QA Investigation Results

Pennsylvania Department of Health
ENDOSCOPY ASSOCIATES OF VALLEY FORGE, LLC
Building Inspection Results

ENDOSCOPY ASSOCIATES OF VALLEY FORGE, LLC
Building Inspection Results For:


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Initial Comments:
Name - Component - --

Based on an Emergency Preparedness Survey completed on December 11, 2018, it was determined that Endoscopy Associates of Valley Forge was not in compliance with the requirements of 42 CFR 416.54.




Plan of Correction:




416.54(a)(1)-(2) STANDARD
Plan Based on All Hazards Risk Assessment

Name - Component - --
[(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:]

(1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.*

*[For LTC facilities at 483.73(a)(1):] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing residents.

*[For ICF/IIDs at 483.475(a)(1):] (1) Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach, including missing clients.

(2) Include strategies for addressing emergency events identified by the risk assessment.

* [For Hospices at 418.113(a)(2):] (2) Include strategies for addressing emergency events identified by the risk assessment, including the management of the consequences of power failures, natural disasters, and other emergencies that would affect the hospice's ability to provide care.

Observations:

Based on documentation review and interview, it was determined the facility failed to conduct an all-hazards risk assessment for the facility and include it in the Emergency Response Plan.

Findings include:

1. Review of documents on December 11, 2018, between 8:30 am and 10:30 am, revealed the facility failed to provide an emergency preparedness plan that identified the following:

A. Community based risk assessment;
B. Facility based risk assessment.

Interview with the Administrator at the exit conference on December 11, 2018, at 11:45 am, confirmed the facility did not have an all-hazards risk assessment for the facility included in the Emergency Response Plan.









Plan of Correction:

Corrective Action/Systemic Changes:
The facility developed an Emergency Preparedness Plan Policy and Procedure by December 11,2018. approved by the Governing Body December 31,2018. The Center Staff was in-serviced on the policy on December 31, 2018. A memo was sent to the Physicians/CRNAs apprising them of the Emergency Preparedness policy by January 2, 2019.

A Hazards Vulnerability Risk Assessment (HVRA) was developed on December 11, 2018, approved by the Governing Body December 31,2018. It will be implemented upon approval by the Governing Body on 1/8/19. The Center Staff was inserviced on the policy on December 31, 2018. A memo was sent to the Physicians/CRNAs apprising them of the Emergency Preparedness policy by January 2, 2019.

Both Emergency Preparedness Plan and the HVRA will be reviewed and revised on an Annual basis.

To ensure this corrective action is systematized, the DON will schedule a review of the policy and its revisions on an annual basis. Twice a year Emergency drills will be conducted either as response to an actual emergency or in planned exercises; other Quarterly Emergency drills will be conducted at least quarterly.

Responsible Party and Monitoring:
DON and Governing Body will be responsible for implementing Emergency preparedness drills in accordance to facility policy. Implementation date February 13, 2019.

QA monitoring of the center's compliance to the requirements of the Emergency Preparedness Plan will be conducted during the designated Emergency Preparedness drills, and upon Annual Review. Results of the monitoring will be discussed at the QA Committee and Governing Body Meetings on a quarterly basis.



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

Name - Component - --
[(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 document review and interview, it was determined the facility failed to develop an emergency preparedness plan, affecting the entire facility.

Findings include:

1. Documents review on December 11, 2018, between 8:30 am and 10:30 am, revealed the facility failed to provide an emergency preparedness plan that identified efforts to contact officials to engage in collaborative planning for an integrated emergency response.

Interview with the Administrator at the exit conference on December 11, 2018, at 11:45 am, confirmed the documentation was unavailable.










Plan of Correction:

Corrective Action/Systemic Changes:
The Governing Body approved the Emergency Preparedness plan on December 11, 2018. The Director of Nursing (DON) or designee will establish contracts with officials from the local hospitals (Phoenixville and Pottstown), Linfield Fire Department, Limerick Police Department, and Friendship Ambulance Department to engage in collaborative planning for an integrated emergency response. This will be accomplished by January 31, 2019.

As of December 19, 2018 the DON became a member of the Emergency Preparedness Coalition for Montgomery County. The DON will be attending monthly meetings with the coalition. Any strategies and information gathered from the coalition will be considered and incorporated as necessary into the center's Emergency Preparedness Plan annual review.

