Sapphire Community Dialysis

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 30952 Based on review of medical records (MR), facility policy, and interview with staff, it was determined the facility failed to ensure staff completed the Comprehensive Interdisciplinary Assessments (CIA) within 15 days of the Plan of Care (POC). This affected Patient Identifier (PI) # 5, PI # 2, PI # 1, PI # 4, four of five MRs reviewed, and had the potential to affect all 42 hemodialysis and 8 peritoneal dialysis (PD) patients receiving services at this facility. Findings include: Facility Policy: General Policy for Patient Assessment and Plan of Care Policy Number: None listed Policy Date: None listed ...The patient assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of a minimum, the patient..., a registered nurse (RN), the patient’s attending physician or physician extender, qualified Master’s Social Worker (SW), and qualified registered dietitian (RD). ...An initial assessment must be conducted on all new patients and a Plan of Care developed... Comprehensive assessment and modifications to the Plan of Care must be... reassessed annually thereafter on all stable patients. The modified Plan of Care must be implemented within 15 days of the reassessment. 1. PI # 5 was admitted to the facility on 9/1/24 with a diagnosis of End Stage Renal Disease (ESRD) for home therapy PD services. Review of the PD Comprehensive Interdisciplinary Assessment 90 Day Plan of Care, dated 1/6/25, revealed the POC implementation date was 1/27/25. There was no date by the RD assessment. The surveyor was unable to determine when the assessment was completed. Review of the facility support documentation revealed the RN assessment was completed on 1/6/25, which was 21 days before the POC approval/implementation date. The SW assessment was dated 2/3/25, which was 7 days following the POC approval/implementation date. An interview was conducted on 2/4/25 at 1:38 PM with Employee Identifier (EI) # 2, PD, RN, who confirmed the RN and SW assessments were not completed within the required timeframe. EI # 2 confirmed there was no date by the electronic signature on the RD assessment, and no way to determine when it was completed. 2. PI # 2 was admitted to the facility on 3/13/24 with a diagnosis of ESRD. Review of an Initial Plan of Care, dated 4/23/24, revealed there were no dates on the assessments by the RN, and SW. The surveyor was unable to determine when the assessments were completed. Further review of the 4/23/24 POC revealed no RD and physician assessments were completed, and no date was documented when the IDT approved the POC for implemention. An interview was conducted on 2/4/25 at 3:00 PM with EI # 1, Facility Administrator, who confirmed there were no dates by the electronic signatures on the assessments, the RD and physician assessments were not completed, and the updated/modified POC did not have an implementation date. 39098 3. PI # 1 was admitted to the facility on 10/7/19 with a diagnosis of ESRD. Review of the POC dated 1/15/25 revealed there were no dates when the nutrition or MD assessments were completed. The surveyor was unable to determine when the assessments were completed. An interview was conducted on 2/4/25 at 4:35 AM with EI # 1, who confirmed there were no dates for the nutrition and MD assessments. 4. PI # 4 was admitted to the facility on 4/29/21 with a diagnosis of ESRD. Review of the POC dated 10/26/24 revealed the RN and MD failed to complete the assessment. Further review revealed there were no dates when the CIA was completed by the SW and RD. The surveyor was unable to determine when the assessments were completed. An interview was conducted on 2/4/25 at 4:28 PM with EI # 1, who confirmed there were no dates for the SW and RD assessments.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 36271 Based on review of medical records, the Medication Discrepancy Report, facility policies and procedure, and staff interview it was determined the facility failed to ensure facility policies and procedures, physician’s orders, and the patient’s Plan of Care was developed and followed during care delivery. These deficient practices had the potential to negatively affect the forty-four patients currently receiving in-center hemodialysis at the facility and the ten patients who receive Peritoneal Dialysis home training and support. Refer to: V 542, V 545, V 546, and V 547.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 36271 Sapphire Community Dialysis is not in compliance with the Condition for Coverage for Quality Assessment and Performance Improvement (QAPI) as evidenced by failure to demonstrate an effective QAPI program; failure to recognize and prioritize major problems which impact patient’s health and safety, and failure to take action to address identified problems. This deficient practice has the potential to affect forty-four incenter hemodialysis patients and ten home peritoneal dialysis patients served by this facility. Findings: refer to V 0626, V 0630, V 0631, V 0632, and V 0634.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 30952 Based on observation, review of Patient Rights, medical records, facility policies, facility Venofer Protocol, Adverse Occurrence documentation, Medication Discrepancy Report, facility quality and performance improvement data, it was determined the Medical Director failed to ensure: 1. Patients were informed, able to exercise their rights, and participate in planning his/her care: Refer to the Condition at V 450 and associated tags. 2. Staff and Medical Director followed policies for Patient Plan of Care: Refer to the Condition at V 540 and associated tags. 3. The facility Quality Assessment Performance Improvement Committee collected, reviewed, and evaluated facility quality data to improve patient care delivery: Refer to the Condition at V 625 and associated tags.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 30952 Based on review of the Patient Bill of Rights, the facility Medication Discrepancy Report, facility Adverse Occurrence and Grievance documentation, staff and patient interviews, medical record (MR) documentation, facility policies, the facility Venofer Drug Protocol, Quality Assessment Performance Improvement (QAPI) program data, Medical Staff By-Laws, and Medical Director (MD) Duties and Responsibilities, it was determined the Governing Body failed to provide sound fiscal operation and management of the facility and ensure: 1. Patients were informed of the lack of medications at the facility and missed doses of ordered medications. Refer to Conditions for Coverage (Cfc) and associated tags at V 450. 2. The delivery of patient care was safe and effective for patient outcome improvement and the the Interdisciplinary Team developed and implemented a Patient Plan of Care. Refer to Cfc and associated tags at V 540. 3. An active and effective QAPI Program was conducted and maintained. Refer to Cfc and associated tags at V 625. 4. The Medical Director complied with the facility bylaws and MD duties and responsibilities. Refer to Cfc and associated tags at V 710.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 30952 Based on review of Patient Bill of Rights, facility Medication Discrepancy Report, incident and grievance report documentation, and interviews with patients and staff, the facility staff failed to inform the patients of all aspects of his or her care which included failure to administer medications ordered by the Medical Director and included in the patient Plan of Care. Failure to inform patients of changes to their medication treatments, the failure to administer prescribed medications for the management of nutrition, mineral metabolism, and anemia, did not allow the patient’s rights and the ability to exercise their rights to be protected. This failure had the potential to not allow the patient the opportunity to make informed decisions about his/her care and had the potential to affect the forty-four incenter hemodialysis patients and ten Peritoneal Dialysis (PD) who receive home training/support at the facility. Findings include: Physician’s Choice Dialysis Patient Rights, Responsibilities, and Facility Rules Your Rights As A Patient: Each patient receiving services at Physicians Choice Dialysis shall have the following: 1. To be informed of these rights...by written acknowledgement, or by documentation by staff in the medical record (MR)...in terms the patient could understand... 2. To be fully informed of all services available in the facility... 4. To receive from the patient’s physician (or) clinical practitioner(s), in terms...the patient understands, an explanation of his or her complete medical/health condition...recommended treatments...options...and expected result(s). If this information would be detrimental to the patient’s health, or if the patient is not capable of understanding the information, the explanation shall be provided to the next of kin...documented in the patient’s MR. 5. To participate in the planning of the patient’s care and treatment, and to refuse medication and treatment...documented in the patient’s MR. ...7. To voice grievance or recommend changes in...services to facility personnel, the governing authority...free from interference, coercion, discrimination, or reprisal. 8. To receive a full explanation of the...recommended treatment...risks and side effects, and other treatment/appointment options before giving consents to treatment/appointments(s). 9. To be free from...exploitation...Drugs and other medications shall not be used...for the convenience of facility personnel. 11. To be treated with courtesy, consideration, respect, and recognition of the patient’s dignity... 13. To exercise civil...liberties, including the right to independent personal decision... In addition, you are responsible for adhering to the rules of the facility... 3. You have the responsibility to adhere to all aspects of your dialysis treatment...as prescribed by your Physician. If you disagree with the prescription or desire that changes be made, you must discuss it with your attending Physician. Your Physician is the only one who can order these changes. ...7. You are considered an important part of your healthcare team and you are encourage to participate in the planning process... Review of the facility Medication Discrepancy Report dated 8/1/24 to 11/13/24 revealed forty- five patients plus one transient patient failed to receive prescribed medications, including Hectorol, Venofer, Mircera, CinaC (Cinacalcet), IDPN, Calcitriol, and Protein Supplement (ONS). Medications were held and the reasons documented on the report were “not in stock,” and “not in supply.” Review of the facility Incident log revealed no missed medication dosages were documented in 2024. Review of the facility Grievance log revealed no complaints/grievances documented in 2024. Interviews were conducted on 11/13/24 at 8:35 AM with ten of eleven patients receiving dialysis treatments. The patients were asked if they had been receiving all medications ordered by their physician? No patients reported missed medications due to the medications not being available and out of stock at the dialysis clinic. An interview was conducted on 11/13/24 at 11:28 AM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed ordered medications were not consistently administered since August because they were not in stock/available at the facility. EI # 3 confirmed the Medical Director was told on rounds medications were not in stock. EI # 3 confirmed patients were not informed of the missed medication doses. An interview was conducted on 11/14/24 at 3:50 PM with EI # 1, Medical Director, who confirmed patients were not told the facility did not have prescribed medications for their care available for administration during dialysis treatments. An interview was conducted on 11/15/24 at 12:45 PM with EI # 2, Chief Clinical Officer, who reported “I was under the impression they (patients) knew” the medications were not administered as prescribed.