Fmc Cahaba Valley

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 49894 Based on review of facility policies, personnel files, the facility Post Worker Carbon Tank-TCL-1 Log (chlorine testing log), the faility GranuFlo Mixing Log, and staff interview, it was determined the Medical Director failed to ensure: 1. Staff monitoring carbon filter performance were qualified to perform total chlorine testing. 2. Staff mixing, testing, and verifying GranuFlo (acid concentrate solution for dialysate) were deemed comptetent in the GranuFlo Dry Acid Dissolution System (DADU) and Hydrometer (used to test specific gravity of final dialysate) use. Refer to V 713.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49894 Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, facility Absence and Hospitalization log, the facility Adverse Event documentation, facility policies and procedures, the facility total chlorine logs, the facility GranuFlo Mixing Log, personnel files, observations, medical record review, and staff interviews, it was determined the Governing Body failed to ensure: 1. The facility followed State Licensure Rules for End Stage Renal Disease for reporting all unusual occurrences to the State Survey Agency for unscheduled transports to a hospital. 2. Staff followed the facility policy for hand hygiene. 3. Staff wore the proper Personal Protective Equipment on the dialysis treatment floor per the facility policy. 4. Staff properly wore a face mask during Central Venous Catheter (CVC) exit site care. 5. Staff dedicated clean areas for clean, unused equipment and supplies. 6. Staff cleaned and disinfected the dialysis station between patients. 7. Staff administered pre-drawn heparin within four hours of preparation. 8. Staff used sterile syringes and needles to prepare medication. 9. Staff labeled multidose medication vials per facility policy. 10. Staff performed CVC exit site care per facility policy. 11. Staff performing total chlorine testing were deemed competent. 12. Staff mixing, testing, and verifying GranuFlo batches were deemed competent. 13. The building in which dialysis services are furnished was maintained to ensure safety of patients, staff, and the public. 14. Staff reported abnormal Blood Pressures (BP) to the Registered Nurse (RN). 15. The RN reported abnormal BP to the patient’s physician. 16. The RN reported post treatment weights greater than one kilogram above or below the Estimated Dry Weight to the patient’s physician. 17. Staff followed the physician’s order for Ultrafiltration Rate. 18. Staff performed vital signs and safety checks at least every thirty minutes or more as needed but not to exceed forty-five minutes. 19. Staff followed the physician’s order for Blood Flow Rate. 20. Staff followed the physician’s order for Dialysate Flow Rate. 21. The Medical Director ensured staff performing total chlorine testing and mixing, testing, and verifying GranuFlo batches were competent. 22. The Medical Director ensured staff followed policies and procedures for water and dialysate. Refer to V 101, V 110, V 113, V 115, V 116, V 122, V 143, V 147, V 175, V 196, V 260, V 402, V 543, V 544, V 710, V 713, V 750, and V 751.”

“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: 49894 Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers, Chapter 420-5-5, the facility Absence and Hospitalization log, the facility Adverse Events Report, the facility Patient Safety Data Entry Site documentation, and staff interviews, it was determined the facility failed to report all unusual occurrences to the State Survey Agency (SSA) for unscheduled transports to a hospital. This affected two unsampled patients and had the potential to negatively affect all 44 patients served by the facility. Findings include: Rules of Alabama State Board of Health Alabama Department of Public Health (ADPH) Chapter 420-5-5 End Stage Renal Disease Treatment (ESRD) and Transplant Centers Amended December 18, 2007 page 7 420-5-5-.01 General (7) Unusual Occurrences Unusual occurrences (UO) which threaten the welfare, safety and health of patients, personnel or visitors shall be reported by the ESRD facility within 24 hours, either by telephone (and confirmed in writing), or by facsimile to the ADPH... 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 Absence and Hospitalization log dated 6/10/24 to 6/10/25, the facility Adverse Events Report dated 6/10/24 to 6/10/25, and the facility Patient Safety Data Entry Site documentation revealed unsampled patient # 1 was transported to the hospital on 6/14/24 for sustained loss of consciousness during the hemodialysis treatment. Review of the SSA UO online reports submitted by the facility from 6/10/24 to 6/10/25 revealed no documentation the 6/14/24 transfer to the hospital was reported to the SSA online system. An interview was conducted on 6/12/25 at 4:23 PM with Employee Identifier (EI) # 1, Director of Operations, who confirmed the facility failed to report the UO to the SSA for the 6/14/24 transfer to the hospital. 2. Review of the facility Absence and Hospitalization log dated 6/10/24 to 6/10/25, the facility Adverse Events Report dated 6/10/24 to 6/10/25, and the facility Patient Safety Data Entry Site documentation revealed unsampled patient # 2 was transported to the hospital via ambulance on 8/28/24 for hemodialysis access infiltration. Review of the SSA UO online reports submitted by the facility from 6/10/24 to 6/10/25 revealed no documentation the 8/28/24 transfer to the hospital was reported to the SSA online system. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, who confirmed the facility failed to report the UO to the SSA for the 8/28/24 transfer to the hospital.”

