University of Colorado Hospital Authority

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 44751 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation, §482.21 Quality Assessment and Performance Improvement Program, was out of compliance. A-0283 (b) & (c) QUALITY IMPROVEMENT ACTIVITIES (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. Based on observations, interviews and document reviews, the quality assessment and performance improvement (QAPI) program failed to assess the effect of the staffing shortage in the sterile processing department (SPD) to ensure patient safety. (Cross-reference A-0749)”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 49541 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 Infection Prevention and Control and Antibiotic Stewardship Program, was out of compliance. A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, document reviews, and interviews, the facility failed to follow manufacturer’s instructions for use (IFU), national guidelines, and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturer’s IFU in four of four observations of the instrument reprocessing and sterilization process. Additionally, the facility failed to ensure staff were adequately trained to reprocess surgical instruments. (Cross-reference A-0283)”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 44751 Based on observations, interviews and document reviews, the quality assessment and performance improvement (QAPI) program failed to assess the effect of the staffing shortage in the sterile processing department (SPD) to ensure patient safety. (Cross-reference A-0749) Findings include: References: The Clinical Quality & Patient Safety Plan 2024-2025 read, the facility uses the Failure Mode and Effects Analysis (FMEA) or other risk assessment tools for proactive risk assessment. Failure modes are any errors or defects in a process that affects patients or staff and can be potential or actual. The purpose is to proactively take actions to eliminate or reduce failures, starting with the highest priority ones and to evaluate risk management priorities for mitigating known threat vulnerabilities. The Association of periOperative Registered Nurses (AORN), 2025, Guidelines for Perioperative Practice, Guideline for Sterilization read, leadership should prioritize quality improvement efforts in accordance with regulatory requirements, industry guidelines, and concerns specific to the health care organization. Leaders should maintain a staffing plan for sterilization personnel. The AORN, 2025, Guidelines for Perioperative Practice: Guideline for Quality Practice read, the QAPI program should facilitate the identification of problem areas and the development of patient safety indicators. These indicators are crucial in measuring the care provided to ensure a culture of patient safety. QAPI programs also assist personnel in evaluating and improving the quality of patient care and formulating plans for corrective action when concerns have been identified. The American National Standards Institute/The Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79, 2022, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Prevention of Instrument Damage read, long delays in processing can result in the formation of tenacious and difficult-to-remove biofilm that will shield microorganisms from routine cleaning procedures and interfere with disinfection or sterilization. The ANSI/AAMI ST79, 2022, Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, Pre-cleaning and IFUs read, instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them. 1. The facility failed to implement preventive measures to mitigate the decreased SPD staffing before it opened four new operating rooms (ORs) and increased the volume of surgical instruments reprocessed. A. Observations i. On 7/14/25 at 3:06 p.m., observations were conducted in the first-floor SPD decontamination area. Observations revealed 17 three-tiered stainless steel case carts (a metal cart with three shelves designed to hold and transport contaminated surgical instruments) in SPD. Each cart contained between 11 and 30 contaminated surgical instrument sets. The instrument sets were stacked both inside and on top of the case carts. Observations further revealed the surgical instrument sets were open to air and heavily soiled with dried blood and tissue. (Cross-reference A-0749) ii. On 7/16/25 at 9:46 a.m., observations were conducted on the second-floor OR hallway and the soiled utility room (area where contaminated surgical instruments and sets were held after surgical procedures). Observations revealed the OR hallway and the soiled utility room on the second-floor contained multiple three-tiered stainless steel case carts with contaminated surgical instrument sets. There were two case carts in the OR hallway and nine case carts in the soiled utility room. During the observation, an interview was conducted with registered nurse (RN) #9. RN #9 stated SPD had ongoing reprocessing backlogs in the decontamination room. RN #9 stated the case carts with contaminated surgical instrument sets were placed in the soiled utility room and the OR hallway when SPD was backlogged. iii. An additional observation was conducted in SPD on 7/21/25 at 3:57 p.m. At the time of the observation, 12 case carts with contaminated surgical instrument sets were in the decontamination room. The observation further revealed numerous contaminated instrument sets had remained in the decontamination room unprocessed for over 24 hours. During the observation, SPD technician (Tech) #1 stated it was not uncommon for case carts with contaminated surgical instrument sets to remain unprocessed for greater than 24 hours. SPD Tech #1 further stated, at times, contaminated surgical instruments were not reprocessed for up to six days after the surgical procedure. These observations were in contrast to the ANSI/AAMI ST79, which read, staff should have prevented the drying of biological material onto or within surgical instruments. Additionally, delayed reprocessing of contaminated surgical instruments caused biofilm formation and resulted in less effective disinfection and sterilization. B. Document Review i. A review of SPD huddle reports from 4/1/25 through 7/16/25 revealed delayed reprocessing of contaminated surgical instrument sets. Examples included: a. On 4/3/25, 4/12/25, 4/16/25, 4/22/25, 4/29/25, and 4/30/25, there were 100 to 191 contaminated surgical instrument sets each day that remained unprocessed in SPD. On 4/17/25 and 4/25/25, more than 250 contaminated surgical instrument sets remained unprocessed in SPD each day. On 4/9/25, 4/10/25, 4/11/25, 4/18/25, 4/19/25, 4/23/25, and 4/24/25, the number of contaminated surgical instrument sets left unprocessed in SPD ranged from 309 to 461 sets per day. b. According to the May 2025 SPD huddle reports, during the month of May, there were 20 days where the number of contaminated surgical instrument sets left unprocessed in the SPD exceeded 112. Specifically, on 5/9/25, 5/22/25, 5/24/25, 5/29/25, and 5/30/25, more than 250 contaminated surgical instrument sets remained unprocessed in SPD each day. On 5/1/25, 5/2/25, 5/3/25, and 5/23/25, the number of contaminated surgical instrument sets left unprocessed in SPD ranged from 305 to 371 sets. Lastly, on 5/10/25 and from 5/14/25 through 5/17/25, more than 400 contaminated instrument sets remained unprocessed, and the total surpassed 500 sets on 5/17/25. c. According to the June 2025 SPD huddle report, unprocessed contaminated surgical instrument sets exceeded 120 on 18 days, including over 400 unprocessed instrument sets on 6/5/25 and 6/6/25. d. Lastly, the July 2025 SPD huddle reports revealed nine days between 7/1/25 and 7/16/25 with over 110 contaminated surgical instrument sets unprocessed. Specifically, more than 300 sets remained unprocessed on 7/3/25 and 7/11/25, with the number of unprocessed instrument sets exceeding 400 on 7/10/25 and 7/16/25. ii. A review of the 1/21/25 Board of Directors meeting minutes revealed additional ORs would be opened in June of 2025 and construction in SPD would begin to expand the department. iii. Review of the OR and SPD Construction Request document provided by the facility on 7/21/25 revealed prior to the opening of additional ORs, SPD required 65.2 full-time equivalents (FTEs, represent the number of full-time employees and part-time employees combined to make a full-time equivalent). The required number of SPD technicians needed after the additional ORs opened increased to 85.2 FTEs, 20 more than previously required. Upon request, the facility was unable to provide evidence SPD staffing levels had been increased to meet the post-expansion requirement. C. Interviews a. On 7/23/25 at 3:40 p.m., an interview was conducted with SPD Director (Director) #7. Director #7 stated the day to day activities and SPD staffing were reported to facility leadership daily in the SPD huddle report. Director #7 stated after the morning peri-operative huddle with VP #4, they emailed the SPD huddle report to VP #4. Director #7 stated the SPD huddle report listed the number of contaminated surgical instrument sets in SPD that had not been processed from prior surgical procedures. Director #7 stated VP #4 was informed of the staffing shortage in SPD, however, additional resources were not provided. Director #7 stated patients could contract infections and their health could decompensate when surgical instruments were not cleaned according to the manufacturers instructions for use (MIFU). b. On 7/23/25 at 4:18 p.m., an interview was conducted with chief quality officer (Officer) #11. Officer #11 stated the QAPI program had been unaware of the staffing shortage in SPD and did not monitor SPD staffing levels as a quality indicator (QI). Officer #11 stated the program also had not identified SPD staffing as a high-risk, high-volume, or problem-prone area that could impact patient safety. Officer #11 further stated prior to opening the additional ORs, the QAPI program had not evaluated how the lack of SPD staffing would affect patient health outcomes and quality of care. c. On 7/21/25 at 4:29 p.m., an interview was conducted with vice president of perioperative and procedural services (VP) #4. VP #4 stated when the additional ORs were opened, they had been aware there was a staffing shortage in SPD. VP #4 stated the facility’s pay rate for agency staff was lower than market rates, making it difficult to secure agency staff. VP #4 further stated the facility had not considered adjusting the surgical schedule to address the SPD staffing shortage. The interview with VP #4 contrasted with Officer #11’s interview. According to VP #4, when the additional ORs were opened they had been aware of the SPD staffing shortage, while Officer #11’s interview indicated the QAPI program had been unaware of the SPD staffing shortage, and had not evaluated its potential impact on patient safety or quality of care. These interviews were also in contrast to AORN guidelines which stated, the facility should have maintained and implemented a staffing plan for the SPD, and identified problem areas within the SPD to guide corrective actions and improve patient care and safety. Additionally, the interviews contrasted with the facility’s Clinical Quality & Patient Safety Plan 2024-2025. According to the plan, facility leadership should have acted on the SPD staffing shortage and implemented corrective measures to mitigate and prevent risks to patient safety.