Initial Comments:
Based on the findings of an unannounced onsite Medicare recertification survey completed May 9, 2023, FMC Whitehall 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 May 9, 2023, FMC Whitehall 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 a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) 'Central Venous Catheter Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1)
Findings include:
A review was conducted of facility policy/procedure on May 9, 2023 at approximately 10:00 a.m.
'Clinical Services' 'Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Prior to Initiation: Assessment and Machine Parameters' Step (1):"Perform hand hygiene and don full PPE." Step (9): Put mask on patient, doff (remove) gloves, perform hand hygiene then don new gloves."
Clinical Services' 'Preparing the Catheter: Dressing Change' "Refer to 'Changing the Catheter Dressing' procedure." 'Changing the Catheter Dressing Procedure' section 'Applying the Dressing' (2) "Remove backing of adhesive dressing or apply tape to edges of gauze dressing." (Note: There is no handwashing step noted in the procedure after applying the dressing to the site).
'Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Preparing the Catheter: Disinfection of Catheter Connections, Heparin removal, Flushing the Catheter and Heparin Administration' step (1) "Check to make sure catheter clamps are closed. (2) Remove cap from clamped arterial limb. (3) Using a sterile alcohol pad .....scrub sides (threads) and end of hub ...." (Note: There is no handwashing step noted in the procedure prior to beginning step (1), after applying the sterile dressing).
Observations conducted in patient treatment area on 05/05/23 between approximately 9:10 a.m. - 1:25 p.m. revealed the following:
Observation #1: Observation #1 of two (2) 'Central Venous Catheter Exit Site Care' and 'Initiation of Dialysis with Central Venous Catheter' observations on 01/20/23 at approximately 11:30 a.m., of patient #8, station #9, Employee #17 did not remove gloves/perform hand hygiene/donn clean gloves after applying the sterile dressing to the CVC site and prior to initiating dialysis (placing clean field under CVC ports/closing the catheter clamps and disinfecting CVC hubs).
An interview with the facility Clinical Nurse Manager on May 9, 2023 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:The clinic manager (CM) or designee re-educated all the direct patient care (DPC) staff on the following policy:
- Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer
- Central Venous Catheter Exit Site Care
Special emphasis will be placed on ensuring that hand hygiene is always performed per policy. This includes completing hand hygiene and donning new gloves after applying a new dressing to the catheter site and prior to initiation of treatment. The meeting will also review the importance of performing hand hygiene any time gloves are removed and before donning new gloves.
The in-servicing of staff will be completed by May 24, 2023, 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. At that time, if compliance is sustained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan od 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: July 7, 2023
494.40(a) STANDARD
SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL
Name - Component - 00
5.2.4 Softeners: auto regen/timers/salt/salt level
Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as "regeneration," which involves exposure of the resin bed to a saturated sodium chloride solution.
5.2.4 Softeners
Refer to RD62:2001, 4.3.10
Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.
The face of the timers used to control the regeneration cycle should be visible to the user.
6.2.4 Softeners
Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated.
The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head.
Observations:
Based on a review of facility policy/procedure, observations, and an interview with the facility Clinical Nurse Manager, the facility failed to ensure salt pellets fill at least half of the brine tank for one (1) of one (1) water treatment area observations (Observation #1).
Findings include:
A review was conducted of facility policy/procedure on May 9, 2023 at approximately 10:00 a.m.
'Clinical Services' 'Setting: IC, IPS' 'Water Softener' 'monitoring of Water Softener Operational Performance' 'For all water softeners:' "At a minimum, facility staff will monitor and document water softener(s) for the following each operational day: Check brine tank daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary."
Observations conducted in patient treatment area on 05/05/23 between approximately 9:10 a.m. - 1:25 p.m. revealed the following:
Observation #1: on 05/05/23 at approximately 8:40 a.m. during observations of the water treatment area, the brine tank was not at least half full with salt. The tank was filled with approximately 1/4 of salt. There was a label attached ("Salt Level") to the exterior of the tank approximately 1/4 up from the bottom of the tank.
An interview with the facility Clinical Nurse Manager on May 9, 2023 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:To ensure compliance the CM or designee will re-educate all DPC staff on the following policy:
- Water Softener
- Water Softener Monitoring Procedure
Special emphasis will be placed on ensuring that staff check the brine tank each day to ensure that the tank is filled with salt at least halfway. Salt must be added if the salt level is below half. Documentation of the monitoring must be completed daily.
Inservicing will be completed by May 24, 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: July 7, 2023
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 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 two (2) of two (2) treatment floor observations (Observation #1, Observation #2)
Findings include:
A review was conducted of facility policy/procedure on May 9, 2023 at approximately 10:00 a.m.
