QA Investigation Results

Pennsylvania Department of Health
FRESENIUS MEDICAL CARE OVERBROOK
Health Inspection Results
FRESENIUS MEDICAL CARE OVERBROOK
Health Inspection Results For:


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Initial Comments:

Based on the findings of an on-site, unannounced Medicare recertification survey conducted on May 1, 2018 through May 4, 2018, Fresenius Medical Care Overbrook 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 conducted on May 1, 2018, through May 4, 2018, Fresenius Medical Care Overbrook 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 494.62, Subpart B, Conditions for Coverage of Suppliers of End-Stage Renal Disease, (ESRD), Services-Emergency Preparedness.









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 direct observation in the clinical area, facility policy and an interview with facility staff, the facility failed to ensure that handwashing and glove changes were conducted according to facilty policy for patients with arteriovenous graphs or fistulae (vascular accesses) or central venous catheter for two (2) of seven (7) observations. Observation # 1, 2, and 3.

Findings include:

A review of policy FMS-CS-IC-II-155-090A, "Hand Hygiene" conducted on May 1, 2018, at 1:30 P.M.: "Hands will be... Decontaminated using alcohol based hand rub or by washing hands with antimicrobial soap and water before and after direct contact with patients, entering and leaving the treatment area, before performing any invasive procedure such as vascular access cannulation or administration of parenteral medications, and immediately after removing gloves."

On May 1, 2018 at approximately 1:10 p.m., review of agency procedure policy entitled, "Initiation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer", Document Number FMS-CS-IC-I-105-028C, Revised 6-JAN-2014, revealed that once dialysis, (the process of removing excess water, solutes and toxins from the blood), is initiated, the following steps should be continued:
Step #6, Attach lines securely to the patient's clothing.
Step #7, Take notice of the time dialysis started.
Step #8, Obtain vital signs.
Step #9, Discard the gloves and perform hand hygiene.
Step #10, Document all required patient and machine data information. (This facility uses the dialysis machine computerized control panel .)

On May 1, 2018 at approximately 1:30 p.m., review of agency procedure policy entitled, "Termination of Treatment Using Arteriovenous Fistula, (a surgically-created flow between an artery and a vein to ensure access to hemodialysis), or Graft and Optiflux Single Use Ebeam Dialyzer", Document Number FMS-CS-IC-I-105-028C, Revised 19-JAN-2013, revealed in the policy:
"Termination: Disconnecting the Patient: 5. Discard the extra-corporeal circuit (plastic tubing that takes the blood outside of the body to the dialysis machine) in appropriate biohazard waste receptacle. 6. Discard the gloves and perform hand hygiene..."
Observations of the clinical/treatment area were conducted on May 1, 2018, and May 2, 2018, from approximately 10:45 A.M. to 1:30 P.M.

Observation #1 on May 1, 2018, at approximately 11:30 a.m., at station #10, after initiating dialysis treatment, the PCT keyed information into the computerized control panel on the dialysis machine, returned to the patient to secure CVC lines, and returned to enter data into the control panel without discarding gloves, or washing hands.

Observation #2: On May 1, 2018, at 11:08 A.M. at station #11, during discontinuation of dialysis and post dialysis access care for a patient with an AV fistula or graft, the Patient Care Technician (PCT) did not remove his/her gloves, perform hand hygiene, and don clean gloves after disconnecting the blood lines and and prior to aseptically removing the access cannulas. The PCT failed to perform hand hygiene after removing gloves and donning clean gloves during the glove changes performed after removing the access cannulas and prior to replacing the clean bandage on the cannula sites.

An interview with the facility administrator and regional director on May 4, 2018, at approximately 1:30 P.M. confirmed the above findings.





















