Davita Americus Dialysis

“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: 03383 Based on observation, staff interviews, a review of facility Policies and Procedures, and review of the Center for Disease Control and Prevention (CDC) recommendations, it was determined that the Infection Control Committee failed to ensure that five of 19 patients (P), (P#9, P#10, P#11, P#12 and P#13) observed at Station (S)1, S5, S9, S12, and S16 respectively, who held pressure to their access sites for hemostasis (stopping of the flow of blood after hemodialysis), performed hand hygiene (wash hands with soap and water or use an alcohol based hand sanitizer) after glove removal and prior to leaving the facility. This deficient practice had the potential for cross contamination. Findings include: During observation in the Patient Treatment Room on 12/11/24 between 8:47 a.m. and 10:00 a.m., the following was observed: - P#9, P#10, P#11, P#12, and P#14 held pressure to their dialysis access sites and left the facility without performing hand hygiene. These patients were not reminded by Direct Patient Care staff (nurses and technicians) to wash their hands nor were offered to use hand sanitizer after glove removal. During staff interviews on 12/11/24 between 9:35 a.m. and 9:40 a.m., Patient Care Technician (PCT) KK and PCT LL stated that they did not ask the patient to perform hand hygiene after glove removal and before leaving the facility. An interview with the Facility Administrator was conducted on 12/11/24 at 9:50 a.m. The Facility Administrator stated staff will receive retraining. A review of Facility Policy: 8-04-01 titled, “Infection Control for Dialysis Facilities”, with last revision date of April 2020, showed: Patients and caregivers will be encouraged to: a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area. According to CDC recommendations, 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.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 03383 Based on tour of the facility, staff interview, and policy review, it was determined that the facility failed to ensure that access to the water purification system was secured and restricted to those individuals responsible for monitoring and maintenance of the system. Findings include: During a tour of the facility with the Facility Administrator on 12/10/24 at 11:37 a.m., the following was observed: The keypad lock on door to the water room was broken. The water room was located in the Storage Room and is accessible to those who were not responsible for tasks in the water room. During an interview during the tour on 12/10/24 at 11:37 a.m, the Facility Administrator stated “it has been broken since last Wednesday (12/4/24)”. The Facility Administrator also stated that if the door is closed, the keypad is not working, and staff would not be able to get into the water room. The Facility Administrator stated that someone was here last Thursday to take a look at the keylock but were unable to repair it. An interview was conducted with the Biomed Technician (BT) on 12/12/25 at 11:15 a.m.. The BT stated that they must wait for the vendor to repair and wasn’t sure when this would be. A review of Policy: 8-04-01 titled, “PHYSICAL ENVIRONMENT” last revised in April 2018 revealed the following: Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 03383 Based on tour of the facility and staff interview, it was determined that the facility failed to ensure that there was a safe environment for all patients and staff, as evidenced by failure of the facility to ensure that one of one double door in the Storage Room, was maintained to prevent entry of insects, rodents, or other vermin. Findings include: During a tour of the facility on 12/10/24 at 11:37 a.m., the following was observed: The double door in the Supply Room leading to the outside had approximately 1/4 inch - 1/2-inch gap between the top of double door and the floor that could allow insects, rodents, and other vermin to enter the building. The metal stripping was loose and damaged. Two dead roaches were observed in the electrical room located next to delivery doors. An interview was conducted with the Facility Administrator during the tour of the facility on 12/10/24 at 11:37 a.m.. The Facility Administrator confirmed the above findings. During an interview with the Biomed Tech on 12/10/24 at 11:15 a.m., the Biomed Tech stated that the owners of the building are responsible for repairing the delivery door and a request had been made. A re-inspection of the back exit doors on 12/12/24 at 1:00 p.m. showed unrepaired gap between the double doors and the floor.”

