Davita Shamrock 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 interviews, 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. One of one Registered Nurse (RN AA) did not adhere to facility Policy and Procedures (P & P) relative to initiation of hemodialysis treatment for one of one sampled patient (P#1) who had a central venous catheter (CVC - a type of access used for hemodialysis using a soft, flexible tube that is inserted into a large vein close to the heart). This failure resulted in P#1’s exsanguination (a severe and potentially fatal blood loss) during hemodialysis treatment that led to P#1’s hospitalization. The facility census was 62. Findings include: Cross Reference: V 715 - Failure of the Medical Director to ensure that RN AA adhered to facility P & P to ensure safe patient care.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 03383 Based on a review of facility records and staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure resulted in patient’s (P#1’s) exsanguination (a severe and potentially fatal blood loss) during hemodialysis treatment. The facility census was 62. Findings include: Cross-Reference: V 715 - Failure of the Medical Director to ensure that one of one Registered Nurse (RN AA) adhered to facility policy and procedures relative to initiation of hemodialysis treatment for one of one sampled patient (P#1) who had a central venous catheter (CVC - a type of access used for hemodialysis using a soft, flexible tube that is inserted into a large vein close to the heart). This failure resulted in P#1’s exsanguination (a severe and potentially fatal blood loss) during hemodialysis treatment that led to P#1’s hospitalization.”

“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 observation and staff interview, it was determined that the facility failed to ensure that one of nine patients (P#4) observed in the Patient Treatment Room at Stations (S) 11, had her vascular access site and bloodline connections 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 62. Findings include: During observation in the Patient Treatment Room on 6/9/25 between 11:40 a.m. and 12: 00 p.m., the following was revealed: - P#4 had a blanket that completely covered her body from neck to toe at 11:48 a.m. The patient’s dialysis access site (right upper arm arteriovenous graft) and bloodline connections were not visible during treatment. The Facility Administrator was informed of the above findings on 6/9/25 at 1:15 p.m. and stated that they have two patients who will not leave their access uncovered and named P#4 as one of the patients. Also stated that the patient complained of “getting very cold.””

“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), adhered to facility P & P relative to initiation of hemodialysis treatment for one of one sampled patient (P#1) who had a central venous catheter (CVC - a type of access used for hemodialysis using a soft, flexible tube that is inserted into a large vein close to the heart). This failure resulted in P#1’s exsanguination (a severe and potentially fatal blood loss) during hemodialysis treatment that led to P#1’s hospitalization. The facility census was 62. Findings include: A review of the facility’s “Risk Event Management (REM) Log” showed the following: - On 6/4/25: P#1 experienced blood loss greater than (>) 500 cc (cubic centimeters). A review of P#1’s “Treatment Details Report” dated 6/4/25 showed the following: - At 10:21 a.m., RN AA documented “Treatment started without complications. Pt (Patient) c/o (complained of) weakness and not feeling well.” - At 10:34 a.m., RN AA documented “Pt getting settled. No complaints.” - At 10:40 a.m., RN AA documented “Pt states she does not feel well. Began checking lines and machine. Venous disconnected. Turned pt to left side and pt began foaming at the mouth. [sic] Oxygen applied and saline opened up.” - At 10:44 a.m., RN AA documented “Pt breathing but foaming at mouth. Good pulse. Oxygen still in use.” - At 10:52 a.m., RN AA documented “Squad here. Second bag of saline hung. Paramedics took over. Treatment ended earlier.” - Close Treatment Reason showed Patient Medical Emergency (paramedics called and/or patient sent to ER (Emergency Room). A review of the “Facility Incident Report Form” dated 6/6/25 showed the following: On 6/4/25 at 10:00 a.m.: Pt (P#1) placed on machine via CVC catheter by nurse. Nurse went to desk to check lobby as it was shift change. Machine started going off. Pt stated before being placed on machine she did not feel well. Went back to pt and checked