Forest Park Dialysis Center

“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: 46466 Based on observations and facility document review, the facility staff failed to properly perform hand hygiene between donning and doffing gloves per policy while providing care to four (4) patients. The findings include: On February 21, 2025 at 9:51 AM, Staff Member #3 was observed wearing gloves while touching dialysis machine at station #5. After touching the machine, Staff Member #3 removed their gloves, donned clean gloves without performing hand hygiene between gloving. On February 21, 2025 at 10:15 AM, Staff Member #3 was observed wearing gloves while touching dialysis machine at station #7. After touching the machine, Staff Member #3 removed their gloves, donned clean gloves without performing hand hygiene between gloving. On February 21, 2025 at 10:20 AM, Staff Member #3 was observed wearing gloves while touching a dialysis machine. After touching the machine, Staff Member #3 removed their gloves, donned clean gloves without performing hand hygiene between gloving. On February 21, 2025 at 11:40 AM, Staff Member #3 was observed performing CVC (Central Venous Catheter) exit site care on a patient at station #6. Staff Member #6 removed the patient’s old CVC bandage, removed their gloves and did not perform hand hygiene prior to donning clean gloves. A review of the facility’s policy “G40 Infection Control”, last revised 11/29/2022, indicated in part: “...8. Hands are always washed after gloves are removed and between patient contacts...9. Antiseptic hand cleaners must be alcohol-based and may be used in placed of soap and water...”.”

“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: 46466 Based on observations, interviews and document review, it was determined that the facility staff failed to properly clean and disinfect contaminated surfaces of the medical devices and equipment. The findings included: On February 21, 2025 at 10:07 AM, Staff Member #3 was observed disinfecting the dialysis machine at station #5 while the patient was still seated in the chair. On February 21, 2025 at 11:20 AM, Staff Member #3 was observed disinfecting the chair at a patient station after the dialysis machine had been prepared for the next patient. On February 21, 2025 at 2:05 PM, in an interview Staff Member #1 explained that the dialysis machine and patient area should be disinfected after the patient had left. A review of the facility’s policy “G45 Cleaning and Disinfection of Equipment, Supplies & Treatment Area”, last revised 6/20/2024, indicated in part: “...7. All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment...”.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 46466 Based on observations and document review, the facility staff failed to maintain aseptic technique for a CVC (central venous catheter) dressing change. The findings include: On February 25, 2025 at 11:40 AM, Staff Member #3 was observed performing CVC (Central Venous Catheter) exit site care on a patient at station #6. Staff Member #6 removed the patient’s old CVC bandage, removed their gloves and without performing hand hygiene donned clean gloves. Staff Member #3 also performed disinfection of the exit site by cleaning the exit site first, then rubbing the disinfectant swab away from the patient’s body, up the CVC limbs and then back down the limbs towards the patient’s body and back to the exit site. After disinfecting, Staff Member #3 immediately placed a bandage over the exit site without waiting for the disinfectant to dry. A review of the facility’s policy “IC05C CVD: Dressing Change”, last revised 9/1/23, indicated in part: “...3. Remove the old dressing from the catheter site and discard with contaminated gloves. Hand hygiene done new gloves...6. Depending on the type of catheter and patient’s tolerance, the exit site may be cleaned disinfected with various products...Allow disinfectant to air dry...7. Hand hygiene and don clean gloves. 8. Apply clean dressing over the clean exit site using aseptic technique...”. A review of the facility’s policy “IC05A CVD: Initiation & Discontinuation of Treatment”, last revised 10/22/2024, indicated in part: “1. Prior to treatment initiation, CVC (Central Venous Catheter) Exit Site must be inspected...2. Wash hands and don new clean gloves. Place a clean field under the catheter limbs/caps. disinfect according the manufacturer’s instructions...Allow disinfectant to air dry...3. Prior to cap removal, disinfect the arterial cap, and limb, Using the same antiseptic pad, apply antiseptic with friction to the catheter, moving from the hub at least several centimeters towards the body. Hold the limb until the antiseptic is dry. Discard antiseptic pad...”.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 46466 Based on observation, interview and facility document review, the facility failed to properly secure the drawer containing medications. The findings include: On February 21, 2025 at 10:20 AM, the surveyor found a drawer containing medications unlocked. On February 21, 2025 at 10:40 AM, in an interview Staff Member #2 stated that they did not know if the drawer lock was broken because they have never locked the drawer since they started working at this facility last year. On February 21, 2025 at 11:15 AM, in an interview Staff Member #1 stated the medication drawer was lockable but they were not sure if the lock was broken. Staff Member #1 informed the surveyor that they placed today a work order for the drawer lock to be replaced. A review of the facility’s policy “G48 Medications: Handling, Administration, Storage & Disposal”, last revised 1/13/2025 indicated in part: “...4. Medications must never be left unsecured or unattended...”