ACCC Releases Biomarker Testing Implementation Roadmap

J Clin Pathways. 2021;7(9):18-19.

The Association of Community Cancer Centers (ACCC) released an innovative learning tool that helps multidisciplinary cancer care teams obtain the knowledge they need to implement, expand, and sustain biomarker testing for patients with advanced non–small cell lung cancer (NSCLC). The Roadmap gives users information about how to lay the groundwork for biomarker testing, how to train and prepare care teams to offer testing, how to implement testing, and how to evaluate ongoing progress. 

Section 1. Laying the Groundwork

It is important to have a strong foundation to implement, expand, and sustain biomarker testing at an institution. In this section of the Roadmap:

• Learn the basics of biomarker testing. There are now multiple biomarker-defined patient subgroups, with evidence showing that treatment with targeted therapies and immunotherapies leads to superior clinical outcomes when compared to traditional cytotoxic chemotherapy.
• Understand who should be tested and when. In the latest National Comprehensive Cancer Network recommendations, the NSCLC Panel recommends that clinicians obtain biomarker testing results for actionable biomarkers before administering first-line therapy, if clinically feasible. In the event comprehensive biomarker testing cannot be performed prior to therapy initiation, repeat testing should be considered at time of progression on first-line therapy if a lesion can be successfully accessed. 
• Gain insight into costs to institutions and patients.
• Assess the institution’s buy-in.
• Conduct an organizational readiness assessment. In this section of the Roadmap, access frameworks, tools, and resources available that can be adapted to meet an organization’s assessment needs.

Section 2. Preparing the Care Team

When planning to implement biomarker testing, it is important to prepare all care team members. In this section of the Roadmap:

• Learn about the role of clinical and nonclinical staff in biomarker testing. It is critical to develop institutional guidelines or reflex testing that everyone agrees upon. Communication is key. Ideally, oncology, pulmonology, and pathology would come together and decide on the panel that is going to be ordered, who is going to order it, and when. This shortens the timeline for patients and removes the guesswork for providers.
• Assess staff and communication needs. Biomarker testing requires a structured process that has stakeholder buy-in with minimal effort. The bare bones minimum is a four-person team: a person who acquires the tissue, a person who processes the tissue, a person who treats the patient and incorporates the results of the biomarker analysis, and an administrator to make sure the flow works. 
• Develop a project plan. When developing a project plan, account for the following: institutional buy-in, a physician champion, an operations team, a map of the current biomarker testing process, metrics to measure change from current to new process, an implementation timeline, and a process to assess the initiative once launched. 

Section 3. Implementing Biomarker Testing

Implementing biomarker testing can require different tools and resources for clinicians and patients. In this section of the Roadmap:

• Learn about selecting a laboratory for biomarker testing. Before selecting a third-party laboratory, ask questions like: What is the turnaround time? How many cells are needed for a panel? What is the policy if a patient cannot pay? What does the report look like?
• Assess clinical workflow needs. These include reflex texting policies, standard operating procedures, electronic health record order sets, algorithms, and more.
• Pilot and refine the initiative. The most common barriers to comprehensive biomarker testing include inadequate tissue samples, lack of established diagnostic pathways, and poor communication among providers, care teams, and patients. Look for opportunities to standardize or improve biomarker testing like professional education on sampling techniques, laboratory processes, and interdisciplinary communication; integration of pathology into the cancer care team; and use of  “lean” or other operational methodologies.

Section 4. Evaluating Progress

It is important to continually evaluate progress. In this section of the Roadmap:

• Learn why this evaluation is important. Evaluation allows for tracking of progress, as well as identification of areas where improvement is needed. Ideally, planning for evaluation should happen during development of the initiative. It is important to identify baseline data (if any are available), establish aim(s), develop metrics to measure success, and identify the types of data to be collected.
• Assess progress. Key metrics to review and measure include numerator and denominator (ie, how many people present with a new diagnosis of cancer in a specified timeframe); specimen stage distribution; distribution of patients who receive biomarker testing; adequacy of tissue for biomarker testing; and turnaround time for biomarker testing.
• Share results for continual improvement. An evaluation plan will help strategically capture, review, and share progress. The evaluation plan should identify how, when, and by whom data will be collected, as well as when data will be reviewed. Successful evaluation plans are based on metrics that measure if the intervention is working and data that are structured and easily accessible for quick review, including qualitative data from patients, providers, and/or staff.