Fresenius Medical Care Dialysis Services North Orange County

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 50003 Based on interview and record review, the facility failed to ensure the dialysis prescription was followed for one of three sampled patients (Patient 1). Patient 1 was being dialyzed with several different BFR for treatment dated 8/25/25, when the dialysis order for the BFR was at 400 ml/min. In addition, the nephrologist was not notified when the prescribed BFR was not being followed due to issues with patient’s vascular access. This failure had the potential to cause inadequate dialysis clearance and negative health outcome of the patient. Findings: Review of the facility’s P&P titled Nursing Supervision and Delegation dated 11/6/23, showed the Registered Nurse must evaluate each patient preferably within an hour or according to state requirements to: -Confirm identify -Review the patient’s condition -Review accuracy and completeness of treatment and patient data -Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. -Confirm that the correct vascular access is being used, and that the access is visible. Observe patient’s response to treatment. -Verify machine safety checks have been completed. -Talk to the patient to elicit information such as changes in condition, response to treatment, new injuries, information/education needs or complaints, satisfaction with care. On 11/14/25, review of Patient 1’s medical record was initiated. Patient 1 was admitted to the facility on 1/18/21. Further review of Patient 1’s dialysis prescription order dated 8/25/25, showed the dialysis order was for the BFR at 400 ml/min. Review of the treatment flowsheet dated 8/25/25, showed Patient 1’s dialysis treatment was initiated at 0357 hours and ended at 0717 hours. - At 0359 hours, the treatment was initiated with a BFR at 400 ml/min. - At 0410 hours, the BFR was lowered to 350 ml/min with RN documentation showing that the BFR was lowered due to arterial pressure dropping despite repositioning of the needles. - At 0432 hours, the BFR was lowered to 300 ml/min with no documentation of justification. - At 0534 hours, the BFR was increased to 350 ml/min with RN documentation of the BFR adjusted to 350 ml/min and vascular access would be monitored. - At 0616 hours, the BFR was lowered to 300 ml/min with no documentation of justification. - At 0617 hours, the BFR was increased to 320 ml/min with RN documentation showing the BFR was set at this rate due to arterial pressure dropping. - From 0632 hours to 0717 hours, the BFR was maintained at 350 ml/min. Further review of the RN post treatment assessment dated 8/25/25, failed to show that the nephrologist was informed regarding concerns with vascular access and unmet prescribed BFR. On 11/19/25 at 1427 hours, an interview and concurrent record review was conducted with RN 2. RN 2 confirmed that Patient 1 had an order for the BFR of 400 ml/min. RN 2 stated that the prescribed BFR was not met due to issue with high arterial pressure. RN 2 further stated that the nephrologist should have been informed because dialyzing patient with lower BFR rate could lead to poor dialysis clearance. On 11/19/25 at 1645 hours, the Clinical Manager acknowledged the findings.”

“PR-INFORMED-D/C & TRANS P&P INC IVD CFR(s): 494.70(b)(1) The patient has the right to- (1) Be informed of the facility’s policies for transfer, routine or involuntary discharge, and discontinuation of services to patients; This Standard is not met as evidenced by: 50003 Based on interview and record review, the facility failed to inform one of one sampled patient (Patient 1) regarding his immediate involuntary discharge and the discontinuation of dialysis services. This failure had potential for negative health outcome. Findings: Review of the facility’s P&P titled Immediate and Non-Immediate Involuntary Patient Discharge dated 11/4/24, showed the following under the patient notification section of immediate involuntary discharge: - Contact the patient via phone informing them that they are being immediately discharged from the facility. - Send the patient an immediate patient discharge letter by certified mail/delivery service with signature confirmation and regular mail. In addition, the facility is to notify the ESRD Network and the State survey agency of the intended discharge the same day the letter is provided to the patient. Medical record review for Patient 1 was initiated on 9/12/25. Patient 1 was admitted to the facility on 8/19/25, with the diagnosis of ESRD on hemodialysis treatment four times a week. Review of physician’s progress notes dated 8/29/25, showed the following: -During patient’s last treatment on 8/26/25, patient only received 50 minutes of treatment before he demanded to be taken off the machine. He proceeded to have physical altercation with dialysis RN 2 and struck her in the head with his hands. He reportedly lit up a cigarette while in the treatment room, and left the facility partially dressed. The police department was called to file a report and the patient was escorted off the premises to the hospital by the police. Due to the physical violence and the assault of nursing staff, the patient would be discharged from the clinic effective immediately. Review of the