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Case Study

Collaborative Model between Breast Surgery and Genetic Counseling Clinics to Reduce Wait Time for Pretest Genetic Counseling

University of Arizone Cancer Center Banner Health

General Information

Institution Name: University of Arizona Cancer Center Banner Health

Primary Author and Title: Lauren Maynard, MS, CGC

Co-Authors and Titles: Carolyn Donohue, MS, PA-C; Alexa Rosenblum, MS, CGC; Sima Ehsani, MD; Leigh Neumayer, MD; and Nova Foster, MD

Name of Case Study: Collaborative Model between Breast Surgery and Genetic Counseling Clinics to Reduce Wait Time for Pretest Genetic Counseling

What Was Done?

Global Problem Addressed

Advances in genetic testing technology, increases in affordability of genetic testing, and utilization of germline genetic test results to influence treatment decisions have led to an increasing proportion of individuals with breast cancer who are recommended to undergo genetics evaluation. Even with the rapid growth of the field, a workforce study commissioned by National Society of Genetic Counselors (NSGC) identified that there will be a shortage of 1,569 genetic counselors in direct patient care roles in the United States or ~35 percent of what is required in 2020 (Hoskovec et al., 2017). Many professional societies including American College of Medical Genetics (ACMG) (Pal et al., 2019), National Comprehensive Cancer Network (NCCN) (NCCN, V1.2020), National Accreditation Program for Breast Centers (NAPBC) (NAPBC, 2018 Standards), and Commission on Cancer (COC) (COC, 2020 Standards), recommend that genetic testing for hereditary cancer be conducted and interpreted in the context of genetic counseling with a trained genetics professional or health care providers with expertise in cancer genetics. The traditional genetic counseling model includes counseling the patient about getting the test (pre-test) and then counseling the patient once the results have been received whether positive or negative (post-test). As the proportion of breast cancer patients who meet criteria for genetic testing increases, genetic counselors are struggling to meet these needs with a traditional model.

Identification of Local Problem

Wait time in 2018 and 2019 for pre-test genetic counseling at our institution was tracked as a part of a quality initiative. The average number of business days from referral to the pre-test genetic counseling appointment increased steadily each quarter as an increasing number of patients were referred to genetic counseling. In quarter 2 of 2018, the average wait time for pre-test genetic counseling for a patient with breast cancer was 18 business days (~3.5 weeks). By quarter 2 of 2019, the average wait time to see a genetic counselor had increased to 116 business days (over 5 months). Importantly, during this time period genetic counselors accommodated STAT referrals for patients whose genetic testing results would influence treatment decision making within 3 to 7 business days. For patients with a family history of breast cancer and other indications to be seen by the genetic counselors, the next available appointment in quarter 2 of 2019 was ~9 months.

How Was the Quality Improvement (QI) Activity Put in Place?

Context of the QI Activity

University of Arizona Cancer Center Banner Health is a National Cancer Institute-designated Comprehensive Cancer Center in Tucson, AZ,with NAPBC and COC accreditation. Genetic counseling for hereditary cancer is provided in an outpatient setting in the High Risk Clinic, which is staffed by a multidisciplinary team of physicians, a physician’s assistant (PA), two American Board of Genetic Counselors certified genetic counselors (CGC), oncology certified nurse coordinators (RN) and other support staff. The greater Tucson metropolitan area has a population of nearly one million people. In 2018 and 2019 there were 1-3 CGCs providing clinical genetic counseling services for hereditary cancer in the Tucson area.

Starting in late 2018, Banner Health started a system wide initiative to increase access to patient care by setting a goal to accommodate all new patient appointments in a 3- to 5-day period. This aligned with our own goals for a quality improvement project to reduce the wait time for pre-test genetic counseling.

Planning and Development Process

Due to the unacceptably long wait period for pre-test genetic counseling, genetic counselors evaluated the referral patterns for patients with a diagnosis of breast cancer and those referred for family history of breast cancer. Many patients referred for family history of breast cancer would establish care in the high risk breast clinic and then be referred to the genetic counselors for pre-test counseling and genetic testing. A significant proportion of these patients would be routed back to the high risk breast clinic for management due to either positive genetic test results or residual risk for breast cancer based on family history which would warrant high risk screening based on NCCN guidelines (NCCN, V1.2019). Simultaneously, a physician assistant role supporting the breast surgery clinic was established and tasked with growing the high-risk breast clinic.

