Pennsylvania Department of Health
AMBULATORY SURGERY CENTER AT ST MARY, LLC, THE
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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AMBULATORY SURGERY CENTER AT ST MARY, LLC, THE - 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 onsite on February 15, 2024, at the Ambulatory Surgery Center at St. Mary. 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:

51.31 LICENSURE Exceptions - Principle:

51.31. Principle

The Department may grant exceptions to this part when the policy and objectives contained therein are
otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.

Observations:

Based on review of facility document, review of personnel files (PF) and Credential Files (CF) and interviews with staff (EMP), it was determined the facility failed to provide the annual mandatory education for an exception granted by the Department in four of eight Personnel Files reviewed (PF1, PF3, PF5, and PF6) and six of seven Credential Files reviewed (CF1, CF2, CF3, CF5, CF6, and CF7).

Findings Include:

Review on February 15, 2024, of the facility's exception letter from the Department, dated July 8, 2011, relating to the use of flammable agents in the surgical suite revealed the facility was required to provide annual mandatory education regarding the use of flammable agents in the surgical suite to its employees.

Review on February 15, 2024, of PF1, PF3, PF5, and PF6 revealed no documented evidence these employees received annual mandatory education as required by the Department's exception granted to the facility on July 8, 2011.

Review on February 15, 2024, of CF1, CF2, CF3, CF5, CF6, and CF7 revealed no documented evidence these medical providers received annual mandatory education as required by the Department's exception granted to the facility on July 8, 2011.

An interview on February 15, 2024, around 2:15PM with EMP1 and EMP2 confirmed the above findings.

Plan of Correction - To be completed: 03/31/2024

Chloraprep training has been developed by the Director of Nursing to include training video followed by attestation and post-test to be assigned to all staff involved in the use of surgical skin preparations that contain combustible agents. This activity is currently being administered to staff members and has been added to our annual training program moving forward. Completion of training for 2024 target date is March 31, 2024.

555.22 (c)(1-5) LICENSURE Surgical Services - Preoperative Care:

555.22 Pre-operative Care

(c) Written instruction for preoperative procedures, which have been approved by the medical
staff, shall be given to the patient or responsible person, and shall include:
(1) Applicable restrictions upon food and drink before surgery
(2) Special preparations to be made by the patient
(3) The required proximity of the patient to the ASF for a specific time following surgery if applicable.
(4) An understanding that the patient may require admission to the hospital in the event of medical need.
(5) The requirement that, upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether such patients require a responsible person to escort them home.

Observations:

Based on review of medical records (MR), and interviews with staff (EMP), it was determined the facility failed to ensure the patient was informed of the possibility of transfer to another facility in case of medical necessity in ten of ten medical records reviewed (MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, and MR10).
Findings include:
Review on February 15, 2024, of MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, and MR10 revealed there was no documented evidence in these medical records that the patients were informed of the possibility of transfer to another facility in case of medical necessity.
Request was made to EMP1 on February 15, 2024, for documented evidence that the patients in MR1, MR2, MR3, MR4, MR5, MR6, MR7, MR8, MR9, and MR10 were made aware of the possibility of transfer to another facility in case of medical necessity. None was provided.
An interview on February 15, 2024, at approximately 2:30 PM with EMP1 and EMP2 confirmed the above findings.

Plan of Correction - To be completed: 03/31/2024

Effective 2/29/24, the following language has been added to our facility Consent for Treatment as well as included in our pre-admission contact questionnaire in our EMR:
"I understand that I may be transferred to another facility or hospital in case of medical necessity or in the event of an emergency."

EVERY patient signs the electronic Consent for Treatment upon arrival and check-in at the facility without fail - they cannot proceed to preop unless this step is complete. This ensures the correct form is applied to all patients from the implementation date forward.
Nurses will additionally document patient acknowledgement during pre-operative phone call in EMR, this has been added as a hard-coded question in our preop phone call section which the RN must acknowledge.
The updated consent has been temporarily approved for use but will be formally approved by Board of Managers on 3/11/24.
The Director of Nursing will audit 10 charts every two weeks for two weeks to ensure the new consent form has been properly adapted.
The Administrator has full responsibility to ensure this plan of correction is fully implemented.

567.41 LICENSURE MAINTENANCE SERVICE - Principle:

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 observation, and review of facility documents, and interview with staff (EMP), it was determined the facility failed to ensure preventive maintenance was performed on equipment.
Findings include:
Observation on February 15, 2024, of facility equipment revealed two (2) Styker High Vacuum machines, in a closet, without stickers indicating preventive maintenance was performed.
An interview on February 15, 2024, at approximately 11:30 AM with EMP1 confirmed the above findings. EMP1 further confirmed preventative maintenance was required for the above equipment and the equipment is currently used by the facility.

Plan of Correction - To be completed: 03/01/2024

Biomedical services was called on-site immediately after survey and the machine was inspected February 15, 2024.
A meeting was then held between facility leadership and biomedical contractor to discuss future process and ensuring inspection of all items. The Director of Nursing, OR Coordinator and any applicable leadership will meet with biomedical services annually at inspection time (December 2024) to review all equipment in facility and compare to master list.
The Administrator has full responsibility to ensure this plan of correction is fully implemented).

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