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1 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 GUIDELINES FOR THE REPORTING OF NON-GYNECOLOGIC CYTOPATHOLOGY SPECIMENS: From the College of American Pathologists Facilitator: Barbara A. Crothers DO* *Conflict of Interest Statement: Dr. Crothers is the Vice Chair of the College of American Pathologists Cytopathology Committee and a co-author of the paper from which much of this information is obtained. She has no relevant financial interests in the products or companies described in this discussion. GENERIC REPORT FORMAT I. Demographic Information / Specimen Information -Patient s full name and identifiers (DOB, hospital number, SSN) -Accession number -Date obtained and received -Specimen type -Specimen source/ site -Procedure type (endoscopic, US guided, bronchioalveolar lavage, brushings) -Clinical information II. III. Gross Descriptions -Preparation type (smear, cell block, cytospin, liquid-based preparation) -Number of slides -Types of stains -Status of specimen upon receipt -Gross description of fluids; fixed/ fresh Diagnostic Report A. Lead line (tissue type, body site, procedure) B. Adequacy statement -Satisfactory (with limiting factors) -Unsatisfactory (state reason) C. Interpretation 1. Concise descriptive diagnosis in a format similar to surgical pathology OR 2. General category and a descriptive diagnosis as above - When a specific diagnosis cannot be made, a description of the limitations of the specimen should be included - Statements regarding the representative nature of the specimen should be included where appropriate (e.g., if the material obtained does not appear to be derived from the clinical lesion described) Roundtable Discussion #2: NG Cytopathology Reporting Page 1

2 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 E. Fine Needle Aspiration Procedures: - Include specific description of the procedure - Include intraprocedural adequacy checks and/ or assessment and by Whom IV. Pertinent Relevant Information and Comments A. Cross-references to relevant ancillary studies or existing specimens if reviewed B. Intra- and extra-departmental consultation C. Contact of healthcare providers concerning clinical information or notification of abnormal interpretation D. Educational notes, recommendations for further follow up V. Special Studies Report special studies performed on specimen with summarized interpretation - IHC -Flow cytometry -Cultures -Molecular tests VI. Report Header and Footer -Laboratory name, address (required) -Phone number/ website/ director name (optional) -Submitting physician/ clinic -Date (required), time (preferred) of collection -Signature blocks -Date (required), time(optional) of certification -Initials (transcriptionists, CT, residents/ fellows) -ICD, CPT, SNOMED codes -CLIA certificate number Roundtable Discussion #2: NG Cytopathology Reporting Page 2

3 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 REFERENCES: Crothers BA, Tench WD, Schwartz MR, Bentz JS, Moriarty AT, Clayton AC, Fatheree LA, Chmara BA, Wilbur DC. Guidelines for the reporting of nongynecologic cytopathology specimens. Arch Pathol Lab Med, 2009; 133: American Society of Cytopathology. Non-gynecological cytology practice guideline. Adopted 2 March Available at: accessed 23 August Moriarty AT et al. Recommendations from the CAP Cytopathology Resource Committee on Reporting for Non-Gynecologic Specimens. Accessed 18 January The Papanicolaou Society of Cytopathology Task Force on Standards of Practice. Guidelines of the Papanicolaou Society of Cytopathology for fine-needle aspiration procedure and reporting. Diag Cytopathol 1997;17(4): Roundtable Discussion #2: NG Cytopathology Reporting Page 3

4 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 TOPIC: GUIDELINES FOR THE REPORTING OF NON-GYNECOLOGIC CYTOPATHOLOGY SPECIMENS: From the College of American Pathologists Facilitator: Barbara A. Crothers DO* *Conflict of Interest Statement: Dr. Crothers is the Vice Chair of the College of American Pathologists Cytopathology Committee and a co-author of the paper from which much of this information is obtained. She has no relevant financial interests in the products or companies described in this discussion. BACKGROUND: Non-gynecologic cytopathology specimen reporting has been governed by federal regulations (Clinical Laboratory Improvement Amendments) since 1988, and nearly all laboratories already follow federal and state requirements. Why, then, do so many cytopathology reports remain difficult for clinicians to understand and use? Why is there so little standardization of terminology? How is it that discussions about cytology reporting sometimes become heated and emotional? All of the major cytopathology organizations have commented on or published guidelines touting appropriate cytopathology reporting (see attached references). There is significant concordance between organizations on appropriate guidelines. Over the past decade, medicine has begun to focus on sources of medical error and error prevention as a means to ensure patient safety. In recent years, Congress has become interested in shifting medical reimbursement away from pay for service to pay for performance ; specifically, quality performance that rewards providers for good outcomes and adherence to evidence-based medical guidelines. Cytopathology reports are the primary product of cytopathology laboratories and are therefore suitable for evaluating quality. In the future, compensation for the cytopathology service will likely be based, in part, on the thoroughness and usefulness of the cytopathology report. The College of American Pathologists has recognized that pathologists should take the lead in defining quality for our profession and have already championed the use of synoptic reporting for malignant tumors. Following on the heels of this effort, the College recognizes that there remain many areas of reporting that could be standardized to ensure that all relevant information is in a report, that the report is comprehensive and useful to the provider, and that the language is understandable. Of these, the most difficult to standardize is language. Pathologists formulate interpretations based upon their experience and training. They are accorded the privilege to say what they wish through their license to practice medicine. Reciprocally, the pathologist is wholly responsible for the report, both medically and legally. These factors play a significant role in pathologist s acceptance of changes to reporting cytopathology specimens. Roundtable Discussion #2: NG Cytopathology Reporting Page 1

