Fresenius Medical Care Savannah South

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, a review of the facility’s policies and procedures (P & P), a review of the manufacturer’s Directions for Use (DFU) and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Patient Care Techincian (PCT AA) observed during preparation and initiation of hemodialysis treatment of two of two patients (P) (P#10 and P#11), to verify the final dialysate pH (acidity), as required by the manufacturer’s DFU and the facility’s P & P, particularly when the Bibag (a sealed single-use bag filled with sodium bicarbonate to generate the dialysate solution), System was not in use on the Fresenius 2008T dialysis machines with Bluestar (automated technologies) capabilities. And failure of the facility to ensure that one of one Biomedical Technician (BMT) was knowledgeable on the correct operation of the 2008T machines, including procedures for dialysate verification when Bibags were not used. This deficient practice had the potential to negatively affect the health and safety of P#10 and P#11 at S19 and S18 respectively, as well as the other seven patients who were undergoing hemodialysis treatment at (S1, S8, S9, S11, S12, S16, and S20), at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 72. Findings include: Cross References: V 250 - Failure of the facility to ensure that one of one Biomedical Technician (BMT) was knowledgeable on the use of the Fresenius 2008T dialysis machines with Bluestar capabilities and failure to ensure that one of one Patient Care Technician (PCT AA) observed, verified the machine’s dialysate pH, according to the manufacturer’s DFU and facility P&P. V 253 - Failure of the facility to ensure that one of one BMT performed microbial monitoring (cultures and endotoxins), of two of 23 hemodialysis (HD) machines (#11 and #12), at least once per year.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, staff interviews, review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedures (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of all 72 patients who dialyzed at this facility. Findings include: Cross References: V 250 - Failure of the facility to ensure that one of one Biomedical Technician (BMT) was knowledgeable on the use of the Fresenius 2008T dialysis machines with Bluestar capabilities and one of one Patient Care Technician (PCT AA) observed, verified the machine’s dialysate pH, according to the manufacturer’s DFU and facility P&P. V 253 - Failure of the facility to ensure that one of one BMT performed microbial monitoring (cultures and endotoxins), of two of 23 hemodialysis (HD) machines (#11 and #12), at least once per year.”

“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: 49321 Based on observation, staff interviews, a review of Centers for Disease Control and Prevention (CDC) guidelines, and a review of the facility’s policies and procedures (P & P), it was determined that the facility failed to ensure that six of six Direct Patient Care Staff (Registered Nurses- RN AA and RN CC, Patient Care Technicians - PCT AA, PCT BB, PCT DD, and Licensed Practical Nurse - LPN AA ), who were present during this observation, immediately and thoroughly cleaned and disinfected blood-contaminated surfaces on the cover of four of four sharps containers, between patient use. This failure could lead to the transmission of dangerous pathogens through cross contamination and had the potential to negatively affect the health and safety of all 72 in-center hemodialysis patients who were under the care of this facility. Findings include: - On 9/23/25, at 10:30 a.m., one to three (1/2 centimeter) dried drops of blood were observed on four of four sharps containers, located at Stations (S)4, S14, S15, and S16. During an interview with the Facility Administrator on 9/23/25 at 10 :45 a.m., the Facility Administrator stated that staff were aware that visible blood was to be cleaned immediately. According to CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of facility Policy with Reference Number 47806, titled, “Cleaning and Disinfection of Dialysis Station”, published 9/5/23, stated: - Use 1:100 bleach solution to clean surfaces with visible blood. - After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface... - Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible. A review of Policy Reference Number 47685 titled, “General Cleanliness and Infection Control Guidelines”, published 2/7/22, stated: All containers for storage or disposal of needles/sharps shall be replaced when no more than 2/3 to 3/4 full...”

