Date of Graduation

Spring 5-19-2016

Document Access

Project/Capstone - Global access

Degree Name

Master of Science in Nursing (MSN)


School of Nursing and Health Professions

First Advisor

Elena Capella

Second Advisor

Carlee Balzaretti


Breast Cancer Specimen Collection, Handling & Adherence to ASCO/CAP Guidelines


Specimens removed from their blood supply begin to degrade immediately. Specimens are placed in formalin to halt the process of degradation. Under or over-exposure of specimens to formalin can result in false positive or false negative test results for estrogen receptors, progesterone receptors & Her-2/neu receptors.

Goals & Objectives

Improve the process of breast cancer specimen collection & handling and insure that the process is consistent with ASCO/CAP Guidelines (College of American Pathologists, 2013). The objectives included: Documentation of the time the specimen was removed from the blood supply. Documentation of the time the specimen was initially placed in formalin. Documentation of the cold ischemic time (the interval time between removal of the specimen from the blood supply until it is initially placed in formalin). The cold ischemic time will be 60 minutes or less. The total time the specimen remains in formalin will be a minimum of 6 hours and a maximum of 72 hours. The benchmark for these indicators was 90%. The Her-2/neu Positivity Rate of invasive breast cancer specimens will be within a range of 15 – 20%.


This quality improvement project consisted of three PDSA Cycles that each contained a planning phase, a retrospective chart audit, data analysis, and an intervention to improve the process. Patients who had undergone mastectomy or lumpectomy were selected for the chart audits.


Documentation of the time the specimen was removed from the body improved from 87.5% to 95%. Documentation of the time the specimen was placed in formalin improved from 80% to 90%. The cold ischemic was calculated in thirty-eight of the forty-two charts, or 90%, an improvement from 82.5%. The cold ischemic times in forty-two of forty-two cases were within sixty minutes, or 100%. All specimens were in formalin longer than six hours. Twenty of forty-two cases were in formalin for seventy-two hours or less, or 48%. Seventeen of the twenty-two cases, (78%) in which the specimen spent over seventy-two hours in formalin were performed on either a Thursday or Friday. Out of the thirty-six patients who had a diagnosis of invasive breast cancer, six were positive for Her-2/neu. The Her-2/neu positivity rate of 19% was within the expected range of 15% - 20% (Wolf et al., 2013).


The interventions were successful in improving five of six indicators which met or exceeded their benchmarks.