5 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 The purpose of this roundtable discussion is to re-introduce participants to cytopathology reporting requirements and to emphasize the need to include certain optional, but preferable, items in reports that have not yet been mandated by federal law but that can improve report quality and safety. It will also target common report deficiencies. Participants will be able to discuss their solutions to reporting problems and explain reporting limitations that have impacted their laboratories. The following questions will be used to stimulate discussion and survey common existing practices among laboratories. DISCUSSION QUESTIONS 1. What is your pet peeve about NG reporting of cytopathology specimens? 2. What is the major reporting error or problem that you encounter in your practice (intralaboratory or in consultation)? Formatting 1. What two patient identifiers are required on your reports? - CLIA= two unique identifiers - CAP= patient name + unique identifier 2. Are both the time of specimen submission and the time of specimen collection, if appropriate, included on your report? - CLIA and CAP= required on requisition; not necessarily in report 3. To what lengths do you go to obtain pertinent clinical information? Who is responsibility for appropriate clinical history in the report? 4. Is your laboratory director s name on the report, and if so, where is it located? 5. Are cytotechnologist s names included on the final report? 6. Where are specimen collection procedures (e.g. core needle biopsy, ultrasound guidance, CT-guidance, touch preparations) reported? Roundtable Discussion #2: NG Cytopathology Reporting Page 2

6 Reporting Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, When is an exact site important in lead-in lines in nongynecologic cytology reporting? Are there times when a site is unnecessary? 2. When is an adequacy statement appropriate? 3. What constitutes an Unsatisfactory or Inadequate sample? 4. Do you use any standardized terminology in your NG reports? Are they site-specific, generic or both? How compliant is the group in applying standard terminology? 5. What terminology do you use for nondiagnostic or unsatisfactory specimens? Do you include a descriptive diagnosis? (e.g.; only blood. ) 6. What is your generic negative terminology? For benign specimens, are there times when it is inappropriate to use negative as the diagnosis? 7. Do you use a general category in your NG reports? If so, what categories do you use? What is the value of using a category? What are the disadvantages? 8. How do you report ancillary studies performed on the specimen? Documentation 1. How do you document FNA adequacy assessment? What additional information, do you include in the report? (E.g.; who received the information; who performed adequacy; immediate initial diagnosis; number of passes; type of stain; time out.) 2. Do you document time in formalin for cell blocks/ core biopsies in the report? Do you record other indicators such as anoxic time, type of fixation, brand of fixation, etc? 3. If tests are performed at one site but signed out at another, how do you indicate this in the report, if at all? 4. Do you document cytology-histology correlations in the report? If so, it is for every case with relevant surgical/ hematologic specimens, or on a case-by-case basis? 5. Do you record bio-repository (research) collection of part of the specimen in the report? 6. What other items are routinely documented in your reports? Roundtable Discussion #2: NG Cytopathology Reporting Page 3

7 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 Key Learning Points NON-GYN CYTOPATHOLOGY REPORTING-Common Areas of Deficiency: Formatting: Incomplete address/ phone number of laboratory Gross description lacking Clear labeling of report as Provisional/ Preliminary, Consultation, Review of Slides, Amendment/Addendum Name, address, contact information of secondary laboratories (ancillary studies under different CLIA certificate) Reporting: Lead-in line site/ laterality/ location Precise procedure (e.g. ultrasound-guided ) Adequacy statements (particularly when specimen is suboptimal or unsatisfactory for interpretation) Immediate adequacy check results and information Suggested follow up to atypical or unsatisfactory specimens Correlation with concomitant proximate specimens Documentation: Name/location of second laboratory where screening/interpretation occurs Notification of unexpected results, when, to whom (laboratory-defined) Summation of ancillary test results (what do they mean in context of the case?) Intra- and extra-departmental consultation FNA procurement information Time in formalin (cell block/ core biopsies- for ER/PR) Cytopathology reports must be clear, consistent, contain all elements necessary for decision making, and be formatted for easy retrieval of data. ** **Moriarty AT, Prey M, Mody D. The debate over how to report nongynecologic cytology. CAP Today, February Available at Accessed 14 August Roundtable Discussion #2: NG Cytopathology Reporting Page 4

8 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 TOPIC: GUIDELINES FOR THE REPORTING OF NON-GYNECOLOGIC CYTOPATHOLOGY SPECIMENS: From the College of American Pathologists Facilitator: Barbara A. Crothers DO* *Conflict of Interest Statement: Dr. Crothers is the Vice Chair of the College of American Pathologists Cytopathology Committee and a co-author of the paper from which much of this information is obtained. She has no relevant financial interests in the products or companies described in this discussion. NONGYNECOLOGIC REPORTING- PROBLEM CASES 1. NECK, FINE NEEDLE ASPIRATION: ATYPICAL CELLS PRESENT. 2. SOFT TISSUE ASPIRATION: NEGATIVE FOR MALIGNANCY. RARE ATYPICAL CELLS PRESENT. 3. THYROID: SATISFACTORY. A FEW FOLLICULAR CELLS FORMING MICROFOLLICLES WITH LITTLE TO NO COLLOID PRESENT. 4. ENDOBRONCHIAL ULTRASOUND-GUIDED FINE NEEDLE ASPIRATION: ADEQUATE CELLULARITY FOR INTERPRETATION. CATEGORY 1: BENIGN. 5. URINE: PAPILLARY GROUPS OF UROTHELIAL CELLS. 6. MISCELLANEOUS: SATISFACTORY FOR EVALUATION. MALIGNANT CELLS CONSISTENT WITH ADENOCARCINOMA. CATEGORY 4- MALIGNANT. Roundtable Discussion #2: NG Cytopathology Reporting Page 1

