Fresenius Kidney Care Phenix City

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 30952 Based on observations, review of facility reporting of unusual occurrences to the State Survey Agency, medical records reviews, facility policies and procedures, the facility GranuFlo (an acid concentrate) Mixing Log documentation, staff training and competency documentation, it was determined the Medical Director failed to ensure the staff followed state licensure laws, policies and procedures for Infection Control, Water and Dialysate Quality, Equipment Maintenance, Patient Assessment/Plan of Care, and Quality Assessment Performance Improvement. Refer to V 101, V 113, V 115, V 122. V 132, V 143, V 175, V 229, V 245, V 246, V 250, V 260, V 510, V 520, V 540, V 543, V 544, V 547, V 550, V 580, V 594, V 595, V 599, V 634, V 638, V 715.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 30952 Based on review of the facility’s policies and procedures, GranuFlo mixing logs, staff training and competency documentation, medical records, home program water quality test, and interviews, it was determined the governing body failed to ensure the Medical Director was responsible for the delivery of patient care and the care provided at the facility was safe for patients which included the Water and Dialysate Quality, and the Patient Plan of Care. Refer to the Conditions for Coverage: V 175, V 540, V 580, and V 710.”

“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 review of the Alabama Department of Public Health (ADPH) Rules End Stage Renal Disease (ESRD) Treatment and Transplant Centers Chapter 420-5-5, the facility Discharged to the Hospital Report documentation, and interview, it was determined the facility failed to follow state licensure rules for ESRD and report all unusual occurrences to the State Survey Agency (SSA) which included unscheduled transports to a hospital. This affected eight of nine unscheduled transfers from 3/4/23 to 3/4/24 and had the potential to affect all patients served by the facility. Findings include: Rules of Alabama State Board of Health Alabama Department of Public Health Chapter 420-5-5 End Stage Renal Disease Treatment and Transplant Centers Amended December 18, 2007 page 7 420-5-5-.01 General (7) Unusual Occurrences Unusual occurrences which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the ADPH, Division of Health Care Facilities, and other agencies/authorities as required. Examples of unusual occurrences include...Any acute event that results in a patient receiving emergency treatment must be reported. Emergency treatment includes unscheduled transportation to a hospital or receipt of cardiac life support from a hospital, ambulance service or rescue squad, or staff member... 1. Review of the facility Discharged to the Hospital Report documentation dated 3/4/23 to 3/4/24 revealed a total of nine patients were discharged to the hospital from the facility. The SSA was notified of one of the nine transferred to the hospital. An interview was conducted on 3/7/24 at 11:05 AM with Employee Identifier # 1, Clinic Manager, who confirmed the facility failed to report eight of nine unscheduled transfers over the past 12 months to the SSA.”

“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 policies, and staff interviews, it was determined the facility failed to ensure: 1. Staff removed gloves and performed hand hygiene in two of three observations for initiation of dialysis with an Arteriovenous Fistula/Arteriovenous Graft (AVF/AVG) included Patient Identifier (PI) # 8, PI # 9. 2. Patients performed hand hygiene after removing gloves in one of three observations of discontinuation of dialysis with an AVF/AVG and included PI # 11. This had the potential to affect all patients, visitors, and staff at the facility. Findings include: Facility Policy: Hand Hygiene Published: 11/06/23 Reference Number: 47664 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: ...2. Before performing any invasive procedure such as vascular access cannulation. ...4. When moving from a contaminated body site to a clean body site of a patient. Hand hygiene: Patients Patients should perform hand hygiene if able, prior to and after each dialysis treatment. To help ensure the prevention of cross contamination to their family members or other patients, hand hygiene must be performed. Facility Policy: Access Assessment and Cannulation Published: 7/5/22 Reference Number: 45178 Version: 3 Purpose: The purpose of this procedure is to provide guidance for assessing patency and placement of needles in an AV Fistula or AV Graft to obtain access to the circulatory system for hemodialysis. Responsibility: Direct Patient Care Staff, patient 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... Assessment of the Vascular Access: Follow the steps below to assess the vascular access: ...5. Look... 6. Listen... 7. Feel... ... ...9. Remove gloves and perform hand hygiene. 1. An observation of care was conducted on 3/4/24 at 10:38 AM, at station 3 with Employee Identifier (EI) # 5, Patient Care Technician. With gloves on, EI # 5 evaluated PI # 8’s AVF sites with the stethoscope and palpation. EI # 5 applied antiseptic using two alcohol pads to the cannulation sites and inserted the cannulation needles without first changing gloves and performing hand hygiene. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1, Clinic Manager, who verified staff must change gloves and perform hand hygiene after access evaluation. EI # 1 confirmed staff failed to follow facility policy. 2. An observation was conducted on 3/4/24 at 10:53 AM with EI # 5 to discontinue dialysis with an AVF/AVG for PI # 11 at station 4. After holding cannulation sites with a gloved hand, PI # 11 removed the glove and exited the treatment floor without performing hand hygiene. An interview was conducted on 3/7/24 at 9:30 AM with EI # 1 who confirmed the staff failed to ensure the patient followed the facility policy for hand hygiene. 3. An observation was conducted on 3/4/24 at 11:50 AM at station 5 with EI # 6, Certified Clinical Hemodialysis Technician (CCHT) during initiation of dialysis with an AVF/AVG for PI # 9. After evaluating (look, listen, feel) the access, EI # 6 failed to remove gloves and perform hand hygiene prior to cleaning the access for cannulation. An interview was conducted on 3/7/24 at 9:30 AM with EI # 1, who confirmed staff failed to perform hand hygiene per clinic policy. 30952”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 49894 Based on observation, facility policy and procedure, and staff interview, it was determined the staff failed to ensure patients wore masks properly during Central Venous Catheter (CVC) exit site care and initiation of dialysis with a CVC in one of two observations. This included Patient Identifier (PI) # 13 and had the potential to affect all patients dialyzing at the facility with a CVC. Findings include: Facility Policy: Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer Reference Number: Not Documented Version: 7 Published: 7/6/21 Purpose: The purpose of this procedure is to provide direction initiating hemodialysis treatment using a CVC... Responsibility: Fresenius Kidney Care Direct Patient Care Staff Supplies: The following supplies are needed for this procedure: ...Personal Protective Equipment (PPE) -one additional mask for the patient Prior to Initiation: Follow these steps... 1. Perform hand hygiene and don full PPE ...9. Put mask on the patient... 1. An observation was made on 3/4/24 at 12:20 PM at station 6 with PI # 13. Employee Identifier (EI) # 9, Registered Nurse, performed exit site care and initiated treatment. PI # 13 had their mask below the nose during the entire procedure. An interview was conducted on 3/7/24 at 9:30 AM with EI # 1, Clinic Manager, who confirmed that staff failed to ensure the patient wore their mask according to policy during CVC care.”

