Direct-to-Patient Mammogram Results: It’s the Law | FDA
27 hours ago MQSA regulations have a unique provision that requires mammography facilities to send each patient a written summary of the mammography report in lay terms. >> Go To The Portal
While health care providers routinely receive their patients’ test results, the Mammography Quality Standards Act The Mammography Quality Standards Act was enacted by the United States Congress to regulate the quality of care in mammography. The act was officially effective in 1994, and was extended in 2004 to continue through 2007. The U.S. Food and Drug Administration began inspections of mammography facilities to ensure compliance in 1995. In 1997, more comprehensive regulation was added to become effe… (MQSA) regulations have a unique provision that requires mammography facilities to send each patient a written summary of the mammography report in lay terms.Mammography Quality Standards Act
Full Answer
What happens if MQSA inspects a mammography facility?
If MQSA inspectors find problems at a mammography facility that could significantly affect the quality of the x-rays and the results, the facility or Certifying Body will notify patients and their physicians. A poor quality mammogram can mean the exam results might be wrong.
Can a facility be cited under MQSA for not retaining records?
Some facilities claim they are bound by State or local law to retain permanent records, but this practice is contrary to the MQSA regulations. If the facility has a signed statement by the patient requesting the transfer, the facility will not be cited under MQSA for failure to retain the records.
What does mqsRA stand for?
A report by the United States Senate Committee on Health, Education, Labor and Pensions, which accompanies S. 1879, the Mammography Quality Standards Reauthorization Act (MQSRA) of 2004, touts the success of this program with statistics indicating that over 60 percent of facilities have no violations, only 2 percent have serious non-compliance ...
When was mqsRA reauthorized?
During the 108th Congress, the ACR worked closely with the American Cancer Society (ACS) and the Susan G. Komen Breast Cancer Foundation to develop reauthorization language for MQSA. On November 18, 2003, S. 1879, the MQSRA of 2004, was introduced in the Senate by Senator Barbara Mikulski (D-MD).
What does MQSA stand for in mammography?
Mammography Quality Standards ActMammography Quality Standards Act (MQSA) | FDA. The .gov means it's official.
What are the MQSA requirements?
Complete 40 hours of initial training in mammography, which includes breast anatomy, physiology, positioning, compression, quality assurance and quality control techniques, and imaging of patients with breast implants. Complete 25 mammography examinations under the supervision of an MQSA-qualified individual.
What is MQSA in radiology?
The Mammography Quality Standards Act (MQSA) became law on October 27, 1992 (P.L. 102-539). MQSA required the Department of Health and Human Services (HHS) to develop standards that would be enforced through strict accreditation, certification and inspection of equipment and personnel at mammography facilities.
What is MQSA inspection?
The annual inspection under the Mammography Quality Standards Act (MQSA) is the time when an MQSA certified inspector assesses a facility's compliance with MQSA quality standards.
Why is MQSA important?
Congress enacted MQSA to ensure that all people have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. The Act refers to the MQSA as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA).
How long is ACR accreditation good for?
In response to increasing limitations and restrictions of physicist access to imaging facilities due to the COVID-19 outbreak, the ACR will extend the annual medical physicist equipment survey accreditation requirement to a 16-month window from date of last equipment evaluation.
What is the difference between analog and digital mammogram?
Both use X-ray radiation to produce an image of the breast, but conventional mammograms are read and stored on film, where digital mammograms are read and stored in a computer so the data can be enhanced, magnified, or manipulated for further evaluation. There are no other differences between the two.
Can you self refer for a mammogram?
We have created a new national self-referral template letter that all breast screening services must use to send to women who have self-referred into the programme.
Do mammogram scripts expire?
Payers that preauthorize or precertify imaging studies often include an expiration date. However, unlike prescriptions for medication, there is not a standard expiration date for imaging orders.
How do I contact MQSA?
For policy questions, check the Policy Guidance Help System first. Facility staff can call the Facility Hotline at 1-800-838-7715. You can also fax your question(s) to 1-443-285-0689 or email us at MQSAhotline@versatechinc.com.
Does FDA certify facilities?
