QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE CITY LINE DIALYSIS
Health Inspection Results
FRESENIUS MEDICAL CARE CITY LINE DIALYSIS
Health Inspection Results For:


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Initial Comments:


Based upon the findings of an unannounced onsite Medicare recertification survey conducted March 6-8, 11, 2019, Fresenius Medical Care City Line Dialysis was identified to have the following standard level deficiency that was determined to be in substantial compliance with the following requirements of 42 CFR, Part 494.62, Subpart B, Conditions for Coverage for End-Stage Renal Disease (ESRD) Facilities-Emergency Preparedness.











Plan of Correction:




494.62(b)(9)  STANDARD
Dialysis Emergency Equipment

Name - Component - 00
[(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least annually. At a minimum, the policies and procedures must address the following:]

(9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available.

Observations:


Based on review of medical records (MRs), facility policy, and an interview with Clinical Nurse Manager and the Director of Operations, it was determined the facility failed to ensure the Emergency Evacuation Box contained specific emergency medications per facility policy and itemized log maintained for one (1) of one (1) observations (observation#2).


Findings include:




A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. Policy 'FMS-CS-IC-II-130-007A' 'Emergency Medications, Equipment and Supplies' 'Definitions' states "An emergency evacuation box contains .... and provide saline as needed for every licensed station in a secure location". "Refer to 'FMS-CS-IC-II-007D2' Emergency Evacuation Box checklist". The checklist states 'Material' "Saline Bags" 'Quantity' "All licensed stations". 'Material' "Heparin 1:1000 units/ml" 'Quantity' "2".

Observation #2: Contents of the Emergency Evacuation Box were inspected. The Box contained approximately eight (8) bags of saline (0.9% sodium chloride 1000 ml). The facility has a total of seventeen (17) stations. The Box checklist section 'Saline bags' specifically states "All licensed stations".
A facility specific 'Emergency Supply Bin Monthly Checklist' which was lying on top of the Evacuation Box, included 'Medical Supplies' '50% Dextrose' "(1) Box", '1000u Heparin' "(1) box". Neither Dextrose nor Heparin was in the Evacuation Box.
The Monthly Checklist had dates "Jan. 2019" thru "Dec. 2019" with entry fields for "signature/title/print name". There were no entries for January, February, or March. These fields were blank.



An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.






Plan of Correction:

The Director of Operations (DO) and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-II-130-007A Emergency Medications, Equipment and Supplies Policy
- FMS-CS-IC-II-007D2 Emergency Evacuation Box checklist
- FMS-CS-IC-II-120-008A Expiration Date of Sterile Supplies Policy

Emphasis was placed on:
- The Clinical Manager must develop, implement, and follow all emergency preparedness policies and procedures. The emergency evacuation Box must contain an adequate number of supplies for patient use always based on current census.
- All supplies must be maintained and monitored for expiration according to manufacturer's guidelines and recommendations for use.
- A process and individual will be identified as responsible for supply integrity and safety.
On 03/22/2019, The content was verified against the Emergency Evacuation Box List of content, any items deemed required were replaced immediately
Effective 03/22/2019, the Clinical Manager or designee will conduct audits monthly, utilizing a Plan of Correction Auditing Tool for 3 months. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 05/10/2019



494.62(d)(3) STANDARD
ESRD Patient Orientation Training

Name - Component - 00
The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section.

Observations:


Based on review of facility policy, review of medical records, and an interview with Clinical Nurse Manager and the Director of Operations, the facility failed to ensure patients were provided with quarterly emergency training for two (2) of five (5) in-center patient medical records (MRs) reviewed (MR#2, MR#3).

Findings:

A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. FMS-CS-IC-II-130-013C 'Procedure' 'Defining Responsibilities during a Fire Drill' states "......ensures roles are practiced by staff during quarterly fire drills". Form 'FMS-CS-IC-II-130-013D2' states "Complete the form for each drill (4 per year) and place form in patients medical record".

