QA Investigation Results

Pennsylvania Department of Health
DUNMORE DIALYSIS
Health Inspection Results
DUNMORE DIALYSIS
Health Inspection Results For:


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Initial Comments:

Based on the findings of an unannounced, onsite Medicare recertification survey conducted May 18, 2021 through May 21, 2021, Dunmore Dialysis 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, onsite Medicare recertification survey conducted May 18, 2021 through May 21, 2021, Dunmore Dialysis was found was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the requirements of 42 CFR, Part 494, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.




Plan of Correction:




494.40(a) STANDARD
DIALYS PROPORT-MONITOR PH/CONDUCTIVITY

Name - Component - 00
5.6 Dialysate proportioning: monitor pH/conductivity
It is necessary for the operator to follow the manufacturer's instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient.




Observations:

Based on review of the facility policies/procedures, observational tour, and based on in-center hemodialysis (ICHD) staff interview and interview with the administrator, the facility failed to ensure independent verification of hemodialysis machine conductivity and pH was performed per facility policy/procedure for one (1) of three (3) ICHD machines. (Station #1/Machine #8196886)


Findings include:

On May 20, 2021 at approximately 3:29 PM, review of facility policy 1-03-06U, titled "Priming a NON-ETO Sterilized Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Streamline Blood Lines for Subsequent Treatment Shifts" revealed the following under the procedure/rational table:
Procedure: 33. Check independent conductivity with approved independent meter for testing dialysate...
Rationale: Acceptable range for final dialysate conductivity is 13-15.5 mS (millisiemens--measure of electrical conductance). If the physician orders dialysate sodium of 136 or less in specific circumstances, then the acceptable range for the final dialysate is 12.8 to 15.5 mS. If the final dialysate is not within this range, do not initiate treatment and investigate the reason the values are outside the acceptable range.
Procedure: 36. Check independent pH with approved test method for final dialysate. Acceptable range for final dialysate pH is 6.9 to 7.6.

During observational tours of the hemodialysis treatment area conducted between May 18, 2021 at approximately 10:01 AM and May 20, 2021 at approximately 11:20 AM revealed two (2) pHoenix meters (device utilized to obtain independent measurement of hemodialysis machine temperature, conductivity (ability of a solution to conduct electricity) and pH (measure of acid or base level)) were available for staff use.

On May 20, 2021 between the approximate times of 10:00 AM and 11:20 AM, observation of ICHD station #1 (Machine #8196886) revealed a patient care technician (PCT-employee #4) and registered nurse (RN-employee #9) initiated/completed the hemodialysis machine preparation for the second hemodialysis shift. Employee #4 was observed entering data obtained from hemodialysis machine #8196886 into the electronic database. Employees #4 and #9 failed to independently verify the conductivity and pH for machine #8196886.
During interview on May 20, 2021 at approximately 11:16 AM, the PCT (employee #4) confirmed machine conductivity and pH was not independently verified with the pHoenix meter.
During interview on May 20, 2021 at approximately 11:20 AM, the RN (employee #9) confirmed machine conductivity and pH was not independently verified with the pHoenix meter.

During interview on May 31, 2021 at approximately 3:45 PM, the administrator confirmed independent verification of machine conductivity and pH was not performed as per facility policy and procedure.












Plan of Correction:

The Facility Administrator (FA) held mandatory in-service(s) for all Clinical Teammates (TMs) starting on 5/24/2021. Surveyor observations were reviewed. Education included but was not limited to: 1) a review of Policy 1-03-02 Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate with emphasis on performing independent pH is required to be performed prior to each treatment. 2) a review of Policy 1-03-06U Priming a non-ETO Sterilized Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery and Streamline Bloodlines for Subsequent Treatment Shifts emphasizing on performing independent conductivity with approved independent meter for testing dialysate. TMs must verify conductivity is within acceptable range prior to delivering a dialysis treatment. Included in the education was a review of acceptable calibration ranges.. TMs must document these values in the patient's electronic treatment record or flowsheet. Verification of attendance will be evidenced by TM signature on in-service sheet. All clinical TMs will complete the Phoenix Meter Skills Checklist.
The FA or designee will perform audits of 50% the post treatment flow sheet daily for two (2) weeks on random shifts then weekly for two (2) weeks then on 10% of the post treatment flow sheet ongoing monthly with the facility's internal medical records audits to verify compliance. Instances of non-compliance will be addressed immediately. The results of the audits will be reviewed with the TMs during homeroom meetings and with the Medical Director during monthly Facility Health Meetings (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.



494.110(b) STANDARD
QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE

Name - Component - 00
The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time.


Observations:

Based on a review of the facility policies/procedures and documentation, and based on interview with the biomedical technician and the administrator, the facility failed to ensure corrective actions for variances noted water and dialysate (bicarbonate-dialysis solution) system logs were implemented during the quality assessment/performance improvement meetings (FHR-Facility Health Record) for two (2) of two (2) months in 2021. (March and April 2021)

Findings include:

On May 20, 2021 at approximately 9:51 AM, review of facility policy 1-14-06, titled "Continuous Quality Improvement Program" revealed the following under "Policy": 7. The facility will measure, analyze and track quality indicators or other aspects of performance...

On May 20, 2021 at approximately 9:28 AM, review of facility policy 2-04-02, titled "Daily Water Treatment System Monitoring" revealed the following:
Purpose: To verify that the dialysis water treatment system operates safely and reliably through daily observations and/or testing of specific component parameters...
Policy: 5. All observations and test results will be within the limits specified on the Daily Water Treatment Log...