Responsible Party and Monitoring:
The DON or designee will ensure that contracts will be obtained with each local emergency response group. Once the contracts are established an annual emergency preparedness drill will be implemented to engage in collaborative planning for an integrated emergency response with these groups.

QA monitoring of the center's compliance to the requirements of the Emergency Preparedness Plan will be conducted during the designated Emergency Preparedness drills, and upon Annual Review. Results of the monitoring will be discussed at the QA Committee and Governing Body Meetings on a quarterly basis.



416.54(b)(6) STANDARD
Roles Under a Waiver Declared by Secretary

Name - Component - --
[(b) Policies and procedures. The [facilities] 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:]

(8) [(6), (6)(C)(iv), (7), or (9)] The role of the [facility] under a waiver declared by the Secretary, in accordance with section 1135 of the Act, in the provision of care and treatment at an alternate care site identified by emergency management officials.

*[For RNHCIs at 403.748(b):] Policies and procedures. (8) The role of the RNHCI under a waiver declared by the Secretary, in accordance with section 1135 of Act, in the provision of care at an alternative care site identified by emergency management officials.

Observations:

Based on documentation review and interview, it was determined the facility failed to address 1135 Waivers that may be issued by US Health and Human Services Secretary, in the Emergency Response Plan for the facility.

Findings include:

Review of documents on December 11, 2018, between 8:30 am and 10:30 am, revealed the facility failed to address 1135 Waivers that may be issued by US Health and Human Services Secretary, in the Emergency Response Plan.

Interview with the Administrator at the exit conference on December 11, 2018, at 11:45 am, confirmed the facility failed to address Waivers that may be issued by US Health and Human Services Secretary, in the Emergency Response Plan.







Plan of Correction:

Corrective Action/Systemic Changes:
The Director of Nursing (DON) developed an 1135 Waiver policy and supportive documents as of December 19, 2018. The 1135 Waiver policy will presented for approval by the Governing Body on January 4, 2019. After approval is obtained, the DON will hold a staff meeting on January 11, 2019 to educate them on the 1135 Waiver. Implementation of the policy will be completed by January 31, 2019.

Responsible Party and Monitoring:
The DON and Governing Body will be responsible for implementation of the 1135 Waiver policy. The DON will hold a staff meeting on January 11, 2019.
QA monitoring of the center staff's sustained understanding of the facility's 1135 Waiver policy will be conducted during the designated Emergency Preparedness drills and continuing education will be provided. Results of the monitoring will be discussed at the QA Committee and Governing Body Meetings on a quarterly basis.




Initial Comments:
Name - CLASS B ASF (ENDOSCOPY CENTER) Component - 01

Facility ID# 21711501
Component 01

Based on a Recertification/Relicensure Survey completed on December 11, 2018, it was determined that Endoscopy Associates of Valley Forge was not in compliance with the following requirements of the Life Safety Code for existing Ambulatory health care occupancy. Compliance with the National Fire Protection Association's Life Safety Code is required by 42 CFR 416.44(b).

This is a two-story, Type II (000), unprotected non-combustible construction, which is fully sprinklered.

Approved as a Class B Endoscopy Ambulatory Surgical Facility (ASF).


Plan of Correction:




NFPA 101 STANDARD
Multiple Occupancies

Name - CLASS B ASF (ENDOSCOPY CENTER) Component - 01
Multiple Occupancies - Sections of Ambulatory Health Care Facilities
Multiple occupancies shall be in accordance with 6.1.14.
Sections of ambulatory health care facilities shall be permitted to be classified as other occupancies, provided they meet both of the following:
* The occupancy is not intended to serve ambulatory health care occupants for treatment or customary access.
* They are separated from the ambulatory health care occupancy by a 1 hour fire resistance rating.
Ambulatory health care facilities shall be separated from other tenants and occupancies and shall meet all of the following:
* Walls have not less than 1 hour fire resistance rating and extend from floor slab to roof slab.
* Doors are constructed of not less than 1-3/4 inches thick, solid-bonded wood core or equivalent and is equipped with positive latches.
* Doors are self-closing and are kept in the closed position, except when in use.
* Windows in the barriers are of fixed fire window assemblies per 8.3.
Per regulation, ASCs are classified as Ambulatory Health Care Occupancies, regardless of the number of patients served.
20.1.3.2, 21.1.3.3, 20.3.7.1, 21.3.7.1,42 CFR 416.44

Observations:

Based on observation and interview, it was determined that the facility failed to maintain the proper fire resistance rating of the tenant separation wall affecting one of two floors within the facility.

