College of American Pathologists

Pathology and Laboratory Quality Center Bone Marrow Synoptic Reporting for Hematologic Neoplasm

Draft Recommendations This guideline is intended to provide a framework for adopting synoptic reporting for bone marrow pathology reports. As currently defined by the CAP, synoptic reporting entails the following elements: reporting of scientifically validated data elements that influence clinical outcome and therapeutic decisions; display of each data element in a “variable:result” format on a single line; display of data elements on separate lines, listed together in one location of the report. This report format assures that critical information is transmitted consistently and succinctly in every report to the clinician. It does not exclude incorporation of additional information such as detailed differential counts, panels of immunohistochemical and special stains needed for pathologic work up, or explanatory narratives interpreting the clinical relevance of complex findings. The draft recommendations presented below are based on the results of evidence graded literature search and the considered judgment of the expert panel. A noticeable absence of recommendations pertains to the quality of the primary bone marrow specimen. While a high quality specimen is desirable for optimal diagnostic work up, the minimum requirements depend on clinical circumstances and diagnostic needs. Since high level evidence is not readily available for all scenarios, this was considered out of scope for formal evidence based recommendations at this time; the reader will be referred to relevant published literature as judged by the expert panel in the final manuscript. Key questions that we attempted to answer are as follows:

1) Considering the possible primary bone marrow morphologic descriptors, which ones are required on a synoptic report if completeness is the outcome of interest?

2) Considering the possible ancillary studies that could be ordered on a bone marrow specimen, which ones are required on a synoptic report if completeness is the outcome of interest?

3) What sequence of results reporting should be followed?

4) Which components required for correct coding and data repositories should be included

in the report?

5) What clinical or laboratory information should be included in the report?

Key Question One: Considering the possible primary bone marrow morphologic descriptors, which ones are required on a synoptic report if completeness is the outcome of interest? Statement 1: Synoptic reporting for bone marrow pathology reports should be adopted for clearly defined neoplasia or widely applied classification schemes and receive appropriate institutional support. Agree: 79 Disagree: 14 4/21/2014 Sometimes bone marrow diagnosis is not clear cut. Adopting synoptic report forces toward premature diagnosis and wrong treatment. Strongly disagree. This is an unnecessary burden on community pathologists and non-hematopathologists. It opens the window for errors and inaccurate classification for borderline cases. The use of this synoptic should be optional and reserved for experts in the field. Only concern is that there be room for individuality in exact details of reporting. I would hate to see us move toward canned descriptors and differential diagnoses. Pathology is an art as well as a science. Can we not recommend the latest WHO Classification here specifically? I am curious as to what this synoptic template would "look" like as part of a report. While I agree that the elements of a synoptic should always be included, it depends on how it looks in a bone marrow report. Bone marrows do not lend themselves to a similar report style as other cancer cases do. Reports should be complete and easy to read. 4/28/2014 No description of required elements is offered so this is a blank check to require an infinite groups of exotica and there are very few truly agreed upon proven really needed even for AML say. I think consistency across institutions is important but given the complexity of developing a synoptic for "bone marrow reports" rather than specific entities (as has been done for colon cancer, pancreatric cancer, etc) poses a lot of problems secondary to the extreme heterogeneity of hematopoietic disorders one may see in the bone marrow. Most Marrow samples are just to Stage an oncologic Patient and have a low probability of involvement with the malignancy. This reporting system would add layers of unnecessary verbiage to the reports and require a peripheral blood smear report also unnecessary. This should only be done at the discretion of the Pathologist reviewing the case. As long as the entities truly are clearly defined and widely agreed upon. As we have a bone marrow transplant program at our hospital, I review many outside bone marrow biopsy reports. While they typically contain the pertinent information, often they are cumbersome or confusing. Also, our oncologists work at several hospitals in the area and a more consistent report would be useful for them. Agree, but why restrict this to neoplasia. Would we not serve our patients better with a standardized format in s synoptic display? There still needs to be room for free text narrative For cases which are not clearly neoplastic or do not fit a specific classification, any ambiguity regarding diagnosis should be clearly stated. 5/05/2014 Synoptic reports are unattractive, overly long, and not human-reader-friendly. None of my

