Attachment_5_2014.docx

Attachment 5 Attachment 5 Mammography Continuing Education (MEU) Policy For Mammography Quality Standards Act (MQSA) Certified Inspectors (January 2015)

Background and GOAL

42 USC 262 Subpart 3D(d)(1)(B)(i) of the Mammography Quality Standards Act (MQSA) requires the establishment of minimum qualifications and appropriate training for inspectors. Following initial training in basic radiation physics, quality assurance, quality control, mammography and inspection procedures, it is important that certified MQSA inspectors maintain and improve their understanding of inspection procedures and the physical principles underlying these procedures. Further, continuing education in recent developments in mammography, as well as state-of-the-art mammography equipment contributes to the knowledge and expertise of the MQSA Inspector.

Continuing Education Requirements for Maintaining Active Status

Following the third anniversary date of certification and annually thereafter, an MQSA-certified Inspector shall have taught or earned a total of 15 Mammography Continuing Education Units (MEUs) (15 contact hours) during the 36 months immediately preceding the date of the inspector’s annual MQSA audit or the last day of the calendar quarter preceding the audit or any date in between the two. The inspector may choose their dates each assessment year in determining the 36-month period that the MQSA FDA Auditor shall use to confirm that the continuing education requirements were met (Reference page 2 - Acceptable MEUs - for guidance concerning specific teaching requirements and acceptable MEUs.)

The required 15 MEUs are a minimum for certified inspectors. However, FDA encourages inspectors to obtain more than the minimum requirement, up to the allotted funding (Reference Funding – pg. 4). MQSA FDA Auditors, on the other hand, are required to maintain a total of 20 MEUs over 36-months (five additional) which may be earned through attendance at FDA-sponsored Auditor’s Workshops.

In addition to the required MEUs, the Division of Mammography Quality Standards (DMQS) (formerly known as the Division of Mammography and Radiation Programs (DMQRP)), Food and Drug Administration (FDA), may require participation in additional mandatory workshops, training courses, home study or teleconferences such as those concerned with major changes in MQSA regulations or changes in the inspection procedures and/or software. DMQS will periodically assess training needs and notify inspectors of any mandatory training.

Acceptable MEUs

Training courses, conferences, and/or home study for which MEUs can be earned parallel the FDA issued guidance concerning acceptable areas for meeting the continuing education requirements for mammography facility personnel as required by the MQSA.

Both the guidance and the MQSA regulations state that all continuing education credits related to the diagnosis or treatment of breast disease or to other areas that aid facility personnel in improving the quality of mammography are recognized in meeting the MQSA personnel requirements. Sources include:

Training courses, conferences or home study recognized by an organization that determines the number of units that may be awarded and documents the number awarded in writing;

Teaching and/or preparation time for a specific course, training session or conference. The inspector can count the course taught only once in a 36-month period for credit(s), regardless of the number of times taught during the period. Teaching and preparation time must be reviewed and approved by an organization that awards continuing medical education units to an individual. The organization determines the number of units that may be awarded and must document that number in writing.

3. Credit for continuing medical education may be obtained by publishing a paper if they are awarded the credits or units by an organization that has the authority to award continuing medical education units to an individual for such publications. The organization determines the number of units that may be awarded and must document that number in writing.

NOTE: The number of continuing education credits that may be awarded is not determined by ORA, DMQS, or CRCPD. The number is determined by an organization, such as ASRT or the AMA that reviews continuing education material and determines the number of continuing education credits that may be awarded. These organizations, or their sponsoring organization, must indicate (in writing) the number of credits awarded. If there is a question regarding the appropriateness of the number of MEUs earned, DMQS should be consulted.

PRE-APPROVAL PROCESS

The FDA has eliminated the required MEU course appropriateness pre-approval process. Inspectors shall work through their respective FDA or State Supervisors to coordinate approval of continuing education courses. This method eliminates a burdensome administrative process. It places the responsibility for selecting and tracking acceptable continuing education on the MQSA inspector. Based on documentation provided by the inspector, FDA’s Division of Human Resource Development (DHRD) will track the number of MEUs earned. DHRD will provide monthly updates to DMQS. However, a funding availability verification process is required as outlined below.

· STATE INSPECTORS

The FDA requires funding availability verification by DHRD via the Funding and MEU Verification Form (Enclosure 1). FDA’s Office of Partnerships, (formerly known as the Division of Federal-State Relations (DFSR)) will provide the verification of available contract funds to support the MEU training on the same form. Inspectors shall submit the completed form to DHRD, including approval by the inspector’s supervisor per instructions on the form, along with course documentation to support the proposed number of MEUs and travel dates (e.g., agenda). DHRD will provide confirmation via email of the signed form back to the inspector for training initiation or denial.

