What is mqsa inspection

Instead, FDA should only require that all mammography machines used for non-biopsy interventional procedures be accredited under the basic MQSA requirements. It is essential that accreditation body reviewers passing judgment on the performance quality of mammography facilities have considerably more experience than the minimum established by the regulations for physicians interpreting mammograms. Likewise, reviewers evaluating images of a specific modality e. With its initial accreditation application, the results of a mammography equipment evaluation that was performed by a medical physicist no earlier than 6 months before the date of application for accreditation by the facility.

The ACR currently requests only the equipment evaluation results with the initial accreditation application. The FDA has approved this process. Prior to accreditation, an annual survey that was performed no earlier than 6 14 months before the date of application for accreditation or accreditation renewal by the facility. Prior to accreditation, an annual survey that was performed no earlier than 14 months before the date of application for accreditation or accreditation renewal by the facility.

The way it is currently written may force a facility to unnecessarily have more than one annual survey in the same year. Facilities submit the results of such surveys and any other information that the body may require to the body at least annually. The current requirement that facilities also submit annual survey results to the AB each year is a redundant process and an unnecessary burden for mammography facilities.

Eliminating this redundancy would allow the AB to focus on obtaining important identification and contact information. Collect and submit to FDA the information required by 42 U. In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by the FDA for accreditation of all mammography units. The facility shall submit to such body or entity the information required in 42 U. Facilities must notify their accrediting body of new units and begin accreditation before use.

A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate suspended or revoked by FDA, may apply to have the certificate reinstated so that the facility may be considered to be a new facility and thereby be eligible for a provisional certificate. A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate suspended or revoked by FDA, may apply to have the certificate reinstated so that the facility may be eligible for a provisional certificate.

The current wording confuses facilities. The facility will choose one of these dates to determine the 24 month period previous two calendar years.

Continuing experience obtained outside of the U. Following the second anniversary date in which the requirements of paragraph a 1 i of this section were completed, the interpreting physician shall have interpreted or multiread at least mammographic examinations during the previous two calendar years.

Basing these numbers on calendar years will simplify compliance with no loss of quality. While at a foreign facility they continue to interpret mammograms using the skills they obtained while qualified in the U. They should not be prevented from using the examinations interpreted at a foreign site as long as it is adequately documented toward meeting the continuing experience requirements in the U.

Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph a 1 i of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the previous three calendar years. The facility will choose one of these dates to determine the 36 month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice.

Following the third anniversary date in which the requirements of paragraph a 1 i of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical education units in mammography during the previous three calendar years. It is more important to allow the physician to select CMEs for continuing experience to help improve breast disease interpretation skills.

These do not change with the modality used. The facility will choose one of those dates to determine the 36 month period previous three calendar years. Following the third anniversary date in which the requirements of paragraphs a 2 i and a 2 ii of this section were completed, the radiologic technologist shall have taught or completed at least 15 continuing education units in mammography during the previous three calendar years.

The current timeframe for counting this education has been extremely confusing for personnel and even inspectors. At least six of the continuing education units required in paragraph a 2 iii A of this section shall be related to each mammographic modality used by the technologist. This continuing education shall include training appropriate to each mammographic modality used by the technologist. The current requirement that technologists and, in effect, continuing education-granting organizations designate credits with the modality i.

Most current existing credits are either on general breast disease or specific to screen-film mammography, thus, awarding 6 credits is excessive. They should just be required to include some as with the original requirements for medical physicists. Following the second anniversary date in which the requirements of paragraphs a 2 i and a 2 ii of this section were completed or of April 28, , whichever is later, the radiologic technologist shall have performed a minimum of mammography examinations during the previous two calendar years.

The current timeframe for counting this experience has been extremely confusing for personnel and even inspectors. The facility shall choose one of these dates to determine the 36 month period previous three calendar years. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs.

Units earned through teaching a specific course can be counted only once toward the required 15 units in a 36 month period three calendar years, even if the course is taught multiple times during the 36 months this time period. Following the third anniversary date in which the requirements of paragraph a 3 i or a 3 ii of this section were completed, the medical physicist shall have taught or completed at least 15 continuing education units in mammography during the previous three calendar years.

Units earned through teaching a specific course can be counted only once toward the required 15 units in three calendar years, even if the course is taught multiple times during this time period. The facility shall choose one of these dates to determine the 24 month period previous two calendar years. No more than one survey of a specific facility within a month period or a specific unit within a period of 60 days can be counted towards this requirement.

Following the second anniversary date in which the requirements of paragraph a 3 i or a 3 ii of this section were completed or of April 28, , whichever is later, the medical physicist shall have surveyed at least six mammography units during the previous two calendar years. It is becoming more difficult for medical physicists to provide services to more than one facility over a month period. Some facilities do not allow employees to provide outside consulting. In addition, the ratio of units to facilities has increased significantly since MQSA went into effect 1.

Many large facilities have over 10 units. Physicists have adequate experience surveying mammography units and evaluating QA at one place of employment. Overall final assessment of findings, classified in one of the following categories:. These changes will make the regulations more consistent with the BI-RADS categories and minimize confusion between the interpreting physician and the clinicians. The FDA has already approved these changes in an alternative standard.

For cases rated 0 because of need for prior examinations, reassessment must be performed within 30 days to assign category. These changes will make the regulations more consistent with the BI-RADS category and minimize confusion between the interpreting physician and the clinicians.

The FDA has already approved the change in an alternative standard. The facility shall identify a lead interpreting physician who shall have the general responsibility of ensuring that the quality assurance program meets all requirements of paragraphs d through f of this section. Lead interpreting physician must provide regular feedback to technologist on quality of images. Requiring regular feedback may improve quality for facilities overall. The optical density of the film at the center of an image of a standard FDA-accepted phantom shall be at least 1.

