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1 Process Risk Assessment Tumor Site: Breast Process Presence or Risk absence Assessment of cancer in first-degree blood relatives documented in patients with invasive breast Presence cancer or absence of cancer in first-degree blood relatives documented in patients with invasive breast cancer Presence or absence of cancer in second-degree blood relatives documented in patients with invasive Presence breast cancer or absence of cancer in second-degree blood relatives documented in patients with invasive breast cancer Age at diagnosis documented for each blood relative diagnosed with cancer Age at diagnosis documented for each blood relative diagnosed with cancer Genetic testing for patients with invasive breast cancer and high hereditary risk Genetic testing for patients with invasive breast cancer and high hereditary risk Process Appropriateness of Care Process Needle biopsy Appropriateness rate of Care Needle biopsy rate Sentinel node biopsy utilization Sentinel node biopsy utilization Sentinel node biopsy: utilization, DCIS Sentinel node biopsy: utilization, DCIS Sentinel node biopsy: false negative rate Sentinel node biopsy: false negative rate Breast conservation surgery rate Breast conservation surgery rate Post breast conserving surgery radiation Post breast conserving surgery radiation Post-mastectomy radiation therapy considered or Post-mastectomy administered if >4 radiation positive lymph therapy nodes considered or administered if >4 positive lymph nodes Percent of patients with invasive breast cancer for whom presence Percent or absence of patients of cancer with in invasive firstdegree cancer relative for was whom documented presence breast or absence of cancer in firstdegree Percent relative of patients was with documented invasive breast cancer for whom presence Percent or absence of patients of cancer with in invasive seconddegree cancer relative for was whom documented presence breast or absence of cancer in seconddegree Percent relative of patients was with documented invasive breast cancer for whom age at Percent diagnosis of of patients blood relative with invasive with breast cancer cancer was documented for whom age at diagnosis of blood relative with cancer Percent was of eligible documented patients with invasive breast cancer referred for Percent genetic testing, of eligible or patients received with invasive genetic testing breast (see cancer USPSTF referred for genetic guidelines testing, for definition or received of highrisk 4 ) testing (see USPSTF genetic guidelines for definition of highrisk 4 ) stereotactic or needle biopsy stereotactic or needle biopsy Percent of eligible breast cancer Percent patients of undergoing eligible breast sentinel cancer node patients biopsy undergoing sentinel node biopsy Percent of DCIS patients receiving Percent mastectomy of DCIS who patients also undergo receiving mastectomy sentinel node who biopsy also undergo sentinel node biopsy Percent of patients undergoing Percent sentinel of node patients biopsy undergoing with negative sentinel initial result node and biopsy either with positive negative initial result result on full and pathology either positive or result recurrence on full 18 pathology or recurrence 18 Percent lumpectomy of patients or partial receiving mastectomy lumpectomy rather than total or partial (simple), mastectomy modified rather radical, than or radical total (simple), mastectomy modified radical, or radical mastectomy Percent of patients <70 years of Percent age who of underwent patients <70 breast years of age conserving who underwent surgery and breast received conserving radiation therapy surgery within and 1 received year radiation (365 days) therapy of date within of diagnosis 1 year (365 days) of date of diagnosis Percent of patients undergoing Percent mastectomy of patients for breast undergoing cancer with mastectomy four or more for positive breast lymph cancer nodes with four for whom or more radiation positive therapy lymph was nodes for considered whom radiation or administered therapy was considered or administered Average: 0.4% of all women are at high-risk 5, 5%-10% of Average: all breast 0.4% cancer of are all women due to are BRCA1/2 at high-risk mutations 5, 5%-10% 6 ; Ideal of all Benchmark: breast cancer 100% are of due to BRCA1/2 patients who mutations are 6 high-risk ; Ideal Benchmark: for hereditary 100% breast of cancer 7 patients who are at high-risk for hereditary breast cancer 7 Average: 90% 10 ; NQF Recommendation: Average: 90% 10 ; Needle biopsy should NQF Recommendation: precede surgical Needle biopsy should excision/resection precede surgical 11 excision/resection Ideal benchmark: % of Ideal T1-T2 benchmark: invasive