Fort Bend Dialysis Center

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 10802 Based on observation, and record review, the patient’s attending nephrologist failed to document two weekly face to face assessment of patient’s in 1 of 6 sampled patients ; patient#4 Findings: Review of the facility’s medical staff bylaws revised August 25, 2011, directs medical staff as follows: 9.3 DELINQUENT MEDICAL RECORDS 9.3.1 For purposes of this Section 9.3, a medical record, whether paper or electronic, shall be considered delinquent if: (d) the medical record fails to comply with medical records requirements under State law or with applicable medical record Policies and Procedures 11.3 Rounding/Patient Visits and Documentation Requirements; Rounding Schedule a. The Attending Physician and/or Advanced Practitioner must visit or see his/her patient a least monthly. At a minimum, monthly medical progress notes (which also denote the site of the visit) must be in every patient’s medical record that document that an Attending Physician or Advanced Practitioner has seen the patient ... Patient #4 On 04/15/2024 at 8:22 a.m. Patient #4 was observed on the treatment unit at station #16. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 600 mls/ minute via a right double lumen central venous catheter. Review of patient #4’s history and physical dated 11/13/2023 revealed the patient was admitted to the facility on 12/09/2022 with diagnosis of hypertension and end stage renal disease on in center hemodialysis three times weekly. Review of the patient’s clinical record revealed documentation (physician progress notes) which indicated the patient’s physician’s visit was dated 3/08/2024. The record did not indicate the patient’s physician conducted visits with patient #4 every two weeks. On 04/15/2024 the Surveyor requested documentation from facility’s administrative staff ( area team lead) of the patient’s nephrologist visit every two weeks. The area team lead personnel said there was none. She said the patient’s nephrologist planned on conducting a visit on Wednesday 4/17/2024 but there was no documentation of a physician’s visit since 3/08/2024.”

“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: 10802 Based on observation and interview, facility’s direct care staff failed to ensure contaminated hemodialysis machines do not cross contaminate terminally cleaned hemodialysis machine primed and set up for on coming patient in 2 of 2 hemodialysis machines. Hemodialysis machine #s 1 and 10. Findings: Observation on 02/26/2024 at 11:15 a.m. of station #11 revealed hemodialysis machine #1 was terminally cleaned with external blood lines and dialyzer primed with Normal Saline, in place in preparation for an on-coming patient. Observation revealed hemodialysis machine #1’s prime bucket and hoses were in direct contact with hemodialysis machine #10 who had random patient #9 receiving hemodialysis treatment utilizing the hemodialysis machine #10. The chase cupboard door located to the back of station #11 had paper tape holding the door. When the tape was removed by Patient Care Technician (D) at the request of the Surveyor, revealed the door hinge was broken and could not remain closed. Paper tape securing the chase door prevents complete terminal cleaning of the chase. The Surveyor immediately notified the facility’s charge nurse of the cross contamination of hemodialysis machine numbers 1 and 10. The facility’s charge nurse states: “I will remove it. I will notify biomed of the door.””

“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: 10802 Based on observation, interview and record review, the facility’s direct care staff failed to clean and disinfect, Hansen connectors, back of hemodialysis machines, stethoscope, chase, and television console in 1 of 2 staff observed terminally cleaning hemodialysis stations. Patient Care Technician (D) Findings: Observation on 02/26/2024 at 11:10 a.m. at station #12 revealed Patient Care Technician (D) was observed terminally cleaning the hemodialysis unit, post hemodialysis treatment of a patient. Observation revealed during terminal cleaning of the unit, Patient Care Technician (D) did not clean and disinfect the Hansen connectors, back of hemodialysis machines, stethoscope, chase, and television console. On 02/26/2024 at 11:29 a.m. Patient Care Technician (D) was observed setting up clean blood lines and dialyzer in preparation for an on- coming patient. The Surveyor immediately notified her that she did not clean/ disinfect the Hansen connectors, back of hemodialysis machines, stethoscope, chase, and television console. Patient Care Technician (D) states” The television was not used.” Review of the facility’s current policy and procedure on Cleaning and Disinfecting the Dialysis Station; policy #47806, Published 09/05/2023 directs staff as follows: “(1).Don the appropriate PPE (2). Remove non-disposable linen or dispose of disposable linen in appropriate waste container. (3). Use a cloth wetted with 1:100 bleach solution or EPA-approved disinfectant to clean and disinfect the dialysis station (chair/bed, tables, machine, television, chase wall behind chair ). Place the chair in Trendelenburg position and open side panels, if chair has swing open sides so all surfaces of the chair are accessible. (4).Clean all surfaces. Make the surface glitteringly wet and allow to air dry unless otherwise specified by the manufacturer.””

