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 September 12 through September 14, 2018, 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 September 12 through September 14, 2018, 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 STANDARD
IC-SANITARY ENVIRONMENT

Name - Component - 00
The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas.


Observations:

Based on review of facility policies and procedures and the Food and Drug Administration (FDA) website download, observational tour, and based on interview with the clinical care coordinator and the administrator, the facility failed to ensure three (3) of four (4) hemodialysis staff maintained a sanitary environment in the hemodialysis treatment area. (Employees #2, #3 and #4)

Findings include:

On September 14, 2018 at 1:25 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."

On September 14, 2018 at 1:30 PM, review of the downloadable pamphlet titled "Be Smart with Sharps" from the FDA website revealed that contaminated sharps should not be forced into Sharps containers and that fingers should not be placed into Sharps containers.

Observational tour conducted between September 12, 2018 at 10:16 AM and September 14, 2018 at 10:43 AM revealed the following:

Employee #2: On September 12, 2018 at 11:23 AM, the registered nurse (RN) was noted to be preparing the hemodialysis (HD) machine at HD station #5 for the next patient shift. The RN was noted to be wearing gloves and holding a Bicart cartridge (disposable bicarbonate container). While wearing the same gloves and while holding the Bicart cartridge, the RN proceeded to reset the alarming HD machine for the HD patient seated at HD station #6. While wearing the same gloves the RN utilized to reset the alarming HD machine at station #6, the RN proceeded to secure the Bicart cartridge, which the RN had noted to be holding to the HD machine at HD station #5.

Employee #3: On September 14, 2018 at 10:43 AM, after removing the hemodialysis access needle from the patient located at HD station #4, the RN proceeded to insert the needle portion of the access needle into the "Sharps" container by inverting the access needle which required the RN to push/force the extension tubing, which was attached to the access needle, into the "Sharps" container. During the access needle disposal procedure, the RN was observed making contact with the lid/insertion port of the "Sharps" container. Using the same gloved hands which made contact with the lid/insertion port of the "Sharps" container, the RN proceeded to touch the access site of the patient located at HD station #4.

Employee #4: On September 12, 2018 at 11:42 AM, the patient care technician (PCT) was noted to be preparing the HD machine at HD station #2 for the next patient shift. The PCT was wearing gloves and holding an unopened package containing a set of hemodialysis bloodlines. The PCT proceeded to remove the plastic packaging from the set of hemodialysis bloodlines. After removing the plastic packaging and while still holding the set of hemodialysis bloodlines, the PCT proceeded to force the plastic packaging into a garbage container. Observation of the garbage container revealed soiled gloves and paper towels were present in the container. The PCT proceeded to complete the HD set-up procedure using the same gloves utilized to force the plastic packaging into the garbage container, and the PCT proceeded to attach the set of hemodialysis bloodlines the PCT had been holding when the PCT made contact with the garbage container to the HD machine at HD station #2.

During interview on September 14, 2018 at 12:45 PM, the clinical care coordinator and the administrator confirmed that the above identified HD staff failed to maintain a sanitary environment in the hemodialysis treatment area on the above identified dates/times.






Plan of Correction:

The Surveyor's observations were reviewed with the clinical teammates (TMs) by the Assistant Facility Administrator (AFA) immediately following the survey.


The AFA held a mandatory in-service for all clinical TMs on 09/17/18. In-service included but was not be limited to a review of Policy # 1-05-01: Infection Control for Dialysis Facilities emphasizing: 1) TMs must wear disposable gloves appropriately when caring for the patient or touching the patient's equipment at the dialysis station; 2) TMs must remove gloves and perform hand hygiene between dirty and clean tasks with same patient, between each patient and station; 3) TMs must remove contaminated gloves and perform hand hygiene before embarking on a clean task; 4) TMs must perform hand hygiene every time gloves removed. In addition, the AFA will re-educate clinical TM on policy 4-03-07 by 10/05/18 with emphasis on: 1) Sharps are discarded at the point of origin into a sharps container; 2) Sharps containers are to be sealed when full and placed in designated area for medical waste pickup. TM were instructed to never force sharps into the sharps container to avoid cross contamination and/or harm. Verification of attendance at in-service will be evidenced by TMs signature on in-service sheet.

The AFA or designee will conduct infection control audits utilizing the "Clean Sweep Tool" daily for two (2) weeks on all shifts, then weekly for two (2) weeks on all shifts, and then monthly during Clean Sweep Audits. Instances of non-compliance will be addressed immediately. The FA will review results of all audits with TMs during home room meetings and with Medical Director during monthly Facility Health Meeting (FHM-QAPI) with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.

