QA Investigation Results

Pennsylvania Department of Health
Health Inspection Results
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Initial Comments:

This report is the result of an Annual Registration survey conducted on May 10, 2022, at PPSP West Chester Health Center. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.

Plan of Correction:

29.33(1) STANDARD
Requirements for Abortion

Name - Component - 00
Each medical facility shall have readily available equipment and drugs necessary for resuscitation. If local anesthesia is utilized to perform an abortion in a medical facility during the first trimester, then the following equipment shall be ready to use for resuscitative purposes:

(i) Suction Source
(ii) Oxygen Source
(iii) Assorted size oral airways and endotracheal tubes
(iv) Laryngoscope
(v) Bag and mask and bag and endotracheal tube attachments for assisted ventilation
(vi) Intravenous fluids including blood volume expanders
(vii) Intravenous catheters and cut-down instrument tray
(viii) Emergency drugs for shock and metabolic imbalance
(ix) An individual to monitor respiratory rate, blood pressure and heart rate.


Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to ensure non-licensed employees who monitored the patients' blood pressure had training and competencies for five of five non-licensed personnel files (PF) reviewed (PF1, PF2, PF3, PF4, PF5)

Findings include:

Review of Laboratory quality assessment policy and work plan Creation Date: October 2013, Revised date: March 1, 2021, "VII Laboratory Competency Assessment Procedure: ... 2. As per the Clinical Laboratory Improvements Amendment, the following six procedures are the minimal requirements for assessment of competency for all Laboratory Testing Personnel: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing, and testing. ... 3. At PPSP, the Technical Consultant will ensure that all Testing Personnel are evaluated for competency on a yearly basis. The Center Manager will arrange for clinical observations of the lab Testing Personnel, and the Technical Consultant/Lab Supervisor will directly observe the Testing Personnel individually."

Review of PF1, PF2, PF3, PF4, and PF5 Laboratory Personnel Competency Record did not show any blood pressure competencies.

Interview with EMP1 on May 11, 2022, at 11:30 AM confirmed there were no blood pressure competencies.


Based on review of facility documents, observation, and staff interview (EMP) it was determined the facility failed to ensure intravenous tubing and alcohol pads were not expired in the emergency cart.

Findings include:

Review of facility Policy: "Inventory Management - Inventory Storage and Monthly Counts: Creation Date: 6/25/15, Revised Date: 10/25/2017 ... Emergency Medication and Supplies: Emergency medication and supplies are inventoried and ordered in advance of expiration dates, however if emergency supplies are used or wasted replacement must be expedited. They may require off schedule ordering and delivery which is pre-approved by Patient Services Administration."

Observation of the emergency cart revealed four intravenous tubing (a soft flexible tube placed inside a vein to provide fluid and / or medication) were expired with expiration date of 9/19/21. Twenty alcohol pads (used to clean your skin prior to injection) were expired with expiration date of 2016.

Interview with EMP1 on May 11, 2022, at 1:15 PM confirmed the items were expired.

Plan of Correction:

Blood pressure monitoring:
To correct the finding and ensure ongoing compliance, the facility's Laboratory Quality Assessment Program Policy was updated on 5/11/22, to include the requirement for non-licensed employees who monitor blood pressure to have initial training and annual competency review. Specifically, the policy was updated with the following language "Lab testing personnel must be trained and approved as competent in order to perform vitals (including blood pressure) on patients independently. New employee training is documented using a training checklist and includes instruction, observation, performance under supervision, completion of CAL training courses, and competency sign-offs. Personnel are reviewed on an annual basis; competency documentation is completed on the lab audit tool of their performance evaluation." Training records will be kept in center-based personnel files.  

By 6/30/22, all non-licensed employees who monitor blood pressure will have successfully completed their competency check with observation and sign-off by the technical consultant/lab supervisor. The Center Manager will ensure completion of competency review with documentation on the Lab Competency Record. PPSP's Risk and Quality Management (RQM) Coordinator will audit the lab competency forms to ensure all non-licensed staff have evidence of competency no later than 7/30/22 and once completed will audit annually.

The Director of Patient Services will ensure the Plan of Correction is implemented and compliance is maintained.

Emergency cart expired items:
Immediately following the 5/10/22 site visit, the Center Manager removed and replaced the expired intravenous tubing and alcohol pads and informed the RN of the expired items and of the PPSP policy.

The Director of Clinical Services is responsible for ensuring staff understand and follow the existing PPSP policy Medical and Surgical Emergencies, which states "Fully stocked kits are to be kept locked with breakaway locks with expiration date of all medication clearly marked on outside of kit. Supplies and expiration dates to be checked monthly and documented on Emergency Kit Supply List". By 6/15/22, the Director of Clinical Services will communicate the findings and the policy requirements to the facility staff including recovery room nurses, providing training as needed. Training will be documented using sign-off sheets that will be maintained in the facility training files.

By 6/30/22, the Center Manager will review with facility staff where to locate expiration dates on packaging, where to document dates and how to ensure supplies are ordered in a timely fashion. For monitoring compliance, the Center Manager will audit the emergency cart for outdated medications and materials twice a month for 3 months, with the first audit being completed by 7/15/22. After 3 months, the Center Manager will return to once a month checks.

By 7/30/22, the Risk and Quality Management (RQM) Coordinator will conduct a site visit and will review the audits to date and will open the emergency cart to check contents and their expiration dates. The RQM coordinator will monitor the completion of the twice monthly audit and after 3 months, will return to annual reviews of the Emergency Kit Supply List.

The Director of Patient Services will ensure the Plan of Correction is implemented and compliance is maintained.