Plan of Correction:

V113
The Education Coordinator (EC) or designee will re-educate all the Direct Patient Care (DPC) staff on:
- FMS-CS-IC-11-155-090A Hand Hygiene Policy
- FMS-CS-IC-I-105-002C Initiation of Treatment Using a Central Venous Catheter and Optiflux® Single Use Ebeam Dialyzer Procedure
- FMS-CS-IC-I-105-029C Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux® Single Use Ebeam Dialyzer Procedure

Special emphasis will be placed on ensuring that hand hygiene is performed every time gloves are changed, this includes after touching the computer keyboard, after disconnecting the blood lines and prior to removing the patient's fistula needles.
In-servicing is scheduled to be completed by 5/20/18
All training documentation is on file at the facility.
The Charge Nurse (CN) or designee will perform daily audits for 2 weeks on the DPC for proper glove use and hand hygiene until evidence of improved compliance is observed. If compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time if compliance is sustained, the audits will then be completed monthly following the Quality Assurance Improvement (QAI) program. A Plan of Correction (POC) specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The Facility Administrator (FA) will review the audits and report the findings monthly at the QAI Committee meeting. The QAI committee will report the audit results to the GB monthly for further guidance and ongoing oversight.
Completion date: 6/18/18



494.30(a)(4)(ii) STANDARD
IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL

Name - Component - 00
[The facility must demonstrate that it follows standard infection control precautions by implementing-
(4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-]
(ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment.



Observations:


Based on observation, review of policy and procedures, and interview with the Facility Administrator, it was determined, the facility failed to ensure infection control procedures were followed for cleaning and disinfecting waste container(s) and Hansen connectors for two, (2), of nine (9) hemodialysis machines observed. (Machine #10, and 16)

Findings include:

On March 1, 2018 at approximately 1:30 P.M., a review of facility policy FMS-CS-IC-II-155-110A entitled "Cleaning and Disinfection of the Dialysis Station" stated, "Cleaning the Dialysis Machine, Externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment..."

On March 1, 2018, at approximately 1:30 P.M., a review of facility policy FMS-CS-IC-IC-I 105-007C entitled "Priming Bucket Disinfection", stated "Procedure: 2. Clan 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..."

Observations in the clinical area on May 1, 2018, from approximately 10:30 AM through 12:30 PM and on May 2, 2018, from approximately 9:30 AM through 12:00 PM. revealed the following:

On May 1, 2018 at approximately 11:15 A.M., it was observed that Patient Care Technician, (PCT), did not disinfect the Hansen connectors or the priming bucket attached to the dialysis machine at station #10, prior to the start of the next dialysis treatment.

On May 1, 2018 at approximately 11:35 A.M., it was observed that Registered Nurse, (RN), did not disinfect the Hansen connectors or the priming bucket attached to the machine at station #16, prior to the start of the next dialysis treatment.

An interview with facility administrator and regional director on May 4, 2018, at approximately 1:30 PM. confirmed the above findings.



















Plan of Correction:

V 122
The EC or designee will re-educate all the DPC staff on:
- FMS-CS-IC-II-155-110A Cleaning and Disinfection of the Dialysis Station
- FMS-CS-IC-I-105-007C Prime Bucket Disinfection Procedure
The emphasis of the meeting will be on ensuring that the prime buckets and the Hansen connectors are cleaned and disinfected prior to the start of the next dialysis treatment.


In-servicing is scheduled to be completed by 5/20/18
All training documentation is on file at the facility.
The CN or designee will perform daily audits for 2 weeks on the DPC staff until evidence of improved compliance is observed. If compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time if compliance is sustained, the audits will then be completed monthly following the QAI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The FA will review the audits and report the findings monthly at the QAI Committee meeting. The QAI committee will report the audit results to the GB monthly for further guidance and ongoing oversight.
Completion date: 6/18/18



494.90(a)(1) STANDARD
POC-MANAGE VOLUME STATUS

Name - Component - 00
The plan of care must address, but not be limited to, the following:
(1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient's volume status;


Observations:


Based on review of facility policies, medical records (MR), and staff interviews, the facility failed to ensure vital signs were documented every thirty minutes during the hemodialysis treatment for three (3) of ten (10) in-center hemodialysis patients who were dialyzed in March and April, 2018. (MR # 6, 8, and 10).

