Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on August 12 and 13, 2025, Riddle Dialysis Center 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 on August 12 and 13, 2025, Riddle Dialysis Center 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:
494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE
Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.
Observations:
Based on a review of facility policies/procedure, staff observations (OBS) in the treatment area, and an interview with the facility administrator and manager of clinical services, it was determined that the facility failed to ensure to follow its policy on infection control for five observations: OBS # 1, 2, 3 and 4.
Findings include:
A review of agency ' s policies was conducted on 7/18/25 starting at 1 pm.
A policy titled, " INFECTION CONTROL FOR DIALYSIS FACILTIES " reads, " ...HAND HYGEINE: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene ... b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact ... "
Observation in the treatment area was conducted on August 12, 2025 from approximately 8:40 am to 11:30 am.
OBS #1 on 9/12/25 at approximately 10:20 am, at station#7, the PCT (Patient Care Technician #2) did not remove gloves and perform hand hygiene after the Central Venous Catheter (CVC) exit site care and prior to initiation of dialysis. After initiation of dialysis, PF#4 touched her own mask prior to removing gloves and performing hand hygiene. PF#4 did not perform hand hygiene after removing gloves.
OBS #2 on 8/12/25, at approximately 9 am, at station#6, the PCT (Patient Care Technician #2) did not remove gloves and perform hand hygiene after discontinuation of CVC dialysis and prior to touching a patient ' s wheelchair handles.
OBS #3 on 8/12/25, at approximately 10 am, at station#3, the PCT (Patient Care Technician #1) did not remove gloves and perform hand hygiene after palpitation of cannulation site and prior to inserting cannulation needle.
OBS #4 on 8/12/25, at approximately 9:05 am, at station #6, the PCT (Patient Care Technician #2) did not perform hand hygiene after cleaning and disinfection of the dialysis station.
An interview with the administrator and manager of clinical services on 8/13/25 starting at 3:30 pm.
Plan of Correction:V 0113 The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/21/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-05-01 "Infection Control for Dialysis Facilities" with emphasis on but not limited to: 1) All teammates will perform hand hygiene... b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee immediately conducted an audit of treatment initiation and termination chairside to observe that policy is being followed. The Facility Administrator or designee will conduct infection control audits to verify teammates are compliant with hand hygiene prior to gloving and immediately after removing gloves per policy: daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly infection control audit. Instances of non-adherence will be corrected immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction. This will be completed by 10/17/2025.
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on review of facility policy, medical records (MR) and interview with the administrator and manager of clinical services, the facility to ensure that the plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status for three (3) of ten (10): MR# 3, 8 and 9.
Findings include:
A review of agency ' s policies was conducted on 8/13/25 starting at 2 pm.
A policy titled, " PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT " reads, " ... POLICY: ... PRE-TREATMENT COLLECTION/ASSESSMENT: 4. Any abnormal findings or findings outside of any patient specific digestion order the parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse (refer to " Abnormal Findings " section of this policy). If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis ... INTRADIALYTIC DATA COLLECTION/ASSESSMENT: 8. The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law ... 10. If the dialysis the prescription is not being met including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed. 11. Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to " Abnormal Findings " section in this policy). The licensed nurse will use his/her clinical judgment based on individual patients needs to determine if any clinical interventions are necessary ... 13. All findings, interventions and the patient response will be documented in the patient ' s medical record ... POST TREATMETN DATA COLLECTION/ASSESSMENT: ... 16. If a abnormal finding(s) or concern is identify the post the treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 17. Licensed nurse will use their clinical judgment to based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility ... ABNORMAL FINDINGS: ... Blood Pressure - Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg ... Blood Pressure - Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg, Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg ... Blood Pressure Post Treatment: ... Sitting BP (blood pressure) for patient ' s that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg, sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg ... Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or irregular beat ... Pre/Intra/Post Patient Records/Complaints and/or teammate observation of: ... bleeding, ... weakness or numbness ... Vascular Access: Any ... bleeding ... "
A review of patient medical records (MR) was conducted on 8/12/25 starting at 12:40 pm.
Review of clinical files determined that on following abnormal findings were not reported to the licensed nurse on duty per facility policy.
MR #3: Admission Date:11/8/23.
Treatment record for 8/6/25 showed Intra-treatment Blood Pressure of 152/110 at 12:01 pm, 121/91 at 12:02 pm. Treatment record did not indicate that the nurse was notified according to policy.