clinicians likes any of them. 5/12/2014 I agree with the general premise of synoptic marrow reports, and that developing reports where data is easily found and relevant data elements are all there would be great goal. However, bone marrows evaluate a wide range of malignancies so adopting a "one synoptic fits all" system is not going to work well. The synoptics used for solid tumors are specifically designed for those tumors. E.g. the M:E ratio may be relevant in evaluation of myeloid malignancy, but in staging marrow for NHL with normal counts, what value does it add? We polled our clinicians and they polled their patients, providing examples of both prose and synoptic formats. The patients and hematologists strongly preferred a prose format rather than synoptic format. While all the requisite information should be in there, we have some obligation to provide reports that the patient can also appreciate. Synoptic reports need to be prepared by the LIS from drop-down lists. Use of check-boxes would make reports inconveniently long for both pathologists and hematologists, and create demand for free-text summaries, which in turn increase the chances for internal inconsistencies. Synoptic templates from LIS suppliers may be costly, and not all departments have sufficient IS support for other options. 5/19/2014 Synoptic reporting would be useful to ensure completeness of BM reports. However, the pathologists' comment/ interpretation of all available data at the top of the report is essential and so how synoptic reports are 'adopted' is critical.

Key Question One: Considering the possible primary bone marrow morphologic descriptors, which ones are required on a synoptic report if completeness is the outcome of interest? Statement 2: When reporting peripheral blood specimens for bone marrow synoptic reports, clinically and diagnostically pertinent elements, if available, should be reported. These key elements may include one or more complete blood cell count parameters, absolute cell counts and relevant morphologic descriptors. Expert Panel Discussion: Given the variety of neoplastic and nonneoplastic disease processes that involve bone marrow, it is not surprising that the available literature fails to identify a set of key data elements that are relevant to all bone marrow reports. However, the literature does emphasize some data elements more than others, and it is these that inform statements #2, #3 and #4. Individual institutions can prepare templates that include these as well as additional data elements relevant to the majority of marrows evaluated at that institution. Such a template would provide clinicians with easy access to necessary diagnostic information in a familiar format, and would facilitate comparison of data between sequential marrow evaluations of an individual patient and across institutions. Agree: 83 Disagree: 6 4/21/2014 I disagree with the phrase, if available. A CBC with peripheral blood smear evaluation is an integral part of the bone marrow report. Enough is enough. The proliferation of synoptic reports serves to make it easier for clinicians to perform their duties while making it harder for pathologists to perform theirs. A CBC with differential should be included on every case and should be listed in a single line format (as opposed to a paragraph format). The same format should be used for Bone Marrow differentials. The "paragraph" style saves space but is very difficult to use when you want to find information quickly. Too much descriptive information will be provided, If the CBC and other data is reported elsewhere in EMR, we might be able to refer to more complete results there, and summarize key important data for the current specimen. I agree with including morphologic descriptors. 4/28/2014 I think at minimum, a recent CBC and differential should be reported and ideally, a peripheral smear should be part of the case materials. We are making that change in our institution. Not all the time tandem peripheral blood is provided by clinicians and they need to be educated. This is particularly important for evaluation of myeloid dysplasia. In secondary causes of cytopenia, such information is supportive. 4 or 5 page marrow report is unhelpful and clutter This would unnecessarily clutter reports. We cannot generate a "ONE SIZE FITS ALL" mentality. Agree. We are unable to report the CBC data using our current EMR (Ulticare), but this is an important part of the report. I don't feel as strongly about reporting absolute counts. Although useful for pathologists, many clinicians are more used to and feel more comfortable with percentages. Peripheral blood info is usually already available to the clinician and can be trended more easily in the LIS. I see reports with all the CBC parameters inserted on a new acute leukemic which only serves to clutter the report. Put in CBC data as the pathologist determines it is needed for the diagnosis. Unless the LIS inserts the data it leaves one open to transcription errors or heaven

