Rcg Oneonta

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49894 Based on observations, review of facility policies and procedures, the facility GranuFlo (Acid Concentrate) Mixing Log documentation, facility Total Chlorine Testing Log (Post Worker Carbon Tank-TCL-1) documentation, TCL Weekly Review Log documentation, staff competency documentation, and interviews, it was determined the facility failed to ensure the water used for dialysis was safe and staff were competent. This had the potential to negatively affect all 36 patients dialyzing at this facility. Refer to V 184, V 196, V 219, and V 260 for findings.”

“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: 49894 Based on observations, review of facility policy, and staff interviews it was determined the facility failed to ensure: 1. Staff removed gloves and performed hand hygiene after access evaluation in one of three observations for initiation of dialysis with an Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG), which included Patient Identifier (PI) # 6. 2. Staff removed gloves and performed hand hygiene in two of two observations for discontinuation of dialysis with an AVF/AVG and included PI # 3, and PI # 7. 3. Staff ensured the patient performed hand hygiene after removing gloves in one of three observations of discontinuation of dialysis with and AVF/AVG, and included PI # 7. This had the potential to negatively affect all thirty-six patients dialyzing at this facility, staff, and visitors. Findings Include: Facility Policy: Hand Hygiene Reference Number: 47664 Published: 11/06/23 Version 8 Responsibility: All Staff, patients ...must follow the same requirements for hand hygiene. Policy: Hand hygiene includes either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content. Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: Before and after direct contact with patients. Entering and leaving the treatment area. Before performing any invasive procedure such as vascular access cannulation... Immediately after removing gloves. After contact with inanimate objects near the patient. After contact with other objects within the patient station or treatment space. Hand hygiene: Patients Patients should perform hand hygiene if able, prior to and after each dialysis treatment. 1. An observation of care was conducted on 3/18/24 at 11:49 AM with Employee Identifier (EI) # 9, Certified Clinical Hemodialysis Technician (CCHT), at station 8 to initiate dialysis for PI # 6 with an AVF/AVG. With gloves on, EI # 9 evaluated PI # 6’s AVF/AVG sites with a stethoscope and palpation. EI # 9 applied an alcohol pad to the cannulation sites and inserted the cannulation needles without first changing gloves and performing hand hygiene. An interview was conducted on 3/20/24 at 9:55 AM with EI # 1, Clinic Manager (CM), who confirmed staff failed to follow the facility policy and change gloves and perform hand hygiene after access evaluation. 2. An observation was conducted on 3/18/24 at 1:34 PM at station 10 with EI # 12, CCHT, performing discontinuation of dialysis with an AVF/AVG for PI # 3. After removing the cannulation needle and discarding in the sharps container, EI # 12 failed to remove the gloves and perform hand hygiene. An interview was conducted on 3/20/24 at 9:50 AM with EI # 1, who confirmed the facility failed to ensure staff performed hand hygiene per facility policy after removing the cannulation needle. 3. An observation of care was conducted on 3/18/24 at 3:27 PM with EI # 8, Patient Care Technician, to discontinue dialysis with an AVF/AVG at station 2 for PI # 7. After reinfusing the extracorporeal circuit, EI # 8 failed to remove gloves and perform hand hygiene. EI # 8 exited the station with gloves on, retrieved PI # 7’s walker and returned to the station. EI # 8 removed the gloves but failed to perform hand hygiene after glove removal and before accessing the clean glove supply. With gloves on, EI # 8 removed the vascular clamp from the IV pole, exited the station, placed the clamp in the bleach container and returned to the station. With the same gloves, EI # 8 taped the access site, and removed the second cannulation needle. EI # 8 failed to change gloves and perform hand hygiene before access site contact. With gloves on, EI # 8 removed the bicarbonate bag from the dialysis machine, discarded the bag into the biohazard container, and returned to the station. EI # 8 failed to remove gloves and perform hand hygiene after contact with the dialysis delivery system. Wearing the same gloves, EI # 8 taped the second cannulation site. At approximately 3:49 PM, after holding both access sites with a gloved hand, PI # 7 removed his/her glove and proceeded to exit the treatment floor without performing hand hygiene per facility policy. An interview was conducted on 3/20/24 at 9:55 AM with EI # 1, who confirmed staff failed to ensure the staff and patients performed hand hygiene per facility policy. 30952”