“POC-MONITOR ESA RESPONSE CFR(s): 494.90(a)(4) The patient’s response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review facility’s anemia manager failed to monitor patients for low hemoglobin levels when erythropoietin stimulating agent dose is on hold, in 1 of 9 sampled patients: Patient #7 Findings: Review of the facility’s current Policy and Procedure on Medical Algorithm; Policy # 46935, published 07/03/2023 directs staff as follows: “Policy: Algorithms are orders that must be executed ...” Review of the Fresenius Kidney Care Mircera Algorithm Incenter 4.0 directs the staff as follows: Exception Criteria “ HGB is > 11.2 g/dl: Minimum Days Since Dose Change = 14; Action = Dosing week: Hold Mircera dose. Reevaluate weekly HGB. Restart Mircera when Spectra (lab the facility uses) HGB is </= 11.1 g/dl “ Resume from Hold: HGB </= 11.1 g/dl on Held Doses: Minimum Days Since Dose Change = 1; Action = Restart Mircera based on the previous dose.” Patient #7 On 02/26/2024 at 7:29 a.m. Patient #7 was observed at station #4, hemodialysis machine #6. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of Autoflow 1.5 x (600 mL/min) via a left lower arm vascular access. Review of the facility’s laboratory report on 02/27/2024 revealed the following hemoglobin results for Patient #7: 12/27/2023 hemoglobin 11.2 g/dl 01/03/2024 hemoglobin 11.8 g/dl 01/10/2024 hemoglobin 12.3 g/dl 01/24/2024 hemoglobin 11.6 g/dl 01/31/2024 hemoglobin 11.6 g/dl 02/07/2024 hemoglobin 10.7 g/dl 02/14/2024 hemoglobin 9.7 g/dl 02/21/2024 hemoglobin 8.7 g/dl Review of the patient’s clinical record (Lab Results/Medication Administration Summary) dated 02/27/2024 revealed the patient did not receive anemia management when his hemoglobin level decreased from 11.6 g/dl on 01/31/2024 to 10.7 g/dl on 02/07/2024. The report also revealed Mircera 200 mcg IVP was administered on 12/31/2023 and Mircera 150 mcg IVP was later administered on 02/19/2024. Review of the patient’s clinical record (Patient Transfer) revealed an order for: Mircera 150 mcg IVP during dialysis every 2 weeks dated 02/19/2024. The patient’s clinical record revealed an Algorithm on file dated 9/29/2023 for “CMAB recommended Algorithm for Mircera- Mircera IVP Admin (Incenter only) Version 4.0 Every Treatment.” The patient’s hemoglobin on 02/07/2024 was 10.7 which triggers the restart of Mircera doses to be administered to the patient per the Facility’s Mircera Incenter 4.0 algorithm. Review on 02/26/2024 of the patient’s clinical record (treatment sheet) revealed Mircera was administered to the patient on 02/19/2024. The medication was not administered timely when the patient’s hemoglobin dropped to 10.7 as recommended by the algorithm. Interview with Clinical Manager (A) on 02/27/2024 at 09:07 a.m.: the Surveyor notified Clinical Manager (A) of the patient’s low hemoglobin result on 02/07/2024 and Mircera dose was not administered until 02/19/2024. Clinical Manager (A) stated, “We usually make the changes in the system on Saturdays but let me check with our registered nurse.” Observation of Clinical Manager (A) and Registered Nurse (G) on 02/27/2024 at 9:15 a.m. revealed them to look into the computer at the nurse’s station. Registered Nurse (G) then notified the Surveyor that he was unable to find any nursing notes from the Anemia Manager of why the Mircera dose was not administered until 02/19/2024.”

