MQSA Updates Quick Reference Guide by Mammologix

MQSA UPDATES QUICK REFERENCE GUIDE

Introduction

Welcome to the MQSA Updates Quick Reference Guide, proudly presented by Mammologix, powered by I/O Trak, Inc

This comprehensive guide is designed to help mammography facilities navigate the recent amendments to the Mammography Quality Standards Act (MQSA) regulations, as authorized by the FDA and set to become effective on September 10, 2024

At the outset of this guide, you will find a checklist of all the revisions cited from the amendments to 21 CFR part 900 This list is a valuable tool, enabling you to quickly identify the updates requiring corresponding adjustments to your mammography practice's policies and procedures Compliance is vital in ensuring the delivery of safe and high-quality mammography services, and this checklist will serve as your roadmap to achieving regulatory excellence

Following the checklist, you will find an executive summary that provides a concise overview of the revisions made to each relevant section of the MQSA regulations being updated This summary will clearly explain the fundamental changes and their implications for your practice

The guide presents a side-by-side comparison of each update alongside the original regulation to assist you in this process further This quick reference layout offers a convenient way to compare the changes set to take effect on September 10, 2024, with the prior rules, facilitating a seamless transition to the updated standards

Mammologix is dedicated to empowering healthcare providers with the knowledge and tools they need to meet the evolving demands of mammography regulations. Our commitment to excellence in breast health care aligns with your dedication to patient safety and well-being

We trust that this MQSA Updates Quick Reference Guide will be an indispensable resource in your compliance and regulatory readiness journey Should you have any questions or need further assistance, our knowledgeable support team is just a phone call or emailing info@mammologix.com.

Together, let's embrace these changes and continue to elevate the standards of mammography practice, ensuring that patients receive the best care possible Compliments of info@mammologixcom

MQSA UPDATES QUICK REFERENCE GUIDE

Disclaimer

Disclaimer: The MQSA Updates Quick Reference Guide provided by Mammologix, powered by I/O Trak, Inc , is intended for reference purposes only While every effort has been made to ensure the accuracy and comprehensiveness of the information presented, users are advised to refer to the official source documents available from the Federal Register for the most current and authoritative regulations

Document Citation: 88 FR 15126, Page: 15126-15171 (46 pages), CFR: 21 CFR 900, Agency/Docket Number: Docket No. FDA-2013-N-0134, RIN: 0910-AH04, Document Number: 2023-04550 (https://wwwfederalregistergov/documents/2023/03/10/2023-04550/mammography-quality-stan dards-act#p-57)

For any specific inquiries or questions, contacting the FDA/MQSA Program is recommended directly Facility staff can reach out to the Facility Hotline at 1-800-838-7715 Alternatively, questions can be faxed to 1-443-285-0689 or emailed to MQSAhotline@versatechinc com

This guide is a supplementary tool to aid in understanding the updates to the MQSA regulations

Users are advised to exercise due diligence and use the official source documents for definitive guidance and compliance Mammography practices should always rely on the Federal Register as the primary reference for the MQSA regulations and consult with the appropriate authorities for regulatory or operational concerns.

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§900 Revisions Checklist for Policy/Procedure Updates

§900.2 Definitions

Revise paragraphs (c)(2), (k), (z), and (aa)(1) and (2)

Add paragraph (aa)(3)

Revise paragraph (ii)

§900.4 Standards for Accreditations Bodies

Revise paragraphs (a)(6) and (f)(1)(ii)(B)

§900.11 Requirements for Certifications

Revise paragraph (c)(4)

§900.12 Quality Standards

Revise paragraph (a)(4);

Add paragraphs (b)(2)(i) and (ii);

Revise paragraph (b)(11);

Add paragraph (b)(16);

Revise paragraphs (c)(1) and (2), (c)(3)(ii), (c)(4), and (f)(1);

Add paragraph (f)(4)

Revise paragraph (j)

§900.14 Suspension or Revocation of Certificates

Revise paragraphs (a) introductory text and (a)(3), (5), and (6)

Add paragraph (a)(7)

§900.15 Appeals of Adverse Accreditation or Reaccreditation Decisions that Preclude Certification or Recertification

Revise paragraph (d)(1)

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Executive Summary

Section 900.2 Definitions

The FDA has undertaken a significant effort to modernize key definitions in the Mammography Quality Standards Act's regulations.

These updates primarily encompass two crucial aspects.

Firstly, the FDA has embraced "healthcare provider" to encompass entities actively involved in breast healthcare planning and treatment for patients seeking mammography. This progressive step broadens the scope of care, moving beyond the traditional limitation to doctors alone.

Secondly, obsolete breast imaging technologies have been eliminated from mammography practices since the enactment of MQSA In contrast, new advanced digital modalities that rely on ionizing radiation to create breast images have been added.