medical record from the acute hospital showed Patient 1 was admitted to Hospital A on 8/26/25 then transferred to Hospital B on 8/27/25 for continuation of care. Review of Patient 1’s Immediate Discharge Letter issued on 8/28/25, showed the letter was sent certified to Patient 1’s board and care address while Patient 1 was in the hospital. Further review of the Notification of Involuntary Discharge documentation showed the Network was notified of the immediate involuntary discharge on 8/29/25. In addition, the Department of Public Health was also notified on 9/10/25. On 9/12/25 at 1508 hours, an interview was conducted with the Covering FA. The Covering FA verified that the certified Patient Discharge Letter was sent on 8/28/25 to Patient 1’s board and care address during his hospitalization. She further stated that it should be handed to the patient in the hospital to ensure the patient was aware of his immediate discharge. In addition, the Covering FA also verified the Network and the State Agency was not notified of the involuntary discharge on the same day that the letter was issued. On 9/24/25 at 1515 hours, the Clinical Manager acknowledged the findings.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50003 Based on interview and record review, the facility failed to ensure patient’s abnormal blood pressure readings of pre-treatment and during treatment were addressed by the registered nurse as per the facility’s P&P for one of five sampled patients (Patient 5). This failure had the potential to place the patient at risk for delays in receiving immediate intervention and treatment necessary to ensure patient’s safety. Findings: Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed the following: * Pre-treatment: the Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed such as: - Systolic blood pressures greater than 180 mm/Hg and/or diastolic blood pressures greater than 100 mm/Hg - Systolic blood pressures less than or equal to 100 mm/Hg systolic during treatment. * During treatment: - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations - Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations - Recheck blood pressures after a drop that requires interventions such as administering normal saline. - Reposition electronic cuff or use a manual cuff for aberrant blood pressure readings. - Report to the nurse: - Systolic blood pressures greater than 180 mm/Hg - Diastolic blood pressure greater than 100 mm/Hg - Blood pressure less than or equal to 100 mm/Hg systolic On 8/13/25, review of Patient 5’s medical record was initiated. Review of the treatment flowsheet showed the following: The treatment flowsheet dated 8/11/25, showed Patient 5’s pre-treatment BP was 90/50 mm Hg at 0822 hours. However, the RN’s pre-treatment assessment failed to address Patient 5’s low blood pressure reading. The RN documentation also indicated, “no unusual findings noted.” Further review of the treatment flowsheet dated 8/11/25, showed Patient 5’s treatment was initiated at 0832 hours with a BP of 97/63 mm Hg. Documentation showed the PCT informed the RN regarding the low blood pressure reading. At 0935 hours, the blood pressure reading was 96/61 mmHg. Documentation showed the RN was notified of the abnormal blood pressure reading; however, Patient 5 was not assessed by the RN until nearly two and a half hours later. At 1105 hours, RN documentation also failed to address Patient 5’s low blood pressure reading when attending the patient during this time. On 8/13/25 at 1500 hours, an interview and concurrent interview was conducted with RN 2. RN 2 verified the findings and stated that she should have addressed Patient 5’s low blood pressure during the pretreatment assessment as well as during his treatment on 8/11/25. RN 2 stated this was to ensure that patient’s blood pressure was monitored, and interventions were provided timely to prevent further complications associated with the low blood pressure during dialysis. On 8/13/25 at 1705 hours, the Clinical Manager acknowledged the findings.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 50003 Based on interview and record review, the facility failed to ensure the dialysis prescriptions were followed for one of three sampled patients (Patient 3). Patient 3 was being dialyzed with the BFR at 450 ml/min for the treatment on 7/7/25, when the dialysis order was for the BFR at 500 ml/min. This failure had the potential to cause access complication, inadequate dialysis clearance, and negative health outcomes to the patient. Findings: Review of the facility’s P&P titled Nursing Supervision and Delegation dated 11/6/23, showed the Registered nurse must evaluate each patient preferably within an hour or according to state requirements to: - Confirm identify - Review the patient’s condition - Review accuracy and completeness of treatment and patient data - Review patient treatment prescription and equipment parameters to verify correct settings, and if dialysis prescription is being followed. - Confirm that the correct vascular access is being used, and that the access is visible. Observe patient’s response to treatment. - Verify machine safety checks have been completed. - Talk to the patient to elicit information such as changes in condition, response to