Prairie Lakes Healthcare System, Inc.

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 18559 48106 46511 50715 Based on observation, interview, policy review, and review of manufacturer’s instruction for use (IFU), the provider failed to ensure: *Proper concentration of Prolystica enzymatic detergents and water had been measured per manufacturer’s IFU in two of two areas (decontamination and echocardiogram room). *All contaminated instruments containing blood and bodily fluids from two of two tables had been pretreated, wet, and transported in a sealed, leak proof container. *Sixteen of sixteen SafeGuide Over the Guidewire Esophageal Dilation System dilators had been stored per manufacturer’s IFU. *Two of two endoscopes’ reprocessing medivator’s (disinfects endoscopes) reusable mesh disinfectant filters had been cleaned monthly per manufacturer’s IFU. Findings include: 1. Observation and interview on 10/21/24 at 3:10 p.m. in the decontamination room with sterile processing technician C revealed: *A large sink used to rinse and soak contaminated instruments. *Within the large sink there had been a smaller container placed to the right where Prolystica enzymatic detergent was mixed with water to clean and brush surgical instruments. *She had stated the instructions were to mix ½ ounce (oz) of Prolystica per gallon of water. *The sink was to be filled with three gallons of water and 48 milliliters (ml) of Prolystica. *There had been no mark on the container to indicate three gallons of water. *She had confirmed there had been no measurement on the container to properly measure the enzymatic detergent to water per manufacturer’s IFU. Interview on 10/21/24 at 3:30 p.m. in the decontamination room with sterile processing department coordinator B confirmed: *There had been no mark on the container to properly measure the enzymatic detergent to water per manufacturer’s IFU. *She stated, “We use stickers, but they just fall off.” *There should have been a mark on the container to ensure proper measurement of enzymatic detergent to water. Observation and interview on 10/22/24 at 3:00 p.m. and on 10/23/24 at 8:25 a.m. with cardiac sonographer H of the echocardiogram room revealed: *There was a Philips washing tube and a bottle of Steris Prolystica Enzymatic Cleaner on the countertop to the left of the sink. *The provider cleaned the transesophageal echocardiogram (TEE) scopes in the room. *The provider’s X8-2T TEE IFU policy was taped to the wall above the sink. *There was no line in the sink to fill the show how much water for mixing the enzymatic cleaner. *She stated there was not a line in the sink to ensure they were meeting the manufacturer’s IFU for enzymatic chemistry dilution. *She hadn’t measured the amount of water added to dilute the enzymatic solution. Review of the provider’s 7/29/24 X8-2T TEE IFU policy stated to fill the sink 1/4th full with lukewarm water and add three pumps of the enzymatic pre-soak solution. Review of the Steris Prolystica Enzymatic Presoak and Cleaner IFU revealed: *Fill the sink with warm water to the appropriate level to immerse surgical instruments. *”Dilute chemistry 1/8 to 1/2 fl. oz. per gallon (1 to 4mL per Liter) of warm water. 2. Observation and interview on 10/21/24 at 3:10 p.m. in the decontamination room with certified surgical technician D revealed: *Surgical instruments used during the operation had been separated and placed into different containers with no lids on them. *The containers had been placed on a table with wheels for transportation to decontamination and central processing (department where re-usable instruments are cleaned and repackaged). *The table and instruments had been moved out of the operating room (OR) and rolled to decontamination and central reprocessing area. *The needles and sharp objects had been separated and discarded separately. *All the used instruments were sprayed with a pre-klenz (pre-treatment gel) or placed in water prior to transporting to decontamination. *A large drape had been placed over the instruments in the containers. *A large red drape containing a biohazard label was then draped over the entire table containing the instruments. *The red drape covering the instruments was not sealed, leak proof, or puncture resistant. *She confirmed sealed, leak proof containers had not been used to transport contaminated surgical instruments. Observation and interview on 10/21/24 at 3:30 p.m. in the decontamination room with sterile processing technician C revealed: *Seven containers of contaminated instruments including scissors, drills, irrigation cannulas, pickups, and screwdrivers were on a long table with wheels. *Some instruments had not been placed in containers and were lying flat on the table. *The table was pushed from the OR into the OR corridor and rolled to decontamination. *The instruments had been separated and treated with pre-klenz and were not placed in sealed containers. *The irrigation cannulas contained dried blood and were not soaked in a container. *A large drape had been placed over the instruments in the containers. *A large red drape containing a biohazard label was then draped over the entire table containing the instruments. *She confirmed: -The containers for transporting the used instruments did not have lids. -Every single instrument could have punctured the drape if they fell off the table. -Not all contaminated instruments had been sprayed with pre-klenz. -“It’s not the expectation of OR staff to spray the instruments even though surgical leadership says it is.” Interview on 10/21/24 at 3:50 p.m. with sterile processing department coordinator B confirmed: *Contaminated surgical instruments should have been pretreated with pre-klenz or placed in water in the operating room (OR). *Contaminated surgical instruments had not been transported in sealed, leak proof, puncture resistant containers. *The surgical instruments could have punctured through the red drape covering the surgical instruments. *The sterile processing department follows