Fmc Tucker

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on facility record review, and staff interviews, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operation of the facility. This deficient practice caused one of one patient (P#1), to suffer an excessive blood loss that required a blood transfusion. This failure could also negatively affect the health and safety of the other 54 in-center hemodialysis patients who were under the care of this facility. Findings include: Cross References: V 407 - Failure of two of two Registered Nurses (RN and Charge Nurse [RN/CN] and RN CC - who were responsible for and accountable to, patients’ quality of nursing care rendered, based on Nursing Services standards), and four of four Patient Care Technicians (PCTs - PCT AA, PCT CC, PCT DD, and PCT EE), to ensure that six of 15 patients (P) P#3, P#6, P#9, P#13, P#14, and P#15 observed on first shift, and two of 16 patients (P#21 and P#22) observed on second shift, had their vascular accesses (dialysis needle insertion sites) uncovered and visible to the staff and monitored throughout their dialysis treatment per facility P & P. This deficient practice could provide an opportunity for occurrence of accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood), even after this facility already had an incidence of exsanguination that occurred on 12/1/25. V 757 - Failure of the Facility Administrator to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe patient care, as evidenced by one of one patient being hospitialized due to blood loss because there was 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.”

“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: 49321 Based on observation, patient and staff interviews, and a review of facility records including facility Policy and Procedures (P & P), it was determined that two of two Registered Nurses (RN and Charge Nurse [RN/CN] and RN CC - who were responsible for and accountable to, patients’ quality of nursing care rendered, based on Nursing Services standards), and four of four Patient Care Technicians (PCTs - PCT AA, PCT CC, PCT DD, and PCT EE), failed to ensure that six of 15 patients (P) P#3, P#6, P#9, P#13, P#14, and P#15 observed on first shift, and two of 16 patients (P#21 and P#22) observed on second shift, had their vascular accesses (dialysis needle insertion sites) uncovered and visible to the staff and monitored throughout their dialysis treatment per facility P & P. This deficient practice could provide an opportunity for occurrence of accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood), even after this facility already had an incidence of exsanguination that occurred on 12/1/25. 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 55. Findings include: During observation in the Patient Treatment Room on 12/10/25, (first shift), from 9:30 a.m to 10:00 a.m., the following was observed: There were 15 patients who were receiving hemodialysis treatment. P#6, P#9, P#13 and P#15 at Stations (S) 6, S9, S14 and S16, respectively, had their access sites covered with thick blankets. P#3 at S3 had his eyes and face covered with a thick coat with fur trim around the hood. His access site was also covered with a thick blanket. - RN/CN was notified about P#3 at S3 regarding the covered face and access site. RN/CN walked over to S3 and told P#3, “The State is in the building, and you need to uncover your face and access”. During observation in the Patient Treatment Room, on 12/10/25 (on second shift), from 12:30 p.m. to 1:00 p.m., the following was revealed: - P#21’s Central Venous Catheter (CVC - a tube placed in a large neck, chest or groin vein, acting as direct access to the bloodstream for hemodialysis), and bloodlines were covered with a thick blanket. - At 12:36 p.m., PCT AA was notified of the above observation. PCT AA stated that she could see the top of the catheter (CVC) but she would ask the patient to uncover the lines. - At S2, P#22’s access site was covered with a thick blanket. He also had a hat pulled down over his face and mouth. - RN CC was observed documenting P#22’s 30-minute check (intradialytic monitoring, [real time tracking of vitals signs, fluid shifts... during hemodialysis] - which included but not limited to: blood pressure (BP) reading, pulse, and verification that the access was uncovered and secured), at P#22’s chairside computer. After documenting the findings on the chairside computer at S2, RN CC walked away from S2 and sat behind the nurses’ station. RN CC did not look/observe P#22, did not check his access site and did not ask P#22 how he felt and did not address the covered access site. A review of RN CC’s documentation (on P#22’s treatment flowsheet), stated that P#22’s access site was visible and uncovered (which was a contradiction to what actually happened during this surveyor’s observation). The RN Facility Administrator (RN/FA) was informed of the above observation. RN/FA instructed RN CC to return to S2, uncover P#22’s access site and face, and educate P#22 regarding the risks of having his access site and face covered during dialysis treatment. - During an interview with RN CC on 12/10/25 at 1:15 p.m., RN CC was asked how a 30-minute check was supposed to