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 39098 Based on staff interviews, review of medical records (MR), and facility policy, it was determined the facility failed to ensure staff completed the comprehensive interdisciplinary assessment (CIA) and Plan of Care (POC) which included all team members participation and collaboration. This deficient practice affected seven of eight MR’s reviewed, and did affect Patient Identifier (PI) # 2, PI # 4, PI # 7, PI # 1, PI # 8, PI # 3, PI # 5, and had the potential to affect all patients dialyzing at this facility. Findings include: Facility Policy: General Policy for Patient Assessment and Plan of Care Policy Number: None listed Policy Date: None listed ...Responsibility: ...The patient assessment and Plan of Care must be developed and implemented by an interdisciplinary team consisting of a minimum, the patient..., a registered nurse, the patient’s attending physician or physician extender, qualified Master’s Social Worker and qualified registered dietitian. ...An initial assessment must be conducted on all new patients and a Plan of Care developed... Comprehensive assessment and modifications to the Plan of Care must be... reassessed annually thereafter on all stable patients. The modified Plan of Care must be implemented within 15 days of the reassessment. An interview was conducted on 11/14/24 at 11:16 AM with Employee Identifier (EI) # 7, Social Worker, who reported there are no care plan rounds and no care plan meetings for the in-center HD patients. EI # 7 reported there is no schedule for POC rounds and stated “the care planning needs to tighten up”. An interview was conducted on 11/14/24 at 4:00 PM with EI # 3, Facility Administrator, who confirmed no collaborative POC meetings are held. Each team member completes his/her portion of the patient POC, then signs the signature page that is kept in a red binder on the treatment floor. An interview was conducted on 11/14/24 at 4:26 PM with EI # 1, Medical Director, who reported he/she comes to the clinic twice monthly. EI # 1 confirmed there is no collaborative team meeting for review/approval of the patient POC. EI # 1 stated the problem is lack of coordination with scheduling and emergencies. 1. PI # 2 was admitted to the facility on 8/13/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Initial Plan of Care, dated 9/13/2024, revealed assessments by the Registered Nurse (RN) and Social Worker (SW). There was no date by the signatures to indicate when the assessment was completed. There was no documentation on the POC by the physician or dietitian (RD). The surveyor requested the signature page to indicate who participated in the Plan of Care meeting. The page contained no signatures by the team, or the patient. An interview was conducted on 11/15/24 at 10:15 AM with EI # 3, who confirmed the POC was incomplete and there was no evidence the POC was reviewed with the patient. 2. PI # 4 was admitted to the facility on 2/7/24 with an initial diagnosis of Acute Kidney Injury. Review of the Initial Plan of Care, dated 3/11/24, revealed an assessment by the RN. There was no documentation by the RD, SW, or physician. The POC was incomplete. The surveyor was provided a signature sheet titled “...Care Plan” by EI # 3, who stated the signature sheets were kept in a binder on the treatment floor for the patient to sign. The sheet was signed by the patient, physician, RN, RD, and SW. An interview was conducted on 11/15/24 at 10:19 AM, with EI # 3, who confirmed the POC was incomplete. 3. PI # 7 was admitted to the facility on 3/14/24 with a diagnosis of ESRD. Review of the MR revealed three POC’s. One dated 4/23/24 and was marked “Initial,” and was greater than 30 days after admission. One dated 6/18/24, also marked as “Initial.” The other POC was dated 10/19/24 and was marked as “90 Day,” which was seven months after admission. Review of the POC dated 4/23/24 revealed no documentation by the physician. There were no dates by the RN, SW, or RD signatures. The surveyor was unable to determine what dates the comprehensive assessments were completed. Review of the POC dated 6/18/24 revealed there was no documentation by the physician. There were no dates by the RN, SW, or RD signatures. The surveyor was unable to determine what dates the comprehensive assessments were completed. Review of the POC dated 10/19/24 revealed no assessments/documentation by the SW, RD or physician. There was no signature page provided, and no evidence of any discussion with PI # 7. An interview was conducted on 11/15/24 at 10:28 AM with EI # 3, who confirmed the POC’s were late, incomplete, and not discussed with the patient. 30952 4. PI # 1 was admitted to the facility on 5/31/22 with a diagnosis of ESRD. MR review revealed an HD (Hemodialysis) Re-Evaluation Interdisciplinary Assessment, Stable, dated 7/18/23. There were no assessments/documentation by the SW, RD or physician. There was no signature page provided, and no evidence of any discussion with PI # 1. Further record review revealed an Annual, Stable HD CIA, dated 9/26/24. The Nephrologist Assessment-MD (medical doctor) was blank, and not signed by the physician. There was a CIA signature page dated 9/26/24 which was not signed by PI # 1 as evidence of discussion/review of the POC. An interview was conducted on 11/15/24 at 9:47 AM with EI # 3, who confirmed the POC’s were incomplete. 5. PI # 8 was admitted to the facility on 1/22/21 with a diagnosis of ESRD. MR review revealed an HD Re-Evaluation Interdisciplinary Assessment, Stable, dated 9/13/23. There were no assessments/documentation by the RD, SW or physician. There was no signature page provided for the 9/13/23 document, and no evidence of discussion with PI # 8. Further record review revealed an Initial, Stable, HD Comprehensive Interdisciplinary Assessment, dated 10/22/24. There were no assessments/documentation by the RD, and the Nephrologist Assessment-MD was blank, and not signed by the physician. There was no signature page provided, and no documentation the POC was reviewed with PI # 8. An interview was conducted on 11/14/24 at 3:32 PM with EI # 3 who confirmed the POC’s were incomplete, and there was no evidence of discussion of the POC with PI # 8. 6. PI # 3 was admitted to the facility on 10/7/19 with a diagnosis of ESRD. MR revealed a document, titled, HD CIA Assessment, dated 5/17/23, the Monthly, Unstable POC. The Nephrologist Assessment-MD was not complete, and not signed by the physician. There were no dates the Nurse, RD, SW, completed their assessments. The signature page attached was blank for all IDT members. There was no documentation the POC was discussed with PI # 3. There were no additional CIA/POC’s provided for review and no documentation when the IDT determined PI # 3 was determined to be stable. An interview was conducted on 11/15/24 at 9:54 AM with EI # 3, who reported “I don’t see why he/she was unstable”. EI # 3 confirmed the POC was incomplete. 7. PI # 5 was admitted to the facility on 8/3/22 with a diagnosis of ESRD. MR review revealed an Annual Stable HD Comprehensive Interdisciplinary Assesment dated 12/29/23 not completed by the Nurse, RD, SW, or physician. The documentation revealed, “unable to complete patient out of town on vacation.” There was no Annual POC provided to the surveyor. An interview was conducted on 11/14/24 at 3:07 PM with EI # 3 who confirmed she/he was unsure if the annual POC was rescheduled and completed. The staff failed to develop, review, and implement an annual POC for PI # 5.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 30952 Based on review of the Medication Discrepancy Report, medical record (MR) review, and interview it was determined the facility failed to administer Intradialytic Parental Nutrition (IDPN) as ordered which affected Patient Identifier (PI) # 3, in one of two MR’s reviewed, and five patients on the current census with IDPN orders. Findings include: Review of the Medication Discrepancy Report, dated 8/1/24 to 11/13/24, revealed five patients did not receive IDPN. Six patients’ whose MR’s were not reviewed, did not receive oral nutritional supplements (ONS) as ordered for nutrition management. 1. PI # 3 was admitted to the facility on 10/7/19 with a diagnosis of End Stage Renal Disease. Review of the document titled, Orders, dated 11/14/24, revealed an order for IDPN-HD (hemodialysis), IVPB ( intravenous piggy back), administer every dialysis, start date 3/25/2020. Review of the Treatment Sheets dated 10/9/24 and 10/11/24 revealed IDPN was “Held,” with a remark of “not in stock.” An interview was conducted on 11/15/24 at 9:54 AM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed there was no documentation of IDPN administration. EI # 3 reported IDPN shipments were delayed due to weather. EI # 3 confirmed no adverse event/occurrence report was completed for omitted IDPN doses.”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 30952 Based on review of the facility Medication Discrepancy Report, medical records (MR), and interviews, it was determined the facility failed to ensure staff administered medications for management for mineral metabolism as ordered by the physician. This deficient practice affected one of seven records reviewed, including Patient Identifier (PI) # 5, and did affect nineteen patients on the current census. Review of the Medication Discrepancy Report, dated 8/1/24 to 11/13/24, revealed eighteen patients did not receive Cinacalcet (CinaC), six patients did not receive Calcitriol, and three patients did not receive Hectorol as ordered for mineral metabolism. 1. PI # 5 was admitted to the facility on 8/3/22 with a diagnosis of End Stage Renal Disease. Review of the document titled, Physician Order, revealed a handwritten order dated 7/13/24 to decrease Cinacalet to 90 mg (milligram), and add Hectorol 3 mcg (microgram) QHD (every hemodialysis). Review of Treatment Sheet (TS) dated 8/5/24 revealed CinaC 90 was “Held”, no remark was documented, and Hectorol 3 mcg was “Held”, with a remark of “not in stock.” Review of TS’s dated 8/7/24 and 8/9/24 revealed Hectorol 3 mcg was “Held” with a remark of “Not in Supply.” Review of TS dated 8/12/24 revealed CinaC 90 and Hectorol 3 mcg was “Held”, with a remark of “not in stock.” Review of seventeen TS dated from 8/14/24 to 9/20/24 revealed Hectorol 3 mcg was “Held”, with a remark of “not in stock/not in supply.” Review of TS’s dated 9/23/24, and 9/25/24 revealed CinaC 90 and Hectorol 3 mcg were “Held”, with a remark of “not in stock/not in supply.” Review of the TS’s dated 11/6/24, 11/8/24 and 11/11/24 revealed Hectorol 3 mcg was “Held”, with a remark of “not in stock/not in supply.” An interview was conducted on 11/14/24 at 3:07 PM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed CinaC and Hectorol for mineral metabolism were not administered as ordered. EI # 3 reported “we didn’t have it.””

