Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed November 8, 2023, Fresenius Kidney Care Southside Dialysis 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 November 8, 2023, Fresenius Kidney Care Southside Dialysis was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services.
Plan of Correction:
494.30(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 acting Clinical Nurse Manager, the facility failed to ensure the staff followed infection control protocols, included but not limited to, cleaning and disinfecting surfaces and equipment, for three (3) of four (4) treatment area observations (Observation #2 - Observation #4).
Findings include:
A review was conducted of facility policy/procedure on November 8, 2023 at approximately 12:00 p.m.. 'Cleaning and Disinfection of the Dialysis Station' 'Purpose' "The purpose of this policy is to provide guidance to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients,, staff, and visitors." 'Background' "The Centers for Medicare and Medicaid Services(CMS) has regulations that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients."
('CMS ESRD (End Stage Renal Disease) Core Survey Version 1.6' 'Cleaning and disinfection of the Dialysis Station' 'Action' "Remove all bloodlines and disposable equipment, ...." "Empty prime waste receptacle, if present on the machine." Remove gloves, hand hygiene, don clean gloves." "Use disinfectant-soaked cloth/wipe to visibly wet all machine top, front, and side surfaces ...." Wipe wet all internal and external surfaces of the prime waste container ...")
('Centers for Disease Control and Prevention (CDC) Checklist: Dialysis Station Routine Disinfection' 'Part A: Before beginning routine disinfection of the dialysis station:' "..... Ensure that the priming bucket has been emptied. ....." 'Part B: Routine Disinfection of the Dialysis Station-After patient has left station:' ",.... Apply disinfectant to all surfaces ........ Disinfect all surfaces of the priming bucket. ...... ")
Observations conducted in the patient treatment area on November 6, 2023 between approximately 8:40 a.m. and 2:30 p.m. revealed the following:
Observation #2: The observation on 11/06/23 at approximately 11:14 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for station O, employee #4 did not empty the prime waste receptacle (bucket/container) and remove gloves/perform hand hygiene/don clean gloves prior to the disinfection of the dialysis machine/chair. Employee #4 emptied the prime waste receptacle after initiating disinfection of the dialysis machine/chair.
Observation #3: The observation on 11/06/23 at approximately 11:20 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for the isolation room, employee #2 did not empty the prime waste receptacle (bucket/container) and remove gloves/perform hand hygiene/don clean gloves prior to the disinfection of the dialysis machine. Employee #2 emptied the prime waste receptacle after after initiating disinfection of the dialysis machine/chair.
Observation #4: The observation on 11/06/23 at approximately 11:20 a.m. of 'Cleaning and Disinfection of the Dialysis Station' for for station Q, employee #4 did not empty the prime waste receptacle (bucket/container) and remove gloves/perform hand hygiene/don clean gloves prior to the disinfection of the dialysis machine. Employee #4 emptied the prime waste receptacle after after initiating disinfection of the dialysis machine/chair.
An interview with the facility acting Clinical Nurse Manager on November 8, 2023 at approximately 12:30 a.m. confirmed the above findings.
Plan of Correction:
To ensure compliance the Clinic Manager (CM) or designee will in-service all the direct patient care (DPC) staff on the following policies:
- Cleaning and Disinfection of the Dialysis Station
- Priming Bucket Disinfection
The meeting will focus on ensuring that the prime waste bucket is emptied prior to the cleaning and disinfection of the dialysis machine and station. The meeting reinforced that all internal and external surfaces of the prime waste bucket must be cleaned and disinfected.
Inservicing will be completed by November 28, 2023. 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 compliance is observed the audits will then be completed 2/week for 2 weeks to ensure ongoing 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: January 8, 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 acting Clinical Nurse Manager, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for two (2) of two (2) 'Central Venous Catheter (CVC) Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1, Observation #2) and one (1) of two (2) 'Discontinuation of Dialysis with Central Venous Catheter' observations (Observation #1).
Findings:
A review was conducted of facility policy/procedure on November 8, 2023 at approximately 12:00 p.m..
Policy 'Changing the Catheter Dressing Procedure' (Setting: IC, HT) 'Timing of Exit Site Dressing Change' states "Catheter exit site disinfection and dressing change is to be completed prior to cap and hub connector disinfection." 'Removal of dressing and inspection of Site' 'Important note: The patient and caregiver must wear a mask for all procedures that required accessing the catheter.' Step (8) states "Discard dressing and remove gloves. Perform hand hygiene. 'Cleaning the Site' step (1) states "Perform hand hygiene and don clean gloves." Step (2) states "Remove swabstick from package by stick end without touching foam applicator ...."
