Los Robles Hospital & Medical Center

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 39520 The Condition of Participation is NOT met as evidenced by: Based on observation, interview, and record review, the hospital’s Governing Body (GB) failed to assume full legal responsibility for implementing, and monitoring policies governing the hospital’s total operation, and provide oversight for quality health care in a safe environment as the following: 1. The hospital’s GB failed to ensure steam sterilizers were cleaned in accordance with the Manufacturer’s Instructions for Use (MIFUs) on both campuses. Multiple reusable surgical instruments were not cleaned or were damaged and were available for patient use on both campuses. Failed to ensure decontamination sinks (special sink used to clean and remove harmful germs, chemicals, or dirty substances from instruments) did not have damaged, worn adhesive tape and were maintained according to national standards. Failed to ensure the floor Campus A Sterile Processing Department (SPD) supply storage and pre and pack area, were maintained in accordance with the hospitals’ Policy and Procedure (P&P) and national standards. Failed to follow national standards for cleanable surfaces and tape, tape adhesive, soiled, ripped, curled, or deteriorated tape were present on surfaces at both Campus A and Campus B. These failures resulted in the hospital not meeting the Condition of Participation (COP) for Infection Prevention Control and Antibiotic Stewardship. (Cross Reference A-0747) 2. The hospital’s GB failed to ensure Enzymatic spray (specialized ready-to-use foams designed to immediately cover soiled surgical instruments which prevent bioburden [blood, tissue, mucus] from drying, it breaks down contaminants and protects the instruments from corrosion before they reach the decontamination area) was used at point of use (in the operating room). Failed to ensure correct cleaning sequence, hand hygiene after glove changes, tape was removed from the operating room (OR) table, and aprons were cleaned after OR procedure during room turnover (cleaning, sanitizing, and preparing a room between patients in the operating room). Failed to ensure contaminated instruments and medical devices were not used on patients during surgical procedures and patients were not placed under anesthesia unnecessarily due to not confirming the sterility of instrument trays before the surgical cases started. Failed to ensure the environment of care committee reviewed the recall of sterile supplies used in surgical cases. Failed to ensure surgical services were well organized and were provided in accordance with acceptable standards of practice, policies, and procedures. These failures resulted in the hospital not meeting the Condition of Participation (COP) for Surgical Services. (Cross Reference A-0940) The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure effective surgical services and infection prevention control system-wide programs in the provision of quality patient care in a safe environment.”

“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: 39520 The Condition of Participation (CoP) is not met as evidenced by: Based on observation, interview, and record review, the hospital failed to ensure they had an effective, active system-wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients, as evidenced by: 1. Three of three sampled steam sterilizers were not cleaned in accordance with the Manufacturer’s Instructions for Use (MIFUs) on both campuses. (Campus A - Sterilizer 1 and Sterilizer 2, Campus B - Sterilizer 1). (Cross Reference A-0749) 2. Multiple reusable surgical instruments were not cleaned or were damaged and were available for patient use on both campuses (Campus A and Campus B). (Cross Reference A-0749) 3. Two of two sampled decontamination sinks (special sink used to clean and remove harmful germs, chemicals, or dirty substances from instruments) had damaged, worn adhesive tape and were not maintained according to national standards (campus A). (Cross Reference A-0749) 4. Ensure the floor Campus A Sterile Processing Department (SPD) supply storage and pre and pack area, were maintained in accordance with the hospitals’ Policy and Procedure (P&P) and national standards. (Cross Reference A-0750) 5.Follow national standards for cleanable surfaces and tape, tape adhesive, soiled, ripped, curled, or deteriorated tape were present on surfaces at both Campus A and Campus B. (Cross Reference A-0750) These failures had the potential to cause negative patient care outcomes, cross-contamination of equipment, spread harmful microorganisms to patients and staff, lead to procedural and surgical site infections, and increase the risk of hospital-acquired infections and illness. The cumulative effects of these systemic problems resulted in the hospital’s inability to provide an effective hospital wide infection control program. Resulting in the hospital’s inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control/Antibiotic Stewardship Program.”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 39520 The CONDITION OF PARTICIPATION is not met when: Based on observation, interview, and record review, the hospital failed to ensure surgical services policies and procedures/ practices, and protocols were followed for quality care when : 1. Enzymatic spray (specialized ready-to-use foams designed to immediately cover soiled surgical instruments which prevent bioburden [blood, tissue, mucus] from drying, it breaks down contaminants and protects the instruments from corrosion before they reach the decontamination area) not used at point of use (in the operating room). (Cross Reference A-0951) 2. Incorrect cleaning sequence, no hand hygiene after glove changes, tape not removed from the operating room (OR) table, and aprons not cleaned after OR procedure during room turnover (cleaning, sanitizing, and preparing a room between patients in the operating room). (Cross Reference A-0951) 3. Patient 900 and Patient 902 went under anesthesia and then the OR procedure was cancelled because of contaminated instruments. (Cross Reference A-0951) 4. A recall of sterile gowns and drapes was not reviewed by the environment of care committee. (Cross Reference A-0951) 5. Patient 901 and Patient 904 had OR procedures with contaminated instruments. (Cross Reference A-0951) 6. Patient 903 had an OR procedure with contaminated TEE probe (transesophageal echocardiogram-a special medical ultrasound attached to a thin flexible tube inserted through the mouth and into the throat to get detailed images of the heart). (Cross Reference A-0951) The hospital failed to ensure the surgical services department met the needs of the patients, compromised the health and safety of patients, and had potential for surgical site infections (and possible death) when contaminated instruments were used in surgical cases. The cumulative effects of these systemic problems resulted in the hospital’s inability to provide quality patient care in a safe and effective manner and in accordance with §482.51 Condition of Participation for Surgical Services.”

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 41023 Based on interview and record review, the facility failed to ensure Patient 200 was informed of their rights in advance of furnishing care by not delivering the Important Message (IM) from Medicare within two calendar days of admission. This failure had the potential to compromise the patient’s right to appeal the discharge. Findings: During a concurrent interview and record review on 5/4/2026, at 4:30 p.m. with the Patient Access Director (PAC), the medical record for Patient 200 was reviewed. The medical record indicated Patient 200 was admitted to the facility 1/26/26 at 6:41 p.m. The IM form was signed, dated and witnessed 1/29/26 at 3:14 p.m. During a review of the facility policy and procedure (P&P) titled “Procedure for Delivery of the Important Message from Medicare ...”, dated 4/2026, the P&P indicated “The IM informs hospitalized patients of their discharge appeal rights. This notice must be delivered within two calendar days of admission”. PAC acknowledged the form was not provided to the patient within two calendar days of admission.”

“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: 50132 Based on observation, interview, and record review, the facility failed to provide care in a safe setting when: 1. Expired supplies found in a urology supply cart. 2. Water filter for ice/water dispensing machine was found expired. 3. Water filter for ice/water dispensing machine was found undated. This failure had the potential for expired products to be used on patients and the use of unfiltered water had the potential to place patients, staff, and visitors at risk. Findings: 1. During a concurrent observation and interview on 5/6/26, beginning at 8:15 am, with the Manager of In-Patient Services at Thousand Oaks Surgical Hospital (TOSH), supply room were toured. In the urology cart two (2) pairs of sterile size 7 ½ gloves were found with an expiration date of 12/25. Eighteen (18) sterile 30cc syringes were found with an expiration date of 12/25. The Manager of In-Patient Services verbalized and confirmed that the supplies were expired and should be removed from the cart and not used for patient care. The facility was unable to provide a policy for expired supllies or supply carts. 2. During a concurrent observation and interview on 5/6/26, beginning at 8:15 am, with the Manager of In-Patient Services at Thousand Oaks Surgical Hospital (TOSH), in the nutrition room 2, the water filter for the ice/water dispenser was found labeled “change 12/29/25 next change date 3/29/25”. Facilities was called for clarification. Facilities stated that the water filter maintenance is contracted out to an outside company for water filters to be changed every three (3) months. Facilities stated that the date should be 3/29/26 not 3/29/25 but it is still past the change date. 3. During a concurrent observation and interview on 5/6/26, beginning at 8:15 am, with the Manager of In-Patient Services and Facilities at Thousand Oaks Surgical Hospital (TOSH), in the nutrition room 1, the water filter for the ice/water dispenser was found with no label. Facilities stated there is no way to determine when the filter was installed or when the filter should be changed because there is not a label on it. The facility was unable to provide a policy regarding water filtration system or a contract with the outside company for the water filters service.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 39520 Based on interview and record review, the hospital failed to ensure the Quality Assessment Performance Improvement (QAPI) department measured, analyzed, and tracked an adverse patient event when an investigation (root, cause, analysis-RCA) was not performed when Patient 904 underwent a craniotomy (a surgical procedure where a neurosurgeon removes a section of the skull to access the brain to treat brain tumors, blood clots, and traumatic injuries) with contaminated instruments and this adverse event was not reported to the state agency (CDPH-California Department of Public Health). This hospital failure resulted in the hospital failing to assess, monitor, analyze, improve systems and processes, for the quality of care and safety of surgical services provided to patients leading to potential negative outcomes, infection, (and possible death) for patients. Findings: During a review of the facility’s policy and procedure (P&P) titled, “Incident/Occurrence Notification Reporting System” dated 9/24, the P&P indicated in part ... “Adverse Event: any deviation from usual medical care that causes an injury to the patient or poses a risk of harm. Events include errors, preventable adverse events, and hazards ...An untoward, undesirable, and usually unanticipated occurrence ...” During a review of Patient 904’s “Neurosurgical Consultation Note” dated 2/6/26, The note indicated in part...Patient 904 brought in my ambulance having right hemiplegia (paralysis affecting one side of the body), left gaze deviation (a forced or sustained movement of both eyes towards the left typically indicating left side damage to the brain, typically from a stroke), and expressive aphasia (person knows what they want to say but struggles to get the words out) ...scan showed left MCA (left middle cerebral artery occlusion- when a blood clot blocks the main artery supplying blood to left side of brain) occlusion ...plan for stat craniotomy ...tray in the OR with possible contamination with “eye lash” ...room turnover 2 hours ...explained to Patient 904’s husband option of transfer to another hospital as we did not have back up craniotomy tray ... During an interview on 5/6/26, at 2:45 p.m., with the surgical services director (SSD), SSD was asked about Patient 904 who had a craniotomy with contaminated instruments, SSD verbalized when the instrument tray was opened there was contamination of false eyelashes noted in the tray. SSD verbalized there were no other craniotomy trays available. SSD verbalized upon further investigation there were two other trauma trays available, however staff were unaware that these trays could have been utilized because they had a different physician’s name (MD 2) assigned to them. SSD verbalized using contaminated instruments is a “never event” and should not happen. During a concurrent interview and record review on 5/12/26, at 11:50 a.m., with the director of patient safety (DPS), the incident report involving Patient 904 was reviewed. DPS verbalized ST 5 had filed the incident report and indicated the instrument tray had rust and debris (hair) found in the craniotomy tray. The physician (MD 1) declined to wait for replacement tray and opted to use the contaminated instrument tray. When asked if the facility did an investigation and an RCA, DPS stated, “No the facility did not do an RCA and the facility did not think the incident was a serious event”. When asked if using contaminated instruments on a patient is a serious event and/or adverse event, DPS stated “Yes” and verbalized the incident should have been investigated and escalated to administration. During a review of the facility’s policy and procedure (P&P) titled, “Incident/Occurrence Notification Reporting System” dated 9/24, the P&P indicated in part ...Serious events, as defined in the [name of facility] Serious Preventable Adverse Event Policy should be immediately be reported to the risk management department ...The director/manager responsible for reporting oversight will pull reports each work day to monitor submissions ...The manager will ensure that the report has been referred to another manager for initial review and follow-up as appropriate ...The director/manager will confirm appropriate review/investigation has been conducted and has resulted in accurate primary cause and contributing factors ...Appropriate disposition type and federal, state, and local reporting requirements ...Process for Investigation and Analysis of Incident Trends ...Standard summary reports are available to aggregate data and analyze trends and patterns ...These reports are utilized for risk identification, performance improvement, and committee reporting as appropriate ...Data should be utilized to assist with the development of educational and improvement initiatives for the facility ....” During a review of the facility’s “Quality & Performance Improvement Plan” dated 2026, indicated in part ... “Goals and Objectives: The goal of the organization and the Quality & Performance Improvement Program is to create an environment where departments and services work collaboratively to identify opportunities for improvement in a coordinated, systemic organization-wide approach. The results being to improve patient care, process outcomes, and prevent and reduce medical errors ...Patient Safety: In addition to performance improvement, a focus on patient safety requires an environment in which patients, their families, and organizational staff and leaders can identify and manage actual and potential risks to safety ...The Patient Safety Program utilizes the Plan-do Check-Act model of performance improvement which is the formal performance improvement methodology adopted by [name of facility] and emphasizes the improvement of systems and processes, retrospectively and proactively, in a reporting, flexible, and learning working environment using techniques such as root cause analysis, proactive risk assessments, evidence-based methods, and monitoring of measurements over time ...” During an interview on 5/12/26, at 1:47 p.m., with the director of regulatory (DOR), the DOR was asked if the incident of Patient 904 undergoing a craniotomy with contaminated instruments, was reported to the state agency as an adverse event, the DOR verbalized the incident was not reported to the state agency and that decision was made by the facility leadership (administration) not to report. When asked if this incident is an unusual occurrence, the DOR stated, “Yes this was an unusual event”. During a review of the Health & Safety Code (HSC) indicated in part ...Adverse Event reporting requirements per HSC 1279.1 (a) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law.”