A review of medical records was conducted on March 8, 2019 between approximately 9:00 a.m. - 3:00 p.m. and March 11, 2019 between approximately 9:00 a.m. - 11:00 a.m. Patients admission date is listed below:

MR#2 Date of admission 04/08/13: No quarterly emergency training documentation provided for 2nd quarter of 2018.

MR#3 Date of admission 11/15/17: No quarterly emergency training documentation provided for 3rd quarter of 2018.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.













Plan of Correction:

The Director of Operations (DO) and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-II-130-013C Fire Drill Procedure
- FMS-CS-IC-II-130-013D2 Patient Participation in Fire Drills

Emphasis was placed on:
- Communicate to all patients that a fire drill will be scheduled to prevent unnecessary panic. Potential forms of notification may include: Posted notices in the facility lobby, waiting and treatment areas, verbal notification and Flyers prior to the drill. Additional emphasis was placed on the inclusion to the admission paperwork the addition of the "Patient Participation in Fire Drills" form to ensure all new admissions have timely fire drill participation outside of the routine date of occurrence if missed.

By 03/22/2019, All Facility Patient will participate in a facility wide Fire Drill, and the Patient Participation in Fire Drill form will be added to the admission paperwork for timely completion of drill participation for all new admissions to the Facility.
Effective 03/22/2019, the Clinical Manager or designee will conduct audits monthly, utilizing a Plan of Correction Auditing Tool for 3 months. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 05/10/2019



Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted March 6-8, 11, 2019, Fresenius Medical Care City Line Dialysis was found not to be in 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 (ESRD) Services. As a result of the recertification survey, one (1) condition level and seven (7) standard level citations were issued. Immediate Jeopardy was not identified.












Plan of Correction:




494.30 CONDITION
CFC-INFECTION CONTROL

Name - Component - 00



Observations:

Based on observations, reviews of policies/procedures, and interviews with the Clinical Nurse Manager and the Director of Operations, it was determined that the facility failed to demonstrate adequate infection control practices and provide oversight for infection control practices.

This CONDITION is not met as evidenced under the following standards:



42 CFR 494.30 Infection Control -Provide & Monitor Sanitary Environment (TAG 0111): Facility failed to ensure the staff followed infection control protocols, included but not limited to, use of Personal Protective Equipment (PPE), for one (1) of one (1) 'Cleaning and Disinfection of the Dialysis Station' observations.

42 CFR 494.30(a)(1) Infection Control- CDC RR-5 as Adopted by Reference- Wear Gloves/Hand Hygiene (TAG 0113): Facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for two (2) of two (2) 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' observations (Observations #1, Observation#2) and one (1) of two (2) 'Central Venous Catheter Exit Site Care' observations (Observation #3).

42 CFR 494.30(a)(1)(i) Infection Control CDC RR-5 as Adopted by Reference (TAG 0115): Facility failed to ensure the staff followed infection control protocols, included but not limited to, wearing personal protective equipment (PPE) according to facility policy for one (1) of one (1) 'Discontinuation of Dialysis with Central Venous Catheter' observations.

42 CFR 494.30(a)(4)(ii) Infection Control CDC RR-5 as Adopted by Reference-Disinfect Surfaces/equip/written Protocol (TAG 0122): Facility failed to follow standard infection control precautions for three (3) out of three (3) observations of 'Cleaning and Disinfection of the Dialysis Station'(122)


The cumulative effect of these systematic problems resulted in the ESRD's inability to ensure the provision of quality healthcare in a safe/sanitary environment.



























