QA Investigation Results

Pennsylvania Department of Health
BMA OF HARRISBURG
Health Inspection Results
BMA OF HARRISBURG
Health Inspection Results For:


There are  13 surveys for this facility. Please select a date to view the survey results.

Surveys don't appear on this website until at least 41 days have elapsed since the exit date of the survey.



Initial Comments:


Based upon the findings of an unannounced onsite Medicare recertification survey completed September 17, 2019, BMA of Harrisburg 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 on-site unannounced Medicare recertification survey completed September 17, 2019, BMA of Harrisburg 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)(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 facility policy, observations and an interview with the clinical nurse manager, the facility failed to ensure the staff followed infection control protocols, included but not limited to, hand hygiene/don clean gloves, for one (1) of two (2) 'Discontinuation of Dialysis with Central Venous Catheter (CVC)' observations (Observation #2), for one (1) of two (2) 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' observations (Observation #1),
for two (2) of two (2) 'Parenteral Medication Preparation and Administration' observations (Observation #1-Observation #2), and one (1) of one (1) treatment area observations (Observation #1).

Findings include:

A review of facility policies was conducted on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy FMS-CS-IC-I-105-028C, FMS-CS-IS-I-520-031C 'Termination of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer' 'Prior to Termination: Preparation' section #3 states "....... perform hand hygiene then don new gloves".

Observations conducted in patient treatment area on September 9, 2019 between approximately 9:00 a.m. - 1:40 p.m. and on September 11, 2019 at approximately 12:40 p.m. revealed the following:

Observation #2: During observation of 'Discontinuation of Dialysis with Central Venous Catheter (CVC)' on 09/09/19 at approximately 1:30 p.m., station #16; employee (Emp) #10 did not perform hand hygiene prior to placing field under CVC ports and reinfusing the extracorporeal circuit. EF#10 wrote patient data in the 'weight management tracker' folder at the nursing station desk, then returned to the station and donned gloves and proceeded with CVC termination.


A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMS-CS-IC-I-115-013C/'FMS-CS-IS-I-520-035C' 'Post Treatment Needle Removal' 'Needle Removal' step #1 states "The person who is removing needles must perform hand hygiene and don new gloves'.

Observation #1: During observation of 'Discontinuation of Dialysis and Post Dialysis Care for AV Fistula or Graft' on 09/09/19 at approximately 9:00 a.m., of patient #2, Employee (Emp) #10 at station #14, did not perform hand hygiene before donning new gloves after reinfusing the extracorporeal circuit and disconnecting the bloodlines and before removing needles aseptically.

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMS-CS-IC-II-120-040A' 'Medication Preparation and Administration' 'Purpose' states "To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control". Policy 'FMS-CS-IC-II-155-090A 'Hand Hygiene' 'Purpose' states "the purpose of this policy is to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination".

Observation #1: During observation of 'Parenteral medication Preparation and Administration' on 09/09/19 at approximately 1:05 p.m., of patient #1, Emp#17 at station #2, did not perform hand hygiene after prepping medication/taking to patient station and before wiping injection port with antiseptic. Emp#17 only donned new gloves.

Observation #2: During observation of 'Parenteral medication Preparation and Administration' on 09/11/19 at approximately 12:40 p.m., of patient #14, Emp#6 in the isolation room, did not perform hand hygiene prior to prepping medication. Emp#6 only donned new gloves. Emp #6 did not perform hand hygiene after prepping medication/taking to patient station and before wiping injection port with antiseptic. Emp#6 only donned new gloves.

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMS-CS-IC-II-155-090A 'Hand Hygiene' states "Hands will be decontaminated using alcohol based hand rub or by washing hands with soap and water when entering and leaving the treatment area".

Observation #1: On 09/09/19 at approximately 10:50 a.m. Emp #12 was observed removing PPE gown and exiting the treatment area into the water treatment room/supply room without performing hand hygiene. Emp#12 was carrying two (2) patient pillows.


An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.







































Plan of Correction:

Emphasis was placed on the strict adherence to all reviewed Fresenius Kidney Care policies and procedure. Specific emphasis was discussed regarding usage of personal protective equipment and the strict performance of hand hygiene while following those tasks identified to prevent transmission of pathogenic microorganisms to patients and staff through cross contamination.

