Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted April 30, 2019 through May 3, 2019, Bryn Mawr Dialysis 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 April 30, 2019 through May 3, 2019, Bryn Mawr Dialysis, 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(b)(2) STANDARD
IC-ASEPTIC TECHNIQUES FOR IV MEDS
Name - Component - 00
[The facility must-]
(2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and
Observations:
Based on observation, facility policy and an interview with the clinical manager, the facility did not follow its policy for medication administration for one (1) of two (2) medication preparation and administration observations. Observation #2.
Findings include:
A review of facility policy FMS-CS-IC-II-120-040A "Medication Preparation and Administration Policy" conducted on May 3, 2019 at 11:00 AM states: "Infection Control...Cleanse the diaphragm of a vial prior to accessing the vial...."
Observation of the treatment area was conducted on April 30, 2019 from 9:30 AM- 1:00 PM and May 1, 2019 from 9:00 AM- 1:00 PM.
Medication preparation and observation #2 was conducted on May 1, 2019 at 12:50 PM. The registered nurse did not wipe the vial of Venofer with alcohol or other antiseptic prior to entering. The medication was administered to the patient at station #6.
An interview with the clinical manager and operations director on May 3, 2019 at 11:30 AM confirmed the above findings.
Plan of Correction:To ensure compliance the Clinic Manager (CM)/Education Coordinator (EC) will in-service all direct patient care (DPC) staff on:
- FMC-CS-IC-120-040A: Medication Preparation and Administration Policy
- FMC-CS-IC-120-040C: Medication Preparation and Administration Procedure
The meeting will place emphasis on ensuring that the stopper of medication vials will be wiped with alcohol every time before entering the vial to draw up the medication.
The in-service will be completed by 5/10/2019. All training documentation will be on file at the facility for review.
The CM or designee will perform daily audits for two (2) weeks until evidence of improved compliance is observed. If compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time if compliance is sustained, the audits will then be completed monthly following the Quality Assurance Improvement (QAI) program. A Plan of Correction (POC) specific auditing tool will be used for the audits.
The audits will be available at the facility for review.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audits and report the findings monthly at the QAI Committee meeting. The QAI committee will monitor for sustained compliance.
Completion date: 6/21/2019
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 a review of facility policy, observation of the treatment area and an interview with the clinical manager, the facility staff did not follow facility policy as ensured by the medical director for two (2) of two (2) observations of discontinuation of dialysis with a central venous catheter. Observation# 1 and 2 and did not follow its policy for hand hygiene for four (4) of four (4) post treatment patient observations. Observation # 1, 2, 3, and 4.
Findings Include:
A review of facility policy was conducted on May 3, 2019 at 11:00 AM.
Policy FMS-CS-IC-105-029C"Termination of Treatment with a 2008 Series Hemodialysis Machine using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer" states: "Step 4. While closely monitoring the catheter site, return blood through the arterial line either by gravity or by applying gentle pressure to the saline bag. Do not apply excessive pressure on the saline bag; this may damage the access..."
Observation of the treatment area was conducted on April 30, 2019 from 9:30 AM- 1:00 PM and May 1, 2019 from 9:00 AM- 1:00 PM.
During Observation #1 at station # 2 on April 30, 2019 at 10:19 AM, the patient care technician (PCT) was observed squeezing and twisting the saline bag during termination of treatment for a CVC.
During Observation #2 at station #4 on April 30, 2019 at 11:29 AM, the PCT was observed squeezing and twisting the saline bag during termination of treatment for a CVC.
Policy FMS-CS-IC-II-155-090C "Hand Hygiene" states: "All staff, patients, patient care givers, including physicians and non-physician practitioners, social workers, dietitians and any other indirect patient care staff must follow the same requirements for hand hygiene...Hands will be decontaminated using alcohol based hand rub or by washing hands with antimicrobial soap and water ...entering and leaving the treatment area..."
Observation #1 station 2 on April 30, 2019 at 11:00 AM- the patient did not perform hand hygiene prior to leaving the treatment area post treatment.
Observation #2 station 3 on April 30, 2019 at 11:35 AM- the patient did not perform hand hygiene prior to leaving the treatment area post treatment.
Observation #3 station not noted on May 1, 2019 at 9:30 AM- the patient did not perform hand hygiene prior to leaving the treatment area post treatment.
Observation #4 station 11 pm
An interview with the clinical manager and operations director on May 3, 2019 at 11:30 AM confirmed the above findings.
Plan of Correction:V 715 494.150(c)(2)(i) MD RESP-ENSUREALLADHERE TO P&P
On 5/10/2019 the DO and the CM will meet with the Medical Director to discuss Medical Director Responsibilities as defined in the Conditions for Coverage. Emphasis will be placed on the Medical Director responsibilities to ensure staff adherence to policy and procedure as it relates particularly to the safe termination of patient's treatments. The policies reviewed with the Medical Director were:
- FMS-CS-IC-1-105-029C Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux R Single Use Ebeam Dialyzer
- FMS-CS-IC-11-155-090A Hand Hygiene Policy
The Medical Director meeting minutes will be on file at the facility.
The Medical Director determined at the meeting that all DPC staff will be reeducated on the policies reviewed at the meeting with the DO and CM. The focus of the reeducation will be on ensuring safe termination of patient treatments by applying gentle pressure to the saline bag when returning blood to the patient. The meeting will also focus on staff reminding the patients to wash their hands post treatment before leaving the treatment floor.
The Medical Director also determined that patients would receive education on the importance of hand washing post treatment by the DPC staff. The patients will sign an attestation of the education which will be placed in their medical record.
The inservicing of staff and patients will be completed by 5/10/2019 with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is observed. AT that time the audits will then follow the monthly QAI 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 QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: 6/21/2019
V 715 494.150(c)(2)(i) MD RESP-ENSUREALLADHERE TO P&P
On 5/10/2019 the DO and the CM will meet with the Medical Director to discuss Medical Director Responsibilities as defined in the Conditions for Coverage. Emphasis will be placed on the Medical Director responsibilities to ensure staff adherence to policy and procedure as it relates particularly to the safe termination of patient's treatments. The policies reviewed with the Medical Director were:
- FMS-CS-IC-1-105-029C Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux R Single Use Ebeam Dialyzer
The Medical Director meeting minutes will be on file at the facility.
The Medical Director determined at the meeting that all DPC staff will be reeducated on the policy reviewed at the meeting with the DO and CM. The focus of the reeducation will be on ensuring safe termination of patient treatments by applying gentle pressure to the saline bag when returning blood to the patient.
The inservicing will be completed by 5/10/2019 with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that compliance is observed. AT that time the audits will then follow the monthly QAI 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 QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: 6/21/2019
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