machine and pt. As I was returning to check machine, pt had arm tangled in lines. I silenced machine and looked at pt. PT [sic] began losing consciousness. I then checked CVC and venous limb was disconnected. Line clamped and dialysis stopped. Unable to return blood. Pt placed on left side and fluids given. Pt received approximately 1500 cc NS (Normal Saline) EMS (Emergency Medical System) called. Upon arrival pt was breathing and continued to have a pulse throughout the event. Pt began vomiting but did not answer questions nor follow commands. Injury: Yes Blood loss and change in consciousness; Treatment Required: Yes Pt went to the ER and was dx (diagnosed) with GI bleed. [sic] A review of P#1’s “Hospitalist Discharge Summary” signed and dated 6/7/25 showed the following: Hospital course: This 59-year-old... presents to the ED (Emergency Department) on 6/4/25 due to nausea and vomiting. Patient reported her symptoms started today while she was getting dialysis. She said she had vomited some blood. The main component at bedside reported it was a fairly large amount. Patient reports that she was on anticoagulant. This is the 1st event. Also mentioned that she is feeling very weak ... Labs are remarkable for: Hemoglobin 7.6 ... Patient was admitted and the [sic] received blood transfusion, underwent upper endoscopy, which was negative for source of bleeding, EGD (Esophagogastroduodenoscopy - a procedure that uses an endoscope to examine the lining of the esophagus, stomach, and duodenum [the first part of the small intestine] was normal. Free Text DxA&P (Diagnosis, Assessment and Plan): GI bleed - patient reports coffee ground emesis... - EGD - Normal upper GI (gastrointestinal) anatomy... ESRD on HD (End Stage Renal Disease on Hemodialysis) - patient reports bleeding from one of the ports on the Perma cath (CVC)... Anemia - bleeding from Perma cath possible cause of anemia - status post 1 unit of red blood cells transfused Plan: The patient will be transfused 1 unit of blood while on hemodialysis... During an interview with P#1 on 6/9/25 at 11:48 a.m., P#1 stated she is new to dialysis and started on 5/30/25. When asked how things are going, P#1 stated “It’s good today but it wasn’t last Wednesday (6/4/25) when it (venous bloodline) wasn’t hooked up, the nurse did not hook me up right. I passed out and was transferred to the hospital. I was in the hospital until Saturday (6/7/25) and the hospital staff told me that I lost a lot of blood. I was given blood, and I feel pretty good today.” Stated she did not want to come back for dialysis because what happened last dialysis treatment was scary. Stated this is her first treatment since she was discharged from the hospital and no one from this facility has explained to her what happened. Stated that she requested an incident report and told staff that she does not want the same nurse to care for her anymore. Stated they are honoring her wishes. During an interview with RN AA on 6/9/25 at 11:56 a.m., RN AA stated that she has worked at this facility for three years. Stated “I hooked the patient (P#1) up, walked away and the alarm went off. I didn’t connect the line tight enough.” When asked about how venous line was connected, RN AA stated “The line screws on and if not tight enough will come off. This has never happened to me before (line becoming disconnected).” When asked if she would do anything differently, RN AA stated “I would recheck the lines to make sure connections are tight enough.” RN AA stated P#1 was fiddling with blanket, and this may have caused the venous line to become disconnected. Stated she put in a REM report but has not been discussed with the Facility Administrator yet, as she has been out. During an interview on 6/9/25 at 12:06 p.m., the Facility Administrator stated that she just returned to the facility today (6/9/25), and stated she wasn’t here when the incident happened. Stated that the REM was put in wrong because the patient had less than 500 cc of blood loss. The Facility Administrator indicated she would not have reported the incident to the state if blood loss was less than 500 cc. A review of P#1’s medical records revealed that P#1 did not have an initial baseline hemoglobin drawn since admission to this facility. The Facility Administrator confirmed this finding on 6/9/25 at 12:47 p.m. - A review of facility Procedure: 1-04-02B titled, “CENTRAL VENOUS CATHETER (CVC WITH CLEARGUARD HD ANTIMICROBIAL END CAPS PROCEDURE”, dated October 2024 showed the following: 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.”