Plan of Correction:

V110 CFC– Infection Control CFR(s): 494.30 CONDITION RESPONSE
The Governing Body of this facility acknowledges its responsibility to ensure that the facility:
- Staff will follow policy regarding donning of all required Personal Protective Equipment (PPE) correctly to ensure no potential exposure may occur.
- Direct Patient Care staff will always follow all related policies and procedures to ensure adequate cleaning/disinfection of all contaminated surfaces utilizing the Personal Protective Equipment required.
- Direct patient care staff will ensure that the policies and procedures related to access assessment, cleansing, and cannulation of the site utilizing the appropriate personal protective equipment and hand hygiene requirements to ensure no cross contamination occurs.
- Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient, task or station.
- The full and proper use of a face shield/mask, as required by policy to prevent employees from blood or other infectious material to pass through to or reach the employees skin, eyes, mouth, other mucous membranes.
- Direct patient care staff will follow policies and procedures to ensure adequate cleaning/disinfection of all contaminated surfaces, medical devices such as prime buckets, and equipment within the dialysis unit prior to preparing the machine/circuit for the next patient.
- Direct patient care staff will follow policies/procedures for CVC access site care and initiation of Dialysis to ensure appropriate infection control practice is utilized.

The Governing Body (GB), on March 20, 2019, reviewed the Statement of Deficiencies (SOD) and developed the following Plan of Correction ensuring that deficiencies are addressed, both immediately and with long term resolution. The following action steps were implemented.
The Governing Body will meet weekly to monitor the progress of the Plan of Correction. The continuation of the meetings will be determined by the governing body based on the progress of the plan and that the corrective actions have resulted in resolution of the cited issues. Once sustained resolution is determined by the Governing Body, they will return to quarterly or as needed Governing Body Meetings.
Effective immediately:
- The Director of Operations (DO) will present a report weekly to the GB Meeting on the Plan of Correction data and all actions taken toward the resolution of the deficiencies at the Governing Body Meeting through to the sustained resolution of all identified issues.
- The Clinical Manager (CM) and or the Director of Operations (DO) will analyze and trend all data, monitoring, and daily audit results as related to this Plan of Correction prior to presenting the monthly data to the QAPI Committee.
- A specific plan of action encompassing the citations as cited in the Statement of Deficiencies has been added to the facility's monthly QAPI agenda.
- The QAPI committee is responsible to review and evaluate the Plan of Correction to ensure it is effective and is providing resolution of the issues.


V 110 CFC-INFECTION CONTROL CFR(s) 494.30
The Governing Body, at its meeting on March 20, 2019, designated the Director of Operations to serve as Plan of Correction Monitor and provide additional oversight. She will actively participate in each QAPI and weekly Governing Body Meeting-either in person or via conference call. This additional oversight is to ensure the ongoing correction of deficiencies cited in the Statement of Deficiencies through to resolution as well as ensure the Governance of the Facility is presented with current and complete data to enhance their governance oversight role.
Minutes of the Governing Body and QAPI Meetings, as well as monitoring forms and educational documentation will provide evidence of these actions, the Governing Body's direction and oversight and the QAPI Committee's ongoing monitoring of facility activities. All training documentation, GB Minutes and QAI Minutes will be available for review at the facility.
All daily audits and reviews will be summarized and reported to the Governing Body weekly. The Governing Body will review the audit results and determine when there can be a reduction in the frequency of the audits. Monthly the results will be trended and analyzed through the QAI process for progress towards sustained compliance.
Date of Completion: 04/10/ 2019

V 111 Refer to the Plan of Correction listed below for the specific Plan of Correction including short and long terms resolutions.
V 113 Refer to the Plan of Correction listed below for the specific Plan of Correction including short and long terms resolutions.
V 115 Refer to the Plan of Correction listed below for the specific Plan of Correction including short and long terms resolutions.
V 122 Refer to the Plan of Correction listed below for the specific Plan of Correction including short and long terms resolutions.



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 reviews of observations, facility policy, and an interview with the Clinical Nurse Manager and the Director of Operations, the facility failed to ensure the staff followed infection control protocols, included but not limited to, use of Personal Protective Equipment (PPE), for one (1) of one (1) 'Cleaning and Disinfection of the Dialysis Station' observations (Observation #2).


