Fresenius Kidney Care North Georgia

“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, a review of Centers for Disease Control and Prevention (CDC) recommendations, staff inyterview, and a review of facility policy, it was determined that the Infection Control Committee failed to ensure that five of five patients (seated at Stations 6, 14, 15, 25, and 26) observed who held pressure to their access sites for hemostasis (stopping of the flow of blood) after dialysis, 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 and increased risk of infection and could negatively affect the health and safety of 61 patients who were dialyzing at this facility. Findings were: During observation in the Patient Treatment Room on 1/3/24 between 12:05 p.m. and 1:43 p.m., the following was observed: - The patients who were seated at Stations (S) 14, 15, 25, and 26 held pressure to their dialysis access sites and left the facility without performing hand hygiene. - Patient (P) #3, who was seated at S6 held his access site. The blood went through the gauze and spilled onto his pants and chair. RN AA wiped/cleaned P#3’s access arm and cleaned/disinfected the chair, but nothing was done about the blood spot (approximately 4 cm. oblong) on P#3’s pants. P#3 left the treatment area without performing hand hygiene and walked into the waiting room to wait for a ride. - Patients who were seated at S6, S14, S15, S25, and S26 were not reminded by the staff to wash their hands nor were offered to use hand sanitizer after glove removal. 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. The Nurse Manager was informed about the above observations on 1/3/24 at 4:45 p.m. and surveyor requested hand hygiene and blood spill policy which was provided on 1/3/24 at 4:50 p.m. A review of Policy titled, “Hand Hygiene” dated 11/06/23 indicated “Hands Will Be... Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water...immediately after removing gloves...”

“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: 03383 Based on observations and staff interviews, it was determined that the facility failed to ensure that two of 14 patients [P#2 and a patient who was seated at Station (S) 21] observed during dialysis, had their vascular access sites uncovered/visible to the staff throughout dialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility census was 61. Findings were: An observation in the patient treatment area on 1/3/24 between 11:30 a.m. and 1:20 p.m. revealed that P#2 and the patient seated at S21 had their access sites covered by a blanket. The patients’ dialysis access sites were not visible to the staff during their treatment. A review of P#2’s treatment flowheet dated 1/3/24 showed the following: - Certified Clinical Hemodialysis Technician (CCHT) MM documented “access visible” at 12:03 p.m. However, this surveyor observed that at 12:03 p.m., P#2’s access site was covered with a blanket. - Registered Nurse (RN) BB documented “access visible” at 1:10 p.m. However, it was observed that dialysis ended at 1:11 p.m. and P#2’s access site was not uncovered and visible until dialysis was discontinued. During an interview with RN BB on 1/3/24 at 1:24 p.m., RN BB stated that staff reminded P#2 to uncover his access site but was unable to find documented evidence. The Nurse Manager (NM) was informed of the above findings on 1/3/23 at 4:07 p.m. The NM was unable to provide documentary evidence that patients were reminded by staff to keep their dialysis access uncovered, to ensure their safety during dialysis.”