9 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 NONGYNECOLOGIC REPORTING EXAMPLES- TEST YOURSELF! 1. A 45 year-old woman had fine needle aspiration of a right inner quadrant breast mass performed. The lesion was approximately 3 cm from the nipple at the 1:00 position. The smears showed discohesive, monotonous and bland single cells with moderate cytoplasm, round nuclei with fine chromatin and prominent nucleoli. You called the clinician, Dr Washington, to inform her of the cytologic diagnosis of ductal adenocarcinoma. TISSUE, SITE, PROCEDURE: ADEQUACY: DIAGNOSIS: CATEGORY: COMMENTS: 2. A 32 year-old man presented with a 2.0 dominant left middle thyroid lobe nodule and had fine needle aspiration of the nodule performed under ultrasound guidance. Abundant colloid with scattered flat, 2-dimensional uniform follicular groups was obtained. A few macrophages were present. TISSUE, SITE, PROCEDURE: ADEQUACY: DIAGNOSIS: CATEGORY: COMMENTS: 3. You receive a voided urine on an 86 year old man who has a prior history of high grade urothelial carcinoma, treated 1 month ago with intravesicle chemotherapy. The urine was submitted on Saturday and was not processed until Monday afternoon, so there is marked cellular degeneration present. You are very concerned that the specimen contains tumor cells, but because of degeneration, you cannot unequivocally call them cancer. TISSUE, SITE, PROCEDURE: ADEQUACY: DIAGNOSIS: CATEGORY: COMMENTS: 4. You receive an intraoperative peritoneal lavage from a 50 year old woman that contains 3- dimensional clusters of fairly bland epithelial cells with occasional cytoplasmic vacuoles. You investigate and discover that your partner is reviewing her ovarian surgical slides from the same procedure and will certify his report as a serous borderline tumor of the ovary with ovarian surface Roundtable Discussion #2: NG Cytopathology Reporting Page 2

10 Round Table Discussion # 2 ASC 58 th Annual Scientific Meeting; Boston, MA DATE: Sunday, November 14, 2010 implants. You review the slides with him and determine that the cells in the lavage are cytologically identical. TISSUE, SITE, PROCEDURE: ADEQUACY: DIAGNOSIS: CATEGORY: COMMENTS: 5. You perform a fine needle aspiration biopsy of a left neck lymph node on a 23 year old man and suspect lymphoma, so you perform 3 additional passes for flow cytometry. While reviewing his records, you notice that he has also had flow cytometry on his peripheral blood and the results are identical to the ones that are returned on his FNA material- CD1, CD2, CD5, CD7, CD10 and CD38 positive, with dual staining for CD4 and CD8, but negative for CD3. These findings are characteristic of precursor T-cell acute lymphoblastic leukemia/ lymphoma. TISSUE, SITE, PROCEDURE: ADEQUACY: DIAGNOSIS: CATEGORY: COMMENTS: Congratulations! Good job! You can check your answers in the following article, page 1752: Crothers BA et al. Guidelines for the reporting of nongynecologic cytopathology specimens. Arch Pathol Lab Med 2009;133: Roundtable Discussion #2: NG Cytopathology Reporting Page 3

