Mammography - FAQs

How long do we need to keep our quality control (QC)/assurance records?

The facility must maintain quality assurance (QA) records including but not limited to:

1. Personnel responsibilities: Qualified mammography personnel assigned appropriate QA tasks.

2. Technique charts/tables: Proper techniques and procedures used in conducting mammograms.

3. Quality Control (QC) records: QC test procedures, test performance and monitoring, data analysis, and timely corrective action.

4. Policy and Procedures: to include safety and protection of patients and personnel.
These records must be maintained until the next inspection that would verify compliance or the individual test has been performed two additional times at the required frequency, which ever is longer. Verifying compliance implies that if QC records for a given test were found to be deficient and the facility was cited during an inspection, these records must be kept until the facility corrects the violation to the satisfaction of the Food and Drug Administration (FDA). This means for semi-annual testing the last four must be kept, and for annual testing the last two must be kept.

What needs to be done prior to using a mammography machine in Nevada?

Three administrative paperwork issues must be addressed prior to offering mammography services in Nevada:

1. A certificate must be issued by the FDA for lawful operation of all mammography machines.

2. An accreditation certificate from The American College of Radiology, the only accreditation body recognized by     Nevada.

3. You must also obtain a state certificate of authorization from Nevada Radiation Control Program (RCP). All           three certificates must be posted.

How long does it take to get the certificate?

If the application is complete, it is often less than 60 days. If the application is missing necessary information, we will issue a deficiency letter.

Who can operate a mammography machine?

Only a technologist who holds a Certificate of Authorization from the State of Nevada RCP can operate a mammography X-ray machine. This includes, but is not limited to; general mammography and needle guided biopsy mammography.

Where can I find a list of FDA certified Mammography Facilities in my area?

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mqsa.cfm

Policy Guidance Help System (PGHS)

PGHS:
The Policy Guidance Help System has useful information for mammography facilities and their personnel. It shows the Food and Drug Administration’s (FDA) current view on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The FDA uses mandatory language, such as "shall," "must," and "require," when it refers to statutory or regulatory requirements. The FDA uses non-mandatory language, such as "should," "may," "can," and "recommend," when it refers to guidance. Each facility needs to follow the final regulations.

The following link has been provided:
http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/default.htm

Under its own authority, the State may impose more requirements than those specified under MQSA and its implementing regulations. A facility should check with Chapter 457 of the Nevada Revised Statute and Nevada Administrative Codes.

The following links have been provided:
NRS 457: https://www.leg.state.nv.us/NRS/NRS-457.html
NAC 457: http://www.leg.state.nv.us/nac/nac-457.html

Breast Density

Breast Density:
NRS 457.1857  Report provided to patient who undergoes mammography to include certain information regarding category of breast density and other information relating to mammograms; regulations.

1.  If a patient undergoes mammography, the owner, lessee or other person responsible for the radiation machine for mammography that was used to perform the mammography must ensure that each report provided to the patient pursuant to 42 U.S.C. § 263b(f)(1)(G)(ii)(IV) includes, without limitation, a statement of the category of the patient’s breast density which is determined based on the Breast Imaging Reporting and Database System or such other guidelines as required by the State Board of Health by regulation, and the notice prescribed by the State Board of Health pursuant to subsection 2.
2.  The State Board of Health shall prescribe by regulation the notice to be included in a report pursuant to subsection 1. The notice must include:
(a) A statement regarding the benefits, risks and limitations of mammograms;
(b) A description of factors that may affect the accuracy of a mammogram, including, without limitation, the density of breast tissue or the presence of breast implants;
(c) A statement that encourages the patient to discuss with his or her provider of health care the patient’s specific risk factors for developing breast cancer; and
(d) A statement that encourages the patient to discuss with his or her provider of health care whether the patient should adjust his or her schedule for mammograms or consider other appropriate screening options as a result of the patient’s breast density.
3.  The notice prescribed by regulation pursuant to subsection 2 may include, without limitation:
(a) A statement regarding the prevalence of dense breast tissue, the relationship between breast density and breast cancer and the manner in which breast density may change over time; and
(b) A description of the factors that affect the risk of developing breast cancer.
4.  Nothing in this section shall be construed to:
(a) Create a duty of care or other legal obligation beyond the duty to provide the notice as set forth in this section.
(b) Require a notice to be provided to a patient that is inconsistent with the notice required by the provisions of 42 U.S.C. § 263b or any regulations promulgated pursuant thereto.
(Added to NRS by 2013, 2052)

Clarification Concerning Digital Breast Tomosynthesis

In February 2011, FDA approved the first digital breast tomosynthesis (DBT) system, from the manufacturer Hologic, for use in the United States. In August 2014, FDA approved the second DBT system, manufactured by GE. Due to the technological differences between the DBT units, as well as their different FDA-approved Indications for Use (IFU), each manufacturer's DBT system is currently a new mammographic modality. Under MQSA, personnel need to receive 8 hours of initial new-modality training prior to using any new mammographic modality.

