Fkc Newport Pike

“IC-CDC MMWR 2001 CFR(s): 494.30(a) The facility must demonstrate that it follows standard infection control precautions by implementing- (1)(i) The recommendations (with the exception of screening for hepatitis C), found in “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients,” developed by the Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report, volume 50, number RR05, April 27, 2001, pages 18 to 28. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html. The recommendation found under section header “HBV-Infected Patients”, found on pages 27 and 28 of RR05 (“Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients”), concerning isolation rooms, must be complied with by February 9, 2009. This Standard is not met as evidenced by: 44819 Based on observation and review of facility policies, it was determined that staff failed to disinfect the access arterial sampling port of bloodlines when obtaining post-treatment bloodwork for 1 of 1 (P12) patients observed who had post-treatment bloodwork obtained. Findings include: The CDC Recommendations and Reports No. RR-5 titled “Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients” dated 4/27/01 revealed, “...The infection control practices recommended for hemodialysis units will reduce opportunities for patient-to-patient transmission of infectious agents ... via contaminated ...supplies, environmental surfaces ...pathogens are transmitted in...hemodialysis units...a health-care worker’s hands...can transfer the virus to...blood line access port...when the...access port is punctured with a needle...Contact transmission can be prevented by...disinfection of environmental surfaces...” The Facility policy titled “Drawing Labs Pre and Post Treatment Procedure” dated 9/5/23 revealed, “...Post hemodialysis...lab draws shall be drawn...Clean the arterial sampling port...with an alcohol prep pad and insert the vacutainer with needle into the port...” During an observation on 5/6/25 of P12’s discontinuation of dialysis treatment at 9:05 AM, EMP8 inserted a vacutainer with needle into the arterial sampling port without cleaning the port with an alcohol prep pad. EMP8 confirmed this finding during the observation.”

“IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P CFR(s): 494.30(b)(1) The facility must- (1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit; This Standard is not met as evidenced by: 44819 Based on observation and facility policy review, it was determined that staff failed to wash the hemodialysis access before initiating treatment for 1 of 3 patients (P6) observed during the initiation of dialysis with arteriovenous (AV) fistulas or grafts. Findings included: The facility policy titled “Access Assessment and Cannulation” dated 5/5/25 revealed, “...Follow the steps below to assess the vascular access...ask patient to wash access area with soap and water...If the patient is unable to wash their own access, the staff...should wear gloves to wash the patient’s access with soap and water...staff may use hand sanitizer with 60-70% alcohol to clean access arm...” During an observation on 5/5/25 between 11:00 and 11:50 AM, the following was observed: - EMP5 transported P6 in a wheelchair from the facility’s waiting room into the dialysis unit and weighed the patient. - EMP5 transported the patient in a wheelchair directly from the scale to the treatment chair at Station #16 and set up the supplies to initiate hemodialysis treatment. - EMP5 assessed the access, prepped the skin, and cannulated the access. EMP5 failed to clean the access with hand sanitizer or ensure that P6 washed the AV Graft access with soap and water before assessing and cannulating the access. EMP5 confirmed the finding on 5/5/25 at 11:50 AM.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 28297 Based on observations, interviews, and policy review, the facility failed to meet the Condition for Coverage (CfC) for V110 Infection Control when it failed to: 1. Ensure staff and patients sanitized hands as required for two of four observations. 2. Ensure patients wore Personal Protective Equipment (PPE) appropriately during disconnection of the Central Venous Catheter (CVC) (A long, flexible tube inserted in the neck, chest, or groin, that leads to the vena cava, a large vein that empties into the heart that can be used for hemodialysis) for two of three observations. 3. Ensure that there was a separation of clean and dirty spaces for one of three observation days. 4. Ensure staff carried biohazard supplies and needles in a manner to prevent contamination of other surfaces for two of three survey days. 5. Ensure staff completed medication preparation in a sanitary manner for one of two observations. 6. Ensure staff completed Central Venous Catheter (CVC) preparation appropriately for one of two observations. Findings include: 1. The facility failed to ensure staff and patients sanitized hands as required for two of four observations. Cross Reference V113. 2. The facility failed to ensure patients wore Personal Protective Equipment (PPE) (equipment worn to minimize exposure to hazards that cause serious injuries and illnesses.) appropriately for two of three observations of CVC disconnection. Cross Reference V115. 3. The facility failed to ensure that there was a separation of clean and dirty spaces when clean supplies were stored next to biohazard containers for one of three observation days. Cross Reference V117. 4. The facility failed to ensure staff carried biohazard supplies and needles in a way to prevent contamination of other surfaces for two of three survey days. Cross Reference V122. 5. The facility failed to ensure staff completed medication preparation in a sanitary manner for one of two observations. Cross Reference V143. 6. The facility failed to ensure staff completed CVC preparation correctly for one of two observations. Cross Reference V147.”