the Association for the Advancement of Medical Instrumentation (AAMI) to guide their practice and write policies. Interview on 10/22/24 at 9:34 a.m. with director of surgical services A confirmed: *Contaminated surgical instruments should have been transported in a sealed, leak proof, puncture resistant container. *The expectation was all contaminated surgical instruments should have been sprayed with pre-klenz in the OR prior to transport to decontamination room. Review of the provider’s November 2023 Waste Disposal, Including Infectious/Biohazardous policy revealed: *”All infectious waste must be placed in a closeable, leak proof containers or bags marked with the biohazard warning symbol or red in color. *All containers utilized for blood and/or other potentially infectious/hazardous material collections must be transported in containers that prevent leaking.” Review of the provider’s 5/19/24 Lippincott Procedures-Cleaning and Transporting Instruments, OR revealed: *”At the completion of the surgical procedure, perioperative staff must properly prepare instruments for transport to protect the instruments from damage and prevent injuries. *Separate sharp instruments from other instruments and place them in a puncture-resistant container for transport to limit the risk of injury. *Keep instruments moist before cleaning. -Place the instruments in a biohazard transport bag or an appropriate enclosed transport container or tray and place a towel moistened with sterile water on top of the instruments to prevent blood and organic material from drying. -Apply an instrument cleaner to all surfaces of the instruments to prevent rusting and corrosion and biofilm formation. *Place soiled instruments in a leakproof, puncture-resistance, closed container or cart that is large enough to fit all items and is labeled with a fluorescent orange or biohazard label. *Transport instruments in closed bins or carts to the sterile processing department.” Review of AAMI national guidelines ST 79:2017 pg. 35-36 revealed: *”Prior to transport, instruments should be prepared in such a way to prevent organic soils from drying by: -Placing a towel moistened with water (not saline) over the instrument. -Applying a product designed for pretreatment. *Contaminated items should be contained during transport from the point of use to the decontamination area. *To help prevent damage to reusable items and avoid contamination of the environment, transport carts or other system should: -Be designed to prevent items from falling over or off during transport. -Be large enough to maintain the security and package integrity of the items being transported. -Be covered or closed. *Prior to transportation, items contaminated with blood and other potentially infectious materials should be placed in a container that is puncture-resistant, leak-proof on the bottom and sides, labeled as biohazardous, and sealed. *Rationale: Materials contaminated with blood or other bodily fluids can serve as a source of infection to personnel unless the materials are completed contained. Containment minimizes the possibility of airborne or contact spread of microorganisms.” 3. Observation and interview on 10/22/24 at 9:10 a.m. in the scope storage room with RN E revealed: *A carrying case containing 16 esophageal dilators was hung on the wall. -The carrying case had been lined with foam to protect dilators. *The dilators were cleaned using high level disinfectant (HLD) according to the manufacturer’s IFU. *After HLD, the dilators were placed back into the carrying case. *She stated, “This has always been the practice.” *Confirmed the carrying case lined with foam had not been cleaned. Review of providers August 2024 Cleaning, Disinfecting, and Sterilization of Instrumentation and Medical Equipment policy revealed, “Department directors and managers will have oversight and responsibility that IFU’s for patient care items, instruments and medical equipment used in their department are followed.” Review of the manufacturer’s February 2023 SafeGuide Over the Guidewire Esophageal Dilatation System IFU revealed: *Storage -“The SafeGuide Dilators should be out of direct light, and at room temperature. -SafeGuide Dilators may be stored flat or hung vertically in any of the esophageal dilator storage solutions from Diversatek Healthcare including the wall-mount storage cabinet, horizontal storage cart, or vertical storage cart.” 4. Interview on 10/23/24 at 9:10 a.m. with registered nurse (RN)/ infection prevention staff F and G revealed: *Contaminated surgical instruments should have been transported in a closed, puncture resistant, leak proof container labeled as biohazardous. *Contaminated instruments were cleaned at point of use with pre-klenz. *Storing the esophageal dilators in a lined foam case after HLD would not have been an acceptable practice. *The foam lining within the carrying case would not have been cleanable. *Staff should have been following the manufacturer’s IFU regarding the storage of esophageal dilators. *RN, Infection Prevention G stated, “This will get fixed immediately.” 5. Observation and interview on 10/22/24 at 9:13 a.m. with RN E of the endoscope reprocessing medivator’s filter change logs revealed: *Medivator A/B reusable mesh disinfectant filter should have been cleaned monthly. -Documentation of a filter clean had been completed every three months instead of monthly. *Medivator C/D reusable mesh disinfectant filter should have been cleaned monthly. -Documentation of a filter clean had been completed every three months instead of monthly. *She was unaware if the medivator’s manufacturer’s IFU had changed. *She would need to speak with biomed to clarify the correct process. Interview on 10/23/24 at 3:00 p.m. with director of surgical services A and sterile processing department coordinator B confirmed: *The disinfectant filters for both medivators should have been cleaned monthly per the manufacturer’s IFU. *They would have expected documentation on the filter change logs to reflect cleaning had been performed. *Biomed would begin cleaning the reusable mesh disinfectant filters monthly. Review of the manufacturer’s 2015 Medivators DSDEDGE Endoscope Reprocessing System IFU pg. 64 revealed, “The filter is located below the overflow valve and is part of the drain manifold assembly. This should be checked and cleaned on a monthly basis.