forbid, cut and pasting on the wrong patient. 5/12/2014 CBC (and often retic count) make the data complete. If such numeric data is incorporated, the only descriptors of smear need to relate to morphology, not counts. Need to get institutional support to interface CBC results into path report. Think reporting absolute counts much better than %, especially for neutrophil, lymphs - prevents confusion in cases with relative lymphocytosis etc. The CBC should be delineated somewhere, but the absolute values should only be used where relevant, since otherwise it congests the report. 5/19/2014 The CBC data obtained on or near the date of the bone marrow examination should be a part of the bone marrow report (whether in the history or in the data elements). This enables a unified interpretation of the patient's disease and for the evolving natural history of the disease, especially important before and after therapy. Like progress notes or H & P notes, path reports should include pertinent objective data and an overall summary or interpretation of all available data. However, unlike those clinical notes, the diagnosis and interpretation should be on top of the page. The peripheral smear findings are part of diagnostic criteria I we'll established hematologist malignancies they give information for or against your differential diagnosis. I was told a hematopathologist always start with looking at peripheral Smear

Key Question One: Considering the possible primary bone marrow morphologic descriptors, which ones are required on a synoptic report if completeness is the outcome of interest? Statement 3: When reporting aspirations for bone marrow synoptic reports, clinically and diagnostically pertinent elements should be reported. These key elements may include (but are not limited to) blast percentage, dyspoiesis, myeloid:erythroid ratio, morphology of lymphoid elements, and enumeration of lymphoid elements and plasma cells. Expert Panel Discussion: Given the variety of neoplastic and nonneoplastic disease processes that involve bone marrow, it is not surprising that the available literature fails to identify a set of key data elements that are relevant to all bone marrow reports. However, the literature does emphasize some data elements more than others, and it is these that inform statements #2, #3 and #4. Individual institutions can prepare templates that include these as well as additional data elements relevant to the majority of marrows evaluated at that institution. Such a template would provide clinicians with easy access to necessary diagnostic information in a familiar format, and would facilitate comparison of data between sequential marrow evaluations of an individual patient and across institutions. Agree: 79 Disagree: 6 4/21/2014 Evaluation of aspirate samples should include both aspirate smears and aspirate clot sections. Since we do not know which elements will be clinically relevant, a list of pertinent data elements should be defined. I.e. Are the percent of sideroblasts important? Too much unnecessary information can be listed. If lymphocytes or plasma cells are not increased, a specific enumeration of them (3.2% lymphocytes) is not necessary particularly in some clinical scenarios (e.g. follow-up for AML). On the other hand, in cases of lymphoma or myeloma this enumeration would be very important and should be specifically quantitated (2% plasma cells). I agree with the above elements. How will "adequacy for evaluation" be addressed in the report? If an aspirate is "hemodilute and aspiculate," for example, should this also be reported? 4/28/2014 Morphologic evaluation of aspirate is essential since many hemtologists especially newly trained hematologist are not trained properly for this even though they can professionally perform and bill for this service. Incorporation of clinical data is of particular importance since secondary causes of dysplastic features exist. Hematologist need to be specifically commented on this in case dysplastic features are obvious in an aspirate. As descriptors these are nice but not often n/a A benign marrow does not need anything but a general diagnosis of ongoing normal hematopoiesis. I agree with all but morphology of lymphoid elements. I only report on this in a case of lymphoma staging and not marrows for other reasons. I do, however, include the percentage of lymphocytes and plasma cells in the differential. 5/12/2014 The so called key elements vary depending on the disease being evaluated. Discussion of lymphocyte morphology e.g. is redundant in patient with CML. Instead of a single synoptic for all diseases, can the group come up with key data elements required in general clinical scenarios - e.g.comment on dysplasia in patients with cytopenias, but not needed if CBC normal etc

