Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed February 10, 2022, Fresenius Medical Care of South Allentown 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 February 10, 2022, Fresenius Medical Care of South Allentown 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 (EF#8), the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for two (2) of three (3) 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' observations (Observation#1, #3) and failed to ensure the staff followed infection control protocols, included but not limited to, staff performing hand hygiene prior to exiting the treatment area, for two (2) of two (2) observations (Observation#1-#2).
Findings include:
A review was conducted of facility policy/procedure on February 10, 2022, at approximately 8:30 a.m.
Policy 'Clinical Services' Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer' '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 Needle Removal' 'Procedure' section (2) states "Person removing needles perform hand hygiene and don clean gloves."
Observations conducted in patient treatment area on 02/07/22 between approximately 8:55 a.m. -11:45 a.m. and on on 02/08/22 between approximately 11:05 a.m. -11:40 a.m. revealed the following:
Observation #1 of (3): During observation of 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 02/07/22 at approximately 10:20 a.m., of patient #11, Employee #4 at station #13 did not perform hand hygiene/don clean gloves after reinfusing the extracorporeal circuit and disconnecting the bloodlines and before removing the needles.
Observation #3 of (3): During observation of 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 02/07/22 at approximately 11:45 a.m., of patient #12, Employee #4 at station #15 did not perform hand hygiene/don clean gloves after reinfusing the extracorporeal circuit and disconnecting the bloodlines and before removing the needles.
Policy 'Clinical Services' 'Hand Hygiene' 'Purpose' states "The purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination". 'Policy' states "Hands will be ....'Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water' 'When: ..."Entering and leaving the treatment area."
Observation #1 of (2): During treatment area observations on 02/07/22 at approximately 9:45 a.m. Employee #3 did not perform hand hygiene prior to exiting the treatment area and before entering the adjacent supply room area.
Observation #2 of (2): During treatment area observations on 02/07/22 at approximately 10:08 a.m. Employee #9 did not perform hand hygiene prior to exiting the treatment area and before entering the adjacent main hallway.
An interview with the facility Clinical Nurse Manager on February 10, 2022 at approximately 10:30 a.m. confirmed the policy as current and confirmed the above findings.
Plan of Correction:To ensure compliance, the Clinic Manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Hand Hygiene
- Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer
- Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux Single Use Ebeam Dialyzer
- Post Treatment Fistula Needle Removal
Special emphasis will be placed on ensuring that gloves are removed, and hand hygiene performed, and new gloves donned per policy when removing the patient's fistula needles. The in-service will also review that the staff must perform hand hygiene prior to exiting the treatment floor.
The in-servicing will be completed by February 22, 2022, with documentation of the training on file at the facility.
The CM or designee will perform daily audits on the DPC staff 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 Improvement (QAI) 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: March 18, 2022
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 review of facility policy and an interview with the facility Clinical Nurse Manager (EF#8), the facility failed to ensure expired items were discarded for one (1) of one (1) observations (Observation #1).
Findings include:
A review was conducted of facility policy/procedure on February 10, 2022, at approximately 8:30 a.m.
Policy 'Clinical Services' 'Expiration Dates and Sterile Supplies' 'Purpose' states "This policy provides guidance on checking expiration dates to assure that sterile supplies are taken out of circulation by the expiration date." "Sterile items will be checked before use to ensure that they have not expired. Appropriately dispose of sterile items that have reached the expiration date."
Observations conducted in patient treatment area on 02/07/22 between approximately 8:55 a.m. -11:45 a.m. and on on 02/08/22 between approximately 11:05 a.m. -11:40 a.m. revealed the following:
Observation #1: On February 7, 2022 at approximately 8:55 a.m. the following expired items were observed in the treatment area cupboards by the nursing station:
Approximately seventy-five (75) BD-Vacutainers (4.0 ml) with an expiration date of 09/30/2019.
Approximately seventeen (17) BD-Vacutainers (8.0 ml) with an expiration date of 05/31/2020.
An interview with the facility Clinical Nurse Manager on February 10, 2022 at approximately 10:30 a.m. confirmed the policy as current and confirmed the above findings.
Plan of Correction:For immediate compliance all expired items found at the time of the survey were removed and discarded on 2/10/2022 by the bio-medical technician (BMT).