On 10/02/2019, the Clinical Manager held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following policies and procedure:
FMS-CS-IC-II-155-090A Hand Hygiene Policy

FMS-CS-IC-I-105-028C Termination of Treatment Using a Central Venous Catheter and Optiflux® Single Use Ebeam Dialyzer Policy

FMS-CS-IC-II-120-040A Medication Preparation and Administration Policy

FMS-CS-IC-I-105-029A Termination of Treatment Using a Graft or Fistula and Optiflux Hollow Fiber Dialyzer Policy

FMS-CS-IC-I-115-013C Post Treatment Fistula Needle Removal Procedure

Effective10/7/2019 Clinical Manager or designee will conduct daily audits utilizing a developed Plan of Correction Auditing Tool for two weeks. Audits will then be reduced to weekly for an additional two weeks. Once compliance is sustained, the Governing Body will decrease frequency to Monthly then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinical Practice Audits.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.


494.30(a)(2) STANDARD
IC-STAFF EDUCATION-CATHETERS/CATHETER CARE

Name - Component - 00
Recommendations for Placement of Intravascular Catheters in Adults and Children

I. Health care worker education and training
A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections.
B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters.

II. Surveillance
A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site.

Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients.

VI. Catheter and catheter-site care
B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections].





Observations:


Based on reviews of observations, facility policy, and an interview with the clinical nurse manager, the facility failed to ensure that clinical staff maintain aseptic technique for the care of vascular accesses, including intravascular catheters for one (1) of two (2) 'Initiation of Dialysis with Central Venous Catheter' observations (Observation #1).

Findings:

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Procedure 'FMS-CS-IC-I-105-002C, IS-I-520-021C' 'Initiating Treatment using a Central Venous Catheter with an Optiflux Single Use Ebeam Dialyzer' 'Preparing the catheter: Disinfection of the Catheter Connections, Heparin removal, Flushing the Catheter and Heparin Administration' step #3 states "Using a sterile alcohol pad ..... scrub the side (threads)and end of hub thoroughly with friction ........ Note: Do not place uncapped catheter limbs on under pad to prevent contamination". Step #5 states "Hold the limb while allowing the antiseptic to dry".

Observations conducted in patient treatment area on September 9, 2019 between approximately 9:00 a.m. - 1:40 p.m. and on September 11, 2019 at approximately 12:40 p.m. revealed the following:

Observation #1: On 09/09/19 at approximately 9:08 a.m. while observing 'Initiation of Dialysis with Central Venous Catheter' for patient #13, station #16; EF#10, after performing open hub disinfection, let catheter limbs fall directly on underpad (field) and then immediately placed sterile syringes on hubs.

An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.






























Plan of Correction:

Emphasis was placed on the strict adherence to FKC Company policies and procedures regarding Catheter access and care. Specific emphasis was discussed regarding the disinfection of the CVC hubs and the requirement to hold the limbs until dry to avoid the possibility of cross contamination from contact with any surface prior to any connection being completed.

On 10/3/19 the Clinical Manager (CM) held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following policy:
FMS-CS-IC-I-105-002A Initiation of Treatment Using a Central Venous Catheter and Optiflux® Single Use E-beam Dialyzer Policy

Effective 10/3/2019  Clinical Manager (CM) or designee will conduct daily audits utilizing a develop Plan of Correction Auditing Tool for two weeks. Audits will then be reduced to weekly for an additional two weeks. Once compliance is sustained, the Governing Body will decrease frequency to monthly then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Clinical Practice Audits.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.




494.40(a) STANDARD
BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE

Name - Component - 00
4.1.2 Bacteriology of water: med dir resp
The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation

Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels.


Observations:


Based on review of water log testing results, facility policy, and an interview with the facility clinical nurse manager, the facility failed to notify the medical director, per policy, of water culture limits for colony count/water endotoxin limits reaching action level, for two (2) of two (2) water log reviews (Water Log Review #1, Water Log Review #2).

