Diamond Dialysis -Missouri City

“POC-OUTCOME NOT ACHIEVED-ADJUST POC CFR(s): 494.90(b)(3) If the expected outcome is not achieved, the interdisciplinary team must adjust the patient’s plan of care to achieve the specified goals. When a patient is unable to achieve the desired outcomes, the team must- (i) Adjust the plan of care to reflect the patient’s current condition; (ii) Document in the record the reasons why the patient was unable to achieve the goals; and (iii) Implement plan of care changes to address the issues identified in paragraph (b)(3)(ii) of this section. This Standard is not met as evidenced by:”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to wash/sanitize hands after removal of contaminated gloves: 1 of 3 staff observed: Registered Nurse (A) Cross reference V 113 B) Based on observation and interview, the facility’s direct care staff failed to prevent cross contamination by taking a contaminated writing pen and placing it on top of the clean pad used to prep medications and by drawing up medications with contaminated hands in 1 of 3 staff observed: Registered Nurse (A) C) Based on observation and interview, the facility’s direct care staff failed to prevent cross contamination by touching the clipboard hanging on the intravenous (IV) pole of the hemodialysis machine with contaminated hands/gloves and writing on the patient’s treatment sheet in 2 of 3 staff observed: Registered Nurse (A) and Licensed Vocational Nurse (B) Cross reference V 117 D) Based on observation, interview and record review, the facility failed to offer and administer Hepatitis B vaccinations to patients whose Hepatitis B antibodies are less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus) in 2 of 9 sampled patients: Patient #s 1 and 6 Cross reference V 126 E) Based on observation, interview and record review, the facility’s nurses failed to implement infection control measures by not using aseptic technique in connection of a central venous catheters in 1 of 2 nurses observed: Registered Nurse (A), Patient #8 Cross reference V 147 Review of the facility’s current policy and procedure on Hand Washing and Gloves for Patient Use #IC 08 directs the staff as follows: Implementation 8. Gloves are to be used while performing intended procedures, then discarded. Handwashing is done before and after each procedure. Any break in gloves requires handwashing and new gloves before proceeding. Rationale: To prevent any entry area for infectious agents or cross contamination between patients. Review of the package insert for Engerix-B revealed the following: -----------------------DOSAGE AND ADMINISTRATION----------------------- For intramuscular administration. (2, 2.2) o Adults on hemodialysis: A series of 4 doses (2 mL each) as a single 2-mL dose or as two 1-mL doses on a 0-, 1-, 2-, 6-month schedule. (2.3)”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 48020 Based on record review and interview, the facility’s quality assessment performance improvement team failed to address deficiencies cited during its Medicare Recertification Survey conducted. Cross reference V 638 B) Based on observation, interview and record review, the facility failed to offer and administer Hepatitis B vaccinations to patients whose Hepatitis B antibodies are less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus) in 2 of 9 sampled patients: Patient #s 1 and 6 Cross reference V 126 C) Based on observation, record review and interview, the facility’s direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 1 of 9 sampled patients: Patient #6. Cross reference V 463 Findings: Review of the facility’s quality assessment performance improvement meeting minutes dated 07/17/2024 revealed no evidence that the committee addressed deficiencies cited during the Recertification survey of 6/26/2024. Hepatitis B vaccination Record review and interview during the Recertification survey revealed deficiencies were cited for the facility’s failure to offer or administer the Hepatitis B vaccination. Review on 08/06/2024 of patient’s clinical record revealed documentation which indicated that one of nine sampled patients was not offered or administered the Hepatitis B vaccination when the patient’s Hepatitis B antibodies was less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus). Review on 08/06/2024 of patient’s clinical record revealed documentation which indicated that one of nine sampled patients was not offered or administered the fourth dose of the Engerix-B Hepatitis B vaccination when the patient’s Hepatitis B antibodies was less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus). Review of the quality assessment performance plan meeting minutes revealed no documentation which indicated this issue was identified or addressed in the facility’s quality assessment improvement meeting minutes conducted on 07/17/2024. Plan of Care Record review and interview during the Recertification survey revealed deficiencies were cited for the facility’s failure to administer patients’ hemodialysis treatments based on physicians’ orders. Review on 08/05/2024 of patient’s clinical record revealed documentation which indicated that one of nine sampled patients did not receive the hemodialysis treatment at the prescribed dialysate flow rate. The patient’s hemodialysis machine was set to administer dialysate flow at 800 mL/min instead of the prescribed 500 mL/min. Review of the quality assessment performance plan meeting minutes revealed no documentation which indicated this issue was identified or addressed in the facility’s quality assessment improvement meeting minutes conducted on 07/17/2024. On 08/06/2024 the Surveyor reviewed the quality assessment performance improvement meeting minutes with the Facility’s Administrator who confirmed these deficient practices were not addressed in the minutes of the meeting.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 48020 Based on observation, interview and record review facility’s registered nurses failed to conduct assessments on patients and report the findings to the nephrologists when patients present with unusual findings during pre-treatment assessment and when patients experienced a change in condition during hemodialysis treatment in 3 of 9 sampled patients: Patients #s 7, 2 and 1 Cross Reference V 715 Findings: RN Assessments Observation on 08/05/2024 revealed Patient #7 was seated at station #4 machine #17 receiving hemodialysis treatment. Review on 08/06/2024 of the patient’s treatment sheet dated 08/05/2024 revealed a documented blood pressure of 195/96 at the end of the hemodialysis treatment. There was no mention of the patient’s blood pressure by the registered nurse in the post assessment or in the additional notes. Observation on 08/05/2024 reveled Patient #2 was seated at station #13 receiving hemodialysis treatment. The patient’s blood pressure 163/108. Review on 08/06/2024 of the patient’s treatment sheet dated 07/26/2024 revealed a documented blood pressure of 172/124 pre-treatment and the diastolic blood pressure remained elevated during the patient’s hemodialysis treatment. There was no documentation that the elevated diastolic blood pressure was reported to the patient’s nephrologist before the treatment began. There was no documented reassessment on the elevated diastolic blood by the registered nurse during dialysis. There was no mention of the patient’s elevated diastolic blood pressure in post assessment or in the additional notes. Observation on 08/05/2024 revealed Patient #1 was seated at station #17 receiving hemodialysis treatment. Review on 08/06/2024 of the patient’s treatment sheet dated 07/22/2024 revealed a pretreatment blood pressure of 200/77. The systolic blood pressure remained elevated during the patient’s hemodialysis treatment. There was no documentation that the elevated systolic blood pressure was reported to the patient’s nephrologist before the treatment began. There was no documented reassessment on the elevated systolic blood by the registered nurse during dialysis. There was no mention of the patient’s elevated systolic blood pressure in the post assessment or in the additional notes. Interview with the Facility Administrator on 08/06/2024 revealed she said, “Okay, we will get this taken care of.””

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 48020 Based on observation, record review and interview, the facility’s registered nurses failed to check the functionality of the Automated External Defibrillator (AED) device and suction machine and fill out log on every operational day. Findings: Observation on 08/05/2024 at 9:43 a.m. revealed an External Defibrillator (AED) device and suction machine sitting on top of the emergency cart on the treatment floor. Review of the facility’s water and equipment logs on 08/05/2024 revealed no documentation that the Automated External Defibrillator (AED) or suction machine were functional and no initials of the person performing the emergency equipment checks on 7/3/2024, 7/17/2024, 7/19/2024, and 7/22/2024. The logs were left blank for these days. Interview with the Facility Administrator on 08/05/2024 confirmed the missing documentation on the Crash Cart Checks sheet. She also confirmed the checks should be performed each operational day.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility governing body failed to ensure: all direct care staff are certified in Basic Life Support in 1 of 2 personnel files reviewed: Registered Nurse (A) B) all staff participated in fire drills in the facility in 1 of 2 personnel files reviewed: Registered Nurse (A) Findings: Review of the facility’s current policy and procedure on C.P.R. Training #PER 20 directs the staff as follows: Licensed personnel must be certified in Basic Life Support and will complete re-certification on an as needed basis. Registered Nurse (A) On 08/05/2024 Registered Nurse (A) was observed on the treatment floor providing care and services to hemodialysis patients. Review of the facility’s patient schedule revealed Registered Nurse (A) was assigned the charge nurse role and provided care and services to hemodialysis patients on: 07/22/2024, 07/24/2024, 07/26/2024, 07/29/2024, 07/31/2024, 08/02/2024, and 08/05/2024. Review of Registered Nurse (A’s) personnel and training file revealed she was hired as an experienced nurse on 06/24/2024. There was no documentation of Basic Life Support certification or that the Register Nurse (A) participated in a fire drill. On 08/06/2024, the Surveyor requested documentation from the Facility Administrator of Basic Life Support certification or staff fire drill participation. No documentation was provided.”

