This is an Archived Document - Not for Official Use

The Final Regulations with Inspection Guidance

Slide 1: Final MQSA Regulations

Good morning (afternoon), I am (name) and I'm pleased to have this opportunity to speak with you about the final regulations implementing the Mammography Quality Standards Act of 1992 (MQSA) that took effect on April 28, 1999.

In addition to the regulations themselves, I'll be discussing some of the guidance that FDA has developed to assist facilities in complying with the regs. The FDA has developed a large body of guidance for facilities, so I won't be able to cover all of it. But at the end of my talk I'll tell you where you can obtain more guidance and information.

Slide 2: Objectives

There are five general areas that I'll describe for you today.

• First, I'll bring you up to date on some revisions to the final regulations in the 2 years since they were published on October 28, 1997. These revisions were published in the Federal Register (FR) at various times.
• Next, I'll explain how FDA develops guidance to help you understand the regulations.
• Throughout the talk I'll highlight areas of the final regulations that inspectors will examine during the annual MQSA inspection and tell you how to best prepare for it.
• I'll also tell you about new requirements not covered in the interim regulations but now included in the final regulations, ranging from equipment requirements to breast implants.
• And finally, I'll let you know where you can find the additional information I mentioned earlier.

Slide 3: MQSA Final Regulations

First, a little history to help you understand how we got where we are.

When Congress passed the Mammography Quality Standards Act of 1992, it mandated that all facilities be certified by October 1, 1994. In order to meet this deadline, FDA established interim regulations using existing standards such as those of the American College of Radiology (ACR) and the State of Michigan. Concurrent with the implementation of the interim standards, FDA proceeded with the development of the final regulations.

In April 1996, FDA published the Proposed Final Regulations for public comment and received around 1,900 responses containing approximately 8,000 comments. These comments were analyzed with the assistance of the National Mammography Quality Assurance Advisory Committee. Where appropriate, the Agency modified the final rule in response to the public comments.

The Final Regulations were published in the Federal Register on October 28, 1997, with the implementation date scheduled for April 28, 1999. The FDA allowed for this 18-month preparation period to ease the transition from the interim rule to the final rule.

Slide 4: Amendments to the Regulations as Published on 10/28/97

Since publishing the final regulations on October 28, 1997, FDA has published three amendments to those regulations. Among the technical changes published on October 22, 1998, two are of key interest to radiologic technologists and medical physicists, and concern their continuing experience, or CE, requirements. As amended, the start dates for meeting these CE requirements now coincide with the April 28, 1999, start date of the final regulations. I'll discuss the impact of this during the review of personnel requirements.

Those of you who read Mammography Matters on a regular basis know that FDA had to correct a problem with the requirement for the alignment of the x-ray field and the image receptor. The April 14, 1999, FR notice amended the MQSA regulation so that the x-ray field is permitted to, but does not have to, extend beyond any non-chest wall edge of the image receptor by up to two percent of the source-to-image distance. This will allow most, if not all, installed mammography units to meet the requirement without modification.

The FDA published both a Proposed Rule and a concurrent Direct Final Rule in the Federal Register on June 17, 1999. The purpose of this Rule is to incorporate the communication-of-results-to-patients requirement and other specific wording of the Mammography Quality Standards Reauthorization Act (MQSRA) into the regulations. If no significant adverse comments are received, the rule will go into effect on November 1, 1999. The result will be one document that contains all the quality standards, as opposed to two — namely, the final regulations and the MQSRA.

Slide 5: MQSA Reauthorization

MQSA was originally authorized for 5 years. It has been extended until 2002 by MQSRA, signed into law on October 9, 1998. Although the Reauthorization Act continued the provisions of the original Act largely unchanged, there are some important additions you may wish to note.

In passing the Reauthorization Act, Congress listened to the consensus of consumer groups regarding the reporting of their examination results to patients. Facilities are now required to provide all patients with a written lay-language summary of their mammography report. This requirement went into effect on April 28, 1999.

In addition, the Act confirms the final regulations requirement that, when requested by patients or their representatives, facilities must provide original — not copies of — mammography films for both temporary and permanent transfer.

Slide 6: Inspection Demonstration Project

MQSRA also authorizes FDA to establish a demonstration project to examine the feasibility of conducting less-than-annual inspections of facilities that are "substantially free of incidents of noncompliance." The Act states that this demonstration project may not begin before April 2001. When further information is available on this project, it will be posted on FDA's mammography website.

Slide 7: Good Guidance Practices 1997

FDA is often asked questions about the implementation of the regs and satisfactory ways of meeting them. To assist facilities in understanding and meeting the requirements, FDA issues guidance. It's important to note that "guidance" is not "regulation." While guidance may suggest ways for facilities to comply with specific aspects of the final regulations, there may be other ways for facilities to comply.

Under FDA's Good Guidance Practices, new guidance will generally be available for public comment before it's implemented. Such guidance is first published as "proposed" guidance on FDA's mammography website and is open for a 90-day public comment period. The Internet address, by the way, is http://www.fda.gov/cdrh/mammography, as shown on the screen. The availability of the proposed guidance is announced in the Federal Register. Although this process will cause a delay in answering questions, FDA sees a great benefit in obtaining public input before issuing guidance in final.

