Davita Candler County Dialysis

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 03383 Based on a review of facility records including facility’s Policies and Procedures (P & P), and staff interview, it was determined that the Medical Director (MD) failed to ensure that all Direct Patient Care Staff (Registered Nurse - RN AA and Patient Care Technicians - PCTs AA, DD, FF, II), adhered to facility’s P & P pertaining to hypertension [elevated blood pressure (BP)] to ensure that two of two patients, (P#1 and P#4) sampled, who experienced high BP readings during dialysis treatment, received medical care and supervision appropriate to their dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg (millimeters of mercury) before dialysis and below 130/80 mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services (CMS) - Version 2.5. 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. The facility census was 36. Findings include: Cross Reference: V 715 - Failure of the Medical Director to ensure that all Direct Patient Care Staff (RN AA and PCTs AA, DD, FF, and II) sampled, adhered to the facility’s P & P and followed the Standing Order pertaining to hypertension to ensure that two of two patients (P#1 and P#4) sampled, who experienced high BP readings during dialysis treatment, received medical care and supervision appropriate to the patients’ dialysis needs.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on observation, facility record review, staff interviews, and a review of the facility’s Policies and Procedures, 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 36 in-center hemodialysis patients who were under the care of this facility. Findings include: Cross-Reference: V 715 - Failure of the Medical Director to ensure that all Direct Patient Care Staff adhered to the facility’s P & P pertaining to hypertension [elevated blood pressure (BP)] to ensure that two of two patients (P# 1and P#4) sampled, who experienced high BP readings during dialysis treatment, received medical care and supervision appropriate to the patients’ dialysis needs.”

“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 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 Governing Body failed to ensure that the Infection Control Committee implemented P&P as evidenced by two of three patients, (P#6 and P#7) who held pressure to their access sites for hemostasis (stopping of the flow of blood after hemodialysis), did not perform 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 and increased risk of infection in the hemodialysis unit. The facility census was 36. Findings include: During observation in the Patient Treatment Room on 1/27/25 between 1:33 p.m. and 3:45 p.m., the following was observed: - P#6 and P#7 who were seated at Stations, 10 and 2 respectively, held pressure to their dialysis access needle sites and left the facility without performing hand hygiene. Both P#6 and P#7 were not reminded by the staff to wash their hands nor were offered to use hand sanitizer after glove removal. - This surveyor informed RN AA about the above observation on 1/27/25 at 3:54 p.m. RN AA stated that she tried to remind patients to perform hand hygiene before leaving the treatment room, but she was not the one who assisted P#6 and P#7 when they left the hemodialysis unit. 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. - A review of facility Policy: 1-05-01, titled, “Infection Control for Dialysis Facilities”, with latest revision date of April 2023, stated: 2. Patients and caregivers will be encouraged to ... b. Perform hand hygiene after treatment before leaving treatment area. The above observation was reported to the Facility Administrator and Regional Operations Director on 1/27/25 at 4:10 p.m.”

“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 observation 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 doors in the Storage Room, was maintained to prevent entry of insects and vermin. The facility census was 36. Findings include: During a tour of the facility with the Facility Administrator on 1/27/25 at 1:03 p.m., the following was observed: The double doors in the Storage Room that led to the outside had approximately 1/4 inch - 1/2 inch gap between the right side of the double doors and the floor (12 inches across the right door), that could allow insects and vermin to enter the building. A re-inspection of the back exit doors on 1/29/25 at 10:30 a.m., showed unrepaired gap between the double doors and the floor.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 03383 Based on observation, staff interview, and a review of facility Policy, it was determined that the facility failed to maintain a safe environment in one of one Patient Treatment Room, as evidenced by torn leather upholstery on five of 18 hemodialysis chairs at Stations (1, 2, 3, 4, and 10). This failure could hinder effective cleaning and disinfection of the surfaces, thus had the potential for microbial growth and could negatively affect the health and safety of all patients who used these hemodialysis chairs during their hemodialysis treatment. The facility census was 36. Findings include: During observation in the Patient Treatment Room on 1/27/25 between 1:33 p.m. and 3:45 p.m., the following was observed: The hemodialysis chairs at Stations 1, 2, 3, 4, and 10, had torn upholstery ranging from approximately 1/4 inches to 3 inches in length and diameter, along the right arm rest and on the seat of one chair. - The Charge Nurse (RN AA), who was present during the discovery of these torn upholstery, confirmed the above findings on 1/27/25 at 3:54 p.m. RN AA stated, the chairs were under a lifetime warranty and they had tried contacting the vendor however, they had not been able to get in touch with the vendor since the hurricane in September 2024. A review of Policy: 8-04-01, titled, “Physical Environment” dated April 2018, stated: The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.”

