Lake District Hospital

“COMPLIANCE WITH FED, ST, AND LOCAL LAWS CFR(s): The CAH and its staff are in compliance with applicable Federal, State and local laws and regulations. This Condition is not met as evidenced by: 44104 Based on observations, interviews, review of the CAH’s list of locations, review of OARs, review of SA licensing records, and the SA FPS Unit’s project review applications, it was determined that the CAH failed to ensure that it was in compliance with applicable Federal and State laws and rules: * On-campus outpatient services were provided without the required SA FPS Unit review, approval and licensure. * Hospital services provided in one area of the hospital were relocated to another hospital space, a change of use. This change of use occurred without the required SA FPS Unit review and approval. * The CAH had previously been cited in 2019 for provision of outpatient physical rehabilitation services in an on-campus space previously licensed as a SNF without the required SA FPS Unit review, approval and licensure. * The CAH had been previously cited in 2019 for provision of outpatient immunization, reproductive health, substance use, rehabilitation, and mental health services at five off-campus locations without the required SA FPS Unit review, approval and licensure. This Condition-level deficiency reflects the CAH’s limited capacity to provide safe and appropriate care and services. Findings include: 1. Refer to the findings at Tag C-816, CFR 485.608(c), Licensure of CAH, that reflects outpatient services were provided in an on-campus space not approved and licensed by the SA. Hospital services were relocated to another hospital space without the review and approval by the SA FPS Unit.”

