Initial Comments:
Based on the findings of an unannounced Medicare recertification survey conducted September 9 through September 12, 2024, with the off-site portion of the survey being completed on September 13, 2024, BMA of Wilkes-Barre 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 unannounced Medicare recertification survey conducted September 9 through September 12, 2024, with the off-site portion of the survey being completed on September 13, 2024, BMA of Wilkes-Barre 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 for End-Stage Renal Disease Facilities.
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 review of facility policies/procedures, observational tour, and interview with the clinical manager (Employee #5), the facility failed to ensure the disinfection process for three (3) of three (3) hemodialysis (HD) machines included disinfection of the sharps container (container utilized for disposing contaminated needles and syringes) which is mounted on the HD machine. (HD Machines at Stations #7, #27 and #30)
Findings include:
On September 12, 2024 at approximately 9:02 AM, review of the facility policy titled "Cleaning and Disinfection the Dialysis Station" revealed the following:
Definitions...Dialysis Station...Area including the dialysis machine...Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine/cycler and attachments...
General Cleaning...The dialysis station could become contaminated with blood and other body fluids during treatment...
Cleaning the Dialysis Machine....Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment.
During observational tour conducted between September 9, 2024 and September 10, 2024 revealed the following:
09/09/2024 at approximately 10:45 AM: Hemodialysis staff failed to disinfect the sharps container mounted on the HD machine after completion of the HD treatment at station #27.
09/10/2024 at approximately 9:58 AM: Hemodialysis staff failed to disinfect the sharps container mounted on the HD machine after completion of the HD treatment at station #30.
09/10/2024 at approximately 10:55 AM: Hemodialysis staff failed to disinfect the sharps container mounted on the HD machine after completion of the HD treatment at station #7.
During interview on September 12, 2024 at 4:34 PM, the clinical manager confirmed HD staff members failed to disinfect the sharps container which was mounted on the HD machines at the above referenced HD stations.
Plan of Correction:V122 IC-Disinfect surfaces/equip/written protocols
To ensure compliance, the Clinical Manager (CM) or designee will in-service all DPC staff on the following policies: Cleaning and Disinfection of the Dialysis Station
The meeting will focus on ensuring that sharps container mounted on the hemodialysis (HD) machine are cleaned and disinfected as part of the hemodialysis station as per policy. The meeting will review that a 1:100 bleach wipe is used to clean all surfaces of the dialysis station, including the mounted sharps container.
Inservicing will be completed by 10/2/2024. 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 2x/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: 10/24/24
494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU
Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.
Observations:
Based on review of manufacturer's recommendations, documentation, and interview with the technical technician (Employee #6), a patient care technician (PCT-Employee #8), and the clinical manager (Employee #5), the facility failed to ensure documentation was maintained which provided evidence that testing for absence of the chemical disinfectant was performed after disinfection of the water treatment system for one (1) of six (6) months between March and August 2024. (July 2024)
Findings include:
On September 17, 2024 at approximately 3:59 PM, review of manufacturer's recommendations, which was forwarded via email by the clinical manager, revealed the following:
Chapter 6: Cleaning, disinfection, preservation...6.2 Precautions...
6.2.1 Patient Safety...Test for the absence of residual disinfectant. When using disinfectants, an appropriate test for the absences of residual disinfectant must be performed...
On September 11, 2024 between the approximate times of 9:24 AM and 10:50 AM, review of water treatment system disinfection documentation revealed chemical disinfection of the water treatment system was performed on July 11, 2024. There was no documentation which provided evidence that testing for absence of the chemical disinfectant was performed after disinfection of the water treatment system on 07/11/2024.
During interview conducted on September 11, 2024 at approximately 10:55 AM, the technical technician (Employee #6) reported hemodialysis (HD) staff complete testing for absence of the chemical disinfectant the morning after disinfection of the water treatment system is completed.
During interview conducted on September 12, 2024 at approximately 4:13 PM, the PCT (Employee #8) reported testing for absence of the chemical disinfectant would have been performed on 07/12/2024 prior to the initiation of HD treatments.