FDA uses a state-of-the-art database, which tracks certification, inspections, and accreditation information, that allows it to assess facilities' compliance with MQSA.
How often must the Quality Control QC image shown be performed for each mammography unit?
(1) Frequency of review. The accreditation body shall review phantom images from each facility accredited by the body at least once every 3 years. (2) Requirements for the phantom used.
How many questions are on the mammography registry?
115 questions with multiple choice answers. Exam software simulates taking the registry, with answers and explanations and enforcing the 2.5 hour time limit.
How often must the Quality Control QC image shown be performed for each mammography unit?
(1) Frequency of review. The accreditation body shall review phantom images from each facility accredited by the body at least once every 3 years. (2) Requirements for the phantom used.
When was the MQSA regulation amended?
On March 27, 2019, the FDA issued a Proposed Rule Amending the MQSA Regulations. Comments to this proposed rule should be submitted to the docket no later than 90 days after date of publication. The information currently on this webpage refers to the MQSA legislation, passed in 1992, and the MQSA regulations published in 1997, ...
How long is a MQSA certificate valid?
Full Certification: Fully certified facilities that have completed the accreditation review process and have been issued an MQSA certificate that is valid for three years. Provisional Certification: Provisionally certified facilities that have had their applications accepted by an FDA-approved accreditation body.
What is the Mammography Quality Standards Act?
The Mammography Quality Standards Act requires mammography facilities across the nation to meet uniform quality standards. Congress passed this law in 1992 to assure high-quality mammography for early breast cancer detection, which can lead to early treatment, a range of treatment options, and increased chances of survival.
Why is a consumer complaint mechanism required in mammography facilities?
A consumer complaint mechanism is required to be established in mammography facilities to provide patients with a process for addressing their concerns.
Why is the FDA's annual inspection important?
FDA's annual inspection process provides a valuable, systematic means of helping to ensure that these higher standards are maintained. Many facilities had to improve their services to meet the MQSA standards, but very few facilities had to close for failing to meet the standards.
How many facilities are there in the US for mammography?
FDA's Mammography Program Definitions. Congress passed the Mammography Quality Standards Act to ensure that mammography performed at the approximately 10,000 facilities in this country is safe and reliable.
When did the FDA start regulating mammography?
FDA, along with the National Mammography Quality Assurance Advisory Committee, developed comprehensive regulations (issued on October 28, 1997) that became effective on April 28, 1999. The current regulations apply to the following:
What is the MQSA?
MQSA required the Department of Health and Human Services (HHS) to develop standards that would be enforced through strict accreditation, certification and inspection of equipment and personnel at mammography facilities.
When was MQSRA reported?
On November 21, 2003, Chairman Judd Gregg (R-NH) of the Senate HELP Committee conducted a mark-up and MQSRA was ordered to be reported. S. 1879 passed the Senate on February 2, 2004, and was referred to the Subcommittee on Health of the House of Representatives Committee on Energy and Commerce.
When was MQSA reauthorized?
On November 18, 2003, S. 1879, the MQSRA of 2004, was introduced in the Senate by Senator Barbara Mikulski (D-MD). Traditionally, MQSA, which was last reauthorized in 1998, has been on a five-year appropriations reauthorization cycle. The ACR, ACS and Komen, however, negotiated a two-year reauthorization with Senator Mikulski and Senate HELP Committee Chairman Judd Gregg (R-NH) to allow for the timelier incorporation of results from separate studies by the Institute of Medicine (IOM) and the Government Accountability Office (GAO) that are scheduled for release in 2005.#N#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. While GAO has yet to release its report, IOM published its findings, Improving Breast Imaging Quality Standards, on May 23, 2005. 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.#N#On November 21, 2003, Chairman Judd Gregg (R-NH) of the Senate HELP Committee conducted a mark-up and MQSRA was ordered to be reported. S. 1879 passed the Senate on February 2, 2004, and was referred to the Subcommittee on Health of the House of Representatives Committee on Energy and Commerce.#N#In the House of Representatives, Representative John Dingell (D-MI) introduced companion legislation, H.R. 4555. Of greatest significance, this bill reauthorizes appropriations through FY 2007 for breast cancer screening surveillance research grants and for mammography facilities certification activities not supported by fees.#N#Additionally, the Energy and Commerce Health Subcommittee amended H.R. 4555 with a provision adding two industry representatives with expertise in mammography equipment to the National Mammography Quality Assurance Advisory Committee. Energy and Commerce Committee chairman, Joe Barton (R-TX) believes industry representation on the Advisory Committee should be beneficial to HHS and the FDA as they determine appropriate quality standards and regulations for mammography facilities.