In cases where guidance must be issued immediately or may be considered minor in nature, FDA may implement guidance without public comment. In these cases, the public has the opportunity to comment at the time of issuance or implementation.

Once the comments are in, FDA considers them and then issues the final version of the guidance. There's a large volume of information, so FDA has tried to streamline for you the process of searching for answers to your questions. If you go into the MQSA Policy Guidance Help System on the FDA mammography website, you will find the guidance organized by subject area and key words.

Slide 8: The Inspection Process

At this point I would like to review the inspection process with you. To start the process rolling, the inspector will work with the facility to schedule the inspection so that any inconvenience to the facility's daily operations is minimized. Normally the inspector gives the facility advance notice of at least five business days.

Inspections with a single x-ray unit/film processor usually take about five hours, with one hour needed to evaluate the equipment and the balance of the time being spent in review of the facility's procedures and records. To minimize disruption of the facility's activities, FDA suggests that the facility schedule a block of time to evaluate each x-ray unit/film processor. The facility should also organize and consolidate the records the inspector will need to review and have them readily available.

Upon arrival, the inspector will first meet with designated facility staff to verify preliminary information and briefly outline the proposed inspection agenda. This is the time for the facility to request any changes to the inspector's proposed schedule. To close the inspection, the inspector will again meet with facility staff for an exit interview.

Slide 9: Specific Inspection Items

In addition to testing the facility's equipment, the inspector will be looking for specific information, including personnel qualifications, recordkeeping, reporting and tracking systems, quality assurance records, and standard operating procedures. At this point, I'm just going to touch on these items, some of which will be discussed in greater detail later.

• The inspector will confirm that the facility has a valid certificate prominently displayed in each patient waiting area.
• Records for all personnel who have provided mammography services since the facility's last inspection must be available. These records must cover the status of both permanent and temporary staff from the start of employment through their termination.
• Equipment tests will be performed on each x-ray system used for regulated mammography activities.

Slide 10: Specific Inspection Items (cont.)

Other specific items to be inspected are:

• the Quality Assurance and Quality Control Program,
• the two most recent Medical Physicist's Survey Reports, and
• evidence that all equipment, which is new to the facility or that has undergone a major repair, has been evaluated by a qualified medical physicist and all problems corrected before being placed in service.
• The inspector will also review selected patient medical records to ensure 1) that they identify the interpreting physician and use the required assessment categories, and 2) to determine that the appropriate records are being generated and maintained.

Slide 11: Specific Inspection Items (cont.)

• The inspector will review the facility's procedure for communicating exam results to both referring physicians and patients, as well as the facility's mechanism for providing quick communication when the assessment is "Suspicious" or "Highly suggestive of malignancy."
• The medical audit and outcomes analysis program will be reviewed to ensure that it meets the requirements.
• The inspector may ask to look at other standard operating procedures to confirm that the regulations are being met.

Slide 12: Personnel Standards: General Notes

Now, the personnel standards.

Inspectors will examine facility records that document the qualifications of all personnel who are performing, or have performed, the duties of interpreting physician, radiologic technologist, and medical physicist at the facility since the last MQSA inspection. They will check to ensure that personnel meet initial requirements, under either the interim or the final regulations, as well as continuing education and experience requirements.

Facilities are responsible for ensuring that their personnel meet all appropriate requirements before allowing them to provide mammography services. To avoid being cited, it is recommended that facilities monitor the continuing education and experience status of their personnel.

Before I review the requirements for each personnel category, I want to point out that all interpreting physicians and radiologic technologists who qualified under the interim regulations (before April 28, 1999) are exempt from any additional initial requirements under the final regulations. They are, in essence, "grandfathered." This is not the case for medical physicists, however. Each medical physicist who qualified under the interim regulations must check to make sure that he or she meets the final regulations initial, or alternative initial, requirements.

Under the final regs, inspectors will be checking to ensure that personnel have had 8 hours of training with each mammographic modality used. This requirement will become more significant when a mammographic modality other than screen-film becomes available.

Slide 13: Personnel Standards: General Notes (cont.)

In evaluating whether personnel have met the continuing education and experience requirements, inspectors will use one of the following three options for determining the evaluation date. Facilities may determine which option to use for each staff member. However, FDA recommends that the facility try to consistently use the same option for all interpreting physicians, radiologic technologists and medical physicists.

For continuing education credits, the inspector will count back 36 months and for continuing experience, the inspector will count back 24 months from the selected date.

• For Option 1, the inspector counts back from the date of the inspection.
• For Option 2, the inspector counts back from the end of the full calendar quarter immediately preceding the date of the inspection. For example, if the date of the inspection is May 15, the inspector will begin counting back from March 31.
• Under Option 3, a facility may opt for the inspector to start on any date between the inspection date and the end of the previous full calendar quarter. Using the above example, the inspector will begin counting back from a date between March 31 and May 15.

