QA Investigation Results

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


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Initial Comments:
Based on the findings of an unannounced Medicare recertification survey conducted August 17 through August 19, 2021, Childs 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 Medicare recertification survey conducted August 17 through August 19, 2021, Childs Dialysis 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 and documentation, observational tour, and based on interview with in-center hemodialysis (HD) staff and the administrator, the facility failed to ensure three (3) of four (4) ICHD staff disinfected the HD machine prime container (container in which excess HD priming solution waste is captured) as per facility policy/procedure. (Employees #1, #3 and #4)

Findings include:

On August 19, 2021 at approximately 1:50 PM, review of facility policy 1-05-01, titled "Infection Control for Dialysis Facilities", revealed the following:
Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment...
Dialysis Station Management...66. Teammates (HD staff) will thoroughly wipe down...the inside and the outside of the prime (waste) container...with an appropriate disinfectant after every HD treatment...

On August 18, 2021 at approximately 9:08 AM, review of the personnel file review form revealed the following:
Employee #1: The date of hire of the registered nurse (RN)/administrator/clinical manager was 02/04/2002.
Employee #3: The date of hire of the patient care technician (PCT) was 12/20/2019.
Employee #4: The date of hire of the PCT was 07/03/2013.

Observation of the HD machine disinfection procedure revealed the following:
Employee #1: On August 18, 2021 at approximately 7:57 AM, the RN failed to wipe/disinfect the interior and exterior portions of the prime container during the HD machine disinfection process at station #2.
Employee #3: On August 19, 2021 at approximately 8:05 AM, the PCT failed to wipe/disinfect the interior and exterior portions of the prime container during the HD machine disinfection process at station #5.
Employee #4: On August 18, 2021 at approximately 10:24 AM, the PCT failed to wipe/disinfect the interior and exterior portions of the prime container during the HD machine disinfection process at station #3.

During interview on August 19, 2021 at approximately 9:39 AM, the PCT (employee #3) confirmed that during the HD machine disinfection process, the interior and exterior portions of the prime container are to be wiped/disinfected.

During interview on August 19, 2021 at approximately 2:45 PM, the administrator confirmed that the above referenced HD staff failed to wipe/disinfect the interior and exterior portions of the prime container during the HD machine disinfection process at the aforementioned HD stations.















Plan of Correction:

The Facility Administrator held a mandatory in-service for all clinical teammates on 8/23/2021. In-service included but was not limited to a review of policy # 1-05-01: Infection Control for Dialysis Facilities emphasizing teammates must thoroughly wipe down... the inside and outside of the prime (waste) container... with an appropriate disinfectant after every HD treatment. Verification of attendance at in-service will be evidenced by teammates signature on in-service sheet.

The Facility Administrator or designee will conduct infection control audits focusing on disinfection of the prime containers daily for (2) weeks on all shifts, then weekly for (2) weeks on all shifts then monthly during internal infection control audits. Instances of non-compliance will be addressed immediately. The Facility Administrator will review results of all audits with teammates during homeroom meetings and with Medical Director during monthly Facility Health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this 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 and documentation, observational tour, and based on interview with in-center hemodialysis (HD) staff interview and the administrator, the facility failed to ensure two (2) of three (3) HD staff obtained a manual (independent) HD machine pH (acid/base level) measurement (reading) prior to the initiation of the HD treatment. (Employees #3 and #4)

Findings include:

On August 18, 2021 at approximately 12:00 PM, review of facility policy 1-03-06L, titled "Priming an ETO Sterilized Single Use Dialyzer Utilizing B Braun Dialog+ Dialysis Delivery Systems and Streamline Blood Lines" revealed the following under the procedure/rational table:
Procedure: 44...check manual pH...
Rationale 44...pH testing must be performed prior to each patient treatment.

During observational tours of the hemodialysis (HD) treatment area conducted between August 18, 2021 at approximately 7:25 AM and August 19, 2021 at approximately 9:35 AM revealed a vial of pH testing strips was stored in a plastic container located near the clean sink at the central counter/cabinet area in the HD treatment room.

During interview conducted on August 19, 2021 at approximately 1:23 PM, the biomedical operations manager reported that the B Braun Dialog+ dialysis delivery systems (hemodialysis machine) does not calculate/display a HD machine pH and that a manual pH measurement is to be obtained prior to the initiation of each HD treatment.

On August 18, 2021 at approximately 9:08 AM, review of the personnel file review form revealed the following:
Employee #3: The date of hire of the patient care technician (PCT) was 12/20/2019.
Employee #4: The date of hire of the PCT was 07/03/2013.

Observation of the hemodialysis machine preparation/treatment initiation procedure revealed the following:
Employee #4: On August 18, 2021 at approximately 10:35 AM, the PCT failed to obtain a manual pH measurement prior initiation of the HD treatment at station #2.
Employees #3 and #4: On August 18, 2021 at approximately 10:48 AM, the PCT's cooperated in the preparation of the HD machine at station #4. The PCT's failed to obtain a manual pH measurement prior to initiation of the HD treatment at station #4.

During interview on August 19, 2021 at approximately 9:39 AM, the PCT (employee #3) confirmed a manual HD machine pH measurement is to be obtained prior to the initiation of each HD treatment.

During interview on August 19, 2021 at approximately 2:45 PM, the administrator confirmed the above reference HD staff failed to obtain a manual HD machine pH measurement prior to the initiation of the HD treatment at the aforementioned HD stations.











Plan of Correction:

All clinical teammates were in-serviced by the Facility Administrator on 8/23/2021 with the review of policies Policy 1-03-06L Priming an ETO Sterilized Single Use Dialyzer Single Use Dialyzer Utilizing B Braun Dialog+ Dialysis Delivery Systems and Streamline Blood Lines emphasizing pH testing must be performed prior to each patient treatment. Verification of attendance is evidenced by teammate signature on in-service sheet. The Facility Administrator or designee will perform audits to include observation of pH testing daily for (2) weeks on all shifts, then weekly for (2) weeks on all shifts then on ten percent (10%) of the flow sheets during monthly medical records audits. Instances of noncompliance will be addressed immediately. The Facility Administrator will review results of all audits with teammates during homeroom meetings and with the Medical during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The Facility Administrator is responsible for compliance with this plan of correction.