.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 46466 Based on observation and interview, the facility failed to post the mailing address and contact information for the state survey agency where it can be easily accessible for patients. The findings include: On February 21, 2025 at 9:30 AM, the surveyor observed all of the signs posted in the facility’s main lobby. The state survey agency information - address and telephone numbers for complaint unit were not included in the facility’s signs. On February 21, 2025 at 2:05 PM, Staff Member #1 stated in an interview that the state survey agency information was not posted in the main lobby but would be placed there by the end of close of business today.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 46466 Based on medical record and facility document review, the facility staff failed to follow physician’s orders for the prescribed dose of dialysis BFR (blood flow rate) and/or DFR (dialysis flow rate) for two (2) of five (5) in-center dialysis patients included in the sample. The findings included: On February 21, 2025 at 1:00 PM, a review of five (5) sampled medical records was conducted. Surveyor reviewed Patient #1’s treatment flowsheets from February 7, 2025 through February 19, 2025. One (1) treatment flowsheet from February 14, 2025 documented a DFR of 500 when the prescribed order was for 600. The “Order Verification/Safety Check” was verified by two (2) staff members. There was no documentation to indicate why the DFR was changed from the prescribed rate. Surveyor reviewed Patient #2’s treatment flowsheets from February 8, 2025 through February 21, 2025. One (1) treatment flowsheet from February 15, 2025 evidenced a DFR documented at 800 when the prescribed order was for 500. The “Order Verification/Safety Check” was verified by two (2) staff members. There was no documentation to indicate why the DFR was changed from the prescribed rate. A review of the facility’s policy “IC08 Monitoring & Documentation of Patient Care During Treatment, last revised 11/29/2022, indicated in part: “...if the patient’s prescription was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation...”.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 46466 Based on observation and facility document review, the facility staff failed to care for a patient’s arteriovenous (AV) graft/fistula according to the facility’s policy. The findings included: On February 21, 2025 at 10:25 AM, Staff Member #3 was observed initiating cannulation of patient’s AV graft/fistula at station #7. Staff Member #3 applied antiseptic to the patient’s skin over the cannulation site, palpated the site after disinfection and without disinfecting the site again inserted the needle. A review of the facility’s policy “G40 Infection Control”, last revised 11/29/2022, indicated in part: “...30. Aseptic technique will be used to prepare the access site prior to needle insertion...”.”

“EP Testing Requirements CFR(s): §416.54(d)(2), §418.113(d)(2), §441.184(d)(2), §460.84(d)(2), §482.15(d)(2), §483.73(d)(2), §483.475(d)(2), §484.102(d)(2), §485.68(d)(2), §485.542(d)(2), §485.625(d)(2), §485.727(d)(2), §485.920(d)(2), §491.12(d)(2), §494.62(d)(2). *[For ASCs at §416.54, CORFs at §485.68, REHs at §485.542, OPO, “Organizations” under §485.727, CMHCs at §485.920, RHCs/FQHCs at §491.12, and ESRD Facilities at §494.62]: (2) Testing. The [facility] must conduct exercises to test the emergency plan annually. The [facility] must do all of the following: (i) Participate in a full-scale exercise that is community-based every 2 years; or (A) When a community-based exercise is not accessible, conduct a facility-based functional exercise every 2 years; or (B) If the [facility] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event. (ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [facility’s] emergency plan, as needed. *[For Hospices at 418.113(d):] (2) Testing for hospices that provide care in the patient’s home. The hospice must conduct exercises to test the emergency plan at least annually. The hospice must do the following: (i) Participate in a full-scale exercise that is community based every 2 years; or (A) When a community based exercise is not accessible, conduct an individual facility based functional exercise every 2 years; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full scale community-based exercise or individual facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (3) Testing for hospices that provide inpatient care directly. The hospice must conduct exercises to test the emergency plan twice per year. The hospice must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual facility-based functional exercise; or (B) If the hospice experiences a natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community based or facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop led by a facilitator that includes a group discussion using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the hospice’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice’s emergency plan, as needed. *[For PRFTs at §441.184(d), Hospitals at §482.15(d), CAHs at §485.625(d):] (2) Testing. The [PRTF, Hospital, CAH] must conduct exercises to test the emergency plan twice per year. The [PRTF, Hospital, CAH] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the [PRTF, Hospital, CAH] experiences an actual natural or man-made emergency that requires activation of the emergency plan, the [facility] is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an [additional] annual exercise or and that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [facility’s] response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the [facility’s] emergency plan, as needed. *[For PACE at §460.84(d):] (2) Testing. The PACE organization must conduct exercises to test the emergency plan at least annually. The PACE organization must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or (B) If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or individual, a facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the PACE’s response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE’s emergency plan, as needed. *[For LTC Facilities at §483.73(d):] (2) The [LTC facility] must conduct exercises to test the emergency plan at least twice per year, including unannounced staff drills using the emergency procedures. The [LTC facility, ICF/IID] must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise. (B) If the [LTC facility] facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the [LTC facility] facility’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the [LTC facility] facility’s emergency plan, as needed. *[For ICF/IIDs at §483.475(d)]: (2) Testing. The ICF/IID must conduct exercises to test the emergency plan at least twice per year. The ICF/IID must do the following: (i) Participate in an annual full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise; or. (B) If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the emergency event. (ii) Conduct an additional annual exercise that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the ICF/IID’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID’s emergency plan, as needed. *[For HHAs at §484.102] (d)(2) Testing. The HHA must conduct exercises to test the emergency plan at least annually. The HHA must do the following: (i) Participate in a full-scale exercise that is community-based; or (A) When a community-based exercise is not accessible, conduct an annual individual, facility-based functional exercise every 2 years; or. (B) If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility based functional exercise following the onset of the emergency event. (ii) Conduct an additional exercise every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following: (A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or (B) A mock disaster drill; or (C) A tabletop exercise or workshop that is led by a facilitator and includes a group discussion, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (iii) Analyze the HHA’s response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA’s emergency plan, as needed. *[For OPOs at §486.360] (d)(2) Testing. The OPO must conduct exercises to test the emergency plan. The OPO must do the following: (i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is led by a facilitator and includes a group discussion, using a narrated, clinically relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the emergency event. (ii) Analyze the OPO’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the [RNHCI’s and OPO’s] emergency plan, as needed. *[ RNCHIs at §403.748]: (d)(2) Testing. The RNHCI must conduct exercises to test the emergency plan. The RNHCI must do the following: (i) Conduct a paper-based, tabletop exercise at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. (ii) Analyze the RNHCI’s response to and maintain documentation of all tabletop exercises, and emergency events, and revise the RNHCI’s emergency plan, as needed. This Standard is not met as evidenced by: 42929 Based on interview and facility document review, it was determined the facility failed to conduct annual emergency exercises to test the emergency plan. Findings: On 04/23/2024 the surveyor reviewed the facility’s emergency preparedness binder. There was no documentation of any exercise to test the emergency plan in 2022. On 04/23/2024, Staff Member #1 confirmed that if there was no documentation of an emergency drill or exercise for 2022, “then it was probably not completed”. The above concern was discussed again with Staff Member #1 at the exit conference on 04/24/2024 at 4:00 p.m.