Fmc Tallassee

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 30952 Based on observation, facility policy and interview, it was determined the staff failed to display the current CMS (Centers for Medicare and Medicaid Services) Performance Score Certificate in a prominent area in the facility visible to patients and families. This had the potential to negatively affect the thirty patients who dialyze at the facility. Findings include: Fresenius Kidney Care Government Reporting and Clinical Informatics Title-Annual Posting of the Performance Score Certificates Date: December 11, 2019 Purpose...provide directions to facilities regarding the mandatory posting of the Calendar Year... Performance Score Certificate (PSC)... Background ...CMS has chosen...to mandate...facilities post their PSC...in a prominent location where it is visible to patient and families... During the tour of the lobby area on 9/9/24 at 8:30 AM, the surveyor observed the facility 2018 CMS performance score posted in the lobby. There was no 2024 PSC posted in a prominent location visible for patients and families. An interview was conducted on 9/9/24 at 1:25 PM with Employee Identifier # 2, Director of Operations, who confirmed the 2024 PSC was not displayed in an area visible to patients and families.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 30952 Based on observations, facility policy and procedure, and an interview, it was determined the facility failed to ensure treatment chairs were maintained and free of tears in the vinyl. This had the potential to affect the thirty patients who dialyze at this facility. Findings include: Facility Policy and Procedure Title: Cleaning and Disinfecting the Dialysis Station Published: 9/5/23 Reference Number: 47806 ...The purpose of this policy...prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe...aesthetically pleasant environment for patients, staff, and visitors... ...Dialysis Station Area including...chair/bed... General Cleaning The dialysis station could become contaminated with blood and other body fluids during treatment... ...Work Surface Cleaning and Disinfection w (with)/out Visible Blood using Bleach Solutions All work surfaces shall be cleaned and disinfected with 1:100 (one part bleach, one hundred parts water) bleach solution after completion of procedures...glistening wet and let to air dry.... Observations of care were conducted on the treatment floor on 9/9/24 from 8:40 AM to 4:30 PM. Tears in the vinyl on the following patient treatment chairs were observed: 1. At station five, an approximate three-inch-long tear in the vinyl on the chair seat. 2. At station four, two vinyl tears, one approximate one-inch long tear in the chair seat, and one approximate two-inch-long tear in the chair seat. 3. At station eight, two tears in the chair seat, one approximate four-inch-long, and one approximate four- and one-half inch long tear. There was one approximate two- and one-half inch long tear on the left arm rest. An interview was conducted on 9/10/24 at 1:55 PM with Employee Identifier # 6, Biomedical Technician I, who confirmed the vinyl tears on the patient treatment chairs.”

“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: 30952 Based on observation, facility policy, and interview, it was determined the facility failed to ensure staff performed hand hygiene and donned clean gloves before intravenous (IV) medication administration. This affected Patient Identifier (PI) # 9, in one of two IV medication preparation and administration observations and had the potential to affect the 30 patients who dialyze at the facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 ...Infection Control The following steps must be taken to ensure infection control. Perform hand hygiene prior to accessing supplies...preparing or administering medications... 1. An observation on IV Venofer preparation and administration was conducted on 9/11/24 at 10:05 AM with Employee Identifier (EI) # 3, Registered Nurse. EI # 3 unlocked the cabinet, and retrieved the syringe/needle, and Venofer vial. EI # 3 sanitized hands, donned gloves and prepared the IV Venofer. EI # 3 exited the medication preparation counter with gloves on, Venofer, normal saline flush, and alcohol pad in hand. EI # 3 entered station six, cleaned the IV port with alcohol, attached the IV Venofer and began slow IV push. EI # 3 failed to remove gloves, perform hand hygiene, and don clean gloves before medication administration. Following the observation on 9/11/23 at 10:15 AM in an interview with EI # 3, the failure to change gloves and perform hand hygiene was confirmed. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, Clinic Manager, who confirmed staff should perform hand hygiene and don clean gloves before IV medication administration.”