“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: 28297 Based on observation, interview, and policy review, the facility failed to ensure staff changed gloves and sanitized hands as required during one of two observations of Central Venous Catheter (CVC-a long, flexible tube inserted in the neck, chest, or groin, that leads to the vena cava, a large vein that empties into the heart that can be used for hemodialysis) dressing change. In addition, the facility failed to ensure patients (P) washed or sanitized their hands after holding access site for one of two observations. The failure to ensure proper hand hygiene has the potential for increased risk for infections and this could impact all 61 in-center patients. Findings include: Review of the facility policy titled, “Hand Hygiene,” revised 11/06/23 indicated, “...Patients should perform hand hygiene if able, prior to and after each dialysis treatment ...Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids, such as when self-cannulating or holding access sites post treatment to achieve hemostasis. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed...” 1. Observation on 02/24/25 at 11:45 AM revealed Patient Care Technician (PCT)1 was at Station 3 completing the CVC dressing change for P7. PCT1 removed the old dressing, cleaned the access site, and placed a clean dressing over the CVC without washing or sanitizing hands as required. During an interview on 02/24/25 at 12:10 PM, PCT1 indicated that he/she had washed or sanitized his/her hands after he/she removed the old dressing however that was not observed by the surveyor. PCT1 stated that it was required to change gloves and sanitize hands after removing the old dressing and before cleaning and applying a new dressing to prevent cross contamination of the CVC access site. During an interview on 02/26/25 at 1:20 PM the Charge Nurse stated staff were required to change gloves and sanitize hands when removing the old dressing from the CVC and prior to cleaning and applying a new dressing to the CVC. Review of the facility’s policy titled, “Central Venous Catheter (CVC) Dressing Change,” revised 05/06/24, indicated, “...Discard dressing and remove gloves. Perform hand hygiene...”” 2. Observation on 02/24/25 at 3:15 PM revealed P4 was holding the left upper arm access site with a gloved hand. After the bleeding stopped, the patient removed the glove at the patient station and gathered his/her belongings. PCT2 escorted the patient to the scale to retrieve the patient’s weight. P4 left the unit without washing or sanitizing his/her hands as required. During an interview on 02/24/25 at 3:35 PM, PCT 2 stated he/she had never been told that patients needed to wash or sanitize hands after holding their access sites. During an interview on 02/26/25 at 11:00 AM, P4 stated he/she had never been instructed or educated that it was required to wash or sanitize hands after holding his/her access site. During an interview on 02/26/25 at 1:20 PM, the Charge Nurse stated patients should wash or sanitize their hands after holding access sites for infection control purposes.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 28297 Based on observation, interview, and policy review, the facility failed to ensure patients had a mask covering the nose and mouth during two of three observations of Central Venous Catheter (CVC- A long, flexible tube inserted in the neck, chest, or groin, that leads to the vena cava, a large vein that empties into the heart that can be used for hemodialysis ) disconnection. This failure has the potential for exposure of the CVC to infectious material which could impact all 16 patients with CVCs. Findings include: Review of the facility policy titled, “Initiation and Termination Using a Central Venous Catheter (CVC)” revised 11/04/24 indicated, “ ...A mask must be worn that covers the nose and mouth by staff, patients and care partner for all procedure that require accessing the catheter.” Observation on 02/25/25 at 10:40 AM revealed Registered Nurse (RN)2 was at Station 13 with Patient (P)12 discontinuing the dialysis treatment via CVC. The patient’s mask did not cover the mouth or nose as required. Observation on 02/25/25 at 11:15 AM revealed RN2 was at Station 9 discontinuing the treatment via the CVC for P13. The patient’s mask was not covering the nose as required. During an interview on 02/25/25 at 11:20 AM, RN2 confirmed P13’s mask was not covering the nose as required and that P12’s mask was not on as required during the previous observation. RN2 stated the mask should be covering the mouth and nose during discontinuation via the CVC to prevent contamination of the CVC. During an interview on 02/26/25 at 3:35 PM, the Facility Administrator confirmed that patients’ masks must cover the nose and mouth during discontinuation of dialysis via the CVC to prevent exposure to bacteria.