Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on May 19, 2025 through May 20, 2025, Bryn Mawr Dialysis Services, LLC., 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 May 19, 2025 through May 20, 2025, Bryn Mawr Dialysis Services, LLC., 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 observation of the clinical area, facility policy and an interview with the Regional Operations Director, the facility did not ensure infection control procedure regarding glove removal and handwashing for thee (3) of eleven (11) observations (OBS). (OBS# 4, 5, and 6).
Findings include:
A review of policy "Hand Hygeine" on May 14, 2024 at 12:30 p.m states: "Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water 1) before and after direct contact with patients, 2) Entering and leaving the treatment area, 3) Before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, 4) Immediately after removing gloves, 5) After contact with bloody fluids or excretions...6) After contact with inanimate objects near the patient, 7)When moving from a contaminated body site to clean site of the same patient, 8) After contact with the dialysis wall box, concentrate...9) After contact with other objects within the patient station or treatment space..."
Observation of the clinical area was conducted on May 19, 2025, between 9:40 AM through 11:50 AM revealed the following:
OBS #4. Station 16, PCT 5, After removing needles from patients AV fistula/graft, PCT moved to station 17 to turn off alarming machine. Did not discard gloves, perform hand hygiene and don new gloves.
OBS #5. Station 17, PCT 5, After turning off alarm from station 17, PCT moved to patient at station 16 to place clamp on AV fistula/graft site. Removed gloves, but did not perform hand hygiene and don new gloves.
OBS #6. Station 16, PCT 5, After placing clamp on patients AV fistula/graft site, PCT moved to patient at station 17 to remove tubing from patient. Did not discard gloves, perform hand hygiene and don new gloves.
An interview with the Regional Operations Director conducted on May 20, 2025, at approximately 1:40 PM confirmed the above findings.
Plan of Correction:The clinic manager (CM) or designee will re-educate all the direct patient care (DPC) staff on the following policy:
- Hand Hygiene
The meeting will place special emphasis on ensuring that gloves are to be removed, and hand hygiene performed after removing the patient's fistula needles and/or placing a clamp on the site prior to answering an alarm on a machine. The meeting will also re-educate the DPC staff on ensuring that anytime gloves are removed, hand hygiene must be completed before donning new gloves.
The in-servicing of staff and patients will be completed by June 13, 2025, with documentation of the training on file at 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. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion Date: July 11, 2025
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 during a tour of the facility, review of policy and procedure, and interview with the Facility Administrator, it was determined, that the facility failed to maintain a functional treatment environment by storing expired medications (OBS#1) and the facility failed to provide a safe environment for access to the crash cart (OBS#2).
Findings include:
A review of facility policy titled, "Medication Preparation and Administration" conducted on May 20, 2025, at approximately 1:25 PM states, "Monitoring Expired Medications: Expiration dates for all stored medications are to be monitored on a monthly basis..."
A review of facility policy titled, "Emergency Equipment and Supplies" conducted on May 20, 2025, at approximately 1:30 PM states, "Emergency Cart: The emergency cart should be located where is is readily accessible during medical emergency situations and shall NOT be blocked by wheelchairs, equipment, or other facility supplies..."
OBS#1. A tour of the dialysis unit treatment area on May 19, 2025, at approximately 10:45 AM revealed two (2) boxes of ten (10) vials each of Vancomycin 1 gram vials with an expiration date of 5/1/2025.
OBS#2. A tour of the dialysis unit treatment area on May 19, 2025, at approximately 10:50 AM revealed access to the crash cart was blocked by two (2) trash containers.
An interview with the Regional Operations Director conducted on May 20, 2025, at approximately 1:40 PM confirmed the above findings.
Plan of Correction:
For immediate compliance on May 20, 2025, all expired items, including vancomycin, identified during the survey tour observation were discarded by the CM. All items were replaced with current, non-expired supplies. The CM also relocated the 2 trash containers blocking the crash cart and informed the staff of the new storage location for the trash containers.
For ongoing compliance, the CM or designee will in-service all DPC staff and the Home Therapy (HT) staff on the following policy:
- Emergency Medications, Equipment and Supplies
Emphasis will be placed on ensuring that all medications and supplies are all within the current date for use. This includes anything that is stored in the emergency cart and medication station. The meeting reviewed that all supplies and medications must be rotated First in-First out (FIFO) when being stocked to ensure that items do not expire. The meeting will reinforce that staff must check the expiration date of medications and supplies monthly.
All facility staff will be educated by the CM on the policy:
- General Cleanliness and Infection Control Guidelines
The meeting will reinforce that the unit must be maintained in a clean, neat and orderly manner at all times. Staff will be informed that the crash cart must always be quickly assessable and not blocked by any items, supplies or equipment. This includes trash containers.
The inservices will be completed by June 13, 2025, and the education records will be on file in the facility.
The CM or designee will perform weekly audits for expired medications, items for 2 months. At that time, if one-hundred percent (100%) compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
The CM or designee will also complete daily audits of the crash cart access for 2 weeks. At that time if 100% compliance is observed the audits will then be completed 2 times/week for 2 weeks 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 QAPI Committee at the monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion Date: July 11, 2025
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on a review of facility policy, medical records (MR), and an interview with the Regional Director of Operations, the facility did not follow its policy for patient assessment and monitoring for three (3) of seven (7) MRs reviewed, (MR # 4, 6, and 7).