“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 review of facility policies and procedures, observations, and interviews, it was determined the facility failed to ensure the dialysis station was cleaned and disinfected according to facility policy and procedure in two of four observations for cleaning and disinfection of the dialysis station. This had the potential to negatively affect the thirty-six patients who dialyze at the facility. Findings include: Facility Policy and Procedure: Cleaning and Disinfecting of the Dialysis Station Published: 09/05/2023 Reference Number: 47806 Version: 14 Purpose ...of this policy is to provide guidelines to prevent the spread of infectious disease...maintain a clean. safe...environment for patients, staff, and visitors. ...Dialysis Station Area including the dialysis machine, chair/bed and other reusable equipment...include (but is not limited to) the following: Dialysis machine...and attachments, such as IV (intravenous) pole...hand sanitizer/holder... Dialysis Wall Box...located in the chase wall...routinely cleaned at the end of each treatment day... Cleaning of the Dialysis Machine Externally disinfect the dialysis machine with 1:100 (one part bleach to one hundred parts water) bleach solution after each dialysis treatment... Facility Policy: Use of Priming Buckets Published: 01/24/24 Version: 4 Purpose All facilities will utilize a priming bucket...to collect Normal Saline (NS) prime pre-treatment. ...Procedure ...4. At completion of the patient treatment, remove the priming bucket...dispose of the NS in the utility room hopper or dirty sink... 1. An observation was conducted on 3/18/24 at 11:30 AM at station 9 with Employee Identifier (EI) # 9, Certified Clinical Hemodialysis Technician (CCHT) for cleaning and disinfection of the dialysis station. EI # 9 failed to clean the wall box and countertop behind the dialysis station per facility policy for routine end of the day cleaning. An interview was conducted on 3/20/24 at 9:50 AM with EI # 1, Clinic Manager (CM), who confirmed staff failed to follow the policy for dialysis station cleaning and disinfection. 2. An observation was conducted on 3/18/24 at 12:52 AM at station 3 with EI # 8, Patient Care Technician (PCT), for cleaning and disinfection of the dialysis station. EI # 8 removed the priming bucket and disposed of the NS solution in the wall box behind the dialysis station, and not in the utility hopper or dirty sink. EI # 8 failed to disinfect the Hansen hoses, and the sharps container. An interview was conducted on 3/20/24 at 9:50 AM with EI # 1, who confirmed staff failed to follow the policy for dialysis station cleaning and disinfection. 49894”

“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: 49894 Based on observations, review of facility policy and procedure, and staff interview it was determined the facility failed to ensure: 1. Staff scrubbed the threads and end of the luer lock (hub) of the Central Venous Catheter (CVC) for 10-15 seconds per facility policy. 2. Staff cleaned the CVC exit site per facility policy. This affected Patient Identifier (PI) # 4, in one of two observations for discontinuation of dialysis with a CVC, and PI # 6, PI # 1, in two of three observations of CVC exit site care and two of two observations of initiation of dialysis with a CVC. Findings include: Facility Policy: Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer Published: 2/7/22 Reference Number: 45640 Version: 7 Purpose ...to provide direction to reinfuse blood in the extracorporeal system to the patient at completion of the hemodialysis treatment... Termination: Disinfection of Catheter and Disconnecting the Patient Follow the steps to disinfect the catheter and to disconnect the patient ... Threads and end of luer lock (hub) must be scrubbed with 70 % sterile alcohol pad ...for 10-15 seconds any time the caps are removed, or bloodlines are disconnected ...to reduce risk of contamination. ...Step 5: Disconnect the arterial bloodline from the catheter limb. 6. Using a sterile alcohol pad ...scrub the sides (threads) and the end of the hub thoroughly with friction, making sure to remove any residue ... This step should take 10-15 seconds ...9. Repeat ...for the venous end of the catheter limb ... Facility Procedure: Changing the Catheter Dressing Published: 2/5/24 Reference Number: 45664 Version: 8 Purpose: ...is to provide instruction for cleaning the hemodialysis catheter exit site, changing the catheter dressing... and maintaining a protective barrier in order to prevent infection. ...Cleaning the Site: Follow the steps below to clean the catheter exit site: ...2. Remove swabstick from package...2% (percent) Chlorhexidine (SP) and 70% alcohol (Chloraprep): Using gentle back and forth friction, clean the exit site beginning in the center and continuing outward in the area of the size of the dressing to be applied (2 inches) in a concentric circle for 30 seconds and allow to dry a minimum of 30 seconds... 