“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 the facility’s Fiscal Year (FY) 2025 Quarterly Dialysis Facility Report (QDFR: 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), a review of facility records, and staff interview, it was determined that the Quality Assessment and Performance Improvement (QAPI) Committee failed to make changes to plans of action to improve and sustain the facility’s fluid management, mineral metabolism/bone disorder, vascular access, adequacy, anemia, and nutrition outcomes for in-center hemodialysis (ICHD) patients and/or home program patients, in six of six months (July 2024 - December 2024) of QAPI meeting minutes reviewed. This deficient practice had the potential to negatively affect the health and safety of 36 patients who were receiving dialysis services at this facility. Findings include: A review of the FY2025 QDFR, revealed that the facility was above the United States (US) threshold in the following: 1. Anemia: (Hemoglobin less than [<] 10) - facility was 21.9 %, whereas the US was 16.8 % nationally. 2. Mineral Metabolism and Bone Disorder: (Phosphorus greater than [>] 7.0) - facility was 21.1%, whereas the US was 12.6% nationally. 3. Fluid Management: (Average UFR [Ultrfiltration Rate] > 13 ml/kg/hr - milliLiter/kilogram/hour) - facility was 14.3 %, whereas US was 9.4%, nationally. UF (Ultrafiltration - a process that removes excess fluid and waste from a patient’s blood during dialysis). 4. Vascular Access: (Long-Term Central Venous Catheter (CVC) Rate > 90 days/3 months) - facility was 16.2%, whereas US was 10.7 % nationally. In Comparison, a review of the facility’s third and fourth quarter 2024’s QAPI meeting minutes from July 2024 to December 2024 revealed that the facility was above the United States (US) threshold in the following: - Percent of patients at this facility with Anemia (Hemoglobin < 10), was 33.3% in July 2024, 21.1% in August 2024, 19.4% in October 2024, 18.9 % in November 2024 and 21.6% in December 2024, while the US was at 16.8% nationally. - Percent of patients at this facility with Phosphorus > 7.0 was 22.2 % in July 2024, 13.9 % in August 2024, 32.4 % in September 2024, 17.1% in October 2024, 23.5 % in November 2024 and 30.6 % in December 2024, while the US was at 12.6% nationally. - Percent of patients at this facility with CVCs only > 90 days/3 months) was 16.7% in July 2024, 16.7% in August 2024, 11.8% in September 2024, 17.1% in October 2024, 17.6 % in November 2024 and 2024, 19.4.6% in December 2024, while the US was at 10.7 % nationally. Additionally, the facility’s QAPI meeting minutes from July 2024 - November 2024 revealed documentary evidence that the interdisciplinary team (IDT) conducted a review of anemia; however, the facility was tracking Hemoglobin < 9 instead of Hemoglobin < 10. And although the IDT was tracking mineral metabolism and bone disorder, and vascular access (CVC), there were no changes made to the action plans to attain and sustain improvement. The Facility Administrator and Clinical Nurse Manager were present during the review on 1/28/25 at approximately 10:30 a.m., and both stated that the IDT will work toward improvement of these outcomes. The Facility Administrator also confirmed there were no changes made to the plans for anemia or vascular access in June 2024 through December 2024. A review of Policy: 1-14-06 titled, “Continuous Quality Improvement Program” dated April 2021, stated: The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not be limited to, the following: o Adequacy of Dialysis (Kt/V) o Nutritional Status (Albumin) o Mineral Metabolism and Renal Bone Disease o Anemia Management o Vascular Access Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvements are sustained.”

