S02 - Attachment D - VHA Directive 1105-03 - Mammography Program Procedures and Standards.pdf

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Department of Veterans Affairs Veterans Health Administration Washington DC 20420

VHA DIRECTIVE 1105.03

Transmittal Sheet

May 21, 2018

MAMMOGRAPHY PROGRAM PROCEDURES AND STANDARDS

1. REASON FOR ISSUE: This Veterans Health Administration (VHA) directive is issued to provide policy for the administration, accreditation, staffing, and functioning of mammography programs in Department of Veterans Affairs (VA) facilities, facilities managed by VHA, and community-based outpatient clinics (CBOCs) or leased facilities.

2. SUMMARY OF MAJOR CHANGES: This revised VHA directive updates implementation instructions and procedures for the administration, accreditation, staffing, and performance of mammography programs in VA facilities; those managed by VHA, CBOCs, and leased facilities. Changes include:

a. Incorporating VHA Handbook 1105.03, dated April 28, 2011.

b. Adoption of American Cancer Society breast cancer screening guidelines.

c. A requirement that facilities complete implementation of this directive no later than July 16, 2018.

3. RELATED ISSUES: VHA Directive 1330.01, Health Care Services for Women Veterans; dated February 15, 2017, and VHA Directive 1088, Communicating Test Results to Providers and Patients, dated October 7, 2015.

4. RESPONSIBLE OFFICE: The National Director, Radiology Program, Diagnostic Services (10P11D), is responsible for the contents of this directive. Questions may be referred to (919) 384-8593.

5. RESCISSIONS: VHA Handbook 1105.03, Mammography Program Procedures and Standards, dated April 28, 2011, is rescinded.

6. RECERTIFICATION: This VHA directive is scheduled for recertification on, or before the last working day of May 2023. This VHA directive will continue to serve as national VHA policy until it is recertified or rescinded.

Carolyn Clancy, M.D Executive in Charge

NOTE: All references herein to VA and VHA documents incorporate by reference subsequent VA and VHA documents on the same or similar subject matter.

DISTRIBUTION: Emailed to the VHA Publications Distribution List May 24, 2018.

May 21, 2018 VHA DIRECTIVE 1105.03 i

CONTENTS

MAMMOGRAPHY PROGRAM PROCEDURES AND STANDARDS

1. PURPOSE

2. BACKGROUND

3. DEFINITIONS

4. POLICY

5. RESPONSIBILITIES

6. REFERENCES

APPENDIX A

ACCREDITATION, CERTIFICATION AND ALTERNATIVE STANDARDS ..................A-1

APPENDIX B

FOOD AND DRUG ADMINISTRATION (FDA) .............................................................B-1

APPENDIX C

MAMMOGRAPHY PROGRAM DOCUMENTS MANAGEMENT ................................. C-1

APPENDIX D

MEDICAL PHYSICS SURVEYS ................................................................................. D-1

APPENDIX E

QUALITY ASSURANCE, QUALITY CONTROL, AND QUALITY ADMINISTRATION

PROGRAM ...................................................................................................................E-1

APPENDIX F

PATIENT REPORTS AND RECORDS MANAGEMENT .............................................. F-1

APPENDIX G

FULL FIELD DIGITAL MAMMOGRAPHY ................................................................... G-1

APPENDIX H

VETERANS HEALTH ADMINISTRATION (VHA) MAMMOGRAPHY REPORT FINAL

ASSESSMENT CATEGORY: WORDING AND ASSOCIATED CODES .................... H-1

ii

APPENDIX I

BREAST TISSUE COMPOSITION CODES: WORDING AND ASSOCIATED CODES

...................................................................................................................................... I-1

APPENDIX J

ACCREDITATION DENIAL .......................................................................................... J-1

MAMMOGRAPHY PROGRAM PROCEDURES AND STANDARDS

1. PURPOSE

This Veterans Health Administration (VHA) directive establishes policy for the performance and interpretation of Radiologic Mammography services in Department of Veterans Affairs (VA); medical facilities as required by Federal statutes and regulations.

It also provides procedures for the administrative structure and management of mammography services provided in VHA medical facilities and their outreach functions.

This directive further defines requirements unique to VHA. Unless otherwise stated, requirements found in this directive are specifically intended for use and application for VHA in-house, on-site mammography programs that provide breast imaging services to women, men, and transgender Veterans. AUTHORITY: Title 38 U.S.C. 7319, 7322

2. BACKGROUND

VHA has been providing routine mammography to Veterans since the passage of Public Law 98-160, the Veterans’ Health Care Amendments of 1983. VHA mammography programs may range in complexity and configuration from a comprehensive on-site program that provides screening, diagnostic mammography, and interventional procedures to on-site programs that provide limited services. VHA medical facilities with a small number of active women enrollees in VA healthcare provide mammography services through community care providers.

3. DEFINITIONS

a. Accrediting Body. For purposes of this directive, an accrediting body (AB) is a private, non-profit entity approved by FDA under 21 CFR 900.3(d) to accredit mammography facilities.

b. Audit Interpreting Physician. An audit interpreting physician (IP) is a mammography qualified IP, listed as an interpreting physician in the for the mammography program, and designated to review the medical outcomes audit data at least once every 12 months.

c. Full Field Digital Mammography. A full field digital mammography (FFDM) is a method for breast radiography using low energy x-rays recorded by an electronic digital detector instead of film. This electronic image can be displayed on a video monitor.

