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Commentary: American Society of Cytopathology Rapid On-Site Evaluation (ROSE) Position Statement
Volume LII | Number 2
March 2015 T h e A S C B u l l e t i n ® i s p u b l i s h e d b y t h e A m e r i c a n S o c i e t y o f C y t o pat h o l o g y
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Commentary: American Society of Cytopathology Rapid On-Site Evaluation (ROSE) Position Statement
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Case Study: Oropharyngeal Fine Needle Aspiration on a 54 year old Woman
X
Cytopathology Program Directors ROSE Survey
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Book Review: Comprehensive Cytopathology
Commentary: American Society of Cytopathology Rapid On-Site Evaluation (ROSE) Position Statement Brian T. Collins, MD, Barbara DuBray-Benstein, PhD, SCT(ASCP)cm, Kalyani Naik, MS, SCT(ASCP), Michele A. Smith, MS, SCT(ASCP), and Patricia G. Tiscornia-Wasserman, MD, Position Statement and Guidelines Review Committee
Brian T. Collins, MD Washington University in St. Louis St. Louis, Missouri
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athologists are important members of the health care team that provide patient care. In all patient care settings, laboratory testing and diagnosis are critically important to the evaluation and treatment of patients. This spans the gamut from pathology consultation for transfusion reactions in the blood bank, frozen section interpretation in the operating room and pathologist performance of bone marrow biopsies. For cytopathology, the pathologist has traditionally been integrated into real time collaborative patient care for fine needle aspiration (FNA) biopsy. Pathologists can perform superficial and ultrasound-guided FNA biopsy as well as work collaboratively with a clinician performing an FNA biopsy in a deep seated organ or endoscopic procedure. The process of examining an FNA biopsy in real time at the procedural point of care is generally known as rapid on-site evaluation (ROSE).
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Barbara DuBray-Benstein, PhD, SCT(ASCP)CM University of Tennessee Health Science Center Memphis, Tennessee
Kalyani Naik, MS, SCT(ASCP) University of Michigan Medical Center Ann Arbor, Michigan
With the mounting emphasis on accurate and specific diagnoses in this era of personalized medicine, the use of ancillary and molecular studies will continue to expand.
The aim of this commentary is to expand and further extrapolate the ideas and concepts found in the American Society of Cytopathology (ASC) Position Statement for ROSE for FNA Biopsy. By necessity and in order to be as clear and effective as possible, position statements are ideally simple, short and clear. As a consequence, some of the more detailed explanations are limited. This commentary seeks to expound upon the ideas and concepts contained in the position statement in order to provide more explicit explanations for the concepts articulated. A complete and exhaustive discussion of the topic is beyond the scope of this exercise. The primary goal of the authors and committee members is for this commentary to provide a lucid and more in-depth explanation for the ideas and concepts expressed in the ASC’s Position Statement. At its core, ROSE is the immediate evaluation of FNA biopsy material by a pathologist or cytotechnologist. Its purpose is to assess the quality of the procedural biopsy and then use the information to determine how to optimally manage the patient’s procedure. An individual patient is at the center of the service. We believe it helps an individual patient and the clinician performing the FNA biopsy because of evidenced based studies and individual case experience. Clinicians performing the FNA biopsy ask a pathologist to assist with the FNA biopsy because they have seen how it benefits their patient. ROSE is not a required or mandated service. Clinicians who choose to forgo ROSE are free to do so. The physician performing the FNA biopsy has the primary responsibility for the patient and can choose to consult a pathologist for ROSE. The fact that many do request it and continue to use it speaks directly to their judgment about its value and contribution to patient care. Its use in many different healthcare systems throughout North America makes its value self-evident. Benefits for the individual patient include an assurance of adequacy and diagnosis. The ability to visualize a lesion, document placing a needle in it and then making aspirate smears is no guarantee of diagnostic adequacy. There are many variables which can contribute to absent or suboptimal tissue sampling to which the performing clinician is unaware or blinded without the assistance of a pathologist and ROSE. Cellularity alone is not adequacy. The organ being sampled, the clinical circumstances and past medical history all contribute to a global judgment of an on-site evaluation. By numbering and designating individual FNA passes, specific feedback can be provided which would assist further tissue sampling. For instance, if 3 FNA samples were performed, with pass #1 and pass #2 consisting of blood with pass #3 having some suspicious cells present, the performing clinician can take that information and direct the biopsy to an area near that #3 biopsy in an effort to obtain additional material and produce a diagnostic biopsy. In other circumstances, multiple lesions exist and if the first is nondiagnostic, a second can be attempted. Without ROSE, the clinician is faced with a choice between biopsying only one and not knowing the outcome, or biopsying both sites in an attempt to improve the chances for a diagnosis, despite being blinded to the results. When ROSE is available, the clinician can attempt a “smaller” lesion that is more accessible anatomically in hopes of having a diagnostic sample. If ROSE is able to confirm a diagnosis, the clinician was able to select a less clinically risky anatomic location and obtain a diagnosis. If the “smaller” lesion proves to be nondiagnostic, then the clinician is better justified in selecting and biopsying an area that is more difficult yet still clinically necessary for patient care. ROSE service provides the feedback and consultation necessary for the clinician to make those decisions in real time and be given information necessary to improve diagnostic yield for the patient. ROSE can be achieved in a wide variety of ways. The effectiveness of specific configurations will vary between different health care delivery systems. Some will work better than others, depending on the needs and demands of the individual infrastructure. For instance, a hospital based system where a cytology laboratory is in relative close physical contact to radiology or endoscopy suites will have its own resources and challenges. A hospital system where the FNA biopsies are performed in more outpatient settings or in buildings physically separate will have different challenges. And some delivery models will have a mix or spectrum of clinical practice II
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Michele A. Smith, MS, SCT(ASCP) Wisconsin State Laboratory of Hygiene Madison, Wisconsin
Patricia G. TiscorniaWasserman, MD Columbia University New York, New York
With recent improvements in molecular pathogenesis and the detection of specific targetable genetic variations in certain malignancies, molecular classification and genotyping are now vital for best therapeutic management.
