Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 6, 2023, through September 8, 2023, Dialysis Center of Montgomery East 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 September 6, 2023, through September 8, 2023, Dialysis Center of Montgomery East 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 review of facility policy, observation (OBS) of treatments performed, and an interview with the Clinical Manager, the facility did not ensure that patient care staff removed gloves, performed hand hygiene, and donned clean gloves while cannulating an AV fistula for one (1) of three (3) observations (OBS 1).
Findings include:
A review of facility policy on September 8, 2023, at approximately 1:00 P.M. revealed the following:
Policy #47806 titled "Access Assessment and Cannulation" states, "Assessment of Vascular Access: Prior to treatment, ask the patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access. Wash hands and don PPE... Look... Listen... Feel... Remove gloves and perform hand hygiene. Don new gloves... Perform skin antisepsis on one side at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection... Perform hand hygiene and don new gloves... Insert needle into previously prepped site... Remove gloves. Perform hand hygiene."
Policy # 47664 titled "Hand Hygiene" states, " Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of medications, immediately after removing gloves, after contact with body fluids or excretion, mucous membranes, non-intact skin, and wound dressings if hands are not visibly soiled, after contact with inanimate objects near the patient, when moving from a contaminated body site to a clean body site of the same patient, after contact with the dialysis wall box, concentrate, drain or water lines. "
Observation of the treatment area was conducted on September 6, 2023, from approximately 9:15 A.M. to 12:15 P.M. revealed the following:
OBS #1, Station #12 at approximately 9:28 A.M., during initiation of dialysis with an AV fistula, employee (EMP) #1 performed hand hygiene and donned gloves, touched the dialysis machine, cleansed the access site, palpated the cannulation sites, applied antiseptic to the cannulation sites, and inserted the cannulas without performing the required glove changes and hand hygiene during the procedure.
An interview with the Clinical Manager on September 8, 2023, at approximately 1:30 P.M. confirmed the above findings.
Plan of Correction:For ongoing compliance, the Clinic Manager (CM) will in-service all direct patient care (DPC) staff on policy:
· Hand Hygiene
· Access Assessment and Cannulation
The in-service will focus on the staff ensuring that hand hygiene is always performed per policy. This includes removing gloves and performing hand hygiene after touching the dialysis machine and prior to cannulation of the access.
In-servicing will be completed by September 29, 2023, and the training documentation will be on file at the facility.
The CM or designee will perform daily audits for two (2) weeks. At that time if one-hundred percent (100%) compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (POC) specific auditing 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: November 25, 2023
494.30(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK
Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.
Observations:
Based on review of facility policy, observations (OBS) of the patient treatment area during patient care, and interview with the Clinical Manager, the facility failed to ensure patients wore face masks during central venous catheter (CVC) exit site care and initiation of dialysis with with a CVC for one (1) of two (2) observations (OBS). (OBS #2).
Findings Included:
Review of facility policy titled "Central Venous Catheter Dressing Change" on September 8, 2023, at approximately 1:00 P.M. stated, "Removal of Dressing and Inspection of Site: Note: The patient and Inpatient Services Staff must wear a mask for all procedures that require accessing the catheter to help prevent contamination by airborne nasal bacteria."
Observations in the patient treatment area conducted on September 6, 2023, from approximately 9:15 A.M. 12:15 P.M. revealed the following:
OBS #2, Station #10 at approximately 11:48 A.M., patient #10 was observed with their mask below their nose and mouth while employee (EMP) #3 performed CVC exit site care and initiation of dialysis with a CVC.
An interview with the Clinical Manager on September 8, 2023, at approximately 1:30 P.M. confirmed the above findings.
Plan of Correction:For ongoing compliance, the CM will in-service all DPC staff on policy:
· Central Venous catheter Dressing Change
The in-service will focus on the staff ensuring that the policy for catheter care is always followed. This includes ensuring that the staff and the patient are wearing their mask properly with the nose and mouth covered by the mask.
In-servicing will be completed by September 29, 2023, and the 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. At that time, if compliance is maintained, the audits will then follow the monthly QAPI schedule. A POC specific auditing 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: November 25, 2023
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 observations and an interview with the Clinical Manager, the facility failed to remove expired supplies from the emergency cart and the emergency box located in the clinical area.
Findings include:
Observation of the equipment/supplies located in the facility's emergency cart and the emergency box in the clinical area conducted on September 7, 2023, at approximately 2:45 P.M. revealed the following:
Three (3) standard nasal cannulas were located in the emergency cart that had expired on June 19, 2023.
Twelve (12) standard nasal cannulas were located in the "Emergency Box" that had expired in September, 2021.
An interview with the Clinical Manager on September 8, 2023, at approximately 1:30 P.M. confirmed the above the findings.