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to: wash/sanitize hands after removal of contaminated gloves: 1 of 3 staff observed: Registered Nurse (A) Findings: Review of the facility’s current policy and procedure on Hand Washing and Gloves for Patient Use #IC 08 directs the staff as follows: Implementation 8. Gloves are to be used while performing intended procedures, then discarded. Handwashing is done before and after each procedure. Any break in gloves requires handwashing and new gloves before proceeding. Rationale: To prevent any entry area for infectious agents or cross contamination between patients. Registered Nurse (A) Observation on 08/05/2024 at 8:24 a.m., revealed Registered Nurse (A) terminating hemodialysis treatment and completing central venous care on Patient #3 at station #1. Registered Nurse (A) removed her gloves, walked across the treatment floor, removed her gown and hung it up, opened the door with her contaminated hands and left the treatment floor without washing/sanitizing her hands. Observation on 08/05/2024 at 8:40 a.m., revealed Registered Nurse (A) setting up the hemodialysis machine at station #2. She opened the normal saline bag and laid it on top of the hemodialysis machine, walked over to Patient #7 who was sitting at station #3. Registered Nurse (A) lifted up the chairside table, walked back to station #2 and grabbed the clean supplies that she was using to set up the hemodialysis machine and took them to the hemodialysis machine at station #3. Patient #7 was sitting at station #3 while registered nurse prepared the unit for the patient’s hemodialysis treatment. She did not remove her gloves and wash/sanitize her hands after she adjusted the chairside table at station #3. She touched the clean supplies at station #2 with her contaminated gloves and used these supplies to set up the hemodialysis machine at station #3. The Surveyor notified Registered Nurse (A) at 09:12 a.m. that she did not wash/sanitize her hands after removal of contaminated gloves. Registered Nurse (A) said, “I should have washed my hands.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 48020 Based on observation and interview, the facility’s direct care staff failed to prevent cross contamination: by taking a contaminated writing pen and placing it on top of the clean pad used to prepare medications and by drawing up medications with contaminated hands in 1 of 3 staff observed: Registered Nurse (A) B) by touching the clipboard hanging on the intravenous (IV) pole of the hemodialysis machine with contaminated hands/gloves and writing on the patient’s treatment sheet in 2 of 3 staff observed: Registered Nurse (A) and Licensed Vocational Nurse (B) Findings: Registered Nurse (A) Observation on 08/05/2024 at 9:09 a.m., revealed Registered Nurse (A) at station #3 initiating treatment. Registered Nurse (A) adjusted the hemodialysis machine settings and removed her gloves and did not wash or sanitize her hands. She grabbed the clipboard hanging on the IV pole with her contaminated hands, grabbed the writing pen hanging on her gown, used it to push buttons on the hemodialysis machine and wrote down data on the treatment sheet attached to the clipboard. She returned the clipboard with the treatment sheet to the IV pole. She then walked over to the medication preparation station, placed the contaminated pen on the clean pad used to prepare medication and began drawing up medication syringes with her contaminated hands. The Surveyor notified Registered Nurse (A) at 09:12 a.m. that she failed to prevent cross contamination by touching the clipboard and treatment sheet with contaminated hands, by laying the contaminated pen on the clean medication prep pad, and by drawing up medications with contaminated hands. Registered Nurse (A) said, “Okay.” Licensed Vocational Nurse (B) Observation on 08/05/2024 at 9:28 a.m., revealed Licensed Vocational Nurse (B) completing central venous catheter care and treatment initiation on Patient #9 at station #2. She did not remove her gloves and did not wash or sanitize her hands. She grabbed the clipboard hanging on the hemodialysis machine IV pole, began documenting on the attached treatment sheet with her contaminated gloves and returned the clipboard with the treatment sheet to the IV pole. She then removed her gloves, performed hand hygiene and grabbed the contaminated clipboard and continued documenting on the treatment sheet. The Surveyor notified Licensed Vocational Nurse (B) at 09:35 a.m. that she failed to prevent cross contamination by touching the clipboard and treatment sheet with her contaminated gloves and then touching the same contaminated clipboard with her clean hands. Licensed Vocational Nurse (B) said, “Okay” and confirmed that the clipboard and treatment sheet are considered clean.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s nurses failed to implement infection control measures by not using aseptic technique in connection of a central venous catheters in 1 of 2 nurses observed: Registered Nurse (A), Patient #8 Findings: Registered Nurse (B) Patient #8 On 08/05/2024 at 9:57 a.m., Patient #8 was observed at station #5 receiving central venous catheter (CVC) care before the hemodialysis treatment. Registered Nurse (A) was observed to clean the exit site with gauze soaked in an antiseptic. She then opened a package of sterile 2x2 gauze with her contaminated gloves, folded the gauze and placed it under the catheter lumens. She then walked over to the clean supply station and cut a piece of the occlusive dressing and applied it to the patient’s catheter exit site without changing her gloves and washing/sanitizing her hands. The Surveyor notified Registered Nurse (A) at 10:25 a.m. of the break in infection control by failing to remove her gloves and perform hand hygiene after cleaning the exit site and applying the sterile gauze and she before she walked over to the clean supply station to cut and apply the occlusive dressing to the patient. Registered Nurse (A) stated “Okay, I will do better.””

“PA-ASSESS RENAL BONE DISEASE CFR(s): 494.80(a)(5) The patient’s comprehensive assessment must include, but is not limited to, the following: (5) Evaluation of factors associated with renal bone disease. This Standard is not met as evidenced by: 48020 Based on observation, interview, and record review the facility’s registered nurses failed to ensure medication prepared for patients are not left unsecured at patients’ chairside and are administered as prescribed by the physician in 3 of 9 patients observed: Patient #s 1, 2 and 6. Findings Patient #1 On 08/05/2024 at 7:14 a.m. Patient #1 was observed on the treatment floor of the facility at station #17. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. Observation of the patient’s chairside table revealed a medication cup with one orange capsule with a label inside of the cup that read “Calcitriol” left unsecured at the chairside. The medication was not in view of the registered nurse. The nurses were giving care to other patients while the medication was unsecured at the chairside. Review of the Patient’s clinical record revealed a physician’s order dated 05/24/2024 for Oral Calcitriol (Vitamin D) 0.50 mcg 3x/week. Review of the patient’s treatment sheet, located in the chairside computer revealed documentation by the registered nurse that the patient was administered Calcitriol 0.50 mg at 05:30 a.m. The registered nurse documented that the patient was administered the medication although the medication was left unsecured at the patient’s chairside. Patient #2 On 08/05/2024 at 7:19 a.m. Patient #2 was observed on the treatment floor of the facility at station #13. The patient was asleep and receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 800 mL/min. Observation of the patient’s chairside table revealed a medication cup with one orange capsule with a label inside of the cup that read “Calcitriol” left unsecured at the chairside. The medication was not in view of the registered nurse. The nurses were giving care to other patients while the medication was unsecured at the chairside. Review of the Patient’s clinical record revealed a physician’s order dated 08/02/2024 for Oral Calcitriol (Vitamin D) 0.25 mcg 3x/week. Review of the patient’s treatment sheet, located in the chairside computer revealed documentation by the registered nurse that the patient was administered Calcitriol 0.25 mg at 06:30 a.m. The registered nurse documented that the patient was administered the medication although the medication was left unsecured at the patient’s chairside. Patient #6 On 08/05/2024 at 7:44 a.m. Patient #6 was observed on the treatment floor of the facility at station #17. The patient was asleep and receiving hemodialysis treatment at a blood flow rate of 300 mL/min and dialysate flow rate of 800 mL/min. Observation of the patient’s chairside table revealed a medication cup with one orange capsule with a label inside of the cup that read “Sensipar” left unsecured at the chairside. The orange capsule was the only medication in the cup. There was no Sensipar in the medication cup. The medication was not in view of the registered nurse. The nurses were giving care to other patients while the medication was unsecured at the chairside. Review of the Patient’s clinical record revealed a physician’s order dated 06/26/2024 for Oral Calcitriol (Vitamin D) 0.50 mcg 3x/week. Review of the patient’s treatment sheet, located in the chairside computer revealed no documentation by the registered nurse that the patient was administered Calcitriol 0.50 mg. Subsequent review of the patient’s treatment sheet on 08/06/2024, revealed documentation by the registered nurse that the patient was administered Calcitriol 0.50 mg at 06:00 a.m. The registered nurse documented that the patient was administered the medication although the medication was left unsecured at the patient’s chairside. Interview with the Facility Administrator on 08/06/2024 at 11:20 a.m.: the Surveyor notified her that the oral medications were left unattended at the chairside and were signed off by the registered nurse as given. The Facility Administrator said, “I’ve gone over that with them before.””

