Davita Satilla River Dialysis

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on a review of patient’s (P#1’s) records, staff interviews and a review of facility Policies and Procedures (P&P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This deficient practice negatively affected the health and safety of P#1 who experienced low blood pressure (BP) readings after an exsanguination (severe blood loss) incident which could have contributed to P#1’s death due to cardiac arrest. The facility’s in-center hemodialysis census was 56. Cross reference: V 715 - Failure of the Medical Director to ensure that one of one Registered Nurse (RN AA) and one of one Patient Care Technician (PCT AA), adhered to facility P & P pertaining to abnormally low BP readings resulting from exsanguination, to ensure that one of one patient (P#1) sampled, received medical care and supervision appropriate to P#1’s dialysis needs.”

“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: 50523 Based on a review of facility records, staff interviews, and a review of facility Policy and Procedures (P&P), it was determined that the Medical Director failed to ensure that one of one Registered Nurse, (RN AA, who was responsible for and accountable to patients’ quality of nursing care rendered), and one of one Patient Care Technician (PCT AA) sampled, adhered to facility P&P relative to hypotension (low BP - blood pressure) which resulted from exsanguination (severe blood loss), of one of one sampled patient (P#1). This deficient practice negatively affected the health and safety of P#1 who experienced low BP readings after an exsanguination incident which could have contributed to P#1’s death due to cardiac arrest. During exsanguination, the body rapidly loses critical blood volume, leading to catastrophic drop in BP, insufficient oxygen delivery (hypoxia) to organs, and severe shock, causing the heart to fail, brain damage, organ shutdown, and ultimately death, typically after losing 40% or more of blood, unless bleeding is stopped and fluid/blood replaced quickly. Failure to promptly and properly address hypotension can lead to syncope (fainting), fatigue or weakness, confusion and more serious and potentially life-threatening complications such as shock, organ failure, or death. The facility census was 56. Findings include: - A review of P#1’s “Treatment Details Report” and “Hospital Admission Records” dated 11/20/25 revealed the following: P#1’s pre weight was 107.7 kilograms (kg) with a BP reading of 116/55 mmHg. P#1’s hemodialysis treatment was initiated at 11:04 a.m. with a total of 19 volume (fluid) removed (VolRm). Blood flow rate was set at 300 milliLiter (mL) per minute At 11:34 a.m., P#1’s BP was 117/58 mmHg with a total of 544 VolRm. At 12:04 p.m., P#1’s BP was 126/59 mmHg with a total of 1032 VolRm. At 12:23 p.m., P#1’s hemodialysis treatment was terminated with a BP reading of 69/22 mmHg with a total of 1,242 milliliters (mL), VolRm. There was no documentary evidence on how P#1’s low BP reading was addressed or treated. P#1’s estimated post-dialysis weight was 104.2 kg, a reduction of 3.5 kg from her pre-dialysis weight, with one hour and 13 minutes of treatment duration. Although the total amount of fluid removed by hemodialysis was 1,242 mL, approximately 2,258 mL of fluid remained unaccounted for. P#1’s post-assessment note from the “Treatment Details Report” by the Charge Nurse (CN/RN BB), stated: Patient unresponsive, CPR (Cardiopulmonary Resuscitation ) performed and AED (Automated External Defibrillator- a portable medical device used to provide an electrical shock to the heart to restore a normal rhythm during a cardiac arrest) pads attached. Continued compressions until EMS (Emergency Medical Services) arrived and took over. The CPR note by CN/RN BB dated 11/20/25, stated: CPR was initiated at the facility at 12:24 p.m., and AED pads were applied at 12:25 p.m. Chest compressions were continued until EMS arrived and took over CPR at 12:30 p.m., then P#1 was transported to the hospital via EMS at 12:45 p.m., with a pulse of 94 beats per minute (per EMS personnel when they left with P#1). P#1 presented to the Emergency Department with a primary diagnosis of cardiac arrest. P#1 was pronounced expired on 11/20/25 at 1:43 p.m. - A review of the facility’s “Risk Event Management” (REM) records dated November 20, 2025 revealed that the facility experienced a blood loss greater than (>) 500 milliLiters (mL). It was reported at 12:19 p.m., that the air detector alarm went off on P#1’s hemodialysis machine. PCT AA immediately muted the hemodialysis machine and obtained P#1’s blood pressure of 69/22 mmHg. P#1 was awake, alert and talking with clear speech. PCT AA then assessed the blood lines on P#1’s access and discovered an estimated 1000 ml of blood was on the floor and P#1’s venous lumen (returns the filtered blood from the dialysis machine back to the patient) on her Central Venous Catheter (CVC - A flexible tube inserted into a vein and threaded into a large vein above the right side of the heart), was open and disconnected from the venous bloodline. CN/RN BB was notified and PCT AA clamped the venous lumen on P#1’s CVC. CN/RN BB disconnected the arterial blood line from the arterial