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 28297 Based on observation, interview, and review of facility policy, the facility failed to ensure clean supplies were clearly separated from dirty areas for one of three survey days. This failure has the potential for clean supplies to be contaminated by the dirty supplies that were being disposed of in the biohazard containers, and this could affect 61 in-center patients. Findings include: Review of the facility policy titled, “Dialysis Precautions,” revised 01/04/12, indicated, “...Clean areas should be clearly designated for the preparation and handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled and stored...” Observation on 02/24/25 at 9:40 AM revealed the red biohazard container was stored across from Station 10 right under the counter where clean supplies such as dialyzers and clean lines were stored for the next shift of patients. At 9:45 AM, a red biohazard container was stored across from Station 12 under the counter where clean supplies such as dialyzers and lines were stored for the next shift of patients. During an interview on 02/24/25 at 9:45 AM, the Facility Administrator confirmed the dirty red biohazard containers were stored next to clean supplies across from Station 10 and Station 12. Observation on 02/24/25 at 11:37 AM revealed the dirty red biohazard container stored across from Station 6 had dirty dialyzer lines hanging out of the red biohazard container with both ends of the lines uncapped and hanging down outside the biohazard container. During an interview on 02/24/25 at 11:40 AM, the Facility Administrator confirmed the observation of the red biohazard container across from Station 6 and stated the dirty lines should have been inside the container with the lid closed to prevent splatter of infectious fluid on the treatment floor.”

“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: 28297 Based on observation, interview, and review of facility policy, the facility failed to ensure contaminated bloodlines, dialyzers, and fistula needles were capped and transported in a manner to prevent contamination of other surfaces for two of three survey days. The failure to abide by proper infection control practices has the potential for surfaces within the dialysis unit to be contaminated and this could affect 61 in-center patients. Findings include: Review of the facility’s policy titled, “Post Treatment Fistula Needle Removal,” revised 07/01/24 indicated, “ ...Engage the safe needle device per manufacturer’s instructions for use. Discard in sharps container as soon as feasible ...” The facility did not provide a policy on proper disposal of contaminated dialyzer and lines. Observation on 02/24/25 at 2:35 PM revealed that Patient Care Technician (PCT)4 carried dirty dialyzers and lines from Station 12 down the treatment floor to the red biohazard container stored across from Station 13. Observation on 02/24/25 at 3:15 PM revealed PCT 2 carried dirty dialyzers and lines from Station 13 across the floor to the red biohazard container stored across from Station 16. During an interview on 02/24/25 at 3:30 PM, PCT 2 stated he/she was told to carry the needles and dirty biohazard supplies to the centrally-located sharps containers and biohazard containers. PCT2 stated he/she could see where there could be leakage of biohazard fluid by carrying supplies across the treatment floor. Observation on 02/24/25 at 3:30 PM revealed that PCT4 carried dirty needles from Station 10 across the floor to the sharps container. Observation on 02/26/25 at 10:30 AM PCT 4 carried dirty dialyzers and lines from Station 3 down to the biohazard container stored across from Station 1. During an interview on 02/26/25 at 1:20 PM, the Charge Nurse stated the contaminated needles and biohazard supplies should be disposed of closer to the patient station and not carried down the treatment floor to prevent contamination of other surfaces. During an interview on 02/26/25 at 3:35 PM, the Facility Administrator stated the sharps containers and biohazard containers should be brought closer to the dialysis station when the patients’ treatments are completed to ensure biohazard supplies are disposed of near the station and not carried down the treatment floor and potentially contaminate other surfaces.”