These regulatory changes aim to enhance patient care, promote technological advancements, and ensure mammography practices meet the highest quality standards.

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Section 900.2 Definitions

FROM:

(c) * * *

(2) Failure to send mammography reports within 30 days to the referring physician or in a timely manner to the self-referred patient; and

TO:

(c) * * *

(2) Failure to send mammography reports within 30 days to the referring healthcare provider or in a timely manner to the self-referred patient; and

FROM:

(k) Consumer means an individual who chooses to comment or complain in reference to a mammography examination, including the patient or representative of the patient (e.g., family member or referring physician).

TO:

(k) Consumer means an individual who chooses to comment or complain in reference to a mammography examination, including the patient or representative of the patient ( e.g., family member or referring healthcare provider).

FROM:

(z) Mammographic Modality means a technology, within the scope of 42 U S C 263b, for radiography of the breast. Examples are screen-film mammography and xeromammography

TO:

(z) Mammographic modality means a technology, within the scope of 42 U.S.C. 263b, for radiography of the breast. Examples are screen-film mammography, full field digital mammography, and digital breast tomosynthesis. Compliments of

MQSA UPDATES QUICK REFERENCE GUIDE

Section 900.2 Definitions

FROM: (aa)***

(1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures; or

(2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of this chapter

TO:

(aa) * * *

(1) Radiography of the breast performed during invasive interventions for localization or biopsy procedures;

(2) Radiography of the breast performed with an investigational mammography device as part of a scientific study conducted in accordance with FDA's investigational device exemption regulations in part 812 of this chapter; or

(3) Computed tomography of the breast.

FROM:

(ii) Patient means any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a physician or is self-referred

TO:

(ii) Patient means any individual who undergoes a mammography evaluation in a facility, regardless of whether the person is referred by a healthcare provider or is self-referred.

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Executive Summary

Section 900.4 Standards for Accreditation Bodies

The FDA has undertaken crucial updates to specific regulations about accreditation body standards.

These revisions fall into two essential categories.

Firstly, the FDA is working towards greater inclusivity by adopting the term "healthcare provider" to include entities actively engaged in breast healthcare planning and treatment for patients seeking mammography. This ensures a broader approach to patient care beyond the confines of physician.

Secondly, a new ruling has been implemented to address facilities with a chronic tendency to fail accreditation. If a facility fails to obtain accreditation for three consecutive attempts, no accreditation body will accept their application for a period of one year from the most recent failure date. This rule aims to maintain high standards and encourage facilities to meet the required quality benchmarks

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Section 900.4 Standards for Accreditation Bodies

FROM:

(a) * * *

(6) When an accreditation body denies accreditation to a facility, the accreditation body shall notify the facility in writing and explain the bases for its decision The notification shall also describe the appeals process available from the accreditation body for the facility to contest the decision

TO:

(a) * * *

(6)(i) When an accreditation body denies accreditation to a facility, the accreditation body shall notify the facility in writing and explain the bases for its decision. The notification shall also describe the appeals process available from the accreditation body for the facility to contest the decision.

(ii) If a facility has failed to become accredited after three consecutive attempts, no accreditation body shall accept an application for accreditation from the facility for a period of 1 year from the date of the most recent accreditation failure.

FROM:

(f)(1)(ii)* * *

(B) Review of facility documentation to determine if appropriate mammography reports are sent to patients and physicians as required;

TO:

(f)(1)(ii)* * *

(B) Review of facility documentation to determine if appropriate mammography reports are sent to patients and providers as required;

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Executive Summary

Section 900.11 Requirements for Certification

The FDA has taken steps to update standards for certification in the Mammography Quality Standards Act's regulations. One notable rule is that if a facility's certificate was revoked due to specific acts described in 42 U.S.C. 263b(i)(1), as implemented by § 900.14(a) [also revised in these updates], the individuals who owned or operated that facility at the time of the act may not own or operate ANY mammography facility for two years from the date of revocation. This measure ensures accountability and prevents those involved in improper practices from owning or operating mammography facilities during the specified timeframe.

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Section 900.11 Requirements for Certification

FROM:

(c) * * *

(4) If a facility's certificate was revoked on the basis of an act described in 41 U.S.C. 263b(i)(1), no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within 2 years of the date of revocation

TO:

(c) * * *

(4) If a facility's certificate was revoked on the basis of an act described in 42 U.S.C. 263b(i)(1), as implemented by §900.14(a), no person who owned or operated that facility at the time the act occurred may own or operate a mammography facility within 2 years of the date of revocation.

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Executive Summary

Section 900.12 Quality Standard

Revise Paragraph (a)(4)

The new regulation provides a clearer definition of required personnel records, mandates a 24-month retention period after an employee's departure, and establishes specific provisions for record access by both current and former employees, especially in cases where the facility closes or ceases its mammography services.

