Attachment_4.docx

Attachment 4

DMQS’ State Contract Policy for Training MQSA Inspectors and Assigning Inspection Equipment (November 2013)

The mammography inspection program has reached a maintenance level for the number of trained State and FDA inspectors to conduct annual inspections of certified mammography non-federal facilities throughout the U.S. under the Mammography Quality Standards Act (MQSA).

BACKGROUND

In 1996, the Division of Mammography Quality Standards (formerly Division of Mammography Quality and Radiation Programs – DMQRP) (DMQS) established and publicized a policy that outlined its rationale for determining the number of inspectors per State necessary to cover the number of non-federal facilities located within that State. DMQS has since revisited its policy, evaluated its experience with inspections over the last few years, and has determined that the original position regarding the number of inspectors to be trained remains valid.

POLICY

Since establishing this policy, States have raised questions about the formula used by the Food and Drug Administration (FDA) to determine the optimum number of inspectors within a State. As a reminder and for your future reference, we are providing you with our policy which sets upper limits on the number of inspectors per State. These limits should not be interpreted as a goal or requirement under State contracts.

In setting limits on the number of inspectors trained per State, DMQS considered the following issues: (1) training costs charged to State contracts, including tuition (if any) for Courses I and II. Travel and per diem for Course III; (2) inspector equipment costs IT equipment); (3) training costs incurred by DMQS for training non-federal facilities, speakers, materials, staff time and effort; (4) the minimum number of inspections that should be performed by an inspector each year to maintain his/her proficiency (allowing that if too many inspectors are trained, some may not be able to remain active and qualified); (5) the cost in time and effort incurred by DMQS for inspector continuing education and annual audits, updating inspectors, and addressing inspector needs and questions (this commitment increases as the number of inspectors increases); and, (6) a legitimate need to train supervisors or program managers and back-up inspectors to cover State turnover or additional non-federal facilities throughout the year.

Additional inspector training, including supervisors or program managers that is beyond the number of allowed inspectors (including back-up inspector) will be an option pending availability of training capacity and will be at the expense of the State.

For training purposes, we estimated that an inspector could complete 2 non-federal inspections per week, or 100 non-federal inspections per year (2 non-federal facilities x 50 weeks). This estimate has proven accurate, with some inspectors completing as many as 5 non-federal facilities per week when working full-time on MQSA. Therefore, we will continue to allow each contract State to train (at FDA expense) up to one inspector per 50 certified non-federal facilities, plus one back-up inspector per State.

For example: If there are 138 non-federal facilities, the State is allowed to have 2 inspectors plus one back-up inspector. If there are175 non-federal facilities, the State is allowed to have 3 inspectors plus one back-up inspector.

States may choose to use inspectors for mammography inspections on a full-time basis and, therefore, may only need one inspector per 100-125 non-federal facilities.

Training slots for each State will be provided on a one-for-one priority basis as inspectors leave the State mammography program.

EQUIPMENT ISSUANCE

FDA will not provide the back-up inspector with a laptop computer. Furthermore, FDA will not issue any equipment (laptop computer) to any inspector that exceeds the number of inspectors allowed per State.

FDA will also not supply supervisors and program managers with field inspection test equipment or a laptop computer. It is the contractor’s responsibility to ensure that all inspectors, including back up inspectors, receive vital policy communications. For further clarification, in situations where an MQSA inspector leaves one State to work in another State, DMQS will recall their equipment and evaluate the State’s needs and reissue equipment according to the policy.