Davita Duluth Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s directions for use (DFU) and a review of the facility’s Policy and Procedures (P&P), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) observed, verified the hemodialysis machine’s dialysate pH (acidity), according to the manufacturer’s DFU and facility P&P. This failure had the potential to negatively affect the health and safety of 10 of 10 patients seated at Station (S) 1, S2, S3, S6, S7, S8, S9, S11, S12, and S15, who were undergoing hemodialysis treatment 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 in-center hemodialysis census was 32. Findings were: Cross Reference: V 250 - Failure of the facility to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) observed, verified the machine’s dialysate pH, according to the manufacturer’s Directions For Use (DFU) and facility P&P.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, a review of records, 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 32 in-center hemodialysis patients who dialyzed at this facility. Findings were: Cross Reference: V 250 - Failure of the facility to ensure that three of three Patient Care Technicians (PCT AA, PCT BB and PCT CC) observed, verified the machine’s dialysate pH, according to the manufacturer’s Directions For Use (DFU) and facility P&P.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 50523 Based on observation, staff interview, a review of the Food and Drug Administration (FDA) recommendations and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that expired medications in one of one Evacuation Kit were removed and not made available for use. This deficient practice had the potential to negatively affect the health and safety of 32 in-center hemodialysis patients who were under the care of this facility. Findings include: During a tour in the Patient Treatment Room on 1/13/25 from 10:14 a.m. though 10:55 a.m., the following medications and supplies had expired, thus these were not suitable for use. In the Evacuation Kit: -One Muli-dose vial of Heparin 30 Heparin Sodium 30,000 Units/30 mL (milliliter) 1000 Units/mL expired 8/16/24. - 9 bags of 0.9% Sodium Chloride Injection, USP 1000mL expired 1/2024 On 1/13/25, Facility Administrator (FA) acknowledged these findings at 10:55 a.m. According to FDA recommendations dated 2/8/21, drug and supplies’ expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective. A review of facility Policy: 1-06-01, titled, “Medication Policy” with latest revision date of October 2023, stated: 13. All open or unopened medication packages (i.e. vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired. A review of facility Policy: 4-07-01, titled, “Facility Emergency Management Plan” with latest revision date of October 2024, stated: Emergency Evacuation Kit 7. FA or designee will review the contents of the kit(s) and replace missing or expired supplies at least monthly.”

“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: 50523 Based on observation, staff interview, a review of facility Policy and Procedures (P& P), and the Centers for Disease Control and Prevention (CDC) guidelines, it was determined that the Governing Body failed to ensure that the Infection Control Committee implemented P&P for prevention of cross-contamination and spread of bacteria/infections. One of two Patient Care Technicians (PCTs) ( PCT AA) observed, failed to perform hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes, and after touching contaminated equipment. Failure to perform infection control techniques such as hand hygiene, increased the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. This failure had the potential to negatively affect the health and safety of 10 of 10 patients seated at Station (S) 1, S2, S3, S6, S7, S8, S9, S11, S12, and S15, who were undergoing hemodialysis treatment at the time of this observation. The facility in-center hemodialysis census was 32. Findings include: During observation in the Patient Treatment Room on 1/13/25 between 10:55 a.m. and 12:16 p.m., the following was revealed: - At 11:02 a.m., PCT AA was observed preparing P#7 for the initiation of hemodialysis treatment at S3 while she wore gloves. Without removing her gloves, PCT AA went to S2 and silenced P#6’s hemodialysis machine. PCT AA then went back to S3 and continued with P#7’s initiation of treatment while she wore the same contaminated gloves. When PCT AA removed her gloves, she donned clean gloves without performing hand hygiene. - At 11:06 a.m., PCT AA was observed with a new pair of clean gloves on. PCT AA silenced the machine at S5 and immediately proceeded to S2 and silenced P#6’s machine while she wore the same pair of gloves used at S5. -At 11:12 a.m., PCT AA silenced P#6’s machine at S2 with ungloved hand. Without performing hand hygiene, PCT AA donned clean gloves and cannulated P#7 at S3 and initiated P#7’s dialysis treatment. When finished, she removed her gloves and did not perform hand hygiene. - PCT AA donned a clean pair of gloves and silenced the machine at S5. PCT AA then proceeded to the clean supply area and obtained one of the clean clamps while she wore contaminated