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 46511 50715 Based on observation, interview, and policy review, the provider failed to ensure two expired sterile water bags and five 0.9% intravenous (IV) solution bags used for irrigation in one of one fluid warmers were not available for patient use. Findings include: 1. Observation and interview on 10/21/24 at 2:30 p.m. with director of surgical services A in the sterile core of the operating room (OR) revealed: *A fluid warmer contained irrigation and IV solutions for patient use. *Irrigation solutions had a sticker affixed with the date the solutions had been placed into the fluid warmer. *A fluid warming guideline had been posted on the fluid warmer to instruct staff on the labeling and expiration date requirements of solutions used for irrigation. -IV bagged solutions for irrigations were good for up to 14 days in the warmer. *Two sterile water irrigation solutions had expired. -One bag had been labeled 8/6/24. -One bag had been labeled 10/2/24. *Five 0.9% normal saline irrigation solutions had expired. -Four bags had been labeled 9/12/24. -One bag had been labeled 4/24. *Director of surgical services A had stated staff should have rotated and removed expired items as part of their duties. *He agreed the irrigation solutions had expired and were available for patient use. Review of the provider’s undated fluid warming guidelines revealed: *”IV bagged solutions for irrigation (with plastic pouch over pouch intact): -Good in warmer for up to 14 days. -Label plastic over pouch with date that the solution had been placed in the warmer.” Review of the provider’s 4/24 Warmers policy revealed: *”Monitoring and maintenance of warming cabinets containing patient use items will be done regularly to ensure that temperatures are in established ranges and warmed patient use items are not expired. *Contents and content manufacturer recommendations for temperature based on intended use and any pertinent expiration date of warmed contents; -Solution stability may vary according to fluid composition and storage containers. Contact the manufacturers of the solution being used to determine the proper length of time for fluid warming. Calculate the length of safe storage according to the highest temperature in the range. *Temperature ranges and any pertinent content expiration guidelines will be posted on warming cabinets. *Cabinet temperature and expiration dates of contents will be monitored daily and recorded on a log or electronic recoding system.””

“FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE CFR(s): 482.41(c)(2) Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality. This Standard is not met as evidenced by: 15036 Based on observation, interview, policy review, and manufacturer’s instructions for use (IFU) review, the provider failed to ensure monthly testing for Automated External Defibrillators (AED) followed the manufacturer’s monthly testing protocol for eight of eight locations (cafeteria, main entrance, medical office building conference center, dialysis, outreach clinic, and the specialty clinic areas (physical therapy, cardiology, and urology) for the safety of patients, staff, and visitors. Findings include: 1. Observation on 10/21/24 at 12:45 p.m. of the AED in the main hospital entrance revealed no indication of the last monthly inspection. No date was observed on the case indicating an inspection. Interview and review on 10/23/24 at 1:57 p.m. with the chief nursing officer (CNO) K regarding the provider’s Code Blue/Emergency Care policy dated May 2024 confirmed: *AEDs were maintained in the above listed locations. -She was not sure which staff member(s) was responsible for the AED in the main entrance lobby or the cafeteria. *The department directors were responsible for AED maintenance, and they had not conducted monthly maintenance checks. *Biomedical conducted battery checks every six-months. *She was not sure if the AEDs could have been connected wirelessly for monthly monitoring and would check on that. Interview on 10/23/24 at 3:35 p.m. with CNO K confirmed the AEDs in the above listed locations were not wirelessly connected for monitoring and should have been checked per the manufacturer’s IFU. Review of the manufacturer’s Maintaining a State of Readiness instruction for use revealed: *”Device readiness should be verified at least each month. If your device has wireless access to LIFELINKcentral AED Program Manager or LIFENET System, you can verify the device status remotely. If your device does not have wireless access, you must check the Readiness indicator on the devices.” *”Verifying Readiness for Devices with Wireless Access. The device performs automatic self-tests daily, weekly, monthly, and every time you turn it on. If the automatic self-tests are successful, the device checks in to LIFELINKcentral AED Program Manager or LIFENET System once each month and reports that it is READY.” *”If your device is wirelessly connected to a LIFELINKcentral AED Program Manager or LIFENET System account and the device fails to check in at least once each month, an email notification is sent to your organization’s designated person. The email describes which of the following actions you need to perform: Replace electrode tray, Replace battery, Contact qualified service personnel.” *If the devices does not have wireless capability or is unable to automatically connect to LIFELINKcentral AED Program Manager or LIFENET System ...You should check the Readiness indicator on the device at least once each month. If the device is not ready, the Readiness indicator does not flash and an alert tone sounds every 15 minutes.””

