Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted on September 14, 2022 through September 16, 2022, BMA of Harrisburg was found to be in compliance with the requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services-Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey conducted September 14, 2022 through September 16,2022, BMA of Harrisburg 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)(i) STANDARD
IC-HANDLING INFECTIOUS WASTE
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-
(i) Handling, storage and disposal of potentially infectious waste;
Observations:
Based on observations and interview with Administrator the clinic failed to ensure staff stored infectious waste within a closed bin for one (1) of six (6) bins observed. BIN #1.
Findings include:
BIN #1, observed in the center of four (4) dialysis stations (Stations #9-12) was observed on 9/14/22 at approximately 9:50 AM to be sitting with it's lid open containing contaminated waste products.
An interview with the clinic Administrator on 9/14/22 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:V 121
For ongoing compliance, the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on the following policy:
- OSHA Bloodborne Pathogen Standards
Emphasis will be placed on ensuring that all infectious waste bins are closed after the contaminated waste is placed in the bin. The lid must be always closed to prevent possible cross contamination.
The inservice will be completed by September 27, 2022, and the education records will be on file in 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 Performance and Improvement (QAPI) schedule. A Plan of Correction (POC) audit tool will be used for the audits.
Staff found to be non-compliant will be re-educated and referred for counseling.
The 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: October 28, 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 observations and interview with the clinic Administrator the clinic failed to ensure staff disinfected medical equipment for two (2) of eighteen (18) observations made. OBS 4 and #18.
Findings include:
OBS #4, 9/14/22 at approximately 11:20 AM, PCT #2 was observed bringing dialysate in a plastic cup from station #5 to station #2 to check the conductivity. Once completed, PCT #2 returned the pHoenix meter to the it's holding place without disinfecting.
OBS #18, 9/14/22 at approximately 9:51 AM Nurse #1 was observed removing a stethoscope from the nursing station and taking it to station #10 to complete a lung assessment. Nurse #1 returned the stethoscope to the nursing station without disinfecting the stethoscope.
An interview with the clinic Administrator on 9/14/22 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:V 122
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Cleaning and Disinfection of the Dialysis Station
The meeting will focus on ensuring that all non-disposal items or supplies taken into the dialysis station are thoroughly cleaned and disinfected after each patient use and before being returned to their storage area. These items include pHoenix meters and stethoscopes.
The inservice will be completed by September 27, 2022, and the education records will be on file in 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 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 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: October 28, 2022
494.50(b)(1) STANDARD
QA-GENERAL/RECORDS/TREND ANALYSIS
Name - Component - 00
14 Quality assurance: general/records/trend analysis
The criteria chosen as the internal standards of a facility shall be documented in its policy and/or procedure manual. Process review should be part of the activity of the individual carrying out the process, and oversight of that review by another qualified member of the staff or a group of staff members should affirm, modify, or repeat these observations to confirm or improve the process. Clinical outcomes serve as the most important indicator of quality of all dialysis treatment practices including reuse. Final oversight is the responsibility of the medical director. See Table 2 for a summary of the audit schedule.
14.1 Records
A record of review, comments, trend analysis, and conclusions arising from QA practices serve as a foundation for future review and as documentation to external evaluation.
Observations:
Based on review of policy/procedures, QA meeting minutes and interview with Administrator the clinic failed to ensure documentation showing review, comments, trend analysis and conclusions were completed by the interdisciplinary team for six (6) of twelve (12) months in year 2021. Jan 201 - Jun 2021.
Findings include:
Review of Policy: 25799; QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT completed 9/16/22 at approximately 1:30PM revealed:
section: MEETING CADENCE & AGENDA "QAPI meetings will be held monthly". SECTION: QAPI Committee Responsibilities, "The additional responsibility for each QAPI committee Member related to their professional role will include: Clinical Manager (CM): Documentation of QAPI minutes".
Review of Quality Assurance Performance Improvement (QAPI) meeting minutes for year 2021 completed 9/16/22 at approximately 12:30 PM revealed the following:
No documentation of meeting minutes for the following months: January 2021, February 2021, March 2021, April 2021, May 2021 and June 2021.
An interview with the clinic Administrator on 9/16/22 at approximately 3:00 PM confirmed the above findings. " I am filling in temporarily until another Administrator can be hired. When I realized there were no minutes I attempted to find the documentation, but was not able to locate them, I'm sure the meetings were held".
Plan of Correction:V 360
To ensure compliance the Director of Operations (DO) or designee will in-service the Interdisciplinary Team (IDT) members on policy:
- Quality Assessment and Performance Improvement
The meeting will focus on ensuring that QAPI meetings will be held monthly with all members of the team attending either in person or via Teams. The meeting will review the importance of documentation of the meeting showing review, discussion, trending and action plans of quality outcomes. The meeting will also review that in the event of temporary coverage of management, a QAPI meeting must still be held with the covering administrator.