Policy 'Initiation of Treatment using a Central Venous Catheter (CVC) and Optiflux Single Use Ebeam Dialyzer' (Setting: IC, IPS) 'Prior to Initiation: Assessment and Machine Parameters' step (9) states ".... doff (remove) gloves, perform hand hygiene then don new gloves." 'Preparing the Catheter: Disinfection of the Catheter Connections, Heparin Removal, Flushing the Catheter and Heaprin 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 November 6, 2023 between approximately 8:40 a.m. and 2:30 p.m. revealed the following:
Observation #1: On 11/06/23 at approximately 12:05 p.m. while observing 'Central Venous Catheter Exit Site Care' observation #1, for patient #6, station G; the patients face mask was not covering their nose during the procedure. Employee #6 did not secure the patients clothing (shirt/sweatshirt) away from the access site. The patient held up their clothing with their left hand. During the procedure the patients clothing made contact with the access site.
The site was not cleansed again after contact.
Observation #2: On 11/06/23 at approximately 12:35 p.m. while observing 'Central Venous Catheter Exit Site Care' observation #2, for patient #7, isolation room; employee #1 did not remove gloves/perform hand hygiene/don clean gloves after removing the old dressing and prior to cleansing the area around the CVC exit site. Employee #1 removed gloves/performed hand hygiene/donned clean gloves after applying antiseptic to the access site.
Policy 'Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Termination: Disinfection of Catheter and Disconnecting the Patient' "Threads and end of the luer lock (hub) must be scrubbed with 70% sterile alcohol pad .......for 10-15 seconds any time caps are removed, or bloodlines are disconnected (i.e. End of treatment or treatment interruption) to reduce the risk of contamination." Step #6 states "Using a sterile alcohol pad, .....scrub the sides (threads) and end of hub thoroughly with friction, making sure to remove any residual (e.g. blood) ... (This should take 10-15 seconds.)" Step #7 states "Hold the limb while allowing the antiseptic to dry." Step #8 states :Immediately attach a prefilled saline syringe to the catheter limb."
Observation #1: On 11/06/23 at approximately 11:19 a.m. while observing 'Discontinuation of Dialysis with Central Venous Catheter' observation #1, for patient #8, station A; employee #3 removed the patient blood lines and scrubbed the hubs for approximately 5 seconds prior to attaching sterile syringes. Employee #3 removed the syringes and scrubbed the hubs for approximately 5 seconds prior to attaching port caps.
An interview with the facility acting Clinical Nurse Manager on November 8, 2023 at approximately 12:30 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 policies and procedure:
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
- Changing the Catheter Dressing Procedure
- Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
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 face mask is covering their nose, and that the patient's clothing is secured away for the access site. The meeting will also review the importance of ensuring that gloves are removed, and hand hygiene is performed per policy. This includes after removing the old catheter dressing. The inservice will reinforce that the threads and hubs of the catheter must be scrubbed for ten (10) to fifteen (15) seconds and the limbs allowed to air dry prior to attaching saline syringes to each port.
The in-servicing will be completed by November 28, 2023, with documentation of the training on file at the facility.
The CM or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2/week for 2 weeks to ensure that 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: January 8, 2024
494.60(c)(4) STANDARD
PE-HD PTS IN VIEW DURING TREATMENTS
Name - Component - 00
Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement).
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility acting Clinical Nurse Manager, the facility failed to ensure the vascular access site and bloodline connections were seen by staff members throughout the dialysis treatment for three(3) of three (3) treatment floor observations (Observation #1 - Observation #3)
Findings include:
A review was conducted of facility policy/procedure on November 8, 2023 at approximately 12:00 p.m.. 'Clinical Services' ''Patient Assessment and Monitoring' 'General Observation/Mental Status' "Ensure each patients face is visible and uncovered." 'Access' " ... Ensure access remains uncovered throughout the treatment."
Observations conducted in the patient treatment area on November 6, 2023 between approximately 8:40 a.m. and 2:30 p.m. revealed the following:
Observation #1: During treatment floor observations on 11/06/23 at approximately 8:30 a.m., patient #10, at station E; The patients AV Fistula access site was covered by a blanket from approximately 8:30 a.m. - 9:04 a.m.
( approximately 34 minutes).
Observation #2: During treatment floor observations on 11/06/23 at approximately 9:00 a.m., patient #11, isolation room; The patients AV Fistula access site was covered by a blanket from approximately 9:00 a.m. - 9:37 a.m.
