Mammography Outcomes Audit D U K E E L D R I D G E, M. S. M E D I C A L P H Y S I C I S T

Mammography Outcomes Audit D U K E E L D R I D G E, M. S. M E D I C A L P H Y S I C I S T

Mammography Medical Outcomes Audit An audit is required by MQSA The ultimate QC test Outcomes

The Current Law Quality assurance-mammography medical outcomes audit. Each facility shall establish and maintain a mammography medical outcomes audit program to follow-up positive mammographic assessments and to correlate pathology results with the interpreting physician's findings. This program shall be designed to ensure the reliability, clarity, and accuracy of the interpretation of mammograms. (1) General requirements. Each facility shall establish a system to collect and review outcome data for all mammograms performed, including follow-up 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 follow-up on surgical and/or pathology results and review of the mammograms taken prior to the diagnosis of a malignancy.

The current Law (2) Frequency of audit analysis. The facility's first audit analysis shall be initiated no later than 12 months after the date the facility becomes certified, or 12 months after April 28, 1999, whichever date is the latest. This audit analysis shall be completed within an additional 12 months to permit completion of diagnostic procedures and data collection. Subsequent audit analyses will be conducted at least once every 12 months. (3) Reviewing interpreting physician. Each facility shall designate at least one interpreting physician to review the medical outcomes audit data at least once every 12 months. This individual shall record the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results, notifying other interpreting physicians of their results and the facility aggregate results. If follow-up actions are taken, the reviewing interpreting physician shall also be responsible for documenting the nature of the follow-up.

You have to answer these questions Current FDA Inspector s Audit Questions

Basic Audit Elements The basic elements of a mammography medical audit system: (1) definition of positive mammograms requiring follow-up, (2) a method to follow-up positive mammograms (3) a system to attempt to collect pathology results for all biopsies performed, (4) methods to correlate pathology results with the final assessment category indicated by the interpreting physicians, (5) a method to include any cases of breast cancer among patients imaged at the facility that subsequently became known to the facclity, and (6) review of medical outcomes audit data for the aggregate of interpreting physicians as well as each individual interpreting physician at least once every 12 months.

PGHS

PGHS Subtopics

FDA Guidance for MMOA

KansasRadiationPhysics.com

1994 DHS Publication 12 Lawrence W. Bassett, M.D(Co-chair) E. Edward Hendrick, PhD(Co-chair) Tamsen L. Bassford, MD Priscilla F. Butler,MS Darryl Carter,MD Marydale DeBor, JD Carl J. D Orsi, MD Carol J. Garlinghouse, MSN, RNC Richard F. Jones III, MD Amy S. Langer, MBA J. Leonard Lichtenfeld, MD Janet R. Osuch, MD Lynda N. Reynolds, BS,RT Ellen Shaw de Paredes, MD Richard E. Williams, MD D. Eldridge, M.S. US Dept of Health and Human Services Public Health Service Agency for Health Care Policy and Research Rockville, Maryland AHCPR Publication No. 95-0632 October 1994

1994 Clinical Determinants

MMOA Results at selected sites

2013 BIRADS 5 TH Edition

Bi-Rads 5 th Edition, 2013

BIRADS

Mammography Medical Outcomes Audit Lead Interpreting Physician:, M.D. has the general responsibility of ensuring that the quality assurance program meets all the FDA requirements. No individual shall be assigned or shall retain responsibility for quality assurance tasks unless the lead interpreting physician has determined that the individual s qualifications for, and performance of, the assignment are adequate. Audit Interpreting Physician:, M.D. will review the medical outcomes audit data at least once every 12 months, recording the dates of the audit period(s) and shall be responsible for analyzing results based on this audit. This individual shall also be responsible for documenting the results, notifying other interpreting physicians of their results and the facility aggregate results. If follow-up actions are taken, the reviewing interpreting physician shall also be responsible for documenting the nature of the follow-up. Interpreting Physicians:, M.D., M.D., M.D., M.D., M.D., M.D. All interpreting physicians must follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality. They must all participate in the facility's medical outcomes audit program. QC Technologist:, R.T.(M) is responsible for all individual tasks within the quality assurance program not assigned to the lead interpreting physician or the medical physicist. The tasks are to be performed by the quality control technologist or by other personnel qualified to perform the tasks. When other personnel are utilized for these tasks, the quality control technologist shall ensure that the tasks are completed in such a way as to meet the FDA requirements. MMOA Outcomes/Recall:, R.T.(M) will assist the Lead Interpreting Physician with tasks pertaining to the keeping of totals for all positive readings on patients and for patients who were initially read as negative but were later found out to have pathology(false Negatives). Patients will be tracked until all follow-up is completed and documented as required by the MQSA. Medical Physicist:, M.S., will perform the mammography equipment survey and oversee the equipment-related quality assurance practices of the facility. At a minimum, the medical physicist shall be responsible for performing the surveys and mammography equipment evaluations and providing the facility with the reports as required within 1 month after the survey.