1. An observation of care was conducted on 3/18/24 at 11:40 AM at station 5 with Employee Identifier (EI) # 7, Registered Nurse (RN), during discontinuation of dialysis with a CVC for PI # 4. During the observation, EI # 7 scrubbed the arterial limb threads and hub with alcohol for five seconds and the venous limb threads and hub for eight seconds. EI # 7 failed to clean each hub for fifteen seconds per policy. An interview conducted on 3/20/24 at 9:55 AM with EI # 1, Clinic Manager, who confirmed staff failed to follow the facility procedure for cleaning the CVC threads and hub. 2. An observation of care was conducted on 3/18/24 at 3:10 PM at station 8 with EI # 7 during CVC exit site care for PI # 6. EI # 7 removed the CVC exit site dressing and cleansed the CVC exit site with a Chloraprep swabstick for seventeen seconds, and not for thirty seconds per facility procedure. An interview was conducted on 3/20/24 at 9:55 AM with EI # 1, who confirmed the staff failed to follow the facility procedure for CVC exit site care. 3. An observation was conducted on 3/19/24 at 9:10 AM at station 2 with EI # 7 performing initiation of dialysis with a CVC and CVC exit site care for PI # 1. EI # 7 scrubbed the CVC exit site with a Chloraprep swabstick for twenty seconds, and not for thirty seconds per facility policy. An interview was conducted on 3/20/24 at 9:50 AM with EI # 1, who confirmed staff failed to follow the facility policy for CVC exit site care. 30952”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 49894 Based on observation, review of facility policy, and staff interview it was determined the facility failed to secure and restrict access to the water treatment area. This had the potential to negatively affect all thirty-six patients dialyzing at the facility. Findings include: Facility Policy: Physical Security and Facility Access: Reference Number: 25825 Version: 3 Published: 9/5/23 Purpose: To ensure a secure and safe environment... Water Treatment Area Security: Restricted access must be maintained to prevent unwanted tampering with the water treatment equipment. The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic. This is accomplished by: Locking all doors that allow access to the water treatment equipment. An observation was made on 3/18/24 at 11:00 AM of the door to water treatment open and unsecured. An observation was made on 3/19/24 at 8:00 AM and again at 9:54 AM of the door to the water treatment area open and unsecured. An interview was conducted on 3/19/24 at 1:00 PM with Employee Identifier (EI) # 4, Biomedical Technician I, EI # 5, Biomedical Technician II, and EI # 6, Area Technical Operations Manager, who confirmed that the door to the water treatment area was unlocked and unsecured. They also confirmed the door to the water treatment area could not be locked because it did not have a locking door knob on it. An interview on 3/20/2024 at 10:30 AM with EI # 2, Director of Operations, confirmed the door was broken and unable to be closed or locked and therefore the facility failed to keep the water treatment area secured.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 49894 Based on review of the Total Chlorine Logs (TCL) (documentation of chlorine testing), TCL Clinic Manager (CM) Weekly Review Log, facility policies, and staff interviews, it was determined the facility failed to ensure total chlorine was tested at a minimum of every four hours and the TCL log was reviewed weekly and documented on the TCL-CM Weekly Review Log per facility policy. This had the potential to negatively affect all thirty-six patients dialyzing at the facility. Findings Include: Facility policy: Carbon Filtration Monitoring for Incenter Central Water Systems Policy Reference Number: 46310 Version: 9 Published: 11/7/22 Test Rationale: Total chlorine testing will be the only testing methodology used to ensure the carbon filters are reducing total chlorine levels. Testing for total chlorine allows for simplified testing for both free chlorine and chloramines. What to test: Worker Carbon Filter When to test: Prior to the initiation of the first patient treatment and at a minimum of every four hours. Routine Chlorine Testing: Routine Total Chlorine Testing will be documented in the approved electronic documentation system... Clinical Oversight: The CM or the nurse in charge is responsible for the oversight of daily testing and documentation of total chlorine testing. The CM or the nurse in charge must do the following: Run and review “FKC Log Readings Grid Report for TCL”. Complete the “TCL Weekly Review Log”. Review of the January 2024 TCL Log revealed on 1/24/24 the total chlorine was tested at 4:21 AM and 9:07 AM, which is five hours and seven minutes, and