be done. RN CC stated that during the 30-minute checks, staff should make sure patients’ BP readings and pulses were stable, and patients’ faces and accesses were uncovered. A review of the facility’s “Patient Safety Events”, (or Adverse Occurrence Reports), stated that on 12/1/25, P#1 sustained significant blood loss due to a system separation (Heparin line was not clamped and the cap of the infusion line was not securely tightened). EMS (Emergency Medical Services), 911 was called, and P#1 was transported to the Emergency Room (ER), where he required transfusion of three units of packed red blood cells (PRBC) due to dangerously low hemoglobin (an iron-rich protein in red blood cells that transports oxygen from the lungs to the body’s tissues). A review of Policy with Reference Number: 45284, titled, “Patient Assessment and Monitoring”, dated 5/1/23, showed the following: Access: Observe connections are secure and visible. - Ensure access remains uncovered throughout the treatment - Observe and ensure: Tape is secure Needles are intact”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 49321 Based on a review of facility records, staff interviews, and a review of facility policies and procedures (P & P), it was determined that the facility failed to ensure that one of one Registered Nurse (RN AA - a new orientee), completed orientation, and Competency Skills Validation Checklist, before assigning her to take care of patients. This deficient practice had the potential to compromise patient safety. The facility census was 55. Findings include: On 12/1/25, Registered Nurse (RN) AA arrived at the facility for her first day of orientation at an End Stage Renal Disease (ESRD) chronic facility after transferring from a hospital dialysis unit as an Acute Dialysis Nurse. Her documented clock-in time was 5:51 a.m. The Facility Administrator (RN/FA), who was assigned as her preceptor, arrived between approximately 8:00 a.m. and 8:30 a.m. There was no documented evidence that RN AA completed an orientation program (including a scavenger hunt, onboarding or education on the facility’s Electronic Medical Record (EMR) system), nor completed a Competency Skills Validation Checklist before being assigned to care for patients. On 12/1/25, RN AA was paired with Patient Care Technician (PCT CC), to care for the patients (P#9, P#10, and P#12) and P#1, who was Hepatitis B (a communicable liver infection from the Hepatitis B Virus [HBV], spread through infected blood/body fluids), positive and was scheduled to run his hemodialysis treatment in the Isolation room (S10), during first shift on Mondays-Wednesdays-Fridays (MWF) schedule, for 3 hours and 10 minutes (treatment duration). P#1 also suffered an excessive blood loss during dialysis on 12/1/25. For additional information, cross reference: E 617 - Failure of the Facility Administrator to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe care as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis caregiver 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, other medical issues and emergencies, for every 12 patients receiving dialysis care; and that each caregiver was not assigned more than four patients at any given time.”

“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: 49321 Based on a review of facility records, patient and staff interviews, a review of facility policies and procedures (P&Ps), it was determined that the Governing Body failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients and provide safe care as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis caregiver 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, other medical issues and emergencies, for every 12 patients receiving dialysis care; and that each caregiver was not assigned more than four patients at any given time (per the minimum state required staffing ratios). Additionally, a Registered Nurse (RN AA), who was an Acute Dialysis Nurse from a hospital unit, and was on her first day as an orientee at this facility, was assigned as a dialysis caregiver to work with a Patient Care Technician (PCT CC). 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. As a result of this deficient practice, one of one patient (P#1) suffered an excessive blood loss and required blood transfusion. The facility census was 55. Findings include: A review of the facility’s Kronos (a comprehensive workforce management system to automate and streamline time tracking, scheduling...) and Patient/Staffing Schedule for 12/1/25, revealed the following: - On Monday, December 1, 2025, there were four Patient Care Technicians (PCTs - PCT AA, PCT BB, PCT CC and PCT DD), one Registered Nurse/Charge Nurse (RN/CN), and RN AA (who was new to this facility and was on her first day of orientation). RN AA’s time of arrival was at 5:51 a.m. - PCT AA’s arrival time was 5:42 a.m. and was assigned as dialysis caregiver to four patients (P#2, P#3, P#4, P#5) at Stations (S) 1, S2, S3, and S4, respectively. - PCT BB’s arrival time was 4:45 a.m., and was assigned as a dialysis caregiver to four patients (P#6, P#7, P#8, and P#9), at S5, S6, S7, and S8. - PCT CC’s arrival time was 6:05 a.m., and was assigned as a dialysis caregiver to four patients (P#10, P#11, P#12) at