[1984] Results of a Quality Assurance Program for Needle Core Breast Biopsies

Scott J Kantola, Natalie S Campbell, Gary L Keeney, Daniel W Visscher, Roberto G Gamez. Mayo Clinic, Rochester, MN

Background: The diagnostic accuracy of needle core breast biopsy is unknown and methods for determining accuracy and quality assurance (QA) have not been well developed.
Design: Daily review of breast core biopsies was performed within 24 hours of sign-out, by a breast pathologist who was blinded to the initial diagnosis. The study period was 45 months. Disagreements were classified as major (MA) or minor (MI) depending on potential for clinical impact as discussed with treating physicians. All major disagreements were arbitrated by a third pathologist. Pathology reports were amended as necessary. Chart review was done continuously to determine clinical follow up and open excision diagnosis (DX).
Results: Of the 2538 cases reviewed, 53 (2.1%) had a MA and 159 had a (6.3%) MI disagreement between the original and QA review pathologist. Of the MA disagreements, 14 were considered to be “significant” based on their potential effect on management.

Table 1: Major Disagreements
 N (%)Excision agrees w/original (%)Excision agrees w/QA (%)Undetermined (%)
Atyp to Benign7(13.2)3(42)2(29)2(29)
Benign to Atyp22(41.5)3(13)8(37)11(50)
Atyp to Atyp1(1.8)001(100)
Benign/Atyp to DCIS3(5.7)02(67)1(33)
DCIS to Benign/Atyp2(3.8)01(50)1(50)
FA to FEL11(20.8)4(37)07(63)
FEL to FA4(7.6)2(50)2(50)0
Incvasive to Benign/Atyp1(1.8)01(100)0
Other2(3.8)   
Invasive ductal carcinoma to DCIS 1(100)00
Benign to Suspicious for cancer 001(100)
Atyp: Atypical, DCIS: ductal carcinoma in situ. FA: Fibroadenoma, FEL: Fibroepithelial lesion

Original DX was done by a general pathologist in 42%, general + breast in 26%, breast only in 17% and 2 breast pathologists in 16% of the cases. Incidence of MA disagreements was higher when a breast specialist was involved in the original DX (58% vs. 42%). The excision DX agreed with the original in 24.5%, with the QA reviewer in 30.5% and was undetermined in 45% of the cases. Undetermined cases were due to loss to follow up (66%), lack of excision DX (17%) or lack of gross-radiology correlation on excision (17%). Lack of clinical significance for many “major” disagreements reflects complex clinical scenarios in which multiple biopsies were performed in patients with known cancer.
Conclusions: 1) Major disagreements centered on intrinsically problematic lesions such as focal atypia, low grade DCIS and cellular fibroepithelial tumors. 2) The data demonstrate that a secondary review diagnoses should not always be viewed as “correct”. 3) Determining “correct” diagnosis in problematic cases is often difficult owing to small lesion size, complex clinical scenarios or incomplete clinical follow up.
Category: Quality Assurance

Tuesday, March 5, 2013 9:30 AM

Poster Session III # 278, Tuesday Morning

 

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