Completion date: October 14th, 2018




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 and procedures, observational tour, and based on interview with a license practical nurse (LPN), the clinical care coordinator and the administrator, the facility failed to ensure two (2) of four (4) hemodialysis staff disinfected the hemodialysis chair as per facility policy/procedure. (Employees #2 and #3)

Findings include:

On September 14, 2018 at 1:25 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...
Facility Hygiene...51. Equipment including dialysis delivery system...the dialysis chair and side tables including opening the chair to reach crevices...will be wiped clean with a bleach solution...after each treatment..."

On September 14, 2018 at 12:30 PM, the LPN (employee #8) reported that when disinfection of the hemodialysis chair is performed, the chair sides are to be opened and the inner aspect of the chair sides are to be disinfected.

Observational tour conducted between September 12, 2018 at 10:16 AM and September 14, 2018 at 10:43 AM revealed the following:

Employee #2: During the hemodialysis (HD) station disinfection procedure, the registered nurse (RN) failed to open and disinfect the inner aspect of the HD chair sides on the following dates/times and at the following HD stations:
-September 12, 2018 at 11:18 AM for HD station #5;
-September 12, 2018 at 11:50 AM for HD station #8; and
-September 12, 2018 at 12:12 PM for HD station #1.

Employee #3: During the hemodialysis (HD) station disinfection procedure, the registered nurse (RN) failed to open and disinfect the inner aspect of the HD chair sides on the following dates/times and at the following HD stations:
-September 12, 2018 at 11:30 AM for HD station #4; and
-September 14, 2018 at 10:43 AM for HD station #4.

During interview on September 14, 2018 at 12:45 PM, the clinical care coordinator and the administrator confirmed that the above identified HD staff failed to open and disinfect the inner aspect of the HD chair sides on the above identified dates/times.





Plan of Correction:


All clinical TMs were in-serviced by the AFA on 09/14/2018 and 09/19/2018 with the review of Policy 1-05-01 Infection Control for Dialysis Facilities emphasizing the following: 1) the dialysis chair will be completely disinfected with bleach solution between each patient use, including opening the sides of the chair to disinfect crevices. Verification of attendance is evidenced by the TMs signature on an in-service sheet. The AFA or designee will perform audits to include observation of disinfection of the dialysis stations daily for two (2) weeks on all shifts, then weekly for two (2) weeks on all shifts, and then monthly during Clean Sweep Audits. Instances of non-compliance will be addressed immediately. The AFA will review results of all audits with TMs during home room meetings and with Medical Director during monthly FHM-QAPI with supporting documentation included in the meeting minutes. The FA is responsible for compliance with this plan of correction.

Completion date: October 14th, 2018




494.40(a) STANDARD
MIXING SYSTEMS-LABELING

Name - Component - 00
5.4.4.1 Mixing systems: labeling
Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine.

Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied.

Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents.

Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility.


Observations:

Based on review of facility policies and procedures, observational tour, and based on interview with the water treatment technician, the clinical care coordinator and the administrator, the facility failed to ensure a permanent label was affixed to the acid storage tank which identified the concentrate type and formulation of the contents of the acid storage tank.

Findings include:

On September 14, 2018 at 12:15 PM, review of facility policy 2-07-05, titled "Acid Concentrate System, Incoming Acid Concentrate and Supply Log and Use of Acid Gallon Concentrate Containers", revealed the following:
"Policy: 13. All dialysate delivery systems, all concentrate ports...storage tanks...will be labeled and color coded (red) according to their concentrate type and formulation..."

Observation of the acid storage tank located in the water treatment room on September 12, 2018 at 10:16 AM, failed to reveal that a label was affixed to the tank which identified the concentrate type and formulation of the acid storage tank contents.

During interview on September 13, 2018 at 10:25 AM, the water treatment technician reported that a permanent label, which identified the concentrate type and formulation of the contents of the acid storage tank, was not reapplied to the acid storage tank after remodeling of the hemodialysis unit was completed.

During interview on September 14, 2018 at 12:45 PM, the clinical care coordinator and the administrator confirmed that a permanent label permanent label, which identified the concentrate type and formulation of the contents of the acid storage tank, was not permanently affixed to the acid storage tank.





Plan of Correction:

All clinical TMs were in-serviced by the AFA on 09/13/18 with the review of Policy 2-07-05 Acid Concentrate System, Incoming Acid Concentrate and Supply Log and Use of Acid Gallon Concentrate Containers emphasizing all dialysate delivery systems, all concentrate ports such as outlet boxes, storage tanks and piping will be labeled and color coded (red) according to their concentrate type and formulation. Verification of attendance is evidenced by the TMs signature on an in-service sheet. Appropriate permanent label was affixed to the Acid Holding tank immediately following the surveyors observation 9/13/17.