On May 20, 2021 at approximately 9:29 AM, review of the DaVita Daily Water Treatment Log template, revealed the facility specific minimum water system flow rates were to be entered on the log.

On May 20, 2021 at approximately 9:50 AM, review of facility procedure 01714, titled "Better Water Dual Tank Bicarb Mixing and Delivery System Nightly Rinsing" revealed the following:
Note: This procedure must be performed at the end of each treatment day. If the facility has a nocturnal program, the rinsing of the dual tank will be completed daily prior to the nocturnal shift, or after the nocturnal shift, but prior to the next day shift. The facility administrator, medical director and biomedical teammate will develop a schedule to meet these requirements...
Procedure...14. Complete Rinse Log...
Rationale...14. For proper documentation.

On May 19, 2021 at approximately 11:59 AM, review of water treatment and dialysate system logs revealed the following:
DAILY WATER TREATMENT LOG: The RO (reverse osmosis-water purification device/process) concentrate flow rate was to be maintained above 1.0.
-Daytime Log: Review of RO concentrate flow rate documentation revealed the flow rate ranged from 0.9 to 1.0 for 10 in-center hemodialysis (ICHD) treatment days in March 2021, 16 ICHD treatment days in April 2021, 5 ICHD treatment days in May 2021.
-Nocturnal (Night) Log: Review of RO concentrate flow rate documentation revealed the flow rate ranged from 0.9 to 1.0 for 7 ICHD treatment days in March 2021, 9 ICHD treatment days in April 2021, 5 ICHD treatment days in May 2021.
BICARBONATE SYSTEM DAILY RINSE LOG: Review of rinsing documentation failed to reveal that the bicarbonate tanks and/or delivery system had been rinsed on/after 15 ICHD treatment days in February 2021, 16 ICHD treatment days in March 2021, 16 ICHD treatment days in April 2021 and 7 ICHD treatment days in May 2021.

Between May 19, 2020 at approximately 3:32 PM and May 20, 2020 at approximately 9:00 AM, review of facility FHR documentation revealed facility logs and/or biomedical reports were reviewed during the March and April 2021 meetings.

During interviews conducted on May 19, 2021 between the approximate times of 1:45 PM and 2:45 PM, the biomedical technician reported that upon installation of the RO machine, the baseline RO concentrate flow rate was determined to be 1.39. The biomedical technician reported that a decreased RO concentrate flow rate can affect the conductivity of the dialysate but that if the conductivity exceeded a specific reading/value (30 mS/cm (millisiemens (measure of electrical conductance) per centimeter), an alarm would sound in the ICHD unit. The biomedical technician reported that the concentrate flow rate was adjusted on 05/19/2021 after the valve setting was adjusted.
The biomedical technician confirmed variances on the "Daily Water Treatment Log" (daytime and nocturnal) and the bicarbonate system daily rinse log were not addressed during the March and April 2021 FHR meetings and that a corrective action had not been implemented for the variances prior to May 19, 2021.

During interview on May 21, 2021 at approximately 3:45 PM, the administrator confirmed variances on the "Daily Water Treatment Log" (daytime and nocturnal) and the bicarbonate system daily rinse log were not addressed during the March and April 2021 FHR meetings and that a corrective action had not been implemented for the variances prior to May 19, 2021.
















Plan of Correction:

The FA held mandatory in-service(s) for all members of the Continuous Quality Improvement (CQI)committee starting on 6/1/2021. Surveyor observations were reviewed. Education included but was not limited to: 1) a review of Policy 1-14-06 Continuous Quality Improvement Program emphasizing that the facility will measure, analyze and track quality indicators or other aspects of performance... In addition, the FA held mandatory in-service(s) for all Clinical TMs ending 5/27/21 to review Policy 2-04-02 Daily Water Treatment System Monitoring, Facility Procedure 01714 Better Water Dual Tank Bicarb Mixing and Delivery System Nightly Rinsing and associated logs. Education included but was not limited to: 1) Daily monitoring is performed to verify that the dialysis water treatment system operates safely and reliably though daily observations and/or testing of specific component parameters. If results are not within specific parameters, including the concentrate flow rate, it must be reported to the biomedical department. 2) All observations and test results will be within the limits specified on the Daily Water Treatment Log which includes the flow rate. 3) The nightly rinse must be performed at the end of each treatment day. If the facility has nocturnal program., the rinsing will be completed daily prior to the nocturnal shift, or after the nocturnal shift, but prior to the next day shift. 4) Once the rinse is completed, TM must document on the rinse log. Verification of attendance will be evidenced by TM signature on in-service sheet. The FA or designee will audit the daily water log and the daily bicarb rinse log weekly for four (4) weeks then monthly for two (2) months to verify compliance. Instances of non-compliance will be addressed immediately. In additions, the Biomedical Service Specialist (BSS) is responsible to audit all all mixing log monthly and report outliers to the CQI committee. The CQI committee will implement an improvement plan and monitor outcomes during the month CQI process until sustained compliance is achieved. The Manager of Clinical Services (MCS) or Regional Operations Director (ROD) will audit CQI meeting minutes to verify improvement plans are present and being followed for variances on the daily water treatment log and the bicarbonate system daily rinse log. Instances of non compliance will be addressed immediately. The results of all audits will be reviewed with the TMs during homeroom meetings and with the Medical Director during FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.