“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: 28297 Based on observation, interview, and review of facility policy, the facility failed to ensure staff prepared medications in a sanitary manner for one of two observations. The failure to prepare medications in a sanitary manner has the potential for contamination of the medication vial and this could affect 61 in-center patients. Findings include: Observation on 02/24/25 at 2:45 PM revealed Registered Nurse (RN)2 was at the nurses’ stations drawing up the medication, heparin, for Patient (P)15 at Station 15. RN2 did not wipe the medication vial with alcohol as required for an open vial, opened a second vial, and failed to wipe that vial prior to drawing up the medication. During an interview on 02/24/25 at 2:50 PM, RN2 confirmed he/she failed to disinfect either vial of heparin as required and that it should have been done for infection control purposes. During an interview on 02/26/25 at 3:35 PM, the Facility Administrator confirmed staff were required to disinfect the medication vial prior to accessing it to prevent contamination of the medication vial. Review of the facility’s policy titled “Medication Preparation and Administration,” revised 02/06/23, indicated, “...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multidose vial, cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle using friction and 70% alcohol...””

“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: 28297 Based on observation, interview, and review of facility policy, the facility failed to ensure staff completed the Central Venous Catheter (CVC-a long, flexible tube inserted in the neck, chest, or groin, that leads to the vena cava, a large vein that empties into the heart that can be used for hemodialysis) care prior to accessing the blood stream for one of two observations. The failure to change the dressing prior to accessing the blood stream had the potential for the catheter to have become dislodged or showed signs of infection without detection until after the bloodstream was accessed and this could affect 16 patients with CVC’s. Findings include: Observation on 02/24/25 at 11:45 AM revealed Patient Care Technician (PCT) 1 initiating the dialysis treatment via the CVC for Patient (P) 7. PCT1 removed the end caps, cleaned the ports with alcohol, withdrew blood from both lines then flushed both CVC lines with normal saline. PCT1 then proceeded to complete the CVC dressing change. After the dressing change PCT1 started the hemodialysis treatment. During an interview on 02/24/25 at 12:10 PM, PCT1 stated he/she had not been told that the CVC dressing change had to be completed prior to accessing the blood stream to assess the CVC for proper function and appearance. During an interview on 02/26/25 at 1:20 PM the Charge Nurse stated it was required for staff to change the CVC dressing change prior to accessing the bloodstream to determine if there are any issues with placement or appearance of the CVC insertion site. Review of the facility’s policy titled, “Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer,” revised 05/06/24, indicated, “ ...The catheter exit site must be examined for signs and symptoms of infection, dislodgement of catheter or other problems and the catheter exit site care and dressing replacement must be completed prior to accessing the bloodstream. If complications noted, inform the nurse in charge or the physician for additional instructions prior to initiating treatment ...””

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 28297 Based on observation, interview and policy review the facility failed to ensure two of eight “Reusable Concentrate Jugs” were labeled with the content of the jug for one of three survey days. Failure to label jugs had the potential for staff to use jugs with unknown content and this could affect 61 in-center patients. Findings include: Observation on 02/24/25 at 2:30 PM revealed two of eight acid concentrate jugs stored in the supply storage closet on the treatment floor that were “ready for use” with clear liquid inside were not labeled with the contents. The jugs were stored on the second level of the cart and two boxes of old dialyzers (no longer in use at the facility) were covered in sediment on the bottom level of the cart. During an interview on 02/24/25 at 2:30 PM with the covering Biomedical Technician and Facility Administrator confirmed the two jugs were not labeled with the contents or the health risk label as required. The Facility Administrator stated everyone was responsible to ensure the jugs were labeled appropriately however the covering Biomedical Technician stated the Patient Care Technicians were required to rinse the jugs monthly and ensure the jugs were labeled. Review of the facility’s policy titled, “Acid Concentrate Storage and Handling,” revised 09/03/24 indicated, “ ...Container labels must be clearly visible, be in good condition and readable ...Do not store acid concentrates above dry materials. (examples: Dialyzers, blood lines).””