Key Differences Between Prior vs. New Regulations

1. The new regulation emphasizes explicitly maintaining records of "training and experience relevant to MQSA qualification."

2. The new regulation sets a specific retention time of 24 months for records of former employees.

3. The new regulation mandates the provision of records to both current and former employees upon request.

4 The new regulation provides specific directives for facilities that close or cease mammography services.

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Section 900.12(a)(4)

FROM:

(a) * * *

(4) Retention of personnel records. Facilities shall maintain records to document the qualifications of all personnel who worked at the facility as interpreting physicians, radiologic technologists, or medical physicists. These records must be available for review by the MQSA inspectors Records of personnel no longer employed by the facility should not be discarded until the next annual inspection has been completed and FDA has determined that the facility is in compliance with the MQSA personnel requirements.

TO:

(a) * * *

(4) Retention of personnel records. Facilities shall maintain records of training and experience relevant to their qualification under MQSA for personnel who work or have worked at the facility as interpreting physicians, radiologic technologists, or medical physicists. These records must be available for review by the MQSA inspectors. Records of personnel no longer employed by the facility must be maintained for no less than 24 months from the date of the departure of an employee, and these records must be available for review at the time of any annual inspection occurring during those 24 months. The facility shall provide copies of these personnel records to current interpreting physicians, radiologic technologists, and medical physicists upon their request. Facilities must provide personnel records to former employees if the former employees communicate their request within 24 months of the date of their departure. If it has been greater than 24 months and the facility has maintained those records, the facility must provide those records to former employees upon request. Before a facility closes or ceases to provide mammography services, it must make arrangements for access by current and former personnel to their MQSA personnel records. This access may be provided by the permanent transfer of these records to the personnel or the transfer of the records to a facility or other entity that will provide access to these records for no less than 24 months from the date of facility closure or cessation of mammography services.

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Executive Summary

Section 900.12 Quality Standard

Add Paragraphs (b)(2)(i) and (ii)

The prior regulation did not have any stipulations on this topic, whereas the new regulation has clear and specific requirements. The new regulation introduces standards and requirements to ensure the quality and safety of devices used in mammography and sets procedures for handling modality conversions.

Key Differences Between Prior vs. New Regulations

1. The new regulation mandates that devices meet FDA premarket authorization requirements.

2. It also addresses the scenario where a mammography unit undergoes a modality conversion, setting standards for its evaluation and accreditation.

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Section 900.12(b)(2)(i) and (ii)

FROM:

[Not present in prior regulation ]

TO:

(b) * * *

(2) * * *

(i) All devices used in mammography must have met the applicable FDA premarket authorization requirements for medical devices of that type with that intended use.

(ii) A mammography unit that is converted from one mammographic modality to another is considered a new unit at the facility under this part and must, prior to clinical use, undergo a mammography equipment evaluation demonstrating compliance with applicable requirements. The facility must also follow its accreditation body's procedures for applying for accreditation of that unit.

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Executive Summary

Section 900.12 Quality Standard

Revise Paragraph (b)(11)

While the prior regulation gave a generalized requirement for the type of X-ray film to use, the new regulation provides more specific directives based on the application and technology.

Key Differences Between Prior vs. New Regulations

1. The new regulation introduces distinctions based on the kind of unit used, breaking down the requirements for screen-film units and digital image transfers separately.

2. The new regulation adds stipulations for facilities that print hard copies of digital images, ensuring they use appropriate film compatible with their printers.

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Section 900.12(b)(11)

FROM:

(b)* * *

(11) X-ray film. The facility shall use X-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography

TO:

(b)* * *

(11) Film. For facilities using screen-film units, the facility shall use x-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography. For facilities using hardcopy prints of digital images for transfer, retention, or final interpretation purposes, the facility shall use a type of film designated by the film manufacturer as appropriate for these purposes and compatible with the printer being used.

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Executive Summary

Section 900.12 Quality Standard

Add Paragraph (b)(16)

The new regulation introduces clear standards for equipment modalities other than screen-film, ensuring they adhere to specific quality assurance measures.

Key Differences Between Prior vs. New Regulations

1 While the prior regulation did not provide guidance on this topic, the new regulation sets clear requirements for systems with image receptor modalities other than screen-film, mandating specific quality assurance testing for compliance. Compliments

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Section 900.12(b)(16)

FROM:

[Not present in prior regulation ]

TO:

(b)* * *

(16) Equipment other modalities. Systems with image receptor modalities other than screen-film shall demonstrate compliance with quality standards by successful results of quality assurance testing as specified under paragraph (e)(6) of this section.

