Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification Survey conducted August 4, 2025 through August 6, 2025, BMA of Northeastern Philadelphia was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare Recertification Survey conducted August 4, 2025 through August 6, 2025, BMA of Northeastern Philadelphia was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on observations (OBS) of the in-center treatment (ICTX) area and interviews with the director of operations and clinical manager, the facility failed to remove expired medications and supplies from the ICTX area for one (1) of three (3) observations (OBS): OBS#2.
Findings include:
Facility Policy Storage of Supplies and Supply Expiration Dates for Inpatient Services, Reference Number: 47588, Version 4 reviewed on August 5, 2025 at approximately 8:00 AM reads in part, "Supplies will be rotated First-in-First-out (FIFO) to ensure products maintain quality and to monitor expiration dates. Any item that is expired, damaged ....will be removed from stock and disposed of appropriately."
OBS #2 of the in-center treatment area conducted August 4, 2025 from 2:15 PM to 3:00 PM revealed the following:
OBS #2
Medication Cart located at the nurses' station contained one (1) bottle Cinacalcet HCl (Hydrochloride) 30 mg (milligram) tablets, lot #PB30221, expired 02/2025; eleven (11) tablets were in the container; and one (1) bottle Cinacalcet HCL 30 mg tablets, lot #PB30586, expired 07/2025. Twenty-five (25) tablets were in the container.
Left cabinet above clean sink (cabinets to the right of the crash cart) contained four (4) unopened bottles Cinacalcet HCl 30 mg tablets (30 tablets in each container). Three containers had the same lot #PB30221 and expiration date: 02/2025, and one container had lot #PB30586, expiration date: 07/2025.
Medication Refrigerator contained one (1) single dose 0.5 ml (milliliter) Influenza Vaccine Flucelvax 2024-2025 Formula, lot #391315, expired: 06/30/2025.
Emergency Evacuation Boxes (top box) contained forty-five (45) 2x2 sterile sponges, lot #91607-1, use by date: 03/2025.
All expired medications and supplies were given to the charge nurse on duty.
An interview conducted with the director of operations and clinical manager on August 6, 2025 starting at 3:30 PM confirmed the above findings.
Plan of Correction:For immediate compliance all expired items found at the time of the survey were discarded on August 5, 2025, by the clinic manager (CM).
For ongoing compliance, the CM or designee will in-service all the direct patient care staff (DPC) staff on the following policy:
- Storage of Supplies
Emphasis will be placed on ensuring that all medications and supplies, including Cinacalet HCL, Influenza vaccines and expired 2x2 sterile sponges, are all within the current date for use. The meeting reviewed that medications and supplies must be within a current date for expiration. The meeting will also review that stock must be rotated First In – First Out when restocking. The meeting will reinforce that staff must check the expiration date of medications and supplies before using them.
The inservice will be completed by August 29, 2025, and the education records will be on file in the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 29, 2025
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
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.
Observations:
Based on review of facility policies and procedures, medical records (MR), dialysis treatment documentation, and an interview with the director of operations and clinical manager, the facility did not follow its policy for monitoring during hemodialysis treatment (HDTX) for six (6) of six (6) in-center medical records reviewed: MR#1, MR#2, MR#3, MR#4, MR#5 and MR#6.
Findings include:
Facility Policy 5008X Patient Assessment and Monitoring, Reference Number 64462, Version 3 reviewed on August 5, 2025 at approximately 9:30 AM reads in part, "Monitoring During Treatment: Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations .....Check machine settings and measurements. Check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow. Record KECN value with 30 minute safety checks."
A review of medical records and hemodialysis treatment (HDTX) records was conducted on August 6, 2025 starting at approximately 7:45 AM, and again on August 7, 2025 starting at approximately 8:00 AM. The admission date (AD) is below.
MR#1 AD 04/30/2025: HD Treatment (HDTX) Record Review:
07/21/2025: HDTX was initiated at 6:13 AM. Documentation of KECN values (a measure used to determine the adequacy of the dialysis treatment) occurred at 6:58 AM, 7:33 AM, 8:02 AM, and 9:32 AM. The interval between 8:02 AM and 9:32 AM was 90 minutes which exceeded the monitoring threshold per facility policy.
07/23/2025: HDTX was initiated at 6:14 AM. Documentation of KECN values occurred at 6:36 AM, 7:01 AM, 8:00 AM, 8:29 AM, and 9:00 AM. The interval between 7:01 AM and 8:00 AM was 59 minutes which exceeded the monitoring threshold per facility policy.
