Traditionally, MQSA, which was last reauthorized in , has been on a five-year appropriations reauthorization cycle. The purpose of these studies is to determine whether some of the original MQSA regulations are unnecessary as well as to examine quality and access issues relating to mammography. The ACR urges Congress to be certain that the IOM-recommended measures are feasible, allow for an adequate period of implementation, and do not reduce access for women.
Of greatest significance, this bill reauthorizes appropriations through FY for breast cancer screening surveillance research grants and for mammography facilities certification activities not supported by fees. The accreditation body shall submit annually to FDA, at the address given in Sec. Annually, each accreditation body shall visit at least 5 percent of the facilities it accredits.
However, a minimum of 5 facilities shall be visited, and visits to no more than 50 facilities are required, unless problems identified in paragraph f 1 i B of this section indicate a need to visit more than 50 facilities. A At least 50 percent of the facilities visited shall be selected randomly. B Other facilities visited shall be selected based on problems identified through State or FDA inspections, serious complaints received from consumers or others, a previous history of noncompliance, or any other information in the possession of the accreditation body, inspectors, or FDA.
C Before, during, or after any facility visit, the accreditation body may require that the facility submit to the body for review clinical images, phantom images, or any other information relevant to applicable standards in this subpart and in subpart B of this part.
The accreditation body shall conduct facility onsite visits according to a visit plan that has been approved by FDA in accordance with Sec. At a minimum, such a plan shall provide for: A Assessment of overall clinical image QA activities of the facility; B Review of facility documentation to determine if appropriate mammography reports are sent to patients and physicians as required; C Selection of a sample of clinical images for clinical image review by the accreditation body.
Clinical images shall be selected in a manner specified by the accreditation body and approved by FDA that does not compromise care of the patient as a result of the absence of the selected images from the facility; D Verification that the facility has a medical audit system in place and is correlating films and pathology reports for positive cases; E Verification that personnel specified by the facility are the ones actually performing designated personnel functions; F Verification that equipment specified by the facility is the equipment that is actually being used to perform designated equipment functions; G Verification that a consumer complaint mechanism is in place and that the facility is following its procedures; and H Review of all factors related to previously identified concerns or concerns identified during that visit.
In addition to conducting clinical image reviews for accreditation and reaccreditation for all facilities, the accreditation body shall conduct clinical image reviews annually for a randomly selected sample as specified by FDA, but to include at least 3 percent of the facilities the body accredits.
Accreditation bodies may count toward this random sample requirement all facilities selected randomly for the onsite visits described in paragraph f 1 i A of this section. Accreditation bodies shall not count toward the random sample requirement any facilities described in paragraph f 1 i B of this section that were selected for a visit because of previously identified concerns.
In performing clinical image reviews of the random sample of facilities, accreditation bodies shall evaluate the same attributes as those in paragraph c of this section for review of clinical images for accreditation and reaccreditation. Clinical images shall be selected in a manner, specified by the accreditation body and approved by FDA under Sec. The accreditation body shall develop and administer a written and documented system, including timeframes, for collecting and resolving serious consumer complaints that could not be resolved at a facility.
Such system shall have been approved by FDA in accordance with Sec. Accordingly, all accreditation bodies shall: 1 Provide a mechanism for all facilities it accredits to file serious unresolved complaints with the accreditation body; 2 Maintain a record of every serious unresolved complaint received by the body on all facilities it accredits for a period of at least 3 years from the date of receipt of each such complaint; h Reporting and recordkeeping.
All reports to FDA specified in paragraphs h 1 through h 4 of this section shall be prepared and submitted in a format and medium prescribed by FDA and shall be submitted to a location and according to a schedule specified by FDA.
Fees charged to facilities for accreditation shall be reasonable. Costs of accreditation body activities that are not related to accreditation functions under 42 U. Such material shall be provided to FDA in a manner and time period specified by the agency. If FDA determines that an accreditation body has failed to perform a major accreditation function satisfactorily, has demonstrated willful disregard for public health, has violated the code of conduct, has committed fraud, or has submitted material false statements to the agency, FDA may withdraw its approval of that accreditation body.