“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: 30952 Based on observations, facility policies and procedures, and interviews, it was determined the facility failed to ensure staff: 1. Cleaned and disinfected the dialysis station between patients. 2. Stored the bleach solution in a container until use. 3. Properly disposed of Normal Saline from the Priming Bucket. This affected two of three observations of dialysis station cleaning and disinfection, and an unsampled patient, and had the potential to affect the 30 patients who dialyze at this facility. Findings include: Facility Policy: Cleaning and Disinfecting of the Dialysis Station Published: 09/05/2023 Reference Number: 47806 Purpose: ...to prevent the spread of infectious disease...maintain a clean, safe...environment for patients, staff, and visitors. ...The Centers for Medicare and Medicaid...has regulations...a dialysis station must be...disinfected between...patients.... ...General Cleaning The dialysis station could become contaminated with blood and other body fluids during treatment... ...All work surfaces shall be cleaned and disinfected with 1:100 (1 part bleach/one hundred parts water) bleach solution after completion of procedures. Make the surface glisteningly wet and let air dry... Bleach-Solutions ...Bleach solution will be stored in... covered opaque containers to prevent disintegration of the chemical...when exposed to sunlight and air. ...Vacating the Machine To prevent cross-contamination between patients, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfection of the station... Procedure Follow the steps below to disinfect the dialysis station after each dialysis treatment: ...3. Use a cloth wetted with 1:100 bleach solution...to clean and disinfect the dialysis station...chaise wall behind chair... Facility Procedure: Use of Priming Buckets Published: 5/6/24 Reference Number: 45620 ...Procedure Follow the steps...to use the priming bucket... ...4. At the completion of the patient treatment, remove the priming bucket...and dispose of the Normal Saline in the utility room hopper or dirty sink. 5...disinfection with 1:100 bleach solution, replace on machine. 1. During observations of care on 9/9/24 at 9:03 AM, an unsampled patient was holding an access with a gloved hand at station three. Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), entered the station, placed bleach cloths on top of the dialysis station and exited the station. The station had not been vacated before EI # 5 placed the bleach cloths on the HD machine. At 9:24 AM, bleach cloths remained on top of the dialysis machine and the station was vacant. On 9/9/24 at 9:40 AM at station three, EI # 5 began to disinfect the dialysis machine with the bleach cloths exposed to sunlight and air for 39 minutes. EI # 5 failed to disinfect the counter around the dialysis station and the chaise wall behind the chair. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, Clinic Manager, who confirmed staff failed to follow the policy for bleach storage and disinfection of the dialysis station. 2. An observation of cleaning and disinfection of the dialysis station was conducted 9/9/24 at 9:47 AM. EI # 4, CCHT, placed bleach cloths on the chairside table at station seven. At 9:55 AM, EI # 4 used the cloths exposed to sunlight and air for eight minutes to disinfect the blood pressure cuff, and television remote. EI # 4 failed to disinfect the chaise wall and counter. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, who confirmed staff failed to keep the bleach cloths covered until use and failed to disinfect the dialysis station per policy. 3. During observations of care on 9/9/24 at 10:08 AM the surveyor observed EI # 5 empty the Priming Bucket into the wall box at station five, and not the dirty sink or utility hopper. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, who confirmed staff failed to follow the procedure for disposal of the Priming Bucket solution.”

“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: 30952 Based on observation, facility policy, and staff interviews, it was determined the facility failed to ensure medications were not placed on top of the hemodialysis (HD) machine. This affected Patient Identifier (PI) # 9, in one of two observations for intravenous (IV) medication preparation and administration and had the potential to negatively affect the thirty patients who dialyze at the facility. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Purpose To administer medications with...optimal patient safety...and infection control. ...Infection Control ...Aseptic technique will used to prepare and administer IV medications... 1. An observation of care was conducted on 9/11/24 at 10:10 AM with Employee Identifier (EI) # 3, Registered Nurse at station six for IV Venofer preparation and administration for PI # 9. EI # 3 prepared IV Venofer in the medication preparation area, exited the preparation counter to the station, placed a prefilled normal saline (NS) syringe on top of the HD machine momentarily, retrieved the syringe from top of the machine, and exited the station. EI # 3 returned to the station, administered the IV Venofer and NS. EI # 3 failed to ensure the NS syringe was stored in a clean environment until administered. After the observation on 9/11/24 at 10:15 AM, an interview was conducted with EI # 3 who confirmed the NS was placed on the HD machine. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, Clinic Manager, who confirmed the NS syringe should not have placed on top of the HD machine.”