07/25/2025: The HD prescription contained an order for a blood flow rate (BFR) of 400 mL (milliliters)/m (minute). Treatment was initiated at 6:20 AM. BFR was 200 mL/min and remained at 200mL/min until the end of the treatment at 9:32 AM. The RN evaluation note at 6:38 AM states that machine settings were verified. There was no documentation as to the reason for the change in BFR.
07/28/2025: HDTX was initiated at 6:03 AM. Documentation of KECN value occurred at 7:05 AM only which was not in accordance with facility policy.
08/01/2025: HDTX was initiated at 6:15 AM. Documentation of KECN value occurred at 7:00 AM only which was not in accordance with facility policy.
MR#2 AD 01/08/2024: HD Treatment Record Review
07/24/2025: : The HD prescription contained an order for a blood flow rate (BFR) of 400 mL (milliliters)/m (minute). Treatment was initiated at 12:28 PM. BFR 12:31 PM = 350 mL/m, then decreased to 300 mL/m at 1:06 PM and remained at 300mL/min until the end of the treatment (3:03 PM). The RN evaluation note at 12:45 PM states that HD orders and machine setup checked and verified. There was no documentation as to the reason for the change in BFR.
07/26/2025: HDTX was initiated at 12:37 PM. Documentation of KECN values occurred at 12:58 PM and 1:35 PM. There was no further documentation of KECN values which was not in accordance with facility policy.
07/28/2025: The HD prescription contained an order for a BFR 400 mL/m. Treatment was initiated at 5:00 PM. BFR 350 mL/m at 5:00 PM, then decreased to 300 mL/m at 6:06 PM and remained at 300mL/min until the end of the treatment (7:45 PM). There was no documentation as to the reason for the change in BFR. Documentation of KECN value occurred at 6:06 PM only which was not in accordance with facility policy.
07/29/2025: The HD prescription contained an order for a BFR 400 mL/m. Treatment was initiated at 12:11 PM. BFR 280 mL/m at 12:12 PM. BFR remained at 280 mL/m until the end of treatment at 3:22 PM. There was no documentation as to the reason for the change in BFR. No KECN values were recorded.
08/02/2025: The HD prescription contained an order for a BFR 400 mL/m. Treatment was initiated at 12:42 PM. BFR 350 mL/m at 12:43 PM and remained at that rate until 2:32 PM at which time the BFR was decreased to 300 mL/m. Treatment ended at 3:02 PM. There was no documentation as to the reason for the change in BFR.
MR#3 AD 05/10/2024: HD Treatment Record Review
07/21/2025: HDTX was initiated at 7:15 AM. Documentation of KECN values occurred at 8:01 AM, 9:02 AM, and 10:04 AM which was not in accordance with facility policy.
07/25/2025: HDTX was initiated at 7:00 AM. Documentation of KECN values occurred at 8:31 AM and then not again until 9:38 AM which was not in accordance with facility policy.
07/30/2025: HDTX was initiated at 7:10 AM. Documentation of KECN values occurred at 8:04 AM, 8:32 AM and then not again until 9:02 AM and 10:03 AM which was not in accordance with facility policy.
08/04/2025: HDTX was initiated at 7:20 AM. Documentation of KECN values occurred at 8:01 AM, and then not again until 9:02 AM which was not in accordance with facility policy.
MR#4 AD 06/16/2020: HD Treatment Record Review
07/21/2025: HDTX was initiated at 11:30 AM. Documentation of KECN values occurred at 12:04 PM, 12:32 PM, and then not again until 2:05 PM and 3:00 PM which was not in accordance with facility policy.
07/23/2025: The HD prescription contained an order for a blood flow rate (BFR) of 400 mL (milliliters)/m (minute). Treatment was initiated at 11:52 AM. BFR was 430 mL/min and remained at 430 mL/min until the end of the treatment at 4:22 PM. he RN evaluation note at 12:00 PM states that machine settings were verified. There was no documentation as to the reason for the change in BFR.
07/25/2025: HDTX was initiated at 11:31 AM. Documentation of KECN value occurred at 12:03 PM only which was not in accordance with facility policy.
07/30/2025: HDTX was initiated at 12:30 PM. Documentation of KECN values occurred at 1:01 PM, 1:33 PM, and then not again until 3:32 PM which was not in accordance with facility policy.
MR#5 AD 12/15/2023: HD Treatment Record Review
07/23/2025: HDTX was initiated at 14:11 PM. No KECN values were recorded during the entire treatment.
07/25/2025: HDTX was initiated at 14:11 PM. Documentation of KECN value occurred at 4:37 PM only which was not in accordance with facility policy.
07/28/2025: HDTX was initiated at 2:13 PM. Documentation of KECN values occurred at 3:08 PM, 3:32 PM, 4:07 PM, and then not again until 5:37 PM which was not in accordance with facility policy.