gloves. She then proceeded to S3 and clamped P#7’s bloodlines to his shirt. During an interview on 1/15/25 at 12:16 p.m., PCT AA acknowledged the above observations and stated that she did not wash her hands between every glove change. PCT AA stated she was aware that she was supposed to change gloves anytime when her gloves are soiled and before moving to another patient. PCT AA also stated she will get better at performing infection control techniques because she knew she was supposed to perform hand hygiene between each glove change. - A review of facility Policy: 1-05-01, titled, “Infection Control For Dialysis Facilities” with latest revision date of April 2023, stated: Hand Hygiene 1. All teammates, Physicians and Non-Physician (NNP) will perform hand hygiene b. prior to gloving and immediately and after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact, f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse PPE 7a. Gloves should changed when: i. When soiled with blood, dialysate or other body fluids ii. When going from a “dirty” area or task to a “clean” area or task iii. When moving from a contaminated body site to a clean body site of the same patient; and iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touching another patient’s dialysis delivery system According to CDC, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal ...”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 50523 Based on a review of records and staff interview, it was determined that the facility failed to ensure that one of one Medical Director (MD) had current Hepatitis B status/vaccination. This deficient practice had the potential to negatively affect the health and safety of all staff employed and 32 in-center hemodialysis (ICHD) patients and 19 Peritoneal Dialysis (PD) patients who were under the care of this facility. Findings include: A review of personnel files revealed that the MD lacked recent documentation pertaining to hepatitis B testing, vaccination, or declination. The Facility Administrator (FA) was notified of the above findings on 1/15/25 at 10:23 a.m. The FA stated the documents were at the physician’s office but as of exit interview on 1/15/25 at 1:15 p.m., the FA did not produce the missing documents.”

“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: 50523 Based on observation, staff interviews, and a review of the manufacturer’s Directions for Use (DFU), and Policies and Procedures (P&P), it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of three of three Patient Care Technicians (PCTs) (PCT AA, PCT BB and PCT CC) observed, to correctly verify the hemodialysis (HD) machine’s dialysate pH (acidity), according to the manufacturer’s DFU and facility P&P. This failure had the potential to negatively affect the health and safety of 10 of 10 patients seated at Station (S) 1, S2, S3, S6, S7, S8, S9, S11, S12, and S15, who were undergoing hemodialysis treatment 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 in-center hemodialysis census was 32. Findings include: During observation in the Patient Treatment Room on 1/13/25 between 10:55 a.m. and 12:16 p.m., the following was revealed: - At 11:33 a.m., PCT BB was observed testing the dialysate pH using RPC Test Strip at S6. PCT BB dipped the RPC test strip into the dialysate sample for 30 seconds while looking at a clock without a second hand and immediately compared the strip to color scale. During an interview on 1/13/25 at 11:35 a.m., PCT BB stated she had always checked the pH of the hemodialysis machines that way. - The Charge Nurse asked PCT CC to check the machine’s conductivity (ability of the dialysate to conduct electricity) at S6. PCT CC checked the dialysate for conductivity and performed the procedure correctly. However, at 11:39 a.m., PCT CC was observed testing the dialysate pH using RPC Test Strip. PCT CC swished the test strip in the dialysate sample for one minute and 50 seconds without looking at the clock, then immediately compared the test strip to color scale. On 1/13/25 at 11:50 a.m., PCT CC stated that she was supposed to swish the pH test strip into the dialysate sample for 20 to 25 seconds before comparing to color chart. - It was observed at 11:04 a.m. that PCT AA did not test the dialysate pH of the hemodialysis machine at S3 before initiating P#7’s hemodialysis treatment. - At 12:00 p.m., PCT AA was observed during testing of the dialysate pH at S14. PCT AA dipped the RPC test strip into the dialysate sample for 20 seconds without looking at the clock and immediately compared to color scale. During an interview on 1/13/25 at 12:03 p.m., PCT AA stated that she forgot to check the pH at S3 before initiating the patient treatment. PCT AA also stated that she counted in her head before comparing pH test strip to color chart. On 1/13/25 at 12:45 p.m., the Biomedical Technician (BMT) stated that the conductivity and pH must be checked before initiation of each patient treatment. A review of “RPC K100-0117CT E-Z Chek 6.8-8.5 Test Strips Directions for Use” showed the following: 1) Dip or wet pad and briskly shake off excess liquid. 2) Compare test results to color scale on bottle between 20 and 25 seconds. 