“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: 49894 Based on review of facility policy and procedures, observations, and interviews, it was determined the facility failed to ensure: 1. The dialysis station was cleaned and disinfected according to facility policy and procedure, which was observed during random floor observations and during three of three observations for cleaning and disinfection of the dialysis station. 2. The mixed bleach containers were labeled with the bleach solution strength and the bleach cloths used for cleaning were stored in the covered container prior to use. This had the potential to negatively affect all 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 disease...maintain a clean, safe...environment for patients, staff, and visitors. Cleaning of the Dialysis Wall Boxes: Dialysis wall boxes and the area/wall around the wall box must be routinely cleaned at the end of each treatment day... Special attention should be given to removing build-up and/or cleaning splatter or spray of concentrate solution. ...Procedure Follow the steps below to disinfect the dialysis station after each dialysis treatment: ...3. Use a cloth wetted with 1:100 (one part bleach, 100 parts water) bleach solution...to clean and disinfect the dialysis station...machine, IV (intravenous) pole, B/P (blood pressure) cuff...chaise wall behind chair... 4. Clean all surfaces... 5...While wiping...wipe all surfaces of the machine... Facility Procedure: Mixing Bleach Published: 8/25/2020 Version: 4 Procedure: Follow the steps...for mixing bleach: ...2. Pour measure amount of water into labeled opaque container. 3. Slowly pour measured amount of bleach into measured water... 4. Label opaque container with “Bleach Solution”, strength of solution, date, and time prepared... 5. Cover opaque container with lid. 1. A flash tour of the incenter treatment floor was conducted on 3/4/24 at 10:01 AM. The surveyor observed white crystallized substance around the blue and red hose connectors and bottom of the wall box at station 9. There was a buildup accumulation of the white substance around the blue hose connector and wall box bottom at station 8. Staff failed to clean the dialysis wall boxes at the end of each treatment day. An interview was conducted on 3/7/24 at 10:30 AM with Employee Identifier (EI) # 1, Clinic Manager (CM), who confirmed staff failed to follow the policy for cleaning and disinfection of the dialysis station. 2. A flash tour was conducted on 3/4/24 at 10:10 AM. A container was observed with no label of content, date, time prepared, or preparer’s initials. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1 who confirmed staff failed to label bleach solutions per facility policy. 3. A flash tour was conducted on 3/4/24 at 10:15 AM. An abundance of white, crystal substance build up was observed in the dialysis wall box located behind station 2. An interview was conducted on 3/4/24 at 10:30 AM with EI # 1 who confirmed staff failed to follow policy for cleaning of the dialysis wall box. 4. An observation of cleaning and disinfection of dialysis station 9 was conducted on 3/4/24 at 10:47 AM with EI # 6, Certified Clinical Hemodialysis Technician (CCHT). EI # 6 failed to clean the wire basket, the top of the intravenous (IV) pole, the IV hooks, the laminates on the hooks, the sharps container, the hand sanitizer dispenser, and the counter surrounding the station. The surveyor observed the wall panel/box behind the station 9 with buildup of white/brown crystal substance around the red and blue hose connectors and bottom of the wall box. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1 who confirmed staff failed to follow the policy for cleaning and disinfection of the dialysis station. 5. An observation of cleaning and disinfection of dialysis station 2 was conducted on 3/4/24 at 11:02 AM with EI # 6. EI # 6 failed to clean the wire basket, the television arm, the Hansen hoses, and the counter surrounding the station. The surveyor observed the wall panel/box behind the station 2 with greater than a one-day buildup of white/brown crystal substance around the red and blue hose connectors and bottom of the wall box. An interview was conducted on 3/7/24/ at 10:30 AM with EI # 1 who confirmed staff failed to follow the policy for cleaning and disinfection of the dialysis station. 6. An observation was conducted on 3/4/24 at station one at 11:20 AM. The surveyor observed a buildup of a white crystallized substance around the blue hose connector. Staff failed to clean the dialysis wall boxes at the end of each treatment day. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1 who confirmed staff failed to follow the policy for cleaning and disinfection of the dialysis station. 7. An observation was conducted on 3/4/24 at 11:21 AM at station 4 with EI # 5, (Patient Care Technician), for cleaning and disinfection of the dialysis station. EI # 5 failed to wipe the prime bucket inside and out, the Hansen connectors and hoses, the television arm, the sharps container, the wire basket, the hand sanitizer, and the IV pole. The clean blood pressure cuff was then placed back in the dirty basket. The wall box and countertop behind the dialysis machine were not cleaned per facility policy for end of treatment day. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1 who confirmed staff failed to follow facility policy for cleaning and disinfection of the dialysis station. 8. An observation of care was conducted on 3/4/24 at 11:29 AM. EI # 7, CCHT, placed bleach cloths at station 7, and exited the station. At 11:42 AM, EI # 7 returned to the station, and cleaned the station with the bleach cloths that were exposed to sunlight, and not covered. The bleach cloths were exposed to light for 14 minutes, which had the potential to affect the integrity of the bleach solution. An interview was conducted on 3/4/24 at 10:30 AM with EI # 1 who confirmed staff failed to follow the facility policy for cleaning of the dialysis station and bleach storage. 30952”

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 30952 Based on review of the facility policy, the End Stage Renal Disease (ESRD) Core Survey Facility Worksheet: Personnel File, staff training documentation, and interview, it was determined the facility failed to ensure the Home Program Staff Registered Nurse (RN) completed annual infection control training. This affected one of one home therapy training reviews and had the potential to affect negatively affect the 15 home training patients served by the facility. Findings include: Facility Policy: Knowledge, Skills, and Competency for Clinical Staff Published: 10/12/2021 Version: 3 Purpose ...FKC (Fresenius Kidney Care) provides all clinical field employees with initial and ongoing development and evaluation of the knowledge and skills essential for a highly functional and well-trained workforce. ...The following are...required clinical topics covered during training... -Initial, Annual, and One-time Role Specific Training -Initial, Annual, and One-time Role Specific Knowledge Evaluation -Initial, Annual, and One-time 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 past 365 days may be removed from performing independent direct patient care...until competency is demonstrated and documented. ...Documentation Completion dates are entered...for ... annual exam and skills validation...Annual Skills Validation.... 1. A review of the ESRD Core Survey Facility Worksheet: Personnel File dated 3/5/24 included Employee Identifier (EI) # 10, Home Therapy Staff RN whose date of hire was 8/22/22 and infection control training date was 11/15/23. Review of EI # 10’s personnel file documentation provided by the facility on 3/6/24 included the education transcript titled, Infection Prevention Fundamentals, dated 3/5/24, which was after the survey began. There was no education training provided for 11/15/23. The surveyor requested EI # 10’s infection control training completed before the survey began. The surveyor was provided the training document titled, Infection Prevention Fundamentals, dated 9/2/22. There was no documentation annual Infection Control training was completed in 2023. An interview was conducted on 3/6/24 at 1:29 PM with EI # 4, Home Program Manager, who confirmed EI # 10 had failed to complete annual Infection Control training in 2023.”