Category 0 Categories 1 & 2 "Negative" or "Benign" A CANCER within 1 Year A+... Transferred to Another Facility for Work-up & Audit Purposes B "Additional Imaging Required" Utilize Orig. Flow Sheet, Adding "O" Before Each Class e.g. OA, OS+, etc. Follow-up Unavailable C Screening Algorithm Follow-up Result: Category 1 or 2 D Follow-up Result: Continue to Follow as Cat. 3 E Category 3 "Probably Benign" Additional Follow-up Recommended Follow-up Result: Category 4 or 5 Biopsy Recommended Transfer to Another Facility for Work-up & Audit Purposes F Follow-up Unavailable G Category 6, Categories 4A, 4B, & 4C: CANCER within 1 Year D+... Biopsy Recommended, but not Done H Core Biopsy Follow-up Unavailable I Surgical Biopsy The 2003 ACR BI-RADS reporting system has a new Category 6 for known biopsy-proven malignancy, with no therapy undergone by the patient. This was added so that screening patients already known to have cancer would not skew detection rates. The ACR has also added subcategories for Category 4: 4A, 4B, and 4C to encourage pathologists to initiate further evaluation of benign results and should allow clinicians to better understand follow-up recommendations after biopsy for findings placed in Category 4 subsets. Some other nomenclature changes have been made. Biopsy Recommended, but not Done P CANCER within 1 Year P+... Follow-up in 3-6 Months SF CANCER within 1 Year H+... Benign S Return Follow-up in 3-6 months JF Core Biopsy CANCER within 1 Year S+... Benign J CANCER T... CANCER within 1 Year J+... CANCER K... Categories 4 & 5 "Suspicious or Highly Suggestive of Malignancy" Biopsy Recommended Benign U CANCER within 1 Year U+... Surgical Biopsy Benign L CANCER within 1 Year L+... CANCER V... CANCER M... Follow-up Unavailable R D. Eldridge, M.S. 19

Mammography Medical Outcomes Audit Must follow all patients who end up being classified as Category 4 or 5.

Manually following biopsies

Patient Name: I.D.#: (Last) (First) (Middle) Address: P hone#: Primary Physician: Office #: Date of positive mammogram: Dates of prior mammograms: Done by: R.T.(M) Patient information, history, and other information attached. Read by: M.D. on (date) Mammography Reports attached? Initial Reading Category: 0, 1, 2, 3, 4,or 5 Additional interpretive comments: Details of Follow-up (U=Ultrasound, S=Surgical consult, B=Biopsy, C(months)=Clinical Follow-up Exam) Patient Name: I.D.#: (Last) (First) (Middle) C. Date: Type Follow-up: Done by: M.D. Results: Future Follow-up: Date: Recorded by: Details of Follow-up (U=Ultrasound, S=Surgical consult, B=Radiological Biopsy, C(months)=Clinical Exam, X=eXtra views) A. Date: Type Follow-up: Done by: M.D. Results: Future Follow-up: Date: Recorded by: B. Date: Type Follow-up: Done by: M.D. D. Eldridge, M.S. 22 Results: D. Date: Type Follow-up: Done by: M.D. Results: Future Follow-up: Date: Recorded by: E. Date: Type Follow-up: Done by: M.D. Results: Future Follow-up: Date: Recorded by:

Mammography Medical Outcomes Audit # Screenings/year: # Biopsies Recommended: # Biopsies Done: # Cancers Found: Cancer Stage when found:

Mammography Medical Outcomes Audit # Screenings: 6408 # Biopsies Recommended: 190 # Biopsies Done: 164 # Cancers Found: 25

Mammography Medical Outcomes Audit Biopsy Completion Rate (85%): 86.3% Biopsies Rec./1000 patients(32): 29.7 Cancers found/1000 patients(6): 3.9

Mammography Medical Outcomes Audit Disease + Disease - Test + True Positive False Positive Test - False Negative True Negative

Mammography Medical Outcomes Audit Disease + Disease - Categories 4, 5, 0+,3+ True Positive False Positive Categories 1,2,3, & 0 False Negative True Negative

True Positives (TP). Cancer diagnosed within 1 year after biopsy recommendation based on abnormal mammogram. *True Negative (TN). No known cancer diagnosed within 1 year of normal mammogram. *False Negative (FN). Cancer diagnosed within 1 year of a normal mammogram. Although other definitions of false negative exist, this definition is the most widely applied. *False Positive (FP). Benign disease found at biopsy within 1 year after an abnormal mammogram and recommendation for biopsy or surgical consultation. D. Eldridge, M.S. 28

*Sensitivity. The probability of detecting a cancer when a cancer exists, or the percentage of all patients found to have breast cancer within 1 year of screening who were correctly diagnosed at the screening session. Sensitivity = TP/(TP+FN) 85-90% *Specificity. The probability of a normal mammogram report when no cancer exists, or the percentage of all patients not found to have breast cancer within 1 year of screening who were correctly identified as normal at the time of screening. Specificity = TN/(FP+TN). D. Eldridge, M.S. 29

Disease + Disease - Categories 4, 5, 0+,3+ True Positive False Positive Categories 1,2,3, & 0 False Negative True Negative Sensitivity=TP/(TP+FN) Specificity=TN/(FP+TN) D. Eldridge, M.S. 30

Magview

Mammography Medical Outcomes Audit

Mammography Medical Outcomes Audit Analyzing Biopsy Data

Mammography Medical Outcomes Audit Positive predictive value (PPV). Three definitions may be applied, depending on the practice conditions.

*PPV 1 (Abnormal Reading). The percentage of all screening mammography cases that result in a diagnosis of cancer based on abnormal screening examination. PPV 1 = TP/(number of abnormal screening exams), or PPV 1 = TP/(TP+FP 1 ). *PPV 2 (Biopsy recommended). The percentage of all screening mammography cases that result in a diagnosis of cancer based on a recommendation of consideration for biopsy. PPV 2 = TP/(# of cases recommended for biopsy after abnormal screening exams), or PPV 2 = TP/(TP+FP 2 ). *PPV 3 (Biopsy done). The percentage of all screening mammography cases that result in a diagnosis of cancer based on biopsies performed. This is also known as the biopsy yield of malignancy, or the positive biopsy rate. PPV 3 = TP/(number of biopsies), or PPV 3 = TP/(TP+FP 3 ). D. Eldridge, M.S. 35

Staging Cancers AJCC Staging of Breast Cancers... T... N... M... is difficult w/o a mandatory regional tumor registry.

American Joint Committee On Cancer (AJCC) Staging of Breast Cancer revised: 1/1/03 D. Eldridge, M.S. 37 Stage 0 Tis N0 M0 Stage 1 T1 N0 M0 Stage IIA T0 N1 M0 T1 N1 M0 T2 N0 M0 Stage IIB T2 N1 M0 T3 N0 M0 Stage IIIAT0 N2 M0 T1 N2 M0 T2 N2 M0 T3 N1 M0 T3 N2 M0 Stage IIIBT4 N0 M0 T4 N1 M0 T4 N2 M0 Stage IIICAny T N3 M0 Stage IV Any T Any N M1