( approximately 37 minutes).
Observation #3: During treatment floor observations on 11/06/23 at approximately 12:30 p.m., patient #6, station G; The patients Central Venous Catheter access site was connected to the blood lines while the patient was holding their clothing up away from the access site. The patients then let go of his clothing and the clothing draped over the bloodlines. The access was covered with the patients clothing from approximately 12:05 p.m. - 12:27 p.m.
( approximately 22 minutes).
An interview with the facility acting Clinical Nurse Manager on November 8, 2023 at approximately 12:30 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Patient Assessment and Monitoring
The meeting will place special emphasis on ensuring that the patient's access site is visible throughout their treatment. The meeting will also reinforce the importance of verification and documentation that the access is uncovered when monitoring the patient every 30-45 minutes.
The staff in-servicing will be completed by November 28, 2023, with documentation of the training on file at the facility.
All patients will receive re-education by the DPC staff on the need to keep their access uncovered during treatment for safety reasons. Documentation of the access training will be completed in the patient's clinical note. The patients will have their education completed by December 6, 2023.
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 ongoing 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 audits and report the findings to the QAPI Committee at the monthly meeting. Sustained compliance will be monitored by the QAPI committee.
Completion date: January 8, 2024
494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS
Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;
Observations:
Based on a review of facility policy/procedure, a review of medical records, and an interview with the facility acting Clinical Nurse Manager, the facility failed to ensure the staff followed facility procedure for early termination of treatment for two (2) of five (5) medical records (MR) reviewed (MR#4, MR#5).
Findings include:
A review was conducted of facility policy/procedure on November 8, 2023 at approximately 12:00 p.m.. Policy 'Early Termination or Arriving Late for Treatment' 'Policy: Early Termination: "If a patient requests to leave treatment early: *The RN who evaluates the patient must document the rationale for early termination.....*The RN is responsible to notify the physician and document on the 'AMA' (Against medical advice) form.' 'Requirement Documentation- AMA Forms: AMA Forms are "Signed by the patient" and "Signed with each early termination event and filed in the patients medical record". 'Arriving Late' states "There may be times when a patients transportation is delayed and arrives late for their scheduled time. If patient arrives after their scheduled time for dialysis treatment start the patients treatment as soon as possible. Staff should do their best to accomodate the patients prescribed treatment time. If this is not possible ....the physician must be notified to review the time delay and determine the appropriate intervention. ......"
A review of medical records conducted on November 8, 2023 between approximately 9:00 a.m.- 12:00 p.m. revealed the following:
MR#4 Date of admission 04/16/18: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 10/23/23 reviewed. Flow sheet stated "Hours On: "02:27". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 10/25/23 reviewed. Flow sheet stated "Hours On: "03:13". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 10/27/23 reviewed. Flow sheet stated "Hours On: "02:44". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 11/01/23 reviewed. Flow sheet stated "Hours On: "03:38". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 11/03/23 reviewed. Flow sheet stated "Hours On: "03:02". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
MR#5 Date of admission 07/12/23: Physician orders for Hemodialysis state treatment time "Scheduled Hours: 4:00 hours".
Patient treatment flow sheet date 10/20/23 reviewed. Flow sheet stated "Hours On: "03:41". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
Patient treatment flow sheet date 11/03/23 reviewed. Flow sheet stated "Hours On: "03:30". No documentation by registered nurse of rationale for early treatment termination nor of the AMA Form being signed and/or the physician being notified.
An interview with the facility acting Clinical Nurse Manager on November 8, 2023 at approximately 12:30 a.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will in-service all the DPC staff on the following policies:
- Early Termination or Arriving Late for Treatment
- Against Medical Advise (AMA) Form
The meeting will focus on ensuring that the registered nurse (RN) is notified when a patient is requesting to discontinue treatment early with documentation of the RN notification. The meeting will review that the RN must evaluate the patient and document the reason for the early termination of treatment. The staff meeting will also reinforce that the patient must sign an AMA form and that the physician is notified with documentation of the physician notification.
Inservicing will be completed by November 28, 2023. 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 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: January 8, 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 acting Clinical Nurse Manager, the facility failed to ensure that the staff performed proper aseptic technique while initiating treatment for two (2) of two (2) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #1, Observation #2).
