WW TEXAS Health and Human Services John Hellerstedt, M, Texas Department of State Health Services 6 June 2017 TARRANT COUNTY HOSPITAL DISTRICT DBA JOHN PETER SMITH HOSPITAL ATTN SCOTT KAYSER MD RSO- 1201 S MAINE ST STE J FORT WORTH TX 76104 Re: Mammography Certification No.:M00481 FDA Facility ID No.: 232480 Dear Doctor Kayser: The Department of State Health Services Mammography Certifying Agency has been notified of the results of the Additional Mammography Review (AMR) conducted by the American College of Radiology (ACR) for Tarrant County Hospital District, dba John Peter Smith Hospital. The AMR included 30 cases performed between 2 May 2015 and 2 May 2017 that were randomly selected by the ACR. The AMR report dated 2 June 2017 reflects that eighteen (18) out of thirty (30) clinical cases submitted did not meet the ACR’s clinical image evaluation criteria and failed the AMR with deficiencies; some which were severe. The Department has determined that the facility “poses a serious risk to human health.” Due to the mammography image quality issues and the seriousness of these results, the Texas Department of State Health Services Mammography Certifying Agency is requesting that the facility voluntarily suspend providing mammography services until at least one physician and one technologist at the facility has completed the required corrective actions outlined below, and the facility has been reinstated by the American College of Radiology. Ina letter dated 6 June 2017, your facility has agreed to voluntarily cease performing mammography until all corrective actions have been completed and your facility has been reinstated by the American College of Radiology. Each interpreting physician (IP) and each mammography radiologic technologist (RT) are required to participate in and comply with the following requirements described. P.O. Box 149247 - Austin, Texas 78714-347 » Phone: 888-963-7111 » TTY: 800-735-2889 -Tarrant County Hospital District dba John Peter Smith Hospital 6 June 2017 Page 2 INTERPRETING PHYSICIAN REQUIREMENTS, ADDITIONAL TRAINING: A description of any training program selected must be submitted to Department for approval before the training is conducted. * Each IP shall attend image review training. This training must be a minimum of 3 hours of didactic training and must include a review of positioning, adequate compression, contrast and motion on images. OTHER REQUIREMENTS: + All interpreting physician(s) must agree on image quality standards, and, interpret only images that meet standards unless unusual patient condition warrants otherwise. * Agree on and implement a satisfactory method for immediate technologist feedback about image quality for unsatisfactory cases must be established. + Review of the ‘Clinical Image Evaluation’ section of the 1999 American College of Radiology Mammography Quality Control manual, pages 26- 126. * Review the MQSA regulation and guidance on the contents of records and reports. + Each IP must spend at a minimum 2 hours observing the MQSA- qualified training technologist in positioning for the facility's technologist. This will assist the interpreting physician in providing feedback to the technologist(s) for suboptimal image quality. The documentation of this observation must be signed and dated by each interpreting physician and the MQSA-qualified training technologist. RADIOLOGIC TECHNOL! ENTS * Each RT shall attend positioning training taught by an MQSA qualified mammography technologist. The training shall include: 40 hours of hands-on training including the performance of 25 mammograms under direct supervision, review of anatomy and physiology, proper positioning skills, compression, and technique. * A review of the ‘Clinical Image Evaluation’ section of the 1999 American College of Radiology Mammography Quality Contro! manual.Tarrant County Hospital District dba John Peter Smith Hospital 6 June 2017 Page 3 PRECEPTOR QUALIFICATIONS: The Mammography Technologist Preceptor must hold the following qualifications before the Department will approve the proposed training program: * The MQSA qualified technologist must meet current MQSA/DSHS regulations to be a mammography technologist and be trained in the same modality. * The facility with which the training technologist is affiliated has not received any significant violations (Level 1 or 2) during the last two (2) MQSA/DSHS inspections; + Isnot affiliated with the facility or any of the facility RTs and this training presents no conflict of interest for the training technologist; and + Provides an outline of the training course to the Department. This facility may resume mammography operations, after the Lead Interpreting Physician and the Lead Mammography Technologist have met all the requirements included above, the ACR has reinstated accreditation and the Agency has approved resumption of mammography. All other personnel shall complete the training by 31 October 2017. Only personnel who have met the requirements above may provide mammography services at this facility. In accepting the option of voluntary suspension and completion of the required additional training, the facility must submit a written corrective action plan for review on or before 26 June 2017. The corrective action plan must include a statement that resumption of the mammography services will not occur until this additional training has been completed. You will be notified if any submitted actions require additional information. You must submit supporting training documentation indicating that all corrective actions have been completed by 31 October 2017. Please contact me at (512) 834-6688 ext. 2247 if you need further assistance.Tarrant County Hospital District dba John Peter Smith Hospital 6 June 2017 Page 4 Sincerely, CN So Quelte— u Jo Turkette, R.T.(M), Manager Radiation Machine Source Group Radiation Safety Licensing Branch Enclosure(s) cc: Kristine Ethridge, M.D, Lead Interpreting Physician Kathleen Whelan, Vice President of Operations Tommye Lanham, R.T., Mammography Supervisor