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 42042 Based on observation, interview and document review, it was determined the facility staff failed to maintain a sanitary environment of the clinical treatment floor by, not covering and appropriately labeling two (2) bleach containers, not appropriately storing contaminated biohazard items, failing to maintain separation of “clean” and “dirty” areas, and inappropriate use of spray bottles for disinfection. The finding include: The surveyor conducted observations of the treatment floor on 04/22/24 between [10:30 am through 3:30 pm], and again on 04/24/24 between [10:30 am through 11:15 am]. The following infection control related concerns were identified during treatment floor observations on 04/22/24: Two (2) bleach containers not covered. One (1) bleach container was not labeled with the dilution of bleach. No soap in the dispenser at one of the sinks next to the patient scale located by Pod #2 Nursing Station. Two (2) trash cans for regular (not biohazard) trash were overflowing with trash debris beyond capacity. On 04/22/24 at 1:32 pm, observed Staff Member #5 lay dirty gown on the clean laptop workstation. On 04/22/24 at 2:50 pm, the surveyor observed Staff Member #13 using a spray bottle to disinfect the wall box of Hemodialysis Station #4 following patient treatment. In the evening of 04/22/24, the surveyor met with Staff Member #10 for brief interview who confirmed the spray bottle contained white distilled vinegar solution for disinfection purposes. Staff personal cell phone observed laying within the “clean” sink area of Pod #2 Nursing Station throughout observations on 04/22/24. In the afternoon of 04/22/24, the surveyor was provided the facility policy titled, “G40 Infection Control” (with last revision date of 11/29/22) by Staff Member #1. Under “General Infection Control Measures” section of page three (3) stated the following: “Each center will maintain and clearly label separate “clean” and “dirty” work areas. Clean items, such as medications and gloves are kept in the designated “clean” areas. Contaminated items, such as lab samples are to be stored in the designated “dirty” areas. “Dirty areas are those areas where contamination with blood or other biohazardous substances would be expected to be encountered (e.g., treatment area, biohazardous substances would be expected to be encountered (e.g., treatment area, bathrooms, etc.). Depending on center layout and configuration, clean and dirty areas will be designated in a manner that decreases the risk of cross-contamination.” The surveyor was provided the facility policy titled, “G45 Cleaning & Disinfection of Equipment, Supplies & Treatment Area” (with last revision date of 11/15/23) by Staff Member #1 on 04/22/24. On page one (1), under “Policy” section, the document stated, in part, “Bleach solutions for this purpose must be made fresh each day and all containers are labeled per Risk Management policies for labeling of chemical containers and must be covered with a lid to prevent contamination”. The same policy continued to state, “Disinfection will be done using bleach/water identified above, in a container with disposable cloths. Use of spray bottles is prohibited ...” [sic]. The surveyors met with Staff Member #1 to disseminate the above findings on 04/23/24 at approximately 4:00 pm, and again on 04/24/24 at 4:08 pm. Staff Member #1 verbalized understanding without question or concern.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 42042 Based on observation and document review, it was determined the facility staff failed to ensure that non-disposable equipment taken into the dialysis station were cleaned and disinfected prior to returning to a clean common area (stethoscope and Phoenix XL pH and Conductivity Meter). The findings include: On 04/22/24 at approximately 1:30 pm, the surveyor observed Staff Member #10 utilize a non-disposable stethoscope to auscultate a patient being dialyzed at Hemodialysis Station #6. The same staff member was observed using the same stethoscope on a patient being dialyzed at Hemodialysis Station #2 on 04/24/24 at 1:58 pm. On 04/24/24 at 2:05 pm, Staff Member #10 was observed auscultating a patient being dialyzed at Hemodialysis Station #13. On 04/24/24 at 2:56 pm, Staff Member #10 was observed auscultating a patient being dialyzed at Hemodialysis Station #1. Following each patient assessment, the staff member was observed placing the used stethoscope around neck without disinfection in between each use. On 04/22/24 at 3:13 pm, the surveyor observed Staff Member #5 utilize the non-disposable Phoenix XL pH and Conductivity Meter for a dialysis patient at Hemodialysis Station #8. Following use, the meter was observed returning Phoenix Meter to the central nurse’s station without being disinfected prior to returning to the common area. In the afternoon of 04/22/24, the surveyor was provided the facility policy titled, “G40 Infection Control” (with last revision date of 11/29/22) by Staff Member #1. Under “General Infection Control Measures” section of page four (4) stated, in part, “Reusable supplies will not be shared between patients without being disinfected between each use per the appropriate procedure; this includes blood pressure cuffs and stethoscopes”. The surveyors met with Staff Member #1 to disseminate the above findings on 04/23/24 at approximately 4:00 pm, and again on 04/24/24 at 4:08 pm. The surveyor confirmed with the staff member that each dialysis station being used is considered a “dirty” and that all non-disposable equipment shall be cleaned prior to returning to a “clean” designated area. Staff Member #1 verbalized understanding without question or concern.