Davita Houston Dialysis

“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 observation and interview the facility failed to comply with the requirements with applicable Federal and tate laws and regulations pertaining to handling and storage of gas and flammable Liquids per the National Fire Protection Association (NFPA) 329, in accordance with NFPA 99, §9.6. Reviewed: Review of the National Fire Protection Association compliance with NFPA 99, Health Care Facilities Code reads ...A critical aspect of oxygen use, and storage is related to identifying each cylinder as full or empty. In an emergency, it is critical for staff to easily identify which cylinders are full. NFPA 99 section 11.6.5.3 specifically required that empty cylinders be “marked to avoid confusion and delay if a full cylinder is needed in a rapid manner.” This can be accomplished through an integral pressure gauge, individual signage, or separated group signage (for cylinders being stored together). A cylinder is considered “full” provided it still has its seal from the supplier. Once the seal has been removed, the cylinder is no longer considered full and cannot be stored with full cylinders. NFPA 99 requires empty cylinders to be stored separately from full cylinders. Findings: Observation on 11/12/2025 at 9:20 AM during a tour of the patient treatment area along with the Facility Administrator, Staff ID #H the following was observed: Two empty oxygen cylinders were observed stored in the same rack with full cylinders. One oxygen cylinder was observed with the seal from the supplier removed. A piece of tape was adhered to the side of the cylinder with “Full” written on the tape. Interview on 11/12/2025 at 9:30 AM with Staff ID #H confirmed the above findings.”

“ADDITIVES-LABEL SPIKED JUGS/LABEL SPECIFIC PT CFR(s): 494.40(a) 5.4.5 Additives: labeling spiked jugs/labeling if for specific pt (5.4.4.1 Concentrate jugs): If a chemical spike is added to an individual container to increase the concentration of an electrolyte, the label should show the added electrolyte, the date and time added, and the name of the person making the addition. Containers should be labeled to indicate the final concentration of the added electrolyte ...This information should also be recorded in a permanent record. Labels should be affixed to the containers when the mixing process begins. 6.4.2 Additives When additives are prescribed for a specific patient, the container holding the prescribed acid concentrate should be labeled with the name of the patient, the final concentration of the added electrolyte, the date on which the prescribed concentrate was made, and the name of the person who mixed the additive. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s direct care staff failed to label acid concentrate containers per the facility’s policy in 2 of 11 sampled patients: Patient #s 9, 4 Findings: Review of the facility’s current policy and procedure on Acid Concentrate System, Incoming Acid Concentrate and Use of Acid Concentrate Containers, Policy 1-20-06, directs staff as follows: “16. When transferring acid into reusable concentrate containers, the device used to transfer needs to be designated and labeled for a specific acid concentrate. o Label acid concentrate jugs with the content identified o 45X sticker o Hazardous Material Identification Guide (HMIG) sticker ... ACID CONCENTRATE CONTAINERS 20. Upon opening an acid concentrate container, label container with date opened, and initials of teammate.” Patient #9 Observation on 11/12/2025 at 8:56 AM revealed Patient #9 was seated at station #18 machine #2 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via left upper arm vascular access. There was an unlabeled reusable acid concentrate jug of liquid sitting on the base of the hemodialysis machine. The hemodialysis machine acid connector was connected to the unlabeled reusable concentrate jug instead of the acid port of the wall box. The Surveyor ask Patient Care Technician (C) who was chairside why the reusable jug was being used and Patient Care Technician (C) said, “The acid port is leaking.” The Surveyor asked Patient Care Technician (C) why the reusable concentrate was not labeled to identify the contents. Patient Care Technician (C) said, “I know special baths need to be labeled but I did not know this jug needed to be labeled too.” Review of the patient’s Treatment Details Report dated 11/12/2025 revealed Registered Nurse (G) documented the dialysis prescription verification at 7:00 AM and the hemodialysis treatment started at 6:54 AM. 30124 Patient #4 Observation on 11/12/205 at 9:50 AM revealed Patient ID #4 was seated at station #10, hemodialysis machine # 20 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialysis via a right central venous catheter(CVC). There was an unlabeled spiked gallon of 3K, 2.5 Ca liquid acid sitting on the base of the hemodialysis machine being utilized during treatment. The gallon was not labeled as required with the date and initials of person who opened the container. Surveyor observed Patient Care Technician (D), at 9:55 AM attach a piece tape to the gallon container with the date and his initials. Staff ID #D confirmed he should have labeled the contain when he opened it. Review of the patient’s Treatment Detail Report dated 11/12/2025 revealed Registered Nurse (G) documented the prescription verification at 6:25 AM and the hemodialysis treatment started at 6:17 AM.”