08/01/2025: HDTX was initiated at 2:16 PM. Documentation of KECN values occurred at 2:45 PM, 3:09 PM and then not again until 4:10 PM which was not in accordance with facility policy.
MR#6 AD 04/12/2024: HD Treatment Record Review
07/23/2025: HDTX was initiated at 4:11 PM. Documentation of KECN values occurred at 5:05 PM then not again until 6:04 PM which was not in accordance with facility policy.
07/25/2025: HDTX was initiated at 4:03 PM. Documentation of the first KECN value occurred at 6:05 PM which was not in accordance with facility policy. Treatment ended at 8:02 PM.
08/01/2025: HDTX was initiated at 4:01 PM. Documentation of the first KECN value occurred at 6:02 PM, and then not again until 7:03 PM which was not in accordance with facility policy.
An interview conducted with the director of operations and clinical manager on August 6, 2025 starting at 3:30 PM confirmed the above findings.
Plan of Correction:For ongoing compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Patient Assessment and Monitoring
The meeting will provide education on ensuring that the machine parameters and patient safety checks, including the KCEN, must be monitored with documentation every thirty (30) to forty-five (45) minutes during treatment. The inservice will also provide education on ensuring that the physician order for the patient's treatment is always followed. This includes the patient blood flow rate (BFR). Emphasis will also be placed on ensuring that any BFR not within the prescribed physician limits must be reported to the Registered Nurse for evaluation, intervention, and documentation. The reason the BFR is not being achieved must be documented. The staff will be instructed that there must be documentation of the RN notification by the patient care technician (PCT). The RN must document the evaluation of the BFR with interventions taken along with physician notification as indicated.
The inservice will be completed by August 29, 2025, and the education records will be on file in the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if compliance is observed, the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is maintained. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 29, 2025
494.90(b)(2) STANDARD
POC-INITIAL IMPLEMENTED-30 DAYS/13 TX
Name - Component - 00
Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session.
Observations:
Based on a review of facility policies, medical records (MR), and interviews with the home therapy nurse, director of operations, and clinical manager, the facility failed to assure that an initial plan of care occurred within 30 calendar days after admission to the dialysis facility for one (1) of nine (9) MR's reviewed: MR#9.
Findings include:
Facility Policy Home Dialysis Patient Education and Training Guidelines, Reference Number 15598, Version 6 reviewed on August 5, 2025 at 3:10 PM states in part, "Completion of the initial Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC) must be completed within 30 days or 13 treatments of the patient's admission according to the Comprehensive Interdisciplinary Assessment and Plan of Care policy, regardless of when the patient begins contiguous modality training."
Facility Policy Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC), Reference Number 45283, Version 6 reviewed on August 5, 2025 reviewed on August 5, 2025 at 3:30 PM reads in part, "CIA and POC for Transfers or Transients: If the comprehensive patient assessment and plan of care for an experienced dialysis patient transferring from one dialysis facility to another is received with the patient in transfer, the receiving facility's IDT must conduct a reassessment within three months of the patient's admission to the new facility. If a patient is transferring dialysis facility and the transferring facility has NOT provided a current CIA and POC, the receiving facility must complete a CIA and POC within 30 days of admission....patients changing modality are classified as new patients and must have comprehensive interdisciplinary assessment and plans of care completed with the same frequency as patients new to dialysis. The timeline for both the completion of the initial comprehensive assessment and the beginning of implementation of the initial plan of care is the latter of 30 days from the date of admission or 13 treatments at the facility. A follow-up CIA must occur within 90 days. The POC should be adjusted as appropriate and implemented within 15 days of reassessment."
A review of medical records and dialysis treatment (TX) records was conducted on August 6, 2025 starting at approximately 7:45 AM, and again on August 7, 2025 starting at approximately 8:00 AM. The admission date (AD) is below.
MR#9 AD 06/03/2025 was transferred and admitted to BMA of Northeastern Philadelphia (receiving facility) from an out of State Fresenius dialysis center on 06/03/2025. The MR contained a POC dated 07/30/2025. The POC noted that the last POC meeting was held at the previous facility on 03/24/2025 due to the patient's change in modality to peritoneal dialysis (PD) on/around 03/05/2025. There was no 90 day reassessment after the 03/24/2025 POC due to the patient's transfer from the out of State dialysis center. The POC meeting dated 07/30/2025, which occurred at the receiving facility, was classified as an Initial CIA. The interval for the next meeting was 90 days, scheduled for 10/28/2025. The CIA and POC were not completed within 30 days of admission to the receiving facility.
