QA Investigation Results

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


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Initial Comments:


Based on the findings of an unannounced Medicare Recertification Survey conducted on December 16, 2019 through December 18, 2019, Broomall Dialysis was found to be in compliance with the following requirement 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 December 16, 2019 through December 18, 2019, Broomall 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 of Suppliers of End-Stage Renal Disease (ESRD) Services.




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 observation, review of policy and procedures, and interview with the Group Facility Administrator, it was determined, the facility failed to ensure infection control procedures were followed by cleaning and disinfecting the Hansen connectors, waste containers and opening and cleaning the side arms of the dialysis chairs for six (6) of fourteen (16) hemodialysis machines observed. (Dialysis machines at station #'s 1, 3, 8, 13, 15, & 16).

Findings include:

Observations were made in the in patient treatment area on December 16 & 18, 2019 between the hours of 9:00 AM and 12:40 PM .

1. A review of policy number 1-05-01 titled, "Infection Control for Dialysis Facilities " was conducted on December 18, 2019 at approximately 11:30 AM states, " Purpose: To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. . . 66. Teammates will thoroughly wipe down all non-disposable items and equipment . . . with an appropriate disinfectant after every treatment. 67. Priming containers are to be emptied. The interior and exterior should be wiped down with 1:100 (one to one hundred) bleach solution before using on the next patient. . ."

1. On December 16, 2019 at approximately 10:46 AM, it was observed that Registered Nurse #1, did not disinfect the Hansen connectors or open and disinfect the sidearms of the chair at station # 3 prior to the start of the next dialysis treatment.

2. On December 16, 2019 at approximately 10:49 AM, it was observed that Patient Care Technician #1, did not disinfect the Hansen connectors of the dialysis machine at station # 15 prior to the start of the next dialysis treatment.

3. On December 16, 2019 at approximately 11:10 AM, it was observed that Patient Care Technician #2, did not disinfect the Hansen connectors of the dialysis machine at station #13, prior to the start of the next dialysis treatment.

4. On December 16, 2019 at approximately 11:32 AM, it was observed that Patient Care Technician #1, did not disinfect the Hansen connectors of the dialysis machine at station # 16, prior to the start of the next dialysis treatment.

5. On December 16, 2019 at approximately 12:20 PM, it was observed that Patient Care Technician #2, did not disinfect the Hansen connectors of the dialysis machine at station # 1, prior to the start of the next dialysis treatment.

6. On December 16, 2019 at approximately 12:38 PM, it was observed that Registered Nurse #2, did not disinfect the prime waste container of the dialysis machine at station # 8, prior to the start of the next dialysis treatment.

An interview was conducted with the Group Facility Administrator on December 18, 2019 at approximately 11:26 AM. The Administrator confirmed the above identified findings.

Based on review of facility documentation, review of policy and procedures, and interview with the Group Facility Administrator, the facility failed to document the daily heat disinfection and weekly bleach disinfection for nine (9) of eighteen (18) dialysis machines for the days of June 12; July 24; September 20; and September 27, 2019. (Dialysis Machine #'s 3, 5, 6, 7, 8, 9, 11, 14, & 17).
Findings include:
A review of the policy number 2-02-01 titled "Fresenius Dialysis Delivery System Cleaning and Disinfection Policy" was conducted on December 18, 2019, at approximately 11:40 AM states, " Purpose: To promote patient safety by cleaning and disinfection of Fresenius dialysis delivery systems. Policy: 1. Only trained teammates will perform cleaning and disinfection of Fresenius dialysis delivery systems. . . Examples of Cleaning/Disinfection Procedures and Intervals: Heat Disinfection, Each Treatment Day; Citric Acid, Vinegar Rinse, Each Treatment Day; Bleach or Peracetic Acid Disinfection, Weekly. . . 6. Facilities will develop a specific Dialysis Delivery System Cleaning and Disinfection Log in conjunction with the Biomedical Department and with approval by the Biomed Operations Manager (BOM). . . Cleaning and disinfection of dialysis delivery systems will be documented on this log. . . 8. Completed logs will be filed in the designated facility log book and maintained for the entire time the equipment is owned by DaVita. . ."1. A review of the Dialysis Delivery System Cleaning and Disinfection Log on December 17, 2019, at approximately 11:00 AM revealed the following: On June 12, 2019 there was no documentation that machine #'s 6 & 8 had been disinfected with neither citric acid nor bleach or heat at the end of the day; On July 24, 2019 there was no documentation that machine # 8 had been disinfected with neither citric acid nor bleach or heat at the end of the day; On September 20, 2019 there was no documentation that machine #'s 3, 5 & 7 had been disinfected with neither citric acid nor bleach or heat at the end of the day; and on September 27, 2019 there was no documentation that machine #'s 9, 11, 14, & 17 had been disinfected with neither citric acid nor bleach or heat at the end of the day;

