Initial Comments:
Based on the findings of an onsite unannounced recertification survey conducted on December 5, 2023 through December 7, 2023, Delco Dialysis Unit, 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 recertification survey conducted on December 5, 2023 through December 7, 2023, Delco Dialysis Unit, 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 observations, review of agency policy and procedures, and interview with the facility administrator, it was determined that the facility staff did not practice proper infection control during initiation of dialysis treatments, for two (2) of eighteen (18) observations. Observation #9 and #12
Findings include:
Reviewed facility ' s policies and procedures on December 7, 2023 from 10:15AM until approximately 11:00AM.
Observation tour of treatment area was conducted on December 5, 2023 from approximately 9:50AM until approximately 1:40PM revealed:
Policy titled "Access Assessment and Cannulation" states, " ...Assessment of Vascular Access ...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. 2. Wash hands and done PPE: gloves, gown/apron, safety glasses and mask, or full-face shield ...9. Remove gloves and perform hand hygiene. Don new gloves ...Skin Disinfection - 1. Disinfect cannulation site ... "
Observation #9:
At approximately 10:44AM, PCT3 was observed preparing for the initiation of dialysis for an AV fistula patient at station #12. With gloved hands, PCT3 documented on the computer, walked over to the sink that was located a few feet across from station #12, and gathered materials to wash the patient ' s access site. With same gloved hands, PCT3 washed the patient ' s access site, located and palpated the access site, and applied antiseptic to the patient ' s skin over the cannulation site. PCT3 did not remove gloves, perform hand hygiene, or don clean gloves, prior to disinfecting the cannulation site.
Policy titled "Changing the Catheter Dressing Procedure" states, " ...Removal of Dressing and Inspection of Site ...1. Place an underpad under catheter limbs to protect work area and clothing ...3. Perform hand hygiene. 4. Don clean gloves. 5. Inspect and remove the old dressing. Check to see if dressing looks visibly soiled with exudate or blood. 6. Visually inspect the exit site and surrounding area ...8. Discard dressing and remove gloves. Perform hand hygiene ... "
Observation #12:
At approximately 12:13PM, PCT4 was observed performing central venous catheter (CVC) exit site care for the patient at station #3. PCT4 performed hand hygiene, donned clean gloves, and performed central venous catheter exit site care using proper technique. After PCT4 applied the sterile dressing to the CVC exit site, PCT4 did not remove gloves, perform hand hygiene or don clean gloves. PCT4 used the same gloved hands to close the catheter clamps, disinfect CVC hubs, connect sterile syringes, flushed with sterile saline, and initiated treatment. PCT4 removed gloves and performed hand hygiene after connecting and flushing the sterile saline for the patient at station #3.
An interview with the agency facility administrator, on December 7, 2023 at approximately 3:15PM confirmed the above the findings.
Plan of Correction:On or before 12/26/2023, the Clinical Manager will review citations from the Statement of Deficiencies either via staff meetings or huddles, to stress the importance of maintaining adherence to policies and sustaining compliance, related to improper infection control practices.
Before 12/26/2023, Clinical Manager or designee will meet with staff to re-educate and reinforce the expectations and responsibilities of the facility staff on the following policies and Procedures:
Access Assessment and Cannulation (Version 3)
Changing the Catheter Dressing Procedure (version 7)
Initiation of treatment Using a Central Venous Catheter and Opiflux Single Use Ebeam Dialyzer (Version 7)
Personal Protective Equipment (Version 6)
Emphasis was placed on:
Importance of donning gloves when touching any part of the dialysis machine or equipment at the dialysis machine, to include but not limited to answering alarms or entering data into the dialysis machine computer screen. Then removing gloves, sanitizing or washing hands, before touching clean cart supplies. Putting on new gloves before washing access, palpating the access (AVF or AVG), or prepping skin for cannulation.
Importance placed on following policy for catheter exit site care, using proper infection control techniques. Changing gloves and performing hand hygiene, per policy after each step to prevent cross contamination.
Effective 12/27/2023, Clinical Manager or designee will conduct daily infection control audits with focus on ensuring staff perform glove changes and hand hygiene per policy, as required, utilizing Infection Control Audit Tool for 2 weeks and then weekly for an additional 2 weeks. The Governing Body will determine on-going frequency of the audits based on compliance. Once compliance sustained monitoring will be done through the Clinic Audit Checklist per QAI calendar.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to presenting to the QAI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The QAI Committee is responsible for providing oversight, reviewing findings, and taking actions as appropriate. The root cause analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAI monthly.
The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAI and Governing Body minutes, education and monitoring documentation are available for review at the clinic.
494.60 STANDARD
PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT
Name - Component - 00
The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment.