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 42042 Based on observation and interview, it was determined the facility staff failed to maintain a safe environment for dialysis care by not removing expired medication and not appropriately labeling intravenous (IV) medications. The findings include: The surveyors conducted a “flash tour” with Staff Member #1 on 04/22/24 at 10:22 am to include the areas pertaining to the Home Peritoneal (PD) and Hemodialysis (HD) training areas, water room, and in-center treatment floor. During tour of the home program on 04/22/2024 at 10:05 am, the surveyor observed one (1) open vials of heparin dated 03/12/2024 and one (1) open vial of heparin dated 03/14/2024, both vials had been open for greater than twenty-eight (28) days and were available for patient use. On 04/22/24 at 10:22 a.m., the surveyor observed five (5) vials of heparin in the medication cabinet with an expiration date of 03/2024. The expired medications were given to Staff Member #6. On 04/22/24 at 10:40 a.m., the surveyor observed three (3) heparin filled syringes on the clean counter that were not initialed or labeled with the time the heparin was drawn up. While on the treatment floor on 04/22/24 at 10:45 am, the surveyor inspected the Medication Storage Refrigerator located in Pod #1 and identified an opened multi-dose medication vial indicating Tuberculin (“Mantoux”) Medication (Lot # 3CA18C1), 1.0 mL (milliliter). The surveyor observed writing indicating date opened as 03/21/24. The surveyor was supplied the facility policy titled, “G48 Medications: Handling, Administration, Storage & Disposal” (with last revision date of 06/23). Under “Handling & Administration” section on page one (1), the policy stated, “Multi-dose medication vials can be used for up to 28 days after initial entry, as long as the vial is handled aseptically and stored per manufacturer instructions ...After 28 days (or a lesser period of time as specified by the manufacturer) the vial and any remaining medication in the vial must be discarded” [sic]. On page two (2) of same policy, the document continued to state, in part, “Any medication drawn up before the time it is to be administered shall be labeled with: ...date/time medication was drawn up, and initials of nurse who drew up the medication” [sic]. On 04/22/24 at approximately 10:50 am, Staff Member #6 was made aware of the expired medications during interview and confirmed that opened medications should only be retained for twenty-eight (28) days once opened.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 40084 Based on interview and document review, it was determined the facility failed conduct required colorblindness testing for three (3) of eleven (11) staff members. (Staff Member #6, Staff Member #7, and Staff Member #9) The findings include: In the afternoon of 04/23/24, the surveyor initiated personnel file review of all clinical staff [Registered Nurses (RNs), Facility Technical Manager (FTM), and Patient Care Technicians (PCTs)]. Staff Member #1 provided the surveyor with a binder containing required documentation to include licenses, certifications, and Ishihara Test results for colorblindness testing. Following review of the completed Personnel File Worksheet and personnel staff binder, the surveyor identified the following staff as having no evidence of being tested for colorblindness: Staff Member #6, Staff Member #7, and Staff Member #9. On 04/24/24 at 3:22 pm, the surveyor met with Staff Member #1 regarding the Ishihara Test results. The surveyor confirmed with Staff Member #1 that the three (3) aforementioned staff were required to have been tested for colorblindness as required for chlorine testing. Following verification, Staff Member #1 verbalized they were unable to provide evidence of the three (3) staff member’s colorblindness testing. On 04/24/24 at 3:45 pm, Staff Member #9 presented to the conference room and was tested for, and passed, the Ishihara Colorblindness Test by Staff Member #1. In the evening of 04/24/24, Staff Member #1 stated they were unable to locate an appropriate policy related to the testing of clinical staff for colorblindness but provided the surveyor with the facility document titled, “”New” Hiring Process - ARA Field” The document outlined the required tasks and responsibilities for all clinical staff, and stated, in part, “Hiring Manager is responsible for completing the following onboarding tasks ...Colorblindness Testing”. On 04/24/24 at 4:05 pm, Staff Member #1 provided confirmation that they were the associated staff member responsible for the completion and retainment of the aforementioned staff members’ colorblindness testing.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 42042 Based on observation and facility policy review, it was determined the facility staff failed to ensure the access site for two (2) patients remained visible throughout the dialysis treatment. The findings include: On 04/22/24 at 10:50 am, the surveyor observed Patient #5 being dialyzed at Hemodialysis Station #12 with access site covered. On 04/22/24 at 12:13 pm, the surveyor observed Patient #8 being dialyzed at Hemodialysis Station #12 with access site covered. The surveyor observed both patients’ accesses remained covered throughout the remaining duration of dialysis treatment without staff prompting or other intervention. The facility’s policy titled “IC08 Monitoring & Documentation of Patient Care During Treatment” (last revision date of 11/29/22) stated, in part, the following: “Purpose: To ensure: that patients are monitored to ensure safety during the hemodialysis treatment .... 