“POC-PTS SEEN BY MED STAFF 1X/MO CFR(s): 494.90(b)(4) The dialysis facility must ensure that all dialysis patients are seen by a physician, nurse practitioner, clinical nurse specialist or physician’s assistant providing ESRD care at least monthly, as evidenced by a monthly progress note placed in the medical record, and periodically while the hemodialysis patient is receiving in-facility dialysis. This Standard is not met as evidenced by: 10802 Based on observation, and record review, the patient’s attending nephrologist failed to document monthly face to face assessment of patient’s in 3 of 9 sampled patient’s; patient #s 8, 1, 2 Findings: Review of the facility’s medical staff bylaws revised August 25, 2011, directs medical staff as follows: 9.3 DELINQUENT MEDICAL RECORDS 9.3.1 For purposes of this Section 9.3, a medical record, whether paper or electronic, shall be considered delinquent if: (d) the medical record fails to comply with medical records requirements under State law or with applicable medical record Policies and Procedures 11.3 Rounding/Patient Visits and Documentation Requirements; Rounding Schedule a. The Attending Physician and/or Advanced Practitioner must visit or see his/her patient a least monthly. At a minimum, monthly medical progress notes (which also denote the site of the visit) must be in every patient’s medical record that document that an Attending Physician or Advanced Practitioner has seen the patient ... Patient #8 On 02/27/2024 at 8:15 a.m. Patient #8 was observed on the hemodialysis unit at station #8. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 600 mls/ minute via a left upper arm vascular access. Review of the patient’s clinical record ( physician’s progress notes) revealed documentation which indicated the physician had face to face visits with the patient’s nephrologist on 1/2/2024, 1/13/2024, 1/20/24 and and 1/27/2024. There was no documented visit for February 2024. Interview on 02/27/2024 9:04 a.m. with the Facility’s Director of Operations revealed she said there is no documented visit for the physician for February 2024. 48020 Patient #1 On 02/26/2024 at 06:53 a.m., Patient #1 was observed at station #4 machine #32 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of Autoflow 1.5 x (600 mL/min) via a left upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) revealed the patient had a face-to-face visits with the physician on 01/03/2024 and 02/19/2024. There was no documentation for face-to-face visits from the physician on 01/17/2024 or 01/31/2024. Patient #2 On 02/26/2024 at 6:49 a.m. Patient #2 was observed at station #5, hemodialysis machine #18. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of Autoflow 1.5 x (600 mL/min) via a left upper arm vascular access. Review of the patient’s clinical record (physician’s progress notes) revealed the patient had a face-to-face visits with the physician on 01/03/2024 and 01/22/2024. There was no documentation for face-to-face visits from the physician on 01/31/2024 or 02/14/2024 . Interview with the Facility’s Director of Operations on 02/27/2024 at 11:32 a.m. revealed she said, the physician did not round on the patients for the dates in question.”

