Initial Comments:
Based on the findings of an unannounced complaint investigation survey conducted July 21, 2025, Allegheny Valley Dialysis was found to have the following standard level deficiencies that was 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(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on review of manufacturers recommendations, observations, and staff (EMP) interviews, the agency failed to ensure dehumidifiers had annual preventative maintenance or documentation of cleaning for two (2) of two (2) dehumidifiers observed on the treatment floor.
Findings include:
Treatment floor observations on 7/21/25 at 9:27 a.m. revealed the following:
A Hisense dehumidifier Model # DH7019K1G, Serial # KF8DSJG0529 was placed against the wall between dialysis stations six and seven, and had a light buildup of black and white material on all outside surfaces of the unit, the filter was not visible. This unit did not contain a sticker or other documentation of annual preventative maintenance.
A second General Electric Dehumidifier Model # ADEL5OLZQ1, Serial # AT012866Q was behind the nurses station and had a heavy buildup of black and white material on all outside surfaces of the unit, the filter was observed to have a heavy buildup of grey material on the filter. This unit did not contain a sticker or other documentation of annual preventative maintenance.
During an interview on 7/25/25, at 10:00 a.m. EMP1 The Biomedical Service Specialist confirmed the agency does not complete annual preventative maintenance for the two dehumidifiers.
A review of the agency supplied manufacturers recommendations on 7/21/25, at 10:42 a.m. for the General Electric Dehumidifier Model # ADEL5OLZQ1, Serial # AT012866Q indicated the water bucket is to be cleaned every few weeks to prevent the growth of mold, mildew and bacteria. The air filter should be checked and cleaned at least every 250 hours operation or more often if necessary.
A review of the agency supplied manufacturers recommendations on 7/21/25, at 10:46 a.m. for the Hisense dehumidifier Model # DH7019K1G, Serial # KF8DSJG0529 indicated the water bucket is to be cleaned every few weeks ... to avoid the growth of mold, mildew and bacteria.
During an interview on 7/21/25 at 1:44 p.m. EMP2 the Administrator and EMP3 the Operations Director confirmed the above findings, and that the agency did not have a policy on or documentation of preventative maintenance or cleaning of the dehumidifiers.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/04/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 8-04-01 "Physical Environment" with emphasis on but not limited to: 1) The facility will maintain a program to verify equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufactuer's reccomendations. Verification of attendance will be evidenced by teammate's signatures on in service sheet.
Use of dehumidifiers was discontinued and units were removed from the treatment floor on 07/21/25. Therefore, no annual preventive maintenance will be needed. The Facility Administrator and Biomed technician reviewed annual preventive maintenance schedule to verify all equipment
is listed and scheduled for 2025, and results will be reported in Facility Health Meetings upon completion.
The Facility Administrator or designee will conduct physical plant audits to verify equipment including emergency equipment, dialysis delivery systems and the water treatment systems is maintained and operated in accordance with manufacturer's recommendations, including but not limited to no build up on equipment of exterior white, or dark substances on the filters; annual preventive maintenance stickers are current: weekly for two (2) weeks, and monthly for two (2) months. 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.
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 a review of facility policy, clinical records (CR) and staff (EMP) interview, it was determined that the facility failed to ensure treatments were delivered in accordance with the dialysis prescriptions ordered by the physician for three (3) of six (6) in center hemodialysis patient clinical records reviewed (CR1, CR4, CR6).
Findings included:
Review of facility policy "Prescribed Treatment Time Not Met" on 7/21/25, at 1:03 p.m. Indicated it's purpose is to provide requirements for teammates to follow when a patent's treatment time is terminated early or extended. 1. The Registered Nurse (RN) will verify that patient signs the Early Termination of Treatment Against Medical Advice (AMA) form any time the patent requests to terminate their treatment earlier than the prescribed run time. 3. If a patients treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record. Documentation will include as appropriate: the amount of time by which the treatment was shortened, a description of why the treatment was shortened, whether the patient's nephrologist was notified, a description of the followup medical orders by the attending nephrologist, if any. 5. Additionally if the patient's dialysis treatment is terminated 30 or more minutes to the ordered treatment length, the reason must be documented in the patients electronic health record at the time the treatment was terminated while reconciling the treatment times.
Review of Clinical Records (CR) on 7/21/25 at 12:25 p.m. Treatment Detail Reports (documentation of ordered treatment time and duration administered) from 7/7/25 (Monday) through 7/12/25 (Saturday) revealed the following:
CR1, admitted on 4/24/19, review of the Treatment Detail Report dated 7/12/25, indicated the prescribed treatment duration time ordered by the physician was 210 minutes, review of the treatment duration revealed it was 182 minutes (28 minutes short). There was no documentation that staff notified the physician of the changes in the dialysis prescription, or a description of why the treatment was shortened and did not contain a signed AMA document.
CR4, admitted on 2/2/21, review of the Treatment Detail Report dated 7/8/25, indicated the prescribed treatment duration time ordered by the physician was 210 minutes, review of the treatment duration revealed it was 196 minutes (14 minutes short). There was no documentation that staff notified the physician of the changes in the dialysis prescription, or a description of why the treatment was shortened and did not contain a signed AMA document.
CR6, admitted on 3/26/24, review of the Treatment Detail Report dated 7/7/25, indicated the prescribed treatment duration time ordered by the physician was 195 minutes, review of the treatment duration revealed it was 165 minutes (30 minutes short). There was no documentation that staff notified the physician of the changes in the dialysis prescription, or a description of why the treatment was shortened.
During an interview on 7/21/25 at 1:44 p.m. EMP2 the Administrator and EMP3 the Operations Director confirmed the above findings.
Plan of Correction:The Facility Administrator or designee held mandatory in-services for all clinical teammates starting on 08/04/25. Surveyor observations were reviewed. Education included but was not limited to a review of Policy 1-01-09 "Prescribed Treatment Time Not Met" and Policy 1-03-08 Pre- Intra- Post Treatment Data Collection, Monitoring and Nursing Assessment" with emphasis on but not limited to: A . 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 a patient's treatment is shortened/early terminated, the RN will document the event in the patient's electronic health record. Documentation will include, as appropriate: the amount of time by which the treatment was shortened; a description of why the treatment was shortened; whether the patient's nephrologist was notified; a description of the follow-up medical orders provided by the patient's attending nephrologist (if any). 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. B. Pre- Intra- Post Treatment Data Collection: 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: ... treatment time ... 2) If the dialysis prescription is not being met ... 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. Verification of attendance at in-service will be evidenced by teammate's signature on in-service sheet.
The Facility Administrator or designee will conduct audits to verify: a) For any documentation of abnormal findings, including prescription time is not being met, the licensed nurse is notified, and nurse response is documented 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.
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