Findings include:

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMS-CS-IC-II-140-600A1, IS-II-600-070A1' 'microbiological Monitoring of Central Water and Concentrate Mixing and Delivery Systems' 'Interpretation of Results' states "Microbiological reports received from a laboratory must be reviewed, interpreted and if needed an action plan developed within 48 hours. Interpret the results below against the standards table and corresponding decision trees below. FMS Water Standards Table: Test - Colony Count Action Level 20 CFU (colony forming unit)/ml (milliliter), Allowable Limit 100 CFU/ml. Endotoxin 0.125 EU (endotoxin unit)/ml, Allowable limit 0.25 EU/ml". 'Water System Decision Tree' states "All samples taken from the RO (reverse osmosis) machine (if applicable) and distribution system for the sampling period will be reviewed as a collective system and compared to the following decision tree: Review Water System Results. Only one sample is above FMS action level - Implement Water Action Plan A".

'FMS Clinical Services' 'FMS-CS:ICII-140-600D3. IS-600-070D3' "Water Action Plan A' 'Action Plan': Step #1 states "Notify: Medical Director, Clinical Manager, and Technical Manager no later than next treatment day".

Water log review conducted on September 10, 2019 at approximately 10:00 a.m. revealed the following:


Water Log Review #1: Documentation provided of the facility water testing period of 2017-2019. Water samples drawn from 'R.O. 1, Permeate-1424059' on 09/27/2017 with a result "0.135 EU/ml". Water samples re-drawn 10/03/2017 with results of "0.040 EU/ml". No documentation of the medical director, clinical manager, and technical manager being notified of the action level test results.

Water Log Review #2: Documentation provided of the facility water testing period of 2017-2019. Water samples drawn from 'Distribution Loop 1, Return' on 05/11/2018 with an Endotoxin result of "0.172 EU/ml". Water samples re-drawn 05/18/2018 with results of "0.043 EU/ml". No documentation of the medical director, clinical manager, and technical manager being notified of the action level test results.

An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.





















Plan of Correction:

Emphasis was placed on the strict adherence to policy regarding acceptable action level values, as well as the decision tree associated with notification of the Medical Director of all results outside of acceptable and actions required per policy.

By 9/27/2019, the Area Techincal Operations Manager (ATOM) held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following policy:
FMS-CS-IC-II-140-600A1, IS-II-600-070A1 Microbiological Monitoring policy of Central Water System

Effective 9/12/2019, Area Techincal Operations Manager (ATOM) or designee will review cultures results monthly utilizing Microbiological Summary Report for six months. Once compliance is sustained, the Governing Body will resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Microbiological Summary Report.

Effective 9/27/2019, In addition any above action results will be submitted to Regional Technical Operations Mananger (RTOM) with corresponding action plan for final approval all documentation will be present in the QAI Program.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.


494.80(a)(2) STANDARD
PA-ASSESS B/P, FLUID MANAGEMENT NEEDS

Name - Component - 00
The patient's comprehensive assessment must include, but is not limited to, the following:

Blood pressure, and fluid management needs.




Observations:


Based on observations, review of facility policy, and an interview with the clinical nurse manager, the facility failed to ensure blood pressure/safety check monitoring, per facility policy, was documented every 30 minutes/45 minutes while receiving dialysis treatment for four (4) of seven (7) clinical records (CR) reviewed (CR #1, CR #3, CR#5, CR#6).

Findings include:

A review was conducted of facility policy on September 13, 2019 at approximately 9:00 a.m.
Policy 'FMS-CS-IC-I-110-141A' 'Patient Safety Checks' 'Policy' states "Safety checks will be performed pre treatment and every 30 minutes or more frequently as needed once the treatment has begun.
Policy: 'FMS-CS-IC-I-110-131C' 'Patient Assessment and Monitoring' 'Monitoring During Treatment' states "Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes or per state regulation".

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

CR#1 Date of admission 06/05/19: Treatment flowsheet on 08/28/19 revealed the following Intradialytic (or during dialysis) assessments were not documented every 30/45 minutes as follows:
On 08/28/19 the post treatment flow sheet contained documentation of a blood pressure assessment at 12:32 p.m.; according to the flow sheet, the next blood pressure assessment did not occur until 1:36 p.m.. Sixty four (64) minutes between assessments.
A safety assessment conducted at 12:32 p.m.; according to the flow sheet, the next safety assessment did not occur until 1:23 p.m. Fifty one (51) minutes between assessments.