Such notification shall be made within a time period and in a manner approved by FDA. If FDA determines that an accreditation body has demonstrated deficiencies in performing accreditation functions and responsibilities that are less serious or more limited than the deficiencies in paragraph a of this section, FDA shall notify the body that it has a specified period of time to take particular corrective measures directed by FDA or to submit to FDA for approval the body's own plan of corrective action addressing the minor deficiencies.
FDA may place the body on probationary status for a period of time determined by FDA, or may withdraw approval of the body as an accreditation body if corrective action is not taken. The accreditation body shall notify all facilities accredited or seeking accreditation by it of its loss of FDA approval, within a time period and in a manner approved by FDA.
The appeals process shall be specified in writing by the accreditation body and shall have been approved by FDA in accordance with Sec. Subpart B--Quality Standards and Certification After October 1, , a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart.
To obtain a certificate from FDA, facilities are required to meet the quality standards in Sec. The facility shall submit to such body or entity the information required in 42 U. The provisional certificate will enable the facility to perform mammography and to obtain the clinical images needed to complete the accreditation process. To apply for and receive a provisional certificate, a facility must meet the requirements of 42 U.
A provisional certificate shall be effective for up to 6 months from the date of issuance. A provisional certificate cannot be renewed, but a facility may apply for a day extension of the 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 considered to be a new facility and thereby be eligible for a provisional certificate.
The following requirements apply to all personnel involved in any aspect of mammography, including the production, processing, and interpretation of mammograms and related quality assurance activities: 1 Interpreting physicians. All physicians interpreting mammograms shall meet the following qualifications: i Initial qualifications. Unless the exemption in paragraph a 1 iii A of this section applies, before beginning to interpret mammograms independently, the interpreting physician shall: A Be licensed to practice medicine in a State; B 1 Be certified in an appropriate specialty area by a body determined by FDA to have procedures and requirements adequate to ensure that physicians certified by the body are competent to interpret radiological procedures, including mammography; or 2 Have had at least 3 months of documented formal training in the interpretation of mammograms and in topics related to mammography.
The training shall include instruction in radiation physics, including radiation physics specific to mammography, radiation effects, and radiation protection. The mammographic interpretation component shall be under the direct supervision of a physician who meets the requirements of paragraph a 1 of this section; C Have a minimum of 60 hours of documented medical education in mammography, which shall include: Instruction in the interpretation of mammograms and education in basic breast anatomy, pathology, physiology, technical aspects of mammography, and quality assurance and quality control in mammography.
All 60 of these hours shall be category I and at least 15 of the category I hours shall have been acquired within the 3 years immediately prior to the date that the physician qualifies as an interpreting physician. Hours spent in residency specifically devoted to mammography will be considered as equivalent to Category I continuing medical education credits and will be accepted if documented in writing by the appropriate representative of the training institution; and D Unless the exemption in paragraph a 1 iii B of this section applies, have interpreted or multi-read at least mammographic examinations within the 6-month period immediately prior to the date that the physician qualifies as an interpreting physician.
This interpretation or multi-reading shall be under the direct supervision of an interpreting physician. All interpreting physicians shall maintain their qualifications by meeting the following requirements: A Following the second 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 interpreted or multi-read at least mammographic examinations during the 24 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in-between the two.
The facility will choose one of these dates to determine the month period. B 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 36 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two.
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; and C Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.
D Units earned through teaching a specific course can be counted only once towards the 15 required by paragraph a 1 ii B of this section, even if the course is taught multiple times during the previous 36 months. A Those physicians who qualified as interpreting physicians under paragraph a 1 of this section of FDA's interim regulations prior to April 28, , are considered to have met the initial requirements of paragraph a 1 i of this section.
