Pennsylvania Department of Health
INTEGRATED SURGICAL INSTITUTE, LLC
Patient Care Inspection Results

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INTEGRATED SURGICAL INSTITUTE, LLC
Inspection Results For:

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INTEGRATED SURGICAL INSTITUTE, LLC - Inspection Results Scope of Citation
Number of Residents Affected
By Deficient Practice
Initial comments:
This report is the result of a State licensure survey conducted on April 16, 2024, at Integrated Surgical Institute Llc. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.


 Plan of Correction:


567.41 LICENSURE MAINTENANCE SERVICE - Principle:State only Deficiency.
567.41 Principle

The ASF shall be equipped, operated and maintained to sustain its
safe and sanitary characteristics and to minimize health hazards in the ASF
for the protection of patients and employes.

Observations:

Based on review of the Pennsylvania Code for Labor and Industry, observation, and interview with staff (EMP), it was determined the facility failed to ensure the autoclave sterilizers used for sterilization of surgical supplies were inspected.

Findings include:

Review on April 16, 2024, of the Pennsylvania Code for Labor and Industry, 34 3a. revealed Autoclaves and quick opening vessels.
(a) An inspector shall inspect autoclaves and quick opening vessels with close examination of all moving parts, locking devices, pins and interlocking devices, in accordance with ANSI/NB 23.
(b) An autoclave and quick opening vessel must have interlocking systems to prevent charging the vessel until all openings and locking devices are fully in place.
(c) A pressure-relieving device must be sized in accordance with the data plate for pressure. The capacity must be based on the pressure and pipe size or the total Btu valve of the boiler. (d) Inspection of autoclaves and quick opening vessels shall be performed in accordance with 3a.111(8) (relating to field inspections).

Observation on April 16, 2024, of the facility's sterilization area revealed two AMSCO 400 Series Small Steam Sterilizers.

A request was made on April 16, 2024, for documentation of the current boiler/pressure vessel inspections. None was provided.

Interview with EMP1 on April 16, 2024, confirmed there was no documentation of current boiler/pressures vessels inspections for the two sterilizers.






 Plan of Correction - To be completed: 05/15/2024

Corrective Action: The ASF
has contracted with the sterilize
manufacturer to
inspect and maintain the two
autoclaves. The ASF will
ensure that inspection and
maintenance will follow the
manufacturer's written
instructions for use (MIFU), of
at least twice per year,
to include the boiler/pressure
vessel inspections.
Responsible: Administrator
Monitoring activity: The
Administrator will review
contracts and maintenance
records monthly and will
report to the QAPI committee
any issues, preventive
maintenance(PM) or contract
updates.
Any deviations will be reported
to the Governing board.

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