CR#3 Date of admission 10/17/18: Treatment flowsheet on 09/17/19 revealed the following Intradialytic (or during dialysis) assessments were not documented every 30/45 minutes as follows:
On 09/17/19 the post treatment flow sheet contained documentation of a blood pressure assessment at 10:36 a.m.; according to the flow sheet, the next blood pressure assessment did not occur until 11:34 a.m. Fifty eight (58) minutes between assessments.

CR#5 Date of admission 06/12/19: Treatment flowsheet on 09/06/19 revealed the following Intradialytic (or during dialysis) assessments were not documented every 30/45 minutes as follows:
On 09/06/19 the post treatment flow sheet contained documentation of a blood pressure assessment at 3:33 p.m.; according to the flow sheet, the next blood pressure assessment did not occur until 4:34 p.m. Sixty one (61) minutes between assessments.
A safety assessment conducted at 3:34 p.m.; according to the flow sheet, the next safety assessment did not occur until 4:34 p.m.. Sixty (60) minutes between assessments.

CR#6 Date of admission 08/21/13: Treatment flowsheet on 09/09/19 revealed the following Intradialytic (or during dialysis) assessments were not documented every 30/45 minutes as follows:
On 09/09/19 the post treatment flow sheet contained documentation of a blood pressure assessment at 6:33 a.m.; according to the flow sheet, the next blood pressure assessment did not occur until 7:39 p.m.. Sixty six (66) minutes between assessments.

An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.















Plan of Correction:

Emphasis was placed on the strict adherence to FKC Company procedure for monitoring of Hemodialysis Patients during DIalysis Treatments. Secific emphasis was discussed regarding the routine monitoring of stable patients every 30 minutes and not exceeding 45 minutes. 

On 10/2/2019, the Clinical Manager (CM) held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Procedure:
FMS-CS-IC-I-110-131C Patient Assessment and Monitoring Procedure

Effective 10/3/2019, Clinical Manager (CM) or designee will conduct daily audits utilizing a developed Plan of Correction Auditing Tool for two weeks. Once improved compliance in noted audits will be reduced to weekly for two weeks. Once compliance is sustained, the Governing Body will decrease frequency to monthly then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the Medical Record Data Audit Tool.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.


494.80(d)(2) STANDARD
PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO

Name - Component - 00
In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted-

At least monthly for unstable patients including, but not limited to, patients with the following:
(i) Extended or frequent hospitalizations;
(ii) Marked deterioration in health status;
(iii) Significant change in psychosocial needs; or
(iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis.





Observations:


Based on observations, review of facility policy, and an interview with the clinical nurse manager, the facility failed to ensure patient was classified as unstable, due to an extended hospitalization (longer than 15 days), for one (1) of seven (7) clinical records (CR) reviewed (CR#6).

Findings include:

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMS-CS-IC-110-125A' 'Comprehensive interdisciplinary Assessment and Plan of Care' 'CIA/POC for Unstable Patients' states "The following are unstable criteria" Extended or frequent hospitalizations: (a) Hospitalization of more than 15 days with discharge occuring within the last 30 days, .........".

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

CR#6 Date of admission 08/21/13: Documentation provided of patient hospitalization records. Patient was hospitalized on "05/27/2019 - 06/12/2019" (17 days). Patients first treatment after hospitalization was 06/14/19. Patient was not classified as unstable due hospitalization greater than fifteen (15) days.

An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.




















Plan of Correction:

Unstable patients must be reassessed by the IDT monthly. Monthly re-assessment and any POC updates related to the reason the patient is considered "unstable" must be documented until the issues have been resolved or the IDT (including the patient if possible) determines that the condition is chronic.The following are unstable criteria:
Extended or Frequent hospitalizations:
a. Hospitalization of more than 15 days with discharge occurring within the last 30 days, or
b. More than 3 admissions in the last 30 days

On 9/12/2019, A Meeting was held with the Interdisplinary Team and Patient # 1 was reviewed and status was changed to "Unstable" based on an extended Hospitalizations

On10/3/19 the Clinical Manager held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policy and Flow Diagram:
FMS-CS-IC-I-110-125A Comprehensive Interdisciplinary Assessment and Plan of Care Policy

FMS-CS-IC-I-110-125D3 Comprehensive Patient Assessment and Plan of Care Frequency Flow Diagram

Effective 10/3/19, Clinical Manager or designee will conduct Monthly audits utilizing a developed Plan of Correction Auditing Tool for two months. Once compliance is sustained, the Governing Body will decrease frequency resuming the regularly scheduled audits based on QAI calendar. Monitoring will be done through the Patient Hospitalization Tool.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.