“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: 49321 Based on observation, staff interviews, a review of the facility’s policies and procedures (P & P), a review of the manufacturer’s Directions for Use (DFU) and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis,” 2004 (RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of one of one Patient Care Techincian (PCT AA) observed during preparation and initiation of hemodialysis treatment of two of two patients (P) (P#10 and P#11), to verify the final dialysate pH (acidity), as required by the manufacturer’s DFU and the facility’s P & P, particularly when the Bibag (a sealed single-use bag filled with sodium bicarbonate to generate the dialysate solution), System was not in use on the Fresenius 2008T dialysis machines with Bluestar (automated technologies) capabilities. And failure of the facility to ensure that one of one Biomedical Technician (BMT) was knowledgeable on the correct operation of the 2008T machines, including procedures for dialysate verification when Bibags were not used. This deficient practice had the potential to negatively affect the health and safety of P#10 and P#11 at S19 and S18 respectively, as well as the other seven patients who were undergoing hemodialysis treatment at (S1, S8, S9, S11, S12, S16, and S20), at the time of this observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) could result if dialysate composition is incorrect. The facility census was 72. Findings include: During observation in the Patient Treatment Room on 9/23/25 between 11:00 a.m. and 12:10 p.m., the following was revealed: - PCT AA did not verify the machines’ final dialysate pH at S18 (P#11) and at S19 (P#10), during preparation and before initiation of their dialysis treatment. During an interview with PCT AA on 9/23/25 at 12 :00 p.m., PCT AA stated that the nurses will put a “P” for pass in the pH box on the dialysis machine. She also stated that no one told her the machine needed to be tested for pH. During an interview with the Facility Administrator on 9/23/25 at 12: 10 p.m., she stated that Bibags were not used in each dialysis machines, therefore the pH must be tested. And she aslo added that the DPC staff were aware of the protocol. During an interview with the BMT on 9/23/25 at 12:30 p.m., the BMT stated that the dialysis machines in the Patient Treatment Room were BlueStar Machines. He also added that he instructed the DPC staff that they did not need to test the machines for pH because the machines “did all of that”. This surveyor brought to the BMT’s attention that the bibags were not used in the dialysis machines. The BMT answered, “That did not matter because these machines still test for pH and the DPC staff did not need to test the dialysate for pH”. A review of Policy #64339, titled, “TSB - Regulatory Guidance for Using the 2008 Independent Conductivity”, version 3, published 2/1/2023, stated: DETERMINING INDEPENDENT VERIFICATION: If the dialysis machine IS NOT using disposable Bibags, the machine will only INDEPENDENTLY verify CONDUCTIVITY. Staff MUST test the dialysate pH using an independent means such as with a handheld meter or pH test strips. DOCUMENTATION Conductivity Pass/Fail Option Added to Chairside Machine Setup Screen: - A new pH pass/fail (p/f) field was added to the machine set up screen to allow staff using machines enabled with BlueStar software and bibag systems to enter a pass/fail in the independent pH field as displayed on the machine. PLEASE NOTE: This field is only to be used by trained staff who have Bluestar enabled software with bibags. A review of the “Fresenius Medical Care 2008T Hemodialysis Machine Operation’s Manual” (490122 REV AB) stated: P 71 If the Independent Conductivity self - test was successfully completed but a bibag disposable IS NOT the bicarbonate source, check the dialysate’s pH level. According to ANSI/AAMI RD52: 2004, Section 5.6, “Dialysate Proportioning”, 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. The Facilty Administrator and the Director of Operations were notified of the above findings on 9/23/25 at 12:45 p.m.”