Because of the delays in pre-test genetic counseling, a workflow change to streamline pre-test genetic consent was developed and implemented with the following goals:

  1. To reduce the wait time for pretest genetic counseling
  2. To increase the volume of pretest genetic counseling
  3. To expand the number of women with a high-risk for breast cancer followed in the high-risk breast clinic in order to promote early detection of breast cancers in the Tucson community.

A multidisciplinary panel including CGCs, a PA, breast surgeons, breast medical oncologists, RNs, and management met to develop a workflow using a collaborative model between the genetic counseling clinic and the high risk breast clinic. After agreement upon the quality project, we evaluated existing resources at our institution. Existing genetic counseling resources included a pedigree-generating and risk assessment software, Progeny Genetics (Progeny Genetics LLC, Delray Beach, FL, progenygenetics.com), and visual aids for pretest genetic counseling.

Ideas for the workflow change were taken from published literature of alternative service delivery models for genetic counseling (McCuaig et al, 2018). Many ideas for our workflow were inspired by a collaborative approach using nurse navigators as “genetic counselor extenders” in remote community hospitals (Cohen and Nixon, 2016). Additionally, several genetic testing laboratories have developed workflows to integrate genetic testing directly into mammogram centers or other clinics to increase the rate of genetic testing, such as the Comprehensive Assessment, Risk & Education (CARE Program) by Ambry Genetics. While many ideas were taken from these valuable sources, these ideas were modified to meet NAPBC and COC standards for genetic counseling and genetic testing.

Description of the Quality Improvement Activity

Action items to implement the workflow included:

  1. Further education of the breast surgery PA: Completion of a formal genetic course through American Society of Clinical Oncology (ASCO) and shadowing of genetic counseling appointments with the CGCs for ~3 months.
  2. Designing of the workflow: CGCs proposed a workflow for the collaborative clinic model to a multidisciplinary team comprised of the breast surgery PA, RNs, breast surgeons, and medical oncologists.
  3. Implementation of workflow: CGCs selected patients with personal or family history of breast cancer to be scheduled with the breast surgery PA. During the first month, CGCs shadowed appointments conducted by breast surgery PA and provided feedback as necessary. CGCs provided training to breast surgery RN coordinators on filling out forms and required documentation as genetic testing orders were placed. PA requested modification of the scheduling template to reflect new workflow.
  4. Maintenance and re-evaluation: Monthly meetings occurred for the breast surgery PA, breast surgery RNs, and CGCs to discuss and troubleshoot issues with the workflow.
  5. Report of initial data: CGCs presented data to multidisciplinary breast team in December 2019 after 6 months of the workflow implementation. Data collected to measure quality improvement included number of patients seen by breast surgery PA for pre-test genetic counseling, genetic testing criteria met, outcomes of genetic testing, and discrepancies in clinical criteria, testing sent and incoming referrals.
workflow-for-the-collaborative-clinic.png

Final workflow developed (Figure 1) is summarized below:

  • New patients referred for breast cancer or family history of breast cancer can be scheduled with the breast surgery PA for pretest genetic counseling.
  • A new patient coordinator contacts patients to obtain the patient’s email and the genetics medical assistant sends out the personal and family history questionnaire. All patients with insurance specific requirements for genetic counseling are rescheduled with CGCs due to implications for genetic testing coverage.
  • When the patient arrives for their appointment, the breast surgery PA uses the same resources as available to the CGCs including genetics risk assessment software and visual aids, to provide a genetic risk assessment and pre-test counseling.
  • If the patient elects to proceed with testing, RNs complete the required forms and send out the testing.
  • A copy of each pedigree is provided to the CGCs along with all test results as they are reported. A CGC reviews the pedigrees and new test results weekly to ensure proper test selection, assist with insurance issues for genetic testing, and track data for the project.
  • Breast surgery PA and CGCs review all genetic testing results.

    • Negative genetic test results: posttest counseling is provided by breast surgery PA

    • Variant of Uncertain Significance (VUS) genetic test results: posttest counseling is provided by a CGC

    • Positive genetic test results: Breast surgery PA discloses the result and the patient is scheduled for an in person posttest genetic counseling appointment with a GCC within 1 week of the positive results disclosure

  • All patients receive a copy of their test results and a summary letter. Additional resources are provided as needed.

Implementation of the new workflow occurred in July 2019.

Resources Used and Skills Needed

The primary drivers of the quality improvement project were two CGCs and one breast surgery PA. Additional supporting staff included two RNs, one new patient coordinator, one medical assistant, and a centralized scheduling department.

