Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on October 6, 202, Fresenius Medical Care Penn Hills 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 completed on October 6, 2023, Fresenius Medical Care Penn Hills 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:
494.90(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 reviews of medical records (MR), facility policy, and staff (EMP) interview, the facility failed to provide the necessary care and services to manage the patient's volume status for three (3) of five (5) in center dialysis records reviewed. (MR1, 4, & 5)
Findings included:
Review of facility policy on August 29, 2023, at approximately 1:30pm revealed:
"Patient Assessment and Monitoring...During Treatment...Blood Pressure...Report to the nurse: Systolic blood pressures greater than 180mm/Hg, Diastolic blood pressurer greater than 100mm/Hg..."
"Nursing Supervision and Delegation...Daily Treatment Record Review ...Prior to discharge, the RN must review the treatment record to: Whether patient is achieving dry weight and identifying reason for: patient not achieving dry weight...."
Review of MR on 10/6/2023, at between approximately 11:00am and 1:00pm revealed:
MR1, admission date 8/28/23, treatment dates reviewed 9/20/23-10/2/23.
9/20/23- Target weight ordered 95.0 kilograms (kg), documented weight at end of treatment
91.4kgNo documentation of notification to physician of 3.6kg difference from target
weight or identifying reason for patient not achieving dry weight.
9/22/23- Target weight ordered 95.0kg, documented weight at end of treatment 91.6kg. No
documentation of notification to physician of 3.4kg difference from target weight or
identifying reason for patient not achieving dry weight.
9/27/23-6:41pm blood pressure (b/p) of 151/102 obtained by Patient Care Technician
(PCT). No documentation of nurse notification.
MR4, admission date 6/8/19, treatment dates reviewed 9/20/23-9/29/23.
9/27/23-9:33am b/p of 89/37 obtained by PCT, 10:06am b/p of 90/53 obtained by PCT.
No documentation of nurse notification.
9/29/23-9:00am b/p of 92/52 obtained by PCT, 10:33 b/p of 95/61 obtained by PCT,
11:01am b/p of 95/61 obtained by PCT. No documentation of nurse notification.
10/2/23- 10:00am b/p of 97/51 obtained by PCT. No documentation of nurse notification of
b/p out of parameters..."
MR5, admission date 5/24/23, treatment dates reviewed 9/7/23-9/23/23.
9/7/23- Target weight ordered 106.5kg, documented weight at end of treatment
108.6kg. No documentation of notification to physician of 2.1kg difference from target
weight or identifying reason for patient not achieving dry weight.
At 7:22am b/p 173/105 obtained by PCT, 8:34am b/p 164/118 obtained by PCT,
9:39am b/p 195/128 obtained by PCT, 10:03am b/p 174/109 obtained by PCT,
10:34am b/p 158/110 obtained by PCT, 11:04am b/p 155/105 obtained by PCT. No
documentation of nurse notification of b/p out of parameters.
9/9/23- Target weight ordered 106.5kg, documented weight at end of treatment 108.9kg.
No documentation of notification to physician of 2.4kg difference from target weight
or identifying reason for patient not achieving dry weight.
7:17am b/p 183/104 obtained by PCT, 8:02am b/p 171/112 obtained by PCT,
8:33am b/p 179/115 obtained by PCT, 9:03am b/p 183/105 obtained by PCT. No
documentation of nurse notification of b/p out of parameters.
9/12/23- Target weight ordered 106.5kg,documented weight at end of treatment 109.8kg.
No documentation of notification to physician of 2.3kg difference from target weight or
identifying reason for patient not achieving dry weight.
7:18a, b/p 193/117 obtained by PCT, 8:06am b/p 201/121 obtained by PCT, 9:54am
b/p 186/101 obtained by PCT. No documentation of nurse notification of b/p out of
parameters.
9/14/23- Target weight ordered 107.5kg, documented weight at end of treatment 108.9kg.
No documentation of notification to physician of 2.4kg difference from target weight or
identifying reason for patient not achieving dry weight.
7:29am b/p 156/131 obtained by PCT, 7:35am b/p 138/114 obtained by PCT, 8:03am
b/p 143/119 obtained by PCT, 9:04am b/p 171/124 obtained by PCT, 9:33am b/p
184/112 obtained by PCT, 10:02 b/p 188/109 obtained by PCT, 11:31am b/p 184/109
obtained by PCT. No documentation of nurse notification of b/p out of parameters.
9/21/23- Target weight ordered 107.5kg, documented weight at end of treatment 111.5kg.
No documentation of notification to physician of 4kg difference from target weight or
identifying reason for patient not achieving dry weight.
7:35am b/p 166/112 obtained by PCT, 9:39am b/p 188/115 obtained by PCT, 10:00am
b/p 183/101 obtained by PCT. No documentation of nurse notification of b/p out of
parameters.