3) Determine pH value for the closest color match. During a telephonic interview with RPC Director of Technical Support on 1/28/25 at 1:56 p.m., it was revealed that if the strip was left in the sample for longer than one second, it will cause overexposure which can lead to inaccurate results due to chemical reactions. Stated that the manufacturer’s DFU was specific and was determined and validated by their laboratory. The RPC Director of Technical Support also stated that it is critical to dip or wet the strip with the sample for one second and to compare test result to color scale on bottle between 20 and 25 seconds. A review of “Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Operator’s Troubleshooting Guide” showed the following: Page 9 - Miscellaneous - On the Test and Options screen, Independent Conductivity does not show pH (the pH is not available). - Warning! Always verify the conductivity and approximate pH of the dialysate solution through independent means (e.g. using a conductivity meter or pH paper or meter, as applicable) before initiating each dialysis treatment. Verify that the conductivity is reasonably close to the theoretical conductivity value (TCD) and the pH is between 6.9 and 7.6. If they are not, do not initiate dialysis. - A review of the facility’s Policy: 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” with latest revision date of April 2020 stated: 6. Independent pH is required to be performed prior to each treatment. A review of facility Procedure: 1-21-09 titled, “Testing pH for Acid Base Dialysate Using RPC E-Z Chek K100-0117CT 6.8 - 8.5 Test Strips” with latest revision date of February 2024 showed the following: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. 4. Within 20 to 25 seconds, compare the color reaction on strip to the color chart. The Facility Administrator was notified of the above findings on 1/13/25 at 1:15 p.m. and acknowledged the findings.”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 50523 Based on a review of Fiscal Year 2025 Quarterly Dialysis Facility Report (QDFR: A report prepared by Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), facility records, and staff interviews, it was determined that the facility failed to effectively manage patients’ nutritional status by identifying root causes and commonalities among patients who did not reach the minimum expected target of albumin (a protein in blood plasma) equal or greater than (>) 4.0 g/dL (grams per deciliter) per “CMS Measures Assessment Tool”, in six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (June 2024 - November 2024). The facility also failed to take remedial action or adjust portions of the plan that are not successful, to maximize the number of patients who achieve the goal. Low albumin levels are highly predictive of mortality risk amongst dialysis patients. This facility had 32 in-center hemodialysis (ICHD) patients and 19 Peritoneal Dialysis (PD) patients. Findings include: A review of the facility’s QAPI meeting minutes from June 2024 - November 2024, revealed no documentary evidence that the QAPI team conducted analysis of the underlying reasons for the facility’s low albumin levels for both ICHD and PD patients. A review of Fiscal Year 2025 QDFR revealed that 61.0% of ICHD patients and 87.0% of PD patients at this facility had albumin levels of < 4 g/dL. The U.S. average was 51.8%. This facility’s average albumin of <4 g/dL for the past six months (June 2024 - November 2024) was 68% for ICHD and 88% for PD. A review of this facility’s ICHD Albumin report for the last six months, showed the following: - In June 2024, 61% of patients had Albumin levels of <4.0 g/dL. - In July 2024, 60% of patients had Albumin levels of <4.0 g/dL. - In August 2024, 46% of patients had Albumin levels of <4.0 g/dL. - In September 2024, 60% of patients had Albumin levels of <4.0 g/dL. - In October 2024, 64% of patients had Albumin levels of <4.0 g/dL; and - In November 2024, 68% of patients had Albumin levels of <4.0 g/dL. A review of this facility’s PD Albumin report from June 2024 - November 2024 revealed the following: - In June 2024, 87% of patients had Albumin levels of <4.0 g/dL. - In July 2024, 88% of patients had Albumin levels of <4.0 g/dL. - In August 2024, 88% of patients had Albumin levels of <4.0 g/dL. - In September 2024, 76% of patients had Albumin levels of <4.0 g/dL. - In October 2024, 76% of patients had Albumin levels of <4.0 g/dL; and - In November 2024, 88% of patients had Albumin levels of <4.0 g/dL. Although the facility data was collected monthly, there was no documented evidence that a root cause analysis was conducted. The plan for the last six months was to educate patients on foods rich in protein. There was a lack of documented evidence that the interdisciplinary team modified or adjust part of the plan nor actively intervene on actionable factors. At 11:24 a.m. on 1/15/25, the Facility Administrator stated that a more thorough investigation will be implemented to identify the underlying cause for both modalities. The Medical Director (MD) acknowledged the above findings on 1/15/25 at 3:30 p.m.”