“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: 28297 Based on observation, interview, and review of the facility’s policy and procedure, the facility failed to keep patient hemodialysis access sites uncovered and visible for two of three days of the survey. The needle insertion sites and line connections for all patients on treatment must be visible to staff at all times to ensure the lines and needles do not become dislodged or disconnected that could lead to an undetected blood loss and could affect all 61 in-center patients receiving treatment in the facility. Findings include: Observation on 02/24/25 at 9:30 AM revealed Patient (P) 9 at Stations 1, P10 at Station 6, and P11 at Station 16 had their access sites covered, with a blanket. Observation on 02/25/25 at 11:30 AM revealed P16 was at Station 7 with their access covered. Patient Care Technician (PCT) 3 went over to Station 7 at 11:35 AM and completed a documentation check and asked the patient if he/she was ok. PCT 3 then left the station without pulling back the blanket to view the access or to ensure the access remained uncovered during treatment. During an interview on 02/25/25 at 11:35 AM PCT 3 confirmed he/she did not uncover the access and should have as the access site must always remain uncovered. During an interview on 01/26/25 at 1:20 PM the Charge Nurse confirmed that patient access sites must be visible at all times during treatment to ensure there has been no bleeding from the access site. During an interview on 02/26/25 at 3:35 PM the Facility Administrator stated that all patient access sites must always be visible to ensure patient don’t have undetected blood loss. Review of the facility policy titled, “Patient Assessment and Monitoring,” revised 05/01/23 indicated, “ ...During Treatment ...Access-Observe connections are secure and visible ...ensure access remains uncovered throughout the treatment. Observe and ensure: Tape is secure, Needles are intact, No bleeding or infiltration is noted ...””

“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: 28297 Based on observation, interview and review of facility policy, the facility failed to ensure the State Contact information for filing a grievance had the correct address and phone number for one of three survey days. In addition, the facility failed to have the state contact information and ESRD Network contact information in a location that ensured it was prominently displaced where patients could read for three of three survey days. The failure to have the correct information posted and to not have information prominently displayed had the potential for patients not to be able to contact agencies is desired for a grievance. Findings include: Observation on 02/24/25 at 8:20 AM upon entrance to the facility revealed the posting for the state contact information did not include the correct address and phone number for the state agency. It was determined that the address and phone number were from the old location, however the office relocated in 2022 according to the Delaware state agency web site. Observation on 02/24/25, at 8:20 AM, 02/25/25 at 8:30 AM and 08/26/25 at 8:30 AM revealed the State agency and ESRD Network information was posted in an enclosed container approximately 7-8 foot high. The print to read the information was in small lettering. There was a holder at the entrance to the unit that contained handouts of important numbers, however it did not contain the State Contact number or the ESRD contact information. During an interview on 02/26/25 at 3:35 PM the Facility Administrator stated that the secretary was responsible to ensure the contact information was correct on the form posted in the lobby. The Facility Administrator observed the location of the posting and confirmed it was not visible or readable to patients who were in a wheelchair or visually impaired. During an interview on 02/26/25 at 4:15 PM the Administrative Assistant stated he/she was responsible for changing the posting in the lobby however he/she only changed it when the Director of Operations and Facility Administrator contact information was changed. He/she state corporate office was responsible for updating the state contact information or ESRD Network information. Review of the facility’s policy titled, “Patient Grievance,” revised 01/02/14 indicated, “ ... Facilities must hang a poster titled “Patient and Staff Partnerships,” in a visible and accessible location with multiple quantities and most up to date versions of: Patient Grievance Procedure handout titled “What to do if you have a concern” Handout titled “Important Numbers.””