“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: 30952 Based on observations, review of facility procedure, and interview, it was determined the facility failed to ensure staff followed the facility procedure Central Venous Catheter (CVC) Exit Site Care. This affected Patient Identifier (PI) # 1, PI # 5, in two of two observations for CVC Exit Site Care and had the potential to negatively affect all patients who dialyze with a CVC. Findings include: Facility Procedure Title: Changing the Catheter Dressing Published: 2/5/24 Reference Number: 45664 Purpose ...is to provide instruction for cleaning the hemodialysis catheter exit site... ...Cleaning the Site: Follow the steps below to clean the catheter exit site: ...2. Remove swab stick from package...If using povidone pad: Using gentle friction, disinfect the exit site...in a concentric circle for 30 seconds and allow to dry for at least 2 (two) minutes... 1. An observation of care was conducted on 9/9/24 at 9:29 AM at station one with Employee Identifier (EI) # 3, Registered Nurse, during CVC Exit Site Care and treatment initiation for PI # 1. During the observation, EI # 3 disinfected the CVC exit site with a povidone swab-stick for 25 seconds and allowed the exit site to dry for 40 seconds. EI # 3 failed to disinfect the exit site with povidone for at least 30 seconds and allow the exit site to dry for at least 2 minutes per procedure before dressing application. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, Clinic Manager, who confirmed staff failed to follow the facility procedure for CVC Exit Site Care with povidone. 2. An observation of care was conducted on 9/9/24 at 11:30 AM at station five with EI # 3 during CVC Exit Site Care and treatment initiation for PI # 5. During the observation, EI # 3 disinfected the CVC exit site with a povidone swab-stick for 20 seconds and allowed the exit site to dry for 30 seconds before dressing application. EI # 3 failed to disinfect the exit site with povidone for at least 30 seconds and allow the exit site to dry for at least 2 minutes. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, who confirmed the staff failed to follow the facility procedure for CVC Exit Site Care.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30952 Based on review of End Stage Renal Disease (ESRD) CORE Survey Facility Worksheet: Personnel File, staff competency and training documentation which included Direct Patient Care (DPC) Skills Validation documentation of water testing, facility policies, and interview, it was determined the facility failed to ensure all staff had current competencies for water test skills validation. This affected two of five staff DPC Skills Validations reviews, and had the potential to affect the 30 patients who dialyze at the facility. Findings include: Facility Policy: Knowledge, Skills, and Competency Evaluation for Clinical Staff Published: 6/4/24 Reference Number: 57015 Purpose: ...ongoing knowledge and skills development, and evaluation for all clinical field employees...initial and ongoing development and evaluation of the knowledge and skills essential for... Background: ...Initial, Annual, and One-Time Role Specific Training Initial, Annual, and One-Time Role Specific Knowledge Evaluation Initial, Annual, and Role Specific Skills Evaluation Policy: ...Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given timeframe. Employees without current documented competency within the last 365 days may be removed from performing independent direct patient care (DPC) until competency is demonstrated and documented. Documentation: Completion dates are entered in Learning Management System (LMS) for initial and annual exams and validation... Facility Policy: Medical Director Compliance Guidelines Version 3 Effective Date: 1/1/2007 ...1. Specific Medical Director Responsibilities ...Assuring adequate training of nurses and technicians... 1. Review of ESRD CORE Survey Facility Worksheet: Personnel File documentation revealed Employee Identifier (EI) # 5, CCHT, hire date was 8/14/17. Review of EI # 5’s water, dialysate, machine training titled DPC Skills Validation revealed the last completion date was 4/24/22, which was greater than 365 days. An interview was conducted on 9/10/24 at 12:00 PM with EI # 7, Area Technical Program Manager, who confirmed EI # 5’s DCP Skills Validation was not current. 2. The surveyor requested float staff, Registered Nurse, EI # 8’s DPC Skills Validation documentation which revealed an initial competency validation was completed 11/15/22, which was greater than 365 days. An interview was conducted on 9/11/24 at 11:16 AM with EI # 9, Administrative Assistant, who confirmed EI # 8’s water skill competency validation was not completed annually.”

