1. Implementing universal Lynch Syndrome screening in a large healthcare system

2. 1. Getting started 2. Challenges with infrastructure 3. Overcoming barriers

3. The goal of universal Lynch Syndrome screening is to provide a population based approach to identify individuals at increased cancer risk resulting in: – Enhanced surveillance – Early cancer detection – Decreased disease-specific mortality – Overall cost savings due to earlier detection and prevention of cancer. 1. Getting Started

4. Identify who will play a role in moving universal screening forward. Getting Started

5. Inform, consult & support Implementation Decision makers What are the roles of stakeholders? Getting Started

6. Consider what information is relevant to each stakeholder group and foster communication around the benefits to the healthcare system, clinicians, and patients. — Administrators — Clinical providers (e.g., oncologist, surgeon, pathologist, and geneticist) — Laboratory and IT Services Getting Started

7. Administrators (business services, institutions) — Goal of universal screening — Clinical overview of Lynch Syndrome — Community standard for MSI/IHC testing — Cost benefit, both short term and long term perspectives for institutions Getting Started

8. Clinical providers (oncologist, surgeon, pathologist, and geneticist) — Evolving national and international standards — Evidence based data showing improved patient outcomes from universal Lynch syndrome screening testing — Examples of clinical management algorithms Getting Started

9. Laboratory and IT Services — Lynch Syndrome diagnostic and tumor testing criteria recommendations — Evolving standards for universal testing Getting Started

10. EGAPP recommendations for screening www. egapp reviews.org/docs/ EGAPP WG- Lynch Rec.pdf www. egapp reviews.org/docs/ EGAPP WG- Lynch Rec.pdf Journal articles www.ncbi.nlm.nih.gov/pmc/articles/PMC2929365 www.ncbi.nlm.nih.gov/pubmed/23674164 www.ncbi.nlm.nih.gov/pmc/articles/PMC2929365 www.ncbi.nlm.nih.gov/pubmed/23674164 Examples of algorithms describing tumor screening processes http://jco.ascopubs.org/content/30/10/1024.full http://jco.ascopubs.org/content/30/10/1024.full PowerPoint presentations with focus on benefits of Lynch Syndrome screening Resources to inform stakeholders Getting Started

11. 2. Challenges with infrastructure Identifying and understand challenges in a large healthcare system from communication with stakeholders System culture - how new program decisions are made? – Evidence based review- does the science support the decision? – Financial impact (Prevention vs. Treatment) – New technology required?

12. What resources are needed during : – Development – Implementation – Ongoing From lab order through results management, what departments will be most impacted? – Pathology: Accommodating increased specimen management for testing – Laboratory/ IT : Increased resources for developing and implementing universal screening – Genetics: Increased resources during development as well as an potential change in volume of referrals. Challenges with infrastructure

13. How does a new process get integrated into complex, well established workflows? – What is the existing workflow for Lynch Syndrome screening? – Who are the owners of the current workflow? – Anticipate resistance to change! – Training requirements when new system is established.

14. Laboratory, pathology, and IT services require high level of commitment for process development. Engage identified leaders who will manage the development for the laboratory flow Determine pathology specimen flow from surgery to pathology laboratory – Specimen management by Inpatient pathologist and tech staff – Specimen management by Regional Lab pathologist and tech staf f Challenges with infrastructure

15. Laboratory/Pathology Design detailed work flow — Engage IT for programing of automated orders in computerized pathology system — Flow design of Lynch syndrome screening to complete with IT, lab, and genetics stakeholders — Identify training needs to ensure implementation processes are followed — Test the processes – QC from start to finish Challenges with infrastructure

16. Genetics – Lynch screening test results Development of appropriate work flow for results and patient education – Consistency in receiving results from testing lab – Incorporation of results into medical record – Appropriate providers informed of results – Disclosure of results to patient – Coordination of appropriate reflex testing – Lynch syndrome screening billing processes – Genetic counseling for patient as indicated – Workflow should maximize patient compliance

17. 3. Overcoming barriers Frequent communication before, during, and after implementation Identify and address problems as they arise — Pathologist work load impact- delay in specimen review, and sending to central laboratory causes delay for patient receiving results — Identifying need for training with lab staff Communicate with stakeholders after implementation has begun to: — Provide opportunity for feedback — Assess need for changes — Inform and keep engaged

18. Overcoming barriers Elements for successful Lynch screening implementation : — Identify decision makers — Engage stakeholders — Provide information to inform and facilitate buy-in — Meet with key personnel to develop the implementation plan — Keep channels of communication going during the process to ensure implementation plan is progressing — When hurdles arise- look to stakeholders and key personnel to assist with resolution of the problem Ongoing communication is a must with: — Pathology — Laboratory, IT — Genetics — Surgery — Oncology

19. Genetics – Lynch screening test results Development of appropriate work flow for results and patient education – Consistency in receiving results from testing lab » Will they be mailed/faxed/incorporated into electronic medical record? » A point person or department is essential as is a consistent method of sending/receiving results. – Incorporation of results into medical record » Where in the chart will the results go? » Will they be incorporated into the original pathology report? » They should be in the same place for each patient to ensure consistency and ease of locating results. Overcoming barriers

20. Genetics – Lynch screening test results Development of appropriate work flow for results and patient education – Appropriate providers informed of results » How do providers involved in care typically receive lab results? » Consider routing results directly to relevant stakeholders, holding a case conference with stakeholders for all screen positive cases, etc. – Disclosure of results to patient » How will results be disclosed to patient? » Letter or phone call with appropriate stakeholder; determine if all results or only abnormal results will be provided to patients etc. Overcoming barriers

21. Genetics – Lynch screening test results Development of appropriate work flow for results and patient education – Coordination of appropriate reflex testing » Who will be involved? What consenting may be indicated? » Consider how current workflows could be modified. » Consider which stakeholders should be closely involved with this task. – Lynch syndrome screening billing processes » What are the current billing processes/barriers? » Is an order in the EMR necessary for billing purposes? » Determine how will this impact workflow for a screening program. Overcoming barriers

22. Genetics – Lynch screening test results Development of appropriate work flow for results and patient education – Genetic counseling for patient as indicated » Consider patient education handouts for screen positive cases (prior to reflex testing if available). » Comprehensive Lynch syndrome screening program should consider genetic counseling of high risk cases if resources are available. » What will the patient population be in a more formal Genetics clinic setting once screening is in place? How will this impact clinic workflow? – Workflow should maximize patient compliance » EGAPP cost-effective analyses are based on appropriate at risk family members receiving cancer surveillance. » Strive to obtain patient compliance data to track screening implementation process successes. Overcoming barriers