Pcd Montgomery Community

“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: 39098 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) # 1, PI # 3, PI # 2, PI # 4, PI # 5, five of five MR’s reviewed, and had the potential to affect all 58 hemodialysis and 9 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, 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. 1. PI # 1 was admitted to the facility on 10/22/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Plan of Care, dated 12/12/24, revealed there were no dates on the assessments by the registered nurse (RN), social worker (SW), registered dietician (RD) or medical doctor (MD). The surveyor was unable to determine when the assessments were completed. An interview was conducted on 1/27/25 at 2:10 PM with Employee Identifier (EI) # 1, Facility Administrator, who confirmed there were no dates by the electronic signatures on the assessments, and there was no way to determine when they were completed. 2. PI # 3 was admitted to the facility on 11/4/19 with a diagnosis of ESRD. Review of the Plan of Care, dated 10/11/24, revealed there were no dates on the assessments by the RN, SW, or RD. There was no assessment documented by the MD. The surveyor was unable to determine when the assessments were completed. An interview was conducted on 1/27/25 at 2:25 PM with EI # 1, who confirmed there were no dates by the electronic signatures on the assessments. 30952 3. PI # 2 was admitted to the facility on 10/17/24 with a diagnosis of ESRD. Review of the Hemodialysis (HD) Monthly POC, dated 11/29/24, revealed there were no dates on the comprehensive assessments by the RN, RD, SW, and physician. The surveyor was unable to determine when the assessments were completed. An interview was conducted on 1/27/25 at 2:48 PM with EI # 1, who confirmed there were no dates by the electronic signatures on the assessments. 4. PI # 4 was admitted to the facility on 7/8/22 with a diagnosis of ESRD. Review of the HD Annual POC, dated 11/14/24, revealed there were no dates on the comprehensive assessments by the RN, RD, SW, and physician. The surveyor was unable to determine when the assessments were completed. An interview was conducted on 1/27/25 at 2:45 PM with EI # 1, who confirmed there were no dates by the electronic signatures on the assessments. 5. PI # 5 was admitted to the facility on 7/10/24 with a diagnosis of ESRD. PI # 5 was a PD home therapy patient. Review of the PD 90 Day POC, dated 10/14/24, revealed there were no dates on the comprehensive assessments by the RN, RD, SW, and physician. An interview was conducted on 1/27/25 at 2:44 PM with EI # 1, who confirmed there were no dates by the electronic signatures on the assessments.”

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 30952 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 fifty-eight patients currently receiving in-center hemodialysis at the facility and the nine patients who receive Peritoneal Dialysis home training and support. Refer to: V 542, V 545, V 546, V 547, and 553.”

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 30952 Montgomery 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 fity-eight incenter hemodialysis patients and nine home peritoneal dialysis patients served by this facility. Findings: refer to V 0626, V 0628, 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: 39098 Based on observations, review of Patient Rights, medical records, facility policies, 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 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. This had the potential to affect all patients served by this facility. Findings include: Refer to V 0754 for findings.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 39098 Based on observation and interview, it was determined the facility failed to ensure single dose saline flushes were available for patient use, or saline flushes were prepared in a safe and sanitary manner. This had the potential to affect all 58 patients dialyzing at this facility. Findings include: During observations on the treatment floor on 12/12/24 at 8:35 AM, the surveyors interviewed staff regarding the availability of supplies. Employee Identifier (EI) # 4, Charge Nurse stated the saline used for flushing Central Venous Catheters, was drawn from the medication pig tail of the intravenous tubing, which is already connected to the dialysis machine at the time the saline is withdrawn. EI # 4 confirmed during the interview, staff failed to prepare saline flushes in the clean medication preparation area.”

“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 failed to ensure staff: 1. Administered medications ordered by the Medical Director included in the patient Plan of Care. 2. Informed the patients of all aspects of his or her 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 fifty-eight current incenter hemodialysis patients and nine Peritoneal Dialysis (PD) patients 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... ...7. You are considered an important part of your healthcare team and you are encouraged to participate in the planning process... Review of the facility Medication Discrepancy Report (MDR) dated 7/1/24 to 12/9/24, revealed 54 of 58 patients missed ordered Mircera and Venofer for anemia management, 28 patients missed Cinacalcet, and 36 patients missed Calcitriol for mineral/bone management. Six patients missed oral nutritional supplements (ONS), and six missed intradialytic parental nutrition (IDPN), prescribed for nutrition management. Documentation revealed medications were held. The reasons documented on the report were “not in stock,” “out of supply”, or no reason was documented. Interviews were conducted on 12/9/24 and 12/10/24 with nine incenter patients, whose names were included on the MDR. All nine reported they had received prescribed medications during dialysis treatments included in their patient plan of care. Review of the facility Incident log revealed no missed medication dosages were documented in 2024. Review of the facility Grievances revealed no complaints were documented in 2024. An interview was conducted on 12/11/24 at 1:10 PM with Employee Identifier (EI) # 4, Clinical Nurse Manager, who reported patients were informed meds (medications) were not in stock, and most would say “ok, and a few (patients) asked me if it was affecting their health, I told them we were monitoring their lab work, and if levels dropped, we’d send them for blood transfusion.” EI # 4 reported there was no MR documentation the patients were told meds were not in stock. EI # 4 confirmed staff failed to document missed medications as facility occurrences/incidents. An interview was conducted on 12/12/24 at 11:45 AM with EI # 1, Medical Director, who confirmed every patient was not informed each time medications out the stock were not administered. EI # 1 reported, “I would mention when I make rounds, but they (patients) were not informed in writing or by letter...some were not getting (their medication), then (the facility) started getting (medications) in.””