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 48020 Based on record review and interview, the facility’s quality assessment performance improvement team failed to address deficiencies cited during its Medicare Recertification Survey conducted. B) Based on observation, interview and record review, the facility failed to offer and administer Hepatitis B vaccinations to patients whose Hepatitis B antibodies are less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus) in 2 of 9 sampled patients: Patient #s 1 and 6 C) Based on observation, record review and interview, the facility’s direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 1 of 9 sampled patients: Patient #6. Findings: Review of the facility’s quality assessment performance improvement meeting minutes dated 07/17/2024 revealed no evidence that the committee addressed deficiencies cited during the Recertification survey of 6/26/2024. Hepatitis B Record review and interview during the Recertification survey revealed deficiencies were cited for the facility’s failure to offer or administer the Hepatitis B vaccination. Review on 08/06/2024 of patient’s clinical record revealed documentation which indicated that one of nine sampled patients was not offered or administered the Hepatitis B vaccination when the patient’s Hepatitis B antibodies was less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus). Review on 08/06/2024 of patient’s clinical record revealed documentation which indicated that one of nine sampled patients was not offered or administered the fourth dose of the Engerix-B Hepatitis B vaccination when the patient’s Hepatitis B antibodies was less than 4 mIU/mL (patients are susceptible to the Hepatitis B virus). Review of the quality assessment performance plan meeting minutes revealed no documentation which indicated this issue was identified or addressed in the facility’s quality assessment improvement meeting minutes conducted on 07/17/2024. Plan of Care Record review and interview during the Recertification survey revealed deficiencies were cited for the facility’s failure to administer patients’ hemodialysis treatments based on physicians’ orders. Review on 08/05/2024 of patient’s clinical record revealed documentation which indicated that one of nine sampled patients did not receive the hemodialysis treatment at the prescribed dialysate flow rate. The patient’s hemodialysis machine was set to administer dialysate flow at 800 mL/min instead of the prescribed 500 mL/min. Review of the quality assessment performance plan meeting minutes revealed no documentation which indicated this issue was identified or addressed in the facility’s quality assessment improvement meeting minutes conducted on 07/17/2024. On 08/06/2024 the Surveyor reviewed the quality assessment performance improvement meeting minutes with the Facility’s Administrator who confirmed these deficient practices were not addressed in the minutes of the meeting.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 48020 Based on observation, record review, and interview, the facility’s governing body failed to implement the facility’s policy to ensure all dialysis nurses take and pass the Nephrology Competency Exam in 1 of 2 personnel files reviewed: Registered Nurse (A) Findings: Review of the facility’s current policy and procedure on Nephrology Competency Exam #PER 23 directs the staff as follows: “All dialysis nurses are required to take the Nephrology Competency Exam as a condition of employment. Subsequent Nephrology exams are required annually thereafter by all licensed nurses with the exception of those possessing Certified Nephrology Nurse (CNN) licensure. A passing score or 80% must be achieved on Nephrology exams to maintain employment at this facility.” Registered Nurse (A) On 08/05/2024 Registered Nurse (A) was observed on the treatment floor providing care and services to hemodialysis patients. Review of the facility’s patient schedule revealed Registered Nurse (A) was assigned the charge nurse role and provided care and services to hemodialysis patients on: 07/22/2024, 07/24/2024, 07/26/2024, 07/29/2024, 07/31/2024, 08/02/2024, and 08/05/2024. Review of Registered Nurse (A’s) personnel and training file revealed she was hired as an experienced registered nurse on 06/24/2024. There was no documentation of the Nephrology Competency Exam. On 08/06/2024, the Surveyor requested documentation from the Facility Administrator of competency examination for Registered Nurse (A). No documentation was provided.”

“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: 48020 Based on observation, interview and record review facility’s registered nurses failed to conduct assessments on patients and report the findings to the nephrologists when patients present with unusual findings during pre-treatment assessment and when patients experienced a change in condition during hemodialysis treatment in 3 of 9 sampled patients: Patients #s 7, 2 and 1 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 Facility’s Policy and Procedure: Review of the facility’s current Policy and Procedure on Predialysis Assessment #HD 05 directs staff as follows: “All patients undergoing hemodialysis shall be pre-assessed by a licensed hemodialysis nurse prior to the initiation of each treatment, this baseline information is necessary for assessing the patient’s response to the hemodialysis procedure. Procedure: Assess, evaluate and document the following: neuro status, pulmonary status, circulatory status Specific notation should include at least: 3. Heart Rate: Acceptable findings: 60-100 regular rhythm/rate per minute Unacceptable findings: <60 or >100 per minute; Irregular rate or rhythm ... 5. Blood Pressure: Acceptable findings: <90 diastolic or <150 systolic Unacceptable findings: >150 systolic or > 90 diastolic And <90 systolic or <40 diastolic standing or sitting ... Should the patient’s condition be unstable, upon assessment, notify the nephrologist before initiating the procedure.” Patient #7 On 08/05/2024 at 7:44 a.m., Patient #6 was observed seated at station #4 machine #17 receiving hemodialysis treatment at a blood flow rate of 300 mL/min and a dialysate flow rate of 800 mL/min via right central venous catheter. Vital signs were as follows: blood pressure 172/88 pulse 46. Treatment sheet dated 08/05/2024: Review on 08/06/2024 of the patient’s clinical record (treatment sheet) dated 08/05/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 161/76 pulse of 58 beats per minute Pre-treatment assessment documented by the Registered Nurse revealed: Orientation- A&Ox3, Breath Sounds: clear, Heart Sounds: Reg, Abdomen: Soft, Edema: Trace, Access: patent, Mobility: walker. 09:04 a.m.: documented blood pressure of 172/88 and pulse rate of 46 beats per minute- treatment initiation 09:30 a.m.: documented blood pressure of 157/82 and pulse rate of 46 beats per minute 10:00 a.m.: documented blood pressure of 169/86 and pulse rate of 61 beats per minute 10:30 a.m.: documented blood pressure of 124/77 and pulse rate of 66 beats per minute- this is a 45-point drop in systolic blood pressure that was not rechecked or reported to the charge nurse. 11:00 a.m.: documented blood pressure of 146/83 and pulse rate of 74 beats per minute 11:30 a.m.: documented blood pressure of 120/73 and pulse rate of 73 beats per minute 12:00 p.m.: documented blood pressure of 166/95 and pulse rate of 82 beats per minute 12:04 p.m.: documented blood pressure of 195/96 and pulse rate of 69 beats per minute- treatment termination Post treatment vital signs: documented blood pressure of 112/66 and pulse rate of 75 beats per minute- this is an 83-point decrease in systolic from the last blood pressure. The Licensed Vocational Nurse documented in the Additional Notes, “Pt blood pressure elevated at end of tx. Instructed patient to assess BP before resuming b/p medication after dialysis tx. Patient verbalized understanding. CN aware.” Post assessment documented by the Registered Nurse revealed: Orientation- AOx3, Breath Sounds: CTA, Heart Sounds: HRRR, Abdomen: nontender, Edema: 0, Access: patent, Mobility: walker. There was no mention of the patient’s elevated blood pressure by the registered nurse in the additional notes. Patient #2 On 08/05/2024 at 7:19 a.m. Patient #2 was observed on the treatment floor of the facility at station #13. The patient was asleep and receiving hemodialysis treatment at a blood flow rate of 400 mL/min and dialysate flow rate of 800 mL/min. Vital signs were as follows: blood pressure 163/108 pulse 87. Treatment sheet dated 07/26/2024: Review on 08/06/2024 of the patient’s clinical record (treatment sheet) dated 07/26/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 172/124 pulse of 88 beats per minute Pre-treatment assessment documented by the Registered Nurse revealed: Orientation- AAOx3, Breath Sounds: clear, Heart Sounds: Regular, Abdomen: soft, Edema: Generalized, Access: bruit + thrill, Mobility: Ambulate. There was no mention of the patient’s blood pressure. 