It is often enough to say that lymphocytes and plasma cells are not increased, but agree that rigor could be added by giving the percentages and saying that they are morphologically unremarkable. 5/19/2014 Morpholocy of myeloid, erythroid and megakaryocytic elements, not just lymphoid. I would also include morphology of myeloid elements, and enumeration of myeloid elements; In practice, I report on three lineages, lymphoid elements, and "other" (such as significant iron-laden macrophage component, hemophagocytosis, and other disease-/treatment-/condition relevant specific parameters.) I would like to include: Spicules: absent/few/several Cellularity: hypo/normo/hyper Myeloid maturation: normal/left-shifted/dysplastic Erythroid matuaryion: normal/megaloblastic/dysplastic Megakaryocyte number: normal/decreased/increased Megakaryocyte morphology: normal/dysplastic M:E ratio Besides Blast% Lymph% Plasma%, include Myeloid% Erythroid % Would include megakaryocyte number and morphology

Key Question One: Considering the possible primary bone marrow morphologic descriptors, which ones are required on a synoptic report if completeness is the outcome of interest? Statement 4: When reporting core biopsies for bone marrow synoptic reports, clinically or diagnostically pertinent elements should be reported. These key elements may include (but are not limited to) cellularity, fibrosis, distribution pattern of hematopoietic elements, morphology of lymphoid elements, and enumeration of lymphoid elements and plasma cells. Expert Panel Discussion: Given the variety of neoplastic and nonneoplastic disease processes that involve bone marrow, it is not surprising that the available literature fails to identify a set of key data elements that are relevant to all bone marrow reports. However, the literature does emphasize some data elements more than others, and it is these that inform statements #2, #3 and #4. Individual institutions can prepare templates that include these as well as additional data elements relevant to the majority of marrows evaluated at that institution. Such a template would provide clinicians with easy access to necessary diagnostic information in a familiar format, and would facilitate comparison of data between sequential marrow evaluations of an individual patient and across institutions. Agree: 75 Disagree: 9 4/21/2014 It is difficult to determine what will be pertinent for a patient in the future. A list of essential data elements should be made available, allowing institutions to expand the list; i.e. tryptase for mast cells, CD138 for plasma cells, PAS/congo red for amyloid, etc. Too much information sometimes discourage the thorough reading With the caveat that morphologic "enumeration" of lymphoid cells in a bone marrow biopsy yields a fairly inexact result, unlike an aspirate cell count. A good reference that I did not see listed in the EP's list of references is S.-H. Lee et al, ICSH guidelines for the standardization of bone marrow specimens and reports. 2008 Int. Jnl. Lab. Hem. 30:349-364. The following are my elements for required morphologic descriptors on synoptic report, underscoring the standardized reporting of adequacy for each specimen type and some objective descriptors that can serve as quality marker (e.g. trephine length of marrow space) Specimen adequacy for each specimen type (analogous to cytology reporting: satisfactory, suboptimal, unsatisfactory...); Aggregate length of biopsy core / total length of marrow space may be considered; Erythropoiesis, granulopoiesis, megakaryopoiesis should be listed as present / decreased / absent; blast % listed (and what specimen type it is taken from); plasma cell % listed (when applicable) (and what specimen type it is taken from); cellularity of biopsy (ranges); in lymphoma cases, % involvement by lymphoid infiltrate (of total cellularity) and % involvement by lymphoid infiltrate (of marrow space) (reporting of % involvement seems variable and non-standardized in current practice); lymphoid aggregates present / absent (and type: e.g. focal nonparatrabecular, focal paratrabecular, intravascular/intrasinusoidal, diffuse interstitial, diffuse solid) 4/28/2014 Abnormal infiltrates or changes in architecture should be reported. Such interpretation is required since general pathologist may expect to see trilineage hematopoiesis but details are required for supporting a diagnosis. A comprehensive hematopathology report is required to achieve final diagnosis considering limitation of each observation.

