Initial Comments:
This report is the result of a State licensure survey completed on July 25, 2024, at The Children's Hospital of Philadelphia Brandywine Valley Specialty Care and 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:
567.42 (a) LICENSURE
Policies and Procedures
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567.42 Policies and procedures
(a) A schedule of preventive maintenance shall be developed for the
physical plant, biomedical and all other equipment.
Observations:
Based on review of facility documents, observation and interview with staff (EMP), it was determined the facility failed to ensure the developed schedule of preventive maintenance was followed for all equipment.
Findings include:
Review of facility policy "Medical Equipment Management Program," effective 1/1/2024, revealed "... EQUIPMENT PREVENTIVE MAINTENANCE/ INSPECTION INTERVALS The hospital identifies the activities and associated frequencies in writing for maintaining, inspecting, and testing all medical equipment on the inventory. These activities and associated frequencies are in accordance with manufacturer's recommendations or with strategies of an alternative equipment maintenance (AEM) program. Note1: The strategies of an AEM program must not reduce the safety of equipment and must be based on accepted standards of practice, such as the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook ANSI/AAMI EQ56:2013, Recommended Practice for a Medical Equipment Management Program. Note2: Medical equipment with activities and associated frequencies in accordance with manufacturers' recommendations must have a 100% completion rate. Note3: Scheduled maintenance activities for both high-risk and non-high risk medical equipment in an alternative equipment maintenance (AEM) program inventory must have a 100% completion rate ..."
Observation on July 24, 2024, revealed a Medtronics NIM Vital (nerve monitoring equipment) with an inspection sticker that was past due for inspection in May 2024.
Interview on July 24, 2024, at 1:15 PM, with EMP1 confirmed the above findings.
Plan of Correction:Immediately following the survey, Biomedical Engineering reviewed the Computerized Maintenance Management System (CMMS) to identify when the last preventive maintenance was conducted on the Medtronics NIM Vital equipment. It was identified that there was a technical issue surrounding the data migration when the Biomedical department transitioned from one CMMS to another in August 2023. This identified piece of equipment did not have an assigned maintenance schedule so therefore did not automatically generate a work order within the month it was due for maintenance. On 7/25/24 the Medtronics NIM Vital was inspected and the preventative maintenance record was populated. No issues were identified with the equipment. The piece of equipment was immediately associated with a maintenance definition upon discovery.
Policy review: The policy, Medical Equipment Management Program, was reviewed, and revisions were made to list out CHOP's ambulatory surgical centers individually within the document.
Staff education: All Biomed staff will be re-educated to report any device without an automated work order and requires preventative maintenance. There is an active request form to request any change in maintenance scheduling. Staff education will be conducted through both a department and leadership meeting, with detailed meeting minutes recorded for reference. Attendance will be tracked to ensure all relevant personnel are present. A follow-up email will be sent to all staff for each meeting to ensure those who are unable to attend are informed.
CMMS Audit: The Clinical Engineering team will conduct an internal review of the medical device database to confirm all devices that require preventative maintenance are actively linked to a maintenance schedule. Data will be analyzed and compared to the prior CMMS if needed.
CMMS Control Measures: With the transition to the new CMMS, controls have previously been implemented to ensure all new devices onboarded trigger a task to be automatically generated. This task is to confirm the device is part of a maintenance schedule if required. The Clinical Engineering team will continue to look at additional enhancement measures which could be implemented to prevent any human or technical error which may result in such a finding.
Audit results will be reported to the Environment of Care Committee.
The Sr. Director Biomedical Engineering & Clinical Technology Services is responsible for the plan of correction.
569.35 (7) LICENSURE
General Safety Precautions
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569.35 General Safety Precautions
The following safety precautions shall be met:
(7) Only nonflammable agents may be present in a surgical suite.
Observations:
Based on review of facility documents, medical records (MR) and staff interview (EMP), it was determined the facility failed to follow their established policy regarding skin preparation for three of ten medical records reviewed (MR5, MR7, and MR9).
Findings include:
Review on July 24, 2024, of the facility policy "Preoperative/Pre-procedural Skin Preparation Policy Brandywine" with an effective date of March 11, 2024, revealed "... Intraoperative/pre-procedural Skin Site Preparation: Prior to skin site preparation, clinicians review and verify the patient's allergy and sensitivity status in the patient's electronic health record. It is recommended to use alcohol-containing pre-operative skin preparation agents if no contraindication exists. Hospital approved unit-dose applicators/packets of skin preparation solution that ensure controlled delivery to the patient include: 2% chlorhexidine gluconate with 70% IPA ... Povidone-iodine; and 70% Isopropyl Alcohol (IPA) All staff involved must use care to prevent pooling of the skin preparation solution at the incision/puncture site as well as beneath the patient ..."
Interview with EMP1 on July 25, 2024, revealed staff are to complete the site preparation form in the MR and answer the question "was skin prep dry before draping" by selecting yes or no.
Review of MR5 revealed a skin preparation was used and the question regarding skin prep being dry before draping was not answered.
Review of MR7 revealed a skin preparation was used and the question regarding skin prep being dry before draping was not answered.
Review of MR9 revealed a skin preparation was used and the question regarding skin prep being dry before draping was not answered.
Interview with EMP1 on July 25, 2024, confirmed the above findings.
Plan of Correction:Immediately following the survey, the policy on skin preparation was reviewed with the operating room staff.
The documentation wording in EPIC will be changed to read "For alcohol-based preps, was skin dry before draping?" The EPIC change was completed on 7/31/24.
The policy "Preoperative/Pre-procedural Skin Preparation Policy" will be updated to include the documentation skin dry before draping when using alcohol-based preps.
Staff education will include a clear explanation of the deficiency, including why it's a problem, how it affects patient care, a review of the policy, and the new verbiage for documenting skin dry before draping for alcohol-based preps. This will be completed through email and staff meetings.
The monitoring of corrective action plan will be completed through auditing of charts. Beginning the week of 8/5/24, a review of charts over the next three weeks will be conducted to ensure 100% compliance is achieved with the documentation of skin dry before draping when using alcohol-based preps.
Following the initial audit, monitoring will continue until 3 consecutive months of 100% documentation compliance is achieved.
The result of the audit will be reported to the ASC Steering Committee, Quarterly Patient Safety Meeting, and Quarterly Board Meeting.
The ASC Administrator is responsible for the plan of correction.
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