11 CAP Laboratory Improvement Programs Guidelines for the Reporting of Nongynecologic Cytopathology Specimens Barbara A. Crothers, DO; William D. Tench, MD; Mary R. Schwartz, MD; Joel S. Bentz, MD; Ann T. Moriarty, MD; Amy C. Clayton, MD; Lisa A. Fatheree, BS, SCT(ASCP); Beth Anne Chmara, CT; David C. Wilbur, MD Context. Gynecologic cytology terminology and report formatting have been nationally standardized since the implementation of The Bethesda System of 1988, but standard reporting for nongynecologic cytology has never been formally addressed on the same scale. Objectives. To promote patient safety through uniform reporting in nongynecologic cytology (including fine-needle aspiration cytology) and to improve communication between laboratories and health care providers. Data Sources. Sources include the College of American Pathologists Cytopathology Resource Committee; the College of American Pathologists Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization; the College of American Pathologists Laboratory Accreditation Program inspection checklists; the Joint Commission for Accreditation of Healthcare Organizations; and the Clinical Laboratory Improvement Amendments of Conclusions. We describe the major elements of quality nongynecologic cytology reporting and discuss areas of controversy in cytology reporting. Standardized nongynecologic specimen reporting will expand the concept of common report elements already widely implemented in gynecologic cytology reporting. The intent is to improve communication with the health care team while remaining in compliance with federal mandates and accreditation guidelines. (Arch Pathol Lab Med. 2009;133: ) The primary product of pathologists is the interpretive report. The pathology report is the result of a medical consultation with the pathologist to examine the patient (in the form of his or her tissue) and provide an opinion regarding the presence or absence of a diseased state. These consultations, especially in cytopathology, often require a comprehensive evaluation of the circumstances surrounding the patient s complaint, including review of his or her clinical laboratory test results, imaging studies, clinical symptoms, and personal or family medical history. Pathology reports represent a pivotal point in clinical care; they influence decisions to treat or not to treat as well as direct therapy decisions. As such, pathology reports are a primary target for quality improvement efforts in anatomic pathology. Cancer checklists for reporting the results of pathologic examination are already Accepted for publication January 27, From the Department of Pathology and Area Laboratory Services, Walter Reed Army Medical Center, Washington, District of Columbia (Dr Crothers); the Palomar Medical Center Laboratory, Escondido, California (Dr Tench); the Department of Pathology, The Methodist Hospital, Houston, Texas (Dr Schwartz); the Department of Pathology, University of Utah, Salt Lake City (Dr Bentz); the Department of Pathology, AmeriPath Indiana, Indianapolis (Dr Moriarty); the Department of Anatomic Pathology, Mayo Clinic, Rochester, Minnesota (Dr Clayton); the Department of Cytology Surveys, College of American Pathologists, Northfield, Illinois (Mss Fatheree and Chmara); and the Department of Pathology, Massachusetts General Hospital, Boston (Dr Wilbur). The authors have no relevant financial interest in the products or companies described in this article. Reprints: Barbara A. Crothers, DO, Department of Pathology and Area Laboratory Services, Walter Reed Army Medical Center, MCHL- UAP Ward 47, 6900 Georgia Ave NW, Washington, DC ( barbara.crothers@us.army.mil). widely implemented by most pathology practices as a means of ensuring the inclusion of critical data elements into the pathology report. In keeping with its long tradition of leadership in promoting best practices in pathology reporting and terminology, the College of American Pathologists (CAP) has initiated efforts to provide standardized reporting protocols for tissue specimens other than cancer in addition to those already established for most conventional tumors. During the past 20 years, there has been considerable interest in and effort toward improving pathology reporting through the use of report protocols, synoptic reports, electronic or paper templates, worksheets, and checklists. 1 3 Protocols are outlines for the formatting of an entire document to guide one s practice. Synoptic reports are summarized, streamlined versions of case findings determined to be significant based on potential clinical relevancy. 4 Templates are preformatted outlines for tabular data. 5 Tumor worksheets or checklists are shortened versions of the key elements that should be included in a report and are to be used as a prompt or reminder to include specific data, and they may be applied to one portion or several portions of a report. The effort toward standardized formatting serves many functions: it ensures that vital staging, grading, and prognostic information is included in the report; it reminds pathologists to report specific elements; it enhances data extraction for billing personnel and tumor registries; it supports research efforts by prospectively reporting potentially critical information; it promotes computer data capture; and it facilitates retrieval of information by the reader. It is only recently that attention has been focused on the granularity (or number of small, labeled segments of data) of report format- Arch Pathol Lab Med Vol 133, November 2009 NG Cytopathology Report Guidelines Crothers et al 1743

12 ting and its influence on reader comprehension and retention. Searching for information in diagnostic narratives in the form of free text is often tedious to the reader. Tange et al 6 reported that subdividing information into labeled segments enhances retrieval of important information in medical records, but too much subdivision reduces the speed of retrieval. There is a considerable volume of literature on sentence structure and formatting as they relate to human cognition and comprehension that is beyond the scope of this article. However, the major findings can be concisely summarized through the following observations from the Agency for Healthcare Research and Quality: (1) People do not remember much; (2) lots of data does not translate into better decisions; (3) people prefer information they can easily evaluate; and (4) hierarchies help people understand and remember information. 7 Despite pathologists best intentions, changes in report formatting, including attempts to streamline reports, may actually decrease comprehension. 8 This may be related to the degree of familiarity an individual has with a particular format and emphasizes the need to engage clients in overall report design. A pathology report is the only documentation of what a pathologist does and thinks; it is a pathologist s note in the patient s record. It should reflect the logical sequence of events that resulted in the final assessment of that patient. Nongynecologic cytopathology is ideally suited to standardization because a model currently exists that of The Bethesda System for Reporting Cervical Cytology. 9 Many concepts from the gynecologic system of reporting Papanicolaou test results are incorporated into the currently proposed nongynecologic cytology protocol. The protocol mirrors standards already established by tumor protocol subcommittees and follows requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 10 the Joint Commission on Accreditation of Healthcare Organizations, and the CAP Commission on Laboratory Accreditation s Laboratory Accreditation Program (LAP) 11 checklists. For convenience, this protocol includes the CAP LAP numbers identifying the specific professional standards in the 2007 inspection checklist. This protocol (Table 1) is not intended to be used for litigation or to enforce rigid adherence to one report design. Although standardized reporting enhances efforts to ensure appropriate reimbursement, this protocol should not be required for reimbursement. This effort is intended to act as a guide with which to ensure that critical information is entered into a cytopathology report. Because of computer reporting constraints or difficulty in obtaining accurate information from submitting providers, certain elements, although desirable, may not be feasible to include in a report. However, this protocol offers an idealized model for the reporting of nongynecologic cytology specimens and is a worthwhile addition to quality improvement efforts. DATA SOURCES The CAP Cytopathology Resource Committee, in conjunction with the CAP Council on Scientific Affairs Ad Hoc Committee on Pathology Report Standardization, reviewed existing regulatory requirements for the reporting of pathology specimens and drafted a list of required, desirable, and optional report elements. This document was delegated to a Cytopathology Resource Committee task force for further modification. The task force reviewed Table 1. Nongynecologic Cytopathology Report Protocol a Report header (required) [LAP CYP.05300, CYP.05350] Laboratory name and address Indicative of where the test is performed; if more than one site, state both in report. Laboratory phone number (optional) Laboratory World Wide Web URL (optional) Laboratory director s name (optional) Submitting physician, health care provider, and/or clinic name Physician/health care provider phone number (optional) Physician/health care provider World Wide Web URL (optional) Physician/health care providers to be copied (optional) Date and time of specimen collection (date required; time desirable) May be alternatively documented on the specimen requisition Date and time of specimen receipt in laboratory (desirable) Demographic data (required) [LAP CYP.05300] Patient full name (last, first, middle) Patient age and/or birth date of patient Patient ethnicity (optional) Patient sex (optional) Patient unique identifier or hospital identification number Laboratory accession number History and/or clinical information (required) Specimen content/anatomic source of specimen b (required) Specimen type/collection method c (required) [LAP CYP.05300] Fluid type Urine Cerebrospinal fluid Sputum Vitreous Pericardial, pleural, or peritoneal fluid Body site from which specimen is collected Laterality (required, where applicable) Brushing Washing Scraping Lavage Voided Aspiration Fine-needle aspiration (biopsy) With core needle biopsy, if applicable Core needle biopsy If accessioned to cytopathology as a cell block along with touch preparations for reporting Procedural guidance (optional) Additional descriptors that clarify procedural events, such as endoscopic, ultrasound, radiographic, computed tomography scan, or other imaging modalities Specimen preparation (required) and stains Preparation type and stains may be described under other headings; list is not exclusionary; see text for details. Smears Cytospin or other concentration technique Monolayer preparation Specify type: ThinPrep (Hologic Inc, Marlborough, Massachusetts), SurePath (BD Diagnostics, Franklin Lakes, New Jersey), MonoPrep (MonoGen Inc, Vernon Hills, Illinois), or other liquid-based preparation Membrane filter Cell block Stains (optional) Papanicolaou, Romanowsky, toluidine blue, hematoxylineosin Other (specify) Description of specimen received (desirable) [LAP CYP.05350] Status and appearance of specimen upon receipt; applicability depends upon specimen content and source Arch Pathol Lab Med Vol 133, November 2009 NG Cytopathology Report Guidelines Crothers et al