During interview conducted on September 12, 2024 at approximately 4:34 PM, the clinical manager confirmed there was no documentation which provided evidence that testing for absence of the chemical disinfectant after water treatment system disinfection had been performed on 07/12/2024.
Plan of Correction:V403 PE-Equipment maintenance-manufacturer's DFU
To ensure compliance, the Area Technical Operations Manager (ATOM) or designee will in-service all DPC staff on the following:
AquaB plus Water Purification System Reverse osmosis system service manual
The meeting will focus on:
Direct patient care (DPC) staff will ensure the testing for residual chemical (Minncare) and chemical consumption is completed after chemical disinfection of the reverse osmosis (RO) system.
DPC staff will ensure Post RO Disinfection Residual Testing is completed and documented via Total Maintenance System (TMS) prior to starting treatments.
By 10/24/2024, assigned direct patient care staff will be re-validated on post loop disinfection residual testing minncare direct feed Aqua B Chemical Disinfection.
For ongoing compliance, the CM or designee will conduct monthly audit for 3 months to ensure documentation is complete via TMS. A POC specific auditing tool will be used for the audits. The Governing Body will determine on-going frequency of the audits based on compliance. The Area Technical Operations Manager will monitor monthly for compliance. If compliance is not met, the ATOM will be responsible for the follow up. Monthly monitoring is completed through the QAI Technical workbook.
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: 10/24/24
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 review of facility policies/procedures, observational tour, and interview with the clinical manager (Employee #5), the facility failed to ensure vascular access sites (opening into a blood vessel which allows blood to travel through soft tubes to the dialysis machine) and patient faces were visible during the hemodialysis (HD) treatment for the patients receiving hemodialysis at twelve (10) of twenty-four (24) hemodialysis stations. (Stations #1, #2, #9, #12, #13, #14, #22, #26, #28 and #32)
Findings include:
On September 12, 2024 at approximately 9:00 AM, review of the facility policy titled "Patient Assessment and Monitoring" revealed the following:
General Observation/Mental Status...Ensure each patient's face is visible and uncovered.
Access...Ensure access remains uncovered throughout the treatment...
During observational tour conducted between September 9, 2024 and September 10, 2024 revealed the following:
09/09/2024 between the approximate times of 10:25 AM and 12:45 PM: Access sites were covered with a blanket for the patients receiving HD treatments at stations #1, #2, #9, #12, #13, #22, #26 and #28. At station #28, the patient's face was also noted to be covered with a blanket.
09/10/2024 at approximately 11:00 AM: Access sites were covered with a blanket for the patients receiving HD treatments at stations #1, #12, #14 and #32. At station #14, the patient's face was covered with a blanket.
During interview conducted on September 12, 2024 at approximately 4:34 PM, the clinical manager confirmed HD staff failed to ensure patient access sites and patient faces were visible during the HD treatment for the patients receiving hemodialysis at the above referenced HD stations.
Plan of Correction:V407 PE-HD pts in view during treatments
BMA WILKES BARRE
Plan of Correction for Recertification
Provider Identification Number: 39-2512 Date of Survey: 9/13/24
To ensure compliance the Clinical Manager (CM) or designee will in-service all direct patient care (DPC) staff on: Patient Assessment and Monitoring
Safety Checks
The meeting will focus on:
Ensuring that patient's vascular access remains uncovered and is visible at all times throughout the treatment.
Ensuring patient monitoring and safety checks are being performed, verifying patient's access remains uncovered and visible.
Ensuring all patients receive a patient newsletter which includes the importance of access visibility throughout entire treatment.
DPC staff will re-educate/reinforce on the importance of access visibility if needed.
Inservicing will be completed by 10/2/2024. 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 one hundred percent (100%) compliance is observed the audits will then be completed 2x/week for 2 weeks to ensure that 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: 10/24/24
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 review of facility policies/procedures and medical records, and based on interview with the medical director (Employee #9) and the clinical manager (Employee #5), the facility failed to ensure interventions and/or assessments related to fluid volume management had been completed per facility policy/procedure/protocol and/or physician orders for five (5) of ten (10) patients. (Patients #1, #2, #6, #8 and #9)
Findings include:
On September 12, 2024 at approximately 4:27 AM, review of the facility policy titled Volume Management in ESRD (End Stage Renal Disease) Patients on Hemodialysis::
Definitions...Estimated Dry Weight (EDW): Lowest tolerated post-dialysis weight with minimal signs or symptoms of hypovolemia (a condition of low fluid volume in your body) or hypervolemia (higher fluid volume in your body). EDW is used to calculate the target weight removal for each dialysis treatment...
