Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 19, 2024, BMA of Easton was identified to be in compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed July 19, 2024, BMA of Easton 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/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' observations (Observation#2)
Findings include:
A review was conducted of facility policy/procedure on July 18, 2024 at approximately 1:15 p.m.
Policy 'Clinical Services' Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer' (Setting: IC. IPS) Termination: Disconnecting the Patient' step (3) states "Disconnect the bloodlines from the needle lines and remove the needles according to the Post Treatment Needle Removal Procedure'.
Policy 'Clinical Services' 'Post Treatment Fistula Needle Removal' (Setting: IC. HT, IPS) 'Procedure' section (2) states "Person removing needles perform hand hygiene and don clean gloves."
Observations conducted in the patient treatment area on July 16, 2024 between approximately 8:20 a.m. and 12:15 p.m. and on July 17, 2024 between approximately 11:00 a.m. and 11:30 a.m, revealed the following:
Observation #2: During observation #2 of 2 of 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 07/16/24 at approximately 9:20 a.m., of patient #7, Employee #12 at station #4 did not perform hand hygiene/don clean gloves after reinfusing the extracorporeal circuit/disconnecting the bloodlines and before removing the needles.
An interview with the facility Clinical Nurse Manager on July 18, 2024 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:To ensure compliance the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on:
- Post Treatment Fistula Needle Removal
- Termination of Treatment Using Arteriovenous Fistula of Gratf and Optiflux Single Use Ebeam Dialyzer
The meeting will focus on ensuring that hand hygiene is always performed per Fresenius policy. This includes always completing hand hygiene after disconnecting the bloodlines when terminating treatment. New gloves must then be donned before removing the patient's fistula needle.
Inservicing will be completed by August 2, 2024. All training documentation is 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/week for 2 weeks to ensure that compliance is maintained. At that time, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A Plan of Correction (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. Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 6, 2024
494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE
Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children
I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.
II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.
Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.
VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for one (1) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #2).
Findings:
A review was conducted of facility policy/procedure on July 18, 2024 at approximately 1:15 p.m.
Policy 'Central Venous Catheter (CVC) Dressing Change' (Setting: IPS) 'Purpose' states "The purpose of this procedure is to ....... and maintaining a protective barrier to prevent infection." 'Removal of Dressing and Inspection of Site' 'Follow the steps below to remove a catheter dressing and inspect the exit site before initiation of treatment: ...Step (5) "Inspect and remove the old dressing. ..." ...... 'Applying the dressing' Step (1) ....Apply the catheter dressing over the dry exit site, ....
Policy 'Initiation of Treatment using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer' (Setting: IC, IPS) 'Preparing the Catheter: Dressing Change' "..... dressing replacement must be completed prior to accessing the bloodstream. ...." 'Prior to Initiation: Assessment and Machine Parameters' Step (1) "Perform hand hygiene and donn full PPE." ....Step (9) "....perform hand hygiene then donn new gloves." 'Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heparin Administration' step (1) states "Check to make sure catheter clamps are closed. Step (2) states "Remove cap from clamped arterial limb." Step (3) states "Using a sterile alcohol pad ....."
Observations conducted in the patient treatment area on July 16, 2024 between approximately 8:20 a.m. and 12:15 p.m. and on July 17, 2024 between approximately 11:00 a.m. and 11:30 a.m, revealed the following:
Observation #2: On 07/16/24 at approximately 9:00 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #2, for patient #2, station #1; employee #7 left the CVC site exposed and began 'Initiation of Dialysis with Central Venous Catheter'. After completing the initiation steps and connecting sterile syringes to each port, employee #7 then applied a sterile dressing to the CVC exit site.
An interview with the facility Clinical Nurse Manager on July 18, 2024 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all DPC staff on the following policies and procedure:
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
- Changing the Catheter Dressing Procedure
The meeting will emphasize that all staff must ensure that strict infection control practices per policy are adhered to when caring for a patient with a central venous catheter (CVC). The meeting will reinforce that the patient's CVC dressing replacement is completed, including the application of the new catheter dressing, prior to accessing the bloodstream.
The in-service will be completed by August 2, 2024. Documentation of the meeting will be onsite 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/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. Sustained compliance will be monitored by the QAPI committee.
Completion date: September 6, 2024
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 a review of facility policy/procedure, manufacturers directions for use, and an interview with the facility Clinical Nurse Manager, facility failed to ensure home therapy dialysis machines were maintained per the manufacturers directions for use for six (6) of six (6) dialysis machine (DM) maintenance documentation records reviewed (DM#1- DM#6).