“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: 44104 Based on observations, interview, documentation in 2 of 2 employee training records (Employee 47 & Employee 51), review of infection control P&Ps, and other documentation, it was determined that the CAH failed to ensure it had developed and implemented infection prevention P&Ps that demonstrated adherence to nationally recognized infection prevention and control guidelines, and to ensure it maintained a clean and sanitary environment in the following areas: * P&Ps to ensure a clean and sanitary environment, including P&Ps for instrument/device pre-cleaning, disinfection and sterilization processing, were not fully developed, implemented, and were inconsistent with nationally recognized standards. * Expired, unlabeled, and reusable patient care supplies identified for sterilization were available for patient use or for use with patient care equipment. * Patient care equipment used in surgery were not maintained in a clean or sanitary manner. * Anethesia evaluations and risks provided by a qualified practioner were not clearly documented in patients’ medical records. This Condition-level deficiency reflects the CAH’s limited capacity to provide safe and appropriate care and services. Findings included: 1. A policy titled, “Instruments Cleaning and Transporting Contaminated Instruments Procedure” dated “Last Approved 6/26/2025” was reviewed and reflected: * “Cleaning and Transporting Guidelines ... The guidelines for cleaning and transporting contaminated instruments from point of use (ED, OB, Vascular, Acute, Radiology, Surgery, Clinics) to the Sterile Processing Decontamination Room are as follows ... “ - “1. Immediately after use, place contaminated instruments in open position into a measure marked basin filled with warm tap water to the 4 quart mark (one gallon). Never soak instruments in saline as it will damage the instruments.” - “2. Add one full pump of enzymatic detergent (Enzol).” - “3. Allow instruments to soak for a [in bold lettering] minimum of one minute in the Enzol and water.” - “4. Scrub each instrument with the provided disposable scrub brush(s), paying particular attention to hinged, serrated and ratcheted areas. Used brushes will be discarded daily. New brushes will be obtained at the beginning of morning shift each day.” - “5. After scrubbing each instrument, rinse instruments in clean, warm water to remove all detergent.” - “6. Allow instruments to air dry or dry with a towel.” - “7. Place cleaned, rinsed and dried instruments in the provided plastic puncture proof, lidded transport container, leaving hinged instruments in the open position.” - “8. Transport instruments to the Sterile Processing Decontamination Room. Remove instruments from the transport container and place on the cart labeled ‘Leave Clean Instruments Here’. [sic] Surgical staff will then process instruments for terminal sterilization and return them to appropriate department.” - “9. Wipe the transport container, inside and out, with Hydrogen Peroxide wipe. Keep surface wet for at least 30 seconds for decontamination. Return container to appropriate department.” - “10. Tag broken/dull/rusty instruments with repair/sharpen tags if needed.” * “Objectives ... Removed [sic] as many organisms as possible from instruments before sterilization ... Remove debris and protein deposits that might interfere with sterilization and cause tissue reaction in a patient if they should dislodge during use ... Keep instruments in good condition.” * “Methods of Cleaning ... Manual: Detergent with stiff brush (except fine instruments) ... All instruments are to be washed in instrument cleaner and rinsed with tap water ... Special effort is required to clean box locks, hinges, and serration.” * “Washer: All instruments placed in appropriate container and ran through appropriate cycle ... Remove from washer and allow to air-dry.” * “Inspection/proper handling ... All instruments will be checked for functionality, cleanliness and integrity ... Separate routine instruments from delicate items ... Wash delicate items separately, protect all sharp edges ... Open all hinged instruments to allow cleaning medium and stream steam to reach all surfaces ... Dissemble all instruments consisting of two (2) or more parts to expose all surfaces ... Inspect each instruments [sic] for appositions of jaws and teeth, locks holding, alignment, etc.” * “Sterilization ... Instruments and sets wrapped/placed in containers as appropriate and ran through appropriate cycle per manufacturer’s recommendation ... Autoclave four (4) minutes at 270 degrees F., dry for 30 minutes, or per manufacturer’s recommendation ... After cooling: Distributed to appropriate locations throughout the facility.” * “References: Pre PolicyStat Number: 9-660-091, 9-675-205.” * “All Revision Dates ... 7/6/2018, 3/21/2017, 8/21/2015, 11/22/1994.” * “Approval Signatures ... Chief of Surgery ... Chief Executive Officer ... Surgery Manager.” The hospital failed to develop and implement a complete and clear policy that adhered to nationally recognized standards for sterilization processes. The policy failed to ensure staff who were precleaning instruments were trained, or whether staff competency was validated. The policy failed to specify the maximum amount of time instruments could soak in the enzymatic solution and instead specified the minimum amount of time. For example, it was unclear whether soaking instruments for 90 minutes would be in accordance with the hospital’s P&Ps, refer to Findings 7.a. and 7.b., observations of critical and semi-critical instruments. The P&P failed to include relevant manufacturer’s IFUs for precleaning prior to placing them in the biohazard bin for transporting, i.e.; “Initiate cleaning of device within 2 hours of use ... Remove excess gross soil as soon as possible after use by rinsing or wiping the device. All devices must be processed in the completely open position ... allow solution contact of all surfaces.” Refer to Finding 2, V. Mueller IFUs. Additionally, Sklar IFUs, Finding 3, reflected, “Pre-Treatment ... General ... Blood and body fluids can cause pitting on instruments and if left to dry, can be difficult to remove. In order to achieve successful decontamination, disinfection and sterilization, always wipe or rinse instruments immediately after use. If rinsing is not immediately available, pre-treat instruments with a neutral pH/enzymatic solution at point of service.” Refer also to Finding 7.b., additional observations and visualization of dried blood on a Sklar instrument, 90 minutes after point of use, and contrary to manufacturer IFUs. Both manufacturers recommended drying instruments with a “lint-free” towel, however, the P&P did not specify that the towel be lint-free; there was no mention of lubricating hinged items, nor what PPE was required for precleaning or other processing steps. Refer to Findings 2 and 3, manufacturer IFUs. The policy failed to take into account the manufacturer IFUs for the “Aesculap BD511R” forceps which had a slightly higher validated sterilization temperature, and which was not met by this policy. Refer to Finding 4, Aesculap BD511R forceps IFUs. It was unclear whether failure to “Remove debris and protein deposits that might interfere with sterilization and cause tissue reaction in a patient if they should dislodge during use ... “ was considered an acceptable practice if a patient did not have a “tissue reaction.” It was unclear whether references to nationally recognized standards were used to develop the P&P. It was unclear whether Infection Control, a key stakeholder, was included in P&P development. 2. A manufacturer’s IFU document titled, “V.Mueller® Products and Services General Surgical Instrument Cleaning and Sterilization Guide” was reviewed and reflected: * “Reusable Devices Instructions For Use ... These instructions for use are intended for reusable surgical instruments tabled with the CareFusion, V. Mueller® name. This cleaning and sterilization guide does not replace device-specific instruction for use already included with the device.” * “Warnings ... improper care and maintenance of the device may render the device non-sterile prior to patient use and cause serious injury to the patient or health care provider.” * “Cautions ... If there are any variations between these instructions and either your facility’s policies and/or your cleaning/sterilization equipment manufacturer’s instructions, those variations should be brought to the attention of the appropriate responsible hospital personnel for resolution before proceeding with cleaning and sterilizing your devices ... Only the cleaning and sterilization processes which are defined within these instructions for use have been validated.” * “Pre-processing Instructions ... Initiate cleaning of device within 2 hours of use. Transport devices via the institution’s established transport procedure. Remove excess gross soil as soon as possible after use by rinsing or wiping the device. All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow solution contact of all surfaces.” * “Manual Cleaning ... Ensure all pre-processing instructions are followed prior to cleaning ... Prepare the enzymatic/neutral pH detergent solution, utilizing tap water with a temperature range of 27°C [80.6°F] to 44°C [111.2°F] ... per manufacturer’s instructions ... Place device in the open/relaxed position ... and completely immerse in the detergent solution and allow device to soak for a minimum of 5 minutes. Actuate all movable parts during the initiation of the soak time ... Using a soft bristled brush, remove all visible soil from the device. Actuate device while brushing, paying particular attention to hinges, crevices and other difficult to clean areas. Note: It is recommended that the detergent solution is changed when it becomes grossly contaminated (bloody and/or turbid) ... Rinse the device by completely immersing in tap water with a temperature range of 27°C [80.6°F] to 44°C [111.2°F] ... for a minimum of 30 seconds to remove any residual detergent or debris ... Dry the device with a clean, lint-free towel ... Visually examine each device for cleanliness ... If visible soil remains, repeat cleaning procedure.” * “Automatic Cleaning ... Ensure all pre-processing instructions are followed prior to cleaning ... Clean the devices via the Automatic cleaning parameters ... If visible moisture is present dry the instrument with a clean, lint-free towel ... Visually examine each device for cleanliness ... If visible soil remains, repeat cleaning procedure.” * “Inspection/Maintenance ... Before sterilizing, lubricate the device with instrument milk or a steam permeable/water soluble lubricant, following the lubricant manufacturer’s instructions ... Let devices drip dry for three (3) minutes before packaging for sterilization.” * “Packaging ... Devices can be loaded into dedicated packaging systems ... Use in accordance with packaging manufacturer’s sterilization instructions being sure to protect jaws and cutting edges from damage.” * “Sterilization ... All devices must be processed in the completely open position (i.e. flushports, jaws, etc.) to allow sterilant contact of all surfaces. All devices with concave surfaces shall be configured so that water pooling does not occur ... Prevacuum Steam Sterilization Parameters ... Minimum Preconditioning Pulses: 3 ... Minimum Temperature ... 132°C (270°F) ... Minimum Exposure Time: 3 minutes ... Minimum Dry Time: 30 minutes ... Sterilization Configuration: Wrapped (2 layer 1-ply or 1 layer 2-ply).” * “Storage ... After sterilization, devices must remain in sterilization packaging and be stored in a clean, dry environment.” 3. A manufacturer’s IFU document titled, “Sklar Stainless Steel Surgical Instruments Recommended Care & Cleaning Instructions” was reviewed and reflected: * “CAUTION: The following instructions are for all Sklar stainless steel surgical instruments. Read instructions prior to use. Improper operation and care or use for purposes other than that intended can lead to premature wearing out of the surgical instruments. Always process new instruments prior to initial use ... “ * Pre-Treatment ... General ... Blood and body fluids can cause pitting on instruments and if left to dry, can be difficult to remove. In order to achieve successful decontamination, disinfection and sterilization, always wipe or rinse instruments immediately after use. If rinsing is not immediately available, pre-treat instruments with a neutral pH/enzymatic solution at point of service.” * “Rinsing ... General ... Immediately after surgery, remove organic material by rinsing soiled instruments under cold running water. Never process Steel, Magnesium, Aluminum or Zinc based materials with Stainless Steel. Always wear protective apparel as a standard precaution. Refer to OSHA and AORN standards for recommended precautions.” * “Cleaning ... “ - “General ... Transport instruments to decontamination processing/cleaning area. Always keep instruments covered during transport to prevent exposure to blood borne pathogens or other potentially infectious organisms. Before beginning the cleaning process, ensure that instruments have been thoroughly rinsed with copious amounts of cool running water. Separate instruments with dissimilar metals. Several methods of cleaning are available. Improper cleaning methods can result in damage to instruments or equipment and limit the warranty. See also AAMI TIR 12.” - “Soak .. An enzymatic cleaning bath or neutral pH detergent effectively breaks down organic material from instruments when fully submerged for 10 minutes. Take care to prevent sharp tips (scissors, knives, osteotomes, etc.) from touching. Do not mix dissimilar metals. Thoroughly rinse instruments with cool running tap water (use distilled or demineralized water if possible) to remove solution(s). Change solutions as directed.” * Automatic Washer Sterilizer ... Mechanical cleaning of surgical instruments is the preferred cleaning method as it efficiently removes soil and provided consistent washing and rinsing parameters. Follow manufacturer’s operating instructions. Ensure instruments are lubricated after the final rinse cycle and before sterilization.” * “Manual Cleaning ... Always wash instruments in a manner that provides proper decontamination ... Mix a neutral pH detergent/enzymatic solution with luke-warm water following the manufacturer’s mixing instructions and immerse instruments if possible. Highly acidic or highly alkaline pH detergents are not recommended for use on Sklar instruments ... Use a soft nylon brush to manually scrub instruments, concentrating on hinged areas, bone files or burs ... Brush delicate instruments carefully, separating them from general instruments whenever possible ... Prevent scratching by not allowing sharp tips (scissors, knives, osteotomes, etc.) from touching ... Visibly check instruments to ensure surfaces are clean and free from damage, stains and bioburden ... Check instruments for proper function and condition: smooth blade closure and opening, proper jaw alignment, working hinges, and proper locking ratchets ... Thoroughly rinse instruments using running water (distilled or demineralized water is recommended), paying close attention to hinged areas, box locks and moving parts to ensure they are rinsed thoroughly and no debris remains ... If to be stored, use a clean, lint-free cloth to dry instruments ... Lubricate instruments prior to packaging or sterilization ... Always store in a clean, dry environment.” * “Sterilization ... “ - “General ... All blood, body fluids and tissue should be completely removed from instruments prior to sterilization. Separate dissimilar metals prior to sterilization.” - “Lubrication ... Lubrication is key to preserving the proper function of your instruments. Lubricate all hinged instruments that have metal-to-metal contact at the screw or box lock. A non-silicone, water-soluble lubricant is recommended. Do not rinse. Do not use industrial oils or lubricants.” - “Autoclaving ... Process instruments individually or in sets ... Protect sharp tips. Place heavy instruments on the bottom of sets ... Always process all instruments in the open position. Instruments locked during sterilization can develop cracked hinges or other problems from heat expansion ... Autoclave instruments according to AAMI ST79 standards. Sklar stainless steel instruments have been validated for the following steam sterilization cycles (wrapped configuration): Pre-Vacuum Steam, 4min. @ ... 132°C/270°F with 20 min. Dry Time ... Note: Make sure autoclave chambers are cleaned regularly and as recommended by the manufacturer.” * “Note: The re-processor is responsible for ensuring that its processes are performed adhering to procedures, and using the requisite equipment, materials, and personnel in its facility to achieve the desired result. Routine monitoring and validation of the process is necessary to ensure the integrity of the process and result ... any deviation by the user from the instructions provided must be rigorously evaluated for effectiveness and to identify potential adverse consequences.” 4 The forcep manufacturer’s IFUs for its product “Aesculap BD511R” was retrieved on 09/30/2025 at 1020 from https://surgical-instruments.bbraun.com. It reflected: * “Processing - validated method” - “Mechanical cleaning/disinfection ... Mechanical alkaline cleaning with thermal disinfection ... at 90°C [194°F] for 5 min...” - “Validated steam sterilization process ... Fractionated vacuum at 134°C [273°F], Holding time t = 5 min.” - “Processing - other possible methods ... 134 °C [273 °F], max holding time 60 min.” 5. The manufacturer’s published “Knowledge Center” article dated “March 25, 2025” for the hospital’s “Washer/Disinfector” (equipment used in SPD) and titled, “How to Load Washer Racks in Sterile Processing” was downloaded from the manufacturer’s website, Steris Healthcare, on 08/18/2025 at 1715. It was reviewed and reflected: * “Efficient washer rack loading helps ensure that medical instruments are thoroughly cleaned and ready for the next step in reprocessing. Understanding best practices for rack loading and using the appropriate rack and related accessories helps deliver efficient and consistent cleaning from your automated washer/disinfector. This article explores various washer racks and available accessories, provides guidelines for proper washer rack loading, and offers tips to help deliver your washer’s expected throughput while minimizing rework.” * “Common Mistakes in Washer Rack Loading ... Some common errors can occur, which prevents the washer/disinfector from properly cleaning devices ... Overloading the Rack ... This prevents effective cleaning as the cleaning solution may not reach all device surfaces ... Improper Placement of Instruments ... Incorrect placement can lead to shadowing, where parts of the instruments are not exposed to the mechanical cleaning process. It’s best to avoid stacking trays or placing items directly over other items. Disassembling multi-layer instrument sets and placing each layer separately on the rack shelves can also help prevent shadowing ... Not Using the Correct Rack or Accessories ... Using the wrong rack or not using necessary accessories can result in inadequate cleaning ... Not using the correct accessories or washer racks could cause the need for re-work and washing devices ... Ignoring Manufacturer’s Instructions ... Not following the device manufacturer’s ... IFU ... can lead to improper cleaning and potential damage to instruments, Properly disassembling devices and using validated cleaning chemistries helps ensure optimal cleaning performance ... Failure to Inspect and Maintain Racks ... Dirty or damaged racks can impede cleaning ... Incorrect loading sequence ... Unbalanced loading of a washer rack can affect the rack’s stability and cleaning efficacy, potentially causing items to move around during washing.” * “Examples of Improperly Loaded Washer Racks ... Instruments that are not organized appear to have been “tossed” into the tray, causing possible shadowing ... Instruments on stringers should be placed with the bar laying down flat and the instrument tips pointed upward for optimal washing ... All ring-handled instruments should be on a larger stringer and placed in an open position ... Excessive loading can cause instruments not to be cleaned properly.” The examples included pictures of scissors and speculums sitting on top of each other, with some devices in the closed position; heavier items mixed with lighter items; layered instruments; and instruments properly secured, but which appeared to exceed 25 lbs and heavier trays placed on the top rack instead of the bottom rack. * “Standards and Guidelines for Loading Washer Racks ... Key standards that mention washer/disinfector loading include ANSI/AAMI ST79:2017 & 2020 Amendments ... The Healthcare Sterile Processing Association ... also provides guidance in the 9th edition of the Sterile Processing Technical Manual, guiding technicians on proper preparation and providing tips for proper loading of racks.” * “Tips for Medical Washer Rack Loading Success ... Remove items that impede washing ... allow water to flow freely through all instrument sets and levels of the washer rack ... Instruments should be disassembled per the device IFU, and all small parts should be removed and placed into a closed basket designed for use in a washer/disinfector. Be sure to follow all cleaning instructions provided by the instrument manufacturer ... Hinged instruments must be opened to access the box lock so the cleaning solution can reach all crevasses ... Multi-level trays should be opened and separated to be washed as individual trays and all lids removed.” * “Loading the Instruments Into Washer Racks ... Load from the bottom up ... Avoid ‘shadowing’ to ensure exposure of all instrument parts to cleaning and disinfection processes ... Use positioning accessories ... to help position the instruments ... can also prevent instruments ... from shifting during the cleaning process ... Don’t overload racks - Overloading racks can prevent effective cleaning and may require re-washing of instruments ... Ensure enough space between items for the cleaning solution to reach all surfaces ... Consider set weights - A tray with more than 25 lbs. would be challenging to sterilize in steam sterilization properly - if it’s too heavy for the sterilizer, why would this work for the washer? This simple rule can help avoid overloading too many instruments into one mesh tray.” 6. A document titled, “Documentation of Certification to Practice Surgical Technology in Oregon” version date in the footnote of “4/5/18” was reviewed and reflected: * Option 1 I have completed a training program for surgical technologists in a branch of the armed forces of the United States or in the United States Public Health Service Commissioned Corp. ... I have completed 16 hours of continuing education every two years relevant to the medical-surgical practice of surgical technology ... Documentation is attached / will be maintained in my possession ... This documentation needs to be renewed two years from the date of signing on __________________ Date.” * “Option 2 I have completed a surgical technology education program accredited by the ... Commission on Accreditation of Allied Health Education Program (CAAHEP) or ... Accrediting Bureau of Health Education Schools (ABHES) ... I have certification as a surgical technologists issued by the Nation [sic] Board of Surgical Technology and Surgical Assisting (NBSTSA) or completed the CAAHEP or ABHES educational program within the past twelve months ... Documentation is attached / will be maintained in my possession ... This documentation needs to be renewed twelve months after completing the educational program if NBSTSA certification is not obtained on __________________ Date.” * “Option 3 I have practiced surgical technology at least two years between January 1, 2014 and January 1, 2017 in a hospital, ambulatory surgical center or as an employee of a federal government agency or institution ... I have completed 16 hours of continuing education every two years relevant to the medical-surgical practice of surgical technology ... Documentation is attached / will be maintained in my possession ... This documentation needs to be renewed two years from the date of signing on __________________ Date.” * “Option 4 [In bold lettering] “Only available to surgical technologists practicing in a rural or medically underserved community.” This was followed by: “I am currently attending an approved educational program by the ... Commission on Accreditation of Allied Health Education Program (CAAHEP) or ... Accrediting Bureau of Health Education Schools (ABHES) ... I have been practicing at the hospital for less than three years. Start date: _____ ... Documentation is attached / will be maintained in my possession ... This documentation needs to be renewed upon three years of practice at the hospital on __________________ Date.” * “Signature of Employee” was signed by the ST on 01/08/2017. * “Signature of Hospital Representative” was signed by an unknown person on 01/08/2017. * The date of each signature were identically written. The hospital failed to provide complete and current documentation of personnel qualified through education, training, experience, or certification who could safely process equipment in the Sterile Processing Department.. For example, it was unclear when the ST’s training document was originally signed and dated as the version date of the document was approximately 14 months after the dated signatures, “4/5/18.” Option 1, Option 2, and Option 4 had no items marked as having been completed, and there were no dates noted for renewal of documentation. Option 3 had “I have practiced surgical technology at least two years between January 1, 2014 and January 1, 2017 in a hospital, ambulatory surgical center or as an employee of a federal government agency or institution,” however, there was no “renewal” documentation provided for the training. Per the “Documentation of Certification to Practice Surgical Technology” form, Option 3, “documentation needs to be renewed two years from the date of signing on ... “ but that date line was blank. There was no “renewal” documentation of training or certification provided for the ST every two years as required. The hospital failed to provide required training documentation for the following years: 2019, 2021, 2023, and 2025. No additional qualifications, training or competencies were provided for the ST who had been conducting sterile processing since 2016, refer to Finding 7.a., SPD observation and ST interview. 7.a. During an observation of the SPD and Surgical Services, and interview with the ST on 08/12/2025, beginning at 0940, the following information was gathered: * “Stryker ... Waste Management System” equipment for suctioning and collecting fluids during surgical procedures was observed stored in a EVS housekeeping supply closet. The suction equipment was situated and connected to a docking/recharging port approximately 4 inches away from the floor sink which contained an empty mop bucket and another housekeeping bucket with a scrub brush. A drainage hose lead from the suction equipment docking station to the floor sink. Dried splash droplets were visible on the floor between the sink and the suction equipment as well as residual water stains in between the docking station and the sink. The floor sink was discolored and stained. There was an uncovered trash can approximately 3 inches from the suctioning equipment. The top of the cleaning solution container was discolored with dust and dirt. There was a mop head on the floor behind the cleaning bottle. * The docking station was discolored with black specks and dust. It was approximately 1-2 inches away from the floor sink. * The SPD ST was asked whether the hospital performed any High-Level Disinfection [HLD]. The ST replied, “Yes. Housekeeping comes in and cleans the SPD ...” on a regular schedule. The surveyor explained that HLD was a disinfection process used on semi-critical instruments. The ST was not aware of any HLD processes being performed in the hospital. * The ST was asked whether they had received training on sterilization. They answered, “No,” but did have hands on experience in the hospital. * The ST was asked how dirty instruments were transported to the SPD from other departments. The ST stated that instruments were cleaned at the point of use, then soaked in an enzymatic solution, dried and transported to the SPD in a covered biohazard container. The instruments are then removed and sprayed down in the sink. The ST demonstrated this without the use of eye protection or a gown for splash protection. Gloves used to handle the instruments were not puncture resistant gloves, but regular hospital issued gloves. * The SPD ST was asked to demonstrate how an instrument tray was processed in the automatic washer. The ST loaded a tray with a variety of instruments with some placed over the top of other instruments; a pair of surgical scissors was observed in the closed position. Six forceps were observed with the manufacturer name and product identification number of “Aesculap BD511R.” * The ST placed the loaded tray in the washer/disinfector and stated that the washer pressure was so powerful that they have collected instruments from the bottom of the washer/disinfector chamber due to being tossed by the water pressure. * Other observations in the SPD included: - Five sterilized packages of instrument sets processed “11Aug 2025” containing forceps, hemostats and scissors were observed with the hemostats and the scissors in the closed position. The ST was asked whether it was acceptable to process instruments in the closed position and the ST responded, “No, but the top of the forceps are not locked, so they are open.” When asked whether that was the part of the instrument that would have contact with the patient, the ST responded, “No.” The ST acknowledged that the instruments, specifically the tips that contact patients, were not processed in the open position. - A drawer containing two packages of “Non-woven filter paper” available for wrapping items for sterilization were observed with an expiration date of “2021/06/26.” - A box of “Single-Use Sterilization Pouch[es]” was observed with an expiration date of “2023-08-31.” - Two packages of “Sterile Petri Dish[es]” were observed with an expiration date of “2023-06-30.” - Chrome wire shelving units containing sterilized items and sterilization supplies were observed without protective lining on the bottom shelves to prevent possible cross-contamination from floor particles and dust. One shelving unit was observed with a bottom shelf that measured 6 inches from the floor. The ST was asked whether 6 inches was an acceptable height for a bottom storage shelf for sterile items in the SPD. The ST responded, “No,” and that “eight inches” was the lowest acceptable height for storing sterilized items. 7.b. Additional observations of precleaned and sterilized critical and semi-critical instruments included: * On 08/13/2025 at 1030, a red biohazard container half filled with liquid and containing a metal tenaculum, a metal ring forcep, and a metal speculum was observed in a dirty utility room. The biohazard container had no lid and was sitting partially on the counter and partially over the sink, directly under the faucet. The speculum was halfway submerged in the liquid. There was dried blood visible on the non-submerged and distal end of the speculum. A unit RN was asked how long the instruments had been soaking and they stated, “Since 9:00 am,” one and a half hours prior to the observation. It was unclear whether the instruments had been scrubbed or wiped down per hospital P&P. An outdated policy, “Cleaning and Transporting Contaminated Instruments Procedure” dated “Last Approved: 8/31/2020” was posted directly above the sink. * On 08/13/2025 at 1038, a non-hospital grade electric razor was observed in a dirty utility room on the Acute Medical unit. It did not contain a biomedical sticker. The razor was sitting on a paper towel, and had been taken apart. Gray residue and grime were present on the individual parts, including the blades. A drawer under the counter was labeled, “Razors ... Toenail clippers.” It was unclear whether any HLD was performed on these shared items, which have the potential to come into contact with non-intact skin, a semi-critical classification requiring HLD. * On 08/13/2025 at 1514, four packages of sterilized instruments were observed in the Wound Care Clinic. Three of the processed packages contained scissors which were in the closed position. The WCRN was asked whether the items appeared properly sterilized for patient use. They responded, “Yes,” because the ST had processed and released them for use. The WCRN was asked whether there were other indications demonstrating proper sterilization. The WCRN stated, “Yes,” the CI inside the packages proved they had passed the sterilization process. When asked whether the items were acceptable for patient care, the WCRN stated, “Yes.” * A fourth processed package in the WCC contained a callus remover with what appeared to be a wire jetting out from the top of the blade. The WCRN was asked whether that item appeared properly processed. The WCRN stated, “Yes,” but that they don’t use that instrument often. When the package was further examined, the “wire” became loose and fell to the bottom of the package. A flat, slightly rounded particle of organic matter was observed and had the appearance of a toenail or dried skin. * On 08/13/2025 at 1520, a biohazard container was observed in the Wound Care Clinic with several dry instruments. There were stickers of a pair of feet on the instruments which would hinder the ability of steam to contact all surfaces of the instrument. * On 08/14/2025 at 1029, and accompanied by the COO, the non-hospital grade electric razor previously observed was still on the paper towel in a dirty utility room on the Acute Medical unit. The COO confirmed with nursing staff that the razor was used in patient care and shared among patients. The hospital failed to implement and follow its sterilization processes in accordance with its P&P. Refer to Finding 1, the “Instrument Cleaning and Transporting Contaminated Instruments Procedure,” and Finding 7.a.. SPD observations. For example, hinged instruments were not processed in the open position, items were not secured to prevent them from shifting or being tossed by the power washer, and heavy items were not separated from lighter items, potentially damaging the instruments which may interfere with the sterilization process. Stickers were placed on instruments, creating a barrier to steam penetration and sterilization. It was unclear whether items were properly pre-cleaned prior to sterilization as eveidenced by the dried blood on the speculum, instruments soaking in liquid for 90 minutes or longer, and the observation of dried, organic material in a processed, sterile instrument package that had been released for patient use. Nationally recognized standards for SPD environments and sterilization processes were not implemented, i.e., the ST indicated they had not received formal training; the ST failed to use appropriate PPE for handling contaminated instruments; supplies used for sterilization were expired; shelving used to store SPD supplies and sterilized items lacked protective barriers and not all shelving was consistent with shelf height requirements; and lastly, patient care instruments supplied to the WCC did not meet sterilization standards, and were available for use in patient care. The WCRN, who was also the IPRN and responsible for IP audits, was not able to readily identify items that did not meet nationally recognized standards for sterilized equipment used in patient care. 8. An email received from the ST on 08/18/2025 at 1342 provided the manufacturer information for the contaminated instruments observed in the ED Soiled utility room. They wrote, “The Speculum is Sklar and the Tenaculum and Ring Forcep are V. Mueller ...” Refer to Finding 7.b., additional observations. 9. Refer to the findings cited under Tag C-1144 at CFR §485.639(b)(2), Standard: Anesthetic Risk and Evaluation. The CAH failed to document that a qualified practitioner examined each patient before surgery to evaluate the risk of anesthesia.”

