Pennsylvania Department of Health
ST. LUKE'S ANDERSON AMBULATORY SURGERY CENTER
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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ST. LUKE'S ANDERSON AMBULATORY SURGERY CENTER - 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 30, 2024, at St. Luke's Anderson Ambulatory 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:

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 facility policies and procedures, review of medical records (MR) and interview with staff (EMP), it was determined the facility failed to ensure patients that received local anesthesia were medically cleared by the surgeon to leave the facility without a responsible person to escort them home for three of three medical records reviewed. (MR8, MR9, MR10).

Findings include:

Review on April 30, 2024, of facility policy "Discharge Criteria" reviewed 12/2023, revealed no documentation for the patient receiving local anesthesia, was to be evaluated prior to discharge, to determine if a responsible escort was needed.

Review on April 30, 204, of MR8, MR9 and MR10 revealed these patients had procedures performed at the facility using local anesthesia between February 8, 2024 to April 29, 2024. Further review of the above medical records revealed no documentation the patients were medically cleared by the physician to leave the facility without an responsible escort.

Interview on April 30, 2024, with EMP2 at approximately 10:30 AM confirmed there was no documentation in MR8, MR9 and MR10, the patients were cleared by the physician to be discharged from the facility without an responsible escort.

Plan of Correction - To be completed: 06/27/2024

The Medical Director of the ASC will be responsible for educating all providers that patients receiving local anesthesia must be medically cleared to leave the facility without a responsible person to escort them home. The Medical Director will also educate all providers that they must document this medical clearance in the patient's electronic medical record. The Administrator of the ASC will also educate all nursing staff that there needs to be documentation in the patient's electronic medical record that the patient is medically cleared to leave the hospital without a person to escort them home.

The Director of Nursing or designee will be responsible for performing audits of the electronic medical record of 10 patients receiving local anesthesia at the Anderson ASC monthly. The audits are to ensure patients have been medically cleared to leave the facility without a responsible person to escort them home.

The audits will be reviewed with the Administrator of the ASC monthly and will also be reviewed at the quarterly Quality/PI committee meeting. Additionally, issues of non-compliance will be reported to the Medical Director, who will then provide counseling and re-education to the non-compliant provider(s). The Administrator is ultimately responsible for the plan of correction.

555.33 (d)(1) LICENSURE Anesthesia Policies and Procedures:

555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(1) A patient requiring anesthesia shall have a pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.

Observations:

Based on review of facility policy, medical records (MR) and interview with staff it was determined the facility failed to provide pertinent information to the patient regarding the choice of anesthesia for three of three medical records reviewed. (MR8, MR9, MR10)

Findings include:

Review on April 30, 2024, of facility policy "Informed Consent" revised 12/2023, revealed "... In order to obtain informed consent, the treating physician should first engage in a discussion with the patient about the proposed treatment. The treating physician has the affirmative responsibility to provide sufficient information to enable the patient to give an informed consent. The patient gives informed consent when they grant permission for treatment based upon a realistic understanding of the treatment's potential risks and benefits and of the available alternatives to the proposed treatment...."

Review on April 30, 2024, of MR8, revealed the patient presented to the surgery center on February 8, 2024, for a procedure that required the use of local anesthesia. Further review of physician documentation "Informed Consent for Surgical or Diagnostic Procedures," dated January 5, 2024, revealed "... 7. I understand and consent to the administration of conscious sedation ..." The document was signed and dated by a signature that represented the patient identified in MR8 and provider obtaining the informed consent.

Review on April 30, 2024, of MR9, revealed the patient presented to the surgery center of February 12, 2024, for a procedure that required the use of local anesthesia. Further review of physician documentation "Informed Consent for Surgical or Diagnostic Procedures," dated February 1, 2024, revealed "... 7. I understand and consent to the administration of conscious sedation ..." The document was signed and dated by a signature that represented the patient identified in MR9 and provider obtaining the informed consent.

Review on April 30, 2024, of MR10, revealed the patient presented to the surgery center of February 12, 2024, for a procedure that required the use of local anesthesia. Further review of physician documentation "Informed Consent for Surgical or Diagnostic Procedures," dated March 24, 2024, revealed "... 7. I understand and consent to the administration of conscious sedation ..." The document was signed and dated by a signature that represented the patient identified in MR10 and provider obtaining the informed consent.

Interview on April 30, 2024, with EMP1 at approximately 10:30 AM confirmed there was no documenation in MR8, MR9, MR10, the patient was provided an informed consent for the use of local anesthesia.