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. This Standard is not met as evidenced by: 39098 Based on review of medical records (MR), Medication Discrepancy Report, Hemodialysis (HD) Venofer Dosing Protocol, and interviews, it was determined the facility failed to ensure staff administered Venofer and/or Mircera for anemia management as ordered by the physician. This deficient practice affected seven of eight records reviewed, including Patient Identifier (PI) # 2, PI # 4, PI # 7, PI # 1, PI # 8, PI # 3, PI # 5, and did affect all patients on the current census. Findings include: Review of the Medication Discrepancy Report, dated 8/1/24 to 11/13/24, revealed 39 of 45 patients had missed multiple doses of Mircera, and 33 of 45 patients had missed multiple doses of Venofer. 45 of 45 patients missed ordered doses of medication for the treatment of anemia management. 1. PI # 2 was admitted to the facility on 8/13/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Monthly Comprehensive Provider note, dated 10/15/24 revealed the following dialysis medication order: Venofer 100 mg (milligrams) IV (Intravenous) Push, every dialysis, start date 8/20/24. A review of ten Treatment Sheets (TS), dated 10/19/24 to 11/9/24, revealed the Venofer was “Held” every treatment with a remark of “Not in Stock,” “Not in Supply,” or there was no reason documented why the Venofer was held. An interview was conducted on 11/15/24 at 10:15 AM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed staff failed to administer ordered Venofer to PI # 2 due to the facility having none available. 2. PI # 4 was admitted to the facility on 2/7/24 with a diagnosis of Acute Kidney Injury. Review of the Changed Order Report, dated 11/14/24, revealed an order for Mircera 150 mcg (micrograms), IV, every other week, start date 5/10/24. Review of the TS dated 10/11/24 revealed the Mircera was “Held” with a remark of “Not in Supply.” Review of the Monthly Comprehensive Provider Note, dated 10/14/24, revealed the following documentation by EI # 1, Medical Director: “Hg (Hemoglobin) 6.9, Transfuse 2 (two) units of PRBC’s (Packed Red Blood Cells)/ [check] stools for occult blood.” There was no evidence provided of an occult blood test. An interview was conducted on 11/15/24 at 10:19 AM with EI # 3, who confirmed staff failed to administer ordered Mircera to PI # 4 due to the facility having none available, and failed to check the stool for occult blood. EI # 3 further confirmed PI # 4 received a blood transfusion due to the low hemoglobin. EI # 3 confirmed the physician was not notified each time a dose of medication was missed, and there were no incident forms completed for the missed medication. 3. PI # 7 was admitted to the facility on 3/14/24 with a diagnosis of ESRD. Review of the Orders, printed on 11/14/24, revealed an order for Venofer 100 mg, IV Push, every dialysis, start date 7/16/24. Review of 12 TS, dated 9/3/24 to 9/28/24, revealed the Venofer was “Held” every treatment with a remark of “Not is Supply” or “Not in Stock.” An interview was conducted on 11/15/24 at 10:28 AM with EI # 3, who confirmed staff failed to administer Venofer to PI # 7 due to the facility having none available. 30952 4. PI # 1 was admitted to the facility on 5/31/22 with a diagnosis of ESRD. MR review revealed HD Orders dated 6/23/23 that included Venofer (Iron Sucrose) Dosing Protocol as follows: Iron Dosing Goal: Maintain T-Sat (Transferrin saturation) greater than equal to 30 % and less than equal to 50%; Maintain Ferritin greater than equal to 200 ng (nanogram)/mL and less than 800 ng/mL... HD Iron Maintenance: 1. If the patient’s T-Sat is 30-50 % and the Ferritin is < 800 ng/mL, administer iron...therapy as indicated below...Iron sucrose 100 mg IV Push every two weeks... Review of the Monthly Lab (laboratory) Summary revealed PI # 1’s June TSAT 10 (less than 30 %), and Ferritin 688 (>200, and <800). Review of the TS dated 7/11/24 revealed Venofer 100 mg IV push was “Held” with a remark of “Not in Supply.” Review of the Changed Order Report, dated 11/14/24, revealed an order for Mircera 200 mcg, IV, every other week, start date 4/20/24. Review of the TS dated 7/13/24 revealed the Mircera and Venofer was “Held” with a remark of “Not in Supply.” Review of the TS dated 7/16/24 revealed the Venofer 100 mg IV push was “Held” with a remark of “Not in Supply.” An interview was conducted on 11/15/24 at 9:47 AM with EI # 3, who confirmed staff failed to administer ordered Venofer and Mircera due to the facility having none available. EI # 3 confirmed the physician was not notified each time ordered medications were missed, and occurrence/adverse event reports were not completed when medications were missed/omitted. 5. PI # 8 was admitted to the facility on 1/22/21 with a diagnosis of ESRD. Review of the document, titled, “Orders”, dated 11/14/24 revealed Mircera 150 mcg IV Push every other week 3rd dialysis start 7/27/24, and Venofer 100 mg IV Push every other week 3rd dialysis start date 7/16/24. Review of the TS dated 9/7/24 revealed the Mircera and Venofer was “Held” with a remark of “not in stock.” Review of the TS dated 9/14/24 revealed the Venofer was “Held” with a remark of “not in supply.” An interview was conducted on 11/14/24 at 3:32 PM with EI # 3, who confirmed staff failed to administer ordered Venofer and Mircera due to the facility having none available. 6. PI # 3 was admitted to the facility on 10/7/19 with a diagnosis of ESRD. Review of the Monthly Lab Summary revealed September 2024 TSAT 30, and Ferritin 631, and October 2024 TSAT 46, and Ferritin 720. Review of a document, titled, “Orders”, dated 11/14/24 revealed Mircera 200 mcg IV Push every other week 3rd dialysis start 5/10/24, and Venofer 100 mg IV Push every dialysis start date 11/11/24. Review of the eleven TS’s dated 10/7/24 to 10/30/24 revealed no Venofer was administered. Further review of the 10/11/14 TS revealed the Mircera was “Held” with a remark of “not in stock.” An interview was conducted on 11/15/24 at 9:54 AM with EI # 3 who confirmed the missed Mircera dosage on 10/11/24. The surveyor asked EI # 3 if PI # 3’s September and October monthly labs meet the Venofer/Iron Sucrose Protocol criteria? EI # 3 confirmed PI # 3 would qualify for Venofer. EI # 3 stated, “we didn’t start it cause we didn’t have it.” 7. PI # 5 was admitted to the facility on 8/3/22 with a diagnosis of ESRD. Review of the document titled, Changed Order Report, dated 11/15/24 revealed Mircera 75 mcg every other week, start date 8/23/24. Review of TS’s dated 8/23/24, 9/6/24, 9/20/24, revealed Mircera 75 mcg was “Held”, with a remark of “not in stock.” An interview was conducted on 11/14/24 at 3:07 PM with EI # 3 who confirmed Mircera was not administered as ordered.”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 36271 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Medication Discrepancy Report, Adverse Occurrence Trends for Hemodialysis Year 2024, policies, and interviews with staff it was determined the facility failed to demonstrate an active and effective QAPI program as evidenced by failure to: 1. Conduct QAPI meetings monthly and record minutes as required in the facility policy. 2. Identify patterns of missed/omitted medications, track/trend, analyze the cause, and implement an action plan to ensure patients received all ordered medications. 3. Provide the QAPI Committee accurate data for quality indicators, clinical variance reports and concerns/problems identified by staff. 4. Document medication errors as incidents/events as directed in the facility policy and report to the QAPI Committee. Findings include: Facility Policy: Hemodialysis Quality Assessment and Performance Improvement Program Policy Number: 216 Date: No date Purpose: To provide optimal patient care and continuity of care. Policy: The dialysis facility’s QAPI program...is responsible for monitoring, problem solving, and reporting as specified...A QAPI meeting will be held monthly...The QAPI committee should communicate on a regular basis with the facility staff regarding improvement activities and projects. Responsibilities: The Medical Director, Chief Clinical Officer (CCO)...and Facility Administrator (FA) are responsible for monitoring and evaluating the effectiveness of the QAPI Program...QAPI Committee members include...Medical Director, CCO, FA, Dietitian, Social Worker... QAPI Meeting Requirements: QAPI Program activities...include: Completion and analysis of the QAPI trending tools Evaluate clinical indicators monthly... Develop a plan... Implement the plan. Monitor the effectiveness of the plan... A. Improvement projects will be prioritized by the QAPI Committee, considering the prevalence and severity of identified problems...which have potential to affect patient health and safety...The facility must take immediate, appropriate actions to address any serious threats and ensure patient safety. Incident Review: All Clinical Variance Reports will be reviewed by the QAPI Committee to ensure appropriate interventions... Facility Policy: Incident/Event Reporting Policy Number: RM 2000 Date: No Date Policy: A confidential incident report must be competed for any incident, accident or event that is not within the routine safe operation of the location/clinic...or could have resulted in a deviation from the expected plan of care... Purpose: To improve the management and treatment of the patient To provide a data base for problem analysis, correction, and continuing education... Guidelines: 10...The following incidents must always be reported on a Clinical Variance Report: D. Any...medication reaction or medication errors Review of the facility QAPI program data revealed no evidence the QAPI Committee met monthly and discussed the data. Two sign in sheets were provided which included “Data Reviewed for Month of Mar/Apr/May” and “Jun/Jul/Aug.” These two forms were signed by the Medical Director, CCO, FA, SW, and PD (peritoneal dialysis) Nurse. No meeting date/time or minutes were documented. There was no dietitian signature. Further review of the QAPI program data revealed documentation for July - October 2024 Nutrition Management and Anemia Management not meeting goals - cause included medications not available at the clinic. There was no documentation the QAPI committee took action to ensure required medications were obtained and available for administration as ordered by the physician. Review of the Adverse Occurrence Trends for Hemodialysis Year 2024 revealed Medication: Omission/missed medications data was documented as zero. Vaccination - percentage of patients received vaccination - no data was recorded. Hospitalizations - number of unplanned admissions - data recorded in QAPI indicators did not match the number of hospitalized patients on the hospitalization report provided to the surveyor. Review of the Medication Discrepancy Report dated 8/1/24 to 11/13/24, an 80-page document, revealed forty-eight patients did not receive prescribed medications as ordered during dialysis treatments. The facility failed to ensure QAPI meetings were conducted monthly, quality indicators and outcomes were analyzed, accurate and complete data was provided to the QAPI committee and action plans were developed and implemented to improve patient outcomes. An interview conducted on 11/14/24 at 4:00 PM with Employee Identifier (EI) # 3, FA, who confirmed the QAPI Committee did not meet together to discuss/analyze quality data. The FA further stated the “material is printed out and placed out for review and they sign the sign in sheet quarterly.” An interview with EI # 1, Medical Director, conducted 11/14/24 at 4:45 PM, confirmed he/she did not attend or participate in quality meetings.”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 36271 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Medication Discrepancy Report, policy, and interviews with staff it was determined the facility failed to ensure: a. Quality indicators for nutrition and medication errors/omissions were tracked, trended, and analyzed by the QAPI committee monthly. b. An action plan for improving patient nutritional outcomes was developed and implemented by the QAPI Committee. c. The QAPI Committee responded to recommendations from the dietitian to improve patient nutritional outcomes. Findings include: Facility Policy: Hemodialysis Quality Assessment and Performance Improvement Program Policy Number: 216 Date: No date Purpose: To provide optimal patient care and continuity of care. Policy: The dialysis facility’s QAPI program...is responsible for monitoring, problem solving, and reporting as specified...The QAPI committee should communicate on a regular basis with the facility staff regarding improvement activities and projects. Responsibilities: The Medical Director, Chief Clinical Officer (CCO)...and Facility Administrator (FA) are responsible for monitoring and evaluating the effectiveness of the QAPI Program...QAPI Committee members include...Medical Director, CCO, FA, Dietitian, Social Worker... QAPI Meeting Requirements: QAPI Program activities...include: Completion and analysis of the QAPI trending tools Evaluate clinical indicators monthly... Develop a plan... Implement the plan. Monitor the effectiveness of the plan... A. Improvement projects will be prioritized by the QAPI Committee, considering the prevalence and severity of identified problems...which have potential to affect patient health and safety...The facility must take immediate, appropriate actions to address any serious threats and ensure patient safety. Incident Review: All Clinical Variance Reports will be reviewed by the QAPI Committee to ensure appropriate interventions... Review of the QAPI program data for July-October 2024 and facility reports revealed goals for albumin were not being met. There was no documentation the QAPI committee analyzed the data provided by the dietitian, which included a root cause of inadequate medication supply, and no plan was implemented to obtain the required medications for improved patient outcomes. Review of the Medication Discrepancy Report dated 8/1/24 to 11/13/24, an 80-page document, revealed forty-eight patients did not receive prescribed medications as ordered during dialysis treatments, including nutritional supplements, and intradialytic parental nutrition (IDPN). There was no documentation the QAPI committee was provided data regarding the number of medications ordered by the physician that were missed/omitted. The QAPI indicator report revealed zero medication errors/omissions for 2024. An interview conducted 11/14/24 at 4:00 PM with Employee Identifier # 3, FA, confirmed the QAPI Committee did not meet together to discuss/analyze quality data. The FA further stated the “material is printed out and placed out for review.””

“QAPI-INDICATOR-CKD-MBD CFR(s): 494.110(a)(2)(iii) The program must include, but not be limited to, the following: (iii) Mineral metabolism and renal bone disease. This Standard is not met as evidenced by: 36271 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Medication Discrepancy Report, policy, and interviews with staff it was determined the facility failed to ensure: a. Quality indicators for mineral metabolism/renal bone disease were tracked, trended, and analyzed by the QAPI committee monthly. b. An action plan for improving patient calcium, phosphorus and PTH (parathyroid hormone) outcomes was developed and implemented by the QAPI Committee. c. The QAPI Committee responded to recommendations from the dietitian to improve patient outcomes. d. The QAPI Committee was provided accurate data for medication errors/omissions. Findings include: Facility Policy: Hemodialysis Quality Assessment and Performance Improvement Program Policy Number: 216 Date: No date Purpose: To provide optimal patient care and continuity of care. Policy: The dialysis facility’s QAPI program...is responsible for monitoring, problem solving, and reporting as specified...The QAPI committee should communicate on a regular basis with the facility staff regarding improvement activities and projects. Responsibilities: The Medical Director, Chief Clinical Officer (CCO)...and Facility Administrator (FA) are responsible for monitoring and evaluating the effectiveness of the QAPI Program...QAPI Committee members include...Medical Director, CCO, FA, Dietitian, Social Worker... QAPI Meeting Requirements: QAPI Program activities...include: Completion and analysis of the QAPI trending tools Evaluate clinical indicators monthly... Develop a plan... Implement the plan. Monitor the effectiveness of the plan... Review of the QAPI program data for August - October 2024 and facility reports revealed goals for bone mineral management were not being met. There was no documentation the QAPI committee analyzed the data provided by the dietitian, which included a root cause of inadequate medication supply-patients not receiving ordered Hectorol and Cinacalcet, and no plan was implemented to obtain the required medications for improved patient outcomes. Review of the Medication Discrepancy Report dated 8/1/24 to 11/13/24, an 80-page document, revealed forty-eight patients did not receive prescribed medications as ordered during dialysis treatments, including Hectorol and Cinacalcet. There was no documentation the QAPI committee was provided data regarding the number of medications ordered by the physician that were missed/omitted. The QAPI indicator report revealed zero medication errors/omissions for 2024. An interview conducted 11/14/24 at 4:00 PM with Employee Identifier # 3, FA, confirmed the QAPI Committee did not meet together to discuss/analyze quality data. The FA further stated the “material is printed out and placed out for review.””