“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: 49797 49894 Based on observations, review of facility policies and procedure, and staff interview, it was determined the facility failed to ensure staff performed hand hygiene per facility policy. This affected Patient Identifiers (PI) # 1, in one of two observations of Central Venous Catheter (CVC) exit site care, PI # 6, in one of two observations of discontinuation of dialysis with a CVC, PI # 5, in one of three observations of medication administration, and a random observation, and had the potential to negatively affect all 44 patients dialyzing at the facility, staff and visitors. Findings include: Facility Policy: Hand Hygiene Reference Number: 47664 Version: 8 Date Published: 11/6/23 Policy Hands will be... ...Decontaminated using alcohol-based hand rub or by washing with antibacterial 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 or administration of parenteral medications, immediately after removing gloves, after contact with bodily fluids or excretion..., after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient. Hand Hygiene: Patients Patients should perform hand hygiene...prior to and after each dialysis treatment... Gloves must be provided to patients when performing procedures which risk exposure to blood or body fluids. Caution Regarding Fingernails Do not wear artificial fingernails, extenders or nail wraps when having direct contact with patients. Facility Procedure: Changing the Catheter Dressing Procedure Number: 45664 Version: 8 Date Published: 5/2/25 ...8. Discard dressing, and remove gloves. Perform hand hygiene... 1. On 6/11/25 at 9:06 AM, the surveyor observed EI # 5, Certified Clinical Hemodialysis Technician (CCHT), with acrylic fingernails. EI # 5 confirmed in an interview they were an acrylic overlay. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, Director of Operations, who confirmed staff failed to follow the facility policy for hand hygiene and artificial fingernails. 2. An observation was conducted on 6/11/25 at 10:36 AM with EI # 6, CCHT, with an unsampled patient at station 15, during the initiation of dialysis. EI # 6 walked out of the station wearing gloves to retrieve a stethoscope, returned to the station and continued with care without changing gloves or performing hand hygiene. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, who confirmed staff failed to perform hand hygiene and glove change per facility policy. 3. An observation was conducted on 6/11/25 at 11:23 AM with Employee Identifier (EI) # 3, Registered Nurse (RN) performing CVC exit site care for PI # 1 at station 2. During the observation, EI # 3, removed the old dressing from the CVC exit site and cleaned the site without removing his/her gloves, performing hand hygiene, and putting on a clean pair of gloves. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, who confirmed the staff did not follow the facility procedure for performing CVC exit site care. 4. An observation was conducted on 6/11/25 at 11:35 AM with EI # 4, RN, discontinuing dialysis with a CVC for PI # 6 at station 20. EI # 4 disconnected the arterial and venous blood lines from the CVC and gave them to PI # 6, who was not wearing a glove, to hold. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, who confirmed staff failed to provide a glove to a patient at risk of exposure to blood. 5. An observation was conducted on 6/11/25 at 1:30 PM with EI # 3, preparing and administering medication to PI # 5 at station 19. Prior to preparing the medication, EI # 3 failed to perform hand hygiene before donning gloves. During medication administration, EI # 3 removed the gloves used to prepare the medication, and without performing hand hygiene, retrieved a clean pair of gloves from the glove box, and donned them. After administering the medication, EI # 3 removed his/her gloves and exited the station without performing hand hygiene. He/she returned to the nurse’s station and charted in the electronic medical record. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, who confirmed staff failed to perform hand hygiene per facility policy.”