The radiologist can manipulate the digital mammogram electronically to magnify an area, change contrast, or alter the brightness.

d. Diagnostic mammography. A diagnostic mammogram is ordered for patients that have clinical signs or symptoms of breast disease, or if the radiologist detected findings of concern on a screening mammogram and ordered additional mammographic views.

e. Digital Breast Tomosynthesis. A digital breast tomosynthesis (DBT) is a 3-dimensional (3-D) mammogram that involves acquiring images of a stationary compressed breast at multiple angles during a short scan. The individual images are then reconstructed into a series of thin high-resolution slices that are displayed individually or in a dynamic ciné mode. Tomosynthesis can reduce or eliminate the tissue overlap effect.

f. Interpreting Physician. An interpreting physician (IP) is a physician who is qualified to independently interpret mammograms by meeting MQSA requirements.

g. Lay Summary Report. A summary of the written report that is sent directly to the patient in terms easily understood by a lay (non-medical) person.

h. Lead Interpreting Physician. The lead interpreting physician (LIP) is an IP assigned to the general responsibility for ensuring that a facility’s mammography Quality Assurance (QA) program meets all of the requirements. The administrative title and other supervisory responsibilities of the individual, if any, are left to the discretion of the VA medical facility.

i. Lossless Compression. Data compression techniques in which no data is lost.

j. Lossy Compression. Data compression techniques in which some data is lost and cannot be reversed.

k. Mammography Program. A mammography program refers to a specific VA Radiological subspecialty department operating on-site within the larger context of a VHA facility’s physical plant.

l. Ordering Practitioner. An ordering practitioner is a practitioner authorized to enter and sign orders for diagnostic tests by privileges or acting under a scope of clinical practice.

m. Other Qualified Personnel. Other qualified personnel mean persons with documented technical training appropriate for the task(s) assigned to them. Examples include a radiological technologist qualified under MQSA with appropriate training, a technologist who is trained to do the QC test(s) by the Lead Mammography Quality Control (LMQC) Technologist or other radiology support persons appropriately trained to do the task(s) and supervised by the LMQC technologist. A receptionist, clerk, or a secretary whose sole qualification is to copy documents, type, make appointments or answer the phone is not included under “other qualified personnel.”

n. Screening mammogram. A screening mammogram is a radiological breast examination in asymptomatic, average-risk women.

4. POLICY

All mammography performed within VA for the diagnosis or detection of breast cancer must meet the requirements of 21 CFR Part 900 (MQSA), be in compliance with the procedures outlined in this directive, meet the requirements of applicable VA and VHA policies and procedures listed in the references, and where relevant, must also meet other applicable requirements.

5. RESPONSIBILITIES

a. Under Secretary for Health. The Under Secretary for Health is responsible for ensuring overall VHA compliance with this directive.

b. Office of the Principal Deputy Under Secretary for Health. The Principal Deputy Under Secretary for Health is responsible for ensuring that VA retains exclusive oversight and enforcement responsibilities even though accreditation, mammography standards inspections, exam interpretation, procedure performance, and medical physicist responsibilities may be performed by independent third parties.

c. Director, National Radiology Program. The Director, National Radiology Program is responsible for:

(1) Ensuring all VHA mammography programs maintain current accreditation with the ACR and successfully obtain approval to provide mammographic services by receiving VHA certification.

(2) Recommending Denial, Revocation, Suspension, or Termination of Certification.

The Director, National Radiology Program, recommends to the Principal Deputy Under Secretary for Health through recognized organizational channels, action to revoke, suspend, or terminate the certification of VHA mammography programs that do not comply with, or meet, established mammography standards as found in 21 CFR Part 900, or programs that have demonstrated ongoing and uncorrected deficiencies, or otherwise fail to meet VHA policy. VA medical facilities may appeal denial of certification directly with the Director, National Radiology Program. The Principal Deputy Under Secretary for Health may approve, remand, or reject recommendations by the National Director Radiology Program.

d. Mammography Program Director. The Mammography Program Director reports to the National Director, Radiology Program and is responsible for:

(1) Collecting and analyzing compliance data from all VHA on-site mammography programs. On a routine basis, mammography inspection and accreditation results are provided by VHA Mammography Program Office (VHAMO) to the individual facilities and National Director Radiology for use in program improvement, compliance, and oversight activities.

(2) Providing recommendations on interpretation of regulatory requirements found in Federal statutes, regulations, and guidance pertaining to mammography quality standards.

(3) Preparing recommendations to Veterans Integrated Service Networks (VISNs) on the baseline requirements for program establishment, continuation, or closure.

(4) Developing recommendations to the National Director, Radiology Program, concerning program certification; i.e., granting extension, revocation, suspension, or denial.