“PA-TRANSPLANTATION REFERRAL CFR(s): 494.80(a)(10) The patient’s comprehensive assessment must include, but is not limited to, the following: (10) Evaluation of suitability for a transplantation referral, based on criteria developed by the prospective transplantation center and its surgeon(s). If the patient is not suitable for transplantation referral, the basis for nonreferral must be documented in the patient’s medical record. This Standard is not met as evidenced by: 30952 Based on record review and interview, it was determined the facility failed to ensure the Comprehensive Interdisciplinary Assessment (CIA) included a complete transplant Assessment in one of nine records reviewed who verbalized an interest for a transplant. This affected Patient Identifier (PI) # 3. Findings include: 1. PI # 3 was admitted to the facility on 12/15/22 with a diagnosis of End Stage Renal Disease. Review of the Hemodialysis CIA dated 1/16/24, a Monthly Stable Plan of Care, included a Social Work assessment. Further review of the 1/16/24 POC revealed no update to the Transplant Referral Suitability since 9/8/23 when PI # 3 reported transplant interest and was to discuss with the nephrologist. An interview was conducted on 12/12/24 at 10:36 AM with Employee Identifier # 3, Facility Administrator, who confirmed the 1/16/24 Stable POC was incomplete, and not updated with a current transplant referral assessment.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 30952 Based on medical record (MR) review, and interview, it was determined the facility failed to ensure Comprehensive Interdisciplinary Assessments were completed within 30 days or 13 treatments. This affected Patient Identifier (PI) # 4, in one of nine record reviews and had the potential to negatively affect all patients admitted to this facility. Findings include: 1. PI # 4 was admitted to the facility on 4/17/24 with a diagnosis of End Stage Renal Disease. Review of the MR revealed a Hemodialysis Comprehensive Interdisciplinary Assessment dated 7/16/24, marked as “90 Day, Stable”. There was no MR documentation an Initial/30 Day Plan of Care (POC) was completed. An interview was conducted on 12/12/24 at 10:26 AM with EI # 3, who confirmed the Interdisciplinary Team failed to complete the initial/30 Day Comprehensive Assessments and develop an initial 30 Day POC.”

“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 review of medical records (MR), facility policy, and interviews with staff, 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 nine of nine MR’s reviewed, and did affect Patient Identifier (PI) # 1, PI # 7, PI # 2, PI # 6, PI # 4, PI # 5, PI # 3, PI # 8, PI # 13, 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 ...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, 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 12/12/24 at 10:18 AM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed the IDT failed to have in-person interaction or conference calls (telehealth) for development and approval of the patient care plans. An interview was conducted on 12/12/24 at 12:39 PM with EI # 1, Medical Director, who reported there are no collaborative IDT care plan rounds or meetings. EI # 1 reported he/she has had no contact with the RD (Registerd Dietitian) since August and the SW (Social Worker) is sometimes present during rounds. 1. PI # 1 was admitted to the facility on 8/14/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Initial Plan of Care, dated 9/13/2024, revealed no documented assessment by the physician. There was no date by the signatures of the registered nurse (RN), RD, or SW)to indicate when the assessments were completed. The signature page of the POC was blank. The surveyor was unable to determined who participated in the Plan of Care meeting. Review of the 90 Day POC, dated 11/19/24, revealed no documentation by the RN, SW, or physician. There was no date by the RD signature to indicate when the assessment was completed. The signature page was blank. An interview was conducted on 12/12/24 at 9:59 AM with EI # 3, who confirmed the POC’s were incomplete and there was no evidence the POC’s were reviewed with the patient. 2. PI # 7 was admitted to the facility on 5/20/22 with a diagnosis of ESRD. Review of the POC dated 12/12/23 revealed the comprehensive assessments by the RN, RD, and SW were not dated, and the physician assessment was documented by a RN. An interview was conducted on 12/12/24 at 9:50 AM with EI # 3, who confirmed there was no way to determine when the assessments were completed, or if a doctor completed the physician assessment. 3. PI # 2 was admitted to the facility on 1/21/20 with a diagnosis of ESRD. Review of the POC, dated 12/12/23, revealed the RN failed to assess the blood pressure and fluid management. Further review of the POC dated 12/12/23 revealed the physician’s assessment was documented by a RN. Further review of the POC dated 12/12/23 revealed the signatures by the RN, RD, and SW were not dated. There was no way to determine when the comprehensive assessments were completed. An interview was conducted on 12/12/24 at 10:04 AM with EI # 3, who confirmed there was no way to determine when the comprehensive assessments were completed, or if the doctor completed the physician assessment. 4. PI # 6 was admitted to the facility on 10/22/24 with a diagnosis of ESRD. Review of the Initial POC, dated 11/22/24, revealed the RN, SW, and physician failed to complete the comprehensive assessments. The RD signature was not dated. There was no way to determine when the RD assessment was completed. Further review of the POC dated 11/22/24 revealed the POC signature page was blank. There was no signature by PI # 6 to indicate the POC was reviewed with him/her. An interview was conducted on 12/12/24 at 9:38 AM with EI # 3, who confirmed staff failed to complete the POC, and failed to document a review of the POC with the patient. 30952 5. PI # 4 was admitted to the facility on 4/17/24 with a diagnosis of ESRD. Review of the MR revealed a HD (Hemodialysis) Comprehensive Interdisciplinary Assessment, dated 7/16/24, marked “90 Day, Stable.” There was no MR documentation an Initial/30 Day POC was completed. Further review of the POC dated 7/16/24 revealed no date the RN, and SW completed the CA (Comprehensive Assessment). There were no RD and no physician CA’s completed. There was no IDT POC signature page provided, and no evidence of any discussion of the POC with PI # 4. An interview was conducted on 12/12/24 at 10:26 AM with EI # 3, who confirmed the initial/30 Day POC was not complete, the surveyor was unable to determine what dates the comprehensive assessments were completed by the RN and SW, and the RD and physician failed to complete the 90 day CA’s, and there was no collaborative IDT POC review and no discussion with PI # 4. 6. PI # 5 was admitted to the facility on 7/25/22 with a diagnosis of ESRD. Record review revealed a Stable POC dated 11/14/24 which did not include a physician CA. There were no dates the CA’s were completed by the RN, SW, and RD. There was no IDT signature page and no POC discussion with PI # 5 was documented. An interview was conducted on 12/12/24 at 10:18 AM with EI # 3, who confirmed the Stable POC was incomplete, and all IDT CA’s were not conducted. The surveyor was unable to determine the date the SW and RD comprehensive assessments were completed, and there was no POC discussion with PI # 5. 7. PI # 3 was admitted to the facility on 12/15/22 with a diagnosis of ESRD. Review of the HD Comprehensive Interdisciplinary Assessment dated 1/16/24, a Monthly Stable POC, revealed CA’s by the RN, RD, SW, and physician were not dated. An interview was conducted on 12/12/24 at 10:36 AM with EI # 3, who confirmed the 1/16/24 Stable POC was incomplete, and the surveyor was unable to determine the dates the CA’s were completed. 8. PI # 8 transferred from incenter HD to Peritoneal Dialysis (PD) home training and support service on 8/28/24 with a diagnosis of ESRD. Record review revealed a PD CIA dated 11/16/24. There were no RD, SW, and physician CA’s completed. The RN CA was not dated. Further review of the 11/16/24 POC revealed no SW signature documented on the 11/20/24 CIA signature document. An interview was conducted on 12/12/24 at 9:43 AM with EI # 9, PD RN, who confirmed there were no RD, SW, and physician assessments, the RN assessment was not dated, and the SW failed to sign the CIA review. 9. PI # 13 was admitted to the facility on 8/6/24 with a diagnosis of ESRD. Record review revealed a HD CIA, dated 9/10/24, marked as initial unstable POC. There were no dates the initial CIA’s were completed by the RN, RD, and SW. There was no CA completed by the physician. There were no IDT signatures and no evidence of discussion of the POC with PI # 13. Further record review revealed a HD CIA, dated 10/15/24, marked Monthly Stable POC. There were no dates the Monthly CA’s were completed by the RN, RD, and SW. There was no CA completed by the physician. There were no IDT signatures and no evidence of discussion of the POC with PI # 13. An interview was conducted on 12/12/24 at 10:45 AM with EI # 3, who confirmed all CA’s had not been completed, CA’s were not dated, and IDT signatures were not documented. There was no documentation the POC was discussed with PI # 13.”