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 49541 Based on observations, document reviews, and interviews, the facility failed to follow manufacturer’s instructions for use (IFU), national guidelines, and facility policy to ensure methods were in place to prevent and control the transmission of infections. Specifically, the facility failed to ensure staff reprocessed surgical instruments according to the manufacturer’s IFU in four of four observations of the instrument reprocessing and sterilization process. Additionally, the facility failed to ensure staff were adequately trained to reprocess surgical instruments. (Cross-reference A-0283) Findings include: Facility policies: The Sterile Processing Policy read, pre-cleaning, decontamination, and sterilization processes will be performed in alignment with manufacturer’s instructions for use (MIFU) and follow evidence-based guidelines. Point of Use should be performed to remove all visible debris or bioburden (microbial contamination on a medical device or product). A manufacturer and/or facility approved product may be used to aid in removing visible debris or bioburden as needed or required per MIFU. The Compliance Education and Training Policy read, the need for ongoing specialized training will be identified by the Team Member’s leadership and will be coordinated and monitored for completion by such leadership. In addition, Compliance leadership may also identify a training need and encourage and/or require its completion. The Competency Policy read, all mechanisms for validating competency must be documented, dated, and maintained in the employee’s departmental file or unit file. Department Managers are responsible for ensuring that staff competence is assessed and documented at least every three years or more frequently as required by organization policy or in accordance with law and regulation. All members of the department should continuously maintain satisfactory work performance levels, maintaining comprehensive documentation to support and demonstrate employee competency. References: According to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI), Pre-cleaning and IFUs - Instruments, instruments should be precleaned immediately following use. Gross debris should be removed, and instrument lumens should be flushed with sterile distilled water as recommended by the manufacturer. The instruments should be maintained in a moist state before cleaning in order to prevent the drying of surgical debris onto or within them. According to ANSI/AAMI Sterile Processing - Knowledge, Skills, Competencies, cleaning is the most important step in sterile processing; thorough cleaning removes most microorganisms and other organic material from contaminated items. Unless an item is clean, it cannot be effectively disinfected or sterilized. Any soil, no matter how little, can prevent disinfectant or sterilant from contacting the surface of an item. We can assess visible contamination by examining items carefully, but microorganisms are invisible so we consider items contaminated even when we cannot see any soil. The best resource for determining how best to manage an item is the manufacturer’s IFU. According to ANSI/AAMI Sterile Processing - Education and training, sterile processing personnel should receive an initial orientation covering all tasks performed in the sterile processing area, including orientation in policies and procedures regarding infection prevention and control, safety, attire, personal hygiene, and compliance with state and federal regulations. Sterile processing personnel should receive continuing education at regular intervals to review and update knowledge and skills and to maintain competency and certification. The Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice, Instrument Cleaning, 2020, read, failure to correctly clean and decontaminate surgical instruments and other medical devices used in invasive procedures can lead to subsequent failures in high-level disinfection and sterilization that put patients at risk for developing a surgical site infection (SSI). Approximately 50% of SSIs are preventable with the use of evidence-based strategies. Effective decontamination and subsequent sterilization are essential SSI prevention measures. Begin preparation for instrument decontamination at the point of use. Moistening and removing gross soil at the point of use can help prevent organic material and debris from drying on instruments. Organic material and debris are more difficult to remove from surgical instruments when they are allowed to dry, and residual soil can affect the efficacy of subsequent disinfection and sterilization processes. Use brushes or other items that meet the specifications (eg, diameter, length, materials) in the instrument or medical device manufacturer’s IFU to clean crevices and lumens. Soil can become lodged in crevices, box locks, lumens, and other areas of instruments. Perform brushing under the surface of the water during manual cleaning. Brushing under water reduces the risk of aerosolization of chemicals and contaminants during manual cleaning. The Integra Lifesciences Surgical Instruments IFU read, Precleaning: Remove gross debris from surgical instruments with a lap sponge and sterile water routinely during the procedure to prevent drying on of blood and body fluids, etc. It is important to rinse instruments that have been exposed to blood and saline solution before these substances dry. Maintain moisture: Immediately after the surgical procedure, place the instruments in an instrument tray/container and cover with a towel moistened with sterile distilled water. Foam, spray or gel products, specifically intended for use with surgical instruments, are available to keep the soil moist. Cleaning: To prevent the formation of biofilm, cleaning should occur as soon as possible after instrumentation is used. Biofilm is an accumulation of a biomass of bacteria and extracellular material that tightly adheres itself to the surface of the instruments. It cannot be easily removed, and protects microorganisms from being easily removed by ordinary cleaning/decontamination methods used in hospitals. Enzymatic Soak: Immerse fully opened and/or disassembled instruments in an enzymatic solution, specific for use with surgical instruments. Prepare the solution and use per the enzymatic manufacturer’s recommendations, paying special attention to instructions for correct dilution, temperature and soak time. Cleaning Instruments: Using a small, clean hand-held brush, remove soil from all surfaces of the instrument while fully immersed in the solution. Remove the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument must be thoroughly cleaned after each use. A build-up of soil, debris, lubricants, etc. in these areas will make it difficult to use the instrument and eventually irreparably damage it. Vigorously flush channels with the cleaning solution. Manual cleaning should remove all visible residue. It is essential to keep the box locks and hinges open during any manual or automated cleaning process. Rinse: Remove from the enzymatic soak after the time period recommended by the enzymatic manufacturer and rinse thoroughly with tap water. Flush lumens until rinse water runs clear. The Symmetry Surgical Inc. surgical instruments IFU read, completely submerge instruments in the enzymatic solution and gently shake them to remove trapped bubbles. Actuate (open and close) instruments with hinges or moving parts to ensure contact of the solution with all surfaces. Lumens, blind holes and cannulas should be flushed with a syringe to remove bubbles and ensure contact of the solution with all instrument surfaces. Soak instruments for a minimum of 10 minutes. While soaking, scrub surfaces using a soft nylon-bristled brush until all visible soil has been removed. Actuate moveable mechanisms. Particular attention should be given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs. Remove the instruments from the enzymatic solution and rinse in tap water for a minimum of one minute. Actuate all moveable and hinged parts while rinsing. Thoroughly and aggressively flush lumens, holes, cannulas and other difficult to access areas. The Pre-Klenz IFU read, apply at point of use, Pre-Klenz Instrument Transport Gel initiates pre-cleaning, keeps surgical soils moist, and controls odors. Spray evenly over the surgical tray to ensure soils are covered. Transport instruments for further processing. 1. The facility failed to pre-clean and manually clean all surgical instruments in an enzymatic detergent prior to sterilization in accordance with facility polices, manufacturers’ IFUs, and national guidelines. A. Observations i. On 7/14/25 at 3:06 p.m., observations were conducted in the sterile processing department (SPD). Observations revealed 17 three-tiered stainless steel case carts with contaminated surgical instruments were spread throughout the SPD, making it difficult to navigate throughout the department. Further observations revealed over 30 contaminated surgical trays stacked on top of the case carts that were open to air. Additional observations revealed a surgical case cart with a kidney transplant surgical tray. Surgical instruments were grossly soiled with dried blood and tissue. Further observations revealed surgical instruments were dry and had not been precleaned. ii. On 7/14/25 at 3:15 p.m., observations were conducted in the SPD. Observations revealed a surgical dilation and curettage (D&C, surgical procedure where the cervix was dilated and the lining of the uterus scraped) set which contained visibly soiled surgical instruments. Further observations revealed sterile processing technician (Tech) #1 had sprayed the instruments with Pre-Klenz (a gel based solution used to treat surgical instruments at the point of use). Tech #1 stated the surgical instruments were not pre-cleaned in the operating room (OR). Tech #1 stated the surgical instruments were grossly soiled with dried blood and tissue. Tech #1 stated the staff failed to spray the instruments with Pre-Klenz prior to being transported to the SPD. Tech #1 stated if the surgical instruments were not pre-cleaned, the bioburden could harden, making it difficult to clean. Tech #1 stated hardened bioburden in areas difficult to visualize, such as lumens and hinge boxes, could be missed, and the instrument would not be able to be cleaned. Tech #1 stated if the instruments were not cleaned appropriately they would not be able to be sterilized and could cause a surgical site infection (SSI). Observations on 7/14/25 at 3:15 p.m. were in contrast to the Pre-Klenz IFU which stated, staff should have applied the product at the point of use. Pre-Klenz Instrument Transport Gel initiated pre-cleaning, kept surgical soils moist, and controlled odors. Staff should have sprayed the gel evenly over the surgical tray to ensure complete soil coverage and transported the instruments for further processing. Observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were in contrast to the Sterile Processing policy which stated, staff should have performed pre-cleaning, decontamination, and sterilization processes in alignment with MIFU and followed evidence-based guidelines. Staff should have performed Point of Use cleaning to remove all visible debris or bioburden. Observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were also in contrast to the Integra