S9, S11, and S12, respectively. PCT CC was also assigned to P#1 at S10 - (Isolation room). P#1 experienced significant blood loss and was sent to the hospital for three units of blood on 12/1/25. - PCT DD’s arrival time was 5:27 a.m., and was assigned as a dialysis caregiver to four patients (P#13, P#14, P#15, and P#16) at S13, S14, S15, and S16, respectively. - There were 16 patients receiving hemodialysis treatment between 5:45 a.m. (the first documented treatment start time) and at approximately 8:30 a.m., (when the second nurse, the Facility Administrator - RN/FA, arrived). Between 5:45 a.m. and approximately 8:30 a.m., there was only one qualified licensed nurse RN/CN, who was responsible for all 16 patients. - RN AA’s (new orientee’s) arrival time was at 5:51 a.m. RN AA was originally assigned to be with her Preceptor (RN/FA) on this date, however since the RN/FA did not arrive until approximately between 8:00 a.m.- 8:30 a.m., RN AA was the nurse assigned to work alongside PCT CC. - RN/CN (who was salaried), was scheduled to arrive at 5:15 a.m., and was supposed to administer/perform nursing duties to 12 patients, however, because RN AA was new to the facility, RN/CN assumed responsibility for all 16 patients who were dialyzing from 5:45 a.m. until the arrival of RN/FA. A review of the patients’ Treatment Sheets for 12/1/25 (first shift), revealed that RN/CN documented all medication passes and pre- and post- assesments for all 16 patients. - A review of P#1’s Treatment Sheets revealed that: - P#1 was Hepatitis B (a communicable liver infection from the Hepatitis B Virus [HBV], spread through infected blood/body fluids), positive and was scheduled to run his hemodialysis treatment in the Isolation room (S10), during first shift on Mondays-Wednesdays-Fridays (MWF) schedule, for 3 hours and 10 minutes (treatment duration). - On 12/1/25, P#1’s treatment was initiated at 6:11 a.m., by PCT CC. There was no pre-treatment nursing assessment documented as completed, on the treatment sheet. The machine set up (prescription verification) was completed by RN/CN and PCT CC. - P#1’s first documented blood pressure (BP) was 147/86 mmHg (millimeter mercury), pulse was 63 beats per minute at 6:14 a.m. The blood flow rate (BFR-how fast blood is pumped from the body through the dialyzer (filter) to clean it), was set at 300 milliLiter per minute (mL/minute). Safety checks (access- fistula/graft) was marked as done by PCT CC. - At 06:30 a.m., P#1’s BP reading was 146/67 mmHg, pulse was 59 beats/minute. BFR was at 400 mL/minute. Safety checks (access- fistula/graft) was marked as done by PCT CC. - At 07:00 a.m., P#1’s BP reading was 144/63 mmHg, pulse was 59 beats/minute. BFR 400 mL/minute. Safety checks (access- fistula/graft) was marked as done by PCT CC. - At 07:36 a.m., P#1’s BP reading was 92/45 mmHg, pulse was 50 beats/minute and the BFR was at 450 mL/minute. Safety checks (access- fistula/graft) was marked as done by PCT CC. PCT CC’s documentation stated: RN (RN/CN) was notified, green AMP light, P#1 denies complaints, UF (ultrafiltration - the essential process of using pressure to remove excess fluid from the body during dialysis), off. P#1 was given 100 mL of Normal Saline. P#1 alert, large amount of blood spill noted on the floor of the dialysis machine. BP assessed, oxygen 2 liters per minute via nasal cannula. - At 7:50 a.m., P#1’s BP reading was 119/54, pulse was 52 beats/minute, 250 mL of Normal Saline was given and treatment was discontinued. - At 7:52 a.m -- Problem : treatment ended. During the above-mentioned 30-minute checks, the safety check boxes for Hemaclip (a safety device used to prevent accidental disconnection of bloodlines) and Heparin (anticoagulant) Pump (were not checked off). - RN/CN completed the Post Dialysis Vitials and Evaluation, and documented that medications were not given. Completed nursing evaluation was documented at 2:28 p.m. P#1 was discharge from the facility and taken to the hospital Emergency Room [ER], via EMS [Emergency Medical Services], at 7:53 a.m. - RN/CN documented in the Electronic Medical Records (EMR), dated 12/1/25 at 4:44 p.m., stating: “PCT alerted charge RN during routine 30 min (minute) monitoring to a large amount of blood on the floor and machine. Source of blood loss identified as a loose connection in the Heparin line. Patient (P#1) was evaluated and found to be hypotensive, pale and weak, with noted lethargy and decrease alertness compared to baseline. Approximately, 400ml of normal saline administered and oxygen was given. EMS contacted, MD, NP and CM (clinic manager- facility administrator) notified. Patient (P#1) transferred to Emory University Hospital for futher evaluation and management”. Note: P#1 did not have a prescribed order to receive Heparin. A review of Hospital records, dated 12/1/25, revealed: - P#1’s hemoglobin (protein in the red blood cell that carries oxygen from the lungs to the rest of the body) was 4.4 g/dL (grams per deciliter). P#1 received 3 units of packed red blood cells and his hemoglobin rose to 8.2 g/dL. P#1 was discharge to home. - On 12/3/25, P#1 returned to the dialysis facility and lodged a verbal grievance to the Facility Administrator (RN/FA), who documented the grievance