“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: 40358 Based on observation, interview, and record review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, identifying, reporting, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations when: 1. Three of three sampled steam sterilizers were not cleaned in accordance with the Manufacturer’s Instructions for Use (MIFUs) on both campuses. (Campus A - Sterilizer 1 and Sterilizer 2, Campus B - Sterilizer 1). 2. Multiple reusable surgical instruments were not cleaned or were damaged and were available for patient use on both campuses (Campus A and Campus B). 3. Two of two sampled decontamination sinks (special sink used to clean and remove harmful germs, chemicals, or dirty substances from instruments) had damaged, worn adhesive tape and were not maintained according to national standards (campus A). Findings: During an interview on 5/4/26, at 9:30 a.m. on Campus A, during a complaint validation survey an interview was conducted with the Infection Prevention Nurse (IPN) and the Director of Infection Prevention (DIP) via phone who stated that the hospital followed Infection Control National standards from the following: -AORN (Association of periOperative Registered Nurses, a professional organization for nurses working before, during, and after surgery {perioperative care}. AORN sets evidence-based guidelines, provides education, advocates for patient and staff safety, and supports career development for its members, ensuring high standards in surgical settings), -CDC (Center for Disease Control, the national public health agency of the United States), -CMS (Center for Medicare and Medicaid - United States federal agency that provides healthcare coverage in partnership with the healthcare community to improve quality, equity and outcomes in the healthcare system), -ANSI/AAMI ST79 (American National Standards/Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology); and -APIC (Association for Professionals in Infection Control and Epidemiology, a professional organization for infection preventionists and healthcare epidemiology professionals. 1. During a concurrent observation and interview on 5/4/26, at 9:49 a.m., on Campus A, a tour of the Sterile Processing Department (SPD - a place in the hospital where specially trained staff clean, disinfect [clean using special chemicals to kill most germs], and sterilize [remove or kill all germs]medical instruments and equipment so they are free of germs]) with the IPN, the Vice President of Operations (VPO), the Chief Operating Officer (COO), and Sterile Processing Department Interim Manager (SPDIM)1 two steam sterilizers (also known as an autoclave - a machine that uses steam under pressure to kill germs) were observed. Steam Sterilizer 1 and Steam Sterilizer 2 were inspected, and the following were observed: -Steam Sterilizer 1 contained multiple stickers/labels, partial stickers/labels, and sticker/label residue from previously processed trays stuck to the interior chamber walls along with a “Load No” (a sticker tracking load and date a tray was sterilized) label and several white spots scattered on the chamber floor. - Steam Sterilizer 2 contained multiple stickers/labels, partial stickers/labels, and sticker/label residue from previously processed trays stuck to the interior chamber walls. SPDIM 1 stated she was not concerned about the stickers in the chamber, and she was not going to “burn herself” climbing into the chamber to remove the stickers. SPDIM 1 stated an outside vendor cleaned the autoclave chambers. During an interview, the IPN stated that adhesives could not be cleaned and were an infection control concern. During a follow-up interview and concurrent record review on 5/5/26 at 10:10 a.m., On Campus A, in the SPD clean workroom with the SPDIM 1, a review of the document titled, “Daily Autoclave Cleaning Log” dated March 2026, indicated, “Place your initials on the date Autoclave Chambers Cleaning was performed (daily), assuring that Chamber Drain Strainer is clean and free of debris ...”. Surveyor requested the completed chamber cleaning log, SPDIM 1 stated the facility did not track autoclave chamber cleaning and that an outside vendor performed the cleaning. Surveyor requested the steam sterilizer preventative maintenance and cleaning logs. A review of document provided titled “[company name] Field Service Report”, dated 11/18/25 for Steam Sterilizer 1 indicated preventative maintenance was last performed 11/18/25. A review of document titled “[company name] Field Service Report”, dated 01/22/26 for Steam Sterilizer 2 indicated installation and specialty service were last performed on 01/22/26. There was no documentation that indicated the vendor had cleaned Campus A’s chambers for Steam Sterilizer 1 and Steam Sterilizer 2. The SPDIM 1 stated the vendor should have been contacted for cleaning of the autoclave chambers. The review of the facility’s P & P titled “Disinfection and Sterilization,” reviewed 1/25/2025, indicated “ ...Sterilization Equipment: ...C. All sterilizers should have routine cleaning of the interior chamber and routine maintenance. Cleaning and maintenance must be logged ...” The review of the facility’s document titled, “AMSCO 600 Medium Steam Sterilization Operator Manual” dated 2025, indicated, “...Chamber Cleaning Frequency ...In general, chamber cleaning should be performed under the following circumstances: when spills or other soiling have occurred, routinely to maintain sterilizer cleanliness and appearance ...” During a telephone interview on 5/5/26 at 11:29 a.m., with [company name] Sterilizer Representative, (SR) 1 stated he worked in the life science division for [company name] and the Manufacturer’s Instructions for Use (MIFU) require autoclave chambers “should be on a cleaning schedule and cleaned after spills or other soiling. When asked about stickers and adhesive on interior chamber walls, SR 1 stated “stickers from previously processed instruments must be removed. SR 1 stated the material from the stickers could degrade over time and “particles could disrupt the sterilization process”. On 5/6/26, at 8:30 a.m., on Campus B, with the DIP and Assistant Vice President of Infection Control (AVPIC), DIP stated P & P are shared by both campuses and it is an expectation that the P & P were followed. During a concurrent observation and interview on 5/6/26, at a.m., on Campus B a tour of the Sterile Processing Department (SPD) with the DIP, AVPIC, Sterile Processing Department Interim Manager (SPDIM) 2, and Sterile Processing Department Technician (SPD Tech) 3 Steam Sterilizer 1 was inspected, and the following was observed: - Steam Sterilizer 1 contained multiple labels, partial labels, and label residue from previously processed trays stuck to the interior chamber walls and chamber floor. SPDIM 2 stated the autoclave vendor should clean the autoclave chambers every six months. SPD Tech 3 stated she cleaned the autoclave drain daily and did not clean the chamber walls. She stated there was no chamber cleaning log. A sticker on Steam Sterilizer 1 indicated the last vendor service was on 10/25. SPD Tech 3 stated the autoclave vendor should be contacted to clean the chamber. The review of the facility’s P&P titled “Infection Prevention Plan, last revised 2/26 indicated, “ ...Authority Statement/Program Responsibility The Infection Prevention program is authorized by facility leadership to facilitate a functioning program, coordinating all activities related to the surveillance, prevention, and control of infections, including improvement of processes and outcome ...RELEVANT POLICIES AND PROCEDURES ...[name of facility] has written policies and procedures to guide its activities and methods for preventing and controlling the transmission of infections within the hospital and between the hospital ...The creation, implementation, and management of these policies is in collaboration with partner services lines (ex. Emergency Management, EVS ...Surgical Services ...) Reprocessing reusable medical devices DISINFECTION AND STERILIZATION - Central Service ...Policy/policies must address procedures to guide activities related to the following the hierarchy of resources for devise use, reprocessing, and/or preventing or controlling the transmission of infection including: applicable law and regulation, manufacturer’s instructions for use IFU’s), and nationally recognized evidence-based guidelines and standards of practice ...” 2. a. A concurrent interview and inspection of surgical trays were conducted with Sterile Processing Department Technician (SPD Tech) 1, the Sterile Processing Department Interim Manager (SPDIM) 1, and the Infection Prevention Nurse (IPN) on 5/4/2026, at 10:14 a.m., in Campus A’s SPD clean workroom. SPD Tech 1 stated the surgical tray sets contained reusable surgical instruments and were ready for patient use. Four of five sampled surgical tray sets had concerns. The following concerns were observed: -Tray Set 2 contained 22 instruments, dated 3/17/26. One of 22 sampled instruments was discolored with white residue and water stains; and; -Tray Set 3 contained 38 instruments, dated 3/19/26. One of 38 sampled instruments was discolored with multiple white residue water spots; and; -Tray Set 4, a Craniotomy (brain surgery) tray, contained 124 instruments, dated 3/3/26. Two of two sampled interior metal instrument trays and 32 of 124 sampled instruments were of concern. The two interior metal instrument trays had multiple visible scratches, and the scratches/nicks were rough to touch. Two instruments had white residue, water spots, and dark staining; 30 instruments contained multiple water spots; and; -Tray Set 5, a vendor femur antegrade tray, contained two sampled instruments with pitting and nicks, and a guide wire with a white flaky substance. SPDIM 1 scraped off the substance and stated it was a piece of plastic, which should not be in a sterilized tray and required reprocessing (clean instruments again to make them safe). SPD Tech 1 validated the observations for the five observed trays and stated the metal trays were compromised (damaged and not safe to use) and should have been removed and sent for repair. SPD Tech 1 stated that if one instrument had spotting or discoloration the entire tray should be reprocessed. SPDIM 1 stated the stained instruments should have been returned to decontamination to soak in an anti-staining solution and stated the rule of thumb was that five instruments with water marks required reprocessing of the entire tray. The IPN stated there had been issues with water quality, validated the multiple water spots, and stated the number of instruments identified for reprocessing was “statistically significant” for potential contamination and required reprocessing. SPD Tech 1 stated Tray Set 2, Tray Set 3, Tray Set 4, and Tray Set 5 were not ready for patient use. Surveyor requested SPD P&P for processing and inspecting instruments, including procedures for damaged, stained, or discolored instruments. No hospital P&P was provided for inspecting instruments or for handling damaged, stained, or discolored instruments. During a concurrent interview and record review on 5/7/26 at 9:40 a.m., in a classroom, with Scrub Technician 1 (ST 1), ST 1 stated she inspected instruments prior to surgery for bioburden (germs from blood, tissue, body fluid) rust, nicks, spots and water marks. ST 1 stated “if any instrument” does not pass inspection, “the whole tray goes back” to decontamination for reprocessing. ST 1 stated she was not aware of a P&P for inspecting instruments. ST 1 confirmed an educational handout document provided with training titled, “Examples of Instrumentation That Should Be Removed from Circulation”, undated, was used in recent training. The handout indicated “all examples provided pose a safety risk for our patients. Instruments with Water Marks, Metal Discoloration, and Rust like Staining, Instrumentation with physical damage implicating the instruments’ purpose, Instrumentation displaying severe damage such as dents and deep scratches, Instrumentation with pitting labeling, color tap, or engraving (photos included to show examples of each safety risk) ...”ST 1 stated instruments with any of the listed compromised instruments create a risk of infection and should be removed from circulation. ST 1 stated any instrument with one of the listed conditions resulted in the entire tray being sent to decontamination. 2.b. During an interview on 5/6/26, at 8:20 a.m., in the lobby at Campus B, with the DIP and AVPIC, the DIP stated Campus A and Campus B followed the same P&P and national standards. During a concurrent interview and inspection of surgical trays on 5/6/26 at 10:14 a.m., in Campus B’s SPD clean workroom, with the SPD technician (SPD Tech 3), the SPD Interim Manager (SPDIM 2), and the DIP, AVSIC, SPD Tech 3 stated the surgical tray sets contained reusable surgical instruments and were ready for patient use. One sampled surgical tray set had concerns. The following concerns were observed: -Major tray set contained 94 instruments, dated 4/23/26. Eleven of 94 sampled instruments were discolored and had multiple water stains. Two of the discolored instruments had non-moveable brown stains. SPD Tech 3 validated observations and stated, “if we have a stain”, staff pull the instrument, soak in Surgistain (a healthcare/SPD cleaning product used to remove rust, stains, spotting, corrosion and mineral deposits) to remove the stain and then reprocess the entire tray set. SPD Tech 3 stated if one reprocessed instrument in a tray is potentially contaminated, the whole tray required reprocessing. SPD Tech 3 stated the tray set was not ready for patient use. On 5/4/26 surveyors requested the SPD P&P for cleaning instruments and managing compromised instruments. The facility did not provide a P&P. The review of the ANSI/AAMI ST79: 2017, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” indicated, “7.6 Cleaning: 7.6.1 General Considerations ...g) Instruments should be carefully inspected for flaws [defects], damage, debris, detergent residue, and completeness, then dried ...” The review of the facility’s P&P titled “Infection Prevention Plan, last revised 2/26 indicated, “ ...Authority Statement/Program Responsibility The Infection Prevention program is authorized by facility leadership to facilitate a functioning program, coordinating all activities related to the surveillance, prevention, and control of infections, including improvement of processes and outcome ...RELEVANT POLICIES AND PROCEDURES ...[name of facility] has written policies and procedures to guide its activities and methods for preventing and controlling the transmission of infections within the hospital and between the hospital ...The creation, implementation, and management of these policies is in collaboration with partner services lines (ex. Emergency Management, EVS ...Surgical Services ...) Reprocessing reusable medical devices DISINFECTION AND STERILIZATION - Central Service ...Policy/policies must address procedures to guide activities related to the following the hierarchy of resources for devise use, reprocessing, and/or preventing or controlling the transmission of infection including: applicable law and regulation, manufacturer’s instructions for use IFU’s), and nationally recognized evidence-based guidelines and standards of practice ...” 3. During a concurrent observation and interview on 5/4/26 at 12:10 p.m., in Campus A’s Sterile Processing Department (SPD) decontamination (the process of removing or neutralizing germs) workroom with the SPD technician (SPD Tech 2), IPN, and SPDIM 1, the decontamination sinks were observed with damaged and peeling adhesive water line labels. SPD Tech 2 stated one sink was used for washing items with detergent and water to remove debris, blood, bioburden, and another sink was used to rinse detergent and debris. SPDIM 1 validated the damaged labels and stated the sinks needed replacement. SPDIM 1 stated damaged labels in decontamination sinks allowed bioburden to collect in cracks and crevices and could contaminate other instruments. The IPN stated that adhesive, labels, tape could not be cleaned and had the potential to cause for cross-contamination (spreading germs from one thing to another). On 5/4/26 surveyors requested the SPD P&P for cleaning instruments and managing compromised instruments. The Facility did not provide a P&P. A review of ANSI/AAMI “ST79: 2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities”, indicated “ ...3.3.5 General facility design requirements: All surfaces ... should be durable, smooth, and cleanable ... Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices ...” According to the Centers for Disease Control (CDC), undated, retrieved 8/2/24 from https://www.cdc.gov/infection-control/hcp/environ mental-control/appendix-c-water.html, indicated, “Microorganisms (a tiny living thing so small you need a microscope to see such as bacteria) have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface) ...” The review of the facility’s P&P titled “Infection Prevention Plan, last revised 2/26 indicated, “ ...Authority Statement/Program Responsibility The Infection Prevention program is authorized by facility leadership to facilitate a functioning program, coordinating all activities related to the surveillance, prevention, and control of infections, including improvement of processes and outcome ...RELEVANT POLICIES AND PROCEDURES ...[name of facility] has written policies and procedures to guide its activities and methods for preventing and controlling the transmission of infections within the hospital and between the hospital ...The creation, implementation, and management of these policies is in collaboration with partner services lines (ex. Emergency Management, EVS ...Surgical Services ...) Reprocessing reusable medical devices DISINFECTION AND STERILIZATION - Central Service ...Policy/policies must address procedures to guide activities related to the following the hierarchy of resources for devise use, reprocessing, and/or preventing or controlling the transmission of infection including: applicable law and regulation, manufacturer’s instructions for use IFU’s), and nationally recognized evidence-based guidelines and standards of practice ...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 40358 Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations. The facility’s infection control program failed to: 1. Ensure the floor Campus A Sterile Processing Department (SPD) supply storage and pre and pack area, were maintained in accordance with the hospitals’ Policy and Procedure (P&P) and national standards, 2. Follow national standards for cleanable surfaces and tape, tape adhesive, soiled, ripped, curled, or deteriorated tape were present on surfaces at both Campus A and Campus B. Findings: During an interview on 5/4/26, at 9:30 a.m. on Campus A, during a complaint validation survey an interview was conducted with the Infection Prevention Nurse (IPN) and the Director of Infection Prevention (DIP) via phone who stated that the hospital followed Infection Control National standards from the following: -AORN (Association of periOperative Registered Nurses, a professional organization for nurses working before, during, and after surgery {perioperative care}. AORN sets evidence-based guidelines, provides education, advocates for patient and staff safety, and supports career development for its members, ensuring high standards in surgical settings), -CDC (Center for Disease Control, the national public health agency of the United States), -CMS (Center for Medicare and Medicaid - United States federal agency that provides healthcare coverage in partnership with the healthcare community to improve quality, equity and outcomes in the healthcare system), -ANSI/AAMI ST79 (American National Standards/Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology); and -APIC (Association for Professionals in Infection Control and Epidemiology, a professional organization for infection preventionists and healthcare epidemiology professionals. 1. During a tour, on 5/4/26, at 9:40 a.m., on Campus A, during a tour of the Sterile Processing Department (SPD) with the Infection Prevention Nurse (IPN), the Vice President of Operations (VPO), the Chief Operating Officer (COO), and SPD Interim Manager (SPDIM) 1 the following were observed: -Gray fuzzy matter under a sterile supply storage cart in the clean supply storage area; and -Multiple black scuff marks scattered on the floor throughout the SPD clean workroom During a concurrent interview with the Sterile Processing Department Interim Manager (SPDIM) 1, she validated the observation and stated the SPD area should be terminally cleaned daily on the night shift. During an interview with the IPN who was present during the tour, she stated dust should not be present in the clean storage area because it could “contaminate supplies”. During an interview with the VPO, who was also present during the tour, he stated the SPD area should be cleaned nightly and the floors did not appear terminally cleaned, and he would not expect to see black marks the morning after terminal cleaning. During a concurrent interview and record review on 5/6/26 at 3:12 p.m., with the Environmental Services Manager (EVSM), Environmental Services Supervisor (EVSS), and the Director of Infection Prevention (DIP), EVSM stated there should be no dust or particles present after staff complete the cleaning checklist. The EVSS stated night shift staff should contact the floor team to address scuff marks and confirmed the process was not in a policy and was not documented. EVSS validated that a night shift EVS employee completed the checklist and that the shift supervisor initialed the “Supervisor Inspection” box. EVSS stated the supervisor should not have initialed the box until the floor team completed the cleaning. The DIP stated the daily cleaning checklist should include a section for comments when additional cleaning is required. The review of the facility’s P&P titled “Central Service Cleaning”, last revised 5/22, indicated “Central Services contains one of the most critical areas of the hospital. Extreme care must be taken to ensure the following schooled is carried out rigorously and in accordance with departmental procedures ...B. STERILE STORAGE AREAS: ...2 Damp dust all vents, floors and edges ...3. Mop floor surfaces ...C. STERILE ASSEMBLY AREA: 1. Will be the responsibility of Central Service Staff, except floor care. 2. Mop floor surfaces with a clean microfiber mop ...” The review of the facility’s P&P titled “Infection Prevention Plan, last revised 2/26 indicated, “ ...Authority Statement/Program Responsibility The Infection Prevention program is authorized by facility leadership to facilitate a functioning program, coordinating all activities related to the surveillance, prevention, and control of infections, including improvement of processes and outcome ...RELEVANT POLICIES AND PROCEDURES ...[name of facility] has written policies and procedures to guide its activities and methods for preventing and controlling the transmission of infections within the hospital and between the hospital ...The creation, implementation, and management of these policies is in collaboration with partner services lines (ex. Emergency Management, EVS ...Surgical Services ...) Reprocessing reusable medical devices DISINFECTION AND STERILIZATION - Central Service ...Policy/policies must address procedures to guide activities related to the following the hierarchy of resources for devise use, reprocessing, and/or preventing or controlling the transmission of infection including: applicable law and regulation, manufacturer’s instructions for use IFU’s), and nationally recognized evidence-based guidelines and standards of practice ...” 2. a. During a tour, on 5/4/26, at 9:55 a.m., on Campus A, during a tour of the SPD workroom with the IPN, the Vice President of Operations (VPO), the Chief Operating Officer (COO), and SPD Interim Manager (SPDIM) 1the following were observed: -Multiple pieces of grayish white, lifting, overlapping and ripped construction tape were adhered to the floor and the bottoms of four steam sterilizers; -clean instruments in peel packs stuck to a white board with sterilization tape During a concurrent interview with the IPN, she validated the observations and stated it was part of a construction project and needed to be removed. The IPN validated the construction tape was dirty and stated it was an infection control concern as adhesive cannot be terminally cleaned. Surveyor requested the P&P or national standard the facility followed for tape. During a concurrent observation and interview on 5/5/26 at 10:30 a.m., on Campus A, in the SPD clean workroom with the Director of Infection Prevention (DIP) and the Assistant Vice President of Infection Control (AVPIC), the DIP validated the construction tape was still stuck to the floor and steam sterilizer, was lifting , dirty and could not be cleaned. The DIP stated she used a checklist to monitor tape in the facility. Surveyor requested a copy of the checklist. No P&P or checklist indicating facilities procedure for tape use, tape cleaning and infection control was provided. A review of ANSI/AAMI “ST79: 2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities”, indicated “ ...3.3.5 General facility design requirements: All surfaces ... should be durable, smooth, and cleanable ... Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices ...” A review of AORN “Guidelines for Environmental Cleaning”, dated January 2020 indicated, “ ...terminal cleaning and disinfection of operating or procedure rooms be performed daily when these areas are in use. This process involves thorough cleaning of all surfaces and equipment to reduce the risk of infection ...” According to the Centers for Disease Control (CDC), undated, retrieved 10/10/2025 from Environmental Cleaning Procedures | HAIs | CDC titled “Environmental Cleaning Procedures” Indicated, “ ...The clean area (used for storing reprocessed equipment) should: Have shelves that are smooth, non-porous, and easy to clean. Be protected from water and soil, dirt, and dust ...” According to the Centers for Disease Control (CDC), undated, retrieved 5/4/26 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html indicated, “Microorganisms (a tiny living thing so small you need a microscope to see such as bacteria) have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface) ...” 2.b. During a concurrent observation and interview on 5/6/26 at 9:17 a.m., with the SPDIM 2, the DIP and the AVPIC, a red “do not cross” tape line separating the SPD clean workroom from the hallway was observed worn and ripped, exposing a dark gray, soiled underlying tape layer. The DIP validated the red tape was damaged, dirty and stated it needed to be replaced. The DIP tape and uneven surfaces were not cleanable and could harbor bacteria. The DIP stated the facility followed national standards, was unsure if a P&P addressed tape and stated she did use a rounding tool that addressed tape. No P&P or checklist indicating facilities procedure for tape use, tape cleaning and infection control was provided. A review of ANSI/AAMI “ST79: 2017 - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities”, indicated “ ...3.3.5 General facility design requirements: All surfaces ... should be durable, smooth, and cleanable ... Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices ...” A review of AORN “Guidelines for Environmental Cleaning”, dated January 2020 indicated, “ ...terminal cleaning and disinfection of operating or procedure rooms be performed daily when these areas are in use. This process involves thorough cleaning of all surfaces and equipment to reduce the risk of infection ...” According to the Centers for Disease Control (CDC), undated, retrieved 10/10/2025 from Environmental Cleaning Procedures | HAIs | CDC titled “Environmental Cleaning Procedures” Indicated, “ ...The clean area (used for storing reprocessed equipment) should: Have shelves that are smooth, non-porous, and easy to clean. Be protected from water and soil, dirt, and dust ...” According to the Centers for Disease Control (CDC), undated, retrieved 5/4/26 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html indicated, “Microorganisms (a tiny living thing so small you need a microscope to see such as bacteria) have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface) ...” The review of the facility’s P&P titled “Infection Prevention Plan, last revised 2/26 indicated, “ ...Authority Statement/Program Responsibility The Infection Prevention program is authorized by facility leadership to facilitate a functioning program, coordinating all activities related to the surveillance, prevention, and control of infections, including improvement of processes and outcome ...RELEVANT POLICIES AND PROCEDURES ...[name of facility] has written policies and procedures to guide its activities and methods for preventing and controlling the transmission of infections within the hospital and between the hospital ...The creation, implementation, and management of these policies is in collaboration with partner services lines (ex. Emergency Management, EVS ...Surgical Services ...) Reprocessing reusable medical devices DISINFECTION AND STERILIZATION - Central Service ...Policy/policies must address procedures to guide activities related to the following the hierarchy of resources for devise use, reprocessing, and/or preventing or controlling the transmission of infection including: applicable law and regulation, manufacturer’s instructions for use IFU’s), and nationally recognized evidence-based guidelines and standards of practice ...””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 39520 Based on observation, interview, and record review, the hospital failed to ensure surgical services were provided in a safe manner when surgical services policy and procedures for surgical protocols and practices were not followed when: 1. Enzymatic spray (specialized ready-to-use foams designed to immediately cover soiled surgical instruments which prevent bioburden [blood, tissue, mucus] from drying, it breaks down contaminants and protects the instruments from corrosion before they reach the decontamination area) not used at point of use (in the operating room). 2. Incorrect cleaning sequence for room turnover (cleaning, sanitizing, and preparing a room between patients in the operating room). 3. No hand hygiene after glove changes during room turnover. 4. Tape not removed from the operating room (OR) table during cleaning. 5. Lead aprons not cleaned after OR procedure. 6. Patient 900 and Patient 902 went under anesthesia and then the OR procedure was cancelled because of contaminated instruments. 7. A recall of sterile gowns and drapes was not reviewed by the environment of care committee. 8. Patient 901 had OR procedure with unsterilized instruments. 9. Patient 903 had an OR procedure with contaminated TEE probe (transesophageal echocardiogram-a special medical ultrasound attached to a thin flexible tube inserted through the mouth and into the throat to get detailed images of the heart). 10. Patient 904 had an OR procedure with contaminated instruments. The hospital failed to ensure the surgical services department met the needs of the patients, compromised the health and safety of patients, and had potential for surgical site infections (and possible death) when contaminated instruments were used in surgical cases. Findings: 1. During a concurrent observation and interview on 5/4/26 at 12:24 p.m. with the sterile processing department technician (SPD Tech 2), a dirty instrument tray (with visible blood on the instruments) was observed. SPD Tech 2 was asked if the dirty instrument tray was brought to the sterile processing department (SPD) from a surgical case. SPD Tech 2 verbalized yes, the instrument tray was brought from a surgical case and should have been cleaned and sprayed with an enzymatic spray prior to transporting to SPD. SPD Tech 2 verbalized the instrument trays should not have blood drying on the instruments. SPD Tech 2 verbalized the “Green Sheets” should be completed and signed by two OR personnel. The “Green Sheet” was observed and read in part ... “The instruments should be wiped clean using a sterile water-moistened sponge ...soiled instruments shall be placed on top of the towel, in the open position, and should be kept wet in the transport container by spray intended for this purpose ...” SPD Tech 2 verbalized some of the scrub technicians from the OR are not following the point of use cleaning instructions on the “Green Sheet” and are still signing that the tasks have been completed. SPD Tech 2 acknowledged grossly soiled (bloody) instrument trays should not be transported to SPD like that and should have point of use cleaning done. During a review of the facility’s policy and procedure (P&P) titled, “Handling and Transportation of Soiled Instruments” dated 1/24 , the P&P indicated in part ... “Definitions: Biofilm accumulated mass of bacteria and extracellular material that is tightly adhered to a surface and cannot be easily removed ...Gross Soil is organic material such as blood, tissue/bone or debris that accumulates on surgical instruments during the operative procedure ...Point-of-use (POU) Cleaning refers to the removal of gross soil from a device that occurs at the point of use, either periodically during the procedure or immediately after use ...Procedure ...From OR/Procedural Areas to SPD ...1. Preparation of contaminated instruments prior to transport to Central Sterile ...6. Saturate instruments generously with enzymatic cleaning solution ....” 2. During a concurrent observation and interview on 5/5/26, at 12:50 p.m., with an environmental services orderly (EVSO 1), in OR 1, during room turn-over, EVSO 1 started cleaning the outer part of the room and cleaned the tables and the stands. EVSO 1 then cleaned part of the OR bed (in center of the room dirtiest), then back up to clean the OR lights, then back down to clean bottom of the OR bed, then back up again to clean equipment, and then cleaned pillows that were on the OR bed. EVSO 1 was asked about the cleaning sequence of the room, EVSO 1 verbalized you should start from outer to inner, clean to dirty. EVSO 1 was informed his sequence went from outer to inner (clean to dirty) then dirty to clean, then back out to periphery (outer). EVSO 1 was also informed his cleaning sequence went from bottom to top (dirty to clean). EVSO 1 acknowledged the cleaning was not done from cleanest too dirtiest. During a review of the facility’s policy and procedure (P&P) titled, “Surgical and Operative Suites Cleaning Procedures”, dated 3/25, the P&P indicated in part ... “Cleaning of OR/Procedural room between procedures must be done with a facility approved EPA (Environmental Protection Agency)-registered disinfectant ...wipe from top-to-bottom and front to back ...” Review of the AORN website, Environmental Cleaning | AORN guidelines+ (aornguidelines.org) accessed on 5/5/26, indicated “Cleaning the least soiled areas before moving to the most soiled areas diminishes the likelihood of spreading contaminants from dirtier areas to cleaner surfaces. The room may be cleaned in a clockwise or counterclockwise direction in conjunction with clean-to-dirty and top-to-bottom methods. When mopping, progress from the cleanest to dirtiest areas of the floor. The center of the room, where most of the patient care occurs, is most likely to are higher levels of contamination.” 3. During a concurrent observation and interview on 5/5/26, at 12:54 p.m., with an environmental services orderly (EVSO 2) and the surgical services manager (SSM), in OR 1, during room turn-over, EVSO 2 was observed changing gloves multiple times without performing hand hygiene between glove changes. SSM acknowledged and confirmed EVSO 2 did not perform hand hygiene after glove changes. EVSO 2 was informed of not performing hand hygiene between glove changes and acknowledged that he should have. During a review of the facility’s policy and procedure (P&P) titled, “Hand Hygiene and Surgical Hand Scrub”, dated 3/26, the P&P indicated in part... “Hand Hygiene practices are the single most effective way to prevent the spread of infecting microorganisms, reduce cross-infection and self-infection, and provide a practice to promote health in daily living ...Procedure: A. Indications for Hand Antisepsis (either handwash or hand rub): ... 10. Decontaminate hands after removing gloves ...” 4. During a concurrent observation and interview, on 5/5/26, at 1:00 p.m., the surgical services manager (SSM) and the surgical services director (SSD), in OR 1, after room turn-over, the surgical bed had pieces of tape adhered to the mattress and bed frame, from the previous surgical procedure. The SSM and SSD both acknowledged and confirmed the surgical bed in operating room one had pieces of tape adhered to the mattress and frame. SSD verbalized that tape should not have been there, as it could not be cleaned (can harbor bacteria). A review of AORN “Guidelines for Environmental Cleaning”, dated January 2020 indicated, “ ...terminal cleaning and disinfection of operating or procedure rooms be performed daily when these areas are in use. This process involves thorough cleaning of all surfaces and equipment to reduce the risk of infection ...” According to the Centers for Disease Control (CDC), undated, retrieved 5/4/26 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html indicated, “Microorganisms (a tiny living thing so small you need a microscope to see such as bacteria) have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface) ...” 5. During a concurrent observation and interview, on 5/5/26, at 1:10 p.m., with the surgical services director (SSD), in OR 1, after room turn-over, two lead aprons were observed on chairs in OR 1 and had not been cleaned. When asked if the lead aprons are cleaned and then stored in the OR, the SSD verbalized the lead aprons are not stored in the OR, the lead aprons should have been cleaned and removed from the room. SSD verbalized the facility had a special cleaner for cleaning lead aprons. SSD acknowledged and confirmed the lead aprons should be cleaned after each use. During a review of the facility’s policy and procedure (P&P) titled, “Lead Apparel and Protective Devices”, dated 1/2025, the P&P indicated in part... “Cleaning: any lead apparel that appears visibly soiled will be cleaned with the approved lead apparel cleaner (Scrubbles). No unapproved cleaner shall be used on the apparel as it may cause damage or loss of integrity to the lead. Cleaning will occur during the time of annual inspection or any time the apparel is found to be visibly soiled ...” 6. During a review of Patient 900’s “History and Physical” (H&P), dated 2/12/26, the H&P indicated Patient 900 had history of diverticulitis (a painful condition that occurs when small bulging pouches in the lining of your large intestine become inflamed or infected) and elected to have a sigmoid colectomy (a surgical procedure to remove the lower section of the large intestine commonly performed to treat diverticulitis). During a review of Patient 900’s “Physician Clinical Note” dated 2/12/26, The note indicated in part...Patient 900 was prepped for surgery, taken back to the operating room, and given general anesthesia. The initial tray set up was deemed to be unusable ...at this point, instruments were brought from another hospital while the surgical team was awaiting to begin. The second tray was also deemed unusable. The case was decided to be canceled at this time ... During a review of Patient 900’s “Physician Clinical Note” dated 2/13/26, The note indicated in part...Two operative set-ups deemed contaminated: no other instruments available ... During a review of Patient 900’s “Anesthesia Record” dated 2/12/26, The record indicated in part ...Anesthesia start time 2:42 p.m., Patient 900 intubated (a breathing tube inserted into your airway) at 2:50 p.m., Patient 900 extubated (the breathing tube is removed from your airway) at 4:45 p.m., to the PACU (post anesthesia recovery unit) at 4:50 p.m., ... attempted robotic sigmoid colectomy ...case cancelled due to surgical instruments contaminated x two ... During a concurrent interview and record review on 5/4/26, at 4:15 p.m., with the anesthesiologist (Anesth 1), Patient 900’s medical record was reviewed. Anesth 1 was asked about Patient 900 and about the surgical procedure being cancelled. Anesth 1 verbalized was unable to remember all the details but remembers there was something wrong with the instruments and could not move forward with the case. When asked about instrumentation and room set up, Anesth 1 verbalized the room is set up before the patient gets moved to the operating room. When asked why Patient 900 received general anesthesia before the room was ready to go, Anesth 1 stated, “When I’m informed that the patient is ready to be taken to the OR, I’m under the assumption everything is ready to go. I have not been to any hospital where I have had to asked if instruments have been checked and are ready to go, that is not my job.” In review of Patient 900’s anesthesia record, Anesth 1 verbalized Patient 900 was intubated at about 2:50 p.m. and extubated around 4:45 p.m. Anesth 1 verbalized Patient 900 was under anesthesia for about an hour to an hour and a half. When asked if there are risks of being under anesthesia, Anesth 1 verbalized there are always risks when given anesthesia. Anesth 1 acknowledged if the operating room and instruments were ready, Patient 900 would not have received general anesthesia unnecessarily and further verbalized the instruments should have already been checked and ready to go. Anesth 1 verbalized the facility had been having issues with sterile processing of instruments over the last year. During an interview on 5/5/26, at 9:15 a.m., with a scrub technician (ST 2), ST 2 was asked about Patient 900 and about the surgical procedure being cancelled. ST 2 verbalized could not remember all the details but came into the operating room to help. ST 2 verbalized ST 5 and the operating room circulating nurse were having a debate about the instruments. ST 2 verbalized there was blood in the needle holder. ST 2 was asked about room set up and checking instruments. ST 2 verbalized when opening instrument trays there should be a two-person check. The first person (usually the circulating nurse) is checking the indicators making sure the instruments have been sterilized. The second person (usually the scrub tech) checks the instrument’s integrity and makes sure there is no contamination. ST 2 verbalized when going into the operating room to help, Patient 900 was already under anesthesia. ST 2 verbalized Patient 900 should not have been brought to the OR until the instruments were ready to go. During a review of Patient 902’s “History and Physical” (H&P), dated 2/4/26, the H&P indicated in part ...Patient 902 with past medical history of melanoma diagnosed on 2016 and treated with chemotherapy, was transferred from another hospital when found to have multiple brain masses ...Patient 902 elected to proceed with a craniotomy for tumor resection .... During a review of Patient 902’s “Anesthesia Record”, dated 2/4/26, The record indicated in part ...Anesthesia start time 1:23 p.m., Patient 902 intubated at 1:30 p.m., Patient 900 extubated (the breathing tube is removed from your airway) at 4:15 p.m., to the PACU (post anesthesia recovery unit) at 4:32 p.m., ... left frontal tumor removal craniotomy aborted ...equipment sterility issues ...MD 2 elected to abort ... During a review of Patient 902’s “Intraoperative Nursing Note”, dated 2/4/26, the Operative Note indicated in part ...Case aborted after anesthesia induction prior to surgery start ... During a review of Patient 902’s “Physician Clinical Note” dated 2/4/26, The note indicated in part...the OR not prepared for surgery on 2/4 so have to reschedule for 2/5 .... During an interview on 5/12/26, at 9:58 a.m., with a registered nurse (RN 4), RN 4 was asked about Patient 902 and about the surgical procedure being cancelled. RN 4 verbalized could not remember all the details and verbalized the case was cancelled because there were problems with the sterility of the instrument trays. RN 4 verbalized another tray was brought to the operating room by the interim Sterile Processing Department (SPD) manager and the instrument tray was wet. RN 4 verbalized the patient had already been put under anesthesia at this point. RN 4 was asked about room set up and checking instruments. RN 4 verbalized when opening trays, having two sets of eyes (two people) checking the indicators and the sterility of the instruments. RN 4 verbalized would not bring the patient to the OR until the room and instruments were ready. RN 4 verbalized before these incidents, the nurses and scrub techs did a verbal hand off for when the operating room and instruments were ready. RN 4 verbalized now we have a “Green Sheet” we document on for the two person check and hand off. RN 4 verbalized the scrub technician (ST 5) had filed an incident report about the instrumentation issues. During a concurrent interview and record review on 5/12/26, at 11:11 a.m., with the director of patient safety (DPS), the incident report involving Patient 902 was reviewed. DPS verbalized ST 5 had filed the incident report and indicated the instrument tray had possible bone fragment, Patient 902 had been intubated, the instrument tray was not sterilized. The instrument tray indicator strip did not pass, and sterility could not be verified. The physician (MD 2) did not want to continue with the case. DPS confirmed the timeline that Patient 902 had undergone anesthesia before confirming sterility of the instrument tray. The facility did not have a policy and procedure about opening the operating room and/or the induction of Anesthesia. The DPS verbalized the facility has a practice of the two-nurse verification “Green Sheet” audit tool. The facility “Green Sheet” was reviewed. The “Green Sheet” read in part ... “Pre-Validation: prior to the case proceeding the instrument sterility & integrity has been examined by 2 OR personnel ...” During a review of the facility’s policy and procedure (P&P) titled, “Disinfection and Sterilization”, dated 2/25, the P&P indicated in part ... “To ensure disinfection and sterility of instruments, supplies, and equipment are processed with steam or hydrogen gas...Procedure:..B. Sterilization or reduction CANNOT take place if an instrument has not been cleaned...C. Manual Cleaning must be completed according to manufacturer’s instructions for use (IFU), assuring that all bioburden has been removed prior to ultrasonic wash and washer decontaminator...Monitoring of Sterilization Process: A. Sterile Processing and the OR jointly monitor the following: 1. Sterilizer indicators...2. Sterilization tape...3. Dryness and integrity of supplies/packaging...” 40560 7. During an interview on 5/6/26, at 11:55 a.m., with the Director of Supply Chain (DSC), the DSC was asked about a recall of surgical gowns and drapes that were issued by the manufacturer on 1/6/26, due to possible sterility concerns of the products. The DSC verbalized the hospital removed the recalled gowns and drapes from patient use within a twenty-four-hour period. When asked if this recall was reviewed by the Environment of Care Committee (a group that oversees the physical environment, ensuring it is safe, functional, and complaint with regulatory standards for patients, staff, and visitors) the DSC verbalzied and confirmed it was not. During a review of the facility’s policy and procedure titled “Safe Medical Device Act (SMDA) and Product Recalls” dated 12/23, indicated in part “All defective product reports, product recalls and medical device hazards are reviewed by the Environment of Care Committee.” 8. During a review of PT 901’s “Emergency Provider Report” indicated on 1/7/26, PT 901 presented to the emergency room “Severe10/10 back pain.” During a review of PT 901’s “Operative Report” dated 1/8/26, indicated in part PT 901 underwent a surgical procedure performed by medical doctor (MD 5) at 00:59 of a Lumbar wound exploration, evacuation of hematoma (a localized collection of clotted or pooled blood that gathers outside of a blood vessel, usually caused by injury, trauma, or surgery) and complex multi-layered wound closure superficial muscle, fascia, deep subcutaneous tissue, superficial subcutaneous tissue and skin. During a review of PT 901’s “Clinical Event Note” dated 1/8/26, indicated in part “On 1/8/2026, I (MD 5) met with the patient (PT 901) ... at bedside accompanied by a member of the OR administration and a representative from hospital quality & patient safety. We discussed that earlier in the day I (MD 5) was made aware that one of the instrument trays used in the wound exploration and evacuation of hematoma surgery was not confirmed to have been sterilized. We discussed that additional investigation as to how it happened was ongoing.” During an interview on 5/6/26, at 2:41 p.m., with the Surgical Services Director (SSD), the SSD was asked how dirty instruments ended up being used on PT 901. The SSD verbalized the scrub technician (ST 3) and nurse circulator (RN 6) for the surgical case were not working together to ensure the sterility of instruments and both missed multiple opportunities to notice the dirty trays indicators (specialized strips, tags, or labels placed inside or on a surgical/instrument tray which verify that surgical instruments have successfully met the critical parameters (such as time, temperature, and sterilant penetration) required for sterilization. The facility “Green Sheet” was reviewed. The “Green Sheet” read in part ... “Pre-Validation: prior to the case proceeding the instrument sterility & integrity has been examined by 2 OR personnel ...” 9. During a review of PT 903’s “Surgery Invasive, Blood & Complex Procedure Consent” dated 1/15/26, indicated PT 903 consented for Medical Doctor (MD 3) to perform a “Transcatheter Aortic Valve Repair/Replacement (TAVR) - Possible Open Heart Surgery.” During a review of PT 903’s “Clinical Note” dated 1/16/26, indicated in part “Of note, after induction of anesthesia, a transesophageal echocardiogram probe was utilized for preoperative measurements and post deployment evaluations. The TEE (an imaging tool used during TAVR) was inserted atraumatically and initial images were obtained. Shortly thereafter, the anesthesia team was made aware that the probe used was not sterilized after its use with the previous patient. The probe was immediately removed and replaced with a clean probe. The proceduralist [MD 3] was notified of the mistake and the case proceeded uneventfully.” During a review of PT 903’s “Clinical Note” dated 1/19/26, indicated in part “Following the procedure on January 15, 2026. I (MD 3) immediately came over and spoke to the daughter and the son about the procedure and accidental placement of the TEE probe that was used in the prior patient.” During an interview on 5/6/26, at 2:41 p.m., with the Surgical Services Director (SSD), the SSD verbalized the dirty TEE probe from the previous case had been left in the operating room during room turnover (the rapid, highly coordinated process of preparing a surgical suite for a new patient immediately after the previous surgery finishes) and PT 903’s surgical team thought the dirty probe left in the room was clean. The SSD verbalized the previous cases circulator nurse should have removed the dirty TEE probe but had not. During a review of the facility’s policy and procedure (P&P) titled, “Surgical and Operative Suites Cleaning Procedures”, dated 3/25, the P&P indicated in part ... “Cleaning of OR/Procedural room between procedures must be done with a facility approved EPA (Environmental Protection Agency)-registered disinfectant ...4. Wash the O.R. table, turning table pads to clean all surfaces; overhead light and swing arms, video boom arm surfaces, and rolling furniture with germicidal solution...Surgery Suites...2. Remove all portable equipment from room...” 10. During a review of PT 904’s “Surgery Invasive, Blood & Complex Procedure Consent” dated 2/6/26, indicated PT 904 consented for Medical Doctor (MD 1) to perform a “Right Craniotomy clot evacuation and all related procedures.” During a review of PT 904’s “Neurosurgical Progress Note” dated 2/7/26, indicated in part “Tray (surgical tray containing surgical instruments) in OR (operating room) with possible contamination with eyelash. Turnover over 2 hrs (hours) explained to husband option of transfer to another hospital as we did not have back up craniotomy tray, he could like surgery done here, all risks explained of increased infection.” During an interview on 5/6/26, at 2:41 p.m., with the Surgical Services Director (SSD), the SSD verbalized the hospital should not have used a dirty surgical instrument on PT 904 and it was a negative event. The facility “Green Sheet” was reviewed. The “Green Sheet” read in part ... “Pre-Validation: prior to the case proceeding the instrument sterility & integrity has been examined by 2 OR personnel ...” During a review of the facility’s policy and procedure (P&P) titled, “Disinfection and Sterilization”, dated 2/25, the P&P indicated in part ... “To ensure disinfection and sterility of instruments, supplies, and equipment are processed with steam or hydrogen gas...Procedure:..B. Sterilization or reduction CANNOT take place if an instrument has not been cleaned...C. Manual Cleaning must be completed according to manufacturer’s instructions for use (IFU), assuring that all bioburden has been removed prior to ultrasonic wash and washer decontaminator...Monitoring of Sterilization Process: A. Sterile Processing and the OR jointly monitor the following: 1. Sterilizer indicators...2. Sterilization tape...3. Dryness and integrity of supplies/packaging...””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 39520 Based on observation, interview, and record review, the hospital’s Governing Body (GB) failed to assume full legal responsibility for implementing, and monitoring policies governing the hospital’s total operation, and providing the oversight for quality health care, in a safe environment as follows: 1.The hospital failed to meet the regulatory requirements for the Condition of Participation for Patient Rights as evidenced by the hospital’s inability to ensure the provision of quality health care in a safe environment while patient rights were protected. (Cross Reference Condition of Participation A-115). 2. The hospital failed to meet the regulatory requirements for the Condition of Participation for Nursing Services as evidenced by the hospital’s inability to ensure nursing care and services were provided in a safe manner when hospital policies and procedures (P&P) and standards of professional nursing practice were not followed. (Cross Reference Condition of Participation A-385). 3. The hospital failed to meet the regulatory requirements for the Condition of Participation for Pharmaceutical Services as evidenced by the hospital’s inability to provide safe pharmaceutical services when failing to follow policy and procedures, standards of practice, manufacturer’s instructions, and state regulations regarding the maintaining of pharmacy PAPRs (a powered air-purifying respirator, which is used where workers are exposed to airborne contaminants), the storage of patient’s own medications in the hospital’s Security Office, the administration of Amiodarone (a medication used to treat and prevent serious life-threatening abnormal heart rhythms given intravenous [in the vein]), regarding sterile compounding cleaning products, regarding the reordering or renewal of antibiotic medication orders, and regarding the hospital’s formulary. (Cross Reference Condition of Participation A-489). 4. The hospital failed to meet the regulatory requirements for the Condition of Participation for Food and Dietetic Services as evidenced by the hospitals inability to ensure the hospital’s food and nutrition services met the needs of the patients. (Cross Reference Condition of Participation A-618). 5. The hospital failed to meet the regulatory requirements for the Condition of Participation for Infection Prevention Control and Antibiotic stewardship as evidenced by the hospitals inability to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients. (Cross Reference Condition of Participation A-747). The cumulative outcome of these failures resulted in the Governing Body not ensuring the safety and quality of care provided for patients in the hospital.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 40560 Patient Rights COP A-115 Based on observation, interview, and record review, the facility failed to ensure patients received care in a safe setting and patient rights were protected and promoted when: 1. The facility failed to follow its policy process for grievance resolution. (Reference A-118). 2. The facility failed to update the communication/care board inside a patient’s room. (Reference A-129). 3. The facility failed to follow it’s policy and procedures for written and informed consents. (Reference A-131). 4. The facility failed to follow its policy and procedure pertaining to patient identification (Reference A-143). 5. The facility failed to ensure a resuscitation bag was on a crash cart. (Reference A-144). 6. The facility failed to remove expired supplies from an anesthesia cart, supply cart and pediatric cart. (Reference A-144). 7. The facility failed to follow its policy and procedure pertaining to patient restraints. (Reference A-184). The cumulative effects of these systemic problems resulted in the hospital’s inability to ensure the provision of quality health care in a safe environment while patient rights were protected.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 39520 Based on observation, interview, and record review, the hospital failed to ensure nursing services were provided in a safe manner, when hospital policies and procedures (P&P) and standards of practice were not followed when: 1. The facility failed to ensure care plans were developed for 2 of 57 sampled Patients (Patient 101 and Patient 503). These failures had the potential to compromise patient safety and cause a delay in treatment. (Cross Reference A-396). 2. The facility failed to ensure Patient 101 had continuous cardiac monitoring when on an Amiodarone IV Drip (a medication used to treat and prevent serious life-threatening abnormal heart rhythms given intravenous [in the vein]) and cardiac assessments while in the Emergency Department (ED). 3. The facility failed to ensure staff performed pain assessments and reassessments for 6 out 57 sampled patients (Patient 100 in the ED, Patient 102 on the mother/baby unit, Patient 103 in PACU (post anesthesia recovery unit) on labor and delivery unit, Patient 508 and Patient 509 on 3 medical, and Patient 706 on the orthopedic floor. 4. The facility failed to ensure staff performed vital signs per policy and procedure for Patient 706 on the orthopedic floor. 5. The facility failed to ensure staff labeled IV sites as per policy and procedure for (Patient 511- 3 Medical, Patient 502 - 3 Telemetry and Patient 514 - 3 Telemetry). These failures placed patients at risk of not receiving the appropriate nursing care and services, and had the potential to result in injury, harm, and jeopardized the quality of patient care. (Cross Reference A-398). 6. The facility failed to ensure that staff verified the use of patient owned medication while admitted in the hospital for 2 out of 57 sampled patients (Patient 512 and Patient 513). This facility failure had the potential for drug interactions that could harm the patient. (Cross Reference A-413). The cumulative effects of the hospital’s systematic failure to follow policy and procedures and standards of practice resulted in the hospital’s inability to ensure the provision of safe patient care.”

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 13095 Based on observation, interview, and record review the hospital failed to ensure that safe pharmaceutical services had been provided and that these services meet the needs of each patient as evidenced by: 1. The hospital failed to ensure that the hospital had implemented all of their policies and procedures regarding two Pharmacy PAPRs along with the manufacturer’s specifications for their use, to maintain record keeping, and to ensure that appropriate cleaning and servicing of these PAPRs had been completed for the safety of the Pharmacy staff who had used these devices. (Refer to A-491). 2. The hospital failed to ensure that the hospital had implemented all of their policies and procedures regarding the Storage of Patient’s Own Medications in the hospital’s Securtity Office including enviormental controls and in accordance with State regulations. The hospital also failed to follow the hospital’s “Guidelines For The Administration of I.V. Drugs” as well as the Manufacturer’s specifications for the administration of Amiodarone. (Refer to A-500). 3. The hospital failed to ensure that the hospital had implemented all of their policies and procedures regarding Sterile Compounding cleaning products and ensuring that all products which had been used/opened were withing date and on the hospital’s approved cleaning list. (Refer to A-505). 4. The hospital failed to ensure that the hospital had implemented all of their policies and procedures regarding the reordering or renewal of antibiotic medication orders and to ensure that Pharmacy had a Medical Executive Staff and Governing Body approved Protocol in place for doing this. (Refer to A-507). 5. The hospital failed to ensure that the hospital had implemented all of their policies and procedures regarding the hospital’s formulary medications and ensuring that the drugs on the hospital’s “Guidelines for the Administration of I.V. drugs”, matched the drugs on the hospital’s formulary. (Refer to A-511). The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality health care, in compliance with the Condition of Pharmaceutical Services.”

“FOOD AND DIETETIC SERVICES CFR(s): 482.28 The hospital must have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company may be found to meet this Condition of Participation if the company has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company maintains at least the minimum standards specified in this section and provides for constant liaison with the hospital medical staff for recommendations on dietetic policies affecting patient treatment. This Condition is not met as evidenced by: 27157 Based on observation, interview, and record review, the hospital did not meet the requirements for Conditions of Participation (CoPs), CFR (Code of Federal Regulations) 482.28 Food and Dietetic Services when the hospital failed to: 1. Ensure the Director of Food & Nutrition Service (DFNS) for the Main Campus, and Certified Dietary Manager (CDM) for Acute Rehabilitation Unit (ARU) East Campus effectively directed and provided oversight related to safe food handling and sanitary environment within the foodservice operation related to: (Cross Refer A-0620) a. Raw chicken was allowed to be stored in the refrigerator up to 5 days before cooking. The facility lacked a policy and procedure (P&P) on labeling and dating to guide staff on safe timeframe’s to store raw thawed chicken in the refrigerator. b. Multiple floor sink drains, floors and foodservice equipment were not maintained in a sanitary condition. There lacked proper air gaps for a walk-in refrigerator and ice-machine in the kitchen. c. There were ongoing issues with black colored substances on the ceiling above the high temperature dish machine where excessive steam was produced without prompt resolution to ensure sanitary conditions in the kitchen. In addition, the FSD did not ensure effective integration into the hospital wide infection control program. (Cross Refer A-0618, A-0619) d. There lacked consistent and clear standardized recipes and oversight to ensure standardized recipes were utilized and followed for accuracy and quality of pureed meals related to the correct texture, flavor and nutritive value. At the ARU East Campus located in the kitchen: e. Expired enteral feeding formula (delivery of liquid nutrition via oral route or via tube to the stomach and/or small intestine) was located in the emergency food supply storage room. f. There lacked proper air gap in front of walk-in refrigerator, and for the ice-machine’s located in the kitchen and on the 2nd floor nourishment room, sink floor drains in the kitchen and underneath the ice-machine’s located in the 1st and 2nd floor nourishment room were not clean, and the ice machine located in the kitchen and in the 2nd floor nourishment room was not maintained in a sanitary condition. At the main campus located on the three medical floor g. Expired enteral feeding formula was found inside the nourishment room located on three medical floor (specific area where patients are treated). 2. Ensure integration of Food and Nutrition Services (FANS) into the hospital-wide QAPI (Quality Assessment and Performance Improvement) and Infection Control Program (ICP). Facility failure to integrate FANS department into the hospital-wide QAPI and ICP could impede adequate resources from being allocated to a PI project to promote improved patient health outcomes, and/or decrease patient risks, complications and/or re-admission rates in a manner to sustain resolution of an identified concern. (Cross Refer A-0618, A-0619, A-0620, A-0621, A-0629) 3. The hospital’s FANS were not organized, directed and staffed in such a manner to ensure the nutritional needs of the patients were met in accordance with practitioners’ orders and acceptable standards of practice. (Cross Refer A-0618, A-0619, A-0621, A-0629) a. The Hospitality Director, Food and Nutrition (Food Service Director) job description did not require this position to be integrated into the hospital-wide QAPI and ICP. (Cross Refer A-0618, A-0619, A-0620) b. CMS CoPs for Food and Dietetic Services required the hospital to be in compliance with Federal and State licensure requirements for food and dietary personnel as well as food service standards, laws and regulations. The hospital allowed Registered Dietitian’s (RDs) to initiate oral nutrition supplements (ONS) for patient’s without any ONS being described as part of a diet order, within the parameters of the diet order, per the hospital’s diet manual, nor was criteria established for when RDs should initiate ONS and maximum quantity per day, which placed the RDs working out of their scope of practice per the California (CA) Business and Professions Code (BPC) 2586. (Cross Refer A-0618, A-0619, A-0630) c. One of one sampled patient (Patient 802) was provided 3-4 more ounces of fluid on his lunch meal tray than allowed per the Food and Nutrition Services department’s “Fluid Sheet (FS)” guidance. Clinical Nutrition Manager (CNM/RD) did not ensure the FS structure used by Diet Clerk’s who were responsible for checking patient menus to ensure foods and beverages selected corresponded with the 1,000 ml fluid restriction (per 24 hours) ordered for Patient 802 when pudding was not listed on FS as a fluid source. This failure could cause delayed healing of Patient 802’s exacerbation (worsening of) of CHF (congestive heart failure: the heart was not pumping blood effectively, leading to fluid buildup in the body). (Cross Refer A-0621) d. One of one sampled patient (Patient 805) with a latex allergy had not received nutrition education to ensure Patient 805 was aware of the potential for cross-reactivity (when an antibody reacts with a molecule that is similar to another molecule) with certain foods related to his latex allergy in order to be able to self-identify potential reactions from food in which he may want to be provided the opportunity to discuss further with RD and/or his doctor. This failure had the potential for Patient 805 latex allergy that may be associated with allergies to certain foods to go unrecognized and nutrition care plan needs unmet. (Cross Refer A-0621) e. The facility failed to ensure the non-select (menu served when a patient was not available to make their own selections) were consistently developed and implemented in accordance with the physician’s orders as defined in the hospital’s diet manual and/or Nutrition Care Manual (NCM) of the Academy of Nutrition and Dietetics (AND) in accordance with recognized dietary practices (Dietary Guidelines for Americans; Dietary Reference Intakes (DRIs), which include the RDA’s (Recommended Daily Allowances) for the following routinely ordered diets; Regular (House Diet), Cardiac (heart), Consistent Carbohydrate (CCHO for diabetes), Renal (kidney disease)/Dialysis (a medical procedure that removes waste products and excess fluid from the blood when the kidneys are unable to do so), Renal/CCHO, and Low Fat (< (less than) 50 gm (grams) of fat a day) diets. According to the hospital’s “Diet List (DL)”, dated 5/19/25, the “DL” indicated there were 77 patients on a regular house diet, there were 57 patients on a cardiac diet, there were 29 patients with a CCHO diet order, 5 patients on a renal/dialysis diet, and 3 patients on a renal/CCHO diet. Facility failure to consistently develop menus to ensure food served to patients for the house diet and therapeutic diets (a diet ordered as part of a treatment plan for a specific disease or condition) according to physician’s orders/diet manual and recognized dietary practices placed the patients at risk of nutritional and/or medical complications. (Cross Refer A-0629) f. Ensure Sufficient RD supervision of nutritional aspects of patient care when RDs scheduled follow-up dates to monitor high risk patients nutrition plan of care 5 days after an initial nutrition assessment despite being aware that patient’s nutritional needs were not being met for two of two sampled patient (Patient 800, Patient 801), with potential to affect further patients as that was the hospital’s approved structure which was not in accordance with current standards of practice. Facility failure to follow up on a high nutrition risk patient until 5 days after the initial nutrition assessment and while being aware a patient’s nutritional needs were not being met was not sufficient supervision by an RD over aspects of nutritional care to promote improved medical status and to help prevent and/or minimize complications, minimize length of stay and promote reduction of re-admission rates. (Cross Refer A-0618, A-0629) The cumulative effect of these systemic problems resulted in the inability of the hospital’s food and nutrition services to ensure the needs of the patients was met as required by the mandated Condition of Participation for Food and Dietetic Services. This had the potential to affect the hospital census of 313 highly susceptible patients. According to the FDA (Food and Drug Administration) Food Code 2022, “A “Highly susceptible population” means persons who are more likely than other people in the general population to experience foodborne disease because they are: (1) Immunocompromised; ... or older adults; and (2) Obtaining food at a facility that provides services such as...health care...hospital.””