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 36271 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Medication Discrepancy Report, policy, and interviews with staff it was determined the facility failed to ensure: a. Quality indicators for anemia management were tracked, trended, and reviewed by the QAPI committee monthly. b. An action plan for improving patient outcomes was developed and implemented by the QAPI Committee. c. The QAPI Committee responded to recommendations from the dietitian to improve patient nutritional outcomes. d. The QAPI Committee was provided accurate data for medication errors/omissions. Findings include: Facility Policy: Hemodialysis Quality Assessment and Performance Improvement Program Policy Number: 216 Date: No date Purpose: To provide optimal patient care and continuity of care. Policy: The dialysis facility’s QAPI program...is responsible for monitoring, problem solving, and reporting as specified...The QAPI committee should communicate on a regular basis with the facility staff regarding improvement activities and projects. Responsibilities: The Medical Director, Chief Clinical Officer (CCO)...and Facility Administrator (FA) are responsible for monitoring and evaluating the effectiveness of the QAPI Program...QAPI Committee members include...Medical Director, CCO, FA, Dietitian, Social Worker... QAPI Meeting Requirements: QAPI Program activities...include: Completion and analysis of the QAPI trending tools Evaluate clinical indicators monthly... Develop a plan... Implement the plan. Monitor the effectiveness of the plan... A. Improvement projects will be prioritized by the QAPI Committee, considering the prevalence and severity of identified problems...which have potential to affect patient health and safety...The facility must take immediate, appropriate actions to address any serious threats and ensure patient safety. Incident Review: All Clinical Variance Reports will be reviewed by the QAPI Committee to ensure appropriate interventions... Review of the QAPI program data for August-September 2024 and facility lab reports revealed goals for anemia management were not being met. There was no documentation the QAPI committee was provided data regarding the lack of medications to manage anemia and no plan was implemented to obtain the required medications for improved patient outcomes. Review of the Medication Discrepancy Report dated 8/1/24 to 11/13/24, an 80-page document, revealed forty-eight patients did not receive prescribed medications as ordered during dialysis treatments, including Mircera and Venofer. There was no documentation the QAPI committee was provided data regarding the number of medications ordered by the physician that were missed/omitted. The QAPI indicator report revealed zero medication errors/omissions for 2024. An interview conducted 11/14/24 at 4:00 PM with Employee Identifier # 3, FA, confirmed the QAPI Committee did not meet together to discuss/analyze quality data. The FA further stated the “material is printed out and placed out for review.””

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 36271 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Adverse Occurrence (AO) Trends for Hemodialysis Year 2024, Medication Discrepancy Report, policies, and interviews with staff it was determined the facility failed to ensure: a. Medication errors/omissions were documented as adverse events, tracked, trended, and analyzed by the QAPI committee monthly. b. An action plan for minimizing the number of medication errors was developed and implemented by the QAPI Committee. c. The QAPI Committee tracked potential negative patient outcomes resulting from medication errors/omissions such as blood transfusions and hospitalizations. Findings include: Facility Policy: Hemodialysis Quality Assessment and Performance Improvement Program Policy Number: 216 Date: No date Purpose: To provide optimal patient care and continuity of care. Policy: The dialysis facility’s QAPI program...is responsible for monitoring, problem solving, and reporting as specified...The QAPI committee should communicate on a regular basis with the facility staff regarding improvement activities and projects. Responsibilities: The Medical Director, Chief Clinical Officer (CCO)...and Facility Administrator (FA) are responsible for monitoring and evaluating the effectiveness of the QAPI Program...QAPI Committee members include...Medical Director, CCO, FA, Dietitian, Social Worker... QAPI Meeting Requirements: QAPI Program activities...include: Completion and analysis of the QAPI trending tools Evaluate clinical indicators monthly... Develop a plan... Implement the plan. Monitor the effectiveness of the plan... A. Improvement projects will be prioritized by the QAPI Committee, considering the prevalence and severity of identified problems...which have potential to affect patient health and safety...The facility must take immediate, appropriate actions to address any serious threats and ensure patient safety. Incident Review: All Clinical Variance Reports will be reviewed by the QAPI Committee to ensure appropriate interventions... Facility Policy: Incident/Event Reporting Policy Number: RM 2000 Date: No Date Policy: A confidential incident report must be competed for any incident, accident or event that is not within the routine safe operation of the location/clinic...or could have resulted in a deviation from the expected plan of care... Purpose: To improve the management and treatment of the patient To provide a data base for problem analysis, correction, and continuing education... Guidelines: 8. The Facility Administrator (FA) will, on a regular basis, review all incidents with the facility Medical Director and report aggregate Clinical Variance Report information to the Safety and/or Quality Assurance Committees. 10...The following incidents must always be reported on a Clinical Variance Report: D. Any...medication reaction or medication errors Review of the QAPI program data for August-September 2024 and facility Adverse Occurrence Trends for Hemodialysis 2024 report revealed Medication Errors Omissions/missed medications as zero. Review of the facility AO Trends for Hemodialysis Year 2024 documentation revealed a total of two events, one patient transfer to an emergency room, and one vascular access needle dislodgement. There were zero omission/missed medications for calendar year 2024 documented on the facility AO Trends. Review of the Medication Discrepancy Report dated 8/1/24 to 11/13/24, an 80-page document, revealed forty-eight patients did not receive prescribed medications as ordered during dialysis treatments. There was no documentation the QAPI committee was provided data regarding the number of medications ordered by the physician that were missed/omitted. An interview conducted 11/14/24 at 4:00 PM with Employee Identifier # 3, FA, confirmed the QAPI Committee did not meet together to discuss/analyze quality data. The FA further stated the “material is printed out and placed out for review.””

“MD RESP-MED DIR QUAL/ACCOUNTABLE TO GOV BODY CFR(s): 494.150 The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients. This Standard is not met as evidenced by: 39098 Based on review of medical records (MR), Medical Staff By-Laws, Medical Director Duties and Responsibilities, and interviews, it was determined the Medical Director failed to ensure: 1. Patients were informed of all aspects of his or her care which included failure to receive medications ordered by the Medical Director and included in the patient Plan of Care. 2. Patient Comprehensive Assessments were completed and Plans of Care were developed for all patients through collaboration of the Interdisciplinary Team (IDT). 3. Medications required for patient care were available at the facility, including Venofer, Mircera, Hectorol, Calcitriol, Cinacalcet, Oral Nutritional Supplements (ONS), and Intradialytic Parenteral Nutrition (IDPN), and were administered per physician orders. 4. An active and effective QAPI program was conducted at the facility, with meetings and discussion of all aspects of patient care, including tracking and trending of patient outcomes, and facility adverse occurrences. This affected all patients being dialyzed at this facility. Findings include: Facility Publication: Medical Staff By-Laws Date: None Listed ...Purpose The purpose of the Medical Staff shall be: 1. To insure that all patients admitted to the Facility shall receive the best possible care. ...Section 1 - Medical Directors ...The Medical Director shall serve as the official channel of communication between the Medical Staff and the Governing Body... ...the Medical Director shall be responsible for... 1. Insuring the proper coordination and functioning of all services. 2. Developing adequate facilities and supervising the operation and maintenance of the equipment and acquisition of supplies for the unit. ...4. Insuring adequate supervision of the dialysis operation. 5. Maintaining all records relating to the care and treatment of the unit patients in accordance with the regulations issued by the appropriate public health agency... Facility Publication: Medical Director Duites (Duties) and Responsibilities Date: None listed The Medical Director is directly responsible for the creation and preservation of high quality professional care of patients at a facility. ...the Medical Director shall be responsible for the delivery of patient care and outcomes in the Facility and is accountable to the Governing Body for the quality of medical care provided to patients at the Facility... I. General Medical Director Duties (Conditions for Coverage Related Issues) Patient care and delivery of high-quality, safe and effective dialysis. Facility’s quality assessment and performance improvement program (QAPI program). Interdisciplinary team participation in comprehensive patient assessments and reassessments, patient plans of care, and the QAPI program... The Medical Director is expected to get involved if the interdisciplinary team members fail to appropriately participate, complete documentation, respond to QAPI activities, etc. ...4. Ensure, with the assistance of Facility management, that appropriate qualified Facility staff is participating on each patient’s interdisciplinary team. ...Ensure that all patients have a current, properly signed, patient comprehensive assessment and patient plan of care for stable and unstable patients... 5. Have operational responsibility for the QAPI program. An interview was conducted on 11/14/24 at 4:00 PM with Employee Identifier (EI) # 1, Medical Director. EI # 1 confirmed he/she did not inform the patients that medications ordered during dialysis treatments as part of the Plan of Care were not available for administration at the facility. EI # 1 reported the patients were told a medication, Auryxia, was being added to their home medications as it is a phosphate binder with iron. EI # 1 confirmed no interdisciplinary team meetings were held for discussion, review, and approval of the patient’s Plan of Care. EI # 1 reported documents are reviewed and signed, but with no team collaboration. EI # 1 reported for the past three to four months, he/she was aware the clinic did not consistently have medications ordered in the patient plan of care for the treatment of anemia, mineral metabolism, and nutritional management. EI # 1 reported he/she made two calls to Corporate, but medications are still not available on a consistent basis. EI # 1 confirmed no monthly quality assurance meetings were held to evaluate facility quality data for performance improvement activities.”

“MD RESP-QAPI PROGRAM CFR(s): 494.150(a) Medical director responsibilities include, but are not limited to, the following: (a) Quality assessment and performance improvement program. This Standard is not met as evidenced by: 39098 Based on review of Medical Staff By-Laws, Medical Director Duties and Responsibilities, and interviews, it was determined the Medical Director failed to ensure an active and effective QAPI program was conducted at the facility, with meetings and discussion of all aspects of patient care, including tracking and trending of patient outcomes. This affected all patients being dialyzed at this facility. Findings include: Facility Publication: Medical Staff By-Laws Date: None Listed ...Purpose The purpose of the Medical Staff shall be: 1. To insure that all patients admitted to the Facility shall receive the best possible care. ...Section 1 - Medical Directors ...The Medical Director shall serve as the official channel of communication between the Medical Staff and the Governing Body... ...the Medical Director shall be responsible for... 1. Insuring the proper coordination and functioning of all services... Facility Publication: Medical Director Duties (Duties) and Responsibilities Date: None listed The Medical Director is directly responsible for the creation and preservation of high quality professional care of patients at a facility. ...the Medical Director shall be responsible for the delivery of patient care and outcomes in the Facility and is accountable to the Governing Body for the quality of medical care provided to patients at the Facility... I. General Medical Director Duties (Conditions for Coverage Related Issues) Patient care and delivery of high-quality, safe and effective dialysis. Facility’s quality assessment and performance improvement program (QAPI program). Interdisciplinary team participation in comprehensive patient assessments and reassessments, patient plans of care, and the QAPI program... The Medical Director is expected to get involved if the interdisciplinary team members fail to appropriately participate, complete documentation, respond to QAPI activities, etc. ...5. Have operational responsibility for the QAPI Program. The Medical Director shall provide leadership of the Facility’s QAPI Program by serving as the chair of the QAPI Committee... The Medical Director shall: Prepare for, attend and, as Chair, lead the monthly QAPI Committee meetings. An interview was conducted on 11/14/24 at 4:00 PM with Employee Identifier (EI) # 3, Facility Administrator. The surveyor asked EI # 3 to explain the facility QAPI process for data collection, tracking/trending, and the QA (Quality Assurance)Committee’s process for data analysis/evaluation. EI # 3 reported he/she compiles the clinic data, puts it in the QA format, and emails the QA report to the Registered Dietician, Social Worker, and Medical Director. EI # 3 reported there is no monthly QAPI meeting and no discussion and evaluation of the facility data by the QA team. An interview was conducted on 11/14/24 at 4:45 PM with EI # 1, Medical Director, who confirmed the facility did not conduct monthly QAPI meetings and review facility quality data.”

