Davita Atlanta Airport 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 and staff interview, it was determined that the Medical Director failed to demonstrate accountability for the clinical operations of the facility to ensure the delivery of safe patient care. This failure had the potential to negatively affect the health and safety of 78 patients who were dialyzing at this facility. Findings include: Cross Reference: V 715 - Failure of the Medical Director to ensure that all Direct Patient Care Staff (Registered Nurses- RN AA, RN BB and RN GG; and Patient Care Technicians - PCT CC, PCT DD, PCT EE, PCT FF, and PCT HH), adhered to facility policy and procedures pertaining to abnormal blood pressure (BP) readings and rapid heart rates, to ensure that six of six patients, (P#1, #2, P#3, P#4, P#5, and P#16) sampled, who experienced high or low BP readings and elevated heart rates during dialysis treatment, received medical care and supervision appropriate to 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 facility policy 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 78 dialysis patients who were under the care of this facility. Findings were: Cross-References: V715 - Failure of the Medical Director to ensure that all Direct Patient Care Staff (Registered Nurses- RN AA, RN BB and RN GG; and Patient Care Technicians - PCT CC, PCT DD, PCT EE, PCT FF, and PCT HH), adhered to facility policy and procedures pertaining to abnormal blood pressure (BP) readings and rapid heart rates, to ensure that six of six patients, (P#1, #2, P#3, P#4, P#5, and P#16) sampled, who experienced high or low BP readings and elevated heart rates during dialysis treatment, received medical care and supervision appropriate to patients’ dialysis needs. V757 - Failure of the Facility Administrator 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.”

“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 staff interviews and a review of medical records including facility Policy and Procedures (P & P), it was determined that the Medical Director failed to ensure that all Direct Patient Care (DPC) Staff, (Registered Nurses - RN AA, RN BB, and RN GG) and Patient Care Technicians - (PCT CC, PCT DD, PCT EE, PCT FF, and PCT HH), adhered to facility P & P pertaining to high and low blood pressure (BP) readings and rapid heart rates, to ensure that six of six patients sampled, (P#1, #16, P#5, P#3, P#4, and P#2) respectively, who experienced high or low BP readings and rapid heart rates 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 78. Findings include: A review of P#1’s medical records revealed the following: - P#1 - had a standing order of clonidine 0.1 mg orally every 4 hours as needed, dated 10/24/23 with no end date. - A review of the P#1’s “Treatment Details Report”, dated 2/18/25, showed the following: - Duration of treatment: 3h 45 m (225 min); Blood Flow Rate (BFR 450); Dialysate Flow Rate (DFR 600); - Estimated Dry Weight (EDW) 85 kilograms [kg]; Hemodialysis (HD) Access: Left Upper Arm (LUA) Arterio-Venous Fistula (AVF). P#1’s pre-treatment weight was 90.2 kg and pre-treatment BP was 195/80 mmHg. PCT EE entered the following documentation as, “Initial Entry”: - At 6:31 a.m., “Treatment started without complications”. BP 215/106 mmHg, Heart Rate (HR) - 86 beats/min. - At 7:02 a.m., “Patient monitored, eyes closed; patient resting”. BP 204/100 mmHg, HR - 83 beats/minute - At 7:32 a.m., “Patient monitored; watching TV no complications”. BP 189/101 mmHg, HR - 75 beats/minute - At 8:05 a.m., “Treatment terminated”. BP 177/92 mmHg, HR - 88 beats/minute - At 8:06 a.m., “Manual Entry: BP was normal”. BP 177/92 mmHg, HR - 70 beats/minute - At 8:34 a.m., “BP taken before CPR”. (CPR-Cardio-Pulmonary-Resuscitation). BP 185/161 - HR 78. There was a lack of documentary evidence that PCT EE notified the nurse of P#1’s high BP readings, or if clonidine PRN was offered by a licensed nurse. There was a lack of documentary evidence that the physician was notified of P#1’s persistently elevated BP readings during dialysis treatment and if the physician was notified of P#1’s cardiac arrest. PCT EE entered the following documentation as “Updated” entry: - At 8:23 a.m., “Patient awake, alert; and states no complaints at this time”. No recorded vital signs (VS). - At 11:51 a.m., “BP taken on the leg”. No VS recorded. - At 11:54 a.m., “Patient monitored eyes closed; patient resting; BP taken on the leg”. BP 178/93 mmHg. No HR. - At 11:56 a.m., BP 185/101 mmHg. No HR. - At 12:00 p.m., “Nurse notified about pt. condition”. No VS. - Pre-treatment assessment documentation was entered by RN AA in the “Treatment Details Report” at 1:01 p.m. and post-assessment was entered by RN AA at 2:59 p.m. - A review of P#1’s “CardioPulmonary Arrest Report”, stated that the date/time the event was recognized was on 2/18/25 at 8:17 a.m., stating, “patient unresponsive” and CPR was initiated at 8:23 a.m. An Automated External Defibrillator (AED- a portable medical device designed to analyze the heart rhythm and deliver an electric shock to the heart) was used at 8:30 a.m., then an electric shock was given at 8:35 a.m. There was no mention of when the Emergency Medical Services (EMS) was activated with a 911 call, however, the report showed that EMS took over at 8:40 a.m. and P#1 was transported to the ER at 8:50 a.m. - A review of “Ambulance En-Route Information” stated, date and time call received was on 2/18/25 at 0908 a.m., and date and time of service was on 2/18/25 at 9:11 a.m. - A review of the Hospital Emergency Department report stated, date and time of arrival was on 2/18/25 at 9:21 a.m. and date and time of death was on 2/18/25 at 9:31 a.m., due to Cardiac Arrest, Cause Unspecified. During a telephonic interview with the Medical Director (MD) on 2/24/25 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 that there were different doctors scheduled for Mondays, Wednesdays, Fridays (MWF) and Tuesdays, Thursdays, Saturdays (TTS). The Medical Director explained that he had MWF patients, and his nephrologist partner (NN AA), had the TTS schedule. After the 2/18/25 incident with P#1 happened, the Medical Director explained, we determined that the current procedure was confusing (I had one set of instructions, and NN AA had another set of instructions), so we came up with one parameter: systolic blood pressure (SBP) greater than (>) 180 and diastolic blood pressure (DBP) >100. The MD further stated that as of last week, the new protocol was: If a patient presented with a BP reading that exceeded the established parameter (SBP > 180 or DBP > 100), to give clonidine (for the treatment of high BP), 0.1 milligram (mg) tablet orally and wait 30 minutes for response; if BP is still too high, the nurses need to notify the physician for further instructions. The physician may want to hold Heparin (anticoagulant) and start the patient on dialysis if the high BP reading was fluid-related and try to pull 3-4 liters off. The MD also stated, we told patients not to take their BP medications before coming to dialysis, so we had better control over their BP. If clonidine is ineffective, a physician may want the patient to be