not at a minimum of every four hours per policy. Further review of the January 2024 TCL Log revealed on 1/25/24 the total chlorine was tested at 5:57 AM and again at 1:09 PM, which is six hours and twelve minutes, and not at a minimum of every four hours per policy. Review of the TCL-CM Weekly Review Log for January 2024 revealed only two entries for the month of January on 1/8/24 and 1/15/24 and not weekly per facility policy. Review of the Total Chorine Log for February 2024 revealed on 2/9/24 the total chlorine was tested at 4:40 AM and 8:50 AM, which is four hours and ten minutes, and not at a minimum of every four hours per policy. Review of the TCL-CM Weekly Review Log revealed no entry for the the week 2/4/24-2/10/24. Review of the Total Chlorine Log for March 2024 revealed on 3/9/24 the total chlorine was tested at 9:15 AM and 1:42 PM, which is four hours and twenty-seven minutes, and not at a minimum of every four hours per policy. Further review of the March 2024 log revealed on 3/16/24 the total chlorine was tested at 7:00 AM and 11:17 AM, which is four hours and seventeen minutes, and not at a minimum of every four hours per policy. Review of the TCL-CM Weekly Review Log for March 2024 revealed no entry for the week of 3/3/24-3/9/24. An interview was conducted on 3/20/24 at 9:30 AM with EI # 1, CM, who confirmed staff failed to test total chlorine at a minimum of every four hours per facility policy. EI # 1 also confirmed TCL-CM Weekly Review was not completed and documented weekly per facility policy.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 49894 Based on review of the Manufacturer’s Directions for Use for the MarCor Purification Central Water Purification (CWP) 100, CWP Disinfect Start Log, CWP Disinfect End Log, and interview, it was determined the facility failed to ensure the staff documented the disinfection of the Reverse Osmosis weekly. This had the potential to negatively affect all thirty-six patients dialyzing at this facility. Findings include: Facility Policy: Reverse Osmosis Water Purification, Operation, and Maintenance Reference Number: 47434 Version: 5 Published: 8/11/21 Policy: Membrane Cleaning and Disinfection RO Machine’s membranes will be cleaned and/or disinfected in accordance with manufacturer’s instructions for use, or at a minimum of monthly, whichever is more frequent. Manufacturer’s Directions for Use: MarCor Purification CWP 100 Operators Guide Version: E Published: Not Available ...7. Record Number of Chemical Disinfects This step allows the technician to record the number of chemical disinfection procedures performed. The number of chemical disinfections is displayed under Tech Level 1 in the menu item “N:o disinf.”. Chemical disinfection is recommended to be performed on a weekly basis. By recording this value, the technician can determine if the chemical disinfections are being performed per recommendations. Review of the CWP Disinfect Start Log for January 2024 revealed on 1/2/24 there was documentation the CWP disinfection was started. There was no documentation on the CWP Disinfect End Log for January 2024 of the disinfection being completed and necessary testing performed on 1/3/24. Further review of the January 2024 CWP Disinfection Start Log revealed the CWP Disinfection process was started on 1/8/24. There was no documentation on the CWP Disinfect End Log of the disinfection being completed and necessary testing performed on 1/9/24. Further review of the January CWP Disinfect Start/End Logs revealed the disinfection process was started on 1/15/24 and ended on 1/15/24. It also revealed on 1/22/24 the disinfection process was started and there was no documentation of it being stopped on 1/23/24 with necessary testing being performed. Review of the February 2024 CWP Start Log/End Log revealed on 2/19/24 the start of the disinfection process was not documented. The process was documented as ended on 2/20/24. Review of the March 2024 CWP Disinfect Start/End Log revealed on 3/4/24 the disinfection process was started. There is no documentation the process ended on 3/5/24 with necessary testing being performed. An interview was conducted on 3/19/24 at 1:30 PM with Employee Identifier (EI) # 4, Biomedical Technician I, EI # 5, Biomedical Technician II, and EI # 6, Area Technical Operations Manager confirmed the weekly disinfection process as follows: the closer (person who performs end of the day tasks) puts the system in chemical disinfect on Tuesday, and the opener (person who performs start of the day tasks) takes the system out of the disinfection process and performs necessary testing on Wednesday morning, before the start of patient treatments. An interview was conducted on 3/20/24 at 9:30 AM with EI # 1, Clinic Manager, who confirmed the staff failed to follow the CWP weekly chemical process per facility policy and manufacturer’s instructions for use.”