Treatment record for 7/28/25 showed Intra-treatment Blood Pressure of 123/103 at 11:31 pm, 88/66 at 12:01 pm. A PCT note from 12:01 pm reads, " UF (ultrafiltration) off c/o low BP. " A PCT note from 12:05 pm reads, " UF on. " Treatment record did not indicate that the nurse was notified according to policy.
MR #8: Admission Date: 9/22/20.
Treatment record for 8/6/25 showed Intra-treatment heart rate over 100 BPM (beats per minute) at 12:02 pm and from 12:51 pm to 2:37 pm. A nurse note at 12:51 pm reads, " patient awake; alert; and states no complaints at this time. " A nurse note at 1:02 pm reads, " patient appears to be tolerating treatment well at this time. " A nurse note at 1:47 pm reads, " patient monitored; watching tv no complications. " A nurse note at 2:02 pm reads, " patient monitored; watching tv no complications. " Nurse assessment completed at 2:59 pm and it reads " Standing heart rate of 49 BPM, Blood Pressure of 112/90 mmHg ...Sitting Heart rate of 118 BPM, Blood Pressure of 137/96... Observations: Regular Rate & Rhythm ... " There is no documentation that the nurse used their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician were indicated per policy.
Treatment record for 8/1/25 showed pre-treatment Standing Blood Pressure of 174/113 and Sitting Blood Pressure of 179/112 at 10:24 am. Treatment started without nurse being notified according to policy. Nurse assessment completed at 10:46 am and it reads " Standing Blood Pressure of 174/113 and Sitting Blood Pressure of 179/112... Observations: Regular Rate & Rhythm ..." There is no documentation that the nurse used their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician were indicated per policy.
MR #9: Admission Date: 5/22/23.
Treatment record for 8/1/25 showed Intra-treatment Heart Rate over 100 BPM from 10:30 am to 12:30 pm. Treatment record did not indicate that the nurse was notified according to policy.
An interview with the administrator and manager of clinical services on 7/13/25 starting at 3:30 pm confirmed the above findings.
Plan of Correction:
V 543 The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 8/21/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-03-08 "Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: [Pre-treatment Data Collection]: 1) Any abnormal findings or findings outside of any patient specific physician ordered parameters discovered during pre-treatment data collection will be documented and immediately reported to the licensed nurse ... If an abnormal finding is reported to the licensed nurse pre-treatment, the nurse will assess the patient prior to the initiation of dialysis. [Intradialytic Data Collection / Assessment]: 2) The licensed nurse will round on those patients without reported abnormal findings and complete the nursing assessment within one (1) hour of dialysis treatment initiation or sooner as required by state law. 3) Intra dialytic treatment monitoring and data collection which may be performed by the PCT or licensed nurse includes vital signs and treatment monitoring at least every 30 minutes. At a minimum, obtain and document the following: i. Blood pressure ii. Heart or pulse rate ... 4) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 5) All findings, interventions and patient response will be documented in the patient's medical record. 6) The PCT or licensed nurse will obtain and document basic data on each patient post dialysis and will compare it to pre-dialysis findings. 7) If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge. 8) Licensed nurse will use their clinical judgment based on individual patient needs to determine if any clinical interventions or notification of physician (or NPP as applicable) is necessary prior to discharge of the patient from the facility. 9) Abnormal Findings: a) Blood pressure: Pre-dialysis: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. b) Blood Pressure-Intradialytic: Systolic greater than 180 mm/Hg or less than 90 mm/Hg; Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. c) Blood Pressure Post Treatment: If the patient can stand: Standing systolic BP greater than 140 mm/Hg or less than 90 mm/Hg; Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg; If patient is not able to stand, document reason and sitting BP; Sitting BP for patient's that cannot stand: Sitting systolic BP greater than 140 mm/Hg or less than 90 mm/Hg o Sitting diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. d) Heart or Pulse Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat. e) Pre-Intra-Post Patient Complaints or observations of: bleeding... weakness or numbness ... Vascular access: any bleeding... Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct flowsheet audits to verify with any documentation of abnormal findings, [including blood pressure readings or heart rate] there is also documentation of report to the licensed nurse, and nurse response is documented, including but not limited to assessment or physician notification as needed, per policy: on twenty five percent (25%) of the flow sheets daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits to verify compliance. Instances of non-compliance will be addressed immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction. this will be completed by 10/17/2025
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/procedure, medical records (MR), and an interview with the administrator and manager of clinical services, the facility failed to ensure the blood flow rate (BFR), Dialysate Flow Rate (DFR), treatment duration were administered per physician order for three (3) of six (6) in-center hemodialysis patient MR's reviewed: MR# 7, 8 and 9.