“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 11 sampled patients: Patient #s 10, 11, 4 Findings: Review of the facility’s current policy and procedure on Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment, Policy 1-03-08, directs staff as follows: “POLICY 3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment or as allowable by state law. Prescription components include but are not necessarily limited to: a. Dialyzer make and model b. Treatment time c. Target weight d. UFR and Max UFR e. UF Profiling f. Blood flow rate g. Dialysate flow rate h. All accesses evaluated i. Correct dialysate composition (potassium, calcium, base sodium and bicarb) and settings j. Heparinization (intradialytic infusion setting)” Patient #10 On 11/12/2025 at 9:10 AM Patient #10 was observed on the treatment floor of the facility at station #13 machine #14. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a right central venous catheter. There was a jug of CitraPure 2 potassium, 3 calcium connected to the hemodialysis machine. The Surveyor asked Survey Support RN (K) who was chairside to reveal the dialysate settings on machine #14. The machine dialysate settings were: 2 potassium, 2.5 calcium, 35 bicarbonate, 138 sodium. The Surveyor next ask Patient Care Technician (C) to pull up the patient’s hemodialysis order on the chair side computer. The hemodialysis orders revealed physician’s order for Calcium 3.0 (mEq/L). The Surveyor notified Clinical Coordinator (B) at 9:19 AM that Patient #10 was not receiving the hemodialysis treatment at the prescribed Calcium 3.0 (mEq/L). Clinical Coordinator (B) said, “Okay.” Review of the patient’s Treatment Details Report dated 11/12/2025 revealed the Clinical Coordinator (B) documented the dialysis prescription verification at 6:45 AM and the hemodialysis treatment started at 6:40 AM. The patient received calcium 2.5 mEq/L for 2 hours and 34 minutes of the prescribed 3 hour (180 m) hemodialysis treatment. Patient #11 Observation on 11/12/2025 at 9:34 AM revealed Patient #11 was seated at station #14 machine #6 receiving hemodialysis treatment at a blood flow rate of 300 mL/min and a dialysate flow rate of 700 mL/min. The patient was utilizing an Elisio-17H non reuse dialyzer via a via left upper arm vascular access. Treatment Details Report review: Blood Flow Rate Review of the patient’s Treatment Details Report dated 11/10/2025 revealed the Dialysis Prescription Blood Flow Rate of 300 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 350 mL/min from 6:33 AM - 10:31 AM. The registered nurse documented the Nurse Prescription Verification at 6:46 AM. There was no justification documented for the blood flow rate of 350 mL/min. Dialysate Flow Rate Review of the patient’s Treatment Details Report dated 11/05/2025 revealed the Dialysis Prescription Dialysate Flow Rate of 700 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 500 mL/min from 6:30 AM - 10:15 AM. The registered nurse documented the Nurse Prescription Verification at 6:46 AM. There was no justification documented for the dialysate flow rate of 500 mL/min. Review of the patient’s Treatment Details Report dated 10/31/2025 revealed the Dialysis Prescription Dialysate Flow Rate of 700 mL/min but the patient received the hemodialysis treatment at a blood flow rate of 500 mL/min from 6:32 AM - 10:36 AM. The registered nurse documented the Nurse Prescription Verification at 6:52 AM. There was no justification documented for the dialysate flow rate of 500 mL/min. Interview during record review on 11/12/2025 at 2:48 p.m. with Clinical Coordinator (B) confirmed Patient #11 did not receive the hemodialysis treatments as prescribed for the dates in question. Clinical Coordinator (B) said, “I will have to educate the staff on this.” 30124 Patient #4 On 11/12/2025 at 9:50 AM Patient #4 was observed on the treatment floor of the facility at station #10 machine #20. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 700 mL/min. The patient was utilizing an Elisio-17H non-reuse dialyzer via a right central venous catheter. There was a gallon jug of CitraPure 3 potassium, 2.5 calcium connected to the hemodialysis machine. The Surveyor asked Patient Care Technician(D) who was chairside to reveal the dialysate settings on machine #10. The machine dialysate settings were: 2 potassium, 2.5 calcium, 35 bicarbonate, 138 sodium. The Surveyor next ask Patient Care Technician (D) to pull up the patient’s hemodialysis order on the chair side computer. The hemodialysis orders revealed physician’s order for potassium 3.0 (mEq/L). The Patient Care Technician (D) immediately changed the dialysate setting on the machine to the ordered 3.0 potassium 2.5 calcium bath. Patient #4 was not receiving the hemodialysis treatment at the prescribed Calcium 3.0 (mEq/L). Record review documented Registered Nurse (G) had verified the patient’s prescription matches what is currently being delivered at 6:25 AM. Patient Care Technician (D) had verified the correct prescription at 5:12 AM. Hemodialysis treatment was initiated at 6:17 AM. Interview on 11/12/2025 at 9:50 AM with staff (D) confirmed the patient was not receiving the hemodialysis treatment as prescribed.”