Under the facility's selected option, the inspector will examine all applicable continuing education credits and experience for each individual.

Slide 14: Interpreting Physicians Initial Qualifications

The first personnel category I'll discuss is the interpreting physician.

All interpreting physicians who qualify after April 28, 1999, must meet the following initial qualifications:

• He/she must be licensed by a State to practice medicine.

• He/she must be certified by an FDA-approved body in radiology or diagnostic radiology OR have 3 months of documented training in mammography interpretation, radiation physics, radiation effects, and radiation protection.

  Presently, the FDA-approved bodies are the American Board of Radiology (ABR), the American Osteopathic Board of Radiology (AOBR), and the Royal College of Physicians and Surgeons of Canada (RCPSC).

• He/she must have 60 hours of documented medical education in mammography.

  All 60 of these hours must be category I, and at least 15 of these hours must have been obtained within the 3 years immediately before the physician's qualification date. Time spent in residency is considered equivalent to category I.

• He/she must have read/interpreted at least 240 mammography examinations in the 6-month period immediately before the physician's qualification date. These mammograms must have been read under the direct supervision of an MQSA-qualified interpreting physician.

  There is an exception to this rule. Physicians who become board certified at the first allowable time may satisfy this requirement during any 6-month period within the last two years of their residency program.

Slide 15: Interpreting Physicians Continuing Requirements

To remain qualified, interpreting physicians must meet continuing experience and continuing education requirements.

He/she must interpret or multi-read at least 960 mammographic examinations over a 24-month period. This can be done at more that one facility, but physicians who need to total their readings from several facilities to reach 960 exams should make sure that each facility has documentation about the number of mammograms interpreted at the other facilities.

To meet the continuing education requirement, he/she must have taught or completed at least 15 category I CME credits over a 36-month period, at least 6 of which must be related to each mammography modality used. In order for a physician to be able to claim CME for teaching a course, writing a paper, or reading an article, an organization authorized to award credit must assess and document the appropriate amount of category I CME awarded. Teaching a specific course may be counted as CME only once during any 36-month period. Mammography personnel should get a letter or other documentation from the authorized organization stating how many category I CME's are awarded and the date the credit was given.

Note that under the interim regulations, CME credits earned before April 28, 1999, may be either category I or II. Credits earned after April 28, 1999, must be category I. Therefore, category II credits earned before April 28, 1999, can be counted toward the required 15 credits as long as they were obtained within the 36-month period.

A physician must have 8 hours of training in any mammographic modality in which he/she was not previously trained before independently interpreting mammograms produced by that mammographic modality.

Slide 16: Interpreting Physicians Reestablishing Qualifications

Interpreting physicians who fail to maintain these continuing requirements must stop interpreting mammograms independently until they have reestablished their qualifications.

To reestablish the continuing experience requirement, physicians must interpret or multi-read under direct supervision either 240 mammography examinations or enough to bring their total number of examinations read over 24 months to 960, whichever is less. These interpretations must be done within the 6 months immediately preceding resumption of independent interpretation.

Requalification only allows the interpreting physician to read independently again; it does not waive meeting the requirement of reading 960 mammographic examinations in 24 months. Nonetheless, once requalified, and for a period of 6 months after the requalification date, the interpreting physician will be exempt from an adverse finding for this requirement. This 6-month exemption allows the physician time to independently read a sufficient number of mammograms to meet the requirement.

Physicians who fail to meet the continuing education requirement must obtain the additional category I credits in mammography to bring their total up to the required 15 credits over the most recent 36-month period before resuming independent interpretation.

Slide 17: Radiologic Technologists Initial Qualifications 

Now, let's turn to the radiologic technologists (RTs). Although some RTs performing mammography are men, most are women, so in this section I'll be using the feminine pronoun for simplicity.

All RTs who qualify after April 28, 1999, must meet the following initial qualifications:

• She must be licensed by a State OR be certified by a FDA-approved body.

  Currently, these are the American Registry of Radiologic Technologists (ARRT) and the American Registry of Clinical Radiography Technologists (ARCRT), if now registered with ARRT.

• She must have 40 hours of documented training in mammography, including training in:

  • Breast anatomy and physiology,
  • Positioning and compression,
  • Quality assurance (QA) and quality control (QC) techniques, and
  • Imaging of patients with breast implants.
• She must have performed a minimum of 25 mammography examinations under the direct supervision of an MQSA-qualified radiologic technologist.
• She must have at least 8 hours of training in each mammographic modality to be used.

Slide 18: Radiologic Technologists Continuing Requirements

To remain qualified, RTs must meet both continuing experience and education requirements.

The continuing experience requirement is new under the final regulations and requires technologists to perform 200 examinations over a 24-month period. The start date for this is April 28, 1999, or the date at which the technologist meets the initial requirements, whichever is later. Because of the 24-month period, no one will be cited until after June 30, 2001, for failure to meet this requirement.

Generally, it will be sufficient if the technologist's file contains a letter, table, or printout from each facility at which he or she performs mammography examinations, signed by a responsible facility official. The document should state that the technologist performed a given number of examinations at that facility in a given time period. The FDA recommends that these records be updated on at least a quarterly basis.

