(a)  Do the procedures include a mechanism for providing ongoing IP feedback on image quality to RT’s or other designated facility personnel?
(b)  Do the procedures require documenting any corrective actions taken and documenting the effectiveness of any corrective actions taken?

Yes. All mammography policies and procedures must be in written form in Texas. The system must include mechanisms for ongoing IP feedback and for documenting and assessing corrective actions. The details of those mechanisms will not be assessed by the inspector. He/she will assess that a system is in place and contains those two elements.

For the purpose of this inspection question, the IP is responsible for determining if images are of poor quality and providing feedback.

No. The mechanism for the IP to provide feedback on poor image quality is left up to the facility.

It is up to the facility to determine how to document any corrective action taken or the effectiveness of any corrective actions taken.

No.

No. It is up to the facility how it determines the effectiveness of any C/A taken.

The facility determines its timeframe for completing any needed corrective action.

No. There is no requirement on how long the facility should retain clinical image quality feedback from the IP.

Yes.

(a)  Do the procedures include a mechanism for regular reviews of image quality attributes of a sample of mammograms performed by each active RT and a sample of mammograms accepted for interpretation by each active IP?
(b)  Is there documentation of such review since the last inspection?

Yes. The reviews need to be done at least annually and occur within the same calendar months as the previous review. More frequent review (i.e., monthly, quarterly) is encouraged.

Yes. A verbal demonstration or discussion will not be accepted. Documentation can include such things as a summary report, signed statement by LIP that a review was performed, clinical image review meeting records, memos of review results to RTs and IPs, etc.

No. Repeat/reject rates are not necessarily directly linked to poor quality images presented for interpretation to the IP.

No. It is the responsibility of the facility to ensure the review is performed. Anyone may gather and compile data in order to report on the clinical image quality for the facility.

No.

Yes.

No.

No. The sample size of images to review is left up to the facility to determine.

No. The review must include all RT’s and IP’s.

No. Only employees that are actively performing/interpreting mammograms at the time of the review need to be included in the review.

No. The sole IP at the facility would also be the LIP and would need to assess his/her own images for quality.

There are eight image quality attributes listed in 900.4(c)(2)(i-viii). They are: positioning, compression, exposure level, contrast, sharpness, noise, artifacts, and examination identification.

Yes. Clinical image quality is not specific to any particular technology. The image quality attributes can be used to evaluate images of all 3 mammographic modalities (DBT, FFDM, and screen/film).

Yes.

The regulatory program is facility based, so each facility must have its own review, targeted at only the doctors who interpret for the facility. The answer is the same regarding technologists who work in several different facilities.

(a)  Does the procedure include requirements for LIP oversight of QA/QC records, including review of the frequency of performance of all required tests?
(b)  Does the procedure include requirements for LIP review to determine whether appropriate corrective actions were performed when needed?

Yes. The LIP oversight requirement is not a new element of the Texas regulation. LIP review of the quality assurance records at a 3 month interval has been in the Texas regulations since the original release. At a minimum, a valid record of the review should include the date of the review and the reviewer’s initials.

A record of the LIP’s review, validated by the LIP’s dated initials or signature.

Yes. The LIP may designate someone other than the LIP to perform the oversight, but the LIP is the one responsible and will be the one signing an SOP.

Yes. If that person is designated as the LIP for MQSA purposes, then he/she must comply with the MQSA regulations which state that oversight of QA/QC records and corrective actions are the LIP’s responsibility.

Yes. Texas regulations require the LIP to review the QA/QC test results at least every 3 months or more frequently if consistency has not been achieved. The intent of the review is to ensure the test results were within acceptable limits, tests were performed at the required frequency and any corrective action needed was taken.

No.

No. The facility still needs to provide a valid record of the review including the date of the review and the reviewer’s initials.

The EQUIP initiative places emphasis on the significance of clinical image quality, one of the most important determinants of the accuracy of mammography. It also highlights the LIP’s responsibilities for image quality.

No. Each facility is responsible for implementing a program that is appropriate for its site.

The effective date of the educational year will begin January 1, 2017.

A facility should contact its inspector first with questions related to the clinical image quality requirements. Inspector contact information can be found on the “MQSA Inspection Confirmation“. Facilities may also contact:

MammographyBranch@dshs.texas.gov

Trae Windham at 512.934.6835