“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: 49894 Based on staff interviews, review of personnel files, facility policies, GranuFlo (citrisate dry acid concentrate used in dialysis treatment) mixing logs, and the Central Water Purification (CWP) Disinfect Log, it was determined the facility failed to ensure staff were properly trained to verify mixed GranuFlo batches and start/stop the CWP disinfection process. This had the potential to negatively affect all thirty-six patients dialyzing at this facility. Findings include: Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit (DADU) Reference Number: 25910 Version: 7 Published: 9/5/23 ... Operator: A staff member who meets the qualifications of “Policy: Trained Staff” located in this document that is the primary staff member making the current batch of acid. Specific Gravity: The ratio of the density of a liquid to the density of water. Verifier: A staff member that meets the qualifications of “Policy: Trained Staff” located in this document that will confirm the operator’s test results/actions when required or will repeat the required test/actions themselves and document as required. Trained staff: Prior to being allowed to operate the DADU, the staff must complete training necessary to perform their assigned operational responsibilities. This includes one or more of the following areas: ... Performing specific gravity tests. Completing batch records using DADU batch production record. Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation thereafter. Table of Specific Gravities or Citrisate Dry Table of Specific Gravities: Specific gravity from the DADU will be tested: Once the mixing process is completed by the operator and verified by a second staff member. Batch Records: Each batch record must be reviewed and verified as complete by two qualified staff members at the end of every batch. Facility Policy: Acid Concentrate Specific Gravity Testing Procedure Reference Number: 46325 Version: 3 Published: 7/5/22 Purpose: Provides a step by step procedure for measuring the specific gravity of batches of acid concentrate which is the method used to verify a batch of acid concentrate has been mixed appropriately... Hydrometer: An instrument used to measure the specific gravity (or relative density) of liquids. Specific Gravity (SG): The ratio of the density of a liquid to the density of water. Facility Policy: Knowledge, Skills, and Competency Evaluation for Clinical Staff Reference Number: Not Published Version: 3 Published: 10/12/21 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, including initial and annual exam. Employees are required to pass all skills requirements, including an initial and annual slills validation... Employees without current documented competency within the last 365 days may be removed from performing independent direct patient care until competency is demonstrated and documented. Documentation: Completion dates are entered in Learning Management System (LMS) for initial and annual exams and validation. 1. Review of the Granuflo Mixing Log for the month of January 2024 revealed Employee Identifier (EI) # 13, Registered Nurse (RN), documented verification of the Granuflo batch on January 5, 2024 and January 26, 2024. Review of the personnel records for EI # 13 Annual Direct Patient Care (DPC) Skills Validation, revealed EI # 13 did not have competency in hydrometer use, which is necessary to verify the acid batch. An interview was conducted on 3/20/2024 at 9:30 AM with EI # 1, Clinic Manager (CM), who confirmed the verifier of the acid batch preparation was not competent in hydrometer use per the facility policy. 2. Review of the the Granuflo Mixing Log for January 2024 revealed EI # 7, RN, documented verification of the GranuFlo batch on January 19, 2024. Review of the GranuFlo Mixing Log for February 2024 revealed EI # 7 documented verification of the GranuFlo batch on February 5, 2024 and February 19, 2024. Review of the GranuFlo Mixing Log for February 2024 revealed EI # 7 documented verification of the GranuFlo batch on March 15, 2024. Review of the personnel records for EI # 7, Annual DPC Skills Validation revealed EI # 7 did not have competency in hydrometer use, which is necessary to verify the acid batch. An interview was conducted on 3/20/24 at 9:30 AM with EI # 1, who confirmed the verifier of the acid batch preparation was not competent in hydrometer use per the facility policy. 