9/23/23- Target weight ordered 107.5kg, documented weight at end of treatment 111.2kg.
No documentation of notification to physician of 3.7kg difference from target weight or identifying reason for patient not achieving dry weight.
Interview with Center Manager on October 6, 2023 at approximately 10:30am reviewed Quality monitoring to include facility identification and action plan to address fluid volume management. Review of action plan included obtaining orders for appropriate target weights for individuals consistently unable to meet target weight.
Interview with the Center Manager on October 6, 2023, at approximately 3:00pm confirmed findings.
Plan of Correction:Fresenius Kidney Care
Penn Hills Dialysis
Recertification POC
October 2023
V 543
For ongoing compliance, the Clinic Manager (CM) or designee will in-service all direct patient care (DPC) staff on policy:
- Patient Assessment and Monitoring
- Nursing Supervision and Delegation
The in-service will focus on ensuring that the patient's estimated dry weight (EDW) is being achieved. If the EDW is not met, the registered nurse (RN) must be informed who will notify the physician if indicated. The identified reason why the EDW was not achieved must be documented. The meeting will also reinforce the importance of the reporting of any vital signs (VS), including blood pressures (BP), that are out of range to the RN. The staff will be reminded that they must document the RN notification.
In-servicing will be completed by October 27, 2023, and the training documentation will be on file at the facility.
The CM or designee will perform daily audits on twenty-five percent (25%) of patients per shift for two (2) weeks. At that time if ninety-five (95) % compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time, if compliance is maintained, the audits will then follow the monthly Quality Assessment and Performance Improvement (QAPI) schedule. A plan of correction (POC) specific auditing tool will be used for the audits.
Issues of non-compliance will be addressed by the CM with re-education and counseling.
The CM will review the audit results and report the findings at the monthly QAPI meetings for ongoing oversight and compliance.
Completion Date: November 30, 2023
V544
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Patient Assessment and Monitoring
Emphasis will be placed on ensuring that any machine parameters not within the prescribed limits must be reported to the RN for evaluation, intervention and if not able to be resolved, physician notification. These parameters include the blood flow rate (BFR). The reason the BFR is not being achieved must be documented. The staff will be instructed that there must be documentation of the RN notification by the patient care technician (PCT).
Inservicing will be completed by October 27, 2023. All training documentation will be on file at the facility.
The CM or designee will perform daily audits for four (4) weeks. At that time, if improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAPI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion Date: November 30, 2023
V 550
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 site with soap, the staff must clean the access sites. The meeting will also reinforce that if the patient touches their access site after being cleaned, the site must be cleaned again.
Inservicing will be completed by October 27, 2023. All training documentation will be 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: November 30, 2023
494.90(a)(1) STANDARD
POC-ACHIEVE ADEQUATE CLEARANCE
Name - Component - 00
Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
Observations:
Based on reviews of medical records (MR), facility policy, and staff (EMP) interview, the facility failed to ensure the blood flow rate (BFR) was administered per physician order for four (4) of five (5) in center dialysis records reviewed. (MR1, 3-5)
Findings included:
Review of facility policy on August 29, 2023, at approximately 1:30pm revealed:
"Patient Assessment and Monitoring...During Treatment...Machine Parameters and Extracorporeal Circuit...Check machine settings and measurements: check prescribed blood flow is being achieved or reason is documented in the medical record if unable to meet prescribed blood flow..."
Review of MR on 10/6/2023, at between approximately 11:00am and 1:00pm revealed:
MR1, admission date 8/28/23, treatment dates reviewed 9/20/23-10/2/23.
9/20/23- Blood Flow Rate (BFR) ordered 450. At 5:11pm, 5:35pm, 6:06pm, 7:03pm,
7:32pm, 8:03pm, and 8:26pm BFR documented to be 475. 6:36pm BFR documented to
be 500. No evidence of documentation to reflect BFR not as per order.
9/22/23- BFR ordered 450. At 6:35pm, 7:36pm, and 8:32pm BFR documented to be 500.
No evidence of documentation to reflect BFR not as per order.
9/29/23- BFR ordered 450. At 5:33pm, 6:01pm, 6:32pm, 7:00pm, and 7:31pm BFR
documented to be 400. No evidence of documentation to reflect BFR not as per order.
10/2/23- BFR ordered 450. At 7:06pm, 7:33pm, and 8:14pm BFR documented to be 465.
No evidence of documentation to reflect BFR not as per order.
MR3, admission date 9/21/18, treatment dates reviewed 9/22/23-10/2/23.
9/20/23- BFR ordered 450. At 5:09am, 5:33am, 6:05am, 6:35am, 7:05am, 7:36am,
8:09am, and 8:39am BFR documented to be 400. No evidence of documentation to
reflect BFR not as per order.