“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: 30952 Based on observations, Digital Dialysate Meter Manufacturer’s Instructions for Use (IFU), facility procedure, Preventative Maintenance (PM) document review, and interview, it was determined the facility failed to ensure staff: 1. Rinsed the Myron L D6 Meter with clean water after each use. 2. Performed monthly Myron L D6 Meter calibration. This affected Patient Identifier (PI) # 6, and one unsampled patient, in two of three observations for preparation of the hemodialysis (HD) machine and had the potential to negatively affect the 30 patients who dialyze at this facility. Findings Include: Digital Dialysate Meter Operation Manual Myron L Company Water Quality Instrumentation 18 February 16 V1. After Using the Dialysate Meter A... Rinse out the conductivity cell with clean water... Facility Procedure Title: Myron L D6 Meter Maintenance Procedures Published: 9/1/22 Reference Number: 64380 ...Monthly Maintenance On a monthly basis perform and document the following: Clean conductivity cell cup per manufacturer...and perform a “Conductivity Cell Cleanliness Check”. Verify/Replace 9-volt battery...Check pH (potential of hydrogen) sensor performance... Documentation ...Maintenance and repairs will be documented...in the electronic maintenance records. 1. An observation of care was conducted on 9/9/24 at 9:50 AM to observe (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), prepare the HD machine for PI # 6 at station one. EI # 5 obtained a sample of dialysate from the HD machine, tested final dialysate pH and conductivity at the Tri-Station, set the meter on the counter, and exited the Tri-Station. EI # 5 failed to rinse the meter after use. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, Clinic Manager, who confirmed the facility policy was not followed for rinsing the Myron L D6 Meter after use. 2. Observations of care were conducted on 9/9/24 at 11:20 AM. EI # 5 entered the Tri-Station with a final dialysate sample from the HD machine at station four for an unsampled patient. EI # 5 tested the solution, discarded the sample, returned the meter to the Tri-Station counter, and exited the Tri-Station. EI # 5 failed to rinse the meter with clean water after use. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, who confirmed the staff failed to follow the procedure and rinse the Myron L D6 Meter after each use. 3. An interview was conducted on 9/10/24 at 1:15 PM with EI # 6, Biomedical Technician I, following review of the facility Water and Dialysate, and Machine/Equipment Maintenance documentation. EI # 6 confirmed the facility had failed to perform monthly maintenance for the two Myron L D6 meters in use at the facility. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1 who confirmed the facility failed to perform and document monthly Myron L meter maintenance.”

