider’s 11/2025 Ultrasound Probe Disinfection policy revealed: *If the Nanosonics Trophon is down, use Revital-Ox Resert for disinfectant. *”Follow instructions for use from Revital-Ox for proper steps for disinfection.” 50715 2. Observation on 12/2/25 at 3:40 p.m. in the labor and delivery unit revealed: *Two peel packs (disposable packages used to hold instruments during sterilization) containing a sterile scissor and a pair of tweezers that were ready for patient use, contained surgical tape. *The surgical tape had: -Been placed flat on the instrument. -Not been wrapped 1.5 times around the instrument per the manufacturer’s IFU. -Not been laid flat without gaps. -Had cracks, tears, and discoloration. Observation on 12/2/25 at 4:00 p.m. in the emergency department revealed: *A single ring forceps (instrument used for grasping, holding firmly, or exerting traction upon objects) contained within a sterilized surgical pack and ready for patient use had surgical tape which had been: -Wrapped more than 1.5 times around the handle of the instrument. -Not been laid flat without gaps. Interview on 12/2/25 at 4:15 p.m. with operating room supervisor C and surgical technician (ST) E regarding the above instruments revealed: *Surgical instruments containing tape are inspected before sterilization to ensure the tape was correctly placed on the instrument. *If the tape needs to be replaced, that was done in the sterile processing department. *She agreed that those tape issues created the potential for bacteria to remain on surgical instruments that could potentially infect the patient leading to serious complications. *She agreed that the tape should have been removed and replaced per the manufacturer’s IFU. Observation on 12/3/25 at 9:45 a.m. in the sterile processing room revealed: *Two peel packs containing sterilized scissors. *The surgical instruments contained tape that: -Had been wrapped more than 1.5 times around the handle of the instrument. -Was not laid flat without gaps. Observation on 12/3/25 at 9:30 a.m. in the clinic procedure rooms revealed: *Four peel packs containing sterilized scissors and one peel pack containing a sterilized forceps. *The surgical instruments contained tape that: -Had been wrapped more than 1.5 times around the handle of the instrument. -Was not laid flat without gaps. -Had cracks. Interview on 12/3/25 at 9:45 a.m. with clinic manager L revealed: * Instruments used in the clinic are taped to distinguish them from hospital instruments. *Tape on instruments should have been inspected by the hospital’s sterile processing staff. *They did not have a clinic policy regarding the taping of surgical instruments. *She would have expected the surgical staff to follow the manufacturer’s IFU regarding surgical tape. *She agreed that issues with surgical tape created the potential for bacteria to remain on surgical instruments that could potentially infect the patient leading to serious complications. Interview on 12/3/25 at 10:00 a.m. with ST D revealed: *Instruments that needed sterilization and contained surgical tape should have been inspected to ensure the tape was placed correctly and undamaged. *She stated, “I’m sorry, I must have missed those instruments you had found yesterday. I will get them retaped, but I did not realize the tape had an expiration date, so I will need to order more tape.” *All instruments used in the clinic are taped to ensure they are returned to the clinic after sterilization. They would not have taped instruments used in the operating room. *She would have followed the manufacturer’s IFU to reapply surgical tape to instruments. Interview on 12/3/25 at 12:15 p.m. with the director of acute patient A confirmed: *The provider did not have a policy specifically on the use and care of tape on surgical instruments. *Staff would have been expected to inspect each instrument containing tape, replace as needed, and follow the manufacturer’s IFU. Interview on 12/4/25 at 9:13 a.m. with the director of quality, infection control B revealed: *She would have expected staff to inspect the surgical tape on instruments and replace it as needed per the manufacturer’s IFU. *She agreed that issues with surgical tape created the potential for bacteria to remain on surgical instruments. Review of the provider’s 4/2025 Decontamination of Instruments policy revealed, “All surgical instrument and medical device or equipment manufacturer’s validated instructions should be followed regarding the types of cleaning methods to be used for decontamination. Review of the provider’s 3/2023 Instrument Cleaning and Processing policy revealed, “All instruments, equipment and supplies to be used for patient care and procedures must be appropriately processed according to the manufacturers written instructions for use to ensure they are free from infectious bacteria.” Review of the manufacturer’s revised 6/2018 Key Surgical Identification Tape IFU revealed: *”Wrap tape 1.5 times on a stainless-steel instrument. Tape should lay flat without gaps. *Inspect tape prior to each use. Identification tape is not intended as a permanent mark and will discolor, break, chip, or flake over time. *Replace as soon as these are noticed.””