settings, therefore no one style or form of ROSE can be said to be superior or preferred over another without knowledge of how it will be applied and in what setting it will be used. There is no “one size fits all” solution and there are innumerable acceptable practice configurations. Notwithstanding the valuable aspect of specimen adequacy (assessing if the quantity and the quality of material are satisfactory for diagnosis and ancillary work up), there are other significant benefits of ROSE. There are numerous clinical situations where evaluation and cellular material triaging can be critically important, aiding in reaching more accurate diagnoses and guiding in the selection of essential ancillary studies. With the mounting emphasis on accurate and specific diagnoses in this era of personalized medicine, the use of ancillary and molecular studies will continue to expand. With cytopathology at the forefront of cellular procurement, ROSE will be essential to ensure the correct collection and triage of patient’s cellular material. In specimen triage or sample allocation, the cytology professionals’ role is to direct the specimen and to request the tests deemed necessary for diagnostic, prognostic and therapeutic purposes. ROSE allows for a preliminary diagnosis so that additional material can be requested for ancillary studies. Specimens from superficial and deep-seated FNA are triaged first by staining an air dried smear immediately with Romanowsky stain for an on-site evaluation to determine specimen adequacy and, possibly, a preliminary diagnosis at the point of care. Later, alcohol-fixed direct smears are stained using the Papanicolaou technique for confirmation and final diagnosis. For each pass, the needle is rinsed (or samples are placed directly) in a liquid-based solution which allows for additional slide preparations and cell block evaluation. If appropriate, the rinsing may be placed in a transport medium, such as RPMI for flow cytometry to evaluate monoclonality in cases suspicious for lymphoproliferative disorders. Specimen aliquots or dedicated passes can be also triaged for genomics and proteomics typing as well as for molecular technologies, such as fluorescent in-situ hybridization (FISH), polymerase chain reaction (PCR) and next generation sequencing. With aspirates of fluid from cystic or cystic/solid lesions, such as in pancreatobiliary specimens, chemical analysis for tumor markers (such as CEA, amylase, etc) may be indicated. When an infectious process is suspected due to granulomatous inflammation or abscess appearance, the specimen is placed in culture transport medium for appropriate stains and cultures in the microbiology laboratory. Intra-procedural consultation or on-site evaluation of the FNA materials by a cytopathologist is cost-effective, allows for optimal sampling, and minimizes the result of unsatisfactory specimens. In addition, fewer passes are needed, diminishing the exposure to possible patient complications. There is robust evidence that triaging can be effectively done not only by cytopathologists but also by trained cytotechnologists and fellows. Many institutions use their expertise despite the absence of billing for their services. As the demand for ROSE increases and fee-for-service diminishes, cytotechnologists will take a greater role in the future. With recent improvements in molecular pathogenesis and the detection of specific targetable genetic variations in certain malignancies, molecular classification and genotyping are now vital for best therapeutic management. Many cytologic methods employed to acquire patient material for molecular testing have been proposed. These cytologic methods are becoming essential in an age of personalized medicine. These cytologic techniques include the use of cell blocks, direct cytologic smears and enriched techniques such as ThinPrep™ and cytospins preparations. With the current emphasis of minimally invasive diagnostic procedures such as EBUS, testing for epidermal growth factor receptor gene (EGFR) and anaplastic lymphoma kinase (ALK) is increasingly performed on small biopsy samples. Moreover, in patients with late-stage disease, FNA specimens may be the only material available for testing. Minimally invasive procedures such as EBUS are the procedure of choice in cases of surgically unresectable cancers due its lower rate of complications. In the latest guidelines from the CAP, International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology, cytologic samples are suitable for molecular testing, and cell blocks are the preferred medium. A recent study III
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The use of next-generation sequencing for the study of a broad genetic panel – including TERT, HRAS, BRAF V600E, TP53 and PIK3CA mutations and any gene fusions - has been found to significantly improve cancer diagnosis in indeterminate thyroid nodules, thus facilitating optimal management for these patients.
shows high concordance between results of lung adenocarcinoma molecular testing performed on cytology cell blocks and histology specimens and between primary and metastatic sites. Therefore, it is probable those results acquired from molecular testing of cytology specimens, such as in lung adenocarcinoma, are valid, and that cell blocks offer an effective medium. Lung adenocarcinomas have mutations of EGFR and Kirsten rat sarcoma (KRAS) that provide sensitivity to tyrosine kinase inhibitors. Targeted therapies with tyrosine kinase inhibitors improve survival in patients harboring EGFR mutations. Approximately 5% of NSCLC harbor ALK gene rearrangements. Targeted ALK tyrosine kinase inhibitors have been shown effective anticancer activity, thus ALK rearrangement presence confers significant therapeutic implications. FISH is currently considered the definite test for ALK status testing. Therefore, guaranteeing adequate lesional material during FNAs for the appropriate subclassification of NSCLC and subsequent molecular testing is of vital importance. The gamut of molecular tests applied to non-gynecologic cytology is rapidly growing. For example, PCR and FISH assays are applied to study the presence of specific gene rearrangements in lymphoproliferative processes and soft tissue neoplasms. FISH is widely used as an adjunct in the diagnosis of urothelial neoplasms. Human epidermal growth factor receptor 2 (HER2)/neu gene amplification is utilized in patients with breast cancer for prognostic and clinical management. Ancillary molecular studies in thyroid FNAs play an important role in the clinical management of patients. A panel of genetic mutations, including BRAF, RET-PTC and paired box gene-8peroxisome proliferator-activated receptor gamma (PAX8-PPARy), increase the diagnostic sensitivity and predictive value of indeterminate thyroid FNAs. The use of next-generation sequencing for the study of a broad genetic panel – including TERT, HRAS, BRAF V600E, TP53 and PIK3CA mutations and any gene fusions - has been found to significantly improve cancer diagnosis in indeterminate thyroid nodules, thus facilitating optimal management for these patients. Cytology professionals assist as consultants to clinicians in choosing appropriate molecular tests, operating as essential links between clinicians and the laboratory. Numerous studies have shown the relevance of cytology specimens for molecular testing. Cytologic specimens acquired with minimally invasive techniques tied with molecular analysis, offers a sophisticated way of enhancing diagnosis, establishing prognosis, predicting therapy response and disease monitoring. There are different points of view regarding who is best suited for providing ROSE; however, all have one main tenant in common and it is that those who provide the service must be appropriately trained and competent to provide the assessment. Currently, there are no standard training and assessment tools as expectations change based on organ system, medical facility, and available healthcare professionals. The main groups of healthcare professionals who have training to provide ROSE include: pathologists (residents/cytopathology fellows, cytopathologists and pathologists), and cytotechnologists. There are some non-laboratory physician clinicians who perform ROSE. Cytotechnologists spend a year of training in the field of cytopathology. It is expected that during the training program, that cytotechnology students will at least observe FNA biopsies during their clinical rotations. There are no standard numbers of hours or procedures that must be attained. Depending on the program and clinical rotation opportunities, student experiences may be as few as one or two per organ site. Cytotechnologists spend their year of training primarily honing morphologic location and interpretation skills. Upon graduation, it is expected that they will be well equipped to find abnormal cells and categorize them efficiently and accurately; two skills integral to efficiently and accurately determining adequacy during FNA procedures. What they frequently do not have is experience working closely with diverse medical professionals during FNA biopsy procedures. In this way, new cytotechnologists may be intimidated by clinical procedural physicians and must learn confidence skills on the job with the help of mentors. The role of a cytotechnologist for ROSE and FNA procedure varies by laboratory and can range from having little to no hands-on experience to serving as the main contact for FNA IV
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It was determined that final pathology diagnoses are the gold standard, but with intensive training pulmonologists in this study were able to provide an adequacy assessment.