For ongoing compliance, the CM or designee will in-service all DPC staff on the following policy:
- Expiration Dates Sterile Supplies
Emphasis will be placed on ensuring that all supplies, including those stored in the lab cupboards, are all within the current date for use. The meeting reviewed that supplies must be rotated First In – First Out when restocking.
The inservice will be completed by February 22, 2022, and the education records will be on file in the facility.
The CM or designee will perform daily audits on the DPC staff 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 QAI 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 QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.
Completion Date: 3/18/2022
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 review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager (EF#8), the facility failed to ensure the staff followed infection control protocols for one (1) of two (2) 'Central Venous Catheter Exit Site Care' observations (Observation #2).
Findings include:
A review was conducted of facility policy/procedure on February 10, 2022, at approximately 8:30 a.m.
Policy ''Clinical Services' 'Changing the Catheter Dressing' 'Background' states "Catheter related infections are one of the leading causes of hospitalization and death. Strict infection control practices and adherence to the catheter dressing change procedure is essential to prevent serious complications."
Observations conducted in patient treatment area on 02/07/22 between approximately 8:55 a.m. -11:45 a.m. and on on 02/08/22 between approximately 11:05 a.m. -11:40 a.m. revealed the following:
Observation #2: During observation of the 'Central Venous Catheter Exit Site Care' on 02/08/2022 at approximately 11:30 a.m., of patient #8, Employee #7 at station #1, Employee #7 did not secure the patients button-up long sleeve shirt away from the exit site. The shirt made contact with the exit site twice, after the old dressing was removed and discarded and before the new sterile dressing was applied. Employee #7 held the patient's shirt back away from the exit site with her left hand as she applied the sterile dressing with her right hand.
An interview with the facility Clinical Nurse Manager on February 10, 2022 at approximately 10:30 a.m. confirmed the policy as current and confirmed the above findings.
Plan of Correction:The CM or designee re-educated all the DPC staff on the following policy:
- Changing the Catheter Dressing
Special emphasis was placed on ensuring that no contact is made with the catheter dressing site while the catheter dressing is being changed. This includes the patients clothing
The in-servicing of staff and patients will be completed by February 22, 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 Improvement (QAI) 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: March 18, 2022
494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS
Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:
Blood pressure, and fluid management needs.
Observations:
Based on review of facility policy/procedure, clinical record review, and an interview with the facility Clinical Nurse Manager (EF#8), it was determined the facility failed to follow policy for addressing patient hypertension during treatment for one (1) of five (5) incenter patient clinical records (CR) reviewed (CR#3).
Findings include:
A review was conducted of facility policy/procedure on February 10, 2022, at approximately 8:30 a.m.
Policy 'Clinical Services' 'Hypertension' 'Treating Hypertension' "Follow the steps below to address hypertension: Step #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. Step #2. The RN will assess the patient and determine if further nursing interventions are needed. .... Step#5. Document in patients treatment record."
A review of clinical records was conducted on 02/10/2022 between approximately 12:30 p.m.-3:00 p.m. and on 02/11/22 between approximately 8:30 a.m.-10:00 a.m. Patients admission date is listed below:
CR#3 Date of admission 09/24/2020: Treatment flowsheet dated 01/29/2022 with a treatment time span of 6:54 a.m.-10:18 a.m.
At 8:34 a.m., blood pressure was recorded as 191/112 by EF#5 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#5 reporting hypertension to a registered nurse.
At 9:03 a.m., blood pressure was recorded as 199/123 by EF#5 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#5 reporting hypertension to a registered nurse.
At 9:32 a.m., blood pressure was recorded as 188/127 by EF#7 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#7 reporting hypertension to a registered nurse.
At 10:03 a.m., blood pressure was recorded as 199/124 by EF#7 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#7 reporting hypertension to a registered nurse.
Treatment flowsheet dated 02/05/2022 with a treatment time span of 6:25 a.m.-10:12 a.m.
At 8:04 a.m., blood pressure was recorded as 203/126 by EF#6 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#6 reporting hypertension to a registered nurse.