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 observation and an interview with the facility clinical nurse manager, it was determined the facility failed to dispose of sterile items that have reached their expiration date for one (1) of one (1) observations (Observation #1).

Findings include:

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMC-CS-IC-II-120-040A' 'Medication Preparation and Administration' 'Expired Medications' states "Expiration dates for all stored medications are to be monitored on a monthly basis". "Expired medications are to be discarded via Fresenius Medical Services off-site return program or in accordance with local/or state law".

Observations conducted in patient treatment area on September 9, 2019 between approximately 9:00 a.m. - 1:40 p.m. and on September 11, 2019 at approximately 12:40 p.m. revealed the following:

Observation #1: Treatment area medication cabinet contained twenty five (25)Gentamicin injection, Usp. 2ml vials which were expired on "08/18".

An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.

















Plan of Correction:

All employees are expencted to follow FKC policy and Procedures related to monitoring and disposal of expired Medications. Expiration dates for all stored medications are to be monitored on a monthly basis. Any expired medications or medication nearing expiration are to be discarded via Fresenius Medical Services offsite return program or in accordance with local and/or state law.

On 9/12/2019, the Registered Nurse discarded 25 vials of Gentamycin that had reached expiration as of 8/2018.

By 09/30/19, A comprehensive List of Medications and dates of expiration was developed and any Medication nearing expiration were removed from the inventory.

On 10/3/2019, the Clinical Manager (CM) held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policy:
FMS-CS-IC-II-120-040A  Medicaltion Preparation and Administration Policy

Effective 10/3/2019, Clinical Manager (CM) or designee will conduct monthly audits utilizing the comprehensive Medication Inventory List for two months. Once compliance is sustained, the Governing Body will decrease frequency to monthly then resume regularly scheduled audits based on QAI calendar. Monitoring will be done through the comprehensive medication list for the clinic.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.



494.180(f)(1)-(3) STANDARD
GOV-GB&MED DIR RESP STAFF FLW DC/TRANSFER P&P

Name - Component - 00
The governing body must ensure that all staff follow the facility's patient discharge and transfer policies and procedures.

The medical director ensures that no patient is discharged or transferred from the facility unless -
(1) The patient or payer no longer reimburses the facility for the ordered services;
(2) The facility ceases to operate;
(3) The transfer is necessary for the patient's welfare because the facility can no longer meet the patient ' s documented medical needs;



Observations:


Based on a review of clinical records and an interview with the facility clinical nurse manager, it was determined the facility failed to notify the Department of Health of a patients involuntary discharge/transfer, per facility policy, for one (1) of one (1) clinical records (CR) reviewed (CR#15).

Findings include:

A review was conducted of facility policy on September 12, 2019 between approximately 8:00 a.m. - 11:00 a.m. Policy 'FMC-CS-IC-I-103-011A' 'Routine and Involuntary Patient Discharge' 'Required Notifications' states "The patient must receive notification at least 30 days prior to the non-immediate involuntary discharge or transfer. The ESRD Network and State survey agency must also be notified at this time".

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

CR#15 Date of admit 10/02/17: Patient notified on 08/30/19 of patients involuntary discharge/transfer to occur on 09/29/19. The facility did not adhere to facility policy and notify the Pennsylvania Department of Health at this time.

An interview with the facility clinical nurse manager on September 12, 2019 at approximately 11:45 a.m. confirmed the above findings.

















Plan of Correction:

Emphasis was placed on the patient receiving written notification at least 30 days prior to the non-immediate involuntary discharge or transfer, and notification of both the ESRD Network and State survey agency. Additional emphasis was placed on the patient being informed of the possibility of discharge from the facility if a Physician to oversee his/her care is not secured. Every attempt will be made to assist the patient with securing either another physician at the current location or another treatment center that offers the care required by the patient. 