treatment, new injuries, information/education needs or complaints, satisfaction with care. On 7/11/25, review of Patient 3’s medical record was initiated. Patient 3 was admitted to facility on 9/27/24. Review of Patient 3’s dialysis prescription order showed the dialysis order was for the BFR at 500 ml/min. Review of the treatment flowsheet dated 7/7/25, showed Patient 3’s dialysis treatment was initiated at 0846 hours, and ended 1259 hours. Between 0846 to 0921 hours, an AFT was conducted with the BFR at 300 ml/min as per the facility’s policy. At 0931 hours, the BFR was resumed at 500 ml/min as prescribed after completion of the AFT. For the rest of the treatment from 1001 to 1259 hours, the BFR was lowered to 450 ml/min with no documentation of justification from the nurse. On 7/11/25 at 1530 hours, an interview was conducted with RN 3. RN 3 confirmed Patient 3 had an order for the BFR of 500 ml/min. He further stated Patient 3 had the AFT done at the beginning of treatment for about 30 minutes at the BFR of 300 ml/min. After completion of the access flow test, RN 3 stated Patient 3 should resume the dialysis treatment with the BFR at the prescribed rate of 500 ml/min. If the BFR was not able to achieve as prescribed, the nurse should have a documentation of justification. RN 3 further stated dialyzing patient at a low BFR could result in poor dialysis clearance leading to uremia and other health issues. On 7/11/25 at 1700 hours, the Clinical Manager acknowledged the findings.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50003 Based on interview and record review, the facility failed to ensure the patients’ BPs were monitored for two of two sampled patients (Patients 1 and 2) as per the facility’s P&P as evidenced by: 1. The PCT did not notify the RN of Patient 1’s abnormal BP readings as per the facility’s P&P. 2. The PCT did not notify the RN of Patient 2’s abnormal BP readings as per the facility’s P&P. These failures had the potential to place the patients at risk for delays in receiving the immediate interventions and treatments necessary to ensure the patients’ safety. Findings: Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed the following: * The steps for monitoring patient during the treatment include the following: - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. - Record blood pressure: recheck blood pressures after a drop that requires interventions such as administering normal saline and reposition electronic cuff or use a manual cuff for aberrant blood pressure readings. - Report to the nurse of the SBP greater than 180 mmHg, DBP greater than 100 mmHg, or SBP less than or equal to 100 mmHg. 1. On 2/19/25, review of Patient 1’s medical record was initiated. Review of the treatment flowsheets showed the following: a. The treatment flowsheet dated 1/13/25, showed Patient 1’s dialysis treatment was initiated at 0429 hours and ended at 0801 hours. Patient 1’s BP was 170/80 mmHg at 0637 hours and dropped to 138/62 mmHg at 0708 hours (a drop of 32 mmHg for the SBP). However, there was no documented evidence the PCT had informed the RN of the decreased BP readings. b. The treatment flowsheet dated 2/19/25, showed Patient 1’s dialysis treatment was initiated at 0436 hours and ended at 0802 hours. Patient 1’s BP was 179/85 mmHg at 0505 hours and dropped to 146/83 mmHg at 0537 hours (a drop of 33 mmHg for the SBP). However, there was no documented evidence the PCT had informed the RN of the decreased BP readings. 2. On 2/19/25, review of Patient 2’s medical record was initiated. Review of the treatment flowsheets showed the following: a. The treatment flowsheet dated 2/17/25, showed Patient 2’s dialysis treatment was initiated at 0803 hours and ended at 1133 hours. Patient 2’s BP was 132/54 mmHg at 0803 hours and dropped to 109/53 mmHg at 0832 hours (a drop of 23 mmHg for the SBP). However, there was no documented evidence the PCT had informed the RN of the decreased BP readings. b. The treatment flowsheet dated 2/19/25, showed Patient 2’s dialysis treatment was initiated at 0809 hours and ended at 1139 hours. Patient 2’s BP was 129/64 mmHg at 0902 hours and dropped to 103/54 mmHg at 0937 hours (a drop of 26 mmHg for the SBP). However, there was no documented evidence the PCT had informed the RN of the decreased BP readings. On 2/19/25 at 1315 hours, an interview was conducted with PCT 1. When asked about the parameter that required the attention of the RN, PCT 1 stated that any BP reading trending up or down of 20 mmHg or more compared to the previous reading would require a notification of the RN during dialysis treatment. On 2/19/25 at 1435, an interview and concurrent review of Patient 1 and Patient 2’s medical records was conducted with RN 1. RN 1 verified the findings. RN 1 stated the PCTs were expected to notify the RN for any increase or decrease in the BP of greater than 20 mmHg compared to the previous BP reading during treatment for further assessment. On 2/19/25 at 1630 hours, an interview and concurrent record review was conducted with the Clinical Manager. The Clinical Manager acknowledged the findings. The Clinical Manager stated the PCTs were expected to inform the RN of a change of BP of 20 mmHg or greater compared to previous BP reading during the dialysis.”

