Davita Snellville Dialysis

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on facility record review, and staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This deficient practice had the potential to negatively affect the health and safety of 72 in-center hemodialysis patients and 12 peritoneal dialysis patients who were under the care of this facility. Findings include: Cross-References: V757 - Failure of the Governing Body to ensure that the facility had adequate number of qualified staff to meet the needs of all patients and provide safe patient care; and to be in compliance with the minimum State required staffing ratios of one licensed and qualified nurse for every 12 patients who were receiving dialysis care and one qualified patient care giver for every four patients. V765- Failure of the Governing Body to ensure that three of three patients’ (P), (P#1’s, P#4’s, and P#5’s) complaints/grievances were investigated and followed through to resolution.”

“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 supplies in one of one Laboratory cabinet were removed and not made available for use. This deficient practice 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 on 2/3/25 from 10:35 a.m. though 11:20 a.m., the following supplies had expired, thus these were not suitable for use: In the Laboratory cabinet: - 100 gold top tubes expired on 12/31/24. - The Facility Administrator (FA) acknowledged these findings on 2/3/25 at 11:15 a.m. According to FDA recommendations dated 2/8/21, the 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. Once the expiration date has passed there is no guarantee that the supplies will be safe and effective. 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: 32734 Based on observation, staff interview, a review of Centers for Disease Control and Prevention (CDC) recommendations, and a review of the facility’s Policy and Procedures (P & P), it was determined that the Governing Body failed to ensure that one of one Patient Care Technician (PCT AA) observed, did not wear gloves when touching the patient’s, (P) (P#8’s), equipment and performing direct patient care; nor performed hand hygiene (wash hands or use an alcohol-based hand sanitizer) after performing a “dirty” task. Failure to wear gloves when touching contaminated surfaces and failure to perform hand hygiene increased the risk for cross contamination with the potential to expose all patients and staff to bloodborne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect the health and safety of all 72 in-center hemodialysis patients who were dialyzing at this facility and all the Direct Patient Care Staff (Registered Nurses- RNs, Licensed Practical Nurses - LPNs and PCTs). Findings were: During observation in the Patient Treatment Room on 2/3/25 at 10:40 a.m., PCT AA silenced the machine alarm and then adjusted the dialyzer of the patient, (P#8), at Station (S8), without wearing gloves. PCT AA did not perform hand hygiene after touching P#8’s machine and dialyzer. During an interview on 2/3/25 at approximately 10:45 a.m., PCT AA was asked if he was aware that he was not wearing gloves when touching the dialysis machine at S8. PCT AA stated, “They do things different at every clinic I go to”. According to CDC RR-5 “Recommended Infection Control Practices for Hemodialysis Units at a Glance”, staff must 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. - A review of the facility’s 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 (NPP) will perform hand hygiene b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse”

“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 (July 2024 - December 2024). The facility also failed to take remedial action or adjust portions of the plan that were not successful, to maximize the number of patients who achieved the goal. Low albumin levels are highly predictive of mortality risk amongst dialysis patients. This facility had 12 Peritoneal Dialysis (PD) patients. Findings include: A review of the facility’s QAPI meeting minutes from July 2024 - December 2024, revealed no documentary evidence that the QAPI team conducted analysis of the underlying reasons for the facility’s low albumin levels for PD patients. A review of Fiscal Year 2025 QDFR revealed 64.1% of PD patients at this facility had albumin levels of less than (<) 4 g/dL. The U.S. average was 51.8%. This facility’s average albumin of <4 g/dL for the past six months (July 2024 - December 2024), was 73% for PD patients. A review of this facility’s PD Albumin report from July 2024 - December 2024 revealed the following: - In July 2024, 64% of patients had Albumin levels of <4.0 g/dL. - In August 2024, 60% of patients had Albumin levels of <4.0 g/dL. - In September 2024, 45% of patients had Albumin levels of <4.0 g/dL. - In October 2024, 67% of patients had Albumin levels of <4.0 g/dL. - In November 2024, 67% of patients had Albumin levels of <4.0 g/dL; and - In December 2024, 73% 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. There was a lack of documented evidence that the interdisciplinary team modified or adjusted part of the plan nor actively intervened on actionable factors. The PD manager, and the Facility Administrator acknowledged the above findings during the exit interview on 2/5/25 at 3:15 p.m.