“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: 39098 Based on review of medical records (MR), Medication Discrepancy Report, and interviews it was determined the facility failed to administer Intradialytic Parental Nutrition (IDPN) and oral nutritional supplements (ONS) as ordered for nutritional management. The facility failed to ensure the Interdisciplinary Team (IDT) included nutritional services provided by a Registered Dietician (RD), who provided education and counseling for patient nutrition needs. This affected three of three records reviewed with ONS and IDPN ordered, including PI # 7, PI # 4, PI # 5, and had the potential to negatively affect all incenter patients. Findings include: Review of the Medication Discrepancy Report, dated 7/1/24 to 12/9/24, revealed three patients did not receive IDPN, and six patients did not receive ONS as ordered for nutritional management. An interview was conducted by phone on 12/11/24 at 3:13 PM with Employee Identifier (EI) # 7, incenter Interim RD. EI # 7 reported he/she has been functioning as interim RD since mid-August. The surveyor asked EI # 7 how many times he/she had been to the facility. EI # 7 reported, none. EI # 7 stated he/she phones the patients to discuss dietary needs. The surveyor asked EI # 7 how frequently is it required to contact the patients. EI # 7 reported he/she tried one time a month, but a lot of them do not pick up (the phone). EI # 7 reported he/she uses a cell phone to make calls to the patients. The surveyor asked approximately how many patients had he/she spoken to since mid-August. EI # 7 reported out of 100 or so calls, 10 patients had answered the phone to discuss dietary needs. EI # 7 reported he/she has an out of state phone number patients may not be answering for this reason (number is not local/familiar). The surveyor asked EI # 7 if the facility had a telecommunication policy/procedure. EI # 7 responded he/she did not know. An interview was conducted on 12/11/24 at 4:30 PM with EI # 3, Facility Administrator, who confirmed the RD coverage was insufficient and ineffective to meet the patients dietary needs. 1. PI # 7 was admitted to the facility on 5/20/22 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Physician Progress Note Report dated 8/7/24 revealed orders including IDPN, 1 EA (Each) IVPB (Intravenous piggy back), every dialysis, starting 12/8/22, and Protein supplement (ONS), 1 EA p.o. (by mouth), every dialysis, starting 1/16/24. Review of 11 Treatment Sheets (TS), dated 8/5/24 to 9/23/24, revealed the ONS was “Held” due to OOS (Out of Stock), or no remark. Review of four TS, dated 8/2/24 to 9/11/24, revealed the IDPN was documented as “Held” with a remark of OOS. An interview was conducted on 12/12/24 at 9:50 AM with EI # 3, Facility Administrator, who confirmed the patient did not receive the medication due to none available in the facility. EI # 3 further stated the IDPN orders were not renewed by the dietitian. 30952 2. PI # 4 was admitted to the facility on 4/8/24 with a diagnosis of ESRD. Review of the Nutrition Report revealed an albumin level was low, 3.5 in September, and 3.4 in October. Review of six TS, dated 9/2/24 to 10/28/24, revealed the ONS was “Held” due to “OOS”, or no reason held was documented. Record review revealed no Registered Dietician (RD) counseling was documented. An interview was conducted on 12/12/24 at 9:05 AM with EI # 3, who confirmed PI # 4 did not receive ONS as the medication was not in stock and there was no RD counseling regarding the low albumin. 3. PI # 5 was admitted to the facility on 7/25/22 with a diagnosis of ESRD. Review of the Nutrition Report revealed an albumin level was low, 3.4 in July, and 3.2 in August. Review of the Progress Note dated 7/25/24 documented by the physician, revealed Dialysis Medications included IDPN-HD 1 dose per IV infusion every dialysis, start date 8/29/23. Review of six TS, dated 8/8/24 to 9/12/24, revealed the IDPN was “Held” due to “OOS” or no reason was documented. An interview was conducted on 12/12/24 at 10:18 AM with EI # 3, who confirmed PI # 5 did not receive IDPN as the RD had resigned, and the IDPN was not reviewed and renewed.”

