Optimizing Workflow for OncotypeDX Result Turnaround Time at a Safety Net Hospital.

INTRODUCTION
Breast cancer is one of the most common cancers. Each year, about 16,700 women are diagnosed and 2500 die from breast cancer in New York.[1] At our large, public safety-net hospital in New York City, there are about 100 new cases of breast cancer per year, and 30 cases per year are early-stage hormone-positive breast cancer cases. The current treatment for early-stage hormone-positive breast cancer includes surgery, chemotherapy, hormone therapy, and radiation therapy. Whether chemotherapy is offered has been dependent on the OncotypeDX Recurrence Score (OncotypeDX).
OncotypeDX has been used in the postoperative setting for patients with breast cancer with early-stage (I–IIIa), hormone-receptor–positive, HER2-negative disease. It predicts the benefit of adjuvant chemotherapy in addition to hormone therapy, aiding clinicians in individualizing patient care and treatment decisions. It is reported on a 0–100 scale, divided into low-risk (< 18), intermediate-risk (18–30), or high-risk (> 30) categories.[2–4] Patients in the high-risk OncotypeDX category have a high chance of recurrence and derive the most benefit from adjuvant chemotherapy. Currently, OncotypeDX is typically reported within 7–10 days after the vendor receives the sample. However, for a patient with breast cancer and the multidisciplinary breast oncology provider team, the critical time of treatment starts at the time of curative surgery. Turnaround time (TAT) for a biomarker that determines adjuvant treatment such as OncotypeDX should be defined as the time interval from surgical specimen collection to receipt of OncotypeDX results.
At our center, we found that therapy initiation for patients with breast cancer after surgery took about 3 months. A previous study found that delay of initiation of adjuvant chemotherapy past 61 days is associated with worse survival.[5] Other studies have also found that delaying initiation of adjuvant hormone therapy past 150 days and adjuvant chemotherapy past 91 days is associated with adverse outcomes.[6,7] This suggests that early initiation of adjuvant therapy can change outcomes, and we wanted to maximize the opportunity for cure. Thus, we initiated this quality improvement project to reduce the TAT of OncotypeDX results and postoperative decision-making.
As a quality improvement project, we implemented a strategy to reduce the TAT from breast surgery to OncotypeDX report at Bellevue Cancer Center, a network affiliate site of NYU Langone Health. Bellevue Cancer Center is the tertiary oncology referral center of the NYC Health and Hospitals System, the largest public health system in the United States.
We identified a road map that included identifying patients by clinicians, handling specimens by pathology, and communications between various healthcare teams that also involve insurance and the vendor. Extended TATs can delay the discussion of adjuvant therapy and worsen anxiety for both patients and clinicians. Delivering OncotypeDX results in a timely manner is important for making informed treatment decisions.
Although some studies have tried to optimize TAT for tests other than OncotypeDX to determine the usefulness of adjuvant therapy, few studies have documented a systematic approach to reduce TAT for OncotypeDX testing.[8–12] Given the potential of OncotypeDX in individualizing patient care and critical treatment decisions, identifying and implementing interventions to reduce TAT is essential.
We identified the old workflow as three steps after curative surgery: referral to medical oncology at the first postoperative visit, OncotypeDX ordering by medical oncology, and treatment planning based on OncotypeDX result at the second medical oncology visit. This approach reflects the general process of patients in healthcare settings in the United States.

METHODS
The Plan-Do-Study-Act (PDSA) method of quality improvement was used for the project to reduce TAT from surgery to OncotypeDX result. Baseline assessment included reviewing the process of ordering OncotypeDX before the intervention in 2023. The breast surgery, medical oncology, and pathology team collaborated to review the process together within the safety net hospital before implementation of the strategy. The study adhered to the Standards for Quality Improvement Reporting Excellence for Education (SQUIRE) 2.0 guidelines, ensuring methodologic rigor and transparency in reporting.[13] This project was exempted by the institutional review board at NYU Langone.

Study Population
The intervention was implemented at Bellevue Cancer Center, part of the largest public health system in the United States and a network affiliate site of NYU Langone Health. We used a team-based approach to streamline the process of OncotypeDX ordering and result retrieval from 2023 to 2024.

