Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed September 26, 2022, Liberty Dialysis - Doylestown, Llc. 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 September 26, 2022, Liberty Dialysis - Doylestown, 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)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL
Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, it was determined the facility failed to ensure blood spills were cleaned effectively for one (1) of one (1) patient treatment area observations (Observation#1).
Findings:
A review was conducted of facility policy on September 26, 2022 at approximately 9:00 a.m. Policy 'Cleaning and Disinfecting of the Dialysis Station' (Setting: IC, HT) 'Purpose' states "...to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulation, ..." 'Work Surface Cleaning and Disinfection with Visible Blood less then or equal to 10 ml. and other Potentially Infectious Material Using Bleach Solutions' states "Use 1:100 bleach solution to clean surfaces with visible blood." "After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface."
'Work Surface Cleaning and Disinfection with Visible Blood greater then 10 ml. and other Potentially Infectious Material Using Bleach Solutions' states "Use a new cloth wetted with 1:10 bleach solution to clean surfaces with visible blood." "After cleaning up all visible blood, use a new cloth with 1:100 bleach solution for a second cleaning of the surface." (Note: These are the only policies/procedure provided by the facility for cleaning up blood spills.)
Observations conducted in the patient treatment area on September 21, 2022 between approximately 9:25 a.m. and 11:45 a.m. and on September 22, 2022 between approximately 11:40 a.m. and 12:00 p.m. revealed the following:
Observation #1: During the 'Discontinuation of Dialysis and Post Dialysis Access Care for AV Fistula or Graft' procedure, on 09/22/22 at approximately 11:45 a.m. at station #9, patient #8 was observed holding his access site with gauze. The access site started bleeding and there were several blood drops on the floor next to the patients dialysis chair. Employee #12 cleaned the blood drops off the floor with a bleach soaked cloth. Employee #12 did not use a new cloth or towel to apply disinfectant a second time.
An interview with the facility Clinical Manager on September 26, 2022 at approximately 11:30 a.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 policy:
- Cleaning and Disinfection of the Dialysis Station
The meeting will focus on ensuring that all surfaces and equipment of the dialysis station contaminated with blood or other potentially contaminated material are cleaned and disinfected per policy. The meeting reviewed that the use of a new cloth with bleach solution to clean surfaces with visible blood, including drops of blood on the floors, is required.
The inservice will be completed by October 13, 2022, and the education records will be on file in 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. Sustained compliance will be monitored by the QAPI committee.
Completion date: November 11, 2022
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 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' observations (Observation #1) and for one (1) of two (2) 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #2).
Findings:
A review was conducted of facility policy on September 26, 2022 at approximately 9:00 a.m. Policy 'Central Venous Catheter Dressing Change' (Setting: IPS) states " ... Aseptic technique must be followed to prevent infections." Policy 'Changing the Catheter Dressing (Setting: IC, HT) 'Background' states ".... Strict infection control practices ....is essential to prevent serious complications."
Policy 'Initiation of Treatment using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer' (Setting: IC, IPS) ''Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heparin Administration' 'Follow the steps below to disinfect the catheter connections: "......(2) Remove cap from clamped arterial limb. (3) Using a sterile alcohol pad .... scrub the sides (threads) and end of hub thoroughly with friction, ......" (4) Using the same sterile alcohol pad, ..... applying friction to remove any blood or residue, move from the hub at least several centimeters towards the body of the catheter (Steps 3 and 4 should take 10-15 seconds). (5) Hold the limb while allowing antiseptic to dry. (6) Immediately attach a sterile syringe to limit exposure to air. Repeat steps 1-6 for venous catheter limb.)
Policy 'Initiation of Termination of Treatment Using a Central Venous Catheter (CVC) 'Background' states " ....Strict infection control practices and adherence to the procedure is essential to prevent serious complications."
Observations conducted in the patient treatment area on September 21, 2022 between approximately 9:25 a.m. and 11:45 a.m. and on September 22, 2022 between approximately 11:40 a.m. and 12:00 p.m. revealed the following:
Observation #1: On 09/21/22 at approximately 11:25 a.m. while observing 'Central Venous Catheter Exit Site Care' observation #1, for patient #10, station #20; employee #16 did not ensure the patients shirt was secured away from the exit site. The patients shirt made contact with the access site after the old CVC dressing was removed.