“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: 15036 Based on observation, interview, and manufacturer’s instruction for use (IFU), the provider failed to ensure: *Staff followed manufacturer’s mixing instruction for use for the Prolystica and enzymatic cleaner. *Patient commode buckets were properly disinfected by one of one patient care technician (N). Findings include: 1. Observation and interview on 10/22/24 at 9:46 a.m. with senior director of inpatient services O in the critical care unit (CCU) soiled utility room revealed: *Two gray commode buckets turned upside down on the counter. *Patient care technicians (PCTs) were responsible for disinfecting the commode buckets. *There were no instructions posted for the commode disinfection process. -There was no PCT assigned for CCU today and she would have another PCT come and explain the disinfection process. *PCT N arrived at 9:52 a.m. to the CCU soiled utility room and explained her disinfecting process for the commode buckets as follows: -To clean the commode buckets three pumps of Prolystica (enzymatic cleaner) was put into the buckets. -The bucket was then filled halfway or all the way with water depending on how soiled they were. --Warm or cold water could have been used. --If extremely soiled she would have washed them out first in the hopper. -Once the bucket had been cleaned she wiped the outside with a Prime Sani-Cloth the wipes in the container with a purple top, and then turned upside down to dry. -The inside of the bucket was not wiped with a Prime Sani-Cloth or a Bleach Sani-Cloth. -The above-described process was how she had been taught. Interview on 10/22/24 at 10:40 a.m. with registered nurse (RN) infection prevention staff F and G revealed: *The process described above would not have disinfected the commode buckets. *Prolystica was an enzymatic cleaner and staff had been educated to use Sani-cloth bleach wipes in the container with the orange top. *To prevent potential cross-contamination bleach wipes should have been used on the entire commode bucket. *Bleach wipes were effective against Clostridioides difficile (C. diff). *C. diff is a bacterium that can cause diarrhea and other intestinal conditions. *The hospital at times had patients that were admitted with C. diff. Review of the Prolystica manufacturer’s IFU revealed: *This was an enzymatic presoak and cleaner detergent that could have been used for surgical instruments or medical devices in the manual cleaning process. *For manual cleaning: -“Fill the sink or basin with warm water to the appropriate level to fully immerse surgical instruments.” -The dilution ratio was “1/8 to 1/2 fluid ounce per (1 to 4 ml [milliliter]) of warm water.” --The water temperture should not have exceeded 130 degrees Fahrenheit. -“Clean for a minimum of 1 to 5 minutes.” -“After cleaning, all surfaces should be thoroughly rinsed with warm water.””