04:55 a.m.: documented blood pressure of 172/114 and pulse rate of 88 beats per minute- treatment initiation 05:30 a.m.: documented blood pressure of 163/120 and pulse rate of 82 beats per minute 06:00 a.m.: documented blood pressure of 175/104 and pulse rate of 84 beats per minute 06:30 a.m.: documented blood pressure of 177/114 and pulse rate of 83 beats per minute 07:00 a.m.: documented blood pressure of 158/104 and pulse rate of 86 beats per minute 07:30 a.m.: documented blood pressure of 161/112 and pulse rate of 83 beats per minute 08:00 a.m.: documented blood pressure of 175/122 and pulse rate of 90 beats per minute 08:30 a.m.: documented blood pressure of 161/114 and pulse rate of 81 beats per minute 08:55 a.m.: documented blood pressure of 166/100 and pulse rate of 82 beats per minute- treatment termination Post treatment vital signs: blood pressure of 160/100 pulse of 92 beats per minute Post assessment documented by the Registered Nurse revealed: Orientation- AAOx3, Breath Sounds: clear, Heart Sounds: Regular, Abdomen: soft, Edema: Generalized, Access: bruit + thrill, Mobility: Ambulate. There was no mention of the patient’s blood pressure. There was no documentation that the elevated diastolic blood pressure was reported to the patient’s nephrologist before the treatment began. There was no documented reassessment on the elevated diastolic blood by the registered nurse during dialysis. There was no mention of the patient’s elevated diastolic blood pressure in the additional notes. Patient #1 On 08/05/2024 at 7:14 a.m. Patient #1 was observed on the treatment floor of the facility at station #17. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and dialysate flow rate of 500 mL/min. Treatment sheet dated 07/22/2024: Review on 08/06/2024 of the patient’s clinical record (treatment sheet) dated 07/22/2024 revealed the following documentation: Pretreatment vital signs: blood pressure of 200/77 pulse of 55 beats per minute Pre-treatment assessment documented by the Registered Nurse revealed: Orientation- Reg, Breath Sounds: clear, Heart Sounds: HRRR, Abdomen: BS+, Edema: Trace, Access: patent, Mobility: Amb. There was no mention of the patient’s blood pressure. 05:10 a.m.: documented blood pressure of 190/68 and pulse rate of 52 beats per minute- treatment initiation 05:30 a.m.: documented blood pressure of 197/77 and pulse rate of 51 beats per minute 06:00 a.m.: documented blood pressure of 190/69 and pulse rate of 54 beats per minute 06:30 a.m.: documented blood pressure of 181/71 and pulse rate of 50 beats per minute 07:00 a.m.: documented blood pressure of 175/69 and pulse rate of 50 beats per minute 07:30 a.m.: documented blood pressure of 175/69 and pulse rate of 61 beats per minute 08:00 a.m.: documented blood pressure of 169/69 and pulse rate of 68 beats per minute 08:30 a.m.: documented blood pressure of 176/77 and pulse rate of 59 beats per minute- treatment termination Post treatment vital signs: blood pressure of 176/77 sitting, 181/78 standing, pulse of 59 beats per minute Post assessment documented by the Registered Nurse revealed: Orientation- AAOx3, Breath Sounds: clear, Heart Sounds: Regular, Abdomen: nontender, Edema: Trace, Access: patent, Mobility: Ambulate. There was no mention of the patient’s blood pressure. There was no documentation that the elevated systolic blood pressure was reported to the patient’s nephrologist before the treatment began. There was no documented reassessment on the elevated systolic blood by the registered nurse during dialysis. There was no mention of the patient’s elevated systolic blood pressure in the additional notes. Review of treatment sheets on 07/19/2024, 07/24/2024, 07/26/2024, 07/29/2024 showed the same trend of not assessing and reporting the patient’s elevated systolic blood pressures. Interview with the Facility Administrator on 08/06/2024 at 2:22 p.m., the Surveyor notified the Facility Administrator that the registered nurses are not assessing and reporting elevated blood pressure and low heart rates to the patient’s nephrologists. The Facility Administrator said, “Okay, we will get this taken care of.””

“GOV-ADM RESP FOR RESOURCES FOR QAPI CFR(s): 494.180(a)(4) The governing body or designated person responsible must appoint an individual who serves as the dialysis facility’s chief executive officer or administrator who exercises responsibility for the management of the facility and the provision of all dialysis services, including, but not limited to- (4) Allocation of necessary staff and other resources for the facility’s quality assessment and performance improvement program as described in §494.110. This Standard is not met as evidenced by: 48020 Based on record review and interview, the facility’s governing body failed to address deficiencies cited during its Medicare Recertification Survey conducted. Findings: Review of the facility’s governing body meeting minutes revealed no evidence that the governing body addressed deficiencies cited during the Recertification survey of 06/26/2024. Review of the Facility’s Governing Meeting Minutes on 08/06/2024 revealed the most current governing body was held on June 25, 2024. The topic for discussion was Critical Lab Reporting Process. There was no documentation of governing body meeting minutes after this date. There were no governing body meeting minutes addressing the deficiencies found during the Recertification survey of 06/26/2024. Interview of Facility Administrator (G) on 08/06/2024 confirmed there were no governing body meetings held after 06/26/2024. The governing body did not discuss or address the deficiencies cited during the Recertification survey of 06/26/2024.”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to take action on critical potassium laboratory results of patients when reported by the laboratory in 2 of 15 sampled patients: Patient #’s 7 and 8. Facility’s staff not following up on critical laboratory values potentially placed all patients receiving hemodialysis treatment health and safety at risk. (B) facility’s governing body failed to ensure Pneumococcal vaccinations were administered to patients as prescribed by patient’s physicians in 7 of 15 sampled patients. Patient #s 3, 4, 5, 8, 1, 6 and 15. Findings: Patient #7 Review of Patient #7’s clinical record ( nurse’s notes) dated 06/11/2024 revealed a critical potassium laboratory report documented as 7.5 mEq/L, the physician was called, and he gave an order to repeat the potassium laboratory on the next dialysis treatment on 06/13/2024. The facility failed to repeat the patient’s potassium laboratory. Potassium laboratory range 3.5 - 5.5 MEq/L . 10802 Patient #8 Review of patient #8’s laboratory values located in the patient’s record revealed the following laboratory values: 05/06/2024= Potassium 5.8 mEq 06/03/2024 = potassium 6.8 mEq Review of the record revealed no documentation by the registered nurse that the patient’s nephrologist was notified of the elevated potassium level and action taken to address the abnormal laboratory value. Cross reference V 505 Pneumococcal vaccination Review of 7 of 15 sampled patients; Patient #s 3, 4, 5, 8, 1, 6 and 15. clinical records revealed no documentation that patients were offered or administered the pneumococcal vaccine. Interview on 06/24/2024 at 2:30 p.m. with Registered Nurse ( C) when asked about administration of Pneumococcal vaccine she states “ I have been working here since October 2023, and I have never administered pneumococcal vaccination to patients.” Cross reference V 506”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to implement infection control measures by utilizing supplies stored in their pockets for patient care in 1 of 4 sampled staff: Registered Nurse (C), Patient #6 and random Patient #13 Findings: Registered Nurse (C) Patient #6 On 06/24/2024 at 8:47 a.m., Patient #6 was observed at station #10 receiving central venous catheter (CVC) care post hemodialysis treatment. Registered Nurse (C) was observed to pick up trash from the floor, remove her contaminated gloves, reach into her pockets, don a pair of gloves stored in her pockets, grab her stethoscope from around her neck and listen to the patient’s lung sounds. The Surveyor notified Registered Nurse (C) at 8:58 a.m. of the break in infection control by using gloves stored in her pockets for patient care. Registered Nurse (C) said, “I didn’t know that I couldn’t do that.” 10802 Registered Nurse (C) Patient #13 On 06/24/2024 at 8:41 a.m., Patient #13 was observed at station #5 hemodialysis machine #18, The patient was receiving central venous catheter (CVC) care for hemodialysis treatment. Observation revealed Registered Nurse (C) lifted her contaminated gown with her hands, remove a pair of gloves from her pocket under the gown, donned the gloves and reset the patient’s hemodialysis machine and reposition the patient’s blood lines with the gloves removed from her pocket. The registered nurse touching her contaminated gown and storing the gloves in her pocket potentially contaminates the gloves.”

“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: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to clean and disinfect the wall boxes and chase cabinets behind the hemodialysis machines in 1 of 3 sampled staff. Patient Care Technician (B). Findings: Review of the facility’ s current policy and procedure on Disinfecting Patient Equipment # IC 04 directed staff as follows: “It is the policy of ___ Dialysis that all patient care equipment shall be thoroughly cleaned and disinfected by assigned personnel. SPECIAL INSTRUCTIONS “In compliance with Center for Disease Control, routine disinfecting shall be done on all dialysis equipment using 1:100 bleach solutions.” Review of the Center for Disease Control (CDC) Dialysis Safety: Dialysis Wall Boxes and Drains states: “ wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections. Wall boxes are part of the immediate patient care environment and are considered contaminated or dirty.” Patient Care Technician (B) Station #9 - hemodialysis machine #14 Observation on 06/24/2024 at 8:50 a.m. revealed Patient Care Technician (B) terminally cleaning station #9 post hemodialysis treatment of a patient. During terminal cleaning of the hemodialysis machine #14 at station #9, Patient Care Technician (B) failed to clean the wall box and chase cabinet. Station #11 - hemodialysis machine #17 Subsequent observation on 06/24/2024 at 9:42 a.m. revealed Patient Care Technician (B) terminally cleaning station #11 post hemodialysis treatment of a patient. During terminal cleaning of the hemodialysis machine #17 at station #11, Patient Care Technician (B) failed to clean the wall box and chase cabinet. The Surveyor notified Patient Care Technician (B) at 9:47 a.m. that he failed to clean and disinfect the wall boxes and chase cabinets at stations #9 and #11. Patient Care Technician (B) said, “I’m sorry, I’ll clean it.””

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview the facility’s direct care staff, failed to administer Hepatitis (B) vaccination to a patient whose Hepatitis B antibodies are less than 10 mIU; patient susceptible to the Hepatitis B virus in 1 of 2 peritoneal dialysis patients records reviewed and 1 of 2 direct care staff record reviewed. Patient #14 and Licensed Vocational Nurse (E) Patient #14 Review of the patient’s #14’s clinical record revealed he was admitted to the facility on 1/9/2023 with diagnosis of end stage renal disease on in center hemodialysis. The record revealed the patient changed modality on 1/26/2024 to peritoneal dialysis with training and support from facility’s staff. Review of Patient #14’s clinical record revealed a consent signed by the patient on 1/26/2024 for Hepatitis B vaccination consent /waiver form. Review of the patient’s clinical record revealed a laboratory report dated 03/06/2024 for Hepatitis B Antibody of less than 4 mIU/ ml. Review of Patient #14’s clinical record revealed a physician ‘s order not dated, for Hepatitis b vaccine 40 mcg IM., full series if patient B antibody ,10. If HBsAb <responsive status, 10 after first series, repeat full series. If no conversion after that time refer to attending MD for determination of non - status. “ Review of the patient’s clinical record revealed no documentation that the patient was administered the Hepatitis B vaccination. Interview on 06/ 26/2024 at 10:30 a.m. with the facility’s quality assurance personnel, the surveyor reviewed the patient’s record with her and requested documentation that the patient was administered the Hepatitis B vaccination. She states, “The patient change modality and had refused the vaccine initially but after the change in modality he signed the consent for the Hepatitis B vaccination, but it was not given.” Licensed Vocational Nurse (E) On 06/24/2024 Licensed vocational Nurse (E) was observed on the hemodialysis treatment unit providing care and services to the patients. Review on 06/26/2024 of Licensed Vocational Nurse (E’s) personnel file revealed he was hired to the facility on 01/02/2024. Review of Licensed Vocational Nurse (E’s) personnel file revealed a Hepatitis B laboratory result dated 3/18/2024 which indicated the staff was susceptible to the Hepatitis (B) virus. Review of the record revealed no documentation that he was offered the vaccination or refused administration of the Hepatitis (B) vaccination. On 06/26/2024 the Surveyor requested documentation from the facility’s administrator that the nurse was offered the Hepatitis (B) vaccination. None was provided.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, the facility failed to ensure hemodialysis machines used for hemodialysis of patients are maintained based on manufacture’s direction for use in 2 of 6 hemodialysis machines monitored. Hemodialysis machine #s 10 and 3 (B) Failed to ensure expired supplies are not stored with supplies in use for patients’ care and services. Findings: Review of the manufacture’s Preventative Maintenance Procedures Part # #508138 directs uses as follows: “Preventative maintenance for 2008 K 2 hemodialysis machine is simple and straightforward. Maintenance is performed in only two intervals. Six (6) months and annually or 4000 hours of operation. The maintenance procedures have been devised to require a minimum of time while ensuring the machine is maintained in optimum operating condition. “ Review of the Cardiac Science Powerheart G3 Plus AED Manual page 2-2 directs use as follows: “9131 Defibrillation Electrodes Cardiac Science 9131 Defibrillation Electrodes are single and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging.” Hemodialysis machine #10 On 06/24/2024 at 6:39 a.m. hemodialysis machine Fresenius 20082, #10 was observed at station 6. The hemodialysis machine was utilized for a patient receiving hemodialysis treatment. Observation of the current reading on hemodialysis machine #10 meter, 10,087 hours Review of the facility’s preventive maintenance log revealed documentation of the following preventative maintenance preformed on hemodialysis machine #10: 01/30/2024; annual preventative maintenance documented performed, machine hours 10,087. 7/10/2023; 6 months preventative maintenance documented performed, machine hours 10,087. 1/10/2023; annual preventative maintenance documented performed, machine hours 14,012. 7/25/2022; 6 months preventative maintenance documented performed, machine hours 13,111. The record revealed the hours on the machine decreased over time. Interview on 06/26/2024 at 12:10 p.m. with the facility’s Chief Biomedical Technician revealed he said the meter on the hemodialysis machine is broken and he was not aware of this. Hemodialysis Machine #3 On 06/24/2024 at 7:27 a.m. hemodialysis machine Fresenius 2008 2 K, #3 was observed at station 13. The hemodialysis machine was utilized for a patient receiving hemodialysis treatment. Observation of the current reading on hemodialysis machine #3 meter 25,783. Review of the facility’s preventive maintenance log revealed documentation of the following preventative maintenance preformed on hemodialysis machine #3: 9/12/2023; annual preventative maintenance documented performed, machine hours 23,944 hours. 3/7/2023; 6 months preventative maintenance documented performed, machine hours 10,102. 9/6/2022; annual preventative maintenance documented performed, machine hours 9,725 hours. Review of the preventative maintenance log revealed the hours increased from 10,102 - 23, 944 hours between 3/07/2023 and 09/12/2023. There is no documented preventative maintenance performed between machine hours 10,102 and machine hours 23,944 hours. Interview on 06/26/2024 with the Facility’s Chief Biomedical Technician revealed he said prior to the last recorded hours of 23,944, preventative maintenance on the hemodialysis machine was done by another person. He said he did not know how they came up with the hours documented. 48020 Observation on 06/20/2024 during tour of the facility revealed the following expired supplies were observed co-mingled with supplies in use for patient care: Observation in the peritoneal dialysis training room revealed the following expired supplies were co-mingled with stocks in use: 2- Cardiac Science AED pads: Lot 120612-02 expired 12/2014 13- Baxter 12 Foot Extension Set: Lot # H19F19113 expired 06/19/2024 7- Baxter UltraSet CAPD Disposable Disconnect Y-Set: Lot # H22E23054 expired 05/23/2024 The Surveyor immediately notified Peritoneal Dialysis Nurse (F) of the expired supplies. Peritoneal Dialysis Nurse (F) said, “Okay, I will remove them.””