Lifesciences Surgical Instruments IFU which stated, staff should have removed gross debris from surgical instruments with a lap sponge and sterile water throughout the procedure to prevent blood and body fluids from drying on the instruments. Staff should have rinsed instruments exposed to blood and saline solution before the substances dried. Immediately after the procedure, staff should have placed the instruments in a tray or container and covered them with a towel moistened with sterile distilled water. Foam, spray, or gel products, specifically intended for use with surgical instruments, should have been used to keep the soil moist. Additionally, observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were in contrast to ANSI/AAMI Guidelines on Pre-cleaning and IFUs, where staff should have precleaned instruments immediately after use. They should have removed gross debris and flushed instrument lumens with sterile distilled water as recommended by the manufacturer. Instruments should have been maintained in a moist state before cleaning to prevent surgical debris from drying on or inside them. Furthermore, observations on 7/14/25 at 3:06 p.m. and 3:15 p.m. were in contrast to AORN Guidelines for Perioperative Practice which stated, staff should have prepared instruments for decontamination at the point of use. They should have moistened and removed gross soil to help prevent organic material and debris from drying on the instruments. When allowed to dry, organic material and debris became more difficult to remove and interfered with the effectiveness of subsequent disinfection and sterilization processes. iii. On 7/14/25 at 3:23 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the D&C surgical instrument set being processed and cleaned by Tech #3. Tech #3 placed closed-hinged instruments into the surgical sink with an enzymatic detergent solution before pre-rinsing them. During manual cleaning, Tech #3 only visually inspected multiple instruments, brushed only the front side of the hinged instruments, and did not actuate the hinges while cleaning. Additionally, Tech #3 brushed the instruments above the water line. During the observation a dilator (device that widens a body opening) was observed to be tarnished with visible rust, Tech #3 continued to reprocess the instrument and did not remove the instrument from the tray to be repaired or replaced. Tech #3 removed the instruments from the sink without performing a final rinse and placed them on a nearby rack to dry. During the observation, Tech #3 stated they followed the manufacturer’s IFU when cleaning surgical instruments to prevent SSIs. iv. On 7/14/25 at 3:40 p.m., observations were conducted in the SPD. Observations revealed surgical instruments from the laminectomy (a surgical procedure that involves removing part or all of the lamina, the bony arch on the back of the vertebra, to relieve pressure on the spinal cord or nerves) set being processed and cleaned by Tech #2. Further observations revealed visibly soiled surgical instruments with dried bioburden. Tech #2 placed closed-hinged instruments into the surgical sink, which contained an enzymatic detergent solution, without pre-rinsing. During manual cleaning, Tech #2 only visually inspected the instruments and did not brush them to remove visible bioburden. Tech #2 opened visibly soiled hinged instruments on a stringer (device used to organize and prepare surgical instruments for cleaning and sterilization), briefly placed them in the enzymatic detergent, failed to manually clean or rinse them, and placed them in a nearby surgical tray. Further observations revealed Tech #2 picked up a Blount Mallet (a type of orthopedic surgical mallet) from the counter, briefly placed the instrument into an enzymatic detergent solution, and then placed the instrument on a nearby rack. All observations conducted on 7/14/25 were in contrast to the Sterile Processing Policy which stated, staff should have performed pre-cleaning, decontamination, and sterilization processes in alignment with MIFU and followed evidence-based guidelines. Staff should have also performed point-of-use cleaning to remove all visible debris and bioburden. Manufacturer or facility-approved products should have been used to aid in removing debris or bioburden as needed or as required by MIFU. The observations on 7/14/25 were also in contrast to the ANSI/AAMI Sterile Processing - Knowledge, Skills, Competencies which stated, cleaning was the most important step in sterile processing. Thorough cleaning removed most microorganisms and other organic material from contaminated items. Unless an item had been cleaned, it could not be effectively disinfected or sterilized. Any soil, no matter how little, could prevent disinfectant or sterilant from contacting the surface of an item. Staff could assess visible contamination by examining items carefully, but microorganisms were invisible, so items were considered contaminated even when soil could not be seen. The best resource for determining how best to manage an item was the manufacturer’s IFU. Observations on 7/14/25 were in contrast to the AORN Guidelines for Perioperative Practice: Instrument Cleaning which stated, failure to correctly clean and decontaminate surgical instruments and other medical devices used in invasive procedures could lead to subsequent failures in high-level disinfection and sterilization that put patients at risk for developing a SSI. Approximately 50% of SSIs were preventable with the use of evidence-based strategies. Effective decontamination and subsequent sterilization were essential SSI prevention measures. Brushes or other items that met the specifications (e.g., diameter, length, materials) in the instrument or medical device manufacturer’s IFU to clean crevices and lumens should have been used. Soil could become lodged in crevices, box locks, lumens, and other areas of instruments. Instruments should have been brushed under the surface of the water during manual cleaning to reduce the risk of aerosolization of chemicals and contaminants. Additionally, observations on 7/14/25 were in contrast to the Integra Lifesciences Surgical Instruments IFU which stated, after the surgical procedure, instruments should have been placed in a covered container with a towel moistened with sterile distilled water. Foam, spray, or gel products, specifically intended for use with surgical instruments, should have been used to keep the soil moist. To prevent the formation of biofilm, cleaning should have occurred as soon as possible after instrumentation was used. Biofilm was an accumulation of a biomass of bacteria and extracellular material that tightly adhered to the surface of the instruments, and could not be easily removed. Instruments should have been immersed fully opened and/or disassembled in an enzymatic solution, specific for use with surgical instruments. The solution should have been prepared and used per the enzymatic manufacturer’s recommendations, with special attention to instructions for correct dilution, temperature and soak time. Staff should have used a small, clean hand-held brush and removed soil from all surfaces of the instrument while fully immersed in the solution. Staff should have also removed the soil from the ratchets, jaws, tips, box locks, and/or hinge mechanism. The box lock and hinge portion of an instrument should have been thoroughly cleaned after each use. Additionally, staff should have vigorously flushed channels with the cleaning solution. Manual cleaning should have removed all visible residue. It was essential to keep the box locks and hinges open during any manual or automated cleaning process. Staff should have removed instruments from the enzymatic soak after the time period recommended by the enzymatic manufacturer and rinsed thoroughly with tap water. Lumens should have been rinsed until the water ran clear. Furthermore, the observations conducted on 7/14/25 were in contrast to the Symmetry Surgical Inc. surgical instruments IFU which stated, instruments should have been completely submerged in the enzymatic solution and gently shook to remove trapped bubbles. Staff should have actuated instruments with hinges or moving parts to ensure the solution came into contact with all surfaces. Lumens, blind holes and cannulas should have been flushed with a syringe to remove bubbles to ensure contact of the solution with all instrument surfaces. Staff should have soaked instruments for a minimum of 10 minutes. While the instruments soaked, surfaces should have been scrubbed with a soft nylon-bristled brush until all visible soil had been removed. Particular attention should have been given to crevices, hinged joints, box locks, instrument teeth, rough surfaces and areas with moving components or springs. The instruments should have been removed from the enzymatic solution and rinsed in tap water for a minimum of one minute. All moveable and hinged parts should have been actuated while rinsing. Lumens, holes, cannulas, and other difficult to access areas should have been thoroughly and aggressively flushed. In addition, the observations conducted on 7/14/25 were in contrast to the Pre-Klenz IFU which stated to apply at point of use. Pre-Klenz Instrument Transport Gel initiated pre-cleaning, kept surgical soils moist, and controlled odors. Staff should have sprayed the surgical tray evenly to ensure soils were covered. Instruments should have been transported for further processing. B. Medical Record Review i. Medical record review revealed, Patient #2 was admitted on 7/9/25 for a microscopic direct laryngoscopy (surgical procedure to examine the vocal cords using a microscope) for magnification, with an attempted fat injection. Review of the operative note revealed the procedure was delayed for several hours while staff evaluated, cleaned, and assembled the Bruening syringe (a specialized syringe used for vocal cord fat injection). Staff took the patient to the OR and administered general anesthesia (medically induced loss of consciousness that renders a patient unarousable, even by painful stimuli). They attached the Bruening syringe and attempted to use the first needle, which was severely bent. The second needle was missing entirely. They attached the third needle and attempted to inject fat, but the fat did not pass through and could not be cleared. Additional attempts to find a compatible needle were unsuccessful. Staff injected Juvederm XL (injectable substance used to add volume and fullness to the skin) into the patient’s vocal fold. After the surgery, Provider #10 notified risk management and the patient’s family about the defective equipment and the inability to perform the procedure. C. Interviews i. Interviews conducted with staff over the course of the survey between 7/14/25 and 7/24/25 revealed the following: a. An interview was conducted with Tech #5. Tech #5 stated the surgical instruments had to be pre-cleaned in the OR in accordance with the IFU before being transported to SPD. Tech #5 stated when instruments were not pre-cleaned, the bioburden hardened, and it became difficult to reprocess. Tech #5 stated hardened bioburden in areas difficult to visualize, such as lumens and hinge boxes, could be missed, and the instrument would not be able to be cleaned. This was in contrast to multiple observations of the SPD on 7/14/25, which revealed surgical instrument IFUs were not followed. Tech #5 also stated it was possible for