breast 100% of T1-T2 cancer invasive (not recommended breast cancer for advanced (not recommended invasive for breast advanced cancer) invasive 14 breast cancer) Ideal benchmark: % Ideal when benchmark: mastectomy 100% is when planned mastectomy 16 is planned 16 Average false negative Average rates: single false SLN negative removed rates: 4.3%, single multiple SLN SLNs removed 4.3%, removed multiple 14.3% SLNs 19 ; Best removed observed: 0.21% 14.3% ; Best observed: 0.21% 20 National Cancer Database National Average: Cancer 53% 21, Database Highest Average: observed: 53% 75% 21, in Highest observed: Massachusetts 75% 22 in ; NAPBC Massachusetts Ideal Benchmark: 22 ; NAPBC >50% Ideal Benchmark: >50% National Cancer Database National Average: Cancer 72% 25 ; Database Average: ACoS/CoC 72% CP3R 25 ; Required ACoS/CoC Performance CP3R Rate: Required >90% 26 Performance Rate: >90% 26 as Ideal per ASCO Benchmark: guidelines 100% as per ASCO guidelines Measure 1 Measure 1 Measure 2 Measure 2 Measure 3 Measure 3 ACoS/CoC 8, QOPI 9 ACoS/CoC 8, QOPI 9 NAPBC, 12, NQF #0221 NAPBC, 13, 12, PCHQR Core NQF # Set, PCHQR Core Set ASCO 15, NAPBC, ASCO PQRS 15, NAPBC, PQRS (Proposed) (Proposed) ASCO 17 ASCO 17 ACoS 23, NCCN 24, ACoS NAPBC 23, NCCN 24, NAPBC ACoS/CoC 27 ACoS/CoC ASCO 28, NAPBC, 27 ASCO NCCN, 28 NQF, NAPBC, NCCN, # NQF # NAPBC 30, NAPBC ASCO 31 30, ASCO 31 5

2 Process Appropriateness of Care Combination chemotherapy for hormone receptor negative breast cancer Percent of women <70 years of age with AJCC T1c or Stage II or III hormone receptor (ER/PgR) negative breast cancer where combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis. ACoS/CoC CP3R Required Performance Rate: >90%, Ideal Benchmark:100% ASCO/QOPI 32, ACoS/CoC/RQR S, AMA-PCPI, NAPBC, NQF # , PCHQR Tamoxifen or third generation aromotase for hormone receptor positive breast cancer Percent of women over 18 with AJCC T1cN0M0, or Stage II or III hormone receptor (ER/PgR) positive breast cancer where adjuvant hormonal therapy (Tamoxifen or third generation aromatase inhibitor) is considered or administered within 1 year (365 days) of diagnosis. ACoS/CoC CP3R Required Performance Rate: >90%, Ideal Benchmark:100% ASCO/QOPI 34, ACoS/CoC/RQR S, AMA-PCPI 35, NAPBC, NQF # , # , PCHQR IV bisphosphonates or denosumab administered for breast cancer bone metastases Percent of patients with breast cancer bone metastases who receive IV bisphosphonates or denosumab of eligible patients as per ASCO Clinical Practice Guidelines 38 ASCO/QOPI Measure 39, NCCN ER/PgR measurement Percent of breast cancer patients (including newly diagnosed patients and patients with local/distant recurrence) assayed for ER and PgR receptor status on surgical pathology specimen of newly diagnosed cases, repeat testing in 100% of cases with local or distant recurrence as per Joint ASCO/CAP Guideline 40 ASCO/QOPI, CAP 41, NAPBC Renal function assessed prior to the first administration of IV bisphosphonates or denosumab Percent of patients with renal function assessment prior to first administration of IV bisphosphonates or denosumab Ideal benchmark: 100% of eligible patients as per ASCO Clinical Practice Guidelines 42 ASCO/QOPI Measure 43 Mammography call-back rate Percent of patients called back for follow-up studies due to abnormal findings NCCN: 5-15% 44 HER2/neu measurement Percent of breast cancer patients (including newly diagnosed patients and patients with local/distant recurrence) tested for HER2/neu overexpression or gene amplification Benchmark: 100% as per Joint ASCO/CAP Guideline 45 ASCO/QOPI 46, CAP, NAPBC Process Timeliness of Care Time to diagnostic mammogram Time from reporting of abnormal screening mammogram results to completion of diagnostic mammogram Average: 6.5 working days 47, Best observed at organization: Diagnostic mammogram same day as abnormal screening mammogram 48 ; Ideal Benchmark: fewer than 7 calendar days 6

3 Process Timeliness of Care Time to needle biopsy Time from diagnostic mammogram to needle biopsy Average: 6.0 days 49, Best observed: same day 50 ; Ideal Benchmark: fewer than 7 calendar days Time to surgical biopsy Time from diagnostic mammogram to surgical biopsy Average: 13.9 days 51 Pathology turnaround time: biopsy Time from biopsy to reporting of pathology results Average: 2-4 days 52, Best observed: same day 53 Time to initial cancer surgery Time from needle biopsy to initial cancer surgery Average: 14.0 days 54 Pathology turnaround time: surgery Time from surgery to reporting of pathology results Average: 2.0 days, Best observed: same day 55 Process Patient-Centered Care Patient satisfaction: cosmetic Percent of patients satisfied with general results of breast reconstruction Best observed patient general satisfaction