transferred to the Emergency Room (ER) if symptomatic; and further instructions will be based upon the physician’s judgment. - During an interview with PCT EE on 2/24/25 at 12:49 p.m. and 1:08 p.m., PCT EE revealed the following when caring for P#1 on 2/18/25: - PCT EE stated that P#1 came in heavy, 4000 needed to come off. He missed treatments and had been counseled about importance of not missing treatment. His BP was good when he came in. He requested that his BP cuff be placed in his right leg for BP checks because it had been his preference for the last two years since she (PCT EE) started working here, and the MD was aware. P#1’s BP readings would vary depending on his position. He would jump around or moved around during treatments. When his BPs were high, he didn’t want me to talk to the nurse; however, this did not happen on 2/18/25. His BP was good on 2/18/25, which was 190 not > 200. Patients take their BP meds (medications) after treatment. P#1 did not want the nurse to assess him and he didn’t take his BP meds. - During an interview with RN AA on 2/24/25 at 4:09 p.m., RN AA was not sure why there were so many entries made on P#1’s “Treatment Details Report” dated 2/18/25, even after P#1’s cardiac arrest; but he stated they were probably late entries. - 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 nurses about P#1’s elevated BP readings, nor any documented evidences of interventions performed by a licensed nurse, nor any physician notification/discussion. On 2/4/25, P#1’s BP readings were: - At 6:32 a.m., BP was 203/106 mmHg per PCT FF. - At 6:38 a.m., BP was 201/106 mmHG per PCT FF. - At 7:02 a.m., BP was 221/111 mmHg per PCT DD. - At 7:37 a.m., BP was 196/100 mmHg per PCT DD. - At 8:02 a.m., BP was 210/110 mm Hg per PCT FF. - At 8:35 a.m., BP was 157/126 mmHg. PCT DD. - At 9:02 a.m., BP was 220/97 mmHg per PCT DD. - At 9:37 a.m., BP was 155/81 mm Hg per PCT DD. - At 9:59 a.m., BP was 227/90 mmHg per PCT DD. - P#1’s post-treatment sitting BP was 227/90; no standing BP was taken. P#1 was discharged to home. On 2/11/25, P#1’s BP readings were: - At 6:02 a.m., BP was 208/110 mmHg at initiation of treatment, per PCT CC. - At 6:32 a.m., BP was 223/130 mm Hg per PCT CC. - At 6:33 a.m., BP was 198/107 mmHg per PCT CC. - At 7:01 a.m., BP was 214/78 mmHg per PCT CC. - At 7:31 a.m., BP was 214/82 mm Hg per PCT CC. - At 8:01 a.m., BP was 168/101 mmHg. PCT CC. - At 8:33 a.m., BP was 152/98 mmHg per PCT CC. - At 9:01 a.m., BP was 205/87 mm Hg per PCT CC. - At 9:32 a.m., BP was 192/94 mmHg per PCT CC. - At 9:36 a.m., P#1’s BP was 222/112 mmHg per PCT CC. - P#1’s post-treatment sitting BP was 197/87; no standing BP was taken. P#1 was discharged to home. - There were no documentary evidences that PCTs CC, DD and PCT FF notified the nurses about P#1’s elevated BP readings on 2/4/25 and 2/11/25. There was a lack of documentary evidence that clonidine PRN was offered by a licensed nurse, nor a documentary evidence that the physician was notified of P#1’s persistently high BP readings on these dates as well. Other patients were also sampled: - P#16, on 2/13/25, had the following high BP readings: - Pre-dialysis BP was 220/89 mmHg. - At 6:16 a.m. during initiation of treatment, BP was 207/82 mmHg per PCT DD. - At 6:32 a.m., BP was 206/82 mm Hg per PCT DD. - At 7:02 a.m., BP was 215/76 mm Hg per PCT DD. - At 7:32 a.m., BP was 224/76 mmHg. per PCT DD. - At 8:02 a.m., BP was 222/75 mmHg per PCT DD. - At 8:32 a.m., BP was 214/74 mm Hg per PCT DD. - At 9:02 a.m., BP was 213/84 mmHg per PCT DD. - At 9:18 a.m., BP was 216/69 mmHg per PCT DD. - At 