“PA-MSW-PSYCHOSOCIAL NEEDS CFR(s): 494.80(a)(7) The patient’s comprehensive assessment must include, but is not limited to, the following: (7) Evaluation of psychosocial needs by a social worker. This Standard is not met as evidenced by: 30952 Based on review of facility policy, Medical Record (MR), and interview, it was determined the facility failed to ensure the Social Worker (SW) completed a psychosocial Comprehensive Assessment and approved/signed the Patient Plan of Care. This affected Patient Identifier (PI) # 4, in one of five record reviews and had the potential to affect the 30 patients who dialyze at the facility. Findings include: Facility Policy Title: Comprehensive Interdisciplinary Assessment and Plan of Care Published: 7/3/23 Reference Number: 45282 ...purpose...is to provide guidance on the requirements for the Comprehensive Interdisciplinary Assessment (CIA) and the patient Plan of Care (POC). Responsibility: Interdisciplinary Care Team (RN) {Registered Nurse}, Attending Physician ...Social Worker...Registered Dietitian) {RD} ... General Policy for Patient Assessment and Plan of Care The CIA and POC must be developed and implemented by an Interdisciplinary Team (IDT)...the patient...RN...physician...SW... RD. ...The POC must be signed at the time of the IDT team meeting for those...in person. If...attending remotely...signed by the...member within 30 days of the...meeting. ...Components of the Patient CIA ...Evaluation of psychosocial needs by a qualified SW... 1. PI # 4 was admitted to the facility on 12/15/17 with a diagnosis of End Stage Renal Disease. MR review revealed a POC meeting dated 2/29/24 for the 6-month CIA Update. There was no documentation the SW, Employee Identifier (EI) # 10, approved/signed the 2/29/24 POC. Further review of the MR revealed IDT Annual Comprehensive Assessments dated 7/25/24 completed by the physician, RN, and RD. There was no documentation of an assessment by a SW of the patient’s psychosocial needs. There was no documentation the 7/25/24 Annual Stable POC was approved/signed by a SW. An interview was conducted on 9/10/24 at 3:42 PM with EI # 1, Clinic Manager, who confirmed there was no documentation the SW approved/signed the CIA/ POC’s, and no documentation the CIA/POC annual psychosocial assessment was completed.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 30952 Based on review of facility policy, medical record (MR), and interview, it was determined the facility failed to ensure Comprehensive Interdisciplinary Assessments were completed within 30 days or 13 treatments. This affected Patient Identifier (PI) # 1, in one of one newly admitted patient reviews and had the potential to negatively affect all patients admitted to this facility. Findings include: Facility Policy Title: Comprehensive Interdisciplinary Assessment and Plan of Care Published: 7/3/23 Reference Number: 45282 ...The purpose of this policy is to provide guidance on the requirements for the Comprehensive Interdisciplinary Assessment (CIA) and the patient Plan of Care (POC). Responsibility: Interdisciplinary Care Team (RN {Registered Nurse}, Attending Physician ..., Social Worker {SW}, Registered Dietitian {RD} ... Patients diagnosed with AKI (Acute Kidney Injury) ...transitioning...must follow the same timelines for CIA/POC completion as a new...patient... CIA and POC for Patients New to Dialysis An initial CIA and POC must be conducted on all patients new to dialysis within the later of 30 calendar days or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. ...The timeline for both completion of the initial comprehensive and the beginning of implementation of the initial POC is the latter of 30 days from...admission or 13 hemodialysis treatments... 1. PI # 1 was admitted to the facility on 8/8/24 with a primary diagnosis of AKI. Record review revealed the SW completed the Comprehensive SW Assessment on 8/22/24, the RN completed the Comprehensive RN Assessment on 8/27/24, the Nutrition History Assessment was completed by the RD on 8/29/24, and a face-to-face Provider Rounding Note was completed on 9/5/24. Further MR review revealed no new Patient POC was developed, approved, and implemented by the care team within 30 days of admission per facility policy. An interview was conducted on 9/9/24 at 3:39 PM with Employee Identifier # 1, Clinic Manager, who confirmed the Interdisciplinary Team failed to complete the initial/new patient POC within 30 days.