Specifications include, but are not limited to: The DSHS Texas Mammography Accreditation Program (TMAP) is seeking an approved mammography accreditation body that has expertise and experience in USFDA MQSA regulations and develop a Clinical Image Review process, conduct accreditation for image reviews, perform quality assurance audits on image reviewers, provide annual training, and issue image review reports. Contractor will provide Clinical Image Reviews/accreditations for Texas mammography facilities in DSHS Public Health Regions 1 through 11 that have selected TMAP as their accreditation body. Contractor will conduct accreditation image reviews for Texas Mammography facilities that apply to DSHS for accreditation. The types of reviews required for mammography accreditation are as follows: A Clinical Image Review will be done for new facilities, facilities undergoing reaccreditation after three (3) years, facilities that add a new unit or replace an old unit with a new unit, or as deemed necessary by TMAP due to major changes in personnel and/or equipment during their accreditation. This Clinical Image Evaluation will include the following: a. The facility will choose two sets of patient images (for a total of eight (8) films) to be reviewed for accreditation. These should be examples of the facility’s best work. b. All films must be of a dense breast meeting BI-RADS® Breast Composition Category c (heterogeneously dense) or Category d (extremely dense). The other set to be submitted must be of a fatty breast meeting BI-RADS® Breast Composition Category a (composed almost entirely of fat) or Category b (scattered fibro glandular densities). c. All films submitted must be interpreted as "negative" (BI-RADS® Assessment Category 1). Facilities may submit “benign” images (BI-RADS® Assessment Category 2) for evaluation upon special request to TMAP if accompanied by the physician’s formal interpretation describing the presence of the benign findings. d. Likewise, if a facility informs TMAP that they only conduct diagnostic imaging and would not be able to provide clinical images that are either negative or benign, they may submit images with findings as long as the cases are accompanied by the physician’s formal interpretation describing the presence of these findings. e. Contractor will review these images utilizing Contractor approved personnel and under the criteria standards that have been approved by the FDA.