To meet the continuing education requirement, RTs must have taught or completed at least 15 continuing education units (CEUs) over a 36-month period. At least 6 of the 15 CEUs must be in each mammographic modality used. In order for a technologist to be able to claim CME for teaching a course, writing a paper, or reading an article, an organization authorized to award credit must assess and document the appropriate amount of CME awarded. Teaching a specific course may be counted only once as CME during any 36-month period. Mammography personnel should get a letter or other documentation from the authorized organization stating how many CME's are awarded and the date the credit was given.

One more point on continuing requirements: before beginning to use a new mammography modality, a technologist must obtain at least 8 hours of training in that modality.

Slide 19: Radiologic Technologists Reestablishing Qualifications

An RT who fails to maintain these continuing requirements must stop independently performing mammographic examinations until she has reestablished her qualifications.

To reestablish the continuing experience requirement, she must perform 25 examinations under direct supervision. Requalification only allows the RT to perform mammographic examinations again; it does not waive meeting the requirement of performing 200 mammographic examinations in 24 months. Nonetheless, upon requalification, the RT will be exempt from an adverse finding for the continuing experience requirement for a period of 6 months after the requalification date to give her time to comply with this requirement.

An RT who fails to meet the continuing education requirement must bring her total CEUs up to 15 in the most recent 36-month period before she can again perform mammographic examinations independently.

Slide 20: Medical Physicist Initial Qualifications 

The last personnel category to look at is medical physicist.

There are two avenues that medical physicists can follow to meet their initial qualifications under the final regulations. The first is available to all physicists. The second, or alternative, avenue is for physicists who qualified before April 28, 1999, under the interim regulations and have met specific additional requirements under the final regulations. It's important to note that a medical physicist who was qualified under the interim regulations might not be qualified under the final regulations.

To use the first route, which is the only one available to medical physicists who qualify after April 28, 1999, he/she must meet the following initial qualifications:

• Be licensed or approved by a State OR certified by a FDA-approved body.
• Currently, the FDA-approved bodies are the American Board of Radiology (ABR) and the American Board of Medical Physicists (ABMP).
• Have a master's degree or higher in a physical science from an accredited institution.
• Have 20 semester hours of undergraduate or graduate level physics.
• Have 20 contact hours of documented mammography survey training.
• Have the experience of surveying 1 mammography facility and a total of at least 10 mammography units.
• Have obtained 8 hours of training in each mammographic modality surveyed before independently surveying that modality.

Slide 21: Medical Physicists Alternative Initial Qualifications

The alternative approach allows experienced physicists without a master's degree, who met the initial requirements under the interim regulations before April 28, 1999, to continue to provide physics services to mammography facilities.

To qualify by this route, a physicist must have maintained the active status of his/her state license or approval, or certification from a FDA-approved body (the ABR or ABMP).

Slide 22: Medical Physicists Alternative Initial Qualifications (cont.)

In addition, he/she must:

• Have a bachelor's degree in a physical science with 10 semester hours of undergraduate or graduate level physics;
• Have 40 contact hours of documented specialized training in conducting surveys of mammography facilities; and
• Have conducted surveys of at least 1 mammography facility and 20 mammography units.
• Note that the 40 hours of training and the survey experience must have been obtained after the physicist earned the bachelor's degree and before April 28, 1999.

Slide 23: Medical Physicists Continuing Requirements

To remain qualified, each medical physicist must survey at least 2 mammography facilities and a total of at least 6 mammography units within a 24-month period. This requirement may be met by performing 2 surveys of the same facility as long as the surveys are at least 10 months apart. Similarly, more that 1 survey of a mammography unit may be counted as long as the surveys are at least 2 months apart.

Medical physicists also must have taught or completed at least 15 continuing education units (CEUs) over a 36-month period. At least some of the 15 CEUs must be in each mammographic modality for which the physicist provides services. In order for a physicist to be able to claim CME for teaching a course, writing a paper, or reading an article, an organization authorized to award credit must assess and document the appropriate amount of CME awarded. Teaching a specific course may be counted only once as CME during any 36-month period. Mammography personnel should get a letter or other documentation from the authorized organization stating how many CME credits are awarded and the date the credit was given.

Finally, before independently surveying a particular mammographic modality, a medical physicist must obtain 8 hours of training in that modality, if they were not previously trained in it.

Slide 24: Medical Physicists Reestablishing Qualifications

Physicists who fail to maintain their continuing qualifications may perform MQSA surveys only under the direct supervision of a qualified medical physicist until they have reestablished their qualifications.

To meet the continuing experience requirement, physicists must bring the total number of supervised surveys up to 2 facilities and 6 units in the most recent 24-month period. Again, surveys of a specific mammography unit must be at least 2 months apart to be counted more than once.

To meet the continuing education requirement, physicists must obtain a total of 15 CEUs in the most recent 36-month period.