Findings include:

A review of facility policies was conducted on May 1, 2018, at approximately 1:00 P.M. policy FMS-CS-IC-I-110-133A titled "Patient Monitoring During Patient Treatment" stated, "Vital Signs/Mental Status: Vital signs will be monitored at the initiation of dialysis and every 30 minutes, or more frequently, as needed..."

A review of MR conducted on May 2, 2018, from approximately 1:00 P.M. through 3:30 P.M. and May 3, 2018, from approximately 10:00 A.M. through 3:00 P.M revealed the following:

1. MR #6, admission date May 4, 2012: On April 27, 2018, the staff providing care failed to document intradialytic treatment monitoring and data collection every 30 minutes during the dialysis treatment. Blood pressure, heart rate, blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement, vascular access visible and line connection intact, and patient subjective statements were documented at 7:44 A.M. and 8:40 A.M. ( approximately one hour between checks). The staff also failed to document safety and access checks at 12:03 P.M., 12:40 P.M., 1:38 P.M. and 1:50 P.M.


2. MR #8, admission date June 13, 2017: On March 3, 2018, the staff providing care failed to document intradialytic treatment monitoring and data collection every 30 minutes during the dialysis treatment. Blood pressure, heart rate, blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement, vascular access visible and line connection intact, and patient subjective statements were documented at 12:38 P.M. and 1:43 P.M. ( approximately one hour between checks).

On March 8, 2018, the staff providing care failed to document intradialytic treatment monitoring and data collection every 30 minutes during the dialysis treatment. Blood pressure, heart rate, blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement, vascular access visible and line connection intact, and patient subjective statements were documented at 12:40 P.M. and 1:38 P.M. (approximately one hour between checks).

3. MR#10, admission date June 23, 2017: On April 20, 2018, and April 30, 2018, the staff providing care failed to document intradialytic treatment monitoring and data collection every 30 minutes during the dialysis treatment. Blood pressure, heart rate, blood and dialysate flows, arterial and venous pressures, fluid removal and/or replacement, vascular access visible and line connection intact, and patient subjective statements were documented on April 20, 2018, statements were documented at 3:55 P.M. and 5:04 P.M. (approximately one hour between checks). On April 30, 2018, statements were documented at 3:57 P.M. and 5:30 P.M. (Approximatlely one and one half hours between checks).

An interview with the facility administrator and regional director on May 4, 2018, at approximately 2:00 P.M. confirmed that not all staff are documenting intradialytic treatment monitoring and data collection every 30 minutes during dialysis treatment in accordance with facility policy.










































Plan of Correction:

V 543
The EC or designee will re-educate all the DPC staff on:
- FMS-CS-IC-I-110-133A Monitoring During Patient Treatment Policy
The emphasis of the meeting will be on ensuring that patients' vital signs (VS) as well as safety and access checks are monitored and documented at a minimum of every twenty minutes, not to exceed thirty minutes.
In-servicing is scheduled to be completed by 5/20/18
All training documentation is on file at the facility.
The CN or designee will perform daily audits for 2 weeks on the DPC staff until evidence of improved compliance is observed. If compliance is observed the audits will then be completed 2 times/week for 2 weeks. At that time if compliance is sustained, the audits will then be completed monthly following the QAI program. A POC specific auditing tool will be used for the audits.
Staff found to be non-compliant will be re-educated and counseled.
The FA will review the audits and report the findings monthly at the QAI Committee meeting. The QAI committee will report the audit results to the GB monthly for further guidance and ongoing oversight.
Completion date: 6/18/18



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 direct observation of clinical staff, facility policy and an interview with the clinical manager and regional director, the medical director did not ensure that staff adhere to facility policy when discontinuing treatment using arteriovenous fistula, (a surgically-created flow between an artery and a vein to ensure access to hemodialysis), or graft for one (1) of two (2) treatment discontinuations: Discontinuation #1; and did not ensure the proper technique when discontinuing treatment for a central venous catheter (CVC) for one (1) of two (2) treatment discontinuations: Discontinuation #2.