“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: 39435 The Condition of Participation is not met as evidenced by: Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients, as evidenced by: 1. The hospital failed to provide effective infection control monitoring and surveillance for their Sterile Processing Department (SPD), a department where surgical instruments are cleaned, undergo sterilization, and are packing into surgical trays for procedures to be used for surgeries and procedures. Multiple surgical instruments had brown staining (Refer to A-0749 finding 1) 2. In the hospital sterile processing department, two (2) of 3 autoclaves (machines used to sterilize surgical instruments) had large amounts of brown staining within the chambers (the area inside the autoclave where trays of instruments are placed for sterilization). (Refer to A-0749 finding 2) 3. The floor of the Sterile Processing Department was not clean and maintained, with black marks, stains, caulking around the base boards and autoclaves, and multiple large patches of linoleum of differing colors. (Refer to A -0749 finding 3) 4. In the decontamination area of Sterile Processing dirty surgical instruments underwent manual cleaning that was not according to national guidelines from the American Association of Medical Instruments (AAMI) which guidelines the facility follows, and the Manufacturer’s Instructions for Use (MIFUs). (Refer to A-0749 finding 4) 5. In decontamination area, manual cleaning of used surgical instruments was not conducted in accordance with the MIFUs of the enzymatic cleaner, or the programmable Sin-Q enzymatic dispenser which displayed the correct amount to use (Refer to A-0749 finding 5) 6. In the Decontamination area the eye wash station was connected to the decontamination sink (where caustic chemicals are used). National standards require the eyewash station not be placed near the decontamination sinks (Refer to A-0749). 7. Failed to ensure autoclaves (machines used to sterilize patient reusable instruments according to manufacturer’s surgical instruments) were cleaned according to manufacturer’s instructions for use (IFUs) in the sub sterile rooms of the operating rooms (Ors) at the offsite campus surgical hospital. (Refer to A-0749). 8. Failed to ensure lead aprons integrity were intact in the OR at the offsite campus surgical hospital. (Refer to A-0749). 9. Failed to ensure clean patient care equipment was not stored in the soiled utility room in the post anesthesia care unit (PACU) at the offsite campus surgical hospital. (Refer to A-0749). 10. Failed to ensure infection control practices when hand hygiene was not performed before and after removing gloves in various areas of the hospital: in Emergency Department (ED), in the operating room (OR) during gastrointestinal (GI) procedure, and on the medical surgical units. When staff were drinking beverages in the patient care areas. (Refer to A-0749). These failures had the potential to result in negative patient care outcomes, cross contamination of equipment, the potential to spread harmful microorganisms to patients and staff, potential to result in procedural and surgical site infections and result in an increased for hospital acquired infections and illness. (Refer to A-0749). The cumulative effects of these systemic problems resulted in the hospital’s inability to provide an effective hospital wide infection control program. Resulting in the hospital’s inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control/Antibiotic Stewardship Program.”

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 51706 Based on interview and record review, the facility failed to follow their policy process for grievance resolution for one of one complainant (Patient 706). This failure had the potential to result in an inconsistent investigation of the grievance filed with the facility. Findings: During a review of the facility’s policy and procedure (P&P) titled, Patient Grievance and Complaint Management Model Policy, dated 3/2024, the P&P indicates in Section C. Grievance Resolution Process item 2. “Upon receipt of a grievance, the Director of Patient Safety shall confer with the appropriate department manager to review, investigate and resolve ...” During an interview on 5/28/2025 at 3:58 p.m. with the Chief of Medicine (CMO), the CMO stated, “[ Director of Patent Safety] oversees grievance...if issue is of clinical concern, 100% go to peer review committee...”. The CMO outlined the process where the Director of Patient Safety (DPS) reviews the chart, the DPS calls the director or manager who investigates and shares their findings, the MD involved is called if needed, DPS sends letter to complainant. CMO confirmed this is the expectation of the process and the P&P for grievance management dated 3/2024 is current and accurate. During an interview on 5/27/2025 at 4:02 p.m. with Nurse Manager of Medical Surgical Orthopedics (NMMSO), NMMSO stated “ by Tuesday afternoon (5/20/2025) evening...do not recall receiving anything, do not recall a phone call and did not participate in any meetings or discussion regarding a grievance (5/19/25)”. During an interview on 5/27/2025 at 4:05 p.m. with the nursing Director of Telemetry Medical/Surgical (DTMS), the DTMS stated she did not receive information regarding the grievance (5/19/25) and had not been invited to any discussion about a grievance. During an interview on 5/27/2025 at 3:15 pm with the Director of Patient Safety (DPS), the DPS stated the complainants receive a letter after grievance is reviewed by the manager. “I reviewed...I’m a nurse”.”

“PATIENT RIGHTS: EXERCISE OF RIGHTS CFR(s): 482.13(b) Patient Rights: Exercise of Rights This Standard is not met as evidenced by: 39912 Based on observation and interview, the facility failed to update the communication/care board inside the patient’s room. This facility failure had the potential for the patient not knowing the person taking care of her and the plan of care for the day. Finidings: During a concurrent observation and interview with the director of telemetry and medical/surgical (DTMS) in room 3153 at the 3 Medical unit on 5/19/25 at 3:40 pm, the care board in the patient’s room had the previous shift staff and care plan. The DTMS acknowledged the care board was not updated for the current shift. The facility pamphlet titled “Patient Rights And Responsibilities” indicated “The patient right to be informed of the names and function of all the physician and other health care professionals who are providing direct care of the patient.””

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 40560 Based on record review and interview, the facility failed to provide a patient (Patient 1) with physical therapy as indicated in PT 1’s plan of care. This failure had the potential for PT 1 to experience negative outcomes and a decline in functional mobility. Findings: During a concurrent record review and interview, on 5/20/25, beginning at 11:07 a.m., with the Quality Coordinator (QC 1) and Physical Therapist (PT 2), Patient1’s physical therapy records were reviewed. Patient 1’s physical therapy evaluation dated 8/6/24, indicated Patient 1 was to receive physical therapy at a frequency of five times a week for two weeks, beginning on 8/6/24. Patient 1’s physical therapy evaluation indicated the rehabilitation potential was good and would benefit from continued physical therapy for improved functional mobility to regain mobility and safety. Facility records indicated Patient 1 only received two of the scheduled five sessions of physical therapy during the first week. The PT 2 verbalized and confirmed the Patient 1 only received two physical therapy sessions the first week instead of the five planned physical therapy sessions and could not provide documentation indicting the remaining three physical therapy sessions were put on hold or canceled for Patient 1. During a concurrent record review and interview, on 5/20/25, at 2:50 p.m., with the Director of Rehab (DOR 2), Patient 1’s physical therapy records were reviewed. Patient 1 was reevaluated for physical therapy services on 8/20/24, with physical therapy ordered to be done daily. The 8/20/24 physical therapy evaluation indicated in part “Pt (Patient 1)...has prolonged hospital stay resulting in deconditioning and limiting mobility. Pt (Patient 1) has generalized weakness, decrease balance and activity tolerance requiring max assist for mobility and unable to progress to gait at this time. Pt (Patient 1) will benefit from further skilled therapy services.” The DOR 2 verbalized no documentation could be found indicating a rationale as to why Patient 1 did not receive physical therapy on 8/24/24 and 8/27/24. During a review of the facility’s policy and procedure titled “Rehabilitation Services - Physical Therapy Evaluation” dated 5/24, indicated in part “The Rehabilitation Services department is committed to providing a comprehensive physical therapy (PT) evaluation and treatment plan which is integrated into the patient’s interdisciplinary plan of care.””

“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: 39520 Based on interview and record review, the facility failed to follow their policy and procedures for written informed consents when the consent to have a scheduled repeat cesarean section (a surgical procedure used to deliver a baby through incisions in the mother’s abdomen and uterus) was incomplete and the consent to receive anesthesia was incomplete for one of 57 sampled patients (Patient 103). This facility failure had the potential risk of Patient 103 not having the right to make an informed decision and potential for not understanding the risks and benefits of the surgical and anesthesia procedures. Findings: During a concurrent interview and record review on 5/27/25, at 1:00 p.m., with the Director of Women & Children’s Department (DWC), Patient 103’s medical record was reviewed. The medical record indicated Patient 103 was admitted to labor and delivery on 5/20/25 for a scheduled repeat cesarean section. During a review of the cesarean section procedure consent and anesthesia consent, the signature page had a line for the operating physician to sign name and date, and it was left blank. The signature page read...”I have informed the patient or the patient’s representative of the nature, risk, alternatives and benefits of the above procedure” Upon further review, the signature page had a second line for the anesthesiologist physician to sign name and date, and it was left blank. The signature page read...”I have informed the patient or the patient’s representative of the nature, risk, alternatives of anesthetic agents or drugs” DWC acknowledged both the operating physician and anesthesiologists’ signature were missing from the written consent form and should be there. DWC further acknowledged the consent form was incomplete. During a review of the facility’s policy and procedure (P&P) titled, “Consents” dated 10/23, the P&P indicated in part...”8. Informed Consent: “Physician Responsibility: The physician is responsible for providing the patient or patients designated decision-maker with the information that is necessary to allow an “informed decision” to be made. The topics that must be addressed, at a minimum are: 8.1.1 The nature of the procedure, including other care, treatment or medications...8.1.2 The risks, complications and expected benefits of the procedure;...8.1.3 Reasonable alternatives and relevant risks, benefits and side effects related to such alternatives, including the possible results of not receiving care or treatment...8.3.1 The patient’s physician must document in the patient medical record that they have conveyed the information required for an informed decision. The informed consent attestation is documented after the physician has completed the assessment and physical exam of the patient prior to the procedure. If the “Authorization and Consent to Surgery, Care, Treatment, Special Diagnostics or Therapeutic Procedure” consent form has not been completed or the informed consent attestation is not documented in the medical record prior to the procedure, the nurse must contact the physician providing the service to obtain documentation...””

“PATIENT RIGHTS: PERSONAL PRIVACY CFR(s): 482.13(c)(1) The patient has the right to personal privacy. This Standard is not met as evidenced by: 39912 Based on observation and interview the facility failed to ensure patient identifier was only on the patient and not anywhere else as per policy and procedure. This facility failure had the potential for not identifying the patient correctly and a possible breach of patient privacy. Findings: During a tour of room 4116 at 4 Ortho, with the Director of Telemetry and Medical Surgical (DTMS) on 5/20/25 at 3:10 p.m., a patient identification with bar codes sticker was found stuck on the computer monitor at the patient’s room. During an interview on 5/20/25 at 3:13 p.m.,with the DTMS, the DTMS acknowledged the patient identifier should have not been left there. The facility policy and procedure titled “Patient Identification” dated 12/2024 indicated, “The patient must be wearing the identification band, bands taped to the bed or bedside table are not considered acceptable means of identification.””

“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: 40560 Based on observation, interview, and record review, the facility failed to provide care in a safe setting when: 1. Expired supplies were found in an operating room. 2. Expired supplies were found in a supply cart. 3. An expired pediatric Foley catheter was found in a pediatric cart. 4. Expired baby solution was found in a pediatric cart. 5. A resuscitation bag was missing was missing from a crash cart. These failures had the potential for expired products to be used on patients and had the potential to result in a delay of care during an emergency situation. Findings: 1. During a concurrent observation and interview, on 5/22/25, beginning at 9:52 a.m., with the Director of Surgical Services (DSS), operating room six located at Thousand Oaks Surgical Hospital, was toured. In the anesthesia cart were five expired BIS Quatro sensors (a sensor that measures brain activity in adult patients undergoing general anesthesia). Four of the sensors had an expiration date of 5/7/25, and one sensor had an expiration date of 1/22/25. The DSS verbalized and confirmed the five sensors in the anesthesia cart in operating room six were expired and needed to be discarded. Surveyor: CARNINE, JENNIFER 2. During a concurrent observation and interview on 5/19/25 at 11:45 a.m., with the Director of the Emergency Department (DED), during a tour of the ED, in the triage room, a supply cart was observed. The supply cart was observed to have several nasal culture swabs being stored, in a container, on top of the cart. The nasal swabs had expired on 5/16/25. The DED acknowledged the nasal swabs were expired, removed them from the cart, and acknowledged they would need to be replaced. DED further acknowledged supplies should not be used if expired. 39520 3. During a concurrent observation and interview on 5/19/25 at 12:10 p.m. with the Emergency Department Supervisor (EDS) in the Emergency Department (ED), an expired pediatric Foley catheter (urinary catheter) was found in the ED pediatric cart. The catheter label was observed with a ‘use by date’ of 10/19/24. The EDS confirmed and stated the catheter was expired and should not be in the pediatric cart. 4. During a concurrent observation and interview on 5/19/25 at 12:10 p.m. in the ED with the EDS, an expired Pedialyte baby solution was found in the ED pediatric cart. The Pedialyte label was observed a ‘use by date’ of 1 April 2025. The EDS confirmed the Pedialyte was expired and should not be in the pediatric cart. During a review of the facility’s policy and procedure (P&P) titled, “Labeling and Dating”, dated 11/20, the P&P indicated, “All outdated foods are discarded.” During a review of the facility’s policy and procedure (P&P) titled, “Managing Products with Expiration Dates” dated 3/05/21, the P&P indicated in part...”To communicate the process for managing warehouse/storeroom/pharmacy/POU including Pharmacy Pyxis/Omnicell that have expiration dating ...Supplies should be evaluated against expiration dates to ensure proper use of dated product is occurring so potential risk to the patients is lessened and product isn’t being wasted ...All expired merchandise (including intravenous solutions, kits with pharmaceuticals, other various medical devices, etc.) that is no longer saleable must be identified and expeditiously removed physically and systematically from the warehouse/storeroom/pharmacy/POU area (including Emergency Department Pediatric Cart) ...” 48380 5. During a concurrent observation and interview with the Telemetry Manager (TM) on 5/20/25 at 10:29 a.m., the crash cart was inspected and was missing an ambu bag/resuscitation bag (device used to deliver breaths to a patient who is having trouble breathing or is not breathing at all). The TM acknowledged the ambu bag was not on the crash cart and should have been. The facility policy titled “Cardiopulmonary Emergency Protocol” dated 7/24/24 indicated in part “...Crash carts restocking check list: Top of the cart, Cardiac Monitor/Defibrillator, Suction Machine with canister, Defibrillator Pads (x2), Electrodes, Paper for Cardiac Monitor (2 rolls in zip lock bag) Resuscitation Bag (1) with adult mask and Res-Q-Pod (1) inside bag (hooked to side of cart).” 39912”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(i) When restraint or seclusion is used, there must be documentation in the patient’s medical record of the following: The 1-hour face-to-face medical and behavioral evaluation if restraint or seclusion is used to manage violent or self-destructive behavior. This Standard is not met as evidenced by: 39912 Based on observation, interview and record review, the hospital failed to ensure two of 2 sampled patients (Patient 500 and Patient 505) observed with restraints, were being monitored in accordance with the hospital’s policy and procedure for restraints. This failure had the potential for unnecessary use of restraints. Findings: During an observation at 4 Surgical Unit with the Director of Telemetry and Medical/Surgical unit (DTMS) on 5/21/25 at 10:23 a.m., in room 4157, Patient 500 was observed in bed with eyes closed and had soft restraints on both arms. During a concurrent interview and record review with the DTMS on 5/21/25 at 10:28 a.m., the restraints documentation of safety, dignity and rights for non critical care log was reviewed. The log indicated there should be monitoring 3 times per hour. The log from 9 a.m. to 10 a.m. did not have a documentation of monitoring. The DTMS acknowledged that the nurse should have documented the monitoring of the restraints. During a review of Patient 505 health records on 5/22/25 at 10:50 a.m., Patient 505 had an order for restraints signed by the physician on 5/16/25. There was no evidence of documentation related to restraints assessment and/or monitoring and a care plan. During an interview with the Charge Nurse (CN) and intensive care nurse/rapid response Registered Nurse (RN 20) on 5/22/25 at 11 a.m., the CN and RN 20 acknowledged no documentation and care plan for restraints was completed. The facility policy and procedures titled “Restraint of Patients” dated. 7/21/21 indicated “Staff assess, monitor and reevaluate the patient regularly and release the patient from restraint when the criteria for release is met.””

“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: 27157 Based on observation, interview, and record review, the facility failed to ensure: 1. There was data collected to evaluate and review the hospital’s established time frames for Registered Dietitian (RD) follow-up for high nutrition risk patient’s to ensure provision of dietetic services were being provided in an effective manner to improve, and/or prevent or minimize nutritional decline when the standards of practice for initial follow up for a high risk patient was within 3 days per the American Society for Parenteral and Enteral Nutrition (ASPEN) dated 2022, and not within 5 days which was the hospital’s policy and procedure (P&P) for 2 of 2 sampled patients (Patient 800, Patient 801). (Cross Refer A-0629) 2. The hospital took action aimed at performance improvement when the Registered Dietitian’s had repeatedly informed nursing of ongoing lack of documentation of patients consumption of meals and nutrition interventions such as oral nutrition supplements (ONS, such as with one of one sampled patient (Patient 807) that impeded accuracy of assessment of nutritional intake as compared to a patient’s assessed needs that may warrant a revision in a patient’s nutrition plan of care before a potential negative outcome occurred. (Cross Refer A-0629) 3. The Food and Nutrition Services (FANS) department was integrated into the hospital wide Quality Assessment and Performance Improvement program, and effectively integrated into the hospital wide infection control program, appropriate to the scope and complexity of FANS department. (Cross Refer A- 0619, A-0620) Facility failure to put in place systems that promote early effective interventions and timely monitoring of interventions, and ensure nursing documented pertinent patient intake of meals and ONS data, placed the patient’s at risk for complications, delayed improvement in medical condition and/or increased risk for re-admission and further nutritional decline. Failure to ensure FANS department was integrated into the hospital-wide QAPI and Infection Control Program to include both foodservice operations and clinical nutrition services impeded effective data collection to identify gaps in effective FANS services related to high volume, high risk and problem prone areas that could improve patient outcomes to assist with appropriate allocated resources for the development of PI, and track performance to ensure that improvements are sustained. Findings: 1. During a concurrent interview and record review on 5/21/25 at 11:36 a.m. with Registered Dietitian (RD) 2, Patient 800’s “Nutrition Assessment (NA)”, dated 5/23/25 was reviewed. The “NA” indicated, “Nutrition Assessment trigger: Follow up Parenteral nutrition. Pertinent diagnosis: FTT [failure to thrive], frequent falls . . .Nutrition related history: 6/20: ST [speech therapy] - NPO [no food or drink allowed by mouth], 6/21: ST - Puree diet, moderately thick liquids by spoon, strict supervision. . .0% po intake today per pt [patient] husband, reports pt not awake enough for safe intake today. . .Starter PPN [peripheral parenteral nutrition] D10 [dextrose (sugar) 10% (percent) solution] 4.25%AA [amino acids -protein building blocks] @ [at] 40ml [milliliter]/hr [per hour]. . .Nutrition problem 1: Inadequate oral intake, acute illness, po intake < [less than] 25% x 5 days this admit, started on PPN. Nutrition Intervention: Texture modified diet per ST, Nutrition prescription: 1. Continue puree diet, moderately thick liquids per ST. . .Follow up Level: 1, Reassessment date: 5/28/25. RD 2 stated she had discussed her recommendation to start tube feeding (delivery of nutrients via a tube to the stomach) with Patient 800 but MD said no. RD 2 stated she left recommendations to advance the PPN to a goal rate to meet Patient 800’s nutritional needs in three days. RD 2 stated she was aware Patient 800 had eaten less than 25% po intake since admission five days earlier. RD 2 stated she had not seen any documentation by ST that trial puree diet had started yet and so she did not know how well Patient 800 would do with puree diet texture and ability to consume a sufficient amount to meet her nutritional needs, yet she scheduled an RD follow up appointment for 5 days later. RD 2 stated she was aware at that time that Patient 800’s nutritional needs continued to not be met since admission and that there was no new weight and that she had spoken with a nurse and requested Patient 800’s weight to be taken. RD 2 was asked how returning to Patient 800 in an additional 5 days was adequate RD supervision of her nutrition plan of care. RD 2 stated I documented a return date for 5/28/25 but I could see Patient 800 sooner “such as if I see RDs received a trigger for any skin issue for a patient”. RD 2 again stated she left recommendations on how to advance the PPN to an eventual goal rate in three more additional days, but acknowledged she would not know whether Patient 800 would do okay on puree diet, potentially could start eating better and perhaps the PPN could be discontinued, and an RD would not assess nutrition adequacy until 5 more additional days. FSD stated but RDs write notes that RD 2 could see or another RD could read and they have the ability to check in on those things before 5/28/25 scheduled follow up visit. RD 2 was asked if she had left notes in her office to herself and/or to other RDs requesting a quick check in on status of tolerating trial po intake with ST, or perhaps to check whether PPN was being advanced per her recommendation, and RD 2 stated, no. During a concurrent interview and record review on 5/21/25 at 12:00 p.m. with Registered Dietitian (RD) 2 in the presence of FSD, Patient 801’s NA, dated 5/14/25 was reviewed. RD 2 stated she was one day late completing this NA, as for a Level 1 nutrition risk the RDs had 48 hours to complete the NA. Patient 801’s NA indicated, “Nutrition Assessment trigger: Malnutrition screen, Pertinent diagnosis: Renal (kidney) Failure, 5/14 per reports - possible plans for renal biopsy today, pmhx (past medical history): lung cancer with brain mets (metastasized: spread to other parts of the body). . .CKD (chronic kidney disease). . .Pt reports decline in appetite with nausea for at least 2 months PTA (prior to admission), Nutrition Order: NPO for exam/procedure, Nutrition intake: NPO Day 2. . .last BM (bowel movement). . .weight kg: 67.273 (148 pounds [#]). . .Weight history: Per pt, ht [height] 67” [inches], UBW (usual body weight) -162#, reports weight loss to CBW (current body weight) 148 # (10% wt [weight] loss. . .Nutrition signs and symptoms 1: Weight loss 10% of UBW, po intake < 75% > 2 months PTA (prior to admission), , ***risk for sev PCM (severe protein calorie malnutrition), Nutrition problem 2: Inadequate oral intake, plans for biopsy today, NPO day 2, Nutrition Intervention 1: Recommend goal regular diet, initiation per MD. . .Nutrition prescription: 1. oral diet initiation post procedure per MD, recommend goal regular diet. Will monitor need for restriction [due to renal failure] when po >50% [when eating more than 50% of meals] consistently, 2. Will monitor need for supplements when diet initiated, Follow up Level 1, Reassessment date: 5/19/25.” RD 2 stated Patient 801 was NPO at that time and reported a weight loss of at least 10% of body weight prior to admission to the hospital, and reported a decline in appetite with nausea and no bowel movement for 2 days, and had lung cancer with mets known to increase nutritional needs. RD2 stated she made the RD nutrition assessment follow up scheduled on 5/19/26, five days later despite knowing Patient 801 had not had her nutritional needs met since admission, and despite RDs evaluation of Patient 801 being at severe risk for protein-calorie malnutrition (PCM) (PCM: a condition characterized by a deficiency of both protein and calories in the diet, leading to various clinical manifestations, including wasting. It can result from inadequate food intake, absorption problems, or increased nutrient requirements.). During a review of Nutrition Care Manual from the Academy of Nutrition and Dietetics titled, “Oncology: Nutrition Monitoring & Evaluation (ONM)”, dated 2022, the “ONM” indicated, “Meeting protein and energy needs is a primary goal for ensuring preservation of muscle mass, maintaining weight in patients with cancer and, ultimately, improving overall outcomes. Monitoring meal timing and frequency as well as total estimated energy, protein, and fluid intake is essential to determine diet adequacy and to further develop and modify nutrition interventions.” During a concurrent interview and record review on 5/22/25 at 4:25 p.m. with FSD, was asked whether following up 5 days after an RD identified a patient was not meeting their nutritional needs for a patient identified by the hospital’s nutrition screening process as being a high nutrition risk patient was in accordance with standards of care. FSD stated she had not collected data in order to analyze and evaluate whether nutrition recommendations that may be provided during the 5 day follow up nutrition assessment could have benefited the patient two to three days earlier. FSD stated the RDs wanted to follow up in 5 days. FSD stated she used NCM and ASPEN (American Society for Parenteral and Enteral Nutrition) as standards of practice to develop the facility’s nutrition care P&P. During an interview on 5/27/25 at 3:40 p.m. with Director of Regulatory (DOR), DOR stated the average length of patient stay in the hospital at the main campus was “4.94” days. During a review of Nutrition Care Manual (NCM) from Academy of Nutrition and Dietetics (AND), dated 2025, the NCM indicated time frames for rescreening and reassessments and follow-up should be based on average length of stay. During a review of ASPEN’s standards of care guidance titled “ASPEN Adult Nutrition Care Pathway (Age 18+ years) (ANCP)”, dated 9/14/22, the “ANCP” indicated once inadequate nutrient intake had been identified “Monitoring & Evaluation: Follow-up within 3 days, monitor parameters; tolerance of nutrient intake, oral intake including supplements, vitamins, minerals, anthropometric data (weight trends), functional status.” During a review of the facility’s policy and procedure (P&P) titled “Screening, Assessment and Reassessment”, dated 5/2024, the P&P indicated, “To identify patients at nutritional risk and develop a care plan to facilitate optimal patient outcomes. . .Attachment 3: Reassessment Guidelines: Level 1 Acute Care Within 5 Days. Compromised nutritional status or at high risk for nutrition related problems (may include but not limited to the following): 1. Patients receiving Enteral nutrition . . .malnourished patients not meeting >75% nutrient needs 2. Patients receiving TPN (total parenteral nutrition) or PPN, 3. NPO >5 days, 4. Nutrition education need identified and not completed. 5. Unintentional weight loss of >5% past month or >10% in 6 months, 6. Appetite loss resulting in decreased intake for the previous 5-7 days, and po intake <50% of nutrient needs, 7. Patients transitioning to oral feeding with poor tolerance/acceptance, 8. Patients with pressure ulcer(s) <75% nutrition needs, 9. Pertinent medical history affecting current hospitalization, Level 2 Acute Care Within 7 days- Moderate risk of compromised nutritional status (including but not limited to the following) 1. Primary or secondary diagnosis indicates possible nutrition risk, 2. Receiving additional nutritional support a. nourishment, b. oral supplement, 3. Patients stable on enteral feeding. . .4. Long term stabilized TPN patients. . .5. Patients with pressure ulcer(s) following protocol with PO intake meeting > greater than or equal to nutrition needs. Level 3 Acute Care Within 14 Days- No nutritional problems identified or anticipated. All previous nutrition problems have been addressed and are stable. . .” 2. During a concurrent interview and record review on 5/22/25 at 11:15 a.m. with RD 3 and FSD, Patient 807’s “Nutrition Assessment (NA)”, dated 5/18/25 was reviewed. The “NA” indicated, “NA trigger: Consult. . .Nutrition order: Regular diet, PO [by mouth]: no record. . .Provide Ensure (ONS) BID (two times a day)- encouraged pt [patient] to take. RD 3 stated she entered Ensure ONS one can for breakfast and one can for dinner into a software program located in the Food and Nutrition Services (FANS) department. RD 3 stated there was not an order from the doctor for ONS. RD3 and FSD acknowledged it would be challenging for the IDT (interdisciplinary team) to be aware of what and when ONS were scheduled for a patient to ensure oversight that it was provided and intake documented, and in which, had a physician known may have changed a plan of care. During a concurrent interview and record review on 5/22/25 at 11:21 a.m. with RD 3 and FSD, Patient 807’s electronic health record (EHR) under intake and output, dated 5/18/25 - 5/22/25 was reviewed. RD 3 stated the oral supplement line under the I & O (intake and output) screen was only documented one time by nursing on 5/19/25 at 11:59 p.m. that indicated Patient 807 consumed 240 ml of ONS. Both RD 3 and FSD stated the majority of the time nursing staff do not document percent consumption of meals or quantity consumed of ONS. FSD stated she had repeatedly spoken to nursing about this and explained the importance as it impacted accuracy of a nutrition assessment but had not seen any improvement. FSD stated she had not communicated the concern to the hospital’s QAPI program. During a review of AND’s NCM, dated 2025, NCM indicated a component of a nutrition assessment includes evaluation of “energy intake compared to estimated energy needs [individualized for the patient]” which then can accurately lead to a problem statement such as, “Inadequate oral intake, Inadequate energy intake, Malnutrition (undernutrition)” for the development of a nutrition care plan to include interventions to meet the gap of unmet nutritional intake. 3. During an observation on 5/19/25 at 3:30 p.m. in the kitchen with FSD, Executive Chef (EC), and Vice President of Operations (VPO), extensive steam was observed rising to the ceiling tiles from the dirty side of the high temperature (temp) dish machine. Seven large ceiling tiles above the high-temp dish machine were extensively discolored with black substances that posed a risk for cross-contamination. FSD and EC stated facilities would switch out the tiles here and there. During an interview on 5/22/25 at 4:25 p.m. with FSD, FSD stated she did not attend the hospital-wide QAPI (Quality Assessment [QA] and Performance Improvement [PI]) meetings, nor reported any FANS departmental PI projects to QAPI nor received any feedback on any data collection, tracking, trending and analyzing any departmental PI projects that focused on high risk, high volume and problem prone and could improve the outcomes of patient care. FSD stated she did attend nutrition support committee meetings but currently did not have any clinical nutrition PI projects in place, other than monitoring nutrition assessments to ensure they are coded accurately when malnutrition exists. FSD stated about a year ago she did a clinical nutrition care PI on tube fed patients (patients receiving nutrition through a tube) to ensure they received the tube feeding quantity of formula (liquid nutrition via a tube) as ordered, such as monitoring as to whether staff turned the pump back on timely when needing to turn off to provide patient care. FSD stated she did not report that PI to QAPI and receive feedback from QAPI for tracking, trending, and quality indicators for improved patient outcomes as a result. FSD stated currently she was working with the diet aides for PI to ensure accuracy of patient meal trays during trayline. FSD stated she has not tracked, trended and analyzed the data nor reported to any type of hospital wide QAPI meeting and had not been asked to do so. During an interview on 5/22/25 at 4:30 p.m. with FSD, FSD stated she did not attend any hospital wide infection control meetings. FSD stated she thinks EVS (Environmental Services) may do quarterly rounds in the kitchen but was not sure if it was an exact set schedule. FSD stated the hospital’s infection preventionist (IP) was present during the EVS rounds in the kitchen. FSD was asked if there were any identified concerns as a result of those EVS/IP audits in the foodservice operation or if she and/or IP initiated any performance improvement (PI) related to infection control concerns within the foodservice operation, and FSD stated, no. FSD was asked to provide the last three EVS/IP audits of the foodservice operation. During an interview on 5/27/25 at 11:28 a.m. with VPO, VPO stated he was unsure if FSD attended Quality Forum as part of the hospital-wide QAPI program. VPO stated FSD did attend “Care Experience Meetings” which was primarily based on Press Ganey (PG) scores which was a way of measuring patient satisfaction using surveys. VPO acknowledged that PG scores, although important, was not a method of data collection that would lend itself to identifying unsafe food handling and unsanitary conditions within the foodservice operation, nor identify any gaps in RD supervision over nutritional aspects of patient care that may not have been in accordance with standards of practice. During an interview on 5/27/25 at 11:53 a.m. with VPO and Director of Quality (DQ), DQ stated Quality Forum was attended by physicians, case management, critical care, nursing, respiratory (respiratory therapists working with patients to help with breathing), sepsis (microorganisms enter the bloodstream and trigger a systemic inflammatory response) coordinator and surgical departments. DQ stated the FANS department was not part of Quality Forum and verified the FANS department was not integrated into the hospital-wide QAPI program. DQ stated she was not aware FSD had a PI project for tube fed patients about a year ago related to nutrition care because the structure was for FANS departments to keep their projects within their department. (Cross Refer A-0283, A-0619) During a concurrent interview and record review on 5/27/25 at 3:10 p.m. with the VPO who had an oversight role per the hospital’s organization chart over the Food and Nutrition Services department, the above WO’s related to the ongoing black colored substances on the ceiling above the high temp dish machine were reviewed. In addition, the facility provided the previous two EVS/IP audits of the kitchen titled, “Infection Control Survey”, dated 10/25/24 at ARU East Campus, 11/22/24 at Main Campus, 1/24/25 at ARU East Campus, 2/7/25 at Main Campus, 4/25/25 at Main Campus, and 5/15/25 (location not specified on form), in which all areas on all of the above audits were marked “Department Compliance: 100%.” VPO stated the FANS department for both the main campus and the ARU East Campus were not effectively integrated into the hospital wide infection control program, as evidenced by the continuous unsanitary conditions in the dishmachine room that posed a risk for cross contamination and illness amongst staff and patients that went unidentified by the infection control program. During a review of the hospital’s “2025 Quality & Performance Improvement Plan (QAPI)”, the QAPI indicated, “Patient Safety Committee: The Committee provides leadership and oversight for organization-wide patient safety improvement activities and identifies and prioritizes system-wide opportunities to improve patient safety. The Patient Safety Committee reports to Quality Forum. . .The Patient Safety Committee is held at least bi-monthly. Patient Safety Committee membership includes but is not limited to: representatives from quality, pharmacy, lab, risk management, environmental health and safety, physicians and nursing. Departments, Divisions and Patient Care Units assess the quality of care provided in their areas (e.g., Patient Care Services, Ambulatory Care, Emergency Department, Rehabilitation, etc.). Departments, Divisions and Patient Care Units identify opportunities to improve patient care, and when requested provide a brief report to the Quality Forum or other committee on the status of performance improvement and safety projects utilizing the [name of hospital] quality improvement approach. They also report, when requested, at the Manager/Director meetings.” During a review of the hospital’s “Infection Prevention Plan (IPP)”, dated 4/25, the “IPP” indicated, “The hospital’s QAPI program addresses problems identified by the infection Prevention leader(s).””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 39912 Based on interview, and record review, the facility failed to ensure care plans were initiated in accordance with the facility’s policies and procedures (P&P) when: 1. No pain care plan initiated for Patient 503 2. No cardiac care plan initiated upon admission for Patient 101 These failures had the potential to compromise patient safety and cause a delay in treatment. Findings: 1. During a review of Patient 503’s health records on 5/21/25 at 12:21 p.m., Patient 503 had orders for pain medications (drugs used to treat pain) Tramadol 50 milligrams (mg) orally every 4 hours as necessary, Tramadol 75 mg orally as necessary and Hydromorphone 0.5 mg intravenously (IV). From 5/19/25 to 5/21/25 no care plan for pain was initiated. During an interview with the Director of Telemetry and Medical/Surgical (DTMS) on 5/21/25 at 12:43 p.m., the DMSO acknowledged a care plan was not initiated related to pain from 5/19/25 to 5/21/25. The facility policy and procedure titles “Plan For Provision Of Patient Care” dated 4/9/25 indicated in part, “...The care plan is dynamic and will reflect the constant and changing needs of the patient. Monitoring and evaluation of care will be continuous throughout the patients’ treatment. Modification of the Care Plan will address newly identified needs and outcomes achieved.” 39520 3. During a review of Patient 101’s “Emergency Room Notes” dated 5/19/25, at 6:35 a.m., the notes indicated Patient 101 came to the emergency department (ED) for irregular heartbeat and fast heart rate. The chief complaint was cardiac related. During a review of Patient 101’s “History and Physical” (H&P), dated 5/19/25, indicated on arrival to the ED, Patient 101 showed atrial fibrillation (a rapid irregular heart rate that commonly causes poor blood flow)with RVR(rapid ventricular response-a type of irregular heart rhythm where the upper chambers beat chaotically and irregularly and the lower chambers beat too quickly). During a review of Patient 101’s “Physician Orders”, dated 5/19/25 at 6:55 a.m., indicated to give Amiodarone 100 ml IV (a medication used to treat and prevent serious life-threatening abnormal heart rhythms given intravenous [in the vein]) bolus X 1 STAT (immediately). The orders further indicated to give Amiodarone 200 ml IV X 1 STAT as a continuous drip at 8:27 a.m. During a review of Patient 101’s “Physician Orders”, dated 5/19/25 at 8:53 a.m., indicated Patient 101 to be admitted for cardiac care to the telemetry monitoring floor. During a concurrent interview and record review on 5/22/25, at 4:15 p.m., with the Quality Coordinator (QC 2), Patient 101’s medical record was reviewed. Patient 101’s Cardiac Care Plan was initiated on 5/20/25 at 5:22 a.m. (21 hours and 31 minutes after the admission to telemetry for monitoring and cardiac care). QC 2 acknowledged the cardiac care plan should have been initiated sooner upon admission. When asked what the time frame is to initiate a patients care plan, QC 2 verbalized would have to refer to the care plan policy and acknowledged nursing staff should follow the policy for initiating care plans. During a review of the facility’s policy and procedure (P&P) titled, “Assessment/Reassessment of Patients” dated 1/2025, the P&P indicated in part,”...1.Various disciplines will share and provide information relevant to their scope of care by means of the interdisciplinary Plan of Care...C. Initial Screening/Assessment: 1. Each admitted patient’s initial assessment will be conducted within the time frames specified by established department specific assessment criteria based on the complexity and dynamics of care (See Appendix A) ...Appendix A: Telemetry: initial assessment upon admission...plan of care initiated within 4 hours of admission...plan of care evaluated every shift...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 39520 Based on observation, interview, and record review, the facility failed to ensure: 1. Patient 101 had continuous cardiac monitoring when on an Amiodarone IV Drip (a medication used to treat and prevent serious life-threatening abnormal heart rhythms given intravenous [in the vein]) in the Emergency Department (ED). 2. Staff performed cardiac assessments as per policy and procedure for Patient 101 while in the ED. 3. Staff performed pain assessments as per policy and procedure for Patient 100 in the ED, Patient 102 on the mother baby unit, and for Patient 103 in PACU (post anesthesia recovery unit) on labor and delivery unit. 4. Staff checked the adult and pediatric crash carts on the pediatric unit to safeguard against expired supplies and ensure it was ready for use during an emergency. 5. Staff performed pain assessments and reassessments as per policy and procedure for Patient 706 on the orthopedic floor. 6. Staff performed vital signs per policy and procedure for Patient 706 on the orthopedic floor. 7. Staff labeled IV sites as per policy and procedure for (Patient 511- 3 Medical, Patient 502 - 3 Telemetry and Patient 514 - 3 Telemetry) 8. Staff performed pain assessments and reassessments as per policy and procedure for (Patient 508, Patient 509) on 3 Medical These failures placed patients at risk of not receiving the appropriate nursing care and services, and had the potential to result in injury, harm, and jeopardized the quality of patient care. Findings: 1. During a review of the facility’s policy and procedure (P&P) titled, “Telemetry Monitoring” dated 2/2024, the P&P indicated in part...Patients being monitored on continuous telemetry will be observed by a telemetry technician or Registered Nurse (RN) who is competent in cardiac rhythm interpretation & arrhythmia (irregular heart beat) detection...Patients requiring telemetry will have their cardiac rhythm continuously monitored and documented every 4 hours and prn (as needed) with cardiac rhythm changes...application/initiation of monitoring and transfer to another unit...(Appendix B: Telemetry initiation workflow)...a. the RN/designee: I. Obtains a tele box from telemetry technician; if none are available in the unit ...ii attaches cables and places battery in the telemetry box, and log the box number in the units Tele tracking sheet...Appendix B-Telemetry Initiation Workflow: provider order for telemetry ...telemetry initiated within 30 minutes...telemetry applied by competent care giver...telemetry verified with monitor/telemetry technician: patient identification, room and bed number, and tele box number...documentation of telemetry start time in Meditech...” During a concurrent observation and interview on 5/19/25 at 12:35 p.m. with RN 9, in the ED, Patient 101 was observed to have an IV infusion of Amiodarone. RN 9 verbalized Patient 101 came into the ED with heart palpations and had an abnormal heart rhythm (atrial fibrillation-a rapid heart rate that commonly causes poor blood flow). When RN 9 was asked about continuously monitoring Patient 101’s heart rhythm, RN 9 verbalized Patient 101 was on a portable cardiac monitor but was only continuous if standing in front of the patient and observing. RN 9 verbalized having other patients at that time and could not always be watching the cardiac monitor and further verbalized there was no audible alarm on the cardiac portable monitor to alert RN 9 if something was wrong with patient. When asked about a heart monitor box that is used on patients, that transmits signal remotely to a central monitoring system, where technicians are continuously observing the heart rhythm, RN 9 verbalized the heart monitor box would need to be specific to the ED to show up on the centralized monitoring system. RN 9 further verbalized Patient 101 had been admitted to the telemetry unit for continuous heart monitoring but there were no beds on the telemetry unit so Patient 101 was holding (waiting for a bed) in the ED. During a review of the facility’s “Guidelines for the Administration of I.V. Drugs” dated 12/24 ...indicated in part...”Guidelines & Special Instructions...2. Monitor Blood Pressure & EKG (a test that records the electrical activity of the heart) for hypotension (low blood pressure) and arrhythmias (irregular heartbeat)...” During an interview on 5/19/25, at 12:47 p.m., with the Director of the Emergency Department (DED), the DED was asked about a patient being on an Amiodarone infusion and if the patient should have continuous cardiac monitoring, DED verbalized if the physician wrote an order for continuous monitoring, then yes, a patient on Amiodarone for atrial fibrillation should be continuously monitored. DED further verbalized it is best practice. DED verbalized having 15 remote heart monitoring boxes for the ED and Patient 101 should be on one. DED acknowledged Patient 101 was not on continuous cardiac monitoring and should be and further verbalized the rhythm should be assessed and documented in the patient’s medical record. During a review of Patient 101’s “Physician Orders”, dated 5/19/25 at 8:53 a.m., indicated Patient 101 to be admitted for cardiac care to the telemetry monitoring floor. During a review of the facility’s policy and procedure (P&P) titled, “Scope of Service Emergency and Trauma Departments” dated 4/9/25, the P&P indicated in part...”Depending on bed availability, patients may need to remain in the emergency department until a bed is available...Every attempt will be made to provide the appropriate level of care as determined by hospital policy...Patients admitted on telemetry will have the remote telemetry monitor applied prior to moving to the acute patient care room thus allowing the monitor technician to observe the patient in transit...” 2. During a review of Patient 101’s “Emergency Room Notes” dated 5/19/25, at 6:35 a.m. The notes indicated Patient 101 came to the emergency department (ED) for irregular heartbeat and fast heart rate. The chief complaint was cardiac related. During a review of Patient 101’s “History and Physical” (H&P), dated 5/19/25, indicated on arrival to the ED, Patient 101 showed atrial fibrillation (a rapid irregular heart rate that commonly causes poor blood flow)with RVR(rapid ventricular response-a type of irregular heart rhythm where the upper chambers beat chaotically and irregularly and the lower chambers beat too quickly). During a review of Patient 101’s “Physician Orders”, dated 5/19/25 at 8:53 a.m., indicated Patient 101 to be admitted for cardiac care to the telemetry monitoring floor. During a review of the facility’s policy and procedure (P&P) titled, “Telemetry Monitoring” dated 2/2024, the P&P indicated in part...Patients being monitored on continuous telemetry will be observed by a telemetry technician or Registered Nurse (RN) who is competent in cardiac rhythm interpretation & arrhythmia (irregular heart beat) detection...Patients requiring telemetry will have their cardiac rhythm continuously monitored and documented every 4 hours and prn (as needed) with cardiac rhythm changes... During a concurrent interview and record review on 5/22/25, at 4:00 p.m., with the quality coordinator (QC 2), Patient 101’s medical record was reviewed. Patient 101 had a cardiac rhythm assessment documented on 5/19/25 at 7:40 a.m., 8:30 a.m., 12:17 p.m., and 2:42 p.m. Upon further review of Patient 101’s medical record indicated there were no other cardiac rhythm assessments documented until the next day on 5/20/25 at 5:22 a.m. (14 hours and 40 minutes later). QC 2 acknowledged the cardiac rhythm assessments were not performed every 4 hours per policy and procedure and should be. 3. During a review of Patient 100’s “Emergency Room Notes” dated 5/11/25, at 4:11 a.m., the notes indicated Patient 100 came to the emergency department (ED) for rib and shoulder pain and pain was 6/10. The notes further indicated, at 7:20 a.m., Patient 100 complained that no one was taking care of her since she had arrived at the ED and had requested pain medication, however, wanted the order to come from her kidney doctor. During a review of Patient 100’s “Emergency Provider Report”, dated 5/11/25, at 4:11 a.m., indicated on arrival to the ED, Patient 100’s chief complaint of left shoulder and left rib pain. Patient 100 had similar episodes in the past and was usually managed with pain medication, denies injury to the area and pain had been bothering her for two days. Upon further review of Patient 100’s medical record, indicated there was no phone call or discussion with Patient 100’s kidney doctor, documented in the medical record. During a review of Patient 100’s “Physician Orders”, dated 5/11/25 indicated Patient 100 was ordered Norco 5/235 (a medication to relieve moderate to moderately severe pain) 1 tablet by mouth at 7:44 a.m. and a second order of Norco 5/235 1 tablet by mouth at 7:59 a.m., for pain management (3 hours and 33 minutes later), after Patient 100 arrived at the ED. During a concurrent interview and record review on 5/22/25, at 2:57 p.m. with the quality coordinator (QC 2), Patient 100’s medical record was reviewed. Patient 100’s electronic medication record (EMAR), dated 5/11/25, indicated Patient 100 received Norco 5/235 1 tablet at 7:53 a.m. and there was no pain assessment prior to giving this medication. The record indicated the last pain assessment was documented at 4:11 a.m. (3 hours and 42 minutes prior to giving pain medication). QC 2 acknowledged it had been over three hours since the first pain assessment and further acknowledged there was no pre-pain assessment prior to giving the first dose of Norco. Upon further review of Patient 100’s EMAR, Patient 100 received a second dose of Norco 5/235 1 tablet at 8:05 a.m. and the pain assessment indicated Patient 100 had a pain of 10/10 in the left shoulder. The record had no other documentation of a pain reassessment after receiving the second dose of Norco. QC 2 acknowledged there was no pain reassessment documented after the second dose of Norco and there should be. During a review of the facility’s policy and procedure (P&P) titled, “Pain Management” dated 4/2025, the P&P indicated in part...”H. Documentation: 1. Documentation of pain scores in a systematic and consistent manner is an important mechanism for identifying unrelieved pain. Pain assessment and reassessment is documented in the patient’s medical record...a. The patient’s pain rating prior to receiving pain medication and after the medication has taken effect will be documented in the medical record within one hour after pain medication administered ...b. Documentation will be included in the admission assessment, plan of care, interdisciplinary education and nursing progress notes when appropriate...” During a concurrent interview and record review on 5/27/27, at 11:45 a.m. with the Director of Women & Children’s Department (DWC), Patient 102’s medical record was reviewed. Patient 102’s medical record indicated the patient had a vaginal delivery on 5/20/25 at 8:27 p.m. Patient 102 had requested pain medication at 9:31 p.m. for head and neck pain and rated the pain 2/10. Patient 102’s medical record indicated she received Ibuprofen 600 mg (a medication to relieve pain) 1 tablet by mouth at 9:31 p.m. Upon further review there was no pain reassessment documented after Patient 102 received the Ibuprofen. DWC acknowledged there was no pain reassessment documented after receiving the Ibuprofen and there should have been. During a concurrent interview and record review on 5/27/27, at 11:50 a.m. with the DWC, Patient 102’s medical record was further reviewed. On 5/21/25, at 4:39 a.m., Patient 102 was complaining of severe pain in the anus and rated the pain 7/10. Patient 102’s medical record indicated she received Hydrocortisone 1% cream (is a steroid medication used to calm the body’s immune response to reduce pain, itching, and swelling) at 5:02 a.m. Upon further review there was no pain reassessment documented after Patient 102 received the Hydrocortisone cream. DWC acknowledged there was no pain reassessment documented after receiving the Hydrocortisone cream and there should have been. DWC acknowledged there should be pain assessments performed before and after a pain intervention. During a concurrent interview and record review on 5/27/27, at 12:30 p.m. with a registered nurse from labor & delivery (RN 11), Patient 103’s medical record was reviewed. Patient 103’s medical record indicated the patient had a scheduled cesarean section (a surgical procedure used to deliver a baby through incisions in the mother’s abdomen and uterus) on 5/20/25, the baby delivered, and Patient 103 went to PACU (post anesthesia recovery unit) for recovery on the labor and delivery unit. Patient 103 was in PACU at 9:23 a.m. to 11:11 a.m. RN 11 verbalized when patients are in recovery, they receive a full head to toe assessment, and vital signs are taken every 5 minutes, for one to two hours, or as needed. When asked if there should be a pain assessment documented in Patient 103’s PACU recovery record, RN 11 verbalized yes, there should be a pain assessment documented when the patient is in recovery. Upon further review, RN 11 acknowledged there was no pain assessment documented for Patient 103 when recovering in PACU and there should be. During a review of the facility’s policy and procedure (P&P) titled, “Vital Signs” dated 3/10/2025, the P&P indicated in part...”III. Policy Statement: Vital Signs include: 1. Blood pressure...2. Temperature...3. Pulse...4. Respirations...5. Oxygen Saturation-with the exception of women’s and children’s ... 6. Pain Assessment...D. Postoperative Surgical Patients: 1. Postoperative patients will have their vital signs taken immediately upon arrival to PACU... 2. PACU postoperative vital signs: a. Every five (5) minutes X 3...b. Every fifteen (15) minutes X 4...c. Every ½ hour X2...d. Every hour X 2...” 4. During an observation and concurrent interview on 5/20/25, at 2:46 p.m., with the director of women & children’s department (DWC), an initial tour of the Pediatric unit was conducted. An adult and a pediatric emergency crash cart (a wheeled container that carries medicine and equipment for use in life-saving emergencies) were observed and found to have a portable defibrillator (device that sends an electric pulse or shock to the heart to restore normal heartbeat), suction equipment, portable oxygen tank, supplies and medications, and an Ambu bag (a portable hand held device used for rescue breathing to ventilate patients who are struggling to breathe or have stopped breathing). The May 2025 “Crash Cart Control Sheet” located on top of the crash carts indicated the crash carts should be checked once a shift for operational readiness. Upon further review of the crash cart control sheets, nursing staff did not check the crash carts on, 5/19/25, on the day shift. DWC acknowledged the crash carts were not checked by the nursing staff on 5/19/25, on the dayshift, and should have been. During a review of the facility’s policy and procedure (P&P) titled, “Cardiopulmonary Emergency Protocol” dated 7/24/2024, the P&P indicated in part...”Every defibrillator is evaluated for operational readiness on a routine basis...D. Operational Readiness, Monitoring, and Maintenance of Crash Carts: 1. Crash carts will remain locked between uses to ensure integrity of medication and supplies...2. Crash carts will be checked by the designated unit personnel at least once a shift when the department is open for business. This check includes a. Lock integrity...b. the suction unit will be tested to ensure minimum vacuum of 40 mmHg ...c. The oxygen tank will be checked to ensure minimum volume of 1000 psi...” 51706 5. During an interview on 5/28/2025 at 11:22 a.m. with the Nursing Director of Telemetry Medical/Surgical (DTMS), the DTMS stated, “all reassessments for pain medication are to be documented in the Electronic Medication Administration Record (EMAR)”. During a review of the Patient 706’s EMAR dated 10/08/2024 to 10/13/2024, the EMAR orders for Percocet indicated, “PLS [Please] Document on MAR PRE & POST PAIN Assessment using PAIN SCALE: 0-10/10” (a pain assessment tool used to measure pain intensity by asking patients to rate their pain on a scale typically 0-10, zero usually represents no pain and 10 represents the worst pain imaginable). During a concurrent interview and record review on 5/28/2025 at 11:22 a.m. with the DTMS, Patient 706’s EMAR dated 10/08/2024 to 10/13/2024 was reviewed. The EMAR indicated, Percocet (a narcotic based pain medication) 1 tab was administered at: 0633 on 10/08/2024 for severe pain 8/10; no location 1726 on 10/13/2024 for severe pain 7/10 in back 2215 on 10/13/2024 for severe pain 7/10 in abdomen Nursing reassessment was not documented. The DTMS stated entries were not considered a reassessment and should have included a location and [numeric] intensity. During a review of the facility’s policy and procedure (P&P) titled, “Pain Management “dated 4/2025, the P&P indicated, in Section V. Procedure, Subsection B. Reassessment, Item 1. “Pain will routine be reassessed...after administration of pain medication”. 6. During a concurrent interview and record review on 5/28/2025 at 10:12 a.m., with the DTMS, Patient 706’s medical record, dated 10/12/2024 was reviewed. The medical record indicated a diastolic blood pressure (the second number in a blood pressure reading, measuring the pressure in your arteries-oxygenated blood vessels- when your heart is a rest between beats. A normal diastolic blood pressure is less than 80) of 102 without documentation of notification to the physician. The DTMS stated the nurse should “call the doctor if the diastolic is greater than 100”. The DTMS confirmed no notification to the doctor was documented. During a review of the facility’s P&P titled, “Vital Signs” dated 3/10/2025, the P&P indicated, In Section V. Routine Vital Signs, Subsection G. Abnormal Vital Signs, Item 1. “Abnormal vital signs...should be communicated to the physician and documented in the medical record”. 39912 7. During an observation in room 3154 at 3 Medical unit on 5/19/25 at 3:49 p.m., Patient 511 is bed. Patient 511 has an Intravenous (IV) access (the process of accessing the bloodstream through a vein to administer fluids, medications, or blood products) on the left hand. The IV access dressing had no date. During an interview with the Registered Nurse (RN 19) on 5/19/25 at 3:54 p.m., RN 19 acknowledged there should have been a date labeled/written on the IV access. During a concurrent observation and interview with the Director of Telemetry and Medical/Surgical unit (DTMS) in room 4111 at 4 Ortho unit on 5/20/25 at 3:15 p.m., Patient 502 was in bed with an IV access on the right forearm, the IV access does not have a date label. The DTMS acknowledged the IV site should have a date. During a concurrent observation and interview with the Director of Telemetry and Medical/Surgical unit (DTMS) in room 4108 on 5/20/25 at 3:26 p.m., Patient 514 was in bed and had a peripherally inserted central catheter (PICC line) (a long thin tube inserted into a vein in the arm, extending into a large vein near the heart, used for long term medication administration, fluid delivery, blood draws and other medical procedures) on the right upper arm. The PICC line does not have a date label on it. The DTMS acknowledged the PICC line should have a date. The facility policy and procedure titled “Venous Access Device Insertion, Maintenance, and Removal” dated 2/19/2025 indicates “Adult and pediatric venous access device (VAD) dressing changes should occur: i. Every 2 days for non transparent or gauze dressing. Ii. At least 7 days for transparent dressings.” 8. Review of Patient 508 health records with the charge nurse (CN 2) on 5/22/25 at 2:40 pm indicated, Patient 508 had an order for Oxycodone ( a narcotic drug used for pain relief) 5 mg every 4 hours by mouth as necessary for pain scale 4-6. Oxycodone was administered on 5/22/25 at 8:24 a.m. Pain reassessment was done on 11:24 a.m. The CN 2 stated pain reassessment should have been done 1 hour after pain medication administration. The facility policy and procedure titled “Pain Management” dated 4/2025 indicated, “The patients pain rating prior to receiving pain medication and after the medication has taken effect will be documented in the medical record within one hour after pain medication administered.” Review of Patient 509’s health record with the CN 2 on 5/22/25 at 2:49 p.m., indicated, Patient 509 was assessed to have a pain level of 5/10. There was no documentation of any interventions done. Review of the patients 508’s pain care plan did not show any interventions. During an interview on 5/22/25 at 3:58 with CN 2, CN2 stated if the pain level of the patient is 5/10 she would ask the patient if the patient wants to have pain medication. If the patient refuses, she would document it on the health records and would continue to reassess the patient’s pain. The CN 2 acknowledged that the pain care plan was incomplete. The facility policy and procedure titled “Pain Management” dated 4/2025 indicates “Pain will be assessed and treated promptly, effectively and for as long as pain persist. All patients will have individualized pain management plan that is based on the patient’s initial assessment.””

“SELF-ADMINISTRATION - DRUGS FROM HOME CFR(s): 482.23(c)(6)(ii) [The hospital may allow a patient (or his or her caregiver/support person where appropriate) to self -administer both hospital-issued medications and the patient’s own medications brought into the hospital, as defined and specified in the hospital’s policies and procedures.] (ii) If the hospital allows a patient to self-administer his or her own specific medications brought into the hospital, then the hospital must have policies and procedures in place to: (A) Ensure that a practitioner responsible for the care of the patient has issued an order, consistent with hospital policy, permitting self-administration of medications the patient brought into the hospital. (B) Assess the capacity of the patient (or the patient’s caregiver/support person where appropriate) to self-administer the specified medication(s) and also determine if the patient (or the patient’s caregiver/supplier person where appropriate) needs instruction in the safe and accurate administration of the specified medication(s). (C) Identify the specified medication(s) and visually evaluate the medication(s) for integrity. (D) Address the security of the medication(s) for each patient. (E) Document the administration of each medication, as reported by the patient (or the patient’s caregiver/support person where appropriate), in the patient’s medical record. This Standard is not met as evidenced by: 39912 Based on observation, interview, and record review the facility failed to verify the use of patients’ own medications while admitted in the hospital for two of 57 sampled patients (Patient 512 and Patient 513). This facility failure had the potential for drug interactions that could harm the patient. Findings: During a tour of telemetry unit with the Telemetry Manager (TM) on 5/20/25 at 10:52 a.m., Patient 512 was in bed in room 3107. At the bedside table, 3 bottles of eyedrops were observed. Patient 512 stated it was her own eyedrops and was using it. The eyedrops did not have a hospital pharmacy label. The TM acknowledged the eyedrops needed to be verified by the hospital pharmacy. During a tour of 4 Ortho with the Director of Telemetry and Medical Surgical (DTMS) on 5/20/25 at 3:15 p.m., Patient 513 was in bed in room 4116, at the bed side table was a Breo inhaler (used to treat asthma and chronic obstructive respiratory disease), a bottle of eyedrops and a tube of topical antibiotic ointment were observed. Patient 513 stated the medications belong to her and was using them. The DTMS acknowledged there were no hospital pharmacy labels on these medications. During an interview on 5/20/25 at 3:13 p.m. the Registered Nurse (RN18), RN18 acknowledged the patients’ medications observed at bedside have not been checked by the hospital’s pharmacy. The facility policy and procedure titled “Patients’ Own Medications” dated 8/2024 indicated that “...if the patient’s personal supply of medication is used, the pharmacist shall:...3. Affix to the container a label indicating verification and approval to use the patient’s own medication.””

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 13095 Based on inspection of the hospital’s pharmacy, interview with Pharmacy Administrative staff, interview with the hospital’s Director of Safety, and review of the PAPR’s manufacturer’s package insert information, the facility failed to ensure that the two PAPRs which had been assigned to the hospital’s Pharmacy, were in good working order, based on the PAPR’s manufacturer specifications. The hospital also failed to maintain a record of each time that the PAPR had been used, cleaned, and serviced and/or vital parts had been replaced. (A PAPR is defined as a powered air-purifying respirator, which is used where workers are exposed to airborne contaminants) Findings include: Inspection of the hospital’s Pharmacy on 5/21/2025 at 12:00 pm revealed a very dusty black bag that almost appeared to be gray in color. On the top of this dust covered bag was an open PAPR hood without a covering and without any employee’s name on the outside of the hood. Interview with the hospital’s Pharmacy Administrative Staff revealed that they were expecting Pharmacy Staff to store hoods/helmets for the PAPR inside of a reusable container for protection and that the user of the hood/helmet, put his or her name on the hood for identification. The hood that was found on top of the dusty black bag was not protected and did not have any user identifying information on it. Review of 3M’s Technical Bulletin dated 8/2020, which was provided by the hospital, read: “.....Cleaning: ...TR-600 should be cleaned regularly, (yet the hospital had no logs for regular cleanings). “Wipe Down Cleaning”: The outer surfaces of the TR-600 motor/blower assembly and battery pack (still attached) may be wiped with a soft cloth dampened in a solution of water and mild, PH neutral detergent (which the hospital had no record of doing)....See Table A for a list of tested cleaners and their effects”. Table B in the manufacturer’s package insert is a table of “Non-acceptable Cleaners/Disinfectants”, which includes: “Sani-Cloth AF3 Germicidal Disposable Wipe (Gray Top)”. On 5/21/2025 at 12:55 pm, the Pharmacy Administrative staff were asked to bring into their office, the product that staff had been using to clean the Pharmacy’s motor/blower assembly and battery packs. The Administrative Pharmacy staff brought in the Sani-Cloth AF3 (Gray Top) wipes indicating that this bottle of wipes had been stored on top of the PAPRs for cleaning, contrary to the Manufacturer’s Cleaning specifications. Again, the hospital’s Pharmacy had not developed a specific policy and procedure for the use of PAPRs in their area. Review of the hospital’s: “Aerosol Transmissible Disease”, policy dated 3/2025, reads under: “Storage, Maintenance, Repair”: “..2) Prior to use, inspect the tubes, airflow and battery life... 4) Label the PAPR Hoods with the Health Care Personnel (HCP) name, and discard when hood ....5) Disinfect the hood, hose, belt, and filter/battery housing with appropriate hospital approved disinfectant wipe after each use.” All of which the hospital’s Pharmacy failed to keep record of. Additional review of 3M’s Technical Bulletin entitled: “Inspection, Cleaning and Storage Procedures for 3M Versaflo”, dated 8/2020 read: “ ...Note: Gasket should be replaced every 30 uses or yearly, whichever comes first, to minimize use of worn gaskets ... “Plug gaskets should be replaced every 30 uses or yearly, whichever comes first, to minimize use of worn gaskets”. The hospital’s Pharmacy and the hospital’s Director of Safety failed to keep or provide any documentation/evidence that these gaskets had been changed since the hospital’s original purchase date of the two PAPR machines in 5/2019 (6 years ago). Further review of the 3M Technical Bulletin #221, entitled: “Conducting Airflow Check on 3M Versaflo PAPR TR-600”, dated 9/2014, read: “ ....While the TR-600 is pre-calibrated to help ensure required airflow, the 3M Airflow Indicator TR-971 should be used to verify that the minimum required airflow is attained prior to each day’s use ...Airflow check: Must be conducted before each day’s use”. Yet the hospital was unable to provide any documentation that the TR-971 had been used prior to each day’s use, as outlined above.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 13095 Based upon inspection of the hospital’s Patient Own Medication storage area (at the hospital’s Security Office), inspection of the Patient Own Medications stored inside the Security Office’s safe, review of the Patient’s Own Medication, interview with the hospital’s Security Supervisor, interview with the Pharmacy’s Administrative Staff, and review of the hospital’s policies and procedures, the hospital failed to ensure that: 1) Patient’s Own Medications were overseen and monitored by the hospital’s Pharmacy, in accordance with the hospital’s policies and procedures and California State Regulations. 2) The hospital also failed to ensure that they followed the hospital’s: “Guidelines For The Administration Of I.V. Drugs”, and the manufacturer’s specification regarding obtaining a baseline Thyroid function test prior to the administration of Amiodarone. Findings include: 1) Inspection of the hospital’s Security office on 5/22/2025 at 3:45 pm revealed that all controlled and non-controlled Patient’s Own Medications were being stored at the Security office (next to the hospital’s main lobby), inside of a safe, which only Security staff had the combination to. Additional inspection of this safe and the hospital’s Security Office revealed that these Patient Own medications had not been stored in compliance with the hospital’s policy and procedure entitled: “Storage of Medications and Temperature Monitoring”, dated: “3/2023, read: “Medications shall be stored under the proper conditions of sanitation, temperature, light, moisture, ventilation, organization, segregation, safety, and security ....Storage conditions utilized shall assure that the integrity, stability, and effectiveness of medications are maintained.” The Security Office had no system to monitor the medications storage environment as outlined in the hospital’s medication storage policy and procedure above. Interview with the Pharmacy’s Administrative staff on 5/22/2025 at 4:30 pm confirmed that this safe with Patient Own medications had not had Pharmacy oversight or monitoring for at least the last 6 months. Review of the hospital’s policy and procedure entitled: “Patient Own Medications” dated: “8/2024”, helped confirm Pharmacy’s oversight failure of these medications. The hospital’s policy and procedure read: “ ...If the patient or family doesn’t pick up the medications (Patient’s Own Medications) within 30 days of discharge, medication shall be documented and destroyed in cactus sink with a 2nd witness in Pharmacy.” Inspection and review of the Security’s Office Patient Own medication log (which was entitled: “L R Hospital Medical Center Valuables Log”, revealed numerous Patient Own Medication supplies which were still inside the safe even though several patients had already been discharged from the hospital. Examples of this include: 1) an unsampled patient’s own medications had been placed into the Security Office’s safe on 9/15/2024 at 5:16 am by Security. This unsampled patient had been discharged from the hospital on 9/17/2024 (two days later), but their medications remained inside the Security safe until 5/22/2025 (a total of 247 days after this patient’s discharge from the hospital), without these medications being destroyed within 30 days after the patient’s discharge. 2) a second unsampled patient’s own medications had been placed into the Security Office’s safe on 9/15/2024 at 1:40 am by Security. This second unsampled patient had been discharged from the hospital on 10/3/2024 (a total of 231 days after this patient’s discharge from the hospital), without these medications being destroyed within 30 days after the patient’s discharge. 3) a third unsampled patient’s own medications had been placed into the Security Office’s safe on 10/26/2024 at 7:38 pm by Security. This second unsampled patient had been discharged from the hospital on 1/2/2025 (a total of 140 days after this patient’s discharge from the hospital), without these medications being destroyed within 30 days after the patient’s discharge, as outlined above. 4) a fourth unsampled patient’s own medications had been placed into the Security Office’s safe on 10/23/2024 at 1:51am by Security. This second unsampled patient had been discharged from the hospital on 3/19/2025 (a total of 64 days after this patient’s discharge from the hospital), without these medications being destroyed within 30 days after the patient’s discharge, as outlined above. 5) a fifth unsampled patient’s own medications had been placed into the Security Office’s safe on 11/26/2024 at 1:21 am by Security. This second unsampled patient had been discharged from the hospital on 1/10/2025 (a total of 132 days after this patient’s discharge from the hospital), without these medications being destroyed within 30 days after the patient’s discharge, as outlined above. 6) a sixth unsampled patient’s own medications had been placed into the Security Office’s safe on 12/25/2024 at 6:39 pm by Security. This second unsampled patient had been discharged from the hospital on 12/26/2024 (a total of 147 days after this patient’s discharge from the hospital), without these medications being destroyed within 30 days after the patient’s discharge, as outlined above. Interview with Hospital Administrative staff on 5/22/2025 confirmed that the hospital’s Security is a contracted service for the hospital. Review of the hospital’s Security contract revealed that Security had nothing in their contract or in Security’s job description which allowed the hospital’s Security to independently handle, and store both controlled and non-controlled drugs. Review of the hospital’s policy and procedure entitled: “Security of Medications”, dated: 8/2024, read: “All medications shall be stored securely in accordance with State and Federal Regulations and ensure access only by authorized individuals ...Accepted secure storage locations include: Automated Dispensing Machine Cabinet (ADC), Medication Refrigerator, Pneumatic Tube, Medication Room, and Tamper-evident Bag (in the pharmacy) ....Access to medication storage areas is restricted to these authorized hospital staff: Physicians, Dentists, Podiatrists, Nurses, Physician Assistants, Pharmacists, Pharmacy Technicians, Physical Therapists, Respiratory Therapists, CNA’s (who administer medications within the Scope of their Practice), ED (Emergency Room) Technicians, Licensed Radiologic Technicians, Licensed Nuclear Medicine Technicians”. Security was not listed as an “Authorized individual”, who should have had access to medications as outlined in the hospital’s policy and procedure above. Review of the hospital’s policy and procedure entitled: “Patient Valuables, Belongings, Essentials, and Lost And Found”, dated 9/2024, read: “...2) Responsibility of Security Staff ...Labeled medications should be taken to the Pharmacy”, contrary to Security staff’s practice above. Authorized personnel having access and the act of taking labeled medications to Pharmacy for storage, is consistent with California State Regulations which reads: “A Pharmacist shall have overall responsibility for the pharmaceutical service. He shall be responsible for the procurement, storage and distribution of all drugs ....”. 2) Review of the clinical record for Patient 901 on 5/27/2025 4:00pm revealed that this patient received a Bolus dose of Amiodarone on 4/20/2025 and this patient was started on a continuous Amiodarone drip on 4/23/2025 at 2:34 pm. Review of Patient 901’s medical record revealed that this patient did not have a baseline TSH level prior to starting the Amiodarone as outlined in the hospital’s “Guidelines For The Administration Of I.V. Drugs” and as specified in the Drug Manufacturer’s Package insert. Review of the hospital’s: “Guidelines For The Administration Of I.V. Drugs”, under the hospital’s: “Guidelines & Special Instructions” section, dated 2/2025, reads: “...2 Monitor BP & EKG for hypotension, arrythmias, QTc prolongation, Torsade’s de Pontes, and periodically for LFTs, pulmonary status and thyroid function.” Additional review of the multiple package inserts provided by the hospital’s Pharmacy for CORDARONE’s (Amiodarone) including the one provided by Wyeth Pharmaceuticals, dated: October 2018 read: “5.6 Thyroid Abnormalities CORDARONE (Amiodarone) inhibits peripheral conversion of thyroxine (T4) to triiodothyronine (T3) and may cause increased thyroxine levels, decreased T3 levels, and increased levels of inactive reverse T3 (rT3) in clinically euthyroid patients. CORDARONE can cause either hypothyroidism (reported in up to 10% of patients) or hyperthyroidism (occurring in about 2% of patients). Monitor thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction.” Again, no baseline TSH level had been obtained prior to the start of this patient’s Amiodarone drip. The hospital’s Pharmacy Administrative staff reached out to Patient 901’s physician to see if he had a TSH level prior to starting the Amiodarone drip only to find out that the patient’s physician did not have a recent baseline TSH level for this patient.”