Findings include:

A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. 'FMS Clinical Services' 'Personal Protective Equipment' page 3 states "Stripping machine after patient treatment: requires gloves, fluid resistant gown, and full face shield or mask and protective eyewear with full side shield". FMS-CS-IC-II-155-080A 'Personal Protective Equipment' states "Employees shall use personal protective equipment namely the combination of fluid-resistant gown, full face shield or mask, and protective eyewear .... .. in accordance with the type of patient contact expected and anticipated exposure".

Observation conducted in patient treatment area on March 6, 2019 at approximately 11:07 a.m. revealed the following:

Observation #2: On March 6, 2019 at approximately 11:07 a.m. Emp#10 was observed at station #15, patient #9, wiping dialysis machine/station down with disinfectant soaked wipe/cloth without wearing a gown.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.























Plan of Correction:

V111

The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-II-155-080A Personal Protective Equipment Policy
- FMS-CS-IC-II-155-110A Cleaning and Disinfection of the Dialysis Station Policy

Education emphasis was placed on:

- The strict adherence to the above Policy always when there is an anticipated and/or expected risk of exposure during patient contact. Additional emphasis was placed on the full and proper use of a gown, face shield/mask, and protective eye wear as required by policy dependent on the task to be performed.

Effective 03/22/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool for 2 weeks. Once 100 % compliance has been demonstrated Audit will be reduced to two times weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 04/10/2019



494.30(a)(1) STANDARD
IC-WEAR GLOVES/HAND HYGIENE

Name - Component - 00
Wear disposable gloves when caring for the patient or touching the patient's equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station.




Observations:


Based on reviews of observations, facility policy, and an interview with the Clinical Nurse Manager and the Director of Operations, the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for two (2) of two (2) 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' observations (Observations #1, Observation#2) and one (1) of two (2) 'Central Venous Catheter Exit Site Care' observations (Observation #3).


Findings include:

A review was conducted of facility policy on March 8, 2019 at approximately 3:00 p.m. FMS-CS-IC-I-105-002A 'Initiation of treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Infection Control' section states "Employees must follow hand hygiene practices to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination .....".

A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. Policy #FMS-CS-IC-I-105-032C 'Changing the Catheter Dressing' step #8 states "Discard dressing and remove gloves. Perform hand hygiene". Policy FMS-CS-IC-I-105-029C 'Termination of treatment Using Arteriovenous Fistula or Graft' step #3 states "Disconnect the bloodlines from the needle lines and remove the needles according to......". Step #5 states "Discard the extracorporeal circuit....". Step #6 states "Discard the gloves and perform hand hygiene". Step #8 states "Perform hand hygiene after ...... and prior to leaving the patient station".


Observations conducted in patient treatment area on March 6, 2019 between approximately 11:15 a.m. - 2:26 p.m. and on March 8, 2019 at approximately 10:45 a.m. revealed the following:

Observation #1: During observation of 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 03/06/19 at approximately 11:15 a.m., of patient #7, Emp#9 at station #3, did not remove gloves, perform hand hygiene, and don new gloves after removing needles aseptically/ holding needle site with clean gauze and before cleaning dialysis machine and removing prescription bath jug/carrying prescription bath jug over to common supply cart.

Observation #2: During observation of the 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 03/06/19 at approximately 2:26 p.m., of patient #13, Emp# 11 at station #10, EMP #11 did not remove gloves, perform hand hygiene, and don new gloves after removing a soiled pad and disposing of it in the trash. After disposing of the soiled pad, the employee returned to the patient and removed the second needle from the site.

Observation #3: During observation of the 'Central Venous Catheter Exit Site Care' on 03/08/19 at approximately 10:45 a.m., of patient #3, Emp# 7 at station #9, the employee removed the central catheter site dressing and immediately cleansed the site. The employee did not remove gloves, perform hand hygiene and don clean gloves immediately after removing the old dressing.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.