When was the ACR last updated?
These regulations were last updated in October 2002. The ACR is one of four FDA-approved accreditation bodies. A report by the United States Senate Committee on Health, Education, Labor and Pensions, which accompanies S. 1879, the Mammography Quality Standards Reauthorization Act (MQSRA) of 2004, touts the success of this program ...
What is the MQSA?
102-539) was enacted on October 27, 1992, and is codified under the Public Health Service (PHS) Act ( 42 U.S.C. 263 b; section 354 of the PHS Act). Under the MQSA, all mammography facilities, except facilities of the Department of Veteran Affairs (VA), must be accredited by an approved accreditation body and certified by FDA (or an approved State certification agency) to provide mammography services ( 42 U.S.C. 263 b (b) (1), (d) (1) (iv)). FDA is proposing these amendments to the mammography regulations (set forth in part 900 ( 21 CFR part 900 )) under section 354 of the PHS Act ( 42 U.S.C. 263 b), and sections of the FD&C Act (sections 519, 537, and 704 (e); 21 U.S.C. 360 i, 360nn, and 374 (e)). Start Printed Page 11671
What is the FDA's plan for updating the mammography regulations?
We are proposing updates to modernize the regulations by incorporating current science and mammography best practices. These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers ( by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.
What is the FDA's proposed amendment to the Mammography Reporting Regulations?
FDA also is proposing to amend section “Medical records and mammography reports ” (§ 900.12 (c)). The proposed rule would amend the mammography reporting requirements as described below (see § 900.12 (c)). Our goal is to revise the mammography reporting regulations to increase the clarity of communication among mammography facilities, healthcare providers, and patients, facilitate the retrieval of mammography images, and help ensure that healthcare providers and patients are obtaining the necessary information from the report of the results of a mammographic examination to enable a woman and her healthcare provider to make informed healthcare decisions.
How long do you have to keep a mammogram?
Current § 900.12 (c) (4) (i) requires facilities to 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 mammogram s of the patient are performed at the facility, or a longer Start Printed Page 11677 period if mandated by State or local law. FDA's experience has shown that, with the widespread use of electronic media for the storage of soft copy images, facilities face new technical challenges regarding maintaining the availability of current and recent mammograms. Since the loss of these images can have a significant impact on patient care, facilities must address these challenges. The proposed rule (proposed § 900.12 (c) (4) (i)) would amend this section to require each facility to implement policies and procedures to minimize the possibility of loss of these records. In addition, since copying or digitizing a mammographic image can degrade the quality of the image and potentially lead to incorrect diagnoses, the proposed rule would also require that, to preserve image quality, the mammograms must be retained in retrievable form in the mammographic modality in which they were produced and cannot be produced by copying or digitizing hardcopy originals.
How does image quality affect mammogram interpretation?
Image quality contributes to accurate interpretation of mammograms. The MQSA and implementing regulations are intended to ensure that quality images are produced. However, FDA's experience has shown that some facilities copy or digitize clinical images, and submit these copies, of lesser quality than the original images, to the interpreting physician for interpretation. This can adversely affect accuracy of interpretation. Therefore, to ensure that the interpreting physician interprets the actual images, which were performed in compliance with MQSA quality standards, FDA is proposing to change this section on content and terminology of medical records and mammography reports to require that the mammograms submitted for interpretation be presented in the mammographic modality in which they were originally produced, and not be copied or digitized (§ 900.12 (c) (1)).
What are the three categories of improvements to mammography?
FDA is proposing three categories of improvements to our mammography regulations: Improvements that address changes in mammography technology; improvements that enhance enforcement of quality standards; and improvements in the way mammography results are categorized, reported, retained, and transferred to patients and healthcare providers.