1:04 a.m., P#1’s BP was 199/69 mmHg per RN AA; RN AA entered, “Updated by [RN AA]” - P#16’s post-treatment sitting BP was 216/69; no standing BP was taken. P#16 was discharged to home. P#5 had elevated BP readings on the following dates: - On 2/13/25 - Treatment was started at 8:22 a.m. by PCT HH and ended at 11:28 a.m. by PCT CC. SBP ranged between 200 - 204 mmHg. - On 2/15/25 -Treatment was started at 8:41 a.m. by PCT HH and ended at 12:14 p.m. by PCT CC. SBP ranged between 181 - 219 mmHg; and DBP ranged between 100 - 112 mmHg. - On 2/20/25 - Treatment was started at 7:58 a.m. by PCT EE and ended at 11:02 a.m. by PCT CC. SBP ranged between 182 - 204 mmHg. - On 2/22/25 -Treatment was started at 8:31 a.m. by PCT CC and ended at 11:37 a.m. by PCT EE. SBP ranged between 182 - 213 mmHg. P#3 had elevated BP readings: - On 2/19/25 - Treatment was started at 10:17 a.m. by PCT DD and ended at 10:18 a.m. by PCT FF. SBP ranged between 182 - 197 mmHg. and DBP ranged between 101 - 106 mmHg. P#4 had elevated BP readings on the following dates: - On 2/14/25 -Treatment was started at 5:51 a.m. and ended at 9:52 a.m., by RN GG. SBP ranged between 188 - 197 mmHg. - On 2/17/25 - Treatment was started at 5:55 a.m. and ended at 10:06 a.m., by RN AA. SBP ranged between 182 - 189 mmHg. - There was a lack of documentary evidence that the PCTs (CC, DD, EE, FF, and HH) notified the nurses (RN AA or RN GG) about P#16’s, P#5’s, P#3’s, and P#4’s elevated BP readings, or if the licensed nurses offered clonidine PRN. There was a lack of documentary evidence that the physician was notified of the persistently elevated BP readings before, during, and after dialysis treatment. P#2 - had the following low BP readings and rapid heart rates: - On 2/13/25, treatment started at 8:46 a.m. and ended at 12:34 p.m. SBP ranged between 94 - 99 mmHg and DBP ranged between 48 - 66 mmHg. HR ranged between 104 - 119 beats per minute. - On 2/15/25 -Treatment started at 8:41 a.m. and ended at 12:14 p.m. HR ranged between 102 - 120 beats per minute. - On 2/18/25 -Treatment started at 9:03 a.m. and ended at 12:33 p.m. SBP ranged between 80 - 89 mmHg; and DBP ranged between 50 - 54 mmHg. HR ranged between 101 - 111 beats per minute. - On 2/20/25 -Treatment started at 8:44 a.m. and ended at 12:22 p.m. HR ranged between 104 - 114 beats per minute. - On 2/22/25 - Treatment started at 8:41 a.m. and ended at 12:18 p.m. HR ranged between 101 - 110 beats per minute. There was a lack of documentary evidence that the PCTs notified the nurses of P#2’s low BP readings and rapid HR. - A review of facility Policy: 1-03-08 dated April 2024 and titled PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT revealed the following: 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: a. 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 180mm/Hg or less than 90mm/Hg - Diastolic greater than or equal to 100mm/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: o Sitting systolic BP greater than 140mm/Hg or less than 90 mm/Hg o Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg Heart or Pulse Rate Pre/Intra/Post: o Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat - On 2/24/25 at 4:30 p.m., the covering Facility Administrator, Manager of Clinical Services, and the Facility Administrator/RN Preceptor of a sister facility, were informed about concerns with elevated BPs and HR without providing interventions. The Facility Administrator stated that the facility had initiated Plans of correction and presented to this surveyor, initial documentary evidence of the facility’s corrective action plan.”