Findings include:
A review was conducted of facility policy/procedure on November 8, 2023 at approximately 12:00 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." 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 November 6, 2023 between approximately 8:40 a.m. and 2:30 p.m. revealed the following:
Observation #1: On 11/06/23 at approximately 11:45 a.m., patient #9 at station K, employee #2 began to initiate dialysis treatment. Employee #2 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. The patient was not observed washing their own access site upon entry into the treatment area.
Observation #2: On 11/08/23 at approximately 11:52 a.m., patient #1 at station N, employee #4 began to initiate dialysis treatment. Employee #4 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. The patient was not observed washing their own access site upon entry into the treatment area.
An interview with the facility acting Clinical Nurse Manager on November 8, 2023 at approximately 12:30 a.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 meeting will also reinforce that if the patient touches their access site after being cleaned, the site must be cleaned again.
The staff inservicing will be completed by November 28, 2023. 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 December 6, 2023.
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: January 8, 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, a review of medical records, and an interview with the facility acting Clinical Nurse Manager, it was determined the facility failed to ensure facility water logs were completed per policy/procedure for one (1) of one (1) water logs reviewed (Log Review #1) and failed to ensure the nurse in charge was made aware of patient hypertension/change in patients condition during treatment for two (2) of five (5) in-center patient medical records (MR) reviewed (MR#2, MR#4).
Findings include:
'Manufacturers Instructions for Use' 'AquaBplus' RO (reverse osmosis) System' '10.6.7.1 Documentation/Releasing the System' states "Finally, the completed Disinfection Report is signed by the Clinic Technician and the system is released for dialysis. The Disinfection Report is filed in the documentation accompanying the system, which is kept with the reverse osmosis system."
Policy 'Reverse Osmosis Water Purification, Operations, and Maintenance' 'Installation and Maintenance' states "The RO machine will be installed, operated, and maintained in accordance with FKC policies and Procedures, and the manufacturers instructions for use (IFU)." 'Membrane Cleaning and Disinfection' states "RO machines membranes will be cleaned and/or disinfected in accordance with manufacturers instructions for use, or at a minimum of monthly, ...."
Facility 'RO Post Disinfection Checking for Negative Minncare' form with staff directions for after system disinfection (this form is attached to the RO system by the BioMed after disinfection) state "A disinfection was performed on the RO and Loop. Please check for Negative Minncare at the following sample ports with residual Minncare strips (on top of the RO). We no longer are filling out the ROCS-AQB log. We now only need to document in TMS Tablet Post RO Disinfection Residual Testing Log. ....."
Facility 'RO Post Disinfection Checking for Negative Minncare' form with staff directions for after system disinfection (this form is attached to the RO system by the BioMed after disinfection) state "A disinfection was performed on the RO and Loop. Please check for Negative Minncare at the following sample ports with residual Minncare strips (on top of the RO). We no longer are filling out the ROCS-AQB log. We now only need to document in TMS Tablet Post RO Disinfection Residual Testing Log. ....."
A review of facility water logs conducted on November 7, 2023 between approximately 9:00 a.m.- 11:30 a.m. revealed the following:
Water Log #1: The 'AquaBplus RO Logs' April 2023 - October 2023 were reviewed. Documentation provided of monthly RO disinfection being performed on July 11, 2023 and on August 8, 2023. There were no 'Post RO Disinfection Residual Testing' forms completed after monthly RO system disinfection for the months of July 2023 and August 2023. The form contains but is not limited to the following instructions/ranges: 'Is RO Permeate Negative for Residual Disinfectant? (Minncare= <1ppm, Bleach = < 0.5 ppm). Using the proper test strips test for residual at the RO permeate test port. ...' 'Are all disinfection signs removed ? .....' 'Employee ID'.
Policy 'Patient Assessment and Monitoring' 'During treatment' 'Follow the steps below for monitoring patient and machine parameters during treatment:' Step (1) Blood pressure. Record blood pressure. 'Report to the nurse:' "Systolic blood pressures greater than 180 mm/Hg. Diastolic blood pressure greater than 100 mm/Hg. Blood pressure less than or equal to 100 mm/hg systolic." 'Data Collection' "..... if the PCT/LPN note any changes or abnormal findings in the patients condition or vascular access are observed or reported by the patient, ......., the registered nurse must assess the patient." "The registered nurse will assess/reassess any findings addressed pre or during treatment as needed."