Plan of Correction:

V113

The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:
- FMS-CS-IC-II-155-090A Hand Hygiene Policy
- FMS-CS-IC-II-155-090C Hand Hygiene Procedure
- FMS-CS-IC-I-105-029A Termination of Treatment Using a Graft or Fistula and Optiflux Hollow Fiber Dialyzer Policy
- FMS-CS-IC-I-105-032A Changing the Catheter Dressing Policy
- FMS-CS-IC-I-105-002A Initiation of Treatment Using a Central Venous Catheter and Optiflux® Single Use E-beam Dialyzer Policy
- FMS-CS-IC-I-105-032C Changing the Catheter Dressing Procedure
- FMS-CS-IC-I-105-029C Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux® Single Use Ebeam Dialyzer Procedure


Education emphasis was placed on:

- The strict adherence to the above Policies and procedures always when there is an anticipated and/or expected risk of exposure during patient contact. Additional emphasis was placed on the wearing of disposable gloves when caring for the patient or touching the patient's equipment or supplies at the dialysis station. Staff must remove gloves and wash hands between each patient, tasks or station. The full and proper use of a gown, face shield/mask, gloves and protective eye wear as required by policy dependent on the task to be performed.

Effective 03/22/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool for 2 weeks. Once 100 % compliance has been demonstrated Audit will be reduced to two times weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 04/10/2019




494.30(a)(1)(i) STANDARD
IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK

Name - Component - 00
Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory.


Observations:


Based on reviews of observations, facility policy, and an interview with the Clinical Nurse Manager and the Director of Operations, the facility failed to ensure the staff followed infection control protocols, included but not limited to, wearing personal protective equipment (PPE) according to facility policy for one (1) of one (1) 'Discontinuation of Dialysis with Central Venous Catheter' observations (Observation #1).

Findings include:

A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. Policy #FMS-CS-IC-II-155-080A 'Personal Protective Equipment' states "Personal protective equipment such as a full face shield or mask and protective eyewear with full face shield, fluid resistant gowns and gloves will be worn to protect and prevent employees from blood or other infectious material to pass through to or reach the employees skin, eyes, mouth, other mucous membranes......".

'Discontinuation of Dialysis with Central Venous Catheter' observations were conducted in patient treatment area on 03/06/19 at approximately 10:35 a.m. revealed the following:

Observation #1: Emp (employee)#12 wore a face mask during the above stated procedure. The face mask did not cover the employee's nose. Only the employee's mouth was covered.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.

















Plan of Correction:

V115

The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-I-105-028C Termination of Treatment Using a Central Venous Catheter and Optiflux® Single Use Ebeam Dialyzer
- FMS-CS-IC-II-155-080A Personal Protective Equipment Policy


Education emphasis was placed on:

- The strict adherence to the above Policy always when there is an anticipated and/or expected risk of exposure during patient contact. Additional emphasis was placed on the full and proper use and placement, when donning or doffing of a gown, face shield/mask, and protective eye wear as required by policy dependent on the task to be performed. Adherence to policy and procedure prevents blood or other infectious material to pass through to or reach the employees skin, eyes, mouth, other mucous membranes.


Effective 03/22/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool for 2 weeks. Once 100 % compliance has been demonstrated Audit will be reduced to two times weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 04/10/2019



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 reviews of observations, facility policy, and an interview with the Clinical Nurse Manager and the Director of Operations, the facility failed to follow standard infection control precautions for three (3) out of three (3) observations of 'Cleaning and Disinfection of the Dialysis Station' (Observation #1-3).

Findings include:


A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. 'FMS-CS-IC-1-105-007C' 'Procedure' states "Follow the steps below to perform surface disinfection of the priming bucket post treatment: (1) Dispose of saline solution down any marked dirty sink or utility room hopper. (2) Clean all surfaces of the priming bucket or approved receptacle, with a wipe that has been wetted with 1:100 bleach solution as per facility surface disinfection procedures. (3) Return clean priming bucket or approved receptacle to the machine".


