QA Investigation Results

Pennsylvania Department of Health
BMA OF WILKES-BARRE
Health Inspection Results
BMA OF WILKES-BARRE
Health Inspection Results For:


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Initial Comments:

Based on the findings of an unannounced Medicare recertification survey conducted September 24 through September 28, 2018, BMA of Wilkes-Barre 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 24 through September 28, 2018, BMA of Wilkes-Barre 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 procedures, observational tour, and interview with the administrator, the facility failed to ensure three (3) of six (6) hemodialysis staff members removed personal protective equipment (PPE) before transporting patients to and from the facility waiting room. (Employees #17, #19 and #20)

On September 28, 2018 at 3:26 PM, review of the facility procedure titled "Infection Control Overview" revealed the following: "Introduction...The nature of dialysis, with frequency exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients, makes a dialysis clinic a high risk for spreading infectious disease..."

During observational tour conducted on September 25, 2018 between 10:00 AM and 11:35 AM, the following was observed:
-After providing direct patient care to patients located in "Pod 1" of the hemodialysis (HD) treatment area, a HD member (employee #19) proceeded to transport a patient from the HD treatment area into the waiting area while wearing the same PPE (gown/apron with sleeves) the HD staff member wore while providing direct patient care in the HD treatment area. The HD staff member proceeded to walk further into the waiting area to escort a wheelchair-bound patient into the treatment area while wearing the same PPE.
-After providing direct patient care to patients located in "Pod 2" of the hemodialysis treatment area, a HD staff member (employee #20) entered the waiting room wearing the same PPE (gown/apron with sleeves) the HD staff member wore while providing direct patient care in the HD treatment area and proceeded to escort a patient into the HD treatment area.
-After providing direct patient care to patients located in "Pod 1" of the hemodialysis treatment area, a HD staff member (employee #17) entered the waiting room wearing the same PPE (gown/apron with sleeves) the HD staff member wore while providing direct patient care in the HD treatment area and proceeded to escort a patient into the HD treatment area.

During interview on September 28, 2018 at 1:55 PM, the administrator confirmed that the above referenced HD staff members failed to remove the PPE (gown/apron with sleeves) prior to entering the waiting room.













Plan of Correction:

Beginning on 10/11/18 until 10/23/18, the Clinical Manager (CM) or RN designee, will review and educate all direct patient care staff during daily huddles on the following policy:

- FMS-CS-IC-II-155-080A "Personal Protective Equipment"
With emphasis on:

- Staff removing all Personal Protective Equipment (PPE) prior to leaving the treatment area
The CM and/or designee will conduct daily audits on PPE removal prior to leaving the treatment Sarea each shift x2 weeks or until 100% compliance is observed. Once 100% compliance is observed, audits will continue weekly x 4 weeks. If compliance has been sustained audits will continue monthly per QAI clinical audit checks.

Education and audit records will be on file in the facility.

Staff found to be non-compliant will be re-educated and/or counseled. Repeat non-compliance will result in the initiation of the progressive discipline process.

For ongoing compliance, the CM will present audit results at monthly QAI meetings for committee review

Completion date: 10/28/18



494.30(a)(1)(i) STANDARD
IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS

Name - Component - 00
Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled.

When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station.

Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients.


Observations:

Based on review of facility procedures, observational tour, and interview with the clinic manager and the administrator, the facility failed to ensure dialysis supplies were stored in area which prevented exposure to blood or contaminated fluids.

On September 28, 2018 at 3:26 PM, review of the facility procedure titled "Infection Control Overview" revealed the following: "Introduction...The nature of dialysis, with frequency exposure to blood and body fluids, close proximity of patients and staff, and the immunocompromised status of dialysis patients, makes a dialysis clinic a high risk for spreading infectious disease..."

On October 1, 2016 at 12:58 PM, review of the emailed facility policy/procedure titled "Storage of Supplies" revealed the following: "Background...Proper storage conditions are necessary to provide a safe environment and to ensure supplies are not contaminated..."

During observational tour conducted on September 24, 2018 between 11:40 AM and 12:49 PM, the following was noted:
-An unzipped plastic storage bag, which was noted to contain a total of ten (10) hemodialysis access supply kits, was present on the countertop of the laboratory processing area. Two (2) additional hemodialysis access supply kits were noted to be resting directly on the countertop of the laboratory processing area.
-A clean supply cart, for which the contents included, but were not limited to boxes of gloves and gauze, was stored in the in-center NxStage (home hemodialysis machine) hemodialysis treatment room between the biohazard container and a standard garbage container. Multiple droplets of a dried reddish-orange colored substance were noted on the wall adjacent to the biohazard container.

On September 24, 2018 at 2:40 PM, the clinic manager confirmed that the above referenced dialysis supplies were not stored in area which prevented exposure to blood or contaminated fluids.

During interview on September 28, 2018 at 1:55 PM, the administrator confirmed that the above referenced dialysis supplies were not stored in area which prevented exposure to blood or contaminated fluids.