“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: 48020 Based on observation, record review and interview, the facility’s registered nurses failed to conduct post treatment assessment when patients present with unusual findings during pre-treatment assessment in 3 of 9 sampled and closed patients: Patient #s 7, 1, 10 Findings: Texas Board of Nursing RN Scope of practice. Rule 15.28. Assessment The comprehensive assessment is the first step, and lays the foundation for the nursing process. The comprehensive assessment is the initial and ongoing, extensive collection, analysis and interpretation of data. Nursing judgment is based on the assessment findings. The RN uses clinical reasoning and knowledge, evidence- based outcomes, and research as the basis for decision-making and comprehensive care. Based upon the comprehensive assessment the RN determines the physical and mental health status, needs, and preferences of culturally, ethnically, and socially diverse patients and their families using evidence-based health data and a synthesis of knowledge. Surveillance is an essential step in the comprehensive assessment process. The RN must anticipate and recognize changes in patient conditions and determines when reassessments are needed. Patient Diagnosis/Problem Identification/Planning The second step in the nursing process is analyzing data gathered during the assessment and problem identification. The role of the RN is to synthesize comprehensive assessment data to identify problems, formulate goals/outcomes, and develop plans of care for patients, families, populations, and communities using information from evidence-based practice and published research in collaboration with these groups and the interdisciplinary health care team, as appropriate for their educational background and scope. The third step in the nursing process is planning. The RN synthesizes the data collected during the comprehensive assessment to identify problems, participate in the patient diagnoses, and to formulate goals, teaching plans and outcomes. A nursing plan of care for patients is developed by the RN, who has the overall responsibility to coordinate nursing care for patients. Teaching plans address health promotion, maintenance, restoration, and prevention of risk factors. The RN utilizes evidence-based practice, published research, and information from patients and the interdisciplinary health care team during the planning process. Implementation Implementing the plan of care is the fourth step in the nursing process. The RN may begin, deliver, assign, or delegate certain nursing tasks within the plan of care for patients within legal, ethical, and regulatory parameters and in consideration of health restoration, disease prevention, patient independence, wellness, and promotion of healthy lifestyles. The RN ’ s duty to patient safety when making assignments to other nurses or when delegating tasks to unlicensed staff is to consider the education, training, skill, competence, and physical and emotional abilities of those to whom the assignments or delegation is made. The RN is responsible for reasonable and prudent decisions regarding assignments and delegation. The RN scope of practice may include the supervision of LVNs or other RNs. Supervision of LVN staff is defined as the process of directing, guiding, and influencing the outcome of an individual ’ s performance and activity.5 The RN may have to directly observe and evaluate the nursing care provided depending on the LVN ’ s skills and competence, patient conditions, and level of urgency in emergent situations. The RN may determine when it is appropriate to delegate tasks to unlicensed personnel and maintains accountability for how the unlicensed personnel perform the tasks. The RN is responsible for supervising the unlicensed personnel when tasks are delegated. The proximity of supervision is dependent upon patient conditions and skill level of the unlicensed personnel. In addition, teaching and counseling are interwoven throughout the implementation phase of the nursing process. Evaluation and Re-assessment A critical and final step in the nursing process is evaluation. The RN evaluates and reports patient outcomes and responses to therapeutic interventions in comparison to benchmarks from evidence-based practice and research findings, and plans any follow-up care and referrals to appropriate resources that may be needed. The evaluation phase is one of the times when the RN reassesses patient conditions and determines if interventions were effective and if any modifications to the plan of care are necessary. Review of the facility’s current Policy and Procedure on Patient Assessment and Monitoring; Policy # 45284, published 05/01/2023 directs staff as follows: “Lung sounds, edema, heart sounds. The registered nurse will assess/ reassess post treatment as indicated” Patient #7 On 02/26/2024 at 7:29 a.m. Patient #7 was observed at station #4, hemodialysis machine #6. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of Autoflow 1.5x (600 mL/min) via a left lower arm vascular access. Review of the patient’s clinical record (treatment sheet) dated 02/26/2024 revealed the following documentation: 07:31 a.m.: registered nurse documented the pretreatment assessment which revealed “Came aaox3, hrr w/O2 3l/min nasal cannula his maintenance as per MD. Pt has standing order. avf+b/t no s/s of infection noted. Gain >2.0 kg. educate about fluid management. Uf goal of 3.0 kg as per tolerance, v/s evaluated, continue to monitor. Symptoms ... Lower Leg - Severity: 1+: 2 mm or less, disappears rapidly Ankle - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: bilateral Edema Lower Leg - Location: bilateral” 12:02 p.m.: registered nurse documented the post treatment assessment which revealed “tx completed, uf goal met, bp wnl, hr slightly low, asymptomatic, ok to discharge as per standing order.” The edema reassessment was not documented. Review of the patient’s treatment sheets dated 02/09/2024 - 02/21/2024 revealed no edema reassessments were documented when the patient was found to have edema in the pre-treatment assessments. Interview with Registered Nurse (G) on 02/27/2024 at 10:40 a.m.: the Surveyor notified Registered Nurse (G) of the failure to complete the edema reassessment. Registered Nurse (G) stated, “It’s my fault, I was rushing and did not check.” Patient #1 On 02/26/2024 at 06:53 a.m., Patient #1 was observed at station #4 machine #32, receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of Autoflow 1.5x (600 mL/min), via a left upper arm vascular access. Review of the patient’s clinical record (treatment sheet) dated 02/12/2024 revealed the following documentation: 06:16 a.m.: registered nurse documented the pretreatment assessment which revealed “Came aaox3, hrr w/O2 2l/min per nasal cannula as her maintenance but denies c/o cp or ha, no n/v. avf+b/t no s/s of infection noted. Gain >2.0 kg. educate about fluid management. Uf goal of 3.0 kg as per tolerance, bp evaluated, asymptomatic, continue to monitor. Symptoms ... Ankle - Severity: 1+: 2 mm or less, disappears rapidly Lower Leg - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: bilateral Edema Lower Leg - Location: bilateral” 10:14 a.m.: registered nurse documented the post treatment assessment which revealed “tx completed, uf goal not met d/t trending bp that resolved, access secured, and no bleeding seen, bp improved, left stable, aaox3, not in distress and denies complaint, left w/2.6 kg above edw, educate about fluid management pt verbalized understanding.” The edema reassessment was not documented. Interview with Registered Nurse (C) on 02/27/2024 at 10:43 a.m.: the Surveyor notified Registered Nurse (C) of the failure to complete the edema reassessment. Registered Nurse (C) stated, “Sometimes I miss doing it.” Patient #10 Review of the patient’s clinical record on 02/26/2024 revealed the patient was admitted to the facility 10/19/2017. Review of the patient’s clinical record (treatment sheet) dated 01/02/2024 revealed the following documentation: 13:12 p.m.: registered nurse documented the pretreatment assessment which revealed “No unusual findings noted. Pt arrived late ... AAOx3. Denies c/o headache, CP, N/V, and SOB. Access clean and free from infection. Vitals withing normal limits. UF goal set to 1.0L as tolerated. Monitoring. Symptoms ... Lower Leg - Severity: 1+: 2 mm or less, disappears rapidly Ankle - Severity: 1+: 2 mm or less, disappears rapidly Edema Ankle - Location: bilateral Edema Lower Leg - Location: bilateral” 16:74 p.m.: registered nurse documented the post treatment assessment which revealed “tx ended early due to late arrival. AMA signed. Pt aware of complications. Post v/s with in normal. Access taped and secured; no bleeding noted. Pt left clinic stable condition.” The edema reassessment was not documented. Interview with Clinical Manager (A) on 02/27/2024 at 10:38 a.m.: the Surveyor notified Clinical Manager (A) of the failure to complete the edema reassessment. Clinical Manager (A) stated, “We went over that. They are supposed to be checking for it.””