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Executive Summary

Section 900.12 Quality Standard

Revise (c)(1)

The new regulation provides a more comprehensive structure and specificity regarding the content and nature of mammographic reports.

Key Differences Between Prior vs. New Regulations

1. The new regulation emphasizes that the mammographic examination presented for interpretation must be in the original mammographic modality and should not be a digitized copy of hardcopy original images.

2. The new regulations have added the facility's name and detailed location information.

3. The categories for final assessment in the new regulation are more detailed and explicitly worded. The "incomplete" classifications have been expanded, differentiating between the need for more imaging and prior mammograms for comparison.

4. The new regulation has introduced specific classifications for incomplete results and a requirement for a follow-up report.

5. Assessment of breast density is a new feature in the new regulations to provide an overall assessment of breast density has been added, with four categories to classify breast density.

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6. While both regulations emphasize addressing clinical questions, the new regulation includes breast density assessment as a mandatory feature.

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Section 900.12(c)(1)

FROM: (c)* * *

(1) Contents and terminology. Each facility shall prepare a written report of the results of each mammography examination performed under its certificate The mammography report shall include the following information:

(i) The name of the patient and an additional patient identifier;

(ii) Date of examination;

(iii) The name of the interpreting physician who interpreted the mammogram;

(iv) Overall final assessment of findings, classified in one of the following categories:

(A) "Negative:" Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be explained)";

(B) "Benign Finding(s):" Also a negative assessment;

(C) "Probably Benign Finding(s):" Initial short-interval follow-up suggested Finding(s) has a high probability of being benign;

(D) "Suspicious Abnormality:" Biopsy should be considered Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;

(E) "Highly suggestive of malignancy:" Appropriate action should be taken. Finding(s) has a high probability of being malignant:

(F1) "Known Biopsy Proven Malignancy:" Appropriate action should be taken. (This alternative standard was approved and became effective on August 29, 2003 )

(F2) "Post Procedure Mammograms for Marker Placement"

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(This alternative standard was approved and became effective on September 17, 2003.)

(v) In cases where no final assessment category can be assigned due to incomplete work-up, "Incomplete: Need additional imaging evaluation and/or prior mammograms for comparison" shall be assigned as an assessment and reasons why no assessment can be made shall be stated by the interpreting physician; and

(vi) Recommendations made to the health care provider about what additional actions, if any, should be taken. All clinical questions raised by the referring health care provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.

TO:

(c)* * *

(1) Contents and terminology. Each facility shall prepare a written report of the results of each mammographic examination performed under its certificate. The mammographic examination presented for interpretation must be in the original mammographic modality in which it was performed, and must not consist of digital images produced through copying or digitizing hardcopy original images. The mammography report shall include the following information:

(i) The name of the patient and an additional patient identifier;

(ii) Date of examination, facility name, and location. At a minimum, the location shall include the city, State, ZIP code, and telephone number of the facility;

(iii) The name of the interpreting physician who interpreted the mammogram;

(iv) Overall final assessment of findings, classified in one of the following categories (the assessment statement is only the word or phrase within the quotation marks):

(A) “Negative.” Nothing to comment upon (if the interpreting physician is aware of clinical findings or symptoms, despite the negative assessment, these shall be documented and addressed);

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(B) “Benign.” Also a normal result, with benign findings present, but no evidence of malignancy (if the interpreting physician is aware of clinical findings or symptoms, despite the benign assessment, these shall be documented and addressed);

(C) “Probably Benign.” Finding(s) has a high probability of being benign;

(D) “Suspicious.” Finding(s) without all the characteristic morphology of breast cancer but indicating a definite probability of being malignant;

(E) “Highly Suggestive of Malignancy.” Finding(s) has a high probability of being malignant;

(F) “Known Biopsy-Proven Malignancy.” Reserved for known malignancies being mammographically evaluated for definitive therapy; and

(G) “Post-Procedure Mammogram for Marker Placement.” Reserved for a post-procedure mammogram used to confirm the deployment and position of a breast tissue marker.

(v) In cases where no final assessment category can be assigned due to incomplete work-up, one of the following classification statements shall be assigned as an assessment and reasons why no final assessment can be made shall be stated by the interpreting physician.

(A) “Incomplete: Need additional imaging evaluation.” Reserved for examinations where additional imaging needs to be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given; or

(B) “Incomplete: Need prior mammograms for comparison.” Reserved for examinations where comparison with prior mammograms should be performed before an assessment category identified in paragraphs (c)(1)(iv)(A) through (G) of this section can be given. If this assessment category is used, a followup report with an assessment category identified in paragraphs (c)(1)(iv)(A) through (E) of this section must be issued within 30 calendar days of the initial report whether or not comparison views can be obtained.

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(vi) Overall assessment of breast density, classified in one of the following categories:

(A) “The breasts are almost entirely fatty.”