Observations conducted in the patient treatment area on March 6, 2019 between approximately 10:40 a.m. - 11:45 p.m. revealed the following:

Observation #1: During observation of 'Cleaning and Disinfection of the Dialysis Station' on 03/06/19 at approximately 10:40 a.m. for patient #8, EF#12 did not empty prime waste receptacle and disinfect prior to preparing the machine/circuit for the next patient.

Observation #2: During observation of 'Cleaning and Disinfection of the Dialysis Station' on 03/06/19 at approximately 11:07 a.m. for patient #9, EF#10 did not empty prime waste receptacle and disinfect prior to preparing the machine/circuit for the next patient.

Observation #3: During observation of 'Cleaning and Disinfection of the Dialysis Station' on 03/06/19 at approximately 11:45 a.m. for patient #10, EF#6 did not empty prime waste receptacle and disinfect prior to preparing the machine/circuit for the next patient.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.
















Plan of Correction:

V122


The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-I-105-007C Prime Bucket Disinfection Procedure
- FMS-CS-IC-II-155-110A Cleaning and Disinfection of the Dialysis Station Policy


Education emphasis was placed on:

- Direct patient care staff will adhere to all policies and procedures to ensure adequate cleaning/disinfection of all contaminated surfaces, medical devices such as prime buckets, and equipment within the dialysis unit prior to preparing the machine/circuit for the next patient utilizing a wetted cloth with 1:100 bleach solution.


Effective 03/22/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool for 2 weeks. Once 100 % compliance has been demonstrated Audit will be reduced to two times weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 04/10/2019



494.60(b) STANDARD
PE-EQUIPMENT MAINTENANCE-MANUFACTURER'S DFU

Name - Component - 00
The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer's recommendations.



Observations:


Based on review of medical records (MRs), facility policy, and an interview with Clinical Nurse Manager and the Director of Operations, it was determined the facility failed to dispose of sterile items that have reached the expiration date for one (1) of one (1) observations (Observation #1);


Findings include:


A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. Policy FMC-CS-IC-I-120-008A 'Expiration Dates of Sterile Supplies' 'Policy' states ".......Appropriately dispose of sterile items that have reached the expiration date".

On March 6, 2019 between approximately 9:30 a.m. - 10:05 a.m. the following observations were conducted:

Observation #1: Emergency Evacuation Box: Six (6) bags saline (0.9% sodium chloride 1000 ml) expired "Feb. 2019". Treatment floor storage cabinets: Three (3) pink top BD Vacutainers expired 01/31/19. One (1) BD Vacutainer C&S urinalysis cup expired "01/2019". Water treatment area: Forty-eight (48) yellow top BD Vacutainers expired "01/31/19".


An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.






Plan of Correction:

V403

On 03/08/2019, All expired Supplies were immediately removed from the Emergency Evacuation box, Treatment floor and Water storage areas and an audit completed of all current stock in those locations to ensure all items are within manufacturers timelines for use.

The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-II-120-008A Expiration Date of Sterile Supplies Policy

Education emphasis was placed on:
- Sterility of a packaged item is event related and depends on the quality of
the wrapper material, storage conditions, conditions during transport, and
the amount of handling. Any item that has a torn wrapper, appears to be
wet, or has been dropped on the floor should not be used.
- Sterile items will be checked before use to ensure that they have not
expired. Appropriately dispose of sterile items that have reached the
expiration date.
- An Emergency Evacuation Box list of supplies will be up dated and maintained monthly along with ensuring enough supplies to support the facility census as required.

Effective 03/21/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool twice weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 05/10/2019




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 observations, review of facility policy, and an interview with the Clinical Nurse Manager and the Director of Operations, the facility failed to ensure that the staff performed proper aseptic technique while initiating treatment for four (4) of four (4) 'Access of AV Fistula or Graft for Initiation of Dialysis' observations (Observation #1-, Observation #4).