(5) Providing periodic on-site visits to ensure maintenance of corrective actions and compliance with the AB and FDA requirements consistent with 21 CFR Part 900.

e. VA Medical Facility Director. VA Medical Facility Directors are responsible for ensuring policies and procedures related to quality, patient education, effective and clear communication with patients, clear communication of mammography results, infection control, and safety are developed and implemented following the ACR practice guidelines and the ACR QC manual.

f. Facility Chief of Staff. VA Medical Facility Chiefs of Staff are responsible for ensuring that each facility has a process in place to ensure tracking and timely follow-up of findings from breast cancer screening.

g. Chief, Radiology Service. The Chief of Radiology Service is responsible for:

(1) Indirect Oversight. While the Chief Radiologist is not directly responsible for the content of the results released by the IP(s), the Chief Radiologist is ultimately responsible for the program’s compliance with 21 CFR Part 900, and VHA policies which include compliance with VHA-imposed measures and monitors, critical results communication, credentialing, etc.

(2) Mammography QA Program. The mammography QA program and each of its elements must only be assigned to individuals who are qualified for their assignments and who are allowed adequate time to perform these duties. All monitors used in the interpretation of mammography and all printers used by the program must be FDA-approved, comply with a QA program that is substantially the same as that recommended by the FFDM manufacturer, and pass the ACR’s phantom and clinical image review process.

(3) VHA Mammography Programs with VHA Interpreting Physician Staff.

(a) The Chief Radiologist designates a LIP who has the responsibility of ensuring that the QA program meets Federal requirements.

(b) The overall direction and coordination of the functions of the program based on the mission, special needs, and size of the facility may be delegated, as appropriate, to the LIP.

(c) The names of the LIP, medical physicist(s), QC technologist(s), Audit IP(s), and any other program personnel with delegated QA responsibilities must be placed in writing.

(d) The Chief Radiologist must issue a statement of responsibilities. Because the regulations, 21 CFR 900.12(a)(1)(30, 2(rr)), already specify the responsibilities of the LIP, medical physicist(s), QC technologist(s), and Audit IP(s), the VA medical facility does not have to restate the responsibilities of the program individuals. However, if the VA medical facility delegates QA responsibilities to someone other than the LIP, medical physicist(s), QC technologist(s), or Audit IP(s), a statement of responsibilities and the credentials for that individual(s) must be provided.

(4) VHA mammography programs with Non-VHA IP Staff.

(a) For mammography programs which may employ a contractor, fee basis, or local contractor as the mammography IP, the Chief Radiologist must identify a LIP who has the general responsibility of ensuring that the contractor, fee basis, or locum tenens QA program meets all requirements.

(b) The Chief Radiologist must clearly and specifically include the following within the contract which must be managed in such a manner as to ensure compliance with 21 CFR Part 900.

(c) The names of the LIP, medical physicist(s), QC technologist(s), Audit IP(s) and any other program personnel with delegated QA responsibilities must be placed in writing.

(d) If the program delegates QA responsibilities to someone other than the LIP, medical physicist(s), QC technologist(s), or Audit IP(s), a statement of responsibilities for that individual(s) and their credentials must be provided.

h. Lead Interpreting Physician (LIP). The LIP is a mammography qualified IP and is responsible for:

(1) Ensuring the QA program, including personnel assignments, all equipment quality control tests, records, corrective actions, the annual physicist’s survey, and medical audit and outcome analysis meet the required standards in 21 CFR Part 900.

(2) Ensuring the individuals assigned to QA tasks are qualified to perform these tasks and that their performance is adequate. NOTE: Non-VHA LIPs are expected to make recommendations to the Chief Radiologist.

(3) Reviewing and discussing medical outcome audits with the IP or assigning this task to another IP (as the Audit IP). The responsibilities of the Audit IP, who must also be a qualified IP, must be consistent with 21 CFR 900.12(f)(3). For programs with only one IP, that person will be the LIP.

(4) Participating in the 3 year accreditation renewal process, the annual FDA inspection, and any other review of mammography quality within the program or required by 21 CFR 900.12 (d)(1)).

(5) Designating a LMQC technologist who meets the mammography technologist requirements, and who is responsible for those QA responsibilities not assigned to the LIP or to the medical physicist. NOTE: Non-VHA LIPs also make recommendations for designation to the Chief Radiologist.

(6) Being directly involved in the selection of a qualified medical physicist to, at a minimum, annually survey the mammography equipment. Because the duties of the medical physicist encompass more than just the annual physics survey, it is an expectation that program staff are able to call on the services of the qualified medical physicist throughout the year, as needed, to maintain the mammography system.

NOTE: Non-VHA LIPs are expected to make recommendations to the Chief Radiologist.

i. Audit Interpreting Physician (AP). The AP is responsible for conducting and reviewing the medical outcomes audit data.

j. Interpreting Physician (IP). The IP is responsible for:

(1) Consulting with referring clinicians regarding the medical significance of the clinical images.

(2) Ensuring the quality of mammography images, they interpret and the content of the reports they verify. IPs need to provide frequent and consistent feedback to the LIP and mammography technologists, according to facility and service policies, concerning the images they are asked to interpret.

(a) High-quality images and QC practices need to be recognized, reinforced, and rewarded.

(b) Poor-quality images need to be identified and improved, as image quality affects the detection of potential breast cancers and abnormal breast conditions, and affects treatment planning.

(3) Participating in the facility’s mammography medical outcomes audit program.

(4) Providing feedback on image quality and QC practices to the LIP and Chief Radiologist, and participating in the facility’s mammography medical outcomes audit program.