An interview conducted with the director of operations and clinical manager on July 6, 2025 starting at 3:30 PM confirmed the above findings.
Plan of Correction:The CM or designee will re-educate the Interdisciplinary Team (IDT) staff on the following policy:
- Comprehensive Interdisciplinary Assessment and Plan of Care
Emphasis will be placed on ensuring that all newly admitted patients have their initial comprehensive assessment and plan of care (CIA/POC) completed on time. This means completion of the CIA/POC within the latter of 30 days or thirteen (13) outpatient treatments. The is-service will also reinforce that a ninety (90) reassessment must also be completed after the initial assessment. The initial CIA/POC applies to any patient changing modalities.
The in-servicing will be completed by August 29, 2025, with documentation of the training on file at the facility.
The CM or designee will perform monthly audits of all patient or modality change patients care plans to ensure timely IDT completion for the next six (6) months. At that time, if 100% compliance is observed, the audits will then be completed following the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Issues of non-compliance will be addressed by the CM with re-education and counseling.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: September 29, 2025
494.100(a) STANDARD
H-IDT OVERSEES HOME TRAINING
Name - Component - 00
The interdisciplinary team must oversee training of the home dialysis patient, the designated caregiver, or self-dialysis patient before the initiation of home dialysis or self-dialysis (as defined in §494.10) and when the home dialysis caregiver or home dialysis modality changes.
Observations:
Based on a review of facility policy, medical records (MR), and interviews with the home training nurse, director of operations and clinical manager, the facility failed to provide evidence of competency for home dialysis for one (1) of three (3) home dialysis MR's reviewed: MR#9.
Findings include:
Facility Policy Home Dialysis Patient Education and Training Guidelines, Reference Number 15598, Version 6 reviewed on August 5, 2025 at 3:00 PM states in part, "Transfer of Trained Home Therapies Patients: The receiving facility must verify the competency of the patient, and if applicable care partner, to safely perform home dialysis .....Training treatments will be documented in the medical record. Patient and care partner (if applicable) training and competency of required material and performing home dialysis procedures must be documented in the patient medical record."
An interview with PF#4 occurred on August 5, 2025 at approximately 3:20 PM. PF#4 noted that a home Continuous Ambulatory Peritoneal Dialysis (CAPD) patient (MR#9) had been transferred into the facility from an out of state Fresenius dialysis location. PF#4 stated that s/he contacted the transferring facility and spoke with the nurse to confirm that the patient had received training and was competent to perform home dialysis. An interview with PF#4 on August 6, 2025 at approximately 1:00 PM reiterated the same information as noted above. In addition, PF#4 stated that MR#9 does not have a care partner.
A review of medical records and dialysis treatment (TX) records was conducted on August 6, 2025 starting at approximately 7:45 AM, and again on August 7, 2025 starting at approximately 8:00 AM. The admission date (AD) is below.
MR#9 AD 06/03/2025. The patient transferred into BMA of Northeastern Philadelphia (receiving facility) from an out of state Fresenius facility. There was no evidence of, or documentation provided, that the receiving facility verified the competency of the patient to safely perform home dialysis upon transfer into the facility per facility policy.
An interview with the director of operations and clinical manager on August 6, 2025 starting at 3:30 PM confirmed the above findings.
Plan of Correction:The CM and the Home Therapy (HT) Program Manager (PM) or designee will re-educate the HTRN staff on the following policy:
- Home Dialysis Patient Education and Training Guidelines
Emphasis of the meeting will be placed on ensuring that the patient and/or care partner are validated as competent to perform home dialysis before they are allowed to function independently. This training must be documented in the patient's medical records. If the patient is transferring into another unit this documentation must be received by the receiving unit and placed in the medical records. This includes any transferring peritoneal dialysis (PD) patients.
The HTPM or designee will conduct monthly audits utilizing Home Therapy Medical Record Audit Tool for three (3) months on all transferred in home patients, including PD patients. Once compliance is sustained, auditing will resume as regularly scheduled based on the QAPI calendar. Monitoring will be done through the Medical Records Audit.
The in-servicing will be completed by August 29, 2025, with documentation of the training on file at the facility.
Issues of non-compliance will be addressed by the CM and/or the HTPM with re-education and counseling.
The HTPM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: September 29, 2025
494.100(b)(2),(3) STANDARD
H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS
Name - Component - 00
The dialysis facility must -
(2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and
(3) Maintain this information in the patient ' s medical record.
Observations:
Based on a review of facility policies, medical records (MR), and interviews with the home therapy nurse, director of operations, and clinical manager, the facility failed to assure that self-monitoring data and other information from self-care patients or their designated caregivers was retrieved and reviewed by the facility for one (1) of three (3) MR's reviewed: MR#9.