Observations:
Based on observations and interview with the facility administrator, it was determined that the facility staff did not follow facility policy to maintain the quality and storage of supplies for three (3) of eighteen (18) observations. Observations #1, #3, and #4
Findings include:
Policy titled "Storage of Supplies" states, " ...Supplies must be rotated First In-First Out (FIFO) to ensure products maintain quality and do not expire. Appropriately dispose of items that have reached the expiration date ... "
Observation tour of medication area near the nurse ' s station and supply carts in treatment area was conducted on December 5, 2023 from approximately 11:15AM until approximately 12:30PM revealed:
The following supplies were expired:
Observation #1
(Located in the prep sink area near the nurse ' s station)
One (1) Bottle of E-Z Check Blood Leak Test Strips Lot 101029, Expired 5/31/2021 (approximately 20 strips remaining)
One (1) Bottle of E-Z Check Blood Leak Test Strips Lot 101041, Expired 11/30/2022 (approximately 22 strips remaining)
(Located in the cabinet above the hand wash sink between station #16 and #17)
One (1) Box of E-Z Check Blood Leak Test Strips (unopened), Lot 101038, Expired 4/30/2022
Observation #3
(Located in the room outside of the BioMed area)
One (1) Box of 0.9% Sodium Chloride Injection USP, Lot V22D24C, Expired 10/2023 (approximately 10 bags remaining)
Observation #4
(Located in the utility clean closet near the conference room)
One (1) Bottle of Hydrogen Peroxide (3%) 16oz, Lot 60661, Expired 11/2023
Two (2) Packs of JAMAR Monofilament Disposable Lops (sensory testing diabetic foot screening tool), Code Q0815GS, Expired 8/15/2020 (20 per pack)
One (1) Pack of JAMAR Monofilament Disposable Lops (sensory testing diabetic foot screening tool), Code O0220GS, Expired 2/20/2022
Two (2) Packs of JAMAR Monofilament Disposable Lops (sensory testing diabetic foot screening tool), Code N0120GS, Expired 1/20/2023 (20 per pack)
One (1) Bottle of ExSept Plus Antimicrobial Exit Site Skin and Wound Cleanser 17oz, Expired 4/23/2023
One (1) Bottle of ExSept Plus Antimicrobial Exit Site Skin and Wound Cleanser 17oz, Expired 11/7/2023
Five (5) Boxes of Sterile Medcom SafeBasics Cotton Tipped Applicators (individually wrapped), Lot 71736, Expired 10/2019 (200 units per box)
Two (2) Boxes of Sterile Medcom SafeBasics Cotton Tipped Applicators (individually wrapped), Lot 85191, Expired 3/2023 (200 units per box)
Six (6) Boxes of Sterile Medcom SafeBasics Cotton Tipped Applicators (individually wrapped), Lot 86869, Expired 5/2023 (200 units per box)
An interview with the agency facility administrator, on December 7, 2023 at approximately 3:15PM confirmed the above the findings.
Plan of Correction:For immediate compliance all expired items, including the hand sanitizer, lab tubes, and monofilaments found at the time of the survey were removed. The items were discarded on 12/05/2023, by the Clinical Manager and staff.
For ongoing compliance, the Clinical Manager or designee will in-service all direct patient care (DPC) staff on the following policy:
Storage of Supplies (Version 2)
Emphasis will be placed on ensuring that all medications and supplies are all within the current date for use. The meeting reviewed that medications and supplies must follow the manufacture's direction for use (MDU) and that stock must be rotated First In – First Out when restocking. The meeting will reinforce that staff must check the expiration date of medications and supplies before using them.
The inservice will be completed by 12/26/2023, and the education records will be on file in the facility.
The Clinical Manager or designee will perform weekly audits for four (4) weeks. At that time, if one hundred percent (100%) compliance is sustained, the audits will then follow the monthly Quality Improvement 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 Clinical Manager will review the audit results and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The QAI Committee is responsible for providing oversight, reviewing findings, and taking actions as appropriate. The root cause analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAI monthly.
The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAI and Governing Body minutes, education and monitoring documentation are available for review at the clinic.
494.80(d)(2) STANDARD
PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO
Name - Component - 00
In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted-
At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.
Observations:
Based on review of medical records, agency policy and procedures, and interview with the facility administrator, it was determined that the facility did not maintain complete and accurate records, for one (1) of seven (7) medical records (MR) reviewed (MR3).
Findings include:
Reviewed facility's policies and procedures on December 7, 2023 from 10:15AM until approximately 11:00AM.