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 13095 Based on inspection of the hospital’s Pharmacy, interview with Pharmacy Administrative staff, and inspection of hospital Pharmacy’s clean room cleaning products, the hospital failed to ensure that unauthorized/unapproved and expired products were not available for cleaning in the Pharmacy’s Sterile Compounding area. Findings include: During an inspection of the hospital’s Pharmacy on 5/27/2025 at 10:45 am, the Administrative Pharmacy staff were asked to bring out the cleaning supplies which were currently being used in the Pharmacy’s Sterile Compounding area. These supplies had been placed inside of a blue carrying bin. Inspection of the blue bin revealed one opened bottle of “Preempt RTU”. Preempt RTU, is a ready to use one step disinfectant and cleaner which uses an Accelerated Hydrogen Peroxide technology. Inspection of the bottle revealed a manufacturer’s expiration date of 1/2025, with an open bottle date written by the user of 5/14/2025. The bottle open date indicated that this product had been opened 4 ½ months after this product had been officially expired. During a concurrent interview with the hospital’s Director of Pharmacy, the Director of Pharmacy indicated that “Preempt RTU”, has not been used by the Pharmacy in almost 1 year and that someone must have pulled this product from the Pharmacy’s stock room by mistake. The Pharmacy Director went on to say, that the “Preempt RTU” bottles were no longer approved by the Pharmacy for cleaning in the Pharmacy’s Sterile Compounding areas. When the Pharmacy Administrative staff were asked, who had opened and had been using the “Preempt RTU”, the Pharmacy Administrative staff indicated that they did not know. Pharmacy Administrative staff indicated that they would have to get back to me with an answer, but Pharmacy Administration staff never followed up on this question.”

“STOP-ORDERS FOR DRUGS CFR(s): 482.25(b)(5) §482.25(b)(5) - Drugs and biologicals not specifically prescribed as to time or number of doses must automatically be stopped after a reasonable time that is predetermined by the medical staff. This Standard is not met as evidenced by: 13095 Based on clinical record review, interview with Pharmacy Administrative staff regarding antibiotics, and review of the hospital’s “Automatic Stop Orders” policy and procedure, revealed that the hospital’s Pharmacy staff had failed to write extension or renewal medication orders for antibiotics, inside of the resident 902’s clinical record. Findings include: Review of the hospital’s “Automatic Stop Order” policy and procedure, dated 4/2025, read: “ ...Purpose A. To establish and implement procedures that assures the safe and effective use of medications. B. To assure that only current drug and treatment orders shall be available, to prevent action on obsolete orders, and to establish limits on the duration of orders in the absence of specific prescriber’s orders. C. To implement procedures that are compliant with applicable regulation and accreditation standards ...The Hospital shall limit the duration of medication therapy in the absence of the prescriber’s specific indication of duration of medication therapy ...B. Upon renewing the medication order by the provider, the Pharmacist will review and verify the order ...” Review of the clinical record for Patient 902 on 5/28/2025 at 3:20 pm revealed that Ceftriaxone (Rocephin) 2 grams I.V. (intravenous) had been originally ordered every 24 hours for this patient from 4/10/2025 to 4/15/2025, yet a closer review of Patient 902’s clinical record revealed that this patient’s Ceftriaxone had been extended to 4/17/2025 and then this order had been extended again from 4/17/2025 to 4/20/2025. For both of these extensions regarding the Rocephin, there was no Physician or Pharmacist’s order in the Patient’s medical record for this medication (an antibiotic) to be extended for the additional 5 days. Concurrent interview with the hospital’s Pharmacy Administrative staff revealed that the hospital’s Governing Body and the hospital’s Medical Staff had not created or approved a protocol for the Pharmacy staff to write orders or renew orders for antibiotics in the patient’s medical record. Concurrent interview with the hospital’s Pharmacy Director on 5/28/2025, she confirmed that the hospital’s Medical Executive Committee and the hospital’s Governing had not approved any protocol for the hospital’s Pharmacists to renew a medication order without writing an renewal order in the patient’s medical record, so that all hospital professional staff would know how and who had extended these antibiotic orders for this patient.”

“FORMULARY SYSTEM CFR(s): 482.25(b)(9) A formulary system must be established by the medical staff to assure quality pharmaceuticals at reasonable costs. This Standard is not met as evidenced by: 13095 Based on review of the hospital’s “Guidelines for the Administration of I.V. Drugs”, interview with Pharmacy Administrative Staff, review of the hospital’s Drug Formulary, and review of the hospital’s policy and procedure entitled: “Formulary of Medications”, the hospital failed to ensure that both the hospital’s 1) “Guidelines for the Administration of I.V. Drugs”, 2) the hospital’s policies and procedures had been followed and 3) the hospital’s Drug Formulary all had matching information, in order to reduce/eliminate any confusion for the hospital’s professional staff. Findings include: Review of a very small sample of medications from the hospital’s: “Guidelines for the Administration of I.V. Drugs” revealed that their list contained multiple drugs which were not on the hospital’s drug formulary, such as: 1) Aciximab (Reopro), which is used to prevent blood clots from forming, 2) Alemtuzumab (Campath), which is used as a protein designed to recognize and bind to (for example cancer cells), 3) Asparaqinase, L- Asparaqinase (Elspar), which is used for the treatment of cancer, and 4) Caspofungin (Cancidas), which is used to treat fungal patient who have developed fungus. Only 15 pages of the hospital’s 73 page “Guidelines for the Administration of I.V. Drugs”, which contained information such as: “Location & restrictions, guidelines and special instructions etc.” which had been revised by the hospital in 12/2024 (less than 6 months ago), and approved by the hospital’s Medical Executive Committee (MEC) were reviewed. The four drugs above were just a sample of the medications which had been identified as drugs which were not presently on the hospital’s drug formulary. Further review of the “Guidelines for the Administration of I.V. Drugs” additional 58 pages would have resulted in the identification of additional drugs which were on the hospital’s “Guidelines for the Administration of I.V. Drugs” but were not found on the hospital’s drug formulary. Review of the hospital’s policy and procedure entitled: “Formulary of Medications”, which was dated: “9/2022, read: “4. The Formulary of Medications shall be the list of pharmaceuticals ....These are medications which shall be routinely available for use in the Hospital ....These medications are listed in the Formulary of Medications as those maintained and available in the Hospital.” Based on interview with the hospital’s Pharmacy Administrative staff and review of the hospital’s: “Guidelines for the Administration of I.V. Drugs”, the hospital’s Pharmacy and Therapeutics (P&T) had developed, reviewed and approved this hospital’s guideline to assist professional staff with the: “safe administration of drug and biologicals”, as outlined in the hospital’s “Formulary of Medications” policy and procedure. Further interview with the hospital’s Pharmacy Administrative staff on 5/20/2025 at 2:35 pm revealed that Pharmacy Administrative staff at the hospital had never done a review comparing the drugs which were on the hospital’s: “Guidelines for the Administration of I.V. Drugs” to the approved list of hospital Formulary Medications, prior to the survey.”

“ORGANIZATION CFR(s): 482.28(a) Organization This Standard is not met as evidenced by: 27157 Based on interview, and record review, the hospital failed to ensure the organization of Food & Nutrition Services department (FANS) was structured in a manner to ensure CMS (Centers for Medicare & Medicaid Services) Condition of Participation (CoP): Food and Dietetic Services would be implemented as required when: 1. The Hospitality Director, Food and Nutrition (Food Service Director) job description did not require this position, and the Food and Nutrition Services department as a whole, to be integrated into the hospital-wide QAPI (Quality Assessment and Performance Improvement) and Infection Control Programs. Facility failure to integrate FANS department into the hospital-wide QAPI and Infection Control Program could impede adequate resources from being allocated to a PI project to promote improved patient health outcomes, and/or decrease patient risks, complications and/or re-admission rates in a manner to sustain resolution of an identified concern. (Cross Refer A-0618, A-0620) 2. CMS CoP for Food and Dietetic Services requires the hospital to be in compliance with Federal and State licensure requirements for food and dietary personnel as well as food service standards, laws and regulations. Registered Dietitian’s (RDs) were allowed to initiate oral nutrition supplements (ONS) for patient’s without any definition of use of supplements within the parameters of the diet order per the diet manual, nor was criteria established for when RDs should initiate ONS, which placed the RDs working out of their legal scope of practice per the California (CA) Business and Professions Code (BPC) 2586. Facility failure to ensure the FSD and FANS department was integrated into the hospital-wide QAPI and Infection Control Program and to ensure nutritional care was provided by RDs within their scope of practice per CA BPC and without effective physician oversight due to lack of structure and communicationed, patients were placed at potential risk of not of unmet care needs. Findings: 1. During an interview on 5/22/25 at 4:25 p.m. with FSD, FSD stated she did not attend the hospital-wide QAPI (Quality Assessment [QA] and Performance Improvement [PI]) meetings, nor reported any FANS departmental PI projects to QAPI nor received any feedback on any data collection, tracking, trending and analyzing any departmental PI projects that focused on high risk, high volume and problem prone and could improve the outcomes of patient care. FSD stated she did attend nutrition support committee meetings but currently did not have any clinical nutrition PI projects in place, other than monitoring nutrition assessments to ensure they are coded accurately when malnutrition exists. FSD stated about a year ago she did a clinical nutrition care PI on tube fed patients (patients receiving nutrition through a tube) to ensure they received the tube feeding quantity of formula (liquid nutrition via a tube) as ordered, such as monitoring as to whether staff turned the pump back on timely when needing to turn off to provide patient care. FSD stated she did not report that PI to QAPI and receive feedback from QAPI for tracking, trending, and quality indicators for improved patient outcomes as a result. FSD stated currently she was working with the diet aides for PI to ensure accuracy of patient meal trays during trayline. FSD stated she has not tracked, trended and analyzed the data nor reported to any type of hospital wide QAPI meeting and had not been asked to do so. During an interview on 5/27/25 at 11:28 a.m. with VPO, VPO stated he was unsure if FSD attended Quality Forum as part of the hospital-wide QAPI program. VPO stated FSD did attend “Care Experience Meetings” which was primarily based on Press Ganey (PG) scores which was a way of measuring patient satisfaction using surveys. VPO acknowledged that PG scores, although important, was not a method of data collection that would lend itself to identifying unsafe food handling and unsanitary conditions within the foodservice operation, nor identify any gaps in RD supervision over nutritional aspects of patient care that may not have been in accordance with standards of practice. During an interview on 5/27/25 at 11:53 a.m. with VPO and Director of Quality (DQ), DQ stated Quality Forum was attended by physicians, case management, critical care, nursing, respiratory (respiratory therapists working with patients to help with breathing), sepsis (microorganisms enter the bloodstream and trigger a systemic inflammatory response) coordinator and surgical departments. DQ stated the FANS department was not part of Quality Forum and verified the FANS department was not integrated into the hospital-wide QAPI program. DQ stated she was not aware FSD had a PI project for tube fed patients about a year ago related to nutrition care because the structure was for FANS departments to keep their projects within their department. (Cross Refer A-0283) During a review of the hospital’s “2025 Quality & Performance Improvement Plan (QAPI)”, the QAPI indicated, “Patient Safety Committee: The Committee provides leadership and oversight for organization-wide patient safety improvement activities and identifies and prioritizes system-wide opportunities to improve patient safety. The Patient Safety Committee reports to Quality Forum. . .The Patient Safety Committee is held at least bi-monthly. Patient Safety Committee membership includes but is not limited to: representatives from quality, pharmacy, lab, risk management, environmental health and safety, physicians and nursing. Departments, Divisions and Patient Care Units assess the quality of care provided in their areas (e.g., Patient Care Services, Ambulatory Care, Emergency Department, Rehabilitation, etc.). Departments, Divisions and Patient Care Units identify opportunities to improve patient care, and when requested provide a brief report to the Quality Forum or other committee on the status of performance improvement and safety projects utilizing the [name of hospital] quality improvement approach. They also report, when requested, at the Manager/Director meetings.” During a review of the hospital’s “Infection Prevention Plan (IPP)”, dated 4/25, the “IPP” indicated, “The hospital’s QAPI program addresses problems identified by the infection Prevention leader(s).” During a review of the facility’s job description (JD) titled, “Hospitality Director, Food and Nutrition (FSD)”, dated 11/25/2024, the JD did not indicate a requirement for the FSD to participate in the hospital-wide QAPI program and hospital wide Infection Control Program. 2. During a concurrent observation and interview on 5/19/25 at 12:17 p.m. with FSD in the kitchen, oral nutrition supplements (ONS) were observed being placed on multiple patients meal trays. FSD stated Registered Dietitian’s (RDs) could initiate ONS for patients based on their nutrition assessments. During a concurrent interview and record review on 5/21/25 at 11:36 a.m. with RD 3, RD 3 stated when RDs initiate ONS the RD will enter the ONS in a software that was only used in the Food and Nutrition Services department and the software did not interface with the medical record. RD 3 was asked how a physician would know what ONS and how often a patient may be receiving one since RD 3 stated it would not appear under a patient’s orders. RD 3 stated a physician could read the RDs nutrition assessment, but RD 3 also stated they most often follow up on a patient 5 days later. During an interview on 5/22/25 at 11:39 a.m. with RD 1, RD 1 stated RDs were not given any criteria that needed to be present in order to initiate ONS for a patient. RD 1 stated she could provide Glucerna or Ensure Max to a patient with diabetes on a CCHO (consistent carbohydrate) diet who was eating 80 percent of their meals per patient request, which would be in addition to their CCHO diet. RD 1 stated she would document that in her nutrition notes in a patient’s electronic health record and enter the ONS in the software located in the FANS department. During an interview on 5/22/25 at 2:50 p.m. with Chief Medical Officer (CMO), CMO stated the medical staff did not grant order writing privileges to RDs as that was not allowed per CA (California) BPC that dictates scope of practice for RDs working in Ca. CMO stated it was the hospital’s intention to have the RDs have the capability to initiate ONS within the parameters of the diet order. CMO verified the definitions of the various diet orders located in the hospital’s diet manual did not include ONS within the parameters of the diet order, and CMO stated, we need to work on improving the system to ensure RDs are able to utilize their expertise but still work within their scope of practice in CA. ,”

“DIRECTOR OF DIETARY SERVICES CFR(s): 482.28(a)(1) The hospital must have a full-time employee who- (i) Serves as director of the food and dietetic services; (ii) Is responsible for daily management of the dietary services; and (iii) Is qualified by experience or training. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure the Food Service Director/Registered Dietitian (FSD/RD) at the main campus and the Certified Dietary Manager (CDM) at the Acute Rehabilitation Unit (ARU) East Campus provided effective daily oversight of the Food and Nutrition Services (FANS) department as there were unsafe food handling and unsanitary conditions when: At the main campus located in the kitchen: 1. Raw chicken was allowed to be stored in the refrigerator up to 5 days before cooking. The facility lacked a policy and procedure (P&P) on labeling and dating to guide staff on safe timeframe’s to store raw thawed chicken in the refrigerator. 2. Multiple floor sink drains, floors and foodservice equipment were not maintained in a sanitary condition. There lacked proper air gaps for a walk-in refrigerator and ice-machine in the kitchen. 3. There were ongoing issues with black colored substances on the ceiling above the high temperature dish machine where excessive steam was produced without prompt resolution to ensure sanitary conditions in the kitchen. In addition, the FSD did not ensure effective integration into the hospital wide infection control program. (Cross Refer A-0618, A-0619) 4. There lacked consistent and clear standardized recipes and oversight to ensure standardized recipes were utilized and followed for accuracy and quality of pureed meals related to the correct texture, flavor and nutritive value. At the ARU East Campus located in the kitchen: 5. Expired enteral feeding formula (delivery of liquid nutrition via oral route or via tube to the stomach and/or small intestine) was located in the emergency food supply storage room. 6. There lacked proper air gap in front of walk-in refrigerator, and for the ice-machine’s located in the kitchen and on the 2nd floor nourishment room, sink floor drains in the kitchen and underneath the ice-machine’s located in the 1st and 2nd floor nourishment room were not clean, and the ice machine located in the kitchen and in the 2nd floor nourishment room was not maintained in a sanitary condition. At the main campus located on the three medical floor 7. Expired enteral feeding formula was found inside the nourishment room located on three medical floor (specific area where patients are treated). 8. The FSD, and CDM, did not ensure performance improvement projects were in place appropriate to the scope and complexity of the food service operations nor integrated into the hospital wide Quality Assessment and Performance Improvement (QAPI) program and hospital wide Infection Control Program. (Cross Refer A-0618 and A-0619, A-0621, A-0629) These failures had the potential to cause foodborne illnesses in a medically vulnerable patient population who consumed food prepared from the kitchen, and had the potential for their nutritional needs to go unmet. Findings: In the kitchen at the main campus: 1. During a review of the Food and Drug Administration Food Code Annex (FDAFCA), dated 2022, the “FDAFCA” indicated, “Freezing prevents microbial growth in foods, but usually does not destroy all microorganisms. Improper thawing provides an opportunity for surviving bacteria to grow to harmful numbers and/or produce toxins.” (3-501.13) During a review of “FoodSafety.Gov (FSG)”, dated 9/19/2023, the “FSG” indicated, “. . .for storing food in the refrigerator. . .short time limits. . .will help keep them from spoiling or becoming dangerous to eat. . .fresh [raw] poultry: chicken whole or chicken pieces 1 to 2 days.” (https://www.foodsafety.gov/food-safety-charts/cold-food-storage-charts) During a concurrent observation and interview on 5/19/25 at 11:30 a.m. with FSD in the kitchen, inside the walk-in refrigerator was a pan of raw chicken labeled to be used within 5 days of refrigeration. The FSD stated the labeling was pre-programmed into their label gun and confirmed the label allowed for the raw chicken to be stored in its thawed state for up to 5 days before being cooked. FSD stated the facility did not have a P&P on labeling and dating to guide staff on “use by” date for safe food handling related to storage of raw chicken in the refrigerator. 2. During a concurrent observation and interview on 5/19/25 at 11:35 a.m. with FSD in the kitchen, a drain that appeared similar to a wide trench drain grate had an extensive build up of debris that was located in front of a walk-in refrigerator. FSD stated the drain was not maintained in a sanitary condition. During a concurrent observation and interview on 5/19/25 at 12:16 p.m. with FSD in the kitchen, a build up of dust was observed on the ceiling of the walk-in refrigerator. FSD stated the ceiling of the refrigerator needed to be cleaned as it was not sanitary. During a concurrent observation and interview on 5/19/25 at 12:22 p.m. with FSD and EC in the kitchen, a build up of black colored debris and/or grime was observed on the floors around the stove range and fryer baskets covered with grease was stored on a shelf next to the stove range. EC stated they no longer used the fryer baskets but did not have anywhere to put them. EC verified the floor and the unused fryer baskets had an accumulation of debris and/or grime and food residue and was not sanitary. During a review of the Food and Drug Administration Food Code (FDAFC), dated 2022, the FDAFC indicated, “The equipment food-contact surfaces and utensils must be clean to sight and touch, the food-contact surfaces of cooking equipment and pans shall be kept free of encrusted grease deposits and other soil accumulations; and the nonfood-contact surface of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris.” (4-601.11) During a review of the FDAFCA, dated 2022, the FDAFCA indicated, “The objective of cleaning focuses on the need to remove organic matter from foodcontact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.” (4-601.11) During a concurrent observation and interview on 5/19/25 at 12:23 p.m. with FSD and EC in the kitchen, the drainage pipes for a refrigerator and ice-machine were observed to lack a proper air gap for backflow prevention. EC stated the drainage pipes needed to be elevated to allow at least a one inch air gap from the drainage pipe and the rim of the floor sink drains. When a P&P was requested, the facility provided a document, dated 5/20/25 at 12:07 p.m., the document indicated, “UPC [Uniform Plumbing Code] air gap requirements California- Google Search, What is the California code for air gap? 114193.1. An air gap between the water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and may not be less than one inch.” During a review of the FDAFC, dated 2022, the FDAFC indicated, “An air gap between water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and may not be less than 25 mm [millimeter] (one inch).” (5-202.13) During a review of the FDAFCA, dated 2022, the FDAFCA indicated, “During periods of extraordinary demand, drinking water systems may develop negative pressure in portions of the system. If a connection exists between the system and a source of contaminated water during times of negative pressure, contaminated water may be drawn into and foul the entire system.” (5-202.13) During a review of “Food and Nutrition Services #22 Sanitation Tech Daily Job Routine Week 3 (JR)”, dated 5/13/25-5/15/25, the “JR” indicated, “Clean all floor drains in kitchen, cafeteria and dishroom, using soap and water and bleach. See Chef for instructions.” The column designated for staff initial’s to indicate the task was completed was left blank from 5/13/25-5/15/25 indicating the task was not completed per FSD. During a review of the facility’s job description (JD) titled, “Executive Chef,” dated 11/25/2024, the “JD” indicated, “Under the supervision of the Director Hospitality Food and Nutrition Services [FSD], the Executive Chef is expected to perform a variety of duties for the preparation, cooking, and serving of all foods for patients. . .Develops and implements work standards, sanitation procedures. . .consistent with. . .food handling principles. Inspects food preparation and serving areas, equipment and storage facilities. . .and violations of current health regulations and orders corrective measures as necessary.” During a review of the facility’s policy and procedure titled, “Equipment Cleaning”, dated 4/2025, the policy and procedure indicated, “Floor Care: All surfaces are swept .....are scrubbed with floor scrubbing machine.” 3. Review of the facility’s P&P titled, “Equipment Cleaning,” dated 4/2025, the P&P indicated, “Purpose: To establish guidelines for cleaning and caring for kitchen equipment. Dish Machine: Daily, when dishwashing is completed. Wash down surrounding walls and floors according to established procedure.” During an observation on 5/19/25 at 3:30 p.m. in the kitchen with FSD, Executive Chef (EC), and Vice President of Operations (VPO), extensive steam was observed rising to the ceiling tiles from the dirty side of the high temperature (temp) dish machine. Seven large ceiling tiles above the high-temp dish machine were extensively discolored with black substances that posed a risk for cross-contamination. FSD and EC stated facilities would switch out the tiles here and there. During a review of the facility’s “Work Order #8468893 (WO)”, dated 11/11/2024, the “WO” indicated, “Priority: High- 72 hours, Date Opened: 11/11/2024, Due Date: 11/14/2024, Completion Date: 11/16/2024: Cleaned T bars, Issue Description: Dirty ceiling cross bars. Additional Comments: I’m not sure who can reach these to clean them. I know we don’t have a ladder tall enough to reach. Location Description: Main kitchen dish room above the dirty side of the dish machine.” During a review of the facility’s WO “#8494827”, dated 11/18/2024, the WO indicated, “Priority: High- 72 hours, Date Opened: 11/18/2024, Due Date: 11/21/24, Completion Date: 1/8/25, Issue Description: Dish room -t bars (T-bar refers to structural support and separation for ceiling tiles) above dirty end of dishwasher need to be cleaned. Please help me get these cleaned.” During a review of the facility’s WO “#7418210”, dated 2/9/2024, the WO indicated, “Priority: Normal -14 days, Date Opened: 2/9/24, Due Date: 2/23/2024, Status: Open, Issue Description: Ceiling tiles in dish room are stained and need to be replaced and T bars cleaned. Additional Comments: Can we please look at replacing the ceiling tiles and doing a deep clean of the area.” During a review of the facility’s WO “#7843167”, dated 5/31/2024, the WO indicated, “Priority: High-72 hours, Date Opened: 5/31/2024, Due Date: 6/3/2024, Issue Description: Ceiling tiles need to be replaced. Additional Comments: Need multiple ceiling tiles replaced and t bars cleaned in the dish room. Would like to coordinate with exterminators to exterminate ceiling as the tiles get replaced.” During a review of the FDAFCA, dated 2022, the FDAFCA indicated, “Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils. The objective of cleaning focuses on the need to remove organic matter from foodcontact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.” (4-601.11). During an interview on 5/22/25 at 4:30 p.m. with FSD, FSD stated she did not attend any hospital wide infection control meetings. FSD stated she thinks EVS (Environmental Services) may do quarterly rounds in the kitchen but was not sure if it was an exact set schedule. FSD stated the hospital’s infection preventionist (IP) was present during the EVS rounds in the kitchen. FSD was asked if there were any identified concerns as a result of those EVS/IP audits in the foodservice operation or if she and/or IP initiated any performance improvement (PI) related to infection control concerns within the foodservice operation, and FSD stated, no. FSD was asked to provide the last three EVS/IP audits of the foodservice operation. During a concurrent interview and record review on 5/27/25 at 3:10 p.m. with the VPO who had an oversight role per the hospital’s organization chart over the Food and Nutrition Services department, the above WO’s related to the ongoing black colored substances on the ceiling above the high temp dish machine were reviewed. In addition, the facility provided the previous two EVS/IP audits of the kitchen titled, “Infection Control Survey”, dated 10/25/24 at ARU East Campus, 11/22/24 at Main Campus, 1/24/25 at ARU East Campus, 2/7/25 at Main Campus, 4/25/25 at Main Campus, and 5/15/25 (location not specified on form), in which all areas on all of the above audits were marked “Department Compliance: 100%.” VPO stated the FANS department for both the main campus and the ARU East Campus were not effectively integrated into the hospital wide infection control program, especially as evidenced by the continuous unsanitary conditions in the dishmachine room that posed a risk for cross contamination and illness amongst staff and patients that went unidentified by the infection control program. 4. During a review of Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2025, the “NCM” indicated Level 4 Puree IDDSI (International Dysphagia [difficulty swallowing] Diet Standardization Initiative) means foods should fall off spoon as an intact spoonful, hold its shape on a plate, and liquid must not separate from solids. During a review of the United States Department of Agriculture (USDA) Food and Nutrition Services (FNS), dated 5/1/2025, “USDA” indicated, “A recipe that has been tried, adapted, and retried several times. . .The recipe has been found to produce the same. . .results and yield every time when the exact procedures are used with the same type of equipment and the same quantity. . .of ingredients.” During a concurrent observation and interview on 5/19/25 at 12:11 p.m. with Cook 1, in the presence of FSD, Cook 1 was observed serving pureed textured pasta/meat sauce and pureed carrots into individual sized serving dishes onto Patient 804’s lunch plate. The pureed texture for both the pureed pasta/meat sauce and pureed carrots appeared thin with water accumulation on top, and liquid separating to the sides of the solids. Cook 1 stated he prepared the pureed texture diets for lunch that day. During a review of Patient 804’s lunch “Meal Tray Card” (MTC; person centered menu directions), dated 5/19/25, the “MTC” indicated, “Diet: Puree, 4 ounce pureed pears, 6 ounce puree pasta/meat, 4 ounce puree carrots. . .” During a concurrent observation and interview on 5/21/25 at 10:55 a.m. with Cook 3, in the presence of FSD, Cook 3 stated a main entree option for lunch that day was Italian herb chicken breast. Cook 3 pointed to a pan, located in the steam table, and Cook 3 stated that was the pureed chicken that he prepared. Cook 3 was asked how he prepared the pureed Italian herb chicken breast. Cook 3 stated he opened a 10-lb (pound) bag of purchased pre-cooked cubed chicken, reheated the chicken, added seasoning and placed the chicken in a food processor to make 12 portions of pureed chicken. Cook 3 was asked a couple of times in different ways if he knew how much chicken he placed in the food processor, and Cook 3 repeated he started by opening a 10 lb bag of cubed chicken and used that. Cook 3 was unable to state specifically how much chicken he added to the food processor to prepare 12 portions of pureed chicken. Cook 3 stated he poured water into the food processor to blend for a puree texture. Cook 3 was asked how much water he poured, and Cook 3 stated, “About 3 cups.” Cook 3 was asked if there was any guidance or resources he used while preparing the pureed food for patient’s lunch that day. FSD asked Cook 3, “You follow the recipe in the binder, right?” Cook 3 stated, “I just know what to do.” Cook 3 stated he was trained on how to prepare pureed textured meals by an employee that used to work there four years ago. During a concurrent interview and record review on 5/21/25 at 11:00 a.m. with FSD, FSD obtained the facility’s recipe that was located in a binder on a shelf near Cook 3’s work station titled, “Italian Seared Chicken Breast Puree”, dated 6/15/2022 for review. The recipe indicated, “4 ounce of Chicken, Pre-Cooked, Pureed and 2 ounce Gravy, Chicken, Low sodium.” FSD stated the recipe meant Cook 3 should have used the Italian herb chicken breast that Cook 3 had finished cooking that day for the regular texture diet orders which was prepared from fresh chicken to blend in the food processor to a pureed texture, and the low sodium chicken gravy was to be served on top. FSD stated they were proud of the food they served because they used fresh ingredients for flavor, and water should not have been used in the food processor as it could dilute flavor and diminish nutritive value. FSD stated the puree recipe titled, “Italian Seared Chicken Breast, Puree”, dated 6/15/2022, was not followed and should have been. FSD stated both Cook 1 and Cook 2 position titles were “Cook II [2]”. During a review of the facility’s P&P titled, “Menus,” dated 6/2024, the P&P indicated,”Procedure: All menus are planned and approved by the Director, Registered Dietitian(s), and the Executive Chef. . .Recipes are used to prepare all foods for regular and therapeutic diets. These foods are palatable and flavorful with the nutritive value conserved and attractively served.” During a concurrent interview and record review on 5/22/25 at 3:00 p.m. with FSD, a recipe titled “Chicken, Pre-Cooked, Pureed”, dated 6/15/2022 was reviewed. The recipe indicated, “3 ounce Chicken, Pre-Cooked, Diced, 1 oz (ounce) Water, Place diced chicken into food processor and blend with enough water to get a smooth, lump free, pudding consistency. . .” FSD stated she did not provide that recipe to the survey team and the recipe was not available in the binder for the cooks to follow, nor would it be a method to promote standardized recipe as it alludes to “adding enough water” which could provide opportunity for variation among cooks, decrease flavor and nutritive value. During a review of the facility’s job description (JD) titled, “Cook II”, dated 9/2017, the “JD” indicated, “Job Summary: Prepares patient and cafeteria food, special functions according to planned menus, using standardized recipes and production sheet. . .Required knowledge and abilities and expectations:. . .Adherence to standardized recipes.” During a review of the facility’s job description (JD) titled, “Executive Chef”, dated 11/25/2024, the JD indicated, “Under the supervision of the Director of Hospitality Food and Nutrition Services. . .Develops and standardizes recipes. . .Supervises and prepares, breakfast, lunch, and dinner meals. . .Supervises Hot Production Staff [Cook II position], including. . .training, counseling, and evaluating.” During a review of the facility’s job description (JD) titled, “Hospitality Director, Food and Nutrition (FSD)”, dated 11/25/2024, the JD indicated, “Directs food production, ensure standardized recipes and production sheets ...leads, directs and manages the daily operations of the Food and Nutrition Services Department. . .” East Campus 5. During a concurrent observation and interview on 5/20/25 at 12:30 p.m. with FSD and CDM in the emergency food supply room located within the kitchen at ARU East Campus, five bottles of enteral nutrition (delivery of liquid nutrition via the stomach and/or small intestine) had manufacturer expiration dates of 4/1/2025 printed on each container. FSD and CDM verified the five bottles of enteral nutrition formula had expired on 4/1/2025 and should not have been available for use. During review of United States Department Of Agriculture Food Safety and Inspection Service (FSIS) titled, “Food Product Dating”, dated 4/23/25, the “FSIS” indicated, “Federal regulations require a “Use-By” date on the product label of infant formula under inspection of the U.S. Food and Drug Administration. Using formula by this date ensures that it contains each nutrient in the quantity listed on the label. Formula must maintain an acceptable quality to pass through an ordinary bottle nipple. . .It is also based on the conditions of handling, storage, preparation, and use printed on the label. Do not buy or use baby formula after its “Use-By” date.” 6. During a review of the FDAFC, dated 2022, the FDAFC indicated, “An air gap between water supply inlet and the flood level rim of the plumbing fixture, equipment, or nonfood equipment shall be at least twice the diameter of the water supply inlet and may not be less than 25 mm [millimeter] (one inch).” (5-202.13) During a concurrent observation and interview on 5/20/25 at 12 p.m. with Maintenance Director, CDM, and FSD in the kitchen, Maintenance Director observed drainage pipe located externally from the walk-in refrigerator lacked a proper air gap over the rim of the sink floor drain, as well as the drainage pipe for the ice-machine located in the kitchen. Maintenance Director stated the pipes needed to be elevated to leave at least a one inch air gap above the rim of the floor sink drain to prevent the potential of backflow that could cause cross contamination. Concurrently, FSD stated the sink floor drains located in the kitchen were not maintained in a sanitary manner. CDM stated it was kitchen staff’s responsibility to clean the sink floor drains. During a concurrent observation and interview on 5/20/25 at 12:07 p.m. with Maintenance Director, CDM, and FSD in the kitchen, the ice-machine lid that covered the bin which stored the ice was observed with a long silver tape across the lid. In addition, white colored substance was observed on the rim of the interior chute where ice could contact the white colored substance. Maintenance Director removed the top panel to the ice-making apparatus in which the filter could be observed fully covered with a thick build up of dust. Maintenance Director stated the filter needed to be changed. Maintenance Director stated he put tape on the lid of the machine because it was cracked and the white colored substance was calcium deposits. Maintenance Director was able to show the ice machine de-scaler and ice-machine sanitizer and cleaned and sanitized the ice-machine frequently but he stated he could get a clean brush and scrub that part harder when he disassembled the chute. FSD verified that tape over the cracked lid impeded effective cleaning and sanitizing. During a concurrent observation and interview on 5/20/25 at 12:13 p.m., with Maintenance Director, in the presence of FSD, Maintenance Director stated, at times, he would use a hose that was connected in the kitchen’s dirty utility closet to spray the evaporator of the ice-machine prior to cleaning and sanitizing. Maintenance Director observed the dirty utility room where the the external large green hose was covered in a black colored substance and parts of it was lying directly on the floor bed of the sink floor in which an empty mom bucket was turned upside down over the hose, and the large yellow mop bucket on wheels was covered in black/brown colored substance. During a review of the ice machine’s manufacturer’s guidelines (MGs), dated 2/2013, the “MGs” indicated, “The recommended cleaning procedures that follow should be performed at least as frequently as recommended and more often if environmental conditions dictate.” There was no indication that a hose should be used to spray the evaporator prior to cleaning and sanitizing. During a review of the facility’s P&P titled, “Care and Maintenance of Ice Machine,” dated 6/2022, the P&P indicated, “The purpose is to ensure the ice machine is thoroughly cleaned and maintained to reduce the incidence of potential build-up of harmful pathogens. The cleaning methods followed are provided by the manufacturer and The Bureau of Epidemiology at The Centers for Disease Control.” During a review of the FDAFC, dated 2022, the FDAFC indicated, “Equipment, Food - Contact Surfaces, Nonfood Contact Surface, and Utensils, the equipment food-contact surfaces and utensils must be clean to sight and touch. . .and the nonfood- contact surface of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris.” (4-601.11) During a review of the FDAFCA, dated 2022, the FDAFCA indicated, “Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils. The objective of cleaning focuses on the need to remove organic matter from foodcontact surfaces so that sanitization can occur and to remove soil from nonfood contact surfaces so that pathogenic microorganisms will not be allowed to accumulate and insects and rodents will not be attracted.” (4-601.11) During record review of FDAFC, dated 2022, the FDAFC indicated, “Physical facilities shall be maintained in good repair.” (6-501.11). 7. During a concurrent observation and interview, on 5/19/25, at 12:44 p.m., with the Nursing Director of Telemetry and Medical-Surgical (DTMS) and the Manager of three Medical-Surgical (MMS), the nourishment room located on three medical was toured. Inside the nutrition room was an expired enteral feeding container dated 5/1/25. The DTMS and MMS verbalzied and confirmed the enteral feeding container was expired and should have been removed from the nutrition room and discarded. During a review of the facilty’s job description (JD) titled, “Hospitality Director, Food and Nutrition (FSD)”, dated 11/25/2024, the JD indicated, “Leads, directs and manages the daily operations of the Food and Nutrition Services Department encompassing but not limited to all patient...floor stock.” 8. During an interview on 5/22/25 at 4:25 p.m. with FSD, FSD stated she did not attend the hospital-wide QAPI (Quality Assessment [QA] and Performance Improvement [PI]) meetings, nor reported any FANS departmental PI projects to QAPI nor received any feedback on any data collection, tracking, trending and analyzing any departmental PI projects that focused on high risk, high volume and problem prone and could improve the outcomes of patient care. FSD stated she did attend nutrition support committee meetings but currently did not have any clinical nutrition PI projects in place, other than monitoring nutrition assessments to ensure they are coded accurately when malnutrition exists. FSD stated about a year ago she did a clinical nutrition care PI on tube fed patients (patients receiving nutrition through a tube) to ensure they received the tube feeding quantity of formula (liquid nutrition via a tube) as ordered, such as monitoring as to whether staff turned the pump back on timely when needing to turn off to provide patient care. FSD stated she did not report that PI to QAPI and receive feedback from QAPI for tracking, trending, and quality indicators for improved patient outcomes as a result. FSD stated currently she was working with the diet aides for PI to ensure accuracy of patient meal trays during trayline. FSD stated she has not tracked, trended and analyzed the data nor reported to any type of hospital wide QAPI meeting and had not been asked to do so. During an interview on 5/27/25 at 11:28 a.m. with VPO, VPO stated he was unsure if FSD attended Quality Forum as part of the hospital-wide QAPI program. VPO stated FSD did attend “Care Experience Meetings” which was primarily based on Press Ganey (PG) scores which was a way of measuring patient satisfaction using surveys. VPO acknowledged that PG scores, although important, was not a method of data collection that would lend itself to identifying unsafe food handling and unsanitary conditions within the foodservice operation, nor identify any gaps in RD supervision over nutritional aspects of patient care that may not have been in accordance with standards of practice. During an interview on 5/27/25 at 11:53 a.m. with VPO and Director of Quality (DQ), DQ stated Quality Forum was attended by physicians, case management, critical care, nursing, respiratory (respiratory therapists working with patients to help with breathing), sepsis (microorganisms enter the bloodstream and trigger a systemic inflammatory response) coordinator and surgical departments. DQ stated the FANS department was not part of Quality Forum and verified the FANS department was not integrated into the hospital-wide QAPI program. DQ stated she was not aware FSD had a PI project for tube fed patients about a year ago related to nutrition care because the structure was for FANS departments to keep their projects within their department. (Cross Refer A-0283, A-0619) 40560 48380”