“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: 49797 49894 Based on observations, facility policy and procedure, and staff interviews, it was determined the facility failed to ensure staff: 1. Wore the proper Personal Protective Equipment (PPE) on the dialysis treatment floor to protect against potential exposure to blood. 2. Properly wore a facemask during the Central Venous Catheter (CVC) exit site care and initiation of dialysis to prevent contamination by airborne nasal bacteria. This affected Patient Indentifer (PI) # 1 and PI # 5 in two of two observations of CVC exit site care and initiation of dialysis, two employees of the facility, and had the potential to affect all patients dialyzing with a CVC and all staff working in the facility. Findings include: Facility Policy: Personal Protective Equipment Reference Number: 47663 Version: 6 Date Published: 11/6/23 The purpose of this policy is to identify PPE and potential areas for use... Occupational Exposure- Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties. Policy Employees who may have occupational exposure shall be provided...appropriate PPE including gloves, fluid resistant gowns, face shields, masks, eye protection with full side shields. Employees shall use PPE in accordance with the type of patient contact and anticipated exposure. Facility Procedure: Changing the Catheter Dressing Procedure Reference Number: 45664 Version: 8 Date Published: 5/2/25 ...Removal of Dressing and Inspection of Site Follow the steps below to remove a catheter dressing and inspect the exit site before the initiation of dialysis treatment: Important note: The patient and care partner must wear a mask for all procedures that require accessing the catheter. ...Step 2: Apply mask to patient and caregiver to help prevent contamination by airborne nasal bacteria. 1. A random observation was conducted on 6/11/25 at 11:10 AM. A biomedical technician and the Administrative Assistant (AA) were on the treatment floor, at a patient station, talking with the staff performing patient care in the station. Neither the biomedical technician or the AA were wearing any PPE to protect against possible occupational exposure to blood. An interview was conducted on 6/12/25 at 4:23 PM with Employee Identifier (EI) # 1, Director of Operations, who confirmed staff failed to wear appropriate PPE in an area where possible occupational exposure to blood could occur. 2. An observation was conducted on 6/11/25 at 11:23 AM with EI # 3, Registered Nurse (RN) performing CVC exit site care, and initiation of dialysis for PI # 1 at station 2. EI # 3’s mask was worn below the nose during the exit site care of the CVC and initiation of dialysis. An interview was conducted on 4/12/25 at 4:23 PM with EI # 1, who confirmed the staff failed to wear the mask appropriately while accessing the CVC per the facility procedure. 3. An observation was conducted on 4/11/25 at 1:30 PM with EI # 4, RN, performing CVC exit site care and initiating dialysis for PI # 5 at station 19. EI # 4’s mask fell below his/her nose during the procedure. EI # 4 did not stop the procedure and correct the mask while the catheter was being accessed. An interview was conducted on 4/12/25 at 4:23 PM with EI # 1, who confirmed staff failed to wear the mask appropriately while accessing the CVC per the facility procedure.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 49894 Based on observation, facility policy, and staff interview, it was determined the facility failed to ensure staff dedicated an area for clean, unused equipment, supplies, and medications. This had the potential to negatively affect all 44 patients dialyzing at the facility. Findings include: Facility Policy: Dialysis Precautions Version: 4 Date Published: 1/4/12 ...Clean Versus Dirty Areas Clean Area: An area designated for clean and unused equipment, supplies, and medications... Clean areas should be clearly separated from dirty areas where used supplies, equipment, or blood samples are handled or stored. Facility Policy: Hand Hygiene Reference Number: 47664 Version: 8 Date Published: 11/6/23 ...Sink Policy Hand washing sinks should be dedicated for hand washing only and should remain clean. A tour of the treatment floor was conducted on 6/10/25 at 3:05 PM. A used jug bath dated 6/2/25, with time and initials, was sitting on the countertop of the handwashing sink located at the back of the treatment floor. An interview was conducted on 4/12/25 at 4:23 PM with Employee Identifier # 1, Director of Operations, who confirmed staff failed to maintain the handwashing sink as a clean area.”

“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 observation, facility policy, and staff interview, it was determined the facility failed to ensure staff cleaned and disinfected the dialysis station between patients. This affected one of two observations of cleaning the dialysis station and had the potential to negatively affect all 44 patients dialyzing at the facility. Findings include: Facility Policy: Cleaning and Disinfecting the Dialysis Station Reference Number: 47806 Version: 14 Date Published: 9/5/23 ...The Centers for Medicare and Medicaid Services has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. The chair and dialysis equipment are used by multiple patients during the day and it is critical that these items be thoroughly disinfected between uses. ...Definition Dialysis Station- Area including the dialysis machine, chair/bed and other reusable equipment or supplies utilized during dialysis treatment... Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments such as Intravenous (IV) pole, Blood Pressure cuff and hand sanitizer/holder, organizer, chair/bed, ... individual television and remote. 49797 1. An observation was conducted on 6/11/25 at 10:45 AM with Employee Identifier # 10, Patient Care Technician (PCT), performing disinfection of the dialysis station, and preparation of the hemodialysis (HD) machine. The hemodialysis machine was cleaned at 10:45 AM. The PCT returned at 11:12 AM with supplies to prepare the HD machine for the next patient. The supplies were placed on top of the dialysis machine. The staff then left the station, performed hand hygiene, and put on gloves. The staff re-entered the station, strung the new set of dialysis blood lines on the machine before cleaning the chair, TV, TV remote, and Blood Pressure cuff for the next patient. An interview was conducted on 4/12/25 at 4:23 PM with EI # 1, Director of Operations, who confirmed the staff failed to follow the facility policy on Cleaning and Disinfecting the Dialysis Station.”