“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: 03383 Based on a review of medical records, staff interviews, and review of Policy and Procedures (P&P), it was determined that the interdisciplinary team failed to ensure that two of two patients sampled (P#1 and P#3) who experienced elevated blood pressure (BP), received medical care/interventions appropriate to the patient’s dialysis needs per their plans of care. This deficient practice had the potential to negatively affect the health and safety of P#1 and P#3. Uncontrolled BP in dialysis patients can lead to severe consequences such as increased risk of heart attack, stroke, and heart failure, as the damaged kidneys are unable to regulate fluid and BP effectively, making cardiovascular complications a major concern for dialysis patients. Findings include: P#1: P#1 had an order dated 5/24/22 for Clonidine (medication used to treat high BP) 0.2 mg by mouth every hour as needed. The order did not include parameters. A review of “Treatment Detail Reports” dated 11/16/24 to 12/10/24 revealed the following: On 6/20/24: - P#1’s weight pre dialysis was 53.3 kg (kilograms) and 53 kg post dialysis. Estimated dry weight (EDW) was 53 kg. Dialysis time was 3:30 hours. - P#1’s BP was 263/114 mmHg (millimeters of mercury) at initiation of dialysis treatment at 9:39 a.m. by Patient Care Technician (PCT) II. PCT II documented “HTN [hypertension] at start of treatment.” - At 10:01 a.m., P#1’s BP was 249/110 mmHg. Documentation did not show PCT II notified a nurse about elevated BP. - At 10:31 a.m., P#1’s BP was 265/117 mmHg. RN PP documented “bp elevated; will continue to monitor.” The treatment record did not show the RN notified the physician. - At 11:01 a.m., P#1’s BP was 270/123 mmHg. RN PP documented, “bp retake cuff readjusted.” The treatment record did not show the RN notified the physician. - At 11:05 a.m. the treatment record showed RN PP administered Clonidine 0.2 mg p.o. (by mouth). - At 11:09 a.m., P#1’s BP was 264/116 mmHg. PCT II documented, “pt alert; states she feels ok just a little sleepy. The treatment record did not show that PCT notified the nurse. - At 12:02 p.m., P#1’s BP was 223/92 mmHg. PCT II documented, “slight improvement in vitals; will continue to monitor.” The treatment record did not show that PCT notified the nurse. - At 12:31 p.m., P#1’s BP was 221/95 mmHg. RN PP documented, “Patient appears to be tolerating treatment well at this time.” The treatment record did not show that RN notified the physician. - At 1:01 p.m., P#1’s BP was 237/93 mmHg. PCT II documented, “Patient states no complaints at this time.” The treatment record did not show that PCT notified the nurse. - At 1:09 p.m., P#1’s BP was 215/94 mmHg. PCT II documented, “Treatment terminated; Patient’s blood returned without complications.” The treatment record did not show that PCT notified the nurse. -At 1:30 p.m., RN PP documented the following response to medication: “BP continues to increase; patient sent to [hospital] by EMS for further evaluation.” Post treatment BP was 255/108 at 1:30 p.m. - There was a lack of documented implementation of the patient’s plan of care pertaining to BP and fluid management coaching. - There was a lack of documentary evidence that the physician was notified of the persistently elevated BP readings before, during, and after dialysis treatment. On 11/16/24: - P#1’s weight pre dialysis was 51.6 kg and 51.1 kg post dialysis. Estimated dry Weight (EDW) was 53 kg. Dialysis time was 3:30 hours. - P#1’s BP was 194/88 mmHg at initiation of dialysis treatment at 9:28 a.m. by PCT NN. - At 9:31 a.m., P#1’s BP was 189/93 mmHg. - At 10:01 a.m., P#1’s BP was 191/97 mmHg. - At 10:31 a.m., P#1’s BP was 199/96 mmHg - At 11:01 a.m., P#1’s BP was 180/88 mmHg. - At 11:31 a.m., P#1’s BP was 179/91 mmHg. - At 12:01 p.m., P#1’s BP was 