QA Investigation Results

Pennsylvania Department of Health
DIALYSIS CLINIC, INC. - CLARION
Health Inspection Results
DIALYSIS CLINIC, INC. - CLARION
Health Inspection Results For:


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Initial Comments:

Based on the findings of an onsite unannounced Medicare recertification survey conducted on August 5, 2024 through August 8, 2024 Dialysis Clinic Inc. - Clarion 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 on August 5, 2024 through August 8, 2024 Dialysis Clinic Inc. - Clarion, was identified to have the following standard level deficiency that was 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 review of facility policies, records review (RR), hemodialysis (HD) treatment orders, and an interview with the clinical manager and covering facility administrator, the facility failed to follow facility policy and procedures and failed to ensure HD prescription was followed for 2 (two) of 5 (five) RR's reviewed. (RR#3 and RR# 4)

Findings include:

A review of facility policy titled " Weight " conducted on August 6, 2024, at approximately 3:00 PM reveals ... " ...2. Careful monitoring should be performed when weighing patients in and out ... A. An RN (registered nurse) should be notified if a patient is 1 (one) kg (kilogram) above or below EDW (estimated dry weight) at the scale post treatment. All staff must evaluate post weight to EDW before patient is discharged. " ...

A review of treatment records was conducted on August 6, 2024, from 1:00 PM to 3:00 PM, and again on August 8, 2024, from 10:00 AM to 10:30 AM.

RR#3 AD: 4/10/2024 review reveals:

Treatment date: 7/24/2024 HD prescription contained an ordered EDW of 104kg. Post treatment weight recorded was 108.5kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 104kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/22/2024 HD prescription contained an ordered EDW of 104kg. Post treatment weight recorded was 109.1kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 104kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/19/2024 HD prescription contained an ordered EDW of 104kg. Post treatment weight recorded was 106.1kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 104kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.


RR#4 AD: 4/02/2021 review reveals:

Treatment date: 8/05/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 100.1. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 8/02/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 100.7kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/31/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 102.6kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/29/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 103.8kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/26/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 102.0kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/24/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 102.3kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

Treatment date: 7/22/2024 HD prescription contained an ordered EDW of 97.0kg. Post treatment weight recorded was 101.9kg. There was no documentation that the RN was notified of the post treatment weight greater than 1 (one) kg above physician ordered EDW of 97.0kg. There was no documentation on the nursing assessment pertaining to or addressing the post treatment weight.

An interview conducted with the clinical manager and covering facility administrator on August 6, 2024 at approximately 2:00 PM confirmed the above findings.





Plan of Correction:

1. All clinical staff will be retrained by the Nurse Manager or Designee by 8/30/2024 on the facility's "Weight" policy. Training on these policies will be conducted with emphasis on (1) careful monitoring of patient when weighing patients before and after initiation of treatment, (2) notifying an RN (registered nurse) if a patient's weight is (1) one kg (kilogram) above or below the EDW (estimated dry weight) post treatment, (3) evaluating patient's post weight to EDW before patient is discharged from the clinic, (4) appropriately documenting on the patient's flowsheet that the RN is notified when the patient's weight is outside the 1 (one) kg parameter of the EDW, and (5) appropriately documenting on the nursing assessment addressing the post weight when outside of the 1 (one) kg parameter of the EDW.

2. Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of policy. Acknowledgement will be placed in facility's education manual and/or employee's personnel file.

3. Initially, Nurse Manager and/or Designee will audit 50% of the treatment flow sheets daily for one (1) week to ensure that staff is following the policy with emphasis on proper evaluation and documentation of post weight and EDW. If standards are met, 50% of the treatment flow sheets will be audited weekly for four (4) weeks. If standards are met, 50% of the treatment flow sheets will be audited monthly for three (3) months. If standards are met, 50% of the treatment flow sheets will be audited semi-annually. The audit results will be reviewed at monthly QAPI meetings.



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 review of facility policy, record reviews (RR), and staff (EMP) interview, the facility failed to ensure the blood flow rate (BFR) was administered per physician order and failed to obtain cannulation order for 1 (one) of 5 (five) RR ' s. (RR#3)
Findings Included:
A review of facility policy titled " Central Venous Catheter (CVC) Removal Protocol " conducted on August 7, 2024, at approximately 3:30 PM reveals ... " 7. Week 8: ...Schedule final follow up appointment if required by Surgeon, request that order for cannulation be sent during final follow up appointment ... 10. Week 10-11: Begin cannulation plan: If first cannulation successful, schedule CVC removal same day, only expert cannulators shall perform cannulation of new AVF (arteriovenous fistula) ... Blood flow rates (BFR) will be determined by needle gauge ... Cannulate with 1(one) -17 gauge needle X 1 (one) TX (treatment), cannulate with 2(two) -17 gauge needles X 2 (two) TXS ... "

A review of treatment records was conducted on August 6, 2024, from 1:00 PM to 3:00 PM, and again on August 8, 2024 from 10:00 AM to 10:30 AM.
RR#3 Admit Date (AD): 4/10/2024 review reveals:

Treatment date: 8/05/2024 contains HD prescription order of BFR: 500 and vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR documentation states patient cannulated with 2 (two) - 15 gauge needles.

Treatment date: 8/02/2024 contains HD prescription order of BFR: 500 and vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR documentation states patient cannulated with 2(two) - 15 gauge needles.