13 Table 1. Continued a Slides (smears, monolayer preparations) Number submitted Wet fixed; include fixative type, if applicable Air dried Fluid Volume Color Clarity Consistency Fresh Fixed, include fixative type Immediate evaluation/consultation (required, if applicable) [LAP CYP (time out); ANP.12000] For fine-needle aspiration or core biopsy touch preparation determination of adequacy and performance of collection procedure. Body site Laterality (if applicable) Name of individual performing the procedure or evaluation (optional) Name of pathologist rendering intraoperative consultation (required) Time-out documentation (optional) May be included in other procedural report or patient record Procedure performed (optional) Fine-needle aspiration procurement On-site adequacy assessment Intraoperative consultation, touch preparations Documentation of adequacy assessment (required) Adequate or preliminary result (eg, malignant cells identified ) Inadequate/nondiagnostic/indeterminate Additional studies performed (optional) May be reported under comment/recommendations or other Name of person receiving the report (optional) Date and time of preliminary assessment (optional) Microscopic Interpretation [LAP CYP.03800; CYP.06100] Lead line (tissue type, body site, procedure) Statement of adequacy (optional) Statements of adequacy are strongly recommended but are not required unless the specimen is inadequate for evaluation. Satisfactory; state any limiting factor or quality indicator as applicable. Other options include satisfactory but limited by and statement of limiting factor or interpretation limited by and statement of limiting factor. Unsatisfactory; state reason. Scant cellularity or acellularity Insufficient epithelial cells for evaluation Obscuring blood, inflammation, necrosis, lubricant gel, lidocaine gel Poor fixation or cellular preservation Inadequate preparation (eg, smear too thick) Not representative of target Lack of pertinent clinical information Interpretation (required) One of two options is preferred 1. General category Descriptive diagnosis (required) Microscopic description (optional) Example (option 1): General category Negative for malignancy/normal/benign May include benign neoplasms Atypical and/or suspicious (must qualify) Malignant (positive for malignancy) Unsatisfactory/nondiagnostic (provide reason) As defined by the reporting institution; does not replace descriptive diagnosis Descriptive diagnosis Description of cytologic findings, cell types, and/or potential diagnosis Use of SNOMED terminology is optional Table 1. Continued a Microscopic description (optional) Detailed description of cytologic features. It is preferable to separate microscopic description and descriptive diagnosis. 2. Concise diagnosis (required) Microscopic description (optional) Example (option 2): Concise diagnosis Use of accepted World Health Organization or SNOMED terminology is desirable, when possible. Microscopic description (optional) Detailed description of cytologic features. It is preferable to separate microscopic description and descriptive diagnosis. Comments/recommendations/educational notes [LAP CYP.06400, CYP.06800, CYP.06850, CYP.07675] Field should allow for free-text documentation of activities or findings that may be required for patient care or to comply with hospital or laboratory accrediting agencies. Documentation of review of other pertinent pathology specimens (optional) Documentation of review of patient records and clinical or radiographic findings (desirable) Cross-reference studies performed in other sections or laboratories but reported separately that influence interpretation (desirable) Documentation of discussion with health care providers (optional) Documentation of health care provider notification of abnormal interpretations (desirable) Health care provider or patient educational information (optional) Cytologic/histologic correlation (optional) Special studies (required) [LAP CYP.06850, ANP (ASR)] Results of billable tests must be recorded within the report if not reported separately. A summarized interpretation of the findings should follow when pertinent to the interpretation. Immunocytochemical procedures Flow cytometry Histochemical stains Cultures for organisms Molecular tests Intradepartmental consultation (optional) Results of, or documentation of, intradepartmental consultation may be included in the report. The content and degree of this information are determined by the laboratory. Signature [LAP CYP.05316; CYP.05332; CYP.07670] Automated electronic certification, date, and time are acceptable Full name of certifying pathologist(s)/attending pathologist(s) Date of certification (required) Time of certification (optional) Other [LAP CYP.07690] Name or initials of transcriptionist(s), if any (optional) Name or initials of cytotechnologist(s), if any (optional) Name or initials of resident(s) and/or fellow(s), if any (optional) ICD, CPT, and/or SNOMED codes (optional) CLIA certificate number (optional) Abbreviations: ANP, anatomic pathology; ASR, analyte-specific reagent; CLIA, Clinical Laboratory Improvement Amendments; CPT, common procedural terminology; CYP, cytopathology; ICD, International Classification of Disease; LAP, Laboratory Accreditation Program; SNO- MED, Systematized Nomenclature of Medicine. a All elements are required unless otherwise indicated. Item placement under certain headings in the report is flexible; the protocol provides suggested locations. b See text for examples; anatomic site may be implied based on the specimen content. c Indicates procedural method(s) for obtaining samples. Arch Pathol Lab Med Vol 133, November 2009 NG Cytopathology Report Guidelines Crothers et al 1745