“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 observation, review of facility policy, and staff interview, it was determined the facility failed to ensure: 1. Staff administered pre-drawn heparin within four hours of preparation. 2. Staff used sterile syringes and needles when preparing medication. 3. Staff labeled multi-dose medication vials with the date and time the vial was opened on the medication label along with their initials. This affected all patients receiving heparin on 6/11/25 and had the potential to negatively affect all 44 patients receiving heparin at the facility. Findings include: Facility Policy: Medication Preparation and Administration Reference Number: 47488 Version: 9 Date Published: 2/6/23 ...Labeling Reconstituted Medications and Syringes All medications in syringes not being administered immediately shall be labeled appropriately with the name of the medication, route, dose, and name of patient, date, time, and initials of the person who prepared the medication. ...Labeling Vials When preparing medications if the vial is not used immediately in its entirety, the nurse must place the date and time the vial was opened on the medication label, along with their initials. Label any multi-dose vial that is not used immediately and store vial accordingly. ...Pre-drawing Medications Medications may be pre-drawn for up to four hours prior to administration. These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area...until delivery to the appropriate patient for administration. ...Infection Control The following steps must be taken to ensure infection control. ...Always use a sterile syringe and needle when entering a vial. A tour of the medication room was conducted on 6/10/25 at 10:22 AM. In the medication room, in baskets on the countertop, the following was observed: Seven three milliliter (ml) syringes, out of the sterile package, and available for patient use. Twenty-one 10 ml syringes, out of the sterile package, and available for patient use. In the cabinet in the medication room the following was observed: Seventeen 10 ml syringes containing pre-drawn heparin with patient labels dated 6/11/25. Four three ml syringes containing pre-drawn heparin with patient labels dated 6/11/25. There was no time, date, or initial of the person who prepared the medication and the medication was labeledfor the next day (6/11/25), which was more than four hours prior to administration. In the medication refrigerator was an opened box of Turbersol (TB skin test medication) five tuberculin units/0.1 ml. The protective cap had been removed from the vial, indicating it had been previously used. There was no date and time the vial was opened and there were no initials of the person who opened it. An interview was conducted on 6/12/25 at 4:23 PM with Employee Identifier # 1, Director of Operations, who confirmed staff failed to prepare pre-drawn syringes within four hours of administration, use sterile syringes and needles to prepare medication, and label multi-dose vials with the date and time of opening and initials of the person who opened the vial per the facility policy.”

“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 observation, review of facility procedure, and staff interview, it was determined the facility failed to ensure staff performed Central Venous Catheter (CVC) exit site care per facility procedure. This affected Patient Identifier (PI) # 5, in one of two observations of CVC exit site care and had the potential to negatively affect all patients dialyzing with a CVC at the facility. Findings include: Facility Procedure: Changing the Catheter Dressing Procedure Reference Number: 45664 Version: 8 Date Published: 5/2/25 Cleaning the Site Follow the steps below to clean the catheter exit site: ...2. Remove the swabstick from package... 2% Chlorhexidine and 70% alcohol: Using gentle back and forth friction, clean the exit site... in a concentric circle for thirty seconds and allow to dry for a minimum of thirty seconds. 1. An observation was conducted on 6/11/25 at 12:26 PM with EI # 4, Registered Nurse (RN), performing CVC exit site care for PI # 5 at station 19. EI # 4 cleaned the CVC exit site for seven seconds, and not thirty seconds per policy, before allowing to dry and applying a clean dressing. An interview was conducted on 6/12/25 at 4:23 PM with EI # 1, Director of Operations, who confirmed staff failed to perform CVC exit site care per facility procedure.”

“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 facility policies, personnel files, the facility Post Worker Carbon Tank-TCL-1 Log (chlorine testing log), and staff interview, it was determined the facility failed to ensure staff monitoring carbon filter performance were qualified to perform total chlorine testing. This deficient practice had the potential to negatively affect all 44 patients dialyzing at the facility. Findings include: Facility Policy: Carbon Filtration Monitoring for Incenter Central Water Systems Reference Number: 46310 Version: 12 Date Published: 5/5/25 ...Policy ...Two trained staff members, one of whom must be a nurse, must be present for the entire test process, will perform and verify total chlorine testing. Facility Policy: Color Blindness Testing Version: 3 Date Published: 1/23/19 ...Background Patient care and biomedical staff are in positions that require the ability to interpret or distinguish color when performing water and/or other quality tests or maintenance on dialysis or other equipment. People who suffer from color blindness may not be able to distinguish between certain colors used in water and other testing methodologies. Policy New hire, rehire, or transfer staff working in a direct patient care or biomedical position are required to take the Ishibara Test for Color Blindness to ensure the ability to perform essential functions of their job. 1. On 6/12/25, a review of the personnel file for Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician, revealed there was no documentation of Color Blindness Testing present in the personnel file for this employee. Review of the chlorine testing log for April 2025 to June 2025 revealed EI # 6 performed water testing for chlorine three of the fourteen days of operation in April 2025, five of the fourteen days of operation in May 2025, and one of the four days of operation in June 2025. An interview was conducted on 6/12/25 at 2:00 PM with EI # 2, Facility Administrator, who confirmed staff testing water for chlorine did not have a documented Color Blindness Test in the personnel file and were not qualified to perform total chlorine testing.”