The inservice will be completed by September 27, 2022, and the education records will be on file in the facility.
The DO or designee will perform monthly audits for four (4) months. At that time if compliance is observed, 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 DO 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: October 28, 2022
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 policy/procedure, observations (OBS) and interview with Administrator the clinic failed to ensure all patients remained visible to staff at all times during treatment for one (1) of eighteen (18) observations made. OBS #17.
Findings include:
Review of policy: 64147 GUIDANCE ON DIALYZING AND INFECTION CONTROL PRACTICES DURING A COVID-19 ENDEMIC IN FRESENIUS KIDNEY CARE (FKC) DIALYSIS CLINIC completed 9/16/22 at approximately 1:00PM revealed: SECTION: POLICY; COHORTING COVID-19, PUI AND CCE PATIENTS:, " Covid-19 positive patients may be cohorted and treated within their home clinic treatment shift with appropriate infection control precautions in place... The patient cohorts should be separated by a minimum of 6 feet from the nearest patient (in all directions), and ideally by a physical barrier, separate pod, or other type of barrier between classification of patients".
On 9/14/22, at approximately 11:42 AM, patient under investigation for Covid-19 (PUI) was observed to be having treatment initated at station #4. Following the start of treatment, a three-panel privacy curtain was placed around the station with the patient inside to create a barrier. The curtains were not clear and the patient could not be seen by the staff.
An interview with the clinic Administrator on 9/16/22 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:V 407
To ensure compliance, the CM or designee re-educated all the DPC staff on the following policy:
- Guidance on Dialyzing and Infection Control Practices During a Covid-19 Endemic in Fresenius Kidney Care Dialysis Unit
Special emphasis will be placed on ensuring that the patient must be visible throughout their treatment. This includes following Covid-19 precautions when treating a positive patient or a patient who had an exposure. All patients being co-horted must be always visible to staff and the patient must be separated by 6 feet from other patients. Any type of privacy curtain that may be used must ensure visibility of the patient.
The in-servicing will be completed by September 27, 2022, 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 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 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: October 28, 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 reviews of policy/procedure. medical records (MR) and interview with Administrator the clinic failed to ensure all patients blood pressures were routinely monitored every thirty (30) minutes while receiving treatment for four (4) of seven (7) records reviewed. MR #1, #4, #5 & #6.
Findings include:
Review of policy PATIENT ASSESSMENT AND MONITORING, completed 9/16/22 at approximately 2:00 PM revealed the following: section: MONITORING DURING TREATMENT:"Obtain blood pressure and pulse rate every 30 minutes as needed but not to exceed 45 minutes or per state regulations... Document machine parameters and safety checks every 30 minutes or more often as needed but not to exceed 45 minutes or per state regulations".
MR #1, Admit date: 7/27/2001, treatment date: 9/13/22: the patients' blood pressure was documented at 1:02 PM and not documented again until 1:47 PM (45 minutes after the last blood pressure check).
MR #4, Admit date:11/30/21, treatment date: 9/13/22: the patients' blood pressure was documented at 5:11 AM and not documented again until 7:32 AM (140 minutes after the last blood pressure check).
on 9/6/22, the patients' blood pressure was documented at 7:32 AM and not documented again until 8:32 AM (60 minutes after the last blood pressure check).
on 9/1/22, the patients' blood pressure was documented at 7:05 AM and not documented again until 7:58 AM (53 minutes after the last blood pressure check).
MR #5, Admit date: 10/1/20, treatment date: 9/13/22, the patients' blood pressure was documented at 8:02 AM and not documented again until 10:15 AM (132 minutes after the last blood pressure check).
on 9/6/22, the patients' blood pressure was documented at 8:34 AM and not documented again until 10:04 AM (119 minutes after the last blood pressure check).
on 9/3/22, the patients' blood pressure was documented at 9:01 AM and not documented again until 9:56 AM (55 minutes after the last blood pressure check).
on 8/30/22, the patients' blood pressure was documented at 6:01AM and not documented again until 7:03 AM (56 minutes after the last blood pressure check).
MR# 6, Admit date: 9/21/20, treatment date: 8/31/22, the patients' blood pressure was documented at 11:39 AM and not documented again until 1:01 PM (80 minutes after the last blood pressure check).
An interview with the clinic Administrator on 9/16/22 at approximately 3:00 PM confirmed the above findings.
Plan of Correction:V 504
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Patient Assessment and Monitoring
The meeting will focus on ensuring that the patient is monitored every 30 minutes and not exceeding 45 minutes. This monitoring includes obtaining blood pressures (BP) with documentation of the BP.
The inservice will be completed by September 27, 2022, and the education records will be on file in 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 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 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: October 28, 2022
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