NOTE: Non-VHA IPs are responsible for providing feedback on VHA IP performance to the Chief Radiologist.

(5) Communicating results to patients according to 21 CFR part 900 and to ordering providers.

k. Medical Physicist. The Medical Physicist must:

(1) Be qualified to survey mammography equipment and oversee the equipment-related QA practices of the program.

(2) Ensure the program’s annual survey includes all the annual quality control tests specified in 21 CFR 900.12(e)(8)(ii)(B), the phantom image quality test, the other (including new) mammographic modality tests, as well as an evaluation of the quality control tests and results that are normally conducted by the QC technologist,

(3) Provide the program with a report of the annual survey.

(4) Ensure mammography equipment evaluations are done (when applicable), e.g., after equipment moves, major equipment repairs, and for new equipment placed into service, as set forth in 21 CFR 900.12(e).

(5) Non-VA physicists are required to comply with the same requirements in reference to mammography as a VA physicist.

l. Lead Mammography Quality Control (LMQC) Technologist. The LMQC Technologist is responsible for:

(1) Ensuring all individual tasks within the QA program not assigned to the LIP or to the Medical Physicist are assigned to a qualified LMQC technologist. NOTE: For programs with only one mammography technologist, that person will be the LMQC technologist. Normally, the LMQC technologist is expected to perform the QC duties, but other qualified personnel may be assigned or trained to do some or all of the tests.

When these duties are assigned to others, the LMQC technologist retains the responsibility to ensure they are performed in accordance with the regulations. NOTE:

FDA recommends having a single LMQC technologist. FDA has found this is a best practice with less fragmentation and generally allows for better management of the mammography program with more consistent results.

(2) Apprising program staff of new mammography standards and modifications to existing mammography standards and of guidance authored by VHA, FDA, ACR, and acting as a resource to the LIP.

(3) Ensuring the program has available current copies of pertinent VHA policies, standard operating procedures (SOPs), and guidance documents dealing with mammography to include inspection, accreditation requirements, equipment QC, and the proficiency programs.

(4) Ensuring all assigned QC and QA tasks are performed in a professional, trackable, and verifiable manner.

(5) Being the point of contact for the FDA mammography standards inspections in the absence of, or as a designee of, the Chief Radiologist or LIP.

(6) Analyzing inspection reports of the program to identify problems and trends, and reporting this information to appropriate facility management and to the Chief Radiologist.

(7) Providing input, as appropriate, to correct deficiencies noted during inspections and to ensure that the noted deficiencies are addressed appropriately to ensure correction and compliance.

(8) Reviewing investigation reports from the FDA, ACR, Office of the Inspector General (OIG), and Medical Inspector (MI) dealing with the mammography program, and following up with the Chief Radiologist and with the LIP to ensure that issues identified in these reports are addressed timely and, as specified in the reports, corrected.

(9) Advising the Chief Radiologist and the LIP of problems and concerns affecting the quality of the work in the program.

(10) Working with the VHAMO to ensure that the program is in compliance with the inspection and accreditation requirements set forth by ACR, FDA, and VHA policies.

NOTE: VHA’s Breast cancer screening guidelines can be found on the National Center for Health Promotion and Disease Prevention website:

http://vaww.prevention.va.gov/CPS/Screening_for_Breast_Cancer.asp. NOTE: This is an internal VA Web site that is not available to the public.

(11) Reviewing records (see Appendix C).

m. Mammography Radiologic Technologist. The Mammography Radiologic Technologist’s responsibilities center on patient care and image quality. More specifically, these include:

(1) Patient positioning;

(2) Compression;

(3) Image acquisition; and

(4) Infection control.

6. REFERENCES

a. Public Law 98-160 Veterans’ Health Care Amendments of 1983

b. Public Law 102-539 Mammography Quality Standards Act (MQSA) of 1992

c. Public Law 104-262 Veterans’ Health Care Eligibility Reform Act of 1996

d. Public Law 105-114, Section 208 Veterans’ Benefits Act

e. Public Law 105-248 Mammography Quality Standards Re-Authorization Act of

f. 38 U.S.C. 7319

g. 42 U.S.C. 263b, 354

h. Title 21Code of Federal Regulations (CFR) Part 900, Mammography

i. VHA Directive 1088, Communicating Test Results to Providers and Patients, dated October 7, 2015

j. VHA Directive 1330.01, Health Care Services for Women Veterans, dated February 15, 2017 http://vaww.prevention.va.gov/CPS/Screening_for_Breast_Cancer.asp

k. VHA Handbook 1004.01, Informed Consent for Clinical Treatments and Procedures, dated August 14, 2009

l. VHA Handbook 1120.05, Coordination and Development of Clinical Preventive Services Guidance, dated July 29, 2015

m. ACR BI-RADS Atlas®, Breast Imaging Reporting and Data System (most current edition)

n. ACR Practice Parameter for Communication of Diagnostic Imaging Findings

o. ACR Practice Parameter for the Performance of Screening and Diagnostic Mammography.

p. ACR Practice Parameter for the Performance of Contrast-Enhanced Magnetic Resonance Imaging (MRI) of the Breast.

q. VHA Clinical Preventive Services Guidance Statement: Screening for Breast Cancer: http://vaww.prevention.va.gov/CPS/Screening_for_Breast_Cancer.asp.