lumen (removes blood from the patient’s body and sends it to the dialysis machine) on P#1’s CVC and PCT AA tried to recirculate (running the patient’s blood through the dialysis machine without returning it to the patient, in a closed loop between the arterial and venous bloodlines to preserve the patient’s blood already inside the dialysis circuit) the bloodlines to return P#1’s blood but the bloodlines clotted and was unable to return the blood to P#1. P#1 stopped talking and became unresponsive, CPR was initiated, and EMS was called. P#1 discharged with EMS at 12:45 p.m., with a pulse of 84. Although P#1 remained alert and conscious when the exsanguination (severe blood loss) was discovered, she was not given normal saline while the arterial bloodline was still connected to her arterial lumen on her CVC. This occurred despite her critically low BP reading of 69/22 mmHg, and prior to the bloodlines clotting during the attempt to recirculate P#1’s blood. - A review of the facility’s “Governing Body Meeting” minutes dated 11/21/25 revealed that the facility had educated and in-serviced all DPC Staff that each hemodialysis machine must be positioned on the same side as the patient’s access. Additionally, all patients with a CVC must have a clearly visible and securely tightened connection, and all patients with a fistula or graft must also have a visible and secure connection. - During an interview on 11/25/25 at 10:59 a.m., PCT AA stated that on 11/20/25 at 12:20 p.m., she discovered that P#1’s venous bloodline had become disconnected from her CVC, and approximately 1000 mL of blood had pooled beneath the hemodialysis chair. PCT AA stated that she immediately checked P#1’s BP, clamped the venous lumen, and called CN/RN BB for assistance. PCT AA reported that CN/RN BB then disconnected the arterial bloodline from the arterial lumen in an attempt to recirculate the lines and return P#1’s blood. PCT AA stated that P#1 was alert and talking, with a blood pressure of 69/22 mmHg. She reported that while they attempted to recirculate the bloodlines, the lines clotted and became unusable. PCT AA stated that shortly afterwards, P#1’s lips became blue, she became unresponsive, and CPR was initiated. - During an interview on 11/25/25 at 11:27 a.m., RN AA stated that on 11/20/25, she initiated P#1’s hemodialysis treatment and secured the bloodlines, taping them down along with P#1’s CVC. RN AA stated that within five to 10 minutes, she noticed P#1 scratching at her CVC, which caused the tape that secured the lines to become loosed. RN AA stated that she educated P#1 about the increased risk of infection associated with scratching the CVC. RN AA then re-secured the bloodlines and CVC before being instructed to go on her lunch break. RN AA stated that when she returned from her lunch break, she observed a large amount of blood beneath P#1’s hemodialysis chair. RN AA stated that P#1 was awake, alert, talking, and had even requested a Kleenex (facial tissue) while CN/RN BB and PCT AA attempted to recirculate P#1’s bloodlines but were unsuccessful due to clotted bloodlines. RN AA stated that P#1 became unresponsive shortly afterward, at which point CPR was initiated. RN AA also stated that no fluid was given back to P#1 prior to CPR. A telephonic interview was conducted on 11/26/25 at 10:00 a.m., with the Assistant Facility Administrator. The Assistant Facility Administrator stated that no saline was administered to treat P#1’s low BP following the exsanguination. The Assistant Facility Administrator explained that the staff attempted to preserve the bloodlines to return P#1’s blood; however, during recirculation, the bloodlines clotted, and as a result, neither fluids nor blood were given to P#1. A telephonic interview was conducted on 11/26/25 at 11:00 a.m., with the Medical Director (MD). The MD stated that the staff were concerned that P#1 might have an air embolus (a life-threatening condition where air bubbles enter the bloodstream, blocking blood flow to vital organs like the brain, heart, and lungs), which is why they did not administer saline to treat P#1’s hypotension. The MD stated that it would have been appropriate to give saline first before attempting to recirculate. The MD stated that the venous lumen could have been aspirated in case there was an air embolus prior to reconnecting the bloodlines. The MD also stated that proper management of hypotension would be reviewed with the governing body and that in-services would begin immediately with the DPC Staff. - A review of Policy: 1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, dated April 2024, showed the following: 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 (bottom number) 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 patients 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. - A review of Policy: 1-09-01 titled, “ Hypotension”, dated October 2025 showed the following: 3. Administer normal saline bolus of 100 - 200 mL for severe hypotensive symptoms. Patient care technicians may give up to 200 mL and will inform licensed nurse of intervention. Rationale: Saline bolus increases intravascular volume. Normal Saline may be administered with a patient specific PRN order and/or written/verbal order.”