Friday, August 11, 2017

Adverse Events, an Investigation, the follow-up, the reporting, and the resolution. A Guide for Success

            Patient presented to ABC FACILITY for an elective cosmetic invasive  surgical procedure, where surgeon 20A7361 was the surgeon.                        Pursuant to the facility’s Medical Staff By-laws, elective invasive cosmetic surgical procedures require that the patient have a current (within             30 days) history and physical, Chemistry Panel, A Medical Clearance for any condition with the Heart, Lungs, Kidneys, etc., EKG            (if               MD feels necessary), and a pregnancy urine dipstick the morning of surgery.

While processing the patient the morning of surgery, the anesthesia provider goes over the anesthesia consent form, the risk, the benefits, and the alternatives to the type of procedure anesthesia being requested by either the patient and/or the physician.  It is also during this process that the RN processing the patient would get a bit personal and discuss the likelihood of the patient being pregnant.  If the patient shows or explains with certainty that there is no biological explanation for a pregnancy, then the nurse would proceed with the urine dipstick and the results would be charted as standard and routine standard of care.  The patient explained with certainty that her husband had been traveling with work and there was no possible chance that she could be pregnant.  Therefore, when the urine dipstick was performed, the results presented a negative reading.  With all the clinical findings present and on the chart, the patient was walked into the operatory room and the anesthesia provider began the IV, hooked the patient up to the critical monitors, and then the time out policy was initiated prior to induction of any anesthesia drugs or gases.  The patient tolerated the procedure well, no complications were noted and the recovery phase began without any triggers otherwise.

Then the following week, the patient presented for her post op visit whereby she explained she had been in the acute hospital suffering from a spontaneous abortion.  The surgeon noted that the patient had experienced a spontaneous abortion, likely from the effects of the general anesthesia.  The surgeon made zero attempts to communicate this to any member of management of ABC FACILITY not the administrator, the Medical Director, nor the Compliance Officer.  It was not until much later, 30+ days post the procedure date that the administrator shared a mutual grocery shopping event whereby the two talked and the Administrator was made aware of the spontaneous abortion.  The administrator immediately contacted both Dr. ABC (Medical Director), and myself, the facility Compliance Officer.

We immediately informed the California Medical Board via the State Adverse Event Form.  (see attached form).  The investigation began immediately upon notification and the results of the investigation were included  on the form that the Medical Board received.   Dr. ABC called a special Medical Executive Committee Meeting to discuss this case.  During the closed door session, the Governing Body approved the following items  to become effective immediately:
1.  Both Physicians and Staff would be oriented and fully trained on the Adverse Event reporting, the timeliness of reporting, and the process for notification of such event to the Medical Board and to the AAAHC offices. - This occurred on June 6 & 7, 2017.
2.  The Medical Staff By-Laws were revised to now require that all child-bearing females must have on the chart prior to surgery, the blood pregnancy test results in addition to the already required H&P, and other blood panels herein.  The chart missing the blood pregnancy test will either be delayed and the stat blood draw performed OR the case will be cancelled and rescheduled accordingly. Completed this task on June 10, 2017.
3.  The added requirement that the anesthesia provider throughly discuss with the patient the dangers of general anesthesia and the pregnant patient.  A letter to all anesthesia providers was compiled with this request, sent out on June 10, 2017.
4.  That we place signage in areas of the surgery center whereby the patient would be residing.  (see attached copy of the signage)
5.  A letter was sent to the surgeon that failed to notify management of the adverse event, requesting that he/she respond to the questions that the committee had in regards to the surgeon not following the letter of the law for the State of California nor the policy of the surgery center.  This letter was sent out on June 21, 2017.  A formal peer review of the findings and of the surgeon’s response will occur once the response has been submitted to the ASC.
6.  Quality Indicators were developed to assist in monitoring the compliance to the above mentioned in #s 1-5, results will be submitted to the Quality Committee Monthly, with a quarterly summation submitted to the Governing Body.  QC indicators were developed on June 12, 2017.

7.  The post op calls questions were revised to include the question about “did your anesthesia provider or surgeon talk to you about the dangers of having surgery if you are suspect of being pregnant?”  The results to this question will be summarized and presented to the Quality Committee and Governing  Body.  Peer Review sessions will be conducted on any triggered noncompliant. The questionnaire was revised and all staff educated on this revision June 8 -10, 2017

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