procedures and assessment. The ways cytotechnologists serve is based on the culture of the laboratory, the hospital facility, the availability of the pathologist, and the knowledge base of the cytotechnologist. Training for becoming an “FNA cytotechnologist” varies as well. Many larger institutions incorporate a milestone approach with a new cytotechnologist being partnered with an experienced cytotechnologist or pathologist. The step by step training moves from observation, to “see-one/do-one,” to handing off duties while both are still present, and finally with the new cytotechnologist taking control upon approval and confidence of the mentor. The timeline for this training process may be a weeks or months; or may never progress, depending on the cytotechnologist and the facility. Often, the reigns are handed over during a short-staffed situation with the cytotechnologist “being thrown into the deep end” at some point during the training. Other methods of cytotechnologist training may include starting out with subcutaneous FNAs and moving into deep seeded procedures needing image guidance. Other times, new cytotechnologists are scheduled to work with clinicians who are open, supportive and agreeable to teaching and training. Radiologists, pulmonologists, gastroenterologists and other medical specialists are trained within their discipline much like pathology residents and fellows so that they may care for their patients. These training programs do not provide comprehensive pathology training, and as such, these professionals do not have adequate experience in tissue or cellular evaluation. Currently, there are no standards for how non-pathology clinicians are trained in ROSE for FNAs. As such, it is generally outside their scope of practice. And if performed within a hospital based facility, they would require specific privileges to practice ROSE independently. Bonifazi et al and others studied ROSE training for pulmonologists. In this study, two pulmonologists were trained in different ways with one receiving three months of weekly three-hour sessions with a pathologist and another studying theory through textbooks. The pulmonologists then evaluated 362 specimens using five diagnostic categories. Pathologists followed providing the same category assessment and provided final diagnoses. Statistical analysis between the pulmonologists and pathologists were comparable in terms of sensitivity (91% pulmonologist/95% pathologist); specificity (72% pulmonologist/92% pathologist); and accuracy (80% pulmonologist/92% pathologist). It was determined that final pathology diagnoses are the gold standard, but with intensive training pulmonologists in this study were able to provide an adequacy assessment. Harada et al and others studied endosonographers to show that ROSE accuracy would improve adequacy assessment on pancreatic FNAs after a two-hour intensive training session. In studies by Savoy and others however, endosonographers were shown to be inferior to cytotechnologists in learning how to interpret adequacy. Hayashi et al studied a group of endosonographers to assess adequacy of pancreatic lesions. The group focused on four out of ten cytological features of pancreatic carcinoma. They recommended that a grading system be used when training endosonographers in ROSE. Due to the lack of standardized training, it may not be possible to determine specific universal training needs because endosonographers have separate needs from pulmonologists; and radiologists would likely need different training because the larger number of lesions sampled. Cytotechnologists are uniquely qualified to not only provide ROSE, but also assist non-pathology clinicians in cytomorphology and adequacy assessment, as needed. Because cytotechnologists and pathologists ultimately have training in cell assessment, they are the most qualified professionals to provide adequacy assessments for FNA procedures. Cytotechnologists and pathologists have always worked closely together, and should continue to do so by providing assessment services as part of the health care team caring for patients. In academic medical centers, residents and fellows in ACGME approved pathology training programs are routinely members of the FNA team who also provide ROSE under the supervision of a credentialed, American Board of Pathology certified pathologist. Supervision may be direct V
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As the practice of medicine continues to move away from volume based reimbursement to value and patient outcomes based reimbursement, ROSE may play a vital role in effective and efficient patient care.
or indirect, depending on their level of experience. Decisions regarding triage of the specimen, procurement of additional material for ancillary testing or to terminate the procedure when sufficient diagnostic material has been obtained are important determinations. Residents and fellows need training in this vital role and, with supervised and progressive experience, may be relied upon to perform this task with indirect supervision. As in the case of cytotechnologists, pathology trainees provide a valuable staffing resource for ROSE service and significant time efficiency for attending pathologists. For medical directors of residency and fellowship programs, the challenge is to be able to determine when these pathology trainees are competent to perform ROSE in a supervised indirect manner. There are currently no specific ACGME program requirements that address this issue and no minimum number or types of procedures that should be performed. Accuracy rates for preliminary diagnosis or for evaluation of specimen adequacy vary for all personnel performing ROSE depending on their experience and clinical factors of individual procedures. With regard to fellows, Nasuti et al showed the accuracy rate for preliminary diagnosis in liver FNABs was 87%. Miller et al showed that the cytology fellows had an accuracy rate for determining specimen adequacy of 74% for abdominal FNABS and 92% for thoracic FNABs. The ability to provide a resident, fellow or cytotechnologist on site when the attending pathologist is unavailable is a true benefit to patient care. FNA with ROSE has been demonstrated to be an accurate, cost-effective procedure for diagnosis of masses in a variety of body sites. ROSE contributes significantly to improved patient care by reducing the need for additional passes, biopsies of additional sites, repeat biopsies and more invasive and costly procedures. In addition, ROSE contributes to more efficient utilization of laboratory resources by reducing the total number of slides needed per patient which translates to reduced cytotechnologist work effort in primary screening. In a study of EBUS FNA procedures, Collins et al demonstrated a 33% reduction in the number of sites sampled and 29.9% reduction in total slides with the introduction of EBUS FNA ROSE service at their institution. This reduction in the number of anatomic sites (235 fewer sites) sampled translated to a savings of 7.3 working days of procedure time, and the reduction in total slides (1790 fewer total slides) translated to slide smear review time savings of 18.6 working days for cytotechnologists and 11.19 working days for cytopathologists. As the practice of medicine continues to move away from volume based reimbursement to value and patient outcomes based reimbursement, ROSE may play a vital role in effective and efficient patient care. Despite these proven benefits, current reimbursement for the procedure fails to provide adequate compensation. The cost of the pathologists’ time and expertise for providing ROSE far outweighs current reimbursement rates. As a result, some pathologists, particularly in the setting of a busy practice, have concluded that their time is better spent at the microscope signing out cases. A study by Layfield et al, focusing on 142 fine-needle aspirations with ROSE performed in a variety of clinical settings, compared compensation for total pathologist attendance time with that of frozen section consultations. The amount of time required for ROSE varied between 34.7 and 56.2 minutes based on the type of procedure while the time required for frozen section was 15.7 minutes; cost exceeded compensation between $40 and $50 per procedure for all types of FNA except clinic aspirates, which exceeded compensation by $18. The study concluded that with the exception of FNAs performed by the cytopathologist (for which both 88172 and 88170 may be billed) Medicare compensation for CPT code 88172 was insufficient for the amount of time required. Despite already suboptimal reimbursement for ROSE, reimbursement was further diminished when CMS recently changed billing to allow only one unit of CPT code 88172 per specimen site, and introduced an “evaluation episode” with CPT code 88177 for each additional pass performed on the same site. A recent study by Mehrotra et al demonstrated that in spite of a rise in FNA procedures over the last four years, compensation declined. There was a decrease VI
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TCP permits the pathologist to save time by working from their office with time savings by decreased travel and improved efficiency when more biopsies have to be performed or other sites sampled.