At 8:04 a.m., blood pressure was recorded as 188/110 by EF#6 (patient care technician). The 'Comments' section included "Green Amp Light: Denies complaints: Access visible."
No documentation of EF#6 reporting hypertension to a registered nurse.
At 8:32 a.m., blood pressure was recorded as 184/123 by EF#4 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#4 reporting hypertension to a registered nurse.
At 9:04 a.m., blood pressure was recorded as 191/116 by EF#3 (patient care technician). The 'Comments' section included "Green Amp Light: Denies complaints: Access visible."
No documentation of EF#3 reporting hypertension to a registered nurse.
At 9:34 a.m., blood pressure was recorded as 205/120 by EF#4 (patient care technician). The 'Comments' section is blank with no entries. No documentation of EF#4 reporting hypertension to a registered nurse.
An interview with the facility Clinical Nurse Manager on February 10, 2022 at approximately 10:30 a.m. confirmed the policy as current and confirmed the above findings.
Plan of Correction:
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Hypertension
Emphasis will be placed on ensuring that the patient care technician (PCT) must report any treatment abnormal findings, including hypertension, to the registered nurse (RN). The staff were also informed that there must be documentation of the RN notification. The RN will then complete an evaluation of the patient with documentation of the assessment. The nurses will also be informed that the physician must be notified if indicated. The RN must also document the physician notification.
Inservicing will be completed by February 21, 2022. All training documentation is 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 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: March 18, 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, observations, and an interview with the Clinical Nurse Manager (EF#8), 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 #2, Observation #3).
Findings include:
A review was conducted of facility policy/procedure on February 10, 2022, at approximately 8:30 a.m.
Policy 'Clinical Services' 'Access Assessment and Cannulation' 'Assessment of Vascular Assess' 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 patient treatment area on 02/07/22 between approximately 8:55 a.m. -11:45 a.m. and on on 02/08/22 between approximately 11:05 a.m. -11:40 a.m. revealed the following:
Observation #2: On 02/07/22 at approximately 11:05 a.m. Employee #3, patient #9 at station #4, began to initiate dialysis treatment. Employee #3 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 02/07/22 at approximately 11:15 a.m. Employee #6, patient #10 at station #9, began to initiate dialysis treatment. Employee #6 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 February 10, 2022 at approximately 10:30 a.m. confirmed the policy as current and confirmed the above findings.
Plan of Correction:The CM or designee re-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 sites are washed with soap and water prior to treatment. The staff were informed that they must ask all patients if they washed their access sites. If the answer is no or the patient is unable to wash the sites themselves, the staff must wash the access for them.
The in-servicing of staff will be completed by February 22, 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 100% compliance is observed, the audits will then be completed 3 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 QAI 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 audits and report the findings to the QAI Committee at the monthly meeting. The QAI committee will be responsible for further guidance and ongoing oversight.
Completion Date: March 18, 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 review of facility policy/procedure, clinical record review, and an interview with the facility Clinical Nurse Manager (EF#8), it was determined the facility failed to follow policy for post hospitalization procedure for two (2) of seven (7) patient clinical records (CR) reviewed (CR#4, CR#7) and one (1) interview conducted (Interview #1); failed to ensure an initial registered nurse evaluation was conducted, prior to the initiation of first treatment, for six (6) of seven (7) patient clinical records (CR) reviewed (CR#1, CR#3-CR#7) and one (1) of one (1) interviews conducted (Interview #1); and failed to ensure COVID-19 screening protocols were followed, per facility policy, for two (2) of two (2) Covid-19 screening forms reviewed (Form #1, Form #2) and one (1) of one (1) interviews conducted (Interview #1).
Findings include:
A review was conducted of facility policy/procedure on February 10, 2022, at approximately 8:30 a.m.
Policy FMS-CS-IC-I-103-012A, FMS-CS-IS-I-500-070A, FMS-CS-HT-II-300-012A, FMS-CS-HT-I-200-020A 'Care transitions' 'Post-Hospital Review: In Center' states "Outpatient licensed nursing staff will initiate the In Center Post Hospitalization Checklist form when a patient returns from a hospital admission. The checklist provides a guideline for the clinic staff and should be completed within 3 treatments post hospitalization. Scan completed checklists into Document Manager. Timely completion of the checklist will assist in preventing readmission."