Plan of Correction:For immediate compliance on September 7, 2023, the expired nasal cannulas found during the survey in the emergency cart and the emergency box were disposed of by the CM. The cannulas were replaced ensuring that they were not expired.
For ongoing compliance, the CM will in-service all DPC staff on policy:
· Evacuation Box Checklist
The in-service will focus that the Evacuation/Emergency box checklist is completed monthly. The meeting will focus on ensuring that all medications and supplies are verified for the expiration dates and replaced if near the expiration date noted on the item.
In-servicing will be completed by September 29, 2023, and the training documentation will be on file at the facility.
The CM or designee will perform bi-monthly audits for three (3) months. At that time if 100% compliance is observed the audits will then follow the monthly QAPI schedule. A POC specific auditing 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: November 25, 2023
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 upon review of facility policy, medical records (MR), and an interview with Clinical Manager, the dialysis facility failed to ensure in-center hemodialysis patient assessments, including blood pressures and machine parameters, were assessed and documented at minimum every 45 minutes, while on hemodialysis as per facility policy for five (5) of five (5) in-center hemodialysis Medical Records reviewed (MR#1, 2, 3, 4, and 5).
Findings include:
Review of facility policy titled "Patient Assessment and Monitoring" on September 8, 2023, at approximately 1:00 P.M. states, "During Treatment: Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulations. Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes or per state regulations... Machine Parameters and Extracorporeal Circuit: Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow. Check dialysate flow rate setting is correct, and the prescribed flow is being delivered..."
A review of MR conducted on September 7, 2023, from approximately 9:30 A.M. to 2:00 P.M. revealed the following:
MR#1, start of care January 3, 2019. Treatment records from August 23, 2023, through September 6, 2023, revealed the following:
No vital signs documented on August 25, 2023, between 1:06 P.M. and 2:10 P.M., 1 hour, 4 minutes.
No vital signs documented on August 28, 2023, between 12:39 P.M. and 1:33 P.M., 54 minutes.
MR#2, start of care July 12, 2023: Treatment records from August 23, 2023, through September 6, 2023, revealed the following:
No documentation of blood flow rate (BFR) or dialysate flow rate (DFR) on August 30, 2023, between 7:05 A.M. and 8:31 A.M., 1 hour, 26 minutes.
No vital signs documented on September 1, 2023, between 12:02 P.M. and 1:03 P.M., 1 hour, 1 minute.
No vital signs documented on September 4, 2023, between 11:02 A.M. and 12:02 P.M., 1 hour.
MR #3, start of care July 10, 2023: Treatment records from August 23, 2023, through September 6, 2023, revealed the following:
No BFR or DFR documented on August 28, 2023, between 9:03 A.M. and 10:35 A.M., 1 hour 32 minutes.
No vital signs documented on August 30, 2023, between 8:35 A.M. and 9:33 A.M., 58 minutes.
MR #4, start of care February 4, 2021: Treatment records from August 23, 2023, through September 6, 2023, revealed the following:
No BFR or DFR documented on August 23, 2023, between 9:31 A.M. and 10:31 A.M., 1 hour.
No BFR, DFR, or vital signs documented on September 1, 2023, between 9:01 A.M. to 10:06 A.M., 1 hour, 5 minutes.
No BFR or DFR documented on September 6, 2023, between 7:04 A.M. and 10:39 A.M., 3 hours, 35 minutes.
No vital signs documented September 6, 2023, between 8:00 A.M. to 9:01 A.M., 1 hour, 1 minute, and 9:01 A.M. to 10:39 A.M., 1 hour, 38 minutes.
MR#5, start of care July 28, 2017. Treatment records from August 23, 2023, through September 4, 2023, revealed the following:
No BFR or DFR documented on August 28, 20233, from 12:01 P.M. to 1:07 P.M., 1 hour, 6 minutes.
No BFR or DFR documented on August 30, 2023, at 12:05 P.M. after start of dialysis treatment, and from 12:33 P.M. to 1:31 P.M., 58 minutes.
An interview with the Clinical Manager on September 8, 2023, at approximately 1:30 P.M. confirmed the above findings.
Plan of Correction:For ongoing compliance, the CM will in-service all DPC staff on policy:
· Patient Assessment and Monitoring
The in-service will focus on ensuring that the patient's vital signs (VS), dialysate flow rate (DFR) and blood flow rate (BFR) are obtained per policy. The meeting will reinforce that the VS, DFR and BFR must be taken and documented during treatment every thirty (30) minutes but not to exceed forty-five (45) minutes.
In-servicing will be completed by September 29, 2023, and the 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. At that time, if compliance is maintained, the audits will then follow the monthly QAPI schedule. A POC specific auditing 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: November 25, 2023
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