“INFECTION PREVENT & CONTROL & ABT STEWAR PROG CFR(s): The CAH must have active facility-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 coordination with the facility-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 44104 Based on observations, interviews, review of employee competency documentation for 2 of 2 employees, (ST and IPRN), review of P&Ps, and other IP Program documentation, it was determined the hospital failed to fully develop and implement an effective hospital-wide IP Program and systems for surveillance, prevention, and control of HAIs. Processes and P&Ps for maintaining a clean and sanitary environment, including oversight of equipment sterilization and processing, had not been fully developed. In addition, P&Ps based on nationally recognized standards for the surveillance, prevention, and control of HAIs had not been fully developed, implemented or enforced. Failures included: * Failure to identify an infection preventionist/infection control professional qualified through experience, education, training or certification in infection prevention principles, including HAI surveillance, who was responsible for the IPC Program; and to ensure the governing body appointed an infection preventionist/infection control professional. * Failure to ensure employees responsible for the hospital’s Sterile Processing Department were qualified to perform sterile processing through initial and regular training in sterile processing procedures. * Failure to conduct consistent monitoring of the hospital’s onsite laundry facilities, laundry storage areas, and the Sterile Processing Department; failure to recognize infection control breaches, respond to identified breaches, and ensure appropriate corrective measures were enforced when breaches in infection prevention protocols occurred. * Failure to ensure P&Ps with an IP component, such as SPD protocols, considered IP recommendations regarding nationally recognized IP standards in the development of policies. This Condition level deficiency represents failure to provide safe and adequate care and services. Findings include: 1. Refer to the findings cited under Tag C-1140 at CFR §485.639 - Surgical Services Condition of Participation: The CAH’s surgical services must be performed in a safe manner in accordance with acceptable standards of practice established by nationally recognized professional organizations (e.g., the Association of periOperative Registered Nurses, Association for Professionals in Infection Control and Epidemiology, etc.) including sterilization and disinfection of equipment. Findings reflect the CAH failed to ensure personnel qualified through education, training, experience, or certification in sterile processing safely processed equipment in the SPD, and that sterilized materials were packaged, handled, labeled, and stored in a manner that ensured sterility had been achieved and maitained in accordance with accepted standards of practice. 2. Refer to the findings cited under Tag C-1204 at CFR §485.640(a) - Standard: Infection Prevention and Control program, organization and policies that reflects the CAH failed to identify an infection preventionist(s)/infection control professional(s) who was qualified through experience, education, training or certification in infection prevention principles, and the governing body failed to appoint an infection preventionist(s)/infection control professional(s) responsible for the IP Program. 3. Refer to the findings cited under Tag C-1206 at CFR §482.640(a)(2), - Standard: Infection Prevention and Control program, organization and policies that reflects the CAH failed to develop and implement an IP Program that employed methods for preventing and controlling the transmission of infections within the CAH, including IP P&Ps that considered and addressed IP issues unique to the Sterile Processing Department and the onsite Laundry Processing Department; and failed to ensure a clean and sanitary environment was maintained in accordance with nationally recognized IP standards. 4. Refer to the findings cited under Tag C-1208 at CFR §482.640(a)(3), Standard: The Infection Prevention and Control program responsibilities that reflects the CAH failed to implement P&Ps for the surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment in accordance with nationally recognized IP standards. 5. Refer to the findings cited under Tag C-1240 at CFR §482.640(c)(2)(v), Standard: Leadership Responsibilities that reflects the CAH failed to ensure the IP program audited staff adherence to IP P&Ps for the maintenance and storage of patient care equipment and linens; failed to audit adherence to IP P&Ps in the areas of: Sterile Processing, WCC, onsite Laundry, and Surgical Services, and that processes in place were consistent with nationally recognized IP standards.”