Findings include:
Facility Policy PD Home Patient Responsibility Consent, Reference Number 23544, Version 6 reviewed August 6, 2025 at 3:50 PM reads in part, "Maintain accurate home treatment records (electronic and/or paper) and equipment logs and bring them with me for review during my monthly clinic visit."
Facility Policy Home Therapies Patient Treatment Record Keeping, Reference Number 47992, Version 2 reviewed on August 5, 2025 at 3:50 PM states in part, "Home treatment records will be reviewed by the home therapy registered nurse during patient monthly clinic visits to identify trends, errors or omissions, and other issues or concerns to be addressed with the patient and/or care partner."
Facility Policy Review and Documentation of Home therapies Patient Health Data, Reference Number 23557, Version 4 reviewed on August 5, 2025 at 3;55 PM reads in part, "In instances in which the patient is not transmitting any data electronically or via portable device, whether intermittently due to patient choice or as the result of connectivity issues, they may be required to document treatment data via paper flowsheets and regularly provide the flowsheets for review by the home therapies nurse....At a minimum, the home therapies nurse will perform a comprehensive monthly review of all treatment data, regardless of the method of data submission. Data review will be discussed with the patient and/or care partner during the patient's regular clinic visit and concerns will be addressed and documented accordingly."
Facility Policy Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC), Reference Number 45283, Version 6 reviewed on August 5, 2025 reviewed on August 5, 2025 at 3:30 PM reads in part, "Patient stability must be reviewed monthly. The interdisciplinary team will offer input to the attending physician who will determine whether the patient is stable or unstable on the criteria included in this policy...Failure to Achieve Plan of Care Outcome: if the patient specific expected outcome as determined by the attending physician, IDT and patient for the POC is not achieved within the identified timeframe, the IDT must adjust the patient's POC and document changes made to the POC and implement the POC changes to address the identified needs."
An interview was held with PF#4 on August 6, 2025 at approximately 1:00 PM. PF#4 stated that MR#9 is to complete paper flowsheets with each continuous ambulatory peritoneal dialysis (CAPD) treatment, does not have a care partner (lives alone) and that MR#9 is not compliant with monthly clinic visits. PF#4 stated that MR#9 came to the facility in July for labwork but did not attend the monthly clinic visit.
A review of medical records and dialysis treatment (TX) records was conducted on August 6, 2025 starting at approximately 7:45 AM, and again on August 7, 2025 starting at approximately 8:00 AM. The admission date (AD) is below.
MR#9 AD 06/03/2025 did not contain any CAPD flowsheets from 06/03/2025 to 08/06/2025 for review. The patient attended clinic with a family member on 06/20/2025. An RN note dated 06/20/2025 stated, "S/he was given flowsheets at initial visit but did not bring in any flowsheets. Unable to assess what s/he does at home. BP (blood pressure) is high; s/he admits to missing doses. Reinforced the importance of documenting vital signs to give him/her insight on how body is functioning." A physician note dated 06/20/2025 stated, "Patient is not adhering to prescription." The patient was seen at the dialysis clinic on 7/16/2025 but apparently did not stay for the clinic visit. An RN note dated 06/20/2025 stated, "S/he is not documenting treatments. S/he has been given flowsheets. S/he states it does not look like the one s/he is used to and s/he cannot see well." The RN review further noted that patient data was not available for review and that treatment data was not complete and satisfactory." The plan of care dated 07/30/2025 did not address the patient's non-compliance with providing flowsheets for patient monitoring.
An interview conducted with the director of operations and clinical manager on August 6, 2025 starting at 3:30 PM confirmed the above findings.
Plan of Correction:The CM and the HTPM or designee will re-educate the HTRN staff on the following policy:
- PD Home Patient Responsibility and Consent
- Home Therapies Patient Treatment Record Keeping
- Review and Documentation of Home Therapies Patient Health Data
- Comprehensive Interdisciplinary Assessment and Plan of Care
Emphasis of the meeting will be placed on ensuring that the home therapies nurses will perform a comprehensive monthly review of all treatment data, regardless of the method of data submission. Any concerns identified will be addressed and documented when variances from the prescription are noted. These concerns are lack of documentation and/or submission of flowsheets, errors or omissions, vital signs (VS), missing monthly clinic visits, which need to be addressed with the patient and/or care partner. Follow up communication with the patient, including interventions or instructions as needed, will be documented in the patient's medical record. Staff will be informed that ongoing compliance concerns need to be updated in the patient's care plan with patient review of consent to adhere to facility requirements.