“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 direct care staff failed to administer patients’ hemodialysis treatments based on physicians’ orders in 2 of 15 sampled patients: Patient #1 and 2. Findings: Patient #1 On 06/24/2024 at 6:50 a.m., Patient #1 was observed seated at station #9 hemodialysis machine #14. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min via right upper arm vascular access. Observation of the patient physician’s order located at the chairside revealed dialysate settings: Bicarbonate setting = 35.0 mEq/L and Sodium (Na) setting = 140 mEq/L. Review of the patient’s clinical record revealed a physician’s order dated 02/02/2024 for Bicarbonate setting = 35.0 mEq/L and Sodium (Na) setting = 140 mEq/L. Observation with Patient Care Technician (A) at 7:00 a.m. revealed the dialysate settings on the patient’s hemodialysis machine were: bicarbonate 38 mEq/L and sodium 141 mEq/L. When the Surveyor pointed out the discrepancy in bicarbonate and sodium dialysate settings, Patient Care Technician (A) said, “My mistake, I will fix it.” Patient #2 On 06/24/2024 at 7:02 a.m. Patient #2 was observed seated at station #11 hemodialysis machine #17. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min via left femoral vascular access. The patient was utilizing an Optiflux 160 non reuse dialyzer. Observation of the patient’s physician’s order located at the chairside revealed dialysate setting: Bicarbonate setting = 35.0 mEq/L and Optiflux 180 non reuse dialyzer. Review of the patient’s clinical record revealed a physician’s order dated 01/03/2024 for Bicarbonate setting = 35.0 mEq/L and Sodium (Na) setting = 140 mEq/L. Observation with Patient Care Technician (A) at 7:15 a.m. revealed the dialysate setting on the patient’s hemodialysis machine for bicarbonate was 38 mEq/L. When the Surveyor pointed out the discrepancy in bicarbonate dialysate setting and the dialyzer size, Patient Care Technician (A) said, “Okay, I will change it.””

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s direct care staff failed to take action on critical potassium laboratory results of patients when reported by the laboratory in 2 of 15 sampled patients: Patient #’s 7 and 8. Findings: Patient #7 Observation on 06/25/2024 at 9:12 a.m., Patient #7 was seated at station #12 machine #8, receiving hemodialysis treatment. The dialysate setting on the patient’s hemodialysis machine was potassium 2 mEq/L, calcium 2.5 mEq/L. Review of Patient #7’s laboratory results as follows: 3/5/24 - Potassium 5.6 mEq/L 4/2/24 - Potassium 5.1 mEq/L 5/7/24 - Potassium 5.3 mEq/L 6/4/24 - Potassium 7.5 mEq/L flagged as Critical High Interview on 06/25/2024 at 8:00 a.m. with Registered Dietitian (H) revealed she said she discovered the abnormal potassium laboratory result on 06/11/2024 when she pulled up the rounding report. She then notified the Facility Administrator who served as the charge nurse on 06/11/2024 of the result. Interview on 06/25/2024 at 10:55 with Facility Administrator (L) revealed she said the critical labs are sent to the printer from the lab. The charge nurse is supposed to check the printer as part of the Charge Nurse Daily Notes and report the results to the Nephrologist. Subsequent interview with the Facility Administrator (L) at 11:25 a.m. revealed the laboratory reported Patient #7’s potassium result on 06/06/2024 and the Charge Nurse Daily Notes for this date does not mention the critically high potassium or actions taken. Review of the Charge Nurse Daily Notes dated 06/11/2024 revealed the critical potassium laboratory was documented as 7.5 mEq/L, the physician was called, and he gave an order to repeat the potassium laboratory on the next dialysis treatment on 06/13/2024. Review of the treatment sheets revealed Patient #7 received hemodialysis treatments on 06/04/2024, 06/06/2024, 06/08/2024, 06/11/2024, 06/13/2024, 06/15/2024, 06/18/2024, 06/20/2024, and 06/22/2024. The facility failed to follow the physician’s order to redraw the laboratory on 06/13/2024. The potassium laboratory was not redrawn until 06/18/2024. Review of Patient #7’s laboratory report dated 06/18/2024 revealed the laboratory was unable to perform testing because the laboratory “received uncentrifuged specimen.” After the surveyor discussed the findings with Facility Administrator (L), the staff redrew the potassium on 06/25/2024. 10802 Patient #8 On 06/24/2024 at 14:47 p.m. Patient #8 was observed on the treatment unit at station #7. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 500 mls/ minute via a intrajugular central venous catheter. Review of the patient’s clinical record revealed a documented blood pressure of 172/103 and pulse rate of 81 beats per minute. Review of patient’s laboratory values located in the patient’s record revealed the following laboratory values: 05/06/2024= Potassium 5.8 mEq 06/03/2024 = potassium 6.8 mEq Review of the patient’s clinical record ( physician Progress notes) revealed the patient most current encounter with his nephrologist is dated 06/03/2024. There is no documentation in the record that the patient’s nephrologist was notified of the potassium level, and action taken to address the abnormal laboratory value. Review of Patient#8’s hemodialysis treatment sheets revealed the patient received hemodialysis treatment in the facility on the following days: 06/03/2024, 06/05/2024, 06/10/2024, 06/12/2024, 06/14/2024, 06/17/2024, 6/19/2024, 6/21/2024 and 6/24/2024. Review of the record revealed no documentation by the registered nurse that the patient’s nephrologist was notified of the elevated potassium level. Interview on 06/26/2024 at 3:15 p.m. with patient #8 revealed he said the nurse talks to him about his blood pressure, but his doctor comes in and states “ Hi how are you doing.” Interview on 06/26/2024 at 3:45 p.m. with the Patient’s Nephrologist revealed he said the patient is non- compliant, he has encounter with the patient but lacks documenting.”