Preintervention
In the baseline workflow, the breast surgery team would first complete the surgery. Once the pathology report from the surgery was finalized, breast surgery then referred the patient to medical oncology. Medical oncology would see the patient, and at this appointment, ordered OncotypeDX. Treatment decision was made after results of OncotypeDX were released. The historical control data were from July 2021 to March 2022.

The Intervention
The intervention was implemented from June 2023 to February 2024. We created a smartphrase in the electronic medical record (EMR) to identify qualifying patients for OncotypeDX. Our smartphrase in EMR for OncotypeDX automatically loads questions regarding the patient’s tumor size, lymph node status, hormone receptor status, neoadjuvant therapy status, and whether surgery is performed for cure (Supplemental Fig. S1, available online).
Breast surgery uses the smartphrase to order OncotypeDX through the vendor’s portal after a discussion with eligible patients (Fig. 1). Breast surgery and pathology coordinate pathology report submission and specimen shipping to the vendor for OncotypeDX. Breast surgery collaborates with the vendor for documents, including prior authorization required by the insurance and Financial Assistance Disclosure and Application Form for patients in need. The vendor sends the OncotypeDX results to the breast surgery provider, who updates the result in the EMR system.
During the first medical oncology visit, medical oncology engages the patient regarding adjuvant treatment options based on the OncotypeDX result (Fig. 1). A PDSA cycle for improvement was used to monitor intervention during the study period. The intended improvement from the intervention was a TAT of 30 days or less.

Measurements
The primary outcome measure was TAT from surgery to OncotypeDX report in EMR. The data from the historical control were from July 2021 through March 2022, whereas the group after strategy implementation covered the timeline from June 2023 to February 2024. De-identified data were collected for comparative analysis of TAT. Other outcome measures include time to first adjuvant treatment initiation and time to first medical oncology appointment after surgery. Process measurements included average time from surgery to pathology result, pathology report to submission of OncotypeDX order to vendor, and from OncotypeDX order to result.

Data Analysis
Chi-square tests were used to compare patient demographics before and after strategy implementation. Mann-Whitney U test was used to determine if changes in TAT, time to first adjuvant treatment initiation, and time to first medical oncology appointment after surgery are statistically significant. Statistical significance was determined at p < 0.05. To analyze the impact of the intervention on the process, a run chart and run control chart were used.

RESULTS
We examined patient characteristics before and after the implementation of our new strategy (Table 1). The two patient groups were similar in the number of patients (26 and 27, respectively) and mean age (61 and 59 years, respectively; p = 0.42). Most patients from both periods were non-White (64% and 59%, respectively; p = 0.12). A higher percentage of patients were from the medically underserved area and population (MUA and MUP) (44%), in contrast to the group before the new strategy (35%) (p = 0.65). There were no significant differences in other demographics examined pre and post intervention, including language, ethnicity, and Health Professional Shortage Area (HPSA).
The average of total TAT from breast surgery to OncotypeDX result was reduced from 42 (SD = 24) to 30 (SD = 10) days (p = 0.0040). This included a 14-day interval from surgery to pathology result, a 1-day interval from pathology report to the submission of OncotypeDX order, and a 15-day interval from OncotypeDX order to result. The median of total TAT from breast surgery to OncotypeDX result was reduced from 38 (range, 21–144) to 29 (range, 14–65) days.
To assess whether the implemented strategy resulted in a sustained process improvement, a run chart of the monthly average TAT was generated (Fig. 2). The run chart demonstrated a shift in TAT immediately following the intervention, with 8 consecutive months of data falling below the preintervention median. A control chart demonstrated a shift in the process post intervention, indicated by the special cause test (Fig. 3).
The average of total time from surgery to first medical oncology appointment after surgery was reduced from 88 (SD = 83) to 50 (SD = 28) days (p = 0.006). The median of total time from surgery to first medical oncology appointment was reduced from 56 to 42 days.
The average of total time from surgery to first adjuvant treatment (endocrine, chemotherapy, or radiation therapy) was reduced from 93 (SD = 50) to 76 (SD = 53) days (p = 0.16). The median of total time from surgery to first adjuvant treatment was reduced from 80 to 72 days.