They may continue to interpret mammograms provided they continue to meet the licensure requirement of paragraph a 1 i A of this section and the continuing experience and education requirements of paragraph a 1 ii of this section.
B Physicians who have interpreted or multi-read at least mammographic examinations under the direct supervision of an interpreting physician in any 6-month period during the last 2 years of a diagnostic radiology residency and who become appropriately board certified at the first allowable time, as defined by an eligible certifying body, are otherwise exempt from paragraph a 1 i D of this section.
Interpreting physicians who fail to maintain the required continuing experience or continuing education requirements shall reestablish their qualifications before resuming the independent interpretation of mammograms, as follows: A Interpreting physicians who fail to meet the continuing experience requirements of paragraph a 1 ii A of this section shall: 1 Interpret or multi-read at least mammographic examinations under the direct supervision of an interpreting physician, or 2 Interpret or multi-read a sufficient number of mammographic examinations, under the direct supervision of an interpreting physician, to bring the physician's total up to examinations for the prior 24 months, whichever is less.
B Interpreting physicians who fail to meet the continuing education requirements of paragraph a 1 ii B of this section shall obtain a sufficient number of additional category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation.
All mammographic examinations shall be performed by radiologic technologists who meet the following general requirements, mammography requirements, and continuing education and experience requirements: i General requirements. A Be licensed to perform general radiographic procedures in a State; or B Have general certification from one of the bodies determined by FDA to have procedures and requirements adequate to ensure that radiologic technologists certified by the body are competent to perform radiologic examinations; and ii Mammography requirements.
Have, prior to April 28, , qualified as a radiologic technologist under paragraph a 2 of this section of FDA's interim regulations of December 21, , or completed at least 40 contact hours of documented training specific to mammography under the supervision of a qualified instructor. A Following the third anniversary date of the end of the calendar quarter 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 36 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two.
B Units earned through teaching a specific course can be counted only once towards the 15 required in paragraph a 2 iii A of this section, even if the course is taught multiple times during the previous 36 months.
C 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. D Requalification. Radiologic technologists who fail to meet the continuing education requirements of paragraph a 2 iii A of this section shall obtain a sufficient number of continuing education units in mammography to bring their total up to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality used by the technologist in mammography.
The technologist may not resume performing unsupervised mammography examinations until the continuing education requirements are completed. E Before a radiologic technologist may begin independently performing mammographic examinations using a mammographic modality other than one of those for which the technologist received training under paragraph a 2 ii C of this section, the technologist shall have at least 8 hours of continuing education units in the new modality.
A Following the second anniversary date of the end of the calendar quarter 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 24 months immediately preceding the date of the facility's annual MQSA inspection or the last day of the calendar quarter preceding the inspection or any date in between the two.
B Requalification. Uncertified units may be used to produce mammographic images only if they meet all of the following conditions: The mammographic images obtained are an integral part of the stereotactic breast biopsy procedure. Facilities must not bill separately for these mammographic images. They must bill only for the stereotactic breast biopsy procedure. If the mammographic images obtained as part of the stereotactic breast biopsy procedure result in the cancellation of the procedure e.
If the procedure is canceled for reasons described in 3 , FDA strongly recommends that the findings or absence of findings be confirmed by an immediate follow-up study performed on an MQSA-certified unit. 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. Thus the ratio of units to facilities has increased without clear indication of the impact on access, from 1. It has become increasingly difficult for medical physicists to meet the two-facility requirement, given the number of units at each facility.
Sufficient experience is possible from quality control evaluations at one multiunit facility, and FDA regulations should be modified to reflect this. Regulation Evidence from ACR site visits suggest radiologic technologists would benefit from improved feedback from physicians regarding image quality; in several instances, technologists have directly requested this feedback. The ACR team reviewing the facility in question recommends several areas for corrective action; improved communication between radiologists and technologists is suggested in Such improvements for all facilities, not only those under review, may positively impact quality overall.