Treatment date: 7/31/2024 treatment initiated at 5:27AM, RR#3 contains HD prescription order of BFR: 500 and vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 15 gauge needles at 5:24AM.
BFR documentation: 6:00AM - BFR350; 6:30AM - BFR360; 7:00AM - BFR350; 7:30AM - BFR400; 8:00 - BFR390; 8:30AM - BFR400; 9:00AM - BFR400.

Treatment date: 7/29/2024 treatment initiated at 5:25AM, RR#3 contains HD prescription order of BFR: 500; vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 16 gauge needles at 5:22AM.
BFR documentation: 6:00AM - BFR400; 6:30AM - BFR370; 7:00AM - BFR360; 7:30AM - BFR390; 8:00 - BFR390; 8:30AM - BFR390; 9:00AM - BFR340; 9:30AM - BFR340.

Treatment date: 7/26/2024 treatment initiated at 5:23AM, RR#3 contains HD prescription order of BFR: 500; vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 16 gauge needles at 4:20AM.
BFR documentation: 5:30AM - BFR400; 6:00AM - BFR370; 6:30AM - BFR400; 7:00AM - BFR400; 7:30AM - BFR400; 8:00 - BFR400; 8:30AM - BFR400; 9:00AM - BFR400; 9:30AM - BFR400, 10:00AM - BFR400.

Treatment date: 7/24/2024 treatment initiated at 5:23AM, RR#3 contains HD prescription order of BFR: 500; vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 16 gauge needles at 4:20AM.
BFR documentation: 5:30AM - BFR400; 6:00AM - BFR370; 6:30AM - BFR400; 7:00AM - BFR400; 7:30AM - BFR400; 8:00 - BFR400; 8:30AM - BFR400; 9:00AM - BFR400; 9:30AM - BFR400, 10:00AM - BFR400.

Treatment date: 7/22/2024 treatment initiated at 5:27AM, RR#3 contains HD prescription order of BFR: 500; vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 16 gauge needles at 5:24AM.
BFR documentation: 5:28AM - BFR330; 6:00AM - BFR360; 6:30AM - BFR360; 7:00AM - BFR360; 7:30AM - BFR410; 8:00 - BFR410; 8:30AM - BFR410; 9:00AM - BFR410.

Treatment date: 7/19/2024 treatment initiated at 5:32AM, RR#3 contains HD prescription order of BFR: 500; vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 17 gauge needles at 5:29AM.
BFR documentation: 6:00AM - BFR300; 6:30AM - BFR280; 7:00AM - BFR250; 7:30AM - BFR260; 8:00 - BFR260; 8:30AM - BFR260; 9:00AM - BFR260.

Treatment date: 7/17/2024 treatment initiated at 5:22AM, RR#3 contains HD prescription order of BFR: 500; vascular access order for RIJ (right Internal Jugular) CVC arterial access port volume 2.2ml (milliliters) and CVC venous access port volume 2.3ml (milliliters) and LUA (left upper arm) fistula needle gauges not documented on HD prescription order. RR#3 documentation states patient cannulated with 2(two) - 17 gauge needles at 5:19AM.
BFR documentation: 5:30AM - BFR300; 6:00AM - BFR310; 6:30AM - BFR310; 7:00AM - BFR280; 7:30AM - BFR320; 8:00 - BFR310; 8:30AM - BFR310; 9:00AM - BFR310.

An interview conducted with the clinical manager and covering facility administrator on August 6, 2024 at approximately 2:30 PM confirmed the above findings.





Plan of Correction:

1. The facility policy titled "Central Venous Catheter (CVC) Removal Protocol, will be eliminated and the following will be added to the "Vascular Access" portion of the Hemodialysis Standing Orders: For new Fistulas (1) Week One – If patient has a catheter: use one 17 gauge needle for the arterial line and on limb of catheter for venous line at BFR < 300 ml/min. (2) Week One – If patient does not have a catheter: use two 17 gauge needles at BFR < 300 ml/min. (3) Week Two – Use two 17 gauge needles at a blood flow rate < 300 ml/min. If cannulation attempts are unsuccessful on two occasions, refer for access intervention. (4) Week Three – Use two 16 gauge needles at a blood flow rate < 350 ml/min. If catheter present: After six successful cannulations, arrange to have catheter removed. (5) Week Four – Use two 16 gauge needles at a blood flow rate < 350 ml/min. (6) Week Five – Use two 15 gauge needles at a blood flow rate < 500 ml/min. (7) Complications: If any vascular access event occurs, such as an infiltration or any other "unsuccessful" cannulation, let AVF "rest" for one week, and then start new protocol on following treatment. If fistula infiltrates a second time, refer for access intervention.

2. All clinical staff will be retrained by the Nurse Manager or Designee by 8/30/2024 on the facility's revised "Hemodialysis Standing Orders" with emphasis on the "Vascular Access" portion of the Hemodialysis Standing Orders.

3. The Nurse Manager or Designee will ensure that all clinical staff review and sign acknowledgement of understanding of the revised "Hemodialysis Standing Orders" – Vascular Access. Acknowledgement will be placed in facility's education manual and/or employee's personnel file.

4. Nurse Manager and/or Designee will perform a record review on all newly admitted patients monthly for (6) months to ensure that the Vascular Access protocol of the Hemodialysis Standing Orders is being followed appropriately. If standards are met, the record review will be performed semi-annually. The audit results will be reviewed at monthly QAPI meetings.