Initial Comments:
This report is the result of a special monitoring survey conducted on May 19,2011, at the Berger and Benjamin. 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:
29.33(8) STANDARD
Requirements for Abortion
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When there is an abortion performed during the first trimester of pregnancy, the tissue that is removed shall be subjected to a gross of microscopic examination, by the physician or a qualified person designated by the physician to determine if a pregnancy existed and was terminated. If the examination indicates no fetal remains, that information shall immediately be made known to the physician and sent to the Department within 15 days of the analysis. If the examination indicates no fetal remains or villi, the physician shall immediately inform the patient of the possibility of an ectopic pregnancy and shall recommend appropriate follow-up. When there is an abortion performed after the first trimester of pregnancy which the physician has determined as not viable, all such tissue removed at the time of the abortion shall be submitted for tissue analysis to a board eligible or certified pathologist. If the report reveals evidence of viability or live birth, the pathologist shall report such findings to the Department within 15 days and a copy of the report shall also be sent to the physician performing the abortion. The findings of the gross or microscopic examination shall be entered in the medical record of the patient. Each facility, including the hospital, shall provide treatment or referral for treatment of any diagnosed pathological condition.
Observations:
Based on review of medical records (MR), and staff interview (EMP), it was determined that the facility failed to ensure that the physician accurately documented the removed tissue examination for one of one medical record reviewed (MR1).
Findings include:
1) Review of the MR1 revealed that the patient had a surgical abortion at 9-10 weeks gestation on May 17, 2011. Review of Lab Post Op Form revealed that the removed tissue examination was signed by the physician on April 29, 2011, (before the procedure). .
2) During the interview with EMP1 on May 20, 2011, at 1:30 p.m., the employee stated that the form was dated the date the patient came for medical abortion and when he did the tissue examination did not notice the error.
Plan of Correction:The pathology findings were noted as required on the pathology sheet with lab findings from a previous encounter.These were signed but bore the date of the first encounter. To correct this pateints having subsequent encounters will have a new lab sheet for that date. These will be signed and dated by the examining physcian at the time of the examination. This has been noted in a policy and procedure update and staff will be trained immediatly. This correction will take place in no more than 3 days.Charts will be monitored on a continuing basis and by random spot checks by the office manager who will be supervised by Drs Berger & Benjamin to assure compliance
29.33(11) STANDARD
Requirements for Abortion
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When general anesthesia or major regional anesthesia blockade, including spinal or epidural anesthesia, is utilized, it shall be administered by a second physician, or a nurse anesthetist under appropriate supervision. Local anesthesia, including para-cervical block, may be administered by the physician performing the abortion.
Observations:
Based on review of facility policy and procedure, review of medical records (MR), and staff interview (EMP), it was determined that the facility failed to ensure that the name and dosage of the medications administrated for local anesthesia were documented for one of one medical record reviewed (MR1).
Finding include:
1) Review of the MR1 revealed that the patient had a surgical abortion with local anesthesia at 9-10 weeks gestation on May 17, 2011. Further review of the records revealed no documented evidence of what local anesthesia medications were utilized and the dose of the medications.
2) During the interview with EMP1 on May 20, 2011, at 1:30 p.m., the employee confirmed that the physician did not document the name and dosage of the medications administrated for local anesthesia for MR1.
Plan of Correction:POC: The records are being updated to require notation of agent, agent strength and dosage given when local anesthesia is used. These forms will be in use within one week. Physicians perfoming procedures are being advised to record the dose and strength on current forms untill the updated forms are available. Policy and procedures will be updated.Charts will be monitored on a continuing basis and by random spot checks by the office manager who will be supervised by Drs Berger & Benjamin to assure compliance
29.36(b) STANDARD
Requirements
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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 review of facility policy and procedure, review of medical records (MR), and staff interview (EMP), it was determined that the facility failed to ensure that the physician had a private medical consultation with the patient prior to performing the abortion for one of one medical record reviewed (MR1).
Findings include:
1) Review of the MR1 revealed that the patient had a surgical abortion at 9-10 weeks gestation on May 17, 2011. Further review of the record revealed no documented evidence that the patient received a private medical consultation by the physician prior to the procedure.
2) During the interview with EMP1 on May 20, 2011, at 1:30 p.m., the employee stated that the physician usually consults with patients on the phone and in this case the physician did not document the telephone consultation.
Review of the facility Policy and procedure book revealed no policy to address the physician private medical consultation with patients prior to the procedure.
Plan of Correction:Patients for surgical abortion are seen prior to the day of surgery by the physician and private consultation and preoperative blood work are done at this time. On rare occasion consutation which is required is given on the phone.In these cases the patient is seen on the subsequent visit by the the physician prior to the procedure (medical or surgical). The patient then signs a form indicating that she has recieved the counsultation 24hr prior to the procedure. This patient received phone counceling and signed the form but the form was dated by the physician
on the day of the encounter and did not document the propper date of consultation.
POC: The counsultation form is being updated to reflect the time the consultation was performed and the method (phone or personal interview) The staff including the physicians were given in-service to be sure all were aware of the importance of this documentation. All charts are being reviewed prior to procedures to assure the the consultation was performed in the proper time frame. Polcy and procedures already reflects these requirement but will be reviewed. This plan was implemented immediatley.Charts will be monitored on a continuing basis and by random spot checks by the office manager who will be supervised by Drs Berger & Benjamin to assure compliance
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