Although a specific regulation requiring documentation may increase facility workload, the Committee agrees that strong communication between radiologists and technologists is an important factor in maintaining quality. The quality of mammography programs abroad, including those in Canada and Europe, has been well documented Dean and Pamilo, ; Hendrick et al.
While FDA currently accepts Canadian Board Certification and Canadian residency programs toward meeting initial requirements for interpreting physicians, interpreting physicians obtaining their initial qualifications in any other foreign country e.
FDA should further expand the initial qualification requirements to allow highly qualified interpreting physicians trained in foreign countries other than Canada to interpret mammograms under MQSA. Personal communication, P. Mandatory preceptorship training is typically recommended for mammography personnel deemed to be performing at a substandard level. However, such training can currently be avoided if the individual in question moves to a different facility.
The state of Texas accreditation body has reported multiple instances of this, for both interpreting physicians and mammography technologists. Individuals with incomplete training requirements should be required to continue and complete training at their new facility.
Facilities should practice due diligence and verify employment history prior to hiring new personnel. Several quality control tests should be modified to better assess current mammography practice. Optical density OD of mammography films is evaluated through weekly quality control tests; FDA inspection data demonstrate few citations for below-threshold OD phantom scores FDA, a. Additionally, the high-contrast films currently in use require higher optical densities for optimal performance Hendrick and Berns, Therefore, the minimum OD requirements should be increased from 1.
Screenfilm contact tests, previously performed semiannually, should be tested annually, given the low failure rate on inspection National Mammography Quality Assurance Advisory Committee, Finally, Digital Mammographic Imaging Screening Trial DMIST data show that annual evaluations of kilovoltage peak kVp accuracy and reproducibility rarely fail for newer medium and high-frequency generators Bloomquist et al.
Older three-phase generators should still be tested annually, along with any new unit or equipment recently undergoing major repair. Facilities should be required to separate screening and diagnostic medical audit data. Further expansion of the medical audit is discussed at length in Chapter 2. Developing specific regulations to adopt the enhanced audit system recommended in Chapter 2 would be the responsibility of FDA. The mammography medical outcomes audit currently requires data to be compiled for each radiologist practicing in each separate facility.
Facilities with the same interpreting physicians should be allowed to merge the medical audit data for their interpreting physicians. Doing so will result in more meaningful physician data and reduce the burden on individual facilities. Although combined audits would be preferable, FDA inspectors should continue to accept nonaggregate data.
Personal communication, K. Mammography letters provided to patients are discussed in regulation This revision should be incorporated into the final regulations because it ensures that the appropriate notification is sent to patients undergoing mammography examinations given that assessment. In addition, each assessment category should also be updated to be consistent with the Breast Imaging Reporting and Data System BI-RADS categories in order to reduce confusion between the clinician and interpreting radiologist.
Currently, cases where an incomplete workup prevents final assessment should be given a deadline for evaluation. The Committee discussed the possibility of requiring interpreting physicians to resolve all BI-RADS Category 0 assessments incomplete—requires comparison with previous films 4 within 30 days; however, such a requirement could prove problematic if a patient does not return for a complete workup within that time period.
Thus resolution of Category 0 assessment should be required within 30 days for cases where full evaluation only depends on obtaining images from previous mammographic examinations. According to FDA guidance, a lay summary must be sent to patients when images are compared with previous films, or when an addendum is added to the medical report, even if there is no change in the findings or recommended course of action FDA, b.
Consequently, a lay summary must be sent even if the addendum merely states that the referring physician had been notified of the examination results. This requirement is burdensome on facilities, but more importantly, patients may be confused by receiving multiple letters that do not directly pertain to interpretation of their mammograms.
Therefore, FDA guidance should be modified to require a patient letter only when images are reviewed and reinterpreted, even if there is no change in interpretation findings. Standard mammography equipment is frequently used for interventional procedures, such as preoperative wire needle localization or ductograms. In addition, specialized mammography units can be used by physicians to guide minimally invasive tissue diagnosis procedures such as core needle biopsy.