“POC-MONITOR ESA RESPONSE CFR(s): 494.90(a)(4) The patient’s response to erythropoiesis-stimulating agent(s), including blood pressure levels and utilization of iron stores, must be monitored on a routine basis. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, facility’s registered nurses failed to administer total prescribed dosage of the medication (Venofer) prescribed by the physician for management of anemia for patients receiving hemodialysis treatment in 2 of 11 sampled patients: Patient #s 9, 11 Findings: Review of the facility’s current policy and procedure on Preparation and Administration of Parenteral Medications, Policy 1-06-01A, directs staff as follows: “Procedure: In all cases, a flush of mL air or saline needs to be administered through the injection luer lock line at the end of medication administration. If utilizing streamline blood line aspirate air from venous short infusion line and fill venous drip chamber to top allowing for no air gap. Rationale: Allows for complete medication administration and purging of venous medication infusion luer lock line of any residual medication.” Patient #9 Observation on 11/12/2025 at 8:56 AM revealed Patient #9 was seated at station #18 machine #2 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min via left upper arm vascular access. A 10 mL syringe was observed attached to the venous chamber medication administration Y-port of the external blood line. The lumen of the medication port was filled with residual intravenous Venofer from previous administration of the medication to the patient. Review of the patient’s flowsheet located in the chairside computer revealed a physician’s order for Venofer 100 mg, Intravenous Push, One time a week. The flowsheet also revealed documentation by the registered nurse that the patient was administered Venofer 100 mg at 7:00 AM. The registered nurse documented that the patient was administered the medication although residual medication was left in the lumen of the medication port. Subsequent observation at 10:40 AM revealed Patient Care Technician (E) was observed to discontinue the patient’s hemodialysis treatment. A 10 mL syringe was observed attached to the venous chamber medication administration Y-port of the external blood line. The lumen of the medication port was filled with residual intravenous Venofer from previous administration of the medication to the patient. After discontinuation of the patient’s hemodialysis treatment revealed, the residual Venofer remained in the medication administration lumen and was discarded with the external blood lines. Patient #9 did not receive the complete dosage of the medication prescribed for anemia management. The surveyor immediately notified Registered Nurse (G) of residual Venofer in the venous chamber medication Y-port lumen. Registered Nurse (G) said in response to the procedure for administering Venofer, “We are supposed to keep the line as clear as possible by flushing it.” Patient #11 Observation on 11/12/2025 at 9:34 AM revealed Patient #11 was seated at station #14 machine #6 receiving hemodialysis treatment at a blood flow rate of 300 mL/min and a dialysate flow rate of 700 mL/min via left upper arm vascular access. A 10 mL syringe was observed attached to the venous chamber medication administration Y-port of the external blood line. The lumen of the medication port was filled with residual intravenous Venofer from previous administration of the medication to the patient. Review of the patient’s flowsheet located in the chairside computer revealed a physician’s order for Venofer 50 mg, Intravenous Push, One time a week. The flowsheet also revealed documentation by the registered nurse that the patient was administered Venofer 50 mg at 6:48 AM. The registered nurse documented that the patient was administered the medication although residual medication was left in the lumen of the medication port. Subsequent observation at 10:45 AM revealed Patient Care Technician (C) was observed to discontinue the patient’s hemodialysis treatment and the patient’s needles were removed. A 10 mL syringe was observed attached to the venous chamber medication administration Y-port of the external blood line. The lumen of the medication port had residual intravenous Venofer from previous administration of the medication to the patient. Patient #11 did not receive the complete dosage of the medication prescribed for anemia management. The surveyor immediately notified Registered Nurse (G) of residual Venofer in the venous chamber medication Y-port lumen. Registered Nurse (G) said, “Okay.””