The HTPM or designee will conduct monthly audits utilizing Home Therapy Medical Record Audit Tool for 3 months on all transferred in PD patients. Once compliance is sustained, auditing will resume as regularly scheduled based on the QAPI calendar. Monitoring will be done through the Medical Records Audit.
The in-servicing will be completed by August 29, 2025, with documentation of the training on file at the facility.
Issues of non-compliance will be addressed by the CM and/or the HTPM with re-education and counseling.
The HTPM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: September 29, 2025
494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P
Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;
Observations:
Based on review of facility policies and procedures, medical records (MR), dialysis treatment documentation, and an interview with the home therapy nurse, director of operations and clinical manager, the facility did not follow its policy for monitoring during treatment for two (2) of nine (9) treatment records reviewed: MR#4 and MR#5, and did not follow its policy for managing home dialysis (HoD) patients for one (1) of three (3) HoD records reviewed; MR#9.
Findings include:
Facility Policy 5008X Patient Assessment and Monitoring, Reference Number 64462, Version 3 reviewed on August 5, 2025 at approximately 9:30 AM reads in part, " Monitoring During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulation. Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations."
Facility Policy Documenting Progress Notes, Transfers, Transplants, Discharges and Order Review, Reference Number 46934, Version 6 states in part, "Progress/clinical note documentation should provide a picture of the patient's care, including response to treatment, change in condition and changes in treatment. Progress notes shall be written as necessary or according to state requirements to document the condition and care of the patient."
Facility Policy Comprehensive Interdisciplinary Assessment (CIA) and Plan of Care (POC), Reference Number 45283, Version 6 reviewed on August 5, 2025 reviewed on August 5, 2025 at 3:30 PM reads in part, "Patient stability must be reviewed monthly. The interdisciplinary team will offer input to the attending physician who will determine whether the patient is stable or unstable on the criteria included in this policy...Failure to Achieve Plan of Care Outcome: if the patient specific expected outcome as determined by the attending physician, IDT and patient for the POC is not achieved within the identified timeframe, the IDT must adjust the patient's POC and document changes made to the POC and implement the POC changes to address the identified needs."
Facility Policy Home Dialysis Patient Education and Training Guidelines, Reference Number 15598, Version 6 reviewed on August 5, 2025 at 3:00 PM states in part, "Transfer of Trained Home Therapies Patients: The receiving facility must verify the competency of the patient, and if applicable care partner, to safely perform home dialysis .....Training treatments will be documented in the medical record. Patient and care partner (if applicable) training and competency of required material and performing home dialysis procedures must be documented in the patient medical record."
Facility Policy PD Home Patient Responsibility Consent, Reference Number 23544, Version 6 reviewed August 6, 2025 at 3:50 PM reads in part, "I understand and agree that I must adhere to the following requirements in order to be qualified to receive treatment as an FKC (Fresenius Kidney Care) home peritoneal dialysis patient and that failure to comply with the patient responsibilities may result in the re-evaluation of my ability to perform home dialysis. Failure to comply with these responsibilities could place me at serious risk. Therefore, my provider and the interdisciplinary team (IDT) may decide that another kind of dialysis treatment is better for ensuring my safety and well-being: Maintain accurate home treatment records (electronic and/or paper) and equipment logs and bring them with me for review during my monthly clinic visit."
Facility Policy Home Therapies Patient Treatment Record Keeping, Reference Number 47992, Version 2 reviewed on August 5, 2025 at 3:50 PM states in part, "Home treatment records will be reviewed by the home therapy registered nurse during patient monthly clinic visits to identify trends, errors or omissions, and other issues or concerns to be addressed with the patient and/or care partner."
Facility Policy Review and Documentation of Home therapies Patient Health Data, Reference Number 23557, Version 4 reviewed on August 5, 2025 at 3;55 PM reads in part, "In instances in which the patient is not transmitting any data electronically or via portable device, whether intermittently due to patient choice or as the result of connectivity issues, they may be required to document treatment data via paper flowsheets and regularly provide the flowsheets for review by the home therapies nurse....At a minimum, the home therapies nurse will perform a comprehensive monthly review of all treatment data, regardless of the method of data submission. Data review will be discussed with the patient and/or care partner during the patient's regular clinic visit and concerns will be addressed and documented accordingly."
A review of the Fresenius Kidney Care template document titled "Find the right dextrose (sugar) solution for you" was reviewed on 08/06/2025 at 3:10 PM. The document is intended to be completed by the facility, in conjunction with the patient, to provide guidance to the patient as to the concentration of dextrose to be used, based on blood pressure (BP), weight, swelling, or the presence or absence of shortness of breath." Dextrose concentrations of 1.5%, 2.5% or 4.25% are chosen based on the above parameters. A concentration of 1.5% dextrose removes the least amount of fluid, while a concentration of 4.25% removes the most amount of fluid.