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 50523 Based on a review of facility records, patient and staff interviews, and a review of minimum state required staffing ratios, it was determined that the Governing Body failed to ensure that the Facility Administrator employed adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients) who was readily available to provide nursing care, take charge and deal with unexpected complications of dialysis, other medical issues and emergencies, for every 12 patients receiving dialysis care; and that each care giver was not assigned more than four patients at any given time. This deficient practice had the potential to negatively affect the health and safety of 72 ICHD patients who dialyzed at this facility. Findings include: - A review of “Patient and Teammate Schedule” (schedule of the number of patients dialyzing each shift and the number of Patient Care Technicians and licensed nurses providing patient care services), from November 2024 to January 2025, revealed the following: - The Patient Treatment Room had four Pods (sections) with four patient Stations (S) in each Pod. - On Mondays, Wednesdays and Fridays (MWF) schedule, there were three shifts, with a total of 16 patients per first and second shifts, and 12 patients on third shift. - On Tuesdays, Thursdays, and Saturdays (TTS) schedule, there were two shifts with a total of 16 patients per shift. -The schedule on the following dates revealed that the licensed nurses, (Registered Nurses - RNs and Licensed Practical Nurses -LPNs), functioned as patient care givers, providing total care to four patients per nurse in a Pod each shift. Both scheduled RNs and/or LPNs not only provided nursing care/tasks including, but not limited to pre and post dialysis assessments, preparation and administration of medications, communicating with doctors as needed, as well as overseeing the care of other patients who were assigned to the other two Patient Care Technicians (PCTs) on the schedule, but the nurses also functioned as patient care givers, providing total care to four patients per shift: - On 11/7/24 - two PCTs, one LPN and one RN. - On 11/29/24 - two PCTs, two RNs. - On 12/6/24 - two PCTs, two RNs. - On 12/9/24 - two PCTs, two RNs. - On 12/11/24 - two PCTs, two RNs. - On 12/12/24 - two PCTs, one LPN and one RN. - On 12/14/24 - two PCTs and two RNs. - On 1/1/25 - two PCTs, one LPN and one RN. - On 1/2/25 - two PCTs, two RNs. - On 1/3/25 - two PCTs, one LPN and one RN. - On 1/6/25 - two PCTs, one LPN and one RN. - On 1/7/25 - two PCTs, one LPN and one RN. - On 1/8/25 - two PCTs, one LPN and one RN. - On 1/10/25 - two PCTs, one LPN and one RN. - On 1/13/25 - two PCTs, one LPN and one RN. - On 1/14/25 - two PCTs, one LPN and one RN. - On 1/22/25 - two PCTs, one LPN and one RN. - On 1/23/25 - two PCTs and two RNs. - On 1/27/25 - two PCTs, one LPN and one RN. - During patient interviews on 2/3/25 between 11:25 a.m. and 11:38 a.m., the following was revealed: - Patient (P) #2, stated that her hemodialysis treatments had been delayed for the last couple of months due to not having enough Direct Patient Care (DPC) staff (Nurses and PCTs), causing for her transportation to be constantly re-scheduled to a later time than her scheduled pick-up time. - P#3 stated that since October 2024 the facility had been short-staffed. P#3 stated that he was constantly getting late being connected to the hemodialysis machine, anywhere between 45 minutes to 90 minutes after his scheduled treatment time because there wasn’t enough DPC staff. P#3 also stated that he had considered transferring to another dialysis facility due to consistently being inconvenienced, (being put on late for hemodialysis treatment and not running his whole prescribed treatment time), due to lack of DPC staffing issues. - During interviews with DPC Staff on 2/3/25, between 11:53 a.m. and 12:45 p.m., the following was revealed: - RN BB stated that the staffing had been an issue for quite a while, and she added that it was overwhelming to be assigned to a Pod of four patients per shift, and to