9. Caregivers must be stationed so that patients remain in view of a caregiver during the dialysis treatment. 10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every [thirty] 30 minutes and PRN [as needed] depending on the patient’s condition includes but is not limited to: ...Visibility of the vascular access and interventions taken to address non-visibility of the access .... 12. The patient’s vascular access should remain uncovered and readily visible through the course of the patient’s treatment. If the patient refuses to allow the access to remain uncovered and visible, the caregiver must enter a detailed note at the first observation that fully explains the patient refusal and may simply document “No visibility of the vascular access” at all remaining checks. Any patient that refuses to allow the access to remain uncovered must be reported as soon as possible to the Center Manager, Attending physician, and Medical Director for intervention ....”. The surveyors met with Staff Member #1 to disseminate the above findings on 04/23/24 at approximately 4:00 pm, and again on 04/24/24 at 4:08 pm. Staff Member #1 verbalized understanding without question or concern.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 42929 Based interview, medical record review, and facility document review, it was determined the facility staff failed to document notification to the charge nurse or physician of post treatment weight greater than 1 kg above or below the target weight for three (3) (Patient #2, Patient #4, and Patient #5) of five (5) in-center patient’s flow sheets reviewed. Findings: On 04/23/2024, the surveyor reviewed the treatment flow sheets for five (5) in-center hemodialysis patients, Patient #1, Patient #2, Patient #3, Patient #4, and Patient #5. There was no documentation that the post treatment weight greater than 1 kg above or below the target weight was reported to the licensed nurse or physician for: Patient #2 04/12/2024 post treatment weight was 71.7 kg, 1.2 kg above the target weight of 70.5 kg and the patient care technician documented “Post Weight within 1 kg +/- EDW [estimated dry weight]: Yes”’; 04/12/2024 post treatment weight was 71.9 kg, 1.4 kg above the target weight of 70.5 kg and the patient care technician documented “Post Weight within 1 kg +/- EDW: Yes”’; 04/19/2024 post treatment weight was 71.9 kg, 1.4 kg above the target weight of 70.5 kg and the patient care technician documented “Post Weight within 1 kg +/- EDW: Yes”’; 04/22/2024 post treatment weight was 71.6 kg, 1.1 kg above the target weight of 70.5 kg and the patient care technician documented “Post Weight within 1 kg +/- EDW: Yes”’. Patient #4 04/17/2024 post treatment weight was 66 kg, 1.5 kg above the target weight of 64.5 kg. Patient #5 04/22/2024 post treatment weight was 46.2 kg, 1.2 kg above the target weight of 45 kg. The facility’s document “Charge Nurse Notification Protocol: Events Reportable To The Charge Nurse By Direct Patient Care Staff” states in part: ... Post Treatment: Weight 1.0 kg < or > EDW post treatment ... The facility’s policy titled “IC08 Monitoring & Documentation of Patient Care During Treatment” last revised 11/29/2022 states in part: Purpose: To ensure: ... that all data collected and documented accurately reflects what occurred during each dialysis treatment.... 10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every [thirty] 30 minutes and PRN [as needed] depending on the patient’s condition includes, but is not limited to: ... Patient status - some note must be entered to indicate how the patient is tolerating the treatment, and any patient problems, complaints or observations about the patient’s status must be documented. In addition, any interventions provided to the patient and the patient’s response must be documented.... 15. Information that must be entered manually includes, but is not limited to: ... interventions for unexpected situations, such as slowing blood flow for access problem, target weight change ... if the patient’s prescription is was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation). The above concerns were discussed with Staff Member #1 at the exit conference on 04/24/2024 at 4:00 p.m.