in the Grievance Log. The nature of the grievance was safety, stating, “The patient wanted to make sure staff were educated”. - Staff education was done on 12/2/25 and 12/3/25. There was no documented evidence that RN AA (orientee), and RN CC, and RN EE (facility nursing staff who reported back to work on 12/3/25), were educated regarding the incident and facility P & P to prevent blood loss from happening again, before returning to their assigned tasks at the Patient Treatment Room. - There was also no evidence that RN AA completed a competency skills validation checkist for chronic hemodialysis, scavenger hunt (to help locate things, supplies, equipment, etcetera-etc.), in the facility. RN AA had not been onboarded on the facility’s computer system before being assigned to patient care. - During an interview on 12/10/25 at 1:00 p.m., PCT DD stated that Monday, 12/1/25, was chaotic. The RN/CN had a nurse orienting with her (not mentioned in the Patient/Staff schedule) and there was a new nurse (RN AA), that she had never seen before working with the patients in bay area three or Pod of four patients at S9, S10, S11, and S12. PCT DD added that RN AA told her it was her first day and she did not know how we documented in the computer. She did not even have accsess to the computer system. PCT DD also added that RN AA kept asking questions about where supplies were kept and how to find medications. RN/CN was doing everything - did all the assessments and medications for first shift because RN/FA did not arrive to the facility until approximately between 8:00 a.m. and 8: 30 a.m. During an interview on 12/10/26 at 1:30 p.m., PCT CC stated that RN/CN could not work with the Isolation patient (P#1), because RN/CN cared for patients that were not in the buffer zone. PCT AA added that the nurse orientee (RN AA), was assigned to work with her in caring for the patients at S9, S10, S11, and S12. RN AA kept asking questions because she did not know anything about the clinic. RN AA did not even know how to start a patient with a CVC. PCT CC also stated that when she went to the Isolation Room, she found blood on the base of the dialysis machine and under the hemodialysis chair. PCT CC also stated that RN/CN who was already overwhelmed, had to come to the Isolation Room to attend to P#1, because the RN AA did not know anything about the patients or the clinic. RN/FA arrived between 8:00 a.m. and 8:30 a.m. During an interview with RN/FA on 12/10/25 at 2:30 p.m., she stated that although RN AA was new to the facility (her first time in the building), and was not familiar with the patients, she did have dialysis experience. RN/FA further stated, “RN AA was the second licensed nurse in the building until I arrived between 8:00 a.m. and 8: 30 a.m.”. During an interview with the Director of Operations on 12/10/25 at 3:00 p.m., she confirmed that RN AA was on her first day of orientation and should not have been functioning as the nurse taking care of patients. RN/FA, who was assigned to orient RN AA, was supposed to be serving as the second licensed nurse on duty. During an interview with P#1 on 12/10/25 at 2:45 p.m., P#1 stated that he was now tired all the time. He reported that he used to be able to walk around the park twice, but he can no longer do so because he became easily fatigued. P#1 expressed concerns about his safety and stated that he filed a complaint. He also wanted to be sure that all staff and not just some staff, were properly educated, especially with all the new faces working in the facility. A review of Policy #57024, published 5/23/23, version 4 titled, “Dialysis Experience Counts”, stated: POLICY STATEMENT: Fresenius Kidney Care is committed to the educational needs of its employees. The Progressive Renal Education Program (PREP) for new clinical employees with previous dialysis experience will include an initial assessment of their skills set. The Individualized training plans will be developed based on their amount of dialysis experience and demonstration knowledge base. DEFINITION OF DIALYSIS EXPERIENCED CLINICAL STAFF: A New employee who has direct patient care experience in dialysis. This applies to Licensed Nurse (RN, LVN- Licensed Vocational Nurse/LPN- Licensed Practical Nurse) and Patient Care Technicians ( PCTs) who have the following experience in the role applied for: - 1500 hours (9 months) dialysis experience in the last 3 years. OR - 1000 hours (6 months) of dialysis experience in the last year. ORIENTATION FOR EXPERIENCED STAFF: The Dialysis Experience Counts orientation provides a training track for staff with previous dialysis experience. New employees entering the experienced PREP track will be assigned a preceptor and a class schedule will be developed under the direction of the Education team. GRADUATION REQUIREMENTS FOR EXPERIENCED STAFF: An experienced new employee must meet the following requirements to successfully graduate from the experienced track of PREP: -Passing score of 80% or above on New Employee Exam or per state regulations - Successful completion of the Skills Validation Checklists - Successful completion of CVC Checklist as applicable - Successful completion of water training requirements and skills validations as assigned.”