surgical instruments to remain unprocessed for up to six days due to the high volume of surgical instruments that needed to be processed. Tech #5 stated the staff were trained to respray the surgical instruments every 72 hours to help prevent the bioburden from hardening. Tech #5 stated if the instruments were not cleaned appropriately, they would not be able to be sterilized and could cause an SSI. b. An interview was conducted with sterile processing director (Director) #7. Director #7 stated each surgical instrument had an IFU which outlined proper cleaning and processing instructions. Director #7 stated it was important to follow the manufacturer’s IFU to ensure adequate instrument processing. Director #7 stated if staff failed to follow the IFU, the facility could not ensure the instruments were cleaned appropriately or sterilized. Director #7 stated OR staff precleaned instruments in the operating room to remove gross bioburden and sprayed them with Pre-Klenz. This was in contrast to the observation conducted on 7/14/25 at 3:06 p.m., which revealed surgical instruments in the kidney transplant tray were dry, grossly soiled with dried blood and tissue, and had not been precleaned. Director #7 also stated SPD staff resprayed instruments with Pre-Klenz every 72 hours because reprocessing a large number of surgical instruments brought to the SPD often took days. Director #7 stated each time the staff sprayed the instruments, it reset the 72-hour window for processing. This was in contrast to the Pre-Klenz IFU which stated, it was to be applied at point of use. There was no evidence in the IFU which indicated respraying the surgical instruments reset the 72-hour window for processing. Director #7 stated if staff did not clean instruments correctly, bioburden could remain, which would prevent sterilization during the steam sterilization cycle. Director #7 stated improperly processed instruments could cause SSIs or serious injury. An additional interview was conducted with Director #7. Director #7 stated the number of direct-hire SPD staff declined over the past year, and the facility prohibited adding agency staff. Director #7 stated, as a result, contaminated surgical instrument sets were not reprocessed in a timely manner and often remained unprocessed overnight. Director #7 stated this information had been communicated to facility leadership daily through the SPD huddle report, which Director #7 stated they emailed to the vice president of perioperative and procedural services (VP) #4. (Cross-reference A-0283) 2. The facility failed to ensure staff received ongoing training and competencies in the SPD to handle and reprocess surgical instruments. A. Document Review i. Personnel file review for Tech #12 revealed an initial competency assessment tool (ICAT) used to validate knowledge in the SPD. Tech #12 was deemed competent to process surgical instruments on 7/19/23. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training. ii. Review of Tech #13’s ICAT revealed Tech #13 was deemed competent to process surgical instruments on 4/4/23. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training. iii. Review of Tech #14’s ICAT revealed Tech #14 was deemed competent to process surgical instruments on 6/19/23. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training. iv. Review of Tech #15’s ICAT revealed Tech #15 was deemed competent to process surgical instruments on 12/20/22. Further review of the personnel file showed no evidence of continuing education in surgical instrument reprocessing and sterilizing training. Upon request on 7/23/25 and 7/24/25, the facility was unable to provide any continuing education or revalidation of competency for Tech #12, Tech #13, Tech #14, or Tech #15. This was in contrast to the Competency Policy which stated, staff documented, dated, and maintained all mechanisms for validating competency in the employee’s departmental or unit file. Department Managers should have ensured staff competence was assessed and documented at least every three years or more frequently, as required by organizational policy or applicable laws and regulations. All department members continuously maintained satisfactory work performance and comprehensive documentation to support and demonstrate employee competency. This was also in contrast to the Compliance Education and Training Policy which stated, team members’ leadership should have identified the need for ongoing specialized training and coordinated and monitored its completion. Compliance leadership also should have identified training needs and encouraged or required their completion. Furthermore, this was in contrast to the ANSI/AAMI Sterile Processing - Education and Training which stated, sterile processing personnel should have received continuing education at regular intervals to review and update their knowledge and skills and to maintain competency and certification. B. Interviews i. Interviews conducted with staff over the course of the survey between 7/14/25 and 7/24/25 revealed the following: a. An interview was conducted with Tech #5. Tech #5 stated they were trained on facility polices and performed competencies on how to reprocess and sterilize surgical instruments when they were hired. Tech #5 stated prior to the survey, they had not been retrained or reassessed for competency since they were hired. Tech #5 stated it was important to stay up to date on how to reprocess surgical equipment to prevent SSIs. b. An interview was conducted with Director #7. Director #7 stated staff received training on decontamination and sterilization policies and procedures, and their initial competencies were verified and documented on the ICAT. Director #7 stated vendors periodically provided additional training throughout the year. Director #7 stated SPD supervisors reported observing staff during instrument reprocessing; however, they could not provide whether staff competencies were regularly validated and documented. This was in contrast to the Competency Policy, Compliance Education and Training Policy, and the ANSI/AAMI Sterile Processing - Education and Training national guidelines, as referenced above.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 52761 Based on interviews and document review, the facility failed to comply with the Medicare provider agreement as defined in §489.20 and §489.24 related to Emergency Medical Treatment and Labor Act (EMTALA) requirements. FINDINGS 1. The facility failed to meet the following requirements under the EMTALA regulations: Tag 2406: (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph. (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital ’ s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. Based on interviews and document reviews, the facility failed to provide an appropriate medical screening examination (MSE) as required by Emergency Medical Treatment and Labor Act (EMTALA) regulations. Specifically, the facility failed to ensure a MSE was performed by a qualified medical professional (QMP) for one of one patients reviewed who presented to the emergency department (ED) with chest pain. (Patient #10)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 52761 Based on interviews and document reviews, the facility failed to provide an appropriate medical screening examination (MSE) as required by Emergency Medical Treatment and Labor Act (EMTALA) regulations. Specifically, the facility failed to ensure a MSE was performed by a qualified medical professional (QMP) for one of one patients reviewed who presented to the emergency department (ED) with chest pain. (Patient #10) Findings include: Facility policies: According to the EMTALA policy, qualified medical providers will perform an appropriate MSE, within the capability of the facility, for any individual who comes to the ED and requests examination or treatment of any medical condition. A request is considered to have been made for an examination or treatment of any medical condition in the ED if a prudent layperson would conclude from the individual’s appearance or behavior that there is a need for examination or treatment of any medical condition. Staff and affiliated providers must know and comply with EMTALA. Furthermore, a QMP will perform the MSE, for any individual requesting examination or treatment, and within the capabilities of the hospital, whether the individual presented directly to the ED or elsewhere on hospital property. Additionally, triage alone does not constitute an appropriate MSE. The policy defines an Emergency Medical Condition (EMC) as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances, and/or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual in serious jeopardy; serious impairment to bodily functions; or serious dysfunction of any bodily organ or part. A MSE is described as the process, conducted by a QMP, required to determine-within reasonable clinical confidence-whether an EMC exists. The MSE may range from a brief history and physical to a more complex evaluation involving ancillary studies, depending on the patient’s presentation. The MSE is an ongoing process and represents a spectrum ranging from a simple process involving only a brief history and physical examination to a complex process that also involves performing ancillary studies and procedures, depending on the patient’s presenting symptoms. A MSE is not an isolated event, but an ongoing process that begins with, but typically does not end with, triage or intake. The MSE is conducted by an individual(s) determined to be qualified by the hospital’s Medical Staff By-Laws, Rules and Regulations. The MSE is an ongoing process that begins with, but is not limited to, triage or intake. Triage is defined as the clinical assessment of an individual’s presenting signs and symptoms at the time of presentation at the hospital in order to prioritize when the individual will be seen by a physician or other qualified medical provider. According to the Combative or Disruptive Person (Code Gray) Response policy, providers will work in coordination with the Security Supervisor during patient assistance calls to ensure that interventions are consistent with the treatment philosophy and plan for the patient. All Security assistance calls will be discussed post-event by the healthcare providers, the Security Supervisor, and other officers and staff involved in the event. Staff will notify their supervisor of any concerns that arise and the measures that were taken to resolve them. All incidents of workplace violence will be reviewed. The Safety and Security Managers and the Environment of Care Committee will review security incidents to identify patterns of potential violence. The reports will be evaluated, and recommendations for workplace design changes, procedural changes, or employee training will be made as necessary. All acts of workplace violence initiated by staff members will be evaluated by the Human Resources Department. A Code Grey is defined as an acting out, combative, disruptive, or violent individual that staff members are unable to redirect and is a danger to injure themselves or others without immediate intervention. References: The Emergency Services Technician Paramedic I-Emergency Department Job Description read, the Pivot technician was responsible for providing patient care under the direction of a physician and reporting changes in physical, mental, and emotional conditions to medical staff. The Managing Disruptive Behavior pathway. provided by the facility on 6/11/25 read, staff should call a Code Gray and notify the attending physician to perform a bedside assessment when a patient exhibits disruptive behaviors and is not actively assaulting or attempting to harm another person. 