“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: 49894 Based on observations, review of facility policy and interview, it was determined the facility failed to ensure: 1. Staff kept pre-drawn medications labeled and under preparer’s control or in a locked designated medication storage area until delivery to the appropriate patient. 2. Staff cleaned the diaphragm of multi-dose intravenous heparin vial with a new alcohol pad each time the vial was accessed with a needle. These deficient practices had the potential to negatively affect all patients dialyzing at this facility, and did affect Patient Identifier (PI) # 10, one of two observations of discontinuation of dialysis with a Central Venous Catheter (CVC), and a random observation of medication preparation. Findings include: Facility Policy: Medication Preparation and Administration Published: 2/6/23 Reference Number: 47488 Version: 9 Purpose To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. ...Labeling Reconstituted Medication Solutions and Syringes All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, name of patient, date, time, and initials of the person who prepared the medication... Oral medications not being administered immediately must also be labeled as indicated above. ...Pre-drawing Medications Medications may be pre-drawn up to 4 (four) hours prior to administration... These pre-drawn medications shall be labeled and must be kept in the preparer’s control or in a locked medication storage area ...until the delivery to the appropriate patient for administration. ...Infection Control The following steps must be taken to ensure infection control. Perform hand hygiene prior to accessing supplies, handling vials...and preparing medications. ...Cleanse the diaphragm of a vial with alcohol prior to accessing the vial. If the vial is a multi-dose vial (MDV), cleanse the diaphragm with a new alcohol pad each time the vial is accessed with a needle... Securement The following steps must be taken for the securement: All medications will be stored in a locked cabinet except when in use... 1. An observation was conducted on 3/4/24 at 10:40 AM at station 12 for PI # 10 for discontinuation of dialysis with a CVC. A plastic bag with CVC supplies was hanging on the patient’s machine. There were two unsecured syringes in the bag labeled with the patient’s name and name/dose of Heparin. The syringes were not labeled with the time and date of preparation or initials of the preparer. At 10:49 AM, EI # 9, Registered Nurse (RN), administered the medication from the two syringes to the patient’s CVC. An interview was conducted on 3/7/24 at 10:30 AM with Employee Identifier (EI) # 1, Clinic Manager (CM), who confirmed staff did not follow facility policy for medication preparation, administration, and storage. 2. A random observation was conducted on 3/5/24 at 10:00 AM at the nurse’s station. EI # 8, RN, was preparing Heparin for the next shift of patients. EI # 8 entered the multi-dose Heparin vial with a new needle eight times without cleaning the diaphragm with a new alcohol pad. The RN then placed the pre-drawn heparin syringes in an unlocked drawer at the nurse’s station. The surveyor also observed medication cups with patient labels on them, with no time, date, or initials of preparer, sitting on the counter at the nurse’s station with medication in them for the next shift of patients. The medications were unsecured. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1 who confirmed staff did not follow facility policy for medication preparation, administration, and storage.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 30952 Based on interviews, review of facility policy, and the facility GranuFlo (an acid concentrate) Mixing Log documentation, it was determined the facility failed to ensure staff who prepared GranuFlo and confirmed the operator’s test results/actions completed the required Dry Acid Dissolution Unit (DADU) batch production record documentation. The deficient practice had the potential to jeopardize the health and safety of the 49 incenter hemodialysis patients who dialyze at this facility. Findings include: Facility Policy Acid Concentrate Mixing and Handling: DADU Published: 09/05/2023 Reference Number: 25910 Version: 7 ...Introduction The DADU...a device used to prepare acid concentrate solution (GranuFlo...) from a dry powder and RO (reverse osmosis) water... Trained Staff Prior to being allowed to operate the DADU, the staff MUST complete training necessary to perform their assigned operational responsibilities. This may include...DADU batch production record...or approved...electronic records system... Batch Records Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation. All data derived by mixing a batch of GranuFlo...concentrate will be recorded on the GranuFlo...Batch Mixing Log... The batch record will contain the following: Case catalog # (number) Each box # Potassium Value... Operator, date, and time ...Solution temperature... Low and high specific gravity (the ratio of the density of a liquid to the density of water) Pass/fail checked Operator’s signature Verifier’s signature Time of transfer to holding tank... 1. A tour of the water treatment room was conducted on 3/4/24 at 9:49 AM with Employee Identifier (EI) # 1, Clinic Manager. During the tour, EI # 1 reported EI # 6, Certified Clinical Hemodialysis Technician (CCHT), and EI # 7, CCHT mixed/prepared acid on the average twice weekly. Review of the facility January 2024 GranuFlo Mixing Log documentation revealed no GranuFlo was mixed from 1/1/24 to 1/23/24, which was 22 days. Further review of the January 2024 GranuFlo mixing Log documentation revealed batches of GranuFlo were prepared on 1/23/24 and 1/30/24. There was no documentation staff mixed GranuFlo twice weekly during January as reported by EI # 1. Review of the facility February 2024 GranuFlo Mixing Log documentation revealed GranuFlo was mixed on 2/1/24, 2/9/24, and on 2/27/24. There was no documentation staff mixed GranuFlo from 2/9/24 to 2/27/24, which was 18 days and no documentation GranuFlo was mixed twice weekly as reported by EI # 1. An interview was conducted on 3/4/24 at 4:55 PM with EI # 1 who confirmed staff failed to document all GranuFlo preparation, mixing, testing for January 2024, and February 2024.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. 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 the valve panel/wall boxes at dialysis incenter station ten, station eleven, and station twelve were labeled with the acid concentration. This had the potential to negatively affect the 49 incenter patients who dialyze at this facility. Findings include: Facility Policy: Concentrate Labeling Requirements Published: 09/05/2023 Reference Number: 46300 Version: 6 ...defines...labeling requirements for...acid concentrate formulas in the hemodialysis machine. ...Labeling strategies must allow for the positive identification of...concentrates entered into the Hemodialysis Machines Definitions and Acronyms ...Valve Panel- A panel or wall box where...acid concentrate and RO (reverse osmosis- purified water] are centrally delivered for use by hemodialysis machines. ...Valve panels or wall boxes must labeled be to identify the fluid that is delivered. These include the following: Water, Bicarbonate, Acid, GranuFlo and Citrasate... 1. Observations of care were conducted on the incenter treatment floor on 3/4/24 at 9:59 AM. The surveyor observed patients dialyzing at station ten, and station twelve. The wall boxes at station ten, station eleven, and station twelve were not labeled. There was no label identifying the acid concentrate delivered to the hemodialysis stations. An interview was conducted on 3/5/24 at 3:45 PM with Employee Identifier (EI) # 3, Area Technical Manager, who verified all wall boxes must be labeled with the acid concentrate delivered during dialysis treatment. Additional treatment floor observations were conducted on 3/6/24 at 4:10 PM and revealed the wall boxes at station ten, station eleven, and station twelve had no label identifying the fluids delivered. An interview was conducted on 3/6/24 at 4:20 PM with EI # 1, Clinic Manager, and EI # 2, Director of Operations, who confirmed the wall boxes at the three stations were not labeled for identification with the acid concentration delivery.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 30952 Based on observations, review of facility policy, and interviews, it was determined the facility failed to ensure the valve panel/wall boxes at dialysis station ten, station eleven, and station twelve were labeled to identify the bicarbonate fluid delivery. This had the potential to negatively affect the 49 incenter patients who dialyze at this facility. Findings include: Facility Policy: Concentrate Labeling Requirements Published: 09/05/2023 Reference Number: 46300 Version: 6 ...policy for labeling requirements...in the hemodialysis machine. ...Labeling strategies must allow for the positive identification of the...Concentrates entered into the Hemodialysis Machines Definitions and Acronyms ...Valve Panel- A panel or wall box where...bicarbonate concentrate...and RO (reverse osmosis-purified water] are centrally delivered for use by hemodialysis machines. ...Policy: Valve panels or wall boxes must be labeled to identify the fluid that is delivered. These include...Bicarbonate... Observations of care were conducted on the incenter treatment floor on 3/4/24 at 9:59 AM and the surveyor observed patients dialyzing at station ten and station twelve. Further treatment floor observations revealed the wall boxes at station ten, station eleven, and station twelve were not labeled identifying the fluid concentrates including bicarbonate delivered to the hemodialysis stations. An interview was conducted on 3/5/24 at 3:45 PM with Employee Identifier (EI) # 3, Area Technical Manager, who confirmed all wall boxes must be labeled with the fluids delivered during dialysis treatment. Observations on the treatment floor conducted on 3/6/24 at 4:10 PM revealed the wall boxes at station ten, station eleven, and station twelve had no label identifying bicarbonate concentrate delivery. An interview was conducted on 3/6/24 at 4:20 PM with EI # 1, Clinic Manager, and EI # 2, Director of Operations, who confirmed wall boxes at the three stations were not labeled for identification of the water, bicarbonate, and acid delivered.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 30952 Based on observations, facility policy, and interviews, the facility failed to ensure staff followed the facility procedure for potential of Hydrogen (pH) testing of the final dialysate. This affected one of two observations of dialysis machine preparation, and a random observation, including Patient Identifier (PI) # 12, and had the potential to negatively affect all patients who dialyze at the facility. Findings include: Facility Policy: Checking Conductivity and pH of Final Dialysate Reference Number: 25912 Published: 4/11/22 Version: 9 ...purpose...provide guidelines to verify final dialysate...pH prior to initiating hemodialysis treatments and during treatments... Policy ...Dialysate pH must be tested when changing acid concentrate formulations...during treatment. If any of the following...occurs...Treatments may not be initiated, or current treatment must be stopped...The dialysate pH is not within or equal to 6.9 to 7.6. Test verification Prior to Treatment Incenter setting: 2 (two) staff members will verify the...pH parameters prior to treatment... Changing Acid Concentrate During Treatment Steps ...Test and document in the treatment notes comments section the dialysate pH if the new acid concentrate is a different formulation... 1. An observation of care was conducted on 3/4/24 at 11:24 AM with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician (CCHT), to test the final dialysate pH with a pHoenix meter. EI # 6 approached the test station with a dialysate sample in a cup, tested the dialysate sample using the pHoenix meter, read the pH as 7.0, and exited the test station. EI # 6 failed to have the pH result verified by another staff member. An interview was conducted on 3/7/24 at 10:30 AM with EI #1, Clinic Manager, who confirmed the pH results should be verified by two staff prior to treatment. 2. At 11:41 AM on 3/4/24 the surveyor observed treatment initiation for PI # 12 at station 2 with the acid line connected to the central delivery system, a 2K (potassium)/2.5CA (calcium) bath. A random observation was conducted at 11:57 AM on 3/4/24 at station 2, with PI # 12, when the machine began to alarm “Low Conductivity”. There was a jug bath labeled 2K 3Ca (prescribed to patient) attached to the machine line, not connected at the beginning of treatment. The surveyor asked EI # 5, (Patient Care Technician), when the jug bath was connected to the machine at station 2. EI # 5 replied, “About three to five minutes ago.” The surveyor then asked if the dialysate pH was checked after the jug bath was connected, and PI # 5 replied, “No.” An interview was conducted on 3/7/24 at 10:30 AM with EI # 1 who confirmed the pH should be verified with a pHoenix meter or pH test strip when changing the dialysate after the start of treatment. 49894”