(B) “There are scattered areas of fibroglandular density.”

(C) “The breasts are heterogeneously dense, which may obscure small masses.”

(D) “The breasts are extremely dense, which lowers the sensitivity of mammography.”

(vii) Recommendations made to the healthcare provider about what additional actions, if any, should be taken. All clinical questions raised by the referring healthcare provider shall be addressed in the report to the extent possible, even if the assessment is negative or benign.

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Executive Summary

Section 900.12 Quality Standard

Revise (c)(2)

The new regulation is more prescriptive, emphasizing precise timelines for communication, especially when results indicate malignancy. The new regulation aims to improve patient awareness, not just about potential malignancies but also the implications of breast density.

Key Differences Between Prior vs. New Regulations

1. Every patient should receive a lay summary of the mammography report within 30 days. If results are "Suspicious" or "Highly Suggestive of Malignancy," a summary must be provided within 7 days.

2. The summary should, at a minimum, include the patient's name, facility details, and an assessment of breast density.

3 Patients not naming a healthcare provider should be sent the report plus a lay notification of results within 30 days. If the results are "Suspicious" or "Highly Suggestive of Malignancy," the report should be sent within 7 days.

4. Facilities accepting patients without a primary care provider should maintain a referral system, especially when mammogram assessments are probably benign, suspicious, or highly suggestive of malignancy.

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5. There's a significant emphasis on breast density in the new regulations, ensuring patients are informed about their breast density and its implications. Specific statements must be included in the lay summary to educate the patient about their breast density and associated risks

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Section 900.12(c)(2)

FROM:

(c)* * *

(2) Communication of mammography results to the patient. Each facility shall maintain a system to ensure that the results of each mammographic examination are communicated to the patient in a timely manner. If assessments are ``Suspicious'' or ``Highly suggestive of malignancy'' and the patient has not named a health care provider, the facility shall make reasonable attempts to ensure that the results are communicated to the patient as soon as possible

(i) As soon as possible, but no later than 30 days from the date of the mammography examination, patients who do not name a health care provider to receive the mammography report shall be sent the report described in paragraph (c)(1) of this section, in addition to a written notification of results in lay terms

(ii) Each facility that accepts patients who do not have a primary care provider shall maintain a system for referring such patients to a health care provider when clinically indicated.

TO:

(c)* * *

(2) Communication of mammography results to the patients. Each facility shall provide each patient a summary of the mammography report written in lay terms within 30 calendar days of the mammographic examination which shall, at a minimum, include the name of the patient; the name, address, and telephone number of the facility performing the mammographic examination; and an assessment of breast density as described in paragraphs (c)(2)(iii) and (iv) of this section. If the assessment of the mammography report is “Suspicious” or “Highly Suggestive of Malignancy,” the facility shall provide the patient a summary of the mammography report written in lay language within 7 calendar days of the final interpretation of the mammograms.

(i) Patients who do not name a healthcare provider to receive the mammography report shall be sent the report described in paragraph (c)(1) of this section within 30 days, in addition to the written notification of results in lay terms. If the assessment Compliments of

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of the mammography report is “Suspicious” or “Highly Suggestive of Malignancy,” the facility shall send this report to the patient within 7 calendar days of the final interpretation of the mammograms.

(ii) Each facility that accepts patients who do not have a healthcare provider shall maintain a system for referring such patients to a healthcare provider when clinically indicated, which shall include when such patients' mammogram assessment is either probably benign, suspicious, or highly suggestive of malignancy.

(iii) If the mammography report identifies the patient's breast density as “The breasts are almost entirely fatty” or “There are scattered areas of fibroglandular density,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

(iv) If the mammography report identifies the breast density as “The breasts are heterogeneously dense, which may obscure small masses” or “The breasts are extremely dense, which lowers the sensitivity of mammography,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

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Executive Summary

Section 900.12 Quality Standard

Revise Paragraph (c)(3)(ii)

The new regulation is more explicit, ensuring results indicating malignancy are communicated promptly and documented to the appropriate medical professionals.

Key Differences Between Prior vs. New Regulations

1. The new regulation specifies the mode of communication, requiring a written report.

2. The new regulation introduces a concrete timeline, ensuring results are deployed within 7 calendar days from the final interpretation.

3. Both regulations prioritize communication with the healthcare provider (or their designee), but the new regulation explicitly states "referring healthcare provider."

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Section 900.12(c)(3)(ii)

FROM: (c)* * *

(3) * * *

(ii) If the assessment is ``Suspicious'' or ``Highly suggestive of malignancy,'' make reasonable attempts to communicate with the health care provider as soon as possible, or if the health care provider is unavailable, to a responsible designee of the health care provider.