Findings include:
A review of facility policy titled "Patient Assessment and Monitoring" conducted on September 11, 2024 at approximately 11:15 AM states, "If the PCT/LPN (patient care technician/licensed practical nurse) note any changes or abnormal findings in the patient's condition or vascular access are observed or reported by the patient, or the patient was hospitalized, the registered nurse must assess the patient. The nurse will notify the patient's physician of any abnormal findings, if necessary, based on clinical judgment for additional instruction. The registered nurse ill assess/re-assess any findings addressed pre or during treatment as needed...During treatment: Blood Pressure: Recheck blood pressures after a drop that requires interventions...Reposition electronic cuff or use a manual cuff for aberrant blood pressure readings, Report to the nurse: Systolic blood pressures greater than 180 mm/Hg; Diastolic blood pressures greater than 100 mm/Hg; Blood Pressure less than or equal to 100 mm/Hg systolic...Reported by patient: Report to the nurse any complaints by the patient during treatment...Document any findings and interventions in the medical record...Safety/Machine checks: Verify dialysate lines are attached and in correct position and DFR (dialysate flow rate) BFR (blood flow rate) and UFR (ultra filtration rate) is set and functioning per treating physician order..."
A review of MRs was conducted on 5/19/2025 from approximately 1:20 PM to 2:20 PM and on 5/20/2025 from approximately 8:45 AM to 10:30 AM.
MR #4, Start of Care: 9/18/15. Review of treatments sheets for 5/5/2025 through 5/16/2025 revealed the following:
5/16/2025:
PCT documented at 11:10 AM, B/P 104/31.
PCT documented at 11:30 AM, B/P 92/39.
PCT documented at 12:02 PM, B/P 90/33.
There is no documentation of a recheck of the blood pressure and no documentation of RN notification of the low blood pressure.
MR #6, Start of Care: 3/17/2025. Dialysis orders include: BFR (blood flow rate): 400, DFR (dialysate flow rate): 800. Review of treatment sheets 5/5/2025 through 5/16/2025 revealed the following:
5/9/2025:
BFR ran at 350 during entire treatment.
There was no indication of reasoning for BFR to run at a different rate than prescribed.
5/12/2025:
BFR at 2:55 PM was at 350 and DFR at 800.
From 3:30 PM through 6:00 PM no BFR/DFR was recorded.
5/16/2025:
PCT recorded at 2:35 PM, B/P 183/104.
There was no recheck of blood pressure and no documentation of RN notification of the high blood pressure.
At 3:34 PM through end of treatment at 6:48 PM, BFR was running at 325.
There was no indication of reasoning for BFR to run at a different rate than prescribed.
MR #7, Start of Care: 1/31/2023. Review of treatment sheets 5/5/2025 through 5/16/2025 revealed the following;
5/7/2025:
PCT documented at 9:55 AM. Post treatment B/P 197/70
There is no documentation of blood pressure recheck or that the PCT notified the RN of the above findings and therefore, no RN patient assessment performed at the time of occurances.
5/9/2025:
PCT documented at 9:30 AM, B/P 194/82.
PCT documented at 9:55 AM, post treatment B/P 194/82.
There is no documentation of blood pressure recheck or that the PCT notified the RN of the above findings and therefore, no RN patient assessment performed at the time of occurances.
5/16/2025:
PCT documented at 6:36 AM, pre-treatment B/P 198/76.
There is no documentation of blood pressure recheck or that the PCT notified the RN of the above findings and therefore, no RN patient assessment performed at the time of occurances.
An interview conducted with the Regional Director of Operations on May 20, 2025, at approximately 1:40 PM confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all the DPC staff on policy:
- Patient Assessment and Monitoring
The in-service will focus on the DPC staff ensuring that the registered nurse (RN) is informed of any vital signs (VS) outside of parameters per policy and/or physician orders. This includes blood pressures (BP) which are not in the acceptable range at any time pre, post or during treatment. The staff will also be re-educated to verify the BP by repositioning the electronic cuff or to use a manual cuff to take the BP. The meeting will reinforce the DPC need to document the RN notification of the out-of-range BP as stated in the policy. The meeting will re-educate the RNs that an assessment of the patient needs to be completed with documentation of the evaluation and any interventions taken along with a follow-up assessment after the intervention. The RN staff will also be instructed to document physician notification as clinically indicated.
The inservice will also reinforce that any machine parameters not within the physician prescribed limits must be reported to the RN for evaluation, intervention, and documentation. These parameters include the blood flow rate (BFR) and dialysis flow rate (DFR). The reason the BFR and/or DFR 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 and/or DFR, and interventions taken along with physician notification as indicated. The meeting will also review that the machine settings must be monitored and documented every thirty (30) to forty-five (45) minutes during treatment.
Inservicing will be completed by June 13, 2025. All training documentation will be on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if 100% compliance is observed the audits will then be completed 2 times/week for 2 weeks 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 audits and report the findings to the QAPI Committee at the monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion Date: July 11, 2025
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