Plan of Correction:

Beginning on 10/11/18 until 10/23/18, the Clinical Manager (CM), and/or designee, will review and educate all direct patient care staff during daily huddles on the following policies:
- FMS-CS-IC-II-155-060A "Infection Control Overview Policy"
- FMS-CS-IC-II-120-005A "Storage of Supplies Policy"
- FMS-CS-IC-II-155-070A "Dialysis Precautions Policy"
With emphasis on separation of, and maintaining a barrier between all clean and dirty supplies to include:
- Storing all clean dialysis supplies in an area that prevents exposure to blood or contaminated fluids
- Keeping carts containing clean supplies away from contaminated areas including biohazard and standard garbage containers

The CM and/or designee, will conduct daily audits on storage and separation of clean/dirty supplies each shift x2 weeks or until 100% compliance is observed. When 100% compliance is achieved, audits will continue weekly x 4 weeks. If compliance has been sustained audits will continue monthly per QAI clinical audit checks.

Education records will be on file in the facility.
Staff found to be non-compliant will be re-educated and/or counseled. Repeat non-compliance will result in the initiation of the progressive discipline process.

For ongoing compliance the CM will present audit results at monthly QAI meetings for committee review

Completion date: 10/28/18



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, observational tour, and interview with the administrator, the facility failed to ensure the disinfection process for eight (8) of eight (8) hemodialysis machines included disinfection of the sharps container (container utilized for disposing contaminated needles) mounting bracket and the full external portion of the sharps container which was mounted on the hemodialysis (HD) machine and the Hansen connectors/tubing (dialysis fluid line connectors which attach to the dialyzer).

On September 28, 2018 at 3:15 PM, review of the facility policy titled "Cleaning and Disinfection of the Dialysis Station" revealed the following:
"Background...The Centers for Disease Control and Prevention (CDC) had recommended that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis stations. The...dialysis equipment are used by multiple patients during a treatment day and it is critical that these items be thoroughly cleaned and disinfected between uses...
Cleaning the Dialysis Machine....Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment. Give special attention to cleaning...other surfaces that are frequently touched and potentially contaminated..."

During observational tour conducted on September 25, 2018 between 10:00 AM and 11:35 AM, the following was observed:
Hemodialysis Stations #3, #4, #7 and #16: During the HD machine disinfection process, the HD staff members failed to disinfect the sharps container mounting bracket and the full external portion of the sharps container, which was mounted on the HD machine, and the Hansen connectors/tubing.

During observational tour conducted on September 26, 2018 between 9:45 AM and 11:45 AM, the following was observed:
Hemodialysis Stations #18, #25, #26 and #29: During the HD machine disinfection process, the HD staff members failed to disinfect the sharps container mounting bracket and the full external portion of the sharps container which was mounted on the HD machine and the Hansen connectors/tubing.

During observational tour conducted between September 25, 2018 at 10:00 AM and September 26, 2018 at 11:45 AM, the contents of the sharps containers mounted to the HD machines were noted to include, but were not limited to, contaminated needles/syringes and HD access needles/extension tubing. The sharps container mounted on the HD machine located at HD station #25 was noted to have a droplet of a bright red substance located on the inner aspect of the sharps container insertion port.

During interview on September 28, 2018 at 1:55 PM, the administrator confirmed that the facility failed to ensure HD staff members disinfected the sharps container mounting bracket and the full external portion of the sharps container, which was mounted on the hemodialysis (HD) machines, and the Hansen connectors/tubing at the above referenced HD stations.








Plan of Correction:

Beginning on 10/11/18 until 10/23/18, the Clinical Manager (CM), and/or designee, will review and educate all direct patient care staff during daily huddles on the following policy:
- FMS-CS-IC-II-155-110A "Cleaning and Disinfection of the Dialysis Station"
With emphasis on:
- Cleaning and disinfection of the sharps container, mounting brackets, and full exterior of the sharps container mounted on the dialysis machine, including inner aspect of the sharps container insertion port
- Cleaning and disinfection of all components of the dialysis machine to include Hansen connectors/tubing
The CM and/or designee, will conduct daily audits on cleaning and disinfection of machines each shift x 2 weeks or until 100% compliance is observed. When 100% compliance is achieved, audits will continue weekly x 4 weeks. If compliance has been sustained audits will continue monthly per QAI clinical audit checks.

Education records will be on file in the facility
Staff found to be non-compliant will be re-educated and/or counseled. Repeat non-compliance will result in the initiation of the progressive discipline process

For ongoing compliance the CM will present audit results at monthly QAI meetings for committee review

Completion date: 10/28/18



494.60(a) STANDARD
PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY

Name - Component - 00
The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public.



Observations:

Based on review of facility procedures, observational tour, and interview with the clinic manager and the administrator, the facility failed to ensure the walls in the hemodialysis (HD) treatment area were free from moisture related damage.