TO:

(c)* * *

(3) * * *

(ii) If the assessment is “Suspicious” or “Highly Suggestive of Malignancy,” the facility shall provide a written report of the mammographic examination, including the items listed in paragraph (c)(1) of this section, to the referring healthcare provider, or if the referring healthcare provider is unavailable, to a responsible designee of the referring healthcare provider within 7 calendar days of the final interpretation of the mammograms.

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Executive Summary

Section 900.12 Quality Standard

Revise (c)(4)

The new regulation is more detailed and prescriptive, clarifying how mammographic records should be maintained, transferred, and accessed and ensuring patients' rights to their medical data.

Key Differences Between Prior vs. New Regulations

1. The new regulation places emphasis on the format of mammograms, specifying that originals should not be reproduced by copying or digitizing. Digital formats should be electronically transferable.

2. There's a defined 15-day timeframe for transferring or releasing mammograms and reports. This provision is extended to cover both the transfer of originals and the provision of copies of mammograms and reports. It retains the requirement that fees must not exceed documented costs For digital mammograms, copies must be available electronically if they are meant for final interpretation.

3. New provisions for facilities that close or cease mammography services mandate ensuring continued access to mammography records and that affected patients are notified. Before ceasing operations, facilities must arrange for continued access to mammographic records by patients and healthcare providers. They can transfer the records to the patient, their

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healthcare provider, or another facility/entity that provides access. If a facility stops performing mammography but remains operational, it may retain records if it satisfies the recordkeeping requirements unless the patient requests a transfer The facility must inform its accreditation body certification agency and make efforts to notify affected patients.

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Section 900.12(c)(4)

FROM: (c)* * *

(4) Recordkeeping. Each facility that performs mammograms: (i) Shall (except as provided in paragraph (c)(3)(ii) of this section) maintain mammography films and reports in a permanent medical record of the patient for a period of not less than 5 years, or not less than 10 years if no additional mammograms of the patient are performed at the facility, or a longer period if mandated by State or local law; and

(ii) Shall upon request or on behalf of, by the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, or to a physician or health care provider of the patient, or to the patient directly;

(iii) Any fee charged to the patients for providing the services in paragraph (c)(4)(ii) of this section shall not exceed the documented costs associated with this service.

TO:

(c)* * *

(4) Recordkeeping. Each facility that performs mammograms:

(i) Shall (except as provided in paragraph (c)(4)(ii) of this section) maintain the original mammograms and mammography reports in a permanent medical record of the patient for the longest of the following: a period of not less than 5 years, a period of not less than 10 years if no additional mammograms of the patient are performed at the facility, or a period, if any, mandated by State or local law. Facilities shall implement policies and procedures to minimize the possibility of loss of these records. The original mammograms must be retained in retrievable form in the mammographic modality in which they were produced. They cannot be produced by copying or digitizing hardcopy originals.

(ii) Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, a physician or healthcare provider of the patient, or to the patient directly during the time specified in paragraph (c)(4)(i) of this section. Transfer of the mammograms and mammography reports must take place within 15 calendar Compliments of

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days of the facility receiving such request. The transferred mammograms must be in the mammographic modality in which they were produced, and cannot be produced by copying or digitizing hardcopy originals. For digital mammograms or digital breast tomosynthesis, if the examination is being transferred for final interpretation purposes, the facility must be able to provide the recipient with original digital images electronically;

(iii) Shall upon request by, or on behalf of, the patient, provide copies of mammograms and copies of mammogram reports to a medical institution, a physician or healthcare provider of the patient, or to the patient directly during the time specified in paragraph (c)(4)(i) of this section. Release of the copies must take place within 15 calendar days of the facility receiving such request. For digital mammograms or digital breast tomosynthesis, if the copies are being released for final interpretation purposes, the facility must be able to provide the recipient with digital images electronically;

(iv) Any fee charged to the patients for providing the services in paragraphs (c)(4)(ii) or (iii) of this section shall not exceed the documented costs associated with this service; and

(v) Before a facility closes or ceases to provide mammography services, it must make arrangements for access by patients and healthcare providers to their mammographic records. This access may be provided by the permanent transfer of mammographic records to the patient or the patient's healthcare provider or the transfer of the mammographic records to a facility or other entity that will provide access to patients and healthcare providers. Access to the records must be provided by such other facility or entity for the remainder of the time periods specified in paragraph (c)(4)(i) of this section. If a facility ceases to perform mammography but continues to operate as a medical entity, and is able to satisfy the recordkeeping requirements of paragraphs (c)(4)(i) through (iv) of this section, it may choose to continue to retain the medical records rather than transfer them to another facility, unless such a transfer is requested by, or on behalf of, the patient. The facility must notify its accreditation body and certification agency in writing of the arrangements it has made and must make reasonable efforts to notify all affected patients.