Policy titled "Comprehensive Interdisciplinary Assessment and Plan of Care (CIA/POC)" states,"...General Policy for Patient Assessment and Plan of Care - ...The patient's Plan of Care will be guided and developed based on the findings identified in the Comprehensive Interdisciplinary Assessment...CIA/POC for Unstable Patients - Unstable patients must be reassessed by the IDT (Interdisciplinary Team) monthly. Monthly reassessment and any POC updates related to the reason the patient is considered "unstable" must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic. The following are unstable criteria: Extended or frequent hospitalizations (a) Hospitalization of more than 15 days with discharge occurring within the last 30 days..."
Review of medical record (MR) on December 6, 2023 at approximately 12:49PM revealed:
MR3. Admit Date: 7/14/2023. DOB: 9/14/1964. Patient receives in-center hemodialysis via central venous catheter for three (3) and one-half hours per day for three (3) days per week.
Reviewed facility's list of "unstable" patients for the past three (3) months on December 5, 2023 at approximately 2:15PM. MR3's current status listed as "unstable" during the month of October (date not determined) due to "hospitalizations". There was no documentation to confirm that the IDT conducted a monthly reassessment of the patient's current unstable status.
An interview with the agency facility administrator, on December 7, 2023 at approximately 3:15PM confirmed the above the findings.
Plan of Correction:The Clinical Manager or designee will re-educate the Interdisciplinary Team (IDT) staff on:
Comprehensive Interdisciplinary Assessment and Plan of Care (Version 6)
Emphasis will be placed on maintaining accurate and complete records referencing the "CIA/POC for Unstable Patients" noted in the policy above. Ensuring that monthly status of all patients to include unstable patients' status is reviewed and documented.
The in-servicing will be completed by 12/26/2023, with documentation of the training on file at the facility.
Starting 12/27/2023, the Clinical Manager or designee will perform monthly audits of all patients to include unstable patients for documented current status accuracy, for the next three (3) months. At that time, if 100% compliance is observed, the audits will then be completed following the monthly QAPI schedule. A POC specific audit tool will be used for the audits.
Issues of non-compliance will be addressed by the Clinical Manager with re-education and counseling.
The Clinical Manager will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The QAI Committee is responsible for providing oversight, reviewing findings, and taking actions as appropriate. The root cause analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAI monthly.
The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAI and Governing Body minutes, education and monitoring documentation are available for review at the clinic.
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 observations, review of agency policy and procedures, and interview with the facility administrator, it was determined that the facility staff did not follow its policy for infection control practices related to patient and visitor PPE, for one (1) of one (1) observation.
Findings include:
Review of facility's policies and procedures on December 7, 2023 from 10:15AM until approximately 11:00AM revealed:
Policy titled "Guidance on Dialyzing and Infection Control Practices of COVID-19 in Fresenius Kidney Care (FKC) Dialysis Clinics...Patient and Visitor PPE (Personal Protective Equipment): All patients and visitors should be provided with a surgical mask upon entry to the FKC dialysis clinic and treatment floor..."
Upon arrival at the facility on December 5, 2023 at approximately 8:50AM, the surveyor was greeted by the facility administrator in the reception area and was escorted through the treatment area where patients were dialyzing and led to the conference room. The surveyor was not given PPE/mask when entering the treatment area.
An interview with the agency facility administrator, on December 7, 2023 at approximately 3:15PM confirmed the above the findings.
Plan of Correction:Before 12/26/2023, the Clinical Manager will hold a staff meeting, elicit input, and reinforce the expectations and responsibilities of the facility staff on the following policy:
Guidance on Dialyzing and Infection Control Practices of Covid-19 in Fresenius Kidney Care (KFC) dialysis clinics.
Emphasis will be placed on this section of the policy, "Patient and Visitor PPE": All patients and visitors should be provided with a surgical mask upon entry to the FKC dialysis clinic and treatment floor. FKC patients and visitors are required to wear surgical face masks upon entry to the dialysis clinic and throughout the duration of dialysis treatment and discharge from the clinic post-treatment.
All in-services and training will be available for review at the facility.
Effective 12/27/2023, the Clinic Manager or designee will conduct daily audits for face mask requirements for 2 weeks utilizing Plan of Correction Audit tool. Once compliance is sustained 95%, the Governing Body will decrease frequency to resume regularly scheduled audits based on the QAI calendar.
The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as related to this Plan of Correction prior to presenting to the QAI Committee monthly.
The Director of Operations is responsible to present the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.
The QAI Committee is responsible to provide oversight, review findings, and take actions as appropriate. The root cause analysis process is utilized to develop the Plan of Correction. The Plan of correction is reviewed in QAI monthly.
The Governing Body is responsible to provide oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.
The QAI and Governing Body minutes, education and monitoring documentation, are available for review at the clinic.
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