“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: 03383 Based on patient and staff interviews, a review of facility records, and a review of minimum state required staffing ratios, it was determined that the Facility Administrator failed to ensure the facility employed an 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, for every 12 patients receiving dialysis care and that each care giver was not assigned to more than four patients at any given time. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to: intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 78. Findings include: - During an interview with patient (P#25), on 2/24/25 at 9:50 a.m., when asked approximately how long it took for staff (nurses and patient care technicians), to respond to machine alarms, P#25 stated, the staff did not respond to machine alarms right away, but took approximately 5-10 minutes to respond. During an interview with Registered Nurse (RN AA), who was also the Charge Nurse (CN), on 2/24/25 at 12:16 p.m., RN AA revealed the following when caring for P#1, on 2/18/25: - RN AA stated that there were four Patient Care Technicians (PCT CC, PCT DD, PCT EE, PCT FF), and two RN (RN AA and RN BB), working on 2/18/25 (Tuesday). There were 20 patients on first shift and the PCTs were assigned to Pods (sections with four patient stations each), such as: Pod 1, Pod 2, Pod 3, and Pod 4. The two RNs (AA and BB), were assigned as dialysis care givers in Pod 5 with two patients per RN. There were two patients with Central Venous Catheters (CVC) as their primary access in Pod 1. RN AA and RN BB performed CVC care (which only licensed nurses can do), set up and take down machines, start and terminate dialysis treatments of their assigned patients, give medications, etcetera (etc.). In addition, the CN (RN AA) followed up on patients who did not show up for treatment, was responsible to oversee the unit, performed assessments on 10 patients on one side of the Patient Treatment Room and RN BB performed assessments to the other 10 patients on the other side of the Patient Treatment Room. Additionally, Pod 4 also had one patient with a CVC during first shift. RN AA further stated that the turnover (shift change) got confusing that day (2/18/25), which started about 8:00 a.m. PCT EE was assigned to Pod 5 that day (2/18/25). A review of facility “Staff/Patients Assignment” form dated 2/18/25, revealed the following: According to the first shift schedule, there were 20 patients total, with two patients (P#13 and P#18) who had CVCs at Pod 1: - PCT FF was assigned to Pod 1 with four patients (P#14, P#13, P#18, P#23). - PCT CC was assigned to Pod 2 with four patients (P#9, P#10, P#21 and P#22). - PCT EE was assigned to Pod 3 with four patients (P#6, P#8, P#15 and P#17). - PCT DD was assigned to Pod 4 with four patients (P#7, P#12, P#16 and P#19). - RN BB was assigned to Pod 5 with four patients (P#1, P#11 P#20 and P#24). Specifically, start and end times of treatment for patients in Pod 5 were: P#11 - 5:15 a.m. - 8:15 a.m. P#20 - 5:30 a.m. - 9:30 a.m. P#24 - 5:45 a.m. - 9:45 a.m. P#1 - 6:15 a.m. - 10:00 a.m. - CN/RN AA was not assigned to any patients. In comparison, this surveyor reviewed the actual patient “Treatment Details Report” dated 2/18/25 (first shift), which revealed the following: There were two RNs (RN AA and RN BB) and four PCTs (PCT CC, PCT DD, PCT EE, and PCT FF) working on this date. P#13 and P#18 had CVCs. - Pod 1, PCT FF with four patients (P#13, P#14, P#18, and P#23) - Pod 2, PCT CC with four patients (P#9, P#17, P#21 and P#22) - Pod 3, PCT EE with four patients (P#8, P#11, P#20; and P#1 at Pod 5- station 20) - Pod 4, PCT DD with four patients (P#7, P#12, P#16, and P#19) - Pod 5, RN BB and RN AA with four patients (P#1, P#14, P#15, and P#24), as dialysis care givers, with responsibilities split between the two nurses, in addition to pre- and post-assessments, preparation and administration of medications, CVC care, treatment oversight, etc. - The Clinical Coordinator (RN GG) initiated and terminated dialysis treatment for P#24; and performed pre- and post-dialysis assessments and administered medications for P#24, however, it was late. Pre-treatment assessment was entered at 11:49 a.m. and post-assessment was entered at 11:48 a.m.; P#24’s treatment ended at 9:35 a.m. - PCT EE initiated and monitored treatment of P#1 at Station (S20), Pod 5. - The review of treatment records also showed that three patients (P#1, P#14, and P#16), experienced extremely elevated blood pressure readings during treatment; and one patient (P#1), became unresponsive and required Cardiopulmonary Resuscitation (CPR), activation of Emergency Medical Services (EMS) 911 call, and was transported to the Emergency Room (ER), where P#1 was pronounced dead. For additional information, please cross reference: V 715. - Additionally, a review of the Mondays, Wednesdays, Fridays (MWF) schedule, revealed that there were three of 20 patients who had CVCs on first shift, and nine of 19 patients had CVCs on second shift and one of five patients had a CVC on third shift. On 2/24/25 at 4:30 p.m., the covering Facility Administrator (cFA), Manager of Clinical Services, and Facility Administrator/ RN Preceptor of a sister facility, were informed about concerns with staffing on 2/18/25, with no feedback provided.”