3. Review of the CWP Disinfection Log for February, 2024 revealed EI # 14, RN, documented the start of the CWP disinfection process on February 26, 2024. Review of the personnel records for EI # 14, Annual DPC Skills Validation, revealed EI # 14 did not have competency in CWP Chemical Disinfect. An interview was conducted on 3/20/25 at 9:30 AM with EI # 1, who confirmed EI # 14 was not competent to start the CWP disinfection process per facility policy.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 47295 Based on review of medical records (MR), facility policy, and interview, it was determined the facility failed to ensure the comprehensive assessment was completed monthly for unstable patients. This affected one of two unstable record reviews, including Patient Identifier (PI) # 2, and had the potential to negatively affect all patients dialyzed at the facility. Findings include: Facility Policy: Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) Published: 7/3/23 Reference Number: 45283 Version: 6 CIA/POC for Unstable Patients: Unstable patients must be reassessed by the Interdisciplinary Team (IDT) monthly. Monthly reassessment and any POC updates...must be documented until the issues have been resolved or the IDT...determines...the condition is chronic... 1. PI # 2 was admitted on 4/26/13 with the diagnosis of End Stage Renal Disease. Review of the POC meeting documentation dated 1/24/24 revealed PI # 2 was stable. During the entrance conference, surveyors requested a list of unstable patients. PI # 2 was on the list with the date determined to be unstable listed as: 1/24/24. MR review revealed a Provider Rounding Note was completed on 2/26/24. PI # 2 was not seen by the physician on 2/26/24 due to not being at the facility when rounds were made. An interview conducted on 3/20/24 at 9:24 AM with Employee Identifier (EI) # 1, Clinic Manager, revealed the physician makes rounds on the last Monday of the month. The POC was to be reviewed and updated on 2/26/24 but was rescheduled for 3/25/24, when the physician will be at the facility again. Further review of the MR revealed Comprehensive Assessment documentation was completed by the Social Worker (SW) on 3/11/24 and by the Registered Dietician (RD) on 3/13/24. An interview was conducted on 3/20/24 at 9:24 AM with EI # 1, who confirmed the staff failed to complete Comprehensive Assessments monthly for unstable patients.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 30952 47295 49894 Based on observations, review of facility policy, and staff interview it was determined the facility failed to ensure: 1. Staff followed the physician’s standing order to adjust the dry weight (DW) as needed (prn). 2. Staff performed and documented blood pressure (BP), pulse, and safety checks every thirty minutes or more as needed but not to exceed forty-five minutes. This affected Patient Identifier (PI) # 2, PI # 1, and PI # 4 in three of five medical records reviewed and had the potential to affect all thirty-six patients dialyzing at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Reference Number: 45284 Version: 4 Published: 5/1/23 ... During treatment: Obtain blood pressure and pulse rate every thirty minutes or more as needed but not to exceed forty-five minutes... 1. PI # 2 was admitted to the facility on 4/26/13 with a diagnosis of End Stage Renal Disease (ESRD). Orders Summary Report for PI # 2 Order: May adjust DW prn Start Date: 6/16/23 Stop Date: 6/14/24 Ordering Physician: Employee Identifier (EI) # 3 Review of the Treatment Sheet (TS) dated 3/1/24 revealed a DW of 88.8 kilograms (kg). The post-weight was 87.3 kg (1.5 kg below the DW). Review of the TS dated 3/4/24 revealed a DW of 88.8 kg. The post-weight was 85.89 kg (2.91 kg below the DW). Review of the TS dated 3/6/24 revealed a DW of 88.8 kg. The post-weight was 83.9 kg (4.9 kg below the DW). Review of the TS dated 3/8/24 revealed a DW of 88.8 kg. The post-weight was 85.7 kg (3.1 kg below the DW). Review of the TS dated 3/11/24 revealed a DW of 88.8 kg. The post-weight was 83.3 kg (5.5 kg below the DW). An interview was conducted on 3/20/24 at 9:24 AM with EI # 1, Clinic Manager, who confirmed that staff failed to follow the physician’s order and adjust the DW prn. 2. PI # 1 was admitted to the facility on 12/21/23 with a primary diagnosis of ESRD. Review of the TS dated 3/16/24 revealed no vital signs and safety checks from 9:16 AM to 10:30 AM, which was seventy-four minutes and greater than forty-five minutes per the facility policy. An interview was conducted on 3/20/24 at 9:06 AM with EI # 1, who confirmed staff failed to document BP, pulse, and safety checks at least every forty-five minutes. 