Observation #2: On September 21, 2022 at approximately 11:45 a.m. while observing 'Initiation of Dialysis with Central Venous Catheter' observation #2 for patient #9, station #15; employee #12 scrubbed the first hub for approximately 5 seconds. Employee #12 did not attach a sterile syringe to the first scrubbed hub and it was left exposed. Employee #12 then scrubbed the second hub for approximately 5 seconds. Employee #12's right hand made contact with the first exposed scrubbed hub. Employee #12 then attached a sterile syringe to both hubs.
An interview with the facility Clinical Manager on September 26, 2022 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all DPC staff on the following policy:
- Central Venous Catheter Dressing Change
- Initiation of Treatment Using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer
- Termination of Treatment Using a Central Venous Catheter (CVC)
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 CVC. The meeting will reinforce that the patient's CVC site does not come into contact with any article of clothing once the CVC dressing is removed. The meeting will also review that the hubs of the catheter must be scrubbed for the proper time per policy and the hub is not left exposed.
The inservicing will be completed by October 13, 2022, 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 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 QAPI schedule. A 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: November 11, 2022
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 two (2) of three (3) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #1, Observation #3).
Findings include:
A review was conducted of facility policy on September 26, 2022 at approximately 9:00 a.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." Step (5) states "LOOK:......" Step (6) states "LISTEN:.....", Step (7) states "FEEL: ...", Step (9) states "Remove gloves and perform hand hygiene. Don clean gloves."
Observations conducted in the patient treatment area on September 21, 2022 between approximately 9:25 a.m. and 11:45 a.m. and on September 22, 2022 between approximately 11:40 a.m. and 12:00 p.m. revealed the following:
Observation #1: On 09/21/22 at approximately 10:25 a.m., patient #11 at station #6, employee #10 began to initiate dialysis treatment. Employee #10 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.
Observation #3: On 09/21/22 at approximately 10:55 a.m., patient #13 at station #9, employee #9 began to initiate dialysis treatment. Employee #9 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 Manager on September 26, 2022 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:The CM or designee educated all the DPC staff on the following policy:
- Access Assessment and Cannulation
The meeting reinforced the importance of ensuring that the patient's access is washed with soap and water prior to the access evaluation. Emphasis will be placed on ensuring that patients wash their access sites. The meeting will reinforce that the DPC staff must ask the patient if the site was washed and if not, the staff are to wash the site with soap and water for them.
The in-servicing will be completed by October 13, 2022. Documentation of the training will be 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 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: November 11, 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 a review of facility policy/procedure, clinical record review, and an interview with the facility Clinical Nurse Manager, it was determined the facility failed to ensure COVID-19 screening protocols were followed, per facility policy, for one (1) 'Covid-19 Staff and Visitor Screening Forms' reviewed (Form #1); failed to ensure an initial registered nurse evaluation was conducted, prior to the initiation of first treatment, for four (4) of seven (7) patient clinical records (CR) reviewed (CR#1, CR#2, CR#6, CR#7); and facility staff failed to ensure the nurse in charge was made aware of patient hypertension during treatment for one (1) of five (5) in-center patient clinical records (CR) reviewed (CR#4).
Findings include:
A review was conducted of facility policy on September 26, 2022 at approximately 9:00 a.m.
Policy 'Guidance on Dialyzing and Infection Control Practices During a COVID-19 Endemic in Fresenius Kidney Care (FKC) Clinics' (Setting: IC, HT) Policy' states "Patient, Visitor, Staff, Physician, and Physician Extender Screening: Regardless of COVID-19 vaccination and/or booster status, all patients, visitors, staff, physicians, and physician extenders entering an FKC dialysis clinic must be screened for ongoing signs and symptoms of COVID-19 disease." "Completed screening forms must be maintained in a secure location within all FKC dialysis clinics ...for future reference as needed."
A review of the COVID-19 screening forms was conducted on 09/21/22 at approximately 8:50 a.m. revealed the following:
Form #1: The 'COVID-19 Patient and Visitor Screening Form' dated 09/20/22 revealed employee #25 was not screened for COVID-19 upon entry into the facility. 'Provider Rounding Note Comp HD' shows employee #25 was in the building on above date.
The 'COVID-19 Patient and Visitor Screening Form' dated 09/21/22 revealed employee #16, employee #21, and employee #24 were not screened for COVID-19 upon entry into the facility. These employees were present at the facility during the onsite survey on 09/21/22. Two (2) patients temperatures were recorded but the question segments of the screening process were left blank with no entires.