of almost 50% in the dollar amount from 2009 to 2013, as well as a decrease in work Relative Value Units (wRVU). The wRVU and average reimbursement for 88177 was 0.42 and $17.38 (2012) while it was 0.64 and $33.32 for CPT code 88172 (2013). The study concluded that even though patient care decisions should not be based on compensation alone, the compensation for ROSE was substantially lower than compensation for surgical pathology biopsy ($42/hour vs $556/hour respectively), and this disparity can impact clinical practice. Strategies to utilize pathologist time and other laboratory resources more effectively given the suboptimal compensation for pathologist time to perform ROSE have included having a cytotechnologist provide adequacy assessment and call upon the pathologist only when difficult cases are encountered. Cytotechnologists may provide only an assessment of adequacy and not a preliminary diagnosis. Therefore use of cytotechnologist without pathologist participation may not be feasible in clinical scenarios where therapeutic decisions are made immediately based upon the on-site evaluation. Adequacy assessments performed by cytotechnologists cannot be billed as part of a professional physician billing system (Medicare/CMS). Nevertheless, laboratories have found it adds value to their multispecialty clinical practice and cytotechnologists are an integral part of their ROSE service. Wotruba et al demonstrated in their study of 167 thyroid FNA biopsies, cytotechnologists accurately provided immediate on-site adequacy assessments (as compared to the pathologist’s preliminary diagnosis) and use of cytotechnologists saved approximately $464 per case (based on gross technical and professional fees at the time the study was performed). In a 2014 CAP survey conducted to gather data regarding variations in the use of ROSE procedures and reported by Tambouret et al, more than two-thirds indicated cytotechnologists participate in ROSE, and half of those respondents indicated cytotechnologists assist on all ROSE cases. As laboratories continue to evaluate whether ROSE will be a financially sustainable in the future, medical reimbursement continues to decline, reimbursement models move away from fees for service, and as demand for FNA increases, cytotechnologists are well positioned to take on a greater role in providing ROSE service. Newer technologic advances can help in delivering ROSE service more efficiently. Chief among these are telecytopathology (TCP) technologies. TCP FNA ROSE service involves providing the microscopic view of the on-site material to the pathologist at a remote location. This is usually done by processing the FNA biopsy on-site in the usual manner, and then having a cytotechnologist use a microscope with a camera provide a live real-time video feed. This requires an investment in infrastructure and necessitates a cytotechnologist on-site for processing and viewing the material, working with the remote pathologist to provide the ROSE service. TCP permits the pathologist to save time by working from their office with time savings by decreased travel and improved efficiency when more biopsies have to be performed or other sites sampled. ROSE FNA service is an important and valuable clinical care activity provided by cytology laboratory professionals. In future, pathologists and cytotechnologists will continue to be an integral part of the patient focused health care team. Select References: 1. American Society of Cytopathology Rapid On‐Site Evaluation (ROSE) Position Statement.
2. http://www.cytopathology.org/wp-content/uploads/2013/05/ASC-ROSE-Position-Final-Committee-Document. pdf (accessed on 1/7/2015).
3. Bonifazi M, et al. The role of the pulmonologist in rapid on-site cytologic evaluation of transbronchial needle aspiration: a prospective study. Chest. 2014; 145(1):60-65.
4. Burlingame O, et al. On-site adequacy evaluations performed by cytotechnologists: correlation with final interpretations of 5241 image-guided FNA biopsies. Cancer Cytopathol. 2012; Jun 25 120(3):177-184.
5. Collins BT, et al. Improved laboratory resource utilization and patient care with the use of ROSE for EBUS FNA Biopsy. Cancer Cytopathol. 2013; 121:544-51
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6. Collins JA, et al. Cytotechnologists and on-site evaluation of adequacy.
Am Jour Roentgenol. 1986; 147:155-158
Korean J Pathol. 2013; 47:405-410.
15. Nasuti JF, et al. Diagnostic value and cost-effectiveness of on-site evaluation
improved self-diagnosed accuracy of EUS-guided FNA cytology of the
16. Nikiforov YE, et al. Highly accurate diagnosis of cancer in thyroid nodules
7. Harada R, et al. An expanded training program for endosonographers pancreas. Scandinavian J Gastroenterol. 2014; 49:1119-1123.
8. Hayashi T, et al. ROSE by endosonographer during EUS-guided FNA
of FNA specimens: review of 5,688 cases. Diagn Cytopathol. 2002; 27:1-4.
with follicular neoplasm/suspicious for follicular neoplasm cytology by ThyroSeq v2 next-generation sequencing assay. Cancer. 2014; In Press.
for pancreatic solid masses. J Gastroenterol and Hepatol. 2013; 28:656-663.
17. Santos GdC, et al. The petals and thorns of ROSE. Cancer Cytopathol.
forum focused on Europe. Cytopathol. 2014; 25:307-315.
18. Savoy AD, et al. Can endosconographers evaluate on-site cytology
9. Herbert A, et al. Training and practice of cytotechnologists: a discussion 10. Heymann JJ, et al. Molecular testing guidelines for lung adenocarcinoma: Utility of cell blocks and concordance between FNA cytology and histology samples. Cytojournal. 2014; 11:12
11. Knoepp SM, et al. Ancillary techniques on direct-smear aspirate slides: a significant evolution for cytopathology techniques. Cancer Cytopathol.
2013; Jan 121(1): 4-8.
adequacy? A comparison with cytotechnologists. Gastrointestinal Endoscopy. 2007; 65(7):953-957.
19. Schmidt RL, et al. The Influence of ROSE on the adequacy rate of FNA
cytology. a systematic review and meta-analysis. Am J Clin Pathol. 2013; 139: 300-308.
2013; 121(3):120-128.
20. Shield P, et al. ROSE of FNA specimens by cytology scientists: a review of
and compensation analysis. Cancer Cytopathol. 2001; 93(5):
21. Stelow EB. Who should perform rapid or on-site assessment of thyroid
Pathol. 2014; 27(Suppl 2):112A-113A.
22. Tambouret RH, et al. ROSE: how practice varies. CAP Today. 2014; May:
12. Layfield LJ, et al. Immediate on-site interpretation of FNA smears – a cost 13. Mehrotra S, et al. (ROSE)-is it affordable to provide this service? Mod 14. Miller DA, et al. FNA Biopsy: The role of immediate cytologic assessment.
3032 specimens. Cytopathol. 2014; 25:322-329.
FNA aspirations? Am J Clin Pathol. 2012; 138:8-9. 29-31.
ASCP/ASC
Advanced Cytopathology Education Personalized for your future
New ASCP/ASC Advanced Cytopathology Education Program Thomas Jefferson University, Philadelphia, PA June 13-14, 2015 “This collaboration between ASC and the ASCP is designed to support cytotechnologists locally as they identify emerging opportunities and strengthen their skill set through personalized education.” Amy Wendel Spiczka, SCT(ASCP)CMMBCM,HTLCM, Manager Anatomic Pathology, Dept. of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, Ariz.
This two-day Cytopathology education program, designed by renowned faculty and customized from your input, will assist Cytotechnologists in developing new skills to meet the latest healthcare advances and challenges. Cytopathologists, Residents, and Students are also encouraged to attend.