Slide 25: Reporting and Recordkeeping Standards Overall Assessment of Findings

Now let's switch to the area of reporting and recordkeeping. As was the case under the interim regulations, a facility must prepare a written report of each mammography examination it performs. The final regs, however, add some specific requirements for the content of the report. The most important of these are: 1) the report must identify the physician interpreting the examination, and 2) the findings must be classified using one of the following six assessment categories. Note that the category must be identified by its name, not by a coding system, although coding systems can be used in addition to the name. FDA is allowing facilities limited flexibility when naming these categories. Additional information may be found in the MQSA Policy Guidance Help System on FDA's Mammography Website.

1. "Negative" meaning that there is nothing to comment upon. However, if a physician is aware of clinical findings or symptoms, despite a negative finding, these must be explained.
2. "Benign" meaning that the finding has a typical benign appearance.
3. "Probably benign" indicating that there is high probability that the finding is benign.
4. "Suspicious" meaning that the finding is without all the characteristic morphology of breast cancer, but indicating a definite probability of being malignant.
5. "Highly suggestive of malignancy" meaning that there is a high probability of malignancy.
6. "Incomplete: Need additional imaging evaluation" in a case where no final assessment category can be assigned. In this instance, the interpreting physician must explain why no assessment can be made.

Slide 26: Reporting and Recordkeeping Standards: Communication of Results

This report must be forwarded to the referring health care provider or, if the patient has no health care provider, to the patient herself within 30 days of the examination. If the assessment is "Suspicious" or "Highly suggestive of malignancy," both the health care provider and the patient must be notified as soon as possible, ideally within 3-5 days.

Facilities are required to have a system to send patients a summary of their report written in terms easily understood by a lay person within 30 days. This summary is to be sent to all patients, not just self-referred patients, as was formerly the case. Patients who don't have a referring health care provider are to receive both the written lay-language summary of the mammography report and the report itself no later than 30 days from the date of the mammography examination.

Slide 27: Reporting and Recordkeeping Standards: Mammographic Image Information

Next, let's examine the recordkeeping requirements. Each mammographic image must have the following information indicated on it in a permanent, legible, and unambiguous manner. This information must not obscure the anatomic structures.

• The name of the patient and an additional patient identifier
• The date of the examination
• The view and laterality
• The facility name and location
• The technologist identification
• The mammography unit identification (if the facility has more than one unit)

Slide 28: Medical Records and Reports

Facilities are required to maintain these mammography films and reports for a period of 5 years or, if no additional mammography is performed on the patient by that facility, for a period of 10 years. However, some state or local laws may require that records be kept for a longer period of time. Of course, facilities must abide by those rules.

As mentioned earlier, both the regulations and MQSRA require that facilities provide original films for both temporary and permanent transfer if requested by patients or their representatives. A facility may charge a fee for transferring films, but the fee may not exceed the documented costs incurred by the facility for providing this service.

Slide 29: Medical Records and Reports (cont.)

To ensure that both the images and reports are being retained as required, and to verify that they contain the information outlined above, the inspector will randomly select records for review.

In addition, in reviewing the facility's medical records and reports, the inspector may ask to see:

• Sample reports sent to the referring health care providers;
• Templates of the lay summary reports that are sent to all patients;
• The facility's system for communicating findings to both patients and referring health care providers; and
• Randomly selected reports of examinations since the last inspection period. The inspector will check that the interpreting physician is identified and that the overall assessment categories are given.

Slide 30: Equipment Standards Overview

Next, I want to talk to you about the equipment standards in the final rule. Obviously, the quality of mammography depends on the capabilities of the equipment. Since the interim rule addressed equipment standards only briefly, much of the final regulations in this area is new.

A key requirement is that all equipment must be designed for mammography. This means that it meets all of the applicable MQSA requirements and is designed by the manufacturer and accepted by the FDA as appropriate for mammography. Of course, this equipment may also be useful for non-mammography procedures because of its unique characteristics, and such use is not prohibited under MQSA.

In drafting these regulations, FDA relied heavily on the recommendations of groups such as the focus groups on equipment convened by the American College of Radiology with the support of the U.S. Centers for Disease Control and Prevention. Through an announcement in the Federal Register, an earlier draft of these proposals was also made available to manufacturers and other interested parties for comment. FDA gave serious consideration to all comments and actually reduced the level of regulation originally proposed for equipment. FDA believes that most mammography equipment manufactured in recent years meets many, if not all, of these requirements. However, some older equipment might have to be retrofitted or replaced.

Slides 31 and 32: Equipment Standards Effective on October 28, 2002

As for equipment standards, I want to point out that almost all the equipment requirements went into effect on April 28, 1999. However, five regulations are not scheduled to go into effect until October 28, 2002. They are as follows:

• Application of compression. Each system must provide an initial power-driven compression that is activated by hands-free controls from both sides of the patient. In addition, each system must have fine adjustment controls that are also operable from both sides of the patient.
• Compression device performance. The maximum compression force for the initial power drive must be between 111 newtons, or 25 pounds, and 200 newtons, or 45 pounds.
• Automatic exposure control (AEC) performance. The AEC must be capable of maintaining film optical density within ±0.15 of the mean optical density, down from ±0.30 prior to October 28, 2002.
• Focal spot condition can be evaluated only by determining the system resolution.
• Radiation minimum output limits go from 513 mR per second to 800 mR per second.