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 42929 Based on interview, medical record review, and facility document review, it was determined the facility staff failed to follow the dialysis treatment orders, specifically for blood flow rate (BFR) and dialysate flow rate (DFR) for two (2) (Patient #1 and Patient #2) of five (5) patients’ flow sheets reviewed. Findings: The six (6) most recent dialysis treatment flow sheets for five (5) in-center hemodialysis patients were reviewed on 04/23/2024. Dialysis orders for blood flow rate (BFR) were not followed in two (2) of the five (5) patients’ flow sheets reviewed. There was no documentation of the reason or of notification to the charge nurse of the change in blood flow rate from the prescribed rate. Patient #1 04/12/2024 BFR documented at 300 and 375 ML/min, when the prescribed rate was 400 ML/min and the patient care technician documented “Blood flow at prescribed rate” at 3:01 p.m. when it was at 375 ML/min. Patient #2 04/12/2024 BFR documented at 400 ML/min, when the prescribed rate was 450 ML/min; 04/15/2024 BFR documented at 400 ML/min, when the prescribed rate was 450 ML/min and the patient care technician documented “Blood flow at prescribed rate” at 4:01 p.m. when it was at 400 ML/min. The six (6) most recent dialysis treatment flow sheets for five (5) in-center hemodialysis patients were reviewed on 03/26/2024. Dialysis orders for dialysate flow rate (DFR) were not followed in two (2) of the five (5) patients’ flow sheets reviewed. There was no documentation of the reason or of notification to the charge nurse of the change in dialysate flow rate from the prescribed rate. Patient #1 04/17/2024 DFR documented at 600 ML/min, when the prescribed rate was 700 ML/min. Patient #2 04/12/2024 DFR documented at 600 ML/min, when the prescribed rate was 700 ML/min; 04/15/2024 DFR documented at 600 ML/min, when the prescribed rate was 700 ML/min. The facility’s policy titled “IC08 Monitoring & Documentation of Patient Care During Treatment” last revised 11/29/2022 states in part: Purpose: To ensure: ... that all data collected and documented accurately reflects what occurred during each dialysis treatment.... 10. Data that must be documented (by direct entry and/or by data feed from the dialysis machine) at least every [thirty] 30 minutes and PRN [as needed] depending on the patient’s condition includes, but is not limited to: ... Compensated blood flow rate (as applicable depending on machine type), Blood flow rate (BFR), Dialysate flow rate (DFR) ... 15. Information that must be entered manually includes, but is not limited to: ... interventions for unexpected situations, such as slowing blood flow for access problem, target weight change ... if the patient’s prescription is was not met for any reason (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation). The above concerns were discussed with Staff Member #1 at the exit conference on 04/24/2024 at 4:00 p.m.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 42042 Based on interview and document review, it was determined the facility’s Quality Assessment and Performance Improvement (QAPI) program failed to timely report/discuss actionable water and dialysate results. The findings include: During review of the facility’s water and dialysate program on 04/23/24, the surveyor was provided the results of the microbiological testing of the “Return” port of the water distribution loop collected on 02/26/24. The surveyor observed the test results read “0.237 EU/mL” which corresponded to being elevated above “Action Level” (Reference: 0.125 EU/mL). On page eight (8) of the same lab result document, the surveyor observed that both the Medical Director and Environmental Technician had acknowledged notification of the Water and Dialysate results with signatures dated approximately one and half months later on 04/12/24. The surveyor observed that there was no corresponding signature by the Facility Administrator. In the afternoon of 04/23/24, the surveyor reviewed the Annual AAMI (Association for the Advancement of Medical Instrumentation) Water Distribution Testing Results of the RO (Reverse Osmosis) Feed collected on 10/09/23. The surveyor observed that there was no corresponding signature by the Facility Administrator. In the afternoon of 04/24/24, the surveyor reviewed the March 2024 QAPI Meeting Minutes with Staff Member #1 and observed that the staff member responsible for disseminating water and dialysate information, Staff Member #9, was not present for the March QAPI meeting. The surveyor was unable to locate any water and dialysate system information ever being reviewed or discussed during the March meeting. The surveyor reviewed the facility’s policy titled “Technical Operations Manual” (with last revision date of 10/27/20). On page thirteen (13), the document stated, in part, “An action level is the level at which remedial steps must be taken ...The action level for RO product, water in distribution plumbing and storage tanks is 50 CFU, and 0.125 EU”. Under “Microbiological Testing: Dialysate” [sic] section of page sixteen (16) of document stated, in part, “The Medical Director must: Review and sign the laboratory reports ...be immediately notified of any results above the action level” [sic]. In the evening of 04/24/24, the surveyor met with Staff Member #1 for interview. The staff member confirmed there were no signatures nor any other documentation reflecting notification of the two (2) aforementioned lab results. Staff Member #1 provided confirmation to the surveyor that all water and dialysate lab results are required to have prompt signature by the Facility Administrator. Additionally, Staff Member #1 advised that the abnormal water testing results collected on 02/27/24 were never disseminated to the Medical Director by the Biomedical Technician until 04/12/24. Staff Member #1 advised that Staff Member #9 did not attend the March QAPI meeting (Meeting Date of 03/28/24) and