“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: 50244 Based on observation, a review of Centers for Disease Control and Prevention (CDC) recommendations, and a review of facility Policy and Procedures, it was determined that the Infection Control Committee failed to ensure that sixteen of sixteen Patients (P) (P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22 and P#23) observed who held pressure to their access sites for hemostasis (stopping the flow of blood) after hemodialysis treatment, failed to perform hand hygiene (wash hands with soap and water or use alcohol- based hand sanitizer) after glove removal and prior to leaving the facility. This deficient practice had the potential for cross contamination and increased the risk of infection and could negatively affect the health and safety of 87 patients who were dialyzing at this facility. Findings include: During observation in the Patient Treatment Room on 2/13/24 between 12:00 p.m. and 1:45 p.m., the following was revealed: - P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, and P#18, at Stations (S) 1, 5, 7, 9, 11, 12, 14, 15, 16, 18 and 20 respectively, held pressure to their dialysis access sites for hemostasis after their hemodialysis treatment and did not perform hand hygiene after removing their gloves and before leaving the facility. The staff did not remind these patients to wash their hands, and did not offer these patients to use hand sanitizer after glove removal. During observation in the Patient Treatment Room on 2/14/24 between 8:00 a.m. and 10:00 a.m., between 1:00 p.m. and 1:15 p.m. and between 5:00 p.m. and 5:15 p. m., the following was revealed: - P#19, P#20, P#21, P#22 and P#23 who were seated at S8, S10, S12, S14, and S15 respectively, also held pressure to their dialysis sites for hemostasis after their hemodialysis treatment. All five patients observed, did not perform hand hygiene after removing their gloves and before leaving the facility. The staff did not remind these patients to wash their hands, and did not offer these patients to use a hand sanitizer after glove removal. The Facility Adminstrator was notified of these observations on 2/14/24 at approximately 5:20 p.m. 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 Procedure: 1-04-01B stated “When patients hold their cannulation sites, the patients will be offered gloves and will perform hand hygiene when completed”.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 50244 Based on observation, a review of facility Policy and Procedures (P & P), and staff interviews, it was determined that the Medical Director failed to ensure that one of one Registered Nurse, (RN JJ) observed, adhered to the facility’s P & P during initiation and discontinuation of hemodialysis treatment of three of three Patients (P), (P#10, P#13 and P#14), observed who had Central Venous Catheters (CVC - a large plastic tube placed in a vein in the neck or groin for exchange of blood to and from the hemodialysis machine during hemodialysis treatment). This deficient practice had the potential for (P#10, P#13 and P#14), to have an increased risk of bloodstream infection and all the other in-center hemodialysis patients who had CVC. Findings include: During observation in the Patient Treatment Room on 2/14/24 at specified times shown below, the following was revealed: - At 5:57 a.m., RN JJ was observed initiating hemodialysis treatment on P#10 at Station (S) 12. During cleansing of P#10’s CVC hubs (end of the CVC that connects to the blood lines or cap), RN JJ scrubbed each hub for 4 seconds. - At 9:15 a.m., RN JJ was observed discontinuing dialysis treatment on P#10 at S12. RN JJ scrubbed the CVC hub for 3 seconds. - At 9:40 a.m., RN JJ was observed initiating dialysis treatment on P#13 at S3. RN JJ scrubbed the CVC hub for 5 seconds. - At 2:00 p.m., RN JJ was observed discontinuing dialysis treatment on P#14 at S19. RN JJ scrubbed each CVC hub for 3 seconds. - A review of facility Procedure: 1-04-02B, titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure”, with latest date of revision, October, 2022, stated: 16. Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue, for example blood... These findings were discussed with the Facility Administrator and RN JJ on 2/14/24 at approximately 2:15 p.m.