“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: 03383 Based on a review of medical records, staff interview, and a review of facility Policy and Procedures (P &P), it was determined that the Medical Director failed to ensure that all Direct Patient Care Staff (Registered Nurse - RN AA and Patient Care Technicians - PCTs AA, DD, FF, II), adhered to facility P & P pertaining to hypertension [elevated blood pressure (BP)] to ensure that two of two patients, (P#1 and P#4) sampled, who experienced high BP readings during dialysis treatment, received medical care and supervision appropriate to their dialysis needs. The professionally accepted clinical practice standards for volume status for an adult hemodialysis patient was euvolemic (normal volume of blood or fluids in the body) and BP below 140/90 mmHg (millimeters of mercury) before dialysis and below 130/80 mmHg after dialysis. This was based on the Kidney Disease Outcomes Quality Initiative (KDOQI) recommendations and the Measures Assessment Tool (MAT) per Centers for Medicare and Medicaid Services (CMS) - Version 2.5. 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. The facility census was 36. Findings include: - A review of medical records revealed that a Standing Order, (a written protocol that authorizes specific healthcare team members like nurses, to perform certain clinical tasks without needing to first get a direct order from the physician for each individual patient, essentially giving pre-approved instructions for routine situations that meet specific criteria, which allows for faster and more efficient patient care), of Clonidine HCL [used to treat hypertension] 0.2 mg orally every four hours PRN (as needed) was established. Administer for BP systolic greater than (>) 180 mmHg (millimeters of mercury) and diastolic > 100 mmHg. Call physician for further instructions if BP has not improved in one hour. During a telephonic interview with the Medical Director (MD) on 1/28/25 at 9:36 a.m., when asked about BP parameters for elevated BPs and what actions should be taken if BP exceeds parameters; the MD stated, parameters for systolic blood pressure (SBP) >180 mmHg and diastolic BP (DBP) > 100 mmHg. The MD added that if a patient presents to the dialysis facility with BPs that exceeded parameters, the DPC staff was to place the patient on dialysis and see if BP readings came down, but if not, to give clonidine as ordered. If the BP is still elevated, call the physician to determine if another dose of clonidine should be given, or may need to change the dosage. MD didn’t indicate what should be done if BP remains elevated after a second dose of clonidine was given. P#1 - A review of P#1’s “Treatment Details Report” dated 1/13/25, showed the following: - P#1’s BP was 215/144 mmHg during initiation of dialysis treatment at 7:08 a.m. PCT AA initiated hemodialysis treatment and documented, “Treatment started without complications; Patient access cannulated without difficulty; patient treatment time extended 30 minutes, sequential (fluid removal only) first two hours per MD order; patient short of breath [SOB]”. (sic) - At 8:03 a.m., P#1’s BP was 218/148 mmHg per Registered Nurse (RN AA). - At 8:33 a.m., P#1’s BP was 221/142 mm Hg per PCT II. - At 9:03 a.m., P#1’s BP was 206/145 mmHg per PCT DD. - At 9:33 a.m., P#1’s BP was 218/138 mmHg per PCT DD. - At 9:41 a.m., RN AA documented, “Ultra-filtration time up dialysate back on UF goal increased by 2.5”. - At 10:03 a.m., P#1’s BP was 192/119 mmHg. PCT DD documented, “BP elevated, UF goal adjusted. - At 10:34 a.m., P#1’s BP was 192/125 mmHg per PCT DD. - At 11:03 a.m., P#1’s BP was 211/136 mm Hg per PCT DD. - At 11:33 a.m., P#1’s BP was 214/144 mmHg per PCT DD. - At 12:03 p.m., P#1’s BP was 215/146 mmHg per PCT DD. - At 12:10 p.m., P#1’s BP was 222/130 mmHg per PCT DD. - P#1’s post-treatment sitting BP was 236/137; no standing BP was taken. P#1 was discharged to home. - There was a lack of documentary evidence that PCT DD notified the nurse about P#1’s elevated BP readings. - There was a