Fluid Assessment...At minimum, fluid assessment will include review of the following indicators...EDW...Pre/post weight...
Fluid Interventions...If any of the following patient clinical conditions occur, refer to the volume algorithm or consult with provider for the appropriate fluid interventions...Pre-treatment weight is less than or equal to EDW...Treatment adjustments based on fluid assessment, symptoms and blood pressure are critical to improve patient's volume status. EDW order should be updated post treatment to reflect treatment adjustments and patient fluid status.
On September 12, 2024 at approximately 9:00 AM, review of the facility policy titled "Patient Assessment and Monitoring" revealed the following:
Blood Pressure...Recheck blood pressure after a drop that requires interventions such as administering of normal saline...
Ultrafiltration Rate (UF-amount of fluid removal)...Monitor UF rate. NOTE: Ultrafiltration rates greater than 13 ml/kg/hr (milliliter per kilogram per hour) should be avoided if possible...
On September 12, 2024 at approximately 4:28 PM, review of the facility policy titled "Intradialytic Hypotension" (low blood pressure which occurs during the dialysis treatment) revealed the following:
Definition: Patient pre-treatment sitting blood pressure (BP) equal to or greater than 110 and then drops below 90 during treatment OR...
Patient pre-treatment sitting blood pressure equal to or greater than 101 but equal to or less than 109 and has a drop of 20 during treatment...
Signs and Symptoms...Dizziness...lightheadedness...nausea or emesis...
Treating Hypotension on Hemodialysis...
1. If BP is low or patient is symptomatic, administer 100-200 ml (milliliters) of fluid bolus as ordered by the provider...
5. Monitor and record the BP every five minutes until any symptoms resolved...
During interview conducted on September 12, 2024 at approximately 4:34 PM, the medical director reported BP should be monitored approximately every 5-15 minutes after administration of normal saline (NSS) for treatment of asymptomatic hypotension.
Patient #1 (Discharged): On September 11, 2024 at approximately 9:14 AM, review of the medical record revealed the following as documented on the "Current Orders Report":
-An EDW of 65 kg (kilograms) was prescribed on 10/17/2023.
-If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD.
Review of "Treatment Sheet for Facility" documentation revealed the following:
-On between 03/02/2024 and 03/12/2024, the patient's pre-dialysis weight as more than 1.5 kg lower than the prescribed EDW. The pre and post-dialysis weights were as follows:
-03/02/2024: Pre-dialysis weight: 63.4 kg; post dialysis weight: 62.4 kg.
-03/05/2024: Pre-dialysis weight: 61.7 kg; post dialysis weight: 62 kg.
-03/072024: Pre-dialysis weight: 61.2 kg; post dialysis weight: 60.7 kg.
-03/09/2024: Pre-dialysis weight: 61.1 kg; post dialysis weight: 60.3 kg.
-03/12/2024: Pre-dialysis weight: 61.9 kg; post dialysis weight: was not obtained due to change in medical condition.
-03/12/2024: 200 ml of NSS was administered at 11:44 AM due to low BP reading of 90/43. The next BP assessment was completed at 12:05 PM which was 21 minutes after the administration of NSS.
There was no documentation in the medical record which provided evidence HD staff had obtained an order to adjust the prescribed EDW between 03/05/2024 and 03/12/2024 nor was documentation present which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on 03/12/2024.
Patient #2: Between September 11, 2024 at approximately 11:21 AM and September 12, 2024 at approximately 9:17 AM, review of the medical record revealed the following as documented on the "Current Orders Report":
-If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD; and
-Do not UF greater than 13 ml of fluid per kilogram of estimated dry weight per treatment unless otherwise noted.