be responsible for four other patient’s medications and nursing assessments. RN BB also stated that she knew that if she was assigned to take care of a Pod of four patients, her patient ratio should only be four patients on her Pod, and not be one nurse to 12 patients. - PCT AA stated that Direct Care Staffing was an issue. PCT AA added that on most days it was only one PCT and two nurses treating 12 patients per shift and had to re-schedule the other patients to make-up for their treatments on other days of the week. - During staff interviews on 2/4/25, the following was revealed: - The Charge Nurse/RN (CN/RN AA) stated at 9:45 a.m., that there had been direct care staffing issues for some time now. CN/RN AA added that most days she did take a Pod and still had to oversee all patients during their treatment time. CN/RN AA also stated that it was a lot of responsibility due to the possibility of causing injury to a patient or a potential to make mistakes because of short staffing. - The Facility Administrator (FA) stated at 2:48 p.m., that he usually scheduled two nurses and two PCT’s as DPC staff for each dialysis treatment day. The FA confirmed what CN/RN AA stated, that most of the time the CN/ RN was assigned to take care of a Pod in addition to overseeing the treatment of patients in the Patient Treatment Room. - A telephonic interview was conducted on 2/4/25 at 3:32 p.m. with P#1. P#1 stated that there was never enough DPC staff to treat the scheduled patients, and the DPC staff were overworked and placed their licenses on the line just to make sure every patient received treatment even when the staff to patient ratio was not correct. P#1 stated the facility will send patients home without received treatment due to insufficient staffing. P#1 stated that most mornings there is only one PCT and two nurses working without a fourth direct care staff. P#1 also stated that sometimes that fourth direct care staff will come hours late or not come at all which caused delayed hemodialysis treatments. - On 2/5/25 at 12:59 p.m., Licensed Practical Nurse (LPN AA), stated it’s not safe for the patients or DPC staff to continue to provide care for the patients when DPC staff is not within proper ratio. LPN AA added that most days there were only four DPC staff, namely; two PCTs and two nurses, and it was extremely overwhelming to be called “everywhere” because she had to perform assessments and administered medications for four other patients in addition to the four patients who were assigned to her, in her own Pod. LPN AA stated there should be more eyes and hands available to assist or provide patient care. LPN AA also revealed that the scheduled CN/RN and herself were always assigned a Pod of four patients per shift, which required the nurses to disinfect dialysis machines, set up or prepare each machine for dialysis, initiate treatments, perform pre-assessments, monitor patients before, during, and after dialysis, perform post treatment assessments, remove used bloodlines, then do it all over again in preparation for all four patients scheduled in the next shift, in their assigned Pod.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 50523 Based on a review of facility records and patient and staff interviews, it was determined that the Governing Body failed to ensure that three of three patients’ (P), (P#s1’s, P#4’s, and P#5’s), complaints/grievances that were received by the facility, were investigated and followed through to resolution. This deficient practice had the potential to negatively affect the health and safety of 72 in-center hemodialysis patients and 12 peritoneal dialysis patients who were under the care of this facility. Findings include: - A review of the facility’s “Patient Grievance Log” from August 2024 to January 2025 revealed the following: - P#1 presented a complaint on 12/18/24 at 3:15 p.m., to the Social Worker (SW) verbally, and was documented by the SW stating that, “Patient notes clinic is short staffed and, ‘the other day they only treated three hours’. He also noted today they started 1.5 hours late. He’s been tempted to call CMS”. - P#4 presented a verbal complaint to the SW on 12/18/24 at 3:15 p.m., and was documented by the SW, stating that she (P#4), was in the lobby waiting for over an hour. - P#5 presented a verbal complaint to the SW on 12/18/24 at 12:00 p.m., and was documented by the SW, stating that she believes it’s unfair that MWF (Monday-Wednesday-Friday) patients have to shorten their treatments. -There was no documentary evidence that the facility conducted interviews and investigation, nor a plan of resolution for all three patients (P#1, P#4, and P#5). The “Grievance/Investigation