Davita Forest Park Dialysis Center

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, a review of the National Fire Protection Association (NFPA) standards, and a review of the facility’s Policies and Procedures (P & P), it was determined that the facility failed to ensure that two of two fire extinguishers within the facility were inspected monthly by a designated, trained staff member. Regular inspections ensure that staff are familiar with fire safety protocols and the proper functioning of equipment, which is crucial for an effective response during an emergency. This deficient practice had the potential to negatively affect all 48 in-center hemodialysis (ICHD) patients under the care of this facility. Findings include: During a tour of the facility on 9/17/25, between 9:30 to 10:30 a.m., with Staff BB (Facility Administrator from another clinic, who came to assist), the following was observed: - The fire extinguisher located by the exit door leading to the back exterior of the building and the other fire extinguisher located by the exit door leading to the hallway towards the Patient Treatment Room were last checked on May 2025, as shown on the attached “Monthly Inspection Card.” During an interview with Staff BB, who was present during this observation on 9/17/25, at 9:43 a.m., she stated that fire extinguishers were being inspected annually. This surveyor then explained that fire extinguishers should be inspected monthly by qualified staff and highlighted the last inspection date to Staff BB. Staff BB acknowledged this surveyor’s observation. According to the NFPA standards, fire extinguishers must undergo a monthly visual inspection by a designated trained staff member to check for accessibility, pressure, and physical condition. Additionally, they must receive comprehensive annual maintenance by a certified technician, including servicing and any necessary testing in compliance with NFPA 10. All inspection and service activities must be documented and retained as part of the facility’s fire safety records. On 9/17/25, at 11:13 a.m., this surveyor presented the above observation to the Biomedical Technician (BMT). The BMT confirmed that the fire extinguishers in the stock room had not been inspected monthly as required. She stated that it was not her responsibility to inspect the fire extinguishers; that duty fell to the company’s Safety Manager. However, she sometimes conducted inspections on her own initiative. She acknowledged the importance of ensuring that all fire extinguishers in the building were routinely inspected to maintain their proper functionality. A review of Policy: 4-07-01, titled, “Facility Emergency Management Plan”, last revised October 2024, stated: Fire Safety Preparedness 3. Fire detection, notification, and extinguishment systems c. Fire extinguishers shall be checked monthly to verify it is: i. Fully charged ii. Safety seals are not broken or missing iii. There is no evidence of physical damage, corrosion, leakage, or clogged nozzle iv. Kept in its designated place at all times except during use v. There are obstructions to access or visibility vi. Documented on the inspection tag or appropriate log During an interview with the Assistant Facility Administrator (Staff AA) on 9/18/25 at 2:43 p.m., she confirmed that the Safety Manager is responsible for inspecting all fire extinguishers in the building every month. She acknowledged the importance of conducting monthly inspections of these fire extinguishers. She also was not able to provide a documentary evidence of the monthly inspection since May 2025. On 9/18/25 at 3:35 p.m., the Medical Director was notified of this observation through a telephonic interview. She stated that this issue would be addressed promptly. The Safety Manager was not available for an interview.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 52051 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, staff interviews, and a review of facility Policy and Procedures (P & P) it was determined that the facility failed to ensure that one of one Registered Nurse (RN BB) and one of one Patient Care Technician (PCT AA) observed, wore gloves and consistently performed hand hygiene (washed hands or used an alcohol-based hand sanitizer) after touching potentially contaminated areas or tasks. Failure to wear gloves when touching contaminated surfaces and failure to perform hand hygiene increased the risk for cross contamination with the potential to expose all patients and staff to bloodborne pathogens in the dialysis environment. This breach in infection control techniques, such as hand hygiene, had the potential to increase the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. The facility had 48 in-center hemodialysis (ICHD) patients. Findings include: During observation in the Patient Treatment Room on 9/17/25 from 11:50 a.m. to 12:30 p.m., the following was revealed: - At Station (S)9 RN AA was observed picking up what appeared to be a gauze packaging (dirty) from the floor with gloved hands. After discarding the packaging into the trash bin, she removed her gloves but did not sanitize her hands. She then proceeded to the nurse’s station, where she grabbed her stethoscope (clean), and placed it around her neck before continuing with her other tasks. - At S5, PCT AA removed her gloves and did not sanitize her hands. She then proceeded to move and reposition the dialysis machine (dirty task) without wearing gloves. Following this, PCT AA moved to the terminal computer (clean task) to chart, without performing hand hygiene first. Subsequently, she was observed attending to a machine alarm at S10, where she touched the dialysis machine screen (dirty) with ungloved hands. Finally, she went to the nurse’s station and picked up a logbook (clean) to chart, again without performing hand hygiene beforehand. CDC recommends healthcare workers to wash their hands immediately before touching a patient, after glove removal, after touching a patient’s equipment or surface, and after contact with body, bodily fluids, or contaminated surfaces. Additionally, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal. During an interview with RN AA on 9/17/25, at 12:10 p.m., she verbalized, “I should have sanitized my hands.” She acknowledged the importance of performing hand hygiene immediately after removing gloves. During an interview with PCT AA on 9/17/25, at 12:15 p.m., she mentioned that she forgot to wear gloves before touching the dialysis machine. She recognized the need to improve her hand hygiene practices after removing gloves and understood the significance of wearing gloves when handling contaminated surfaces. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: HAND HYGIENE: 1.All Teammates, Physicians, Non-Physician (NPP) will perform hand hygiene: b. prior gloving and immediately after removal of gloves g. before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse c. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse PPE 7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station ... ii. When going from a “dirty” area or task to a “clean” area or task. Both the Regional Operations Director (ROD) and the Assistant Facility Administrator (Staff AA) were notified by this surveyor, and they acknowledged the observation mentioned above on 9/18/25, at 1:25 p.m.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 52051 Based on observation, staff interview, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s Policies and Procedures (P & P), it was determined that the facility failed to ensure that five of five Direct Patient Care Staff (Registered Nurses- RN AA and RN CC, and Patient Care Technicians - PCT AA, PCT BB, and PCT CC), who were present during this observation, immediately and thoroughly cleaned and disinfected a surface contaminated with visible blood on one of one sharps container located by the “dirty” sink at the back of the Patient Treatment Room. This deficient practice increased the risk for transmission of bloodborne pathogens and other infections from one patient to another in hemodialysis (HD) unit. The facility had 48 in-center hemodialysis HD patients. Findings include: On 9/18/25, at 5:55 a.m., dried drops of blood were observed on one of one sharps container, located at the back of the treatment room, right next to a “dirty” sink, approximately 7 feet across from Station (S)11. - The container had four dried blood drops, which clearly had not been cleaned since the previous day’s treatment. - This observation was made prior to the treatment of patients for the first shift, and no patients had yet entered the Treatment Room. During an interview with RN AA, Charge Nurse on 9/18/25, at 5:56 a.m., she stated that she would clean the lid of the sharps container mentioned above. She also indicated that staff members were required to clean any visible blood immediately upon discovery. According to CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: DISINFECTION: 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials ... The Assistant Facility Administrator (Staff AA) was notified of this observation, and she acknowledged the observation on 9/18/25 at 6:06 a.m.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 52051 Based on observation, staff interviews, and a review of the facility’s Governing Body (GB) Bylaws, it was determined that the facility failed to ensure that the building in which dialysis services were provided was sanitary and maintained to ensure the safety of all patients and staff. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Stock Room and one of one Dialysate Preparation Room. The facility had 48 in-center hemodialysis (ICHD) patients. Findings include: During a tour of the facility on 9/17/25, between 9:30 to 10:30 a.m., with Staff BB (Facility Administrator from another clinic, who came to assist), the following was observed: In the Stock Room: - The entire cement floor was noticeably dirty and stained with a grayish, grainy substance. Additionally, two dried brown stains, each approximately 1 Foot in size and in different shapes, were observed about 5 Feet from the entrance of the stockroom. - At the exit door leading to the back exterior of the building, the doorstep was partially covered with a mixture of dark brown and black grainy substances, resembling soil and sand. This soiled area measured approximately 3.5 Feet in length and 2 Feet in width. On the left side of the doorstep, pressed against the wall, there was a black plastic palette on which new acid jug containers were seated. The floor underneath this plastic palette was coated with dirt buildup, measuring approximately 4 Feet in length and 2.5 Feet in width. In the Dialysate Preparation Room: - The floor and floor drain on the left side of the Central Water Plant (CWP - a system to purify water for dialysis) were heavily soiled, exhibiting a significant buildup of dark brown and black dirt. This buildup extended to the floor surface in front of the Dry Acid Concentrate Holding Tank, which measured approximately 6 Feet in length and 2 Feet in width. This indicated that these areas had not been cleaned for a considerable period of time. - The floor behind the Secondary Carbon Filter exhibited a moderate accumulation of dark brown dirt. - The floor area beneath the black plastic pallet situated behind the CWP was partially covered with granular, grayish substances or residues. This surveyor pointed out all the environmental concerns to Staff BB. She acknowledged all these observations mentioned above on 9/17/25, at 9:50 a.m. During an interview with the Assistant Facility Administrator (Staff AA) on 9/17/25, at 9:53 a.m., she stated that the current janitorial services covered the cleaning of the Stock Room’s floor. She also mentioned that she would investigate and address the dirt buildup that was observed by the exit door in the Stock Room. A review of the facility’s GB Bylaws, confirmed and adopted by GB on October 4, 2019, stated: ARTICLE III: Management 3.6. Physical Environment The Governing Body shall: a. Ensure that the physical environment which ESRD facilities provide services is functional, sanitary, safe, and comfortable for patients and staff. This surveyor presented all the observations mentioned above to the Biomedical Technician (BMT) on 9/17/25, at 11:07 a.m. The BMT stated that it was the entire team’s responsibility to keep the Dialysate Preparation Room clean and organized. She also noted that the floor needed to be rinsed daily at the end of each day to prevent dirt buildup.