“GOV-ADM RESP FOR FISCAL OPERATIONS CFR(s): 494.180(a)(2) 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- (2) Fiscal operations; This Standard is not met as evidenced by: 30952 Based on review of the facility Patient’s Rights, Medication Discrepancy Report, medical records (MR), Governing Body (GB) Meeting minutes, Quality Assessment and Performance Improvement (QAPI) program data, and interviews, it was determined the GB failed to ensure Patient’s Rights were adhered to, care was provided in accordance with facility policies, the QAPI Committee was active and effective, the Medical Director (MD) complied with the bylaws and MD duties and responsibilities, and the facility operated in a sound fiscal manner and maintained a sufficient amount of medications required for patient care delivery. This affected all in-center hemodialysis patients and Peritoneal Dialysis home support and training patients. Findings include: Review of the Medication Discrepancy Report dated 8/1/24 to 11/13/24, an 80-page document, revealed forty-eight patients did not receive prescribed medications as ordered during dialysis treatments. Review of incenter hemodialysis MR’s revealed seven of eight patients had medications prescribed, not administered, and documented as “Held,” “Not in supply,” or “Not in stock.” Interviews with ten patients and facility staff revealed the patients were not informed of the lack of medications and missed doses of ordered medications therefore were not given the opportunity to exercise their patient rights to participate in their care. Review of the facility QAPI program data and interviews revealed the lack of an organized, active and effective QAPI program and lack of action by the QAPI Committee to improve patient outcomes. Review of the Governing Body documentation revealed Employee Identifier (EI) # 1, Medical Director, EI # 2, Chief Clinical Officer, and EI # 3, Facility Administrator, were identified as facility GB members. Review of the GB Meeting Minutes dated 9/24/24 revealed EI # 1 and EI # 3 were in attendance. The Governing Body Meeting Minutes were as documented: “Reason (s) for the meeting: Sapphire has not received Mircera or Venofer consistently. This has been reported to corporate funding has been a issue. Will continue to monitor and address.” The GB failed to take action and ensure medications were obtained and administered as ordered. An interview was conducted on 11/15/24 at 12:45 PM with EI # 2. The surveyor asked EI # 2 if there had been discussion among the GB regarding transfer of patients to other facilities that could meet patient needs? EI # 2 response, “Yes, but then we started getting the meds (medications) in.” A phone interview was conducted on 11/15/24 at 1:32 PM with the owner of Sapphire Community Dialysis, EI # 8. EI # 8 reported he/she had been aware for one month the clinic did not have medications needed for patient care. EI # 8 reported, “It has been a challenge.” EI # 8 confirmed the facility experienced payment delays during 2023 and 2024 that impacted their ability to obtain all prescribed medications. EI # 8 reported the company was working with banks and new vendors to ensure patient medications were available. EI # 8 reported “the Medical Director has not called me specifically about medications.””

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 41623 Based on observations, review of medical records, the facility Plan of Correction (POC) approved by the State Agency on 12/7/23 and interviews, it was determined the facility failed to follow their own POC to achieve compliance with the deficiencies cited on the survey dated 11/9/23. This deficient practice has resulted in continued noncompliance and has the potential to negatively affect all patients served at this facility. Findings include: The POC approved by the State Agency on 12/7/23 included the following corrective actions: 1. 494.40 CFC (Condition for Coverage) - Water and Dialysate Quality V 250 and V 260 Clinical, Nursing and Technical Staff were in-serviced on 11/13/23 and 11/17/23 which included in part, proper use of the Phoenix meter and rinsing the Phoenix meter cell after use, in between patients. The Facility Administrator, Charge Nurse, or designee would perform visual verification audits that conductivity and pH (percent of hydrogen) testing was completed per the policy prior to each patient treatment every shift for four weeks and monthly for four months. Review of the audit documentation form labeled, “Phoenix Meter Machine Conductivity Checked” revealed the following information to be documented: a. Date of audit. b. Shift. c. Time of audit. d. Initial of staff completing audit. e. Conductivity checked on each machine before a pt (patient) is placed on tx (treatment). f. If bath is changed conductivity is checked after bath is changed. g. Initial of pt. h. Comments. Further review of the form revealed dates of audits from 12/4/23 to 12/19/23. For all dates listed, there were no patient initials listed. There was no documentation every patient, every shift was audited, as stated in the Plan of Correction. To assure all employees have mandatory training 100 % of employees will be audited beginning 12/4/23. There was no documentation provided this corrective action was implemented. Review of the audit documentation form labeled, “pH Cond (Conductivity) Checked before Tx (Treatment) revealed the following information to be documented: a. Date of audit. b. Initial of staff completing audit. c. Initials of patient audited. Further review of the form revealed dates of audits from 12/4/23 to 12/18/23. For all dates listed, there were no patient initials listed. The space for patient initials listed the word, “all.” There was no documentation of which employee performed the pH and conductivity test. Further review of the facility POC audits from 12/4/23 to 12/18/23 revealed no documentation of the results of the monitoring, including if the pH and conductivity was done correctly each time, to include rinsing the cell between conductivity checks, and no documentation of the percent of compliance. In an interview conducted on 12/20/23 at 12:30 PM, EI (Employee Identifier) # 1, Facility Administrator, was asked if the pH and conductivity audits were conducted each day for each patient and 100% of staff. EI # 1 responded “Yes, it was documented as all”. 2. 494.90 - CFC Plan of Care V 544 Education was provided to Clinical and Nursing staff on 11/13/23 which included P/P (Policy and Procedure) 6008 Medication Administration, P/P 5008 Flow Sheet Documentation, and included “all medication must be given per MD (medical doctor) order and documented on the flow sheet at the time given.” Review of the facility Plan of Correction documentation dated 12/7/23 for tag V544 revealed the Facility Administrator or designee would perform an audit on 100 percent of patients daily for four weeks beginning 12/4/23 to ensure Heparin administration was documented. The compliance threshold was documented as 90 percent. Review of the audit documentation form labeled, “Heparin, BFR (Blood Flow Rate), DFR (Dialysate Flow Rate),” revealed the following information to be documented: a. Date of audit. b. Initial of staff completing audit. c. Initials of patient audited. Further review of the audit form revealed dates from 12/4/23 to 12/18/23. There were no patient initials, which employee was audited, or if the Heparin was administered and documented as ordered by the physician. In an interview conducted on 12/20/23 at 12:30 PM, EI # 1 was asked if the pH and conductivity audits were conducted each day for each patient and 100% of staff. EI # 1 responded, “Yes, it was documented as all.” 3. POC - Vascular Access - Monitor/Referrals V 550 Mandatory Education Day on 11/13/23 for Clinical and Nursing staff which included P/P 4200A Placement and Removal of Access Needles and re-education on approved cleaning...clean with alcohol and disinfect with Iodine in this order. Reviewed Aseptic techniques to disinfect access site prior to cannulation. Review of the facility POC documentation for tag V550 revealed the Facility Administrator or designee would audit 100 percent of patients daily for four weeks to assure access site care of AVF/AVG sites per policy 4200A. Audits to begin 12/4/23. Review of the facility monitoring and audit documentation provided to the surveyor on 12/19/23 revealed no documentation of audits for tag V550. There was no documentation the corrective action for this deficiency was implemented. In an interview conducted on 12/20/23 at 12:30 PM, EI # 1 confirmed no audits or monitoring had been performed or documented for tag V550, Vascular Access-Monitor/Referrals.”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 41623 Based on review of review of the facility Emergency Preparedness (EP) Plan dated 1/10/23 and staff interviews, it was determined the facility failed to ensure the EP plan included emerging infectious disease outbreaks. Findings include: Review of the EP Plan dated 1/10/23 revealed no plan for emerging infections disease outbreaks. An interview was conducted on 11/9/23 at 2:55 PM with Employee Identifier (EI) # 2, Facility Administrator and EI # 1, Chief Clinical Officer, who confirmed the facility did not currently have a plan for emerging infections.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 41623 Based on observations and interviews, it was determined the facility failed to ensure the bleach containers were labeled with the concentration of bleach. This deficient practice could result in inadequate disinfection of surfaces and had the potential to affect all 46 incenter hemodialysis patients treated at this facility. Findings include: 1. A tour of the treatment area was conducted on 11/7/23 at 9:15 AM. The surveyor observed three bleach containers on a cart. The middle container was labeled Bleach 1:100 concentration. There was no label indicating the concentration on the other two containers. An interview was conducted on 11/7/23 at 9:30 AM with Employee Identifier (EI) # 10, CCHT (Certified Clinical Hemodialysis Technician), who stated the first container was bleach 1:10 solution, the second was 1:100, and the third container was 1:100 solution. EI # 10 confirmed the first and third containers had not been labeled. An interview was conducted on 11/9/23 at 11:06 AM with EI # 1, Chief Clinical Officer, who confirmed the staff failed to label the bleach containers to indicate the concentration of each.”