1. The facility failed to ensure a MSE was performed by a QMP to rule out an EMC. A. Document Review i. Medical record review revealed after Patient #10 presented to the ED with chest pain, they were not triaged, and a MSE was not performed. a. On 4/21/25 at 9:45 p.m., Patient #10 presented to the ED with chest pain. At 9:59 p.m., emergency service technician (EMT) #2 attempted to obtain Patient #10’s vital signs. Review of EMT #2’s ED note revealed Patient #10 informed EMT #2 the blood pressure cuff was hurting their arm. EMT #2 reassured Patient #10 the blood pressure cuff would release shortly, and Patient #10 became agitated and cursed at them. In response to Patient #10’s outburst, EMT #2 called security to have the patient escorted out of the ED. Further review of Patient #10’s medical record revealed, EMT #2 failed to inform a QMP of Patient #10’s presentation to the ED and their request for medical evaluation and treatment. Additionally, EMT #2 failed to notify a QMP of the disruptive behavior exhibited by the patient and the involvement of security personnel to remove the patient from the ED. Upon request, the facility was unable to provide evidence Patient #10 was seen by a QMP to determine if the patient had an EMC. This was in contrast to the EMTALA policy, the Managing Disruptive Patients pathway, and the Emergency Services Technician Paramedic I-Emergency Department job description. According to the EMTALA policy, a MSE should have been provided to Patient #10 when they presented to the facility and requested an examination or treatment. The policy further stated a QMP should have performed the MSE based on the patients presenting signs and symptoms to rule out an EMC. Additionally, according to the Emergency Services Technician Paramedic I-Emergency Department Job Description, EMTs were responsible for providing patient care under the direction of a physician. EMT #2 should have reported changes in Patient #10’s physical, mental, and emotional conditions to the physician. Lastly, according to the Managing Disruptive Behavior pathway, when Patient #10 exhibited disruptive behaviors and was not actively assaulting or attempting to harm another person, staff should have notified the physician to perform an assessment of the patient and should have called a Code Grey. However, upon request, the facility was unable to provide evidence a Code Gray was called. B. Interviews i. On 6/11/25 at 11:01 a.m., an interview was conducted with EMT #2. EMT #2 stated obtaining the patient’s vital signs was a critical component of the intake process. They further stated vital signs assisted with determining a patient’s acuity (the level of urgency that guides treatment timing). EMT #2 stated patients complained the blood pressure cuff squeezed their arm tightly and caused pain and discomfort. EMT #2 stated if a patient refused to have their blood pressure checked, the patient was educated on the importance of checking their blood pressure. EMT #2 further stated patients could refuse a blood pressure check, and the refusal should be documented in the patient’s electronic medical record (EMR). EMT #2 stated even if a patient refused to have their blood pressure checked, they were still required to be evaluated by a provider. EMT #2 stated when patients became disruptive or aggressive, staff contacted security to assist with de-escalation. EMT #2 stated an overhead announcement would be made throughout the ED to alert the ED provider and charge nurse to respond to the situation. Additionally, EMT #2 stated before a patient was escorted out of the ED, the ED providers were required to assess the patient to ensure they were medically stable. EMT #2 stated it was not within their scope of practice to perform a MSE, or to determine if a patient had an EMC. EMT #2 stated it was important to have a QMP perform a MSE for patients who presented to the ED with chest pain. EMT #2 stated chest pain could indicate the presence of a life-threatening cardiac condition, and the patient could experience rapid decompensation, which could cause patient death. ii. On 6/9/25 at 10:27 a.m., during observations in the ED an interview was conducted with emergency service pivot lead technician (Pivot Lead) #1. Pivot Lead #1 stated their role in the ED involved screening patients upon presentation to assess the level of critical needs the patient required. Pivot Lead #1 stated the screening performed by the EMT was not a triage or a MSE. Pivot Lead #1 stated a MSE was performed by the medical provider. Pivot Lead #1 stated the facility was required to provide every patient with a MSE by a QMP, as mandated by the EMTALA law. Furthermore, Pivot Lead #1 stated security staff were called to help de-escalate patients when a patient was uncooperative or rude during the intake process. Pivot Lead #1 stated patients who became agitated, refused to follow directions, used profane or threatening language, or acted violently were escorted out of the facility by security staff. Pivot Lead #1 stated the medical provider would be notified of the patient’s removal based on the discretion of the intake staff and their assessment of the situation. Pivot Lead #1 further stated intake staff had the ability to decide if a patient should be removed from the ED before the MSE was performed. Pivot Lead #1’s statement contrasted with the Emergency Services Technician Paramedic I-Emergency Department Job Description. The job description read, the Pivot technician was responsible for providing patient care under the direction of a physician and reported changes in physical, mental, and emotional conditions to medical staff. However, Patient #10’s presentation to the ED was not reported to the medical provider, nor was the change in their emotional condition and their removal from the ED. iii. On 6/11/25 at 12:17 p.m., an interview was conducted with ED charge nurse (Charge RN) #4. Charge RN #4 stated patients were not asked to leave the ED, or escorted out by security, before a provider performed a MSE. Charge RN #4 stated the medical provider would be called to immediately assess a patient if there was an implied or assumed threat to the safety of the patient or others. Charge RN #4 further stated the patient would be moved to a private room in the main ED where the medical provider could safely perform a MSE. This was in contrast to Patient #10’s medical record which revealed staff did not relocate the patient or attempt de-escalation before security was contacted to remove the patient from the ED. iv. On 6/11/25 at 2:36 p.m., an interview was conducted with ED Physician #3. Physician #3 stated a MSE was used to determine whether or not a patient was experiencing an EMC and if they were at risk for immediate harm. Physician #3 stated a Pivot technician was not a QMP and was not qualified to perform a MSE. Physician #3 further stated it was not within the Pivot technician’s scope of practice to decide whether or not a patient should be evaluated by a physician. Physician #3 stated if a patient refused to have their blood pressure checked, the Pivot technician should alert the medical provider and arrange for the patient to be moved to a private ED room to ensure the medical provider could perform a MSE. These interviews contrasted with Patient #10’s medical record, which revealed the provider had not been informed the patient had presented with chest pain and there was no evidence the patient had received a MSE. Additionally, there was no evidence intake staff had notified the provider when Patient #10 became agitated and security had been contacted to remove the patient from the ED.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47962 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT RIGHTS was out of compliance. A-0131 The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. Based on observations, interviews, and document review, the facility failed to ensure patients were evaluated for decision-making capacity as their conditions changed in six of ten patients reviewed with capacity concerns.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 47962 Based on observations, interviews, and document review, the facility failed to ensure patients were evaluated for decision-making capacity as their conditions changed in six of ten patients reviewed with capacity concerns (Patients #3, #5, #6, #7, #8, and #10). Findings include: Facility policy: According to the Patient Rights policy, patients have the right to receive care from competent personnel that is respectful and safe and recognizes their dignity, be free from abuse, neglect, and harassment, and participate in decisions involving care, and understand what is expected. References: According to the Decision Making Capacity pathway, the pathway establishes processes to assist the primary team in assessing and documenting a patient’s capacity to facilitate their plan of care. The Physicians and advanced practice practitioners (APP) reassess patients’ capacity as their clinical situation changes. According to Assessing Patients’ Capacities to Consent to Treatment by Paul Appelbaum and Thomas Grisso, dated 12/22/1988, provided by the facility, the right of patients to accept or refuse recommended treatment requires careful reassessment when their decision-making capacities are called into question. Patients must be informed appropriately about treatment decisions and be given an opportunity to demonstrate their highest level of mental functioning. The legal standards for competence include the four related skills of communicating a choice, understanding relevant information, appreciating the current situation and its consequences, and manipulating information rationally. Since competence is a legal concept and can be formally determined only in court, the clinical examiner’s proper role is to gather relevant information and decide whether an adjudication of incompetence is required. Treatment for impairment of mental functioning can sometimes restore patients’ capacities, making it unnecessary to deprive them of their decision-making powers. 