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 52051 Based on a review of Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), a review of facility records, and staff interviews, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to track and trend, perform root cause analysis, develop and implement plans of action, evaluate its effectiveness and make changes to plans of action if necessary, to improve and sustain patient outcomes for the facility’s Hospitalization & Re-admission outcomes and management of patients with high Phosphorus (a mineral found in many foods, however during kidney failure, the kidneys cannot effectively regulate phosphorus, which may lead to bone problems if phosphorus levels become too high), for in-center hemodialysis (ICHD) patients, in six of six months (February 2025 - July 2025) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 48 ICHD patients who were receiving dialysis services at this facility. Findings include: A comparison between the facility’s FY 2025 QDFR and the facility’s QAPI meeting minutes between (February 2025 - July 2025), revealed the following: 1. Hospitalization and Re-admission: - FY 2025 QDFR - 0.83% of ICHD patients was re-admitted to the hospital within 30 days. - QAPI - percent of patients who were re-admitted to the hospital within 30 days, ranged from 20% - 57%. The US threshold was 1.03%. Although the rate decreased to 20% in June 2025, it still remained significantly above the US threshold. 2. Phosphorus >7.0 mg/dL: - FY 2025 QDFR - 12.1% of ICHD patients had Phosphorus >7.0 mg/dL. - QAPI - percent of patients with Phosphorus >7.0 mg/dL ranged from 14.3% - 22.7%. The US threshold was 17.4%. Although the percentage dropped to 14.3% in March 2025, this decrease was not sustained. It increased again and remained above the U.S. threshold for the last four consecutive months that were reviewed. There was a lack of documentary evidence that the entire Interdisciplinary Team (IDT) was fully involved in tracking and trending hospitalizations/re-admissions and phosphorus levels. Additionally, there was also a lack of documentary evidence that the IDT performed root cause analysis, developed and implemented action plans, evaluated their effectiveness, or modified plans to improve and sustain patient outcomes. During an interview with the Registered Dietitian (RD) on 9/18/25, at 1:37 p.m., he mentioned that he had only been working at the facility for about three weeks at the time of this interview. He also stated that he was still in the process of getting to know each patient better and would do his best to address any dietary or nutritional issues that patients might be facing. During a telephonic interview with the Medical Director on 9/18/25, at 3:35 p.m., she emphasized the importance of providing patient education, particularly regarding the proper way to take phosphorus binders. She also mentioned that the dietitian was shared with another facility and highlighted the value of having a dedicated dietitian who was consistently assigned to this facility. This consistency was crucial for effectively addressing the dietary and nutritional needs of each dialysis patient. During a discussion with the Regional Operations Director, currently the acting Facility Administrator and Assistant Facility Administrator (Staff AA) on 9/18/25, at 4:48 p.m., both acknowledged that the IDT should have been more actively involved in tracking and trending facility outcomes. They also recognized that not only should root cause analysis and plans of correction be formulated, but should also be implemented, evaluated, and updated or revised if they were not effective in improving and sustaining outcomes.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 52051 1. Based on observation, staff interviews, a review of the Food and Drug Administration (FDA) recommendations, a review of the Centers for Disease Control and Prevention (CDC) guidelines, and a review of facility Policies and Procedures (P & P), it was determined that the facility failed to ensure that two of two Registered Nurses (RN AA and RN BB), who were responsible for administering medications, discarded and not made available for use, expired medications in one of one Emergency Crash Cart, one of one Emergency Evacuation Kit (black box), and two of two Medication Drawers. Additionally, there was one of one opened vial of Epogen (used to treat anemia in hemodialysis patients) that had been accessed and was over 30 days old in one of one Medication Refrigerator in the Patient Treatment Room. This failure could render medications and supplies to be unsafe and ineffective and had the potential to negatively affect the health and safety of all 48 in-center hemodialysis (ICHD) patients who were under the care of this facility. Findings include: During a tour of the facility on 9/17/25, between 9:30 to 10:30 a.m., the following was observed: In the Emergency Crash Cart: - Two of two tubes of Glutose 15 (oral glucose gel, 15 grams [g] per serving), used to raise low blood sugar, expired 6/30/2025. In the Emergency