Findings:
A review was conducted of facility policy/procedure on July 18, 2024 at approximately 1:15 p.m. 'NxStage Machine: Operational Preparation' (Setting: IC, HT) Policy' states " The NxStage machine will be operated according to the appropriate NxStage Users Guide and if indicated, the Pure Flow Users Guide and Express Warmer Users Guide."
A review was conducted of the dialysis machine manufacturers 'NxStage Pureflow SL User Guide' on July 18, 2024 at approximately 10:30 a.m. 'Item' ''Air Filter' Maintenance Schedule' states "Clean or replace every three months. It might require more frequent cleaning depending on environmental conditions."
Maintenance documentation was requested from the facility home therapy nurse (employee #13) on 07/18/24 at approximately 9:30 a.m. Employee #13 could not produce documentation to show the dialysis machine air filters were maintained according to the manufacturers directions for use. The following machines are currently in use by home therapy patients:
DM#1: This NxStage dialysis machine (serial #51326) is currently utilized by patient #8 (started home therapy 07/05/23). No documentation provided of the machine air filter being cleaned or replaced every three months.
DM#2: This NxStage dialysis machine (serial #37593) is currently utilized by patient #9 (started home therapy 09/11/23). No documentation provided of the machine air filter being cleaned or replaced every three months.
DM#3: This NxStage dialysis machine (serial #41088) is currently utilized by patient #10 (started home therapy 07/17/23). No documentation provided of the machine air filter being cleaned or replaced every three months.
DM#4: This NxStage dialysis machine (serial #45997) is currently utilized by patient #11 (started home therapy 07/05/23). No documentation provided of the machine air filter being cleaned or replaced every three months.
DM#5: This NxStage dialysis machine (serial #55271) is currently utilized by patient #4 (started home therapy 05/22/23). No documentation provided of the machine air filter being cleaned or replaced every three months.
DM#6: This NxStage dialysis machine (serial #6250) is currently utilized by patient #12 (started home therapy 08/01/23). No documentation provided of the machine air filter being cleaned or replaced every three months.
An interview with the facility Clinical Nurse Manager on July 18, 2024 at approximately 1:30 p.m. and email correspondence with the facility Administrator on July 19, 2024 at approximately 10:35 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM will in-service all the Home Therapy (HT) registered nurse (RN) staff and the Home Therapy Program Manager (HTPM) on:
- NxStage Pureflow SL User Guide
The meeting will focus on ensuring that the patients NxStage machine air filter is cleaned or replaced every three months according to the manufacture's operating instructions. The cleaning and/or replacement of the air filter must be documented in the medical records. At the meeting it was determined that the HTRNs would instruct all patients to change or replace their air filters. Documentation of the cleaning and/or will be documented in the medical records.
Inservicing will be completed by August 2, 2024. All training documentation is on file at the facility.
The CM or designee will perform monthly audits for the next 6 months. At that time if 100% compliance is observed 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 covering CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 6, 2024
494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS
Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure that the staff performed proper aseptic technique while initiating treatment for one (1) of two (2) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #2).
Findings include:
A review was conducted of facility policy/procedure on July 18, 2024 at approximately 1:15 p.m.
Policy 'Clinical Services' 'Access Assessment and Cannulation' 'Assessment of Vascular Assess' (Setting: IC, HT) 'Assessment of Vascular Access' Step (1) states "Prior to treatment, ask patient to wash area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access."
Observations conducted in the patient treatment area on July 16, 2024 between approximately 8:20 a.m. and 12:15 p.m. and on July 17, 2024 between approximately 11:00 a.m. and 11:30 a.m, revealed the following:
Observation #2: On 07/17/23 at approximately 11:00 a.m., patient #6 at station #9, employee #8 began to initiate dialysis treatment. Employee #8 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site.
An interview with the facility Clinical Nurse Manager on July 18, 2024 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will re-educate all DPC staff on the following policies and procedure:
- Access Assessment and Cannulation
The meeting will emphasize that all staff must verify that the patient's access site has been washed with soap prior to treatment. If the patient refuses or is unable to wash their own site with soap and water, the staff must clean the patient's access sites.