“MICROB MONITOR-MO DIALYS SAMPLE/COLLECT/FREQ CFR(s): 494.40(a) 7.2 Microbial monitoring methods: 7.2.1 General: Dialysate: monthly dialysate sample/collection/freq Culture ...dialysate fluid weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year. If testing of any dialysis machine reveals a level of contamination above the action level, an investigation should be conducted that includes retesting the offending machine, reviewing compliance with disinfection and sampling procedures, and evaluating microbiological data for the previous 3 months to look for trends. The medical director also should be notified. An example of a decision tree for this process is given in Figure 1. 7.2.2 Sample collection Dialysate samples should be collected from a dialysate port of the dialyzer ... [or] dialysate sampling ports that can be accessed using a syringe. At least 25 mL of fluid, or the volume specified by the laboratory performing the test, should be collected in sterile endotoxin-free specimen containers. This Standard is not met as evidenced by: 49321 Based on a review of records, staff interview, a review of facility Policy and Procedures (P & P) and a review of the American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) “American National Standard for Dialysate: Sample/Collection/Frequency”, 2004, (RD52:2004, Section 7.2.1), it was determined that the facility failed to ensure that dialysate samples were collected from two of 23 hemodialysis (HD) machines (#11 and #12), for microbial monitoring (cultures and endotoxins), at least once per year. This failure had the potential to cause serious health complications to all 72 patients who were under the care of this facility, which could include but not limited to: bacteremia (presence of bacteria in the bloodstream), chronic inflammation which could worsen existing cardiovascular disease, reduce the effectiveness of anemia treatments and contribute to other long-term complications and increased mortality. Findings include: - HD machine #11 with Serial Number 6TOS - 154382 and HD machine #12 with Serial Number 6TOS - 154384, were last tested for microbial sampling, (including endotoxin and colony count), on June 28, 2024 which was 453 days up to the date of this survey. During an interview with the current Biomedical Technician (BMT) on 9/24/25 at 10:00 a.m., he stated that the previous BMT had been out on leave and he (current BMT) had just been assigned to this facility. He stated he could not pull out the machines (#11 and #12) because patients were using the machines. The Director of Operations was informed of the findings on 9/24/25 at 12:00 p.m. A review of policy # 1-19-04, titled, “DIALYSATE ENDOTOXIN TESTING POLICY”, last revised April 2025, stated: Page 1 5. Monthly sample sites include: 10% of all dialysis machines per month, always round up. Machine selection is rotated so that all machines are tested for endotoxin levels at least annually. According to ANSI/AAMI RD52: 2004, Section 7.2.1, “Dialysate: Sample/ Collection/Frequency”, dialysate samples should be collected from at least two machines monthly and from enough machines so that each machine is tested at least once per year.”

“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: 49321 1. Based on a review of facility records, staff interviews, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that all Direct Patient Care (DPC) staff (Registered Nurses-RNs and Patient Care Technicians-PCTs), consistently performed intradialytic monitoring which include but not limited to: blood pressure (BP) and pulse checks at least every 30 minutes, as required by facility policy and by acceptable clinical standards. This deficient practice was revealed in seven of seven sampled patients’ (P#1’s, P#2’s, P#3’s, P#4’s, P#5’s, P#6’s, and P#7’s) hemodialysis treatment sheets. Intradialytic monitoring is a critical safety measure during