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 22676 Based on staff interview, review of the facility’s documents, and policy and procedures, the facility failed to meet the Condition for Coverage (CfC) for Water and dialysate quality when it failed to 1) monitor “Daily Water Treatment Logs to ensure tests were completed and documented, and: 2) failed to ensure staff performing mixing and testing documented evidence of disinfecting one of two bicarbonate holding tanks (Tank #1). The cumulative effects of systemic failures prevent the facility from having water and dialysate quality checks in place to ensure patient safety, and potentially put all 66 patients at risk by exposure to unclean dialysate. Findings include: 1. Based on observation, interview, review of the “Daily Water Treatment Logs,” and the facility’s policy, the facility failed to ensure the staff monitored the end of day hardness of water quality as required by the regulations and facility policy for one of 42 days reviewed (10/27/23). (Refer to V191) 2. Based on interview and policy review, the facility failed to have documented evidence of disinfecting one of two bicarbonate holding tanks (Tank #1). (Refer to tag V239)”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 22676 Based on staff interview, review of the facility’s documents, and policy and procedures, the facility failed to meet the Condition for Coverage (CfC) for patient plan of care (POC) when it failure to, 1) Ensure the patient was included in the POC process or provide the information to the patient in a timely manner for six of seven patients (Patient (P) 6, P7, P8, P10, P11 and P15), and: 2) Failed to ensure that three of 13 patients (Patient (P) 6, P7, and P9) had their POC reviewed within 15 days of the POC assessment. The cumulative effects of systemic failures prevented the facility from having a comprehensive POC process, which followed their POC policy and procedure. This failure had the potential to affect all 66 patients’ health and wellbeing, by failing to educate patients on their current treatment goals, or timely implementing current POC assessments to adjust their goals. Findings include: 1. Based on record review, interviews, and review of the facility’s policy, the facility failed to ensure the six of seven patients (Patient (P) 6, P7, P8, P10, P11 and P15) reviewed participated in the POC or received the information within a timely manner. (Refer to tag V556). 2. Based on record review, interviews, and review of the facility’s policy, the facility failed to ensure three of 13 patients (Patient (P) 6, P7, and P9) POC were reviewed and completed within 15 days of the reassessment as required by federal regulations. (Refer to tag V558).”

“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: 22676 Based on observations, interview, and policy review, the facility failed to ensure staff performed hand hygiene (sanitizing with an alcohol-based hand rub or washing with soap and water) after removing gloves, after touching patient care equipment (dialysis machines and bloodlines), and before contact with the patient, during one of three survey days. Failure to remove gloves and perform hand hygiene provided a mode of cross contamination, with the potential spread of infection, which could negatively impact the 66 patients receiving incenter dialysis treatments in this facility. Findings include: During an observation of the hemodialysis treatment area on 12/13/23 from 9:45 AM to 12:30 PM revealed, Certified Clinical Hemodialysis Technician (CCHT) 13 was observed disconnecting at Station #12 at 10:45 AM. CCHT13 removed his/her gloves and used hand sanitizer to perform hand hygiene, instead of allowing the hands to dry naturally, CCHT13 waved his/her hands in the air prior to donning new gloves. CCHT13 was then observed finishing the machine set up at Station #15. CCHT13 then went to help at Station #9 with the same gloves on. During an observation on 12/13/23 at 11:00 AM to 11:15 AM, CCHT12 was observed removing gloves and obtaining supplies without using hand sanitizer or washing hands. During an interview on 12/13/23 at 11:15 AM, CCHT13 confirmed the above findings. During an interview on 12/13/23 at 11:20 AM with CCHT12 confirmed he/she failed to use hand sanitizer after removing gloves. During an interview on 12/13/23 at 1:40 PM, Clinic Manager 2 confirmed that after removing gloves and donning new gloves hand hygiene should be performed. Clinic Manager 2 confirmed that staff are not to move from one station to the next without removing gloves and using hand sanitizer or washing hands. Review of the facility’s policy titled, “Hand Hygiene,” revision dated 11/06/23, revealed, “Immediately after removing glove. After contact with body fluids or excretion .... after contact with inanimate objects near patient, when moving from a contaminated body site to clean body site of the same patient. After contact with other objects within the patient station.””

“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: 22676 Based on observation, interview, facility policy review, and review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that the wall boxes (dispensing outlets) at four of 16 dialysis stations were clean and free of a build-up of white crystals and yellow substance. This deficient practice had the potential to cause bacteria to grow in the wall boxes and cause harm by infecting the 66 patients receiving in-center hemodialysis at the facility. Findings include: During an observation of all wall boxes on 12/13/23 at 9:45 AM, at Stations #2, #9, #12, and #13 revealed a white sediment build-up on the wall boxes and the outside facing of the boxes. Station #13 had three white three dimensional spots that appeared to be an unknown type of growth. During an interview on 12/13/23 at 10:00 AM, Biomedical Technician6 stated that he/she did not know when the wall boxes were to be cleaned. Biomedical Technician6 confirmed the wall boxes were visibly dirty with white sediments in the wall boxes and around the facing. Biomedical Technician6 confirmed that at Station #13, the wall box had three white three dimensional spots that appeared to be an unknown type of growth. During an interview on 12/13/26 at 12:30 PM, the Certified Clinical Hemodialysis Technician (CCHT) 13 stated they were told today the closing staff would clean them each night. CCHT13 stated he/she did not know when the wall boxes were cleaned last. Review of the facility policy titled, “Cleaning and Disinfection of the Dialysis Station”, dated 09/05/23, indicated, “Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day or immediately if splattered with blood. All surfaces shall be surface disinfected with 1:100 bleach solution. Special attention should be given to removing build-up and/or cleaning splatter and spray of concentrate solution. If concentrate leaks are noted at the wall box, staff should notify biomedical services for repair.” Review of the “CDC Dialysis Safety” located on the CDC website at www.cds.gov titled, “Wall boxes and Drains” page last reviewed: October 25, 2019, indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities ...More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer.””