for implant: 61% 56, TRAM flap reconstruction: 78% 57, DIEP reconstruction: 90% 58 Pre-test genetic counseling Percent of patients referred for genetic testing who also receive pre-test genetic counseling as per ACoS/CoC 2012 Standards 59 ACoS/CoC 60 Post-test genetic counseling genetic testing who also receive post-test genetic counseling as per ACoS/CoC 2012 Standards 61 ACoS/CoC 62, QOPI 63 Process Documentation Completeness Pathology report completeness Percent of pathology reports containing all data elements specified by CAP surgical case summary (important: ensure cancer stage documentation) Average: 100% of pathology reports complete 64, CAP Quality Probe average: 64.7% of pathology reports complete 65 ; ACoS/CoC Requirement: 90% of pathology reports include required data elements as per CAP protocol 66, Ideal benchmark: 100%, QOPI 67, CAP Outcome Survival rate Five-year survival rate by stage at diagnosis All stages - 89% Localized 98.4% Regional 83.4% Distant 23.8% Unstaged 50.7% In situ 100% 68 Flap complications breast reconstruction with flap (TRAM, DIEP) experiencing complications Overall flap complication rate: ~28% with 21% minor complications and 8% major complications including 0.5% total flap loss 69 ; Ideal Benchmark: overall flap complication rate <10%, total flap loss 0% ASCO/QOPI 70 7

4 Outcome Chemotherapy complications resulting in inpatient stay Chemotherapy complications resulting in ED visit Number of chemotherapy complications resulting in inpatient stay per patient per year OR Percent of breast cancer patient inpatient stay related to chemotherapy Number of chemotherapy complications resulting in ED visit per patient per year OR Percent of breast cancer patient ED visit related to chemotherapy National Average: 0.2 chemotherapy-related admissions per breast cancer patient per year, 40% of all breast cancer patient admissions were chemotherapy-related admissions 71 National Average: 0.55 chemotherapy-related ED visits per breast cancer patient per year, 42% of all breast cancer patient ED visits are chemotherapyrelated 72 8

5 Sources 1-3,9,32,39,46,63,67,70. American Society of Clinical Oncology, Quality oncology practice initiative: Summary of measures, Spring 2012, available at: last accessed: August U.S. Preventive Services Task Force, Genetic risk assessment and BRCA mutation testing for breast and ovarian cancer susceptibility, available at: last accessed: June Alexander FE, et al., "Familial breast cancer: Collaborative reanalysis of individual data from 52 epidemiological studies including 58,209 women with breast cancer and 101,986 women without the disease," Lancet, 2001, 358(9291): Campeau P, "Hereditary breast cancer: new genetic developments, new therapeutic avenues," Human Genetics, 2008, 124(1): ,8,23,26,27,59-62,66. American College of Surgeons, Cancer program standards 2012: Ensuring patient-centered care, 2011, available at: last accessed: August ,12. Kaufman CS, et al., "National quality measures for breast centers (NQMBC): A robust quality tool: Breast center quality measures, Annals of Surgical Oncology, 2010, 17(2): ,13. National Quality Forum, NQF Endorsed Measure #0221, Needle biopsy to establish diagnosis of cancer precedes surgical excision/resection, available at: last accessed: June ,15,17. Lyman GH, et al., "American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer, Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 2005, 23(30): Cox CE, et al., "Importance of lymphatic mapping in ductal carcinoma in situ (DCIS): why map DCIS?" The American Surgeon, 2001, 67(6):513-9; Pendas S, et al., "Sentinel node biopsy in ductal carcinoma in situ patients," Annals of Surgical Oncology, 2000, 7(1):15-20; Jakub JW, et al., Current status of sentinel lymph node mapping and biopsy: Facts and controversies, The Oncologist, 2003, 8: Martin RC et al., "Clinicopathologic factors associated with falsenegative sentinel lymph-node biopsy in breast cancer, Annals of Surgery, 2005, 241(6): Wong SL, et al., "Sentinel lymph node biopsy for breast cancer: Impact of the number of sentinel nodes removed on the false-negative rate, Journal of the American College of Surgeons, 2001, 192(6): Cox CE, et al., Guidelines for sentinel node biopsy and lymphatic mapping of patients with breast cancer, Annals of Surgery, 1998, 227(5): ,25. National Cancer Database (NCDB) Benchmark Reports, NCDB Analytic Cases: Diagnosis Year 2009, Partial mastectomy, Less Than Total Mastectomy, United States, available at: Guadagnoli E, et al., "Use of breast-conserving surgery for treatment of stage I and stage II breast cancer," Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 1998, 16(1): ,28. ASCO/NCCN Quality measures: Breast and colorectal cancers, Alexandria (VA): American Society of Clinical Oncology, National Comprehensive Cancer Network, Inc, National Quality Forum, NQF Endorsed Measure #0219, Post breast conserving surgery irradiation, available at: last accessed: June National Accreditation Program for Breast Centers, 2012 Breast cancer standards manual, 2012, available at: last accessed: August, Recht A, et al., "Postmastectomy radiotherapy: clinical practice guidelines of the American Society of Clinical Oncology, Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 2001, 19(5): National Quality Forum, NQF Endorsed Measure #0559, Combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1c, or Stage II or III hormone receptor negative breast cancer, available at: last accessed: June American Society of Clinical Oncology, Quality oncology practice initiative: Summary of measures, Spring 2012, available at: last accessed: August 2012; Winer EP, et al., "American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer: Status report 2004," Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 2005, 23(3): American Society for Therapeutic Radiology and Oncology, American Society of Clinical Oncology, Physician consortium for performance improvement: Oncology physician performance measurement set, Chicago, IL, American Medical Association, National Quality Forum, NQF Endorsed Measure #0220, Adjuvant hormonal therapy, available at: last accessed: June National Quality Forum, NQF Endorsed Measure #0387, Oncology: Hormonal therapy for stage IC through IIIC, ER/PR positive breast cancer, available at: last accessed: August ,42,43. Van Poznak CH, et al., "American Society of Clinical Oncology clinical practice guideline update: Recommendations on the role of bonemodifying agents in metastatic breast cancer, Journal of Oncology Practice, 2011, 7(2):

6 Sources 40,41. Hammond MEH, et al., "American society of clinical oncology/college of American pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version)," Archives of Pathology and Laboratory Medicine, 2010, 134(7):e48-e National Community Cancer Network, Repeat mammography: An Unwelcome Callback, 2012, available at: 4:repeat-mammography&catid=56, last accessed: August, Wolff AC, et al., "American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer," Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology, 2007, 25(1): Mehrara BJ, et al., Complications after microvascular breast reconstruction: Experience with 1195 flaps, Plastic and Reconstructive Surgery, 2006, 118(5): ,72. Kolodziej M, et al., "Benchmarks for value in cancer care: An analysis of a large commercial population, Journal of Oncology Practice, 2011, 7(5): ; Cancer patients receiving chemotherapy: Opportunities for better management, Milliman Client Report, 2012, available at: last accessed August ,48,50,51,54,55,64. Kaufman CS, et al., "National quality measures for breast centers (NQMBC): A robust quality tool: Breast center quality measures," Annals of Surgical Oncology, 2010, 17(2): Gundersen Lutheran Health System, Transforming Healthcare: Breast Cancer Care, John s Hopkins Oncology Center, Breast Health management, Inc., 2009, available at: last accessed August Zarbo RJ, et al., "Intralaboratory timeliness of surgical pathology reports: Results of two College of American Pathologists Q-Probes studies of biopsies and complex specimens," Archives of Pathology & Laboratory Medicine, 1996, 120(3):234-44; Novis DA, et al., "Interinstitutional comparison of surgical biopsy diagnosis turnaround time: A College of American Pathologists Q-Probes study of 5384 surgical biopsies in 157 small hospitals," Archives of Pathology & Laboratory Medicine, 1998, 122(11):951-6; Price CP, et al., "Benchmarking in laboratory medicine: Are we measuring the right outcomes? Benchmarking: An International Journal, 2005, 12(5): Morales AR, et al., "Rapid-response, molecular-friendly surgical pathology: A radical departure from the century-old routine practice," Journal of the American College of Surgeons, 2008, 207(3): ,57. University of Michigan Health System Department of Surgery, "Michigan breast reconstruction outcome study results," 2000, available at: ml, last accessed: August Damen THC, et al., "High satisfaction rates in women after DIEP flap breast reconstruction," Journal of Plastic, Reconstructive & Aesthetic Surgery, 2010, 63(1): Idowu MO, et al., "Adequacy of surgical pathology reporting of cancer: A college of American pathologists q-probes study of 86 institutions," Archives of Pathology and Laboratory Medicine, 2012, 134(7): Howlader N, et al., SEER cancer statistics review, (Vintage 2009 Populations), Bethesda (MD): National Cancer Institute, 2012, available at: last accessed: June

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