An interview was conducted with PF#4 on 08/06/2025 at approximately 3:20 PM. PF#4 was asked if s/he knew which concentration of dextrose MR#9 was using since no flowsheets were provided by the MR#9. PF#4 responded that s/he believed that MR#9 was using "mostly 1.5% dextrose."
A review of medical records and dialysis treatment (TX) records was conducted on August 6, 2025 starting at approximately 7:45 AM, and again on August 7, 2025 starting at approximately 8:00 AM revealed the following:
MR#2 AD 01/08/2024 was admitted to the hospital on 04/28/2025 due to problems with the permacath (catheter used for dialysis). The patient was found to be fluid overloaded during this hospitalization. Discharge date was unknown. The patient was readmitted to the hospital 05/31/2025 to 06/04/2025 due to shortness of breath. The MR contained a plan of care (POC) meeting date of 11/29/2024 at which time the patient was declared stable. Next POC meeting date was scheduled for 11/29/2025. A comprehensive physician note dated 06/12/2025 stated that the patient was not stable, underdialyzed and fluid overloaded despite orders for HD treatments 4 times per week. The note also stated that the patient was not compliant with the treatment frequency due to either missed treatments or shortened treatments (coming late to treatments). The HD prescription was last updated 06/18/2025. A basic physcian note dated 07/01/2025 stated that the patient was not stable. A comprehensive physician note dated 07/29/2025 stated that the patient was not stable, continued to be underdialyzed, fluid overloaded, and not consistently adherent to the dialysis treatment schedule. There was no evidence that the POC was adjusted and changed due to the patient not achieving the expected outcome and the physicians' notes indicating continued instability. There were no progress notes after 06/19/2025 from other members of the IDT addressing the patient's non-compliance to treatment times.
MR#4 AD 09/16/2020 Hemodialysis (HD) Treatment Date 07/23/2025 found that treatment was started at 11:52 AM. Vital signs were documented every 30 to 45 minutes except for the time frame between 2:38 PM and 3:33 PM whereby the interval between vital sign monitoring was 55 minutes which exceeded facility policy.
MR#5 AD 12/15/2023 HD Treatment Date 08/01/2025 found that treatment was started at 2:16 PM. Vital signs were documented every 30 to 45 minutes except for the time frame between 3:09 PM and 4:10 PM whereby the interval between vital sign monitoring was 61 minutes which exceeded facility policy.
MR#9 AD 06/03/2025. The patient began continuous ambulatory peritoneal dialysis (CAPD) around 03/2025 at an out of State dialysis center and was transferred and admitted to BMA of Northeastern Phila (facility) on 06/03/2025. There was no evidence that the facility conducted or verified competency to perform CAPD upon transfer.
The CAPD prescription was last updated 06/02/2025. The CAPD order noted the following: # Exchanges: 2. Days per week: 7. Daytime fill volume: 2500 mL (milliliters). Nighttime fill volume: 2500 mL. Minimum dwell time: 8 hours, 0 minutes. EDW (estimated dry weight): 68 kg (kilograms). Dextrose: 1.5% or 2.5% or 4.5%. There was no completed or customized "Find the right dextrose solution for you" document provided or in the MR to establish which dextrose concentration the patient should be using with each treatment, based on the formerly noted parameters.
There were no CAPD flowsheets provided or contained in the MR for review, for the time frame 06/03/2025 (admission date) to 08/06/2025 (survey exit date).
A review of the treatment history found that the patient's weight progressively increased over a 4 month period: April (70 kg), May (74 kg), June (77.3 kg), July (80.2 kg). Kt/V Peritoneal (a measure used to assess dialysis adequacy) was 0.97 (target is 1.7) in June 2025; previous Kt/V in March 2025 (prior to transfer) was 2.07.
The patient attended a monthly clinic visit on 06/20/2025 with a family member. The physician note stated, "First visit. Does 2 exchanges daily. No RRF (residual renal function). Not enough. Inc (increase) to 3 (exchanges) with 2.5L (liters). BP high, BP rx (medication regimen) adjusted. Add Valsartan (an antihypertensive) 80 mg daily." The physician further documented the following: patient is not adhering to prescription; adequacy target was not met - prescription change discussed with staff and patient; changes to plan of care made in orders; prescription reviewed with patient and daughter. Eventual increase to 4x (4 exchanges per day). The physician documented that the patient was stable and high blood pressure was noted. There was no exam documented, i.e., pulmonary, edema, cardiovascular, feet.