hemodialysis. Failing to monitor and document BP readings and pulse rate at least every 30 minutes may result in undetected episodes of hypotension, hypertension, arrhythmias and or other hemodynamic instability. Delayed recognition of such events can lead to serious, preventable complications, including syncope, cardiac arrest, stroke, or hospitalization. Timely interventions, such as fluid replacement or adjustment of ultrafiltration rate (UFR - the speed at which excess fluid is removed from the body during dialysis), etcetera (etc.), depend on this monitoring. The failure to adhere to this standard had the potential to negatively affect the health and safety of P#1, P#2, P#3, P#4, P#5, P#6, and P#7. The facility census was 72. Findings include: A review of P#1’s, P#2’s, P#3’s P#4’s, P#5’s, P#6’s and P#7’s “Treatment Sheets” between September 10, 2025 to September 23, 2025, revealed the following: P#1: - On 9/22/25: Treatment started at 10:27 a.m. P#1’s first BP check was at 11:08 a.m. and BP reading was 101/33 mmHg (millimeter of mercury) = (41-minute delay) - There was no 30-minute intradialytic monitoting between 11:20 a.m. (BP at 82/43 mmHg) and 12:23 p.m. (BP reading 112/60 mmHg) = 1 hour 3 minutes delay. - Dialysis treatment ended at 2:02 p.m. There was no documented BP reading. - On 9/17/25: There was no 30-minute intradialytic monitoring between 11:07 a.m. (BP at 98/64 mmHg) and 11:52 a.m. (BP at 107/63 mmHg) = 45-minute gap) - On 9/15//25: There was no 30-minute intradialytic monitoring between 2:03 p. m. (BP 104/54 mmHg) and 2:51 p.m. (BP reading 108/54 mmHg) = (48-minute gap) - On 9/10/25: There was no 30-minute intradialytic monitoring between 8:18 a.m. (BP 107/64 mmHg) and 9:08 a.m (BP 101/61 mmHg) = (50-minute gap). Intradialytic monitoring was not conducted again until 09:54 a. m. (BP 102/58 mmHg), which was a 46-minute gap. P#2: - On 9/20/25: There was no 30-minute intradialytic monitoring between 8:37 a.m. (BP 119/73 mmHg) and 10:17 a.m. (BP 114/69 mmHg) = ( 1 hour and 40-minute delay). - On 9/18/25: There was no 30-minute intradialytic monitoring between 6:49 a.m. (BP 137/79 mmHg) and 7:33 a.m. (BP 127/84 mmHg) = (44 minute delay). And between 9:02 a.m. (BP 135/84 mmHg) and 9:43 a.m. (BP 130/78) = (41-minute delay) - On 9/13/25: Treatment started at 06:09 a.m. P#2’s first BP check was at 6:33 a.m. (BP 127/78 mmHg) = (24- minute delay). P#3: - On 9/17/25: There was no 30-minute intradialytic monitoring between 9:53 a.m. (BP 122/68 mmHg) and 11:00 a.m. (BP 166/66 mmHg) = (1 hour 7-minute delay). Then BP was checked at 12:30 p.m. (105/61 mmHg, which was a significant drop of BP reading) and 1:51 p.m. (109/61 mmHg) = (1 hour and 21-minute delay), and the last BP check was done at 2:40 p.m (124/69 mmHg) = (49-minute delay) - On 9/12/25: There was no 30-minute intradialytic monitoring brtween 11: 05 a.m. (BP 121/66 mmHg) and 12:06 p.m. (111/55 mmHg) = (1 hour and 1 minute delay). P#4: -On 9/18/25 : Treatment started at 11:07 a.m. P#4’s first BP check was at 1:34 p.m. (BP 148/78 mmHg) = (2 hours and 27-minute delay). P#5: On 9/20/25: There was no 30-minute intradialytic monitoring between 10:00 a.m. (BP 129/59 mmHg) and 11:02 a.m. (BP reading 134/41 mmHg) = (1 hour 2-minute delay) On 9/18/25: There was no 30-minute intradialytic monitoring between 9:47 a.m. (BP 167/71 mmHg) and 10:44 a.m. (BP reading 181/73 mmHg) = ( 57-minute delay), then at 11:33 a.m. (BP 166/73mmHg) = (46 minute delay). On 9/11/25 : There was no 30-minute intradialytic monitoring between 10:01 a.m. (BP 163/73mmHg) amd 10:47 a.m. (BP reading 146/62 mmHg) = (46-minute delay). Also, 11:00 a.m. (BP 136/62mmHg) and 11:42 a.m. (BP reading 152/62 mmHg) = (42-minute delay) P#6: On 9/13/25: There was no 30-minute intradialytic monitoring between 1:05 p.m. (BP 162/89 mmHg) and 2:12 p.m. (BP 157/88 mmHg) = (1 hour 7 minute delay), and from 2:12 p.m. to 3: 07 p.m. (BP 167/94 mmHg) = (55-minute