DISCUSSION
This is the first report of a strategy implementation that reduces the turnaround time of OncotypeDX from surgery to report in a public hospital system. This reduction from 42 to 30 days is achieved through a team-based approach. As evidenced by the run chart analysis, there was a shift in TAT to below the pre-intervention median. We also report a decrease in time from surgery to first medical oncology appointment to discuss OncotypeDX results from 88 days to 50 days and initiation of treatment from 93 days to 76 days.
The ideal time for adjuvant therapy in patients with breast cancer is between 4 and 6 weeks after surgery without complications, with delay of initiation of adjuvant therapy associated with worse outcomes. At our public hospital with high patient volumes and limited resources, appointment wait times for a new patient to see a medical oncologist can be longer than 2 weeks.
The previous standard workflow from surgery to OncotypeDX was 42 days, which already exceeded the ideal time to start adjuvant therapy. By reducing the TAT of OncotypeDX result—using our new strategy—initiation of adjuvant therapy can be accomplished within 6 weeks of surgery and improve patient survival.
Instead of the traditional process of ordering OncotypeDX by medical oncology, we engaged breast surgery to initiate the discussion and ordering of OncotypeDX. This approach is not only more efficient by decreasing TAT but also saves the patient an extra visit with the medical oncologist. Instead of having a follow-up visit with the breast surgeon and then two subsequent visits with the medical oncologist to make a treatment plan, this strategy enables one visit with the breast surgeon and one visit with the medical oncologist.
This strategy also facilitates a smoother transition of care from breast surgery to medical oncology. As the patient typically sees the breast surgeon first and undergoes curative surgery as part of their oncologic care, the patient establishes strong trust with the breast surgeon first. With this strategy implementation, breast surgeons can use a standardized checklist in the EMR (smartphrase) to determine eligibility for OncotypeDX. It enables the breast surgeon (instead of the medical oncologist) to order OncotypeDX, which will determine the next phase of curative treatment. The multidisciplinary approach of education on OncotypeDX between medical oncology and breast surgery through weekly tumor board meetings empowers the breast surgeon to confidently explain the rationale of the test to the patient.
A multidisciplinary quality improvement initiative between 2014 and 2016 at Dana-Farber/Brigham Cancer Center (DFBCC) also shifted the responsibility of ordering OncotypeDX for patients with breast cancer from medical to surgical oncology.[12] At DFBCC, the surgeon would order reflex OncotypeDX within 1 day of pathology if specific criteria determined that most clinicians would consider OncotypeDX testing for were met.[12] This, along with a streamlined pathology system for receiving and processing OncotypeDx requests, led to a 6.4-day decrease in the mean number of days from last definitive breast surgery to chemotherapy initiation after definitive breast surgery. This process also reduced time from surgery to OncotypeDX result by 7.3 days.[12] Although our intervention had similar improved workflows to shift ordering responsibility to surgeons and to streamline communication with pathologists, this is the first documentation of such implementation in a public hospital system with more limited resources and a decreased TAT of 26 days.
The standardized checklist in the EMR for breast surgeons to determine patient eligibility for OncotypeDX demonstrates the benefit of smartphrases in the EMR. EMR typically includes features such as smartphrases to improve provider efficiency.[14] Smartphrases are features that allow users to organize commonly used information into a condensed phrase. When a smartphrase is typed in the EMR, it loads simple and clear instructions that can be integrated into clinical documentation.[15] In our project, we created a smartphrase for OncotypeDX, which automatically loads questions regarding the patient’s tumor size, lymph node status, hormone receptor status, neoadjuvant therapy status, and whether surgery is performed for cure, enabling the breast surgeons to identify eligible patients for OncotypeDX testing.
Smartphrases have been found to enable quicker note documentation and consistency, as well as reduce errors and misspellings.[15] In a primary care setting, smartphrases have also recently been used to identify and refer patients to a community-based diabetes self-management program, leading to an increase in referrals to the diabetes support program.[14] Their study found that smartphrases could increase patient engagement and streamline documentation. Similarly, in our study, smartphrase utilization by breast surgeons can quickly and accurately identify eligible patients for OncotypeDX testing.
In a public hospital system with various insurances without supplemental portions, the financial authorization process can be longer than in private hospital systems. In this public hospital, there is a high proportion of underinsured patients for whom the cost of the OncotypeDX test is not fully covered. Starting the insurance authorization process earlier can reduce the wait time for testing of OncotypeDX by the vendor. For uninsured patients, clinicians proactively fill out financial forms provided by the vendor to initiate financial assistance. This earlier initiation of Prior Authorization or the OncotypeDX vendor’s Financial Assistance Disclosure and Application Form improves the process. It reduces the extra wait time compared to the standard practice where it was initiated after the first medical oncology encounter, leading to the reduction of overall TAT from surgery to test result.