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 22676 Based on observation, interview, review of the “Daily Water Treatment Logs,” and the facility’s policy, the facility failed to ensure the staff monitored the end of day hardness of water quality as required by the regulations and facility policy for one of 42 days reviewed (10/27/23). This deficient practice had the potential to affect the water quality of the all 66 in-center hemodialysis patients receiving treatment and staff at this facility. Findings include: Review of the facilities paper “Daily Water Treatment Logs” from 10/01/23 through 11/30/23 located in the electronic waterlogs, revealed the facility failed to conduct the end of day hardness on one of 42 days reviewed, on 10/27/23 the area to document the end of the day hardness was left blank. During an interview on 12/12/23 at 2:30 PM, Biomedical Technician 6 confirmed the staff are required to conduct and document, the end of day hardness (a test to confirm the water hardness does not exceed the required limits) on the daily water treatment log at the end of each treatment day. Biomedical Technician 6 confirmed on 10/27/23 the log was blank. A review of the facility’s policy titled, “Water Softener” dated 05/03/23, revealed, “Hardness levels post water softener at the beginning of each operational day and at the end of each operational day.””

“BICARB CONC DISTRIB-WKLY DISINFECT/DWELL/CONC CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: weekly disinfection/dwell times/conc Bicarbonate concentrate delivery systems should be disinfected on a regular basis to ensure that the dialysate routinely achieves the level of bacteriological purity [required by these regulations]. For piped distribution systems, the entire system, including patient station ports, should be purged of bicarbonate concentrate before disinfection. Each patient station port should be opened and flushed with disinfectant and then rinsed; otherwise, it would be a “dead leg” in the system. Appropriate dwell times and concentrations should be used as recommended by the manufacturer of the concentrate system. If this information is not available, bleach may be used at a dilution of 1:100 and proprietary disinfectants at the concentration recommended by the manufacturer for disinfecting piping systems. 6.5 Concentrate distribution: The interval between disinfection should not exceed 1 week. If the manufacturer does not supply disinfection procedures, the user must develop and validate a disinfection protocol. This Standard is not met as evidenced by: 22676 Based on interview and review of the bicarbonate disinfection logs, and policy, the facility failed to evidence of disinfecting one of two bicarbonate holding tanks (one of the solutions used to make the dialysate). This had the potential to cause harm to all 66 in-center hemodialysis patients receiving care at the facility. Findings include: Review of the bicarbonate disinfection electronic logs revealed for 09/01/23 through 11/30/23 revealed the following. a. Review of Tank #1 disinfection log for the month of September, revealed for a total of 34 days there was no evidence the tank was disinfected between 9/01/23 through 10/04/23. b. Review of Tank #1 disinfectant logs for the month of November revealed, that for 21 days there was no documented evidence the tank was disinfected from 11/08/23 through 11/30/23. During an interview on 12/12/23 at 4:00 PM, Certified Clinical Hemodialysis Technician (CCHT) 13 confirmed there was no evidence that bicarbonate Tank #1 was disinfected. As identified above. CCHT13 stated that Tank #1 was disinfected on 11/16/23. CCHT13 confirmed the disinfection log did not have 11/16/23 results entered in the electronic log system. CCHT13 confirmed that a paper log was not used, and he/she failed to notify biomedical of the incident. CCHT13 stated, he/she did not know about the missed September disinfections. During an interview on 12/12/23 at 4:10 PM, CCHT12, confirmed there was no evidence that bicarbonate holding Tank #1 was disinfected as identified above. CCHT12, stated that Tank #1 was disinfected on 11/23/23, but the log did have 11/23/23 results in the electronic log system. CCHT12 confirmed that a paper log was not used, and he/she failed to notify biomedical of the incident. CCHT12 stated, he/she did not know about the missed September disinfections. During an interview on 12/12/23 at 4:15 PM, Biomedical Technician 6 and Clinic Manager 2 confirmed the staff failed to document the disinfection of the bicarbonate Tank #1 as cited above. Both the Clinical Manager 2, and the Biomedical Technician 6 confirmed the staff failed to follow the facility policy and agreed if the electronic log was down, they (CCHT12 and CCHT13) should have initiated a paper log for those days. Biomedical Technician 6 stated “there was no paper log for any of the missed disinfection days”. Review of a facility policy titled, “Disinfection of Bicarbonate Mixers Using Bleach as the Disinfectant” dated 10/14/20, revealed, “The frequency of bleach disinfection will be ...At least once a week ...””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 22676 Based on observation, interview, and facility policy review, the facility failed to ensure that all surfaces of the dialysis chairs were intact for one of three chairs observed. This deficient practice had the potential to increase the risk of infection to all 66 patients receiving in-center hemodialysis treatment at the facility. Findings included: During an observation on the treatment floor on 10/13/2013 at 10:40 AM the patient at Station #13 was standing for the staff to obtain a standing blood pressure prior to disconnect. The dialysis chair at Station #13 had three large splits in the seat cushion of the chair. One split in the center was approximately 3 inches long and the smaller two were approximately 2 inches long. During an observation on 12/13/23 at 11:00 AM, Biomedical Technician 6 replaced the cushion from the dialysis chair from Station #13, and on the cushion material there was visible red stain underneath. During an interview on 12/13/2023 at 11:00 AM Biomedical Technician 6 confirmed the above findings. Biomedical Technician 6 stated that the Vendor was supposed to have changed the bottom cushion last week but failed to replace it as scheduled. Biomedical Technician 6 agreed the chair should have been tagged for removal from service until repairs were made. During an interview on 12/13/23 at 11:15 AM, Certified Clinical Hemodialysis Technician (CCHT) 13 confirmed he/she had set up the dialysis Station #13 that morning. CCHT13 stated, “it (the dialysis chair) had been torn for several weeks”. Review of the facility’s policy titled, “Equipment Installation - Maintenance - Repair- And Disposal (sic)” dated 07/06/21, revealed, “ ...Unless otherwise directed by company policy and procedure, all equipment will be installed, operated, maintained, and repaired in accordance with manufactures instruction.””