'Clinical Services' 'Setting: IC, HT' 'During Treatment' "Follow the steps below for monitoring patient and machine parameters during treatment: 'Step (1):' .... Access: "Observe connections are secure and visible. .... Ensure access remains uncovered throughout the treatment."
Observations conducted in patient treatment area on 05/05/23 between approximately 9:10 a.m. - 1:25 p.m. revealed the following:
Observation #1: During treatment floor observations on 05/05/23 at approximately 9:40 a.m., patient #9, at station #3; The patients AV Fistula access site was covered by a blanket from approximately 9:40 a.m. - 10:06 a.m.
( approximately 26 minutes).
Observation #2: During treatment floor observations on 05/05/23 at approximately 10:15 a.m., patient #10, at station #7; The patients AV Fistula access site was covered by a blanket from approximately 10:15 a.m. - 10:34 a.m.
( approximately 19 minutes).
An interview with the facility Clinical Nurse Manager on May 9, 2023 at approximately 1:30 p.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.
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 in-servicing will be completed by May 24, 2023, with documentation of the training on file at 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 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: July 7, 2023
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, water log review, and an interview with the facility Clinical Nurse Manager, it was determined the facility staff failed to ensure the nurse in charge was made aware of patient hypertension for one (1) of seven (7) in-center patient clinical records (CR) reviewed (CR#4) and failed to ensure facility policy was followed during the temporary use of a deionization (DI) system for one (1) of one (1) DI System utilization logs reviewed (Log review #1).
Findings include:
A review was conducted of facility policy/procedure on May 9, 2023 at approximately 10:00 a.m.
'Clinical Services' 'Setting: IC, HT' '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 01/26/19: Documentation of treatment flowsheet dated 04/25/23; treatment initiated at 8:13 a.m. At 11:03 blood pressure (BP) was "182/102" (entered by Employee #16, patient care technician). At 11:32 blood pressure was "188/104" (entered by Employee #16, patient care technician). At 12:02 BP "181/105" (entered by Employee #16, patient care technician). At 12:30 BP "181/105" (entered by Employee #19, patient care technician). At 12:48 BP "180/106" (entered by Employee #19, patient care technician).
No documentation provided of the personal care technicians notifying the nurse in charge of the patients elevated blood pressure during treatment.
'Biomedical Support Services' 'DI Installation Operation and Maintenance Policy' 'IC, IPS, HT' 'System Installation' "Due to the infrequent use of DI systems, any staff that will be responsible for using, monitoring, or maintaining the system will receive additional training on the system at the time of installation, including monitoring and operating the system correctly and safely. Training should be provided by the vendor at the time of installation and include content from the Biomedical Education Program. ..... Training will include return demonstration by staff."
Log review #1: On 05/09/23 at approximately 9:00 a.m. the DI utilization log was reviewed. A DI system was utilized from 10/25/22 - 11/14/22. A 'FKC of Whitehall Training Record' was provided with a training session conducted on 10/24/22. The training record included nine (9) facility employees. No documentation provided of the training including return demonstration by staff, per policy.
The 'DI Resistivity Monitoring ' log was reviewed. The log included five (5) facility employees (employees #9, #11, #14, #17, #21) who were not listed on the training session dated 10/24/22. No other documentation provided of these employees being provided additional DI system training, per policy.
An interview with the facility Clinical Nurse Manager on May 9, 2023 at approximately 1:30 p.m. confirmed the above findings.
Plan of Correction:By May 24, 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 policies:
- Hypertension
- DI Installation Operation and Maintenance
- DI Resistivity Monitoring Log
The meeting will focus on the importance of the staff always following FMC policies. The meeting will review that the DPC staff must inform the registered nurse (RN) of any blood pressure (BP) elevations for further evaluation and intervention if indicated. The meeting will discuss that there must be documentation of the RN notification by the technician. The Medical Director will be informed at the meeting that if the facility is ever on DI again, all the DPC staff will be re-trained in the operation of the DI system. There will be evidence of a return demonstration of the staff training with complete and accurate in-service training documentation on file.
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 May 24, 2022.
All training documentation will be on file at the facility.
The Medical Director was informed that the CM or designee will perform BP audits daily for 2 weeks. If compliance is noted, the audits will be completed 2 times/week for 2 weeks. If compliance is sustained, the audits will then follow the monthly QAPI schedule. A POC audit tool will be used for the audits.
If the facility is ever on DI again, audits will be completed daily to ensure DPC staff working that day have current and completed DI training on file.
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: July 7, 2023
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