Slide 33: Equipment Standards: Specific Requirements

Let's look at some of the specific equipment requirements, beginning with the motion of tube-image receptor assembly. The assembly must be capable of being fixed in any position where it is designed to operate. Although there is no specific range of motion that the assembly must provide, once it is fixed in any operating position intended by the equipment design, it must remain fixed in that position — even during power interruption to the unit. The intent of this regulation is to ensure patient safety and prevent any injury that could be caused if the tube assembly were to move from the position the technologist placed it in, if the power to the system is interrupted.

Systems using screen-film image receptors must have at least one 18 x 24 cm cassette and one 24 x 30 cm cassette for each mammography x-ray unit in the facility, and these cassettes must be capable of properly functioning with their respective units. Facilities are not prohibited from using additional sizes, but these 2 sizes are required. In addition, facilities must have on hand at least one 18 x 24 cm and one 24 x 30 cm moving grid mechanism for each mammography x-ray unit in the facility.

Slide 34: Equipment Standards: Specific Requirements (cont.)

If the system has a light beam that passes through the x-ray beam-limiting device, that light shall provide an average illumination of 160 lux at 100 cm.

Systems used for magnification must provide at least one magnification in the range of 1.4 to 2.0.

Slides 35 and 36: Equipment Standards: Specific Requirements (cont.)

Systems must be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles shall be flat and parallel to the breast support table. In cases where the paddle is designed not to be flat and parallel, the equipment shall meet the manufacturer's design and maintenance requirements.

As mentioned earlier, by October 28, 2002, all mammography systems must provide an initial power-driven compression that is activated by hands-free controls and operable from both sides of the patient. The system must also include fine adjustment controls that are also operable from both sides of the patient.

Slide 37: Equipment Standards: Specific Requirements (cont.)

Manual selections of mAs or one of its component parts shall be available. The technique factors shall be indicated before the exposure begins.

The AEC shall be operable in all combinations of the equipment configuration provided. There must be flexibility in the placement of the detector under the target tissue. The system shall also allow the operator to vary the selected optical density from the normal (zero) setting.

Slide 38: Equipment Standards: Specific Requirements (cont.)

Other specific requirements address:

• Display of selected focal spot and/or target material
• X-ray film designed for mammography
• Intensifying screens matched to film
• Film processing solutions meet film requirements
• High-intensity lighting (hot-lights) must be available
• Film masking devices must be available

More information about each of these areas is available in the MQSA Policy Guidance Help System on FDA's website.

Slide 39: Inspection Equipment Tests

During the MQSA inspection, inspectors will check each x-ray system that is used by the facility, including equipment that is being leased by, loaned to, or evaluated for purchase, as well as that owned by the facility. The inspector will need assistance from facility staff in setting up the technique factors normally used by the facility and for any other preparatory work needed for each of the following elements.

• The unit is designed specifically for mammography
• The unit has image receptors, moving grids, and compression paddles for both 18 x 24 cm and 24 x 30 cm image receptors
• The X-ray unit has a functioning post-exposure display of the x-ray focal spot and the target material
• Collimation assessment
• Exposure reproducibility

Slide 40: Inspection Equipment Tests (cont.)

• Beam quality and half-value layer (HVL) measurement
• Dose calculation for a cranio-caudal view of a standard breast
• Processor evaluation
• Darkroom fog
• Phantom image quality evaluation

Slide 41: Quality Assurance Standards

Next let's look at the quality assurance (QA) standards in the final rule. A facility's quality assurance program should be designed to ensure that equipment and personnel continue to produce high-quality mammograms and accurate interpretations. The regulations address quality assurance requirements in three separate sections: general administrative requirements, equipment quality assurance, and mammography medical outcomes audit.

Slide 42: General Administrative Requirements

The general administrative section covers staff responsibilities and QA recordkeeping requirements. The regs identify tasks that are assigned to specific personnel categories.

• The lead interpreting physician is responsible for ensuring that the facility's quality assurance programs comply with the requirements.
• The interpreting physicians must follow the facility procedures for corrective action when the images are of poor quality.
• The medical physicist is responsible for performing surveys and mammography equipment evaluations and providing the facility with all appropriate reports.
• The quality control (QC) technologist is responsible for all individual tasks within the quality assurance program that are not assigned to the lead interpreting physician or the medical physicist.

These responsible individuals must ensure that all necessary records are updated and maintained. Records related to the QC tests must be kept either until the next annual inspection has been completed, together with documentation of any corrective action that may have been necessary, or until the quality control test has been performed and documented two additional times, whichever is longer.

Slide 43: Equipment Quality Assurance: Screen-Film Units

For screen-film systems, the regulations specify which tests are to be performed, their minimum frequency, and the action limits for test results. In meeting these requirements, the facility has the freedom to choose the test procedures that best fit its needs.

Operators of non-screen-film equipment must follow the manufacturer's quality assurance instructions.