The staff inservicing will be completed by August 2, 2024. All training documentation will be on file at the facility
All patients will receive re-education by the DPC staff on the importance of washing their access sites with soap and water prior to the start of treatment. Documentation of the access training will be completed in the patient's clinical note. The education will be completed by August 16, 2024.
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 ongoing 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. Sustained compliance will be monitored by the QAPI committee.
Completion date: September 6, 2024
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/procedure, employee files, medical records, and an interview with facility Clinical Nurse Manager, it was determined the facility failed to ensure TB (tuberculosis) screening was conducted according to facility policy for one (1) of three (3) employee files (EF) reviewed (EF#4) and failed to ensure TB (tuberculosis) screening was conducted according to facility policy for three (3) of five (5) medical records (MR) reviewed (MR#1, MR#3, MR#5).
Findings include:
A review was conducted of facility policy/procedure on July 18, 2024 at approximately 1:15 p.m. Policy 'Employee Tuberculosis Testing' (Setting:IC, HT, IPS) 'New Hire Screening Policy' states " TB testing using the two step tuberculin skin test (TST) method is required upon hire. ........."
A review of employee files was completed on July 17, 2024 at approximately 11:40 a.m. Employees date of hire is listed below.
EF#4 Date of hire 07/25/22: Documentation provided of first TST administered late on 04/03/24. No documentation of second step TST being administered.
Policy 'Patient Tuberculosis Testing' (Setting: IC, HT) 'New Admission Screening' states " .... On admission, review the medical records of each patient to determine if they have received TB testing within the last year. ...... Patients who have no documented TB test within the last year will be tested using the TST. ..."
A review of medical records was completed on July 18, 2024 at approximately 1:15 p.m. Patients date of admit is listed below.
MR#1, date of admit 04/19/24: No documentation provided of a TB test (TST) being conducted upon admit.
MR#3, date of admit 02/02/22: Documentation provided of a TB test (TST) being conducted late on 03/02/24.
MR#5, date of admit 03/25/24: Documentation provided of a TB test (TST) being conducted late on 04/30/24.
An interview with the facility Clinical Nurse Manager on July 18, 2024 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:For ongoing compliance all employees' files will be reviewed for their tuberculosis status. If their medical record does not have evidence of a two-step PPD completed upon hire after 2008 when the policy changed from a single PPD to 2 step, a two-step PPD will be administered. Documentation of the PPD test with the results will be available in the employees' personnel file. The audit of the employee files will be completed by August 16, 2024.
By August 2, 2024, the Director of Operations (DO) and the CM will meet with the Medical Director to review the Medical Director Responsibilities as defined in the Conditions for Coverage. The meeting also reviewed the following policy:
- Employee Tuberculosis Testing
The Medical Director will be informed at the meeting with the DO and CM that the CM has received re-education of the above policy with the focus on the importance of ensuring that all new employees receive a two-step tuberculin skin test upon hire. The training will also review the importance of ensuring that there is documentation of the testing in the employee's personnel file.
The CM or designee will perform audits of all newly hired staff within two weeks of the start date. The CM will report the findings of the new hire TB audit at the monthly QAPI schedule. A POC audit tool will be used for the audits.
Issues of non-compliance will be re-education and counseling by the DO.
Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 6, 2024
494.170(b)(2) STANDARD
MR-CENTRALIZE ALL INFO;IDT HAS ACCESS
Name - Component - 00
(2) All clinical information pertaining to a patient must be centralized in the patient's record, including whether the patient has executed an advance directive. These records must be maintained in a manner such that each member of the interdisciplinary team has access to current information regarding the patient's condition and prescribed treatment.
Observations:
Based on a review of facility policy/procedure, medical records, and an interview with facility Clinical Nurse Manager, it was determined the facility failed to ensure documentation of conductivity of dialysate solution prior to patient treatment for two (2) of three (3) incenter hemodialysis patient medical records (MR) reviewed (MR#2, MR#3).
Findings include:
A review was conducted of facility policy/procedure on July 18, 2024 at approximately 1:15 p.m. Policy 'Checking Conductivity and pH of Final Dialysate' 'Purpose' "The purpose of this policy is to provide guidelines to verify final dialysate conductivity and pH prior to initiating hemodialysis treatments and during treatments if required." 'Test Verification Prior to Treatment' ."..... Note: If BlueStar software is enabled for independent conductivity and pH readings, an external meter is not a requirement to measure pre-treatment conductivity and pH. This is only allowed on Bluestar machines with a bibag system." ..... Documentation' "Record conductivity and pH readings in the FKC treatment record."