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 30952 Based on review of facility policy, medical record (MR), and interview, it was determined the Interdisciplinary Team (IDT) failed to complete patient reassessments within three months of transfer and develop a Plan of Care. This affected Patient Identifier (PI) # 5, one of one transfer record reviews, and had the potential to negatively affect all patients transferred to this facility. Findings include: Facility Policy: Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) Published: 7/3/23 Reference Number: 45283 ...purpose...is to provide guidance to clinicians in the requirements for the CIA and the patient POC. Responsibility: IDT, RN (Registered Nurse), Attending Physician and physician extenders as applicable, Social Worker (SW), Registered Dietitian (RD)... CIA and POC for Transfers or Transients If the CIA and POC for an experienced dialysis patient transferring from one dialysis facility to another is received with the patient transfer, the receiving facility’s IDT must conduct a reassessment within three months of the patient’s admission to the new facility. ...Role of the IDT: CIA The physician is responsible for ensuring the completion of the medical portion of the CIA and reviewing the completed IDT CIA and POC. ...Role of the IDT: POC The patient POC will be developed from findings...in the CIA. The IDT members...interact and share information from the comprehensive assessment to facilitate...development of the POC....signed by all members of the IDT... 1. PI # 5 was admitted to the facility on 5/29/24 with End Stage Renal Disease, a transfer from a sister facility. MR review revealed a 90 Day Stable POC was approved by the IDT from the transferring sister facility on 4/24/24. Further MR review revealed the 90-day Comprehensive RN Assessment completed on 8/25/24, the SW Annual CIA Comprehensive SW Assessment completed on 8/19/24, the 90 Day CIA Nutrition History Assessment completed by the RD on 8/26/24, and a face-to-face Provider Rounding Note completed on 9/6/24. Further MR review revealed there was no completed CIA/POC approved by the IDT and implemented by the care team within three months of the facility admit date. An interview was conducted on 9/11/24 at 8:16 AM with Employee Identifier # 1, Clinic Manager, who confirmed the care team failed to complete all reassessment CIA’s, develop, approve, and implement the POC per facility policy.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 30952 Based on review of Medical Records (MR), facility policy, and staff interviews, it was determined the facility failed to ensure staff followed the physician’s order for Blood Flow Rate (BFR) and Dialysate Flow Rate (DFR). This affected Patient Identifier (PI) # 1, PI # 4, PI # 5, PI # 3, in four of five MR reviews and had the potential to affect the 30 patients who dialyze at this facility. Findings include: Facility Policy: Patient Monitoring and Safety Checks During Hemodialysis Treatment Published: 9/5/23 Reference Number: 23502 ...The purpose...is to provide guidance for patient monitoring during hemodialysis treatments. ...Safety Check-Machine Checks Monitor and document...every 30 minutes or more frequently...in the...Treatment Record. ...Verify...correct DFR, BFR...per physician order. 1. PI # 1 was admitted to the facility on 8/8/24 with a primary diagnosis of Acute Kidney Injury. Review of the Orders Summary Report (OSR) revealed Hemodialysis (HD) orders dated 8/22/24 for DFR Manual 700. Review of the Treatment Sheets (TS) dated 9/5/24, and 9/7/24 revealed a DFR 800 for the entire treatment. An interview was conducted on 9/9/24 at 3:39 PM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed staff failed to follow the ordered DFR. 2. PI # 4 was admitted to the facility on 12/15/17 with a diagnosis of End Stage Renal Disease (ESRD). Review of the TS dated 8/27/24 revealed HD orders for BFR 450. Further review of the 8/27/24 TS revealed the BFR was 500 and no reason was documented why the BFR was not 450. An interview was conducted on 9/10/24 at 3:42 PM with EI # 1 who confirmed the staff did not follow physician BFR order. 3. PI # 5 was admitted to the facility on 5/29/24 with a diagnosis of ESRD. Review of the TS dated 8/26/24 revealed HD orders for BFR 425. Further review of the 8/26/24 TS revealed the BFR was 450, and 400. There was no documentation why the BFR was not 425 as ordered. An interview was conducted on 9/11/24 at 8:16 AM with EI # 1 who confirmed the staff failed to follow the BFR physician orders. 4. PI # 3 was admitted to the facility on 6/27/24 with a diagnosis of ESRD. Review of the OSR revealed HD orders dated 7/16/24 for BFR 400 and DFR Manual 800. Review of the TS dated 9/5/24 revealed the BFR was decreased to 350 and the DFR was 700. There was no order for the 350 BFR and 700 DFR. No reason was documented why the BFR and DFR was not delivered as ordered. An interview was conducted on 9/11/24 at 12:32 PM with EI # 1 who confirmed staff failed to follow physician BFR and DFR orders.