“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 facility policies, staff training/competency documentation, the facility GranuFlo (acid concentrate used for bicarbonate-based dialysis) Mixing Log documentation, and staff interviews, it was determined the facility failed to ensure an annual competency validation was completed for staff: 1. Who mixed the GranuFlo acid, which had the potential to negatively affect the 49 incenter dialysis patients. 2. Who completed chlorine testing, collected source water, and dialysate samples for the three home hemodialysis patients at the facility. This affected one of two incenter training records for staff preparing GranuFlo and one of one home program nursing staff who provide home support to home hemodialysis patients. This had the potential to negatively affect all hemodialysis patients served. Findings included: Facility Policy: Knowledge, Skills and Competency Evaluation for Clinical Staff Published: 10/12/21 Version: 3 Purpose ...provides all clinical...employees with initial and ongoing development and evaluation of the knowledge and skills... ...clinical topics covered during training... ...Current and New Clinical Policies and Procedures Initial, Annual and One-time Role Specific Training Initial, Annual and One-time Role Specific Training Knowledge Evaluation Initial, Annual and One-time Role Specific Skills Evaluation Facility Policy: NxStage PureFlow SL (a preconfigured Food and Drug Administration-cleared hemodialysis system): Testing for Water Quality-Chemical Published: 9/5/23 Reference Number: 47326 Version: 4 Purpose To provide guidelines for testing, evaluating, and monitoring the quality of water using PureFlow SL with the NxStage System One. Responsibility FKC (Fresenius Kidney Care) Staff... Facility Policy: NxStage PureFlow SL: Testing for Microbiological Quality Published: 5/2/22 Reference Number: none documented. Version: 3 Purpose To provide guidelines for testing, evaluating, and monitoring the microbiological quality for PureFlow SL with the NxStage System One. Responsibility FKC Staff... Policy...The person collecting samples will be trained in accordance with FKC approved training materials. Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit (DADU) Published: 09/05/23 Reference Number: 25910 Version: 7 Purpose This document defines DADU...and details...policy regarding the operation and disinfection requirements of the DADU. ...Responsibility ...CM (clinical manager) ...Ensure facility staff is trained in use of the DADU mixer. ...Medical Director...The day-to-day responsibility for maintaining water quality lies with the health care professionals...under the leadership of the facility’s Medical Director. Acronyms and Definitions ...Operator...A staff member that meets the qualifications...is the primary staff member making the current batch of acid concentrate. Specific Gravity...The ratio of the density of a liquid to the density of water. Verifier...A staff member that meets the qualifications...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 may include one or more of the following areas: Preparing of GranuFlo...concentrate batches. Performing specific gravity tests. Disinfection procedures. Completing batch records... Acid Concentrate Mixing and handling: DADU Policy.... Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation thereafter. ...Each batch record must be reviewed and verified as complete by two qualified staff members at the end of batch preparation... 1. Review of the Water Skills Validation for Inpatient and Home Therapies dated 9/21/23 for Employee Identifier (EI) # 10, Staff Home Therapy RN (Registered Nurse), revealed no documentation NxStage Total Chlorine Testing, NxStage Source & (and) Product Water Testing, and NxStage Microbiological Testing skill demonstrations were completed. An interview was conducted on 3/6/24 at 1:29 PM with EI # 4, Home Program Manager, who confirmed there was no documentation EI # 10 had annual competency validations for NxStage Total Chlorine testing, and water quality for chemical and microbiological testing. 2. Review of the facility GranuFlo Mixing Log dated 1/23/24, 2/1/24, 2/9/24, and 2/27/24 revealed documentation EI # 6, Certified Clinical Hemodialysis Technician (CCHT), mixed the GranuFlo. Review of EI # 6’s Annual Skills Validation documentation revealed competencies for the DADU and the Hydrometer (equipment required to mix GranuFlo) were completed on 9/20/22. There was no Annual Skills Validation for the DADU and the Hydrometer for 2023 or to date for 2024. An interview was conducted on 3/5/24 at 4:55 PM with EI # 1, Clinic Manager, who confirmed there were no 2023 or to date 2024 skills competency validation documentation for EI # 6 to mix GranuFlo.”

“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 record reviews and interviews, the social worker (SW) failed to address the psychosocial needs for two of seven records reviewed for patients requiring psychosocial intervention. This affected Patient Identifier (PI) # 1, PI # 3, and had the potential to negatively affect all patients with identified psychosocial needs. 1. PI # 1 was admitted to the home hemodialysis training program on 5/31/22 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Clinical Notes report dated 1/16/24 revealed PI # 1 was “seen in the clinic by the Interdisciplinary Team (IDT), lab...medications reviewed, continues to miss treatments, and has been encouraged to complete the prescribed number of treatments weekly. Patient has been referred to the SW to address barriers and provide support to improve compliance.” There was no documentation the SW provided support and investigated barriers to treatment compliance. An interview was conducted on 3/6/24 at 8:30 AM with Employee Identifier (EI) # 4, Home Program Manager, confirmed there was no documentation the SW followed the IDT recommendations and addressed treatment compliance barriers. 49894 2. PI # 3 was admitted to the facility on 8/29/19 with a diagnosis of ESRD. Review of the Plan of Care dated 11/20/23 revealed the SW documented “Patient listed as “unstable” due to concerns, “Patient expresses depression and was referred to EAMH (East Alabama Mental Health).” There was no documentation the SW completed a follow up to evaluate the results of the mental health referral and PI # 3’s psychosocial needs. An interview was conducted on 3/6/24 at 3:30 PM with EI # 1, Clinic Manager, who confirmed the SW failed to document follow up for the mental health intervention.”

“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: 30952 Based on review of medical records (MR), facility policy, and interview, it was determined the facility failed to ensure the comprehensive assessments included an evaluation of psychosocial needs completed by a Social Worker (SW). This affected one of one unstable record reviews, including Patient Identifier (PI) # 5, and had the potential to 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 ...The CIA and POC must be developed be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, ... qualified master’s degree level SW ... CIA/POC for Unstable Patients Unstable patients must be reassessed by the 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 # 5 was admitted on 8/1/17 with the diagnosis of End Stage Renal Disease. Review of the POC meeting documentation dated 12/18/23 and 1/15/24 revealed PI # 5 was determined to be unstable for extended/frequent hospitalizations. MR review revealed no Comprehensive Assessment documentation by the SW for the 12/18/23 and 1/15/24 Unstable POC’s. An interview was conducted on 3/6/24 at 2:59 PM with Employee Identifier # 1, Clinic Manager, who confirmed the SW failed to complete Comprehensive Assessments for the unstable POC’s.”