“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 review of facility policy, the facility GranuFlo Mixing Log, personnel Skills Validation documentation, and staff interview, it was determined the facility failed to ensure staff mixing, testing, and verifying acid concentrate solution for dialysate were deemed competent in the GranuFlo Dry Acid Dissolution System (DADU) and Hydrometer (used to test specific gravity of final dialysate) use. This deficient practice had the potential to negatively all 44 patients receiving dialysis treatment at the facility. Findings include: Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit Reference Number: 25910 Version: 7 Date Published: 9/5/23 ...Introduction The DADU is a device used to prepare acid concentrate solution (GranuFlo) from a dry powder and Reverse Osmosis (RO) water at a central location. Responsibility Clinical Manager- Work with the Technical Department to ensure the DADU mixer is operated in accordance with this policy and ensure facility staff is trained in use of the DADU mixer. Technical Staff- Work with the Clinical Manager to ensure the DADU mixer is operated in accordance with this policy and provide initial training in the use of the DADU mixer and assist with additional staff training as required. Medical Director- The day-to-day responsibility for maintaining water quality lies with the health care professionals at each dialysis facility under the leadership of the facility’s Medical Director. Definitions Operator- A staff member that meets the qualifications of “Policy-Trained Staff” located in this document that is the primary staff member making the current batch of acid concentrate. Specific Gravity- The ratio of density of a liquid to the density of the 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... ...Trained Staff Prior to being allowed to operate the DADU the staff must complete training necessary to perform their assigned operational responsibilities. Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation training thereafter. Quality Assurance Testing Final verification of the batch is done through the measurement of the batch temperature followed by a specific gravity test with a comparison of these results to GranuFlo Dry Acid Table of Specific Gravities... Specific gravity from the DADU will be tested: once the process is completed by the operator and verified by a second staff member. 1. A review of the facility’s GranuFlo Mixing Log from January 2025 to June 2025 was conducted on 6/11/25. The surveyor chose six employee identification numbers documented in the log as operator or verifier and requested documentation of the Skills Validation for those employee identification numbers. Review of the Skills Validation for Employee Identifier (EI) # 7, Certified Clinical Hemodialysis Technician (CCHT), revealed EI # 7 had not been trained in the DADU or Hydrometer Use. Review of the Skills Validation for EI # 9, CCHT, revealed EI # 9 had not been trained in the DADU and Hydrometer use. Further review of the GranuFlo Mixing Log revealed EI # 7 had documented he/she was the operator of the DADU (prepared the acid concentrate) on 4/25/25 and 5/23/25 and the verifier (confirmed the operator’s specific gravity test results) on 4/9/25, 5/16/25, and 6/6/25. The GranuFlo Mixing log review also revealed EI # 9 had documented he/she was the verifier of the acid concentrate batches on 3/3/25 and 3/28/25. An interview was conducted on 6/12/25 at 8:30 AM with EI # 2, Facility Administrator, who confirmed staff mixing, testing, and verifying acid concentrate solution for dialysate were not deemed competent in the DADU and Hydrometer use.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 49894 Based on observation and staff interview, it was determined the facility failed to ensure the building in which dialysis services are furnished was maintained to ensure the safety of patients, the staff, and the public. This had the potential to affect all 44 patients dialyzing at the facility, staff, and visitors. Findings include: 1. Observations of patient care were conducted on 6/11/25 at 10:30 AM on the dialysis treatment floor. Air conditioning vents located on the ceiling of the treatment floor were black, dusty, and had mold/mildew on them. An interview was conducted on 6/12/25 at 4:23 PM with Employee Identifier # 1, Director of Operations, who confirmed the facility failed to maintain the air vents on the treatment floor to ensure the safety of the patients, staff, and visitors.”

