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SARASOTA MEMORIAL HOSPITAL 1700 S TAMIAMI TRL SARASOTA, FL 34239 March 4, 2020
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on staff interview and record review, the hospital failed to create policies to prevent the spread of infection from the donor to the recipient of fecal microbiota transplantation (FMT) procedures. The hospital failed to ensure appropriate screening and testing of the fecal donors prior to the procedures for 9 (Patient #1, #2, #3, #4, #5, #7, #8, and #9 and #10) of 10 patients sampled. The hospital's infection control program failed to employ methods for surveillance of the patients receiving the FMT to ensure they did not develop infections from the procedures.

The findings included:

The U.S Food & Drug Administration (FDA) published Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening and Testing of Stool Donors for Multi-drug Resistant Organisms (6/18/19): "Bacterial infections caused by multi-drug resistant organisms (MDROs) have occurred due to transmission of a MDRO from use of investigational FMT, resulting in the death of one individual. Because these serious adverse reactions occurred with investigational FMT, FDA has determined that additional protections are needed ...
1.Donor screening must include questions that specifically address risk factors for colonization with MDROs, and individuals at higher risk of colonization with MDROs must be excluded from donation ...
2.FMT donor stool testing must include MDRO testing to exclude use of stool that tests positive for MDRO ...
3.All FMT products currently in storage for which the donor has not undergone screening and stool testing for MDROs as described above must be placed in quarantine until such time as the donor is confirmed to be not at increased risk of MDRO ...
4.The informed consent process for subjects being treated with FMT ... should describe the risks of MDRO transmission and invasive infection as well as the measures implemented for donor screening and stool testing.'
(Source: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/information-pertaining-additional-safety-protections-regarding-use-fecal-microbiota-transplantation)

In an interview on 3/3/2014 at 12:30 p.m., the Clinical Manager for Endoscopic Procedures verified FMT procedures had been and were currently being provided in the Endoscopic Division of the hospital. She said they had stopped allowing the procedures after the safety communication was released by the FDA. The Clinical Manager said she relied on the word of physician's providing the FMT procedures to ensure the donor material had been appropriately screened and tested . The Clinical Manager said when patients came in for the procedure they were asked if they had been screened by infectious disease physician. The Clinical Manager said there was no documentation of the screening of the donor providing the fecal material or laboratory tests on the fecal material prior to its use in the procedure.

In a second interview on 3/3/20 at 3:00 p.m., the Clinical Manager said she could not find written guidelines for screening and testing donors. The Clinical Manager provided a two-page consent form with a revised date of 10/19. The Clinical Manager explained after the FDA safety communication, the hospital changed the consent form to inform the patients receiving the FMT procedure of the risk of MDRO infection from the procedure. The Clinical Manager said the guideline for the screening and testing of the donor stool was "hearsay from the physicians". The Clinical Manager verified she had never seen any written guidelines for testing and screening donors before or after the FDA safety communication.

In an interview on 3/3/20 at 3:10 p.m., Pharmacist Staff D said he had assisted the physicians starting to perform the procedure at the hospital in creating guidelines sometime in 2012. The Pharmacist said he was not aware the procedure was still being done at the hospital. The Pharmacist said he would have to contact the physicians who had performed the procedures to obtain the screening and testing for the 4 patients who underwent the procedure (Patient #2, Patient #4, Patient #5 and Patient #6)..

In a second interview on 3/4/20 at 9:00 a.m., the Pharmacist said he was able to find the testing completed on Patient #6. He was not able to find any screening or testing for the other three donors. He provided a copy of "Fecal Microbial Transplantation Protocol" and said the protocol had been updated in 2014. He verified there was no listing of tests to be performed on the stool prior to being used for FMT.

Clinical record review revealed:
Patient #1's procedure was done on 4/19/19.
Patient #2's procedure was completed on 5/20/19.
Patient #3's procedure was completed on 6/27/19.
Patient #4's procedure was completed on 7/3/19.
Patient #5's procedure was completed on 11/26/19.
Patient #7's procedure was completed on 12/6/19.
Patient #8's had two procedures; one was completed on 2/3/20 the other was done on 2/10/20. Patient #9's procedure was completed on 2/11/20.
Patient #10's procedure was completed on 3/13/19.

In an interview on 3/4/20 at 10:20 a.m., the Clinical Manager said she was not aware if the Infection Control Committee or the Infection Control Prevention Manager was made aware of the procedure before or after the FDA regulations for testing MDRO's on donors came out in June 2019.

In an interview on 3/4/20 at 10:30 a.m., the Infection Control (IC) Manager verified she was the person in charge of the Infection Control Committee in the hospital. The IC Manager said she was never informed of the FMT procedures being performed in endoscopy. The IC Manager and the Pharmacist both verified at that time, the FDA regulations for testing MDRO's and the potential for infection of patients receiving the procedure was never brought before the Infection Control Committee. The IC Manager verified there should be infection control policies at the hospital for ensuring donors are screened and the fecal material was properly tested prior to patients having the procedure. The IC Manager said physicians were not currently required to report if patients develop infections or have side effects from the procedure. The IC Manager said there should be policies in place at the hospital for "targeted" surveillance of the patients once the procedure was performed.

In an interview on 3/4/20 at 1:30 p.m., the Pharmacist said he could not find or provide any documentation of the screening or testing of the donor's for Patients #1, #2, #3, #8, #9, or #10.