“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: 50003 Based on observations, interview, and record review, the facility failed to ensure the dialysis access sites of two nonsampled patients (Patients A and B) were visible during their hemodialysis treatments. This failure had the potential for the needle dislodgement and lines disconnection that could result in rapid blood loss. Findings: Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed to ensure the access remains uncovered throughout the treatment. 29558 On 1/10/25 at 1515 hours, the access sites of Patient A at Station A and Patient B at Station B were observed to be covered with the blankets and not visible. RN 2 was informed and acknowledged the findings.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 50003 Based on interview and record review, the facility failed to ensure the patients’ BPs were monitored for two of three sampled patients (Patients 1 and 2) as per the facility’s P&P as evidenced by: 1. The PCT did not notify the RN of Patient 1’s abnormal BP readings and the RN did not address Patient 1’s pretreatment elevated BP during the nursing assessment as per the facility’s P&P. 2. The PCT did not notify the RN of Patient 2’s abnormal BP readings as per the hospital’s P&P. These failures had the potential to place the patients at risk for delays in receiving the immediate interventions and treatments necessary to ensure the patients’ safety. Findings: Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed the following: * Direct patient care staff may collect data such as blood pressure. * If the PCT/LPN note any changes or abnormal findings in the patient’s conditions or vascular access are observed or reported by the patient, or the patient was hospitalized, the RN must assess the patient. * The Registered Nurse will assess/re-assess any findings addressed pre or during treatment as needed. * The steps for obtaining pre-treatment assessment date include to record the blood pressure and verify the following: - SBP greater than 180 mmHg and/or DBP greater than 100 mmHg. - SBP less than or equal to 100 mmHg systolic during treatment. * The steps for monitoring patient during the treatment include the following: - Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. - Record blood pressure: recheck blood pressures after a drop that requires interventions such as administering normal saline and reposition electronic cuff or use a manual cuff for aberrant blood pressure readings. - Report to the nurse of the SBP greater than 180 mmHg, DBP greater than 100 mmHg, or SBP less than or equal to 100 mmHg. 1. On 1/10/25, review of Patient 1’s medical record was initiated. Review of the treatment flowsheets showed the following: a. The treatment flowsheet dated 11/29/24, showed Patient 1’s dialysis treatment was initiated at 0428 hours and ended at 0802 hours. Patient 1’s BP was 174/82 mmHg at 0430 hours and dropped to 131/73 mmHg at 0502 hours (a drop of 43 mmHg for the SBP). However, there was no documented evidence the PCT had informed the RN of the decreased BP readings. Further review of the treatment flowsheet dated 11/29/24, showed the Patient 1’s BP was 151/85 mmHg at 0634 hours and dropped to 99/59 mmHg at 0700 hours (a drop of 52 mmHg for the SBP). However, there was no documentation to show the RN was informed of the decreased BP readings. b. The treatment flowsheet dated 12/16/24, showed Patient 1’s dialysis treatment was initiated at 0500 hours and ended at 0810 hours. Patient 1’s pre-treatment sitting BP was 194/92 mmHg and standing BP was 197/85 mmHg. At 0500 hours, the dialysis treatment was initiated and the patient’s BP was 194/92 mmHg. However, there was no documentation the PCT informed the RN of the elevated blood pressure. Review of the Nursing Evaluation section of the treatment flowsheet dated 12/16/24, showed the RN evaluated the patient on 12/16/24 at 0542 hours. However, there was no documented evidence to show the RN had addressed the patient’s elevated BP during the nursing assessment. c. The treatment flowsheet dated 12/29/24, showed Patient 1’s dialysis treatment was initiated at 0426 hours and ended at 0759 hours. Patient 1’s BP was 175/83 mmHg at 0703 hours and dropped to 128/69 mmHg at 0734 hours (a drop of 47 mmHg for the SBP). However, there was no documentation the RN was made aware of the decreased BP reading. On 1/10/25 at 1400 hours, an interview was conducted with PCT 1. When asked about the parameter that required the attention of the RN, PCT 1 stated that any BP reading trending up or down of 20 mmHg or more from the previous BP reading would require a notification of the RN during the dialysis treatment. On 1/10/25 at 1430, an interview and concurrent review of Patient 1’s medical record was conducted with RN 2. RN 2 verified the findings. RN 2 stated the PCTs were expected to notify the RN of the abnormal BP pre-treatment and during dialysis and the increase or decrease in the BP of greater than 20 mmHg compared to the previous BP reading. RN 2 further stated RN 2 should have addressed the pre-treatment elevated BP during her assessment on 12/16/24. On 1/10/25 at 1630 hours, an interview and concurrent record review was conducted with the Clinical Manager. The Clinical Manager acknowledged the findings. The Clinical Manager stated the PCTs were expected to inform the RN of abnormal findings pre-treatment including the elevated BP of greater than 180 mmHg as well as a change of BP of 20 mmHg compared to previous BP reading during the dialysis treatment. 