What is the proposed rule for digital mammography?
The proposed rule would amend parts of the equipment section to address digital mammography and other changes in technology that have occurred since publication of the current regulations (§ 900.12 (b)).
What is the MQSA?
The Mammography Quality Standards Act (MQSA) requires that "a summary of the written report shall be sent directly to the patient in terms easily understood by a lay person. " This applies to every patient who receives a mammogram, not only self-referred patients. Failure to comply with this reporting requirement will result in a citation by FDA ...
How long does it take for a patient to report suspicious results?
FDA believes that communication of suspicious or highly suggestive results can be accomplished within five working days.
What is a summary of abnormal results?
A summary regarding abnormal results must give clear direction about the appropriate steps to be taken by the patient. The ACR recommends that you send the official interpretation to the referring provider prior to sending a lay summary report to the patient.
Do interpreters have to report mammograms?
Interpreting physicians are required by law to send every patient who receives a mammogram a report written in terms easily understood by a lay person. Failure to comply with this reporting requirement will result in a citation by the FDA.
Table of Contents
I. Executive Summary
- A. Purpose of the Proposed Rule
Mammography is an x-ray imaging examination used to identify signs of breast cancer. For women to receive the full benefit of mammography, the service must be of high quality, including performance of the examination by qualified technologists; using equipment that is tested and p… - B. Legal Authority
The MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is codified under the Public Health Service (PHS) Act (42 U.S.C. 263b; section 354 of the PHS Act). Under the MQSA, all mammography facilities, except facilities of the Department of Veteran Affairs (VA), must be ac…
III. Background
- According to the Centers for Disease Control and Prevention (CDC), in 2014, the most recent year for which numbers are available, over 235,000 women were diagnosed with breast cancer, and more than 41,000 women died of the disease (Ref. 1). According to the National Cancer Institute of the National Institutes of Health, in 2017, over 250,000 women were projected to be diagnose…
IV. Legal Authority
- The MQSA (Pub. L. 102-539) was enacted on October 27, 1992, and is codified at 42 U.S.C. 263b (section 354 of the PHS Act). Under the MQSA, all mammography facilities, except facilities of the VA, must be accredited by an approved accreditation body and certified by FDA (or an approved State certification agency) to provide mammography services (42 U.S.C. 263b(b)(1) and (d)(1)(i…
v. Description of The Proposed Rule
- A. Definitions of Mammography and Mammographic Modality
FDA is proposing to amend the definition of “mammography” to exclude computed tomography (CT) of the breast as the requirements in part 900 relating to mammography personnel qualifications and image quality are not applicable to breast CT (§ 900.2(aa)). FDA is also propo… - B. Repeated Failure of Accreditation
FDA is proposing to add a new subsection to the code of conduct and general responsibilities requirements for accreditation bodies, which would prohibit an accreditation body from accepting an application for accreditation from a facility that has failed to become accredited after three S…
VI. Proposed Effective Date
- FDA proposes that any final rule that may issue based on this proposal become effective 18 months after the date of publication of the final rule in the Federal Register. Facilities need time to become familiar with new requirements and to add breast density reporting to their reporting systems.
VII. Preliminary Economic Analysis of Impacts
- A. Introduction
FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to a… - B. Summary of Benefits and Costs
The proposed rule would modernize mammography regulations by incorporating current science and mammography best practices to improve the delivery of mammography services. The proposed updates include requirements on recordkeeping, reporting, and communication of res…
VIII. Analysis of Environmental Impact
- The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, Start Printed Page 11680neither an environmental assessment nor an environmental impact statement is required.
IX. Paperwork Reduction Act of 1995
- This proposed rule refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The collections of information in part 900 have been approved under OMB control number 0910-0309. The proposed amendments to part 900 in this documen…
X. Federalism
- The MQSA established minimum national quality standards for mammography. The MQSA replaced a patchwork of Federal, State, and private standards with uniform Federal standards designed to ensure that all women nationwide receive adequate quality mammography services. FDA has worked very closely with State officials in developing the national standards for the MQ…
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