14 available recommendations from other sources and solicited cytopathologists expert opinions on practice variation and feasibility of implementation. Where regulations, guidelines, and standards showed slightly different requirements, the most stringent were applied. The final recommendation for the protocol by the Cytopathology Resource Committee was reviewed and approved by the CAP Council on Scientific Affairs. EXPLANATORY NOTES All data elements in the protocol are required for compliance with existing regulations and inspection standards unless otherwise indicated. Pathologists and laboratories are at liberty to design subsections and placement of data elements as best suited to their practices, but in general, reports should have a clear header, demographic section, report body, signature block, and comment fields. Additionally, the authors do not advocate any specific nongynecologic reporting terminology; the terminology used in this protocol is optional. Terminology is best determined by a group practice with input from clinical colleagues. National cytopathology organizations have addressed recommendations for standardized terminology in other settings. Header The header tops the first page but may appear on subsequent pages. It identifies the laboratory, the patient, the submitting health care provider, the specimen accession number, and the type of report. It may include information about dates and times of specimen collection if these are not included elsewhere in the report. The header must include the full name and address of the laboratory 16 where the test was performed or the reporting agency so that the agency can be contacted and slides and reports returned to that agency. Including the name of the medical director of the agency is optional, but if present, the report should be formatted in a manner whereby the director cannot be construed as the individual interpreting the specimen when that is not the case. When processing is performed at one laboratory and interpretation or results are reported by another laboratory under a separate CLIA certificate, the names and addresses of both must be in the report. 17 Laboratories may report this in different areas, as long as each laboratory is identified in the report. It is preferable to include a phone number or URL site for the laboratory when questions regarding the report arise. The submitting physician, health care provider, or clinic must be identified so that the laboratory can ensure that diagnostic information reaches an individual who can provide appropriate follow-up of the patient. This information also provides documentation that test results are released only to authorized individuals responsible for the health care of that patient as mandated by federal regulations. 18 Additional contact information, such as a phone number, fax number, address, or URL for the ordering provider, enables pathologists to contact that individual when additional clinical information is required for the determination of a cytologic interpretation. As an additional safety measure for the patient and courtesy for members of a health care team, it is advisable to list other physicians or providers who should receive a copy of the report. The date on which the specimen is obtained is required on the requisition 19 as well as in the report in order to comply with LAP standards and federal regulations. Because many cytologic specimens are submitted in the fresh state, the date of collection has special significance for cytopathology. Collection times should be indicated on specimens so that the laboratory can determine the potential for cellular degeneration based on the interval of time between collection and processing. The time of submission is not essential for fixed or preserved specimens, but it is relevant to viable specimens collected in cell culture media, such as Roswell Park Memorial Institute. The date of collection must be in the report in order to comply with LAP standards. The date and, if appropriate, time the specimen was received in the laboratory must be recorded, 20 but they are not required in the report. Date and time are useful to measure turnaround times and to identify quality deficits in the submission interval. The header may include a title to clarify the type of report (eg, Nongynecologic Cytopathology Report ) to prevent confusion with other pathology reports. Preliminary reports, appended reports, and amended reports should be clearly distinguishable from final reports. It is preferable to highlight or bold these labels, regardless of their location in the heading or the final interpretation field. It is useful for footers to a report to include the page number and total number of pages so that the reader has an indication of the length of the report. Additional information that further identifies the pages as belonging to a particular report may be added to the header or footer of subsequent pages but should include, at minimum, the patient s full name and laboratory accession number. Demographics Mandatory demographic information necessary to confirm specimen identity and to assist with interpretation includes: complete patient name, date of birth and/or age, and hospital identification number or other unique patient identifier. The CAP LAP requires the name of the patient and a unique identifying number, if available, 21 whereas the CLIA requires either the patient s name and identifying number or a unique patient identifier and identification number. 22 The CLIA may have used this vague language for John Doe cases where the true identity of a patient is not known. If laboratories are not provided with a unique identifier with specimen submission, the patient s date of birth may be used along with the patient s name or pseudonym. Use of the date of birth is preferred to age because many patient names are identical, and in conjunction with the name, date of birth is a more specific identifier than age. Laboratories that have difficulty obtaining unique identifiers from clients should establish a policy defining a second identifier (in addition to the patient s name) and require it for specimen submission. Although the laboratory accession number can serve as a unique identifier of a specimen once it is assigned, the patient s identity must be confirmed by 2 identifiers prior to obtaining a specimen to remain in compliance with Joint Commission standards. Both of these identifiers should be on the requisition and the specimen and, subsequently, in the report. In other words, the patient s name, date of birth, and specimen accession number constitute sufficient evidence that a specific specimen belongs to a specific patient. In fact, the Joint Commission is not specific regarding the definition of unique patient identifiers, as long as the laboratory or hospital has a written policy to ensure patient identity and follows that policy. 23 Inclusion of ethnicity and sex are optional in the report but 1746 Arch Pathol Lab Med Vol 133, November 2009 NG Cytopathology Report Guidelines Crothers et al