“LICENSURE OF CAH CFR(s): The CAH is licensed in accordance with applicable Federal, State and local laws and regulations. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of the CAH’s list of locations, review of OARs and review of SA FPS licensing records it was determined that the CAH failed to ensure that all operations were approved and licensed as required by the State of Oregon hospital licensing requirements. The OARs require that a hospital submit building construction plans to the SA FPS, the Oregon hospital licensing authority, for review and approval prior to building construction or alterations, prior to expansion of existing services, and prior to the addition of new services. Those areas may not operate until approval and licensure to commence services is received from HFLC. The CAH failed to comply as follows: * The CAH commenced provision of outpatient orthopedic, obstetrics and gynecology, general surgery services at one on-campus location without the required SA review, approval and licensure. The outpatient clinic was located on the hospital’s main campus. * The CAH relocated the hospital’s Infusion Services from an acute services area of the hospital into a vacated clinical space without FPS Unit plans review and approval. Findings include: 1.a. OAR 333-500-0045(1) requires: “A hospital proposing to make alterations or additions to an existing facility or to construct a new facility shall, before commencing such alteration, addition or new construction, submit plans and specifications to the Division for preliminary inspection and approval or recommendations with respect to compliance with Division rules and compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified.” 1.b. OAR 333-675-0110(1) “Project Submission and Review ... Any person proposing to make certain alterations or additions to an existing health care facility, long term care facility, assisted living facility, or residential care facility, or to construct new facilities must, before commencing such alteration, addition or new construction, submit these projects to the Oregon Health Authority (Authority), Public Health Division, Facilities Planning and Safety program, for plans approval or recommendations with respect to compliance with rules authorized by ORS 441.025, 443.420 and for compliance with National Fire Protection Association standards when the facility is also to be Medicare or Medicaid certified.” 2.a. The hospital’s license application and list of the CAH’s on-campus locations where CAH services were provided by the hospital were reviewed. That application did not list the outpatient clinic, “Lake Health Specialty Clinic,” at the following location: 720 S Main St, Lakeview, Oregon, 97630. This clinic was located on the hospital’s main campus whose address was listed as 700 South J Street Lakeview, OR 97630, different than the Specialty Clinic. Services provided at the Specialty Clinic were, “General Surgery, OB-GYN, Vascular Studies, Wound Care” per the hospital website accessed on 10/17/2025 at 1701. 2.b. The hospital’s organizational chart dated “July 2025” listed the “Lake Specialty Clinic” as part of the hospital’s organizational chart and under the supervision of the COO. 2.c. A map of the hospital titled, “Lake Health District ... 700 South J Street Lakeview, OR 970630,” reflected: Two entrances labeled, “Lake Health Clinics Entrance,” and “Main Hospital Entrance.” 2.d. During a tour of the Specialty Clinic on 08/13/2025 beginning at 1455 with the COO, the following was observed: * A sign in the hallway to the right of the hospital’s main entrance reflected, “Lake Health Specialty Clinic *General Surgery * Orthopedics * OB/GYN,” and included an arrow that directed hospital patients to the “Specialty Clinic” separated by a doorway. * A sign posted in the “Specialty Clinic”near the registration desk reflected, “Hospital” and an arrow that directed patients to the main hospital which was separated by a doorway. A second sign reflected “Exit” and directed patients toward the right, and toward the hospital. It was not clear whether the clinic was part of the main hospital or a stand alone outpatient clinic as the signs “Hospital” and “Exit” directed patients out of the Specialty Clinic and to the main hospital, and the sign posted in the hospital’s hallway directed patients to the clinic area. There were no nurse staffing postings in the Specialty Clinic nor were there other postings required by OARs, such as a patient’s right to support persons. 2.e. A review of Oregon hospital licensing records maintained by the SA FPS Unit reflected an email was sent to the hospital on 12/21/2018 at 1358 and the “Final Notice of Project Approval” said “Note that it is the responsibility of the facility to verify that licensing requirements have been resolved with Oregon Health Authority’s Health Care Facility Licensing and Certification (OHA/HFLC) at (971) 673-0540 or via mailbox.hclc@state.or.us prior to seeing patients.” revealed no evidence that the CAH had initiated the SA building plans review and licensure The licensure process for the provision of outpatient services in the Specialty Clinic at the location listed above was incomplete. 2.f. The SA FPS Unit’s list of projects for LDH included a request for “Specialty and Wound Care Clinic relocation” submitted on “5/26/17,” however, the relocation for the Specialty Clinic was noted as “700 South J St Lakeview OR 97630;” not the current address noted in Finding 2.a. above. 3.a. During interview with the COO on 08/13/2025 at 1515 they stated that outpatient clinic services were provided under the hospital’s license and acknowledged that the Specialty Clinic was listed under a a separate address from the hospital. 3.b. On 08/19/2025 at 1250 the COO provided the following written information: - “Types of services provided: Orthopedic, Obstetrics and gynecology, general surgery.” - “Number of providers: Three.” - “Number of employees: one receptionist, one medical assistant per provider.” - “Number of patients annually: 991 (7/1/24-6/30/25).” - “Is the service billed under hospital: Yes.” - “Signage in area to reflect “hospital service”: Same signage has been deployed in the specialty clinic as other reception areas in the facility.” - “Hospital website: The specialty clinic is separated from the primary care clinic on our website.” 4.a. A review of the hospital’s “Medical Staff Meeting Minutes” dated “May 15, 2025 - 12:30PM” was reviewed and reflected: * “Clinics Update: Work is underway to redesign the physical layout of the clinics, targeting a go-live date of June 23rd for full integration and alignment of practices. Part of the transition includes relocating infusion services off the main floor, as the current setup negatively impacts the cost report. The North Clinic (formerly Warner Mountain Medical) is being considered for infusion services. The redesign focuses on long-term strategic planning ... “ 4.b. A review of the hospital’s “Board of Director’s Meeting Minutes” dated “May 22, 2025, 5:00PM,” was reviewed and reflected: * “ ... the infusion services currently located in Acute will be relocated to the clinic side. This move aims to improve operational efficiency and address cost report impacts associated with the current setup.” 4.c. During a tour of the Infusion Clinic with the COO on 08/12/2025 beginning at 1115, the following was observed: * A sink had a garbage can, two boxes of “Stericycle 1.4 QT Sharps,” a box of biohazard specimen bags, a box of “iFOB Test” kits, two bottles of Meyer Hand Soap, a preforated sponge, and a what appeared to be used infusion tubing that contained a yellowish liquid. The Infusion Clinic staff stated they were unaware of the items under the sink as the clinic had been previously used by another medical service provider and that they were still finding things that were left behind after Infusion Services had moved into the space. * Other medical equipment and supplies were observed that were not being used by the Infusion Clinic. Items included: - A medical refrigerator which contained cans of soda. Refer to Finding 3.b.in Tag C-1208, Infusion Clinic observations. - Non-hospital grade hand lotion, a tube of benedryl cream. - A cupboard with patient medication and educational items, i.e., ~ six boxes of Rexulti 4 mg antidepressant medication, and at least one 0.5 mg box of Rexulti; an ulcerative colitis countertop plaque, a Xarelto 3D plastic model of the heart, and other items that did not belong to the Infusion Clinic. * The COO confirmed the findings at the time of the observation. 4.d. A review of Oregon hospital licensing records maintained by the SA FPS Unit revealed no evidence that the CAH had initiated the SA building plans review and approval process for relocating the hospital’s Infusion Services as described above.”

“AGREEMENTS AND ARRANGEMENTS CFR(s): §485.635(c)(3) The CAH maintains a list of all services furnished under arrangements or agreements. The list describes the nature and scope of the services provided. This Standard is not met as evidenced by: 40575 Based on observation, interview and review of the CAH’s list of services furnished under contract, arrangement or agreement it was determined that the list of all services furnished under contract, arrangement or agreement was not complete. * The list did not include all such services. * The list did not include descriptions of the nature and scope of the services provided, to include at a minimum: The service(s) being offered; The individual(s) or entity providing the service(s); Whether the services were offered on- or off-site; Whether there were any limits on the volume or frequency of the services provided; and When the service(s) were available. Findings included: 1. An undated document titled, “List of Hospital Services” was reviewed. The document contained a list of 26 “Internal” services offered and a list of “External Contracted” services with sub categories such as “Information Technology (IT),” “Cardiopulmonary,” “Diagnostic Imaging,” “Laboratory” and “Quality.” The list did not reflect all services provided under contract, arrangement or agreement. For example: * During a tour on 08/13/2025 at ~ 1105 observations in the kitchen revealed food and beverage products from various contracted companies that included Sysco, K&K Distributing, Pepsi, Coca Cola, Columbia Distribution and Amazon. During interview with Dietary staff, it was stated that items were ordered as needed and at times difficult spices were ordered from Amazon. The list of services furnished under contract, arrangement or agreement did not include these services. * During a tour on 08/12/2025 beginning at 1005 in the ED, the DON stated that after hours pharmacy services were provided by an “off site pharmacy that verifies medications” through a “Shared Services Agreement.” The list of services furnished under contract, arrangement or agreement did not include those services. * Similarly, throughout the course of the survey the following services furnished under contract, arrangement or agreement that were not identified on the list included: In the Pharmacy department services were identified as furnished by Inmar for expired drugs. In the Laundry department services were identified as furnished by Eco Lab and Steris who were contracted to perform preventive maintenance on equipment. 2. The list of services did not contain a description of the nature and scope of services provided under those contracts, arrangements or agreements. 3. During interview with the CSM on 08/14/2025 at 1245 he/she confirmed that the list did not include all services provided at Lake Health District under contract, arrangement or agreement nor did it contain the required descriptions of the nature and scope of services provided.”

“NURSING SERVICES CFR(s): A nursing care plan must be developed and kept current for each inpatient. This Standard is not met as evidenced by: 40575 Based on interview and review of medical record documentation for 1 of 2 patients reviewed for fall documentation (Patient 28), it was determined the CAH failed to ensure nursing documentation was not complete and thorough for Patient 28 who fell in the bathroom and sustained a skin tear during their hospitalization. Findings include: 1. The policy and procedure titled, “Acute: Medical, Surgical and Swing Bed Care and Documentation Guidelines” dated “Last Approved 6/18/2025” was reviewed. It reflected: * “Perform and document a nursing assessment twice a shift for acute and once a shift for Swing Bed. Document assessment more frequently as condition warrants. Include Fall Risk and Braden with each full assessment.” * “Perform and document “intentional” patient rounds at least every hour. Generally, RN rounds are done every two hours on the odd hours and CNA rounds are done every two hours on the even hours. When patient rounds are made, staff should verbally address the 4 P’s (Pain, Position, Potty, Placement) unless patient is sleeping. Ask the patient if there is anything else they would like done and inform the patient that staff will return in at least one hour to check on them.” 2. The medical record for Patient 28 was reviewed with the DON on 08/14/2025 and reflected that it lacked any documentation of a fall assessment being completed prior to the patient’s fall on 06/26/2025 and the patient had a history of falls.”

“ANESTHETIC RISK AND EVALUATION CFR(s): (1) A qualified practitioner, as specified in paragraph (a) of this section, must examine the patient immediately before surgery to evaluate the risk of the procedure to be performed. (2) A qualified practitioner, as specified in paragraph (c) of this section, must examine each patient before surgery to evaluate the risk of anesthesia. (3) Before discharge from the CAH, each patient must be evaluated for proper anesthesia recovery by a qualified practitioner, as specified in paragraph (c) of this section. This Standard is not met as evidenced by: 44104 Based on review of medical record documentation in 6 of 14 patients provided anesthesia services (Patients 29, 30, 31, 32, 33, and 36), and interview, it was determined that the hospital failed to ensure anesthesia consents for surgical procedures included a documented evaluation of anesthesia by a qualified anesthesiologist, and that consents were appropriate and complete. Findings included: 1. During a review of medical records on 08/12/2025 with the SRN beginning at 1345, the following records were reviewed: 2.a. Patient 29’s “Consent for Anesthesia Services” was reviewed and reflected: * The designated line for the patient’s name at the top of the form was left blank. * At the bottom of the form was noted, “I hereby consent to the anesthesia service checked above and authorize that it be administered by ________ who is credentialed to provide anesthesia services at Lake District Hospital.” The designated area for the credentialed anesthesiologist’s name was left blank. * Instructions listed at the bottom of the form noted, “I expressly desire the following considerations to be observed (or write ‘none’):” and there was a designated area to write the “considerations” or “none,” but that area was left blank. 2.b. Patient 29’s “Acknowledgment of Informed Consent for Test, Treatment, Anesthesia, Moderate/Procedural Sedation and Surgery “ was reviewed and reflected: * Instructions listed under bullet point 3 noted, “The procedure or treatment is to include whatever is necessary to accomplish the purposes, including but not limited to the administration of drugs, blood and blood products and anesthetics, except: (Write specific exception(s), or None).” This was left blank. * Instructions listed under bullet point 4 noted, “If any conditions are discovered at the time of the operation that require procedures (surgical or otherwise) in addition to those mentioned above, I authorize whatever else may be deemed necessary relative to this procedure except: (Write specific exception(s), or None).” This was left blank. 3. Patient 30’s “Consent for Anesthesia Services” was reviewed and reflected: * The designated line for the patient’s name at the top of the form was left blank. * At the bottom of the form was noted, “I hereby consent to the anesthesia service checked above and authorize that it be administered by ________ who is credentialed to provide anesthesia services at Lake District Hospital.” The designated area for the credentialed anesthesiologist’s name was left blank. * Instructions listed at the bottom of the form noted, “I expressly desire the following considerations to be observed (or write ‘none’):” and there was a designated area to write the “considerations” or “none,” but that area was left blank. 4. Patient 31’s “Consent for Anesthesia Services” was reviewed and reflected: * At the bottom of the form was noted, “I hereby consent to the anesthesia service checked above and authorize that it be administered by ________ who is credentialed to provide anesthesia services at Lake District Hospital.” The designated area for the credentialed anesthesiologist’s name was left blank. * Instructions listed at the bottom of the form noted, “I expressly desire the following considerations to be observed (or write ‘none’):” and there was a designated area to write the “considerations” or “none,” but that area was left blank. * The patient’s signature at the bottom of the form lacked a “Date/Time” next to the signature. 5. Patient 32’s “Consent for Anesthesia Services” was reviewed and reflected: * At the bottom of the form was noted, “I hereby consent to the anesthesia service checked above and authorize that it be administered by ________ who is credentialed to provide anesthesia services at Lake District Hospital.” The designated area for the credentialed anesthesiologist’s name was left blank. * Instructions listed at the bottom of the form noted, “I expressly desire the following considerations to be observed (or write ‘none’):” and there was a designated area to write the “considerations” or “none,” but that area was left blank. 6. Patient 33’s “Acknowledgment of Informed Consent for Test, Treatment, Anesthesia, Moderate/Procedural Sedation and Surgery “ was reviewed and reflected: * Two designated lines for the patient’s name at the top of the form were left blank. * The word “Epidural” was handwritten in the designated line for the procedure. * Instructions listed under bullet point 3 noted, “The procedure or treatment is to include whatever is necessary to accomplish the purposes, including but not limited to the administration of drugs, blood and blood products and anesthetics, except: (Write specific exception(s), or None).” This was left blank. * Instructions listed under bullet point 4 noted, “If any conditions are discovered at the time of the operation that require procedures (surgical or otherwise) in addition to those mentioned above, I authorize whatever else may be deemed necessary relative to this procedure except: (Write specific exception(s), or None).” This was left blank. * There was no area designated for the anesthesiologist’s name or signature that indicated a qualified anesthesiologist had evaluated the risks of anesthesia for the patient. 7. Patient 36’s “Consent for Anesthesia Services” was reviewed and reflected: * At the bottom of the form was noted, “I hereby consent to the anesthesia service checked above and authorize that it be administered by ________ who is credentialed to provide anesthesia services at Lake District Hospital.” The designated area for the credentialed anesthesiologist’s name was left blank. 8. Findings 2 - 7 were confirmed by the SRN during the medical documentation review. Additionally, the SRN stated that Patient 33 in Finding 6 was provided the incorrect anesthesia consent form for the “Epidural,” and a “Consent for Anesthesia Services” was not found for Patient 33.”

