An effective interdisciplinary team structure for initiatives based on this QI model would contain the following representatives:

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2 Contents Introduction... 2 QI Leadership and Team... 2 Self Assessment: Baseline Testing Rates and Workflow Processes... 3 Establishing Goals and Objectives... 4 Plan Do Study Act (PDSA)... 4 Examples of Key Barriers and Effective Changes... 5 Resources: Molecular Testing Guidelines... 7 Resources: Medical Oncology... 8 Resources: Pathology... 8 Resources: Pulmonology... 8 Resources: Radiology... 9

3 Introduction This Quality Improvement (QI) Toolkit contains resources that can be used to guide cancer programs and health systems that wish to achieve improvements in the molecular testing process for patients with advanced non small cell lung cancer (NSCLC). This Toolkit is based on Molecular Testing in NSCLC: A Strategic QI Initiative, a systems based initiative developed for medical oncologists, pathologists, pulmonologists, radiologists, surgeons, nurses, cancer registrars, and other health care professionals. The initiative was implemented at the Montefiore Einstein Center for Cancer Care (MECC) through a multifaceted collaboration between Albert Einstein College of Medicine of Yeshiva University and Montefiore Medical Center, Center for Continuing Medical Education (CCME) and MCM Education. Follow up data on molecular testing rates and processes reveal that MECC made significant progress and educated their clinicians about the importance of properly identifying and targeting molecular pathways of tumor progression in advanced NSCLC. Molecular testing rates in NSCLC increased as a result of process changes and clinician behavior. Clinicians at MECC acknowledged the value that the initiative provided and stated that they would continue to identify key opportunities to make ongoing quality improvements in the area of molecular testing in advanced NSCLC. An online CME certified activity that summarizes some key findings from the QI initiative will be available until December 2015 and may be accessed here: QI Leadership and Team Through the leadership of a medical oncologist championing the QI initiative, clinicians at MECC were guided through structured QI methodologies designed to help them improve molecular testing in patients with advanced NSCLC. Leadership and physician involvement from each of the key departments were essential when establishing the core QI team. The interdisciplinary nature of this team strengthened the ability of physicians, nurses, and administrators to work collaboratively to identify workflow improvement processes and establish changes that will improve patient outcomes. An effective interdisciplinary team structure for initiatives based on this QI model would contain the following representatives: Physician champion: a medical oncologist or pathologist who will lead the initiative Medical oncology: physician and nurse representatives from each of the medical oncology groups or practices affiliated with the institution Pathology: physician representatives from the pathology department of the institution Pulmonology: physician and nurse representatives from each of the pulmonology groups or practices affiliated with the institution and involved in lung biopsies Surgery: physician and nurse representatives from each of the thoracic surgery groups or practices affiliated with the institution and involved in lung biopsies

4 Radiology: physician representatives from each of the radiology and/or interventional radiology groups or practices affiliated with the institution and involved in lung biopsies QI representative: a QI professional from the quality/safety department and/or an external consultant or resource to assist and guide the team through process improvement methodologies CME/CE representative: a professional from the CME/CE department who can provide CME/CE credits to the clinicians involved in the QI initiative Administration leadership: a cancer program director or a department chair who will provide support and accountability as the QI initiative unfolds Self Assessment: Baseline Testing Rates and Workflow Processes The first step in this QI model is to review baseline molecular testing rates in patients with NSCLC. This may also be referred to as the current state, since institution specific improvements will be designed to improve molecular testing processes for patients with NSCLC. If the goal, for instance, is to test all eligible patients with advanced NSCLC for EGFR and ALK mutations in a timely fashion, then a process can be established to move the institution towards that goal. When the clinicians at MECC went through the self assessment process, they collected baseline data on EGFR and ALK testing rates for patients with NSCLC. They reviewed their cancer registry and identified NSCLC patients with an adenocarcinoma component. Then, they reviewed their EGFR and ALK testing rates for these patients to see how they were performing. The team also identified clinical workflow processes and analyzed how lung biopsies are performed, how molecular tests are ordered, and how those results are retrieved and utilized by medical oncologists. Key questions that can help guide the self assessment process include: What percentage of our advanced NSCLC biopsies currently undergo molecular testing? This will provide a baseline metric so that future changes can be compared against this standard. Why are some advanced NSCLC biopsies not undergoing molecular testing? This allows the team to perform a series of root cause analyses to identify all the factors that contribute to non testing. If the biopsy tissue is inadequate for molecular testing, how can we improve this? This allows the team to constructively provide feedback and identify opportunities for improvement with the physicians who are performing lung biopsies. Issues may arise that are pertinent or specific to each of the departments: pulmonology, surgery, and radiology. Should the team embrace or improve a pathology driven reflexive molecular testing process for molecular testing in NSCLC? Many cancer centers have established a reflexive pathway to ensure that all samples of advanced adenocarcinoma of the lung will undergo EGFR and ALK testing.

