QA Investigation Results

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


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Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on August 8, 2018 through August 10, 2018, Fresenius Medical Care Sellersville was identified to have the following standard level deficiency that was determined to be in substantial 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:




494.62(a)(4) STANDARD
Local, State, Tribal Collaboration Process

Name - Component - 00
[(a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. The plan must do the following:]

(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the facility's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.

* [For ESRD facilities only at 494.62(a)(4)]: (4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the dialysis facility's efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency.

Observations:


Based on a review of the facility emergency preparedness plan and an interview with the Clinical Manager and Operations Director, the plan did not include a process for cooperation and collaboration with local, tribal, regional, state and federal emergency preparedness officials to maintain an integrated response during an emergency situation.

Findings include;

A review of the facility Emergancy Preparedness binder was conducted on 8/9/18 at 12:30 PM.
The binder did not include facility specific contact information to include state and local emergency planning authorities nor documentation of its efforts to contact them. The facility also had a binder containing regional corporate contact information in a separate binder entitled, "Penndel Emergency Management Plan." The regional corporate information was dated from 2012 and was no longer current. Patient and staff contact information were kept in separate binders located at the receptionist desk. The biomedical technician had a separate list of "FKC Facility Emergency Information Directory" containing contact information for facility management and local providers.
None of this contact information was contained in one binder or in one area of the facility.
A review of facility letters to the local electric, water and gas companies revealed a generic letter generated biannually to these entities not written in business letter format to include in the heading which entity is addressed in the letter. An interview with the biomedical technician on 8/9/18 at 1:30 PM confirmed that the letter is addressed to the entity on the envelop but is not addressed to the entity in the letter heading.

The binders did not contain a process for cooperation and collaboration with local, tribal, regional, state and federal emergency preparedness officials to maintain an integrated response during an emergency situation nor documentation of contact with these entities.

An interview with the Clinical Manager and Operations Director on August 10, 2018 at 1:00 PM confirmed the above findings.








Plan of Correction:

On August 13, 2018 , a Governing Body Meeting was held to review and revise the facility's Emergency Preparedness Plan. A single "Emergency Preparedness" binder was developed and the following documents and/or information was placed in the binder:
- Facility specific contact information for state and local emergency planning authorities
- Staff and patient contact information- reviewed quarterly per FKC policy.
- Current FKC Facility Emergency Information Directory- moved to the binder.
- Revised facility letters to local Electric, water and gas companies in business letter format addressed to each specific entity.
- A process to collaborate with local, tribal, regional;, state and federal emergency preparedness officials during emergency situation, documentation of contact with each.
The Clinical Manager (CM), will develop an audit tool to ensure all documents are reviewed and/or revised quarterly, biannually, and annually as required, and will check the audit tool monthly to ensure document revisions are completed timely.
The CM will present audit checks at monthly QAI meetings for committee review, and quarterly at Governing Body meetings.
Completion date : September 28, 2018


Initial Comments:


Based on the findings of an onsite unannounced Medicare recertification survey conducted on August 8, 2018 through August 10, 2018, Fresenius Medical Care Sellersville was identified to have the following standard level deficiencies that were determined to be in substantial compliance with the following requirements of 42 CFR, Part 494, Subparts A, B, C, and D: Conditions for Coverage for End-Stage Renal Disease Facilities.







Plan of Correction:




494.30(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 Clinical Manager and Operations Director, it was determined, the facility failed to ensure infection control procedures were followed by cleaning and disinfecting the Hansen connectors and for three (3) of twenty (20) hemodialysis machines observed. (Station #'s 5, 16, & 17 ).

Findings include:

A review of policy number FMS-CS-IC-II-155-110A titled, "Cleaning and Disinfection" On August 13, 2018 at approximately 8:15 AM, was conducted. Section 4, Paragraph 1, states " All work surfaces shall be cleaned and disinfected with 1:100 Bleach solution after completion of procedures".

Observations were made in the patient treatment area on August 8 and 9, 2018 between the hours of 9:30 AM and 12:30 PM .

1. On August 8, 2018 at approximately 10:30 AM, it was observed that Patient Care Technician #1, did not disinfect the Hansen connectors at station # 16 prior to the start of the next dialysis treatment.

2. On August 8, 2018 at approximately 11:00 AM, it was observed that Patient Care Technician #1, did not disinfect the prime Hansen connectors at station # 17 prior to the start of the next dialysis treatment.

3. On August 8, 2018 at approximately 11:28 AM, it was observed that Registered Nurse #1, did not disinfect the Hansen connectors at station # 5 prior to the start of the next dialysis treatment.