“INFECTION PREVENT & CONTROL ORG & POLICIES CFR(s): Infection prevention and control program organization and policies. The CAH must demonstrate that: (1) An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body, or responsible individual, as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership; This Standard is not met as evidenced by: 44104 Based on interviews, and other documentation, it was determined that the hospital failed to ensure that the IPRN responsible for the IP program was appointed by the hospital governing body and that the appointment was based on medical staff leadership and nursing staff leadership. The hospital failed to designate an IP with oversight of the IP program who was qualified through education, training, experience, or certification in infection prevention and control. Findings include: 1. During an interview with the IPRN on 08/13/2025 at 1530, the IPRN was asked whether they had any specialized training in Infection Prevention and Control. They stated, “No.” They had certification in Wound Care and Ostomy. The IPRN was asked whether they had been appointed to the position based on the recommendations of medical staff and nursing staff leadership. The IPRN stated, “No.” 2. During an interview with the COO on 08/14/2025 beginning at 1300, the COO was asked whether the IPRN had been appointed to the position based on the recommendations of medical staff and nursing staff leadership. The COO stated, “No.” Additionally, the hospital was asked to provide documentation of the IPRN’s IP training. 3. There was no documentation provided of the IP’s training, experience, or certification in infection prevention and control.”

“INFECTION PREVENT & CONTROL POLICIES CFR(s): The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings; This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of employee competency documentation for 1 of 1 employees, (IPRN), review of P&Ps, and other IP Program documentation, it was determined the hospital failed to fully develop and implement an effective hospital-wide IP Program and systems for surveillance, prevention, and control of HAIs. Processes and P&Ps for maintaining a clean and sanitary environment, including oversight of equipment sterilization and processing, had not been fully developed and implemented. In addition, P&Ps based on nationally recognized standards for the surveillance, prevention, and control of HAIs had not been fully developed, implemented or enforced. Failures included: * Failure to ensure P&Ps for the hospital’s Sterile Processing Department were fully developed, implemented, and enforced in accordance with nationally recognized guidelines. * Failure to ensure P&Ps for the hospital’s onsite laundry facilities, and laundry storage areas were fully developed, implemented, and enforced in accordance with nationally recognized guidelines. * Failure to ensure P&Ps with an IP component, such as SPD protocols, were developed in conjunction with the IP program, and considered IP recommendations regarding nationally recognized standards for infections prevention and control. Findings include: 1. Refer to the findings cited under Tag C-1140 at CFR §485.639 - Surgical Services Condition of Participation: The CAH’s surgical services must be performed in a safe manner in accordance with acceptable standards of practice established by nationally recognized professional organizations (e.g., the Association of periOperative Registered Nurses, Association for Professionals in Infection Control and Epidemiology, etc.) including sterilization and disinfection of equipment. Findings reflect the CAH failed to fully develop and implement P&Ps that ensured sterilized materials were packaged, handled, labeled, and stored in a manner that ensured sterility had been achieved and maintained in accordance with nationally recognized standards of practice. 2. Refer to the findings cited under Tag C-1204 at CFR §485.640(a) - Standard: Infection Prevention and Control program, organization and policies that reflects the CAH failed to designated an IP responsible for the oversight of the IP program who was qualified through education, training, experience, or certification in infection prevention and control. This contributed to the hospital’s inability to maintain patient care equipment in a clean and sanitary manner. 3. Refer to the findings cited under Tag C-1208 at CFR §482.640(a)(3), Standard: The Infection Prevention and Control program responsibilities that reflects the CAH failed to implement, and enforce P&Ps for the surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment in accordance with nationally recognized IP standards. 4. Refer to the findings cited under Tag C-1240 at CFR §482.640(c)(2)(v), Standard: Leadership Responsibilities that reflects the CAH failed to ensure the IP program audited staff adherence to IP P&Ps for the maintenance and storage of patient care equipment and linens; failed to audit adherence to IP P&Ps in the areas of: Sterile Processing, WCC, onsite Laundry, and Surgical Services, and that processes in place were consistent with nationally recognized IP standards.”

“INFECTION PREVENT SURVEIL & CONTROL OF HAIs CFR(s): The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 44104 Based on observations, interview, review of infection control P&Ps, and other documentation, it was determined that the hospital failed to ensure that infection prevention P&Ps had been fully developed and implemented, and provisions for ongoing assessment and evaluation of those put into place. Procedures and processes based on nationally recognized standards to ensure infection prevention such as the prevention of cross-contamination and HAIs, had not been fully developed and enforced in the following areas: * The hospital’s IP program was not fully developed and implemented to address infection prevention and control issues such as inadequate disinfection and sterilization processes. Policies were unclear, inconsistent, and were not in accordance with nationally recognized standards. * The hospital did not fully implement IP policies to maintain a clean and sanitary environment, and patient equipment and supplies were not maintained in a clean and sanitary environment. * Training, qualifications and competencies for key IP and SPD personnel responsible for IP program implementation were either missing or insufficient, and the hospital failed to maintain consistent, up-to-date training for those personnel performing IP and SPD oversight. Findings include: 1. A policy titled, “Infection Control Plan” last approved “11/22/2024” was reviewed and reflected: * “Lake District Hospital designates an Infection Prevention and Control Plan under the direction of the Infection Prevention Nurse.” * “The goals of the Infection Prevention Program are: 1. Protect the patient by minimizing the risk of transmission of infections associated with the use of procedures, medical equipment, and medical devices thus reducing Health Care Associated Infections (HAIs) ... 2. Protect Health Care Workers, visitors, and others in the Health Care environment. This is accomplished by limiting unprotected exposure to pathogens by using administrative controls, engineering controls, isolation, hand hygiene, barrier precautions including personal protective equipment ... that protect employees from job related exposures ... 4. Review and provide recommendations in matters concerning isolation, sanitation, and asepsis policies and procedures ... 7. Provide ... information resource requests that facilitate general infection prevention and control program activities defined by program components and specific activities that support disease prevention, data collection, and reporting. Accomplish the previous two goals in a cost-effective manner by preventing cost to the Health Care payer associated with the treatment and complications due to HAI’s [sic] and avoid costs to the organization resulting from infection-related absenteeism and liability.” * “Implementation of program: 1. Hospital and clinical rounds ... 9. Relias training for staff upon hire annually as needed ... 10. Active member of QAPI ... 11. Active chairperson for IPQC ... 12. Active participant in ad hoc committees requiring IP ... 13. Active participant in other infection prevention activities as identified on an as needed basis ... 15. Participate in education programs related to prevention of infections for LDH ... 17. Participate in the evaluation of equipment and supplies as they relate to infection prevention.” * “Attachments ... No Attachments.” * There were no references listed that indicated the hospital’s Infection Prevention and Control program policy adhered to nationally recognized standards. The hospital failed to provide documentation that the designated “Infection Prevention Nurse” who was tasked with directing the hospital’s “Infection Control Plan” was qualified through education, training, experience, or certification in infection prevention and control, refer to Tag C-1204, Findings 1 and 2, IP training. The hospital failed to fully implement it’s P&P, “Infection Control Plan,” and “Protect the patient by minimizing the risk of infections associated with the use of ... medical equipment, and medical devices” as evidenced by the WCRN/IPRN’s inability to identify the IP breaches in sterilized medical equipment, refer to Tag C-1140, Findings 7.a. and 7.b., SPD observations and WCC observations. Refer also Findings 3.a - 3.d., observations demonstrating the lack of IP oversight in “limiting unprotected exposure to pathogens by using administrative controls, engineering controls, isolation, hand hygiene, barrier precautions including personal protective equipment ... that protect employees from job related exposures” in accordance with hospital policy. 2.a. A policy titled , “Infectious Waste Disposal” last approved “11/22/2024” was reviewed and reflected, * “Infectious waste will be disposed of according to Local, State and Federal regulations.” * “Storage and Holding of Infectious Waste ... Infectious waste is transported by EVS staff from the facility’s Biohazard Waste Storage Room to the refrigerated storage area daily or more frequently if containers are full or an odor is noted.” * “EVS will keep a daily log of the cooler’s temperature.” * “EVS will notify Maintenance and Housekeeping supervisors immediately if the temperature rises above 48 degrees Fahrenheit.” 2.b. A “Work Order Request” dated “7/1/2025” was reviewed and reflected that EVS personnel had reported the following, “Bio Freezer - Gauge reading 58 degrees in the Red.” The request form had a text box with the following information, “Date Started ... Date Completed ... Man Hours ... Completed By ...” all of these areas were blank. The work order did not reflect the time when the refrigerated storage area temperature discrepancy was addressed, corrected or completed. 2.c. A document dated “July 2025” titled, “Lake District Hospital Temperature Log Infectious waste refrigerator” included “Range: 32-48*F” as one of the column labels. This log was reviewed and reflected the following temperatures were logged for July 2025: * On 07/01/2025 it was noted: “Temp ... 34 ... Shift ... PM ... Temp 43 ... Shift ... PM.” There was no temperature of “58 degrees” noted on the log for “7/1/2025.” Other discrepancies included: * On 07/02/2025 a temperature of “29” was noted on the “AM” shift. * On 07/05/2025 there was no temperature documented on either the “AM” shift or the “PM” shift. * On 07/06/2025 a temperature of “25” was noted on the “PM” shift. * On 07/15/2025 there was no temperature documented on either the “AM” shift or the “PM” shift. * On 07/17/2025 a temperature of “41” was noted on the “AM” shift and an arrow was drawn to the row for 07/15/2025. There was no other notation explaining why there was an arrow. The hospital failed to accurately record all discrepancies in temperature fluctuations for the “Bio Freezer” where infectious, biohazard waste was stored. A discrepancy which required immediate attention as indicated in the hospital’s policy was not recorded on the daily log and there was no documentation that the out-of-range temperature had been addressed and corrected in a timely manner. The hospital failed to record daily temperatures in accordance with the hospital’s policy. 2.d. During an interview with the EVS supervisor on 08/13/2025 beginning at 0930 with the EVS supervisor confirmed Findings 2.a. -2.c. The EVS supervisor stated that the biohazard refrigerator was out of range on “July 1st” and that they had notified the Maintenance department and submitted a work order. Additionally, they confirmed that the out of range temperature was not noted on the daily temperature log. 3.a. During a tour of the hospital with the EVS supervisor on 08/13/2025 beginning at 1000, the following was observed: * Clean linen was stored uncovered in clean utility rooms throughout the hospital. For example: - Two linen storage carts consisting of three shelves of blankets, sheets, towels and gowns had the protective covering open and folded over the tops of the carts exposing the clean linen to airborne contaminants. Stacked on top of the carts were seizure pads, a pillow and reusable chux pads, all uncovered. - A metal wire shelving unit with three shelves had no protective covering and contained blankets, gowns, wash clothes and towels. Pillows and reusable chux pads were stacked on top of the unit. An uncovered garbage can was butted up against the shelves. * A handheld calculator and pen were on a counter approximately 1 inch away from a sink in a dirty utility room and within the splash zone. A container of Dr. Teal’s Body Lotion “Lavender” was also next to the sink. It was not clear whether that lotion had been approved by the hospital or whether it was compatible with hospital hygiene products. * In the laundry processing area, hospital employees were observed removing and sorting soiled laundry into several smaller receptacles. Employees were observed leaning over and reaching deep into a large bin of soiled laundry, pulling out the soiled linens and shaking them vigorously as they were removing and sorting them. PPE worn included standard hospital gloves that were non-puncture resistant, and hospital scrubs. The employees did not wear any additional PPE such as gowns, masks, or eye protection, although those items were nearby and readily available for use. The receiving and sorting area opened directly into the washing, drying and sorting of clean laundry area. There was no indication that a negative pressure air system was in use for the soiled laundry processing area to contain airborne contaminants. 3.b. During a tour of the Infusion Clinic with the COO on 08/12/2025 beginning at 1115, the following was observed: * Sinks in the patient care rooms were used for storage, had removable panels with large, gaping holes, and water stains. For example: - One sink observed had a can of disinfectant, and two boxes of red biohazard bags. When the boxes were removed, there was a dead spider, a brown water mark approximately 1 inch in diameter, a perforated sponge, and a paper package insert. There were other splatter marks and debris under an open hole approximately 2.5 inches in diameter that exposed sheet rock centered at the back wall of the undersink cabinet. - A second sink had a garbage can, two boxes of “Stericycle 1.4 QT Sharps,” a box of box of biohazard speciment bags, a box of “iFOB Test” kits, two bottles of Meyer Hand Soap, a perforated sponge, and a what appeared to be used unfusion tubing that contained a yellowish liquid. - A third sink had a three inch wide opening at the bottom of the cupboard that ran the length of the cupboard. Insulation was visualized poking up through the opening. - A fourth sink had an open hole approximately 2.5 inches in diameter that exposed insulation centered at the back wall of the undersink cabinet. - Inspection of a fifth sink revealed that the shelving at the bottom of the sink was removable, exposing a valve, as well as insulation under the sink. It was determined that all of the sinks observed had this same removable bottom shelf. - A sixth sink an open hole approximately 4 inches in diameter that exposed sheet rock and a 4 inch capped pipe centered at the back wall of the undersink cabinet. * A medication refrigerator was observed with four ice packs on the bottom shelf. The top shelf had a bottle of water, a can of ginger ale, and a can of 7Up. 3.c. During a tour of the Rehabilitation unit on 08/13/2025 with the PT/RM beginning at 1245, a hydrocollator unit was observed. The PT/RM stated that the unit was cleaned on a quarterly basis. 3.d. The hydrocollator’s user manual for IFUs was reviewed and reflected, “Maintenance ... Regularly clean and drain the tank (every two weeks) [in bold lettering] ... Cleaning Tips ... The interior of the unit should be cleaned, at least every two weeks, using a low abrasive bathroom cleaner with a soft cloth or green, blue, or white Scoth-Brite type scouring pad.” 4. Refer to the findings cited under Tag C-1140 at CFR §485.639 - Surgical Services Condition of Participation: The CAH’s surgical services must be performed in a safe manner in accordance with acceptable standards of practice established by nationally recognized professional organizations (e.g., the Association of periOperative Registered Nurses, Association for Professionals in Infection Control and Epidemiology, etc.) including sterilization and disinfection of equipment. Findings reflect the CAH failed to fully develop and implement P&Ps that ensured sterilized materials were packaged, handled, labeled, and stored in a manner that ensured sterility had been achieved and maitained in accordance with nationally recognized standards of practice. The hospital failed to provide documentation of the ST’s training and competencies. 5. Refer to the findings cited under Tag C-1204 at CFR §485.640(a) - Standard: Infection Prevention and Control program, organization and policies that reflects the CAH failed to designate an individual (or individuals), qualified through education, training, experience, or certification in infection prevention and control, appointed by the governing body, or responsible individual, as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership. 6. Refer to the findings cited under Tag C-1240 at CFR §482.640(c)(2)(v), Standard: Leadership Responsibilities that reflects the CAH failed to ensure the IP program audited staff adherence to IP P&Ps for the maintenance and storage of patient care equipment and linens; failed to audit adherence to IP P&Ps in the areas of: Sterile Processing, WCC, onsite Laundry, and Surgical Services, and that processes in place were consistent with nationally recognized IP standards.”