5 Working through a series of focus groups, workshops, and educational sessions, the clinicians at MECC identified key opportunities for process improvement and implemented them over the course of a year using Plan Do Study Act (PDSA) cycles for process improvement. Establishing Goals and Objectives The team at MECC decided to provide CME/CE credit for clinicians participating in the QI initiative, so they outlined specific educational learning objectives for each of their workshops, lectures, and discussion meetings to ensure that the information was evidence based, non biased, and compliant with all CME/CE guidelines and regulations. This QI Toolkit is designed to complement a series of educational meetings and discussions that include the following educational objectives: Discuss the importance of obtaining adequate tissue samples at biopsy of patients with NSCLC in order to do molecular testing Discuss the impact of an inadequate tissue sample on patient treatment and outcomes Explain the challenges that may arise in obtaining an adequate tissue sample and strategies to overcome these challenges Identify targeted treatments that would be indicated for patients with advanced NSCLC with positive biomarker findings Explain how the identification of different gene mutations in a patient with advanced NSCLC would affect treatment strategy Plan Do Study Act (PDSA) As the team at MECC reviewed their baseline testing rates and clinical workflow processes, they identified possible opportunities for improvement and used the structured PDSA cycle for improvement. The QI champion played a key role in working with the team to assess and prioritize the ideas that would lead to the greatest improvements.

6 The PDSA Worksheet is a useful tool when implementing a QI initiative. The PDSA cycle is a structured way to evaluate the impact of a change by developing a plan to test the change (Plan), carrying out the test (Do), observing and learning from the consequences (Study), and determining what modifications should be made to the test (Act). The PDSA Worksheet has been used by numerous health care organizations and forms the basis for the Institute for Healthcare Improvement (IHI) Model for Improvement. The QI team should identify 2 to 3 process changes that may lead to improvements in molecular testing and complete a PDSA orksheet for each of those changes. Use some of the resources listed below (guidelines, algorithms, published quality measures, etc.) to establish clear goals for improvement and assign members of the QI team to provide follow up to the larger group in 3 to 6 weeks.

7 Examples of Key Barriers and Effective Changes The following examples outline some effective changes that various health care organizations have implemented to improve their molecular testing process for patients with NSCLC: Key Barriers Clinicians, especially those performing lung biopsies, may not be aware of the latest clinical updates related to molecular testing and the application of targeted medical therapies for advanced NSCLC. Lung biopsy tissue samples are often inadequate for molecular testing, especially when they are obtained via fine needle aspiration (FNA). Physicians performing lung biopsies may not know the quality of their samples or if their samples are sufficient for testing. Molecular testing is delayed while the patient is waiting to be seen by the medical oncologist. The original pathology report may not indicate whether molecular test results have been ordered and are pending. Effective Changes Incorporate education about the clinical importance of EGFR and ALK testing and the use of targeted therapies. Establish consensus among physicians performing lung biopsies to standardize processes and increase the number of samples that are obtained during biopsy. The pathology department could provide Rapid On Site Evaluation (ROSE) at the bedside by sending a cytotechnician, a pathologist, or by using a telepathology service at the time of biopsy. Implementing a pathology driven reflexive testing process for patients with advanced NSCLC can decrease delay. Pathologists can be more proactive to clearly document at the top of the original pathology report about the status of molecular testing: test ordered and results are pending, or test was not ordered.

8 Resources: Molecular Testing Guidelines Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors OA Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Summary of Recommendations Resources: Medical Oncology National Comprehensive Cancer Network (NCCN) Guidelines NSCLC American Society of Clinical Oncology (ASCO) Non Small Cell Lung Cancer Treatment Plan and Summary Resources guidelines/non small cell lung cancer treatment plan and summary resources ASCO Quality Oncology Practice Initiative (QOPI) Quality Measures Resources: Pathology College of American Pathologists (CAP) Cancer Protocol Templates reporting tools/cancer protocol templates CAP Cancer Reporting Tools: Lung Biomarker Reporting Resources: Pulmonology An Official American Thoracic Society/European Respiratory Society Statement: The Role of the Pulmonologist in the Diagnosis and Management of Lung Cancer of Pulmonologist in Lung Ca.pdf Diagnosis and Management of Lung Cancer, 3rd ed: American College of Chest Physicians Evidence Based Clinical Practice Guidelines American College of Chest Physicians (ACCP) Performance Improvement Module on Performing EBUS TBNA to Diagnose Non Small Cell Lung Cancer. nsclc.chestnet.org

9 Resources: Radiology American College of Radiology (ACR) Appropriateness Criteria Radiologic Management of Thoracic Nodules and Masses Society of Interventional Radiology (SIR) Quality Improvement Guidelines for Percutaneous Needle Biopsy 5.pdf CT Guided Core Biopsy of Lung Lesions: A Primer Guidelines for Establishing a Quality Improvement Program in Interventional Radiology 1.pdf Transthoracic Needle Biopsy Pneumothorax after transthoracic needle biopsy of lung lesions under CT guidance