29558 2. On 1/10/25, review of Patient 2’s medical record was initiated. Review of the treatment flowsheets showed the following: a. The treatment flowsheet dated 1/3/25, showed Patient 2’s dialysis treatment was initiated at 0811 hours and ended at 1211 hours. The following was identified: * Patient 2’s BP was 145/66 mmHg at 0833 hours and increased to 169/58 mmHg at 0901 hours (the patient’s SBP was increased 24 mmHg). There was no documented evidence to show the PCT had informed the RN of the elevated BP as of 169/58 mmHg at 0901 hours. * Patient 2’s BP was 196/78, 186/77, and 197/78 mmHg at 1002, 1032, and 1103 hours respectively. There was no documented evidence to show the PCT had informed the RN of the patient’s SBP being more than 180 mmHg. b. The treatment flowsheet dated 1/6/25, showed Patient 2’s dialysis treatment was started at 0812 hours and ended at 1212 hours. The patient’s BP was 197/68 mmHg at 1136 hours. There was no documented evidence to show the RN was notified when the patient’s SBP was more than 180 mmHg at 1136 hours. c. The treatment flowsheet dated 1/8/25, showed Patient 2’s dialysis treatment was started at 0811 hours and ended at 1212 hours. The patient’s BP was 187/77 and 188/81 mmHg at 1101 and 1130 hours respectively. There was no documented evidence to show the RN was notified when the patient’s SBP was more than 180 mmHg at 1101 and 1130 hours. On 1/10/25 at 1430 hours, an interview and concurrent review of Patient 2’s medical record was conducted with the Clinical Manager. The Clinical Manger confirmed the above findings. The Clinical Manager stated the PCT should notify the RN when the patient’s SBP was more than 180 mmHg or there was a change in SBP or DBP of more or less than 20 mmHg comparing to the previous BP reading.”

“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: 50003 Based on observation, interview, and record review, the facility failed to ensure the staff implemented the facility’s P&Ps for one of three sampled patients (Patient 1) and Visitor 1 as evidenced by: 1. The RN 2 did not sign off when administering acetaminophen (a pain medication) to Patient 1 as per the facility’s P&P. 2. The staff did not ensure Visitor 1 wore a barrier gown while being inside the treatment area and removing the barrier gown before leaving the treatment area as per the facility’s P&P. These failures had the potential to result in unsafe patient care in the facility. Findings: 1. Review of the facility’s P&P titled Medication Preparation and Administration dated 2/6/23, showed the following points must be followed to ensure proper documentation of medication preparation and administration: - Medication administration must be documented in the patient’s medical record. - Medication must not be signed off prior to administration. - Document any side effects and any treatment needed. - Medication reactions and errors must be documented appropriately and reviewed by the clinical manager, charge nurse or team leader, and reported to the physician to ensure appropriate follow up and/or intervention. - Document reason for PRN drug administration and effectiveness of medication post administration in the patient’s medical record. The licensed nurse should evaluate the patient response when administering a PRN medication. On 1/10/25 at 1430 hours, an interview and concurrent review of Patient 1’s dialysis treatment flowsheet was conducted with RN 2. Review of the Nursing Evaluation section of the dialysis treatment flowsheet dated 12/9/24, showed at 0620 hours, one tablet of acetaminophen was given to the patient as per the patient’s request due to headache. However, the Medication section of the dialysis treatment flowsheet dated 12/9/24, failed to show acetaminophen was documented as it was administered to the patient. RN 2 verified that one tablet of acetaminophen (325 mg) was given to patient at 0620 hours during treatment on 12/9/24 as needed for headache. She further stated she should have signed off the medication as per the facility’s P&P. On 1/10/25 at 1630 hours, an interview and concurrent record review was conducted with the Clinical Manager. The Clinical Manager acknowledged the findings and stated RN 2 should have followed the facility’s P&P and signed off the medication as administered to the patient. 