Don’t miss this education program personalized to support your future success! For more info visit: ascp.org/ACE
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March 2015 T h e A S C B u l l e t i n ® i s p u b l i s h e d b y t h e A m e r i c a n S o c i e t y o f C y t o pat h o l o g y
I
Commentary: American Society of Cytopathology Rapid On-Site Evaluation (ROSE) Position Statement
IX
Case Study: Oropharyngeal Fine Needle Aspiration on a 54 year old Woman
X
Cytopathology Program Directors ROSE Survey
XII
Book Review: Comprehensive Cytopathology
Commentary: American Society of Cytopathology Rapid On-Site Evaluation (ROSE) Position Statement Brian T. Collins, MD, Barbara DuBray-Benstein, PhD, SCT(ASCP)cm, Kalyani Naik, MS, SCT(ASCP), Michele A. Smith, MS, SCT(ASCP), and Patricia G. Tiscornia-Wasserman, MD, Position Statement and Guidelines Review Committee
Brian T. Collins, MD Washington University in St. Louis St. Louis, Missouri
P
athologists are important members of the health care team that provide patient care. In all patient care settings, laboratory testing and diagnosis are critically important to the evaluation and treatment of patients. This spans the gamut from pathology consultation for transfusion reactions in the blood bank, frozen section interpretation in the operating room and pathologist performance of bone marrow biopsies. For cytopathology, the pathologist has traditionally been integrated into real time collaborative patient care for fine needle aspiration (FNA) biopsy. Pathologists can perform superficial and ultrasound-guided FNA biopsy as well as work collaboratively with a clinician performing an FNA biopsy in a deep seated organ or endoscopic procedure. The process of examining an FNA biopsy in real time at the procedural point of care is generally known as rapid on-site evaluation (ROSE).
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Volume LII | Number 2 | MARCH 2015
Barbara DuBray-Benstein, PhD, SCT(ASCP)CM University of Tennessee Health Science Center Memphis, Tennessee
Kalyani Naik, MS, SCT(ASCP) University of Michigan Medical Center Ann Arbor, Michigan
With the mounting emphasis on accurate and specific diagnoses in this era of personalized medicine, the use of ancillary and molecular studies will continue to expand.
The aim of this commentary is to expand and further extrapolate the ideas and concepts found in the American Society of Cytopathology (ASC) Position Statement for ROSE for FNA Biopsy. By necessity and in order to be as clear and effective as possible, position statements are ideally simple, short and clear. As a consequence, some of the more detailed explanations are limited. This commentary seeks to expound upon the ideas and concepts contained in the position statement in order to provide more explicit explanations for the concepts articulated. A complete and exhaustive discussion of the topic is beyond the scope of this exercise. The primary goal of the authors and committee members is for this commentary to provide a lucid and more in-depth explanation for the ideas and concepts expressed in the ASC’s Position Statement. At its core, ROSE is the immediate evaluation of FNA biopsy material by a pathologist or cytotechnologist. Its purpose is to assess the quality of the procedural biopsy and then use the information to determine how to optimally manage the patient’s procedure. An individual patient is at the center of the service. We believe it helps an individual patient and the clinician performing the FNA biopsy because of evidenced based studies and individual case experience. Clinicians performing the FNA biopsy ask a pathologist to assist with the FNA biopsy because they have seen how it benefits their patient. ROSE is not a required or mandated service. Clinicians who choose to forgo ROSE are free to do so. The physician performing the FNA biopsy has the primary responsibility for the patient and can choose to consult a pathologist for ROSE. The fact that many do request it and continue to use it speaks directly to their judgment about its value and contribution to patient care. Its use in many different healthcare systems throughout North America makes its value self-evident. Benefits for the individual patient include an assurance of adequacy and diagnosis. The ability to visualize a lesion, document placing a needle in it and then making aspirate smears is no guarantee of diagnostic adequacy. There are many variables which can contribute to absent or suboptimal tissue sampling to which the performing clinician is unaware or blinded without the assistance of a pathologist and ROSE. Cellularity alone is not adequacy. The organ being sampled, the clinical circumstances and past medical history all contribute to a global judgment of an on-site evaluation. By numbering and designating individual FNA passes, specific feedback can be provided which would assist further tissue sampling. For instance, if 3 FNA samples were performed, with pass #1 and pass #2 consisting of blood with pass #3 having some suspicious cells present, the performing clinician can take that information and direct the biopsy to an area near that #3 biopsy in an effort to obtain additional material and produce a diagnostic biopsy. In other circumstances, multiple lesions exist and if the first is nondiagnostic, a second can be attempted. Without ROSE, the clinician is faced with a choice between biopsying only one and not knowing the outcome, or biopsying both sites in an attempt to improve the chances for a diagnosis, despite being blinded to the results. When ROSE is available, the clinician can attempt a “smaller” lesion that is more accessible anatomically in hopes of having a diagnostic sample. If ROSE is able to confirm a diagnosis, the clinician was able to select a less clinically risky anatomic location and obtain a diagnosis. If the “smaller” lesion proves to be nondiagnostic, then the clinician is better justified in selecting and biopsying an area that is more difficult yet still clinically necessary for patient care. ROSE service provides the feedback and consultation necessary for the clinician to make those decisions in real time and be given information necessary to improve diagnostic yield for the patient. ROSE can be achieved in a wide variety of ways. The effectiveness of specific configurations will vary between different health care delivery systems. Some will work better than others, depending on the needs and demands of the individual infrastructure. For instance, a hospital based system where a cytology laboratory is in relative close physical contact to radiology or endoscopy suites will have its own resources and challenges. A hospital system where the FNA biopsies are performed in more outpatient settings or in buildings physically separate will have different challenges. And some delivery models will have a mix or spectrum of clinical practice II
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Michele A. Smith, MS, SCT(ASCP) Wisconsin State Laboratory of Hygiene Madison, Wisconsin
Patricia G. TiscorniaWasserman, MD Columbia University New York, New York
With recent improvements in molecular pathogenesis and the detection of specific targetable genetic variations in certain malignancies, molecular classification and genotyping are now vital for best therapeutic management.