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Executive Summary

Section 900.12 Quality Standard

Revise Paragraph (f)(1)

While both regulations emphasize the importance of collecting, reviewing, and analyzing mammography outcome data, the new regulation provides more detailed guidance on the types of mammograms and specific metrics to be considered in the evaluation process.

Key Differences Between Prior vs. New Regulations

1. The regulation differentiates explicitly between two types of mammographic exams: a "screening mammogram" (routine views of asymptomatic patients) and a "diagnostic mammogram" (individualized views for patients with symptoms, signs of breast disease, or abnormal screening mammogram findings).

2 The updated regulation introduces specific metrics that must analyze outcome data individually and collectively for all interpreting physicians (PPV, Cancer Detection Rate, and Recall Rate) to be included in the outcome data analysis, providing more structure and clarity on how facilities should measure and evaluate their mammography outcomes.

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Section 900.12(f)(1)

FROM: (f)* * *

(1) General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including followup on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report Analysis of these outcome data shall be made individually and collectively for all interpreting physicians at the facility. 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.

TO: (f)* * *

(1) General requirements. For the purposes of these audit requirements, a mammographic examination consisting of routine views of an asymptomatic patient shall be termed a screening mammogram, while a mammographic examination consisting of individualized views of a patient with breast symptoms, physical signs of breast disease, or abnormal findings on a screening mammogram shall be termed a diagnostic mammogram. Each facility shall establish a system to collect and review outcome data for all mammographic examinations performed, including followup on the disposition of all positive mammograms and correlation of pathology results with the interpreting physician's mammography report. In addition, for cases of breast cancer among patients imaged at the facility that subsequently become known to the facility, the facility shall promptly initiate followup on surgical and/or pathology results and review of the mammographic examinations taken prior to the diagnosis of a malignancy. Analysis of these outcome data shall be made individually and collectively for all interpreting physicians and, at a minimum, shall consist of a determination of the following:

(i) Positive predictive value percent of patients with positive mammograms who are diagnosed with breast cancer within 1 year of the date of the mammographic examination.

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(ii) Cancer detection rate of the patients initially examined with screening mammograms who receive an assessment of “Incomplete: Need additional imaging evaluation,” “Suspicious,” or “Highly Suggestive of Malignancy” on the screening mammogram or on a subsequent diagnostic mammogram, the number of patients who are diagnosed with breast cancer within 1 year of the date of the initial screening mammogram, expressed arithmetically as a ratio per 1,000 patients.

(iii) Recall rate—percentage of screening mammograms given an assessment of “Incomplete: Need additional imaging evaluation.”

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Executive Summary

Section 900.12 Quality Standard

Add Paragraph (f)(4)

The new regulation introduces clear guidelines on how long a facility should retain specific records and data for compliance purposes. The prior regulation did not mention or provide guidance on this matter.

Key Differences Between Prior vs. New Regulations

1 This retention period extends up to the next annual inspection after the facility has analyzed the information.

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Section 900.12(f)(4)

FROM:

[Not present in prior regulation ]

TO:

(f)* * *

(4) The records and data required to demonstrate compliance with the requirements in paragraphs (f)(1) through (3) of this section must be retained until the annual inspection that follows the facility's analysis of that information.

MQSA UPDATES QUICK REFERENCE GUIDE

Executive Summary

Section 900.12 Quality Standard

Revise Paragraph (j)

The new regulation introduces the State certification agency's role alongside the FDA in mammography quality reviews. It expands the notification process to include referring healthcare providers, with more detailed criteria for triggering such notifications.

Key Differences Between Prior vs. New Regulations

1. The new regulation introduces the role of the State certification agency alongside the FDA in reviewing mammography quality and determining the need for patient notification.

2. The new regulation emphasizes not only notifying the patients but also their referring physicians or other healthcare providers.

3. The new regulation has expanded the scope of potential triggers for the notification process.

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Section 900.12(j)

FROM:

(j) Additional mammography review and patient notification

(1) If FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA, for review by the accreditation body or other entity designated by FDA This additional mammography review will help the agency to determine whether the facility is in compliance with this section and, if not, whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised

(2) If FDA determines that any activity related to the provision of mammography at a facility may present a serious risk to human health such that patient notification is necessary, the facility shall notify patients or their designees, their physicians, or the public of action that may be taken to minimize the effects of the risk. Such notification shall occur within a timeframe and in a manner specified by FDA.

TO:

(j) Additional mammography review and patient and referring provider notification.

(1) If FDA or the State certification agency believes that mammographic quality at a facility has been compromised and may present a significant risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA or the State certification agency, for review by the accreditation body or the State certification agency. This additional mammography review will help FDA or the State certification agency determine whether the facility is in compliance with this section and whether there is a need to notify affected patients, their referring physicians or other healthcare providers, and/or the public that there is a significant risk to human health.