On September 28, 2018 at 12:40 PM, review of the facility procedure titled "Procedure Detail Report...Physical Plant Audit-Patient Care Area" revealed the following: "Walls and base board are intact, free from bloodstains and damage..."

During observational tour conducted on September 24, 2018 between 11:40 AM and 12:49 PM, moisture related damage was noted on the walls adjacent to the countertop and/or at the base of the two (2) dirty (contaminated area) sinks in HD section "Pod 1", and at the base board region located adjacent to HD station #28.
During interview and observational tour on September 24, 2018 at 2:40 PM, the clinic manager confirmed moisture related damage was present at the above referenced locations.

On September 24, 2018 at 2:40 PM, the clinic manager confirmed confirmed moisture related damage was present on the walls adjacent to the countertop and/or at the base of the two (2) dirty (contaminated area) sinks in HD section "Pod 1", and at the base board region located adjacent to HD station #28.

During interview on September 28, 2018 at 1:55 PM, the administrator confirmed moisture related damage was present on the walls adjacent to the countertop and/or at the base of the two (2) dirty (contaminated area) sinks in HD section "Pod 1", and at the base board region located adjacent to HD station #28.










Plan of Correction:

On 10/8/18, a plan was developed to repair the wall damage adjacent to the counter top at the base of the 2 dirty sinks in pod #1 and baseboard area adjacent to station # 28. Damaged areas to be replaced with FRP.
A request for funding has been submitted to the Regional Vice President for approval and proposals for the construction are currently being obtained. Repairs will be scheduled as soon as possible per availability of the chosen vendor.
Clinical Manager will monitor progress and report at monthly QAI meetings for committee review.
Completion date: 10/28/18



494.90(a)(5) STANDARD
POC-VASCULAR ACCESS-MONITOR/REFERRALS

Name - Component - 00
The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement.


Observations:

Based on review of facility policies/procedures and documentation, observation, patient interview and interview with the administrator, the facility failed to ensure two (2) of four (4) hemodialysis (HD) staff washed the vascular access (arteriovenous (AV) fistula or graft--dialysis access types for which access needle insertion is required to perform dialysis) site prior to the application of skin antiseptic and insertion of access needles. (Employees #17 and #18)

Findings include:

On October 1, 2018 at 1:29 PM, review of the emailed facility policy/procedure titled "Access Assessment and Cannulation" revealed the following:
"Purpose...The purpose of this procedure is to provide guidance for placement of needles in an AV Fistula or AV Graft to obtain access to the circulatory system for hemodialysis...
Assessment of Vascular Access...Prior to treatment, ask your patient to wash access area with soap for one minute..."

On September 27, 2018 at 9:34 AM, review of personnel file documentation revealed the following:
Employee #17: The date of hire of the registered nurse (RN) was September 8, 2014.
Employee #18: The date of hire of the patient care technician (PCT) was October 31, 1994.

During observational tour conducted on September 26, 2018 between 9:45 AM and 11:45 AM, the following was observed:
Hemodialysis Station #22: The PCT (employee #18) escorted the patient from the scale to the HD station. The patient was noted to be wearing a sleeveless dress. During the treatment initiation procedure, the HD access site (fistula or graft) was disinfected and access needles were then inserted by the PCT. The PCT failed to ensure the patient washed the HD access site prior to the access site disinfection procedure and the insertion of the HD access needles.
Hemodialysis Station #27: The RN (employee #17) escorted the patient from the scale to the HD station. The patient was noted to be wearing a short-sleeved green shirt. During the treatment initiation procedure, the HD access site (fistula or graft) was disinfected and access needles were then inserted by the RN. RN failed to ensure the patient washed the HD access site prior to the access site disinfection procedure and the insertion of the HD access needles.

During interview on September 28, 2018 at 1:55 PM, the administrator confirmed that the vascular access site (fistula or graft) were not washed by the above referenced HD staff members prior to the application of skin antiseptic and insertion of access needles.







Plan of Correction:

Beginning on 10/10/18 until 10/23/18, the Clinical Manager (CM), and/or designee, will review and educate all direct patient care staff during daily huddles on the following policy:
FMS-CS-IC-I-115-006C "Assessment and Preparation of Internal Access for Needle Placement"
With emphasis on:
- Asking patients to wash access with liquid soap for one minute, rinse well and dry with clean paper towel prior to treatment
- Staff to wash patient's access if patient is unable
- Staff to ensure patient's access is cleaned/washed prior to application of antiseptic and needle insertion
The CM and/or designee, will conduct daily audits on patient access cleaning/washing each shift x2 weeks or until 100% compliance is observed. When 100% compliance is achieved, audits will continue weekly x 4 weeks. If compliance has been sustained audits will continue monthly per QAI clinical audit checks.

Education records will be on file in the facility.
Staff found to be non-compliant will be re-educated and/or counseled. Repeat non-compliance will result in the initiation of the progressive discipline process.

For ongoing compliance the CM will present audit results at monthly QAI meetings for committee review

Completion date: 10/28/18