Findings include:
On May 1, 2018 at approximately 1:30 p.m., review of agency procedure policy entitled, "Termination of Treatment Using Arteriovenous Fistula, (a surgically-created flow between an artery and a vein to ensure access to hemodialysis), or Graft and Optiflux Single Use Ebeam Dialyzer", Document Number FMS-CS-IC-I-105-028C, Revised 19-JAN-2013, revealed in the policy:
"Prior to Termination Preparation: 3. Ensure there is a clean under pad under the access limb to provide a clean work area and to protect patient's clothing...."
"Termination: Returning Blood from Arterial Segment: 5. While closely monitoring the access site, return blood through the arterial line either by gravity, or by applying gentle pressure to the saline bag. Do not apply excessive pressure on the saline bag; this may cause damage to the access..."

On May 1, 2018, at approximately 1:30 P.M., review of agency procedure policy entitled, "Discontinuation of Treatment Using a Central Venous Catheter and Optiflux Single Use Ebeam Dialyzer", Document Number FMS-CS-IC-I-105-028C, Revised 6-JAN-2014, revealed in the policy:
"Prior to Termination Preparation: 5. Ensure that a clean under pad is below the catheter limbs to protect the work area and the clothing....."
"Termination: Returning Blood from Arterial Segment: 5. While closely monitoring the catheter site, return blood through the arterial line either by gravity, or by applying gentle pressure to the saline bag. Do not apply excessive pressure on the saline bag; this may cause damage to the access..."
Observations of the clinical/treatment area were conducted on May 1, 2018, and May 2, 2018, from approximately 10:45 A.M. to 1:30 P.M.

Observation #1: On May 1, 2018, at 11:08 A.M. at station #11, during discontinuation of dialysis and post dialysis access care for a patient with an AV fistula or graft, the Patient Care Technician (PCT) was observed vigorously wringing the saline bag to more quickly reinfuse the extracorporeal circuit.

Observation #2: On May 2, 2018, at 11:35 A.M. at station #20, the PCT did not place an under pad on the work area prior to performing a discontinuation of dialysis with a central venous catheter. The clean supplies were placed directly on the treatment chair tabletop surface. The PCT was observed vigorously wringing the saline bag to more quickly reinfuse the extracorporeal circuit.

An interview with the facility administrator and regional director on May 4, 2018, at approximately 1:30 P.M. confirmed the above findings.


















Plan of Correction:

V 715

On 5/21/18 the FA, the CN and the Director of Operations (DO) will meet with the Medical Director to discuss Medical Director Responsibilities as defined in the Conditions for Coverage. Emphasis will be placed on the Medical Director responsibilities to ensure staff adherence to policy and procedure as it relates particularly to the safe termination of patient's treatments. The policies reviewed with the Medical Director were:
- FMS-CS-IC-1-105-029C Termination of Treatment Using Arteriovenous Fistula or Graft and Optiflux R Single Use Ebeam Dialyzer
- FMS-CS-IC-1-105-029C Termination of Treatment Using a Central venous Catheter and Optiflux R Single Use Ebeam Dialyzer

The Medical Director meeting minutes will be on file at the facility.

After the meeting with the Medical Director all DPC staff will be reeducated on the policies reviewed with the Medical Director. The EC will complete the education.

The focus of the reeducation will be on ensuring safe termination of patient treatments by applying gentle pressure to the saline bag when returning blood to the patient. The meeting will also reinforce the importance of using a clean under pad for placement of clean supplies and not placing supplies on the patients chairside table.

The inservicing will be completed by 5/24/18 with documentation of the training on file at the facility.

The CN or designee will perform daily audits for 2 weeks. At that time if compliance is observed the audits will then be completed 2 times/week for 2 weeks to ensure that compliance is observed. At that time the audits will then follow the monthly QAI schedule. A POC specific audit tool will be used for the audits
Staff found to be non-compliant will be re-educated and referred for counseling.

The FA will review the audit results and report the findings to the QAI Committee at the monthly meeting. Sustained compliance will be monitored by the QAI committee.

Completion Date: 6/18/18