“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: 49894 Based on review of facility policies, medical records, and interviews, it was determined the facility failed to ensure: 1. The Registered Nurse (RN) performed pre-treatment patient assessments per policy. 2. The RN performed post-treatment patient assessments per policy. This affected four of five incenter patients record reviews, including PI # 3, PI # 4, PI # 7, PI # 6 and had the potential to negatively affect all incenter patients dialyzing at the facility. Findings include: Facility Policy: Patient Assessment and Monitoring Published: 5/1/23 Reference Number: 45284 Version: 4 Data Collection... The RN will assess/re-assess any findings addressed pre or during treatment as needed. Post-Treatment: ... The RN will assess/re-assess any findings addressed pre-treatment prior to discharge. During nursing rounds, the RN will review the data collected by direct patient care staff and assess the following parameters as needed: Assess patient for symptoms: The nurse should ask the patient if they had shortness of breath, chest pain or cough, cramping, loss of appetite or vomiting or diarrhea. Lung Sounds: Auscultate the lungs sounds for ... Edema: Assess the patient for edema Heart: Listen for: rate and rhythm Post-Treatment Assessment and Data Collection: Follow the steps for post-treatment data collection: ...Lung Sounds, Edema, Heart Sounds: The RN will assess/re-assess post treatment as indicated. Facility Policy: Nursing Supervision and Delegation Reference: 45265 Version: 6 Published: 11/6/23 Policy: The RN must evaluate each patient preferably within one hour or according to state requirements to: Confirm identity, review the patient’s condition, review the accuracy and completeness of treatment and patient data, review patient treatment prescription..., confirm the correct vascular access is being used, and the access is visible, observe patient’s response to treatment, verify machine safety checks have been completed, talk to the patient to elicit information such as changes in condition, ... Daily Treatment: Prior to discharge the RN must review the treatment record to: Confirm patient is stable for discharge, identify any process that... The record must be reviewed for: Slow/fast/irregular heart rate, low/high blood pressures, whether patient is achieving dry weight..., heart rate less than 60 or greater than 100 with documentation present..., blood pressures less than 100 systolic or greater than 180 diastolic with documentation present..., report fall, and if heparin..., correct dialysate prescription was delivered. 1. PI # 3 was admitted to the facility on 8/29/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Treatment Sheet (TS) dated 1/30/24 revealed the RN documented bilateral lower leg edema on the pre-treatment assessment but failed to assess edema on the post-treatment assessment. Review of the TS dated 2/24/24 revealed the treatment started at 1:19 PM and the pre-treatment assessment was documented at 4:30 PM which was three hours and eleven minutes after treatment start. The RN failed to complete and document the pre-treatment assessment within one hour of treatment start. An interview was conducted on 3/6/24 at 3:30 PM with Employee Identifier (EI) # 1, Clinic Manager, who confirmed staff failed to complete and document pre-treatment and post-treatment assessments per facility policy. 2. PI # 4 was admitted to the facility on 8/18/23 with the diagnosis of ESRD. Review of the TS dated 2/19/24 revealed the treatment was started at 12:30 PM, and the RN documented the pre-treatment nurse assessment at 3:14 PM. This was two hours and forty-four minutes after treatment start, and not within one hour of treatment start time per policy. Review of the TS dated 2/21/24 revealed the treatment started at 12:14 PM, and the RN documented the pre-treatment nurse assessment at 1:24 PM, which was one hour and ten minutes after treatment start, and not within one hour of treatment start time per policy. An interview was conducted on 3/6/24 at 3:18 PM with EI #1, who confirmed staff failed to complete and document pre-treatment nursing assessments according to facility policy. 3. PI # 7 was admitted to the facility on 4/7/22 with the diagnosis of ESRD. Review of the TS dated 1/4/24 revealed a treatment start time of 5:53 AM. The pre-treatment nurse assessment was documented at 7:36 AM which is one hour and forty-three minutes after treatment start, and not within one hour of treatment start time per policy. Review of the TS dated 2/29/24 revealed no documentation of a post-treatment nurse assessment. An interview was conducted on 3/6/24 at 2:50 PM with EI #1, who confirmed staff failed to complete and document pre-treatment and post-treatment nursing assessments according to facility policy. 30952 4. PI # 6 was admitted to the facility on 2/2/24 with a diagnosis including ESRD. Review of the TS dated 2/28/24 revealed the treatment start time at 12:30 PM and ended at 2:58 PM. Further review of the 2/28/24 TS revealed at 4:44 PM the nurse documented the pretreatment assessment, which was four hours fourteen minutes after treatment start time. The RN failed to evaluate the patient within one hour of treatment per policy. Review of the TS dated 3/1/24 revealed the treatment start time was 12:30 PM and end time was 3:03 PM. Further review of the 3/1/24 TS revealed at 2:14 PM the nurse documented the pretreatment assessment, which was one hour twenty-four minutes after the treatment start. The RN failed to evaluate the patient within one hour of treatment per policy. An interview was conducted on 3/6/24/at 3:02 PM with EI # 1 who confirmed staff failed to perform and document the pretreatment nurse assessment per the 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: 49894 Based on review of medical records (MR), facility policies and procedures, and interviews with staff, it was determined the facility failed to ensure: 1. Treatments were administered per the physician’s order for Blood Flow Rate (BFR). 2. Reinfusion of the blood in the extracorporeal system at completion of the dialysis treatment was not greater than 150-200 milliliters/minute (ml/min) per policy. 3. Treatments were administered per the physician’s order for Dialysate Flow Rate (DFR). 4. Staff allowed 3-5 minutes following heparin administration before treatment initiation per policy. 5. Heparin administration to Central Venous Catheter Limbs at the end of dialysis treatment (heplock flush) was not documented prior to treatment end. 6. Against Medical Advice (AMA) forms were completed and signed by the patient(s) for each early treatment termination event. This includes Patient Identifier (PI) # 10, in one of five flash tour prescription verifications, PI # 11, in one of two observations of discontinuation of treatment with an Arteriovenous Fistula or Graft (AVF/AVG), and five of five incenter MR reviews, including PI # 3, PI # 4, PI # 7, PI # 6, PI # 5, and had the potential to affect all patients dialyzing 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 Procedure: Pre-Treatment Safety Checks Procedure Reference Number: 47798 Published: 2/6/23 Version: 3 Predialysis Safety Checks Verify the following by two direct patient care staff members prior to treatment initiation: ... ...prescribed dialysate composition Facility Policy: Termination of Treatment using an Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer Reference Number: 45641 Version: 5 Published: 2/7/22 Purpose: The purpose...is to provide direction to reinfuse blood in the extracorporeal system to the patient at completion of the hemodialysis treatment... Responsibility: Fresenius Kidney Care direct patient care staff Termination: Returning the Blood from Venous Segment Follow the steps to return blood...back to the patient: ...2. Start the blood pump and increase speed to 150-200 ml/min Facility Policy: Heparinization Reference Number: none documented. Version: 4 Published: 8/3/20 Requirement for a Normal Saline Flush with Heparin Administration: Following infusion, prior to treatment initiation, wait 3-5 minutes to allow systemic anticoagulation to occur. Dose and method of Administration: Bolus at initiation: A bolus loading dose is administered 3-5 minutes pre-treatment. 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. Facility Policy: Early Termination or Arriving Late for Treatment Published: 11/7/22 Reference Number: 45263 Version: 3 Purpose: The purpose of this policy is to provide guidelines for staff when patients...request early termination of treatment... Background: Treatment duration...is prescribed by a patient’s physician... Serious health related consequences may result from...terminating treatments earlier than prescribed. Early Termination: If a patient insists on terminating treatment early...the patient must take full responsibility for consequences of the...shortened treatment. If a patient requests to leave treatment early: ...The RN (Registered Nurse) who evaluates the patient must document the rationale for early termination and reinforce the consequences of not receiving the entire prescribed treatment. The RN is responsible to...document on the...AMA form... AMA forms are: Signed by the patient and witnessed by the supervising nurse... Signed with each early termination event and filed in the patient’s medical record... 1. An observation of care to verify PI # 10’s dialysate prescription was conducted on 3/4/24 at station 12 at 9:59 AM with Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician. The BFR was 300 and not 400 as ordered. Review of the Treatment Sheet (TS) dated 3/4/24 revealed the BFR was 300 from 7:32 AM to 9:32 AM. There was no reason documented why the BFR was not 400 as ordered. An interview was conducted on 3/4/24 at 10:00 AM with EI # 6 who confirmed the BFR orders were 400 and not 300 per current delivery. 2. An observation was conducted on 3/4/24 at 10:53 AM at station 4 with PI # 11 during discontinuation of dialysis with an AVF/AVG. EI # 5, Patient Care Technician (PCT), was reinfusing the extracorporeal circuit at a BFR of 250 ml/min and not 150-200 ml/min per policy. An interview conducted on 3/6/24 at 3:18 PM with EI # 1, Clinic Manager, who confirmed the staff failed to follow the policy and return the blood to the patient with BFR of 150-200 ml/min. 3. PI # 3 was admitted to the facility on 8/29/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Current Orders Summary Report revealed orders dated 1/13/24 which included dialysis treatment time three hours and thirty minutes, and BFR 450. Review of the TS dated 1/27/24 revealed the BFR was 400 from 12:25 PM to 3:49 PM. There was no documentation why the BFR was not 450 as prescribed. Review of the TS dated 2/22/24 revealed the BFR was 425 from 1:36 PM to 4:35 PM. There was no documentation why the BFR was not 450 as prescribed. Further review of the 2/22/24 TS revealed the heparin was documented as administered at 12:33 PM and the treatment start time was 12:44 PM. The heparin administration was not three to five minutes prior to treatment start to allow systemic anticoagulation to occur per facility policy. Review of the TS dated 2/24/24 revealed the BFR was 400 from 1:20 PM to 4:30 PM. There was no documentation why the BFR was not 450 as prescribed. Review 0f the TS dated 2/27/24 revealed the BFR was 400 from 1:53 PM to 3:22 PM. There was no documentation why the BFR was not 450 as prescribed. Further review of the TS dated 2/27/24 revealed the treatment time was 1:16 PM to 4:27 PM, which is three hours and eleven minutes and not three hours and thirty minutes as ordered. There was no documentation an AMA early termination form was obtained with the patient’s signature. An interview was conducted on 3/6/24 at 3:30 PM with EI # 1 who confirmed the staff failed to follow the physician’s order for BFR, failed to administer heparin bolus within three to five minutes prior to treatment start to allow systemic anticoagulation to occur, and failed to obtain an early termination form for treatment time less than prescribed per facility policy. 4. PI # 4 was admitted to the facility on 8/18/23 with a diagnosis of ESRD. Review of the Current Orders Summary revealed orders dated 12/1/23 that included the dialysis treatment time, three hours and fifteen minutes, the BFR was 400, and the DFR was 700. Review of the TS dated 2/19/24 revealed the treatment start time was 12:30 PM and the end time was 3:58 PM. The Heparin bolus dose was documented administered at 3:10 PM which was three hours and forty minutes after the treatment started and not three to five minutes before the start of treatment to allow systemic anticoagulation to occur per the facility policy. Further review of the TS dated 2/19/24 revealed the post-treatment heplock was administered at 3:11 PM which was forty-seven minutes before the treatment ended and not after the treatment ended per policy. Review of the TS dated 2/21/24 revealed the treatment start time was 12:14 PM and treatment end time was 2:25 PM, which is 2 hours and 11 minutes and not three hours and fifteen minutes as ordered. There was no documentation an AMA early termination form was signed by the patient. Review of the TS dated 2/23/24 revealed the BFR was 350 from 2:41 PM to 3:12 PM. There was no documentation why the BFR was not 400 as ordered. Review of the TS dated 2/27/24 revealed the DFR was 500 from 6:35 AM to 7:34 AM and from 7:39 AM to 9:45 AM. There was no documentation why the DFR was not 700 as ordered. Further review of the 2/27/24 TS revealed the patient’s blood was rinsed back at a BFR of 250 and not 150-200 per facility policy. Review of the TS dated 3/1/24 revealed the BFR was 350 from 2:30 PM to 2:57 PM. There was no documentation why the BFR was not 400 as ordered. Further review of the 3/1/24 TS revealed the patient’s treatment was from 12:05 PM to 2:57 PM, which is two hours and fifty-two minutesband not three hours and fifteen minutes as ordered. There was no documentation an AMA early termination form with the patient’s signature was obtained. An interview was conducted on 3/6/24 at 3:18 PM with EI # 1 who confirmed the staff failed to follow the physician’s order for BFR/DFR, failed to administer heparin bolus within three to five minutes prior to treatment start, failed to document post-treatment heplock after the completion of treatment, and failed to obtain an AMA early termination form for treatment time less than prescribed per facility policy. 5. PI # 7 was admitted to the facility on 4/7/22 with a diagnosis of ESRD. Review of the TS dated 1/4/24 revealed the dialysis treatment orders included the dialysis treatment time of three hours and thirty minutes, the BFR 400, and DFR 500. Further review of the TS dated 1/4/24 revealed the treatment started at 5:53 AM and the heparin bolus was documented as administered at 5:53 AM, which was not three to five minutes before the start of treatment. Review of the TS dated 1/6/24 revealed dialysis treatment orders including dialysis treatment time of three hours and thirty minutes, the BFR 400, and DFR 500. Further review of the TS dated 1/6/24 revealed the BFR was 300 from 5:51 AM to 7:02 AM and 300 from 8:02 to 9:08 AM. The DFR was 800 from 5:51 AM to 6:33 AM. There was no documentation why the BFR was not 400 and the DFR was not 500 as ordered. Review of the TS dated 2/29/24 revealed dialysis treatment orders including the dialysis treatment time of three hours and thirty minutes, the BFR 400, and DFR 500. The BFR was 300 from 8:35 AM to 9:13 AM. There was no documentation why the BFR was not 400 as ordered. Further review of the 2/29/24 TS revealed the patient’s treatment was from 7:33 AM to 9:13 AM, which is one hour and forty minutes and not three hours and thirty minutes as ordered. There was no documentation an AMA early termination form was completed. An interview conducted on 3/6/24 at 2:50 PM with EI # 1 confirmed the staff failed to follow the physician’s order for BFR and DFR and failed to obtain an AMA for treatment time less than prescribed per facility policy. 6. PI # 6 was admitted to the facility on 2/2/24 with a diagnosis including ESRD. Review of the Clinical Record View Report (CRVR) revealed an order dated 2/21/24 for HD (hemodialysis) with a sequential treatment, and the BFR was 400. Review of the TS dated 2/21/24 revealed the treatment start time was 12:03 PM, and at 12:05 PM the BFR was 350 until 1:32 PM. There was no documentation why the BFR was 350 and not 400 as ordered. Further review of the CRVR revealed orders dated 2/26/24 for incenter HD three times a week, and the BFR was 400. Review of the TS dated 2/28/24 revealed the BFR was 350 from 1:03 PM until treatment end at 2:58 PM. There was no documentation why the BFR was not 400 as ordered. Review of the TS dated 3/1/24 revealed the BFR was 350 from 1:09 PM until treatment end at 3:03 PM. There was no documentation why the BFR was not 400 as ordered. An interview was conducted on 3/6/24/at 3:02 PM with EI # 1 who confirmed staff failed to follow physician’s orders for BFR. 7. PI # 5 was admitted to the facility on 8/1/17 with a diagnosis of ESRD. Review of the HD dialysis prescription dated 2/12/24 revealed orders for three dialysis treatments weekly, the treatment time was 4 hours, and the BFR was 450. Review of the TS dated 2/23/24 revealed the treatment start time was 8:03 AM, and end time was 11:39 AM, total dialysis treatment time was three hours thirty-six minutes. There was no AMA early termination documentation signed by the patient for the treatment ending twenty-four minutes early. Review of the TS dated 2/26/24 revealed the BFR was 400 at 10:30 AM until treatment end at 11:11 AM. There was no documentation why the BFR was not 450 as ordered. An interview was conducted on 3/6/24 at 10:34 AM with EI # 1 who confirmed staff failed to complete an early termination for treatment form and follow orders for the BFR. 30952”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 49894 Based on medical record (MR) review and staff interview, it was determined the facility failed to ensure staff administered intravenous (IV) Mircera (IV medication used for treatment of anemia in patients with chronic kidney disease) per physician’s order. This affected Patient Identifier (PI) # 3 and PI # 7, two of five incenter medical records reviewed, and had the potential to affect all patients dialyzed at the facility. 1. PI # 3 was admitted to the facility on 8/29/19 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Orders Summary Report revealed an order dated 2/10/24 for Mircera 75 micrograms (mcg) to be administered via IV during dialysis every four weeks. Review of the Treatment Sheet (TS) dated 2/22/24 revealed the last dose of Mircera was given on 1/20/24 and the lab for hemoglobin was drawn during the treatment on 2/22/24. There was no documentation Mircera was given. Review of the TS dated 2/27/24 revealed no documentation Mircera was given during this treatment. Review of the TS dated 3/2/24 revealed no Mircera was given during this treatment. An interview conducted on 3/6/24 at 3:30 PM with EI (Employee Identifier) # 1, Clinic Manager, confirmed there was no documentation Mircera was given. 2. PI # 7 was admitted to the facility on 4/7/22 with a diagnosis of ESRD. Review of the Orders Summary Sheet revealed an order dated 12/23/23 for Mircera 200 mcg to be administered during dialysis every 2 weeks. Review of the TS dated 2/29/24 revealed the last Mircera dose administered was on 1/6/24 and there was no documentation Mircera was given. Review of the TS dated 3/4/24 revealed no documentation Mircera given during this treatment. An interview conducted on 3/6/24 at 2:50 PM with EI #1 confirmed staff failed to give Mircera as ordered.”