delay), then at 3:57 p.m. (BP reading 159/88 mmHg) = (50-minute delay) P#7: - On 9/23/25: There was no 30-minute intradialytic monitoring between 5:40 a.m. (BP 104/60 mmHg) and 6:31 a.m. (BP reading 103/56 mmHg) = (51 minute delay). Also between 8:01 a.m. (BP 102/54 mmHg) and 9:10 a.m. (BP 103/63 mmHg) = (1 hour and 9-minute delay). - On 9/16/25: There was no 30-minute intradialytic monitoring between 11:18 a.m. (BP 111/63) and 12:34 p.m. (BP 105/59 mmHg) = (1 hour and 16-minute delay). - On 9/18/25: There was no 30-minute intradialytic monitoring between 5:38 a.m. (BP 124/60 mmHg) and 6:40 a.m. (BP 97/58 mmHg) = (1 hour and 2-minute delay). - On 9/16/25: There was no 30-minute intradialytic monitoring between 5:31 a.m. (BP 111/65 mmHg) and 6:30 a.m. (BP 114/61 mmHg) = (59-minute delay). Also between 8:02 a.m. (BP 117/66 mmHg) and 8:48 a.m. (BP 113/64 mmHg) = (46-minute delay) - On 9/11/25: There was no 30-minute intradialytic monitoring between 6:47 a.m. (BP 123/63 mmHg) and 7:37 a.m. (BP 124/61 mmHg) = (50 minute delay). Also between 8:04 a.m. (BP 125/63 mmHg) and 9:47 a.m. (when treatment was ended), but there was no ducumented BP reading at end of treatment. = (1 hour 43-minute delay) The Facility Administrator and the Director of Operations were made aware of the above findings on 9/24/25 at 1:00 p.m., and both made no comments. A review of Policy #45284, titled, “Patient Assessment and Monitoring”, published 5/1/23 verson 4, stated: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes per state regulation. 2. Based on observation, a review of Food and Drug Administration (FDA) Guidelines, staff interview, a review of Centers for Disease Control and Prevention (CDC) Recommendations, and a review of facility Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that four of four Registered Nurses (RN AA, RN BB, RN CC, and RN DD), and one of one Licensed Practical Nurse (LPN AA), who were responsible for preparing and administering medications, discarded and not made available for use, an opened and expired vial of Tuberculin Purified Protein Derivative (PPD Mantoux - a diagnostic antigen to aid in the detection of infection with Mycobacterium Tuberculosis) testing, in accordance with the manufacturer’s set time frames for use, as well as other expired medication in one of one Medication Refrigerator and in one of one Medication Cabinet. This failure had the potential to negatively affect the health and safety of 72 in-center hemodialysis patients who were under the care of this facility. Findings include: During a tour of the Patient Treatment Room with the Facility Administrator on 9/23/25 between 10:00 a.m. and 11:00 a.m., the following was revealed: In the Medication Refrigerator: - There was an opened and accessed vial of Tuberculin PPD Mantoux, which was dated as first opened on 8/16/25, (38 days since first opened). - A review of FDA guidelines stated: A vial of Tuberculin PPD (Mantoux) Tubersol, which has been entered and in use for 30 days should be discarded... Do not use after expiration date. In the Medication Cabinet at the nurses station: - 1 bottle of Clonidine Hydrochloride 0.1 milligram (mg) tablets, expired 8/2025. The Facility Administrator stated on 9/23/25 at 10:30 a.m., that the nurses should have caught this. - According to CDC Guidelines, multi-dose vials typically contain an antimicrobial preservative to help prevent the growth of bacteria. If a multi-dose vial has been opened or accessed (e.g., needle-punctured) the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial. - A review of the facility’s Policy: 47488, Version 9, titled, “Medication Preparation and Administration”, with latest revision date of February 6, 2023, stated: - Expiration date for all stored medications are to be monitored on a monthly basis. Any open multi-dose vials must be discarded 28 days after opening or per manufacturer’s expiration date.”