A review of medical records conducted on November 8, 2023 between approximately 9:00 a.m.- 12:00 p.m. revealed the following:
MR #2, Date of admission 02/22/23: Treatment flowsheet dated 10/23/23 reviewed. Treatment initiated at 7:03 a.m. At 8:41 a.m. blood pressure (BP) was "218/80" (entered by Employee #4, patient care technician). At 9:09 a.m. blood pressure (BP) was "222/83" (entered by Employee #6, patient care technician). At 9:35 a.m. blood pressure (BP) was "230/89" (entered by Employee #4, patient care technician). At 10:40 a.m. blood pressure (BP) was "232/79" (entered by Employee #4, patient care technician). At 11:08 a.m. blood pressure (BP) was "237/80" (entered by Employee #4, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
Treatment flowsheet dated 10/27/23 reviewed. Treatment initiated at 6:57 a.m. At 8:43 a.m. blood pressure (BP) was "212/79" (entered by Employee #13, patient care technician). At 9:04 a.m. blood pressure (BP) was "215/85" (entered by Employee #4, patient care technician). At 9:33 a.m. blood pressure (BP) was "213/79" (entered by Employee #13, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
Treatment flowsheet dated 10/30/23 reviewed. Treatment initiated at 7:09 a.m. At 10:04 a.m. blood pressure (BP) was "195/68" (entered by Employee #6, patient care technician). At 10:38 a.m. BP was "200/73" (entered by Employee #6, patient care technician). At 11:04 a.m. BP "202/72" (entered by Employee #6, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
Treatment flowsheet dated 11/03/23 reviewed. Treatment initiated at 6:50 a.m. At 8:03 a.m. blood pressure (BP) was "197/78" (entered by Employee #6, patient care technician). At 8:34 a.m. BP was "194/80" (entered by Employee #4, patient care technician). At 9:06 a.m. BP "207/84" (entered by Employee #13, patient care technician). At 9:37 a.m. BP "199/78" (entered by Employee #14, patient care technician). At 10:06 a.m. BP "192/65" (entered by Employee #14, patient care technician). At 10:33 a.m. BP "201/93" (entered by Employee #13, patient care technician). At 10:57 a.m. BP "208/82" (entered by Employee #13, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
MR #4, Date of admission 04/16/18: Treatment flowsheet dated 10/25/23 reviewed. Treatment initiated at 7:37 a.m. At 10:03 a.m. blood pressure (BP) was "244/101" (entered by Employee #15, patient care technician). At 10:33 a.m. blood pressure (BP) was "247/129" (entered by Employee #15, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
Treatment flowsheet dated 10/27/23 reviewed. Treatment initiated at 7:45 a.m. At 9:34 a.m. blood pressure (BP) was "190/87" (entered by Employee #6, patient care technician). At 9:52 a.m. blood pressure (BP) was "190/110" (entered by Employee #6, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
Treatment flowsheet dated 10/30/23 reviewed. Treatment initiated at 7:39 a.m. At 9:38 a.m. blood pressure (BP) was "211/104" (entered by Employee #6, patient care technician). At 10:05 a.m. blood pressure (BP) was "215/99" (entered by Employee #6, patient care technician). At 11:33 a.m. blood pressure (BP) was "201/100" (entered by Employee #4, patient care technician). At 11:49 a.m. blood pressure (BP) was "201/100" (entered by Employee #4, patient care technician). No documentation provided of the personal care technician notifying the registered nurse of the patients high blood pressure readings during treatment.
An interview with the facility acting Clinical Nurse Manager on November 8, 2023 at approximately 12:30 a.m. confirmed the above findings.
Plan of Correction:By November 28, 2023, 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:
- Manufacturers Instructions for Use AquaBplus RO (reverse osmosis) System
- Patient Assessment and Monitoring
The meeting will focus on the importance of the staff always adhering to all Fresenius Medical Care (FMC) policies and Manufacturer's Instructions for Use. This includes that the post RO disinfection residual testing forms are completed after the monthly RO disinfection. The meeting will also review that the patient care staff (PCT) must notify the registered nurse (RN) for any abnormal vital signs (VS), including blood pressures (BP), identified pre and during treatment as needed. The meeting will remind staff to ensure to document the RN notification and the RN to document the findings of the evaluation.
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 or designee will hold a staff inservice and will receive education on the above policies by November 28, 2023.
All training documentation will be on file at the facility.
The Medical Director was informed that the CM or designee will perform daily audits for 2 weeks of twenty percent (20%) of random flowsheets. If compliance is noted at that time, the audits will be completed 2 times/week for 2 weeks. The CM or designee will also complete monthly audits of the AquaBplus RO logs for four (4) months. If 100% compliance is sustained at that time, 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: January 8, 2024
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