Initial Comments:
Based on the findings of an onsite Medicare recertification survey conducted on May 18-20, 2022, 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 Medicare recertification survey conducted on My 18-20, 2022, 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(c)(2) STANDARD
IC-CATHETERS:GENERAL
Name - Component - 00
(2) The "Guidelines for the Prevention of Intravascular Catheter-Related Infections" entitled "Recommendations for Placement of Intravascular Catheters in Adults and Children" parts I - IV; and "Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients," Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html
Observations:
Based on observation, facility policy and procedure and an interview with the clinical manager, the facility did not follow procedure for the care of the central venous catheter (CVC) exit site for two (2) of two (2) observations (OBS). OBS # 1 and 2.
Findings include:
Observation of the clinical area was conducted on May 18, 2022 from 9:15 AM- 1 PM and May 19, 2022 from 10:30 AM-11:30 AM.
A review of procedure FMS-CS-HT-II-320-100 C, "Changing the Central Venous Catheter (CVC) Dressing Prior to Initiation of Treatment" on May 20, 2022 at 11:00 AM states: "Step 2. Inspect and remove old dressing...5. Discard dressing and remove gloves. Wash hands."
OBS #1 station 17 PCT#1 removed the old CVC dressing and did not wash hands change gloves after observing and discarding instead proceeded to cleanse the exit site.
OBS#2 station 18 PCT#1 removed the old CVC dressing and did not wash hands change gloves after observing and discarding instead proceeded to cleanse the exit site.
An interview with the clinical manager on May 20, 2022 at 12:00 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:
Changing the Catheter Dressing
Special emphasis will be placed on ensuring that hand hygiene is performed after inspecting and removing the old dressing and before proceeding with the cleansing of the catheter site.
The in-servicing of staff and patients will be completed by May 31, 2022, 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 QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: June 30, 2022
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 observation, facility policy and an interview with the clinical manager, the facility did not follow its policy for vascular access assessment and cannulation for two (2) of two (2) observations (OBS). OBS#1 and 2.
Findings include:
A review of policy "Access Assessment and Cannulation" on May 20, 2022 at 11:00 AM states: "Step 1 Prior to treatment ask patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access."
Observation of the clinical area was conducted on May 18, 2022 from 9:15 AM- 1 PM and May 19, 2022 from 10:30 AM-11:30 AM.
OBS #1 Patient at Machine #19 did not wash akin over access with soap and water. PCT#2 did not wash the skin over patient's access with soap and water prior to assessing the patient's vascular access and disinfecting it before cannulation.
OBS#2 Patient at Machine #4 did not wash akin over access with soap and water. PCT#3 did not wash the skin over patient's access with soap and water prior to assessing the patient's vascular access and disinfecting it before cannulation.
Further observations made in the clinical area revealed that patients did not wash the skin over the access with soap and water and patient care staff did not wash the skin over the patient's access with soap and water prior to assessing the vascular access and disinfecting it before cannulation.
An interview with the clinical manager on May 20, 2022 at 12:00 PM confirmed the above findings.
Plan of Correction:On May 24, 2022, the Area Team Lead (ALT) and the CM met with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the Medical Staff Bylaws and the following policy: Access Assessment and Cannulation.
The meeting focused on the importance of the staff always following Fresenius Medical Care (FMC) policies. The meeting reviewed that prior to treatment staff is responsible for directing the patient to wash his/her access area with soap per hand hygiene procedure. In the event that the patient is unable or unwilling to wash his/her access area, staff is responsible to clean the access area with soap per hand hygiene.
Minutes of the meeting with the Medical Director will be on file at the facility for review.
The Medical Director was informed at the meeting that the CM and the staff will receive education on the above policies by the CM or designee by May 31, 2022. The staff meeting will emphasize that prior to treatment staff is responsible for directing the patient to wash his/her access area with soap per hand hygiene procedure. In the event that the patient is unable or unwilling to wash his/her access area, staff is responsible to clean the access area with soap per hand hygiene.
All training documentation will be on file at the facility.
The Medical Director was informed that 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.
The Medical Director was informed that staff found to be non-compliant will be re-educated and counseled.
To ensure ongoing compliance the CM will review the audit findings with the Medical Director at the QAI Committee monthly meeting. Sustained compliance will be monitored by the QAI committee with oversight by the GB.
Completion Date: June 30, 2022
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