Policy 'Comprehensive Interdisciplinary Assessment and Plan of Care' 'Prior to Initiation of the patients first treatment for Patients New to Dialysis' states "A registered nurse must perform an assessment on patients NEW to dialysis BEFORE initiation of their first treatment to determine immediate needs. The RN must document the assessment. The assessment may be documented on the CIA in eCC, evaluation cascade in Chairside or multidisciplinary notes and should include at a minimum: *Neurologic: level of alertness/mental status, orientation, identification of sensory deficits. *Subjective complaints. *Rest and comfort: pain status. *Activity: ambulation status, support needs, fall risk. *Access: assessment. *Respiratory: respirations description, lung sounds. *Cardiovascular: heart rate and rhythm; presence and location of edema. *Fluid gains, blood pressure and temperature pre-treatment. *Integumentary: skin color, temperature and as needed, type/location of wounds."
A review of clinical records was completed on 09/26/22 at approximately 11:00 a.m. Patients admission date is listed below:
CR#1, Date of admission 07/07/21: Patients first treatment flowsheet dated 07/07/21 reviewed. Patients treatment initiated 3:50 p.m. Documentation provided of the 'Pre Treatment Initial Nursing Assessment (V715)' form being time stamped at 5:15 p.m.
CR#2, Date of admission 12/04/20: Patients first treatment flowsheet dated 12/04/20 reviewed. Patients treatment initiated 3:45 p.m. Documentation provided of the 'Pre Treatment Initial Nursing Assessment (V715)' form being time stamped at 6:00 p.m.
CR#6, Date of admission 07/25/20: This patient transferred from in-center dialysis to peritoneal dialysis on 03/22/22. Patients first treatment flowsheet dated 07/25/20 reviewed. Patients treatment initiated 12:05 p.m. Documentation provided of the 'Pre Treatment Initial Nursing Assessment (V715)' form being time stamped at 2:30 p.m.
CR#7, Date of admission 12/04/20: This patient transferred from in-center dialysis to home hemo- dialysis on 08/09/21. Patients first treatment flowsheet dated 12/04/20 reviewed. Patients treatment initiated 4:04 p.m. Documentation provided of the 'Pre Treatment Initial Nursing Assessment (V715)' form being time stamped at 7:45 p.m.
Policy 'Hypertension' 'Policy' states "Staff will recognize, report, and immediately address systolic blood pressures greater than 180 mm/Hg and/or diastolic blood pressures greater than 100 mm/Hg." 'Treating Hypertension' states "Follow the steps below to address hypertension" (1) Notify the nurse in charge if a patient has a systolic blood pressure greater than 180 mm/Hg and/or diastolic blood pressure greater than 100 mm/Hg. (2) The RN will assess the patient and determine if further nursing interventions are needed."
CR#4, Date of admission 08/08/17: Documentation of treatment flowsheet dated 09/17/22; treatment started at "11:05." At 11:09 BP was "183/89". At 11:33 blood pressure was "194/93". At 12:02 BP "192/93". At 12:33 BP "199/95". At 13:01 BP "199/95". At 13:37 BP "209/97". At 14:03 BP "182/93". At 14:31 BP "199/103". At 14:52 treatment was ended. No documentation provided of the personal care technician notifying the nurse in charge, at any time during the patients treatment from the beginning to the end, of the patients elevated blood pressure during treatment.
An interview with the facility Clinical Manager on September 26, 2022 at approximately 11:30 a.m. confirmed the above findings.
Plan of Correction:By October 13, 2022, the Area team Lead (ATL) 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:
- Guidance on Dialyzing and Infection Control Practices During a Covid-19 Endemic in Fresenius Kidney Care Dialysis Unit
- Covid-19 Patient and Visitor Screening Form
- Comprehensive Interdisciplinary Assessment and Plan of Care
- Hypertension
The meeting will focus on the importance of the staff always following FMC policies. The meeting reviewed that all staff, patients, physicians, and physician extenders are screened for Covid-19 upon entering the facility. The Medical Director will be informed that the registered nurses (RNs) need to complete an assessment on patients new to dialysis prior to the initiation of treatment with documentation of the assessment. The meeting will also review that the DPC staff must inform the RN of any blood pressure (BP) elevations for further evaluation and intervention if indicated.
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 October 13, 2022.
All training documentation will be on file at the facility.
The Medical Director was informed that the CM or designee will perform audits as stated in the POC for each Vtag citation. Once compliance is observed, the audits will then follow the monthly QAPI schedule. A 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 weekly. The results and progress of the POC will be reviewed at the QAPI Committee monthly meeting. The QAPI committee will be responsible for further guidance and ongoing oversight.
Completion date: November 11, 2022
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