“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: 39098 Based on review of medical records (MR), Medication Discrepancy Report, and interviews, it was determined the facility failed to ensure staff administered medications for management of mineral metabolism as ordered by the physician. This deficient practice affected four of four records reviewed with mineral metabolism orders, including Patient Identifier (PI) # 1, PI # 7, PI # 2, PI # 3, and had the potential to affect all patients needing medication for mineral metabolism. Findings include: Review of the Medication Discrepancy Report, dated 7/1/24 to 12/9/24, revealed 28 patients did not receive Cinacalcet, and 36 patients did not receive Calcitriol as ordered for mineral metabolism. 1. PI # 1 was admitted to the facility on 8/14/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the Physician Progress Note Report, dated 9/9/24, revealed dialysis medications including Cinacalcet 60 mg (milligrams), every dialysis, starting 8/31/24. Review of nine Treatment Sheets (TS), dated 9/2/24 to 9/23/24, revealed the Cinacalcet was “Held” with a remark of OOS (Out of Stock). An interview was conducted on 12/12/24 at 9:59 AM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed the patient did not receive Cinacalcet as ordered due to the facility having none in stock. 2. PI # 7 was admitted to the facility on 5/20/22 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 8/7/24 revealed orders including Calcitriol 0.5 mcg (micrograms), 2 mcg p.o. (by mouth), every dialysis, starting 7/13/24. Review of TS dated 8/2/24 and 8/5/24 revealed the Calcitriol was marked “Held” with no remark on 8/2/24, and “Held” with a remark of OOS on 8/5/24. An interview was conducted on 12/12/24 at 9:50 AM with EI # 3, who confirmed the patient did not receive the Calcitriol due to the facility having none in stock. 3. PI # 2 was admitted to the facility on 1/21/20 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 12/6/24 revealed orders including Calcitriol 0.5 mcg, 1 mcg p.o., every dialysis, starting 7/26/24. Review of seven TS, dated 11/1/24 to 11/14/24, revealed the Calcitriol was marked “Held” with a remark of OOS, or no reason documented. An interview was conducted on 12/12/24 at 10:04 AM with EI # 3, who confirmed the patient did not receive the Calcitriol due to the facility having none in stock. 30952 4. PI # 3 was admitted to the facility on 12/15/22 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 7/29/24 revealed Dialysis Medications including Calcitriol 0.5 mcg, p.o., every dialysis, starting 5/9/24. Review of the TS dated 8/2/24 revealed the Calcitriol was marked “Held,” the remark was blank, and no reason was documented. An interview was conducted on 12/12/24 at 10:36 AM with EI # 3, who confirmed the patient did not receive the Calcitriol due to the facility having none in stock.”