“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 medical records (MR), facility policies, and staff interview, it was determined the facility failed to ensure: 1. Staff reported abnormal Blood Pressures (BP) to the Registered Nurse (RN). 2. Staff reported abnormal BP to the physician. 3. Staff reported post treatment weights greater than one kilogram (kg) above or below the Estimated Dry Weight (EDW) to the physician. 4. Staff maintained the Ultrafiltration Rate (UFR) per the physician’s order. 5. Staff performed vital signs and safety checks at least every thirty minutes or more and did not exceed forty-five minutes. This affected PI # 2, PI # 5, and PI # 1 in three of five MRs reviewed and had the potential to negatively affect all 44 patients dialyzing at the facility. Findings include: Facility Policy: Assessment and Monitoring Reference Number: 45284 Version: 4 Date Published: 5/1/23 ...Data Collection Direct patient care staff may collect data such as weight, BP, pulse, respirations, temperature, general observations, access, and complaints reported by the patient. If the Patient Care Technician/Licensed Practical Nurse notes any changes or abnormal findings in the patient’s condition...the RN must assess the patient. The RN will notify the patient’s physician/physician extender of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The RN will assess/re-assess any findings addressed pre or during treatment as needed. Pre-Treatment 1. The direct patient care staff may obtain the following data: Weight- Record pre-weight and compare to estimated dry weight. BP- Record BP. Verify: Systolic BP greater than 180 or diastolic BP greater than 100, Systolic BP less than or equal to 100 during treatment.... 2. During nursing rounds, the RN will review the data collected above and assess the following parameters as needed: Data collected above- Review the data collected above. Determine if any clinical interventions are necessary. Review the previous treatment data on the Fluid Assessment Tab... 3. Document findings and interventions in the MR. Contact the physician as needed for additional orders based on assessment findings and clinical judgment. During Treatment Obtain BP and pulse rate every thirty minutes or more as needed but not to exceed forty-five minutes... Document machine parameters and safety checks every thirty minutes or more often as needed but not to exceed forty-five minutes... Follow the steps below for monitoring patient and machine parameters during treatment: 1. BP- Record BP...Reposition electronic cuff or use a manual cuff for aberrant BP readings. Report to the nurse: Systolic BP greater than 180, Diastolic BP greater than 100, BP less than or equal to 100 Systolic... Ultrafiltration Rate- Monitor UFR... 3. Machine Parameters and Extracorporeal Circuit- Check machine settings and measurements: Check the amount of fluid removed... 4. Document any findings and interventions in the MR. Post-Treatment Follow the steps below for obtaining post-treatment assessment data: 1. The direct patient care staff may obtain the following: Weight- Obtain the patient’s post weight. BP, Pulse...Ensure vital signs and overall condition are stable for discharge... 2. Document findings in the patient’s record. Facility Policy: Patient Safety Event Reporting and Documentation Reference Number: 61085 Version: 2 Date Published: 2/6/23 ...Procedure Clinical Staff are required to report all Safety Events and Serious Safety Events to the patient’s physician... Below is a table ...event descriptions and definitions of Near Miss, Safety Events, and Serious Safety Events. Category- Treatment Orders Not Met Event Description- Dialysis Weight/UF Goal Variance Definition- Dialysis weight variance above or below the expected post weight... 1. PI # 2 was admitted to the facility on 9/18/24 with a primary diagnosis of End Stage Renal Disease (ESRD). Review of the Orders Summary Report (OSR) revealed Hemodialysis orders dated 5/21/25 for an EDW of 48.5. Review of Treatment Sheets (TS) dated 5/21/25, 5/23/25, 5/26/25, 5/28/25, and 5/30/25 revealed PI # 2 had a post treatment weight greater than one kg above his/her EDW and there was no documentation the physician was notified. Further review of the TS dated 5/21/25, 5/23/25, 5/26/25, 5/28/25, and 5/30/25 revealed there was no documentation staff notified the RN of Systolic BP greater than 180 and/or Diastolic BP greater than 100. Further review of these TS revealed no documentation the physician was notified of the abnormal BP. Further review of the TS dated 5/21/25, 5/23/25, 5/26/25, 5/28/25, and 5/30/25 revealed the UFR for the patient treatment was not 13 milliliters/kg/hour (ml/kg/hr). (The order for UFR was not on the patient’s OSR, but confirmed by RN via electronic medical record and verified by this surveyor). An interview was conducted on 6/12/25 at 4:11 PM with Employee Identifier (EI) # 1, Director of Operations, who confirmed staff failed to notify the physician of post treatment weights greater than one kg above the EDW, notify the RN for abnormally high BP, and follow the physician’s order for UFR. 49797 2. PI # 5 was admitted to the facility on 9/23/24 with a primary diagnosis of ESRD. A review of the TS dated 5/26/25, 5/30/25, and 6/9/25 revealed there was no documentation the staff notified the RN or Physician of Systolic BP greater than 180 and/or Diastolic BP greater than 100. An interview was conducted on 6/12/25 at 4:09 PM with EI # 1, who confirmed the staff failed to notify the RN or Physician of abnormally high BP. 3. PI # 1 was admitted to the facility on 4/25/25 with a primary diagnosis of Acute Kidney Injury. A review of the Order Summary Report revealed an order with a start date of 5/30/25 for an EDW of 121 kg. A review of the TS dated 6/4/25 revealed there was no documentation the staff notified the RN of Systolic BP less than or equal to 100 during treatment. Further review of the TS dated 6/2/24, 6/4/25, and 6/9/25 revealed the staff did not obtain vital signs every 30 to 45 minutes during treatment. Further review of the TS dated 6/6/25 revealed the patient had a post treatment weight greater than one kg above his/her EDW and there was no documentation the physician was notified. An interview was conducted on 6/12/25 at 4:07 PM with EI # 1, who confirmed the staff failed to notify the RN of abnormally low BP, the staff failed to obtain vital signs during treatment per facility policy, and notify the Physician of an EDW greater than one kg above ordered EDW.”