Several areas of improvement for our current strategy can be implemented to further reduce TAT. Enhanced integration of pathology into the OncotypeDX testing process can decrease the lag time between each step for the OncotypeDX results. Currently, the time from surgery to pathology report is 15 days in our new workflow. Multiple discussions with pathology have allowed a higher priority to be given to early-stage breast cancer postoperative specimens so that the pathology report can be generated in as few as 7 days. Furthermore, the time from submitting an OncotypeDX order until the specimen is ready for shipping is 4 days. Proactive notification from breast surgery to pathology when the OncotypeDX order is submitted allows the time from specimen ordering to shipment to be reduced from 4 to 2 days. This would lead to a further reduced TAT from 30 to 22 days. We piloted this enhanced approach for two patients and achieved a TAT of 22 days, indicating this enhanced approach can be feasible.
A study from a private integrated healthcare system reduced OncotypeDX TAT from 23.1 to 19.4 days after the integration of a reflex-testing strategy by pathology.[10] The historical control cohort TAT of 23.1 days was shorter than that of our study. This is due to their integrated health system with resources that allow for better coordination between surgery, medical oncology, pathology, and the vendor, as well as the elimination of the financial assistance step because all patients are privately insured. With our enhanced integration approach, we were able to reduce our TAT from 30 to 22 days, which is similar to the historical control cohort of 23.1 days in this study from a private integrated health system, which is considered the most efficient standard-of-care TAT in a private healthcare setting. Our next step will also include a discussion with pathology to consider reflex-testing using an EMR-related checklist.
In addition, enhanced integration of the OncotypeDX vendor with the EMR can decrease TAT by eliminating extra steps that require entering information into the vendor’s portal and migrating information from the vendor’s portal to our EMR. This can reduce the manual workload for breast surgery from submission and notification to pathology of the order, as well as retrieval of OncotypeDX result. This will allow OncotypeDX result to be visible to all healthcare providers involved, particularly the medical oncologist who makes adjuvant treatment decisions.
There are several limitations in our study. Our sample size is small, and validation of our strategy will be important in a large-scale patient population. There was a nonsignificant increase in patients in the MUA and MUP, which may be due to changes in the population of New York City after the COVID-19 pandemic, with underserved populations coming to New York City for job opportunities after the pandemic. In addition, multidisciplinary meetings may not be feasible for all community hospitals, and education on the OncotypeDX test for the breast surgery team may require an electronic version that clearly communicates the rationale for ordering the test, which also allows potential questions from breast surgery to be readily answered by medical oncology. We are planning to develop electronic educational materials so that they would be accessible to our multidisciplinary team members. Patient education is also an important part of optimal workflow. We are working on patient-friendly materials that can be available in various languages so that our patients who speak diverse languages can better engage in OncotypeDX testing and get more involved in their healthcare.
Additionally, the historical control period was from July 2021 through March 2022, and the intervention period was from June 2023 to February 2024. The historical control period is more than a year earlier than the intervention period. The gap in timeline is due to a period of acute shortage of breast cancer providers at our center. Some potential differences could confound the data. At our center, we have had more patients come to our cancer center, which has put extra strain on the system. Additionally, we have had a decrease in staffing in pathology, which can be a barrier to continue improvement since a critical part of the intervention is for pathologists to send the specimens to the vendor. In that period, we have also had a nurse practitioner join the breast surgery team to follow the intervention and process closely to help achieve the goal.

CONCLUSION
Strategy implementation to reduce TAT for reporting OncotypeDX results can improve workflow among breast surgery, pathology, and medical oncology without additional healthcare resources. Standardizing processes for identifying patients with a smartphrase in the EMR by clinicians, and efficient specimen handling by pathology, along with communication with vendors, helped improve TAT. Multidisciplinary collaboration is vital to improve efficiency. The implementation of the strategy in a large public hospital in the United States demonstrates that it is feasible to reduce TAT for patients with breast cancer awaiting OncotypeDX results for informed treatment decisions in a timely manner.

Supplementary Material