Pennsylvania Department of Health
 FERTILITY PARTNERS OF PENNSYLVANIA SURGERY CENTER, LLC
Patient Care Inspection Results

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FERTILITY PARTNERS OF PENNSYLVANIA SURGERY CENTER, LLC
Inspection Results For:

There are  20 surveys for this facility. Please select a date to view the survey results.

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FERTILITY PARTNERS OF PENNSYLVANIA SURGERY CENTER, 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 May 9, 2024, at Fertility Partners of Pennsylvania Surgery Center. 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:State only Deficiency.
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 review of facility forms, medical records (MR), and interview with staff (EMP), it was determined the facility failed to ensure the practitioner performing the surgical procedure disclosed to each patient, the comparative risks, benefits, and alternatives associated with performing the procedure in the ambulatory surgical center instead of the hospital for seven of ten medical records reviewed (MR1, MR2, MR4, MR5, MR6, MR7 and MR9).

Findings include:

Review on May 8, 2024, of the following facility consent forms: "Embryo Transfer Consent", "Hysterosalpingogram Consent", "Dilation and Curettage Consent" and "Hysteroscopy Consent" revealed no evidence of documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of in a hospital.

Review on May 8, 2024, of MR1 revealed the patient was admitted on December 4, 2023, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

Review on May 8, 2024, of MR2 revealed the patient was admitted on December 4, 2023, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

Review on May 8, 2024, of MR4 revealed the patient was admitted on December 19, 2023, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

Review on May 8, 2024, of MR5 revealed the patient was admitted on December 18, 2023, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

Review on May 8, 2024, of MR6 revealed the patient was admitted on December 18, 2023, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

Review on May 8, 2024, of MR7 revealed the patient was admitted on March 1, 2024, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

Review on May 8, 2024, of MR9 revealed the patient was admitted on March 14, 2024, for a procedure. Further review revealed the signed surgical informed consent form did not contain documentation of the risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical center instead of a hospital.

An interview conducted on May 9, 2024, with EMP1 confirmed the above findings.





 Plan of Correction - To be completed: 05/24/2024

The clinical director identified that 551.21 (e) (3), The comparative risks, benefits, and alternatives associated with performing the procedure in the ambulatory surgical facility instead of a hospital has not been indicated on informed consent documentation. The criteria above has been added to the General Surgery Consent, Anesthesia Consent and HSG informed consent, which will encompass all procedures performed at Fertility Partners of Pennsylvania Surgery Center. The Clinical Director will present the revised form to the Governing Body for approval on 5/22/2024 and utilization of updated forms will begin 5/24/2024.
An Inservice will be provided to staff, physicians, CRNAs, NP and PAs by 5/24/2024 to ensure understanding of requirement criteria.
Compliance will be met by conducting a revision to the current General Surgery Consent, Anesthesia Consent and HSG informed consent to include, The comparative risks, benefits, and alternatives associated with performing the procedure in the ambulatory surgical facility instead of a hospital. All previous General Surgery Consents, Anesthesia Consents and HSG Informed consent forms will be taken out of distribution by 5/23/2024. The clinical director or designee will review all Consent Forms prior to patient procedures and report findings to the Quality Assurance Performance Committee quarterly if discrepancies are noted.

561.25 LICENSURE Distressed drugs, devices and cosmetics:State only Deficiency.
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 review of facility policy, observation, and interview with staff (EMP), it was determined the facility failed to discard expired medications according to facility policy.

Findings include:
A review of facility policy "Administration of Medication/Medication Control and Accountability" effective 8/8/2017, revealed "... 6. Outdated, Discontinued, Deteriorated and Recalled Drugs a. The drug storage and preparation areas shall be devoid of outdated, discontinued, recalled or otherwise unusable drugs. ... i. All outdated drugs will be destroyed and disposed OR All outdated drugs will be returned to the supplier. ii. The Clinical Director or designee inventories all drug supplies at least once per month for outdated medications ..."

A review of facility policy "Pharmacy Services" revised 9/23/2020, revealed "... The Clinical Director or designee will check all routine medications for expiration, deterioration, appropriate labeling, recalls, etc., on a monthly basis ..."

Observation on May 9, 2024, at 1:00 PM revealed a box of 3-0 Vicryl Sutures containing 22 packets that were expired (expired 10/31/2022).

An interview conducted on May 9, 2024, at 1:30 PM with EMP1 confirmed the above findings.







 Plan of Correction - To be completed: 06/01/2024

The clinical director identified that the facility was not in compliance with discarding expired medications. Review of Clinical Policy #75 had, line 6 (ii) revision made to include The Clinical Director or assigned designee inventories all drug supplies at least once per month to identify any outdated medications and supplies. To ensure compliance for inspection of expired medications and supplies, the center will utilize the Expiration Inspection Form, originated 5/14/2024. The Expiration Inspection Form will include signature and date inspection conducted, not to exceed the last day of each month. The Expiration Inspection Form will be utilized 5/24/2024 following completion of Inservice. The Expiration Inspection Form and revision of Policy #75 will be presented to the Governing Body for approval on 5/22/204. The first month of form utilization will begin June 1st, 2024.
An Inservice will be provided to staff, physicians, CRNAs, NP and PAs by 5/24/2024 to ensure understanding of Policy and Documentation Requirements.
Compliance will be completed by conducting a monthly audit of inspection completion for 7 months, the remainder of the year. If compliance is not met at 100%, audit will continue until 100% compliance is met for 3 consecutive months. Data collection and review will include monitoring compliance of all staff actively participating in the inspection of expired medications and supplies.
Data will be reported to our Quality Performance Improvement Committee on a quarterly basis for the remainder of the year or until 100% compliance is met.



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