“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: 41623 Based on observations, CDC (Centers for Disease Control and Prevention) Guidance, and interviews it was determined the facility failed to ensure the staff performed hand hygiene after removing gloves. This affected one of two observations of AVF (Arterio Venous Fistula) or Graft initiations including Patient Identifier (PI) # 19 and had the potential to affect all 46 incenter hemodialysis patients treated at this facility. Findings include: CDC Hand Hygiene Guidance Revised 1/30/20 ...Healthcare personnel should use an alcohol-based hand rub or wash with soap and water for the following clinical indications: ...Immediately after glove removal... 1. An observation of care was conducted on 11/8/23 at 10:05 AM to observe the initiation of dialysis by Employee Identifier (EI) # 5, CCHT (Certified Clinical Hemodialysis Technician). EI # 5 prepped the site with iodine and alcohol removed gloves, donned new gloves, then placed a gauze pad over the site. EI # 5 failed to perform hand hygiene after removing gloves. EI # 5 then auscultated the site with a stethoscope, removed gloves, donned new gloves, then inserted the arterial needle. EI # 5 failed to perform hand hygiene after removing gloves. An interview was conducted on 11/9/23 at 11:05 AM with EI # 1, Chief Clinical Officer, who confirmed the staff failed to perform hand hygiene after removing gloves.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 30952 Based on review of the facility CVC (central venous catheter) Initial and Annual Skills Validation Checklist for dressing change, initiation/termination of treatment, the facility CVC procedure for initiation/discontinuation of treatment, observations, and interview, it was determined the facility failed to ensure staff wore PPE (personal protective equipment) correctly during CVC exit site care and treatment initiation. This affected PI (Patient Identifier) # 6, one of three CVC care observations, and had the potential to negatively affect all patients who dialyze at the facility. Findings include: Facility CVC Initial and Annual Skills Validation Checklist Purpose...may be used as a reference...Refer to...policies and procedures... A. Dressing Change ...Performed PRIOR to treatment initiation ... 1. Wears appropriate PPE... Facility Hemodialysis: Procedure 4500A Title: CVC: Initiation and Discontinuation of Treatment Procedure 2. Wash hands and put on PPE. Mask self, patient, and anyone else close to the CVC Rationale Universal precautions and infection control measures are used to decrease the risk of patient infection. ... 1. Observations of care were conducted on 11/7/23 at 10:40 AM at station four with EI (Employee Identifier) # 1, CCO (Chief Clinical Officer) during CVC exit site care, and initiation of dialysis with a CVC for PI # 6. At 10:50 AM the surveyor observed EI # 1 wear his/her mask beneath his/her nose during CVC exit site care. After heparin administration, EI # 1 exited and returned to the station wearing his/her mask beneath his/her nose and mouth, then connected PI # 6’s CVC to the dialysis lines and initiated treatment. Staff failed to wear the mask above the nose and covering his/her mouth during CVC exit site and treatment initiation. An interview was conducted on 11/9/23 at 11:01 AM with EI # 1 who confirmed he/she failed to wear PPE correctly during CVC care and treatment initiation.”

“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: 30952 Based on observation, facility policy and procedure, End Stage Renal Disease (ESRD) CORE Survey Hemodialysis Care and Infection Control Practices, and interview, it was determined the staff failed to ensure all surfaces at the dialysis station was disinfected between patients. This affected one of three observations for dialysis station cleaning and disinfection had the potential to negatively affect all 46 in-center hemodialysis patients who dialyze at the facility. Findings include: Facility Hemodialysis Procedure 700B Subject: Cleaning Individual Patient Televisions and Direct Touch Systems Date: none documented ...Policy: ...The television shall be cleaned after each patient treatment... ESRD CORE Survey Infection Control Practices, Version 1.6 Cleaning and Disinfection of the Dialysis Station # (number) 6 Notes: All items in this checklist must be disinfected using... hospital disinfectant prepared....in accordance with manufacturer’s instructions... ...Action ...Wipe wet all internal...external surfaces of prime waste container...allow to dry if present; prime waste container must be disinfected before used to prepare for another patient’s treatment... 1. An observation of cleaning and disinfection of dialysis station four was conducted on 11/7/23 at 9:05 AM with EI (Employee Identifier) # 7, Certified Clinical Hemodialysis Technician. EI # 7 disinfected the dialysis machine but failed to disinfect the internal and external surfaces of the prime waste receptacle. EI # 7 failed to disinfect the television and television arm. An interview was conducted on 11/9/23 at 11:01 AM with EI # 2, Facility Administrator who confirmed the prime waste receptacle and television should be disinfected before the next patient is taken to the dialysis station.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 30952 Based on the CDC (Centers for Disease Control) Safe Practices for Medical Injections for Providers, facility policy, observation, and interviews, it was determined the facility failed to ensure staff followed aseptic technique during medication preparation in one of two observations. The failure to perform appropriate medication preparation had the potential for cross contamination and could affect all 46 in-center patients. Findings include: CDC Frequently Asked Questions (FAQ’s) regarding Safe Practices for Medical Injections “Medication Preparation Questions 1. How should I draw up medications? Parenteral medications should be accessed in an aseptic manner...includes...the rubber septum (vial) should be disinfected with alcohol prior to piercing it.” .... Page last reviewed: June 20, 2019 Facility Hemodialysis: Policy 6006 Parental Medication Preparation and Storage PURPOSE: To ensure safe preparation of parental medications from vials... POLICY: 1. Aseptic techniques is used to prepare all parenteral medications. ... 1. An observation was conducted on 11/7/23 at 12:13 PM with EI (Employee Identifier) # 9, Registered Nurse (RN) during medication preparation at the medication preparation area. EI # 9 opened a new vial of Venofer (medication used to treat “iron-poor” blood in people with long-term kidney disease) and failed to disinfect the vial’s rubber septum (stopper) as required before withdrawing the medication. During an interview on 11/7/23 at 12: 20 PM EI # 9 acknowledged he/she failed to disinfect the medication vial septum prior to withdrawing the medication. An interview was conducted on 11/9/23 at 8:20 AM with EI # 1, Chief Clinical Officer, who confirmed the medication vial septum must always be disinfected prior to withdrawing the medication to prevent cross contamination of the medication vial.”

“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: 30952 Based on observations, End Stage Renal Disease (ESRD) CORE Survey Hemodialysis Care and Infection Control Practices, review of the facility Initial and Annual Skills Validation Checklist for CVC (central venous catheter) dressing change, initiation/discontinuation of treatment, medical records (MR), and interviews, it was determined the facility failed to ensure staff wore the mask above the nose/mouth, performed, and documented CVC exit site care, treatment initiation and termination per the facility CVC skills validation requirements. This affected two of three CVC care observations and one of three MRs reviewed with CVCs, and included Patient Identifier (PI) # 6, PI # 7, PI # 4, and had the potential to negatively affect all patients dialyzing with CVC’s. Findings include: ESRD CORE Survey Hemodialysis Care and Infection Control Practices, Version 1.6 Initiation of Dialysis with Central Venous Catheter ...Notes: ...Staff PPE (personnel protective equipment) must be gown, mask, eye protection... All antiseptics and disinfectants must be used per manufacturer’s instructions... Central Venous Catheter Exit Site Care Notes: ...Staff PPE must be gown, mask, eye protection... All antiseptics and disinfectants must be used per manufacturer’s instructions... Facility CVC Initial and Annual Skills Validation Checklist: (includes dressing change, initiation of treatment, and treatment termination) Date, none documented. A. Dressing change...Performed PRIOR to treatment initiation... ...8. Use 2 % CHG (Chlorhexidine Gluconate) with 70% alcohol...to disinfect exit site...Use gentle back and forth friction. Clean the exit site...for a minimum of 30 seconds for CHG... 12. Documents and reports unusual findings. B Initiation of Treatment... 4. Using a new alcohol pad, scrub the thread of the TEGO [a Needle free Hemodialysis Connector]/luerlock (hub) vigorously using back and forth friction for 60 seconds... 5. Connects...syringe to arterial limb. 6. Using a new alcohol pad, scrub threads of the TEGO/luerlock (hub) vigorously, using back and forth friction for 60 seconds... 7. Connects...syringe to the venous limb... C. Termination of Treatment... 8. Using a new alcohol pad, scrubs arterial TEGO/luerlock threads for 60 seconds... 9. Using a new alcohol pad, scrubs venous TEGO/luerlock threads for 60 seconds... 16...Documents and reports unusual findings... 1. An observation of care for CVC exit site care and treatment initiation was conducted on 11/7/23 at 10:40 AM at station four for PI # 6. EI (Employee Identifier) # 1, the Chief Clinical Officer, cleansed around the CVC exit site with a chloraprep swab stick for 15 seconds, and not a minimum of 30 seconds per the facility skills validation checklist. Prior to treatment initiation, EI # 1 used two alcohol pads, wiped the two catheter hubs/threads for two wipes around each hub. EI # 1 failed to scrub the hubs vigorously, using back and forth friction for 60 seconds per the skills validation checklist. During the observation, EI # 1 failed to wear the mask over the nose and mouth during CVC exit site care and treatment initiation. An interview was conducted on 11/9/23 at 11:01 AM with EI # 1 who confirmed staff failed to follow facility CVC care guidelines during CVC exit site care and treatment initiation. 2. An observation was conducted 11/7/23 at 12:37 PM at station five for PI # 7 for treatment termination using a CVC. EI # 9, Registered Nurse, used alcohol pads and wiped the arterial threads four wipes and the venous threads three wipes. EI # 9 failed to scrub the catheter threads vigorously,using back and forth friction for 60 seconds per facility skills validation checklist. An interview was conducted on 11/9/23 at 11:01 AM with EI # 1 who confirmed the staff failed to provide care per policy and procedure during treatment termination with a CVC. 3. PI # 4 was admitted to the facility on 10/7/19 with diagnoses including End Stage Renal Disease. Review of the MR Hemodialysis orders dated 6/22/23 revealed PI # 4’s type access was CVC, with a CVC Protocol dated 6/22/23 and orders to perform catheter care each treatment and instill heparin to each port after hemodialysis (HD). Review of the Progress Note dated 10/11/23 by the nephrologist revealed the presence of a right internal jugular (RIJ) catheter and a left upper arm graft. Review of the Treatment Reports dated 11/3/23 and 11/6/23 revealed no documentation of the presence of a CVC, and no CVC site condition was documented. There was no documentation staff performed CVC exit site care, and no end of treatment heparin administration. There was no MR documentation the CVC was removed. An interview was conducted 11/9/23 at 10:10 AM with EI # 2, Facility Administrator, who confirmed PI # 4 had a CVC and staff failed to document CVC care was performed per the facility CVC protocol.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 30952 Based on observations, facility policy and procedure, and interview, it was determined the facility failed to ensure staff tested the dialysate pH (potential of hydrogen) and conductivity per the facility pHoenix meter testing policy and procedure. This affected Patient Identifier (PI) # 6, in one of four observations for preparation of the hemodialysis (HD) machine and had the potential to negatively affect all 46 in-center hemodialysis patients who dialyze at this facility. Findings Include: Facility Policy 950B Subject: Phoenix Meter Testing Procedure Date: none documented. ...Purpose: Verification of proper Dialysis Machine Conductivity, temperature and PH (potential of hydrogen) prior to initiation of dialysis. ...Qualifications: All Teammates must complete in-service of pHoenix Meter... Procedure: 12. Allow dialysis machine to come up to conductivity. 13. After verification of phoenix meter (see...calibration procedure). 19...measurement is taken... 1. An observation was conducted on 11/7/23 at 10:10 AM with Employee Identifier (EI) # 7, CCHT (Certified Clinical Hemodialysis Technician), to observe the preparation of a Hemodialysis (HD) machine for PI # 6. The surveyor observed EI # 7 test the dialysate pH and conductivity of the 2K (Potassium)/2.5Ca (calcium) bath at station 4. On 11/7/23 at 11:00 AM EI # 1, Chief Clinical Officer initiated dialysis treatment with EI # 7’s assistance. At 11:07 AM EI # 7 exited the treatment floor, returned with a jug bath, a 3K/2.5Ca, and connected the new bath to the dialysis machine at the station. The staff failed to test the dialysate pH and conductivity of the 3K/2.5Ca bath prior to treatment initiation. An interview was conducted on 11/8/23 at 8:25 AM with EI # 1 who confirmed the staff failed to test the dialysate pH and conductivity after the bath change. 41623”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 30952 Based on review of staff training program documentation, facility policy and procedure, and interview, it was determined the facility failed to ensure staff had documented competencies: 1. For use of a pHoenix Meter to test the dialysate pH (potential of hydrogen) and conductivity prior to treatment initiation. 2. For mixing and preparation of Acid (Granulfo) and mixing and preparation of Bicarbonate used during patient dialysis treatments. This affected four of four in-center direct care staff training records and had the potential to negatively affect all 46 in-center hemodialys patients who dialyze at this facility. Findings Include: Facility Policy 950B Subject: Phoenix Meter Testing Procedure Date: none documented. ...Purpose: Verification of proper Dialysis Machine Conductivity, temperature, and PH (potential of hydrogen) prior to initiation of dialysis. ...Qualifications: All Teammates must complete in-service of pHoenix Meter... Procedure: 12. Allow dialysis machine to come up to conductivity. 13. After verification of phoenix meter (see...calibration procedure). 19...measurement is taken... 27. Rinse the Cell, syringe interior, and sampling cup/tube thoroughly with RO water after each use. Technical Training Program Section 200-Technical Training Program Date: September 2011 A. Policy The Technical Training program was developed to provide an understanding of the basic operation of the dialysis and water treatment equipment; to train designated direct patient care staff to perform certain quality control monitoring procedures... All technicians must complete the program...after assuming their position... C. Objectives 2. To have designated staff demonstrate the ability to perform specific quality control procedures... 3...knowledge should be accomplished by way of demonstration and hand-on experience under direct supervision. 1. An interview was conducted on 11/7/23 at 1:05 PM with Employee Identifier) # 7, Certified Clinical Hemodialysis Technician who reported duties include dialysate pH and conductivity testing, mixing/preparation of acid and bicarbonate used during patient hemodialysis treatments. A review of EI # 7’s personnel file conducted on 11/9/23 revealed a hire date of 5/15/23. The personnel file documentation failed to include demonstrated competency of the pHoenix meter in use on the treatment floor, acid (Granuflo) mixing skills, and mixing bicarbonate skills. An interview was conducted on 11/9/23 at 11:14 AM with EI # 3, Technical Manager, who confirmed there was no documentation that EI # 7 had demonstrated competency with the pHoenix meter, acid, and bicarbonate mixing. 2. A review of EI # 9, Registered Nurse, personnel file conducted on 11/9/23 revealed a hire date of 5/30/23. The personnel file failed to include documented competency for use of the pHoenix meter. An interview was conducted on 11/9/23 at 11:14 AM with EI # 3 who confirmed there was no documentation EI # 9 had demonstrated competency with the pHoenix meter. 41623 3. A review of EI # 5’s, CCHT, personnel file conducted on 11/9/23 revealed a hire date of 2/16/22. There was no documentation of competency for use of the pHoenix meter. An interview was conducted on 11/9/23 at 11:14 AM with EI # 3 who confirmed there was no documentation EI # 5 had demonstrated competency with the pHoenix meter. 4. A review of EI # 6’s, CCHT, personnel filec onducted on 11/9/23 revealed a hire date of 3/28/22. There was no documentation of competency for use of the pHoenix meter. An interview was conducted on 11/9/23 at 11:14 AM with EI # 3 who confirmed there was no documentation EI # 6 had demonstrated competency with the pHoenix meter.”