“LEADERSHIP RESPONSIBILITIES CFR(s): (2) The infection prevention and control professional(s) is responsible for:] (v) The prevention and control of HAIs, including auditing of adherence to infection prevention and control policies and procedures by CAH personnel. This Standard is not met as evidenced by: 44104 Based on observations, interviews, review of employee competency documentation for 1 of 1 employees, (IPRN), review of P&Ps, and other IP Program documentation, it was determined the the CAH failed to ensure the IP program effectively audited staff adherence to IP P&Ps for the maintenance and storage of patient care equipment and linens; failed to effectively audit adherence to IP P&Ps in the areas of: Sterile Processing, WCC, onsite Laundry, and Surgical Services, and that processes in place were consistent with nationally recognized IP standards. Failures included: * Deficiencies in IP practices with the potential for significantly impacting both patients and staff were noted in two pivotal departments: SPD and onsite laundry services. It was unclear whether IP audits were effective in identifying breaches in infection control, or whether the IP department was able to effectively develop, implement, and enforce the hospital’s P&Ps in accordance with nationally recognized guidelines. Findings include: 1. Refer to the findings cited under Tag C-1140 at CFR §485.639 - Surgical Services Condition of Participation: The CAH’s surgical services must be performed in a safe manner in accordance with acceptable standards of practice established by nationally recognized professional organizations (e.g., the Association of periOperative Registered Nurses, Association for Professionals in Infection Control and Epidemiology, etc.) including sterilization and disinfection of equipment. Findings reflect the CAH failed to fully develop and implement P&Ps that ensured sterilized materials were packaged, handled, labeled, and stored in a manner that ensured sterility had been achieved and maintained in accordance with nationally recognized standards of practice. 2. Refer to the findings cited under Tag C-1204 at CFR §485.640(a) - Standard: Infection Prevention and Control program, organization and policies that reflects the CAH failed to designated an IP responsible for the oversight of the IP program who was qualified through education, training, experience, or certification in infection prevention and control. This contributed to the hospital’s inability to maintain patient care equipment in a clean and sanitary manner. 3. Refer to the findings cited under Tag C-1206 at CFR §482.640(a)(2), - Standard: Infection Prevention and Control program, organization and policies that reflects the CAH failed to develop and implement an IP Program that employed methods for preventing and controlling the transmission of infections within the CAH, including IP P&Ps that considered and addressed IP issues unique to the Sterile Processing Department and the onsite Laundry Processing Department; and failed to ensure a clean and sanitary environment was maintained in accordance with nationally recognized IP standards. 4. Refer to the findings cited under Tag C-1208 at CFR §482.640(a)(3), Standard: The Infection Prevention and Control program responsibilities that reflects the CAH failed to implement, and enforce P&Ps for the surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment in accordance with nationally recognized IP standards.”

“QAPI CFR(s): (b) Standard: QAPI Program Design and scope. The CAH’s QAPI program must: (2) Be ongoing and comprehensive. (3) Involve all departments of the CAH and services (including those services furnished under contract or arrangement). This Standard is not met as evidenced by: 44104 Based on interview, review of P&Ps and QI meeting minutes, it was determined that the hospital failed to ensure that all departments and services of the CAH were involved in quality improvement meetings to assess and evaluate the processes and outcomes of quality improvement activities, including those services furnished under contract or arrangement. Findings include: 1. A policy titled, “Quality Improvement Policy, “ dated last approved “5/23/2025” was reviewed and reflected: * “All organized services related to patient care, including those services furnished by contractors, are evaluated.” * “Quality and Patient Safety Committee (QPSC): The Quality and Patient Safety [Committee] is a multidisciplinary body that serves to oversee, coordinate, and collaborate on organizational performance improvement activities ... Meets at least quarterly to evaluate the Processes and Outcomes of quality improvement activities ... “ * “The roles and responsibilities of Administration, Hospital Department Heads, Quality Management and Quality and Patient Safety Committee ... are outlined as follows ... Department manager or representatives are required to attend quarterly meetings.” * “A submission log will be submitted to the CEO after every quarterly meeting. CEO may take actions take disciplinary against departments [sic] that fail to report to QPSC and provide coaching/training conversation to department heads.” 2. The quarterly LHD Quality meeting minutes attendance rosters from “June 1, 2023” through “July 24, 2025” were reviewed and reflected: * A total of 10 QI meetings occurred. * A list of 14, easily identifiable departments were reviewed for attendance. Those departments were: Acute Care, ED, Clinic, Lab, Radiology, Dietary, EVS, IP, Rehabilitation, Pharmacy, EMS, Compliance, DME, and QI. * Of the 14 departments whose attendance was reviewed, 11 of the 14, or 79% of the Quality and Patient Safety Committee members had an attendance rate of 70% or below. These departments were: - Acute Care with a 70% attendance. - ED with a 0% attendance rate. - Clinic with a 70% attendance rate. - Lab with a 40% attendance rate. - Radiology with a 60% attendance rate. - Dietary with a 70% attendance rate. - EVS with a 10% attendance rate. - IP with a 50% attendance rate. - Rehabilitation with a 30% attendance rate. - EMS with a 60% attendance rate. - DME with a 60% attendance rate. * Three departments with an attendance rate greater than 70% were: - Pharmacy with an 80% attendance rate. - Compliance with a 90% attendance rate. - Quality with a 100% attendance rate. * Additionally, of the 14 departments identified, the average attendance of departments at any given meeting reflected an average 57% representation rate of the multidisciplinary team. For example: - Q1 2023: 7 of 14 departments attended the QPSC, or 50% of the multidisciplinary team. - Q2 2023, 6 of 14 departments attended the QPSC, or 43% of the multidisciplinary team. - Q3 2023, 6 of 14 departments attended the QPSC, or 43% of the multidisciplinary team. - Q4 2023, 5 of 14 departments attended the QPSC, or 36% of the multidisciplinary team. - Q1 2024, 7 of 14 departments attended the QPSC, or 50% of the multidisciplinary team. - Q2 2024, 8 of 14 departments attended the QPSC, or 57% of the multidisciplinary team. - Q3 2024, 8 of 14 departments attended the QPSC, or 57% of the multidisciplinary team. - Q4 2024, 11 of 14 departments attended the QPSC, or 79% of the multidisciplinary team. - Q1 2025, 11 of 14 departments attended the QPSC, or 79% of the multidisciplinary team. - Q2 2025, 10 of 14 departments attended the QPSC, or 71% of the multidisciplinary team. The hospital failed to ensure that department managers or their representatives attended quarterly QI meetings as required by hospital policy. The hospital failed to involve all departments and services of the CAH in the quality improvement assessment of activities and evaluate the process and outcomes of quality improvement activities as part of the QPSC. It was unclear whether regular attendance by 3 of 14 departments, or 21% of the QPSC committee members, met the definition of a multidisciplinary committee. It was unclear whether a 57% representation by QPSC committee members met the definition of a multidisciplinary committee. 3. During an interview with the QIC on 08/14/2025 beginning at 0930, the QIC confirmed Finding 2 and stated that not all departments were actively involved in the QPSC and that it was a concern identified by the QIC.”