“QUALIFIED DIETITIAN CFR(s): 482.28(a)(2) There must be a qualified dietitian, full-time, part-time, or on a consultant basis. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to ensure nutritional aspects of patient care were structured and supervised in accordance with standards of care by a Registered Dietitian (RD)when: 1. One of one sampled patient (Patient 802) was provided 3-4 more ounces of fluid on his lunch meal tray than allowed per the Food and Nutrition Services department’s “Fluid Sheet (FS)” guidance. Clinical Nutrition Manager (CNM/RD) did not ensure the FS structure used by Diet Clerk’s who were responsible for checking patient menus to ensure foods and beverages selected corresponded with the 1,000 ml fluid restriction (per 24 hours) ordered for Patient 802 when pudding was not listed on FS as a fluid source. This failure could cause delayed healing of Patient 802’s exacerbation (worsening of) of CHF (congestive heart failure: the heart was not pumping blood effectively, leading to fluid buildup in the body). 2. One of one sampled patient (Patient 805) with a latex allergy had not received nutrition education to ensure Patient 805 was aware of the potential for cross-reactivity (when an antibody reacts with a molecule that is similar to another molecule) with certain foods related to his latex allergy in order to be able to self-identify potential reactions from food in which he may want to be provided the opportunity to discuss further with RD and/or his doctor. This failure had the potential for Patient 805 latex allergy that may be associated with allergies to certain foods to go unrecognized and nutrition care plan needs unmet. Findings: 1. During a concurrent observation and interview on 5/20/22 at 11:53 a.m. with Food Service Director/RD (FSD) and Dietary Aide (DA) in the kitchen located at ARU (Acute Rehabilitation Unit) East Campus, Patient 802’s menu indicated, “Cardiac [heart diet], FR [fluid restriction] 1,000 [mm; millimeter per day], diet vanilla pudding, iced tea-4 oz [ounces].” Patient 802’s lunch meal tray had 4 oz iced tea, and an individual sized container of pudding. DA was asked to remove Patient 802’s meal tray from the meal delivery cart to review the fluids on the tray. DA stated she had 4 oz. of iced tea which was circled on her menu and was allowed. DA was asked if the pudding counted as part of the FR, and DA stated, no. FSD told DA pudding was not part of the FR, and yes, you can provide it on the meal tray. FSD was requested to check the facility’s diet manual and/or the Nutrition Care Manual (NCM) from Academy of Nutrition and Dietetics (AND). During a concurrent interview and record review on 5/21/25 at 11:05 a.m. with RD 4, Patient 802’s “Nutrition Assessment (NA)”, dated 5/10/25 was reviewed. The “NA” indicated, “Pertinent diagnosis: CHF exacerbation, liver cirrhosis (liver damage where healthy cells are replaced by scar tissue). . ., ascities (excess fluid accumulates in the abdominal cavity), 4/22: Paracentesis (a medical procedure involving the removal of fluid from the abdominal cavity) -4.8 L (a metric unit of capacity) Fluid Removal, Pertinent medical history: DM [diabetes mellitus: a disease in which the body ’ s ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and elevated levels of glucose (sugar) in the blood and urine). . .Nutrition order: Consistent Carb [carbohydrate]/Cardiac Diet, Fluid Restriction 1,000 ml/[per] day.” RD 4 stated the FR order was important to follow as the patient had CHF and history of ascites. During an interview on 5/21/25 at 11:21 a.m. with FSD, FSD stated the Diet Clerk’s (DCs) screen the patient’s select menus (menus had multiple choices of entrees, desserts and beverages patients could select from) to ensure the selections followed the physician’s order. FSD stated the DCs were provided written guidance via the FS that directed food and beverage items to include in the FR with quantities in ounces. FSD stated the same FR guidance is provided at the ARU East Campus as the main campus and the DC’s can work at either location. During a concurrent interview and record review on 5/21/25 at 11:30 a.m. with DC 1, DC 1 stated she followed the FS as written. DC 1 stated the “FS” listed direction that indicated for a 1,000 cc per day FR the kitchen would provide 500 cc a day broken up into 8 ounces of liquids on breakfast meal tray, 4 ounces of liquids on lunch meal tray, and 4 ounces of liquid on the dinner meal tray. The diet office provides half the amount of total fluids for patients on fluid restrictions and nursing provides the other half. DC 1 stated the FS listed sherbet, ice cream, or fruit sorbet as a liquid; however, pudding was not listed so pudding was not considered a fluid. During an interview on 5/22/25 at 2:40 p.m. with FSD, FSD stated per the NCM, which was a standard of practice, pudding was considered a fluid. FSD stated Patient 802 received 8 oz of fluid on his lunch meal tray on 5/20/25 (4 oz. of iced tea and 4 oz. of pudding) but should have only received 4 oz of fluid per the FS directions given to the DCs to follow. During a review of the facility’s policy and procedure (P&P) titled, “Menus”, dated 6/2024, the P&P indicated, “Purpose: To ensure the patient meals are provided in accordance with the physician’s dietary prescription. . .All patient menus received will be checked daily, by a Registered Dietitian, Diet Technician, or Diet Aide.” During a review of the facility’s P&P titled, “Tray Line”, dated 3/2024, the P&P indicated, “It is the policy of [name of hospital] Department of Food and Nutrition Services to follow the established policy and procedure tray line. Diet Aide. . .Checks assembled tray at the end of the belt [conveyor belt], to ensure that items on tray correspond with the menu. Once tray is checked and approved for accuracy the tray is placed in the food cart.” During a review of the facility’s P&P titled, “Diet Orders”, dated 3/3024, the P&P indicated, “Purpose: To provide appropriate and accurate meal service to patients as prescribed by authorized individuals in a timely manner. Policy Statement: It is the responsibility of the diet office to follow through will all prescribed diet orders and patient preferences as allowed by prescribed diet. . .Diet orders must correspond with those outlined in the approved diet manual. . .Fluid restrictions: Nutrition services will provide half of the prescribed fluid restriction for a 24-hour period. Example: 600 cc fluid will be allowed between breakfast, lunch and dinner on a 1200 cc Fluid Restriction diet. The remainder of the fluid restrictions will be provided by nursing. Fluid includes all liquids: beverages, soups, sherbet, ice cream, sorbet. Nutritional supplements are counted as part of the fluid restriction.” During a review of Academy of Nutrition and Dietetics (AND) Nutrition Care Manual (NCM), dated 2023, the “NCM” indicated, “Indication: A fluid restriction diet is indicated in individuals with congestive heart failure. . .Counting Liquids and Foods for a Fluid Restriction Diet: A fluid is anything that is liquid or any foods that melt at room temperature. These food and liquids must be counted as part of daily fluid intake. Examples of fluids include the following: . . .Pudding. . .” During a review of the facility’s job description (JD) titled, “Clinical Nutrition Manager (RD)”, dated 11/24/2024, the “JD” indicated, “The Clinical Nutrition Manager collaborates as the clinical nutrition leader. . .Develops nutrition care guidelines and ensures adherence to the nutrition care manual, department/facility guidelines and/or protocols to provide evidence-based nutrition care.” 2. During a concurrent interview and record review on 5/22/25 at 4:05 p.m. with FSD , the hospital’s “Diet List (DL)”, dated 5/10/25 was reviewed. The “DL”, for Patient 805, indicated, “Coded Allergies Verified: Latex.” FSD was asked if the RDs had a role of any kind when a patient had a latex allergy. FSD stated the latex allergy did interface with the Food and Nutrition Department’s software that was used to print out Patient 805’s meal tray card (contained person centered directions for meal service including allergies) but no further activities occurred as food service staff already used latex free gloves. During a concurrent interview and record review on 5/22/25 at 4:10 p.m. with FSD, the on-line NCM, dated 2025 was reviewed. The NCM indicated, “A nutrition consult should be ordered when a patient with latex allergy. . .is admitted to the hospital. Patients with latex allergy may need an allergen (a substance that causes an allergic reaction) free prescription.” FSD stated the hospital used NCM as a standard of practice to guide the development of the hospital’s P&Ps. FSD stated she was unaware that a patient with a latex allergy may have a cross- reactive allergy with certain foods, and agreed Clinical RD’s should be aware of the guidance provided in the NCM. During a review of Patient 805’s “Nutrition Assessment (NA)”, dated 5/24/24, the “NA” indicated, the electronic health record (EHR) carried over Patient 805’s latex allergy to the NA screen as indicated at the top of the screen noted”Allergies. . .latex.” It was noted the NA included documentation from an RD that indicated “No known food allergies.” However, there was no documentation that Patient 805 was informed about potential cross reactivity with certain foods due to his known latex allergy. During a review of “What are latex cross-reactive foods?” from Allergy and Asthma Network (AAN), dated 2025, the “AAN” indicated, “Many foods have similar proteins to latex even if they don’t contain actual latex. When a person with a latex allergy eats food with these proteins, they may have an allergic reaction. The foods are called latex cross-reactive foods.” During a review of the facility’s P&P titled, “Nutrition Care Manual (NCM),” dated 1/2024, the P&P indicated, “Policy Statement: It is the policy of [name of hospital] department of Food and Nutrition Services to follow the established policy and procedure for the Nutrition Care Manual. Procedure: The Nutrition Care Manual [NCM] of the Academy of Nutrition and Dietetics is the official diet manual of [name of hospital] Health Systems. The manual is available for use by the medical staff, dietetic staff and other health care personnel. It serves as a reference for our policies and procedures. . .Authorization of the diet manual is provided by the Director of Nutrition Services, Patient Care Services, Medical Executive Committee and the Board of Trustees.””

“COMPETENT DIETARY STAFF CFR(s): 482.28(a)(3) There must be administrative and technical personnel competent in their respective duties. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review the facility failed to ensure 2 of 2 cook’s interviewed demonstrated competent skillset for their respective duties per the facility’s “Cook II” job description when: 1. Cook 1 did not use correct portion sizes to serve patient meals during a lunch trayline observation on 5/19/25. This failure posed potential for a patients nutritional needs to go unmet. 2. Cook 2 was unable to accurately check concentration of a sanitizing solution per the manufacturer’s guidelines to ensure effective sanitizing. This failure placed the patients at an increased risk for foodborne illness. Findings: 1. During a concurrent observation and interview on 5/19/25 at 12:11 p.m. with Cook 1 in the main kitchen, in the presence of Food Service Director/Registered Dietitian (FSD), Cook 1 was observed using a scoop to serve pureed textured pasta/meat sauce into a serving dish and placed a scoop of pureed carrots into another serving dish and placed the dishes onto Patient 804’s lunch plate. Cook 1 stated the scoop size located on the scoop utensil for both the pureed pasta/meat sauce and pureed carrots was 3 ounces (oz). During a review of Patient 804’s lunch “Meal Tray Card” (MTC; person centered menu directions), dated 5/19/25, the “MTC” indicated, “Diet: Puree, 4 ounce pureed pears, 6 ounce puree pasta/meat, 4 ounce puree carrots. . .” During a concurrent observation and interview on 5/19/25 at 12:15 p.m. with Cook 1 in the main kitchen, in the presence of FSD and Executive Chef (EC), Cook 1 was asked what Patient 804’s MTC indicated for the portion sizes, and EC stated but I am giving a heaping scoop size to give more, it’s not a level portion with the scoop. EC was observed providing Cook 1 a 6 oz scoop utensil for the puree pasta/meat and a 4 oz scoop utensil for the pureed carrots to implement the planned menu. During a review of the facility’s “Portion Control Menu Planner (PCMP)”, dated 2024, the “PCMP” indicated a 6 oz disher [scoop utensil] provided 3/4 cup, a 4 oz disher provided 1/2 cup and a 3 oz disher provided 3/8 of a cup. During a review of the facility’s job description (JD) titled, “Cook II”, dated 9/2017, the “JD” indicated, “Job Summary: Prepares patient and cafeteria food, special functions according to planned menus, using standardized recipes and production sheet. . .Required knowledge and abilities and expectations:. . .Adherence to. . .portion control. . .Position Duties And Responsibilities: Serve on trayline using portion control standards.” 2. During a concurrent observation and interview on 5/19/25 at 12:30 p.m. with Cook 2 in the main kitchen, a red bucket with a liquid inside was located on a shelf near Cook 2’s work station. Cook 2 stated the liquid inside the red bucket was a sanitizing solution that she had used about one hour ago. Cook 2 stated she was responsible to check the concentration of the sanitizer to ensure it was at the correct concentration. Cook 2 proceeded to immerse a chemistry strip into the sanitizer solution for approximately several seconds, removed the chemistry strip and held the strip in the air for several seconds before comparing the color to the color coded graph aligned with various PPM readings, and Cook 2 stated it’s less than 200 PPM (parts per million) so she needed to throw it out and get fresh sanitizing solution. Cook 2 stated they were not required to record the results on a log but that she was trained to replace the solution at least every 4 hours or unless soiled. Cook 2 was asked if she were trained on how long to immerse the chemistry strip into the sanitizing solution, and she stated, yes, for 30 seconds. During a review of “Hydrion QT-40 (name of the chemistry strip)” container instructions indicated, “Dip the strip into the sanitizing solution for 10 seconds, then instantly compare the resulting color with the enclosed color chart.” During a review of a poster from the manufacturer of the sanitizing solution, located on the wall inside the kitchen above a sink, the poster indicated, “The correct reading must be 200-400 ppm.” During a review of Food and Drug Administration Food Code 2022 (FDAFC), the FDAFC indicated concentration of the sanitizing solution shall be accurately determined by using a test kit in accordance with the manufacturer’s label. During a review of the facility’s job description (JD) titled, “Cook II”, dated 9/2017, the “JD” indicated, “Required knowledge and abilities and expectations:. . .Knowledge and maintenance of clean and sanitary work environment. Practices infection control. . .””

“THERAPEUTIC DIETS CFR(s): 482.28(b), (b)(1) §482.28(b) Menus must meet the needs of patients. (1) Individual patient nutritional needs must be met in accordance with recognized dietary practices. This Standard is not met as evidenced by: 27157 Based on observation, interview, and record review, the facility failed to: 1. Ensure the non-select (menu served when a patient was not available to make their own selections) were consistently developed and implemented in accordance with the physician’s orders as defined in the hospital’s diet manual and/or Nutrition Care Manual (NCM) of the Academy of Nutrition and Dietetics (AND) in accordance with recognized dietary practices to meet the patient’s nutritional needs for the following routinely ordered diets; Regular (House Diet), Cardiac (heart), Consistent Carbohydrate (CCHO for diabetes), Renal (kidney disease)/Dialysis (a medical procedure that removes waste products and excess fluid from the blood when the kidneys are unable to do so), Renal/CCHO, and Low Fat (< (less than) 50 gm (grams) of fat a day) diets. According to the hospital’s “Diet List (DL)”, dated 5/19/25, the “DL” indicated there were 77 patients on a regular house diet, there were 57 patients on a cardiac diet, there were 29 patients with a CCHO diet order, 5 patients on a renal/dialysis diet, and 3 patients on a renal/CCHO diet. 2. Ensure sufficient Registered Dietitian (RD) supervision of nutritional aspects of patient care related to scheduled follow-up, 5 days after an initial nutrition assessment, to monitor patient’s nutrition plan of care was not in accordance with current standards of practice, especially for two of two sampled patient (Patient 800, Patient 801) whose nutritional needs were not being met. (Cross Refer A-0283, A-0618) Facility failure to consistently develop menus to ensure food served to patients for the house diet and therapeutic diets (a diet ordered as part of a treatment plan for a specific disease or condition) according to physician’s orders/diet manual and recognized dietary practices placed the patients at risk of nutritional and/or medical complications. Facility failure to follow up on a high nutrition risk patient until 5 days after the initial nutrition assessment and while being aware a patient’s nutritional needs were not being met was not sufficient supervision by an RD over aspects of nutritional care to promote improved medical status and to help prevent and/or minimize complications, minimize length of stay and promote reduction of re-admission rates. Findings: 1. During a review of the facility’s policy and procedure (P&P) titled, “Nutrition Care Manual (NCM),” dated 1/2024, the P&P indicated, “Policy Statement: It is the policy of [name of hospital] department of Food and Nutrition Services to follow the established policy and procedure for the Nutrition Care Manual. Procedure: The Nutrition Care Manual of the Academy of Nutrition and Dietetics is the official diet manual of [name of hospital] Health Systems. The manual is available for use by the medical staff, dietetic staff and other health care personnel. It serves as a reference for our policies and procedures. Annual updates are provided by the Academy of Nutrition and Dietetics. The Nutrition Care Manual reflects the standards for nutritional care established by the Academy of Nutrition and Dietetics, USDA [United States Department of Agriculture] dietary guidelines, American Society for Parenteral (delivery of nutrients directly into the bloodstream through the veins) and Enteral (delivery of nutrients through the stomach and/or small intestine] Nutrition, American Diabetes Association and other published guidelines. Authorization of the diet manual is provided by the Director of Nutrition Services, Patient Care Services, Medical Executive Committee and the Board of Trustees.” During a review of the facility’s “NCM Diet Manual Crosswalk (NCMCW)”, dated 8/1/2023, the “NCMCW” indicated, “The following list of diets are in use at [name of hospital] Health Systems: Regular (House Diet), Easy-to-Chew IDDSI [International Dysphagia [difficulty swallowing] Diet Standardization Initiative] Level 7, Minced & Moist IDDSI Level 5 [soft and moist texture of lumps of food as to not require biting and only minimal chewing], Pureed IDDSI Level 4 [texture does not require chewing], CCHO, Cardiac, Renal/Dialysis, Renal/Pre-Dialysis, Renal/CCHO, Low Fat. . .Standard definitions of these diets are also provided per the NCM. . .This document reflects the diets available for patients through a physician order. . .” During an observation on 5/21/25 at 10:55 a.m. in the kitchen at the main campus, the food for the patient’s lunch was hot holding in steam table in preparation for trayline (plating of patient’s lunch meal). The lunch menu consisted of Italian seared chicken breast with a tomato and bell pepper sauce served over orzo pasta with pesto sauce, steamed fresh carrots, no sugar added chocolate pudding, 4 ounces of grape juice, and one pat of margarine. During a review of NCMCW, dated 8/1/2023, the NCMCW indicated, “Facility Diet Order Name: Cardiac Diet, Description: The cardiac diet is low in sodium and fat. . .Low Fat Diet <50 gm [gm and/or g means grams ] [per day; /d]: Cardiac diet menu will be provided.” During a concurrent interview and record review on 5/22/25 at 2:55 p.m. with FSD, the “Cardiac Diet” non-select menu served to patients on 5/21/25 and the “Menu Nutrient Analysis Report (MNAR)” dated 1/9/2019 and printed on 5/19/25 was reviewed. FSD stated the cardiac diet menu served to patients on 5/21/25 and as listed on the MNAR, dated 1/9/2019, provided 70.8 g of fat/d. FSD stated the cardiac menu was not developed in accordance with the diet manual and should have been. FSD stated the physician’s order for cardiac diet was not followed and implemented on 5/21/25 when the non-select menu provided 70.8 g of fat/d and should not have exceeded 50 g fat/day. During a concurrent interview and record review on 5/22/25 at 3:00 p.m. with FSD, the NCMCW, dated 8/1/2023, indicated, “Consistent Carbohydrate Diet [CCHO]: In general, carbohydrates (CHO) will be limited to 60-75 g per meal for males and 45-60 g for females.” FSD stated the CCHO menus were developed to provide 60 g of CHO per meal to meet both male and female patient’s nutritional needs for the management of diabetes. FSD reviewed the MNAR, dated 1/6/2019, that matched the current non-select CCHO 7 day cycle menu provided to patients (patients receive the same menus and food every 7 days for non-select menus). One of the dinner meal’s located on a CCHO menu consisted of lemon rosemary chicken breast, oven roasted potatoes, steamed Italian blend vegetables, sugar free gelatin, decaffeinated sugar free iced tea, and one margarine pat. FSD stated the CCHO diet order for that dinner meal was not followed and implemented as the dinner meal provided only 34 g of CHO and should have provided 60 g of CHO for the meal to meet a patient’s nutritional needs for management of their diabetes. FSD reviewed the MNAR for another non-select CCHO dinner meal that matched the current CCHO menus currently in place consisting of roast turkey with low sodium gravy, mashed potatoes with chicken gravy, fresh green beans, sugar free gelatin, sugar free iced tea, one pat margarine and a sugar substitute packet. FSD stated the CCHO dinner meal provided only 30.8 g of CHO and should have provided 60 g of CHO to meet the nutritional needs of both male and female patients with diabetes. During a concurrent interview and record review on 5/22/25 at 3:05 p.m. with FSD, the NCMCW, dated 8/1/2023, indicated, “NCM Diet Manual Reference Name: Diet for Chronic Kidney Disease, Facility Diet Order Name: Renal/Dialysis Diet: Description: The renal diet is limited in potassium, sodium, phosphorous. . .Females: 70 gm Pro [protein], 2 gm Na [sodium], 3 gm K+ [potassium], 1.2 gm Phos [phosphorus]; Males: 80 gm Pro, 2 gm Na, 2 gm K+, 1.2 gm Phos.” FSD stated the renal/dialysis diet order was not followed and implemented for those patient’s who were served their meals from non-select renal diet menus as the MNAR indicated 3 days out of a 7 day menu cycle, the menus provided a range from 91+ (Plus) g to 115+ g of pro/day, which also impacted the accuracy of the non-select menus for renal/CCHO diet orders, which were not being followed and implemented. During a review of the NCMCW, dated 8/1/2023, the NCMCW indicated, “Facility Diet Order Name: Renal/Consistent Carbohydrate: This diet is a combination of renal and consistent carbohydrate menus. The renal diet menu will be used and adjusted to meet the carbohydrate limits of the patient.” During a concurrent interview and record review on 5/22/25 at 3:15 p.m. with FSD, the NCMCW, dated 8/1/2023, indicated, “Facility Diet Order Name: Renal/Pre-Dialysis Diet: This diet is for patients with CKD [Chronic Kidney Disease] not on dialysis. This diet restricts protein, sodium, potassium, phosphorus. . .Females: 50 gm Pro, 2 gm Na, 3 gm K+, 1.2 gm Phos, Males: 60 gm Pro, 2 gm Na, 3 gm K+, 1.2 gm Phos.” FSD stated the nutrient analysis for the pre-dialysis renal diet exceeded the allowed quantity of pro/day as it ranged from 80 g pro/day up to 101 g pro/day. FSD stated that the pre-dialysis renal diet was available for physician’s to choose, however, was not a routinely used diet order at the hospital. During a review of the hospital’s “Diet List (DL),” dated 5/19/25, the “DL” indicated there were not any patient’s prescribed a pre-dialysis renal diet. During a review of the NCMCW, dated 8/01/2023, the NCMCW indicated, “Facility Diet Order Name: Regular, NCM Diet Manual Reference Name: House Diet/Regular Diet, Description: Most liberal menu, provides foods to meet nutritional needs of patients who do not require dietary restrictions or modifications.” During a review of AND’s current NCM, dated 2025, the NCM indicated the house diet should be evaluated for nutritional adequacy to ensure the house diet meets the Dietary Reference Intakes (DRIs), which include the RDA’s (Recommended Daily Allowances), for macronutrients and micronutrients (vitamins and minerals). The NCM indicated, “The House diet is based on general, healthful nutrition from a variety of foods. It is planned using the Dietary Guidelines for Americans and serves as the basis for all other diets (USDA, 2020)”. During a review of the MNAR, dated 1/9/2019 and printed on 5/19/2025, the MNAR indicated the following vitamins and minerals were included in the nutrient analysis and evaluation for nutritional adequacy of the menus for the Regular House Diet menus, Easy to Chew (Level 7) menus, Minced and Moist (Level 5) menus and Pureed diet (Level 4) menus: Sodium, Potassium, Magnesium, Phosphorus, Iron, Zinc, Vitamin C, Thiamin, Folic Acid, Vitamin B12, Calcium, Vitamin B6 and Vitamin D2+D3. The nutrient analysis of those menus lacked data entry and evaluation for nutrition adequacy for the following vitamins per the RDAs and Dietary Guidelines for Americans, in accordance with recognized dietary practices: Vitamin A, Vitamin E, Vitamin K, Vitamin B2 (Riboflavin), and Vitamin B3 (Niacin). During review of the hospital’s DL, dated 5/19/25, the DL indicated patients were routinely prescribe IDDSI Level 7, Level 5 and Level 4 diets. During a review of the facility’s policy and procedure (P&P) titled, “Menus”, dated 6/2024, the P&P indicated, “Purpose: To ensure the patient meals are provided in accordance with the physician’s dietary prescription and to the extent medically possible to meet the patient’s nutrient requirements as specified by the Dietary Reference Intake values and the Academy of Nutrition and Dietetics. Policy Statement: It is the policy of [name of hospital] Department of Food and Nutrition Services to follow the established policy and procedure for menus provided to the patients. Nutritional analysis is available using a reliable computer menu analysis program. It uses a national nutrient data base and vendor information. A complete analysis of the patient menu is conducted to the extent possible for nutrients stated in the DRIs.” During a review of the facility’s P&P titled, “Diet Orders”, dated 3/3024, the P&P indicated, “Purpose: To provide appropriate and accurate meal service to patients as prescribed by authorized individuals. . .Procedure: Diet orders must correspond with those outlined in the approved diet manual.” During a review of the facility’s job description (JD) titled, “Hospitality Director Food and Nutrition (FSD),” dated 11/25/25, the “JD” indicated, “Specialty-Specific Responsibilities: Leads, directs and manages the daily operations of the Food and Nutrition Services Department. . .Prepares or directs preparation of department records as well as recurring and special reports and analyses indicating number and types of regular and therapeutic diets prepared, nutritional and caloric analyses of meals. . .menus. . .as required/requested.” During a review of the facility’s NCMCW, dated 8/1/2023, the NCMCW indicated, “Nutritional Adequacy of Therapeutic Diets: These menus were created by committee with the Director of Food and Nutrition Services, Executive Chef, Clinical Nutrition Manager and registered dietitian staff. All menus were reviewed for appropriateness of nutrients (within the context of medical nutrition therapy), texture and consistency. Nutritional analysis of the diets completed using [name of software], and available vendor information on foods used in current recipes. National guidelines (Dietary Reference Intake (DRIs) prepared by the Food and Nutrition Board, (Institute of Medicine, National Academies) are referenced to create patient menus that meet or exceed the DRIs.” 2. During a concurrent interview and record review on 5/21/25 at 11:36 a.m. with Registered Dietitian (RD) 2, Patient 800’s “Nutrition Assessment (NA)”, dated 5/23/25 was reviewed. The “NA” indicated, “Nutrition Assessment trigger: Follow up Parenteral nutrition. Pertinent diagnosis: FTT [failure to thrive], frequent falls . . .Nutrition related history: 6/20: ST [speech therapy] - NPO [no food or drink allowed by mouth], 6/21: ST - Puree diet, moderately thick liquids by spoon, strict supervision. . .0% po intake today per pt [patient] husband, reports pt not awake enough for safe intake today. . .Starter PPN [peripheral parenteral nutrition] D10 [dextrose (sugar) 10% (percent) solution] 4.25%AA [amino acids -protein building blocks] @ [at] 40ml [milliliter]/hr [per hour]. . .Nutrition problem 1: Inadequate oral intake, acute illness, po intake < [less than] 25% x 5 days this admit, started on PPN. Nutrition Intervention: Texture modified diet per ST, Nutrition prescription: 1. Continue puree diet, moderately thick liquids per ST. . .Follow up Level: 1, Reassessment date: 5/28/25. RD 2 stated she had discussed her recommendation to start tube feeding (delivery of nutrients via a tube to the stomach) with Patient 800 but MD said no. RD 2 stated she left recommendations to advance the PPN to a goal rate to meet Patient 800’s nutritional needs in three days. RD 2 stated she was aware Patient 800 had eaten less than 25% po intake since admission five days earlier. RD 2 stated she had not seen any documentation by ST that trial puree diet had started yet and so she did not know how well Patient 800 would do with puree diet texture and ability to consume a sufficient amount to meet her nutritional needs, yet she scheduled an RD follow up appointment for 5 days later. RD 2 stated she was aware at that time that Patient 800’s nutritional needs continued to not be met since admission and that there was no new weight and that she had spoke with a nurse and requested Patient 800’s weight to be taken. RD 2 was asked how returning to Patient 800 in an additional 5 days was adequate RD supervision of her nutrition plan of care. RD 2 stated I documented a return date for 5/28/25 but I could see Patient 800 sooner such as if I see RDs received a trigger for any skin issue. RD 2 again stated she left recommendations on how to advance the PPN to an eventual goal rate in three more additional days, but acknowledged she would not know whether Patient 800 would do okay on puree diet, potentially could start eating better and perhaps the PPN could be discontinued, and an RD would not assess nutrition adequacy until 5 more additional days. FSD stated but RDs write notes that RD 2 could see or another RD could read and they have the ability to check in on those things before 5/28/25 scheduled follow up visit. RD 2 was asked if she had left notes in her office to herself and/or to other RDs requesting a quick check in on status of tolerating trial po intake with ST, or perhaps to check whether PPN was being advanced per her recommendation, and RD 2 stated, no. During a concurrent interview and record review on 5/21/25 at 12:00 p.m. with Registered Dietitian (RD) 2 in the presence of FSD, Patient 801’s NA, dated 5/14/25 was reviewed. RD 2 stated she was one day late completing this NA, as for a Level 1 nutrition risk the RDs had 48 hours to complete the NA. Patient 801’s NA indicated, “Nutrition Assessment trigger: Malnutrition screen, Pertinent diagnosis: Renal (kidney) Failure, 5/14 per reports - possible plans for renal biopsy today, pmhx (past medical history): lung cancer with brain mets (metastasized: spread to other parts of the body). . .CKD (chronic kidney disease). . .Pt reports decline in appetite with nausea for at least 2 months PTA (prior to admission), Nutrition Order: NPO for exam/procedure, Nutrition intake: NPO Day 2. . .last BM (bowel movement). . .weight kg: 67.273 (148 pounds [#]). . .Weight history: Per pt, ht [height] 67” [inches], UBW (usual body weight) -162#, reports weight loss to CBW (current body weight) 148 # (10% wt [weight] loss. . .Nutrition signs and symptoms 1: Weight loss 10% of UBW, po intake < 75% > 2 months PTA (prior to admission), , ***risk for sev PCM (severe protein calorie malnutrition), Nutrition problem 2: Inadequate oral intake, plans for biopsy today, NPO day 2, Nutrition Intervention 1: Recommend goal regular diet, initiation per MD. . .Nutrition prescription: 1. oral diet initiation post procedure per MD, recommend goal regular diet. Will monitor need for restriction [due to renal failure] when po >50% [when eating more than 50% of meals] consistently, 2. Will monitor need for supplements when diet initiated, Follow up Level 1, Reassessment date: 5/19/25.” RD 2 stated Patient 801 was NPO at that time and reported a weight loss of at least 10% of body weight prior to admission to the hospital, and reported a decline in appetite with nausea and no bowel movement for 2 days, and had lung cancer with mets known to increase nutritional needs. RD2 stated she made the RD nutrition assessment follow up scheduled on 5/19/26, five days later despite knowing Patient 801 had not had her nutritional needs met since admission, and despite RDs evaluation of Patient 801 being at severe risk for protein-calorie malnutrition (PCM) (PCM: a condition characterized by a deficiency of both protein and calories in the diet, leading to various clinical manifestations, including wasting. It can result from inadequate food intake, absorption problems, or increased nutrient requirements.). During a review of Nutrition Care Manual from the Academy of Nutrition and Dietetics titled, “Oncology: Nutrition Monitoring & Evaluation (ONM)”, dated 2022, the “ONM” indicated, “Meeting protein and energy needs is a primary goal for ensuring preservation of muscle mass, maintaining weight in patients with cancer and, ultimately, improving overall outcomes. Monitoring meal timing and frequency as well as total estimated energy, protein, and fluid intake is essential to determine diet adequacy and to further develop and modify nutrition interventions.” During a concurrent interview and record review on 5/22/25 at 4:25 p.m. with FSD, was asked whether following up 5 days after an RD identified a patient was not meeting their nutritional needs for a patient identified by the hospital’s nutrition screening process as being a high nutrition risk patient was in accordance with standards of care. FSD stated the RDs wanted to follow up in 5 days. FSD stated she used NCM and ASPEN (American Society for Parenteral and Enteral Nutrition) as standards of practice to develop the facility’s nutrition care policies and procedures. During a review of ASPEN’s standards of care guidance titled “ASPEN Adult Nutrition Care Pathway (Age 18+ years) (ANCP)”, dated 9/14/22, the “ANCP” indicated once inadequate nutrient intake had been identified “Monitoring & Evaluation: Follow-up within 3 days, monitor parameters; tolerance of nutrient intake, oral intake including supplements, vitamins, minerals, anthropometric data (weight trends), functional status.””