“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: 22676 Based on review of glucometer logs, interview, review of glucometer policy, and manufacturer’s instructions, the facility failed to ensure the glucometer was in the control range and follow manufacturer’s instructions for one of one glucometer used in the facility. This deficient practice had the potential to provide incorrect blood glucose results and/or mistreated blood glucose levels for all 66 patients receiving care at the facility. Findings included: Review of electronic “Blood Glucose Logs” from 10/01/23 through 10/31/23 revealed the following: On 10/07/23, the recorded acceptable low control range was 92-124, the recorded low control was 125. During an interview on 12/12/23 at 2:30 PM, Clinic Manager 2 confirmed the findings and agreed the staff did not repeat the low-level control as required by the manufacturer’s instruction. Review of the facility’s policy titled, “Blood Glucose Monitoring Device,” dated 11/06/23, revealed, under “Policy Training” section revealed, “Calibration and control testing shall be performed each operating day ...” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/20, revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 22676 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for one of six sampled in-center patients (Patient (P) 7). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the all 66 patients receiving in-center dialysis treatments at this facility. Findings include: Review of P7’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) 400 milliliters per min (ml/min) and a dialysate flow rate (DFR) of 1.5 (the BFR) (600) ml/min. Review of one of five “Post Treatment” flowsheets from 12/01/23 through 12/11/23, in the EMR indicated the following: On 12/11/23, the BFR was documented at 300 ml/min and the DFR at 500 ml/min from 2:08 PM through the end of treatment at 3:21 PM. There was no documented rationale for the change to the prescribed BFR or DFR. During an interview on 12/12/23 at 2:45 PM, the Clinic Manager confirmed the above findings and confirmed that staff did not follow the facility’s policy. Review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check the prescribed blood flow rate is being achieved or the reason is documented in the medical record if unable to meet prescribed flow rate. Check dialysate flow rate setting is correct, and the correct prescribed flow is being ...””