“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: 37322 Based on observation, interview and record review the facility’s Medical Director failed to ensure that employees followed the facility’s current policy and procedure. The facility has a current patient census of 60 hemodialysis patients that could be affected by employees not follwing the facility’s current policy and procedures. 1. Conduct pre-nursing assessment within the first hour of initiation of hemodialysis treatment for 3 of 8 current sampled patient records. (1,12,18) 2. Conduct intradialytic assessments on patients who experienced a change in condition in 1 of 8 current sampled patients records. (Patient ID # 17). Findings: Review of 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 on June 25, 2024, of the facility’s current policy and procedure on pre- intra and post assessment; Policy # 1-03-08, revised April 2024 directs staff as follows: 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment with one (1) hour of dialysis treatment initiation or sooner as required by law. 11. “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 12. The licensed nurse notifies the physician (or NPP if applicable) as needed of changes in patient status. 13. All findings, interventions and patient response will be documented in the patient’s medical record.” Document titled “Patient Parameters”, reportable by direct patient care team to the charge nurse pre, intra or post treatment pulse less than 60 or greater than 100. Patient #1 hemodialysis record review: 06/12/2024 documents treatment initiated at 15:58 PM; pre-nursing assessment completed at 17:08 PM. 06/17/2024 documents treatment initiated at 10:09 PM; pre-nursing assessment completed at 17:15 PM. Patient ID #12 hemodialysis record review: 06/21/2024 documents treatment initiated at 10:01 AM; pre-nursing assessment completed at 11:13 AM. Patient #18 hemodialysis record review: 06/12/2024 documents treatment initiated at 10:57 AM; pre-nursing assessment completed at 12:10 PM. 06/21/2024 documents treatment initiated at 09:49 AM; pre-nursing assessment completed at 11:16 PM. Patient # 17 hemodialysis record review: Hemodialysis treatment sheet dated 06/12/2024 documents treatment initiated by registered nurse, staff ID #D at 11:28 AM with BP 140/54, pulse 64, at 13:02 PM patient care technician, staff ID #H, documented BP 129/47, pulse 57, “Patient awake; alert; and states no complaints at this time”, 13:32 PM BP 119/42, pulse 57, “Patient awake,; alert; and states no complaints at this time”, 14:02 PM BP 124/37, pulse, “Patient awake; alert; and states no complaints at this time”. No documentation was found that staff ID #H notified the registered nurse of the decreased pulse below the acceptable parameters. Review of the patient’s clinical record revealed no documented intradialytic assessment by the registered nurse assigned to the patient although the patient’s heart rate was below acceptable parameters. Hemodialysis treatment sheet dated 06/19/2024 documents treatment initiated at 11:15 AM by patient care technician staff ID #H with BP 131/40, pulse 69. At 12:04 PM staff #H documents BP 126/34, pulse 59 “Patient states no complaints at this time”, 12:32 PM BP 132/43, pulse, 57 “Patient states no complaints at this time; Patient monitored; watching tv no complaints”, 13:02 PM BP 123/43, pulse 56 “Patient awake; alert; and states no complaints at this time, 14:02 PM bp 119/42, pulse 54 “Patient awake, alert and states no complaints at this time; Patient monitored; watching TV, No complaints. No documentation was found that staff ID #H notified the registered nurse of the decreased pulse below the acceptable parameters. Review of the patient’s clinical record revealed no documented intradialytic assessment by the registered nurse assigned to the patient although the patient’s heart rate was below acceptable parameters. Hemodialysis treatment sheet dated 06/21/2024 documents treatment initiated by registered nurse, staff ID #D at 11:17 AM with BP 153/47, pulse 69. Documentation by patient care technician, staff ID #H at 12:32 PM shows BP 122/45, pulse 56 “Patient states no complaints at this time”. No documentation was found that staff ID #H notified the registered nurse of the decreased pulse below the acceptable parameters. Review of the patient’s clinical record revealed no documented intradialytic assessment by the registered nurse assigned to the patient although the patient’s heart rate was below acceptable parameters. Hemodialysis treatment sheet dated 06/24/2024 documents treatment initiated at 11:31 AM by patient care technician staff ID #H with BP 136/57, 68 pulse. At 12:02 PM staff #H documents BP 131/42, pulse 57, “Patient appears to be tolerating treatment well at this time”. No documentation was found that staff ID #H notified the registered nurse of the decreased pulse below the acceptable parameters. Review of the patient’s clinical record revealed no documented intradialytic assessment by the registered nurse assigned to the patient although the patient’s heart rate was below acceptable parameters. Interview on 06/26/2024 at 15:00 PM staff ID #D confirmed the above findings.”