settings, therefore no one style or form of ROSE can be said to be superior or preferred over another without knowledge of how it will be applied and in what setting it will be used. There is no “one size fits all” solution and there are innumerable acceptable practice configurations. Notwithstanding the valuable aspect of specimen adequacy (assessing if the quantity and the quality of material are satisfactory for diagnosis and ancillary work up), there are other significant benefits of ROSE. There are numerous clinical situations where evaluation and cellular material triaging can be critically important, aiding in reaching more accurate diagnoses and guiding in the selection of essential ancillary studies. With the mounting emphasis on accurate and specific diagnoses in this era of personalized medicine, the use of ancillary and molecular studies will continue to expand. With cytopathology at the forefront of cellular procurement, ROSE will be essential to ensure the correct collection and triage of patient’s cellular material. In specimen triage or sample allocation, the cytology professionals’ role is to direct the specimen and to request the tests deemed necessary for diagnostic, prognostic and therapeutic purposes. ROSE allows for a preliminary diagnosis so that additional material can be requested for ancillary studies. Specimens from superficial and deep-seated FNA are triaged first by staining an air dried smear immediately with Romanowsky stain for an on-site evaluation to determine specimen adequacy and, possibly, a preliminary diagnosis at the point of care. Later, alcohol-fixed direct smears are stained using the Papanicolaou technique for confirmation and final diagnosis. For each pass, the needle is rinsed (or samples are placed directly) in a liquid-based solution which allows for additional slide preparations and cell block evaluation. If appropriate, the rinsing may be placed in a transport medium, such as RPMI for flow cytometry to evaluate monoclonality in cases suspicious for lymphoproliferative disorders. Specimen aliquots or dedicated passes can be also triaged for genomics and proteomics typing as well as for molecular technologies, such as fluorescent in-situ hybridization (FISH), polymerase chain reaction (PCR) and next generation sequencing. With aspirates of fluid from cystic or cystic/solid lesions, such as in pancreatobiliary specimens, chemical analysis for tumor markers (such as CEA, amylase, etc) may be indicated. When an infectious process is suspected due to granulomatous inflammation or abscess appearance, the specimen is placed in culture transport medium for appropriate stains and cultures in the microbiology laboratory. Intra-procedural consultation or on-site evaluation of the FNA materials by a cytopathologist is cost-effective, allows for optimal sampling, and minimizes the result of unsatisfactory specimens. In addition, fewer passes are needed, diminishing the exposure to possible patient complications. There is robust evidence that triaging can be effectively done not only by cytopathologists but also by trained cytotechnologists and fellows. Many institutions use their expertise despite the absence of billing for their services. As the demand for ROSE increases and fee-for-service diminishes, cytotechnologists will take a greater role in the future. With recent improvements in molecular pathogenesis and the detection of specific targetable genetic variations in certain malignancies, molecular classification and genotyping are now vital for best therapeutic management. Many cytologic methods employed to acquire patient material for molecular testing have been proposed. These cytologic methods are becoming essential in an age of personalized medicine. These cytologic techniques include the use of cell blocks, direct cytologic smears and enriched techniques such as ThinPrep™ and cytospins preparations. With the current emphasis of minimally invasive diagnostic procedures such as EBUS, testing for epidermal growth factor receptor gene (EGFR) and anaplastic lymphoma kinase (ALK) is increasingly performed on small biopsy samples. Moreover, in patients with late-stage disease, FNA specimens may be the only material available for testing. Minimally invasive procedures such as EBUS are the procedure of choice in cases of surgically unresectable cancers due its lower rate of complications. In the latest guidelines from the CAP, International Association for the Study of Lung Cancer (IASLC), and Association for Molecular Pathology, cytologic samples are suitable for molecular testing, and cell blocks are the preferred medium. A recent study III
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The use of next-generation sequencing for the study of a broad genetic panel – including TERT, HRAS, BRAF V600E, TP53 and PIK3CA mutations and any gene fusions - has been found to significantly improve cancer diagnosis in indeterminate thyroid nodules, thus facilitating optimal management for these patients.
shows high concordance between results of lung adenocarcinoma molecular testing performed on cytology cell blocks and histology specimens and between primary and metastatic sites. Therefore, it is probable those results acquired from molecular testing of cytology specimens, such as in lung adenocarcinoma, are valid, and that cell blocks offer an effective medium. Lung adenocarcinomas have mutations of EGFR and Kirsten rat sarcoma (KRAS) that provide sensitivity to tyrosine kinase inhibitors. Targeted therapies with tyrosine kinase inhibitors improve survival in patients harboring EGFR mutations. Approximately 5% of NSCLC harbor ALK gene rearrangements. Targeted ALK tyrosine kinase inhibitors have been shown effective anticancer activity, thus ALK rearrangement presence confers significant therapeutic implications. FISH is currently considered the definite test for ALK status testing. Therefore, guaranteeing adequate lesional material during FNAs for the appropriate subclassification of NSCLC and subsequent molecular testing is of vital importance. The gamut of molecular tests applied to non-gynecologic cytology is rapidly growing. For example, PCR and FISH assays are applied to study the presence of specific gene rearrangements in lymphoproliferative processes and soft tissue neoplasms. FISH is widely used as an adjunct in the diagnosis of urothelial neoplasms. Human epidermal growth factor receptor 2 (HER2)/neu gene amplification is utilized in patients with breast cancer for prognostic and clinical management. Ancillary molecular studies in thyroid FNAs play an important role in the clinical management of patients. A panel of genetic mutations, including BRAF, RET-PTC and paired box gene-8peroxisome proliferator-activated receptor gamma (PAX8-PPARy), increase the diagnostic sensitivity and predictive value of indeterminate thyroid FNAs. The use of next-generation sequencing for the study of a broad genetic panel – including TERT, HRAS, BRAF V600E, TP53 and PIK3CA mutations and any gene fusions - has been found to significantly improve cancer diagnosis in indeterminate thyroid nodules, thus facilitating optimal management for these patients. Cytology professionals assist as consultants to clinicians in choosing appropriate molecular tests, operating as essential links between clinicians and the laboratory. Numerous studies have shown the relevance of cytology specimens for molecular testing. Cytologic specimens acquired with minimally invasive techniques tied with molecular analysis, offers a sophisticated way of enhancing diagnosis, establishing prognosis, predicting therapy response and disease monitoring. There are different points of view regarding who is best suited for providing ROSE; however, all have one main tenant in common and it is that those who provide the service must be appropriately trained and competent to provide the assessment. Currently, there are no standard training and assessment tools as expectations change based on organ system, medical facility, and available healthcare professionals. The main groups of healthcare professionals who have training to provide ROSE include: pathologists (residents/cytopathology fellows, cytopathologists and pathologists), and cytotechnologists. There are some non-laboratory physician clinicians who perform ROSE. Cytotechnologists spend a year of training in the field of cytopathology. It is expected that during the training program, that cytotechnology students will at least observe FNA biopsies during their clinical rotations. There are no standard numbers of hours or procedures that must be attained. Depending on the program and clinical rotation opportunities, student experiences may be as few as one or two per organ site. Cytotechnologists spend their year of training primarily honing morphologic location and interpretation skills. Upon graduation, it is expected that they will be well equipped to find abnormal cells and categorize them efficiently and accurately; two skills integral to efficiently and accurately determining adequacy during FNA procedures. What they frequently do not have is experience working closely with diverse medical professionals during FNA biopsy procedures. In this way, new cytotechnologists may be intimidated by clinical procedural physicians and must learn confidence skills on the job with the help of mentors. The role of a cytotechnologist for ROSE and FNA procedure varies by laboratory and can range from having little to no hands-on experience to serving as the main contact for FNA IV
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It was determined that final pathology diagnoses are the gold standard, but with intensive training pulmonologists in this study were able to provide an adequacy assessment.