Findings include:
A review of agency ' s policies was conducted on 8/13/25 starting at 5 pm.
A policy titled, " PHYSICIAN ORDERS FOR PATIENT CARE " reads, " ...POLICY: GENERAL: ... 9. The licensed nurse teammate and Registered Dietitian have the right to refuse to carry out orders, which in his/her judgement may be harmful or damaging to the patient. In such an event, he/she must notify the involved physician and administrator/designee immediately. The administrator/designee will in turn notify the Medical Director, and the Reginal Operational Director. The licensed nurse teammate or Registered Dietitian refusing to carry out the order master document (including signature and the date) the reason they have refused to carry out the order in the patient's medical record. Resolution to the licensed nurse teammate or registered dietitian ' s refusal to carry out the order must also be documented ... "
A policy titled, " PRESCRIBED TREATMENT TIME NOT MET " reads, " ...POLICY: A. COMPLETION OF THE EARLY TERMINATION OF TREATMENT AGAINST MEDICAL ADVICE FORM, 1. The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice from any time the patient requests to terminate their treatment earlier than the prescribed run time. ... 3. The RN will obtain the patient ' s signature on the Early Termination of Treatment Against Medical Advice from prior to the patient being rinsed back from their treatment ... 4. A RN must countersign all Early Termination of Treatment Against Medical Advice forms. A witness signature is required only if the patient refuses to sign the form ... B. PRESCRIBED TREATMENT TIME NOT MET: 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient ' s attending nephrologist to discuss the appropriate intervention ... 5. Additionally, if the patient ' s dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling the treatment time ... "
A review of patient medical records (MR) was conducted on 8/12/25 starting at 12:40 pm.
MR #7: Admission Date: 7/14/25. Total treatment records reviewed:6, Treatment records reviewed between 8/8/25 and 7/28/25.
Order reads in part the following: Frequency: Three times a week; target weight: 78.5 kg; Blood Flow Rate (BFR): 350 mL/min; Dialysate Flow Rate (DFR): 500 mL/min; Treatment Duration: 210 min.
Review of Dialysis Treatment Details Reports revealed the BFR and treatment time were not administered at prescribed rates on the following dates:
On 8/6/25, during entire treatment, the BFR was administered at 300 mL/min.
On 8/6/25, treatment duration was 182 minutes.
On 8/4/25, from 3:31 pm to 5:50 pm, the BFR was administered at 250 mL/min.
On 8/1/25, from 2:30 pm to 3 pm, the BFR was administered at 300 mL/min.
On 8/1/25, from 3 pm to 5:33 pm, the BFR was administered at 250 mL/min.
On 7/30/25, from 3:01 pm to 5:51 pm, the BFR was administered at 300 mL/min.
On 7/28/25, from 4:01 pm to 5:52 pm, the BFR was administered at 300 mL/min.
There was no documentation regarding the reason for not meeting ordered BFR and treatment time.
MR #8: Admission Date:9/22/20. Total treatment records reviewed:5, Treatment record reviewed between 8/8/25 and 7/28/25.
Order reads in part the following: Frequency: Three times a week, target weight: 93.5kg; Blood Flow Rate (BFR): 350mL/min; Dialysate Flow Rate (DFR): 700mL/min; Treatment Duration: 240 min.
Review of Dialysis Treatment Details Reports revealed the BFR, DFR and treatment time were not administered at prescribed rates on the following dates:
On 8/8/25, treatment duration was 147 minutes. Treatment record includes "Close Treatment Reason" which reads, " Patient Choice (AMA (against medical advice), feels unwell/cramping, patient behavioral issue) ..." There were no Early Termination of Treatment Against Medical Advice Forms found in the medical record for 8/8/25.
On 8/6/25, during entire treatment, the BFR was administered at 200 mL/min.
On 8/6/25, from 10:37 am to 12:32 pm, the DFR was administered at 500 mL/min.
