Initial Comments:
This report is the result of a State licensure survey conducted on August 21, 2024, at Capital Surgery and Laser 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:
553.3 (1) LICENSURE
Governing Body Responsibilities
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553.3
Governing Body responsibilities include:
(1) Conforming to all applicable Federal, State, and local laws.
Observations:
Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to conform to all applicable State laws.
The facility was not in compliance with the following state law:
"Act 13 of 2002 MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR (MCARE) ACT Section 307. Patient safety plans.
(a) Development and compliance--A medical facility shall develop, implement and comply with an internal patient safety plan that shall be established for the purpose of improving the health and safety of patients. The plan shall be developed in consultation with the licensees providing health care services in the medical facility.
(b) Requirements--A patient safety plan shall:
(1) Designate a patient safety officer as set forth in section 309.
(2) Establish a patient safety committee as set forth in section 310.
(3) Establish a system for the health care workers of a medical facility to report serious events and incidents which shall be accessible 24 hours a day, seven days a week.
(4) Prohibit any retaliatory action against a health care worker for reporting a serious event or incident in accordance with the act of December 12, 1986 (P.L.1559, No.169), known as the Whistleblower Law.
(5) Provide for written notification to patients in accordance with section 308(b).
Section 310. Patient safety committee.
(b) Responsibilities.--A patient safety committee of a medical facility shall do all of the following:
(1) Receive reports from the patient safety officer pursuant to section 309.
(2) Evaluate investigations and actions of the patient safety officer on all reports.
(3) Review and evaluate the quality of patient safety measures utilized by the medical facility. A review shall include the consideration of reports made under sections
304(a)(5) and (b), 307(b)(3) and 308(a).
(4) Make recommendations to eliminate future serious events and incidents.
(5) Report to the administrative officer and governing body of the medical facility on a quarterly basis regarding the number of serious events and incidents and its recommendations to eliminate future serious events and incidents.
This is not met as evidenced by:
Based on review of facility documents and interview with staff (EMP), it was determined the facility failed to have a stand alone Patient Safety Committee.
Findings include:
Review of facility's meeting minutes, "Patient Safety & Quality Assurance Performance Improvement (QAPI) Committee Meeting Minutes" dated April 24, 2024, January 16, 2024, and October 24, 2023, revealed the facility was having combined Patient Safety and Quality Assurance Committee Meetings.
Interview with EMP1 on August 21, 2024, EMP1 confirmed the Patient Safety Meetings and QAPI Meetings were conducted at the same time.
Plan of Correction:The Administrator informed all Patient Safety committee members of the surveyor's observations and findings.
Administrative Policy 160- Subcommittee Meetings was created and approved. Per Policy 160, each subcommittee must be a stand-alone committee and must have a stand-alone meeting and individual meeting minutes.
Our center's Patient Safety Committee and Quality Assurance Committee was separated from a combined committee meeting into two separate committee meetings.
The Patient Safety Committee is now a stand-alone committee. This change will be effective for our 3rd quarter subcommittee meetings scheduled on October 16, 2024.
Education pertaining to Policy 160 and Act 13 of 2002 Medical Care Availability and Reduction of Error (MCARE) Act Section 307 will be provided to all committee members. The education will require all committee members to acknowledge understanding by signing a document.
The administrator will provide findings from the survey, corrective actions and results to the Governing Board, Patient Safety Committee and QAPI Committee.
555.12 LICENSURE
Medical Orders - Oral Orders
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§ 555.12. Oral orders.
Oral orders for medication or treatment shall be accepted only under urgent
circumstances when it is impractical for the orders to be given in written manner
by the responsible practitioner. Oral orders shall be administered in accordance
with § 555.13 (relating to administration of drugs) only by personnel qualified by
their professional license or certification issued by the Commonwealth and
according to medical staff bylaws or rules, who shall document the orders in the
proper place in the medical record of the patient. The order shall include the date,
time and full signature of the person taking the order and shall be countersigned
by a practitioner within 48 hours of the order. If the practitioner is not the attending
physician, the practitioner shall be authorized by the attending physician and
shall be knowledgeable about the patient ' s condition. Countersignatures may be
received by facsimile transmission.
Observations:
Based on review of facility documents, medical records (MR), and employee (EMP) interview it was determined the facility failed to ensure oral orders for a medication was countersigned by a practitioner within 48 hours of the order for one of ten MR reviewed (MR3).
Findings include:
On August 21, 2024, review of facility policy "Medication Usage and Control" last approved by the Board July 11,2023, revealed "Purpose: To establish a system for the use and control of medications used within Capital Surgery and Laser Center. Pharmaceuticals are provided to meet patient needs in accordance with ethical and professional practice and applicable Federal and state laws. Procedure: 12. Oral orders must be followed by a written order signed bya a practitioner knowledgeable about the patient's condition prior to the patient being discharged."
On August 21, 2024, review of MR3 revealed on April 15, 2024, at 10:17 AM a verbal order for 30mg of Ketorolac via IV was entered by EMP2 (Registered Nurse). There was no signature noted on the verbal order by a practitioner.
Interview with EMP1 on August 21, 2024, confirmed the verbal order noted above did not have a signature by a practitioner.
Plan of Correction:The Administrator and Director of Nursing informed all appropriate clinical staff of the surveyor's observations and findings relating to Policy 414, Medication Usage and Control. Per Capital Surgery and Laser Center Policy 414, all oral/verbal orders must be followed by a written order signed by a surgeon and/or an CRNA knowledgeable about the patient's condition prior to the patient being discharged.
Policy 414 was reviewed. Our center's physician order form was reviewed and revised to reflect the required surgeon and/or CRNA signature.
Education will be provided to all appropriate clinical staff regarding required signatures, required documentation for verbal/oral orders and any other pertinent information pertaining to Regulation 555.12 (Medical Orders- Oral Orders) and Policy 414- Medication Usage and Control. The education will require staff to acknowledge understanding by signing a document.
Once 100% compliance of staff education is achieved, audits and education will be conducted on an annual basic to ensure understanding.
The administrator will provide findings from the survey, corrective actions and results to the Governing Board, Patient Safety Committee and QAPI Committee.
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