Higher contrast films that perform better at higher densities are standard since the final regulations were developed, improving the quality of mammography. The regulations should be changed to reflect this. Darkroom fog. The optical density attributable to darkroom fog shall not exceed 0. If the darkroom has a safelight used for mammography film, it shall be on during this test. Screen-film contact. Testing for screen-film contact shall be conducted using 40 mesh copper screen.

All cassettes used in the facility for mammography shall be tested semi- annually. The test shall also be carried out initially for all new cassettes as they are placed in service, and whenever reduced image sharpness is suspected. All cassettes used in the facility for mammography shall be tested annually.

The test shall also be earned out initially for all new cassettes as they are placed in service, and whenever reduced image sharpness is suspected. This is a low-yield test that only needs to be performed annually, and when new cassettes are placed into service, as the majority of rejected cassettes are found upon initial placement into service.

Automatic exposure control performance. The optical density of the film in the center of the phantom image shall not be less than 1. Facilities with older three-phase screen-film systems shall perform the following quality control tests at least annually:. B At the most commonly used clinical settings of kVp, the coefficient of variation of reproducibility of the kVp shall be equal to or less than 0.

Newer units with medium- and high-frequency generators will not require this test. Modern equipment voltage regulation is extremely tight, making this test unnecessary on an annual basis. Reducing the scope of this test during annual surveys would allow the medical physicist to troubleshoot those productive tests that have a higher probability of failing.

The test should be retained for equipment evaluations. System artifacts. System artifacts shall be evaluated with a high-grade, defect-free sheet of homogeneous material large enough to cover the mammography cassette and shall be performed for all cassette sizes used in the facility using a grid appropriate for the cassette size being tested. System artifacts shall also be evaluated for all available focal spot sizes and target filter combinations , targets, and filters used clinically.

System artifacts shall also be evaluated for all available focal spot sizes, targets, and filters used clinically. To assess for image quality and artifacts, only one test of target size, filter, and target is necessary, not combinations. Viewboxes used for interpreting mammograms and clinical image quality review by the technologist should be capable of producing a luminance of at least 3, candela per square meter.

The illumination levels must be less than or equal to 20 lux. Viewing conditions are critical in perceiving subtle contrast on film images. The 3, candela per square meter is consistent with the ACR mammography QC manual recommendations.

Although the 20 lux value for illumination is lower than the 50 lux recommended in the ACR QC manual, more is known now about the importance of low ambient lighting than was known in when the manual was written. Facilities with the same interpreting physicians should combine medical audit data. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms. Allowing facilities with the same interpreting physicians to combine their medical audit data across facilities will allow for more meaningful audit data and decrease the burden on individual facilities.

General requirements. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility for:. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians for:. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography. Viewboxes used for clinical image quality review would not need to be inspected. Quality standards for mammography personnel include specifications for continuing education and experience.

Interpreting physicians are required to read a minimum of mammographic examinations over a given 2-year period as evidence of this continuing experience.

Increasing this volume requirement has been discussed as a potential way to improve interpretive quality, yet doing so may inadvertently jeopardize access to mammography services in some areas.

Furthermore, current literature remains divided on whether volume alone has a positive effect on physician accuracy in detecting breast cancer see Chapter 2. Until consensus is reached on the value of interpretive volume, this minimum requirement should remain unchanged.

MQSA-qualified physicians temporarily practicing mammography abroad are currently prohibited from using this foreign experience toward meeting the MQSA requirements. FDA and the ACR have reported requests for clarification on this policy, and, provided adequate documentation is available, such foreign practice should qualify as continuing experience and count toward the volume requirement.

The requirement for six category I continuing medical education CME credits in each mammographic modality used should be eliminated for interpreting physicians—only the more general requirement for 15 category I CME units in mammography should remain. Continuing education requirements for physicians should be broadened to allow physicians to select CME courses that help improve breast disease interpretation skills, rather than requiring specific courses in each mammographic modality see Chapter 2 for more information on improving interpretive performance.

However, the requirement for initial training in new mammographic modalities regulation Similarly, the requirement for modality-specific continuing education should be more flexible for radiologic technologists. The current regulations should be changed to eliminate the specific requirement for six continuing education units in each modality. Finally, language describing the timeframe for completion of continuing education and experience should be based on calendar years, to improve clarity.

Continuing experience for medical physicists includes surveys of at least two mammography facilities during the previous 24 months. The number of mammography facilities in the United States has decreased by approximately 9. However, the number of mammography units has increased from 12, to 13,, approximately a 13 percent increase, since Destouet et al. Depending on the severity level of the observations found during the inspection, specific regulatory time frames for correcting and responding to observations may apply.

These requirements, as well as instructions on how and where to respond to any adverse inspection observations, will be included along with the final inspection report. As a reminder, if your facility is in a state that also conducts a state inspection, the MQSA and state inspection often happen at the same inspection visit. Therefore, the times above may vary, and the state may have additional requirements that need to be met. By preparing documentation in advance, by setting aside time for the phantom activities and the exit review, and by following the directions for responding to observations, facilities can help themselves and their inspectors have a more positive inspection experience.

During earlier offerings of the training, the courses were provided several times a year to accommodate the immediate need at certifying inspectors needed to properly enforce the act. This course includes a series of expert guest speakers that provide technical depth and clarity.

This course provides participants with information on the basics of clinical mammography, understanding of the regulation, and fundamental roles and expectations of different members involved in mammography. There are over 9, FDA certified facilities nationwide.

A search for MQSA certified mammography facilities can be done by zip code, city, state or facility name. Protect clean air, clean water, and public health and conserve working farms, forests, and natural lands.

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