“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 policy, and staff interview, it was determined the facility failed to ensure: 1. Staff followed the physician’s order for Blood Flow Rate (BFR). 2. Staff followed the physician’s order for Dialysate Flow Rate (DFR). This affected Patient Identifiers (PI) # 1 and PI # 3, in two of five MRs reviewed, and had the potential to negatively affect all 44 patients dialyzing at the facility. Findings Include: Facility Policy: Patient Assessment and Monitoring Reference Number: 45284 Version: 4 Date Published: 5/1/23 ...During Treatment ...3. Machine Parameters and Extracorporeal Circuit. Check machine settings and measurements: Check prescribed blood flow is being achieved or reason documented if unable to meet the prescribed blood flow. Check DFR setting is correct, and the prescribed flow is being delivered... 4. Document any findings in the patient record. 49797 1. PI # 1 was admitted to the facility on 4/25/25 with a primary diagnosis of Acute Kidney Injury. A review of the Orders Summary Report revealed a Hemodialysis (HD) order with the start date of 5/30/25 for a BFR of 400 and a DFR of 800 milliliters/minute A review of the Treatment Sheets (TS) dated 6/6/25 and 6/9/25 revealed the DFR was not at the prescribed rate of 800 mL/min. No documentation of a new order or reason for the DFR was noted. An interview was conducted on 6/12/25 at 4:07 PM with Employee Identifier, (EI) # 1, Director of Operations, who confirmed the staff failed to follow the order for the DFR. 2. PI # 3 was admitted to the facility on 6/23/23 with a primary diagnosis of End Stage Renal Disease. A review of the Orders Summary Report revealed an HD order with a start date of 5/21/25 for a BFR of 400 and a DFR of 500 mL/min. A review of the TS dated 5/30/25 and 6/4/25 revealed the BFR was not at the prescribed rate of 400. No documentation of a new order or reason for the BFR was noted. An interview was conducted on 6/12/25 at 4:11 PM with EI # 1, who confirmed the staff failed to follow the order for the BFR.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 49894 Based on review of facility policies, personnel files, the facility Post Worker Carbon Tank-TCL-1 Log (chlorine testing log), the facility GranuFlo (acid concentrate solution for dialysate) Mixing Log, and staff interview, it was determined the Medical Director failed to ensure: 1. Staff monitoring carbon filter performance were qualified to perform total chlorine testing. 2. Staff mixing, testing, and verifying GranuFlo were deemed comptetent in the GranuFlo Dry Acid Dissolution System (DADU) and Hydrometer (used to test specific gravity of final dialysate) use. This deficient practice had the potential to negatively affect all 44 patients receiving dialysis treatment at the facility. Findings include: Facility Policy: Carbon Filtration Monitoring for Incenter Central Water Systems Reference Number: 46310 Version: 12 Date Published: 5/5/25 ...Policy ...Two trained staff members, one of whom must be a nurse, must be present for the entire test process, will perform and verify total chlorine testing. Facility Policy: Color Blindness Testing Version: 3 Date Published: 1/23/19 ...Background Patient care and biomedical staff are in positions that require the ability to interpret or distinguish color when performing water and/or other quality tests or maintenance on dialysis or other equipment. People who suffer from color blindness may not be able to distinguish between certain colors used in water and other testing methodologies. Policy New hire, rehire, or transfer staff working in a direct patient care or biomedical position are required to take the Ishibara Test for Color Blindness to ensure the ability to perform essential functions of their job. Facility Policy: Acid Concentrate Mixing and Handling: Dry Acid Dissolution Unit Reference Number: 25910 Version: 7 Date Published: 9/5/23 ...Introduction The DADU is a device used to prepare acid concentrate solution (GranuFlo) from a dry powder and Reverse Osmosis (RO) water at a central location. Responsibility Clinical Manager- Work with the Technical Department to ensure the DADU mixer is operated in accordance with this policy and ensure facility staff is trained in use of the DADU mixer. Technical Staff- Work with the Clinical Manager to ensure the DADU mixer is operated in accordance with this policy and provide initial training in the use of the DADU mixer and assist with additional staff training as required. Medical Director- The day-to-day responsibility for maintaining water quality lies with the health care professionals at each dialysis facility under the leadership of the facility’s Medical Director. Definitions Operator- A staff member that meets the qualifications of “Policy-Trained Staff” located in this document that is the primary staff member making the current batch of acid concentrate. Specific Gravity- The ratio of density of a liquid to the density of the 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... ...Trained Staff Prior to being allowed to operate the DADU the staff must complete training necessary to perform their assigned operational responsibilities. Competency and proficiency training will be documented and maintained in the staff’s personnel record for initial training and annual validation training thereafter. Quality Assurance Testing Final verification of the batch is done through the measurement of the batch temperature followed by a specific gravity test with a comparison of these results to GranuFlo Dry Acid Table of Specific Gravities... Specific gravity from the DADU will be tested: once the process is completed by the operator and verified by a second staff member. 