“FREEDOM FROM ABUSE, NEGLECT & EXPLOITATION CFR(s): Freedom from abuse, neglect and exploitation (§483.12(a)(1), (a)(2), (a)(3)(i), (a)(3)(ii), (a)(4), (b)(1), (b)(2), (c)(1), (c)(2), (c)(3), and (c)(4) of this chapter). “ §483.12(a)(1) Freedom from abuse, neglect, and exploitation. The resident has the right to be free from abuse, neglect, misappropriation of resident property, and exploitation as defined in this subpart. This includes but is not limited to freedom from corporal punishment, involuntary seclusion and any physical or chemical restraint not required to treat the resident’s medical symptoms.(a) The facility must-(1) Not use verbal, mental, sexual, or physical abuse, corporal punishment, or involuntary seclusion; “ §483.12(a)(2) Ensure that the resident is free from physical or chemical restraints imposed for purposes of discipline or convenience and that are not required to treat the resident’s medical symptoms. When the use of restraints is indicated, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints. “ §483.12(a)(3) Not employ or otherwise engage individuals who- (i) Have been found guilty of abuse, neglect, exploitation, misappropriation of property, or mistreatment by a court of law; (ii) Have had a finding entered into the State nurse aide registry concerning abuse, neglect, exploitation, mistreatment of residents or misappropriation of their property. “ §483.12(a)(4) Report to the State nurse aide registry or licensing authorities any knowledge it has of actions by a court of law against an employee, which would indicate unfitness for service as a nurse aide or other facility staff. “ §483.12(b) The facility must develop and implement written policies and procedures that: (1) Prohibit and prevent abuse, neglect, and exploitation of residents and misappropriation of resident property, (2) Establish policies and procedures to investigate any such allegations, “ §483.12(c) In response to allegations of abuse, neglect, exploitation, or mistreatment, the facility must: (1) Ensure that all alleged violations involving abuse, neglect, exploitation or mistreatment, including injuries of unknown source and misappropriation of resident property, are reported immediately, but not later than 2 hours after the allegation is made, if the events that cause the allegation involve abuse or result in serious bodily injury, or not later than 24 hours if the events that cause the allegation do not involve abuse and do not result in serious bodily injury, to the administrator of the facility and to other officials (including to the State Survey Agency and adult protective services where state law provides for jurisdiction in long-term care facilities) in accordance with State law through established procedures. (2) Have evidence that all alleged violations are thoroughly investigated. (3) Prevent further potential abuse, neglect, exploitation, or mistreatment while the investigation is in progress. (4) Report the results of all investigations to the administrator or his or her designated representative and to other officials in accordance with State law, including to the State Survey Agency, within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken. This Standard is not met as evidenced by: 40575 Based on interview, incident documentation reviewed for 4 of 7 patients (Patients 21, 22, 23 and 28), review of policies and procedures, and review of other documentation, it was determined that the hospital failed to develop and enforce policies and procedures to ensure patients’ rights were recognized, protected and promoted and all components of an effective abuse and neglect prevention program were evident, including thorough, complete, clear and timely investigations and follow up actions to ensure those incidents did not recur. Findings included: 1. The policy and procedure titled “Incident or Adverse Event Reporting” dated “Last Approved: 7/3/2025” was reviewed. It reflected: “Policy: The facility has a risk management process that evaluates and identifies trends that may represent potential or real harm for patients, staff and visitors.” “Adverse Event Any incident that may cause harm or injury to a patient, visitor or staff ...” “Incident Reports are to be completed by any staff having knowledge of any unusual occurrence. Any staff person is enabled and encouraged to provide an incident report. Incidents may include falls, injuries, medication errors, return to surgery, property theft, disruptive/aggressive people, bed mites, etc. Incidents may involve patients, visitors, staff or property.” “Generally, each manager is responsible for reviewing and investigating incident reports in their department. Depending on severity of impact ... an incident might only receive brief attention but should always be addressed in some fashion by a manager or designee.” “The facility will, whenever possible, * Track events ... * Investigation of the event will begin within 48-72 hours of documentation ... * Develop a plan of action, if indicated, which may address staffing; process changes; environmental changes. * Inform/educate appropriate individuals on the changes. * Evaluate the effectiveness of the changes.” “Incident reports should be completed to the best of the reporters’ ability. Ensure that who, what, when, where, and why are covered to provide a clear picture of the event. Try to include as much detail as possible.” “Incidents which appear to be high risk and/or reportable as a Patient Safety Commission Report should, when possible, receive robust investigation and root cause analysis to implement an improvement plan of action. This may be conducted by the Risk Manager, the department manager or a designee.” 2. Incident documentation for Patient 21 was reviewed and reflected on 08/06/2025 at 0715 “Pt refused to put on prosthesis and use fww to toilet, became angry, demanding the s/s to take [them] to bathroom. Continued with rude and demanding yelling. Pt HOH, this nurse made eye contact with pt and ask pt to be nice. Pt refused to acknowledge my request, pt was taken to toilet using s/s and 2 person assist, ignoring request to assist for safe transfer. Pt called appropriately when finished, pt taken to chair, where pt demanded ‘hot coffee and one fake sugar’ after med administration by LPN. Pt continued to use call light, until ER nurse took coffee to [patient] which was less than 5-minute wait time. Answered call light after 0755, asked pt what [they] needed, pt yelled ‘I told them I don’t want you in my room, now get out, I again ask what [they] needed, Pt yelled 3 more times to get out. This RN left room, notified DON ...” * The “Event Type:” section reflected “Disruptive Behavior.” * The “Initial actions taken:” section reflected “Left room at pts request.” There was no other documentation that any other actions were taken for example, if the DON spoke to the patient about their behavior. Ensuring the RN and preceptor felt comfortable entering the patient’s room about the behavior and if the patient had any other behavioral issues on previous shifts with other staff members. 3. Incident documentation for Patient 22 was reviewed and reflected on 07/25/2025 at 1739 “Was giving evening meds. I was distracted by the change in the insulin order right at administration time. I was so focused trying to figure out how to get the new order for the insulin correct and reviewed that I gave [their] other med without splitting it. Preceptor immediately called. MD verbalized it was fine and to hold [their] evening insulin dose. MD stated, “that’s okay.” * The “Event Type:” section reflected “Medication Event.” * The “Initial actions taken:” section reflected “Notified [RN name] preceptor, [CRN name] and [MD name].” There was no other documentation that any other actions were taken for example, what signs and symptoms should the RN/LPN watch for with this medication. Was the patient assessed after the incident occurred. Where was the preceptor when the LPN gave the wrong dose. Where there any discussions about limiting distractions. Did the medication get scanned before it was given to the patient. 4. Incident documentation for Patient 23 was reviewed and reflected on 07/30/2025 at 1350 “Patient called and told [CNA] [they] had to pee. [CNA] was helping the patient use [their] urinal when [they] said ‘Did you play sports? Because you have an amazing body. I reawlly [sic] like to stare at women.’” * The “Event Type:” section reflected “Patient Behavior.” * The “Initial actions taken:” section reflected “Notified patient’s RN and Team Lead.” There was no documentation that any other follow up actions were taken for example, did the RN or Team Lead speak to the patient regarding the sexual comments and that such behavior was not going to be tolerated. Whether the CNA was comfortable with providing care for this patient after the incident. Whether the patient made any comments to any other staff. 5. Incident documentation for Patient 28 was reviewed and reflected on 06/26/2025 at 1230 “[CNA] walked in patient’s room to give the patient [their] lunch tray. CNA observed the patient out of bed walking into the bathroom without assistance. Pt closed door. CNA put the tray down to go help [them], at this time CNA heard the patient fall in the bathroom and immediately checked on the patient and acquired help from [an RN] and [CNA name].” * The “Event Type:” section reflected “Falls.” * The “Did they have a fall prior to admission” section reflected “Yes.” * The “Was a falls protocol implemented” section reflected “Yes.” * The “Initial actions taken:” section reflected “[CNA name] CNA acquired help from [RN name], RN and [CNA name] CNA. Pt was lifted off of the floor onto the toilet. Pt finished toileting and was moved back to bed. Bed alarm and personal alarm was put on patient. Once patient finished lunch pt will be moved to room 104 which is much closer to the nurse’s station. Pt will continue to have bed and personal alarms on.” * On 07/10/2025 the “Manager’s Actions:” section reflected “Discussed with patient falls committee. Patient on meds that could contribute to fall (clonazepam and buprenorphine) but these were standard home meds and probably didn’t contribute to fall. Remind CNA that if patient is up on [their] own [they] need to stop what [they] are doing and help the patient” and “Reviewed charting and the post fall eval and incident report were not consistent with witnessed vs unwitnessed. Will remind staff to chart accurately and to do fall assessments every shift.” * On 07/17/2025 another Manager Action reflected “Discussed situation with [name] CNA. [They understand] fall mitigation techniques and will utilize them as much as possible.” There was no documentation that reflected why a current fall assessment was not complete and why the patient, who had previous falls and uses an assistive device, did not have a bed alarm activated. It was not clear what the patient’s mental status was before and after the fall. 6. During interview on 08/14/2025 starting at 1105 with the CSM, they confirmed findings 2-5.”

“GRIEVANCES CFR(s): § 485.614(a)(2) Grievances The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. The hospital’s governing body must approve and be responsible for the effective operation of the grievance process and must review and resolve grievances, unless it delegates the responsibility in writing to a grievance committee. The grievance process must include a mechanism for timely referral of patient concerns regarding quality of care or premature discharge to the appropriate Utilization and Quality Control Quality Improvement Organization. At a minimum: This Standard is not met as evidenced by: 40575 Based on interview, review of grievance documentation for 2 of 6 patients selected from the grievance log (Patients 18 and 19), review of policies and procedures and review of other documentation, it was determined that the hospital failed to fully implement policies and procedures that ensured patients’ rights were recognized, protected and promoted as follows: * Responses to and investigations of patient complaints/grievances were not conducted, or were not timely or complete. * A written grievance notice that contained the required elements including the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion was not provided to each patient/patient representative who filed a complaint/grievance with the hospital. Findings included: 1.The policy and procedure titled “Lake Health District Complaint/Grievance Policy” dated “Last Approved: 4/21/2025” was reviewed. It reflected: * “Lake Health District will accept and respond to complaints/grievances from anyone in an efficient and considerate manner, typically within 10 business days of the receipt of the complaint/grievance unless the investigation warrants a longer time period or external review. The Chief Executive Officer (CEO), designates the Compliance Office, and/or the Appropriate Departmental Directors or their designee to investigate all complaint/grievances.” * “A complaint shall be defined as a verbal concern from a patient or the patient’s designated representative regarding the quality or appropriateness of patient care or services that can be effectively addressed or resolved at the time of the complaint by staff present.” * “ ... a grievance is defined as, but not limited to; a written or verbal concern filed by a patient or the patient’s designated representative to request the facility formally review a quality or care concern, abuse or neglect, issues related to the agencies compliance with Conditions of Participation, professional staff behavioral issues, a concern regarding premature discharge ... any violation of Patient Rights ...” * “Investigation of all grievances shall begin no later than 3 business days from receipt. If grievance pertains to an alleges violation involving any staff (including contracted entities, employees and volunteers) furnishing services, immediate action shall be taken to ensure that no further potential violations will occur ...” * “Grievances will be managed within a reasonable time determined by the complexity of the grievance, the investigation, and decision making required.” * “When a final decision has been reached, a written response will be provided to the patient or designated representative ...” * “A grievance is considered resolved when the patient is satisfied with the actions taken on their behalf. There may be situations where the hospital has taken appropriate and reasonable actions on the patient’s behalf to resolve the patient’s grievance, and the patient remains unsatisfied with the actions. In these situations, Lake Health District may consider grievance closed for the purposes of these requirements.” * “The steps, findings, and outcomes/resolution in the grievance procedure will be documented and signed by the appropriate individuals involved.” 2. Grievance documentation for Patient 18 was reviewed and reflected on 07/27/2024 “11-year-old [patient] was in Lakeview visiting [their] grandparents when [they] began experiencing pain in [their] [genital area].” The patient was seen the in the ED and a CT was ordered and completed. The ED MD did not find a cause for the pain and discharged the patient/family, “ ... advised to take over the counter pain killers and contact the primary healthcare provider if the pain continues.” The patient was “ ... taken to Peace Health at Riverbend in Springfield upon [their] return where [they] ended up having to undergo ... surgical procedure ... [Parent] wants to know why an ultrasound was not conducted and why [Patient 18] was sent home only to end up having to undergo a surgical procedure ...” * The “Actions taken:” reflected “Information sent for external review.” The documentation lacked a thorough investigation. Examples included: *There was no investigation that reflected why an ultrasound or any other tests recommended on the peer review were not completed. *There was no information that the ED physician was educated about the outcome for Patient 18 or that any other follow up actions were taken. *There was no documentation that a letter was sent to the complainant. 3. Grievance documentation for Patient 19 was reviewed and reflected on 09/02/24 “[Patient 19] presented to the ER with pain in [their] hand ... when the provider came in, [they] had no chart with [them], leaned against the counter with [their] feet and arms crossed and stated that ‘I can’t help you.’ [Patient 19] stated that [they] insisted [they] examen [them] and that if it had not been for [their] persistence, the provider would have turned [Patient 19] away ... [Patient 19] stated that the provider told [them] to take OTC pain medication and discharged [them]. [Patient 19] states that the providers demeanor was rude and condescending during the entire visit. [Patient 19] states [they] would be more than happy to receive a call from the CEO and/or Medical Director if they wish to speak to [them] directly or have any questions.” *The “Comment” section reflected “Follow up conducted by Clinics Medical Director and Clinics Manager.” The documentation lacked a thorough investigation. Examples included: *There was no documentation that any follow up with the ED physician was completed regarding the patient encounter. *There was no documentation that the patient was called or that a letter was sent. *There was no documentation of the actions taken such as staff interviews and medical record review. 4. During interview on 08/14/2025 starting at 1024 with the CSM, they confirmed findings 2 and 3.”