Slide 44: Equipment Quality Assurance: Tests Other Than Annual

Some tests must be performed on a daily, weekly, quarterly, or semiannual schedule. Others must be performed annually. The tests that must be performed on an other-than-annual schedule are as follows:

• The film processors must be tested on each day that mammograms are processed before any clinical films are processed that day.
• The image quality evaluation test, using an FDA-approved phantom, must be performed at least weekly. Note that this frequency is a change from the requirement for monthly testing under the interim regulations.
• The tests that must be performed on a quarterly basis address fixer retention in the film and the repeat analysis.
• Darkroom fog, screen-film contact, and compression device performance must be tested at least semiannually.

Slide 45: Equipment Quality Assurance: Annual Tests 

All other tests must be conducted annually. They include:

• Automatic exposure control
• Kilovoltage peak accuracy
• Focal spot condition
• Beam quality and half-value layer
• Breast entrance air kerma and AEC reproducibility
• Dosimetry

Slide 46: Equipment Quality Assurance: Annual Tests (cont.)

• X-ray field / light field / image receptor / compression paddle alignment
• Uniformity of screen speed
• System artifacts
• Radiation output
• Decompression

Slide 47: Equipment Quality Assurance: Mobile Units

Mobile units have special considerations. After moving to a new examination location, all units must be tested before examining any patients to verify the accuracy of the image quality. The regs don't specify which test or tests should be used, but the test the facility chooses to use must verify that the image quality remains adequate.

One example of an acceptable test method is the traditional procedure of verifying the adequacy of image quality by producing and evaluating a phantom image after each move, and before any patients are examined.

Another example would be a test method based on demonstrating that the variation in mAs value is within acceptable limits after each move. In this case, a phantom image should be developed with each day's clinical films and evaluated to confirm that the mAs method provides adequate assurance of acceptable image quality.

Other tests designed by qualified personnel could be acceptable, but may have to be evaluated by the inspector on a case-by-case basis. A facility's medical physicist can provide assistance in determining which tests could meet the requirement.

Slide 48: Equipment Quality Assurance: Test Results

After completing all the quality assurance tests, the facility must compare the results of each test to the corresponding action limits for that test. If any test results fall outside of the stipulated action limits, then the staff must identify the source of the problem and take appropriate corrective actions. All corrective actions must be documented.

Slide 49: Equipment Quality Assurance: Corrective Action Time Frames

If test results for the processor, phantom, fog, screen-film contact, compression, dose, other modality receptors, or mobile units indicate problems, the component failing the test may not be used until the facility has corrected the problem. For all other test results, the problems must be corrected within 30 days.

Slide 50: Medical Physicist Survey

At least once a year, each facility must undergo a survey by a qualified medical physicist. During this survey, the medical physicist will perform all of the annual quality control tests, the tests for any mammographic modality other than screen-film that the facility might be using, and the phantom image quality test. The physicist will also review the records of any tests and corrective actions carried out by the facility to confirm that the tests were adequate.

After completing the survey, the physicist will prepare a report that includes a summary of the survey findings along with recommendations for any necessary improvements. The physicist performing or supervising the survey must sign and date the report and deliver it to the facility within 30 days, or sooner if there are any major problems to be addressed.

Slide 51: Mammography Equipment Evaluations

Additional evaluations of mammography units or image processors must be conducted by a qualified medical physicist whenever: 1) a facility installs a new piece of equipment, 2) equipment is dissembled and reassembled, or 3) major components of a unit or processor are changed or repaired. These evaluations must be conducted before any equipment is put into use to ensure that it meets all the requirements. Any problems must be corrected before the new or changed equipment is put into service. The facility must maintain documents that show the date(s) the evaluation was performed, who performed it, and that any detected problems were corrected before use.

Slide 52: Infection Control

Under the infection control requirement, facilities must establish procedures for cleaning and disinfecting their equipment after it has come into contact with blood or other potentially infectious materials. These procedures must comply with existing federal, state, and local infection control rules, as well as the manufacturer's recommendations for cleaning and disinfection.

Slide 53: Inspection of Quality Assurance and Quality Control Programs

The inspector will also check that the facility has established a Quality Assurance (QA) program and that qualified personnel have been designated. The inspector's QA evaluation includes reviewing the facility's QA procedures and records. Although these records must be maintained and available for review, not all of them will always be evaluated during each inspection. However, the inspector will always review data on the following QA/QC items:

• Daily processor quality control tests
• Weekly phantom image tests
• Quarterly analysis of fixer retention in film tests
• Quarterly repeat analysis tests
• Semiannual darkroom fog tests

Slide 54: Inspection of Quality Assurance and Quality Control Programs (cont.)

• Semiannual screen-film contact tests
• Semiannual compression tests
• Personnel responsibilities and procedures for QA/QC testing
• Other QA-related written policies, procedures and records required by the regulations, such as those relating to infection control, breast implants, and consumer complaints
• Mammographic technique charts and information pertinent to optimizing mammographic quality should also be available for inspection

Slide 55: Inspection of Quality Assurance and Quality Control Programs (cont.)