that no other appropriate staff member had covered in place for Staff Member #9’s absence. The surveyor received verbal confirmation by Staff Member #1 that no related water or dialysate system information was discussed during the March QAPI meeting and that the April 2024 QAPI meeting had not yet taken place-thus, the abnormal water results which exceeded Action Level were never discussed in QAPI. Staff Member #1 verbalized understanding of the above findings on 04/24/24 at 4:08 pm. The surveyor received confirmation that the QAPI Program should include all relevant areas to dialysis care such as abnormal water and dialysate testing results and follow-up interventions. Opportunity for questions and concerns given without additional response. At the time of exit conference in the evening of 04/24/24, the surveyor had not acquired a facility based QAPI policy.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 40084 42929 Based on observation, interview, medical record review, and facility document review, it was determined the facility staff failed to document an adverse event for one (1) patient. (Patient #5) Findings: During the flash tour on 04/22/2024 at 10:40 a.m., the surveyor observed a puddle of blood covering the bottom of the machine and the floor under the machine at station #15 where a patient was actively receiving dialysis treatment. The surveyor immediately notified the closest staff member and pointed out the gross blood spill. The staff member turned to station #15 and immediately went to the station. Upon further inspection, the surveyor noted that there was a short, thin tubing attached to the blood lines on the machine that was consistently dripping blood. The surveyor overheard a staff member say that the “heparin line” was not clamped. The staff proceeded to clamp the line and clean up the blood spill. On 04/23/2024, Staff Member #4 confirmed that the Patient #5 was patient with the blood spill at station #15 the prior day. A review of the flow sheet for Patient #5 from the dialysis treatment on 04/22/2024 contained no documentation of the blood loss for that patient. The flow sheet revealed that at 1:24 p.m. the patient’s blood pressure was 105/62 and the patient complained of “not feeling well” and the blood pressure was checked, but the patient “denied water or saline flush”. There was no other documentation in the patient’s medical record including in the nursing notes of documentation of the blood loss or notification to the attending physician. On 4/23/2024, Staff Member #1 confirmed that the blood loss from 04/22/2024 had not yet been documented in the adverse event reporting system, as the staff had been flustered and forgot to enter it. The facility’s policy titled “RM300 Incident/Event Reporting” with the last revision date of 05/2022 states in part: ... Policy: A confidential incident report is to be completed for any incident, accident, near-miss, or event that is not consistent with normal patient care or the routine safe operation of the location/center... 3. A patient incident must be reported to the attending or rounding physician.... 4. A patient event, any related assessment, intervention, or follow-up should be objectively documented in the patient’s Medical Record. 5. The electronic incident reporting system will be used by the Center Manager or designee(s) to file incident reports.... 10. Incident reports should be reviewed by the Center Manager or designee(s) as they occur, but no later than the end of the day of their occurrence.... 15. The following incidents at a minimum must ALWAYS be reported as an incident/event: ... Blood loss if any of the following apply: Greater that [sic] 300 mL ... Blood line separation ...” The facility’s policy titled “IC08 Monitoring & Documentation of Patient Care During Treatment” last revised 11/29/2022 states in part: “Purpose: To ensure: ... that all data collected and documented accurately reflects what occurred during each dialysis treatment... Information that must be entered manually includes, but is not limited to: ... interventions for unexpected situations ... (A detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation)...” The above concerns were discussed with Staff Member #1 at the exit conference on 04/24/2024 at 4:00 p.m.”

“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: 40084 Based on interview and record review, it was determined the facility’s Quality Assurance and Performance Improvement (QAPI) program failed to take action to ensure sustained improvement over time. Specifically, the QAPI program failed to correct known issues related to medication labeling. The findings include: Tag V-0143 The Current Recertification Survey Based on observations and interview, it was determined the facility staff failed to maintain a safe environment for dialysis care by not removing expired medication and not appropriately labeling intravenous (IV) medications. Recertification Survey Ending May 18, 2021 Based on observations, interview and document review, it was determined the facility staff failed to ensure aseptic techniques when drawing up and giving intravenous (IV) medications by not including all of the necessary components of medication labeling for three (3) out of three (3) medication-filled syringes.”