2. Review of facility’s P&P tilted Visitor Policy dated 2/6/23, showed the PPE will be provided along with the instructions for proper use if there is a likelihood that the visitor may be exposed to the bloodborne pathogens during the time that he/she is in the treatment area. The visitors must wash hands after glove removal and before leaving the treatment area. All PPE must be discarded after use or left in the treatment area. On 1/10/25 at 0809 hours, Visitor 1 was observed standing by Station C in the treatment area without donning on the barrier gown, waiting for the patient to complete the post treatment tasks. RN 1 was made aware of the findings and provided a barrier gown to Visitor 1. RN 1 further stated all visitors must wear the barrier gowns when the visitors were inside the treatment floor. On 1/10/25 at 0820 hours, Visitor 1 was observed leaving the treatment floor without removing the barrier gown. On 1/10/25 at 1630 hours, during an interview with the Clinical Manager, the Clinical Manager stated all visitors were required to wear the barrier gowns in the treatment area and remove them before leaving the treatment area.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 37663 Based on interview and record review, the facility failed to ensure the nursing staff evaluated the dialysis prescription during the dialysis treatment after the PCT changed the UF goal from the physician’s prescription for one of four sampled patients (Patient 1). This failure posed the potential for poor health outcomes to the patient. Findings: Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed the following: * Data Collection: If the PCT or LVN note any changes or abnormal findings in the patient’s condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the RN must assess the patient. The RN will assess or reassess any findings addressed pre or during treatment as needed. * During Treatment: Follow the steps below for monitoring patient and machine parameters during treatment: - BP: Record BP, Recheck BP after drop that requires intervention such as administering normal saline. - Ultrafiltration rate: Monitor UF rate. - Reported by the Patient: Ask if any new complaints to report. - General Observation or Mental Status: Observe the patient’s overall condition during treatment, report to the nurse any changes in patient’s overall condition or any changes in mental status. When leaving the treatment room, report off to another staff member to ensure patient observation and monitoring during the dialysis treatment. - Machine Parameters and Extracorporeal Circuit: check machine settings and measurements, checked prescribed blood flow is achieved or reason is documented in medical record if unable to meet prescribed flow, check dialysate flow rate setting is correct, and the prescribed flow being delivered. - Document any findings and interventions in the medical record. Review of the facility’s P&P titled Nursing Supervision and Delegation dated 11/6/23, showed the following: * Delegation: a delegatee to perform a specific patient care task, activity, or procedure that is within the nurse scope of practice and the delegatee’s routine role functions and/or job description, supported by P&P, and for which the delegatee has education, training, demonstrated competency to perform while maintaining accountability for the outcome. * Non-licensed direct patient care staff: Assistive personnel trained to function in a supportive role, to whom responsibility to perform a patient care task, activity or procedure has been delegated. This includes Patient Care Technicians. * The RN is accountable for delivering care within the framework of the nursing process. The RN uses clinical findings to formulate nursing diagnoses and prioritize problems according to patient need. Delegation generally refers to assigning and authorizing patient care activities or care activities or tasks to competent licensed or unlicensed staff who have received specific training and competency validation of the task. The assigned staff or person is responsible for performing the activity or task while the RN must provide supervision of the staff member’s performance and maintains responsibility of the outcome. The licensed RN cannot delegate any task, skill or practice that requires nursing judgement, critical decision making, or the use of the nursing process which is assessment, diagnosis, identification of outcomes, planning, implementation, and evaluation. * Determination of Task Appropriateness for Delegation: The decision of whether to delegate a task or activity is based upon whether the task requires nursing judgement, critical decision making, or implementation of the nursing process. On 10/23/24 at 1051 hours, Patient 1’s medical record was reviewed. Review of Patient 1’ treatment record dated 9/11/24, showed the following: - Patient 1’s estimated dry weight was 83.5 kg. - The pre-dialysis vital signs and evaluation section showed the patient’s pre-weight was 86 kg. The TWR was 3.0 kg. The gained weight was 2.10 kg. The sitting BP was 149/72 mmHg, and the standing BP was 156/71 mmHg. RN 3 confirmed the patient’s identity and dialysis orders on 9/11/24 at 0411 hours. - At 0432 hours, RN 3 documented the patient’s BP was 159/74 mmHg. - At 0503 hours, PCT 1 documented the patient’s BP was 126/63 mmHg (33 mmHg lower). The patient’s BP was dropped. The goal was lowered at 2.7 kg. The RN was aware. - At 0532 hours, PCT 1 documented the patient’s BP was 119/61 mmHg. The BP was dropping and lowered the goal to 2.6 kg. The RN was aware. - At 0601 hours, PCT 3 documented the patient’s BP was 122/59 mmHg. - At 0631 hours, PCT 3 documented