“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, Anemia Management Report, 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 nine of nine records reviewed, including Patient Identifier (PI) # 1, PI # 7, PI # 2, PI # 6, PI # 4, PI # 5, PI # 3, PI # 8, PI # 13, and did affect 54 patients on the current census. Findings include: Review of the Medication Discrepancy Report, dated 7/1/24 to 12/9/24, revealed 50 patients missed multiple doses of Mircera, and 27 patients missed multiple doses of Venofer. 54 of 58 patients missed ordered doses of medication for the treatment of anemia management. 1. PI # 1 was admitted to the facility on 8/14/24 with a diagnosis of End Stage Renal Disease (ESRD). Review of the patient’s labs, dated 8/14/24, revealed a hemoglobin of 6.8, transferrin saturation of 16, and ferritin 318. Further review of the MR revealed there was no ordered Venofer, even though PI # 1’s labs did not meet the Iron Dosing Goal of the Venofer Dosing Guidelines signed by the physician on 8/14/24. Review of the Monthly Comprehensive Provider note, dated 9/25/24, revealed the following dialysis medication order: Mircera 100 mcg (micrograms), IV (intravenous) infusion, every other week, starting 8/31/24. A review of two Treatment Sheets (TS), dated 9/6/24 and 9/20/24, revealed the Mircera was “Held” both treatments with no reason documented on 9/6/24, and OOS (Out of Stock) documented on 9/20/24. An interview was conducted on 12/12/24 at 9:59 AM with Employee Identifier (EI) # 3, Facility Administrator, who confirmed staff failed to initiate Venofer, or administer the ordered Mircera to PI # 1 due to the facility having none available. 2. PI # 7 was admitted to the facility on 5/20/22 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 8/7/24, revealed orders including Mircera 200 mcg, IV push, every other week, starting 5/27/24. Review of four TS, dated 8/9/24 to 9/20/24, revealed the Mircera was “Held” with a remark of OOS or no reason documented. An interview was conducted on 12/12/24 at 9:50 AM with EI # 3, who confirmed staff failed to administer Mircera due to having none available at the clinic. 3. PI # 2 was admitted to the facility on 1/21/20 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 12/6/24 revealed orders including: Mircera 100 mcg, IV push, every dialysis, starting 5/24/24, and Mircera 100 mcg, IV Push, specific days, starting 11/24/24. Venofer 100 mg, IV Push, every dialysis, starting 6/1/24, and Venofer 100 mg IV Push, every other week, starting 12/6/24. Review of four TS, dated 11/1/24 to 11/8/24, revealed the Venofer was “Held” with no remark. Review of three TS, dated 11/8/24 to 11/24/24, revealed the Mircera was “Held” with no remark. An interview was conducted on 12/12/24 at 10:04 AM with EI # 3, who confirmed the patient did not receive the Venofer and Mircera due to the facility having none in stock. 4. PI # 6 was admitted to the facility on 10/22/24 with a diagnosis of ESRD. Review of the Physician Progress Note Report, dated 11/26/24, revealed orders including Venofer 100 mg, IV Push, every dialysis, starting 11/12/24, and Mircera 75 mcg, IV Push, every other week, starting 11/23/24. Review of the TS dated 11/12/24 revealed the Venofer was “Held” with no reason documented. Review of the TS dated 11/23/24 revealed the Mircera was “Held” with no reason documented. An interview was conducted on 12/12/24 at 9:38 AM with EI # 3, who confirmed the medications were not administered due to the facility having none in stock. 30952 5. PI # 4 was admitted to the facility on 4/17/24 with a diagnosis of ESRD. Review of twelve TS, dated 9/2/24 to 10/28/24, revealed a “Medications order” that included Venofer 100 mg IV Push. Further review of the twelve TS’s revealed Venofer was “Held” every treatment with a remark of “OOS”, or the remark was left blank. An interview was conducted on 12/12/24 at 10:26 AM with EI # 3, who confirmed staff failed to administer Venofer to PI # 4 due to the facility not having the Venofer in stock. 6. PI # 5 was admitted to the facility on 7/25/22 with a diagnosis of ESRD. Review of the Monthly Comprehensive Provider Notes dated 7/25/24, and 8/22/24, documented by the physician included Mircera 100 mcg, IV push, every dialysis, start 4/15/24, every other week, 3rd dialysis. Review of three TS dated 8/10/24, 9/7/24, 9/21/24 revealed the Mircera was “Held” “OOS,” or the remark was left blank. An interview was conducted on 12/12/24 at 10:18 AM with EI # 3, who confirmed PI # 5 did not receive Mircera as ordered, as the medication was not in stock at the facility. The surveyor asked EI # 3 if PI # 5 had received any Mircera in August and September, and EI # 3 responded, “It was not given.” 7. PI # 3 was admitted to the facility on 12/15/22 with a diagnosis of ESRD. Review of the Physician Progress Note Report dated 7/29/24 revealed PI # 3’s July hemoglobin was 8.7, and Dialysis Medications included Mircera 200 mcg IV Push every other week, 3rd dialysis, start date 4/11/24. Review of the TS, dated 8/16/24, revealed Mircera 200 mg was “HELD” remark was “OOS.” Review of the Monthly Lab review report revealed on 9/9/24 PI # 3’s hemoglobin was 6.2 (a critical low result). Review of the MR revealed physician orders dated 9/12/24 to refer for 2 units (U) packed red blood cells (PRBC) with type and cross related to anemia. Review of the TS dated 9/13/24 revealed Mircera 200 mg was “HELD,” remark was blank, and no reason was documented. Review of the facility document titled “Transfusion” included PI # 3, the name of a local inpatient facility, and a date of 9/17/24. MR review revealed a consent to release MR information dated 11/19/24 and blood administration documentation dated 9/24/24 for administration of 1-unit PRBC’s. There was no MR documentation that 2 U PRBC’s was transfused as ordered 9/12/24. Review of the TS dated 9/27/24 revealed Mircera 200 mg was “HELD,” remark was blank, and no reason was documented. An interview was conducted on 12/12/24 at 10:36 AM with EI # 3 who confirmed Mircera was not administered as ordered due to not in stock at the facility. EI # 3 reported there was no documentation the physician was notified two U PRBC’s were not administered per orders. EI # 3 confirmed no incident/occurrence report was documented. 8. PI # 8 transferred from incenter dialysis to Peritoneal Dialysis (PD) home training and support services on 8/28/24. Review of the Anemia Management Report revealed from 7/23/24 to 10/10/24 PI # 8’s hemoglobin was less than 10, the Transferrin saturation was less than 20, and the Ferritin was less than 55, which met the criteria for Venofer (iron sucrose) and Mircera on the facility Anemia protocol. MR review revealed a document titled, Orders, which included an area to document Dialysis Medications. There were no physician orders for Mircera and Venofer. MR review revealed from 8/28/24 to 11/20/24 no documentation Mircera and Venofer were administered. An interview was conducted on 12/12/24 at 9:43 AM with EI # 9, PD RN, who confirmed PI # 8 met the iron protocol criteria. EI # 9 confirmed there were no orders for Mircera and Venofer due to the facility not having Venofer in stock. 8. PI # 13 was admitted for incenter HD dialysis on 8/6/24 with a diagnosis of ESRD. Review of the Initial Unstable Plan of Care dated 9/10/24 revealed the goal for hemoglobin was greater than 10 gram/deciliter, T-Sat greater than/ equal to 20 %, and Ferritin greater than 200 and less than 500. Review of the MDR dated 7/1/24 to 12/9/24 revealed PI # 13 was not listed as having had missed/omitted medications including Mircera and Venofer. Review of the Anemia Management Report revealed the following labs: 8/6/24 hemoglobin 10.8 (greater than >10), SAT (iron saturation) 43, Ferr (Ferritin) 502 9/10/24 hemoglobin 8.4 (less than < 10), SAT 47, Ferr 283 9/17/24 hemoglobin 8.9 (<10) No October labs 11/12/24 hemoglobin 7.9 (<10), SAT 30, Ferr 242 11/19/24 hemoglobin-7.4 (<10) 12/3/24 hemoglobin-7.7 (<10), SAT 18 (<20), Ferr 197 (<200) Review of August TS’s, a total of four, dated 8/6/24 to 8/31/24, revealed no Mircera and Venofer was ordered or administered. Review of September TS, a total of six TS, dated 9/7/24 to 9/17/24, revealed no Mircera and Venofer was ordered or administered. Review of October TS, a total of one TS dated, 10/1/24, revealed no Mircera and Venofer was ordered or administered. Review of November TS, a total of five TS, dated 11/9/24 to 11/20/24, revealed no Mircera and Venofer was ordered or administered. MR review revealed physician order dated 11/26/24 to discontinue current Mircera dosage (none was ordered) and begin Mircera 30 mg q (every) month. Review of the TS dated 12/3/24, revealed no Mircera was administered. MR review revealed a physician order dated 12/4/24 to increase Mircera 100 mg every other week, with Venofer 100 mg daily for 10 doses. Review of TS’s dated 12/4/24, 12/5/24, and 12/10/24, revealed no Mircera was administered. An interview was conducted on 12/12/24 at 10:45 AM with EI # 3 who confirmed PI # 13 had not received Mircera and Venofer although lab results that revealed PI # 13 met the anemia management criteria. EI # 3 reported PI # 13 was not on the MDR because no anemia management orders were entered.”