NOTE: This is an internal VA Web site that is not available to the public.

r. ACR Practice Parameter for the Performance of Stereotactic-Guided Breast Interventional Procedures.

s. American Cancer Society, https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/breast-cancer-screening-guidelines.html

t. American College of Radiology, Mammography Accreditation:

http://www.acraccreditation.org/Modalities/Mammography.

u. Food and Drug Administration, Radiation–Emitting Products, Mammography Quality Standards Act and Program: http://www.fda.gov/Radiation- EmittingProducts/MammographyQualityStandardsActandProgram/default.htm.

http://vaww.prevention.va.gov/CPS/Screening_for_Breast_Cancer.asp https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/breast-cancer-screening-guidelines.html https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/breast-cancer-screening-guidelines.html https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/breast-cancer-screening-guidelines.html http://www.acraccreditation.org/Modalities/Mammography http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm http://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/default.htm

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APPENDIX A

ACCREDITATION, CERTIFICATION AND ALTERNATIVE STANDARDS

This section addresses mammography accreditation, certification, and alternative standards for VA medical facilities interested in establishing or maintaining a mammography program.

1. ACCREDITATION

a. VA medical facilities must be accredited by an approved private non-profit organization which meets the requirements established under subsection (e) of Section 354 of the Public Health Service Act (42 U.S.C. 263b) to perform mammography. VA medical facility programs must exclusively use the American College of Radiology (ACR) for the Accreditation Body (AB), as the ACR is currently the only non-profit mammography accrediting body approved by FDA.

b. A VA medical facility interested in establishing a program and performing mammography on site must apply for and attain accreditation. Accreditation provides VA medical facilities with peer review and constructive feedback on staff qualifications, equipment, quality control, quality assurance, image quality, and radiation dose. All VHA mammography programs are required to register with the National Radiology Program’s Mammography Program Office and be issued a VHA certification number.

c. All VHA mammography programs must be accredited by the ACR prior to any patient imaging. A program must be accredited before it can be certified by VHA. For new programs, provisional ACR accreditation must be attained and VHA Mammography Program Office (VHAMO) issue a provisional certification to perform mammography.

ACR accreditation and VHA certification must be maintained to provide mammography services.

d. Programs need to allow 6 – 8 months for the reaccreditation process, which occurs triennially. A program has 45 calendar days from the date the testing materials are sent to the program to return the completed application and testing materials to the ACR. It is a local decision whether a site submits images to the ACR electronically or on film.

e. The clinical images submitted to the ACR are to be selected from those that are obtained from regularly scheduled female patients, while routinely performing screening mammograms. Legally, ethically, and morally it is an unacceptable practice to expose any patient repeatedly to obtain images for the clinical image review.

f. The ACR can, and is expected to take action to revoke or suspend the accreditation of facilities that do not comply with or meet established accreditation standards. Facilities may appeal denial of accreditation directly with the AB (see Appendix J).

APPENDIX A

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g. Costs associated with the application for mammography accreditation activities, medical physicist surveys, and Additional Mammography Review(s) (AMR), if any, must be paid by the respective VA medical facility mammography program.

h. Costs and fees associated with the retention of qualified contract or fee for service medical physicist services as required by Federal regulations are the responsibility of the respective VA medical facility mammography program.

2. CERTIFICATION

a. Each independent VHA mammography program must be certified by VHA and issued a VHA certification number.

b. VHA mammography programs are required to revalidate their certificate with the VHA’s Mammography Program Office after every successful 3-year accreditation renewal. A mammogram may not be legally performed at any VHA facility, unless the mammography program is both accredited and certified. NOTE: VHA may choose not to certify a program even after it has successfully been accredited to perform mammography. The decision not to award certification would be based upon internal VHA information and the concurrence of the Office of the Principal Deputy Under Secretary for Health.

c. VA mammography programs implementing digital breast tomosynthesis (DBT) must follow FDA’s MQSA facility certificate extension requirements process. FDA will notify VHA to extend a site’s mammography certificate to include DBT imaging. VA mammography programs may not use DBT imaging on patients until the VHAMO has extended their mammography certificate.

d. Costs associated with the FDA annual mammography standards inspections are centrally funded through a national Inter-Agency Agreement (IAA) between VHA and FDA. Costs of any additional or repeat program inspections by FDA due to inspection violations, etc., must be paid by the VA medical facility mammography program.

3. ADDITIONAL MAMMOGRAPHY REVIEW (AMR)

If VHA, or the AB, believes that mammography quality at a program has been compromised or may present a risk to human health, the program must provide clinical images and other relevant information, as specified, for review by the AB or to another entity designated by Office of the Principal Deputy Under Secretary for Health.

a. This additional mammography review assists the agency to determine whether the program is in compliance with 21 CFR Part 900, and if not, whether there is a need to make program modifications and notifications.

b. VHA may require notification of patients who received mammograms at the program and their referring physicians, of: the deficiencies presenting such risk, the potential harm resulting from the deficiencies, appropriate remedial measures, and such other relevant information as VHA may require. The notification must occur within a

APPENDIX A

A-3 timeframe and in a manner specified by the Office of the Principal Deputy Under Secretary for Health. VHA may require a program found to have performed mammography of compromised quality or that presents a risk to patients’ health to notify the patients and their referring physicians of the deficiencies and of the risk or potential harm resulting from the deficiencies, of medical measures appropriate to the risk, remedial measures, and of any other relevant information VHA requires the facility to include in the notice.