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 50244 Based on observation and staff interview, and a review of facility Policy, it was determined that the facility failed to ensure that four of 18 Patients (P) (P#1, P#2, P#5 and P#33) observed, had their vascular access sites (dialysis needle insertion sites) uncovered and visible to the staff throughout dialysis treatment. This deficient practice could provide an opportunity for accidental needle dislodgement or line disconnections to go undetected and could result in exsanguination (severe loss of blood). The facility census was 87. Findings include: During observation in the Patient Treatment Room on 2/13/24 between 8:15 a.m. and 9:30 a.m., the following was revealed: - The vascular access sites of P#1, P#2, P#5 and P#33 were covered with blanket during dialysis treatment. - During an interview with the Facility Administrator on 2/13/24 at 9:45 a.m., she stated that staff should ensure that patients’ vascular access sites were uncovered. - A review of facility Policy: 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” stated: “The vascular access, bloodline connections and the patient’s face should be visible throughout the dialysis treatment”.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 50244 Based on a review of medical records, staff interview, and a review of facility Policy and Procedures, it was determined that the interdisciplinary team (IDT) failed to implement the patients’ Plan of Care to effectively manage patient outcomes for adequacy of dialysis (effectiveness of dialysis prescriptions to avoid symptoms of uremia which is a build up of toxins in the blood), for five of 10 sampled in-center hemodialysis Patients (P) (P#8, P#15, P#19, P#27, and P#28). This deficient practice could negatively affect the health and safety of P#8, P#15, P#19, P#27, and P#28. The facility census was 87. Findings include: - P#8 dialyzed with a BFR (Blood FLow Rate) of less than the prescribed BFR of 450 mL/min (mililliter per minute) on nine of 10 dialysis treatment flowsheets reviewed, dated 1/20/24 - 2/12/24. There was a lack of documented reasons for the decreased BFR. - P#15 dialyzed with a BFR of less than the prescribed BFR of 450ml/min on eight of 10 dialysis treatment flowsheets reviewed, dated 1/20/24 - 2/12/24. There was a lack of documented reasons for the decreased BFR. - P#19 dialyzed with a BFR of less than the prescribed BFR of 450 ml/min on six of 10 dialysis treatment flowsheets reviewed, dated 1/20/24 - 2/12/24. There was a lack of documented reasons for the decreased BFR. - P#27 dialyzed with a BFR of less than the prescribed BFR of 400 ml/min on six of 10 dialysis treatment flowsheets reviewed, dated 1/15/24 - 2/12/24. There was a lack of documented reasons for the decreased BFR. The medical record of P#27 showed Kt/V (used to measure the effectiveness of dialysis prescriptions to avoid symptoms of uremia) of 1.19 on 1/17/24 and 1.17 on 2/8/24. The professionally-accepted clinical practice standard for Kt/V for adult on hemodialysis less than 5 hours 3 x/week, was a minimum Kt/V of 1.2 or greater. - P#28 dialyzed with a BFR of less than the prescribed BFR of 400 ml/min on six of 10 dialysis treatment flowsheets reviewed, dated 1/15/24 - 2/2/24. There was a lack of documented reasons for the decreased BFR. A review of facility Policy 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Nursing Assessment” dated October 2023 stated: If the dialysis prescription is not met (including dialysis flow rate or change in ability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. These findings were discussed with the Facility administrator on 2/15/24 at approximately 2:10 p.m.