“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: 30952 Based on observations, facility policy and procedure, and interview, it was determined the facility failed to ensure staff followed the pHoenix meter testing policy and procedure and rinse the pHoenix meter with RO (reverse osmosis) water after each use and prevent the potential dialysate from previous tests was not present in the meter. This affected Patient Identifier (PI) # 1, PI # 6, PI # 19 in three of four observations for preparation of the hemodialysis (HD) machine and had the potential to negatively affect all 46 patients who dialyze at this facility. Findings Include: Facility Policy 950B Subject: Phoenix Meter Testing Procedure Date, none documented. ...Purpose: Verification of proper Dialysis Machine Conductivity, temperature and PH (potential of hydrogen) prior to initiation of dialysis. ...Qualifications: All Teammates must complete in-service of pHoenix Meter... Procedure: 12. Allow dialysis machine to come up to conductivity. 13. After verification of phoenix meter (see...calibration procedure). 14. Rinse the cell, syringe interior, and sampling cup/tube thoroughly with RO water after each use. 18. Draw liquid thorough the cell. 19...measurement is taken... 1. An observation was conducted on 11/7/23 at 9:45 AM to observe EI # 10, CCHT, prepare the Hemodialysis Machine for PI # 1 at Station 10. EI # 10 obtained a sample of dialysate from Station 10 and set the sample cup on the cart with the pHoenix Meter. After testing the sample, EI # 10 set the meter back on the cart and walked away. EI # 10 failed to rinse the pHoenix meter with RO water after testing. An interview was conducted on 11/9/23 at 11:06 AM with EI # 1 who confirmed the facility policy was not followed for rinsing the Phoenix XL Meters after use. 2. Observations of care were conducted on 11/7/23 at 10:10 AM station 4 for PI # 6 which included preparation of the HD machine by EI # 7, CCHT. EI # 7 collected the dialysate sample, exited station 4 to the Tri Station cart, withdrew the dialysate sample into the pHoenix meter, read the pH and conductivity result, exited the testing station, and discarded the dialysate sample to the dirty sink. EI # 7 failed to rinse the pHoenix meter (cell/syringe/sampling tube) thoroughly with RO water after use. An interview was conducted on 11/8/23 at 11:25 AM with EI # 1, Chief Clinical Officer who confirmed the staff failed to follow the procedure and rinse the phoenix meter after each use. 3. An observation was conducted on 11/8/23 at 10:05 AM to observe EI # 5, CCHT, prepare the Hemodialysis Machine for PI # 19. EI # 5 obtained the sample from Station 5 and tested the sample using the pHoenix meter. After the sampling, EI # 5 rinsed the meter one time and returned the meter to the cart. EI # 5 failed to thoroughly rinse the meter after use. An interview was conducted on 11/9/23 at 11:06 AM with EI # 1 who confirmed the facility policy was not followed for rinsing the pHoenix meters after use. 41623”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 30952 Based on review of medical records (MR) and interviews with the staff it was determined the facility failed to ensure physician orders were followed and staff: 1. Notified the MD (medical doctor) when the patient post treatment weight was > (greater than) 3 kg (kilogram) above the EDW (Estimated Dry Weight). 2. Notified the MD for additional orders when the patient needed to remove > 13 ml/kg/hr (milliliter/kilogram/hour) fluid, (the UFR [ultrafiltration rate] is > 13ml/kg/hr). This deficient practice affected one of four in-center Hemodialysis (HD) MR’s reviewed, including Patient Identifier (PI) # 2 and had the potential to negatively affect all 46 patients who dialyzed at this facility. Findings include: 1. PI # 2 was admitted to the facility on 7/6/23 with a primary diagnosis of End Stage Renal Disease. Review of PI # 2’s HD Standing Orders dated 7/10/23 revealed EDW, Call MD if patient is > 3 Kg post treatment, and maximum UFR 13 ml/kg/hour (milliliter/kilogram)-Notify MD for additional orders if patient needs to remove >13 ml/kg/hour. Review of the Treatment Report dated 10/25/23 revealed the EDW was 78 kg, the treatment start time was 10:18 AM, the pre treatment weight was 85.5 kg, and post treatment weight was 83 kg. There was no documentation the MD was notified PI # 2’s post treatment weight was 5 kg above the EDW. Review of the Treatment Report dated 10/27/23 revealed the EDW was 78 kg, treatment start time was 10:08 AM, the pre treatment weight was 86.2 kg and the post treatment weight was 82.8 kg. There was no documentation the MD was notified PI # 2’s post treatment weight was 4.8 kg above the EDW. Review of the Treatment Report dated 10/30/23 revealed the EDW was 80 kg, treatment start time was 10:39 AM, the pre treatment weight was 88.4 kg, the post treatment weight was 84 kg, and the UFR was 15.18 ml/kg/hr. There was no documentation the MD was notified PI # 2’s post treatment weight was 4 kg above the ordered EDW, and the UFR was greater than 13 ml/kg/hr. Review of the Treatment Report dated 11/1/23 revealed the EDW was 80 kg, treatment start time was 10:38 AM, the pre treatment weight was 87 kg, the post treatment weight was 82.3 kg, and the UFR was 16.01 ml/kg/hr. There was no documentation the MD was notified the UFR greater than 13 ml/kg/hr. Review of the Treatment Report dated 11/3/23 revealed the EDW was 80 kg, treatment start time was 10:11 AM, the pretreatment weight was 86.4 kg, the post treatment weight was 82.2 kg, and the UFR was 14.46 ml/kg/hr. There was no documentation the MD was notified the UFR greater than 13 ml/kg/hr. There was no documentation on 10/30/23, 11/1/23, and 11/3/23 that PI # 2 was offered extended or extra treatments for fluid management. An interview was conducted on 11/9/23 at 9:38 AM with Employee Identifier # 2, Facility Administrator, who confirmed there was no documentation staff notified the MD when PI # 2’s post treatment weight was > 3 kg above EDW on the above dates and the UFR was > 13 ml/kg/hour.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 30952 Based on observations, review of medical records (MR), facility policy, and interviews, it was determined the facility failed to ensure the staff followed the physician orders and/or documented the: 1. Blood Flow Rate (BFR). 2. Dialysate Flow Rate (DFR). 3. Heparin mid treatment bolus time. This affected Patient Identifier (PI) # 14, PI # 15, in two of five observations conducted during the flash tour to verify hemodialysis (HD) prescriptions and in three of four in-center HD (hemodialysis) MRs reviewed, including PI # 2, PI # 3, and PI # 1. This had the potential to negatively affect all patients dialyzing at the facility. Findings include: Facility Hemodialysis: Policy 5008 Subject: Flow Sheet Documentation Date: None Listed ...Policy: 1. Every patient flow sheet will be completed in its entirety... 2. ...Late entries may be made, but it must be documented that it is late and the reason it is late... ...5. Ongoing monitoring... every 30 minutes... Blood flow rate... ultrafiltration rate... Heparin administration... 1. During observations of patient care on 11/7/23 at 8:45 AM, the surveyor asked Employee Identifier (EI) # 7, CCHT (Certified Clinical Hemodialysis Technician), to verify the dialysis prescription for PI # 14 at station three. The dialysis prescription revealed an ordered DFR of 800, and the current DFR, confirmed by EI # 7, was 700. EI # 7 then changed the DFR to 800. An interview was conducted on 11/9/23 at 11:05 AM with EI # 1, Chief Clinical Officer, and EI # 2, Facility Administrator who confirmed staff failed to set the DFR to the physician ordered rate. 2. During observations of patient care on 11/7/23 at 8:50 AM, the surveyor asked EI # 7 to verify the dialysis prescription for PI # 15 at station two. The dialysis prescription revealed an ordered BFR of 350, and the current BFR, confirmed by EI # 7, was 300. EI # 7 confirmed there was no documentation why the BFR was 300 and not 350 as ordered. Review of the 11/7/23 Treatment Sheet documentation revealed the BFR was 300 from 6:31 AM until 9:31 AM, the treatment ended at 9:46 AM. There was no reason documented why the BFR was not 350 as ordered. An interview was conducted on 11/9/23 at 11:05 AM with EI # 1 and EI # 2 who confirmed staff failed to set the BFR to the physician ordered rate. 3. PI # 2 was admitted to the facility on 7/6/23 with a primary diagnosis of ESRD (End Stage Renal Disease). Review of the Dialysis Order dated 11/01/23 revealed a Mid Tx (Treatment) Heparin Bolus of 2000 units. Review of the Treatment Sheet dated 11/1/23 revealed treatment start time was 10:38 AM and the nurse documented Heparin mid Tx Bolus-2000 units IV (Intravenous) Push at 2:10 PM. The treatment end time was 2:12 PM. The nurse failed to administer the Heparin mid-treatment as ordered. An interview was conducted on 11/9/23 at 9:38 AM with EI # 2 who confirmed staff failed to administer mid Tx Heparin administration per physician orders. 41623 4. PI # 3 was admitted to the facility on 12/7/21 with a primary diagnosis of ESRD. Review of the Progress Note Report dated 10/6/23 revealed Hemodialysis Orders for BFR of 400 and DFR of 700. Review of the Treatment Sheet dated 10/25/23 revealed the treatment was started at 5:13 AM with DFR of 500 and at 5:31 AM the DFR was increased to 800, and continued at 800 until the end of the treatment at 8:54 AM.There was no documentation of the reason the DFR was increased to 800 and not at the ordered rate of 700. Review of the Treatment Sheet dated 11/1/23 revealed the treatment was started at 5:31 AM with DFR of 500 and at 6:02 AM the DFR was increased to 800 and continued at that rate until the end of treatment at 9:08 AM. There was no documentation of the reason the DFR was increased to 800 and not at the ordered rate of 700. An interview was conducted on 11/9/23 at 10:18 AM with EI # 1 who confirmed there was no documented reason to increase the DFR to 800 and not at the ordered rate of 700. 5. PI # 1 was admitted on 7/27/23 with a primary diagnosis of ESRD. Review of the Progress Note Report dated 9/28/23 revealed Hemodialysis Orders for BFR 400, DFR 700, Heparin bolus 2000 units at start of treatment, and Heparin 2000 units mid treatment. Review of the Treatment Sheet dated 10/7/23 revealed the dialysis treatment was started at 9:53 AM and ended at 1:54 PM. Further review of the Treatment Sheet dated 10/7/23 revealed both the Heparin 2000 unit bolus and the Heparin 2000 units mid treatment was verified as given at 1:55 PM. There was no documentation of the times the Heparin was given at the start of treatment and at mid treatment. An interview was conducted on 11/9/23 at 10:36 AM with EI # 2 who confirmed there was no documentation of the time the Heparin doses were given. Review of the Treatment Sheet dated 10/19/23 revealed the treatment was started at 10:11 AM with BFR 350. At 11:01 AM the BFR was decreased to 300 and at 12:31 PM the BFR was decreased to 250 and continued until the end of treatment at 2:11 PM. There was no documentation why the BFR was decreased and not at the ordered rate of 400. An interview was conducted on 11/9/23 at 10:36 AM with EI # 2 who confirmed the staff failed to follow the physician’s orders for BFR, DFR, and Heparin administration.