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 22676 Based on record review, interviews, and review of the facility’s policy, the facility failed to ensure the six of seven patients (Patient (P) 6, P7, P8, P10, P11 and P15) reviewed, participated in the plan of care (POC), or received the information within a timely manner. Failure to ensure the patients reviewed the POC and understand the goals set had the potential to negatively impact the effectiveness of the dialysis treatments for the 66 patients receiving dialysis treatments at this facility. Findings include: 1. Review of P6’s 30-day POC, in the electronic medical record (EMR) under the “Plan of Care” section, dated 07/20/23, revealed, the facility failed to ensure the patients signature was dated to indicate if the information in the POC was provided within a timely manner. Review of the unstable POC for P6 dated 08/24/23, the facility failed to ensure the patients signature was dated to indicate if the information in the POC was provided within a timely manner. Review of the 90-day POC for P6 revealed the form not signed by P6 and there was no evidence the information on the updated POC was provided to P6 in a timely manner. 2. Review of P7’s 30-day POC, in the EMR under the “Plan of Care” section, dated 08/24/23, revealed the facility failed to document evidence P7 was provided the updated POC information. Review of the 90-day POC for P7 dated 11/30/23 revealed there was no evidence documented when the information was provided to P7. 3. Review of P8’s 90-day POC in the EMR under the “Plan of Care” section, dated 09/28/23, revealed there was no evidence documented the POC information was provided to P8 as of 12/12/2023. 4. Review of P10’s annual POC in the EMR under the “Plan of Care” section, dated 10/26/23, revealed there was no evidence documented the POC information was provided to P10 until 12/12/23. 5. Review of P11’s annual POC in the EMR under the “Plan of Care” section, dated 06/22/23, revealed there was no evidence documented the POC information was provided to P 11 until 12/12/23. 6. Review of P15’s annual POC in the EMR under the “Plan of Care” section, dated 06/22/23, revealed there was no evidence documented the POC information was provided to P 15 until 12/12/23. During an interview on 12/12/23 at 2:30 PM, the Clinic Manager 2 confirmed the facility failed to show the POC information was provided to the patients in a timely manner for P6, P7, P8, P10, P11, and P15). Review of the facility’s form titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” indicated, “ ...the form required a patient signature and date when the plan was reviewed, and the patient understood the plan...” Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/03/23, indicated, “. . .An interdisciplinary Comprehensive Assessment and Plan of care must be completed by the interdisciplinary team members, per the frequency outlined in the Condition for Coverage ...The patient’s plan of care will be signed by all members of the IDT (sic) (Interdisciplinary Team).””

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 22676 Based on medical record reviews, interviews, and review of the facility’s policy and the Comprehensive Interdisciplinary Assessment and Plan of Care form, the facility failed to ensure three of 13 patients (Patient (P) 6, P7, and P9) plan of care (POC) reviewed was completed within 15 days of the reassessment as required by federal regulations. Failure to ensure the POC was developed using current assessment information had the potential to negatively impact the effectiveness of the dialysis treatments for all 66 patients receiving dialysis at this facility. Findings include: 1. Review of P6’s POC in the electronic medical record (EMR) under the “Plan of Care” section, indicated that the 30-day POC meeting was held on 07/20/23. The physician failed to complete the assessment until 07/26/23 six days after the POC meeting. Review of P6’s unstable POC meeting dated 08/24/23, revealed, revealed the physician assessment was conducted on 08/02/22, 22 days before the meeting and there was no evidence of an update. 2. Review of P7’s POC in the EMR under the “Plan of Care” section indicated that the 90-day POC meeting was held on 11/30/23. However, the Registered Nurse (RN) completed the assessment on 11/08/23, 22 days before the POC meeting. 3. Review of P9’s POC in the EMR under the “Plan of Care” section indicated that the annual POC meeting was held on 08/24/23. The physician conducted the assessment on 08/02/23, 22 days before the POC meeting and there was no evidence of an update to the assessment. During an interview on 12/12/23 at 12:30 PM, Clinic Manager 2 confirmed the above findings. Clinic Manager 2 confirmed the facility failed to follow Federal Regulations or the facility’s policy. Review of the facility’s form titled, “Comprehensive Interdisciplinary Assessment and Plan of Care” dated 07/03/23 indicated, “Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional assessments.” Review of the facility’s policy titled, “Comprehensive Interdisciplinary Assessment and Plan of Care,” dated 7/03/23, indicated, “ ... updates of the plan of care must be performed within 15 days of the completion of the additional assessments.””

“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: 22676 Based on interview and policy review, the facility failed to conduct a review of the technical logs through the Quality assessment and performance improvement (QAPI) process in 2023, for the September 23 disinfection logs for one of two bicarbonate holding tanks (one of the solutions used to make the dialysate) (Tank #1). The failure to monitor bicarbonate holding tank logs had the potential to cause harm to all 66 in-center hemodialysis patients receiving care at the facility. Findings include: Review of the Technical audit of the disinfection logs in 2023, for the month of September, under the section “Concentrate Preparation Bicarbonate Mixing and Disinfection” documented that the “logs were complete-Central Delivery System log present and within range per policy.” During an interview on 12/12/23 4:15 PM, Biomedical Technician 6 confirmed the above information, and that the bicarbonate mixing, and disinfection log was checked as being met but it was not. Biomedical Technician 6 stated he/she did not identify the issues with the disinfection of the bicarbonate tank (Tank #1) for the month of September when it was reported out in the monthly QAPI meeting. Biomedical Technician 6 stated that the November logs had not be reviewed as of 12/12/23. Review of the facility policy titled “Quality Assessment and Performance Improvement: dated 05/22, revealed, “Technical Services Representative is responsible for Reporting on technical related issues, including water and dialysate quality. Equipment maintenance and physician plant.””