'Post Hospital Review: Home Therapies' states "outpatient home therapies licensed nursing staff will initiate the Home Therapies Post-Hospitalization Checklist form as soon as they become aware that the patient has been discharged from the hospital. The checklist provides a guideline for home therapies staff and should be completed within 7 days. Scan completed checklist into Document Manager. Timely completion of the checklist will assist in preventing readmission."
A review of clinical records was conducted on 02/10/2022 between approximately 12:30 p.m.-3:00 p.m. and on 02/11/22 between approximately 8:30 a.m.-10:00 a.m. Patients admission date is listed below:
CR#4 Date of admission 09/09/19: Documentation provided of patient (in-center) being hospitalized on 12/01/2021-12/07/21, 12/08/21-12/14/21, 01/05/22-01/06/22, 01/24/22-01/28/22.-02/10/2020. No documentation of a licensed nurse completing the 'In Center Post Hospitalization Checklist' form within 3 treatments post hospitalization on any of above stated dates, per policy.
CR#7 Date of admission 12/16/19: Documentation provided of patient (home therapies) being hospitalized on 11/22/2021-12/09/21 and entering a rehabilitation center from 12/10/21-12/18/21. No documentation of a licensed nurse completing the 'Home Therapies Post Hospitalization Checklist' as soon as they became aware that the patient had been discharged from the hospital, per policy.
Interview #1: An interview was conducted with the Director of Operations (EF#15) on 02/09/22 at approximately 2:30 p.m. Per EF#15, the Post Hospitalization Checklists are only used as a guideline, they are not required to be completed. EF#15 proceeded to explain to the surveyor that some forms are only used as guidelines and are not always actually required to be completed by staff.
Policy 'Clinical Services' '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 documnted 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."
CR#1 Date of Admission 10/31/19: Patient's first treatment flowsheet dated 10/31/19 was reviewed. Treatment initiated at 11:59 a.m. The treatment flowsheet evaluation was completed by a registered nurse with a time stamp of 1:06 p.m. The initial evaluation did not include the minimum required (9) elements, per policy and per regulation, and did not show the initial evaluation was conducted prior to the initiation of the patients first treatment.
CR#3 Date of Admission 09/24/20: Patients first treatment flowsheet dated 09/24/20 was reviewed. Treatment started at 12:49 p.m. The treatment flowsheet evaluation was completed by a registered nurse with a time stamp of 12:26 p.m. The initial evaluation did not include the minimum required (9) elements, per policy and per regulation.
CR#4 Date of Admission 09/09/19: Patients first treatment flowsheet dated 09/09/19 was reviewed. Treatment initiated at 11:38 a.m. The treatment flowsheet evaluation was completed by a registered nurse with a time stamp of 11:40 a.m. The initial evaluation did not include the minimum required (9) elements, per policy and per regulation, and did not show the initial evaluation was conducted prior to the initiation of the patients first treatment.
CR#5 Date of Admission 01/02/22: Patients first treatment flowsheet dated 01/02/22 was reviewed. Treatment initiated at 12:02 p.m. The treatment flowsheet evaluation was completed by a registered nurse with a time stamp of 13:33 p.m. The initial evaluation did not include the minimum required (9) elements, per policy and per regulation, and did not show the initial evaluation was conducted prior to the initiation of the patients first treatment.
CR#6 Date of Admission 12/20/21: Patients 'Clinical Notes Report' dated 12/20/21 was reviewed. "8:00 a.m.: Patient filled with 1000 of 2.5% solution. Patient dwell began." This note was entered by a registered nurse (EF#13). No documentation was provided of an initial evaluation which included all of the minimum required (9) elements, per policy and per regulation. Documentation provided of an 'ESRD Comprehensive RN Assessment' with a 'Last Entry Date' of "12/20/21" and 'Status' marked "Complete." There is no time stamp on the comprehensive assessment documentation which would show the assessment (specifically the minimum required (9) elements) was conducted prior to the initiation of the patients first treatment, per policy and per regulation.