procedures and assessment. The ways cytotechnologists serve is based on the culture of the laboratory, the hospital facility, the availability of the pathologist, and the knowledge base of the cytotechnologist. Training for becoming an “FNA cytotechnologist” varies as well. Many larger institutions incorporate a milestone approach with a new cytotechnologist being partnered with an experienced cytotechnologist or pathologist. The step by step training moves from observation, to “see-one/do-one,” to handing off duties while both are still present, and finally with the new cytotechnologist taking control upon approval and confidence of the mentor. The timeline for this training process may be a weeks or months; or may never progress, depending on the cytotechnologist and the facility. Often, the reigns are handed over during a short-staffed situation with the cytotechnologist “being thrown into the deep end” at some point during the training. Other methods of cytotechnologist training may include starting out with subcutaneous FNAs and moving into deep seeded procedures needing image guidance. Other times, new cytotechnologists are scheduled to work with clinicians who are open, supportive and agreeable to teaching and training. Radiologists, pulmonologists, gastroenterologists and other medical specialists are trained within their discipline much like pathology residents and fellows so that they may care for their patients. These training programs do not provide comprehensive pathology training, and as such, these professionals do not have adequate experience in tissue or cellular evaluation. Currently, there are no standards for how non-pathology clinicians are trained in ROSE for FNAs. As such, it is generally outside their scope of practice. And if performed within a hospital based facility, they would require specific privileges to practice ROSE independently. Bonifazi et al and others studied ROSE training for pulmonologists. In this study, two pulmonologists were trained in different ways with one receiving three months of weekly three-hour sessions with a pathologist and another studying theory through textbooks. The pulmonologists then evaluated 362 specimens using five diagnostic categories. Pathologists followed providing the same category assessment and provided final diagnoses. Statistical analysis between the pulmonologists and pathologists were comparable in terms of sensitivity (91% pulmonologist/95% pathologist); specificity (72% pulmonologist/92% pathologist); and accuracy (80% pulmonologist/92% pathologist). It was determined that final pathology diagnoses are the gold standard, but with intensive training pulmonologists in this study were able to provide an adequacy assessment. Harada et al and others studied endosonographers to show that ROSE accuracy would improve adequacy assessment on pancreatic FNAs after a two-hour intensive training session. In studies by Savoy and others however, endosonographers were shown to be inferior to cytotechnologists in learning how to interpret adequacy. Hayashi et al studied a group of endosonographers to assess adequacy of pancreatic lesions. The group focused on four out of ten cytological features of pancreatic carcinoma. They recommended that a grading system be used when training endosonographers in ROSE. Due to the lack of standardized training, it may not be possible to determine specific universal training needs because endosonographers have separate needs from pulmonologists; and radiologists would likely need different training because the larger number of lesions sampled. Cytotechnologists are uniquely qualified to not only provide ROSE, but also assist non-pathology clinicians in cytomorphology and adequacy assessment, as needed. Because cytotechnologists and pathologists ultimately have training in cell assessment, they are the most qualified professionals to provide adequacy assessments for FNA procedures. Cytotechnologists and pathologists have always worked closely together, and should continue to do so by providing assessment services as part of the health care team caring for patients. In academic medical centers, residents and fellows in ACGME approved pathology training programs are routinely members of the FNA team who also provide ROSE under the supervision of a credentialed, American Board of Pathology certified pathologist. Supervision may be direct V
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As the practice of medicine continues to move away from volume based reimbursement to value and patient outcomes based reimbursement, ROSE may play a vital role in effective and efficient patient care.
or indirect, depending on their level of experience. Decisions regarding triage of the specimen, procurement of additional material for ancillary testing or to terminate the procedure when sufficient diagnostic material has been obtained are important determinations. Residents and fellows need training in this vital role and, with supervised and progressive experience, may be relied upon to perform this task with indirect supervision. As in the case of cytotechnologists, pathology trainees provide a valuable staffing resource for ROSE service and significant time efficiency for attending pathologists. For medical directors of residency and fellowship programs, the challenge is to be able to determine when these pathology trainees are competent to perform ROSE in a supervised indirect manner. There are currently no specific ACGME program requirements that address this issue and no minimum number or types of procedures that should be performed. Accuracy rates for preliminary diagnosis or for evaluation of specimen adequacy vary for all personnel performing ROSE depending on their experience and clinical factors of individual procedures. With regard to fellows, Nasuti et al showed the accuracy rate for preliminary diagnosis in liver FNABs was 87%. Miller et al showed that the cytology fellows had an accuracy rate for determining specimen adequacy of 74% for abdominal FNABS and 92% for thoracic FNABs. The ability to provide a resident, fellow or cytotechnologist on site when the attending pathologist is unavailable is a true benefit to patient care. FNA with ROSE has been demonstrated to be an accurate, cost-effective procedure for diagnosis of masses in a variety of body sites. ROSE contributes significantly to improved patient care by reducing the need for additional passes, biopsies of additional sites, repeat biopsies and more invasive and costly procedures. In addition, ROSE contributes to more efficient utilization of laboratory resources by reducing the total number of slides needed per patient which translates to reduced cytotechnologist work effort in primary screening. In a study of EBUS FNA procedures, Collins et al demonstrated a 33% reduction in the number of sites sampled and 29.9% reduction in total slides with the introduction of EBUS FNA ROSE service at their institution. This reduction in the number of anatomic sites (235 fewer sites) sampled translated to a savings of 7.3 working days of procedure time, and the reduction in total slides (1790 fewer total slides) translated to slide smear review time savings of 18.6 working days for cytotechnologists and 11.19 working days for cytopathologists. As the practice of medicine continues to move away from volume based reimbursement to value and patient outcomes based reimbursement, ROSE may play a vital role in effective and efficient patient care. Despite these proven benefits, current reimbursement for the procedure fails to provide adequate compensation. The cost of the pathologists’ time and expertise for providing ROSE far outweighs current reimbursement rates. As a result, some pathologists, particularly in the setting of a busy practice, have concluded that their time is better spent at the microscope signing out cases. A study by Layfield et al, focusing on 142 fine-needle aspirations with ROSE performed in a variety of clinical settings, compared compensation for total pathologist attendance time with that of frozen section consultations. The amount of time required for ROSE varied between 34.7 and 56.2 minutes based on the type of procedure while the time required for frozen section was 15.7 minutes; cost exceeded compensation between $40 and $50 per procedure for all types of FNA except clinic aspirates, which exceeded compensation by $18. The study concluded that with the exception of FNAs performed by the cytopathologist (for which both 88172 and 88170 may be billed) Medicare compensation for CPT code 88172 was insufficient for the amount of time required. Despite already suboptimal reimbursement for ROSE, reimbursement was further diminished when CMS recently changed billing to allow only one unit of CPT code 88172 per specimen site, and introduced an “evaluation episode” with CPT code 88177 for each additional pass performed on the same site. A recent study by Mehrotra et al demonstrated that in spite of a rise in FNA procedures over the last four years, compensation declined. There was a decrease VI
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TCP permits the pathologist to save time by working from their office with time savings by decreased travel and improved efficiency when more biopsies have to be performed or other sites sampled.