“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: 49894 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 for cannulation per facility policy in two of three observations of access of AVF/AVG for initiation of dialysis including Patient Identifier (PI) # 12 and PI # 9. 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: 1. Prior to treatment, ask patient to wash access area with soap per hand hygiene procedure. Wash access if patient’s unable to clean their 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 3/4/24 at 11:25 AM at station 2 with Employee Identifier (EI) # 5, Patient Care Technician (PCT), performing initiation of dialysis with AVF/AVG for PI # 12. EI # 5 cleaned the arterial site for 15 seconds using 70% isopropyl alcohol pad. After allowing to dry for 15 seconds, EI # 5 touched the skin on the arterial site before cannulating without re-cleaning with alcohol per policy. Using a new alcohol pad, EI # 5, then cleaned the venous site for 20 seconds and allowed to dry for five seconds. Before cannulating the venous site, EI # 5 touched the skin on venous cannulation site without re-cleaning with alcohol per policy. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1, Clinic Manager (CM), who confirmed that staff failed to clean the cannulation sites for 30 seconds and let dry and re-clean the sites after touching per the facility policy for skin disinfection of the cannulation sites. 2. An observation was conducted on 3/4/24 at 11:50 AM at station 5 with EI # 6, Certified Clinical Hemodialysis Tech, performing initiation of dialysis with an AVF/AVG for PI # 9. EI # 6 cleaned the arterial site for 10 seconds using 70% isopropyl alcohol. After allowing the site to dry for five seconds, EI # 6 touched the arterial site before cannulating. Using a new alcohol pad, EI # 6 cleaned the venous site for 10 seconds and allowed to dry for five seconds. Before cannulating the venous site, EI # 6 failed to re-clean the site prior to cannulation. An interview was conducted on 3/7/24 at 10:30 AM with EI # 1, who confirmed that staff failed to clean the cannulation sites for 30 seconds and let dry and re-clean the sites after touching per the facility policy for skin disinfection of the cannulation sites.”