CR#7 Date of Admission 12/16/19: Patients 'Clinical Notes Report' dated 12/16/19 was reviewed. "Exchange 1 using 2.5% dextrose with a fill volume of 2000 ml Explained procedure to patient at length. Drain volume of 2400 ml from exchange 1." No documentation was provided of an initial evaluation which included all of the minimum required (9) elements, per policy and per regulation. Documentation provided of an 'ESRD Comprehensive RN Assessment' with a 'Last Entry Date' of "12/16/19" and 'Status' marked "Complete." There is no time stamp on the comprehensive assessment documentation which would show the assessment (specifically the minimum required (9) elements) was conducted prior to the initiation of the patients first treatment, per policy and per regulation.
Policy 'Clinical Services' 'Coronavirus Disease Screening and Infection Control Practices in Fresenius Kidney Care )FKC) Dialysis Clinics' 'Purpose' states "To prevent transmission of Coronavirus Disease (COVID-19 -virus) ......" 'Patient, visitor, Staff, Physician, and physician extenders entering an FKC dialysis clinic must be screened for ongoing signs and symptoms of COVID-19 disease." 'Screening requirements: Daily monitoring of patients, visitor, staff, physician, and physician extender temperatures. Use the attached screening documents to record temperatures and perform screening ....." "Documentation of Screening of Staff, Physician, Physician extenders, Patients, and Visitors: Documentation of Staff, Physician, Physician extenders, Patients, and Visitor response(s) to the pre-shift screening questions should be recorded in the attached screening document(s) and retained ..."
A review of the COVID-19 screening logs was conducted on 02/08/22 at approximately 9:00 a.m. revealed the following:
Form #1: The 'COVID-19 Patient and Visitor Screening Form' dated 01/31/22, 02/01/22, and 02/05/22 revealed missing entries which included temperature, symptom screening, proximity/direct contact to a COVID-19 positive patient.
Form #2: The 'COVID-19 Employee and Physician Screening Form' dated 01/18/22, 02/01/22, 02/02/22, and 02/08/22 revealed missing entries which included temperature, symptom screening, proximity/direct contact to a COVID-19 positive patient.
Interview #1: An interview was conducted with the Clinical Nurse Manager on 02/08/22 at approximately 9:45 a.m. The Clinical Nurse Manager was asked when the Medical Director (EF#14) was recently in the facility. She stated during the week of 12/13/21-12/17/21 during a PD (peritoneal dialysis) clinic and on 01/21/22 during a QAPI (quality assurance and performance improvement) meeting. A review of the 'COVID-19 Employee and Physician Screening Form' on the above dates showed no documentation of COVID-19 screening for EF#14.
An interview with the facility Clinical Nurse Manager on February 10, 2022 at approximately 10:30 a.m. confirmed the policy as current and confirmed the above findings.
Plan of Correction:
By February 23, 2022, 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 policies:
- In-Center Post Hospitalization Checklist
- Home Therapies Post Hospitalization Checklist
- Comprehensive Interdisciplinary Assessment and Plan of Care
- Coronavirus Disease Screening and Infection Control Practices in Fresenius Kidney Care Dialysis Clinics
The meeting will focus on the importance of the staff always following Fresenius Medical Care (FMC) policies.
Minutes of the meeting with the Medical Director will be on file at the facility for review. The Medical Director will be informed at the meeting that the CM will hold a meeting with the DPC
staff on the above policies by the CM or designee by February 22, 2022. The Medical Director will be informed that the education will focus on ensuring that the post hospitalization checklist for both in-center and home therapy patients will be completed timely. And, that a nursing assessment must be completed by an RN on a patient new to dialysis per policy prior to the initiation of the treatment to determine immediate needs. The staff will also be re-educated regarding the importance of ensuring that all staff, physicians, patients (home therapy and in-center) and visitors are screened for covid per policy.
All training documentation will be on file at the facility.
The CM or designee will perform daily audits for covid screening for 2 weeks. At that time if 100% compliance is observed, the audits will then be completed 3 times/week for 2 weeks to ensure that compliance is maintained. Audit for post hospitalizations and new patient assessments will be completed weekly for 2 months. At that time, if compliance is sustained, the audits will then follow the monthly QAI 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 at the QAI Committee monthly meeting. Sustained compliance will be monitored by the QAI committee with oversight by the GB.
Completion date: March 18, 2022
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