“MAINTENANCE CFR(s): The CAH has housekeeping and preventive maintenance programs to ensure that-- (1) All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition; This Standard is not met as evidenced by: 18559 Based on observation, interview, record review, manufacturer’s instructions for use (IFU) review, and policy review, the provider failed to ensure: *Acceptance testing (test by biomedical technician when a new piece of medical equipment is received) had been performed on one of one Deluxe Professional Stone Heater (warming device used to heat massage stones). *Temperatures had been documented for two of two pieces of equipment (Deluxe Professional Stone Heater and towel warmer) located in the message therapy room. Findings include: 1. Observation and interview on 12/4/25 at 10:49 a.m. with director rehab services J, director of quality and infection control (IC) B revealed: *There was a Deluxe Professional Stone Heater located in the corner of the room without an equipment testing verification sticker for when the last inspection date was. *They confirmed there was no sticker stating the date of the last inspection of the stone warmer. *There was a towel warmer located by the sink in the room. *There was not a temperature log for the stone heater or the towel warmer. *There was not a thermometer in either piece of equipment. *They stated licensed massage therapist I tracked the temperature of the stone heater and the towel warmer but had not documentation to verify the temperatures in a temperature. Interview on 12/4/25 at 11:50 a.m. with director of quality and IC B revealed the field service technician III K if the stone warmer did not have a sticker they would have needed to perform an initial inspection. He did not know who performed the initial inspection. Interview on 12/4/25 at 12:00 p.m. with licensed massage therapist I revealed: *Water temperature should have been between 120 degrees Fahrenheit (F) to 140 degrees Fahrenheit. *She stated she would have tested the water temperature twice during a treatment but would not have documented the temperature. Interview on 12/4/25 at 1:20 p.m. with field service tech III K revealed he: *Thought an acceptance test had been performed on the stone warmer. *Was not able to locate a record of the initial inspection to prove it had been performed. *The stone warmer would have needed an acceptance test but not an annual evaluation. Review of the September 2010 Massage Therapy Journal article (Don’t) Feel the Burn: Hot Stone Massage revealed: *”The only safe way to heat stones in water would have been to accurately control the temperature of the water.” *A calibrated thermometer should have been used to test the temperature of the water instead of relying only on the thermostat of the warmer. Review of the Message Stone Heater IFU revealed an accurate thermometer should have been used to measure the water temperature in the water reservoir. Review of the provider’s July 2018 Massage Therapy Hot Stones policy revealed water temperatures should have been checked to ensure water temperatures between 110 degrees F to 130 degrees F. *The policy did not support how to check the temperatures, how often the temperatures should have been checked, or define a process to support the staff had checked the temperature to ensure it remained within that range. Review of the provider’s May 2024 Medical Equipment Management Plan revealed an incoming inspection to include safety, operational, and functional test should have been performed on all medical equipment entering the facility and prior to use. Review of the provider’s November 2023 Blanket Warmer/Fluid Warmer policy revealed: *The temperature should have been no greater than 130 degrees F. *Temperatures should have been monitored daily. *The external temperature display needed to be compared to the internal temperature. *There was no process within the policy to support how they supported the temperature was checked, how often it should have been checked, and ensured it was within the required temperature range.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 27198 Based on record review and interview, the provider failed to update the emergency preparedness plan agreements (emergency fuel delivery) annually. Findings include: 1. Record review on 12/3/25 at 3:38 p.m. revealed no documentation that the provider’s current emergency preparedness plan memorandums of understanding/agreements were updated annually. For example, the emergency fuel delivery had not been updated annually since 2020. Interview with the Director of Quality, Safety, and Emergency Preparedness at that same time confirmed that finding. She stated they did not have a more current agreement.”