1. The facility failed to ensure patients were evaluated for decision-making capacity as their conditions changed. A. Document review i. Upon request, the facility was unable to provide a policy with guidance on evaluating a patient’s decision-making capacity. ii. Upon request, the facility was unable to provide a list of patients who lacked capacity along with dates of their initial evaluations and re-evaluations. iii. A review of Patient #3’s medical records revealed the facility failed to evaluate them for the capacity to make medical decisions. a. A review was conducted of Patient #3’s medical record which revealed Patient #3 was admitted to the facility on 4/21/24. Patient #3 was diagnosed with vascular dementia and resistant hypertension (high blood pressure). At this time, the facility was coordinating with Patient #3’s adult child to determine disposition. Due to Patient #3’s diagnosis and altered mental status, providers screened Patient #3 for medical decision-making capacity. From 4/21/24 to 9/18/24, providers documented Patient #3 lacked the capacity to make their own medical decisions, including discharge disposition. Although Patient #3’s medical record documented a lack of capacity from 4/21/24 to 9/18/24, the providers failed to re-evaluate Patient #3 after their evaluation on 5/29/24 documented a lack of capacity. The record revealed Patient #3 was not re-evaluated for capacity until the facility was prompted by an Adult Protective Services (APS) social worker on 9/18/24, three months and 20 days later, who believed the patient was capable of making discharge decisions. On 9/18/24, Patient #3’s primary medical team consulted Provider #1 who re-evaluated Patient #3 and determined Patient #3 had capacity for medical decision-making. The medical record revealed providers had not performed recent capacity evaluations and providers found Patient #3 had capacity when they were reevaluated. The medical record also revealed Patient #3 wanted to leave the facility and was not able to do so as the last evaluation had documented Patient #3’s lack of capacity. On 12/5/24 at 12:05 p.m. during a review of Patient #3’s medical record, an interview was conducted with registered nurse (RN) #6. RN #6 stated Patient #3 was on their unit from the end of May 2024 until their discharge on 9/20/24. They stated no significant care or discharge decisions needed to be made between June and September 2024 for Patient #3 which contributed to the lack of capacity evaluations, however, this was an unusually long amount of time between capacity evaluations. RN #6 stated they were aware of a project on their unit which would require capacity evaluations every 30 days but stated this had not yet been implemented. They stated keeping patients with decision-making capacity in the facility involuntarily led to a loss of patient autonomy. Patient #3’s medical record revealed Patient #3’s capacity was not re-evaluated as their health improved which prevented them from being able to leave the facility. This was in contrast to the Patient Rights policy which read, patients had the right to receive respectful care and were able to participate in decisions involving their care. This was also in contrast to the Decision Making Capacity pathway which read, providers reassessed patients’ capacity as their clinical situation changed. iv. A review of other medical records revealed the facility failed to evaluate patients for capacity on a timely and ongoing basis, even after the facility became aware of the concerns with Patient #3’s capacity and lack of ongoing evaluation. a. A review was conducted of Patient #5’s medical record which revealed Patient #5 was admitted to the facility on 9/13/24 for encephalopathy (decreased blood flow or oxygen to the brain). The record revealed a note on 9/16/24 by a psychiatrist who documented Patient #5 lacked the capacity to make medical decisions. On 12/6/24, two months and 20 days after this note, another provider documented a formal evaluation of Patient #5’s lack of capacity. b. A review was conducted of Patient #6’s medical record which revealed Patient #6 was admitted to the facility on 9/7/24 for neglect and failure to thrive (FTT). From 9/8/24 to 10/21/24, the record revealed several provider evaluations documenting Patient #6 lacked capacity. However, Patient #6’s next capacity evaluation was not performed until 12/6/24, one month and 15 days later. c. A review was conducted of Patient #7’s medical record which revealed Patient #7 was admitted to the facility on 11/13/24 for shortness of breath. On 11/14/24, a provider documented “lacks capacity” although the record did not reveal an evaluation of capacity at this time. On 12/6/24, 23 days after admission, a provider documented a formal evaluation of Patient #7’s lack of capacity. d. A review was conducted of Patient #8’s medical record which revealed Patient #8 was admitted to the facility on 9/7/24 for neglect and FTT. On 9/9/24 and 9/10/24, the record revealed a provider evaluation documenting Patient #8 lacked capacity. However, Patient #8’s next capacity evaluation was not performed until 12/6/24, two months and 26 days later. e. A review was conducted of Patient #10’s medical record which revealed Patient #10 was admitted to the facility on 8/27/24 for dementia. From 8/30/24 to 9/19/24, the record revealed provider evaluations documenting Patient #10 lacked capacity. However, Patient #10’s next capacity evaluation was not performed until 12/6/24, two months and 19 days later. On 12/9/24 at 2:33 p.m. during a review of medical records, an interview was conducted with RN #6. RN #6 stated they had recently participated in a leadership huddle during which staff had discussed the newly created 30-day timeframe for repeat capacity evaluations. They stated they learned at this meeting that this was tied to the concerns with Patient #3’s care. The medical records for Patients #5-8 and #10, where the patients were evaluated not to have capacity and did not have frequent ongoing screenings of capacity, revealed the facility failed to re-evaluate their capacity until 12/6/24 even after becoming aware of the failure to evaluate which had impacted Patient #3’s patient rights in September. The medical records for Patients #5-8 and #10 were also in contrast to the Patient Rights policy which read, patients had the right to receive respectful care and were able to participate in decisions involving their care. v. A review of a Collaborative Case Review (CCR) for Patient #3 revealed their case was sent to committee review on 10/10/24. The case summary documented Patient #3 came to the hospital in April 2024 with altered mental status and at that time, did not have capacity. The summary documented Patient #3’s capacity was not reassessed for some time and when their capacity was reassessed, Patient #3 had capacity and was discharged home. On 10/10/24, the committee members created action items to improve care for other similarly presenting patients. One action item, due 12/31/24, was to develop a standardized process for capacity assessment and discharge planning. Another action item, also due 12/31/24, was to develop processes for escalating concerns about capacity. a. During an interview conducted on 12/9/24 at 11:19 a.m. with clinical quality and safety specialist (Specialist) #2, Specialist #2 stated they had participated in Patient #3’s CCR. They stated CCR action items were typically due in 30 days however, the action items for Patient #3’s CCR were scheduled further out to allow for better collaboration and coordination with all team members. b. During an interview on 12/9/24 at 10:26 a.m. with physician and director of clinical operations (Director) #7, Director #7 stated they had participated in Patient #3’s CCR. They stated the facility was working to make systemic changes in capacity evaluations after realizing Patient #3 “fell through the cracks” during their stay. They stated their team had reviewed the literature but did not find policies or national guidelines surrounding the timeframe for repeat evaluations of capacity. Director #7 stated currently, providers repeated the capacity evaluations upon clinical status changes but this was a nebulous and poorly defined concept. They stated the committee’s work to create a standardized process for capacity evaluations was important as providers valued patient rights and did not want to keep someone at the facility who did not want to be there. c. During an interview conducted on 12/9/24 at 10:26 a.m. with the associate chief medical officer of inpatient services (ACMO) #8, ACMO #8 stated they helped oversee the unit that housed Patient #3. ACMO #8 stated the CCR for Patient #3 led to action items which included repeating capacity evaluations every 30 days. They stated as there was no guidance in the medical literature for when to repeat capacity, this was a date the team had chosen. ACMO #8 stated the team had also created a capacity decision-making tool which they rolled out to providers on 12/3/24, which included determining discharge capacity. They stated they had emailed all providers on 12/6/24 with education on this tool and the expectation for capacity evaluations to be done every 30 days. ACMO #8 stated moving forward, there would be checks and balances given the multiple members of the patient care team which would ensure patients were evaluated for capacity when needed. ACMO #8 stated their goal with this project was to respect patient rights and provide patient-centered care. Although Patient #3 was determined to have capacity on 9/18/24, the CCR review of their case revealed concerns with patient rights on 10/10/24, and quality and leadership staff felt systemic changes in capacity evaluations were needed, the facility failed to ensure action plans were implemented in a timely manner to prevent other patients with capacity from remaining at the facility involuntarily for weeks-months. The 10/10/24 CCR and interviews with quality and leadership staff were in contrast to a review of the medical records for Patients #5-8 and #10 which revealed the facility failed to re-evaluate their capacity, although there were concerns with the lack of capacity evaluations, until 12/6/24. vi. A review of a PowerPoint titled “Systems Improvement Conference: Patient Capacity Assessment” and dated 10/10/24 revealed Patient #3 remained in the facility after regaining capacity due to multiple factors, including the lack of documentation of capacity conversations, the patient distrust of the medical system and providers involved, and a lack of protocols for standardized reassessment of capacity. This presentation of Patient #3’s case on 10/10/24 revealed that the facility was aware of systemic failures which led to a violation of Patient #3’s patient rights. However, other similar patients, including Patients #5-8 and #10, were still not re-evaluated for capacity until 12/6/24 (one month and 26 days later). B. Interviews i. On 12/5/24 at 11:03 a.m., an interview was conducted with licensed clinical social worker (Social Worker) #3. Social Worker #3 stated they worked with patients at the facility who had significant discharge barriers. They stated they had participated in disposition planning for Patient #3 and were aware Patient #3’s family was not able to care for the patient. Social Worker #3 stated as such, the care team originally planned to discharge them to a nursing facility. Social Worker #3 stated the medical team had ongoing conversations with all patients about their understanding of their medical conditions and plans for discharge and were aware of changes in condition that could lead to a change in capacity. They stated repeat capacity evaluations were performed if the providers saw improvements in a patient’s condition. Social Worker #3 stated Patient #3 was originally evaluated as lacking capacity for medical decision-making and discharge planning in part because they were paranoid and not able to create a discharge plan. They stated providers reassessed Patient #3 frequently but had not formally reevaluated Patient #3 for capacity as the patient was not able or willing to have conversations with the providers regarding their understanding of their situation, their medical history, and their plan after discharge from the facility. Social Worker #3 stated although Patient #3 displayed the ability to problem-solve towards the end of their stay, they never independently or consistently executed the action items they had identified. Social Worker #3 stated Patient #3 lacked trust in the primary medical and