With the advances in minimally invasive sampling techniques, laboratories can perform multiple ancillary studies on small biopsy and cytology specimens to help in the diagnosis and management of pulmonary pathology. To provide treating physicians with valuable diagnostic, predictive, and prognostic information from small biopsy and cytology specimens, it is critical to establish evidence-based recommendations for the appropriate collection, handling, and triage for relevant ancillary tests.
To develop a clinical practice guideline that:
- Provides recommendations to clinicians obtaining samples within the thorax on how to obtain and handle adequate material for diagnostic testing.
- Provides recommendations to pathologists for the prioritization of testing and the appropriate processing of specimens. Effusions, touch preparations, fine-needle aspirations (FNA), and core needle biopsies (CNB) with lung carcinoma, extrathoracic metastatic disease, sarcoidosis, thymoma, granuloma, spindle cell neoplasm, hematologic disease, and infection will be addressed.
Diagnostic tests covered include immunoperoxidase studies, fluorescence in situ hybridization (FISH), mutational analysis, flow cytometry, cytogenetics, and microbiology performed in the pathology laboratory. The guideline will also address the use of rapid onsite evaluation (ROSE).
Overarching Question: During the collection, triage and processing/handling of minimally invasive pathology specimens from patients with suspected or undiagnosed thoracic abnormalities, what procedural or methodological variables have been shown to optimize testing outcomes so that pathologists can provide an evaluation and accurate diagnosis?
- With regard to each of the specimen types of interest (eg, effusions/pleural fluids, FNA, endobronchial ultrasound guided-FNA [EBUS-FNA], CNB), what evidence is available to determine the most effective protocols for sample collection, including:
- immediate handling of the specimen, such as how the needle biopsy is expelled from needle and selection of the appropriate media
- the minimum and maximum number of passes needed to ensure that the laboratory can obtain adequate materials for diagnostic testing
- the impact of ROSE on adequacy, quality, and triage of specimens
- With regard to each of the specimen types and the tests to be performed, what evidence is available to determine the most effective methods for the handling and processing of specimens, including:
- the selection of appropriate media (eg, liquids, tissue clot coagulum, fixed or unfixed) and the priority by disease
- the optimal ischemic time (ie, time between tissue removal and initiation of fixation)
- With regard to the various pathologic testing methods, what evidence is available to support an algorithm(s) for selection of specimens and sequence of testing, under defined circumstances?
- American Society of Chest Physicians
- American Society of Cytopathology
- American Thoracic Society
- Association for Molecular Pathology
- Papanicolaou Society of Cytopathology
- Pulmonary Pathology Society
- Society of Interventional Radiology
- Society of Thoracic Radiology
- Sinchita Roy Chowdhuri, MD, FCAP, Co-Chair
- Christopher R. Gilbert, DO, Co-Chair
- Sanja Dacic, MD, PhD, FCAP
- Mohiedean Ghofrani, MD, MBA, FCAP
- Peter Bela Illei, MD
- Lester J. Layfield, MD
- Christopher Lee, MD
- Claire Michael, MD
- Ross James Miller MD, FCAP
- Jason W. Mitchell, MD, MBA, MPH
- Boris Nikolic, MD, MBA
- Jan A. Nowak, MD, PhD, FCAP
- Nicholas J. Pastis, Jr., MD
- Carol Ann Rauch, MD, PhD, FCAP
- Amita Sharma, MD
- Paul VanderLaan, MD, PhD
- Jesse S. Voss, CT
- Brooke Billman, MLIS, AHIP
- Lesley Souter, PhD
- Nicole E. Thomas, MPH, CT(ASCP)cm