“H-PRECONFIG HD SYS-TEST H20/DIALY PER DFU/FDA CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: testing of the water and dialysate system in accordance with- (A) The recommendations specified in the manufacturers’ instructions; and (B) The system’s FDA-approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate. This Standard is not met as evidenced by: 30952 Based on review of the facility policy, medical record (MR) review, the source (tap) water environmental test report results, and interview, it was determined the facility failed to ensure the home program staff collected and tested the source/tap water annually. This affected Patient Identifier (PI) # 1, one of one home hemodialysis record reviews, and had the potential to negatively affect the three home hemodialysis training patients. Findings include: Facility Policy: NxStage PureFlow SL (a preconfigured Food and Drug Administration-cleared hemodialysis system): Testing for Water Quality-Chemical Published: 9/5/23 Reference Number: 47326 Version: 4 Purpose To provide guidelines for testing, evaluating, and monitoring the quality of water using PureFlow SL with the NxStage System One. Responsibility-FKC (Fresenius Kidney Care) Staff... Utilize this schedule...source water test results... Sample: Source Water Test Performed: NxStage Source Water Chemical Analysis... Frequency: Initially: prior to starting treatment on the water source that will feed the PureFlow... Annually...Municipal/City Water Sources... Documentation ...Medical Director must review and sign each chemical analysis report obtained... 1. PI # 1 was admitted to the home hemodialysis training program on 5/31/22 with a diagnosis of End Stage Renal Disease. MR review revealed source (tap) water environmental test report results dated 6/14/22. The source water results failed to include the signature of the Medical Director. There was no documentation the source (tap) water environmental test results were collected/tested during 2023. An interview was conducted on 3/6/24 at 8:30 AM with Employee Identifier # 4, Home Program Manager, who confirmed the 6/14/22 water results were not signed by the Medical Director and the staff failed to perform annual source (tap) water testing.”

“H-MEET RD52:2004 CFR(s): 494.100(c)(1)(v) The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly, or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits. This Standard is not met as evidenced by: 30952 Based on review of the medical record (MR), the facility water results, and interview, it was determined the facility failed to ensure the home program staff collected quarterly microbiological water samples from the NxStage Pureflow SL (a preconfigured Food and Drug Administration-cleared hemodialysis system) home hemodialysis dialysate. This affected Patient Identifier (PI) # 1, one of one home hemodialysis record reviews, and had the potential to negatively affect the three home hemodialysis training/support patients. Findings include: 1. PI # 1 was admitted to the home hemodialysis training program on 5/31/22 with a diagnosis of End Stage Renal Disease. Review of the MR revealed the NxStage SAK (prefilled dialysate concentrate) dialysate colony count and endotoxin level samples were collected on 6/28/22, and results were reported on 7/1/22. Further review of the MR revealed no documentation quarterly dialysate colony and endotoxin samples were collected and tested after 7/1/22. An interview was conducted on 3/6/24 at 8:30 AM, with Employee Identifier # 4, Home Program Manager, who confirmed there was no documentation staff performed quarterly dialysate bacteriological culture and endotoxin sample testing.”