“Multiple Occupancies - Contiguous Non-Health CFR(s): NFPA 101 Multiple Occupancies - Contiguous Non-Health Care Occupancies Non-health care occupancies that are located immediately next to a Health Care Occupancy, but are primarily intended to provide outpatient services are permitted to be classified as Business or Ambulatory Health Care Occupancies, provided the facilities are separated by construction having not less than 2-hour fire resistance-rated construction, and are not intended to provide services simultaneously for four or more inpatients. Outpatient surgical departments must be classified as Ambulatory Health Care Occupancy regardless of the number of patients served. 18.1.3.4.1, 19.1.3.4.1 This Standard is not met as evidenced by: 27198 Based on observation, testing, and interview, the provider failed to maintain the fire-resistive rating for one of one randomly observed two-hour building separation wall (at the door to Avera home medical equipment). Findings include: 1. Observation and testing on 12/3/25 at 3:02 p.m. revealed the ninety-minute door in the two-hour, fire-rated separation wall between the hospital and the Avera home medical equipment suite did not automatically close and latch when the fire alarm was activated for a fire drill. That door leaf must automatically close and latch to maintain the two-hour fire-rating of the wall assembly between the business and healthcare occupancies. Interview with the maintenance director at the time of the observation confirmed that finding. He stated he was unaware that condition existed. The deficiency could affect 100% of the occupants of the smoke compartments on either side of the fire-barrier.”

“Gas Equipment - Cylinder and Container Storag CFR(s): NFPA 101 Gas Equipment - Cylinder and Container Storage Greater than or equal to 3,000 cubic feet Storage locations are designed, constructed, and ventilated in accordance with 5.1.3.3.2 and 5.1.3.3.3. >300 but <3,000 cubic feet Storage locations are outdoors in an enclosure or within an enclosed interior space of non- or limited- combustible construction, with door (or gates outdoors) that can be secured. Oxidizing gases are not stored with flammables, and are separated from combustibles by 20 feet (5 feet if sprinklered) or enclosed in a cabinet of noncombustible construction having a minimum 1/2 hr. fire protection rating. Less than or equal to 300 cubic feet In a single smoke compartment, individual cylinders available for immediate use in patient care areas with an aggregate volume of less than or equal to 300 cubic feet are not required to be stored in an enclosure. Cylinders must be handled with precautions as specified in 11.6.2. A precautionary sign readable from 5 feet is on each door or gate of a cylinder storage room, where the sign includes the wording as a minimum “CAUTION: OXIDIZING GAS(ES) STORED WITHIN NO SMOKING.” Storage is planned so cylinders are used in order of which they are received from the supplier. Empty cylinders are segregated from full cylinders. When facility employs cylinders with integral pressure gauge, a threshold pressure considered empty is established. Empty cylinders are marked to avoid confusion. Cylinders stored in the open are protected from weather. 11.3.1, 11.3.2, 11.3.3, 11.3.4, 11.6.5 (NFPA 99) This Standard is not met as evidenced by: 27198 Based on observation and interview, the facility failed to maintain medical gas storage as required. Combustible items were stored within five feet of the oxygen cylinders in one of one observed central storage oxygen storage room. Findings include: 1. Observation on 12/3/25 at 12:21 p.m. revealed combustible materials were stored adjacent to and within five feet of oxygen cylinders in the lower-level med room. Sixteen E-sized oxygen cylinders were found stored in an oxygen cylinder rack. Those cylinders were stored approximately three feet from several cases of supplies (N95 masks and Gowns). Interview with the maintenance director at that same time confirmed that finding. He stated he was unaware those oxygen cylinders were stored in that manner in that location. The deficiency had the potential to affect all occupants of the smoke compartment.”