“EP Program Patient Population CFR(s): §403.748(a)(3), §416.54(a)(3), §418.113(a)(3), §441.184(a)(3), §460.84(a)(3), §482.15(a)(3), §483.73(a)(3), §483.475(a)(3), §484.102(a)(3), §485.68(a)(3), §485.542(a)(3), §485.625(a)(3), §485.727(a)(3), §485.920(a)(3), §491.12(a)(3), §494.62(a)(3). [(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 the following:] (3) Address [patient/client] population, including, but not limited to, persons at-risk; the type of services the [facility] has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.** *[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. The plan must do all of the following: (3) Address resident population, including, but not limited to, persons at-risk; the type of services the LTC facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans. *NOTE: [“Persons at risk” does not apply to: ASC, hospice, PACE, HHA, CORF, CMCH, RHC/FQHC, or ESRD facilities.] This Standard is not met as evidenced by: 42986 Based on observations and interviews during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Physical Plant that the facility failed to comply with Federal, State and local EP requirements to establish and maintain a comprehensive EP program which addresses the patient population, including, but not limited to, persons at-risk; the type of services the facility has the ability to provide in an emergency; and continuity of operations, including delegations of authority and sussession plans (CFR 42 Part 485.625 (a)(3)). Findings include: On 8/12/2025, during record review between 9:20 am and 11:00 am, the facility failed to provide the required documentation for a qualified person who “is authorized in writing to act in the absence of the administrator or person legally responsible for the operations of the facility” also known as written delegations of authority that is within the facility emergency preparedness plan. These findings were confirmed by the Chief Operating Officer and Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“Development of EP Policies and Procedures CFR(s): §403.748(b), §416.54(b), §418.113(b), §441.184(b), §460.84(b), §482.15(b), §483.73(b), §483.475(b), §484.102(b), §485.68(b), §485.542(b), §485.625(b), §485.727(b), §485.920(b), §486.360(b), §491.12(b), §494.62(b). (b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(b):] Policies and procedures. The LTC facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. *Additional Requirements for PACE and ESRD Facilities: *[For PACE at §460.84(b):] Policies and procedures. The PACE organization must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must address management of medical and nonmedical emergencies, including, but not limited to: Fire; equipment, power, or water failure; care-related emergencies; and natural disasters likely to threaten the health or safety of the participants, staff, or the public. The policies and procedures must be reviewed and updated at least every 2 years. *[For ESRD Facilities at §494.62(b):] Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. These emergencies include, but are not limited to, fire, equipment or power failures, care-related emergencies, water supply interruption, and natural disasters likely to occur in the facility’s geographic area. This Standard is not met as evidenced by: 42986 Based on document review and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and the Director of Physical Plant that the facility failed to comply with Federal, State and local EP requirements to establish and maintain a comprehensive EP program to include policies and procedures for risks identified in the facilities risk assessment (CFR 42 Part 485.625(b)). Findings include: On 8/12/2025, during record review between 9:20 am and 11:00 am, the facility failed to develop and implement EP policies and procedures, based on the risks identified in the Hazards Vulnerability Assessment (HVA) or identify all risks that would have an impact on facility operations with subsequent policies and procedures. These findings were confirmed by the Chief Operating Officer and the Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“Subsistence Needs for Staff and Patients CFR(s): §403.748(b)(1), §418.113(b)(6)(iii), §441.184(b)(1), §460.84(b)(1), §482.15(b)(1), §483.73(b)(1), §483.475(b)(1), §485.542(b)(1), §485.625(b)(1) [(b) Policies and procedures. [Facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following: (1) The provision of subsistence needs for staff and patients whether they evacuate or shelter in place, include, but are not limited to the following: (i) Food, water, medical and pharmaceutical supplies (ii) Alternate sources of energy to maintain the following: (A) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (B) Emergency lighting. (C) Fire detection, extinguishing, and alarm systems. (D) Sewage and waste disposal. *[For Inpatient Hospice at §418.113(b)(6)(iii):] Policies and procedures. (6) The following are additional requirements for hospice-operated inpatient care facilities only. The policies and procedures must address the following: (iii) The provision of subsistence needs for hospice employees and patients, whether they evacuate or shelter in place, include, but are not limited to the following: (A) Food, water, medical, and pharmaceutical supplies. (B) Alternate sources of energy to maintain the following: (1) Temperatures to protect patient health and safety and for the safe and sanitary storage of provisions. (2) Emergency lighting. (3) Fire detection, extinguishing, and alarm systems. (C) Sewage and waste disposal. This Standard is not met as evidenced by: 42986 Based on document review and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Physical Plant that the facility failed to comply with Federal, State and local EP requirements to establish and maintain a comprehensive EP program that includes the policy and procedures for provision of subsistence needs for staff and patients whether they evacate or shelter in place (CFR 42 Part 485.625 (b)(1)). Findings include: On 8/12/2025, during record review at 9:20 am and 11:00 am, the facility failed to provide evidence of a secure and stable patient environment in the event of an elongated emergency, to include: (i) defined policies and/or protocols for medical, and pharmaceutical supplies of staff. These findings were confirmed by the Chief Operating Officer and Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“Procedures for Tracking of Staff and Patients CFR(s): §403.748(b)(2), §416.54(b)(1), §418.113(b)(6)(ii) and (v), §441.184(b)(2), §460.84(b)(2), §482.15(b)(2), §483.73(b)(2), §483.475(b)(2), §485.542(b)(2), §485.625(b)(2), §485.920(b)(1), §486.360(b)(1), §494.62(b)(1). [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(2) or (1)] A system to track the location of on-duty staff and sheltered patients in the [facility’s] care during an emergency. If on-duty staff and sheltered patients are relocated during the emergency, the [facility] must document the specific name and location of the receiving facility or other location. *[For PRTFs at §441.184(b), LTC at §483.73(b), ICF/IIDs at §483.475(b), PACE at §460.84(b):] Policies and procedures. (2) A system to track the location of on-duty staff and sheltered residents in the [PRTF’s, LTC, ICF/IID or PACE] care during and after an emergency. If on-duty staff and sheltered residents are relocated during the emergency, the [PRTF’s, LTC, ICF/IID or PACE] must document the specific name and location of the receiving facility or other location. *[For Inpatient Hospice at §418.113(b)(6):] Policies and procedures. (ii) Safe evacuation from the hospice, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s) and primary and alternate means of communication with external sources of assistance. (v) A system to track the location of hospice employees’ on-duty and sheltered patients in the hospice’s care during an emergency. If the on-duty employees or sheltered patients are relocated during the emergency, the hospice must document the specific name and location of the receiving facility or other location. *[For CMHCs at §485.920(b):] Policies and procedures. (2) Safe evacuation from the CMHC, which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For OPOs at § 486.360(b):] Policies and procedures. (2) A system of medical documentation that preserves potential and actual donor information, protects confidentiality of potential and actual donor information, and secures and maintains the availability of records. *[For ESRD at § 494.62(b):] Policies and procedures. (2) Safe evacuation from the dialysis facility, which includes staff responsibilities, and needs of the patients. This Standard is not met as evidenced by: 42986 Based on observations and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Physical Plant that the facility failed to comply with Federal, State and local EP requirements to establish and maintain a comprehensive EP program that includes a defined system to track on duty staff and sheltered patients in the facilities care during an emergency or evacuation (CFR 42 Part 485.625(b)(2)). Findings include: On 8/12/2025, during record review between 9:20 am and 11:00 am, the facility failed to provide a defined system to track the location of on-duty staff and/or sheltered patients in facility’s care during an emergency (for shelter-in-place and evacuation). These findings were confirmed by the Chief Operating Officer and Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“Policies for Evac. and Primary/Alt. Comm. CFR(s): §403.748(b)(3), §416.54(b)(2), §418.113(b)(6)(ii), §441.184(b)(3), §460.84(b)(3), §482.15(b)(3), §483.73(b)(3), §483.475(b)(3), §485.68(b)(1), §485.542(b)(3), §485.625(b)(3), §485.727(b)(1), §485.920(b)(2), §491.12(b)(1), §494.62(b)(2) [(b) Policies and procedures. The [facilities] must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years [annually for LTC facilities]. At a minimum, the policies and procedures must address the following:] [(3) or (1), (2), (6)] Safe evacuation from the [facility], which includes consideration of care and treatment needs of evacuees; staff responsibilities; transportation; identification of evacuation location(s); and primary and alternate means of communication with external sources of assistance. *[For RNHCIs at §403.748(b)(3) and ASCs at §416.54(b)(2) and REHs at §485.542(b)(3):] Safe evacuation from the [RNHCI or ASC or REHs] which includes the following: (i) Consideration of care needs of evacuees. (ii) Staff responsibilities. (iii) Transportation. (iv) Identification of evacuation location(s). (v) Primary and alternate means of communication with external sources of assistance. * [For CORFs at §485.68(b)(1), Clinics, Rehabilitation Agencies, OPT/Speech at §485.727(b)(1), and ESRD Facilities at §494.62(b)(2):] Safe evacuation from the [CORF; Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services; and ESRD Facilities], which includes staff responsibilities, and needs of the patients. * [For RHCs/FQHCs at §491.12(b)(1):] Safe evacuation from the RHC/FQHC, which includes appropriate placement of exit signs; staff responsibilities and needs of the patients. This Standard is not met as evidenced by: 42986 Based on observations and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Phyical Plant that the facility failed to comply with Federal, State and local EP requirements to establish and maintain a comprehensive EP program that includes policies and procedures to address the safe evaucation of all patients (CFR 42 Part 485.625(b)(3)). Findings include: On 8/12/2025, during record review between 9:20 am and 11:00 am, the facility failed to provide the policy and procedure documentation that includes a means for the safe evacuation patients requiring isolation, patients on life support, patients requiring additional assistance (such as bariatric) or patients who refuse to evacuate. These findings were confirmed by the Chief Operating Officer and Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“This report documents the findings of the recertification Life Safety Code survey conducted on 8/12/2025 through 8/13/2025. Lake District Hospital CCN 381309 was found not in substantial compliance with the requirements for participation in Medicare/Medicaid, with 42 CFR, Part 482, Life Safety from fire and the 2012 Edition of the National Fire Protection Association (NFPA) 101, Life Safety Code (LSC), Chapter 19 for EXISTING Health Care Occupancies. Lake District Hospital is a one story building that was constructed in 1970 and is of Type III construction. The building is fully sprinklered and there is a supervised smoke detection located in the corridors, spaces open to the corridors, and in the patient rooms. The facility has 24 certified beds. 24 beds are dually certified for Medicare and Medicaid. At the time of the LSC survey, the census was 10. The requirements of 42 CFR, subpart 483.90(a) were NOT MET as evidence by:”

“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: 42986 Based on observations and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Physical Plant that the facility failed to separate sections of health care facilities from non-healthcare facilities (hospital from medical clinics). This resulted in the potential for the spread of fire and smoke into sections of the health care facility (LSC 19.1.3.4.1). Findings include: On 8/12/2025 at 8:30 am through 8/13/2025 at 3:00 pm, the facility failed to provide the required 2-hour separation between the I-2 Healthcare/Hospital occupancy and B Occupancy Medical Clinics. The life survey team determined the separation requirement was not met through visual inspection of the walls in the interstitial space separating the two occupancies, review of the facility provided drawings (blueprints) for the hospital and the medical clinics, and the certificates of occupancies provided by the facility identifying the hospital as an “I-2” occupancy and the medical clinics a “B” occupancies. Surveyor was accompanied by the Chief Operating Officer and Director of Physical Plant who acknowledged the existence of these conditions.”

“Portable Fire Extinguishers CFR(s): NFPA 101 Portable Fire Extinguishers Portable fire extinguishers are selected, installed, inspected, and maintained in accordance with NFPA 10, Standard for Portable Fire Extinguishers. 18.3.5.12, 19.3.5.12, NFPA 10 This Standard is not met as evidenced by: 42986 Based on observations and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Physical Plant that the facility failed to select, install, inspect and maintain fire extinguishers in accordance with adopted standards for universe all extinguishers of the facility. This resulted in the potential for fires to progress beyond incipient stage (LSC 19.3.5.12, NFPA 10, NFPA 418). Findings include: On 8/13/2025, at 8:25 am, there was not a minimum 10A 120B sized fire extinguisher located at the facilities Helistop. The fire extinguisher located at the Helistop was a Purple K extinguisher. These findings were confirmed by the Chief Operating Officer and the Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“Operating Features - Other CFR(s): NFPA 101 Operating Features - Other List in the REMARKS section any LSC Section 18.7 and 19.7 Operating Features 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 in Form CMS-2567. This Standard is not met as evidenced by: 42986 Based on interviews and record review during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Plant Operations the facility failed to maintain emergency preparedness plan current and readily available to all staff, affecting the entire building. This resulted in the potential for limited staff effectiveness during emergency conditions (LSC 19.7.1 and NFPA 418.10.1-10.2 Findings include: During survey between 8/12/2025 at 8:30 am through 8/13/2025 at 3:30 pm, the facility failed to provide an emergency response plan for heliport operations and documentation for the required annual training for the emergency response plan involved with the heliport emergency operations. These findings were confirmed by the Chief Operating Officer and Director of Physical Plant at the time of discovery and reviewed at the exit conference.”

“Engineer Smoke Control Systems CFR(s): NFPA 101 Engineer Smoke Control Systems 2012 EXISTING When installed, engineered smoke control systems are tested in accordance with established engineering principles. Test documentation is maintained on the premises. 19.7.7 This Standard is not met as evidenced by: 42986 Based on record review and interview during the survey, it was determined through on-going dialog with the Chief Operating Officer and Director of Physical Plant that the facility failed to ensure fire and smoke dampers were inspected, tested and maintained in accordance with NFPA 92, Standard for Smoke Control Systems. This resulted in the potential for the fire doors to fail during a fire event. LSC 19.7.7 and NFPA 92 Chapter 8. Findings include: On 8/12/2025 during record review between 11:00 am and 3:00 pm, the facility provided the third party vendor testing report dated September 24, 2020 for the fire and smoke damper inspection and test. The test report showed 39 fire/smoke dampers that failed the test. The facility did not provide documenation that the failed fire and smoke damper issues have been addressed. These findings were confirmed by the Chief Operating Office and Director of Physical Plant at the time of discovery and reviewed at the exit conference.”