4. ALTERNATIVE STANDARDS

a. An alternative standard is a means to ensure quality mammography replaces or augments existing regulatory standards. Alternative standards must be as effective in ensuring quality mammography as the standard it proposes to replace, and it must be in keeping with the purposes of 38 U.S.C. 7319 and 42 U.S.C. 263b. Alternative standards approved by FDA are acceptable for use by VA medical facilities, unless otherwise precluded by VHA policy.

b. VA medical facilities that would like to propose an alternative standard will need to develop the proposed standard following the guidelines found in 21 CFR 900.18 and submit it to the National Radiology Program, VHAMO, Suite 100, 3022 Croasdaile Dr., Durham, NC 27705, for review and assessment.

c. When a request is received, it is reviewed by the National Mammography Advisory Committee. Proposals with merit are referred to FDA for further comment prior to approval or implementation.

d. The National Director, Radiology Program, through the Chief Consultant, Diagnostic Services, or designee, may recommend approval or denial, in whole or in part, of a request for an alternative standard. The requestor is notified if the proposal is denied and the reason for denial. If the request is approved, the written notice includes the effective date of the approval, a summary of the limitations and conditions attached to the approval, and any other information that may be relevant to the approved request.

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APPENDIX B

FOOD AND DRUG ADMINISTRATION (FDA) MAMMOGRAPHY QUALITY

STANDARDS ACT INSPECTIONS

VHA has entered into an InterAgency Agreement (IAA) with FDA to utilize Federal inspectors to conduct the mandatory annual mammography standards inspections and in so doing meet the requirements of 38 U.S.C. 7319 and 42 U.S.C. 263b.

Mammography inspection results are reported to the individual program to provide feedback and to VHA for program analysis, oversight, and enforcement.

1. MAMMOGRAPHY QUALITY STANDARDS ACT INSPECTION COVERS THE

FOLLOWING

a. Equipment performance (including image quality (phantom) and radiation dose measurements);

b. Technologist and physicist QC and QA tests, tasks, and records;

c. Medical audit and outcome analysis records;

d. Medical records, mammography reports, and clinical image quality; and

e. Personnel qualification records.

2. INSPECTION REPORT SUMMARY

At the conclusion of the inspection, a summary report (results notification) is usually left with the program; it includes any variances or deviations from the standards. Non-compliances are categorized into four levels.

a. Level 1(L1) or Level 1 Repeat are the most serious. It indicates a failure to meet key requirements that may compromise the quality of mammography services performed by the program. ‘Repeat’ is a term used to identify identical violations found during two consecutive inspections and is considered to be of even greater severity.

b. In the absence of Level 1 non-compliances, a Level 2 (L2) or Level 2-Repeat non-compliance indicates that the program meets all key requirements, but fails to meet significant mammography quality items.

c. In the absence of L1 and L2 non-compliances, Level 3 non-compliances indicate that the program meets all major requirements with minor exceptions.

d. The program meets national mammography standards as denoted by FDA as being in Full Compliance or no non-compliances. No action is required.

e. Each mammography program LIP with L1 or L2 non-compliance must prepare a written response, through their respective VA medical facility Director to VHAMO, outlining the program’s corrective action plan to resolve the violation(s).

APPENDIX B

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f. VHAMO, after receipt of the official report from FDA, sets a facility response date to be determined by the severity and number of violations. While the program is expected to correct each violation found during the inspection as soon as possible regardless of its level, it is generally not required to send a written response concerning L3 violations.

g. Corrective actions regarding all violations, no matter the level, are checked during the next annual inspection to ensure resolution.

3. CORRECTIVE ACTION PLAN

a. A corrective action plan consists of:

(1) A written narrative describing the findings of the program’s investigation of the violations, including the conclusions as to the cause(s) of each unacceptable result;

(2) Specific actions taken to prevent reoccurrence; and

(3) Evidence that the problem has been corrected.

b. The number of violations, the severity level, context of the violations, and inspector remarks, may also indicate that additional steps need to be taken. The National Director of Radiology, using established channels, recommends appropriate action through the Principal Deputy Under Secretary for Health, who may require the program and facility to take additional actions, such as:

(1) Providing additional documentation;

(2) Ensuring additional staff training, as deemed appropriate, to resolve the violations;

(3) Implementing further corrective action;

(4) Removing equipment from use;

(5) Re-reading mammograms;

(6) Recalling patients improperly exposed;

(7) Suspending the performance of mammography; or

(8) Closing the program.

c. Mammography may continue to be performed while corrective action is being reviewed and implemented, unless otherwise directed by the office of the Principal Deputy Under Secretary for Health. If the program must cease, temporarily or permanently, while the program undergoes further assessment, e.g., Additional Mammography Review (AMR) or site visit, resumption of mammography may only be

APPENDIX B

B-3 authorized once the program and facility management can verify to the Principal Deputy Under Secretary for Health that the following conditions have been met:

(1) There is no immediate jeopardy to patient health and safety.