3. PI # 4 was admitted to the facility on 1/2/24 with a diagnosis of End Stage Renal Disease. Review of the TS dated 2/21/24 revealed no documentation of vital signs being obtained from 10:36 AM to 11:58 AM, which was one hour and twenty-two minutes, and exceeded the forty-five minutes per facility policy. Review of the TS dated 3/8/24 revealed no documentation of vital signs being obtained from 9:37 AM and 10:33 AM, which was fifty-seven minutes, and exceeded the forty-five minutes per facility policy. An interview was conducted on 3/20/24 at 9:50 AM with EI # 1, who confirmed vital signs documentation exceeded forty-five minutes 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 observations, review of facility policies, review of medical records (MR), and staff interviews, it was determined the facility failed to ensure: 1. Staff followed physician’s orders for Blood Flow Rate (BFR). 2. Staff followed physician’s orders for Dialysate Flow Rate (DFR). 3. Heparin administration to the Central Venous Catheter (CVC) limbs at the end of dialysis treatment (heplock flush) was not documented before the end of treatment. This affected five of five records reviewed and included Patient Identifier (PI) # 1, PI # 2, PI # 3, PI # 4, and PI # 5, and had the potential to negatively affect the thirty-six patients who dialyzed at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 05/01/2023 Reference Number: 45284 Version: 4 ...3. Machine Parameters and Extracorporeal Circuit Check machine settings and measurements: Check prescribed blood flow rate is being achieved or reason is documented in medical record if unable to meet prescribed blood flow rate. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered... Facility Policy: Medication Preparation and Administration Reference Number: 47488 Version: 9 Published: 2/6/23 Documentation: The following points must be followed to ensure proper documentation of medication preparation and administration. Medications must not be signed off prior to administration. 1. PI # 1 was admitted to the facility on 12/21/23 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Orders Summary Report (OSR) revealed hemodialysis treatment orders dated 12/21/23 for heparin infusion 1000 units (U) per hour three times a week. Further review of the OSR revealed the dialysis treatment time was 4 hours, effective 2/22/24. Review of the Treatment Sheets (TS) dated 3/5/24, 3/14/24, and 3/16/24 revealed the patient dialyzed for four hours, and the total heparin infused was 3000 U and not 4000 U as ordered. An interview was conducted on 3/20/24 at 9:06 AM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed staff failed to administer hourly heparin as ordered. 2. PI # 3 was admitted to the facility on 10/22/21 with a primary diagnosis of ESRD. Review of the OSR revealed hemodialysis treatment orders dated 2/26/24 with a BFR of 400 and a manual DFR of 500. Review of the TS dated 3/18/24 revealed the DFR was 800 at treatment start at 9:33 AM until 11:30 AM. There was no order for the DFR 800. Further review of the 3/18/24 TS revealed the BFR was 350 from 10:40 AM to 11:30 AM. There was no reason documented why the BFR was not 400 as ordered. An interview was conducted on 3/20/24 at 9:33 AM with EI # 1, who confirmed staff failed to follow orders for BFR and DFR. 3. PI # 4 was admitted to the facility on 1/4/24 with a diagnosis of ESRD. Review of the TS dated 2/21/24 revealed the treatment start time was 9:29 AM and the end time was 1:22 PM. Further review of the TS dated 2/21/24 revealed the post-treatment heplock was administered at 9:29 AM which was before the treatment ended and not after the treatment ended per policy. An interview was conducted on 3/20/24 at 9:05 AM with EI # 1, who confirmed the staff failed to document post-treatment heplock after the completion of treatment. 