Plan of Correction - To be completed: 06/27/2024

The Medical Director of the ASC will be responsible for educating all providers that patients receiving local anesthesia must be informed regarding their choice of anesthesia. Providers were educated that when completing the informed consent, "with local anesthesia" must be documented as part of the procedure being performed. Additionally, providers were educated that the mention of conscious sedation on the informed consent must be struck out.

The Administrator of the ASC will educate all nursing staff that providers must document "with local anesthesia" on the procedure line of the informed consent and the mention of conscious sedation on the informed consent must be struck out.

The Director of Nursing or a designee will be responsible for performing audits of the informed consent of 10 patients receiving local anesthesia at the Anderson ASC monthly. The audits are to ensure patients receiving local anesthesia have been informed regarding their choice of anesthesia and the mention of conscious sedation on the informed consent was struck out.

The audits will be reviewed with the Administrator of the ASC monthly and will also be reviewed at the quarterly Quality/PI committee meeting. Additionally, issues of non-compliance will be reported to the Medical Director, who will then provide counseling and re-education to the non-compliant provider(s). The Administrator is ultimately responsible for the plan of correction.

555.33 (d)(8)(i-v) LICENSURE Anesthesia Policies and Procedures:

555.33 Anesthesia policies and procedures

(d) Anesthesia procedures shall provide at least the following:
(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:
(i) level of activity
(ii) respirations
(iii) blood pressure
(iv) level of consciousness
(v) oxygen saturation by pulse oximetry.

Observations:

Based on a review of facility policy, medical records (MR) and interview with staff (EMP), it was determined that the facility failed to ensure patients were evaluated for proper anesthesia recovery by the operating room surgeon, prior to discharge for three of three medical records reviewed (MR8, MR9, MR10) and failed to adopt a policy for a post-operative evaluation of patients that received anesthesia

Findings include:

A request was made on April 30, 2024, for a policy related to post-operative evaluation for patients that received anesthesia. None provided.

Review on April 30, 2024, of MR8 revealed the patient was admitted to the surgery center on February 8, 2024, for a procedure that required the use of anesthesia. Further review of MR8 revealed no documentation the patient was evaluated for recovery from anesthesia prior to discharge.

Review on April 30, 2024, of MR9 revealed the patient was admitted to the surgery center on February 12, 2024, for a procedure that required the use of anesthesia. Further review of MR9 revealed no documentation the patient was evaluated for recovery from anesthesia prior to discharge.

Review on April 30, 2024, of MR10 revealed the patient was admitted to the surgery center on April 29, 2024, for a procedure that required the use of anesthesia. Further review of MR9 revealed no documentation the patient was evaluated for recovery from anesthesia prior to discharge.

Interview on April 30, 2024, at approximately 10:30 AM with EMP1 confirmed a post-anesthesia evaluation was not completed for MR8, MR9 and MR10 and the facility failed to adopt a policy for a post-operative evaluation of patients that received anesthesia.

Plan of Correction - To be completed: 06/27/2024

The Medical Director of the ASC will be responsible for educating all providers that patients receiving local anesthesia must be evaluated for proper anesthesia recovery prior to discharge.
Additionally, providers will be educated that they must document in the patient's electronic medical record that the patient was evaluated for proper anesthesia recovery prior to discharge. The Administrator of the ASC will also educate all nursing staff that providers must evaluate patients for proper anesthesia recovery prior to discharge and this must be documented in the electronic medical record.

The Administrator of the ASC will develop a Local Anesthesia policy which includes the requirement to have a post-operative evaluation of patients receiving local anesthesia. All staff will be educated on this new policy by the Administrator of the ASC.

The Director of Nursing or designee will be responsible for performing audits of the electronic medical record of 10 patients receiving local anesthesia at the Anderson ASC monthly. The audits are to ensure patients receiving local anesthesia have been evaluated for proper local anesthesia recovery prior to discharge.

The Local Anesthesia policy will be reviewed annually, or as needed, by the Administrator and the Director of Nursing. Additionally, the policy will be reviewed at the Quality/PI committee meeting annually.

The audits will be reviewed with the Administrator of the ASC monthly and will also be reviewed at the quarterly Quality/PI committee meeting. Additionally, issues of non-compliance will be reported to the Medical Director, who will then provide counseling and re-education to the non-compliant provider(s). The Administrator is ultimately responsible for the plan of correction.

The local anesthesia policy will be reviewed annually, or as needed, by the Administrator and the Director of Nursing. Additionally, the policy will be reviewed at the Quality/PI committee meeting annually.

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