On10/03/2019, the Clinical Manager (CM)  held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Policy:
FKC-CS-IC-I-103-011A Routine and Involuntary Patient Discharge Policy

Effective 10/3/2019, Clinical Manager or designee will conduct an audit of any identified Involuntary Discharge Patients medical records to ensure that

A written order, signed by the attending physician and the medical director, must be in the patient's medical record, for the facility to involuntarily discharge or transfer a patient. Upon written notification to the patient of involuntary discharge or transfer, the facility must contact another dialysis facility and attempt to place the patient there. The Medical Director must be informed of and approve any involuntary discharge or transfer of a patient. The patient must receive notification at least 30 days prior to the involuntary discharge or transfer. The ESRD Network and State survey agency must also be notified at that time.

On 09/26/19 Patient X was accepted and transferred to a facility he was agreeable too.

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.



494.180(i) STANDARD
GOV-RESPONDS TO NW REQUEST/WORKS TOWARD GOALS

Name - Component - 00
The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network's current statement of work. Each facility must participate in ESRD network activities and pursue network goals.



Observations:


Based on documentation of ESRD Network IV documentation/correspondence and an interview with the facility clinical nurse manager, facility failed to demonstrate that it cooperates with the ESRD network designated for its geographic area, in fulfilling the terms of the Network's current statement of work for one (1) of two (2) network activities assigned (Activity #1).

Findings:


Policy requested. No policy provided.


Network survey form reviewed on September 9, 2019 at approximately 9:00 a.m. revealed the following:


Activity #1: Documentation provided by Network IV on September 9, 2019 revealed "The facility is participating in both the Grievance and Patient Family Engagement (PFE) Activities.
"The first step of the grievance activity is for all network 4 facilities to educate all of their patients ..... ". (Facility does not submit anything to the Network. Any and all documentation is done per the facilities policy).
"The second step ... is to re-educate their patients on how to use the Kidney Patient Advisory Committee (KPAC) grievance toolkit, .....".
"The third step will be for all facilities to develop and/or maintain a robust internal process for anonymous grievances that includes ......". "All facilities are expected to complete their internal process for anonymous grievances by October 18, 2019 and have it readily available to the DOH and or Network at any future date".
An interview was conducted on September 10 at approximately 11:00 a.m. with the clinical nurse manager and the social worker. Both were asked what ESRD Network assigned projects and/or activities the facility was working on for 2019. Per the facility administrator and the social worker, they were not aware of the Grievance activity.

An interview with the facility clinical nurse manager on September 12, 2019 at approximately11:45 a.m. confirmed the above findings. Policy requested on September 12, 16, and 17, 2019. Per an email by the regional director of operations on September 17, 2019, "according to the FMC Network Liaison" "FMC does not have a corporate policy on participation in the Network." "FMC follows the reg on this topic".

















Plan of Correction:

The Clinic will participate in the new ESRD Network Liaison Program created to support Fresenius Kidney Care managers with data reporting for ESRD Network Quality Improvement Activities (QIAs).

On 09/11/2019, the Social Worker contacted Network # 4 and confirmed that the clinic is in compliance with all required activity participation.



On 3/11/19, the clinic is actively initiated participation in the transplant initiative and compliant every month for submission.



On 10/3/019, the Clinical Manager held a staff meeting, elicited input, and reinforced the expectations and responsibilities of the facility staff on the following Corporate Memo: ESRD Network Liaison Program

Goals of the ESRD Network Liaison Program:

- Facilitate communication between Fresenius Kidney Care, CMS and the ESRD Networks.

- Understand the Network Statement of Work (SOW) and identify areas to reduce facility data reporting burden from QIAs.

- Provide data to the Networks at the Corporate level when possible to reduce manual reporting at the facility level.

- Identify clinics in ESRD Network projects and share with regional leadership

- Reduce duplicative efforts by sharing the FKC's Quality Agenda with ESRD Networks.

Effective 10/3/2019, Clinical Manager or designee will review in the Quality Assurance Meeting all required Network Activity Progress. Once compliance is sustained, the Governing Body will decrease frequency to monthly then resume regularly scheduled audits based on QAI calendar and Network recommendations. 

The Medical Director will review the results of audits each month at the QAI Committee meeting monthly.
The Clinical Manager is responsible to review, analyze and trend all data and Monitor/Audit results as
related to this Plan of Correction prior to presenting to the QAI Committee monthly. The Director of Operations
is responsible to present 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 to provide oversight, review findings, and take
actions as appropriate. The Governing Body is responsible to provide 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 Clinic Manager is responsible for overall compliance.