Additional valuable input was provided from three breast surgeons, three breast medical oncologists, one nurse navigator, and management. These positions were in place prior to workflow implementation and no additional staff were hired.

No costs beyond normal hospital operations were used and no additional resources beyond those already available to the genetic counseling clinic were acquired to implement or maintain the quality improvement project. No funding was available or used for this project.

What Were the Results?

Overall Results

This collaborative model has increased the number of available pre-test genetic counseling appointment slots by nearly 30 percent. The average wait time for pre- test genetic counseling decreased to 13 business days in quarter 4 2019 (Figure 2).

The breast surgery PA saw a total of 62 patients with a personal or family history of breast cancer in quarters 3 and 4 of 2019 for pre-test genetic counseling.

Outcomes of cases seen by the breast surgery PA for pre-test genetic counseling are described in Table 1. Additional patients with a personal or family history of breast cancer were seen for pretest counseling by the CGCs during this period of time, however tracking of this data was not completed as a part of this project. Of note, 38 percent (11/29) of unaffected patients seen by the breast surgery PA continued to follow in the high-risk breast clinic due to their residual risk for breast cancer after negative genetic testing, thus growing the high-risk program for early detection of breast cancers in our community. Additionally, there we no discrepancies in genetic testing selection and all tests sent by the breast surgery PA were in accordance with published guidelines for genetic testing criteria.

wait-time-for-genetic-counseling-figure.png

Average wait time for pre-test genetic counseling appointments increased through 2018. In Q1 2019, a triage system for STAT referrals was initiated, which reduced wait time for patients with breast cancer as a high proportion receive genetic testing for treatment decision making. In Q2 2019, reduction in genetic counselors workforce for 3 months resulted in a sharp increase in wait time. The trendline added may more accurately represent the increasing wait time for pre-test genetic counseling. Quality improvement project establishing a collaborative clinical model between the breast surgery clinic and the genetic counseling clinic was initiated at the beginning of Q3 2019 and resulted in an overall decrease in wait time by the end of Q4 2019.

Outcomes of Pre-Test Genetic Consults by Breast Surgery PA

Q3 2019 N (%) 

Q4 2019 N (%) 

Pre-test genetic counseling appointments with PA 
13 
49 
Patients without breast cancer meeting high risk criteria1 
5/8 (63%) 
6/21 (29%) 

Testing criteria 

Met genetic testing criteria for BRCA1/2 only 
9 (69%) 
44 (90%) 
Met genetic testing criteria for outside of BRCA1/2 
1 (8%) 
2 (4%) 
Did not meet genetic testing criteria 
3 (23%) 
3 (6%) 

Genetic testing 

Total genetic tests sent 
11 (84%) 
42 (86%) 
Result: Positive 
0 (0%) 
6 (14%) 
Result: Negative 
6 (55%) 
31 (74%) 
Result: VUS 
5 (45%) 
5 (12%) 

Discrepancies 

Testing sent outside of criteria 
1 (9%)2 
0 (0%) 
Testing not offered when BRCA1/2 testing criteria was met 
0 (0%) 
0 (0%) 
Panel selected inappropriate for family history 
0 (0%) 
0 (0%) 
  1. Lifetime risk for breast cancer >20 percent or 5-year risk for breast cancer >1.7 percent (NCCN V1.2019)
  2. Patient verbalized an understanding that she did not meet testing criteria and elected to self-pay for genetic testing

Setbacks

A few issues were encountered during this quality project. First, some patients did not complete the personal and family history survey prior to their appointment due to not receiving this survey or difficulties with the technology. In these instances, the breast surgery PA used her training to hand draw pedigrees. The hand drawn pedigrees were then entered into Progeny Genetics (Progeny Genetics LLC, Delray Beach, FL, progenygenetics.com) by a CGC following the appointment during the weekly review. This is not an ideal solution due to the time-consuming nature of hand generating and inputting pedigrees, thus further investigation of the reason that patients do not receive the survey is underway. Moreover, we are exploring the use of tablets in the waiting room for patients to complete the survey.