(2) The program has provided the Principal Deputy Under Secretary for Health with satisfactory evidence that it has taken steps to correct the problem(s) identified by the unsuccessful performance.

(3) The VA medical facility mammography program, as part of their QA activities, documents periodic, not less than quarterly, reassessment of the corrective action(s) implemented to ensure continued compliance and to prevent violation reoccurrence.

NOTE: The VHAMO may request submission of evidence of the quarterly reviews to verify actions and progress.

4. INSPECTION APPEAL PROCEDURES

a. The National Director of the Radiology Program is responsible for overseeing performance by and follow-up with the individual programs to ensure any needed corrective action(s) have been taken to remedy deficiencies. NOTE: FDA is a contractor for VHA performing a nationally-mandated inspection service and provides VHA with the results of the inspections. VHA retains program oversight and enforcement responsibilities.

b. It is important to document, with photo copies (if pertinent), the items and issues the inspector cited.

c. Any correspondence including an appeal must be submitted through appropriate VA medical center channels and is to include:

(1) A copy of the inspection non-compliances and results report;

(2) A clear statement of the non-compliance issue(s);

(3) Reference(s) to any mammography standards, final mammography regulations, or excerpts from guidance documents that support the program’s position. Include copies of supporting documentation, such as a statement of whether the necessary documentation was made available for the inspector’s review at the time of the inspection, or the date it was provided to the FDA inspector.

(4) The memo and accompanying documents are to be sent to VHAMO. Once it is reviewed, the materials may be forwarded to FDA for review and comment. The program receives a reply in writing from VHAMO, affirming or reversing the cited findings of non-compliance(s). VHA apprises FDA of the final outcome of the review.

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APPENDIX C

MAMMOGRAPHY PROGRAM DOCUMENTS MANAGEMENT

1. RECORD KEEPING

A system for generation, retention, storage, and retrieval of all required mammography records must be maintained; this is to ensure that:

a. Records are completed according to instructions in the relevant SOPs or policies, which are derived from public law, Federal regulations, and VA policies.

b. Records are stored in a manner which maintains their integrity and which permits their retrieval within a reasonable time-frame as defined by the most stringent requirements of VA, FDA, or the accrediting body (see VA Records Control Schedule

(RCS) 10-1).

c. Records are retained for the required period(s) as defined by the most stringent requirements of VA, FDA, or the accrediting body (see RCS 10-1).

2. STANDARD OPERATING PROCEDURE (SOP) DOCUMENTS

a. A comprehensive SOP manual, developed by each mammography program, covering critical functions (technical, clerical, and administrative) performed by the program must be maintained.

b. The SOP documents must be current and must reflect the actual practices in the program.

c. Operator’s manuals, manufacturer’s package inserts, or textbook procedures may be used as a supplement to, or referenced by, the SOP. A copy of any literature referenced by the SOP must be physically present for review.

d. The SOP must be readily available to all mammography program staff.

e. Any deviation from SOP, and justification for such deviation, must be approved and documented by the LIP.

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APPENDIX D

MEDICAL PHYSICS SURVEYS

a. Every 12 months, but not more than 14 months from the previous survey, each mammography program must be surveyed by a mammography qualified medical physicist, or by someone in training under the qualified medical physicist’s direct supervision. The survey must comply with the requirements of 21 CFR 900.12(e) and be available to the program employee requesting the survey, Chief Radiologist, the LIP, and the mammography QC technologist within 30 days of the date of the survey.

b. The annual tests which are part of the survey must be performed using technical factors and test conditions as stated in the regulations, whenever those factors are specified. Otherwise, technical factors that are clinically used in the program must be utilized.

c. Problems with test performance, survey conduct, report content, and the like must be directed to the qualified medical physicist or Contracting Office, if contract medical physicist services are used.

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APPENDIX E

QUALITY ASSURANCE, QUALITY CONTROL, AND QUALITY ADMINISTRATION

PROGRAM

This appendix addresses quality assurance (QA), quality control (QC) activities, and the Quality Administration Program. Quality assurance activities can be subdivided into two major categories: QC procedures and Quality Administration procedures. The radiologist, medical physicist, and QC technologist, working together as a team, are the keys to providing optimum quality mammography images, which will ultimately provide the best medical care possible to the patient.

1. QUALITY ASSURANCE

a. QA in mammography is defined as those planned and systematic activities that monitor and improve the early detection of breast cancer and the evaluation of breast disease.

b. QA program content must meet VHA requirements; Performance Standards for Ionizing Radiation Emitting Products (21 CFR 1020.30, and 1020.31); Occupational Safety and Health Administration (OSHA)’s Blood Borne Pathogens Standard (29 CFR 1910.1030); and the national mammography requirements found in 21 CFR Part 900.

c. QA activities include the employment, training, continuing education, and continuing experience of qualified personnel.

2. QUALITY CONTROL PROCEDURES

a. QC includes the technical components of QA: equipment selection, equipment performance evaluation and routine equipment monitoring, technique factor selection, and evaluation of breast positioning and compression.

b. Performance of required QC tests must include clear and legible documentation.

