Davita Lilburn 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 responsibility for the clinical operations of the facility to ensure the delivery of safe patient care. This failure resulted in patient, (P#1’s) exsanguination (a substantial blood loss that can be fatal) during machine set up and initiation of P#1’s hemodialysis treatment. The facility census was 63. Findings include: Cross Reference: V 715 - Failure of the Medical Director to ensure that Registered Nurse (RN AA, who was also the Charge Nurse), adhered to facility policy and procedures pertaining to the setting up and initiation of hemodialysis treatment of patient, (P#1). This failure resulted in P#1’s exsanguination (a substantial blood loss that can be fatal) during machine set up and initiation of dialysis treatment.”

“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 all 63 dialysis patients who were under the care of this facility. Findings include: Cross-References: V 715 - Failure of the Medical Director to ensure that Registered Nurse (RN AA, who was also the Charge Nurse), adhered to facility policy and procedures pertaining to the setting up and initiation of hemodialysis treatment of patient, (P#1). This failure resulted in P#1’s exsanguination (a substantial blood loss that can be fatal) during machine set up and initiation of dialysis treatment. V757 - Failure of the Facility Administrator to ensure the facility had 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 who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift.”

“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 records including facility Policy and Procedures (P & P), and patient and staff interviews, it was determined that the Medical Director failed to ensure that one of one Registered Nurse (RN AA, who was also the Charge Nurse), adhered to facility P & P relative to hemodialysis initiation of treatment, assessment and monitoring before and during initiation of hemodialysis treatment of one of one patient (P) #1, sampled. This failure resulted in P#1’s exsanguination (a severe and potentially fatal blood loss) during initiation of hemodialysis treatment. The facility had 63 patients who were receiving hemodialysis treatment at this facility. Findings include: - A review of the facility’s Risk Event Management (REM) Log revealed the following: - On 1/13/25 - P#1 experienced blood loss greater than (>) 500 cc (cubic centimeters). Patient was sent to the hospital for evaluation and treatment. A review of P#1’s REM report revealed the following: - P#1’s treatment started at about 1:42 p.m., with blood pressure (BP) reading of 169/88 and heart rate (HR) of 77 beats per minute. Patient came in fluid overloaded, with complaints of extreme fatigue while at work earlier in the day. P#1’s hemoglobin (Hgb- protein in red blood cells that carry oxygen throughout the body), level of 7.4 on 1/6/25. During treatment initiation, Charge Nurse, (RN AA) proceeded to discard Normal Saline prime. This is to prevent overloading patient with more fluid (dumping Saline prime) (sic). RN’s attention was needed for another patient and briefly walked away while venous line was still in prime bucket. 20 seconds later, Patient Care Technician (PCT AA), (while attending to another patient beside P#1’s chair), heard a snoring sound from P#1, and quickly called out for help. RN AA observed that the prime bucket (already filled with 400ML of saline was mixed with P#1’s blood. BP was WNL (within normal limits) of 139/74 HR 75. P#1 was placed in a Trendelenburg (the body is lain supine with the feet elevated above the head) position. NS 600ML was given. P#1 did not lose consciousness. He was verbal, with eyes open and spoke slowly. BP before NS administration was 101/50 HR 63. BP after NS administration was 147/75 HR 78. At 3:50 p.m., EMS arrived, and final BP was 147/79 HR 71. P#1 ambulated independently to the gurney for transportation to NSH Emergency Room (ER). Post HGB blood levels was also drawn. About 1912 (7:12 p.m.), RN AA spoke to P#1 while at the ER waiting room. P#1 stated he felt fine, blood was drawn, but he was yet to be seen by a doctor. RN AA informed patient to wait to be seen for his HGB status. MD notified accordingly. A review of P#1’s “Treatment Details Report” dated 1/13/25, revealed the following: - At 13:42 (1:42 p.m.), RN AA documented, “Treatment started without complications; access site prepped ... Normal Saline (NS) prime given...”. BP reading - 169/88 mmHg (millimeter mercury) - At 13:46 (1:46 p.m.), RN AA documented, “Patient appears to be tolerating treatment at this time”. BP 139/74 mmHg - At 13:50 (1:50 p.m.), RN AA documented, “Treatment terminated; NS 600 mL (milliLiter) given”. BP 147/75 mmHg - At 14:10 (2:10 p.m.), BP reading 101/50 mmHg... - At 15:36 (3:36 p.m.) - Treatment ended - last recorded BP 147/79 mmHg. Close Treatment Reason stated, “Patient Medical Emergency (paramedics called and/or patient sent to ER)”. P#1’s primary access was a Central Venous Catheter (CVC - a type of access used for hemodialyis using a soft, flexible tube that’s inserted into a large vein close to the heart). - During an interview with the Facility Administrator on 3/3/25 at 1:15 p.m., she stated that she was present when the incident with P#1 occurred. RN AA was suspended after the incident occurred (due to not following facility policies). The FA added that she didn’t think the blood loss was over 500 mL. P#1 was admitted to this facility on 12/17/24, new to ESRD (End Stage Renal Disease), with a Hgb of 7.4 g/dL (gram per deciLiter). The FA further explained that P#1 came in on 1/13/25 fluid overloaded. RN AA used to work in acutes (acute hemodialysis) previously, where they used a method to help get the fluid off patients that were overloaded. She connected the arterial line but let the venous prime dump into a bucket. There was blood in the saline prime bucket. We got the patient stabilized, drew labs, in-serviced staff on blood loss; alerted the medical director, centralized anemia manager (CAM), the Manager of Clinical Services (MCS), and reported the incident to the state. The FA also added that there were only seven patients in the Patient Treatment Room when this happened. - During an interview with P#1 on 3/3/25 at 3:13 p.m., he stated that he started dialysis in December 2024. P#1 also added that he had one issue since he started here. He stated, “I woke up and blood was all over the floor. I passed out and came to. I saw what was happening. They asked me if I wanted to go to the hospital, and I said, yes. I stayed in the hospital overnight. They gave me a bill for their mistake. I didn’t know what happened. That lady right there, (pointing at the FA), told me what happened after I returned from the hospital. I didn’t watch the nurse while she was putting me on. I assumed she was professional and knew what she was doing”. - A review of facility Procedure: 1-04-02B, titled, “CENTRAL VENOUS CATHETER (CVC WITH CLEARGUARD HD ANTIMICROBIAL END CAPS PROCEDURE”, last revised in October 2024, stated: 21. Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb. 22. Unclamp and flush each limb (catheter limb) with saline and re-clamp. 23. Attach heparin loading dose to venous limb, as applicable. Unclamp and gently flush back and forth 3-5 times into catheter. Re-clamp. 24. After a minimum of 3 - 5 minutes, remove syringe from each access port one at a time, then attach each blood line carefully, so as not to contaminate blood line tips or catheter limbs. 25. Secure connections and initiate dialysis per procedure. Secure lines to patient/patient clothing. The facility procedure did not mention, “connect the arterial line but let the venous prime dump into a bucket”.”