1. On 6/12/25, a review of the personnel file for Employee Identifier (EI) # 6, Certified Clinical Hemodialysis Technician, revealed there was no documentation of Color Blindness Testing present in the personnel file for this employee. Review of the chlorine testing log for April 2025 to June 2025 revealed EI # 6 performed water testing for chlorine three of the fourteen days of operation in April 2025, five of the fourteen days of operation in May 2025, and one of the four days of operation in June 2025. An interview was conducted on 6/12/25 at 2:00 PM with EI # 2, Facility Administrator, who confirmed staff testing water for chlorine did not have a documented Color Blindness Test in the personnel file and were not qualified to perform total chlorine testing. 2. A review of the facility’s GranuFlo Mixing Log from January 2025 to June 2025 was conducted on 6/11/25. The surveyor chose six employee identification numbers documented in the log as operator or verifier and requested documentation of the Skills Validation for those employee identification numbers. Review of the DPC Skills Validation for EI # 7, Certified Clinical Hemodialysis Technician (CCHT), revealed EI # 7 had not been trained in the DADU or Hydrometer Use. Review of the DPC Skills Validation for EI # 9, CCHT, revealed EI # 9 had not been trained in the DADU and Hydrometer use. Further review of the GranuFlo Mixing Log revealed EI # 7 had documented he/she was the operator of the DADU (prepared the acid concentrate) on 4/25/25 and 5/23/25 and the verifier (confirmed the operator’s specific gravity test results) on 4/9/25, 5/16/25, and 6/6/25. The GranuFlo Mixing log review also revealed EI # 9 had documented he/she was the verifier of the acid concentrate batches on 3/3/25 and 3/28/25. An interview was conducted on 6/12/25 at 8:30 AM with EI # 2, Facility Administrator, who confirmed staff mixing, testing, and verifying acid concentrate solution for dialysate were not deemed comptetent in the DADU and Hydrometer use.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 49894 Based on review of the Alabama Department of Public Health for Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, facility Absence and Hospitalization log, the facility Adverse Event documentation, facility policies and procedures, the facility total chlorine logs, the facility GranuFlo Mixing Log, personnel files, observations, medical record review, and staff interviews, it was determined the Governing Body failed to ensure facility policies and procedures were enforced to promote the health and safety of patients. This deficient practice had the potential to negatively affect all 44 patients dialyzing at the facility. Fingings include: Facility Policy: Governing Body Reference Number: 65276 Date Published: 7/3/23 The purpose of this policy is to provide guidance to the facility ’ s Governing Body members of their federally mandated responsibilities as well as those actions required by Fresenius Kidney Care (FKC) for the ongoing governance of the dialysis facility and oversight of day-to-day operations. General Responsibilities The Conditions for Coverage require that an identifiable Governing Body of designated persons with full legal authority and responsibility (which we will collectively entitle “Governing Body”) is ultimately responsible for the facility ’ s management and oversight of day-to-day operations and for ensuring the delivery of safe treatments and patient satisfaction. Governing Body duties (generally in conjunction with the Medical Director) include but are not limited to: Fiscal management, medical staff appointments, coverage, and compliance with facility policies, ... medical staff appointment...compliance with policy and procedure, Regulatory Compliance to include: Training and educating staff, ... maintaining compliance and adherence to federal healthcare program requirements/state regulations. Review of the Alabama Department of Health Rules for End Stage Renal Disease Treatment and Transplant Centers Chapter 420-5-5, the facility’s Absence and Hospitalization Log, Adverse Event Reports, and Patent Safety Data Entry Site Documentation, GranuFlo Mixing Log, total chlorine logs, medical record reviews, observations, facility policies and procedures, it was determined the Governing body failed to ensure the facility reported all unusual occurences to the State Survey Agency, followed policies and procedures for infection contol, qualified staff mixed, tested, and verified acid concentrate batches and tested water for chlorine, followed physician orders for notifying the Registered Nurse for abnormal blood pressures, notified the physician for abnormal blood pressures and post treatment weights greater than one kilogram above or below the Estimated Dry Weight, followed the physician’s order for Ultrafiltration Rate, Blood Flow Rate, Dialysate Flow Rate, and the Medical Director ensured all policies and procedures of the clinic were followed. An interview was conducted on 6/12/25 at 4:23 PM with Employee Identifier # 1, Director of Operations, who confirmed the Governing Body failed to implement a plan to ensure the facility and staff followed policies and procedures to promote the health and safety of patients.”