Tumor T0: No evidence of primary tumor Tis: Carcinoma in situ T1: Tumor > 2 cm T2: 2 cm < Tumor < 5 cm T3: Tumor > 5 cm T4: Tumor (any size) extending to Chest wall or Skin Also: TX, Tis(CDIS), Tis(LCIS), Tis(Paget s), T1mic, T1a, T1b, T1c, T4a, T4, T4c, T4d Metastasis MX: Distant metastasis cannot be assessed M0: No distant metastasis M1: Distant metastasis Lymph Nodes N0: No regional lymph node metastases N1: Mets to ipsilateral axillary lymph nodes fixed or matted, or in clinically apparent ipsilateral internal mammography nodes in the absence of clinically evident axillary lymph node metastasis N3: Mets in ipsilateral infraclaviculary lymph node(s) with or without axillary lymph node involvement, or in clinically apparent ipsilateral internal mammary lymph node(s) and in the presence of clinically evident axillary lymph node mets; or mets in ipsilateral SCLNs with or without axillary or internal mammary lymph node involvement; Also: NX, N2a, N2b, N3a, N3b, N3cpNX, pn0, PN0(I-), PN0(I+), PN0(mol-), PN0(mol+), PN1, PN1mi, PN1a, PN1b, PN1c, pn2, pn2a, pn2b,pn3, pn3a, pn3b, pn3c D. Eldridge, M.S. 38

In Situ Carcinomas NOS (not otherwise specified) Intraductal Paget s disease and intraductal Invasive Carcinomas NOS (not otherwise specified) Ductal Inflammatory Medullary, NOS Medullary with lymhoid stroma Mucinous Papillary Tubular Lobular Paget s disease and infiltrating Undifferentiated Squamous cell Adenoid cystic Secretory Cribriform D. Eldridge, M.S. 39

EZ Staging

EZ Staging

Breast Cancer MamtreeTM Malignant Code DCIS Invasive Ca Ductal/Lobular < 1 cm. > 1 cm. < 1 cm. > 1 cm. - Nodes Ca1 + Nodes Ca2 Nodes not sampled Ca3 - Nodes Ca4 + Nodes Ca5 Nodes not sampled Ca6 - Nodes Ca7 + Nodes Ca8 Nodes not sampled Ca9 - Nodes Ca10 + Nodes Ca11 Nodes not sampled Ca12 Patient # Initial Category Malignancy Code Comments 1 0,1,2,3,4,5 2 0,1,2,3,4,5 3 0,1,2,3,4,5 4 0,1,2,3,4,5 5 0,1,2,3,4,5 6 0,1,2,3,4,5 7 0,1,2,3,4,5 8 0,1,2,3,4,5 9 0,1,2,3,4,5 10 0,1,2,3,4,5 11 0,1,2,3,4,5 12 0,1,2,3,4,5 D. Eldridge, M.S. 42

Mammography View Abbreviations

Assessment Category Meanings

http://breastscreening.cancer.gov/statistics/ben chmarks/screening/

Cancer Detection Rate/Age

2009 BCSC Benchmarks Cancer Detection Rate: 4.7/1000 Median size of invasive Ca: 14.0 mm % Node-negative of invasive Ca: 77.3% % Minimal Ca: 52.6% Abnormal Recall Rate: 10.6% PPV1 (abnormal interpretation): 4.4% PPV2 (rec. for tissue diagnosis): 25.4% PPV3 (biopsy performed): 31.0% Sensitivity: 79.0% Specificity: 89.8%

Large Facility

What does the Lead Radiologist Want? However, before a complete audit system can be implemented, patient confidentiality and protection of medical audit information from discovery must be insured. Current State peer review statutes protecting peer review activities, such as collection of medical audit data, apply to inpatient facilities. In many States, there is virtually no protection from discovery of quality assurance activities in ambulatory and outpatient settings, where most mammography facilities function.

Mammography Medical Outcomes Audit MAMMOGRAPHY We are performing a complex imaging procedure, Mammograms are difficult to interpret, but Patient follow-up might be the toughest part.

Mammography Medical Outcomes Audit FOLLOW-UP The mammography medical audit is a systematic collection and analysis of mammography results, which are compared with outcomes data. The result should help ensure quality mammography is done.

Mammography Medical Outcomes Audit The MMOA relates technical and interpretive aspects of mammography performance to outcomes.

Mammography Medical Outcomes Audit If done correctly, the audit will help.

Most Importantly Don t lose a patient who has been recommended for biopsy. Do the best you can.

The End Thank you! Duke Eldridge, M.S. KansasRadiationPhysics.com