“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 observation, a review of records, and staff and patient interviews, it was determined that the Facility Administrator failed to ensure the facility had 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 who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. 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, access sites, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, 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 had 63 incenter hemodialysis patients. Findings include: A review of facility “Staff/Patients Assignment” sheet dated 1/13/25, showed the following: - There was one Registered Nurse (RN AA - who was also the Charge Nurse), one Patient Care Technician (PCT BB), who provided direct patient care to patients on the third shift on 1/13/25. - There were nine patients (P#1, P#4, P#9, P#12, P#15, P#17, P#20, P#23 and P#25), who were scheduled to dialyze on the third shift, whose assigned seats were at Stations (S) 1, 2, 5, 8, 9, 11, 12, 16, and at the isolation room). The third shift patient treatment schedule started at 1:00 p.m. and ended at 5:30 p.m. - RN AA was scheduled to work from 4:35 a.m. to 6:45 p.m. - PCT BB was scheduled to work from 4:45 a.m. to 7:00 p.m. - PCT CC was scheduled to work from 4:45 a.m. to 3:15 p.m. - RN DD was scheduled to work from 5:00 a.m. to 2:15 p.m. - PCT EE was scheduled to work from 4:00 a.m. to 2:15 p.m. Third shift: - RN AA functioned as a dialysis care giver (total care) to three patients (P#12, P#1 and P#25) who were at S5, S9, and the isolation room, respectively, as well as P#9 at S8. However, the Facility Administrator, who was a (Licensed Practical Nurse- LPN), initiated hemodialysis treatment for P#9 at S8. - PCT BB initiated dialysis for patient at S11 and terminated dialysis for patient at S12. - PCT CC cared for patient at S16, initiated dialysis for patient at S12, and terminated dialysis for patient at S11. - PCT EE cared for three patients at S1, S2, and S11. - RN AA functioned as a dialysis care giver (total care) to three patients (P#12, P#1 and P#25) who were at S5, S9, and the isolation room, respectively. In addition, RN AA was also assigned to perform all nursing duties such as conducting pre and post nursing assessments, preparation and administration of all medications, addressing patient complaints, physician notification, dealing with unforeseen complications of dialysis/medical issues, and emergency situations that could arise during dialysis treatment for four patients at S1, S2, S11, and S16, who were cared for by PCTs (PCT BB and PCT CC). RN AA cared for P#1 who experienced blood loss > (greater than) 500 cc as a result of RN AA neglecting to hook up the venous line to P#1’s venous catheter limb before turning the machine on to start treatment, on 1/13/25 at 1:42 p.m. RN AA was responsible for the care of P#1 until he was transferred to the hospital at 3:36 p.m. During an interview on 3/3/25 at approximately 10:38 a.m., P#2 stated, “They are a little short, they could use another nurse”. During an interview on 3/3/25 at approximately 11:15 a.m., P#3 at S14 stated, “I think they are overworked; they could use more staff.” During an interview on 3/3/25 at 10:30 a.m., the current Charge Nurse, (RN BB) confirmed that there was only one nurse and one PCT working on third shift on Mondays, Wednesdays, and Fridays (MWF). RN AA cared for P#1 who experienced blood loss > (greater than) 500 cc as a result of RN AA neglecting to hook up the venous line to P#1’s CVC on 1/13/25 at 1:42 p.m. RN AA was responsible for the care of P#1 until he was transferred to the hospital at 3:36 p.m. In addition, cross reference V 715 - Failure of the Medical Director to ensure RN AA followed facility P & P relative to setting up and initiating dialysis treatment for P#1.”