Findings include:

A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. 'FMS-CS-IC-115-014C' FMS-CS-IS-I-520-014C' 'Procedure' 'Assessment of Vascular Access' Step (1) states "Prior to treatment, ask your patient to was access area with liquid soap for one minute, rinsing well. Dry with clean paper towel. Wash access (per above) if patients unable to clean their access".


Observations on March 6, 2019 between 10:40 a.m. and 11:50 a.m. revealed the following:

Observation #1: On 03/06/19 at approximately 10:40 a.m. Employee #9, patient#6 at station #2, began to initiate dialysis treatment. Employee #9 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site.

Observation #2: On 03/06/19 at approximately 11:10 a.m., Employee #12, patient #11 at station #16 began to initiate dialysis treatment. Employee #12 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site.

Observation #3: On 03/06/19 at approximately 11:36 a.m. Employee #7, patient #2 at station #11, began to initiate dialysis treatment. Employee #7 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site.

Observation #4: On 03/06/19 at approximately 11:50 a.m., Employee #9, patient #12 at station #17 began to initiate dialysis treatment. Employee #9 did not wash skin over access with soap and water or antibacterial scrub, prior to evaluating access site, nor verbally confirm that the patient had cleansed the access site.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.
















.
























Plan of Correction:

The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-I-115-014C Access Assessment and Cannulation Procedure

With emphasis on:
- Direct patient care staff will follow policies and procedures to ensure adequate cleaning/disinfection of the vascular access prior to cannulation occur. Additional emphasis was placed on the education and re-enforcement of access cleaning by patients upon entering the clinic and prior to cannulation. Staff will confirm with that the patient performed access cleaning. if the patient is unable or unwilling to perform this task the employee will perform this task at the chair side, prior to the start of the cannulation procedure.

By 03/22/2019, Patient Education will be provided on the importance of access cleansing to reduce the risk of infection and maintain access health prior to cannulation. All Education will be documented in the Patient Medical Record.
Effective 03/25/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool for 2 weeks. Once 100 % compliance has been demonstrated Audit will be reduced to two times weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

Any ongoing non-compliance by staff, per the Conditions for Coverage and the Fresenius Kidney Care policy, will be addressed through corrective action as appropriate.
The Clinical Manager is responsible for reviewing, analyzing, and trending all data and audit results as related to this Plan of Correction prior to presenting to the QAI committee monthly.

The Director of Operations is responsible for presenting the status of the Plan of Correction and all other actions taken toward the resolution of the deficiencies at each Governing Body meeting through to the sustained resolution of all identified issues.

The QAI committee is responsible for providing oversight, review findings, and take actions as appropriate.

The Governing Body is responsible for providing oversight to ensure the Plan of Correction, as written to address the issues identified by the Statement of Deficiency, is effective and is providing resolution of the issues.

Documentation of education, monitoring, QAI, and Governing Body is available for review.

The Clinical Manager is responsible for overall compliance.

Completion Date: 05/10/2019




494.150(c)(2)(i) STANDARD
MD RESP-ENSURE ALL ADHERE TO P&P

Name - Component - 00
The medical director must-
(2) Ensure that-
(i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers;



Observations:


Based on review of medical records (MRs), facility policy, and an interview with Clinical Nurse Manager and the Director of Operations, it was determined the facility failed to ensure medications were administered as ordered for one (1) of five (5) patient medical charts reviewed (MR#3).

Findings include:




A review was conducted of facility policy on March 11, 2019 at approximately 11:00 a.m. Policy 'FMS-CS-IC-II-001A' 'Patient Adverse Event Reporting and Documentation' 'Policy' 'Medication' section states "A medication error in which administration of .........., or failure to administer a prescribed medication occurred". "Any time an adverse event or serious adverse event occurs, staff are required to report, document, and review the event as indicated in this policy. All staff are responsible for timely completion of the policy requirements". 'Reporting' 'Adverse Event Reporting' states "All employees are required to immediately report any AE to the following: *Clinical Manager, Program Manager, or designated facility contact person". *"Director of Operations".