In general, the facility's QC records should show that all tests were:

• Conducted at the frequencies specified in the regulations (at a minimum)
• Conducted according to an appropriate manual or manuals regarding these items
• Followed up by any corrective actions shown to be necessary and that all corrective actions were documented

Slide 56: Medical Outcomes Audit

The medical outcomes audit is another area that has been expanded beyond the requirements of the interim regulations. The purpose of the audit is to ensure the reliability, validity, and accuracy of image interpretations. This audit, conducted annually, is an effective tool for facilities to use in maintaining or improving the quality of service they are providing.

The final regulations require all facilities to establish and maintain a system to track positive mammographic assessments and to correlate the biopsy results with the interpreting physician's findings.

Each facility shall designate at least one interpreting physician who is responsible for ensuring that data is collected and analyzed at least once every 12 months and that any follow-up actions are documented. The data is to be analyzed both individually and collectively for all interpreting physicians at the facility.

Slide 57: Medical Audit and Outcome Analysis Records

What must the system reflect?

At a minimum, the system must track all "positive mammographic findings" (those that are "Suspicious" or "Highly suggestive of malignancy") and correlate the findings with the surgical biopsy results obtained.

In addition, any cases of breast cancer among women imaged at the facility that subsequently become known to the facility shall prompt the facility to initiate followup on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.

The inspector will examine the audit system to ensure that it addresses all requirements. In addition, he or she will ask how the biopsy results are obtained and will want to see examples of the reports. If biopsies were recommended, but no results were obtained, the facility must provide documentation of attempts to get this information. The inspector will also confirm that the analysis is being performed on an annual basis.

Now, let's turn to some other new requirements in the regulations that more directly involve the patient's input.

Slide 58: Breast Implants

It's estimated that there are approximately 2 million women with breast implants. Each of these women is entitled to receive the same high-quality mammography as women without breast implants. Because of the special problems presented by implants, the final regulations address this issue. Facilities are now required to:

• Ask about the presence of implants before the exam, and
• Select the best views to visualize breast tissue.

Regardless of whether or not a facility performs mammography exams on patients with breast implants, it must have a procedure for asking about the presence of implants before the exam. If the facility doesn't provide implant-imaging services, it may refer the patient to other facilities that do provide such services, although this referral is not required.

Inspectors may ask to see the facility's written procedures for meeting this requirement.

As noted earlier, initial training for radiologic technologists, who meet their initial requirements under the final regulations, must include imaging of patients with breast implants.

Slide 59: Consumer Complaint Mechanism

Under the consumer complaint mechanism, facilities are now required to establish a written and documented system for collecting and resolving consumer complaints related to mammography. Within the system, facility staff may respond to different kinds of complaints in different ways. For example, a complaint about the temperature of a waiting room is not as serious as the complaint that the patient did not receive her results.

FDA believes that facilities can effectively address most consumer complaints. However, any serious complaint that facility staff is unable to resolve must be referred to their accreditation body. If their accreditation body cannot resolve it, it is referred to FDA. FDA defines a "serious complaint" as a report of a serious adverse event that significantly compromises clinical outcomes, such as poor image quality or a failure to communicate results. Records of serious complaints must be maintained for at least 3 years from the date the complaint was received.

Slide 60: Additional Mammography Review and Patient Notification

The last new requirement I'll address is the additional mammography review (or AMR) and patient notification. First I'll explain the AMR. For cases in which FDA believes that mammography quality has been compromised, facilities must provide clinical images and other relevant information for review, either by the accreditation body or by another entity that FDA designates. This additional review will help FDA determine if serious conditions exist at a facility that would endanger public health to the extent that patients and their referring health care providers should be notified.

Slide 61: MQSA Internet Site: http://www.fda.gov/cdrh/mammography

In a relatively short time I have given you a great deal of information on the MQSA requirements, yet you still may want or need additional details.

The best, and your most important resource for information about the MQSA is FDA's mammography website. Here you will find the MQSA Policy Guidance Help System (a Windows 95 type of help file) that is indexed by topic and key words. Documents such as current and back issues of Mammography Matters, Federal Register notices, Preparing for MQSA Inspections, Mammography Facility Survey and Medical Physicist Qualification Requirements Under MQSA, pertinent and timely notices and reminders, and other useful information may be found there. The Internet has become the primary avenue for FDA to disseminate information. That address, shown on the screen is:

Slide 62:  ... For More Information on MQSA

In addition, FDA maintains the MQSA Facility Hotline for all facility personnel to call with questions. The staff there is trained to answer your questions and help you understand what is required. Questions that cannot be immediately answered by the staff will be forwarded to FDA. If a question requires the development of guidance, the answer may first appear as proposed guidance on FDA's web site.

Note that any questions regarding interim notice letters, extensions of provisional certificates, reinstatement of accreditation, or any other accreditation-related issue should be directed to the facility's accreditation body, not the facility hotline. The facility hotline will no longer answer questions related to interim notices and 90-day extensions.

The Facility Hotline telephone numbers are:

Updated April, 1999