These are all comment descriptors and are not diagnoses (except maybe fibrosis). I do not feel it necessary to enumerate lymphoid and plasma cells on routine bone marrows as their percentages have been reported in the differential in the aspirate smears section. Also, I do not report on distribution pattern of hematopoietic elements unless it is unusual. Would add % tumor involvement. Adequacy should be # 1 on report. Does the panel recommend that special stains for fibrosis be performed on every case? 5/05/2014 Should also include reporting the quality of specimen. 5/12/2014 The report should include the bone marrow core biopsies length, amount (length) of marrow space (excluding any soft tissue), and degree of aspiration/crush artifact. These are the issues that quite often preclude proper evaluation for staging etc. Agree with comments re incorporate % marrow space involvement by lymphoma, pattern of lymphoid infiltrate for lymphoma evals. Again these elements, as well as plasma cell descriptors, useful in lymphoma evaluation but redundant and waste space for other entities. Again, it is often enough to say that plasma cells are not increased and that there are no lymphoid aggregates. To enumerate them, one would have to do immunos which are a waste of money for many cases. The elements listed may be more efficiently and clearly communicated in text elements in a templated report. 5/19/2014 Don't agree with "morphology of lymphoid elements and enumeration of lymphoid elements and plasma cells". Enumeration of lymphoid elements and plasma cells on the biopsy - this must be a typo. I agree with the rest, and would put in an "other" category A synoptic sub-header of "abnormal infiltrates": none/lymphoid aggregates/plasma cells/granulomas/metastatic tumor/blasts/mast cells Also "bone": normal/osteopenic/osteosclerotic synoptic I agree there should be a standard template including relevant findings flowcytometry, chromosome studies, molecular pathology etc. Also when the studies do not correlate with morphological findings in the marrow. Would include maturation of hematopoietic elements, megakaryocyte number and morphology, significant stromal abnormalities

Key Question 2 Considering the possible ancillary studies that could be ordered on a bone marrow specimen, which ones are required on a synoptic report if completeness is the outcome of interest? Statement 5: If ancillary studies are performed, the results, methodology, performance and interpretation sites should be reported. Expert Panel Discussion: The EP acknowledges that timeliness of reporting (eg, APL) is paramount and that some ancillary studies may need to be released before the full report is available. The EP also acknowledges that some ancillary studies are not supported by data. ie, not all bone marrows require all possible ancillary studies. This will be addressed in the manuscript. Agree: 72 Disagree: 9 4/21/2014 Since some ancillary studies require a fresh sample, will there be a list of essential studies permitted for all bone marrows? Some ancillary studies are performed due to the poor quality of the sample. Cytogenetics and molecular studies are key to many diagnoses. They are usually not available at the time of the BM report. To include them results in unacceptable delay. Also to reiterate the entire methodology makes reports unreadable. A better approach for ancillary studies is to encourage a separate comprehensive report that includes morphology, cytogenetics and molecular. Many times, this is the only way you can arrive at a WHO diagnosis. Leave the ancillary tests to a summary report unless they are available at the time of BM sign out. Brief description only. Too much space occupying description is very bad. I believe that in cases where the clinical utility of ancillary testing is minimal and results are not unexpected the referencing to an external report would be sufficient. For example, a reference that "Karyotype will be reported separately in the medical record" in the case of a myeloma follow-up appears to contain normal numbers of plasma cells and no dysplasia or cytopenias. One may argue why the test is ordered at all in those cases, but clinicians can be persistent customers. If ancillary studies are reported in separate report (especially if sent to reference lab), the main synoptic report could summarize and refer to full report (where details of methodology and performance would be included) There is great variability in different institutions in the source and timeliness of ancillary test results. Thus I think it will be difficult to establish a hard-fast standard of practice for reporting of these data elements. As you indicate, morphology and ancillary results are often released at different times, and in some cases there is clinical pressure to release preliminary reports before all ancillary results are obtained. Performance and interpretation sites do not provide sufficient useful information to justify the additional length of the report 4/29/2014 Current LIS do not make it easy to accommodate evolving Diagnoses as ancillary studies results are received. This makes optimal reporting challenging. Primary report has synopsis of ancillary study findings with original separate reports available for review. Any acute leukemia is a critical call in our institution and requires prompt clinician notification. This usually is diagnosed by flow cytometry but some cytogenetic studies required for definitive diagnosis such as APL which is considered medical emergency to prevent DIC. Such possibility based on the morphology and flow histograms and immunophenotype should be related to