15 may be critical to diagnostic decisions and relevant to particular tumor types. The patient s sex is required on the test requisition. 24 The required laboratory accession number should further uniquely identify that specimen as belonging to a particular patient. The importance of including relevant clinical information and patient history in the report cannot be overemphasized. Pathologists are often dismayed at the lack of significant medical information provided to them on the requisition, even though this information is required by regulation, 25 because of the potential to be misled. For the sake of simplicity and uniformity, some laboratories design a combined anatomic and clinical pathology requisition form with common data elements. This tendency may compromise the request for an anatomic pathology consultation to a physician (the pathologist) and perpetuate the misconception that microscopic examination and reporting of a specimen are a laboratory test. With the advent of the electronic medical record, pathologists have the opportunity to provide a greater service to their patients and clinical colleagues by adding relevant data from the patient s electronic record to the report. When this information is not submitted by the health care provider, the report should specifically state that no clinical information is provided. Pathologists are not obliged to review patient records to find these data because they may not have easy access to those records, especially if the records or the pathologist is outside of a hospital setting. It can be onerous to unearth essential additional information in those cases where it is required, as is often the situation for nongynecologic cytology. Some pathologists task administrative assistants with this duty, whereas others personally contact the health care provider. The ability to review a patient s record for clinical history of prior malignancy, radiographic reports, laboratory results, clinical signs and symptoms, and physical examination findings allows the pathologist to synthesize all data in order to provide an accurate assessment for that patient. Accessibility of an electronic patient record optimizes the outcome for the patient because a pathologist can review all pertinent medical findings and significantly narrow the differential diagnosis for a particular case. At a minimum, pathologists should indicate this review in the pathology report. It is optimal to provide a summary of relevant medical findings and how they relate to the interpretation of the specimen and outcome for the patient. Specimen Content/Anatomic Source of Specimen The type of specimen submitted is a required report element 26 that influences specimen interpretation. In cytopathology, lesions from different organs may have identical cytologic features. For example, Warthin tumor of the salivary gland mimics chronic lymphocytic thyroiditis with oncocytosis; thus, organ or site of collection is central to the diagnosis. The anatomic source designator is often placed in multiple areas of the report and, in combination with location and procedure, is a component of the lead line to the interpretation of fine-needle aspiration (FNA) specimens: tissue, site, procedure. For most body fluids, the anatomic site is inferred by the specimen type, so the anatomic source need not be specifically identified. For example, urine is derived from the urinary bladder; cerebrospinal fluid is derived from the central nervous system; sputum has its origin in the bronchi and lung; and peritoneal fluid is from the peritoneal cavity. Therefore, it is redundant to state peritoneal fluid, peritoneal cavity, when this is the only possible source for the fluid. For FNA specimens and bilateral body sites, documenting laterality and the exact location of masses is critical to patient safety, especially if multiple specimens are collected from different sites in a single organ. Patients with fibrocystic changes of the breast often have multiple nodules, but the position of a malignant mass must be identified as precisely as possible. In the case of multiple aspirations, right breast without an associated designator, such as upper outer quadrant or 11 o clock, would not distinguish between benign and malignant masses. Nonanatomic indicators, such as pass/site no. 1, pass/site no. 2, are also unacceptable unless specifically identified within the body of the report, because they provide no specific anatomic designation to the report recipient. With the advent of ultrasound-guided FNA of the thyroid, it is increasingly common to sample multiple nodules in a single gland. In order to facilitate identification of the suspicious nodule operatively or during intraoperative consultation, it is optimal to designate the FNA site as specifically as possible (eg, right middle lobe, left upper lobe, lateral isthmus). Similarly, in order to prevent wrong-site surgery, documenting laterality is absolutely critical for paired organs. The pathology report is commonly used as a primary reference for future intervention. Because pathology reports often stand out in medical records as a result of their stylized, compartmentalized format, they are easier to locate than other documents containing information on lesion laterality. Formatting of these reports generally facilitates rapid identification of these specific data points, information that is often buried within the text of clinical notes and operative reports. Pathologists may not be provided with information on laterality, nor may they be able to obtain it. In such cases, the pathologist should, at minimum, indicate site/side/laterality not specified in the report. Specimen Collection Method The collection method usually identifies the type of procedure or the type of test performed and is a required report element. 27 It is also a preferable component of the lead line to a cytologic interpretation. Collection method can influence the cytologic interpretation of a specimen. Different cytologic preparations yield different morphologic appearances. Small cell carcinoma of the lung has a different cytologic presentation in sputum smears than it does in bronchioalveolar lavage cytospin preparations, thus delineating the need to specify the procurement method and preparation type for specimens. Typically, one obtains fragments of urothelial epithelium with bladder lavage that are not typical of voided urine specimens. The unsuspecting pathologist may suggest a low-grade urothelial neoplasm when urothelial fragments are detected in urine if the collection method is not indicated. In some cases, the collection method is implied by the specimen type. For example, cerebrospinal fluid is usually obtained by a lumbar puncture, although it may be collected, albeit infrequently, from a ventriculoperitoneal shunt. Peritoneal or pleural fluid is typically obtained by paracentesis or thoracocentesis. One should specifically identify the specimen collection method if it diverges from the standard collection method in order to prevent interpretive error. For example, if peritoneal fluid is obtained by lavage, then the procedure should be reported as peri- Arch Pathol Lab Med Vol 133, November 2009 NG Cytopathology Report Guidelines Crothers et al 1747