Findings include:

Observation made on December 11, 2018, at 11:10 am, revealed that within the PACU patient bath room tenant separation wall had a unsealed penetration inside " inch electrical conduit sleeve.

Interview with the Administrator on December 11, 2018, at 11:45 am, confirmed the unsealed penetration.








Plan of Correction:

K 0131:

Corrective Action/Systemic Changes:
To ensure that the facility maintains the proper fire resistance rating of the tenant separation wall within the facility, the PACU patient bathroom tenant separation wall with an unsealed penetration inside " inch electrical conduit sleeve was sealed.

On December 11, 2018, the Director of Nursing (DON) submitted a request to the building management, Geis Realty, to make the necessary repair on the unsealed penetration inside "inch electrical conduit sleeve.

On December 14, 2018 at 2:46 PM, the completed the repair, sealing the penetrating conduit sleeve with the use of a fire barrier sealant with a firestop tested up to 3 hours in accordance with ASTM E 814 (UL1479), ASTM E 1966 (UL 2079)and CAN/ULC-S115. The firestop sealant is capable of expanding a minimum of 3 times at 1000 degrees Fahrenheit.

Moving forward, the Building Management, Geis Realty, will be conducting Annual inspections of the facility to ensure compliance to Fire Safety regulations.

As a result of our Plan of Correction implementation, during the facility's 2018 annual Fire Safety inspection conducted on December 31, 2018 a door was identified that did not meet the National Fire Protection Association (NFPA) requirement. A work order was submitted to Geis Realty on January 2, 2019, requesting for replacement of the damaged door.

The Director of Nursing has notified the staff of this finding on December 31, 2018; the Center and Physician Staff were made aware the facility's corrective actions.

To ensure there are no penetrations, and to maintain proper fire resistance rating of the separation walls throughout the facility, the Director of the Nursing (DON) has completed the NFPA 80: Inspection, Testing, and Maintenance Requirements for Swing Fire Door Online Training Certificate on December 31, 2018. The DON will be conducting Annual Fires Door inspections. In addition, we are in the process of identifying a fire safety consultant. The consultant will make annual inspection visits, to ensure the facility meets all Fire Safety requirements. Building Management will also be conduct inspections of door openings in the suite on an annual basis.

To ensure that the facility maintains proper fire resistance of the separation walls, a monthly Environment of Care (EOC) checklist will be implemented by January 7, 2019 that includes protocols for inspecting separation walls.

On January 15, 2019, additional information on the 'through firestop' material used was requested by the DOH. Upon consultation with a Fire Safety consultant on 1/15/19, it was determined that evidence of a firestop tube (housing the conduit sleeve) and end caps installation are required, and have not been received from the Building Management fire safety contractor. The facility will ensure the penetration will be sealed using an approved through stop penetration system. The facility DON contacted Building Management on 1/15/19 to request for additional information and work as needed. The requested information and work, are pending at this time. An email was received from the building management on 1/22/19 stating that it is conducting its due diligence in assessing and ordering materials to implement the additional corrections. We will provide the DOH with the additional technical information as soon as it is received from the contractor. Estimated Completion date: February 11, 2019.



NFPA 101 STANDARD
Maintenance, Inspection & Testing - Doors

Name - CLASS B ASF (ENDOSCOPY CENTER) Component - 01
Maintenance, Inspection & Testing - Doors
Fire doors assemblies are inspected and tested annually in accordance with NFPA 80, Standard for Fire Doors and Other Opening Protectives.
Non-rated doors, including corridor doors to patient rooms and smoke barrier doors, are routinely inspected as part of the facility maintenance program.
Individuals performing the door inspections and testing possess knowledge, training or experience that demonstrates ability.
Written records of inspection and testing are maintained and are available for review.
21.7.6, 8.3.3.1 (LSC)
5.2, 5.2.3 (2010 NFPA 80)

Observations:

Based on documentation review and interview, it was determined the facility failed to maintain annual inspections of door openings on one of two levels within this facility.

Findings include:

Review of documentation on December 11, 2018, between 8:30 am and 10:30 am, revealed that the facility was unable to provide annual fire rated door assemblies inspection and testing information.