“POC-HOME DIALYSIS PLAN OR WHY NOT CFR(s): 494.90(a)(7)(i) The interdisciplinary team must identify a plan for the patient’s home dialysis or explain why the patient is not a candidate for home dialysis. This Standard is not met as evidenced by: 39098 Based on review of medical records (MR), facility policy, and interviews, it was determined the facility failed to ensure staff made referrals for home modalities. This affected Patient Identifier (PI) # 6, 1 of 1 MR’s reviewed of patients interested in home modalities, and had the potential to affect all patients interested in home hemodialysis or home peritoneal dialysis. Findings include: Facility Policy: General Policy for Patient Assessment and Plan of Care Policy Number: None Listed Date Reviewed: None Listed The patient assessment and Plan of Care must be developed and implemented by an interdisciplinary team... The completion of assessments and Plan of Care will be monitored through regular medical record audits and the audit results will be reviewed in the Quality Assessment Performance Improvement (QAPI) meeting. Components of the Patient Assessment: The comprehensive assessment must include the following: ...Evaluation of the patient abilities, interest, preferences and goals, include the desired level of participation in the dialysis care process, the preferred modality and setting and the patient expectations for care outcomes. ...Role of the Interdisciplinary Team ...Complete the Comprehensive Assessment upon which the Plan of Care will be based to include: ...Education and evaluation of preferred modality ...Document and communicate assessment findings as appropriate Plan of Care Components: ...Modality Determine if the patient would like to dialyze at home. Identify a plan for the patient’s long term care for either home hemodialysis, home peritoneal dialysis, or provide reason(s) the patient is not a candidate for home dialysis. 1. PI # 6 was admitted to the facility on 10/22/24 with a diagnosis of End Stage Renal Disease. Review of the Initial Plan of Care, dated 11/22/24, revealed the Modality Options were reviewed with PI # 6 by the Registered Nurse (RN). For the statement, “Patient interested in home therapy” the RN documented “Yes.” In the comment section, the following is noted, “If yes, patient referred to home therapy program and surgeon for candidacy review and preparation for training.” The surveyor requested documentation of referral and/or training for home therapy, and none was provided. An interview was conducted on 12/12/24 at 9:38 AM with Employee Identifier # 3, Facility Administrator, who confirmed staff failed to make a referral for PI # 6 for home therapy evaluation.”

“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: 30952 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, facility 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 all 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. This had the potential to negatively affect all patients served by this facility. 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 (SW)... 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 2024 Incenter Hemodialysis (IC HD) and Peritoneal Dialysis (PD) QAPI program data revealed no evidence the QAPI Committee met monthly and discussed the data. Review of the Medication Discrepancy Report dated 7/1/24 to 12/09/24, a 187-page document, revealed fifty-three patients did not receive prescribed medications as ordered during dialysis treatments. Further review of the facility QAPI program data revealed documentation the 2024 Nutrition Management, Anemia Management, and Mineral Metabolism, were not meeting facility and program goals. 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 facility Adverse Occurrence Trends for Hemodialysis Year 2024 revealed Medication: Omission/missed medications data and blood transfusions was documented as zero. There were no medication errors, no medication occurrences, hospitalization data was not complete, and mortalities were not analyzed. 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 12/10/24 at 10:38 AM with Employee Identifier (EI) # 3, FA, who confirmed there was no documentation the QAPI Committee met to discuss/analyze quality data in 2024. Interviews were conducted on 12/11/24 at 11:53 AM with EI # 6, PD Dietician, at 2:15 PM with EI # 8, facility SW, at 3:13 PM with EI # 7, IC HD Dietician, and at 3:50 PM with EI # 9, PD Nurse. The Interdisciplinary Team, all confirmed, the facility did not conduct quality improvement meetings to monitor program data/information, identify, and prioritize areas for improvement, develop, implement, evaluate, and revise facility action plans that could result in improvements in patient safety and care. An interview with EI # 1, Medical Director, was conducted on 12/12/24 at 11:45 AM. EI # 1 reported the last QA meeting was about 4 months ago where he/she and the prior FA sat and went over QA metrics. EI # 1 confirmed the facility incenter and PD programs had not held monthly quality meetings.”

“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: 30952 Based on review of the facility Quality Assessment Performance Improvement (QAPI) documentation, and staff interviews, it was determined the Quality Improvement Committee failed to analyze and trend patient’s mortality and causes. This affected one Peritoneal Dialysis (PD) and five incenter (IC) hemodialysis (HD) patients who died in 2024 and had the potential to negatively affect all patients served by this facility. Findings include: Review of the 2024 IC HD QAPI documentation revealed there was one death in April, one death in May, one death in August, one death in September, and one death in November. Review of the IC HD Mortality Trending Tool revealed no deaths, no cause of death, and no trends were documented. The report was blank, not completed with any data January to November 2024. There was no documentation the facility conducted an investigation, analyzed, and trended causes of IC HD patient deaths and the relationship to the care received at the facility. Review of the PD QAPI Mortality Trending Tool provided revealed no deaths in 2024. Further review of the PD Mortality Analysis documentation revealed one PD patient death, date was 11/6/24, place of death was hospital. Review of the End Stage Renal Disease Death Notification document revealed one PD patient expired on 10/6/24 at home. There were 3 different PD mortality documents, and each document contained different PD death data. There was no documentation the facility conducted an investigation, analyzed, and trended causes of PD patient deaths and the relationship to the care received at the facility. An interview was conducted on 12/11/24 at 3:50 PM with Employee Identifier (EI) # 9, PD Registered Nurse, who reported he/she did not participate in reviews of PD deaths and did not know who was conducting the mortality reviews. EI # 9 confirmed one PD patient death in 2024. An interview was conducted on 12/12/24 at 3:45 PM, with EI # 3, Facility Administrator, who confirmed the facility had not collected accurate death data and conducted mortality analysis for all facility patient deaths.”