However, nationally recognized standards for such procedures were nonexistent at the time of MQSA implementation, and thus interventional mammographic procedures are currently exempted from regulation by FDA. In , the ACR and the American College of Surgery ACoS developed a joint set of qualifications for physicians performing stereotactic breast biopsy procedures, which included requirements for CME training and continuing experience.
Resolving Category 0 assessments in such cases is not, and should not be, required within 30 days. Only those Category 0 assessment cases awaiting comparison with prior films should be resolved within the 30 days. Only 11 are accredited by the ACoS program.
In similar testimonies, speakers on behalf of the Susan G. More than 7 years have passed, and in that time sufficient standards by which interventional breast imaging procedures can be measured have been developed.
Specifically, all stereotactic breast biopsy procedures and equipment should be accredited by the appropriate accreditation body. Equipment used for other interventional procedures e. While there are accreditation programs for stereotactic biopsy, no programs exist for the other interventional procedures; the Committee believes mandatory accreditation of interventional equipment, not the interventional procedures themselves, is sufficient.
In addition, FDA inspectors should be trained to perform onsite inspections of stereotactic breast biopsy procedures and interventional equipment, as a paper review and review of films obtained by the site would be insufficient for ensuring quality.
The lack of specific regulation in MQSA for digital mammography is of particular concern because of the increasing prevalence of its use; the number of FFDM units has increased by 4 percent each month over the past year. The number of facilities offering FFDM rose from approximately approximately 4 percent of all facilities in October to just over 6 percent of all facilities in October Figure 3—1 Destouet et al.
Since FDA regulations were enacted in , little action has been taken to delineate oversight of digital mammography. This can prove burdensome because the manuals are continually updated and there is little consistency between devices. Only the maximum millirad dosage for a breast of average thickness and tissue composition is specifically covered in the regulations at this time.
Specifically, FDA should develop a uniform set of. Data collected by the American College of Radiology and reported by Destouet et al. In press. QC tests and test criteria across all digital systems. Uniform standards should not preclude performance of additional tests on some digital systems, as recommended by the equipment manufacturer. MQSA inspectors should be trained to perform onsite inspections of all digital equipment.
Computer-aided detection CAD is yet another emerging technology utilized in mammography to facilitate interpretation. FDA has considered this issue in the past in conjunction with issues surrounding double reading, and came to the conclusion that CAD was not a technology that could be readily dealt with through regulation.
Personal communication, C. Finder, M. The ACR has reported that between April and October , approximately 19 percent 1, out of 8, fully accredited facilities of their accredited mammography facilities have closed Destouet et al. Approximately one-third reportedly closed for financial reasons; movement to a sister site, equipment problems, and staffing shortages were also cited as reasons leading to closure.
FDA has received a number of complaints from patients who were not informed when their mammography facility closed, and as a result were unable to or unsure of how to access their mammography records FDA, This reflects a serious lapse in patient care. Mammography facilities that close should be required to notify all patients and their doctors of the closure, and should be required to provide information regarding future access to mammography films and reports. However, in cases where facilities are unable to notify patients e.
Review of FDA inspection data from to revealed several inspection areas that could be streamlined, based on the low number of citations issued and the redundancy of the measurements by other entities. Radiation dose is currently measured by the accrediting body and annually by the medical physicist, and measurements rarely fail to meet MQSA regulation. Consequently, FDA should no longer measure radiation dose during inspection; analysis of dose measurements collected by the medical physicist will suffice.
Additionally, inspectors should review and score phantom images taken previously by the facility; generation of new phantom images during the inspection is unnecessary.
The exposure reproducibility coefficient of variation evaluation should be made only for three-phase units, as the medical physicist evaluates this annually. Half-value layer should no longer be evaluated for the same reason.
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