A review of medical records was completed on July 18, 2024 at approximately 1:15 p.m. Patients date of admit is listed below.
MR#2, date of admit 02/17/18: This patient is treated on a '2008T BlueStar Hemodialysis Machine' which utilizes bibags (bicarbonate bags). Patient treatment flowsheet dated 07/06/24 was reviewed. No documentation (flow sheet or elsewhere) of the theoretical conductivity value (TCD) and actual conductivity being within normal limits, prior to the start of treatment.
MR#3, date of admit 05/16/22: This patient is treated on a '2008T BlueStar Hemodialysis Machine' which utilizes bibags (bicarbonate bags). Patient treatment flowsheet dated 07/12/24 was reviewed. No documentation (flow sheet or elsewhere) of the theoretical conductivity value (TCD) and actual conductivity being within normal limits, prior to the start of treatment.
An interview with the facility Clinical Nurse Manager on July 18, 2024 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:By August 2, 2024, the CM in conjunction with the bio-medical technician (BMT) staff will hold a staff meeting, elicit input, and reinforce the expectations and responsibilities of the facility staff on Policies and Procedures:
- Priming an Optiflux Singel Use E-beam Dialyzer
- Fresenius Medical Care Service Bulletin 23-BLU-001 Rev An Independent Conductivity
The meeting will review that the BlueStar machine software allows independent conductivity. Per manufacturer's Instructions for Use, the machine will verify conductivity while running the self-tests. The independent conductivity displayed value or "Pre Tx Conductivity" is located on the "Dialysate" screen. The meeting also reviewed the "Pre Treatment Safety Check" policy with the emphasis on ensuring that 2 DPC staff members verify the conductivity
prior to treatment initiation: The inservice also reviewed that the actual Conductivity is within default conductivity alarm limits of +/- 0.5 mS/cm of the theoretical conductivity. This will be documented by checking "Alarms Verified" on the Machine Setup portion of the Treatment Sheet and signed by 2 patient care staff members.
Emphasis of staff re-education will also be placed on and include:
- Fresenius Medical Care 2008T BlueStar Service Bulletin Regarding Independent Conductivity (a supplement to the IFU)
- Staff Verification that the machines conductivity alarm limits are centered based on the machine's displayed "theoretical" conductivity assuring actual conductivity is within 0.4mS/cm, in accordance with manufacturer's IFU. Note: FKC Policy requires the centering of the conductivity alarm limits to be centered and fixed (non-adjustable) within the machines service settings. If the conductivity falls out of the alarm range of =/-0.4mS, the machine will go into alarm status and go into a bypass mode. The machine will not go into test mode if the conductivity is out of range.
- Flow sheet documentation of the theoretical conductivity is not a requirement per the Manufactures IFU or FMC policy.
- Per policy the machine conductivity and the independent conductivity are documented on the Chairside Treatment sheet.
- If the independent conductivity fails, the machine will show "Test Failure" on the Alarm test screen.
- Staff will utilize the machine's Independent Conductivity test that is completed during every machine's self-test prior to treatment. The machine's independent conductivity test will automatically, and independently, verify the machine's actual conductivity with a second independent conductivity cell. The machine will ensure the two conductivity cells are within ±0.2 mS/cm, exceeding the CMS requirements.
- Priming an Optiflux Single Use E-Beam Dialyzer Policy with attention to the self-test is conducted after priming and prior to each treatment.
- The self-test is documented in ChairSide (Electronic treatment sheet) as and
- Prior to each treatment the patient care staff will verify the machine conductivity and independent conductivity (from the Pre Tx Conductivity reading on the Dialysate screen) and continue to document on the treatment sheet.
By August 2, 2024, each DPC staff was observed and checked off as competent on performing the skills and procedures for checking conductivity utilizing the Blue Star program. The skills checklist is available in each staff member's personnel file.
The CM or designee will perform daily audits for 2 weeks to ensure staff observation of machine display of conductivity and documentation of machine checks complete on the Chairside treatment sheet utilizing a POC specific audit tool ten (10)% of treatment sheets will be audited daily effective August 5, 2024, for 2 weeks to verify documentation utilizing a POC specific audit tool. At that time, the audits will then follow the monthly QAPI schedule for treatment sheet documentation in the Medical Records Audit.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion Date: September 6, 2024
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