(2) Based on the results of the additional mammography review, the facility's failure to comply with the terms of the additional mammography review, or other information, FDA or the State certification agency may determine that the quality of Compliments of

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mammography performed by a facility, whether or not certified under §900.11, was so inconsistent with the quality standards established in this part as to present a significant risk to human health. FDA or the State certification agency may require such a facility to notify all patients who received mammograms at the facility or those patients who are determined to be at risk due to the quality of their mammography, and their referring physicians or other healthcare providers, of the deficiencies and resulting potential harm, appropriate remedial measures, and such other relevant information as FDA or the State certification agency may require. Such notification shall occur within a timeframe and in a manner specified by FDA or the State certification agency. If the facility is unable or unwilling to perform such notification, FDA or the State certification agency may notify patients and their referring physicians or other healthcare providers individually or through the mass media.

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Executive Summary

Section 900.14 Suspension or Revocation of Certificates

The FDA has demonstrated its commitment to enhancing the standards for certification in the Mammography Quality Standards Act's regulations by introducing specific details regarding the suspension or revocation of certificates. These updates complement other recent changes in the newly released final rules

One notable addition is the new regulation related to non-compliance with requests for records of training or experiences relevant to the qualification under MQSA, as outlined in § 900.12(a)(4). If a facility fails to comply with such requests from current or former facility personnel, their certificate may be subject to suspension or revocation. This new rule underscores the importance of transparency and accountability within mammography facilities. Requiring facilities to maintain and provide comprehensive training and experience records ensures that personnel are appropriately qualified and competent to perform their roles. Failure to comply with these requests can have serious consequences, including the potential loss of certification, which serves as a strong incentive for facilities to uphold the highest standards of training and qualifications.

These updates collectively aim to reinforce the integrity of the certification process, foster patient safety, and promote quality mammography services nationwide.

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Section 900.14 Suspension or Revocation of Certificates

FROM:

(a) Except as provided in paragraph (b) of this section, FDA may suspend or revoke a certificate if FDA finds, after providing the owner or operator of the facility with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the owner, operator, or any employee of the facility:

TO:

(a) Except as provided in paragraph (b) of this section, FDA may suspend or revoke a certificate if FDA finds, after providing the owner or operator of the facility with notice and opportunity for a hearing in accordance with part 16 of this chapter, that the facility, owner, operator, or any employee of the facility:

FROM:

(a) * * *

(3) Has failed to comply with reasonable requests of the agency or the accreditation body for records, information, reports, or materials that FDA believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of Sec. 900.12;

TO:

(a) * * *

(3) Has failed to comply with reasonable requests of FDA, the State certification agency, or the accreditation body for records, information, reports, or materials, including clinical images for an additional mammography review under §900.12(j), that FDA or the State certification agency believes are necessary to determine the continued eligibility of the facility for a certificate or continued compliance with the standards of §900.12;

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Section 900.14 Suspension or Revocation of Certificates

FROM:

(a) * * *

(5) Has violated or aided and abetted in the violation of any provision of or regulation promulgated pursuant to 42 U S C 263b; or

(6) Has failed to comply with prior sanctions imposed by the agency under 42 U.S.C. 263b(h)

TO:

(a) * * *

(5) Has violated or aided and abetted in the violation of any provision of or regulation issued pursuant to 42 U.S.C. 263b;

(6) Has failed to comply with prior sanctions imposed by FDA or the State certification agency under 42 U.S.C. 263b(h), including a directed plan of correction or a patient and referring physician notification; or

(7) Has failed to comply with requests of current or former facility personnel for records of their training or experience relevant to their qualification under MQSA, in violation of §900.12(a)(4).

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Executive Summary

Section 900.15 Appeals of Adverse Accreditation or Reaccreditation Decisions that Preclude Certification or Recertification

The FDA has taken proactive steps to update specific standards for certification in the Mammography Quality Standards Act's regulations by reflecting changes in the names of relevant governmental agencies that have occurred since the initial release of the MQSA final rules. These updates ensure that the regulations stay current and aligned with the existing organizational structures, promoting clarity and effective implementation of the standards within the evolving healthcare landscape.

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Section 900.15 Appeals of Adverse Accreditation or Reaccreditation Decisions that Preclude Certification or Recertification

FROM: (d) * * *

(1) References to the Health Care Financing Administration (HCFA) in 42 CFR part 498 should be read as the Division of Mammography Quality and Radiation Programs (DMQRP), Center for Devices and Radiological Health, Food and Drug Administration

TO:

(d) * * *

(1) References to the Centers for Medicare and Medicaid Services in 42 CFR part 498 should be read as the Division of Mammography Quality Standards (DMQS), Center for Devices and Radiological Health, Food and Drug Administration.