Document” form was signed as completed by the Facility Administrator, without a date, except for P#4’s “Grievance/Investigation Document” as signed by the Facility Administrator and date completed was 11/27/24. All three patients’ (P#1’s, P#4’s, and P#5’s) “Grievance/Investigation Document” forms were left blank. A review of the facility’s Policy: 3-01-06 titled, “Patient Grievance” with latest revision date of October 2018 stated: Internal Grievance Process: C. The FA (or her/his designee is to discuss the grievance with the patient, investigate and take appropriate action towards a solution, if possible. This discussion should occur within 10 days of receipt of the grievance. If the patient’s grievance cannot be resolved by the FA, the ROD and Medical Director will be notified ... If the patient grievance cannot be resolved by the ROD and/ or Medical Director, the Divisional Vice President will be notified. - A telephonic interview with P#1 was conducted on 2/4/25 at 3:32 p.m. P#1 stated that there was never enough DPC staff to treat the scheduled hemodialysis patients. P#1 also added that the DPC staff were overworked and were putting their licenses on the line just to make sure every patient received treatment even when the DPC staff to patient ratio was not correct. P#1 also stated that the facility will send patients home without receiving treatment due to insufficient staffing, and that most mornings there was only one PCT and two nurses working without a fourth DPC staff. P#1 also stated that sometimes the fourth DPC staff will come hours late or not come at all which caused delayed hemodialysis treatments. - During an interview with the Social Worker on 2/5/25 at 12:00 p.m., she stated that five patients consistently complained of staffing shortages since the previous Facility Administrator left in October 2024, and the patients complained that they did not feel comfortable with so many different staff (Float staff). The SW also stated that she’s at the facility two days per week and the staff usually tells her the patient’s/patients’ concerns and waits for her to address them. - A telephonic interview was conducted on 2/5/25 at 2:37 p.m. with the Medical Director (MD). The MD stated he was not made aware of the patient’s grievances that were not resolved. The MD also stated that the facility will ensure that each grievance will be addressed and resolved within the appropriate time frame.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 25727 Based on observation and patient and staff interviews, it was determined that the facility failed to ensure that five of five handwashing sinks in the treatment area had warm water available, to encourage staff to wash their hands according to Centers for Disease Control (CDC) recommendations; and that warm water was available for patients to wash their access sites prior to treatment and their hands after treatment. This failure could negatively affect the health and safety of 77 patients who were receiving dialysis treatment at this facility. Findings were: During observation in the patient treatment room on 12/22/23 between 12:15 p.m. and 1:15 p.m., the following was revealed: - There were five handwashing sinks in the patient treatment room. - All sinks did not have warm water after running each faucet for five minutes at a time. - P#6 who dialyzed at S10 was observed washing her hands after treatment before leaving the treatment room. P#6 washed her hands with cold water for four seconds only. - Staff AA was observed washing her hands for five seconds. - Staff BB washed her hands for four seconds. A review of the CDC recommendations showed hand washing incorporate rubbing hands together “vigorously” for 15 seconds ... During staff interviews on 12/22/23 between 1:00 p.m. - 2:00 p.m., the following was revealed: - Staff AA stated that she did not realize that she washed her hands for five seconds only because the water was cold. Stated that she usually just use a hand sanitizer. - Staff BB stated she did not wash her hands longer because the water was cold. - The Charge Nurse confirmed the lack of warm water in the treatment area. - During a telephonic interview with the Biomed Technician, he stated that he reached out to the contractor a month ago. Stated that the water heating valve needed to be replaced and had been ordered by the contractor. However, he was not sure if it has been fixed. - During a telephonic interview, the Facility Administrator stated that the issue with the water was addressed and it was fixed. Stated “nothing is wrong with the water”. The facility was unable to produce documented evidence of the work order or the repair that was done to the water heater.”