Initial Comments:
This report is the result of an initial registration survey conducted on July 14, 2011, at Penn Family Care of the Clinical Practices of the University of PA. It was determined that the facility was not in compliance with the requirements of the Pennsylvania Department of Health Regulations 28 Pa Code, Chapter 29, Subchapter D, Ambulatory Gynecological Surgery in Hospitals and Clinics.
Plan of Correction:
29.36(b) STANDARD
Requirements
Name - Component - 00
Except in a medical emergency where there is insufficient time before the abortion is performed, the woman upon whom the abortion is to be performed shall have a private medical consultation either with the physician who is to perform the abortion or with the referring physician. The consultation will be in place, at time, and of a duration reasonably sufficient to enable the physician to determine whether, based on his best clinical judgment, the abortion is necessary.
Observations:
Based on a review of medical records (MR), facility policy, and staff interviews (EMP), it was determined that the facility failed to ensure that the physician signed and dated a consent form prior to performing an abortion procedure, for one of 11 medical records reviewed (MR9).
Findings include:
1) Review of MR9 revealed that the patient had a surgical abortion at 10 weeks gestation on May 25, 2011. Further review of the record revealed no documented evidence that the physician signed and dated the consent form prior to the surgical abortion.
2) An interview with EMP1 on July 14, 2011, at 1:45 p.m. confirmed that the physician failed to sign and date the consent form for MR9 before performing the procedure as indicated in the facility's policy .
3) Review of the Facility's Quality Audit-Pregnancy Termination form revealed that EMP2 audited MR9 and failed to identify that the physician had not signed the consent form.
Plan of Correction:The Medical Director of Penn Family Care (PFC) reviewed the survey results and consent requirements for abortion procedures, Standard 29.36(b), with the applicable providers and clinicians on 7/15/2011. The education specifically emphasized the need to complete all components of the consent form for abortions, including both patient and provider signature.
An interdisciplinary team led by the PFC Medical Director, convened on 7/22/2011 to review opportunities to improve and sustain compliance with Standard 29.36(b) of the regulations. The action items are:
- Training of applicable nursing staff to review consent forms to ensure completion of patient signature, provider signature, date, and time.
- The team will modify the pre-procedural checklist to include patient signature, provider signature, date, and time for all abortion consent forms.
The Medical Director will submit a summary of the above plan of correction to educate and reinforce the plan with the applicable providers and clinicians.
QUALITY MONITORING PROCESS:
100% of patient medical records will be monitored over the next 3 months to ensure compliance with the requirement to have consent forms with patient signature, provider signature, date, and time for all abortion procedures. The monitoring will continue on a quarterly basis thereafter of a random chart sample to make sure the compliance is sustained.
The PFC Clinical Coordinator will oversee the monitoring and report to Penn Presbyterian Medical Center Clinical Effectiveness and Quality Improvement Committee (CEQI) and take action, if indicated.
(Monitoring Dates 7/22/2011-10/22/2011).
Completion Date: 10/22/2011
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