“H-RECORDKEEPING SYSTEM CFR(s): 494.100(c)(2) (2) The dialysis facility must maintain a recordkeeping system that ensures continuity of care and patient privacy. This includes items and services furnished by durable medical equipment (DME) suppliers referred to in §414.330(a)(2) of this chapter. This Standard is not met as evidenced by: 30952 Based on facility policy, medical record (MR) review, and interview, it was determined the facility failed to ensure all home program training and records were accurate, and complete. This affected two of two home training record reviews, including Patient Identifier (PI) # 1, PI # 2, and had the potential to affect all home training patients served by the facility. Findings include: Facility Policy: Comprehensive Interdisciplinary Assessment and Plan of Care (POC) Published: 7/3/23 Reference Number: 45283 Version: 6 ...Comprehensive Assessment Participation and POC Review ...The patient must sign the POC...to acknowledge the information in the plan. If the patient chooses not to sign...the reason for refusal must be documented... 1. PI # 1 was admitted to the home hemodialysis training program on 5/31/22 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Home Therapies Checklist documentation, completed at the end of the training program, revealed the staff failed to include the date of the home visit, the begin and the end time. Review of the MR revealed the POC Meeting documentation dated 1/17/24. There was no documentation PI # 1 reviewed and signed the Annual Stable POC approved by the Interdisciplinary team on 1/17/24. An interview was conducted on 3/6/24 at 8:30 AM with Employee Identifier (EI) # 4, Home Program Manager, who confirmed there was no documentation PI # 1 signed the POC or chose not to sign the POC. 2. PI # 2 was admitted to the peritoneal dialysis (PD-a type of dialysis that uses the peritoneum in a person’s abdomen) home training program on 9/14/21 with a diagnosis of ESRD. Review of the MR revealed a document titled, Initial Home Visit Checklist, dated 9/14/21. There was no documentation the physician signed the evaluation of the home visit environment. Review of the Home Therapies Checklist dated 9/28/21 revealed documentation of the patient/caregiver demonstration of the PD cycler procedure. There was no documentation the nurse performed an assessment for available hand hygiene supplies, work surface cleanliness, use and cleaning of the blood pressure cuff, scale, thermometer, status of air/heat/vent/fans, use of the patient portal/modem/cycler, and presence of a care partner and no documentation the physician reviewed the 9/28/21 Home Therapies Checklist documentation. An interview was conducted on 3/5/24 at 1:43 PM with EI # 4 who confirmed the home program documents were not complete and not signed by the physician.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 30952 Based on observation, facility policy, and interview, it was determined the facility failed to ensure staff followed the policy for incident/event reporting and recording. This affected one random care observation, Patient Identifier (PI) # 12, and had the potential to negatively affect the 49 incenter patients who dialyze at the facility. Findings Include: Facility Policy: Patient Safety Event Reporting and Documentation Published: 2/6/23 Reference Number: 61085 Version: 2 Purpose...to provide guidelines for all clinical staff on identifying, reporting, and documenting patient related Near Misses, Safety Events, and Serious Safety Events... Policy: When a Near Miss, Safety Event or Serious Event occurs, staff are required to report, document, and review the event as noted in this policy. Staff are responsible for timely completion of these policy requirements. Procedure: Reporting of any patient event and patient information should occur in person or verbally ... ... Clinical Staff are required to report all Safety Events and Serious Safety Events to the patient’s physician. Documentation... Categories, Event Description & (and) Definitions: Category...Treatment Orders Not Met ... Event Description: Incorrect Dialysate Formula Used... 1. An observation of patient care was conducted on 3/4/24 from 11:25 AM to 11:57 AM at station 2. After the dialysis treatment was initiated, staff changed the dialysate prescription from the central wall delivery to a jug concentrate bath, which was a different dialysate prescription. The surveyor requested documentation on 3/6/24 for all facility safety events (occurrences/near misses) documented since 3/4/24 and none was received. An interview was conducted on 3/7/24 at 9:20 AM with Employee Identifier # 1, Clinic Manager, who confirmed an incorrect dialysate was a reportable occurrence and staff failed to report and record a patient safety event as directed per facility policy.”

“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: 30952 Based on review of the facility GranuFlo (dry acid concentrate) Mixing Log, the facility Quality Assessment and Performance Program (QAPI) documentation, facility policy and interviews, it was determined the facility failed to implement a plan to ensure improvement for GranuFlo Mixing preparation, testing, and log documentation. This had the potential to negatively affect the 49 incenter patients who dialyzed at the facility. Findings include: Facility Policy: QAPI Published: 5/2/22 Reference Number: 25799 Version: 5 Purpose: This policy outlines the purpose, structure, and required activities of the facility QAPI Program. Policy: ...QAPI is a continuous ongoing process that includes monitoring the data, prioritizing areas for improvement, determining potential root causes, developing action plans, and focusing on patient safety and improving outcomes. ...QAPI Meeting Objectives: The QAPI Committee will monitor data/information; prioritize areas for improvement; determine potential root causes; develop, implement...action plans that result in sustainable improvements in patient care. Elements to be reviewed will include: ...Technical Operations, including water and dialysate quality and safety... An effective and successful review of the QAPI meeting and program activities will include: ...Prioritizing identified opportunities for improvement. Performing a Root Cause Analysis on the identified opportunities... Following a Root Cause Analysis, action plans will be determined and prioritized by the QAPI Committee, considering the prevalence and severity of identified problems and by ranking those which have potential to affect patient health and safety as a higher priority... The facility must take immediate and appropriate actions to address any serious threats and ensure patient safety. 1. An interview was conducted on 3/4/24 at 9:49 AM with Employee Identifier (EI) # 1, Clinic Manager, who reported staff mix GranuFlo on average twice weekly. Review of the facility GranuFlo Mixing Log documentation for December 2023 to January 2024 revealed GranuFlo was mixed on 12/27/23, and not again until 1/23/24, which was 27 days later. The January 2024 Granuflo Mixing Log documentation revealed GranuFlo was mixed two times, on 1/23/24, and on 1/30/24, and not twice weekly. Review of the facility GranuFlo Mixing Log documentation for February 2024 revealed GranuFlo was mixed on 2/1/24, 2/9/24, and not again until 2/27/24, which was 18 days later. There was no documentation GranuFlo was mixed twice weekly. Review of the January and February 2024 GranuFlo Mixing Logs revealed staff failed to document all acid concentrate batch preparation, quality assurance/safety testing performed, test results, and reviewer verification on the GranuFlo Mixing Log after acid batch completion per the facility policy. An interview was conducted on 3/5/24 at 3:49 PM with EI # 1, who stated monthly water audits are reviewed with staff, and based on the minimal number of times GranuFlo is mixed/prepared for patient use, staff had failed to document GranuFlo batch preparation, final verification of batch testing, and verification by two qualified staff members at the end of the batch preparation per facility policy. Review of the facility QAPI documentation revealed the Technical Dashboard which included the Clinical Logs. Review of the Clinical Log scoring revealed in November 2023, the clinical log score was 52.9. There was a decline in December 2023 to 35.3, and in January, the Clinical log score was 44.4. Review of the Clinical Log “Notes” documentation revealed in December 2023, “no GranuFlo batches documented between 12th and 20th”, in January 2024, “No GranuFlo batches documented between 1st and 22nd”, and in February 2024, “No batches documented between 10th and 16th”. Review of the February GranuFlo Mixing Log documentation revealed no GranuFlo was mixed between 2/10/24 and 2/27/24, which was 17 days. Further review of the facility QAPI program revealed no documented root cause analysis, or action plan was implemented to address the GranuFlo preparation/mixing for the months of December 2023, January 2024, and February 2024. The facility failed to take actions for the identified issue with the GranuFlo preparation/mixing entries since December 2023. An interview was conducted, during the quality review, on 3/7/24 at 1:00 PM with EI # 1 and EI # 2, Director of Operations, who confirmed the facility had not performed a root cause analysis and had not created an action plan to address the GranuFlo mixing, testing, and documentation.”

“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 medical record (MR), the facility policy, and interview, it was determined the Medical Director failed to ensure the Registered Nurse (RN) followed the facility policy and performed and documented a nurse assessment evaluation prior to the first dialysis treatment in one of one new patient record reviews. This affected Patient Identifier (PI) # 6 and had the potential to affect all incenter patients admitted to this facility. Findings include: Facility Policy: Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) Published: 07/03/23 Reference Number: 45283 Version: 6 Purpose ...to provide guidance on the requirements for the CIA and the patient POC. Prior to Initiation of the Patients Fist Treatment for Patients New to Dialysis: A RN must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs. The RN must document the assessment...in Chairside or multidisciplinary notes... 1. PI # 6 was admitted to the facility on 2/2/24 with a primary diagnosis of End Stage Renal Disease. Review of the 2/2/24 Treatment Sheet documentation revealed the initial dialysis treatment was started at 12:01 PM and the nurse evaluation was documented at 1:05 PM, which was 64 minutes later. An interview was conducted on 3/6/24 at 3:02 PM with Employee Identifier # 1, Clinic Manager, who confirmed staff failed to document the initial RN assessment prior to the initiation of the first dialysis treatment.”