The documentation must include test results and the dates when the tests were performed. For each test result that falls outside the action limits, the documentation must also include the date and the corrective actions taken and the results. Data results need to be properly charted or tabulated. NOTE: VA medical facilities may consult any appropriate QC manual for examples of charts and tables or establish their own format for documenting the test data and results, as long as they are consistent with the final regulations. Special attention needs to be given to the AB guidance manuals, manufacturers’ QC manual recommendations, and other approved documents concerning testing methodologies.

c. Documentation must be maintained between inspections. QC documentation must be securely retained for a minimum of two successive FDA annual inspections.

However, if QC records for a given test were found to be deficient and the program was cited during an annual inspection, these records must be kept until the all deficiencies are corrected and the records have been subsequently reviewed by the FDA inspector during three successive annual inspections.

APPENDIX E

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3. QUALITY ADMINISTRATION PROGRAM

a. Quality administration includes monitoring methods that assess interactions and communications between the mammography provider and the patient, and between the IP and the referring physician. It includes steps that assess the skills of the IP by comparing screening and diagnostic results with patient outcomes and other administrative monitors of clinical quality, such as: the evaluation of patient-staff interactions, reporting of abnormal results, report content, dictation timeliness, efforts to improve patient care tracking, and follow-up.

b. Infection Control and Program Cleanliness. All VHA mammography programs are required to have an Infection Control and Program Cleanliness policy and log.

(1) Comply with current VHA directives and other applicable standards related to infection control.

(2) Maintain the proper engineering controls, work practices, and the use of manufacturer recommended biological products in order to reduce the potential for spread of infectious microorganisms to patients, visitors and VA employees.

(3) Establish and follow a protocol for cleaning and disinfecting mammography equipment that has come in contact with blood, other body fluids, or potentially infectious materials consistent with 21 CFR 900.12(e)(13). NOTE: Additional guidance can be found in OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), obtained from facility infectious disease staff, and the mammography equipment manufacturer's specified disinfection procedures.

(4) Have written documentation that shows the steps the program takes for cleaning and disinfecting mammography equipment after contact with blood and other potentially infectious materials. If reference material is cited in the program’s description of its procedures, such as manufacturer’s requirements, the program must have a copy of the referenced material available.

(5) Have documentation (e.g., logs or charts) that indicate the infection control procedures were performed when the mammography equipment came into contact with blood or other potentially infectious materials; this documentation must be kept and available for posting and review. In those cases, where there has not been an episode of contamination, the documentation is to clearly show that fact for FDA inspector reference.

c. Image Viewing Considerations.

(1) Mammography programs, where screen-film mammograms are interpreted or reviewed for comparison must establish, document, and follow adequate protocols for darkroom, screen and viewbox cleanliness, and viewing conditions consistent with 21 CFR 900.12(e)(11). NOTE: Examples of protocols may be found in documents by the AB, in FDA guidance, and specific recommendations by the equipment manufacturer.

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Acceptable documentation would be written procedures for performing the corresponding cleaning activities with records showing that each was conducted at the designated frequency, and was followed, when needed, by the appropriate corrective actions.

(2) The program must provide both hot lights and masking devices to the IPs. Any device that blocks light not required for viewing and interpretation of the image must meet the masking requirement. NOTE: Although not specifically required, it is recommended that hot lights and masking devices be available for technologists to aid in their evaluation of clinical and quality control films.

(3) If a separate view box is used by the LMQC technologist to check the optical density and quality of the mammography films, this viewbox needs to be similar to the reading viewbox in luminance and color of the light; in addition, it needs to be used with ambient lighting conditions similar to those in the room where the mammograms are interpreted.

d. Digital Monitors and Display Stations.

(1) Only digital monitors and display stations specifically approved or cleared for full field digital mammography (FFDM) use by FDA’s Office of Device Evaluation are used by VHA programs in the interpretation of mammograms. Monitors used by the program with its FFDM system need to ensure compliance with a QA program that is substantially the same as that recommended by the FFDM manufacturer. NOTE: VA medical facilities have the option to submit images electronically to the ACR.

(2) Each digital and hardcopy mammographic films used for final interpretation must be labeled as required by 21 CFR 900.12(c)(5). Each image must have a permanent ID label containing at least: the VA medical facility name, city, state, and ZIP code; the patient’s first and last name; and an additional patient identifier; the date of the examination; view and laterality placed on the image near the axilla; technologist identification; cassette identification (CR only); and mammography unit identification.

e. Medical Outcomes Audit

(1) A comprehensive mammography quality assessment program evaluates equipment, image quality, and image processing, and also evaluates the appropriateness and accuracy of image interpretation. Aggregate medical outcome audit data provide a picture of how the program is detecting breast cancer among its patients. Individual analyses are important to identify IPs whose outcomes are very different from the aggregate. The intent of mammography medical audit outcomes tracking is for IP quality improvement. It is not to ensure the patient’s ordering practitioner is addressing continuing follow-up and treatment based on the communicated results.

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(2) Each mammography program must have established a system, consistent with 21 CFR 900.12(f), to collect and review mammogram interpretation outcome data, to track positive mammograms, and to correlate the findings with biopsy results.

(3) The mammography medical audit system must be able to document the identification of the Audit IP(s).

(a) A definition of “positive mammograms” requiring follow-up. NOTE: Positive mammograms are defined by FDA as those with a final assessment category of “Suspicious” or “Highly Suggestive of Malignancy.”

(b) A method established by the…