192/86 mmHg. - At 12:31 p.m., P#1’s BP was 179/84 mmHg. - At 12:51 p.m., P#1’s BP was 186/88 mmHg. at the end of treatment. - There was a lack of documented evidence that a nurse was notified of the elevated BP. - Post treatment BP was 162/103 sitting and 184/101 standing at 12:53 p.m. - There was a lack of documentary evidence that the physician was notified of the persistently elevated BP readings before, during, and after dialysis treatment. During an interview with the Medical Director (MD) on 12/12/24 at 12:20 p.m., the MD stated that patient’s presenting with elevated blood pressures should be sent to the hospital, don’t put them on the machine; “These blood pressures are through the roof.” MD stated, “This is a new nurse, she just started this year.” MD stated, “She (P#1) should have been sent to the hospital.” The MD stated that he was not notified about P#1’s blood pressures on 6/20/24. The MD stated Clonidine should be given for SBP >180 and DBP >100. P#3: P#3 had an order for Clonidine HCL oral tab 0.2mg every four hours as needed dated 11/9/24. The order did not include parameters. A review of “Treatment Detail Reports” showed the following: On 11/30/24: - Pt #3’s pre-weight was 103.3 kg. Target weight was 101 kg. - P#3’s BP was 186/111 mmHg during initiation of dialysis treatment at 7:30 a.m. Treatment was initiated by PCT GG. Documentation did not show that the nurse was notified about elevated BP. - At 7:31 a.m., P#3’s BP was 185/111 mmHg. - At 8:01 a.m., P#3’s BP was 190/115 mmHg. PCT GG documented, “Patient’s blood pressure is elevated. Charge nurse aware.” - At 8:31 a.m., P#3’s BP was 190/113 mmHg. - At 9:01 a.m., P#3’s BP was 181/115 mmHg. RN AA administered Clonidine 0.2 mg p.o. (by mouth). - At 9:31 a.m., P#3’s BP was 182/118 mmHg. PCT NN documented “Patient’s blood pressure is elevated.” - At 10:01 a.m., P#3’s BP was 178/115 mmHg. - At 10:31 a.m., P#3’s BP was 181/113 mmHg. PCT NN documented “Patient’s blood pressure is elevated.” - At 11:01 a.m., P#6’s BP was 161/109 mm Hg. - At 11:16 a.m., P#6’s BP was 165/104 mm Hg. - At 11:38 a.m., RN AA documented “blood pressure improved some.” - P#3’s post dialysis weight was 100.9 kg which was 0.1 kg under his estimated dry weight. - There was no documented evidence that a licensed nurse was notified of elevated BP readings from 7:30 a.m. to 8:01 a.m. and 9:31 a.m. to 11:16 a.m. - There was no documented evidence that the nurse notified the physician of the elevated BP readings. RN AA did not administer Clonidine until 9:18 a.m., nearly 2 hours after initiation of treatment. During an interview on 12/12/24 at 10:00 a.m., the Manager of Clinical Services (MCS) provided a list of staff who attended an inservice on Pre-Intra-Post Treatment Data Collection and Abnormal findings on 12/11/24. The MCS provided ICHD SBAR tool for Hypertension and Abnormal Findings Job Aid: ICHD/DSD that was reviewed during inservice. A review of Policy: 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last revised April 2024, stated: Pre-Treatment Data Collection/Assessment Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment collection will be documented and immediately reported to the licensed nurse. If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. The assessment is a nursing responsibility. The nurse will assess the patient pre-treatment as warranted by the patient’s condition. The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. The physician (or non-physician practitioner [NPP] if applicable) will be notified of any concerns that may preclude the initiation of dialysis. Abnormal Findings: Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time. Blood pressure: Pre-dialysis: Systolic greater than 180 mmHg or less than 90 mmHg Diastolic greater than or equal to 100 mmHg Blood pressure - Intradialytic: Systolic greater than 180 