Note: This requirement does not apply to States as Certifiers.

· FDA INSPECTORS

The FDA requires funding availability verification by ORA’s Office of Partnerships (OP) MQSA Project Officer, via the MEU Funding Verification Form for FDA Inspectors (Enclosure 2). Inspectors shall submit the completed form or an email containing the required components, including approval from the inspector’s supervisor per instructions on the form, along with course documentation to support the proposed number of MEUs and travel dates (e.g., agenda). The OP’s MQSA Project Officer will provide confirmation via email of the signed form back to the inspector for training initiation or denial.

FUNDING LEVELS

· STATE INSPECTORS

Effective June 1998, inspectors are allotted MQSA funds totaling $1,500 each for 36 months by FDA through each state’s MQSA contract.

Verified funding must be used for MEU expenditures for the specifically identified inspector. Expenditures may include costs associated with registration, tuition fees, course materials, and appropriate travel expenses. Salary costs will not be charged against the $1500 allowable funds.

Submit to DHRD, within one month following the course, documentation of final expenses (e.g., copy of state travel voucher), the number of MEUs earned, and a certificate of attendance or other evidence of attendance.

Additional training opportunities may be denied by DHRD without documentation of previous actual training expenditures.

· FDA INSPECTORS

Effective June 1998, new inspectors or current inspectors whose certification was renewed will be allotted MQSA funds totaling $1,500 each through the Office of Regulatory Affairs (ORA), FDA. Funding distributed must be used for MEU expenditures for the specifically identified inspector. Expenditures may include costs associated with registration, tuition fees, course materials, and appropriate travel expenses. Salary costs will not be charged against the $1,500 allowable funds. Reimbursement to FDA inspectors for MEU costs comes through the FDA Office of Regulatory Affairs, Office of Partnerships, MQSA Project Officer.

FDA inspectors shall submit final expenditures (e.g., copy of travel voucher) to the MQSA Project Officer in ORA within one month of the training. The MQSA Project Officer may deny additional training opportunities without documentation of previous actual training expenditures.

ACCEPTABLE DOCUMENTATION OF CONTINUING EDUCATION

Each inspector must maintain evidence of MEUs earned and submit this documentation to DHRD for state inspectors or ORA for FDA inspectors for tracking purposes. Documentation of satisfactory completion of training includes course certificates or a sponsor’s listing (e.g., RSNA, ASRT) of completed continuing education (lecture or course agendas, as necessary).

STEPS FOR REESTABLISHING CONTINUING EDUCATION QUALIFICATIONS

An inspector who fails to maintain the required continuing education credits shall reestablish his/her qualifications before resuming independent inspections, as follows:

· The inspector shall obtain a sufficient number of additional credits in mammography to bring his/her total up to the required credits in the previous 36 months before resuming independent inspections. Additionally, the inspector shall provide documentation of MEUs earned to re-qualify to DHRD. After re-qualifying, inspectors are still responsible for maintaining their required MEUs in the current 36-month period.

NOTE: The date on which the inspector was initially certified as an MQSA inspector does not change due to taking time off or not meeting the continuing education requirements.

STATE INSPECTOR MAMMOGRAPHY CONTINUING EDUCATION PROGRAM

FUNDING AND MEU VERIFICATION REQUEST FORM

Inspector’s Name:

Office phone/ fax #

State :

E-Mail Address:

Course/Conference Title :

Course/ Conference Location:

Course/ Conference Dates :

Accredited Organization: ( ASRT,etc):

Potential MEU’s Earned:

Email to becky.schaar@fda.hhs.gov PRIOR to expenditure of funds.

Any changes in estimated expenses must be approved prior to expenditure of funds.

FINAL EXPENSES along with a copy of the certificate and MEU information must be returned to Jeri Kalins within one month of attendance.

[T] Travel Costs ( Plane, Train, Auto) specify

[H] Hotel (NO. of Nights____ Requested @ $______Per Night

[M] Meals ( No. of Meals Requested______

[P] Parking , Shuttle , Other incidentals

[C] Cost of course (registration fee, Books, etc.)

[O] Other Cost ( Specify):

TOTAL:

FDA USE ONLY

I verify that this state inspector is eligible for this MEU training based on the three year period of certification

I verify that there are available contract funds to support this MEU training