“DIETS CFR(s): 482.28(b)(2) All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals. This Standard is not met as evidenced by: 27157 Based on observation, staff interview, and document review, the hospital failed to ensure patient oral nutrition supplements (ONS: liquid nutrition to increase calories and protein) were provided to patients in accordance with orders from a practitioner responsible for the care of the patient, as required by State law for Registered Dietitians (RDs) per California Business and Professions Code 2586 for one of one sampled patient (Patient 807). This facility practice was a system concern as hospital leadership approved RDs to initiate ONS without a physician order and without the ONS being within the parameters of a physician prescribed diet order according to the facility’s diet manual, which was not in accordance with State law (CA BPC 2586). Facility failure to ensure RDs performed clinical nutrition patient care within their scope of practice in CA placed patient’s at an increased risk of lack of oversight by the medical staff when RDs initiated ONS without established performance criteria, without effective communication to the interdisciplinary team (IDT), including the physician, pertaining to quantity and frequency of ONS provided to a patient, and was outside of scope of practice for RDs practicing in CA. (Cross Refer A-0618, A-0619) According to Centers for Medicare & Medicaid Services (CMS) therapeutic diets refer to a diet ordered (what a patient should eat or drink during their hospital stay or treatment) as part of the patient’s treatment for a disease or clinical condition, to eliminate, decrease, or increase certain substances in the diet. Findings: During a concurrent observation and interview on 5/19/25 at 12:17 p.m. with Food Service Director/Registered Dietitian (RD) (FSD) in the kitchen, ONS(s) were observed being placed on multiple patients meal trays. FSD stated RDs could initiate ONS for patients based on their nutrition assessments and within the parameters of a physician diet order. During a concurrent interview and record review on 5/22/25 at 11:15 a.m. with RD 3 and FSD, Patient 807’s “Nutrition Assessment (NA)”, dated 5/18/25 was reviewed. The “NA” indicated, “NA trigger: Consult. . .Nutrition order: Regular diet, PO [by mouth]: no record. . .Provide Ensure (ONS) BID (two times a day)- encouraged pt [patient] to take. RD 3 stated she entered Ensure ONS one can for breakfast and one can for dinner into a software program located in the Food and Nutrition Services (FANS) department. RD 3 stated there was not an order from the doctor for ONS but that she did not need one as the hospital allowed RDs to provide ONS. FSD stated the software located in FANS did not interface with Patient 807’s electronic health record (EHR). RD 3 was asked how the practitioner responsible for Patient 807’s medical care would know RD 3 had the kitchen staff providing ONS BID. RD 3 stated the doctor could read the RDs nutrition assessments. RD 3 stated the hospital did not provide any patient criteria, nor maximum quantity of ONS per day, in order for RDs to provide ONS without a physician’s order. During an interview on 5/22/25 at 11:43 a.m. with RD 1, RD 1 stated RDs were not given any criteria that needed to be present in order to initiate ONS for a patient. RD 1 stated, for example, she could provide Glucerna (ONS) or Ensure Max (ONS) to a patient with diabetes on a CCHO (consistent carbohydrate) diet who was eating 80% (percent) of their meals per patient request, which would be in addition to their CCHO diet. RD 1 stated she would document that in her nutrition notes in a patient’s EHR and enter the ONS in the software located in the FANS department. RD 1 stated the RDs could follow up on a high nutrition risk patient, even when ONS was initiated by an RD, up to 5 days later. During an interview on 5/22/25 at 11:48 a.m. FSD verified when the RDs were initiating supplements, for the most part, the information on quantity of ONS being provided to a patient was isolated within the FANS department. FSD acknowledged the potential of a physician being unaware of a change in the patient’s plan of care, such as the addition of ONS three times a day, for example, had the potential to impede the physician’s ability to effectively evaluate changes in a patient’s medical care, such as labs. During a review of U.S. Food and Drug Administration published resource titled, “Final Guidance on Frequently Asked Questions About Medical Foods (FDAMF)”, dated March 2023, the “FDAMF” indicated, “Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition.” During a review of the hospital’s approved diet manual (DM, dated August 2023, the “DM” indicated, “. . .List of diets are in use at [name of hospital] as of 8/1/23. Standard definitions of these diets are also provided per the Nutrition Care Manual (NCM) and can be found on the NCM Order Terminology and Definitions handout.” During a concurrent interview and record review on 5/22/25 at 2:40 p.m. with FSD, FSD reviewed the hospital’s approved diet manual (DM) and indicated the definition for the regular diet, and “Sample 1 day menu- Regular Diet” located in the DM did not include use of medical food such as ONS. FSD reviewed the hospital’s definition of CCHO diet in the diet manual and stated ONS was not included within the defined parameters of a CCHO diet order, nor within any of the hospital’s diet orders listed in the DM. During a concurrent interview and record review on 5/22/25 at 2:55 p.m. with Chief Medical Officer (CMO), the hospital’s DM, dated 8/1/23 was reviewed. The DM indicated, “The dietitian has the authority per bylaws [Medical bylaws for non-physician supporting services staff, define the rules and regulations governing their activities within a healthcare organization.] to order oral supplements if patients will benefit from the additional calories, protein and micronutrients they provide.” CMO stated the medical staff did not grant order writing privileges in the medical bylaws to RDs as that was not allowed per CA BPC that dictates scope of practice for RDs working in CA. CMO stated it was the hospital’s intention to have the RDs have the capability to initiate ONS within the parameters of the diet order. CMO verified the definitions of the various diet orders located in the hospital’s DM did not include ONS within the parameters of the diet order, nor criteria and quantity for when they could be initiated, as a way to ensure RDs adding ONS are within the parameters of the diet order, and not exceeding the parameters. CMO stated we need to work on improving the system to ensure RDs are able to utilize their expertise but still work within their scope of practice in CA. , During a review of the facility’s job description (JD) titled “Clinical Dietitian 1 [one]”, undated, the “JD” indicated, “Knowledge/Skills/Abilities: Applies the. . .state standards as part of the delivery of nutrition care services.” During a review of CA BPC 2586, dated 1/1/2023, the CA BPC 2586 indicated, “The registered dietitian. . .may perform nutritional assessments and initiate nutritional interventions within the parameters of the prescribed diet order pursuant to a licensed health care facility’s approved nutrition screening policy and procedure.””

“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: 39435 Based on observations, interviews, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control, guidelines, and regulations. The facility’s infection control program: 1. Failed to ensure three (3) of 3 previously cleaned, sterilized, and ready for surgical use instrument trays were properly cleaned according to infection control standards when twenty (20) out of sixty-one (61) surgical instruments contained brown staining. 2. Failed to ensure two (2) out of 3 autoclaves (machines used to sterilize patient reusable instruments according to manufacturer’s surgical instruments) were cleaned according to manufacturer’s instructions for use (IFUs). 3. Failed to ensure a clean and intact environment when the floor of the Pik and Pack area of the Sterile Processing (a room where cleaned surgical instruments undergo packaging and high-level disinfection) was noted to be stained, patched with differing patterns of linoleum, with numerous areas of caulking especially under each autoclave and the handwash sink. 4. Failed to ensure that used instruments were manually cleaned according to manufacturer directions in the MIFU (Manufacturer’s Instructions for use), and in accordance with hospital policy and national guidelines followed by the facility. 5. Failed to ensure surgical instruments were cleaned according to Manufacturer Instructions for Use (MIFUs) by using twice the maximum amount of Enzymatic Cleaner recommended by the manufacturer. 6. Failed to follow national guidelines by not providing an eyewash station in the Decontamination Room which is independent of the decontamination sink. 7. Failed to ensure hand hygiene was performed after removing gloves and before donning (putting on) gloves in the gastrointestinal (GI) procedure room. 8. Failed to ensure 3 autoclaves (machines used to sterilize patient reusable instruments according to manufacturer’s surgical instruments) were cleaned according to manufacturer’s instructions for use (IFUs) in the sub sterile rooms of the ORs at the offsite campus surgical hospital. 9. Failed to ensure two lead aprons integrity were intact in the OR at the offsite campus surgical hospital. 10. Failed to ensure clean patient care equipment was not stored in the soiled utility room in the post anesthesia care unit (PACU) at the offsite campus surgical hospital. 11. Failed to ensure hand hygiene was performed after removing gloves in Emergency Department (ED). 12. Failed to ensure nursing staff were not drinking a beverage in the patient care area in the ED. 13. Failed to ensure hand hygiene was performed after removing gloves after performing a blood draw in ED. 14. Failed to ensure hand hygiene was performed after removing gloves and before medication pass on the 3 medical unit. These failures had the potential to result in negative patient care outcomes, cross contamination of equipment, the potential to spread harmful microorganisms to patients and staff, potential to result in procedural and surgical site infections and result in an increased for hospital acquired infections and illness. FINDINGS: 1. On 5/19/25 at 11:15 a tour of the Sterile Processing Department was conducted. Three (3) of three previously cleaned, sterilized, and ready for use surgical instrument trays were opened and inspected in the Sterile Processing Department (SPD). Present for the inspection were Infection Preventionist (IP), Chief Operating Officer COO), Supervisor of Central Supply Supervisor (CSS), SPD Technician (SPDT1), and Director of Surgical Services (DSS). The following concerns were identified: A. On 5/19/25 at 11:50 am, a Major Orthopedic Set (a metal tray containing surgical instruments) with 23 total instruments were inspected. Of the 23 instruments inspected, 9 contained brown stains. B. On 5/19/25 at 12:15pm, a Vaginal Delivery Tray 14 (a metal tray containing surgical instruments used for delivering babies) with a total of 22 instruments was examined. Six (6) instruments contained brown stains. C. On 5/19/25 at 12:40 pm, a NICU RDS Tray 1 (a metal tray containing instruments used for newborn infants who need assistance breathing) with a total of 16 instruments was examined. Five (5) contained brown stains. On 5/19/25 at 1:10 pm, Infection Preventionist (IP), Chief Operating Officer (COO), Supervisor of Central Supply Supervisor (CSS), SPD Technician (SPDT1), and Director of Surgical Services (DSS), acknowledged the above findings, stating “what causes those stains”, and “I have never noticed those stains before.” ANSI/AAMI ST79 record review states: “Spotting, staining, and corrosion also interfere with sterilization. Spores can be protected from destruction by layers of iron oxide (rust). Corrosion can result in a shortened instrument life, which results in increased cost ... ...In a sterile processing department (SPD), there are many processes that are validated before being used. These include cleaning and sterilization processes as specified in the manufacturers’ IFU of instruments. It is important to use the validated processes as they are written, but also to periodically verify that they are working correctly in your facility with your specific water supply, steam supply, machinery, and staff. “ AORN Guidelines for Perioperative Practices (2015). Recommendation X (p629), states “Surgical instruments should be inspected and in correct working order after decontamination and if soiled or defective, should be removed from service until they are cleaned or repaired. Items that are not clean or do not function correctly put a patient at risk for injury or SSI (Surgical sight infection). 2. The hospital failed to ensure two (2) out of 3 autoclaves (machines used to sterilize reusable surgical instruments on patients) were cleaned according to manufacturer’s instructions for use (IFUs). A. On 5/19 at 11:15 am during a tour with the Infection Preventionist (IP), Chief Operating Officer COO), Supervisor of Central Supply Supervisor (CSS), SPD Technician (SPDT1), and Director of Surgical Services (DSS) Autoclave #1, an Amsco Eagle 3000 series sterilizer, and Autoclave #2, an Amsco Century sterilizer were noted to have blackened, charred chambers (the area inside the autoclave where instrument trays are placed for the sterilization process) throughout. B. In a concurrent interview with the CSS, she stated” the Sterile processing department does not clean the autoclave chambers, and that sometimes at night the environment services department (EVS) may clean the outside and the drain in the chamber. The EVS (environmental services) are tasked with cleaning the SPD every night. They mop the floors, clean the walls and ceiling, and packing tables.” C. In an interview on 5/19 at 2:15PM, with the director of environmental services (DEVS) stated, “EVS cleans the SPD area between midnight and 4AM every day. They strip and wax the floor once every 6-7 months, and other nights they clean the floors with Virex Germicide. They do not touch the machines and do not touch the inside or outside of the autoclaves.” A review of the EVS cleaning log for February 2025 shows daily cleaning in SPD consists of “removing trash, relining bin, mop floor, Check and remove waste containers. Terminal cleaning is cleaning ceiling, vents, and walls with non-shedding wipes starting farthest from the door. Saturate floor with cleaning solution (alpha disinfectant), scrub with low-speed machine and pick up solution with wet vacuum. All cleaning should be done with Oxivir. Do not use on floors.” All days are signed off as being completed. In a review of the facility Policy & Procedure titled “Disinfection and Sterilization” the section “Sterilization Equipment, Part C states all sterilizers should have routine cleaning of interior chamber and routine maintenance schedules. Cleaning and maintenance must be logged.” On 5/22/25 at 10 am, a record review of the Steris IFU for Amsco Century Weekly Maintenance (section 11.4-part C) states, “the entire chamber should be wiped down and rinsed following any spills or other soiling. IMPORTANT, Chamber must be at room temperature, sterilizer off all night, before washing. Wash the inside of the chamber and shelf assembly with a mild detergent solution such as STERIS Liqui-Jet or current Steris Equivalent.” On 5/22/25 at 2:30 pm review of the IFUs for the Amsco Eagle (section 4-1) states “Daily Maintenance: 1) clean chamber and loading equipment with a mild detergent solution such as Steris’s Liqui-or Sonic detergents; 2) Rinse with tap water, dry with a lint free cloth; 3) Remove chamber drain strainer. Clean out lint and sediment, reverse flush under running water. Place strainer back in chamber drain; 4) Place strainer back in chamber drain.” 3. The Hospital Failed to Ensure a Clean Sterile Processing Area (SPD). On 5/19/25 at 11:15 am during inspection of the SPD area accompanied by the Infection Preventionist (IP), Chief Operating Officer COO), Supervisor of Central Supply Supervisor (CSS), SPD Technician (SPDT1), and Director of Surgical Services (DSS) the floor was noted to be visually unclean and lacked physical integrity. A. There were multiple heavy black marks approximately 2-3 feet long in front of each of the autoclaves. B. The floor of the SPD had multiple linoleum patches of various colors around the room approximately 6-8 inches square. C. The area immediately in front of each of the autoclaves had long lines of caulking between the floor and the base of the autoclaves that flaked when scratched. D. The area below the handwash sink, where the floor meets the wall had lines of caulking that was disintegrating. E. The floor in front of Autoclave #1 (the Amsco Eagle) had been patched with a metal plate measuring approximately 12 inches by 14 inches, and secured with heavy metal bolts, During a concurrent interview, the COO examined the caulking in each of the areas. Initially when checking the caulking on the newest autoclave he stated, “this is not caulking. He then scratched the white substance with his thumb nail, and said “I guess it is caulking” as it flaked off on his thumb. Upon seeing the long black marks on the floor in front of the autoclaves he stated, “it’s probably floor wax.” He scratched the black marks with his thumbnail, but nothing happened There was no response to why there was a large metal plate was screwed into the floor with heavy bolts in front of autoclave #1. AAMI ST79-2017 states: I. General facility design requirements: All surfaces (e.g., floors, walls, ceilings, cabinets) should be durable, smooth and cleanable. Surfaces that are durable, smooth, and cleanable allow for ease of cleaning and assist in preventing buildup of dirt and debris in crevices. 3.3.5.1 states, “Floors should be level, be constructed of non-particulate or non-fiber shedding materials with withstand daily or more frequent cleaning and the application of chemical cleaning agents; and be uncarpeted. Uneven floors make it difficult to push carts, also, uneven floors can cause items on carts to shake and fall off carts. All surfaces in work areas are subject to spills and splashing and should be regularly and thoroughly cleaned to control microbial contamination and to eliminate accumulated dusk which could act as a carrier for microorganisms. 4. The Hospital Did Not Follow Professional Guidelines It Adopts in the Cleaning of Used Surgical Instruments. On 5/20/25 at 10AM, during a tour of the hospital decontamination room, an observation and interview was conducted with SPDT2 while she was manually cleaning a tray of used instruments. Present for the interview was the facility COO. SPDT2 was cleaning a tray of instruments recently used in a procedure with a brush and Rival Enzymatic Cleaner. Observed was a standard sized sink for manual cleaning of instruments. It was one long continuous sink. Nested upon the rim of the sink were two square plastic containers with water. When SPDT2 was asked how much water was in each square container she stated, “5 gallons of water. I am cleaning these long instruments with a brush using Rival Enzymatic cleaner. The entire instrument did not fit into the plastic container, so I clean them above the container with a brush.” The second plastic container contained RO water for rinsing after cleaning. A third plastic container was not observed. At 12PM a review of the AAMI guidelines the facility follows states, “The standard for manual cleaning of instruments using a three-sink method recommends a three-basin sink configuration: one for presoaking/decontamination, one for cleaning and scrubbing, and one for final rinse with treated water. This approach helps to reduce the risk of cross-contamination and ensure proper cleaning of surgical instruments. ANSI/AAMI ST79:2017:” 5. The Hospital Failed to Ensure Surgical Instruments Were Cleaned According to Manufacturer’s Recommendations. On 5/20/25 at 10:10 AM, during a tour of the hospital decontamination room, an observation and interview was conducted with SPDT2 while she was manually cleaning a tray of used instruments. Present for the interview was the facility COO. The SPDT2 was cleaning a tray of instruments recently used in a procedure with a brush and Rival Enzymatic Cleaner. The Rival cleaner had an automatic dispenser (model Sin-Q) with a label attached to it that stated “0.5 oz/gallon of water”. SPDT2 stated each of the plastic containers she was using held 5 gallons of water, and she put in 5 oz. of Rival Enzymatic Cleaner in the container used for washing. The COO immediately stated, “you mean 2.5 oz.”. SPDT2 replied, “no, I put 5 oz in the 5 gallons of water.” This is twice the amount of enzymatic cleaner recommended in the Rival Instructions for use, and posted on the automatic cleaner dispenser. On 5/20/25 a review of the IFU for Revital Enzymatic Cleaner states, “DIRECTIONS: Manual Cleaning: Dilute 1/8 to 1/2 fl. oz (1 to 4 mL per Liter) per gallon of warm water depending on soil load. It’s essential to follow the Instructions for Use (IFU) provided by the manufacturer of the specific enzymatic cleaner. These IFUs will specify the recommended concentrations and rinsing procedures”...”It is important to follow the label instructions on disinfectants. This includes concentration and exposure times. If a disinfectant is recommended for use at 1 ounce per gallon, it should not be assumed that it would be twice as effective at 2 ounces per gallon. This increase in concentration can cause damage to surgical instruments.” 6. The Hospital Failed to Provide an Eyewash Station in the Decontamination Room that was not Connected to the Decontamination Sink. On 5/20/25 at 10:30 during a tour of the hospital decontamination room, a concurrent observation and interview was conducted with SPDT2 while she was manually cleaning a tray of used instruments. The COO was present. On the counter, immediately to the left of the decontamination sink that SPDT2 was using to clean instruments, an eye wash that was built into the sink counter and could be rotated to a position over the decontamination sink was noted. When the COO was asked if it was an eye wash, he replied “yes, it’s an old fashioned one that’s always been here with this sink.” ANSI/AAMI ST58:2024 states, “Eyewash stations should not be in a location that requires flushing of the eyes in a decontamination sink. Plumbed eyewashes/facewashes and showers should be activated weekly for a period long enough to verify operation and ensure that the flushing solution is available. When activating plumbed eyewashes, eye/face washes, and showers, personnel should also verify that they are providing lukewarm, tepid water (between 15°C and 43°C [60°F and 100°F]) (ANSI/ISEA Z358.1). Routine testing should be documented” 39520 7. During an observation on 5/21/25, at 12:03 p.m., in the GI procedure room, an anesthesiologist resident (Resident 1) administered medication to a patient (Patient 104) through the IV (intravenous- in the vein) and was wearing gloves. After finishing the medication administration and removing the gloves, Resident 1 did not perform hand hygiene and proceeded to chart in the medical record. A second observation at 12:03 p.m., the attending anesthesiologist (MD 2), was performing oral suctioning to Patient 4. After the oral suctioning, MD 2 removed his gloves and put on a new pair of gloves without performing hand hygiene. During an interview on 5/21/25, at 12:05 p.m., with the Infection Preventionist (IPC), IPC was informed of Resident 1 and MD 2 not performing hand hygiene when donning (taking off) and doffing (putting on) gloves. The IPC acknowledged and confirmed the observation and verbalized both anesthesiologists should be performing hand hygiene when donning and doffing gloves. During a review of the facility’s policy and procedure (P&P) titled, “Hand Hygiene and Surgical Hand Scrub” dated 7/20/22, indicated in part... “Hand hygiene practices are the single most effective way to prevent the spread of infecting microorganisms, reduce cross-infection, and provide a practice to promote health in daily living ...VI. Procedure: A. Indications for Hand Antisepsis (either hand wash or hand rub): 3. Decontaminate hands before and after having direct contact with patients, whether or not gloves are worn ...10. Decontaminate hands after removing gloves ...” 8. During a concurrent observation and interview on 5/22/25 at 9:40 a.m., with the Director of Surgical Services (DSS) during a tour of the sub sterile room between operating room 5 & 6, at the off campus surgical hospital, an autoclave (Autoclave # 5) was observed. Inside the chamber (the area inside the autoclave where instrument trays are placed for the sterilization process) there was white substance observed on the bottom and sidewalls of the chamber. When asked if there was routine maintenance and cleaning that needed to be performed on the autoclave, on a daily, weekly, and monthly schedule, the DSS did not know and would have to ask the sterile processing department (SPD) for the autoclave reports (CensiTrac), and the manufacturer’s instructions for use (IFU’s). DSS verbalized the autoclaves in the sub sterile rooms are hardly used and acknowledged they still need to be maintained and ready for use. During a second concurrent observation and interview on 5/22/25 at 10:30 a.m., with DSS in the sub sterile room between operating room 3 & 4, an autoclave (Autoclave # 4) was observed. Inside the chamber there was dark black charred substance on the bottom of the chamber and white substance observed on the sidewalls of the chamber. The inside surface of the door to the autoclave, had black substance observed all around the bottom of the rubber door gasket. DSS acknowledged the inside of the chamber and the door gasket to Autoclave #4 were not clean. During a review of the Manufacturer’s Instructions for Use (IFU’s) for the Autoclaves (#5 & #4) indicated... “Daily Maintenance indicates to...1. Clean chamber drain strainers...2. Clean chamber whenever soiled and to have professional cleaning on a yearly basis... Weekly Maintenance indicates to...1. Clean & Flush chamber drain...” There was no monthly routine maintenance. During a concurrent interview and record review on 5/27/25 at 4:30 p.m., with DSS, the daily tasks log for routine maintenance and cleaning the autoclaves, and the SPD autoclave reports (Censi trac) were reviewed. DSS acknowledged there was no documentation of routine maintenance and cleaning of the autoclaves on the daily task log and no documentation on the Censi trac report. DSS acknowledged the staff were not following the routine maintenance and cleaning schedule per the IFU’s and should be. 9. During a concurrent observation and interview on 5/22/25, at 10:17 a.m., with the Director of Surgical Services (DSS) lead aprons were observed hanging on a rack inside of operating room (OR) #1 at the off campus surgical hospital. The blue lead apron was observed to have frayed material on the front side of the apron, and the purple lead apron had a tear on the front side of the apron. DSS acknowledged both the lead aprons integrity were not intact, and would need to be removed from service, and repaired. DSS acknowledged the lead aprons are unable to be clean properly when the integrity of the lead apron is compromised. DSS further acknowledged the lead aprons should be cleaned after each use. During a review of the facility’s policy and procedure (P&P) titled, “Lead Apparel and Protective Devices” revised date 3/20/19, indicated in part... “To ensure that protective lead apparel and other protective devices are free of defects due to damage or normal wear, inspection of each item and device will be conducted. Damaged lead apparel and devices will be removed from service for repair or disposal...Cleaning: any lead apparel that appears visibly soiled will be cleaned with the approved lead apparel cleaner (Scrubbles). No unapproved cleaner shall be used on the apparel as it may cause damage or loss of integrity to the lead. Cleaning will occur during the time of annual inspection or any time the apparel is found to be visibly soiled...” 10. During a concurrent observation and interview on 5/22/25, at 10:49 a.m., with the Director of Surgical Services (DSS), the soiled utility room was observed in the post anesthesia care unit (PACU) at the offsite campus surgical hospital. The soiled utility room contained red biohazard trash bins, regular trash bins, soiled equipment, dirty linen, and a hopper sink (a large deep sink primarily used for disposing of clinical waste in the healthcare setting, and designed for hygienically discarding items like bedpans, vomit bowls, and drainage bags). Behind the door in the soiled utility room, was a patient bedside commode (a portable toilet) with a tag attached to it stating “clean” and a patient two wheeled walker with a tag attached to it stating “clean”. When asked it the clean patient care equipment should be stored in the soiled utility room, DSS verbalized the storage of clean patient care equipment in the soiled utility room was not the ideal storage area and acknowledged the clean equipment should not be stored in there. DSS further acknowledged clean equipment should be separated from dirty equipment. During a review of the facility’s policy and procedure (P&P) titled, “ Surgery and Operative Suites Infection Control practices “ dated 6/22, indicated in part...”Patients, personnel, physicians and outside personnel present in the operating room suites will prevent and control the spread of infection through protocols designed for the operating room environment...B. Supplies: Traffic patterns for clean and sterile supplies are separate from patterns of soiled equipment and waste (utilize different corridors). 51706 11. During an observation on 5/19/2025 at 12:30 p.m. in the Emergency Department, an Emergency Department Technician (EDT) disposed of soiled linens in the hall linen bag, removed gloves, but did not perform hand hygiene (cleaning hands with soap and water or using alcohol-based sanitizers) prior to touching medical equipment. During an interview on 5/19/25 at 12:35 with Emergency Department Supervisor (EDS), EDS stated the process for hand hygiene after removing gloves would be to use soap and water or the wall sanitizer dispensers. EDS agreed that by not performing hand hygiene after glove removal, the tech was not following facility hand hygiene practices. During a review of the facility’s policy and procedure (P&P) titled, “Hand Hygiene and Surgical Scrub” dated 7/20/2022, the P&P indicated in Section VI. Procedure, Subsection A. Indications for hand Antisepsis (either handwash or hand rub): Item 10. “Decontaminate hands after removing gloves.” 48380 12. During a concurrent observation and interview on 5/19/25 at 3:30 p.m. with the Registered Nurse (RN 4) in the ED triage a personal drink tumbler was observed on top of a computer on wheels in the direct patient care area of triage. RN 4 stated staff food and drinks should not be in the direct patient care areas. During an interview on 5/19/25 at 3:40 p.m. with the Emergency Department Supervisor (EDS) in the ED triage, the EDS stated food, and drinks are not to be in direct patient care areas. 13. During a concurrent observation and interview on 5/19/25 at 3:45 p.m. RN 4 the ED triage, blood work was being drawn from PT 600. RN 4 attempted an IV start and blood culture and blood draw resulting in 2 failed attempts. Between attempts, RN 4 doffed gloves, gathered more equipment and failed hand hygiene between attempts before donning new gloves. RN 4 stated she was aware of the failed attempts and stated she should have performed hand hygiene between donning and doffing gloves. During a review of the facility’s policy and procedure (P&P) titled, “Bloodborne Pathogen Exposure Control Plan”, dated 12/2024, the P&P indicated, “Prohibited work practices to protect staff from blood or other potentially infectious materials (OPIM): Eating, drinking...in work areas where there is reasonable likelihood of occupational exposure. Hand hygiene to include appropriate use of alcohol hand rub before donning and after removal of gloves.” 39912 14. During an observation of a nurse with the Director of Telemetry and Medical/Surgical (DTMS) in room 3154 at 3 Medical unit on 5/19/25 at 3:43 p.m., the nurse was taking the patient’s vital signs, after taking the vital signs the nurse proceeded to give the patient a medication. The nurse handled the medication without sanitizing her hands and gave the medication to the patient. During an interview with the DTMS on 5/19/25 at 3:50 pm, the DTMS acknowledged the nurse should have sanitize her hands after taking the vital signs before the medication pass. The facility policy and procedure titled “Hand Hygiene And Surgical Hand Scrub” dated 7/20/22 indicated “Decontaminate hands after contact with a patient’s intact skin (eg. When taking a pulse or blood pressure and lifting a patient.”