4. PI # 2 was admitted to the facility on 4/26/13 with a primary diagnosis of ESRD. Review of the TS dated 3/8/24 revealed hemodialysis (HD) orders with a BFR of 400 and a manual DFR of 500. Further review of the TS dated 3/8/24 revealed the BFR was 300 from 11:49 AM to 1:53 PM and from 2:02 PM to 2:54 PM. There was no reason documented why the BFR was not 400 as ordered. An interview was conducted on 3/20/24 at 9:24 AM with EI # 1 who confirmed staff failed to follow orders for BFR. 5. PI # 5 was admitted to the facility on 4/29/21 with a primary diagnosis of ESRD. Review of the OSR dated 2/28/24 revealed HD orders with a BFR of 375 and a manual DFR of 500. Review of the TS dated 3/4/24 revealed the BFR was 300 for the entire treatment (5:50 AM to 9:20 AM). There was no reason documented why the BFR was not 375 as ordered. Review of the TS dated 3/6/24 revealed the BFR was 350 for the entire treatment (5:53 AM to 9:23 AM). There was no reason documented why the BFR was not 375 as ordered. Review of the TS dated 3/15/24 revealed the BFR was 300 for the entire treatment (5:43 AM to 9:13 AM). There was no reason documented why the BFR was not 375 as ordered. An interview was conducted on 3/20/24 at 9:42 AM with EI # 1 who confirmed staff failed to follow orders for BFR. 47295 49894”

“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: 49894 Based on medical record review and interview it was determined the facility failed to administer oral nutritional supplements per the physician’s order. This affected Patient Identifier (PI) # 4 in one of five medical records reviewed. Findings include: 1. PI # 4 was admitted to the facility on 1/4/24 with a diagnosis of End Stage Renal Disease. Review of the Orders Summary Report dated 3/18/24 revealed an order for nutritional supplement (Jimmy Protein Bar) to be administered every treatment. Review of the Treatment Sheets dated 2/21/24, 3/1/24, 3/4/24, 3/8/24, 3/13/24, and 3/15/24 revealed no documentation the nutritional supplement was administered as ordered by the physician. An interview was conducted on 3/20/24 at 9:50 AM with Employee Identifier (EI) #1, Clinic Manager, who confirmed there was no documentation of nutritional supplement being administered as ordered by the physician.”

“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 staff interviews, it was determined the facility failed to ensure staff performed Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG) site preparation per facility policy. This affected two of three observations of access of an AVF/AVG for initiation of dialysis, including Patient Identifier (PI) # 6 and PI # 13. This had the potential to negatively affect all incenter patients dialyzing at the facility with an AVF/AVG access. Findings include: Facility Policy: Access Assessment and Cannulation Reference Number: 45178 Version: 3 Published: 7/5/22 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: ...2. Wash hands and don Personal Protective Equipment (PPE): gloves... ...5. Look... 6. Listen... 7. Feel... ...9. Remove gloves and perform hand hygiene. Don new gloves. Skin Disinfection: Step 1: Disinfect cannulation sites as follows using any of the disinfectants below: 70% isopropyl alcohol pad: Using gentle friction, clean the access site beginning in the center and continuing outward two inches in a concentric circle for 30 seconds and allow to dry before cannulating. Step 2: Perform skin asepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection... 1. An observation was conducted on 3/18/24 at 11:40 AM at station 1 with Employee Identifier (EI) # 12, Certified Clinical Hemodialysis Technician (CCHT), to initiate dialysis with an AVF for PI # 13. EI # 12 cleaned the arterial cannulation site with an alcohol pad for five seconds. A new alcohol pad was obtained and EI # 12 cleaned the venous cannulation site for three seconds. EI # 12 failed to perform skin asepsis on both cannulation sites, one at a time, for thirty seconds. An interview was conducted on 3/20/24 at 9:50 AM with EI # 1, Clinic Manager, who confirmed staff failed to clean each access cannulation site for thirty seconds per facility policy. 2. An observation of care was conducted on 3/18/24 at 11:49 AM at station 8 with EI # 9, CCHT, to initiate dialysis with an AVF for PI # 6. EI # 9 cleaned the access site with one alcohol pad for thirteen seconds. After skin antisepsis, EI # 9 touched both cannulation sites with his/her gloved finger and inserted the cannulation needles. EI # 9 failed to perform skin asepsis on one cannulation site at a time for thirty seconds and failed to repeat skin antisepsis after touching the cannulation sites. An interview was conducted on 3/20/24 at 9:55 AM with EI # 1 who confirmed staff failed to follow the facility procedure for preparation and cannulation of an AVF/AVG. 49894”