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 30952 Based on review of medical record (MR), facility Oral Nutritional Supplements Program policy, and interviews, it was determined the facility failed to ensure the IDT (interdisciplinary team) followed the patient Plan of Care (POC) for albumin management, monitored monthly nutrition labs, addressed the nutrition for a patient who qualified for ONSP, and administered oral nutritional supplements (ONS) per policy. This affected PI (Patient Identifier) # 2, in one of two record reviews with patient Albumin levels less than 3.5. This had the potential to negatively affect the 30 patients who dialyze at the facility. Findings include: Facility Policy: Oral Nutritional Supplements Program (ONSP) Published: 1/23/23 Reference Number: 43546 Purpose Administer ONS to...dialysis patients who meet the criteria to: Improve nutritional status... Policy: Criteria for Starting and Stopping Supplements Start Albumin 3.5 g/dL (gram per deciliter) or less ... Stop with the occurrence of the first of the following events. Stabilized Albumin: 4.0 G/dL or higher for three consecutive monthly albumin lab draws... 1. PI # 2 was admitted to the facility on 10/1/18 with diagnoses including End Stage Renal Disease. Review of the Patient POC dated 6/24/24 revealed a nutritional goal for Albumin >= (greater than equal to) 4.0 g/dL; Goal Due: 12/31/24. Open 2024-06-20, Educate on albumin management, monitor albumin and other nutrition related labs monthly. Lab test; Albumin 3.8 on 4/18/24; 3.9 on 5/16/24, 3.6 on 6/20/24. Review of the Nutrition Progress Note dated 8/22/24 revealed Albumin goal assessment-below goal on 7/18/24, Albumin 3.4. The 7/18/24 Albumin 3.4, was less than 3.5 which qualified PI # 2 for ONS. Review of the last 6 completed Treatment Sheets dated 7/25/24, 7/27/24, 7/30/24, 9/3/24, 9/5/24, and 9/7/24 revealed no documentation ONS was provided for the declining albumin level. There was no physician order for ONS to address the 3.4 albumin level. An interview was conducted with Employee Identifier (EI) # 1, Clinic Manager on 9//11//24 at 12:42 PM and with EI # 10, Registered Dietician at 12:56 PM, who confirmed no ONS was provided to PI # 2 despite meeting the ONS criteria with an albumin level 3.4.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interview, it was determined the facility failed to ensure Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG) access sites were cleaned with soap and water before treatments per facility policy. This affected two of three observations of initiation of treatment with an AVF/AVG including Patient Identifier (PI) # 7 and PI # 8 and had the potential to negatively affect all patients with an AVF/AVG who dialyze at this facility. Findings include: Facility Policy Title: Access Assessment and Cannulation Published: 5/6/24 Reference number: 45178 Background ...The access must be prepared properly for needle placement to prevent bacteria from entering the bloodstream through the skin. Policy: Evaluation and preparation of the access will be performed routinely prior to cannulation at each dialysis session. Assessment of Vascular Access: Follow the steps below to assess the vascular access: 1. Prior to treatment, ask patient to wash access area with soap and water per hand hygiene procedure. Wash access (per above) if patients unable to clean their access... 1. An observation was conducted on 9/9/24 at 10:20 AM at station three with Employee Identifier (EI) # 5, Certified Clinical Hemodialysis Technician (CCHT), to access an AVF/AVG for initiation of dialysis for PI # 7. EI # 5 assisted PI # 7 into the treatment room via a wheelchair, to the scales, then to the station, cleaned the arterial cannulation site with an alcohol pad and cannulated the access sites. EI # 5 failed to ensure the access area was washed with soap and water. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1, Clinic Manager, who confirmed staff must ensure the access was washed with soap and water prior to treatment. 2. An observation was conducted on 9/9/24 at 11:20 AM at station four with EI # 5 to access an AVF/AVG for initiation of dialysis for PI # 8. PI # 8 ambulated into the treatment area and to the station but failed to wash the skin over the access with soap and water. EI # 5 failed to ensure PI # 8 cleaned the access site. EI # 5 failed to wash the skin over the access with soap and water prior to treatment initiation. An interview was conducted on 9/11/24 at 1:00 PM with EI # 1who confirmed staff failed to ensure the access was washed with soap and water prior to treatment.