Pennsylvania Department of Health
LAUREL LASER & SURGERY CENTER, L.P.
Patient Care Inspection Results

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Severity Designations


Minimal Citation - No Harm	Minimal Harm	Actual Harm	Serious Harm

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LAUREL LASER & SURGERY CENTER, L.P. - 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 18, 2024, at Laurel Laser & Surgery Center, L.P. 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:

Initial comments:
This report is the result of a State licensure survey conducted on April 18, 2024, at Laurel Laser & Surgery Center, L.P. It was determined the facility was in compliance with the requirements of 35 P.S. 448.809 (b).

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 review of medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure the comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital were included in obtaining informed consent for two of 10 medical records reviewed. (MR7, MR10)

Finding include:

1. Review of informed consent documents in MR7 and MR10 revealed no documentation that the comparative risks, benefits and alternatives associated with performing the procedure in the ambulatory surgical facility instead of in a hospital were included in the informed consent process.

2. Interview with EMP1 and EMP2 on April 18, 2024, confirmed the findings.

Plan of Correction - To be completed: 04/30/2024

The facility's failure to ensure the comparative risks, benefits, and alternatives associated with performing the procedure in an ambulatory surgical facility instead of a hospital will be addressed and corrected in the following manner:

The informed consent document that is reviewed by the surgeon at the time of surgical evaluation with the patient will be addended to include the verbiage: "By signing this consent, I agree that I have been informed of the comparative risks, benefits, and alternatives associated with performing the procedure at the Laurel Laser and Surgery Center, L.P. in Brookville, Pennsylvania, an ambulatory surgical facility instead of a hospital setting." The facility's name will be clearly stated at the top of the informed consent as well.

The Clinical Director/Administrator assumes responsibility of the development of the addended form by April 29, 2024, and will be presented to the Governing Body for approval on April 30, 2024.

The Clinical Director/Administrator assumes responsibility for implementation of the corrected form as well as the education of both Medical and clinical personnel, with supporting documentation, prior to May 13, 2024. Should non-compliance be identified, staff will be instructed to notify the Clinical Director/Administrator immediately, at which time, the Clinical Director/Administrator will determine the need for re-education and provision thereof. Non-compliance will be documented and be reported to the Governing Body. The Clinical Director/Administrator will monitor the compliance of the new form beginning on May 13, 2024. If the addended version of the informed consent is not signed prior to the date of surgery, it will be signed on the day of surgery by the surgeon, patient, and witness in the pre-operative area. 10 records per surgery day will be reviewed for complete documentation of the new form. This will be done for 30 days, or until 100% compliance is achieved. Results will be documented and reported to the Quality Improvement committee beginning on June 11, 2024.

555.11 (a) LICENSURE MEDICAL ORDERS - Written:

555.11 Medical orders
Written orders

(a) Medication or treatment shall be administered by authorized persons to administer drugs and medications only upon written and signed orders of a practitioner acting within the scope
of the practitioner's license.

Observations:

Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure that complete medication orders were written for nine of 10 medical records reviewed. (MR1-MR6, MR8-MR10)

Findings included:

Review of policy entitled "Pharmaceutical Services", revealed "... The physician is responsible for writing/giving medication orders. Drugs will be administered to patients only upon written, verbal, or telephone order of a physician ... ."

1. Review of MR1-MR6 and MR8-MR10 revealed preoperative and/or intraoperative, and or postoperative physician orders for various eye drops. None of the orders indicated the right or left eye, stating only operative eye.

2. Interview with EMP1 and EMP2 on April 18, 2024, confirmed the findings.

Plan of Correction - To be completed: 04/30/2024

The lack of documentation identified regarding the ensuring that the completed medication orders were written for preoperative, intraoperative, and postoperative eye drops will be corrected in the following manner:

All medication orders will include a check-box for right eye, left eye, or bilateral eyes on electronic or written order forms. The surgeon will be responsible for selecting the appropriate site of administration, as well as all other required elements of medication orders according to Laurel Laser & Surgery Center's Policy and Procedure manual, section 15-2. Medication orders will not be executed unless a complete order is received. The Clinical Director/Administrator assumes responsibility for the development of the addended order forms by April 29, 2024, and will be presented to the Governing Body on April 30, 2024 for approval. The Medical Staff and clinical staff will receive education on the new documentation form and supporting policies, as listed above, before May 13, 2024 by the Clinical Director/Administrator, who will collect signed documentation at the time of education. Implementation of the form will be done no later than May 13, 2024 under the supervision of the Clinical Director/Administrator. Should non-compliance be identified, staff will be instructed to notify the Clinical Director/Administrator immediately, at which time the Clinical Director/Administrator will determine the need for re-education and provision there-of. Any non-compliance will be reported to the Governing Body. The Clinical Director/Administrator will monitor compliance of the new form beginning on May 13, 2024. 10 records per surgery day will be reviewed for complete documentation of the new form. This will be done for 30 days, or until 100% compliance is reached. Results will be reported beginning on June 11, 2024 to the Quality Improvement committee.

555.22 (b) LICENSURE Surgical Services - Preoperative Care:

555.22 Pre-operative Care

(b) A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of patient's clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who shall participate in the surgery.

Observations:

Based on review of medical records (MR), it was determined the facility failed to ensure that consent forms identified the practitioner participating in the surgery for eight of 10 medical records reviewed (MR1-MR6, MR8-MR9), and failed to identify the name of the facility in which the procedure was to be performed for 10 of 10 medical records reviewed. MR1-MR10)

1. Review of informed consent documents on MR1-MR6, MR8-MR9 revealed none identified the practitioner participating in the surgery.

2. Review of informed consent documents on MR1-MR10, revealed none identified the name of the faciltiy in which the procedure was to be performed.

3. Interview with EMP1 and EMP2 on April 18, 2024, confirmed the findings.

Plan of Correction - To be completed: 04/30/2024

The facility's failure to ensure that the informed consent identifies the practitioner participating in the surgery and the failure to identify the name of the facility in which the procedure is to be performed will be corrected in the following manner:
The informed consent document that is reviewed by the surgeon at the time of surgical evaluation with the patient will be addended to include the verbiage: "I authorize that [surgeon's name] has been identified as the practitioner responsible for performing my surgery at the Laurel Laser & Surgery Center." The surgeon's name will also be clearly identified at the top of the document.
The Clinical Director/Administrator assumes responsibility of the development of the addended form by April 29, 2024, and will be presented to the Governing Body for approval on April 30, 2024. The Clinical Director/Administrator assumes responsibility for implementation of the corrected form as well as the education of both Medical and clinical personnel, with supporting documentation, prior to May 13, 2024. Should non-compliance be identified, staff will be instructed to notify the Clinical Director/Administrator immediately, at which time, the Clinical Director/Administrator will determine the need for re-education and provision thereof. Non-compliance will be documented and be reported to the Governing Body. The Clinical Director/Administrator will monitor the compliance of the new form beginning on May 13, 2024. If the addended version of the informed consent is not signed prior to the date of surgery, it will be signed on the day of surgery by the surgeon, patient, and witness. 10 records per surgery day will be reviewed for complete documentation of the new form. This will be done for 30 days, or until 100% compliance is achieved. Results will be documented and reported to the Quality Improvement committee beginning on June 11, 2024.

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