An interview with the Group Facility Administrator was conducted on December 17, 2019 at approximately 1:50 PM. The Administrator confirmed the above findings.














































































Plan of Correction:

V122
All clinical Teammates (TMs) will be in-serviced by the Facility Administrator (FA) and Clinical Nurse Manager (CNM) to review Policy 1-05-01 Infection Control for Dialysis Facilities emphasizing but not limited to: 1) equipment including the dialysis delivery system and Hansen connectors, the interior and exterior of the prime container and the dialysis chair and side tables including opening the chair to reach crevices, will be wiped clean with a bleach solution of the appropriate strength after completion of procedures and before being used on another patient. In addition, the FA and/or CNM will review Policy 2-02-01 Fresenius Dialysis Delivery System Cleaning and Disinfection Policy emphasizing TMs will clean and disinfect the machines per manufacturer recommendation and document on the Dialysis Delivery System Cleaning and Disinfection log. Verification of attendance at in-services is evidenced by TM signature on in-service sheet. The FA or designee will conduct documented observational audits on random shifts three (3) times a week for two (2) weeks, once a week for two (2) weeks, then monthly using the Clean Sweep and Biomedical Audits. Results of audits will be reviewed with the TMs during homeroom meetings and with the Medical Director during the monthly Facility Health Meeting (FHM-QAPI) with an Improvement Plan developed if needed and supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.




494.30(b)(1) STANDARD
IC-O-SIGHT-MONITOR ACTIVITY/IMPLEMENT P&P

Name - Component - 00
The facility must-
(1) Monitor and implement biohazard and infection control policies and activities within the dialysis unit;



Observations:

Based on observation , interview with the Group Facility Administrator, the facility failed to ensure biohazard and infection control activities, (a disinfecting wipe lying on the base of hemodialysis machines) was followed within the unit for one (1) of sixteen (16) hemodialysis machines. (Hemodialysis machine # 3)

Findings include:

Observation made on December 18, 2019 at approximately 10:30 AM revealed the following:

1. A disinfecting wipe was observed laying on the bottom of hemodialysis machine # 3 for approximately 20 minutes before it was used to disinfect the hemodialysis machine.


Interview with the Group Facility Administrator on December 18, 2019 at approximately 11:30 AM confirmed disinfecting wipes are used to clean the machines and chairs but should not be found on the base of the hemodialysis machines.

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Plan of Correction:

V142
The FA will provide in-services to clinical TMs on 1/3/2020 on Policy #1-05-08: Bleach Policy emphasizing that the bleach solution must not be open to air causing the solution to degrade over time and become less effective. Bleach wipes will not be brought to station prior to immediate use. Verification of attendance is evidenced by TM signature on in-service sheet. The FA will conduct documented observational audits on random shifts three (3) times a week for two (2) weeks, once a week for two (2) weeks, then monthly using the Clean Sweep Audit. Results of audits will be reviewed with the TMs during homeroom meetings and with the Medical Director during the monthly FHM-QAPI with an Improvement Plan developed if needed and supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.