“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 interviews, and a review of facility policy, it was determined that the medical director failed to ensure that all staff adhered to facility policy pertaining to hypertension [elevated blood pressure (BP)] to ensure that one of two patients (P) (P#2) sampled who experienced extremely high BP readings before, during, and after dialysis treatment, received medical care/interventions appropriate to the patient’s needs. The facility also failed to ensure that one of one patient (P#3) who experienced hypotension (low BP), received interventions based on physician orders. This failure could negatively affect the health and safety of P#2, P#3, and the other 59 patients who were dialyzing at this facility. Findings were: A review of treatment flowsheets showed the following: P#3: P#3’s dialysis prescription: Tx (Treatment) time: 3:15 hours (3 hours and 15 minutes), EDW (Estimated Dry Weight): 60 kg (kilogram), BFR (Blood Flow Rate): 450, DFR (Dialysate Flow Rate): 600. On 12/30/23: Pre dialysis weight: 61.80 kg; Post weight: 59.5 kg; time on dialysis: 3:17 (3 hours and 17 minutes). Pre dialysis BP: sitting 152/86 mmHg and standing 160/86 mmHg; pulse: 77. Post dialysis BP: sitting 138/81 mmHg and 114/76 standing; pulse: 67 beats per minute. - P3’s BP was 149/77 during initiation of dialysis treatment at 9:16 a.m. and had dropped to 100/67 at 10:04 a.m. - The record did not show that the Patient Care Technician (PCT NN) who was assigned to care for P#3, notified the Registered Nurse (RN AA) about the drop in P#3’s BP. - Record showed BP was not rechecked until 10:34 a.m. and was 103/74; at 11:04 a.m., BP was 103/67; at 11:36 a.m., BP was 105/71 and the note indicated that PCT NN lowered the goal (for the removal of extra fluid) to 2.3 and Licensed Practical Nurse (LPN CC) was notified. On 1/1/24: Pre dialysis weight: 62.50 kg; Post weight: 59.9 kg; time on dialysis: 2:53 (2 hours and 53 minutes). Pre dialysis BP: 147/88 pulse: 77. Post dialysis BP: sitting 118/72 mmHg and 110/70 mmHg standing; pulse: 67. - At 12:08 p.m., P#3’s BP was 103/72 mmHg and the pulse rate was 72. The BP dropped from 103/72 to 56/39 mmHg and the pulse rate had decreased to 51. - LPN CC discontinued dialysis treatment at 12:15 p.m., notified RN AA, and administered 500 ml bolus of Normal Saline. - The note also showed that P#3 was asymptomatic (showed no symptoms). However, Ondansetron (Zofran - medication used to prevent nausea and vomitting) 4 mg was given at 12:18 p.m. - PCT NN documented BP readings of 118/72 sitting and 110/70 standing. - RN AA did not document an assessment until 12:54 p.m. - LPN CC documented under comments: “hypotension Zofran administered 4 mg” but lacked documentation that P#3 was nauseated. A review of physician orders showed the following: - P#3 had an order written on 9/13/23 for “Midodrine HCL (Proamatine - medication that treats low BP) 5 mg ORAL during dialysis PRN (if needed). May repeat x1 for SBP (systolic BP - upper number) < (less than) 105. - Ondansetron HCl 4 mg IVP (Intravenous Push) during dialysis PRN for nausea was ordered on 12/20/23. The treatment record was reviewed with the Nurse Manager (NM) on 1/5/24 at 7:08 a.m. NM confirmed concerns with patient’s drop in BP without an RN assessment for 39 minutes; given Zofran with no documented complaint of nausea; not given Proamatine as ordered for SBP < 105; under EDW; and early termination of dialysis treatment (before completion of the prescribed treatment time). On 1/3/24: Pre dialysis weight: 62.40 kg; Post weight: 59.80 kg; time on dialysis: 3:21 (3 hours and 21 minutes). Pre dialysis BP: sitting 177/88 mmHg and 160/90 mmHg standing; pulse: 77. Post dialysis BP: sitting 150/99 mmHg and 143/87 standing; pulse: 73. - P3 dialyzed with a BFR of 400 from 9:18 a.m. to 12:37 p.m. The treatment flowsheet lacked documented reason for the decreased BFR of 400 during the entire treatment when the dialysis prescription was BFR of 450. The above findings were reviewed and discussed with the NM on 1/5/24 at 7:39 a.m. The NM confirmed the lack of documented reason for the decreased BFR. P#4: P#4’s dialysis prescription: Tx time: 4 hours, EDW: 114 kg, BFR: 250, DFR: 500. On 1/3/24: Pre dialysis weight: 111.70 kg; Post weight: 111.70 kg; time on dialysis: 2 hours. Pre dialysis BP: sitting 155/ mmHg; pulse: 104 and Post dialysis BP: sitting 206/60 mmHg; pulse: 107. - P#4’s BP was 188/60 mmHg during initiation of dialysis treatment at 2:04 p.m. and had dropped to 147/78 mmHg at 2:33 p.m. while pulse rate increased from 99 to 101 beats per minute. - At 3:35 p.m, P#4’s BP went up to 188/60 mmHg with a pulse rate of 105. - At 4:07 p.m., P#4’s BP increased to 193/111 mmHg and the pulse rate was 106. - Dialysis treatment ended at 4:11 p.m. without problems as documented by PCT NN. - There was a lack of documented evidence that an RN was notified about the elevated BP and pulse rate. - At 4:03 p.m., P#4’s BP was 206/60 and the pulse rate was 107. - The RN evaluation at 4:46 p.m. showed “UF time order to 2 hours per MD; post tx VSS (vital signs stable), tx tolerated well, no acute distress, stable for DC”. - The RN evaluation did not mention the extremely elevated blood pressure readings or pulse rates. The treatment records were reviewed and discussed with the NM and Director of Operations (DO) on 1/4/24 at 9:48 a.m. The DO and the NM confirmed a lack of documentation that showed orders/interventions that addressed the extremely elevated BP readings and pulse rates. A review of Policy titled, “Patient Assessment and Monitoring” dated 9/18/2018 stated: Monitoring During Treatment: BP - Record BP. - Recheck BP after a drop that required interventions such as administering Normal Saline. - Reposition electronic cuff or use a manual cuff for aberrant BP readings. - Report to the nurse: - Systolic (upper number) BP greater than 180 mm/Hg. - Diastolic (lower number) BP greater than 100 mm/Hg. - BP less than or equal to 100 mm/Hg. A review of Policy titled, “Hypertension” (high BP) dated 9/7/21 stated: Staff will recognize, report, and immediately address systolic BP greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg. Treating Hypertension Follow the steps below to address hypertension: - Notify the nurse in charge if a patient has a systolic BP greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg. - The RN will assess the patient and determine if further nursing interventions are needed. - If hypertension is related to hypervolemia, decrease EDW: Follow CMAB Fluid Management algorithm or notify physician for possible EDW adjustment outside of algorithm parameters. - If hypertension is not related to hypervolemia, notify the physician for additional orders/interventions. - Document in patient’s treatment record.”