Evacuation Kit: - Five of five vials of Heparin Sodium Injection (30,000 units per 30 milliLiters [mL]), an anticoagulant used in hemodialysis to prevent clotting in the bloodlines and dialyzer/artificial kidney, expired 9/1/2025. In two of two Medication Drawers: - In Medication Drawer #1, there were 25 vials of Tazicef (1 g per vial) for injection, used to treat a broad spectrum of bacterial infections, all expired 8/2025. - In Medication Drawer #2, there were two boxes (100 capsules per box) of Diphenhydramine Hydrochloride (HCL) 25 milligrams (mg) per capsule, used to treat allergic reactions, itching, and motion sickness in dialysis patients, all expired 3/2025. In the Medication Refrigerator: - There was an opened and accessed multi-dose vial of Epogen 20,000 units per 2 mL, which was dated as first opened on 2/21/24, (574 days since first opened). During an interview with RN AA, charge nurse on 9/17/25, at 10:21 a.m., she stated that she would discard all the expired medications mentioned above. RN AA explained that while nurses were responsible for daily medication inventory, expiration dates were often overlooked. She also mentioned that she had been unaware of the opened Epogen vial in the refrigerator and was unsure if the date of opening had been recorded correctly. During a separate interview with Staff BB (Facility Administrator from another clinic who came to assist) on 9/17/25, at 10:23 a.m., she confirmed that all licensed nurses were responsible for medication stocking and inventory. Staff BB added that the Emergency Crash Cart inventory was conducted daily, while the Emergency Evacuation Kit inventory was performed monthly. She recognized the importance of routinely checking medication expiration dates and acknowledged all observations made. According to FDA recommendations dated 2/8/21, drug expiration dates indicate the period during which a product is expected to remain stable. This means it will retain its strength, quality, and purity when stored according to the conditions specified on the label. Using expired medications or supplies can pose various risks. Once the expiration date has passed, there is no guarantee that the medication or supplies will continue to be safe or effective. According to CDC Guidelines, multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. A review of the facility’s Policy: 1-06-01 titled, “Medication Policy” with the latest revision date of October 2023, showed the following: 29. Medications containing a preservative must be discarded 28 days after opening or accessed (e.g., needle punctured), unless the manufacturer specifies a different (shorter or longer) date ... Each vial is labeled with the initials of the person opening the vial and the expiration date ... 30. All medications in the facility are checked monthly for expiration dates. 31. Medications are ordered and replaced prior to expiration. 32. Disposal of expired medications, including all over-the-counter and nutritional product samples, are removed from the treatment and inventory areas and disposed of per state/local regulations. On 9/18/25 at 3:35 p.m., the Medical Director was notified of this observation through a telephonic interview. She stated that this issue would be addressed promptly. 2. Based on observation, staff interviews, and a review of the facility’s Policy and Procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN AA), who prepared Heparin injections (anticoagulant used in hemodialysis to prevent clotting in the bloodlines and dialyzer/artificial kidney) for second shift patients, labeled 15 of 15 Heparin syringes, with date and time prepared, and initialed. This deficient practice increased the risk for medication errors. The facility had 48 in-center hemodialysis (ICHD) patients. Findings include: During a tour of the facility on 9/17/25, between 9:30 to 10:30 a.m., the following was observed: In the Medication Preparation Area: - There were eight 10 mL (milliLiters) syringes containing Heparin injections for hourly infusion, and seven 5 mL syringes of Heparin injections for bolus infusion, that were prepared and labeled with the patients’ names, but they lacked the initials of the nurse or nurses who prepared them, as well as the date and time of medication preparation. During an interview with RN AA, Charge Nurse, on 9/17/25 at 9:33 a.m., she confirmed that she prepared all the Heparin injections for the second shift patients. She indicated that these Heparin syringes were prepared just a few minutes before this state surveyor entered the Patient Treatment Room on that date (9/17/25). RN AA also mentioned that as the Charge Nurse, it was her responsibility to draw up all medications. She also stated that other nurses, such as RN BB on this day, could administer the prepared medications to the patients. RN AA acknowledged the importance of labeling prepared medications with her initials, as well as time and date prepapred. On 9/17/25, at 9:36 a.m., Staff BB, a Facility Administrator from another facility who came to assist, was notified of the observation and confirmed that licensed nurses could administer heparin for patients after it was prepared by the Charge Nurse. During an interview with RN BB on 9/17/25, at 11:57 a.m., she confirmed that RN AA had prepared the heparin injections. Since RN BB was also a licensed nurse, she was able to administer the heparin injections prepared by the Charge Nurse. A review of facility Policy #1-06-01 titled, “Medication Policy”, dated October 2023, stated: 20. If medications are prepared and administered immediately by the same licensed nurse teammate, they do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient’s name, date, time prepared, dose, and initials of the teammate preparing the medication. - The facility P&P did not to include that all medications shall be administered by the individual who prepared them.”