clinical team as Patient #3 felt they were being held captive. They stated as Patient #3 failed to make progress with planning or involve hospital staff in discharge planning, which they stated was still the patient’s right, staff was not able to ascertain their progress towards increased capacity. Social Worker #3 stated Patient #3 was more forthcoming and engaged with Provider #1 and the social worker from APS which had led to the re-evaluation of their capacity. They stated they and the care team had not realized Patient #3 would feel more trust and respond more openly with outside providers and agencies. Social Worker #3 stated Patient #3’s providers felt they lacked capacity. Social Worker #3 stated capacity evaluations were important to assessing whether patients needed support in making decisions and identifying needs. They stated knowing capacity was important to ensure patients understood the risks versus benefits of their choices and if patients had capacity, that their voices were heard. Social Worker #3 stated there was a risk to patient autonomy if capacity was not re-evaluated. They stated this could lead to emotional harm due to long hospital stays, a lack of support, a lack of freedom to move around, and a significant impact on mental health. Social Worker #3 stated in the long term, there was a risk of physical health as well due to decreased mobility. ii. On 12/5/24 at 12:48 p.m., an interview was conducted with Social Worker #5. Social Worker #5 stated they and their team were brought on to consult several times during Patient #3’s treatment as there were concerns Patient #3 was abandoned by their family. They stated Patient #3 was also not engaged in discharge planning with the care team and had failed to provide financial information and documents pertinent to discharge. Social Worker #5 stated for patients who lacked trust in their care team, such as Patient #3, they created trust by showing honesty, transparency, and sharing the team’s goal of quality patient care. Social Worker #5 stated although it was typically the responsibility of the primary medical team to perform capacity evaluations, once Social Worker #5’s team was consulted for Patient #3, they performed a capacity evaluation. Social Worker #5 stated this had revealed Patient #3 had capacity. Social Worker #5 stated the capacity evaluation was important as it informed the team if the patient was able to engage in discharge and medical decision-making choices. Social Worker #5 stated if capacity changed and a repeat capacity evaluation was not performed, there was a risk to patient autonomy. iii. On 12/5/24 at 2:16 p.m., an interview was conducted with physician assistant (Provider) #4. Provider #4 stated they were one of the providers who had cared for Patient #3. They stated capacity was usually assessed before patients were transferred to their unit. Provider #4 stated then while on the unit, they and the other providers assessed capacity daily in conversation with patients. They stated when a change in capacity was seen, the providers involved the attending physician to perform a formal assessment of capacity. Provider #4 stated there was no set frequency for capacity assessments as this was based on clinical judgment. This statement was in contrast to the medical record for Patient #3 which revealed they had not assessed a change in Patient #3’s capacity as the patient’s condition improved. Provider #4 stated Patient #3 was acutely ill and paranoid when they first transferred to their unit. They stated the patient refused medications, treatments, and diagnostics. Provider #4 stated Patient #3 lacked trust and was frustrated with the social workers and case managers due to not feeling involved in the care plan and seeing various discharge plans falling through. Provider #4 stated they had built trust with Patient #3 by spending time together and remembering their interests. Provider #4 stated although Patient #3 appeared to gain capacity over time, their capacity fluctuated and Patient #3 was not able to speak to their plan for discharge. They stated they were not sure if Patient #3’s inability to work through a discharge plan with the medical team was due to paranoia or frustration. Provider #4 stated Patient #3 lacked insight into their medical concerns and even at discharge, Patient #3 was not able to speak to their discharge plans. Provider #4 stated they continued to be concerned for Patient #3’s safety. Provider #4 stated capacity evaluations were important as this allowed patients autonomy in their medical decision-making. They stated they did not want to imprison a patient even if the patient made decisions about their care or discharge that they as a provider disagreed with. iv. On 12/5/24 at 1:44 p.m. and 12/9/24 at 10:26 a.m., interviews were conducted with Provider #1. Provider #1 stated their team had been consulted to assess Patient #3. They stated when performing capacity evaluations, they gave patients every opportunity to show the fullest extent of their capacity. Provider #1 stated they were an advocate for older adults and it was important that older adults had their voices heard and autonomy respected. Provider #1 stated the assessment of capacity was part of the art of medicine although having standard guidance to provide patient-centered care could benefit the patients. Provider #1 stated capacity reassessments were performed after clinical changes, including acute medical illnesses, losing weight, and changing medications, although there was no set frequency for the evaluations. They stated ideally providers waited until patients were medically stable before assessing capacity. However, Provider #1 stated for patients believed to have dementia and assessed to lack capacity, such as Patient #3, there was no reason to redo the capacity assessment as dementia was a degenerative process. They stated dementia patients were expected to get worse with time and not improve so it was appropriate not to reassess capacity in patients with dementia. Provider #1 stated Patient #3 was a medical mystery as they had initially presented with what appeared to be dementia. They stated Patient #3’s presentation, history, as given by the patient’s adult child, signs, symptoms, imaging, and laboratory workup, led the medical team to a diagnosis of dementia. They stated Patient #3 was an outlier whose course was outside the normal range of illness. Provider #1 stated ensuring providers accurately assessed patients for capacity was important when caring for patients and respecting their autonomy.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 44751 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 PATIENT RIGHTS was out of compliance. A-0144 CARE IN SAFE SETTING The patient has the right to receive care in a safe setting. Based on interviews and document review, the facility failed to ensure a safe environment for patients in the psychiatric behavioral health unit (BHU). Specifically, patients in the BHU were able to access potentially dangerous items (contraband). The facility lacked policies, procedures, and or processes for staff to perform thorough environmental searches to ensure contraband was identified. Moreover, the facility failed to investigate contraband safety events and implement preventive measures to prevent recurrence. These failures were identified in one of one inpatient psychiatric units.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 44751 Based on interviews and document review, the facility failed to ensure a safe environment for patients in the psychiatric behavioral health unit (BHU). Specifically, patients in the BHU were able to access potentially dangerous items (contraband). The facility lacked policies, procedures, and or processes for staff to perform thorough environmental searches to ensure contraband was identified. Moreover, the facility failed to investigate contraband safety events and implement preventive measures to prevent recurrence. These failures were identified in one of one inpatient psychiatric units. Facility findings: Facility policies: The Operational Workflow: Belongings Search, Documentation & Updates policy read, clothing that is unapproved for patient use on the unit are clothing items with strings, torn/soiled clothing, inappropriate/vulgar/graphic designs clothing, crop tops, and shorts of appropriate length, dresses/skirts, and winter jackets. The Patient Safety and Visitor Searches policy read, prohibited items include any instrument, device, or item likely to cause death, injury, or a safety concern to patients, visitors, or staff. These items may include but are not limited to, sharp craft items (needles, latch hooks), other sharp items, and any other items identified by clinical staff to help ensure patient safety. The Occurrence Reporting policy read, individuals who discover, witness, or become aware of the circumstances indicative of an occurrence (including actual, near miss, patient, visitor, employee injuries, and workplace violence events) complete an electronic occurrence report by the end of shift, which includes a brief factual description of the event. Definitions: Adverse Event: an event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient. Occurrence: any event affecting the safety of an individual or facility, including any adverse event or near miss of an adverse event. An occurrence may or may not result in an injury, and may or may not involve error. 1. The facility failed to investigate adverse events (safety events) related to contraband, implement preventative measures to prevent recurrence and establish policies, procedures, and or processes for environmental searches conducted in the BHU to ensure psychiatric patients did not have access to contraband. A. Document review revealed multiple contraband safety events occurred in the BHU between 1/12/24 and 4/24/24. Examples included: i. Medical record review revealed Patient #9 was admitted to the BHU on 1/18/24 at 5:07 p.m. for suicidal ideation (thoughts of suicide) and planned to inflict life-threatening cuts to themselves. On 2/12/24 a safety event occurred with Patient #9. Review of the safety event report entered at 3:20 p.m. revealed, 25 days after admission, Patient #9 cut their forearms with a piece of metal from a pen. Further review of Patient #9’s medical record revealed a Significant Event Note entered at 4:00 p.m. which read, at the time of the safety event, Patient #9 was monitored one on one (continuous visual observation) by BHU staff. ii. A review of Patient #5’s medical record revealed, on 3/1/24 at 4:20 p.m., Patient #5 was admitted to the inpatient BHU with psychosis (disconnection with reality) and suicidal ideation. Patient #5 presented to the emergency department (ED) after admitting they wanted to harm another person and had been found by law enforcement officers holding a knife. According to the Psychiatric Admission H&P entered at 5:40 p.m., Patient #5 heard voices telling them to kill themselves and Patient #5 wanted to end their life. According to the safety event entered on 3/19/24 at 8:30 a.m., 18 days after Patient #5 was admitted, a behavioral health specialist (BHS) saw Patient #5 tying a thin rope around their waist. Patient #5 informed the BHS they used the rope as a belt and had been doing so since they were admitted to the facility on 3/1/24. a. On 4/2/24 at 8:10 p.m., a similar safety event occurred with Patient #7. According to the safety event, BHU