lack of documentary evidence that clonidine PRN was offered by a licensed nurse. - There was a lack of documentary evidence that the physician was notified of the persistently elevated BP readings during and after dialysis treatment. - Further review of P#1’s “Treatment Details Report” on the following dates also revealed elevated SBPs >180 mmHg and DBPs >100 mmHg without documentary evidences of PCTs reporting to the licensed nurse about P#1’s elevated BP readings, nor any documented evidence of interventions performed by a licensed nurse: - On 1/14/25 - Treatment (Tx) started at 8:07 a.m. and ended at 11:57 a.m. DBP ranged from 101 - 114 mmHg. - On 1/15/25 - Tx started at 12:35 p.m. and ended at 2:36 p.m. SBP ranged from 197 - 202 mmHg; and DBP ranged from 105 - 111 mmHg. - On 1/17/25 - Tx started at 12:20 p.m. and ended at 3:54 p.m. SBP ranged from 180 -183 mmHg; and DBP ranged from 103 - 111 mmHg. - On 1/20/25 - Tx started at 11:17 a.m. and ended at 2:22 p.m. SBP ranged from 182 -196 mmHg; and DBP ranged from 108 - 125 mmHg. - On 1/27/25 - Tx started at 10:17 a.m. and ended at 2:17 p.m. DBP ranged from 108 - 124 mmHg. P#4 - A review of P#4’s “Treatment Details Report” dated 1/24/25, showed the following: - P#4’s BP was 209/117 mmHg during initiation of dialysis treatment at 1:11 p.m. by RN AA. - At 1:34 p.m., P#4’s BP was 232/123 mmHg per PCT DD. - At 1:41 p.m., P#4’s BP was 180/111 mmHg per PCT DD. - At 2:04 p.m., P#4’s BP was 208/110 mmHg per PCT FF. - At 3:05 p.m., P#4’s BP was 198/101 mmHg per PCT FF. A 30-minute check was missing between 2:04 p.m. and 3:05 p.m. - At 3:35 p.m., P#4’s BP was 252/101 mmHg per RN AA. - At 4:11 p.m., P#4’s BP was 218/104 mmHg per RN AA. - There was a lack of documentary evidence that PCT DD and PCT FF notified the nurse about P#1’s elevated BP readings. - There was a lack of documentary evidence that clonidine PRN was offered by a licensed nurse. - There was a lack of documentary evidence that the physician was notified of the persistently elevated BP readings before, during, and after dialysis treatment. - Further review of P#4’s “Treatment Details Report” on the following dates also revealed elevated SBPs >180 mmHg and DBPs >100 mmHg without a documentary evidence of PCTs reporting to the licensed nurse about P#4’s elevated BP readings, nor any documented evidence of interventions performed by a licensed nurse: - On 1/17/25 - Tx started at 12:20 p.m. and ended at 3:54 p.m. SBP ranged from 180 -183 mmHg; and DBP ranged from 103 - 111 mmHg. - On 1/20/25 - Tx started at 11:17 a.m. and ended at 2:22 p.m. DBP ranged from 105 - 108 mmHg. - On 1/27/25 - Tx started at 11:22 a.m. and ended at 3:21 p.m. SBP was 191 mmHg at 11:26 a.m.; and DBP ranged from 109 - 110 mmHg. - A review of Policy: 1-03-08, titled, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, dated April 2024, stated: PRE-TREATMENT INTRA, and POST DATA COLLECTION/ASSESSMENT: - Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to “Abnormal Findings” section of this policy). 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 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. Intradialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes: - Vital signs and treatment monitoring: - Non-nocturnal treatments are completed at least every thirty (30) minutes. - The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. POST TREATMENT DATA COLLECTION/ASSESSMENT: 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 mm/Hg or less than 90mm/Hg - Diastolic greater than or equal to 100 mm/Hg or less than 50mm/Hg Blood Pressure-Intradialytic: - Systolic greater than 180mm/Hg or less than 90mm/Hg - Diastolic greater than or equal to 100mm/Hg or less than 50mm/Hg Blood Pressure Post Treatment: If the patient can stand: - Standing systolic BP greater than 140mm/Hg or less than 90 mm/Hg - Standing diastolic BP greater than 90mm/Hg or less than 50mm/Hg Sitting BP for patient’s that cannot stand: - Sitting systolic BP greater than 140mm/Hg or less than 90 mm/Hg - Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg”