Fmc East Central Houston

“COMPLIANCE WITH FED/STATE/LOCAL LAWS CFR(s): 494.20 The facility and its staff must operate and furnish services in compliance with applicable Federal, State, and local laws and regulations pertaining to licensure and any other relevant health and safety requirements. This Standard is not met as evidenced by: 30124 Based on medical record review and interview, per the TAC 117.45(i)(2)(C), the facility failed to ensure it is in compliance with applicable Federal, State and local laws and regulations in that all patients admitted to the facility were seen by a physician once every two weeks, citing of 6 of 12 patients (Patients #s 5, 6, 7, 9, 10, 11) whose clinical records did not include documentation of evidence that they were seen by a physician every two weeks. Findings: During medical record review in the facility on 01/28/2025 along with clinic manager, staff ID #A it was noted the physician failed to document progress notes every 14 days as required. Records Reviewed: Records documented a physician progress notes for the following dates in the patient’s records did not meet every 14-day requirement: Patient ID #5 01/02/2025 Physician note documented. 01/23/2025 Nurse Practitioner note documented. No additional physician note was documented from 01/02/2025 to exit of survey on 01/28/2025. Patient ID #6 10/15/2024 Physician note documented. 10/24/2024 Nurse Practitioner note documented. 11/07/2024 Physician note documented. Patient ID #7 10/15/2024 Physician note documented. 10/24/2024 Nurse Practitioner note documented. 11/07/2024 Physician note documented. Patient ID #8 10/15/2024 Physician note documented. 10/24/2024 Nurse Practitioner note documented. 10/31/2024 Physician note documented. 11/21/2024 Physician note documented. 12/05/2024 Physician note documented. 12/26/2024 Physician note documented. Patient ID #9 10/15/2024 Physician note documented. 10/24/2024 Nurse Practitioner note documented. 11/07/2024 Physician note documented. Patient ID #10 09/21/2024 Physician note documented. 10/10/2024 Physician note documented. 10/29/2024 Physician note documented. 11/14/2024 Physician note documented. 11/30/2024 Physician note documented. Patient ID #11 10/29/2024 Physician note documented. 11/14/2024 Physician note documented. 11/30/2024 Physician note documented. Interview in the conference room on 01/28/2025 at 18:00 PM with the clinic manager, staff #A confirmed there was no documentation of every 2-week physician as required. No additional information was received prior to exit of the survey.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 30124 Based on observation, record review and interview the facility failed to ensure the physician ordered plan of care was followed as ordered for 3 of 12 treatments observed (Patient ID #s 5, 6, 8). Findings: Patient ID #5 On 01/28/2025 at 11:45 AM Patient #5 was observed receiving dialysis along with staff ID #B at station #10. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/min via a central venous catheter and dialysate flow rate of 500 mls/min on an Optiflux 180 dialyzer. Treatment was initiated at 10:01 AM by registered nurse, Staff ID #H. Review of the Patient’s clinical record revealed a physician’s order for an Optiflux 160 dialyzer. Clinical Coordinator Staff ID #B confirmed the Patient was not on the correct dialyzer as ordered by the physician. Staff ID #B stated they would immediately notify the physician of the error and get an order from the physician for a Optifulx 180 dialyzer for today. Record review documented the registered nurse, staff ID #H had initiated the hemodialysis treatment at 10:01 AM and confirmed the patient was on the correct prescription as ordered at 10:01 AM. Interview with Staff ID #H on 01/28/2024 at 12:30 PM confirmed he had initiated the treatment and verified the prescription and did not check the correct dialyzer. Patient #6 On 01/28/2025 at 11:50 AM along with staff ID #B Patient was observed receiving dialysis at station #9. The Patient was observed receiving dialysis with a blood flow rate of 450 mls/min via and arterial venous fistula with a dialysate flow rate of 500 mls/min. Review of the Patient’s hemodialysis order along with Staff ID #B revealed he was ordered to have a dialysate flow rate at 800 mls/min. Staff ID #B immediately adjusted the dialysate flow rate to the ordered rate of 800 mls/min. Treatment was initiated by Patient Care Technician, Staff ID #S at 10:20 AM and orders were verified by registered nurse, Staff ID #H at 10:35 AM. Patient ID #8 On 01/28/2025 at 12:05 PM along with staff ID #B patient was observed receiving dialysis at station #20. The Patient was observed receiving dialysis with a blood flow rate of 400 mls/min and dialysate flow rate of 500 mls/min via a arterial venous fistula. Review of the Patient’s hemodialysis order along with Staff ID #B revealed he was ordered to have a dialysate flow rate at 800 mls/min. Staff ID #B immediately adjusted the dialysate flow rate to the ordered rate of 800 mls/min. Treatment was initiated at 11:14 AM by registered nurse, Staff ID #I and Staff ID # I verified correct dialysis orders at 11:14 AM. Interview on 01/28/2024 at 12:30 PM confirmed the above findings that patients were not receiving hemodialysis per the physicians prescribed orders.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 10802 Based on observation, interview and record review, the facility’s direct care staff failed to ensure patients’ vascular accesses and faces are not covered while receiving hemodialysis treatment and that patients are consistently monitored while receiving hemodialysis treatment. Covering patients’ vascular accesses and not being monitored continually, predisposes patients to bleeding out from the vascular access site, resulting in actual harm and death, which directly affects all patients receiving hemodialysis treatment in the facility. Findings: Review of the facility’s current policy and procedure on Patient Monitoring and Safety Checks During Hemodialysis Treatment; policy # 23502; published 9/05/2023; version 5 directs staff as follows: Note “Patients must be under continual observation. Patients will not be left unattended during treatment.” Safety checks access: “Monitor and document Safety Checks every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the -- Treatment Record. Safety checks includes: . Confirm each patient’s face and access are uncovered . Confirm all patient connections are ALWAYS secure and uncovered due to serious risk of exsanguinations that could go undetected if the access is covered. .Confirm blood lines are secured to the patient ( not chair, bedrail, pillows or bed sheet etc.). .If applicable, confirm HemaClip device is attached to the external CVC venous lumen and blood line connector prior to initiation of blood pump and at each safety check throughout treatment.” Documentation “ Document monitoring and safety checks in --- treatment record and/ or in the Contracted Entity electronic medical record per contractual agreement” On 03/26/2024 at 8:34 a.m Patient # 3 was observed a at station #2. the patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute via a left arm vascular access which was covered with a blue Chux (disposable pad) which was saturated with the patient’s blood and a blanket had absorbed blood running down on the side of the patient unto her clothing. The patient was not in view of the direct care staff assigned to the patient and staff were unaware of the blood loss from the patient’s vascular access site. Covering patient’s vascular access and not monitoring the patient continually predisposes the patient to bleed out from the vascular access, causing actual harm / death. Cross reference V 407”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, the facility’s direct care staff failed to clean and disinfect prime bucket, back of hemodialysis machines, water hoses and chase during terminal cleaning of the unit in 5 of 6 staff observed terminally cleaning hemodialysis stations; Patient Care Technician (C) (E) (D) (L) and (J). Findings: Patient Care Technicians (C) (E) On 03/25/2024 at 11:07 a.m. Patient Care Technician ( C) was observed at hemodialysis station #7, hemodialysis machine #22. Patient Care Technician ( C) was terminally cleaning the hemodialysis station post hemodialysis of a patient. Observation revealed during terminal cleaning of the station, Patient Care Technician ( C) did not clean/ disinfect the prime bucket. The prime bucket remained on the side of the hemodialysis machine with contaminated Normal Saline used during hemodialysis treatment of the previous patient. On 03/25/2024 at 11:35 a.m. Patient Care Technician ( E) was observed setting up clean external blood lines and dialyzer in preparation for an oncoming patient. The contaminated prime bucket containing Normal Saline from the previous patient’s hemodialysis treatment remained on the hemodialysis machine. The Surveyor informed Patient Care Technician ( E) that Patient Care Technician (C ) did not clean and disinfect the contaminated prime bucket during terminal cleaning of the unit. During an interview on 03/25/2024 at 11:40 a.m. the Surveyor informed Patient Care Technician ( C) that the prime bucket was not clean and disinfected during terminal cleaning of the unit. Patient Care Technician ( C) states “ I just forgot about it.” Patient Care Technician (D) On 03/25/2024 at 11:30 a.m. Patient Care Technician (D) was observed at hemodialysis station #11, hemodialysis machine #2. Patient Care Technician ( D) was terminally cleaning the hemodialysis station post hemodialysis of a patient. Observation revealed during terminal cleaning of the hemodialysis station, Patient Care Technician ( D) did not clean/ disinfect the prime bucket, the back of the hemodialysis machine, hoses and the chase box. On 03/25/2024 at 11:50 a.m. Patient Care Technician (D) was observed setting up clean blood lines and dialyzer on the hemodialysis machine in preparation for an on- coming patient. The Surveyor informed her that observation during terminal cleaning of the unit, she did not clean and disinfect the prime bucket, the back of the hemodialysis machine, hoses and the chase box. Patient Care Technician (D) states “ back of machine?” Patient Care Technician L On 03/26/ 2024 at 11:20 a.m. Patient Care Technician (L) was observed at station # 15, hemodialysis machine #15. The patient care technician was terminally cleaning the hemodialysis station post hemodialysis treatment of a patient. Observation during terminal cleaning of the station revealed a word search book, a marker and a dialyzer was observed stored on the chase box of the unit from the previous patient’s hemodialysis treatment. On 03/26/2024 at 11:45 a.m. the Patient Care Technician (L) was observed setting up clean blood lines and dialyzer on the hemodialysis machine in preparation for an on- coming patient. The word search book, a marker and a dialyzer from the previous patient’s hemodialysis treatment remained stored on the chase box of the station. The chase box was not cleaned and disinfected during terminal cleaning of the station. The Surveyor notified the Facility’s Administrator who was present near the station and Patient Care Technician (L) that the chase box was not cleaned and disinfected during terminal cleaning of the station. The Surveyor showed the Facility’s Administrator and Patient Care Technician (L) the word search book, a marker and a dialyzer stored on the chase box of the station. Patient Care Technician ( L) states “ I don’t know whose it is.” 48020 Patient Care Technician (J) Station #12 - hemodialysis machine #4 Observation on 03/26/2024 at 11:20 a.m. revealed Patient Care Technician (J) terminally cleaning station #12 post hemodialysis treatment of a patient. During terminal cleaning of the hemodialysis machine #4 at station #12, Patient Care Technician (J) wiped across the chairside keyboard that had paper tape stuck on it. She did not remove the tape before or after cleaning the keyboard. Patient Care Technician (J) failed to disinfect the back of the hemodialysis machine, wall box and chase cabinet. Patient Care Technician (J) failed to open up the sides of the hemodialysis chair and disinfect them. The Surveyor notified Patient Care Technician (J) at 11:30 a.m. that she failed to clean and disinfect the chairside keyboard, back of the hemodialysis machine, wall box, chase cabinet, and the insides of the hemodialysis chair at station #12. Patient Care Technician (J) said, “Okay.””

“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: 10802 Based on observation, interview and record review, the facility’s direct care staff failed to ensure patients’ vascular accesses and faces are not covered while receiving hemodialysis treatment and that patients are consistently monitored while receiving hemodialysis treatment. Covering patients’ vascular accesses and not being monitored continually, predisposes patients to bleeding out from the vascular access site, resulting in actual harm and death, which directly affects all patients receiving hemodialysis treatment in the facility. Patient #s 3 and 7 Findings: Review of the facility’s current policy and procedure on Patient Monitoring and Safety Checks During Hemodialysis Treatment; policy # 23502; published 9/05/2023; version 5 directs staff as follows: Note “Patients must be under continual observation. Patients will not be left unattended during treatment.” Safety checks access: “Monitor and document Safety Checks every 30 minutes or more frequently as needed but not to exceed 45 minutes or per state regulations in the -- Treatment Record. Safety checks includes: . Confirm each patient’s face and access are uncovered. . Confirm all patient connections are ALWAYS secure and uncovered due to serious risk of exsanguinations that could go undetected if the access is covered. .Confirm blood lines are secured to the patient ( not chair, bedrail, pillows or bed sheet etc.). .If applicable, confirm HemaClip device is attached to the external CVC venous lumen and blood line connector prior to initiation of blood pump and at each safety check throughout treatment.” Documentation “ Document monitoring and safety checks in --- treatment record and/ or in the Contracted Entity electronic medical record per contractual agreement” Patient #3 Observation on 03/26/2024 at 8:10 a.m. revealed Patient Care Technician (G) and Patient Care Technician Orientee (H) who were assigned to the patients, were sitting near the weigh scale using the computer. The patients assigned to the direct care staff were not in view of the Patient Care Technicians (PCT) because of a half wall separating the bay where patients sit from the weigh scale. Observation on 03/26/2024 at 8:25 a.m. revealed Patient #3 was receiving hemodialysis treatment at station #2 . The patient was sleeping in the hemodialysis chair with her head covered with a scarf pulled over the top of her face and a mask covered her nose and mouth. The Surveyor observed the patient’s left vascular access wrapped in a blue chux ( disposable pad) and the blue pad was saturated with blood. The patient had a multicolored blanket partially covering her vascular access on the bottom of the vascular access site. Blood was also observed on the blanket running down on the patient’s clothing. Direct care staff assigned to the patient were not aware of the bleeding from the patient’s vascular access site. The Surveyor immediately summoned the registered nurse who was across the bay with another patient. The registered nurse summoned both patient care technicians to the patient’s chairside and the registered nurse woke up the patient. Patient Care Technician (G) removed the needle and stopped the bleeding (hemostasis). The registered nurse took the patient’s blood pressure. The patient’s vital signs are as follows: 8:25 a.m.: Blood Pressure 152/62. Observation revealed after waking and seeing the bleeding the patient who is non- English speaking was startled. She spoke to the nurse who communicated to the Surveyor that the patient wanted to know who discovered the bleeding. Review of the patient’s treatment sheet dated 03/26/2024 at 8:25 a.m revealed the following documentation by the Registered Nurse assigned to the patient; “Pt with face and access covered; when checking a leaking is visualized; a blood lost was visualized of about 100 ml. Leaking addressed by PCP and RN. Pt asymp; Pt educated about the importance of not cover access or face during TX ; see report.” Review of the patient’s nurse’s notes dated 03/26/2024 at 09:11 a.m revealed the following documentation from the registered nurse assigned to Patient #3: “At 8:24 AM a supervisor from the state alert the RN about the access with visible blood on dressing and pad; when checking pt’s access a leaking from puncture site is verified.; a blood loss was visualized on pt’s clothes and pad of approximately 100 ml; leaking was addressed by PCT and RN. At the time BP was 152/62 Hr 60 bpm, pt was asymptomatic during the event. At 8:32 pt request to stop tx; and a bp drop was noted when rinsing back; bp was 109/53 mmHg, HR was 60 bpm. after rinsing back bp increased; pt verbalized feeling asymptomatic.; pt was educated about importance of not covering her access or face during tx. A HGB was ordered for next tx. Pt asymptomatic with acceptable v/s at d/c. Pt was ambulatory with no complaints. Bp standing post tx was 153/60 mmHg. MD informed ; CM and CC informed too.” Review of the patient’s treatment sheet dated 03/26/2024 revealed the following documented vital sign. 8:00 a.m.: Blood Pressure 167/67 8:25 a.m.: Blood Pressure 152/62 8:30 a.m.: Blood Pressure 109/53 (after hemostasis of the vascular access) 8:32 a.m.: Blood Pressure 124/53 Review of the patient’s clinical record revealed the most current comprehensive care plan dated 5/27/2022 addressing dialysis access indicated was closed out because the goal was met. There was no documentation in the patient’s comprehensive care plan addressing covered vascular access and the potential for blood loss. 48020 Patient #7 On 03/26/2024 at 12:11 p.m., Patient #7 was seated in the isolation room at station #20, machine #7. Patient #7 was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min via a right central venous catheter. Patient’s #7’s vascular access was not visible to the staff and the surveyor due to being covered by her blanket. Immediately the Surveyor notified Clinical Manager (A) of the covered vascular access. Clinical Manager (A) said, “She’s got her catheter covered?””

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 3 of 15 sampled patients: Patient #s 7, 14 and 15 Findings: Patient #7 On 03/26/2024 at 12:11 p.m., Patient #7 was seated in the isolation room at station #20, machine #7. Patient #7 was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min via a right central venous catheter. The patient was utilizing an Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record located in the chairside computer revealed a physician’s order dated 02/26/2024 for dialysate flow rate Manual 800 mL/min. Treatment sheet dated 03/16/2024 Review of the patient’s treatment sheet dated 03/16/2024 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Manual 800 mL/min but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 7:35 a.m. - 10:53 a.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Interview with Clinical Manager (A) on 03/27/2024 at 12:56 p.m.: the Surveyor notified Clinical Manager (A) the patient did not receive hemodialysis treatment at the prescribed dialysate flow rate on 03/16/2024. Clinical Manager (A) said, “Okay.” Patient #14 Review of the patient’s closed clinical record (demographic data) on 03/26/2024 revealed the patient was admitted to the facility 03/10/2023. Review of the physician’s order dated 03/08/2023 revealed the prescribed dialysate flow rate of Manual 500 mL/min. Treatment sheet dated 07/07/2023 Review of the patient’s treatment sheet dated 07/07/2023 revealed documentation which indicated the patient was prescribed a dialysate flow rate of Manual 500 mL/min but received hemodialysis treatment at a dialysate flow rate of 700 mL/min from 17:20 p.m. - 20:07 p.m. There was no justification documented for the dialysate flow rate of 700 mL/min. Interview with Clinical Coordinator (B) on 03/27/2024 at 12:45 p.m.: the Surveyor notified Clinical Coordinator (B) Patient #14 did not receive hemodialysis treatment at the prescribed dialysate flow rate on 07/07/2023. Clinical Coordinator (B) said, “Okay.” Patient #15 Review of the patient’s closed clinical record (demographic data) on 03/27/2024 revealed the patient was admitted to the facility 05/22/2023. Review of the physician’s order dated 06/12/2023 revealed the prescribed dialysate flow rate of Manual 500 mL/min. Treatment sheet dated 07/03/2023 Review of the patient’s treatment sheet dated 07/03/2023 revealed documentation which indicated the patient was prescribed a blood flow rate of 350 mL/min and a dialysate flow rate of Manual 500 mL/min but received hemodialysis treatment at a blood flow rate at 400 mL/min and a dialysate flow rate of 800 mL/min from 15:30 p.m. - 18:01 p.m. There was no justification documented for the blood flow rate of 400 mL/min and a dialysate flow rate of 700 mL/min. Treatment sheet dated 07/07/2023 Review of the patient’s treatment sheet dated 07/07/2023 revealed documentation which indicated the patient was prescribed a blood flow rate of 350 mL/min but received hemodialysis treatment at a blood flow rate at 400 mL/min from 15:47 p.m. - 16:55 p.m. There was no justification documented for the blood flow rate of 400 mL/min and a dialysate flow rate of 700 mL/min. Interview with Clinical Coordinator (B) on 03/27/2024 at 12:52 p.m.: the Surveyor notified Clinical Coordinator (B) Patient #15 did not receive hemodialysis treatment at the prescribed blood flow rate and dialysate flow rate on 07/03/2023 and 07/07/2023. Clinical Coordinator (B) said, “Okay.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 10802 Based on record review and interview, the facility’s quality assessment performance improvement committee fail to include in its quality indicator, patients’ clinical records to include monitoring for treatment and medication errors. Findings: Review of a sample of patients’ clinical records revealed the facility’s registered nurses failed to conduct intradialytic and post treatment assessment on patients who experienced change in their condition during hemodialysis treatments; Patient #s 1, 2 , 6, 14 and 15 . The facility’s licensed nurses and direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders; Patient #s 7, 14 and 15 Review of the Facility’s Quality Assessment Performance improvement committee data and meeting minutes for December 2023, January 2024 and February 2024 revealed no documentation that quality indicator for monitoring of patients clinical records were included. On 03/27/2024 the survey team reviewed the records with the facility’s interdisciplinary quality assessment performance improvements members and regulatory personal. During the review the Quality Assessment Performance Improvement Committee members confirmed that they were not auditing and monitoring patients’ medical records to include monitoring for treatment and medication errors.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility medical rirector failed to delegate authority of the dialysis technician to perform cannulation of the patient’s vascular accesses, administration of heparin, lidocaine, normal saline, and oxygen for this facility in 1 of 7 sampled patient care technicians: Patient Care Technician (J) Findings: Patient Care Technician (J) On 03/26/2023 Patient Care Technician (J) was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of Patient Care Technician (J’s) personnel and training file revealed she was hired to the facility on 06/08/2023. Review of Patient Care Technician (J’s) personnel and training file revealed there is no documentation of delegation by the facility’s medical director for Patient Care Technician (J) to cannulate patients’ vascular accesses and administer: intravenous heparin, intravenous normal saline, subcutaneous lidocaine, and oxygen. Interview with Clinical Manager (A) on 03/27/2024 at 11:29 a.m.: the Surveyor notified Clinical Manager (A) of the missing delegation by the facility’s medical director for Patient Care Technician (J). Clinical Manager (A) said, “Okay, we’ll get that done.””

“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: 10802 Based on observation, record review and interview, the facility’s registered nurse failed to conduct intradialytic and post treatment assessment on patients who experienced change in their condition during hemodialysis treatments in 5 of 15 sampled patients. Patient #s 1, 2 , 6 , 14 and 15 Findings: Texas Board of Nursing RN Scope of practice. Rule 15.28. Assessment The comprehensive assessment is the first step and lays the foundation for the nursing process. The comprehensive assessment is the initial and ongoing, extensive collection, analysis and interpretation of data. Nursing judgment is based on the assessment findings. The RN uses clinical reasoning and knowledge, evidence- based outcomes, and research as the basis for decision-making and comprehensive care. Based upon the comprehensive assessment the RN determines the physical and mental health status, needs, and preferences of culturally, ethnically, and socially diverse patients and their families using evidence-based health data and a synthesis of knowledge. Surveillance is an essential step in the comprehensive assessment process. The RN must anticipate and recognize changes in patient conditions and determines when reassessments are needed. Patient Diagnosis/Problem Identification/Planning The second step in the nursing process is analyzing data gathered during the assessment and problem identification. The role of the RN is to synthesize comprehensive assessment data to identify problems, formulate goals/outcomes, and develop plans of care for patients, families, populations, and communities using information from evidence-based practice and published research in collaboration with these groups and the interdisciplinary health care team, as appropriate for their educational background and scope. The third step in the nursing process is planning. The RN synthesizes the data collected during the comprehensive assessment to identify problems, participate in the patient diagnoses, and to formulate goals, teaching plans and outcomes. A nursing plan of care for patients is developed by the RN, who has the overall responsibility to coordinate nursing care for patients. Teaching plans address health promotion, maintenance, restoration, and prevention of risk factors. The RN utilizes evidence-based practice, published research, and information from patients and the interdisciplinary health care team during the planning process. Implementation Implementing the plan of care is the fourth step in the nursing process. The RN may begin, deliver, assign, or delegate certain nursing tasks within the plan of care for patients within legal, ethical, and regulatory parameters and in consideration of health restoration, disease prevention, patient independence, wellness, and promotion of healthy lifestyles. The RN ’ s duty to patient safety when making assignments to other nurses or when delegating tasks to unlicensed staff is to consider the education, training, skill, competence, and physical and emotional abilities of those to whom the assignments or delegation is made. The RN is responsible for reasonable and prudent decisions regarding assignments and delegation. The RN scope of practice may include the supervision of LVNs or other RNs. Supervision of LVN staff is defined as the process of directing, guiding, and influencing the outcome of an individual ’ s performance and activity. 5 The RN may have to directly observe and evaluate the nursing care provided depending on the LVN ’ s skills and competence, patient conditions, and level of urgency in emergent situations. The RN may determine when it is appropriate to delegate tasks to unlicensed personnel and maintains accountability for how the unlicensed personnel perform the tasks. The RN is responsible for supervising the unlicensed personnel when tasks are delegated. The proximity of supervision is dependent upon patient conditions and skill level of the unlicensed personnel. In addition, teaching and counseling are interwoven throughout the implementation phase of the nursing process. Evaluation and Re-assessment A critical and final step in the nursing process is evaluation. The RN evaluates and reports patient outcomes and responses to therapeutic interventions in comparison to benchmarks from evidence-based practice and research findings and plans any follow-up care and referrals to appropriate resources that may be needed. The evaluation phase is one of the times when the RN reassesses patient conditions and determines if interventions were effective and if any modifications to the plan of care are necessary. Review of the facility’s current policy on Patient Assessment and Monitoring; policy # 45284, published 5/1/2023 directs staff as follows: “ “Direct patient care staff may collect data such as weight, BP, pulse respirations, temperature, general observations, access and complaints reported by the patient. If the PCT/ LPN 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 registered nurse must assess the patient. The RN will notify the patient patient’s physician/ physician extender of any abnormal findings, if necessary, based on clinical judgement for additional instruction. The Registered Nurse will assess / re-assess any findings addressed pre or during treatment as needed.” Patient #1 On 03/25/2024 at 10:42 a.m. Patient #1 was observed on the hemodialysis unit of the facility at station #1. The patient was receiving hemodialysis treatment at a blood flow rate of 300 mls/ minute and dialysate flow rate of 500 mls/ minute via a left arm vascular access. Review of the patient’s treatment sheets for the following days revealed the following findings: Treatment sheet dated 03/20/2024: Review of the patient’s clinical record (treatment sheet) dated 03/20/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 153/56 sitting, pulse of 78 beats per minute, respiration 17. The pre-treatment assessment by the registered nurse at 10:32 a.m. revealed the following findings: Lungs decreased breath sounds. Ankle - Severity 1+2 mm or less disappears rapidly. Edema Ankle - location Bilateral Lungs -sounds - location Bilateral 10:21 a.m.: patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 146/58 and pulse rate of 77 beats per minute. 11:00 a.m.: patient’s documented blood pressure of 155/60 and pulse rate of 76 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:31 a.m.: patient’s documented blood pressure of 143/59 and pulse rate of 76 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:55 a.m.: patient’s documented blood pressure of 161/66 and pulse rate of 75 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 12:32 p.m.: patient’s documented blood pressure of 149/63 and pulse rate of 75 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 13:04 p.m.: patient’s documented blood pressure of 126/52 and pulse rate of 73 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 13:32 p.m.: patient’s documented blood pressure of 123/53 and pulse rate of 71 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 14:01 p.m.: patient’s documented blood pressure of 113/46 and pulse rate of 71 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 14:22 p.m.: patient’s documented blood pressure of 110/51 and pulse rate of 70 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. Documentation indicated the patient’s hemodialysis treatment ended at 14:22 p.m. Review of the patient’s treatment sheet revealed no documentation of intradialytic assessment by the registered nurse assigned to the patient , although the patient’s systolic blood pressure dropped more than 20 points from initiation of hemodialysis treatment. A post treatment documentation by the registered nurse, timed 17:20 p.m. indicated the following documented findings: “ RN evaluation no unusual findings. Tx record reviewed. Pt tolerated tx w/o adverse reaction. Exited clinic in stable condition with 0.9 kg of EDW. Reminded by staff to adhere to fluid/ dietary restrictions and seek Ems tx/ acute neg changes.” There was no documented mention of the presenting symptoms pre- treatment of Lungs decreased breath sounds. Ankle - Severity 1+2 mm or less disappears rapidly. Edema Ankle - location Bilateral Lungs -sounds - location Bilateral . And the drop in systolic blood pressure intradialytic. Reviewed Patient’s treatment sheet dated 03/18/2024. Review of the patient’s clinical record (treatment sheet) dated 03/18/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 140/58 sitting, pulse of 82 beats per minute, respiration 17. The pre-treatment assessment by the registered nurse at 10:32 a.m. revealed the following findings: Lungs decreased breath sounds. Ankle - Severity 1+2 mm or less disappears rapidly. Edema Ankle - location Bilateral Lungs -sounds - location Bilateral 10:24 a.m.: patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 160/64 and pulse rate of 81 beats per minute. A post treatment documentation by the registered nurse, timed 15:36 p.m. indicated the following documented findings: “ RN evaluation no unusual findings. Tx record reviewed . Pt tolerated tx w/o adverse reaction. Exited clinic in stable condition with 0.5 kg of EDW.” There was no documented mention of the presenting symptoms pre- treatment of Lungs decreased breath sounds. Ankle - Severity 1+2 mm or less disappears rapidly. Edema Ankle - location Bilateral Lungs -sounds - location Bilateral . Patient #2 On 03/25/2024 at 10:45 a.m. Patient #2 was observed on the hemodialysis unit of the facility at station #2. The patient was receiving hemodialysis treatment at a blood flow rate of 300 mls/ minute and dialysate flow rate of 500 mls/ minute via a left arm vascular access. Observation of the patient’s hemodialysis machine revealed a blood pressure blood pressure reading of 102/66. Reviewed patient’s treatment sheet dated 03/25/2024. Review of the patient’s clinical record (treatment sheet) dated 03/25/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 153/87 sitting, pulse of 89 beats per minute, respiration 17. The pre-treatment assessment by the registered nurse at 10:03 a.m. revealed the following findings: Lungs clear. Lungs -sounds - location Bilateral, no edema. The registered nurse documented “ Pt aox3/afebrile; pt has diarrhea. Immodium 4 mg as patient complained abd pain, sob, recent medical care, thrill/bruit present w/o s/s of infection at access site; uf goal 2.1 L; orders verified ’ rn rounding complete. Hand crank on machine.” 10:03 a.m.: patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 159/79 and pulse rate of 88 beats per minute. 10:34 a.m.: Patients documented blood pressure of 118/71 and pulse rate of 82 beats per minute. The registered nurse documented on patient “patient complained of diarrhea pre-HD. Immodium given 4 mg. RN rounding done.” 10:46 a.m.: patient’s documented blood pressure of 102/66 and pulse rate of 78 beats per minute. Blood flow rate of 300 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:00 a.m.: patient’s documented blood pressure of 113/64 and pulse rate of 77 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. RN documented “denies complaints, alert. “ 11:30 a.m.: patient’s documented blood pressure of 105/69 and pulse rate of 73 beats per minute. Blood flow rate of 150 mls/ minute and dialysate flow rate of 500 mls/ minute. The patient care technician assigned to the patient documented “denies complaints; pt to the bathroom.” 11:54 a.m.: patient’s documented blood pressure of 87/48 and pulse rate of 79 beats per minute. The patient care technician assigned to the patient documented “denies complaint; pt back from rr. Bp low. Gave 150 ns, notified cn. “ 11:55 a.m.: patient’s documented blood pressure of 87/48 and pulse rate of 79 beats per minute. The registered nurse documented “ denies complaints ; Uf Off BP trend going down; patient asymptomatic. UFG decreased to 1.8 L as per tolerance v/s rechecked legs kept elevated.” 12:33 p.m.: patient’s documented blood pressure of 90/52 and pulse rate of 79 beats per minute. The registered nurse documented “ denies complaints ; Uf Off BP trend going down; patient asymptomatic UF off until BP improve; legs kept elevated, v/s rechecked every 30 minutes.” 13:05 p.m.: patient’s documented blood pressure of 101/54 and pulse rate of 76 beats per minute. The patient care technician assigned to the patient documented “ BP low uf off notified RN.” 13:32 p.m.: patient’s documented blood pressure of 94/51 and pulse rate of 77 beats per minute. 14:07 p.m.: patient’s documented blood pressure of 100/54 and pulse rate of 78 beats per minute. 14:26 p.m.: patient’s documented blood pressure of 104/57 and pulse rate of 80 beats per minute. The patient’s hemodialysis treatment ended at 14:26 p.m. Post hemodialysis blood pressure 133/70 , and pulse rate of 83 Review of the patient’s treatment sheet revealed the following post treatment documentation by the registered nurse : 1.1 L removed; 1.2 kg >EDW. Pt completed tx w/o adverse reaction. Pt denies complaint. Homeostasis achieved.” Review of the patient’s treatment sheet revealed no documented assessment by the registered nurse of the effect of the Imodium administered to the patient and the number of bowel movement the patient’s had. Documentation indicated the patient’s hemodialysis treatment was stopped so that the patient could go to the bathroom. Treatment sheet 03/18/2024 Review of the patient’s clinical record (treatment sheet) dated 03/18/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 119/51 sitting, pulse of 89 beats per minute, respiration 18. The pre-treatment assessment by the registered nurse at 10:03 a.m. revealed the following findings: Lungs clear. Lungs -sounds - location Bilateral, no edema. 09:59 a.m. The patient’s hemodialysis treatment was initiated by the patient care technician. Patient’s documented blood pressure of 142/72 and pulse rate of 86 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 10:28 a.m. patient’s documented blood pressure of 109/61 and pulse rate of 80 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:03 a.m. patient’s documented blood pressure of 133/53 and pulse rate of 77 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 11:32 a.m. patient’s documented blood pressure of 105/61 and pulse rate of 77 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 12:00 p.m. patient’s documented blood pressure of 94/62 and pulse rate of 76 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 12:30 p.m. patient’s documented blood pressure of 104/59 and pulse rate of 76 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 13:03 p.m. patient’s documented blood pressure of 105/61 and pulse rate of 76 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 13:34 p.m. patient’s documented blood pressure of 109/59 and pulse rate of 75 beats per minute. Blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute. 14:00 p.m. patient’s documented blood pressure of 97/61 and pulse rate of 76 beats per minute. Blood flow rate of 150 mls/ minute and dialysate flow rate of 500 mls/ minute. Documentation indicated the patient’s hemodialysis treatment ended at 14:00. Review of the Patient’s treatment sheet dated 03/18/2024 revealed no documentation of an intradialytic assessment and post treatment assessment by the registered nurse although the patient’s blood pressure during hemodialysis treatment fluctuated from a high of 142/72 to a low of 94/62. Interview on 03/27/2024 with the regulatory personnel revealed she states “ the nurse who does the initial assessment on the patient may not be the same nurse who does intradialytic and post treatment assessment on the patient.” 48020 Patient #6 On 03/26/2024 at 12:03 p.m., Patient #6 was seated at station #17 machine #5 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min via a left lower arm vascular access. Review of the patient’s treatment sheets on 03/27/2024 revealed the following: Treatment sheet dated 03/26/2024: Review of the patient’s clinical record (treatment sheet) dated 03/27/2024 revealed the following documentation: 09:38 a.m.: Pretreatment vital signs: blood pressure of 184/99 sitting, 119/68 standing, pulse of 63 beats per minute, respirations 18. 09:43 a.m.: the patient’s hemodialysis treatment was initiated by the patient care technician with a documented blood pressure of 163/71 and pulse rate of 58 beats per minute 10:01 a.m.: documented blood pressure of 137/92 and pulse rate of 58 beats per minute 10:05 a.m.: registered nurse documented the pretreatment assessment which revealed a nursing note “RN Evaluation - No Unusual findings noted. Symptoms Pulse - Rhythm Regular” 10:23 a.m.: documented blood pressure of 169/75 and pulse rate of 54 beats per minute 11:02 a.m.: documented blood pressure of 153/80 and pulse rate of 53 beats per minute 11:30 a.m.: documented blood pressure of 161/88 and pulse rate of 54 beats per minute 11:57 a.m.: documented blood pressure of 162/83 and pulse rate of 55 beats per minute 12:03 p.m.: documented blood pressure of 177/81 and pulse rate of 49 beats per minute 12:09 p.m.: documented pulse rate of 62 beats per minute - registered nurse documented “Irregular HR apical pulse” 12:21 p.m.: documented blood pressure of 140/85 and pulse rate of 46 beats per minute 12:41 p.m.: documented blood pressure of 155/90 and pulse rate of 54 beats per minute 13:00 p.m.: documented blood pressure of 169/73 and pulse rate of 61 beats per minute 13:30 p.m.: documented blood pressure of 157/77 and pulse rate of 62 beats per minute 13:43 p.m.: documented blood pressure of 135/62 and pulse rate of 61 beats per minute - treatment discontinued There was no irregular heart rate reassessment documented post hemodialysis treatment by the registered nurse. There was no post hemodialysis treatment documented by the registered nurse Patient #14 Review of the patient’s clinical record (demographic data) on 03/26/2024 revealed the patient was admitted to the facility 03/10/2023. Review of the patient’s treatment sheets on 03/27/2024 revealed the following: Treatment sheet dated 07/07/2023 Review of the patient’s treatment sheet dated 07/07/2023 revealed the following documentation: 17:09 p.m.: Pretreatment vital signs: blood pressure of 167/89 sitting, pulse of 109 beats per minute, respirations 16. 17:20 p.m.: documented blood pressure of 141/85 and pulse rate of 104 beats per minute - patient care technician documented “high hr, rn notified” 17:33 p.m.: documented blood pressure of 132/80 and pulse rate of 106 beats per minute 18:00 p.m.: documented blood pressure of 127/71 and pulse rate of 103 beats per minute - patient care technician documented “high hr, rn notified” 18:24 p.m.: registered nurse documented the pretreatment assessment which revealed a nursing note “Patient arrived to tx amb without assistance. PT vital signs w/in parameters. PT denies SOB, HA, NV, and chest pain. PT UF goal set to 4.2 kg Pulse - Rhythm Regular” 18:33 p.m.: documented blood pressure of 116/65 and pulse rate of 104 beats per minute 19:02 p.m.: documented blood pressure of 116/90 and pulse rate of 105 beats per minute - patient care technician documented “high hr, rn notified” 19:22 p.m.: patient care technician documented “pt c/o cramping, uf off, rn notified” 19:33 p.m.: documented blood pressure of 114/75 and pulse rate of 106 beats per minute 20:07 p.m.: documented blood pressure of 124/62 and pulse rate of 102 beats per minute - patient care technician documented “high hr, rn notified” 20:14 p.m.: documented blood pressure of 136/80 and pulse rate of 104 beats per minute - treatment discontinued 20:13 p.m.: Post treatment vital signs: blood pressure 133/81 sitting, pulse of 110 beats per minute 21:05 p.m.: registered nurse documented the post treatment assessment which revealed a nursing note “Patient left TX AMB without assistance. PT vital signs stable, even and non-labored breathing. PT aaox3. PT has no complaints. PT left 10 kg over EDW. Patient shortens treatment and has hx of ascites.” There was no documentation of a nursing assessment during dialysis when the patient complained of cramping, nor was there a reassessment post treatment. Interview with Clinical Coordinator (B) on 03/27/2024 at 12:45 p.m.: the Surveyor notified Clinical Coordinator (B) Patient #14 was not assessed for cramping during dialysis nor reassessment post treatment on 07/07/2023. Clinical Coordinator (B) said, “Okay.” Patient #15 Review of the patient’s clinical record (demographic data) on 03/27/2024 revealed the patient was admitted to the facility 05/22/2023. Review of the patient’s treatment sheets on 03/27/2024 revealed the following: Treatment sheet dated 07/03/2023 Review of the patient’s treatment sheet dated 07/03/2023 revealed the following documentation: 15:19 p.m.: Pretreatment vital signs: blood pressure of 93/51 sitting, pulse of 68 beats per minute, respirations 18. 15:30 p.m.: documented blood pressure of 84/47 and pulse rate of 69 beats per minute - patient care technician documented “RN notified; UF Off ... TX initiated with no problems. 100 cc NS bolus given on top of 250, rn notified, uf off” 16:06 p.m.: documented blood pressure of 106/51 and pulse rate of 68 beats per minute 16:23 p.m.: registered nurse documented the pretreatment assessment which revealed a nursing note “pt arrived in stable condition, alert orientedx3, uf set as tolerated, denies any shortness of breath, no chest pain noted, no bleeding on access site, no cramping, no headache, no NV, bp low, will monitor Pulse - Rhythm Regular” 16:32 p.m.: documented blood pressure of 106/54 and pulse rate of 69 17:01 p.m.: documented blood pressure of 95/54 and pulse rate of 68 beats per minute - patient care technician documented “UF Off” 17:33 p.m.: documented blood pressure of 115/59 and pulse rate of 72 18:01 p.m.: documented blood pressure of 117/53 and pulse rate of 72 beats per minute 18:17 p.m.: documented blood pressure of 115/59 and pulse rate of 59 beats per minute- treatment discontinued; post treatment vital signs: blood pressure 133/81 sitting, pulse of 110 beats per minute 18:48 a.m.: registered nurse documented the post treatment assessment which revealed a nursing note “Pt requested to end tx early, ama signed, goes home with <5.3 kg of his EDW, MD notified, vs monitored & recorded, a&aox3, no bleeding on access site discharge in stable condition.” There was no documentation of a nursing assessment during dialysis when the patient’s ultrafiltration was turned off. Interview with Clinical Coordinator (B) on 03/27/2024 at 12:52 p.m.: the Surveyor notified Clinical Coordinator (B) Patient #15 was not assessed during dialysis when his ultrafiltration was turned off by the patient care technician on 07/03/2023. Clinical Coordinator (B) said, “Okay.””

“GOV-GB RESP FOR STAFF ORIENTATION CFR(s): 494.180(b)(3) The governing body or designated person responsible must ensure that- (3) All staff, including the medical director, have appropriate orientation to the facility and their work responsibilities; This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the Facility’s Clinical Manager failed to ensure all staff completed orientation in 3 of 6 staff personnel records reviewed: Patient Care Technician (G), (J) and Attending Physician (K). Findings: Patient Care Technician (G) On 03/26/2023 Patient Care Technician (G) was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of Patient Care Technician (G’s) personnel and training file on 03/27/2024 revealed a facility orientation with the name of another clinic on it. There was no documented orientation to this facility in Patient Care Technician (G’s) personnel file. Patient Care Technician (J) On 03/26/2023 Patient Care Technician (J) was observed on the treatment floor of the facility providing care and services to patients in the facility. Review of Patient Care Technician (J’s) personnel and training file on 03/27/2024 revealed no documented orientation to the facility in Patient Care Technician (J’s) personnel file. Attending Physician (K) Review of Attending Physician (K’s) credential and personnel file revealed no documentation that the physician received an orientation on the medical staff bylaws. Interview with Clinical Manager (A) on 03/27/2024 at 11:31 a.m.: the Surveyor notified Clinical Manager (A) of the missing orientations for Patient Care Technician (G), Patient Care Technician (J), and Attending Physician (K). Clinical Manager (A) said, “Okay, we are looking into this.” No evidence was provided.”