“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: 30952 Based on review of the Medication Discrepancy Report, facility’s Quality Assessment and Performance Improvement (QAPI) program data, 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. This had the potential to negatively affect all patients served by this facility. 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 Medication Discrepancy Report dated 7/1/24 to 12/09/24, a 187-page document, revealed three patients did not receive intradialytic parental nutrition (IDPN) and six patients did not receive oral nutrition supplements (ONS) as ordered for nutritional management. Review of the Incenter hemodialysis (IC HD) and Peritoneal Dialysis (PD) QAPI program data for 2024 and facility reports revealed albumin goals were not being met for IC HD January -October 2024, and for PD five of the last six months. There was no documentation the QAPI committee analyzed the data which included a root cause of inadequate medication supply, and no plan was implemented to obtain the required medications for improved patient outcomes. 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. Interviews were conducted on 12/11/24 at 11:53 AM with Employee Identifier (EI) # 6, PD Dietician, and at 3:13 PM, with EI # 7, IC HD Dietician, who confirmed the PD and IC HD programs had not met goals for Albumin. EI # 6 reported he/she compiles and submits program nutrition statistics, but no QA Committee review or discussion is held. An interview conducted 12/12/24 at 3:45 PM with EI # 3, FA, who confirmed the QAPI Committee had not met monthly to discuss/analyze quality data and no action plans were developed to improve the nutrition outcomes.”

“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: 30952 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Medication Discrepancy Report, facility 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 and medication omissions. This had the potential to negatively affect all patients served by this facility. 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 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 Calcitriol and Cinacalcet, and no plan was implemented to obtain the required medications for improved patient outcomes. Review of the Medication Discrepancy Report dated 7/1/24 to 12/09/24, a 187-page document, revealed 28 patients did not receive Cinacalcet, and 36 patients did not receive Calcitriol as ordered for mineral metabolism. 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 was conducted on 12/10/24 at 10:38 AM with Employee Identifier (EI) # 3, Facility Administrator, who reported “I can’t find a meeting, it was only done in 2023, I asked the staff.” EI # 3 stated, “I printed out the QA (Quality Assessment) materials and placed it in the binder for you to review.” EI # 3 confirmed the facility QAPI Committee had not met to conduct monthly meetings to discuss/analyze facility quality data. An interview was conducted on 12/11/24 at 11:53 AM with EI # 6, Peritoneal Dialysis Registered Dietician, who reported he/she does the statistical analysis for mineral metabolism and prints reports with the outcome data. EI # 6 reported there have been no QAPI meetings for the past 3 years. An interview was conducted on 12/11/24 at 3:13 PM with EI # 7, Interim Incenter Hemodialysis Registered Dietician. EI # 7 reported he/she does not think the facility is meeting calcium goals, the phosphorus is a little high, and the PTH is not at goal. EI # 7 confirmed he/she has not attended or participated in facility QA activities since starting at the facility in August 2024.”

“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: 30952 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Medication Discrepancy Report, policy, facility patient laboratory reports, 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 was provided accurate data for medication errors/omissions. This had the potential to negatively affect all patients served by this facility. 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 incenter hemodialysis 2024 QAPI program data, and facility lab reports for hemoglobin revealed goals for anemia management were not being met May-October 2024. The Transferrin Saturation goal was not met 7 of 11 months, during March, May, June, August, September, October, and November 2024. 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 2024 Peritoneal Dialysis (PD) QAPI program data, and facility lab reports revealed goals for hemoglobin in anemia management were not being met January-September 2024. The Transferrin Saturation goal was not met from January-November 2024. 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 7/1/24 to 12/9/24, a 187-page document, revealed fifty-four 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 2024 incenter hemodialysis and PD program QAPI indicator report revealed zero medication errors/omissions for 2024. An interview was conducted on 12/10/24 at 10:38 AM with Employee Identifier # 3, Facility Administrator, who reported “I can’t find a meeting, it was only done in 2023, I asked the staff.” EI # 3 confirmed the facility QAPI Committee had not met to conduct monthly meetings to discuss/analyze facility quality data. The FA stated “I printed out the QAPI materials and placed it in the binder for you to 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: 30952 Based on review of the facility’s Quality Assessment and Performance Improvement (QAPI) program data, Adverse Occurrence (AO) Trends for Hemodialysis (HD) and Peritoneal Dialysis (PD) Year 2024, Medication Discrepancy Report (MDR), facility Blood Transfusion list, Hospitalizations and Absences Report, facility policies, and staff interview, 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. This had the potential to negatively affect all patients served by the facility. 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 facility Medication Discrepancy Report dated 7/1/24 to 12/09/24, a 187-page document, revealed a total of 54 of 58 patients missed ordered doses of medication for the treatment of anemia management, three patients did not receive intradialytic parenteral nutrition (IDPN), and six patients did not receive oral nutrition supplement (ONS) as ordered for nutritional management, 28 patients did not receive Cinacalcet, and 36 patients did not receive Calcitriol as ordered for mineral metabolism. Review of the facility 2024 QAPI Program data revealed no documentation the QA committee was provided data regarding the number of medications ordered by the physician that were missed/omitted. Review of the facility blood transfusion report revealed five IC (Incenter) HD patients received blood transfusions from 7/1/24 to 12/9/24. Review of the facility Hospitalizations and Absence Report dated 7/1/24 to 12/9/24 revealed a total of 26 patients were hospitalized. Further review of the Hospitalizations and Absence Report revealed 31 hospitalization events failed to have the discharge and/or classification detail (reason for hospitalization), and facility documented. Review of the 2024 IC HD QAPI documentation for Medication Errors and Adverse Occurrence Reports (AOR’s) and Blood Transfusion revealed zero percentage and zero number medication errors. Review of the 2024 Peritoneal Dialysis QAPI documentation for Medication Errors and Adverse Occurrence and Blood Transfusion revealed zero percentage and zero number medication errors, and zero percentage AOR’s and zero number AOR’s. There were no facility QA action plans initiated from 1/2024 to 11/2024 for missed medications, blood transfusions, and hospitalizations. An interview conducted 12/10/24 at 10:38 AM with Employee Identifier (EI) # 3, FA, who confirmed no quality data was collected, reviewed, analyzed for safety and patient outcome improvement from 1/2024-11/2024. There were no QAPI Committee meetings to discuss/analyze quality data. EI # 3 stated, I printed out the material and placed in the binder. EI # 3 confirmed there were no 2024 PI plans developed before December 2, 2024.”