mmHg or less than 90 mmHg Diastolic greater than or equal to 100 mmHg or less than 50 mmHg Blood Pressure Post Treatment: - If the patient can stand: o Standing systolic BP greater than 140 mmHg or less than 90 mmHg o Standing diastolic BP greater than 90 mmHg or less than 50 mmHg If the patient is not able to stand, document reason and sitting BP: Sitting BP for patient’s that cannot stand: o Sitting systolic BP greater than 140 mmHg or less than 90 mmHg o Sitting diastolic BP greater than 90 mmHg or less than 50 mmHg Heart or Pulse Rate Pre/Intra/Post: - Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 03383 Based on medical record review, staff interview, and policy review, it was determined that the interdisciplinary team failed to ensure that the plan of care was developed within 30 days for one of one patient (P#3) sampled as new admission. This deficient practice had the potential to negatively affect the health and safety of P#3. Findings include: A review of P#3’s medical record on 12/11/24 at 6:30 a.m. revealed that P#3 was admitted to the facility on 9/17/24. No documented evidence of a plan of care was available. During an interview on 12/11/24 at 7:04 a.m., the Facility Administrator confirmed the above finding and stated she would look into it. A review of Policy: 1-14-01 titled, “INTERDISCIPLINARY TEAM (IDT) PATIENT ASSESSMENT AND PLAN OF CARE” dated October 2024 stated, “An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 03383 Based on a review of facility records, review of the facility’s Fiscal Year (FY) 2025 Dialysis Facility Report (DFR: A report prepared by the Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients) and staff interview, it was determined that the facility failed to ensure that the Quality Assessment and Performance Improvement (QAPI) Committee track, trend, analyze, and develop plans of action to improve and sustain the facility’s mineral metabolism/bone disorder and adequacy, for six of six months (May 2024 - October 2024) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 70 in-center hemodialysis (ICHD) patients and 11 Peritoneal Dialysis (PD) patients who received care and support at this facility. Findings include: A review of the FY 2025 Pre-Survey DFR, (first quarter 2024), revealed that the facility was above the United States (US) threshold in: ICHD: 1. Anemia: (Hemoglobin <10.0) - facility was 22 %, US was 16.8 % 2. Mineral Metabolism and Bone Disorder: (Phosphorus greater than (>) 7.0) - facility was 22 %, US was 12.6 %. 3. Fluid Management: (Avg UFR>13 ml/kg/hr) - facility was 13.1 %, US was 9.4 %. 4. Vascular Access: (CVCs only >90 days/3 months) - facility was 25.9 %, US was 9.4 %.10.7 %. PD: 5. Adequacy: (Kt/V <1.7 %) - facility was 13.1 %, US was 5.2 %. Specifically, ICHD: 1. Mineral Metabolism and Bone Disorder - The % of patients with Phosphorus >7.0 was 19.2 % in May 2024, 21.3 % in June 2024, 29.7 % in July 2024, 19.7 % in August 2024, 29.6 % in September 2024, and 25.7 % in October 2024. PD: 2. Adequacy - The % of patients with Kt/V <1.7 % was 12 % in August 2024, 10 % in September 2024, and 20 % in October. 3. Mineral Metabolism and Bone Disorder - The % of patients with Phosphorus >7.0 was 25 % in June 2024, 22.2 % in July 2024, 22.2 % in August 2024, 20 % in September 2024, and 20 % in October. Additionally, the facility’s QAPI meeting minutes from (May 2024 - September 2024) revealed documentary evidence that the interdisciplinary team (IDT) conducted a review of adequacy and mineral/bone for PD and mineral/bone for ICHD. However, no changes had been made to the action plans to achieve and sustain improvements in the above-mentioned outcomes. During an interview on 12/11/24 at 10:45 p.m., the Facility Administrator confirmed that no changes had been made to the action plans to ensure and sustain improvements.”