“PA-IMMUNIZATION/MEDICATION HISTORY CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: Immunization history, and medication history. This Standard is not met as evidenced by: 10802 Based on observation, interview and record review, facility’s governing body failed to ensure Pneumococcal vaccinations were administered to patients as prescribed by patient’s physicians in 7 of 15 sampled patients. Patient #s 3, 4, 5, 8, 1, 6 and 15. Findings: Patient #3 On 06/24/2024 Patient #3 was observed on the hemodialysis unit at station # 2. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 700 mls/ minute via a right intrajugular central venous catheter. Review of the patient’s clinical record revealed a consent for pneumonia vaccination consent signed by the patient, but it was not dated. Review of the patient’s clinical record revealed a physician’s order dated 5/4/2024 for, “Pneumococcal Vaccine (dose: 0.5 ml IM upon admission ) Recommended if it cannot be verified that patient has received Vaccination in past five years:” Review of the Patient’s clinical record revealed no documentation that the patient was administered the pneumococcal vaccination. Review of a vaccination report provided by the facility’s quality manger revealed no documentation that the patient was administered the pneumococcal vaccination. Interview with the Facility’s Quality Manager on 06/24/2024 at 2:30 p.m. revealed she reviewed the patient’s clinical record; she said there is no documentation of pneumococcal vaccination administered to the patient. Patient #4 On 06/24/2024 at 6:56 a.m. Patient #4 was observed on the hemodialysis unit at station # 4. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls/ minute and dialysate flow rate of 500 mls/ minute via a left lower arm vascular access. Review of the patient’s clinical record revealed a consent for pneumonia vaccination consent, signed by the patient on 05/21/2021. Review of the patient’s clinical record revealed a physician’s order dated 5/4/2024 for “Pneumococcal Vaccine (dose: 0.5 ml IM upon admission ) Recommended if it cannot be verified that patient has received Vaccination in past five years:” Review of the patient’s clinical record revealed no documentation that the patient was administered the pneumococcal vaccination. Review of a vaccination report provided by the Facility’s Quality Manger revealed no documentation that the patient was administered the pneumococcal vaccination. Patient #5 On 06/24/2024 at 6:50 a.m. Patient #5 was observed on the hemodialysis unit at station # 3. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls/ minute and dialysate flow rate of 500 mls/ minute via a left upper arm vascular access. Review of the patient’s clinical record revealed a consent for pneumonia vaccination consent signed by the patient but not dated. Review of the patient’s clinical record revealed a physician’s order dated 5/4/2024 for “Pneumococcal Vaccine (dose: 0.5 ml IM upon admission ) Recommended if it cannot be verified that patient has received Vaccination in past five years:” Review of the Patient’s clinical record revealed no documentation that the patient was administered the pneumococcal vaccination. Review of a vaccination report provided by the facility’s quality manger revealed no documentation that the patient was administered the pneumococcal vaccination. Patient #8 Review of the patient’s clinical record revealed a consent for pneumonia vaccination consent signed by the patient, but it was not dated. Review of the patient’s clinical record revealed a physician’s order dated 5/4/2024 for “Pneumococcal Vaccine (dose: 0.5 ml IM upon admission ) Recommended if it cannot be verified that patient has received Vaccination in past five years:” Review of the Patient’s clinical record revealed no documentation that the patient was administered the pneumococcal vaccination. Review of a vaccination report provided by the Facility’s Quality Manger revealed no documentation that the patient was administered the pneumococcal vaccination. Interview on 06/24/2024 at 2:30 p.m. with Registered Nurse ( C) when asked about administration of Pneumococcal vaccine she states “ I have been working here since October 2023, and I have never administered pneumococcal vaccination to patients.” 48020 Patient #1 On 06/24/2024 at 6:50 a.m., Patient #1 was observed seated at station #9 machine #14 receiving hemodialysis treatment at a blood flow rate of 400 mL/min and a dialysate flow rate of 500 mL/min via right upper arm vascular access. Review of the patient’s admission record revealed the patient signed a consent on 08/15/2023 to receive the pneumonia vaccination. Review of the patient clinical record revealed the patient received the Prevnar 13 Pneumonia Vaccine on 03/27/2018. A physician’s order dated 05/03/2024, recommends the pneumococcal vaccine “if it cannot be verified that patient has received Vaccination in the past 5 years.” Interview with Quality Assurance Manager (M) revealed no documentation that the patient was administered the pneumococcal vaccination. Patient #6 On 06/24/2024 at 6:53 a.m., Patient #6 was observed at station #10 machine #14 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 800 mL/min via left central venous catheter. Review of the patient’s admission record revealed no documentation of a signed consent for the pneumonia vaccination. Review of the patient clinical record revealed a physician’s order dated 01/26/2024 that states, “Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Interview with Quality Assurance Manager (M) revealed no documentation that the patient was offered or administered the pneumococcal vaccination. Patient #15 Review of the patient’s clinical record revealed the patient was admitted to the facility on 03/25/2022 with diagnosis of diabetes on insulin, hypertension, and end stage renal disease on in center hemodialysis three times weekly. The patient was admitted to peritoneal dialysis 01/24/2024. Review of the patient’s admission record revealed no documentation of a signed consent for the pneumonia vaccination. Review of the patient’s clinical record revealed a physician’s order dated 06/28/2023 that states, “Pneumococcal Vaccine (Dose: 0.5 ml IM upon admission) Recommended if it cannot be verified that patient has received vaccination in the past 5 years.” Interview with Quality Assurance Manager (K) revealed no documentation that the patient was offered or administered the pneumococcal vaccination.”

“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: 10802 Based on observation, interview and record review, facility’s registered nurse failed to ensure medication ( Ferrlecit) prescribed by the physician for management of anemia for patients receiving hemodialysis treatment, total prescribed dosage of the medication were administered to patients in 4 of 15 sampled patients; #s 10, 9, 11 and 12. Findings: Review of the facility’s current protocol for Ferrlecit administration directs staff as follows: “Lab Monitoring: All Patients: TSAT monthly; Ferritin quarterly New Patients: Lab panel with TSAT and Ferritin on 1st tx. Ferrlecit dosing and Maintenance: Transferrin Saturation < 20%, 125 mg IVPX8 consecutive treatments for a total of 1 gram. Ferritin 801-1200 ng/ml 125 mg IVPX4 consecutive treatments for a total of 500 mg, Ferritin > 1201 ng/ml no iron Transferrin Saturation 21-50 %, 62.5 mg every two weeks Transferrin > 51% Ferritin > 1201 ng/ml no iron Transferrin Saturation 21%- 50% 62.5 mg every two weeks, Ferritin 801 -1200 ng/ ml no iron, Ferritin > 1201 ng ml no iron Transferrin Saturation > 51%, no iron, Ferritin < 800 ng/ml no iron, Ferritin 801-12 ng/ ml no iron, Ferritin > 1201 ng/ml no iron” Patient #10 On 06/24/2024 at 6:17 a.m. Patient #10 was observed at station #5. The patient was utilizing hemodialysis machine #18. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls minute and dialysate flow rate of 500 mls/ minute via a left upper arm vascular access. Observation revealed a 10 ml syringe was observed attached to the medication administration port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication documented as administered to the patient at 5:30 a.m. Review of the patient’s clinical record (treatment sheet ) dated 06/25/2024 revealed a prescription for Ferrlecit 62.5 mg intravenously every Tuesday. Review of the patient’s clinical record revealed a physician’s order dated 1/18/2024 for Ferrlecit 62.5 mg every Tuesday. Subsequent observation at 8:29 a.m. revealed Licensed Vocational Nurse (E) was observed discontinuing the patient’s hemodialysis treatment. After discontinuation of the patient’s hemodialysis treatment revealed, the residual Ferrlecit remained in the medication lumen and was discarded with the external blood lines. Patient (#10) did not receive the complete dosage of the medication prescribed for anemia management. The surveyor immediately notified The facility’s administrator (L) of the medication left in the medication lumen. The facility’s administrator (L) states “ Thanks for the information. I will inform them.” Review of the patient’s clinical record revealed the following laboratory result dated 06/18/2024 : Hemoglobin 11.1 g/dl ( CMS Measurement Assessment Tool) recommended goal for end stage renal dialysis patients = greater than 10 g/ dl. 4/2/2024 :Ferritin = 511 g/dl ( laboratory range< = 1200 /dl) Transferrin saturation 06/04//2024 = 35 %. Laboratory reference range 20-50 % Patient #9 On 06/24/2024 at 6:29 a.m. Patient #9 was observed at station #3 on the hemodialysis unit. The patient was utilizing hemodialysis