553.3
Governing Body responsibilities include:
(1) Conforming to all applicable Federal, State, and local laws.
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Observations:
Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to conform to all applicable State Laws.
Village Surgicenter Of Erie was not in compliance with the following State Laws:
Act 13 of 2002 Medical Care Availability and Reduction of Error (MCARE) Act, Chapter 3. Patient Safety ... Section 310. Patient safety committee. ... (2) An ambulatory surgical facility's, abortion facility's or birth center's patient safety committee shall be composed of the medical facility's patient safety officer and at least one health care worker of the medical facility and one resident of the community served by the ambulatory surgical facility, abortion facility or birth center who is not an agent, employee or contractor of the ambulatory surgical facility, abortion facility or birth center. No more than one member of the patient safety committee shall be a member of the medical facility's board of governance. The committee shall include members of the medical facility's medical and nursing staff. The committee shall meet at least quarterly. (2) amended May 1, 2006, P.L.103, No.30) ... "
Act 52 of 2007 Medical Care Availability and Reduction of Error (MCARE) Act - Reduction and Prevention of Health Care-Associated Infection and Long-Term Care Nursing Facilities, Act 52 of 2007. Section 403. Infection control plan. (a) Development and compliance, -- Within 120 days of the effective date of this section, a health care facility, and an ambulatory surgical facility shall develop and implement an internal infection control plan that shall be established for the purpose of improving the health and safety of patients and health care workers and shall include: (1) A multidisciplinary committee including representatives from each of the following if applicable to that specific health care facility: (i) Medical staff that could include the chief medical officer or the nursing home medical director (ii) Administration representatives that could include the chief executive officer, the chief financial officer or the nursing home administrator (iii) Laboratory personnel (iv) Nursing staff that could include a director of nursing or a nursing supervisor(v) Pharmacy staff that could include the chief of pharmacy(vi) Physical plant personnel (vii) A patient safety officer (viii) Members from the infection control team, which could include an epidemiologist (ix) The community, except that these representatives may not be an agent, employee or contractor of the health care facility or ambulatory surgical facility.
This is not met as evidenced by:
Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to ensure that the Patient Safety Committee met independent from other facility committees.
Findings include:
1. Review, at approximately 1:30 PM, on June 28, 2023, of the facility meeting minutes revealed Patient Safety, Quality, and Infection Control meetings were combined for the following meeting dates reviewed September 7, 2022, November 18, 2022, March 1, 2023, and May 8, 2023.
EMP3 confirmed the above findings at approximately 2:40 PM, on June 28, 2023.
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Based on review of facility documentation and employee interview (EMP), it was determined the facility failed to ensure the Infection Control Committee met independent from other facility committees.
Finding include:
Review on May 4, 2021, at approximately 2:30 PM of "Infection Control", no date, revealed "SUBJECT: INFECTION CONTROL ... POLICY: 1. The Center will have an Infection Control Program and noted infections will be reviewed and reported through the Performance Improvement Plan. 2. The Center must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice. 3. The Center must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. The infection control and prevention program require compliance with state and federal regulations, including Occupational Safety and Health Administration (OSHA). ..."
1. Review, at approximately 1:30 PM, on June 28, 2023, of the facility meeting minutes revealed Patient Safety, Quality, and Infection Control meetings were combined for the following meeting dates reviewed September 7, 2022, November 18, 2022, March 1, 2023, and May 8, 2023.
EMP3 confirmed the above findings at approximately 2:40 PM, on June 28, 2023.
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Based on a review of facility documents, medical records (MR), and employee interviews (EMP), it was determined that the facility failed to conform to all applicable state laws.
Village Surgicenter of Erie was not in compliance with the following state law:
"Act 13 of 2002 MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR (MCARE) ACT
Act of Mar. 20, 2002, P.L. 154, No. 13 40 ... Section 307(b)(5) Provide for written notification to patients in accordance with section 308(b). ... 308(b) Duty to notify patient.--A medical facility through an appropriate designee shall provide written notification to a patient affected by a serious event or, with the consent of the patient, to an available family member or designee within seven days of the occurrence or discovery of a serious event. ..."
This is not met as evidenced by:
Based on a review of facility documents, medical records (MR), and employee interviews (EMP), it was determined that the facility failed to demonstrate that written notification was provided within seven days of the occurrence or discovery of a serious event for three of three event medical records reviewed (MR8-MR10).
Findings include:
Review of Village Surgicenter of Erie "Patient Safety Program", no date provided, revealed "...The patient safety program integrates risk management, performance improvement, and a review of processes, functions, and services to improve safety by reducing the risk of system or process failures. ...A patient safety officer will be appointed. ...H. Summary: The Patient Safety Officer (PSO) will have primary oversight of the organization's patient safety improvement and mangement program. ...The PSO will: ... 8. Ensure the disclosure of serious events to patients and/or families is carried out in accordance with the organization policies and law/regulations. ..."
1. Review at approximately 12:00 PM on June 27, 2023, of MR8, revealed an undated letter to the patient in relation to a serious event that occurred on January 16, 2023. The facility did not provide documentation indicating the letter was sent to the patient within seven days of occurrence or discovery of the serious event.
2. Review, at approximately 12:07 PM on June 27, 2023, of MR9, revealed an undated letter to the patient in relation to a serious event that occurred on May 22, 2023. The facility did not provide documentation indicating the letter was sent to the patient within seven days of occurrence or discovery of the serious event.
3. Review, at approximately 12:15 PM on June 27, 2023, of MR10, revealed an undated letter to the patient in relation to a serious event event that occurred on May 17, 2023. The facility did not provide documentation indicating the letter was sent to the patient within seven days of occurrence or discovery of the serious event.
Interview, at approximately 2:35 PM, on June 27, 2023, confirmed the above findings. When informed that the letters were not dated, EMP3 indicated, "they are not [dated]". EMP3 further revealed there was not a log to indicate when the serious event letters were sent to the patient.
| | Plan of Correction - To be completed: 10/05/2023
1. Beginning third quarter, August 24th, 2023, TQM, Infection Control and Patient Safety committees' will be broken down into separately timed sections within the meeting.
2. This process will be the new standard format for all future meetings.
3.Village SurgiCenter has changed the meeting template to ensure separation of time and topic of meetings.
4.Village SurgiCenter will not perform a TQM study as the meetings occur quarterly and the template has been changed.
5. All the changes have been instituted and can be seen in our third quarter minutes. (August 24, 2023)
Patient Notification
1.Patient Safety Officer (PSO) will include date of written notification of a serious event to the Patient.
2.Patient will be notified within seven days of serious event as per (MCARE) act with date included.
3.A QA study will be developed and initiated, monitored by QA coordinator. It will begin in fourth quarter 2023.
4.QA coordination will monitor and report results.
5.Corrective action will begin October 5th, 2023.
Patient Grievance/Complaint log has been created to track events.
This was instituted and completed on 10/5/2023. Monitored by our TQM coordinator
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