“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: 40678 Based on observation, interview, and record review the hospital staff failed to implement the Emergency Medical Treatment and Labor Act (EMTALA) and related policies and procedures when it failed to: 1. Document the ongoing evaluation of vital signs for Patient 6 and Patient 8 while in the emergency department (ED). 2. Obtain a physician order to transfer Patient 2, Patient 3, and Patient 6 from the ED to another facility. 3. Check crash carts (portable cart that carries emergency medical equipment and medications to treat patients experiencing medical emergencies) every shift in the ED. These facility failures had the potential to result in negative patient outcomes, jeopardizing the quality and safety of patient care. Findings: 1. During a concurrent interview and record review on 9/24/24 at 3:14 pm with the EDD. EDD confirmed that Pt 6 and Pt 8 did not have their vital signs monitored every 2 hours per facility policy. Review of Pt 6’s medical record indicated, Pt 6 was given an acuity level (measurement of the severity of a patient’s illness or medical condition) of 2 in the ED. Pt 6’s first set of vital signs were documented at 7:02 p.m. on 7/6/24, the next set of vital signs was documented at 2:30 a.m. on 7/7/24. Review of Pt 8’s medical record indicated, Pt 8 was given an acuity level of 3 in the ED. Pt 8’s first set of vital signs were documented at 7:35 p.m. on 7/25/24, thee next set of vital signs was documented at 10:19 p.m. on 7/25/24. During a review of the facility’s policy and procedure (P&P) titled, “Assessment/ Reassessment of Patients,” dated 5/2021, the P&P indicated, “Reassessment is performed by the RN’s and physicians based on the assessed acuity level...Level 2 Emergent VS every 30-60 mins until stable, then per admit level of care or every 2 hours as appropriate...Level 3 Urgent VS every 2 hours if stable, then per admit level of care or every 2 hours until discharge.” 2. During a concurrent interview and record review on 9/20/24 at 2:50 p.m., with the Quality Director (QD) and the Regulatory Compliance Director (RCD), QD and RCD confirmed that a physician’s order is required to transfer a patient per facility policy and procedure. Pt 2, Pt 3, and Pt 6 were transferred from the ED to another facility without a physician’s order. During a review of the facility’s policy and procedure (P&P) titled, “EMTALA - Transfer Policy,” dated 2/2016, the P&P indicated, “Any transfer of an individual with an EMC must be initiated either by a written request for transfer from the individual or the legally responsible person acting on the individual’s behalf or by a physician order with the appropriate physician certification as required under EMTALA.” 3. During a concurrent observation, interview, and record review on 9/20/24 from 10:43 a.m. until 10:49 a.m. with the EDD, EDD confirmed that review of facility form titled, “Crash Cart Control Sheet,” dated September 2024 indicated, crash carts #8, #1, #39, and #30 were not checked every shift. During a review of the facility’s policy and procedure (P&P) titled, “Cardiopulmonary Emergency Protocol,” dated 2/2024, the P&P indicated, “An external defibrillator is located on every crash cart...Every defibrillator is evaluated for operational readiness on a routine basis...For departments open 24/7, units will be checked once each shift...Both the External Paddle cable and the Defibrillator Pad/Test Load cables will be checked...Crash carts will be checked by the designated unit personnel at least once a shift...This check includes: lock integrity...The suction unit will be tested to ensure minimum vacuum of 40 mmHg...The oxygen tank will be checked to ensure a minimum volume of 1000 PSI...” 35399”

“RECEIVING AN INAPPROPRIATE TRANSFER CFR(s): 489.20(m) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to report to CMS or the State survey agency any time it has reason to believe it may have received an individual who has been transferred in an unstable emergency medical condition from another hospital in violation of the requirements of §489.24(e). This Standard is not met as evidenced by: 35399 Based on interview and record review, the recipient/receiving hospital [Hospital B] failed to report to the State agency or Center for Medicare/Medicaid services (CMS) that the hospital had received the transfer of Patient 19 (mother) and Patient 20 (newborn) into their labor and delivery (L&D) unit, via emergency medical service (EMS) ambulance from the sending hospital [Hospital A] emergency department (ED), without patients being provided with a medical screening examination (MSE), determine if patients had an emergency medical condition (EMC), and stabilized the patients before the patients were inappropriately transferred to Hospital B’s L&D unit. Hospital B’s failure resulted in hospital violating the emergency medical treatment and labor act EMTALA requirements. Findings: A review of the document titled “Ventura County, American Medical Response (AMR) Electronic Patient Care Report”, dated 6/1/24 at 8:04 and 36 seconds, indicated “E46 arrived at a single-family residence to find one female patient (Patient 19) in a hands and knees position with crowning present. Patient stated she was having contractions and started to bear down. Baby (Patient 20) was delivered with no complications. Both were transported with AMR initially to Hospital A, then diverted to Hospital B.” During an interview with Patient 19 on 9/25/24 at 4:45 p.m., patient reported that on 6/1/24 morning at around 8:11 am, she delivered her baby at home. Patient stated “I literally pushed when the paramedics were walking thru the door into my house, and they caught the baby. They were going back and forth whether they were going to take me to Hospital A or Hospital B. My first stop was at Hospital A. When we arrived at Hospital A, there were two nurses standing at the sidewalk and they were telling the paramedics that Hospital A does not have an L&D department. The paramedics said “Well, when I called you, you told me to bring her here.” I heard them arguing back and forth between the nurses and the paramedics. The paramedics were pushing for me to be treated at Hospital A to deliver the placenta, stitch me up because I had a laceration and transfer me to Hospital B for further care. But the two nurses were telling the paramedics “No, you cannot bring her here, we do not have L&D, she cannot stay here.” The paramedics finally decided to take me to Hospital B. Patient was asked if any Hospital A doctor came out to see her in the ambulance. Patient stated “No, there were only two nurses, no doctor standing at the sidewalk, where the ambulance parked.” Patient was asked if she requested to come to Hospital B when she was at Hospital A’s ED. Patient stated “No”. Patient was asked if staff at Hospital B, L&D department asked her if she had been at Hospital A, first, before coming to Hospital B. Patient stated “No, no one asked but I would assume the paramedics told them. I think, I heard the paramedics telling them...” Review of Hospital A’s document titled “Emergency Department Reports, dated 6/8/24 at 12:15 p.m., indicated chief complaint: LATE ENTRY: brought in by BIB AMR s/p delivery approximately x 15 minutes...holding baby in arms...per paramedics’ placenta not delivered, cord clamp not cut... History (History of Present illness) we were contacted by paramedics regarding a live birth. Apparently, the patient is full term and had given birth at home. During a phone conversation with the paramedics, it was our recommendation that the patient be brought to this facility for evaluation, stabilization, and eventual transfer. The paramedics had arrived shortly thereafter. In the ambulance she stated to the emergency medical technicians (EMT’s) that she would prefer to be transferred to [Hospital B’s name] with her child. I therefore had no direct contact with this patient at any time. I never spoke to her directly. She always remained in the ambulance...under the circumstances the paramedics were told to take the patient and child to Hospital B. Hospital A’s transfer document indicated, Transfer Disposition: Yes. Registered Nurse (RN) receiving report: LD Charge. Transported to: Hospital B’s name LD. Date/Time of Transport: 6/1/24 at 08:36 PDT. Estimated time of arrival: 6/1/24 at 08:56 PDT. Reason for transfer: Higher level of care. Hospital A’s document titled “Working View Sections”, in the Textual Results part of the document indicated “6/1/24 08:34 PDT (Clinical Note ED) LATE ENTRY: spoke to LD RN @ Hospital B’s name and made aware of patient coming with ETA 20 minutes. 6/1/24 08:34 PDT (Clinical Note ED) LATE ENTRY: notified Hospital B’s name ER charge regarding incoming LD patient.” Hospital A base station to Hospital B base call transcript: “8:39 a.m., nine seconds. June 1, 2024. Robles 239. Hi Robles, this is Simi base. Alright. We have 433 is coming to you with about a 15-minute ETA. They have mom who was 40 weeks pregnant. Who delivered in the field. Baby and Mom are both stable and doing well. They delivered approximately 15 minutes ago. I don’t have any vital signs. I know mom has access. Think that’s it. OK, OK. Bye. Bye.” Review of Hospital B’s medical records for Patient 19 and Patient 20 was conducted on 9/19/24, 9/20/24 and 9/24/24. During an interview with Hospital B’s emergency department director (EDD) on 9/19/24 at 12:05 p.m., the EDD reported that when the EMS base station staff contacts Hospital B’s base station, they speak to the MICN nurse to provide the age of the patient, the location where the patient was picked up, the gender, a brief situation of the patient’s condition and will provide the ETA to hospital. Mobile Intensive Care Nurse (MICN): RN authorized by the Medical Director of the local Emergency Medical Services (EMS) agency to provide prehospital advanced life support (ALS) or issue instructions to prehospital emergency personnel within an EMS system according to standardized procedures developed. The MICN nurse documents this information on the template sheet which is scan or uploaded into the patient’s medical record. If the patient coming to us is a woman in labor some MICN nurses will call the L&D to notify them the patient is coming and report the information provided by the EMS base station staff. Other MICN nurses will report the information to the ED charge nurse, for the charge nurse to call L&D to notify them patient is coming to them. During a review of the American Medical Response (AMR) Ventura County Electronic Patient Care Report (run sheet), incident number 24-0044789, dated 6/1/24 at 08:04 am and 36 seconds with the EDD on 9/19/24 at 3:55p.m., the EDD reviewed the report thoroughly and stated “It looks like this patient (Patient 19) delivered the baby at home, was initially transported to Hospital A, then, someone directed EMS to bring patient to us. Patient was diverted to Hospital B. If patient would have requested to be transfer to Hospital B, this would have been documented on this run sheet. And this would have occurred through a physician-to-physician transfer. The physician at Hospital A would have contacted the physician at Hospital B and the patient would have been accepted. But then, there would have been some transfer paperwork. This is weird, the patient was taken to Hospital A, first then, diverted to Hospital B, here it doesn’t say the reason why patient was rerouted to Hospital B ...this is weird, there was something wrong with this patient transportation ...” During an interview with Hospital B’s MICNRN on 9/20/24 9:45 a.m., MICNRN stated “I took the call on that date 6/1/24. I recall, the call came from Hospital A. Report from Hospital A, RN indicated, there was a pregnant woman who had delivered the baby in the field. Patient was stable and she was coming to our hospital. I wrote the information on the sheet (template sheet). I notify one of the ED doctors, I don’t remember which doctor, and the charge RN, of the patient coming in to us from Hospital A ... No, I did not call the labor and deliver department to notify them the patient was coming and was on her way to the L & D.” During a concurrent review of Patient 19’s medical record and interview with L&D RN (RN1) on 9/20/24 at 2:00 p.m., RN 1 reported Patient 19 was brought in by EMS ambulance on 6/1/24. RN 1 conducted an MSE at 9:42 a.m. RN 1 was asked what the report was the EMS staff provided to her. RN 1 reviewed the entire record and was not able to find the information reported to her from EMS staff. RN 1 stated “I don’t remember what EMS staff said to me regarding the patient. Or if I was the one who took the report from EMS. There were several nurses when the patient first arrived. I just happened to document the MSE. This was not my patient. I think [RN 2’s name] was the primary nurse for this patient according to the record.” RN 1 was asked to show in the record where it indicated the patient’s placenta had been delivered or the status of the placenta, at the time of patients arrival to the L&D. RN 1 navigated the patient’s medical record for a while, however, RN 1 was not able to locate anywhere in the record the status of the placenta, at the time of the patient’s arrival to the L&D unit. Then, RN 1 reviewed the EMS run-sheet and stated “It looks like this patient was taken to Hospital A first and then the patient was brought here to Hospital B. If the patient was taken to Hospital A, then patient would have been a transfer to us (Hospital B). In this case, the Hospital A doctor would have contacted one of our doctors for one of our doctors to accept the patient and then transfer the patient here.” RN 1 was asked if on 6/1/24, RN was aware Patient 19 was coming to the unit or was notified by the ED staff that this patient was coming to their unit via EMS. RN 1 stated “No, I was not aware.” During a concurrent review of Patient 19’s medical record and interview with L&D RN (RN2) on 9/20/24 at 2:35 p.m., RN 2 confirmed being present when Patient 19 arrived at the L&D unit on 6/1/24. RN 2 was asked to show in the record where it indicated the patient’s placenta had been delivered or the status of the placenta, at the time of patients arrival to the L&D. RN 2 navigated the medical record for a while, however, RN 2 was not able to locate anywhere in the record the status of the placenta, at the time of the patient’s arrival to the L&D unit. RN 2 was asked if on 6/1/24, RN was aware Patient 19 was coming to the unit or was notified by the ED staff that this patient was coming to their unit via EMS. RN 2 stated “No, I was not aware.” During an interview with Hospital B’s L&D charge nurse (CN) on 9/20/24 at 3:36 p.m., CN was asked if on 6/1/24 CN receive a call from the ED staff to notify CN that a patient who had delivered her baby at home was coming to the L&D department via EMS ambulance. CN stated “No I don’t recall getting a call from the ED to notify us that a patient who had delivered a baby out on the field was coming to our department. But they don’t always notify us.” CN further reported that approximately 75 to 80% of the time they don’t get a call from the ED to notify them patients are coming to their unit.” During an interview with Hospital B’s obstetrics physician (OBP) on 9/24/24 at 10:14 a.m., the OBP stated “I remember the patient coming to the L&D on a stretcher by EMS. Patient had delivered baby at home. I remember repairing a perineal laceration. Patient have been brought here for further care.” OBP was asked if OBP deliver the patient’s placenta. OBP stated, “No, the placenta had not been delivered. I deliver the placenta after patient arrived at the unit.” The OBP was asked if the patient’s labor and delivery process had been completed when patient arrived at the L&D unit. OBP stated “No, there are three stages of labor. The first one is the contractions. The second is the delivery of the baby. The third is the delivery of the placenta. Once the placenta has been delivered, at that point, you can consider or say that the labor and delivery process is complete.” The OBP was asked if Patient 19’s labor and delivery process had been completed prior to arrival. OBP stated “No.” During an interview with the L&D director (LDD) on 9/24/24 at 10:58 a.m., the LDD indicated the expectation was that the RN receiving the report from the EMS staff would document the report content in the record. Communicated to the LDD that if the EMS report content would have been documented in Patient 19’s medical record then staff would have known that this patient had been transported to Hospital A, first, before being diverted here to Hospital B. The LDD was asked again, if it was normal for an EMS ambulance to arrive to their L&D unit with a patient who had delivered at home, without the L&D unit being notified of the patient’s arrival. LDD stated “No, it’s not normal.” LDD was then asked, if this is not normal, then the L&D nurse would have questioned the EMS staff, the reason for them showing up to L&D unit without anyone calling to the unit to notify them of their arrival. This event or incident would have triggered for an L &D management member to investigate this incident. If a management member would have investigated this event/incident, that member would have found out, by reviewing the run sheet (EMS report) that this patient was taken to Hospital A first and then patient was re-routed or diverted to Hospital B. As per EMTALA regulations, if EMS transported Patient 19 and 20 to Hospital A’s ED, the patients should have been provided with a medical screening examination MSE, determine if an emergency medical conditions EMC exists, stabilize the patients with the ED capabilities and then transfer the patients to Hospital B that has L&D services which the patients required, and Hospital A does not have. This incident should have been reported to the State agency or CMS by Hospital B. The receiving hospital has a responsibility to report suspected incidences of individuals with a possible EMC being transferred to another hospital without the appropriate transfer method, paperwork etcetera. Hospital B was aware Patients 19 and 20 were transported first to Hospital A’s ED where no care was provided, instead patients were rerouted to Hospital B. Hospital B administration failed to do their due diligence in investigating this incident and reporting it as a possible EMTALA violation. The LDD stated “Yes, ok. I understand” acknowledging that herself or someone in the management team should have investigated the incident. Then, they would have found out the patients were denied care at Hospital A’s ED, this is the reason patients were re-routed to Hospital B. As a result of that finding Hospital B was mandated to report the incident as a possible EMTALA violation and they did not report this. During an interview with the regulatory compliance director (RCD) on 9/24/24 at 11:30 a.m., the RCD was asked if this incident was reported to the State agency or CMS. RCD stated, “No I did not report it to California Department of Public Health CDPH because I was not aware.””

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 40678 Based on interview and record review the facility failed to maintain the accuracy and completeness of the Emergency Department (ED) Emergency Medical Treatment and Active Labor Act (EMTALA) Central Logs when: 1. No disposition, chief complaint, or gender of the patient was documented. 2. Patient 4’s (Pt 4) disposition on log was inaccurate. These failures resulted in the ED EMTALA Central Logs to be inaccurate, incomplete, and out of compliance per regulation. Findings: During a concurrent interview and record review on 9/24/24 at 3:25 p.m. with the emergency department director (EDD), EDD confirmed that the ED EMTALA central logs reviewed for July 2024 and August 2024 were missing disposition, chief complaint, and gender of the patient for multiple patients. During a concurrent interview and record review on 9/24/24 at 3:30 pm with the EDD. EDD confirmed that Pt 4 was discharged home, the disposition on the ED EMTALA Central Log for Pt 4 indicated, “Was Stabilized & Transf’d”. Additionally, EDD confirmed the information on the ED EMTALA Central Log in the disposition column should have the correct information. During a review of the facility’s policy and procedure (P&P) titled, “EMTALA - Central Log Policy,” dated 10/2022, the P&P indicated, “All hospitals must maintain the Central Log in an electronic format...The Central Log...must contain at a minimum, the name of the individual, the date, time and means of the individual’s arrival, the individual’s sex, the individual’s record number, the nature of the individual’s complaint, the individual’s disposition, the individual’s time of departure...””

“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: 35399 Based on interview and record review, the hospital failed to ensure a labor and delivery (L&D) registered nurse (RN) performed a medical screening examination (MSE - process required to reach, with reasonable clinical. confidence, the point at which it can be determined whether the individual has an emergency medical condition EMC or not) to Patient 21 when patient presented to the L&D unit seeking medical attention for fetal concerns prior to patient being admitted to the unit. The hospital’s failure had the risk of patient’s delay in treatment and potential for negative outcome. Finding: A review of the P & P titled “EMTALA- Medical Screening Examination and Stabilization Policy”, dated 9/2022, indicated “An EMTALA obligation is triggered when an individual comes to a dedicated emergency department (DED) and the individual or a representative acting on the individual’s behalf request an examination or treatment for a medical condition... such obligation is further extended to those individuals presenting elsewhere on hospital property requesting examination or treatment for an emergency medical condition (EMC)...then an appropriate MSE, within the capabilities of the hospital...shall we performed.” During a concurrent review of Patient 21’s medical record and interview with the labor and delivery director (LDD) on 9/24/24 at 3:37 p.m., the record indicated patient was a 32-year-old female with intrauterine pregnancy at 38.5 weeks. Patient have had two prior visits to L&D unit within 24 hours. Patient returned to the L&D unit on 5/5/24 at 6:37 a.m., with complaints of fetal concerns. LDD reported during this patient’s visit there was no triage or no MSE conducted by the night RN. It was at change of shift. The nurse communicated to the doctor the patient’s condition at 7:12 a.m. The oncoming nurse did the first assessment at 7:30 a.m., after the patient was admitted to the L&D unit. The LLD reviewed the patient’s 3rd visit records in efforts to locate the MSE that was conducted. However, LDD was not able to locate the MSE documentation for this visit. Therefore, LDD reconfirmed that there was no MSE conducted for the patient’s third visit prior to patient’s admission and delivering her baby. LDD stated “No, there’s no MSE for this visit or patient’s encounter by [L&D night RN’s name]”.”

“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: 39520 Based on interview and record review the facility failed to: 1. Obtain or attempt to obtain an informed refusal of examination (medical screening exam-MSE) form for Patient 100 and failed to inform Patient 100 of the risks of refusing treatment. 2. Obtain or attempt to obtain a leaving against medical advice (AMA) form for Patient 100 and failed to inform Patient 100 of the risks of leaving AMA. 3. Ensure there was documentation that 2 out of 22 sampled patients (Patient 103 and Patient 101) had been informed of the risks of leaving AMA. These failures had the potential to violate the patient’s right to know about the medical risks of leaving AMA and refusing treatment. Findings: 1. During a review of the facility’s EMTALA (Emergency Medical Treatment and Labor Act) and MSE/ Labor and Delivery Competency 2020, indicated in part ... “Medicare-participating hospitals that offer emergency services to provide a Medical Screening Exam (MSE) when a request is made for examination for an emergency medical condition (EMC), including active labor, regardless an individual’s ability to pay. Hospitals are then required to provide stabilizing treatment for patients with EMC’s ...Medical Screening Exam (MSE): An MSE must be done on all patients that arrive seeking an examination for an emergency medical condition. We are required to determine if a women is in active labor or not “after a reasonable amount of observation ...” REFUSAL OF SERVICE: If a patient chooses to decline an examination or desires to leave the hospital prior to the completion of the MSE, the RN must inform the patient that there may be an “unfavorable outcome to either the mother or the baby (fetus) as we have not been able to complete out examination ...” The patient must be asked to sign the WAIVER OF RIGHT TO REFUSE A MEDICAL SCREENING EXAM ...If she signs it, it must be retained in the medical record ...If she refuses to sign it, document that you have informed her of the possibility of an unfavorable outcome by not following through with the MSE and document that she was asked to sign the waiver and refused ...” During an interview on 10/20/23, 3:40 p.m., with the director of perinatal services (DOPS), DOPS was asked about a medical screening exam. When asked what the medical screening exam consists of in labor and delivery, DOPS verbalized the MSE consists of a physical assessment, asking about medical history, chief complaint, putting the patient on the fetal monitor, determine if contracting, and a vaginal exam. During a review of the facility’s policy and procedure (P&P) titled, “Medical Screening Exam of Patients Presenting to the labor and delivery Department” dated 11/2022, indicated in part ... “Medical Screening Examination Procedure ...2. Procedure ...a. patient presents to labor and delivery and is admitted for observation ...b. patient is given a gown to change into and instructed to provide a urine sample for urinalysis dipstick purposes ...c. place patient in bed, place external tocodynameter (a machine that reads uterine contractions) and ultrasound monitor (used to record the baby’s heartbeat) on abdomen ...d. Perform assessment: complete observation history/assessment including admission vital signs ...obtain prenatal records, if available ...obtain fetal monitor strip and evaluate fetal wellbeing ....perform vaginal exam if indicated include dilation, baby presentation, and status of membranes (bag of water) ...assess uterine activity ...perform nursing assessment ....complete medical screening exam scoring form to determine requirement of MD’s presence ...consult with physician ...receiving orders ...receive, document, and carry out orders: if patient is admitted ...if patient is discharged ...if patient is to be transferred ...” During a review of Patient 100’s “L&D Labor Notes” dated 10/3/23, at 10:20 p.m., the notes indicated Patient 100 refused the sterile vaginal exam. The midwife and the father of the baby stated that Patient 100 is refusing an exam and demanded to be admitted. At 10:30 p.m. the notes indicated MD 1 was at the bedside assessing Patient 100. Patient 100 refused to be assessed by MD 1. Further review of Patient 100’s medical record had no documentation about the risks of refusing an MSE and no documentation that an MSE refusal form was completed. During an interview on 10/20/23, at 5:36 p.m., with licensed nurse (RN 2), RN 2 was asked about Patient 100 on the night of 10/3/23. RN 2 verbalized Patient 100 arrived at labor and delivery with a midwife (CP 1) and her husband. Patient 100 was in labor and having painful contractions. RN 2 verbalized walking into Patient 100’s room to help the other nurse (RN 1) with the admission. RN 2 verbalized that RN 1 indicated she needed to do a quick assessment first to check to see how far Patient 100 was dilated. RN 2 verbalized the midwife said they are refusing the vaginal exam. RN 2 then verbalized MD 1 walked in the room to do a vaginal exam. RN 2 verbalized the midwife, and the husband were rude and refused the exam. RN 2 verbalized MD 1 stepped out of the room and went to the nurse’s station. RN 2 verbalized Patient 100 did not want to be checked against her will. When asked how long this conversation was, RN 2 verbalized 5-10 minutes. RN 2 verbalized leaving the room and going back to the nurse station. When asked about MSE refusal and filling out a refusal form, RN 2 verbalized there was no signing of any form. During an concurrent interview and record review of Patient 100’s medical record on 11/13/23, at 10:47 a.m., with the OB physician (MD 1), MD 1 was asked about Patient 100 and the refusal of the medical screening exam (MSE). MD 1 verbalized the MSE consists of doing a physical “head to toe” assessment, listening to the baby, and a vaginal exam. MD 1 verbalized if a patient refuses an exam, would try to find out what was the reason for refusal. MD 1 verbalized the midwife and husband were cursing at MD 1, MD 1 stepped out because she was concerned for her safety. MD 1 verbalized going back to the nurse’s station. When asked about informing Patient 100 about the risks of refusing the MSE, MD 1 verbalized not at that time. MD 1 stated security personnel was at the nurses station, but did not take security personnel to Patient 100’s room, to discuss risk of MSE refusal. Review of Patient 100’s medical record indicated Patient 100 was on the unit for 55 minutes, however MD 1 stated “Did not have time to discuss MSE refusal.” During a review of the facility’s policy and procedure (P&P) titled, “Scope of Service Labor & Delivery” dated 7/2021, indicated in part ... “Governing Rules of The Unit ... “f. The nursing staff may alter these visiting regulations at their discretion, as warranted by the patient’s condition and the activity within the unit. Security personnel are available to help control visitors ...” 2. During a review of the facility’s policy and procedure (P&P) titled, “AMA: Leaving Against Medical Advice” dated 3/19, indicated in part ... “When a competent patient wishes to leave the hospital without a discharge order from the attending physician, the clinical hospital staff should facilitate communication to address any underlying quality of care issues, and the pertinent medical staff should make diligent efforts to inform the patient of possible implications of leaving against medical advice ...The clinical hospital staff is responsible for complete documentation of the incident in the patient’s medical records. A diligent effort should be made to have the patient read and sign the “Leaving Hospital Against Medical Advice” form.” During a review of Patient 100’s “L&D Labor Notes” dated 10/3/23, at 10:50 p.m., the notes indicated Patient 100 left against medical advice (AMA) with the midwife. Patient 100 took off the monitors and had midwife put her in a wheelchair and left. Further review of Patient 100’s medical record had no documentation about the risks of leaving AMA and no documentation that an AMA form was completed. During an interview on 10/27/23, at 3:06 p.m., with licensed nurse (RN 1), RN 1 was asked about Patient 100 on the night of 10/3/23. RN 1 verbalized MD 1 came out of Patient 100’s room, back to the nurse’s station, indicating they (midwife and husband) refused the vaginal exam and were verbally abusive. MD 1 called security and the house supervisor. RN 1 verbalized the midwife comes out to the nurse’s station and stated out loud, “I need Patient 100’s medical records back, we want to leave.” RN 1 verbalized giving the records back to the midwife. RN 1 verbalized seeing the husband and midwife pushing Patient 100 out of the unit in a wheelchair. When asked if anyone had Patient 100 sign the leaving against medical advice (AMA) form and explain the risks of leaving to the patient, RN 1 verbalized printing out the form, but MD 1 said, “Don’t even bother, do not approach them, and do not ask for a signature.” RN 1 stated, “We all heard he midwife say we are going to leave.” RN 1 acknowledged the risks of leaving AMA were not explained to the patient and the AMA form was not filled out. During an interview on 11/13/23, at 10:47 a.m., with the OB physician (MD 1), MD 1 was asked about Patient 100 leaving AMA. MD 1 verbalized not knowing Patient 100 was leaving AMA. MD 1 was informed, staff verbalized you told them not to approach Patient 100, and do not have them sign the AMA form. MD 1 stated, “I was not physically going to go and have them sign the form because they were being hostile towards me.” MD 1 acknowledged security personnel was at the nurse’s station. 3. Review of Patient 103’s medical record indicated Patient 103 was seen by the emergency room doctor (EDMD 1), on 7/10/23, at 9:24 p.m. with the diagnosis of chest pain and palpitations. Patient 103 left AMA (against medical advice) on 7/10/23, at 9:40 p.m. Further review of the medical record for Patient 103, did not reveal any documentation of risks and consequences of leaving the hospital against medical advice. Patient 103 had signed the AMA form however was not signed by the physician. During a concurrent interview and Patient 103’s medical record review on 11/14/23, at 10:12 a.m., with emergency department director (EDD), EDD acknowledged there was no documentation of the risks of leaving AMA in the physician’s narrative note and the AMA form was not signed by the physician and further acknowledged the form should have been signed. Review of Patient 101’s medical record indicated Patient 101 was seen by the emergency room doctor (EDMD 2), on 8/10/23, at 9:11 p.m. with the diagnosis of chest pain. The medical record further indicated Patient 101 did not want to wait for the workup, observation, and treatment; and her UBER ride was there to pick her up. Patient 101 left AMA (against medical advice) and eloped from the emergency room lobby on 8/10/23, at 10:10 p.m. Further review of the medical record for Patient 101, did not reveal any documentation of risks and consequences of leaving the hospital against medical advice (AMA). Patient 101 had eloped and there was no AMA Form in the medical record. During a concurrent interview and Patient 101’s medical record review on 11/14/23, at 10:35 a.m., with emergency department director (EDD), EDD acknowledged there was no documentation of the risks of leaving AMA in Patient 101’s medical record. EDD verbalized the physician needed to document more and at least attempted to have a conversation with Patient 101, before leaving (eloping) from the emergency room. During a review of the facility’s policy and procedure (P&P) titled, “AMA: Leaving Against Medical Advice” dated 3/19, indicated in part ... “When a competent patient wishes to leave the hospital without a discharge order from the attending physician, the clinical hospital staff should facilitate communication to address any underlying quality of care issues, and the pertinent medical staff should make diligent efforts to inform the patient of possible implications of leaving against medical advice ...The clinical hospital staff is responsible for complete documentation of the incident in the patient’s medical records. A diligent effort should be made to have the patient read and sign the “Leaving Hospital Against Medical Advice” form.””

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 40678 Based on observation, interview and record review, the hospital failed to post signs visible to all in the Emergency Department (ED) entrance, waiting room and treatment areas, as well as the main entrance which specified the rights of individuals under the Emergency Medical Treatment and Active Labor Act (EMTALA), regarding examination and treatment for emergency medical conditions and women in labor (ready to give birth). This failure had the potential for patients and families to be unaware of their rights under EMTALA. Findings: During a concurrent observation and interview on 10/25/23 at 12:20 p.m. with the emergency department director (EDD), no signs were posted that specify the rights of individuals to examination and treatment for emergency medical conditions (EMC) and women in labor at the emergency room entrance, inside waiting room, treatment rooms, or in the main lobby, confirmed by EDD. During an interview on 10/25/23, at 1:06 p.m. with regulatory manager (RM), RM confirmed, there is no EMTALA sign in the main lobby. During a review of the facility’s policy and procedure (P&P) titled, “EMTALA - Signage Policy,” dated 10/2022, the P&P indicated, “signage must be conspicuously posted in any place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than the traditional emergency department (e.g., entrance, admitting area, waiting room, labor and delivery, and other treatment areas located on hospital property): signage must be readable from anywhere in the area.””

“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: 40678 Based on interview and record review, the facility failed to ensure that MSE were conducted by an individual(s) who was determined qualified by medical staff bylaws or rules and regulations and who met the requirements of the facility’s policies and procedures concerning emergency services personnel and direction. This failure resulted in individuals performing MSE without competency requirements and facility approval as required under EMTALA. Findings: During an interview on 10/25/23, at 1:15 p.m. with manager of regulatory (MOR), MOR stated that she was not aware that a list of Labor and Delivery nurses who have been approved to perform a MSE should be kept in the office of the Vice President (Patient Care Services) and didn’t know who’s office that would be. During an interview on 10/27/23, at 2:50 p.m. with director of perinatal services (DOPS), DOPS the last required annual competency for Labor and Delivery nurses to perform a MSE was done in 2021. DOPS acknowledged the facility policy is not being followed. During an interview on 11/13/23, at 3:06 p.m. with chief medical officer (CMO), CMO stated that who is determined as qualified to perform a MSE is not in the medical staff bylaws or rules and regulations it is only in the facility’s EMTALA Medical Screening Examination and Stabilization policy. During a review of the facility’s policy and procedure (P&P) titled, “EMTALA - Medical Screening Examination and Stabilization Policy,” dated 3/2014, the P&P indicated, “Purpose: To establish guidelines for providing appropriate medical screening examinations (MSE) and any necessary stabilizing treatment ... as required by EMTALA ... Who May Perform the MSE: Only the following individuals may perform an MSE: A qualified physician with appropriate privileges; other qualified licensed independent practitioner (LIP) with appropriate competencies and privileges; or A qualified staff member who: is qualified to conduct such an examination through appropriate privileging and demonstrated competencies; is functioning within the scope of his or her license and in compliance with state law and applicable practice acts; is performing the screening examination based on medical staff approved guidelines, protocols or algorithms; and is approved by the facility’s governing board as set forth in a document such as the hospital bylaws or medical staff rules and regulations, which document has been approved by the facility’s governing body and medical staff.” During a review of the facility’s policy and procedure (P&P) titled, “Medical Screening Exam of Patients Presenting to the Labor and Delivery Department,” dated 11/2022, the P&P indicated, “Scope: Authorized Registered Nurses who have one year experience in Labor and Delivery, have attended mandatory annual competency classes ... have met expectations in competency testing will perform MSE ... Yearly Competency Requirements: 1. Meet expectation in mandatory competency for the Labor and Delivery Registered Nurse annually. 2. Participate in mandatory annual competency classes. 3. Attend Fetal Monitoring Class every two years, minimal Fetal Monitoring- Intermediate. 4. Yearly validation of competency related to performing this standardized procedure to a MD or RN preceptor. Record of Authorized Nurses: A written record of all Labor and Delivery nurses who have been approved to perform the procedure will be reviewed annually and will be maintained by the Director of Women’s and Children’s Services and in the office of the Vice President, Patient Care Services.””