machine #9. The patient was receiving hemodialysis treatment at a blood flow rate of 450 mls minute and dialysate flow rate of 800 mls/ minute via a left upper arm vascular access. Observation revealed a 10 ml syringe was observed attached to the medication administration port of the external blood line. The lumen of the medication port was filled with residual intravenous Ferrlecit from previous administration of the medication documented administered to the patient at 5:40 a.m. Review of the patient’s clinical record (treatment sheet ) dated 06/24/2024 revealed a prescription for Ferrlecit 62.5 mg intravenously every Tuesday. Review of the patient’s clinical record revealed a physician’s order dated 1/31/2024 for Ferrlecit 62.5 mg every Tuesday. Subsequent observation on 06/24/2024 at 8:05 a.m. revealed Licensed Vocational Nurse (E) was observed discontinuing the patient’s hemodialysis treatment. After discontinuation of the patient’s hemodialysis treatment the residual Ferrlecit remained in the medication 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 The Facility’s Administrator (L) of the medication left in the medication lumen. Facility’s Administrator (L) states “ Thanks for the information, I will inform them.” Review of the patient’s clinical record revealed the following laboratory result dated 06/18/2024 : Hemoglobin 11.1 g/dl ( CMS Measurement Assessment Tool) recommended goal for end stage renal dialysis patients = greater than 10 g/ dl. 4/2/2024 :Ferritin = 1476 g/dl ( laboratory range< = 1200 /dl) Transferrin saturation 05/07//2024 = 87 %. Laboratory reference range 20-50 %. 48020 Patient #11 On 06/25/2024 at 6:56 a.m., Patient #11 was observed at station #7 machine #15 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min. Observation revealed residual Ferrlecit was observed in the venous chamber medication Y-port. Review of the patient’s treatment sheet dated 06/25/2024 revealed documentation by Facility Administrator (J) that Ferrlecit 125 mg q (every) Tuesday, was administered at 4:50 a.m. although residual medication was left in the venous chamber medication Y-port. Subsequent observation at 8:15 a.m. revealed Patient Care Technician (L) discontinuing the hemodialysis treatment on the patient. Patient Care Technician (L) then removed the blood lines from the hemodialysis machine with the residual Ferrlecit remaining in the medication Y-port and discarded them into the biohazard. The patient did not receive the complete dose of Ferrlecit. Review of the patient’s laboratory report revealed the following: 06/18/2024- Hemoglobin = 8.6 g/dl (CMS Measurement Assessment Tool recommended goal for end stage renal dialysis patients = greater than 10 g/dl) 06/04/2024- Transferrin saturation = 16% (laboratory reference range 20-50 %) 04/02/2024- Ferritin = 2025 ng/mL (laboratory range <= 1200 ng/mL) Patient #12 On 06/25/2024 at 7:04 a.m., Patient #12 was observed at station #10 machine #8 receiving hemodialysis treatment at a blood flow rate of 350 mL/min and a dialysate flow rate of 500 mL/min. Observation revealed residual Ferrlecit was observed in the venous chamber medication Y-port. Review of the patient’s treatment sheet dated 06/25/2024 revealed documentation by Facility Administrator (J) that Ferrlecit 62.5 mg q (every) Tuesday, was administered at 6:30 a.m. although residual medication was left in the venous chamber medication Y-port. Subsequent observation at 8:58 a.m. revealed Registered Nurse (K) remove the blood lines from the hemodialysis machine with the residual Ferrlecit remaining in the medication Y-port and discarded them into the biohazard. The patient did not receive the complete dose of Ferrlecit. The Surveyor immediately notified Registered Nurse (K) that the patient did not receive the complete dose of Ferrlecit because of the residual dose left in venous chamber medication Y-port. Registered Nurse (K) said, “Okay, I see what you mean.””

“PQ-CHARGE NURSE-12 MO NURSING+3 MO DIALYSIS CFR(s): 494.140(b)(3)(i)-(ii) The charge nurse responsible for each shift must- (i) Be a registered nurse, a licensed practical nurse, or vocational nurse who meets the practice requirements in the State in which he or she is employed; (ii) Have at least 12 months experience in providing nursing care, including 3 months of experience in providing nursing care to patients on maintenance dialysis; This Standard is not met as evidenced by: 48020 Based on observation, interview and record review, the facility’s governing body failed to ensure all registered nurses assigned the charge nurse role, meet the qualifications to provide nursing care as a charge nurse to patients in 1 of 2 charge nurses observed: Charge Nurse (C). Findings: Charge Nurse (C) On 06/24/2024 Charge Nurse (C) was observed on the treatment floor of the facility providing care and services to hemodialysis patients. Review of Charge Nurse (C)’s personnel and training documents revealed her RN license is current and has an Original Issue Date of 09/29/2023. Charge Nurse (C) has eight months of nursing experience and is not qualified to give care to patients as a charge nurse per federal (12 months = 9 months nursing experience plus 3 months hemodialysis) and state (12 months clinical experience plus 6 months hemodialysis subsequent to completion of the facility’s training program, within the last 24 months) regulations. Review of the facility’s patient schedule revealed Charge Nurse (C) was assigned the charge nurse role and provided care and services to hemodialysis patients on: 05/31/2024, 06/01/2024, 06/03/2024, 06/04/2024, 06/05/2024, 06/10/2024, 06/12/2024, 06/14/2024, 06/15/2024, 06/17/2024, 06/19/2024, 06/21/2024, 06/22/2024, 06/24/2024. Review of the Facility’s Charge Nurse Daily Notes revealed Charge Nurse (C) signed off on the notes as charge nurse for the above dates. Interview on 06/26/2024 at 1:37 p.m. with the Charge Nurse (C) revealed she said, “I was hired in October of last year. I have been working by myself since the second week of January and this is my first job as a nurse.” Charge Nurse (C) also confirmed that she worked independently on the above dates with no charge capable nurses present. Interview with Facility Administrator (L) on 06/26/2024 confirmed Charge Nurse (C) provided nursing care to patients as the charge nurse on the dates in question.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 10802 Based on observation, record review and interview, the facility’s attending physician failed to sign verbal orders given to staff for medication and treatment of patients in 4 of 15 sampled patients: Patient #3, 4, 5, 15 Findings: Review of the facility’s current policy and procedure on Medication profile Policy #med 2 directs staff as follows: “ Telephone orders documenting medication changes must also be written by the nurse and sent to the physician for a signature. If the physician has called a pharmacist with new medications orders, it is not necessary to send a verbal order. The change shall be documented in the Medication Profile and included in the next Plan of Care.” Patient #3 On 06/24/2024 Patient #3 was observed on the hemodialysis unit at station # 2. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls and dialysate flow rate of 700 mls/ minute via a right intrajugular central venous catheter. Review of the patient’s clinical record revealed a physician’s order dated 05/06/2024 for “Increase Epogen to 5000 units q Monday . Review of the patient’s clinical record revealed a physician’s order dated 05/28/2024 for Increase EDW from 117.0 kg to 119.0 Kg . Review of the patient’s clinical record revealed the orders were not signed by the physician who gave the verbal orders. Patient #4 On 06/24/2024 at 6:56 a.m. Patient #4 was observed on the hemodialysis unit at station # 4. The patient was receiving hemodialysis treatment at a blood flow rate of 350 mls and dialysate flow rate of 500 mls/ minute via a left lower arm vascular access. Review of the patient’s clinical record revealed a physician’s order dated 05/6/2024 for “Increase Epogen to 4000 units q Monday and Friday. HB 9.8. Review of the patient’s clinical record revealed the order was not signed by the physician who gave the verbal orders. Patient #5 On 06/24/2024 at 6:50 a.m. Patient #5 was observed on the hemodialysis unit at station # 3. The patient was receiving hemodialysis treatment at a blood flow rate of 400 mls and dialysate flow rate of 500 mls/ minute via a left upper arm vascular access. Review of the patient’s clinical record revealed a physician’s order dated 05/6/2024 for “Increase Epogen to 4000 units q Monday and Wednesday. HB 10.6. Review of the patient’s record revealed the order was not signed by the physician who gave the verbal orders. On 06/26/2024, the surveyor notified the facility’s quality personnel of the unsigned verbal orders by patient’s attending physician. She concurred that physician’s orders were left unsigned. 48020 Patient #15 Review of the patient’s clinical record revealed the patient was admitted to the facility on 03/25/2022 with diagnosis of diabetes on insulin, hypertension, and end stage renal disease on in center hemodialysis three times weekly. The patient was admitted to peritoneal dialysis 01/24/2024. Review of the patient’s clinical record revealed a physician’s order dated 05/22/2024 for “Dialyvite 800mg 1 Tab po, once a day.” The order was not signed by the physician who gave the verbal orders. Interview with Quality Assurance Manager (K) on 06/26/2024 confirmed the physician’s verbal order was not signed by the physician.”