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

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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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 full State Licensure survey initiated on April 22, 2025, and concluded on May 2, 2025, 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:

551.21 (e)(1-3) LICENSURE Criteria for ambulatory surgery:

551.21 Criteria for ambulatory surgery

(e) In obtaining informed consent, the practitioner performing the surgery shall be responsible for disclosure of:
(1) The risks, benefits and alternatives associated with the anesthesia which will be administered.
(2) The risks, benefits and alternatives associated with the procedure which will be performed.
(3) The comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital.

Observations:

Based on a review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure that the comparative risks, benefits, and alternatives associated with performing a procedure in the ambulatory surgical facility instead of the hospital were disclosed to patients for three of ten medical records reviewed (MR8, MR9 and MR10).

Findings include:

Review of the policy titled "Informed Consent" which was approved by Board Managers on April 9, 2024 revealed, "Purpose: To establish expectations for the informed consent process to ensure that the patient rights are protected and to comply with organization policy and state, federal, and other regulations concerning patient consent ...."

A review conducted on April 22, 2025, of MR8 revealed that the consent form did not contain disclosure of the comparative risks, benefits and alternatives associated with performing a surgical procedure at the ambulatory surgical facility instead of in a hospital.

A review conducted on April 22, 2025, of MR9 revealed that the consent form did not contain disclosure of the comparative risks, benefits and alternatives associated with performing a surgical procedure at the ambulatory surgical facility instead of in a hospital.

A review conducted on April 22, 2025, of MR10 revealed that the consent form did not contain disclosure of the comparative risks, benefits and alternatives associated with performing a surgical procedure at the ambulatory surgical facility instead of in a hospital.

An interview conducted on April 22, 2025, at 3:30 PM with EMP1 confirmed the signed consent form did not contain disclosure of the comparative risks, benefits and alternatives associated with performing the procedure at the ambulatory surgical facility instead of in a hospital as stated above.

Plan of Correction - To be completed: 05/09/2025

The ASF has updated it's current Informed Consent form to include verbiage of ambulatory surgical facility instead of hospital. All schedulers have been provided with this updated form to utilize moving forward.
Center staff and physicians have been reeducated on the requirements of Informed Consent and the use of the new form. E-1
Responsible party: Director of Nursing
Monitoring: The center will monitor compliance of use through weekly audits for the first 4 weeks and then through chart audits performed monthly (M1). The results of the audits will be reported to the QAPI committee during their quarterly meetings. Any deviations will be reported to the governing body.

553.3 (8)(i) LICENSURE Governing Body Responsibilities:

553.3 Governing Body responsibilities include:
(8) Establishing personnel policies and practices which adequately support
sound patient care to include, the following:
(i) Require the employment of personnel with qualifications commensurate with a job's responsibilities and authority, including appropriate licensure and certification.

Observations:

Based on a review of facility documents, personnel files (PF) and interviews with staff (EMP), it was determined the facility failed to ensure that certifications for licensed personnel, were maintained for one of ten personnel files reviewed (PF7).

Findings Include:

Review of facility document "Job description: Operating room registered nurse" revealed "... Requirements: Required ... 5. ACLS and PALS (if applicable for patient population) within 6 months of hire ..."

Review of PF7 did not contain a current ACLS (Advanced Cardiac Life Support certification.

Interview on April 22, 2025, at 2:30 PM with EMP1 confirmed the above findings.

Plan of Correction - To be completed: 04/24/2025

Personnel who were lacking ACLS training documentation obtained their ACLS certification. (A-2)
Responsible Party: Administrator
Monitoring: Weekly review of credentialing and personnel records for expiring requirements by the Administrator will occur utilizing a credentialing spreadsheet for the first 3 months, and will then be reviewed on a monthly basis by the Administrator. (M2)
This spreadsheet will be reviewed at the quarterly QAPI committee meetings and any deviations will be reported to the governing board.

561.25 LICENSURE Distressed drugs, devices and cosmetics:

561.25 Distressed drugs, devices and cosmetics

Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.

Observations:

Based on observation and interview with staff (EMP), it was determined that the facility failed to dispose of outdated supplies.

Findings include:

A tour of the anesthesia room and inspection of the anesthesia cart on April 22, 2025, revealed expired supplies including:

Three yellow lab tubes, expired 7/31/2024.

One package of Medline Medgel EG Electrodes Set, expired 06/18/2024.

Six Medline Sterile Hypodermic Needle, expired 12/10/2024.

Two BD Filter needles with 5 Micron Filter, expired 03/31/2025.

An interview conducted with EMP2 on April 22, 2025, at 3:45 PM confirmed the expired items as noted above.

Plan of Correction - To be completed: 05/09/2025

The Center has instituted a new policy "Monitoring and Handling of Expired Products" (A-3). Additionally, the DON will assign staff monthly to check for outdates. Staff were reeducated on the requirements of reviewing expiration dates on sterile products and the new policy.
Responsibility: Director of Nursing
Monitoring: The DON will complete random audits weekly for the first 4 weeks, utilizing the environmental rounding tool (M3). The random audits will then be completed monthly and reported at the quarterly QAPI committee meeting. Any deviations will be reported to the governing board.

567.43 LICENSURE Ventilation System:

The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under
Chapter 571 (relating to construction standards).

Plan of Correction - To be completed: 05/09/2025

The center has reeducated staff on maintaining acceptable ranges for relative humidity and temperatures throughout the facility. The facility has implemented use of an electronic temperature and humidity record. This record has been set to notify key personnel when temperatures and/or humidity are out of range.
Responsible Party: Director of Nursing, Administrator
Monitoring: The Director of Nursing and Administrator receive real-time notifications of temperature and/or humidity levels outside of the set ranges. Trends will be monitored weekly for the first 4 weeks, then on a monthly basis. The director of nursing will bring the monthly temperature and humidity records to the quarterly QAPI meeting for review. Any deviation will be reported to the governing body.

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