the patient’s BP was 102/54 mmHg, (dropped 20 mmHg). There was no documented evidence the RN was notified of the BP dropping 20 mmHg. - At 0636 hours (after 1.33 hours), RN 3 documented the patient’s BP was 112/58 mmHg. The UF goal was at 2.6 kg. On 10/23/24 at 1346 hours, an interview and concurrent review of Patient 1’s medical record was conducted with RN 3. RN 3 was asked about the treatment for Patient 1 on 9/11/24 when the PCT changed the UF goal down to 2.7 kg at 0503 hours and when the UF goal was lowered to 2.6 kg at 0532 hours. RN 3 stated she was on her break at 0503 hours and RN 2 covered for her patients when she was on break. The PCT should confirm from the RN before lowering or adjusting the UF goal. RN 3 was asked when the PCT should notify the RN if there was a change on the patient’s BP. RN 3 stated the PCT should notify the RN when the BP reading was below 100 mmHg with or without associated symptoms or if there was a huge drop on the patient’s BP such as from 180 mmHg down to 130 or 140 mmHg. On 10/23/24 at 1515 hours, an interview and concurrent review of Patient 1’s medical record was conducted with RN 2. RN 2 was asked about Patient 1’s treatment on 9/11/24 when PCT changed the UF goal from 3 kg to 2.7 and to 2.6 kg. RN 2 stated she would go to the patient right away when PCT informed her of abnormal BP. RN 2 stated there were times the PCT would document the RN was notified but the RN was not notified. RN 2 stated she covered RN 3 when RN 3 was on break. However, there was no documented evidence RN 2 reassessed Patient 1 when the PCT changed the UF goal for the patient. On 10/24/24 at 1015 hours, an interview and record review was conducted with the FA. When asked, the FA stated the RN should assess the patient right away when the PCT changed the UF goal. The findings were shared with the FA.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 37663 Based on interview and record review, the facility failed to ensure the PCT notified the RN of the patient’s abnormal BP readings for one of four sampled patients (Patient 1) as per the hospital’s P&P. This failure posed an increased risk for the patient not to receive the immediate treatment. Findings: Review of the facility’s P&P titled Intradialytic Hypotension dated 7/1/24, showed the following: * Definition: Patient’s pre-treatment sitting SBP more than or equal to 110 mmHg and then drops less than 90 mmHg during treatment. OR the patient’s pre -treatment sitting SBP more than or equal to 101 and less than or equal to 109 mmHg and has dropped 20 mmHg during the treatment. * Staff, patient and/or care partner will monitor for the occurrence of intradialytic hypotension and immediately perform interventions to mitigate progression of symptoms and prevent serious consequences and recurrence. Staff, patient, and/or care partner will report intradialytic hypotensive episodes to the charge nurse. The nurse in charge will report to the physician severe or frequent intradialytic hypotensive episodes. * Treating hypotension on hemodialysis: - If BP is low or patient is asymptomatic, administer 100-200 ml fluid bolus as ordered by the provider. - If patient is symptomatic, place patient in modified Trendelenburg (trunk and head are horizontal, legs elevated 30 to 45 degrees, flexing on the hip). - Notify the nurse in charge. Review of the facility’s P&P titled Hypertension dated 9/7/21, showed the following: * Policy: Staff will recognize, report, and immediately address SBPs greater than 180 mmHg and/or DBP greater than 100 mmHg. * Treatment of Hypertension: Follow the steps to address hypertension: - Notify the nurse in charge if a patient has SBP greater than 180 mmHg and/or DBP greater than 100 mmHg. - The RN will assess the patient and determine if further nursing intervention needed. On 10/23/24, review of Patient 1’s medical record was initiated. Review of the treatment records showed the following: - The treatment record dated 9/6/24, showed at 0412 hours, Patient 1’s pre-dialysis sitting BP was 178/82 mmHg. At 0421 hours, the patient’s BP was 188/84 mmHg. At 0435 hours, the patient’s BP was 196/85 mmHg. However, there was no documented evidence the PCT informed the RN of the high BP readings. Further review of the treatment record showed at 0503 hours, the patient’s BP 165/78 mmHg (the patient’s SBP was decreased 31 mmHg). At 0537 hours, the patient’s BP was 132/73 mmHg (the patient’s SBP was dropped 33 mmHg). However, there was no documented evidence the PCT informed the RN of the decreased BP readings. The RN documented the pre-assessment was at 0653 hours. - The treatment record dated 9/11/24 showed at 0601 hours, Patient 1’s BP was 122/59 mmHg. At 0631 hours, the patient’s BP was 102/54 mmHg (the patient’s SBP was decreased 20 mmHg). However, there was no documented evidence the PCT informed the RN of the decrease in BP. On 10/23/24 at 1611 hours, an interview and record review was conducted with PCT 1. PCT 1 was asked about the BP parameter(s) when the PCT should notify the RN. PCT 1 stated she would notify the RN if the patient’s BP was up or down 20 mmHg from the previous BP reading. The findings were shared with the FA.”