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 30952 Based on review of End Stage Renal Disease (ESRD) CORE Survey Facility Worksheet: Personnel File, staff Direct Patient Care (DPC) Skills Validation documentation, facility policy, and interviews, it was determined the facility failed to ensure the Medical Director certified staff completed initial/annual water skills validation of competency. This affected two of two facility Certified Clinical Hemodialysis Technicians (CCHT) and had the potential to affect the 30 patients who dialyze at the facility. Findings include: Facility Policy: Knowledge, Skills, and Competency Evaluation for Clinical Staff Published: 6/4/24 Reference Number: 57015 Purpose: ...ongoing knowledge and skills development, and evaluation for all clinical field employees...initial and ongoing development and evaluation of the knowledge and skills essential for... Background: ...Initial, Annual, and One-Time Role Specific Training Initial, Annual, and One-Time Role Specific Knowledge Evaluation Initial, Annual, and Role Specific Skills Evaluation Policy: Employees are required to pass all exams... Employees are required to successfully complete all skills requirements, including an initial and annual skills validation, within the given timeframe. Employees without current documented competency within the last 365 days may be removed from performing independent direct patient care (DPC) until competency is demonstrated and documented. Documentation: Completion dates are entered in Learning Management System (LMS) for initial and annual exams and validation... Facility Policy: Medical Director Compliance Guidelines Version 3 Effective Date: 1/1/2007 ...1. Specific Medical Director Responsibilities ...Assuring adequate training of nurses and technicians... 1. Review of the ESRD Core Survey Personnel Worksheet revealed EI # 5, CCHT, date of hire was 8/14/17. Review of EI # 5’s DPC Skills Validation for water, dialysate, and machine training revealed the completion date for competency validation was 9/29/22. There was no Medical Director signature on EI # 5’s DPC Skills Validation as evidence the Medical Director assured EI # 5 was competent to perform water quality tests. 2. Review of the ESRD Core Survey Personnel Worksheet revealed EI # 4, CCHT, date of hire was 10/5/15. Review of EI # 4’s Annual DPC Skills Validation water, dialysate, and machine training dated 4/26/24 included no Medical Director signature to assure EI # 4’s competency to perform water quality testing. An interview was conducted on 9/11/24 at 11:16 AM with EI # 9, Administrative Assistant, who confirmed employee annual DPC water skills competency validation did not include evidence the Medical Director assured all staff were competent to perform water quality testing.”

“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: 30952 Based on review of the facility policy, facility Water Chemical Analysis, and Microbiological Levels for Water and Dialysate, and interviews, it was determined the facility failed to ensure the Medical Director reviewed monthly water quality reports. This had the potential to negatively affect the 30 patients who dialyze at the facility. Findings include: Facility Policy: Medical Director Compliance Guidelines Version 3 Effective Date: 1/1/2007 ...2. General Medical Director Responsibilities a. Quality of Patient Care The Medical Director is required to assure adequate supervision of dialysis operations by medical and patient care staff... The Medical Director...is designated in writing to be responsible for the execution of patient care policies. ...The Medical Director must review the results of monthly water analysis and culture reports. 1. Review of the facility water and dialysate documentation on 9/10/24 at 10:30 AM included water and dialysate colony count and endotoxin reports for April 2024, May 2024, and June 2024. There was no Medical Director/Designee signature on the three culture reports. Review of the July 2024 water and dialysate colony count and endotoxin results revealed no date the monthly reports were reviewed/signed by the Medical Director. 2. Review of the facility water system AAMI (Association for the Advancement of Medical Instrumentation) Summary Reports for 11/20/23, 2/21/24, and 5/14/24 were signed by the Medical Director, but there were no dates documented as evidence of the required monthly review. An interview was conducted on 9/10/24 at 12:30 PM with Employee Identifier (EI) # 7, Area Technical Program Manager, who confirmed the water quality documentation failed to include the Medical Director signature and dates of the monthly review. During an interview conducted on 9/11/24 at 1:00 PM, EI # 1, Clinic Manager, confirmed the water quality documents were not signed and or dated by the Medical Director.”