Review of "Treatment Sheet for Facility" documentation revealed the following:
-08/28/2024: The UF exceeded 13 ml/kg between 5:51 AM and 7:05 AM. At 8:43 AM, the patient complained of cramping.
-08/30/2024: 200 ml of NSS was administered at 9:02 AM (BP 86/51). The next BP assessment was completed at 9:19 AM which was 17 minutes after the administration of NSS.
-09/06/2024: The UF exceeded 13 ml/kg between 7:00 AM and 7:21 AM.
-09/11/2024: The UF exceeded 13 ml/kg between 6:03 AM and 6:40 AM. At 7:36 AM, the UF was turned off and fluid removal goal was decreased due to a low BP.
There was no documentation in the medical record which provided evidence UF rate and reassessment of BP after administration of NSS were administered or completed in accordance with the above referenced policies/procedures or protocol on the aforementioned dates.
Patient #6: On September 12, 2024 at approximately 11:34 AM, review of the medical record revealed the following as documented on the "Clinical Record Review Report":
-If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD.
Review of "Treatment Sheet for Facility" documentation revealed the following:
-09/04/2024: 200 ml of NSS was administered at 8:06 AM for BP of 80/55. The next BP assessment was completed at 8:25 AM which was 19 minutes after the administration of NSS.
There was no documentation in the medical record which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on 09/04/2024.
Patient #8: On September 12, 2024 at approximately 1:07 PM, review of the medical record revealed the following as documented on the "Current Orders Report":
-If...hypotension...administer NSS 100-200 ml as needed (PRN), may repeat times five (5) then call MD.
Review of "Treatment Sheet for Facility" documentation revealed the following:
-09/11/2024: 200 ml of NSS was administered at 2:57 PM for a BP of 82/56. The next BP assessment was completed at 3:22 PM which was 25 minutes after the administration of NSS.
There was no documentation in the medical record which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on 09/11/2024.
Patient #9: Between September 12, 2024 at approximately 2:08 PM and September 13, 2024 at approximately 2:25 PM review of the medical record revealed the following as documented on the "Treatment Sheet for Facility":
-09/05/2024: NSS was administered at 12:24 PM for a BP of 77/57. The next BP assessment was completed at 12:41 PM which was 17 minutes after the administration of NSS.
-09/10/2024: 200 ml of NSS was administered at 11:46 AM for a BP of 93/52. The next BP assessment was completed at 12:10 PM which was 26 minutes after the administration of NSS.
There was no documentation in the medical record which provided evidence reassessment of BP after administration of NSS was completed in accordance with the above referenced policy/procedure or protocol on the aforementioned dates.
During interview conducted on September 12, 2024 at approximately 4:34 PM, the clinical manager confirmed interventions and/or assessments related to fluid volume management were not completed in accordance with facility policies/procedures or protocol for the above referenced patients.
Plan of Correction:V543 POC-Manage volume status
BMA WILKES BARRE
Plan of Correction for Recertification
Provider Identification Number: 39-2512 Date of Survey: 9/13/24
To ensure compliance the Clinical Manager (CM) or designee will in-service all direct patient care (DPC) staff on: Patient Assessment and Monitoring
Nursing Supervision and Delegation
Volume Management in ESRD Patients on Hemodialysis Intradialytic Hypotension
The meeting will focus on:
Ensuring Patient care technician (PCT), Licensed practical nurse (LPN) are notifying the Registered nurse (RN) and attending physician as necessary of all patients with hypotensive episodes or any abnormal findings for further evaluation.
Ensuring direct patient care (DPC) staff refers to RN team leader or charge nurse if patient presents with a systolic blood pressure less than 100 mm/Hg.
Monitor and record the BP at least every five minutes until any symptoms related to hypotension have resolved and provide additional interventions as needed.
RN staff will ensure re-assessment of low blood pressure after administration of normal saline (NSS) are completed and interventions applied as specified by the Physician.
Inservicing will be completed by 10/2/2024. All training documentation is on file at the facility.
The CM or designee will perform daily audits of 10% of patient treatment sheets for two (2) weeks. At that time if one hundred percent (100%) compliance is observed the audits will then be completed 2x/week for 2 weeks to ensure that 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: 10/24/24
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