of almost 50% in the dollar amount from 2009 to 2013, as well as a decrease in work Relative Value Units (wRVU). The wRVU and average reimbursement for 88177 was 0.42 and $17.38 (2012) while it was 0.64 and $33.32 for CPT code 88172 (2013). The study concluded that even though patient care decisions should not be based on compensation alone, the compensation for ROSE was substantially lower than compensation for surgical pathology biopsy ($42/hour vs $556/hour respectively), and this disparity can impact clinical practice. Strategies to utilize pathologist time and other laboratory resources more effectively given the suboptimal compensation for pathologist time to perform ROSE have included having a cytotechnologist provide adequacy assessment and call upon the pathologist only when difficult cases are encountered. Cytotechnologists may provide only an assessment of adequacy and not a preliminary diagnosis. Therefore use of cytotechnologist without pathologist participation may not be feasible in clinical scenarios where therapeutic decisions are made immediately based upon the on-site evaluation. Adequacy assessments performed by cytotechnologists cannot be billed as part of a professional physician billing system (Medicare/CMS). Nevertheless, laboratories have found it adds value to their multispecialty clinical practice and cytotechnologists are an integral part of their ROSE service. Wotruba et al demonstrated in their study of 167 thyroid FNA biopsies, cytotechnologists accurately provided immediate on-site adequacy assessments (as compared to the pathologist’s preliminary diagnosis) and use of cytotechnologists saved approximately $464 per case (based on gross technical and professional fees at the time the study was performed). In a 2014 CAP survey conducted to gather data regarding variations in the use of ROSE procedures and reported by Tambouret et al, more than two-thirds indicated cytotechnologists participate in ROSE, and half of those respondents indicated cytotechnologists assist on all ROSE cases. As laboratories continue to evaluate whether ROSE will be a financially sustainable in the future, medical reimbursement continues to decline, reimbursement models move away from fees for service, and as demand for FNA increases, cytotechnologists are well positioned to take on a greater role in providing ROSE service. Newer technologic advances can help in delivering ROSE service more efficiently. Chief among these are telecytopathology (TCP) technologies. TCP FNA ROSE service involves providing the microscopic view of the on-site material to the pathologist at a remote location. This is usually done by processing the FNA biopsy on-site in the usual manner, and then having a cytotechnologist use a microscope with a camera provide a live real-time video feed. This requires an investment in infrastructure and necessitates a cytotechnologist on-site for processing and viewing the material, working with the remote pathologist to provide the ROSE service. TCP permits the pathologist to save time by working from their office with time savings by decreased travel and improved efficiency when more biopsies have to be performed or other sites sampled. ROSE FNA service is an important and valuable clinical care activity provided by cytology laboratory professionals. In future, pathologists and cytotechnologists will continue to be an integral part of the patient focused health care team. Select References: 1. American Society of Cytopathology Rapid On‐Site Evaluation (ROSE) Position Statement.
2. http://www.cytopathology.org/wp-content/uploads/2013/05/ASC-ROSE-Position-Final-Committee-Document. pdf (accessed on 1/7/2015).
3. Bonifazi M, et al. The role of the pulmonologist in rapid on-site cytologic evaluation of transbronchial needle aspiration: a prospective study. Chest. 2014; 145(1):60-65.
4. Burlingame O, et al. On-site adequacy evaluations performed by cytotechnologists: correlation with final interpretations of 5241 image-guided FNA biopsies. Cancer Cytopathol. 2012; Jun 25 120(3):177-184.
5. Collins BT, et al. Improved laboratory resource utilization and patient care with the use of ROSE for EBUS FNA Biopsy. Cancer Cytopathol. 2013; 121:544-51
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6. Collins JA, et al. Cytotechnologists and on-site evaluation of adequacy.
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Korean J Pathol. 2013; 47:405-410.
15. Nasuti JF, et al. Diagnostic value and cost-effectiveness of on-site evaluation
improved self-diagnosed accuracy of EUS-guided FNA cytology of the
16. Nikiforov YE, et al. Highly accurate diagnosis of cancer in thyroid nodules
7. Harada R, et al. An expanded training program for endosonographers pancreas. Scandinavian J Gastroenterol. 2014; 49:1119-1123.
8. Hayashi T, et al. ROSE by endosonographer during EUS-guided FNA
of FNA specimens: review of 5,688 cases. Diagn Cytopathol. 2002; 27:1-4.
with follicular neoplasm/suspicious for follicular neoplasm cytology by ThyroSeq v2 next-generation sequencing assay. Cancer. 2014; In Press.
for pancreatic solid masses. J Gastroenterol and Hepatol. 2013; 28:656-663.
17. Santos GdC, et al. The petals and thorns of ROSE. Cancer Cytopathol.
forum focused on Europe. Cytopathol. 2014; 25:307-315.
18. Savoy AD, et al. Can endosconographers evaluate on-site cytology
9. Herbert A, et al. Training and practice of cytotechnologists: a discussion 10. Heymann JJ, et al. Molecular testing guidelines for lung adenocarcinoma: Utility of cell blocks and concordance between FNA cytology and histology samples. Cytojournal. 2014; 11:12
11. Knoepp SM, et al. Ancillary techniques on direct-smear aspirate slides: a significant evolution for cytopathology techniques. Cancer Cytopathol.
2013; Jan 121(1): 4-8.
adequacy? A comparison with cytotechnologists. Gastrointestinal Endoscopy. 2007; 65(7):953-957.
19. Schmidt RL, et al. The Influence of ROSE on the adequacy rate of FNA
cytology. a systematic review and meta-analysis. Am J Clin Pathol. 2013; 139: 300-308.
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20. Shield P, et al. ROSE of FNA specimens by cytology scientists: a review of
and compensation analysis. Cancer Cytopathol. 2001; 93(5):
21. Stelow EB. Who should perform rapid or on-site assessment of thyroid
Pathol. 2014; 27(Suppl 2):112A-113A.
22. Tambouret RH, et al. ROSE: how practice varies. CAP Today. 2014; May:
12. Layfield LJ, et al. Immediate on-site interpretation of FNA smears – a cost 13. Mehrotra S, et al. (ROSE)-is it affordable to provide this service? Mod 14. Miller DA, et al. FNA Biopsy: The role of immediate cytologic assessment.
3032 specimens. Cytopathol. 2014; 25:322-329.
FNA aspirations? Am J Clin Pathol. 2012; 138:8-9. 29-31.
ASCP/ASC
Advanced Cytopathology Education Personalized for your future
New ASCP/ASC Advanced Cytopathology Education Program Thomas Jefferson University, Philadelphia, PA June 13-14, 2015 “This collaboration between ASC and the ASCP is designed to support cytotechnologists locally as they identify emerging opportunities and strengthen their skill set through personalized education.” Amy Wendel Spiczka, SCT(ASCP)CMMBCM,HTLCM, Manager Anatomic Pathology, Dept. of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, Ariz.
This two-day Cytopathology education program, designed by renowned faculty and customized from your input, will assist Cytotechnologists in developing new skills to meet the latest healthcare advances and challenges. Cytopathologists, Residents, and Students are also encouraged to attend.
Don’t miss this education program personalized to support your future success! For more info visit: ascp.org/ACE
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