Attachment_2.docx

Attachment 2 MQSA Inspector Initial Training-Qualification Process (December 2014)

This document outlines the process and requirements associated with becoming a Mammography Quality Standards Act (MQSA) inspector.

Solicitation:

ORA/DHRD solicits candidates for MQSA inspector training in consultation with the Food and Drug Administration (FDA) Regional Radiological Health Representatives (RRHRs) and ORA/Office of Partnerships (formerly DFSR -Division of Federal-State Relations) six months prior to Course I.

Nomination:

The RRHRs along with the ORA/ Office of Partnerships serve as the FDA’s liaisons with the State Program Directors and FDA supervisors in soliciting nominees for inspector training. The FDA only considers nominees for training based on the receipt by the RRHRs of education and experience background information (specified below) provided by the State Program Directors and FDA supervisors. RRHRs must submit nominees to ORA/ Office of Partnerships no later than 60 days before the start of Course I. Nominations must be submitted on the attached form (Attachment 2-A).

Education/Experience Requirements for New MQSA Inspectors - Any new student nominated to take the MQSA training courses to become a qualified MQSA inspector must have the following minimum education and experience background:

· A Bachelors degree (B.A. or B.S.) with a major in physics or with a major in another field but with at least 30 semester hours in science at the college level, or

· A Bachelors degree in Radiologic Technology, or

· Certification by the American Registry of Radiologic Technologists (ARRT), with at least two years experience in diagnostic radiologic technology or radiological health work, or

· General or unrestricted State licensure to practice diagnostic radiologic technology plus at least two years experience in diagnostic radiologic technology or radiological health work, or

· An Associate’s degree in science, or at least two years of college level courses, with at least 16 semester hours in science, plus at least two years experience in diagnostic radiology or radiological health work.

Once nominations are received, the following approval process takes place:

· The ORA/ Office of Partnerships organizes the nominations along with supporting documentation for need based on the policy in “DMQS’s State Contract Policy for Training MQSA Inspectors” (Attachment 4) and forwards the nomination package to DMQS’ MQSA Training Coordinator.

· The MQSA Training Coordinator conducts a review and evaluation of the nominations and field needs. If there are any nominations that are inconsistent with the Policy, the MQSA Training Coordinator will review his/her evaluations and recommendations with his/her Branch Chief and the Division Director, as necessary.

· DMQS’ MQSA Training Coordinator returns the list of nominees with DMQS’ decisions to ORA / Office of Partnerships.

· ORA/Office of Partnerships and the respective RRHRs will follow-up with the States and/or District/Regional Offices to resolve any issues concerning acceptance, denial or conditional acceptance.

· ORA/Office of Partnerships will return the list indicating the resolution of the issues, if any, to DMQS’ MQSA Training Coordinator.

· The MQSA Training Coordinator prepares and sends a copy of the Final Roster (including the nominees’ contact information) to ORA/Office of Partnerships. The MQSA Training Coordinator initiates training communications and begins the training process.

Training Process:

DMQS requires that all students take MQSA Course I. A passing score on Course I must be attained prior to Course II enrollment. Upon successful completion of the MQSA Course I, nominees to MQSA inspector training must complete Course II and Course III.

A) MQSA Course I (Basic Radiation Physics) - This online course covers the production and properties of radiation, biological effects and measurements and other fundamental concepts in radiation physics. In addition, Course I includes an introduction to the basic survey of radiographic x-ray systems to provide the foundation for inspections of diagnostic x-ray facilities. There are quizzes throughout Course I and both a mid-term and final examination.

· Students must receive an average score of 70% for this course to enroll in Course II.

· DMQS considers a score below 70% as failing.

B) MQSA Course II (Mammography Quality Assurance & Survey Procedures) - This online course covers the basic patient mammography examination, mammography x-ray systems, film and digital image processing, and quality assurance procedures specific to mammography. The final examination consists of 100 questions. Upon completion of this course, students are required to observe three field inspections with a certified MQSA State or FDA inspector before attending Course III. The MQSA Course II Inspection Observation Requirement Form must be completed and submitted to the MQSA Training Coordinator (Attachment 2-B). This requirement must be completed prior to attending Course III.

· Students must score of 75% or greater on the final examination

· Students may complete one (1) Course II final exam retest. It is recommended that students review problem course material prior to retesting. Should students fail the retest, they can not matriculate to Course III, but will be disenrolled from the training.

· Students failing the retest can be considered for future MQSA training only after nomination by their state and/or RRHR. The MQSA Inspector Training Coordinator will notify the student, RRHR, and supervisor of the student’s retest score. See additional attachment above

C) MQSA Course III (MQSA Inspection Procedures) - This in-residence course covers the specific procedures used by qualified State and FDA inspectors in performing MQSA inspections. Course III reinforces hands-on experience with mammography machines, demonstration of simulated facility inspections, evaluation of a mammography x-ray systems, darkroom and processor related tools, digital mammography tools, and equipment evaluation.

The practical hands-on demonstrations consist of records review, simulated facility inspections and entering inspection data into MPRIS. The student’s performance in demonstrating facility inspections is based on inspection results and the instructor’s observation of student skill and competency. The final written examination consists of 30 questions.

· Students must score 70% or greater on the written examination and Satisfactory completion of all hands-on demonstrations.

· Students may complete one (1) Course III written final exam retest. Prior to retest, the RRHR and the State Program Director or FDA supervisor develop training and mentoring programs to correct identified inspector deficiencies in Course III. The RRHR submits a written plan of action for approval to headquarters (i.e., study on their own, receive tutoring and/or obtain field experience in observing inspections from the State, FDA District or RRHR).

· Upon completion of specified training to correct identified deficiencies, the RRHR arranges for the written and/or practical demonstrations through the MQSA Inspector Training Coordinator.

· DMQS requires a score of 70% or greater on the written retest and Satisfactory completion of all hands-on demonstrations to pass Course III. The MQSA Inspector Training Coordinator will notify the student, RRHR, and supervisor of student’s retest score.

· The MQSA Training Coordinator will notify the RRHR and supervisor should a student require any additional hands-on skills reinforcement.

Mentoring:

After successfully completing Course III, DMQS requires students to perform at least three MQSA inspections under the direct supervision (mentoring) of an approved certified MQSA State (for State Inspectors) or FDA inspector (for FDA Inspectors). DMQS recommends that this requirement be accomplished within three months from the completion of Course III. The MQSA Course III Mentorship Requirement Form must be completed and submitted to the MQSA Training Coordinator. (Attachment 2-C)

Qualification and FDA Identification:

Upon successful completion of the Course III mentoring requirement and receipt of their mentorship form (Attachment 2-C), students become fully qualified and DMQS issues the newly trained inspector an MQSA Identification Card.