MR#3 Date of admission 11/05/17: Heparin medications orders include 'Heparin Sodium (Porcine) 1,000 ml systemic Intermittent 2000 units IVP mid run every treatment" with a 'Start Date' of "02/11/19".
Patient treatment flowsheets dated 02/20/19-03/04/19 reviewed. Flowsheet dated 02/27/19 'Anticoagulation' 'Bolus/Intermittent' section 'Description' 'Heparin Sodium (Porcine) 1,000 units/ml Systemic' 'Ordered Dose/Route' "2000.000/intermittent" 'Administered Dose (Units)' "0.000", entered by EF#13.
No documentation provided of EF#13 reporting/documenting this event per facility policy.

An interview with the facility Clinical Nurse Manager and the Director of Operations on March 11, 2019 at approximately 11:30 a.m. confirmed the above findings.





















Plan of Correction:

V715
To ensure compliance, the Director of Operations (DO) and Clinical Manager will meet with the Medical Director on 03/20/2019. Emphasis will be placed on the Medical Director Roles and Responsibilities, associated Policies, and Procedures and the Developed Plan of Correction. The Medical Director is responsibility to ensure the implementation of all Fresenius Medical Care (FMC) policies and procedures. Special emphasis will be placed on the review of the following policies and Procedures:
- FMS-CS-IC-II-165-001A Patient Adverse Event Reporting and Documentation Policy
- FMS-CS-IC-I-101-003A FMCNA Policy and Procedure Guidelines Policy
- Medical Director Duties and Responsibilities
- FMS-CS-IC-II-155-080A Personal Protective Equipment Policy
- FMS-CS-IC-II-155-110A Cleaning and Disinfection of the Dialysis Station Policy
- FMS-CS-IC-II-155-090A Hand Hygiene Policy
- FMS-CS-IC-II-155-090C Hand Hygiene Procedure
- FMS-CS-IC-I-105-029A Termination of Treatment Using a Graft or Fistula and Optiflux Hollow Fiber Dialyzer Policy
- FMS-CS-IC-I-105-032A Changing the Catheter Dressing Policy
- FMS-CS-IC-I-105-002A Initiation of Treatment Using a Central Venous Catheter and Optiflux® Single Use E-beam Dialyzer Policy
- FMS-CS-IC-I-105-032C Changing the Catheter Dressing Procedure
- FMS-CS-IC-I-105-029C Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux® Single Use Ebeam Dialyzer Procedure
- FMS-CS-IC-II-120-008A Expiration Date of Sterile Supplies Policy
- FMS-CS-IC-I-105-007C Prime Bucket Disinfection Procedure
- FMS-CS-IC-II-155-110A Cleaning and Disinfection of the Dialysis Station Policy
- FMS-CS-IC-I-115-014C Access Assessment and Cannulation Procedure

Documentation of the meeting will be on file at the facility.
The Clinical Manager and/or designee will educate and elicit input from relevant staff by 03/20/2019 on the expectations and responsibilities to comply with the following policies and procedures:

- FMS-CS-IC-II-001A Patient Adverse Event Reporting and Documentation Policy

Effective 03/22/2019, the Clinical Manager or designee will conduct audits daily, utilizing a Plan of Correction Auditing Tool. Monitoring will be of Adverse Event Reporting such as Heparin orders versus administration for 2 weeks. Once 100 % compliance has been demonstrated Audit will be reduced to two times weekly for two weeks. If compliance is sustained, monitoring will be completed per the Quality Assessment and Performance Improvement (QAI) calendar with oversight from the Governing Body.

As a result of this meeting and to the Medical Director determined that all DPC staff will receive education on the policies and Procedures as stated above:
Documentation of the DPC in-service will be on file at the facility.
At the meeting with the Medical Director approved the auditing schedule as stated in the plan of correction. Staff found to be non-compliant will be re-educated and referred for counseling.
The CM will review the findings with the Medical Director weekly providing a status update of any identified issues along with the applied interventions.
Completion date: 04/10/2019