An additional issue was that a small proportion of patients (3/62) were scheduled with the breast surgery PA when they should have been scheduled with one of the CGCs. These patients had complex family history of cancers other than breast cancer and all met NCCN criteria for a different indication such as Lynch Syndrome genetic testing. Additionally, certain insurance types require routine pre-test genetic counseling to be completed by health care providers with specific certifications (genetic clinical nurse (GCN), advanced practice nurse in genetics (APNG), ABGC board-certified genetic counselor, or an ACMG board-eligible/board-certified clinical geneticist) in order for the testing to be covered. When the workflow was designed, insurance specific requirements were an anticipated barrier that was addressed by a check of the patient’s insurance type prior to the genetic counseling appointment with the breast surgery PA. Education of the schedulers has reduced the number of patients inappropriately scheduled with the breast surgery PA due to indication or insurance type. However, when a patient is inappropriately scheduled and seen in the breast surgery clinic, the breast surgery PA places a referral to the CGCs instead of completing the full genetics risk assessment and pre-test counseling.

Cost Evaluation

While analysis of the cost saving was not within the scope of the data collected during this quality project, this workflow change appeared to eliminate the immediate need to hire a third genetic counselor for the high risk clinic. Additionally, the combination of the initial high risk appointment with a pre-test counseling appointment could potentially save time and expense to the patient. Presumably, the increase in number of individuals following with the high risk breast clinic increases revenue generated from screening and allows for earlier detection of breast cancer in high risk patients, which is a valuable resource to our community and an overall cost savings.

The first step to a successful workflow change is to evaluate what staff and resources are in place and to ensure adequate buy in from the parties which will be most affected. For our workflow, the majority of the increase in workload was for the breast surgery PA, the breast surgery RNs, and the CGCs. Due to the benefit in growing the high risk clinic and the breast surgery PA’s clinical availability at the beginning of the project, she was able to accommodate this increase in workload. A CGC spends ~2 hours weekly on this project, which allows for an overall increased number of patients obtaining pre-test genetic counseling versus what a CGC would be able to accomplish on their own. Additionally, this project would not have been possible without the support of our physicians and management as well as existing technology to accommodate clinical efficiency already acquired by our institution.

The main reason for the success of this project was the open communication and excellent collaboration between the breast surgery and the genetic counseling clinical teams. All team members had a strong commitment to our goal of providing patients with more timely access to genetics. Meetings occurred almost on a monthly basis to assess workflow issues, and problems were evaluated and resolved collaboratively. We will continue this process as long as the collaborative model for genetic counseling is in place.

Lastly, the authors would like to emphasize that integration of genetic testing into clinical practice is a time-consuming process. It is important that clinicians considering this type of quality improvement take into account their clinical workload and if they will have the continued support of genetic counselors after the integration has taken place. These two elements are vital to the long-term success and stability of a collaborative model like the one developed at our institution.

The authors declare that there are no conflicts of interests to disclose.

References

  1. Cohen SA, Nixon DM. A collaborative approach to cancer risk assessment services using genetic counselor extenders in a multi-system community hospital. Breast Cancer Res Treat. 2016; 159:527-534.
  2. Commission on Cancer. Optimal Resources for Cancer Care. 2020 Standards. Available at: https://www.facs.org/-/media/ files/quality-programs/cancer/coc/optimal_resources_for_cancer_care_2020_standards.ashx. Accessed March 6, 2020.
  3. Hoskovec JM, Bennett RL, Carey ME, et al. Projecting the Supply and Demand for Certified Genetic Counselors: A Workforce Study. J Genet Couns. 2018; 27:16-20.
  4. McCuaig, JM, Armel SR, Care M, Volenik A, Kim RH, Metcalfe KA. Next-Generation Service Delivery: A Scoping Review of Patient Outcomes Associated with Alternative Models of Genetic Counseling and Genetic Testing for Hereditary Cancer. Cancers (Basel). 2018;10:435.
  5. National Accreditation Program for Breast Centers Standard Manual. 2018 Edition. Available at: https://accreditation.facs. org/accreditationdocuments/NAPBC/Portal%20Resources/2018NAPBCStandardsManual.pdf. Accessed November 11, 2019.
  6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. V1.2020. Available at: https://www.nccn.org/professionals/physician_gls/ pdf/genetics_bop.pdf. Accessed December 10, 2019.
  7. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Screening and Diagnosis. V1.2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/breast-screening.pdf. Accessed December 10, 2019.
  8. Pal T, Agnese D, Daly M, et al. Points to consider: Is there evidence to support BRCA1/2 and other inherited breast cancer genetic testing for all breast cancer patients? A statement of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2019 Dec 13 [Epub ahead of print].
  9. Progeny Genetics. Progeny Genetics LLC; Delray Beach, FL. progenygenetics.com.