“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, and interview, 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, 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 ByLaws of Physicians Choice Dialysis Date: None Listed ...Purposes ...Permit all patients to receive quality medical care... Participate in and promote activities designed to improve and protect the general health of those patients... Medical Staff Officer ...The officer of the Medical Staff shall be the Medical Director. ...The Medical Director is appointed by the Governing Body. ...Duties of the Officer ...carry out all of the duties and responsibilities of a Medical Director as required under Medicare rules and regulations... Be physically present in the Facility as necessary to carry out the duties. ...Complete Medical Records as required... Ensure that all long term and short term Care Plans are completed by the attending physician in the time frame required. ...Review all Facility quality indicators on a monthly basis... review at least quarterly, all deaths... and generally oversee quality care in the Facility. ...Supervise the planning of and attending the Facility quality assurance conferences... A telephone interview was conducted on 12/12/24 at 11:45 AM with Employee Identifier (EI) # 1, Medical Director. EI # 1 reported his/her responsibilities included water quality, patient plan of care, and facility quality improvement. EI # 1 confirmed he/she did not inform the patients that all medications ordered during dialysis treatments as part of the Plan of Care were not available for administration at the facility. EI # 1 reported, it has been a constant struggle. EI # 1 stated, “It is hard to focus on all, top priority is meds (medication). “ EI # 1 reported he/she had spoken with the Facility Administrators, the Chief Clinical Officer, and are told “it’s coming...meds are in for a while, we relax, and it starts happening again.” EI # 1 reported he/she and the sister facility Medical Director, in a conference call, spoke with the company owner. EI # 1 stated he/she was told the medication shortage was a result of “delays from an internet hack, and we will get Mircera.” 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 he/she has not seen or met the Interim Dietician, the Social Worker is sometimes here, and comprehensive rounds are made with the nurse. 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 confirmed no monthly quality assurance meetings were held to evaluate facility quality data for performance improvement activities. EI # 1 reported about four months ago, he/she sat with the prior FA and reviewed the facility quality metrics. EI # 1 confirmed there was no evidence of QAPI meetings for incenter and home program services.”

“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 policy, Patient’s Rights, Medication Discrepancy Report, medical records (MR), Governing Body (GB) Meeting minutes, Quality Assessment and Performance Improvement (QAPI) program data, and interviews with patients and staff, 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 incenter hemodialysis (IC HD) patients and Peritoneal Dialysis (PD) home support and training patients. Findings include: Facility Hemodialysis: Policy 200 Title: Governing Body No date listed. Purpose: Each...facility is under the control of a GB which has full legal authority and responsibility for the management and operations of the facility... Policy: ...3. The GB will meet at least quarterly and more frequently as needed. Minutes will be recorded and kept...The signature of the Chief Executive Officer...is required... ...Operational Objective ...The responsibility of the Chief Executive Officer include... Organizing and coordinating the administrative functions of the facility... Authoring expenditures in accordance with established policies and procedures... ...Participating in the...accounting and reporting system...budget, maintenance of fiscal records...and submission to the GB reports of expenses and revenues generated... Review of the Medication Discrepancy Report dated /7/1/24 to 12/09/24, a 187-page document, revealed fifty-eight patients did not receive prescribed medications as ordered during dialysis treatments. Review of IC HD MRs revealed eight of eight patients and one of one PD patient had medications prescribed, not administered, documented as “Held,” “Not in supply,” “Not in stock”, and/or facility protocols were not followed. Interviews with nine IC HD patients and facility staff revealed all 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 GB 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 1/29/24 revealed the EI # 1, EI # 2, and EI # 3 were in attendance. The Governing Body Meeting Minutes was documented as an annual review. There was no documentation regarding facility financial issues/concerns. There were no additional GB meeting minutes provided to the surveyor. A phone interview was conducted on 12/12/24 at 11:45 AM with EI # 1. The surveyor asked EI # 1 if there had been discussion among the GB regarding transfer of patients to other facilities that could meet patient needs? EI # 1 response, “Yes, we had discussed this issue and the best course of action. We talked to the owner about 1.5 months ago.” EI # 1 reported I am not the owner of this company. EI # 1 confirmed the GB meeting minutes was not documented and no quarterly GB meeting minutes had been provided. The GB failed to meet as required and act and ensure medications were obtained and administered as ordered. A phone interview was conducted on 12/12/24 at 1:17 PM with the owner of Montgomery Community Dialysis, EI # 10. EI # 10 reported his/her plan for facilities in Alabama was to work closer with the Medical Directors, going forward not to have a facility without medications, and to ensure each facility begins to order meds for the facility needs, and not to borrow meds. EI # 10 reported he/she has spoken to the vendor, Mircera and Venofer can be obtained. EI # 10 confirmed lending organizations are freely able to provide money while the facility awaits payment for the insurance companies.”