This report is the result of an Annual Registration survey conducted on March 11, 2021 at Planned Parenthood Keystone-Warminster. It was determined 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:
Name - Component - 00
3205 Informed consent
(a) General rule.--No abortion shall be performed or induced except with the voluntary and informed consent of the woman upon whom the abortion is to be performed or induced. Except in the case of a medical emergency, consent to an abortion is voluntary and informed if and only if:
(1) At least 24 hours prior to the abortion, the physician who is to perform the abortion or the referring physician has orally informed the woman of:
(i) The nature of the proposed procedure or treatment and of those risks and alternatives to the procedure or treatment that a reasonable patient would consider material to the decision of whether or not to undergo the abortion.
(ii) The probable gestational age of the unborn child at the time the abortion is to be performed.
(iii) The medical risks associated with carrying her child to term.
(2) At least 24 hours prior to the abortion, the physician who is to perform the abortion or the referring physician, or a qualified physician assistant, health care practitioner, technician or social worker to whom the responsibility has been delegated by either physician, has informed the pregnant woman that:
(i) The department publishes printed materials which describe the unborn child and list agencies which offer alternatives to abortion and that she has a right to review the printed materials and that a copy will be provided to her free of charge if she chooses to review it.
(ii) Medical assistance benefits may be available for prenatal care, childbirth and neonatal care, and that more detailed information on the availability of such assistance is contained in the printed materials published by the department.
(iii) The father of the unborn child is liable to assist in the support of her child, even in instances where he has offered to pay for the abortion. In the case of rape, this information may be omitted.
(3) A copy of the printed materials has been provided to the pregnant woman if she chooses to view these materials.
(4) The pregnant woman certifies in writing, prior to the abortion, that the information required to be provided under paragraphs (1), (2) and (3) has been provided.
Based on review of policy, medical records (MR) and staff interview (EMP), it was determined the facility failed to ensure the required 24 hour parental informed consent was received prior to the termination of a pregnancy in one of seventeen pediatric medical records reviewed (MR6).
Review on March 11, 2021 of facility policy "Abortion Regulations", dated July 16, 2019, revealed "Parental consent: If a woman seeking an abortion is under 18 years of age, informed consent of both the pregnant woman and one of her parents or guardians must be obtained prior to the abortion."
Review on March 11, 2021, of MR6 revealed this pediatric patient had an abortion on December 30, 2020. Further review of MR6 revealed no documented evidence that the parent of the pediatric patient was provided or signed an informed consent prior to the abortion occuring.
Interview with EMP1, on March 11, 2021, at 11:15 AM confirmed there was no documented evidence that the parent of the pediatric patient in MR6 was provided or signed a parental consent prior to the abortion.
Plan of Correction:
All applicable staff were retrained on 24-hour consents by the Center Manager. Meeting minutes were documented on 4.8.2021
The RQM Manager will audit 24-hour consents monthly for the next two months to ensure compliance to regulation. Audits will be completed by 4.30.2021 and 5.31.2021