On 8/1/25, from10:34 am to 12:02 pm, the DFR was administered at 500 mL/min.
On 7/30/25, treatment duration was 213 minutes.
There was no documentation regarding the reason for not meeting ordered BFR, DFR and treatment time.
MR #9: Admission Date: 5/22/23. Total treatment records reviewed: 6, Treatment record reviewed between 8/8/25 and 7/28/25.
Order reads in part the following: Frequency: Three times a week; target weight: 93kg; Blood Flow Rate (BFR): 300mL/min; Dialysate Flow Rate (DFR): 500mL/min; Treatment Duration: 210min.
Review of Dialysis Treatment Details Reports revealed the BFR was not administered at prescribed rates on the following dates:
On 8/8/25, from 10:31 am to 11:01 pm, the BFR was administered at 350 mL/min.
On 8/8/25, from 12:30 pm to 1 pm, the BFR was administered at 200 mL/min.
On 8/6/25, from 11:01 am to 1:54 pm, the BFR was administered at 250 mL/min.
On 8/4/25, from 1:01 pm to 2:06 pm, the BFR was administered at 250 mL/min.
On 7/28/25, from 12:01 pm to 1:31 pm, the BFR was administered at 200 mL/min.
On 7/28/25, from 1:31 pm to 1:56 pm, the BFR was administered at 250 mL/min.
There was no documentation regarding the reason for not meeting ordered BFR.
An interview with the administrator and manager of clinical services on 8/13/25 starting at 3:30 pm confirmed the above findings.
Plan of Correction: V 544
The Facility Administrator or designee held mandatory in-service(s) for all clinical teammates starting on 08/21/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 3-02-03 "Physician Orders for Patient Care", Policy 1-03-08 "Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment" and Policy 1-01-09 "Prescribed Treatment Not Met" with emphasis on but not limited to: A. Physician Orders: Purpose: To verify that orders are properly documented, transcribed, verified and implemented in a timely manner for patient care in DaVita facilities and hospital programs which meet all DaVita, federal and applicable state regulations.
B. Data Collection and Monitoring: 1) Patient identity, prescription and machine settings are verified by teammates prior to initiation of treatment... Prescription components include but are not necessarily limited to: ...Blood Flow rate, Dialysate flow rate ... 2) If the dialysis prescription is not being met [including dialysis flow rate or change to/inability to obtain prescribed blood flow rate] the reason will be documented and the licensed nurse informed. 3) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately ... The licensed nurse will use his/her clinical judgment based on individual patient needs to determine if any clinical interventions are necessary. 4) All findings, interventions and patient response will be documented in the patient's medical record.
C. Prescribed Treatment Time Not Met: 1) The Registered Nurse (RN) will verify that a patient signs the Early Termination of Treatment Against Medical Advice Form any time the patient requests to terminate their treatment earlier than the prescribed run time.
2) If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient's attending nephrologist to discuss the appropriate intervention (if any), including what additional medical orders may be necessary to address the patient's specific needs. 3) Additionally, if the patient's dialysis treatment is terminated 30 or more minutes prior to the ordered treatment length, the reason must be documented in the patient electronic health record at the time the treatment was terminated while reconciling the treatment times. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct flowsheet audits to verify: a) With any documentation of abnormal findings, or prescribed treatment not met, [including but not limited to blood flow rate or dialysate flow rate],there is also documentation of report to the licensed nurse, with nurse response documented, including but not limited to assessment or physician notification as needed, per policy; b) For any documented treatment time not meeting prescribed treatment time, an Early Termination of Treatment Against Medical Advice form is completed, including "patient refused" if patient refuses to sign: on twenty five percent (25%) of the flowsheets daily for two (2) weeks, then weekly for two (2) weeks. Ongoing compliance will be monitored with the monthly ten percent (10%) medical records audits. Instances of non-adherence will be corrected immediately.
The Facility Administrator or designee will review audit results with teammates during homeroom meetings, and with the Medical Director during monthly Quality Assurance and Performance Improvement meetings known as Facility Health Meetings. The Facility Administrator will report progress, as well as any barriers to maintaining compliance. Action plans will be evaluated for effectiveness and new plans developed when needed until sustained compliance is achieved. Supporting documentation will be included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction. this will be completed by 10/17/2025
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