“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: 28297 Based on observation, interview, and review of facility documents and review of facility Medical Director Guidelines, the Medical Director failed to ensure staff completed infection control practices per facility policy. The failure of Medical Directors oversight to the infection control program had the potential to negatively affect patient care and safety for all 61 in-center patients and resulted in Infection Control Condition level findings at V110. Findings include: Review of facility documents titled “Internal Core Survey Audit” conducted on 02/21/24 revealed an issue with staff had not been performing Central Venous Catheter (CVC) dressing changing prior to accessing the bloodstream. The facilities Plan of Correction (POC) was to conduct audits for 2 weeks of staff performing the task and to follow up if there was deficient practice. Review of the corrective action audits from 02/26/24-03/09/24 indicated the Facility Administrator conducted 10 of the 12 audits and the Charge Nurse conducted the other two audits that found no deficient practice with the observations. The 12 audits completed over the two weeks as a part of the corrective action plan did not include which patient or staff were audited. Review of the facility documents titled “Clinic Audit Dashboard” included for observations of CVC exit site care that indicated nine of 12 months from February 2024-January 2025 were 100%, observation of initiation and termination of CVC, from February 2024 -January 2025 indicated 11 of 12 months were 100%, quarterly observation of review of Medication Preparations from April 2024-December 24 indicated there was three of four months 100%, and quarterly observation of Machine Preparations from April 2024-November 2024 indicated four out of five observations were 100%. During an interview on 02/26/25 at 12:00 PM the Medical Director was informed of the multiple issues found with infection control practices (Cross Reference V110). The Medical Director stated he/she had been asking for more in-depth infection control audits that included what exactly what infection control practices were being observed, who was conducting the audit observations, and what staff were being observed. The Medical Director confirmed he/she had not been provided with that additional audit information. When provided the information of the audits reviewed by the surveyor, the Medical Director stated, “I don’t believe it.” During an interview on 02/26/25 at 1:20 PM the Charge Nurse stated he/she was responsible for doing the monthly infection control audits. The Charge Nurse stated that he/she informed the staff prior to conducting audits that he/she was doing the audits. The Charge Nurse confirmed the infection control audits were done with the staff’s knowledge that they were being audited. The Charge Nurse stated that it probably was not the way he/she should be doing them. The Charge Nurse stated the facility conducts multiple team meetings monthly and talks about the importance of infection control and that staff should have knowledge of the facility policies and procedures. During an interview on 02/26/25 at 3:35 PM the Facility Administrator confirmed the Charge Nurse completes the monthly infection control audits and they were uploaded to the Quality Assessment Performance Improvement (QAPI) dashboard. The Facility Administrator stated the step-by-step audits were done however once they answered the questions the program only shows the percentages, and all other information disappeared. The Facility Administrator confirmed the audits should be more subtle, so staff were unaware that they were being observed. Review of the facility policy titled “Medical Director Compliance Guidelines,” revised 01/01/2007, indicated “ ...Specific Medical Director Responsibilities Participation in the selection of a suitable treatment modality, i.e., transplantation, hemodialysis, peritoneal dialysis, and dialysis setting, for all patients; Assuring adequate training of nurses and technicians in dialysis techniques; Assuring adequate monitoring of the patient and the dialysis process. For self-dialysis patients, assuring periodic assessment of patient performance of dialysis tasks ...””

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 47821 Based on medical record review, policy review, document review and staff interview, it was determined that for 1 of 3 patients (Patient #1) in the medical record review sample, the facility failed to ensure that the dialysis prescription was being followed as ordered. Findings include: A. Facility policy titled “Pre-Treatment Safety Checks Procedure” dated 2/6/2023 stated, “...Verify the following elements by two direct patient care staff members prior to treatment initiation...On the “Verify Concentrate Screen” verify the following...Correct acid concentrate has been selected for treatment...Proper “Base NaCL” [sodium chloride] has been entered per prescription...Proper “Bicarbonate” has been entered per prescription...” B. Facility policy titled “Nursing Supervision and Delegation” dated 11/6/2023 stated, “...The registered nurse must...review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed...” C. Treatment Run Sheet for Patient #1 dated 3/12/2024 stated, “...Hemodialysis Orders...Sodium: 135...Bicarbonate machine setting: 32...” D. Document titled “Cardiopulmonary Arrest Root Cause Analysis” stated, “...Date of Event: 3/12/2024...Date of Data Collection: 3/13/2024... Prescription of patient’s treatment not delivered as ordered by the physician for: Base sodium setting, Base bicarbonate setting...” E. Document titled “Device Evaluation Following Patient Event Form” stated, “...Date of Event: 3-12-2024....Time; 10:25 AM... Dialysis Machine... Prescribed Bicarbonate Setting: 32...Actual 34....Prescribed Sodium Setting: 135...Actual 138...” F. Interview conducted on 3/28/2024 with Employee #10, the registered nurse caring for Patient #1 during his/her treatment on 3/12/2024. Employee #10 stated that she/he was unaware of the settings being incorrect that day. Employee #10 stated, “They didn’t tell me they were off.” During an interview conducted with Employee #1 on 3/28/2024 at 2:03 PM, Employee #1 confirmed that the dialysis machine’s base sodium and bicarbonate settings were on the wrong settings during Patient #1’s treatment on 3/12/2024.”