DMQS recognizes that there are many features which are common to different DBT systems, so, to clarify:

•Personnel who have received 8 hours of general new-modality training in DBT need to receive training on the unique features of a specific manufacturer's DBT system before beginning to independently use that system.

•Personnel who have received 8 hours of new-modality training on one DBT system need only receive training on the unique features of another system before beginning to independently use that other system.

The training in the unique features of the particular DBT system the personnel will use may be included in the 8 hours of new-modality training, or this training in the unique features may be obtained separately. For documentation of training in the unique features of a particular DBT system, DMQS will accept a course certificate or letter that clearly indicates that the training included the unique features of the particular system, or a signed attestation, using DMQS's recommended form1 or a form with similar elements, to document training in the unique features. If 8 hours of new-modality training in DBT were obtained prior to August 26, 2014, when Hologic was the only DBT system approved for marketing in the United States, we will accept that the training included the unique features of the Hologic system, even if that is not stated explicitly on the training certificate.

We have included the following Frequently Asked Questions (FAQs) regarding DBT, and the answers to those questions, which you should use to answer facility questions regarding training, and also to assist you with any inspections you conduct at facilities using DBT systems.

1.How does the MQSA definition of a new mammographic modality apply to DBT?
Due to the technological differences between DBT systems, and differences in their FDA-approved Indications for Use (IFU), each manufacturer's DBT system is currently a new mammographic modality under the MQSA definition. Under MQSA, personnel need to receive 8 hours of initial new-modality training prior to using any new mammographic modality. For clarification of eligible training, please see Questions 2 and 3 below.

2.Do personnel with 8 hours of DBT training specific to one manufacturer's system meet the requirements for the initial 8 hours of DBT training for another manufacturer's system?
DMQS recognizes that there are many features which are common to different DBT systems, so personnel who have already received 8 hours of general training in DBT need documentation of training in the unique features of the particular DBT system they will use, while personnel who have received 8 hours of training on any one DBT unit also need documentation of training on the unique features of another DBT system prior to using that other system independently.

3.Must the training be provided by the manufacturer?
No. Under MQSA, the new-modality training, including the training on the unique features (technological differences and IFU) of a particular DBT system, does not need to be provided by the manufacturer. Each of the currently approved manufacturers, Hologic and GE, offers formal training on its own system; however, third-party training courses as well as informal training can also provide new mammographic modality training under MQSA. The individual providing the training must be a qualified instructor, defined as an individual whose training and experience adequately prepare him or her to carry out specified training assignments. For example, peer training by a qualified peer who has previously met the training requirement is permitted. DMQS will accept signed attestation, using DMQS's recommended form1 or a form with similar elements, to document that personnel received training in the new unique features of a particular manufacturer's DBT system.

4.What is the status of training received prior to this clarification?
Such training counts toward the 8 hours of new-modality training for any approved DBT system, but personnel also need to document that they received training in the unique features of whichever DBT system they will use. For documentation of training in the unique features of a particular manufacturer's DBT system, DMQS will accept a course certificate or letter that clearly indicates that the training included the unique features of a particular system, or a signed attestation, using DMQS's recommended form1 or a form with similar elements, to document training in the unique features. If the 8 hours of new modality training in DBT were obtained between February 18, 2011, and August 26, 2014, when Hologic was the only DBT system approved for marketing in the U.S., DMQS will accept that such training included the unique features of the Hologic system, even if that is not stated explicitly on the training certificate.

5.What documentation should MQSA inspectors look for in order to determine that a facility is in compliance with new mammographic modality training?
Personnel need to have acceptable documentation of a total of 8 hours of training in the new mammographic modality, defined as the specific manufacturer's DBT system used by the personnel. The training in the unique features of the particular DBT system the personnel will use may be included in the 8 hours of new-modality training, or this training in the unique features may be obtained separately. Thus, personnel may receive:

•8 hours of training in general DBT topics, plus training in the unique features of the specific DBT system they will use; or

•8 hours of training in one specific DBT system they will use; or

•8 hours of training in one DBT system, plus training in the unique features of another DBT system prior to independent use of that other system

Signed attestation is acceptable for documentation of the training in the unique features of a particular DBT system. Also, if 8 hours of new-modality training in DBT were obtained prior to August 26, 2014, when Hologic was the only DBT system approved for marketing in the United States, we will accept that the training included the unique features of the Hologic system, even if that is not stated explicitly on the training certificate.

6.Our GE DBT MEE was performed prior to this clarification. Must it be done again after manufacturer specific training is completed?
MQSA-certified facilities which have already had their certificate extended to include the GE DBT system and whose MEE was performed prior to this clarification can continue using the equipment if they make arrangements to obtain training in the unique features of GE DBT as soon as possible.

7.Will a facility be cited if proper training for the GE system is not documented?
Due to the confusion that has arisen since the approval of the second DBT system, DMQS does not intend to cite facilities if they demonstrate that their personnel obtained or are obtaining the required training as soon as possible.

http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/Guidance/PolicyGuidanceHelpSystem/ucm052126.htm