“Means of Egress - General CFR(s): NFPA 101 Means of Egress - General Aisles, passageways, corridors, exit discharges, exit locations, and accesses are in accordance with Chapter 7, and the means of egress is continuously maintained free of all obstructions to full use in case of emergency, unless modified by 18/19.2.2 through 18/19.2.11. 18.2.1, 19.2.1, 7.1.10.1 This Standard is not met as evidenced by: 40506 Based on observation and interview, the provider failed to maintain egress paths free of hazards for three of seventeen exits (adjacent to sterilization, stairwell at door 0023, and stairwell at door 0012). Findings include: 1. Observation on 10/22/24 at 9:15 a.m. revealed the path of egress adjacent to the sterilization area was very cluttered on each side of the corridor. The area was over 100 square feet in area and had combustible items (large amounts of cardboard boxes with supplies as well as carts) making the area hazardous. Paths of egress must not be through hazardous locations. An exit enclosure shall not be used for any purpose that has the potential to interfere with its use as an exit and if so designated as an area of refuge. LSC 7.1.3.2.3 2. Observation on 10/22/24 at 9:20 a.m. revealed storage at the bottom of the stairwell accessed through door 0023. The area was directly under the stairs leading to the exit and had combustible items (4 laundry carts and five large boxes) making the stairwell a hazardous location. Paths of egress must not be through hazardous locations. An exit enclosure shall not be used for any purpose that has the potential to interfere with its use as an exit and if so designated as an area of refuge. LSC 7.1.3.2.3 3. Observation on 10/22/24 at 9:27 a.m. revealed storage at the bottom of the stairwell accessed through door 0012. The area was directly under the stairs leading to the exit and had combustible items (carts from the sterilization area, boxes, and a bed) making the stairwell a hazardous location. Paths of egress must not be through hazardous locations. An exit enclosure shall not be used for any purpose that has the potential to interfere with its use as an exit and if so designated as an area of refuge. LSC 7.1.3.2.3 Interview with the facilities management director at the time of the observation confirmed that condition. He was aware of the prohibition of storage in a protected exit. The deficiency had the potential to affect 100% of the smoke compartment’s occupants.”

“Hazardous Areas - Enclosure CFR(s): NFPA 101 Hazardous Areas - Enclosure Hazardous areas are protected by a fire barrier having 1-hour fire resistance rating (with 3/4 hour fire rated doors) or an automatic fire extinguishing system in accordance with 8.7.1 or 19.3.5.9. When the approved automatic fire extinguishing system option is used, the areas shall be separated from other spaces by smoke resisting partitions and doors in accordance with 8.4. Doors shall be self-closing or automatic-closing and permitted to have nonrated or field-applied protective plates that do not exceed 48 inches from the bottom of the door. Describe the floor and zone locations of hazardous areas that are deficient in REMARKS. 19.3.2.1, 19.3.5.9 Area Automatic Sprinkler Separation N/A a. Boiler and Fuel-Fired Heater Rooms b. Laundries (larger than 100 square feet) c. Repair, Maintenance, and Paint Shops d. Soiled Linen Rooms (exceeding 64 gallons) e. Trash Collection Rooms (exceeding 64 gallons) f. Combustible Storage Rooms/Spaces (over 50 square feet) g. Laboratories (if classified as Severe Hazard - see K322) This Standard is not met as evidenced by: 40506 Based on observation and interview, the provider failed to maintain two separate hazardous areas (trash storage 2451, and soiled laundry) as required. Findings include: 1. Observation on 10/21/24 at 4:25 p.m. revealed the storage room at 2451 was in fact a trash storage room containing more than 64 gallons of trash, and had no automatic door closer. 2. Observation on 10/22/24 at 7:25 a.m. revealed the door separating soiled laundry from laundry was not a rated door, nor did it have an automatic door closer. The volume of stored soiled linens was greater than 64 gallons. The integrity of this door was also very low. Interview with the facilities management director at the times of the observations confirmed those findings. The deficiency affected three of numerous requirements for hazardous rooms.”

“Building Services - Other CFR(s): NFPA 101 Building Services - Other List in the REMARKS section any LSC Section 18.5 and 19.5 Building Services requirements that are not addressed by the provided K-tags, but are deficient. This information, along with the applicable Life Safety Code or NFPA standard citation, should be included on Form CMS-2567. This Standard is not met as evidenced by: 40506 Based on observation, testing, and interview, the provider failed to maintain laundry airflow in a clean to dirty relationship and failed to identify a potentially hazardous breathing environment as required. Findings include: 1. Observation and testing on 10/22/24 at 7:45 a.m. of the pressure relationships between clean and dirty spaces in the laundry room revealed the following: a. Using a tissue test, the dirty side of the laundry was determined to have a positive air pressure relationship with the corridor. b. The folding room was immediately across the hall from the dirty laundry, and the doors were held open. This room had a negative pressure relationship to the corridor. The result of these tests show dirty air would flow into the clean area. 2. Observation on 10/21/24 at 1:30 p.m. revealed a room marked as storage on the first floor contained sixteen H-cylinders containing carbon dioxide. The Carbon Dioxide Manufacturers Association lists a “normal” storage amount as one cylinder. There is no listed prohibition or added requirements for ventilation until 3000 cubic feet of storage is reached, however displacement of air may become hazardous. Signage for compressed gas storage is required. Interview with the facilities management director at the time of the observations confirmed those findings. The deficiency affected two of several requirements for ventilation.”