“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: 44819 Based on medical record review, policy and document review, and staff interview, it was determined that for 2 of 3 patients (Patient #1 and #2) in the medical record review sample, the medical director failed to ensure that staff adhered to policies. Findings include: A. The facility policy titled “Patient Assessment and Monitoring” dated 5/1/23 stated, “...the RN [Registered Nurse] will notify the patient’s physician/physician extender of any abnormal findings...based on clinical judgment....During treatment...Obtain blood pressure...every 30 minutes or more as needed...Report to the nurse...Diastolic blood pressure greater than 100mm/Hg [millimetre of mercury] ...” B. The facility policy titled “Hypertension” dated 9/7/2021 stated, “Signs and Symptoms of Hypervolemia, Shortness of breath, dyspnea on exertion, Peripheral edema, Hypertension, Neck vein distension, jugular venous pressure...Notify the nurse in charge if a patient has a... diastolic blood pressure greater than 100mm/Hg...The RN [registered nurse] will assess the patient and determine if further nursing interventions are needed.... If hypertension is not related to hypervolemia, notify the physician for additional orders/interventions...Document in the patient’s treatment record...” C. The facility document titled “Job Title: Charge Nurse” dated 2/11/19 stated, “...Assess patient needs...communicate concerns to rounding physician...” D. The facility policy titled “Nursing Supervisions and Delegation” dated 11/6/23 stated, “...Guidelines...to refer a patient to the Team Leader/Charge Nurse for further assessment...Blood Pressure...B/P less than or equal to 100 mm/Hg systolic during treatment... E. The facility policy titled “Intradialytic Hypotension” dated 7/3/23 stated, “...Staff...will report intradialytic hypotensive episodes to the nurse in charge. The nurse in charge will report to the physician severe or frequent intradialytic hypotensive episodes...” Patient #1 “Treatment Sheet” dated 1/23/2024 stated, “...8:25 AM, BP [blood pressure] 144/101...UF [ultrafiltration] on, access visible, green AMP [amplifier] light, denies complaints...9:00 AM, BP 164/102, UF on, resting comfortably, access visible, green AMP light, denies complaints, patient alert.... nursing evaluation...BP elevated with no c/o [complaints of] chest pain, headache or dizziness...” No documentation noted in Patient #1’s treatment records that the nurse was notified that the patient’s diastolic blood pressure was greater than 100mm/Hg for two consecutive readings. No documentation noted that the nurse assessed the patient to determine if further interventions were needed such as notifying the physician for additional orders/interventions. These findings were confirmed by Employee #1 on 4/1/2024 at 12:47 PM. Patient #2 Review of the medical record revealed patient’s first in-center hemodialysis treatment was on 3/22/24. “Treatment Sheet” dated 3/22/24 documents patient’s pre-treatment blood pressure (BP) was 106/65, treatment was initiated at 11:40 AM, and his/her systolic blood pressure (SBP) fell below the 100mmHg threshold on the following times: - 1:00 PM - 93/55; RN notified, and clinical interventions made - 1:30 PM - 77/50; RN aware, and clinical interventions made - 2:00 PM - 97/52; RN aware, and clinical interventions made - 2:30 PM - 93/47; RN aware, and clinical interventions made - 3:00 PM - 92/45; RN aware, and clinical interventions made - 3:30 PM - 84/44; RN aware, and clinical interventions made There was no evidence that the RN notified the physician or physician extender of the patient’s frequent hypotensive episodes. During an interview on 4/1/23 at 12:50 PM, Employee #1 confirmed there was no evidence Patient #2’s physician or physician extender was notified of the patient’s frequent hypotensive episodes.”