“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: 37663 Based on observation, interview, and record review, the facility failed to ensure the staff implemented the facility’s P&Ps for two of four sampled patients (Patients 1 and 4) as evidenced by: 1. Patient 1’s complaint of the noise from a machine (Machine 15) was not addressed. 2. The medication for Patient 4 was not stored in a secured location. Findings: 1. Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed the following: * Data Collection: Direct Patient Care staff may collect data such as weight, BP, pulse, respirations, temperature, general observation, access, and complaints reported by the patient. * During Treatment: Follow the steps for monitoring patients and machine parameters during treatment and document any findings and interventions in the medical record. Review of the facility’s P&P titled Nursing Supervision and Delegation dated 11/6/23, showed the guidelines for PCT/LVN/RN to refer a patient to a team leader or CN for further assessment such as anytime a patient voices any complaints, indicates a change in their status or at the patient’s request. Review of the facility’s P&P titled Equipment Installation, Operation, Maintenance, Repair, and Disposal dated 2018 showed any equipment or device that is not fully functioning in accordance with IFU or company policy must be replaced as soon reasonably possible. If the faulty equipment poses a risk to the patient or staff the device will be immediately removed from service. Identified issues may include fluid leaks, non-functional, broken or misadjusted parts and components, or aesthetic damages. Any equipment awaiting repair must be tagged in accordance with use of Hemodialysis Ancillary Machine Repair/Return Tag Policy. On 10/23/24 at 1000 hours, Patient 1’s medical record was reviewed. Patient 1’s treatment record dated 9/6/24, showed the patient was assigned Machine 15 for the dialysis treatment. Further review of the treatment record dated 9/6/24, showed at 0730 hours, showed the PCT documented Patient 1 complained of the noise from the machine. However, there was no documented evidence the RN was informed of the patient’s complaint and no documented evidence of intervention addressed the patient’s complaint of the dialysis machine noise. On 10/23/24 at 1237 hours, an interview and concurrent record review was conducted with the Area Technical Operation Manager and FA. The Area Technical Operation Manager was asked about the dialysis machine (Machine 15). The Area Technical Operation Manager stated the Machine 15’s PM for this month has not been completed. The last PM was done on 4/15/24. However, there was no documented evidence the machine was pulled out of service on 9/6/24. On 10/24/24 at 1645 hours, interview was conducted with the Biomed Technician and FA. The FA stated the Biomed Technician performed the PM today for Machine 15. The Biomed Technician was asked about the PM performed for Machine 15. The Biomed Technician stated the PM for the dialysis machines would be every six months. The Biomed Technician stated he replaced the loading pressure valve of the machine, a little part that was making noise. The Biomed Technician was asked if he heard the machine making noise. The Biomed Technician stated it was noticeable at the treatment area and no one had told him about the machine was making noise. He heard the noise before he opened the machine. The FA stated Machine 15 was pulled from the treatment service on 9/19/24 for temperature question, but not for the noise from the machine. 2. Review of the facility’s P&P titled Medication Preparation and Administration dated 2/6/23, showed the medications may be pre-drawn up to four hours prior to administration. The pre-drawn medications shall be labeled and must be kept under preparer’s control or in a locked designated medication storage area or refrigerated, if necessary, until delivery to the appropriate patient for administration. On 10/23/24 at 1130 hours, an observation was performed at the treatment area. A transparent zip lock bag was observed on top of a cart beside the nursing station contained a labeled syringe with a capped needle. The labeled syringe contained clear fluid. In the zip lock bag, the lab tubes were also observed. RN 2 was asked about the syringe contained clear fluid. RN 2 stated it was heparin (anticoagulant medication) 2000 units pre-drawn for the patient (Patient 4) on the 3rd shift. The findings were shared with the FA.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 22781 Based on record review and interview, the facility failed to ensure Patient 1’s blood pressure (BP) was monitored every 30 minutes on 7/15 and 7/17/24 as per the facility’s Policy and Procedure (P&P). The failure had the potential to result in labile BP. Findings: Review of the facility’s P&P titled Patient Assessment and Monitoring dated 5/1/23, showed to obtain blood pressure and pulse rate every 30 minutes or more as needed, but not to exceed 45 minutes or per state regulations; and observe for changes in respirations during the treatment. On 8/5/24, review of Patient 1’s medical record was initiated. Review of the treatment records showed the following: * The treatment record dated 7/15/24, showed Patient 1’s BP was done at 0503 hours and the next BP was not done until 0601 hours * The treatment record dated 7/17/24, showed Patient 1’s BP was done at 0501 hours and the next BP was not done until 0604 hours. On 8/16/24 at 1100 hours, the Facility Administrator verified the findings.”