Exit interview with the Administrator on December 11, 2018 at 11:45 am, confirmed the documentation was unavailable.







Plan of Correction:

Corrective Action/Systemic Changes:
To ensure Fire Doors assemblies are inspected and tested annually in accordance with NFPA throughout the facility, the Director of the Nursing (DON) has completed the NFPA 80: Inspection, Testing, and Maintenance Requirements for Swing Fire Door Online Certification Training on December 31, 2018. The DON will be conducting Annual Fire Door inspections.

In addition, we are in the process of identifying a fire safety consultant. The consultant will make annual inspection visits, to ensure the facility meets all Fire Safety requirements.

The Building Management, Geis Realty, will also be conducting Annual inspections of the facility to ensure compliance to Fire Safety regulations is maintained.

The Director of Nursing has notified the staff of this finding on December 31, 2018; the Center and Physician Staff were made aware the facility's corrective actions.

To ensure that the facility maintains proper fire resistance of the separation walls, an Environment of Care (EOC) checklist will be implemented by January 8, 2019 that includes protocols for inspecting separation walls.

Responsible Party Monitoring:
The Director of Nursing or designee will ensure 100% compliance by ensuring Environment of Care (EOC) monitoring on a monthly basis, effective January 8, 2019 and Fire Swing Door will be inspected on an annual basis, effective December 31, 2018. Findings will be reported to the QA Committee and Governing Body on a quarterly basis.



NFPA 101 STANDARD
Electrical Equipment - Testing and Maintenanc

Name - CLASS B ASF (ENDOSCOPY CENTER) Component - 01
Electrical Equipment - Testing and Maintenance Requirements
The physical integrity, resistance, leakage current, and touch current tests for fixed and portable patient-care related electrical equipment (PCREE) is performed as required in 10.3. Testing intervals are established with policies and protocols. All PCREE used in patient care rooms is tested in accordance with 10.3.5.4 or 10.3.6 before being put into service and after any repair or modification. Any system consisting of several electrical appliances demonstrates compliance with NFPA 99 as a complete system. Service manuals, instructions, and procedures provided by the manufacturer include information as required by 10.5.3.1.1 and are considered in the development of a program for electrical equipment maintenance. Electrical equipment instructions and maintenance manuals are readily available, and safety labels and condensed operating instructions on the appliance are legible. A record of electrical equipment tests, repairs, and modifications is maintained for a period of time to demonstrate compliance in accordance with the facility's policy. Personnel responsible for the testing, maintenance and use of electrical appliances receive continuous training.
10.3, 10.5.2.1, 10.5.2.1.2, 10.5.2.5, 10.5.3, 10.5.6, 10.5.8

Observations:

Based on documentation and interview, it was determined the facility failed to maintain inspection of electrical wiring and receptacle systems on one of two levels within this facility.
Findings include:
1. Review of documentation on December 11, 2018, between 8:30 am and 10:30 am
revealed electrical receptacles at patient bed locations and in locations where deep sedation or general anesthesia is administered, were not tested for non-hospital grade receptacles at intervals not exceeding 12 months, and hospital grade receptacles based on documented performance data or minimally not exceeding 12 months. Receptacle testing should include the following:

a. resident care rooms;
b. visual inspection of physical integrity;
c. correct polarity of the hot and neutral connections;
d. retention force of the grounding blade (except locking-type receptacles) shall be not less than 115g (4 oz).

Interview with the Administrator on December 11, 2018, at 11:45 am, confirmed testing of electrical receptacles was not provided.







Plan of Correction:

Corrective Action:
The facility obtained a Ground Fault Circuit Interrupt (GFCI) outlet tester on December 31, 2018. Outlets in the procedure and recovery area have been labeled. Outlets will be tested on a monthly basis by the Director of Nursing (DON) or Designee to ensure compliance at 100% on a monthly basis. Labeling and testing of all outlets will completed by January 8, 2018.

Systemic Changes:
The DON will assess the physical integrity, resistance, leakage current, and touch current tests for fixed and portable patient-care related electrical equipment on a monthly basis.

Responsible Party and Monitoring:
The DON or designee will ensure compliance by ensuring Environment of Care (EOC) monitoring on a monthly basis is achieved. Findings will be reported to the QA Committee and Governing Body on a quarterly basis.