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 30952 Based on observations, review of the facility Governing Body Meeting Minutes, facility policy and procedure, medical records (MR) and interview, it was determined the staff failed to follow the policy and procedure for access site cleaning/disinfection and access site assessment. This affected two of two in-center observations, including PI (Patient Identifier) # 8, PI # 19, and one of two in-center records with an AVF (arteriovenous fistula)/Graft and included PI # 4, and had the potential to negatively affect all in-center patients who dialyze at the facility. Findings include: Facility Governing Body Meeting Minutes 01/27/23 ...Approved Access cleaning and disinfecting solutions ...Fistula/Graft-Clean with Alcohol Preps and disinfect with Iodine Facility Hemodialysis: Policy 4200 Subject: Access Needles: Placement and Removal Date: none documented Purpose: 1. To achieve adequate vascular access for hemodialysis. ...To decrease the risk of infection via the access. ...Policy: 1. Universal Precautions, aseptic technique and all...applicable...infection control policies and procedures will be used... 2. Initial assessment will be done...and include assessment for...Patency...Infection...Hematomas, Swelling of access extremity 5. All assessment findings will be documented in the patient record... Facility HD: Procedure 4200A Subject: Access Needles: Placement and Removal Date: none documented Placement of Fistula Needles: Procedure ...The access is palpated and inspected...The thrill or bruit must be present to verify patency of the access... ...The needle insertion site and the area (is) cleaned with a (an) approved disinfectant solution...The second needle insertion site is disinfected...site is cleaned 1. An observation of care was conducted on 11/7/23 at 9:50 AM at station 1 with EI (Employee Identifier) # 7, Certified Clinical Hemodialysis Technician (CCHT) during access of an AVF for initiation of dialysis on PI # 8. The surveyor observed EI # 7 wipe the access site with two iodine pads, allow the iodine to air dry, perform hand hygiene, don gloves, wipe the access site with two alcohol pads, then cannulated the access. EI # 7 failed to clean the access site with alcohol preps then disinfect with iodine. An interview was conducted on 11/9/23 at 11:01 AM with EI # 1, Chief Clinical Officer, and EI # 2, Facility Administrator, who confirmed staff failed to clean the access with alcohol, then disinfect with iodine per procedure. 2. PI # 4 was admitted to the facility on 10/7/19 with diagnoses including End Stage Renal Disease. Record review revealed a 10/11/23 Progress Note documented by the nephrologist that revealed the presence of a right internal jugular (RIJ) catheter and a left upper arm graft. Review of Treatment Reports dated 10/25/23, 10/27/23, 10/30/23 revealed the access type was RIJ. There was no documentation the left arm graft access was evaluated for the absence/presence a bruit/thrill and graft site complications. Review of the 11/3/23 and 11/6/23 Treatment Reports documentation revealed the graft access was cleansed with alcohol and Chlorprep, and not the faility approved cleaning and disinfecting solutions, alcohol and iodine. An interview was conducted on 11/9/23 at 11:10 AM with EI # 2, Facility Administrator, who confirmed staff failed to document access assessment findings and failed to perform access site cleaning and disinfection per the facility policy and procedure. 41623 3. An observation of care was conducted on 11/8/23 at 10:05 AM at station 5 with EI # 5, Registered Nurse, during access of an AVF for initiation of dialysis on PI # 19. EI # 5 wiped the access site with iodine pads then wiped the site with alcohol pads. EI # 5 then donned new gloves and cannulated the site. EI # 5 failed to clean the access site with alcohol preps then disinfect with iodine per facility policy. An interview was conducted on 11/9/23 at 11:06 AM with EI # 1, who confirmed the staff failed to clean the access site with alcohol, then disinfect with iodine per facility policy.”

“H-MONITOR HOME ADAPT;HOME VISIT=POC CFR(s): 494.100(c)(1)(i) Services include, but are not limited to, the following: (i) Periodic monitoring of the patient’s home adaptation, including visits to the patient’s home by facility personnel in accordance with the patient’s plan of care. This Standard is not met as evidenced by: 30952 Based on review of the Peritoneal Dialysis (PD) Infection log documentation, medical record (MR) review, facility policy and interview the facility failed to assure a home visit was made to identify an actual or potential problem for one of one home PD patient record reviews. This affected PI (Patient Identifier) # 5 and had the potential to negatively affect all home therapy patients. Facility PD Policy 5006 Subject: Home Visits (HV) Date: none documented PURPOSE: To establish a policy for an initial HV which assesses the patient’s home environment for cleanliness, storage of supplies, appropriate treatment areas... Policy: ...Additional home visit must be complete annually and as needed (PRN) per nursing assessment...multidisciplinary healthcare team member may assist with the HV as...appropriate. Documentation must be made of the HV and placed in the...MR. Findings include: 1. Review of the facility PD Infection log documentation dated April-November 2023 revealed PI # 5 had antibiotics administered 6/26/23, 7/4/23, 7/8/23, 7/12/23, 7/17/23, 9/8/23, 9/11/23, 9/14//23, 9/18/23, 9/21/23, and 9/28/23, the diagnosis was Peritonitis. PI # 5 was admitted to the facility 9/9/22 for PD to be performed in the home. The admission diagnosis was Polycystic Kidney Disease. An initial HV was documented 9/9/22. MR review revealed PI # 5 was hospitalized from 6/19/23 to 6/23/23, discharge diagnosis, Peritonitis related to PD catheter. Further record review revealed no documentation a HV was conducted to investigate/evaluate PI # 5’s repeated Peritonitis. An interview was conducted on 11/18/23 at 2:37 PM with Employee Identifier # 4, PD Coordinator who confirmed staff failed to conduct a PRN HV following the repeated Peritonitis diagnoses per the facility policy.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 41623 Based on review of facility policy, facility Quality Assessment and Performance Improvement (QAPI) data, and staff interview, it was determined the facility failed to ensure the QAPI program tracked and trended complete patient data used for mortality. This had the potential to affect all patient served by this facility. Facility Policy: Hemodialysis: Quality Assessment and Performance Improvement Program Policy number: 216 Policy date: not provided ...The Governing Body of the facility and the management team estabish, maintain, support, and document...an ongoing QAPI program incorporating...clinical indicators and standards. The facility QAPI Committee establishes priorities, developes and implements improvement projects based on established priorities and monitors these projects for effectiveness... Required QAPI Documents: ... Infection Surveillance/Hospitalization/Mortality QAPI Meeting Requirements: ...Identify commonalities among patients who do not reach the minimum expected patient targets... QAPI Minutes: ...Trending tools and any relevant data or reports...will be filed with the QAPI minutes... 1. Review of the Mortality Trending Tool for 2023 revealed documentation of one death in May due to Gastro-Intestinal Hemorrhage and one death in June due to Gastro-Intestinal Hemorrhage. Review of the second quarter QAPI minutes dated September 28, 2023 revealed no documentation the commonality of the causes of death would be tracked or trended. An interview was conducted on 11/9/23 at 3:00 PM with Employee Identifier (EI) # 1, Chief Clinical Officer, and EI # 2, Facility Administrator, who confirmed the facility failed to track and trend complete patient data used for mortality deaths in May and June of 2023.”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 30952 Based on review of medical record (MR), facility policy, and interview, it was determined the facility failed to ensure staff followed the policy for incident/event reporting. This affected Patient Identifier (PI) # 6, in one of four observations for preparation of the hemodialysis (HD) machine and had the potential to negatively affect all 43 patients who dialyze at the facility. Findings Include: Facility Policy RM (Risk Management) 2000 Subject: Incident/Event Reporting Revised 11.15.2027 POLICY: A confidential incident report must be completed for any incident...or event that is not within the routine safe operation...particularly if it did, or could have resulted in deviation from the expected plan of care for a patient... PURPOSE: To improve the management and treatment of the patient ...To assist in the quality assurance process. ...GUIDELINES: 3. The Clinical Variance Report (CVR) should be completed and faxed to Risk Management. ...10. The following incidents must always be reported on an CVR: F. Any incident of Hemodialysis... 1. Observations of care were conducted on 11/7/23 from 10:10 AM to 11:10 AM at station 4 with PI # 6. Observations included preparation of the HD machine by EI (Employee Identifier) # 7, CCHT (Certified Clinical Hemodialysis Technician), and CVC (central venous catheter) exit site care, and initiation of dialysis with a CVC by EI # 1, CCO (Chief Clinical Officer). On 11/7/23 at 10:10 AM, EI # 7 was observed by the surveyor test the dialysate pH and conductivity of the 2K (Potassium)/2.5Ca (calcium) bath. On 11/7/23 at 11:00 AM EI # 1 initiated dialysis treatment with assistance of EI # 7. At 11:08 AM EI # 7 exited the treatment floor, returned with a jug bath, a 3K/2.5Ca, and connected the new bath to the dialysis machine at station 4. Review of PI # 6’s 11/7/23 Treatment Report documentation revealed the dialysis order was a 3K/2.5Ca bath. An interview was conducted on 11/9/23 at 1:41 PM with EI # 1 who verified the treatment prescription was set up incorrectly by staff. EI # 1 confirmed staff also failed to document an event/occurrence/near miss event for the 11/7/23 bath prescription error.”