16 toneal lavage. Some laboratories accession core needle biopsies as cytology specimens if they have associated touch imprints performed for procurement adequacy assessment. Core needle biopsies should be indicated as a procedural type. One method would be to indicate the collection procedure in the lead line to the final diagnosis (eg, Liver, Right Lobe, Touch Preparations and Core Needle Biopsies ). Addition of procedural information in the report also enhances reimbursement. Third-party payers and insurers expect to encounter the exact terminology for a procedure as it is listed in the American Medical Association s Current Procedural Terminology 28 text in order to provide payment for that procedure. 12 Including procedural events that contribute to the specimen collection, such as ultrasound guided, endoscopic, computed tomography guided, and endoscopic ultrasound guided, enhances correlation with clinical or procedural notes in the patient s record and can provide information on inadvertent collection of other cells in a preparation. Endoscopic FNA specimens may include cells from adjacent organs or organs traversed during collection that can result in misinterpretation during microscopic examination. Specimen Preparation and Stains Many laboratory information systems do not contain a separate area to indicate specimen preparation and stains performed, but this information also may be critical to reimbursement for services; therefore, the text should identify the preparation type in terms that are comprehensive to insurers. It is often included in the gross description area of a report. There is no requirement to indicate the stains used for nongynecologic specimens in the report, but this information is helpful to consulting pathologists who might receive the case for review, especially when nonconventional staining techniques, such as toluidine blue or rapid Papanicolaou, are used. This information may also be critical documentation in medicolegal cases. If there is no separate field in the laboratory information system for these data, they can be placed in a comment field. Description of Specimen Received For fluid specimens, recording the state in which the specimen is received (fresh versus fixed) provides information on the anticipated degree of degeneration demonstrated by a specimen. The gross description of the specimen is also a desirable component of the report because it yields useful diagnostic information (eg, milky fluid is a key to identifying chylous effusions). Grossly bloody specimens can inhibit processing methods and may be amenable to additional processing techniques used to eliminate red cells. The volume of the specimen may reflect the extent of an effusion and convey the likelihood that residual material is available for further studies. Color, clarity, consistency, and other pertinent descriptors can be informative when considered in the context of the microscopic findings. Special containers often contain proprietary fixatives, and the description of the container (eg, PreservCyt [Hologic Inc, Marlborough, Massachusetts] vial) often indicates the fixative. If the material is submitted in separate containers with different fixatives or media for special studies, such as in Roswell Park Memorial Institute for flow cytometry, this should be recorded to alert the pathologist that additional material exists. The number of slides submitted, their state upon submission (eg, wet fixed, air dried, smears, cytospin, or other), and types and number of subsequent slides prepared serve as the laboratory s record for archived specimens. In many laboratory information systems, the gross description field allows the processing technician to enter the type of preparation made and ancillary tests performed. If not available as a separate field, this information should be included elsewhere in the report. The disposition of specimens divided for submission for research, additional testing, or biorepositories should be included here. When possible, it is preferable to add biorepository or research numbers to the report in the event that the stored tissue must be retrieved for further clinical evaluation. Reports must specify the condition and deposition of specimens that do not meet the laboratory s criteria for acceptability 29 if they are not outright rejected for submission. Some information systems provide a quality assurance section that permits identification of specimens lacking proper submission requirements, such as leaking vials, lack of patient identifier, submission in an improper fixative, or broken slides. Figure 1 demonstrates an example that could be used to record the gross description of the specimen. The type of fixative used assists with processing decisions and is particularly important if ancillary studies are considered, because fixation type and time influence the reliability of the results. 30,31 Consideration should be given for recording the time spent in 10% buffered formalin for material submitted for cell block or core biopsy, particularly if that specimen is intended for quantitative assays used as prognostic, predictive, or therapeutic markers that may be influenced by duration of fixation. 32,33 Although the focus is currently on buffered formalin fixation, duration of time in other fixatives, such as Saccomano (BBC Biochemical, Seattle, Washington), PreservCytR (Hologic Inc, Marlborough, Massachusetts), and CytoRichR Red (Thermo Fisher Scientific Inc, Waltham, Massachusetts), is likely to become a subject of research interest. Investigators using cytologic specimens for research prefer to control as many tissue variables as possible to prevent misinterpretation of results. Because of the advent of translational medicine and its close relationship of clinical investigators with health care providers, pathologists have experienced increasing pressure to record tissue variables that might influence research results. Some of these variables include anoxic interval (the time from vascular clamping or excision to placement in formalin), length of time in fixative, type of fixative, brand of fixative, processing time in solution, and temperature used in processing. There is a national effort underway, championed by the National Cancer Institute, to record and standardize processing variables for tissue collected for National Cancer Institute supported biorepositories. All pathologic specimens are potential targets for research repositories, even if the investigative protocol is not defined at the time of collection. Many laboratories release tissue blocks to investigators or repositories after obtaining patient consent. Acquiring knowledge about the variables influencing test outcomes can only strengthen the robustness of the research data. This information becomes particularly important when targeted therapies are administered based on test results, such as immunohistochemical stains for specific disease markers. Controlling the variables that might result in false-positive or false-negative results is good medical practice. Most of the emphasis for recording processing variables has been focused on surgical pathology speci Arch Pathol Lab Med Vol 133, November 2009 NG Cytopathology Report Guidelines Crothers et al

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