The patient also interacted with PF#4 on 06/20/2025 during the monthly clinic visit. Recorded BP's were 253/125 (sitting) and 249/133 (standing). Asymptomatic. PF#4 noted that no patient data was available for review and treatment data was not complete or satisfactory, further commenting, "s/he was given flowsheets at initial visit but did not bring in any flowsheets. Unable to assess what s/he does at home. BP is high. S/he admits to missing doses. Reinforced the importance of documenting vital signs to give insight on how body is functioning." Exam by PF#4 revealed 1+ (2mm or less) ankle edema (fluid), decreased breath sounds.
A note by PF#5 on 06/20/2025 found that MR#9 stated that s/he had caregiver support to assist with daily care, but the caregiver did not live with MR#9.
MR#9 came to the dialysis clinic on 7/16/2025 for lab work but did not attend the monthly clinic visit. An RN note dated 7/16/2025 recorded a sitting BP 206/115, and standing BP 159/107. There was no documentation that the physician was notified of the blood pressure readings especially given that the patient had been started on an additional antihypertensive the month prior. The RN note recorded that MR#9 was "having vision issues, was not documenting treatments, had been given flowsheets," and MR#9 stated that "the flowsheets did not look like the one s/he was used to and s/he cannot see well."
A plan of care meeting was held on 07/30/2025. Documentation by PF#4 in the POC on 07/25/2025 found the following interventions: "Increase dialysis time (MD order) (PD); Increase volume (MD order)." PF#4 noted: "Poor eye sight" and "s/he has not met PD adequacy. S/he is resisting the education to increase PDF (peritoneal dialysis fluid) volume)."
There was no mention in the POC meeting dated 07/30/2025 of MR#9 being non-compliant with providing PD flowsheets for review, nor attendance at the most recent clinic visit, especially since continual monitoring of treatment adherence and effectiveness was otherwise absent except for lab values. There was also no discussion in the POC meeting minutes of possible alternative strategies to address the non-compliance such as modifying the PD flowsheet to accommodate the patient's poor vision, changing the modality given the inability to effectively monitor the safety and well-being of the patient (and given that the patient lived alone), and/or contacting the end stage renal disease (ESRD) network for assistance with non-compliance. There was no evidence that consideration was given to establishing the patient as unstable.
While the physician and RN both noted that a prescription change was made to increase the dialysis exchanges from 2 exchanges to 3 exchanges per day, the last prescritpion was dated 06/02/2025 and contained orders for only 2 exchanges. Likewise, an order printed on 08/06/2025 continued to show that only 2 exchanges were ordered.
The patient was hospitalized as of 08/03/2025 due to fluid overload.
An interview conducted with the director of operations and clinical manager on August 6, 2025 starting at 3:30 PM confirmed the above findings.
Plan of Correction:By August 29, 2025, the Director of Operations (DO),the CM and HTPM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policies:
- Patient Assessment and Monitoring
- Medication Preparation and Administration
- Documenting Progress Notes, Transfers, Transplants, Discharges and Order Review
- Comprehensive Interdisciplinary Assessment and Plan of Care
- PD Home Patient Responsibility and Consent
- Home Dialysis Patent Education and Training Guidelines
- Home Therapies Patient Treatment Record Keeping
- Review and Documentation of Home Therapies Patient Health Data
- Document "Find the right dextrose (sugar) solution for you"
The Medical Director will be informed at the meeting with the DO, CM and HTPM that the DPC, HTRN and IDT staff will be re-educated on the above policies. The focus of the meeting will be on:
- Monitoring safety checks and VS q 30-45 minutes
- Review of HT patients' flowsheets
- Updating care plans when needed, when patients are non-compliant, not meeting dry weights, not doing exchanges per prescription
- Transferring HT patients will have training and competency documentaion from transferring unit on file
- Ongoing HT compliance concerns need to be updated in the patient's care plan with patient review of consent to adhere to facility requirements including submission of flowsheets/treatment data
- Home treatment records will be reviewed by the home therapy registered nurse during patent monthly clinic visits to identify trends, errors or omissions, and other issues or concerns to be addressed with the patent and/or care partner
- Completion of the document: Find the right dextrose solution for you"
- Address VS out of acceptable range, including blood pressures (BP) with physician notification and documentation of physical, if indicated
The staff in-service will be completed by August 29, 2025. Documentation of the meeting will be on site at the facility.
The CM, HTPM or designee will perform weekly audits for 2 months. At that time if 100% compliance is observed the audits will then be completed 2/month for 2 months to ensure that compliance is maintained. At that time, the audits will then follow the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the audit results and report the findings to the Medical Director prior to the QAPI meetings. The audit results will also be reviewed at the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 29, 2025
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