9/22/23- BFR ordered 450. At 8:09am BFR documented o be 400. No evidence of
documentation to reflect BFR not as per order.
9/27/23- BFR ordered 450. At 5:30am, 6:04am, 6:30am, 7:05am, 7:41am, 8:06am, and
8:29am BFR documented to be 400. No evidence of documentation to reflect BFR not
as per order.
MR4, admission date 6/8/19, treatment dates reviewed 9/20/23-9/29/23.
9/25/23- BFR ordered 350. At 10:35am and 11:02am BFR documented to be 325. No
evidence of documentation to reflect BFR not as per order.
MR5, admission date 5/24/23, treatment dates reviewed 9/7/23-9/23/23.
9/12/23- BFR ordered at 400. At 7:35am, 7:37am, 8:06am, 8:34am, 9:02am, 9:39am,
9:54am, 10:06am, 10:39am, and 11:06am BFR documented to be 415. No
evidence of documentation to reflect BFR not as per order.
9/14/32- BFR ordered at 400. At 7:50am, 8:03am, 8:44am9:04am, 9:33am, and 10:31am
BFR documented to be 450. No evidence of documentation to reflect BFR not as per
order.
9/21/23- BFR ordered at 450. At8:06am ,8:33am, 9:03am, 9:08am, 9:18am, 9:38am,
10:00am, 10:38amand 11:03am BFR documented to be 400. No evidence of
documentation to reflect BFR not as per order.
9/23/23- BFR ordered at 450. At 7:37am, 8:06am, 8:35am, 9:06am, 9:35am, 10:05am,
10:34am, 11:04am, and 11:19am BFR documented to be 425. No evidence of
documentation to reflect BFR not as per order.
Interview with the Center Manager on October 6, 2023, at approximately 3:00pm confirmed findings.
Repeat deficiency, previously cited: 9/23/2020.
Plan of Correction:Fresenius Kidney Care
Penn Hills Dialysis
Recertification POC
October 2023
V544
To ensure compliance the CM or designee will in-service all DPC staff on policy:
- Patient Assessment and Monitoring
Emphasis will be placed on ensuring that any machine parameters not within the prescribed limits must be reported to the RN for evaluation, intervention and if not able to be resolved, physician notification. These parameters include the blood flow rate (BFR). The reason the BFR is not being achieved must be documented. The staff will be instructed that there must be documentation of the RN notification by the patient care technician (PCT).
Inservicing will be completed by October 27, 2023. All training documentation will be on file at the facility.
The CM or designee will perform daily audits for four (4) weeks. At that time, if improved compliance is observed the audits will then be completed 2 times/week for 2 weeks. If 100% compliance is maintained after the 2 weeks, the audits will be completed monthly following the QAPI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The CM will review the audit results and report the findings to the QAPI Committee at the monthly meeting for ongoing guidance and sustained compliance.
Completion Date: November 30, 2023
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 reviews of facility policy, observations, and staff (EMP) interview, the facility failed to ensure staff followed facility policy for Access of AV Fistula of Graft Initiation of Dialysis for one (1) of three (3) observations of Access of AV Fistula of Graft Initiation of Dialysis (OBS # 2).
Findings included:
Review of facility policy on August 29, 2023, at approximately 2:00pm revealed:
"Access Assessment and Cannulation...Assessment of Vascular Access...1. Prior to treatment, ask patient to wash access area with soap per hand hygiene procedure. Wash access (per above) if patients unable to clean their access...Skin Disinfection...2. Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection...
Observations revealed:
Access of AV Fistula of Graft Initiation of Dialysis OBS #2 conducted at station 11 on 10/5/23 at approximately 8:10am, EMP 7 cleansed access site that as not washed by patient with hand sanitizer. Post antisepsis, freeze spray was applied to access sites. Patient proceeded to wipe freeze spray from both access sites with blue pad. Nurse accessed both sites without performing antisepsis post patient wiping sites with blue pad.
In interview with EMP7 on 10/5/23 at approximately 8:25am, EMP states that if the patient is unable to clean their access sites themselves "we clean it with hand sanitizer and the white clothes we also use for wiping machines..." EMP7 showed surveyor bottle of hand sanitizer used.
Interview with the Center Manager on October 6, 2023, at approximately 3:00pm confirmed findings.
Repeat deficiency, previously cited: 7/31/2017.
Plan of Correction:Fresenius Kidney Care
Penn Hills Dialysis
Recertification POC
October 2023
V 550
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 site with soap, the staff must clean the access sites. The meeting will also reinforce that if the patient touches their access site after being cleaned, the site must be cleaned again.
Inservicing will be completed by October 27, 2023. All training documentation will be 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: November 30, 2023
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