An interview with the Clinical Manager and Operations Director was conducted on August 10, 2018 at approximately 12:55 PM. The manager confirmed that the infection control procedures are to be followed according to policy and that the above cited policy is in effect.





















Plan of Correction:

Beginning on 8/13/2018 until 8/20/2018, the Clinical Manager (CM) and/or designee will review and re-educate all direct patient care staff at daily huddles the following policy:
FMS-CS-IC-II-155-110A "Cleaning and Disinfection of the Dialysis Station" with emphasis on:
Cleaning/disinfecting all work surfaces and equipment in the dialysis station and all components of the dialysis machine to include the Hansen connectors, after every use and prior to the next patient treatment.
Beginning on 8/20/2018, the CM and/or designee will conduct daily audits on complete disinfection of all components of the dialysis machine until 100% compliance is observed. When 100% compliance is achieved audits will continue weekly x's 4 weeks. If compliance has been sustained, audits will continue monthly per QAI clinical audit checks.
Education and audit records will be on file in the facility.
Staff found to be non-compliant will be re-educated and/or counseled. Repeated non-compliance will result in initiation of the progressive discipline process.
For ongoing compliance the CM will present audit results at monthly QAI meetings for committee review.
Completion date: September 28, 2018.


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, facility policy and an interview with the Clinical Manager and Operations Director, the medical director failed to ensure that staff adhere medication administration policy for two (2) of two (2) observations. Observation #1 and 2.

Findings include:

A review of facility policy was conducted on August 10, 2018 at 11:30 AM.

Policy, FMS-CS-IC-II-120-040A, "Medication Preparation and Administration" states: "Infection control The following steps must be taken to ensure infection control....Clean the diaphragm of a vial prior to accessing the vile. If either vial is a multidose vial, cleanse the diaphragm with alcohol each time the vial is accessed with a needle using friction and 70% alcohol. Allow to dry before inserting a device into the vial..."

Policy, FMS-CS-IC-II-120-011A, "Specific Considerations: Venofer" states: "Administration and Dosage; Venofer may be administered undiluted as a slow intravenous injection over 2 to 5 minutes...Venofer will be administered at a rate no faster than 100 mgs over 2 minutes..."

Observations of medication administration was conducted on August 9, 2018 between 12:15- 12:20 PM.

Observation #1 on 8/9/18 at 12:15 PM, the RN did not wipe the medication (Hectorol) stopper with alcohol prior to inserting the needle for medication administration to the patient located at station #8.

Observation #2 on 8/9/18 at 12:20 PM, the RN did not wipe the medication (Venofer) stopper with alcohol prior to inserting the needle for medication administration to the patient located at station # 19. The intravenous Venofer administration was given at a rate of ten seconds not at a rate no faster than 100 mgs over 2 minutes.

An interview with the Clinical Manager and Operations Director on August 10, 2018, at 12:55 PM confirmed the above findings.









Plan of Correction:

On 8/13/2018, the Medical Director, Director of Operations and Clinical Manager discussed via a Governing Body Meeting, the Department of Health findings and the Medical Director's responsibilities and accountability for the quality of medical care provided to all patients as defined by the "Conditions of Coverage", the "Fresenius Medical Staff Bylaws", and the "Fresenius Medical Directors Responsibilities."
The Medical Director has actively participated in the development of this Plan of Correction, including the initiation of staff education and reinforcement as follows:
On 8/13/2018 through 8/20/2018, the Clinical Manager (CM) will conduct a mandatory in-service for all nursing staff to review and re-educate on the following policies/procedures:
FMS-CS-IC-II-120-040A "Medication Preparation and Administration Policy"
FMS-CS-IC-II-120-040C " Medication Preparation and Administration Procedure"
FMS-CS-IC-II-120-011A Policy: "Special Considerations: Venofer"
With emphasis on:
- Cleaning the diaphragm of ta vial with a 70% alcohol pad and friction prior to accessing the vial.
- Cleaning the diaphragm of a multi-dose vial each time the vial is accessed with the needle
- Allowing the alcohol on the diaphragm to completely dry before inserting a needle.
- Ensuring Venofer is administered at a rate no faster than 100mg. over 2 minutes.
Beginning on 8/20/2018, the CM and/or designee, will conduct daily audits on proper cleansing of medication vials and administration rate of Venofer, until 100% compliance is observed. When 100% compliance is achieved, audits will continue weekly x 4 weeks. If compliance has been sustained, audits will continue monthly per QAI clinical audit checks.
Education and audit records will be on file at the facility.
Staff found to be non-compliant will be re-educated and/or counseled. Repeated non-compliance will result in initiation of the progressive discipline process.
For ongoing compliance the CM will present audit results at monthly QAI meetings for committee review.
Completion date: September 28, 2018