staff saw Patient #7 wearing sweatpants with a drawstring. iii. A review of Patient #10’s medical record revealed, on 3/21/24 at 12:32 a.m., Patient #10 was admitted to the inpatient BHU for suicidal ideation. Upon review of the Daily Progress Note entered on 3/25/24 at 2:06 p.m., Patient #10 had thoughts of self-harm and increased suicidal thoughts. According to the safety event entered at 4:48 p.m., Patient #10 had removed the bendable metal nosepiece from the face mask they were given in an attempt to self-harm. a. A similar safety event occurred with Patient #14 on 4/23/24 at 9:13 p.m. Review of the safety event revealed BHU staff had found a facemask with a sharp bendable metal nosepiece in Patient #14’s room. Review of Patient #14’s medical record revealed Patient #14 was admitted to the BHU for suicidal ideation on 4/22/24 at 2:59 p.m. According to the Psychiatry Progress Note entered at 8:44 p.m., Patient #14 was suicidal and had planned to cut themselves. iv. A review of Patient #8’s medical record revealed, Patient #8 was admitted to the BHU on 3/25/24 at 10:31 a.m. According to the Psychiatric Admission H&P, Patient #8 had suicidal ideation and a recent suicide attempt. Further review of the Psychiatric Admission H&P revealed Patient #8 had attempted to commit suicide by cutting their neck. On 3/27/24, two days after Patient #8 had been admitted to the BHU, a safety event occurred with Patient #8. According to the safety event report, Patient #8 was found bleeding from a self-inflicted wound on their neck. Patient #8 had procured a paperclip and used the paperclip to self-inflict a laceration (a cut caused by a sharp object) to their neck. After the safety event occurred, BHU staff conducted a contraband search in Patient #8’s room and found a paperclip broken into two pieces, multiple nicotine patches (anti-smoking medication), and a piece of a glove. a. A similar safety event occurred on 4/20/24 at 4:45 a.m. According to the safety event report, a patient on the BHU found a paperclip on the floor by the group room. These events were in contrast to the Operational Workflow: Belongings Search, Documentation & Updates and the Patient Safety and Visitor Searches policies which read, patients were not allowed to have patient clothing items with strings and any item, instrument, or device that could cause death, injury, or pose a safety risk to on the unit. B. Interviews with staff revealed staff had not been provided additional training and education after contraband had been continually identified on the BHU. i. On 4/18/24 at 12:15 p.m., an interview was conducted with Behavioral Health Specialist (BHS) #3. BHS #3 stated staff conducted contraband searches as part of the environmental checks performed on the unit. BHS #3 stated environmental and contraband searches were performed when the patient was admitted, at the beginning of each shift, and whenever staff suspected patients had dangerous items. BHS #3 stated staff conducted environmental checks and contraband searches to increase patient and staff safety. BHS #3 further stated environmental checks for contraband needed to be more consistent, as staff did not always conduct an environmental check during every shift. BHS #3 stated nurses were informed when contraband was found during environmental checks. BHS #3 stated they were not aware a safety event should be completed when contraband was found on the unit and they had not been trained on how to enter a safety event. ii. On 4/25/24 at 3:36 p.m. an interview was conducted with the supervisor of patient and milieu safety (Supervisor) #6. Supervisor #6 stated environmental searches were supposed to be performed at a minimum of once per shift. Supervisor #6 stated during the environmental searches staff looked for contraband. This was in contrast to the interview with BHS #3 who stated staff did not always conduct an environmental check during every shift. Supervisor #6 stated when contraband was found on the unit staff were to inform the supervisor or charge nurse and complete a safety event report. However, Supervisor #6 stated they were aware not all BHU staff knew how to complete a safety event. iii. On 4/25/24 at 11:20 a.m., an interview was conducted with registered nurse (RN) #4. RN #4 stated staff needed to secure items considered to be contraband. RN #4 stated removal of contraband from the unit was important to ensure patients remained safe. RN #4 stated patients could use contraband to inflict physical injuries and even death to themselves and others. RN #4 stated they were not aware staff were supposed to complete a safety event when contraband was found on the unit. RN #4 further clarified they had not completed a safety event when they identified contraband on the unit and thought safety events were completed based on whether the patient was able to harm themselves or other patients. These interviews were in contrast to the Occurrence Reporting policy which read, a safety event was to be completed by staff for events that resulted in an actual injury, nearly resulted in an injury, or had the potential to result in an injury to a patient. iv. On 4/30/24 at 1:01 p.m., an interview was conducted with nurse manager (Manager) #5. Manager #5 stated environmental checks were supposed to be performed twice a day, once on the day shift and once on the night shift. Manager #5 stated environmental checks were performed to identify and remove items that could be used by patients to self-harm or to harm others. Manager #5 stated during environmental searches, staff searched for contraband in patient rooms, restrooms, common areas, and hallways. Manager #5 stated anytime staff found contraband on the unit a safety event report was to be completed. Manager #5 stated they were not aware some of the BHU staff did not know how to complete a safety event or when a safety event should be completed. Manager #5 stated they reviewed and investigated the contraband safety events on the BHU. Manager #5 stated staff would be provided education about contraband on the unit after contraband events were reviewed. Manager #5 stated the purpose of the education was to reinforce the importance of keeping patients safe by not allowing patients access to items considered contraband. However, upon request, the facility was unable to provide evidence staff education had occurred. On 4/25/24 at 12:47 p.m., upon request, the facility was unable to provide evidence of policies, procedures, and/or processes for staff to perform thorough environmental searches to ensure contraband was identified. Furthermore, the facility was unable to provide evidence of contraband safety event investigations and any preventive measures implemented to prevent recurrence.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 45020 Based on interviews and document review, the facility failed to ensure patients were provided activities of daily living (ADLs). Specifically, the facility failed to provide assistance required for hygiene care in two of three medical records reviewed. (Patients #3 and #4) Findings include: References: According to a document provided by the facility titled Lippincott Procedures - Bed Bath, performing a bed bath not only cleans a patient’s skin but also stimulates circulation, provides mild exercise, and promotes comfort. It also enables assessment of the condition of the patient’s skin as well as joint mobility and muscle strength. Documentation associated with bed bath includes: Date and time of the bed bath, patient’s tolerance of the bed bath, range of motion, self-care abilities, and any unusual findings. Document teaching provided to the patient and family (if applicable), their understanding of that teaching, and any need for follow-up teaching. According to a document provided by the facility titled Lippincott Procedures - Tub Baths and Showers, tub baths and showers provide personal hygiene, stimulate circulation, and reduce tension for a patient. They also allow observation of the condition of a patient’s skin and assessment of joint mobility and muscle strength. Documentation associated with tub baths and showers includes: Patient’s skin condition, any discoloration or redness, patient’s tolerance of the procedure, teaching provided to the patient and family (if applicable), their understanding of that teaching, and any follow-up teaching needed. 1. The facility failed to ensure patients received a bath or shower in accordance with the facility’s expectations. a. Patient #3’s medical record was reviewed. According to the History and Physical (H&P) dated 3/10/24, Patient #3 had a history of polytrauma (multiple injuries that involve multiple organs or systems) from a motor vehicle accident (MVA) with resultant traumatic brain injury (TBI) (an injury that affects how the brain works), cervical spine (the first seven stacked bones of the spine) surgery, osteomyelitis (a serious infection of the bone), splenic laceration (a ruptured spleen), as well as essential hypertension (abnormally high blood pressure), who over the last month had persistent abdominal pain and hematochezia (rectal bleeding). Patient #3 was admitted to the facility on 3/10/24 with the diagnosis of colitis (inflammation of the inner lining of the colon) . Patient #3’s medical record revealed they were hospitalized for 33 days and showed no evidence of bed baths or showers provided on 3/24/24, 3/25/24, and 3/26/24. Also on 4/4/24, 4/5/24, 4/6/24, and 4/27/24, there were no bed bath or showers documented, or patient refusals of bed bath or showers on these days. b. Patient #4’s medical record was reviewed. According to the H&P dated 4/1/24, Patient #4 had a history of chronic kidney disease (CKD), kidney transplant in 2001, poorly controlled insulin (a hormone that lowers the level of glucose (a type of sugar) in the blood) dependent diabetic and hypertension (high blood pressure). On 4/1/24, Patient #4 was admitted to the facility with a diagnosis of suspected pyelonephritis (kidney infection) of the graft kidney. Patient #4’s medical record revealed they were hospitalized for four days and showed no evidence of bed baths or showers on 4/1/24, 4/2/24, 4/3/24 and 4/4/24. There were no refusals of bed bath or showers documented on these days. Patient #4 had a shower on 4/5/24, the day of discharge. c. On 4/23/24 at 9:05 a.m., an interview was conducted with registered nurse (RN) #1. RN #1 stated patients were given hygiene supplies upon admission, which included a toothbrush, toothpaste, and other hygiene necessities. RN #1 stated bed bath or shower refusals were to be documented in the patient’s medical record. RN #1 stated hygiene, including bed baths and showers were important because being clean made patients feel better and it was good for the patients to get up and move. RN #1 also stated hygiene was important because it made patients feel more involved in their care. d. On 4/23/24 at 9:24 a.m., an interview was conducted with patient care assistant (PCA) #2. PCA #2 stated patients were asked daily if they wanted a bed bath or shower. PCA #2 stated if a patient refused a bed bath or shower, the nurse was to be notified and the refusal was expected to be documented. PCA #2 stated patient hygiene was important because there was an increased risk of bacteria being left on the skin which could cause an infection, which could result in sepsis (a serious condition in which the body responds improperly to an infection) if bathing was not completed.”