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 50244 Based on observation, staff interview, and a review of facility Policy, it was determined that the facility failed to ensure that eight of eight Patients (P), (P#6, P#7, P#9, P#12, P#15, P#16, P#21, and P#33) observed, and five of five Direct Patient Care (DPC) Staff (Staff BB, Staff CC, Staff DD, Staff EE and Staff FF), who were Patient Care Technicians - PCTs and Licensed Practical Nurse - LPN), performed vascular access care before initiation of hemodialysis treatment; and nine of nine patients, (P#1, P#5, P#7, P#9, P#16, P#21, P#23, P#24, and P#25) observed, after discontinuation of hemodialysis treatment, per facility Policy. This deficient practice had the potential for risk of vascular access infection which could lead to loss of access for all 13 patients observed before and after hemodialysis treatment. Findings include: During observation in the Patient Treatment Room on 2/13/24 between 9:50 a.m. to 10:30 a.m., and between 11:25 a.m. and 1:25 p.m., the following was revealed: Before initiation of hemodialysis treatment: - P#6, P#7, P#9, and P#16, after weighing at the scale, went directly to their hemodialysis Stations (S), (S16, S11, S5, and S15 respectively), without washing their vascular accesses (Arterio-Venous Fistula - AVF or Arterio-Venous-Graft-AVG). DPC Staff, (Staff BB, Staff CC, Staff DD, and Staff EE), did not remind these patients to wash their vascular access sites. After discontinuation of hemodialysis treatment: - Patients, P#1, P#5, P#7, P#9, and #16, were observed holding their cannulation sites following removal of fistula needles. Once hemostasis (bleeding stopped) was attained, DPC Staff, (Staff BB, Staff EE, Staff DD, Staff CC and Staff EE) respectively, were observed reinforcing the same dressing used to hold the cannulation sites, without discarding the used gauze and without applying a new dressing. During observation in the Patient Treatment Room on 2/14/24 between 5:15 a.m. and 5:45 a.m., and between 8:15 a.m. and 10:00 a.m., the following was observed: Before initiation of hemodialysis treatment: - P#12, P#15, P#21 and P#33, after weighing at the scale, went directly to their hemodialysis Stations, (S17, S16, S8 and S18 respectively), without washing their vascular accesses. DPC Staff - BB, CC, DD, and FF, did not remind these patients to wash their vascular access sites. After discontinuation of hemodialysis treatment: - P#21, P#23, P#24, and P#25 were observed holding their cannulation sites following removal of fistula needles. Once hemostasis was attained, DPC Staff, (Staff BB, CC and FF), were observed repeating the same deficient practice as mentioned above. - A review of facility Policy: 1-05-01 titled, “Infection Control for Dialysis Facilities”, stated: “Patients....will be encouraged to wash their hands and access extremity prior to the initiation of dialysis”. - A review of facility Policy: 1-04-01B titled, “Post Dialysis Vascular Access Care: Fistula/Graft using Safety Fistula Needles” stated: Once bleeding has stopped, discard gauze or band-aid used to hold site. Inspect site for any trauma and for hemostasis. Apply band-aid type or sterile dressing over cannulation site. - These findings were discussed with the Facility Administrator on 2/14/24 at approximately 10:30 a.m.”

“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: 50244 Based on observation, a review of facility Policy and Procedures (P & P), and staff interviews, it was determined that the Medical Director failed to ensure that one of one Registered Nurse, (RN JJ) observed, adhered to the facility’s P & P during initiation and discontinuation of hemodialysis treatment of three of three Patients (P), (P#10, P#13 and P#14), observed who had Central Venous Catheters (CVC - a large plastic tube placed in a vein in the neck or groin for exchange of blood to and from the hemodialysis machine during hemodialysis treatment). This deficient practice had the potential for P#10, P#13 and P#14, to have an increased risk of bloodstream infection and all the other in-center hemodialysis patients who had CVCs. Findings include: Cross References: V 147 - Failure of RN JJ to adhere to the facility’s P & P relative to cleaning and disinfection of CVC hubs during initiation and discontinuation of hemodialysis treatment on patients with a CVC. V550 - Failure of the Direct Patient Care (DPC) Staff (Staff BB, Staff CC, Staff DD, Staff EE and Staff FF) to follow facility policy relative to vascular access care prior to initiation of hemodialysis treatment and after discontinuation of hemodialysis treatment.”