clinician while waiting for definitive diagnosis. I agree all useful/necessary ancillary should be included with marrow reports to keep together and the corollary is that if not available at initial report they should be added and not allowed to be referenced as "see other report". Often, the methodology and performance are not available especially in consultation cases. I think the results should be required and the methodology and performance encouraged if the data is available. The report should give a synopsis of the pertinent diagnostic findings and refer the reader to the complete text of the ancillary study report for those particulars. I am confused by methodology. Does this mean general immunohistochemistry, flow cytometry, iron stain, reticulin stain, FISH, cytogenetics, PCR etc or is it more specific? Otherwise, I think it is important to report what is available as well as the sites. A compromise would be to insert pending to indicate such studies are underway. I suggest the report be held for key diagnostic ancillary tests (e.g. APML, segregation AML vs. ALL if not clear). Reports can be amended with stratification markers. However, that makes the pathologist function as a mini-LIS to accumulate data from many labs at the risk of reports that are cannot fit the synoptic format. I can find such data in our LIS faster than I can find the amended data in an old bone marrow report. We have an SOP that guides us as to which ancillary studies are needed for which diagnoses, situations, and points in treatment. 5/05/2014 Rather than explicit descriptions of all ancillary tests's methodologies and interpretation protocols, reference to a publicly available document describing methodology (web page, journal article) should be permitted. Brief formatting including pertinent details. 5/12/2014 I assume that ancillary tests like IHC, flow that get done rapidly, get incorporated into the bone marrow report in real time. I agree with several prior comments that incorporation of some cytogenetics or molecular studies is key if the study is critical to the diagnosis - e.g. refining diagnosis of AML, but that incorporating cytogenetics/molecular in other scenarios such as follow up of myeloma etc, while theoretically possible and would make for a more complete report, in practice is very time consuming, and should not be a requirement. I don't think the BM report should include "methodology, performance and interpretation site". The individual testing labs report details on methodology etc; if results are incorporated into the bone marrow report the signing pathologist needs to understand limits of methodology to interpret, and can comment on these if appropriate. That could be a very large requirement, depending on the degree of specificity required. (e.g., MDS FISH Panel vs. FISH for 5/5q, 7/7q, 8, and 20q, vs designation of exact probes used and exact methodologic details and specimen tested - fresh marrow vs. cultured marrow; molecular methodologic comments could be even more demanding). The analytical and clinical sensitivities are all in the molecular report. There is no need for someone uneducated in the technical aspects to comment on the performance and methodology of the ancillary test. This could lead to liability issues since the morphologist/pathologist may be held accountable for issues with the molecular result. The role of the morphologist/pathologist is to help place the molecular/cytogenetic results in the context of the bone marrow findings, NOT to reiterate the molecular report. 5/19/2014 Reports can have adjunctive or special procedure report sections to accommodate the ancillary studies (molecular, cytogenetics, FISH), which may not be completed at the time of the

morphology report. The diagnosis cannot be held until all of the ancillary studies are completed (unless required by the diagnosis). Thus, the synoptic report, if not careful, will have a laundry list of ancillary studies that only say- See adjunctive or separate report. Details about the methodology and performance (including limitations) could be included in the report or else the separate molecular report could be cited (see M Gulley, JMD, 2007 regarding Molecular Pathology reporting). Please be sure to not require ancillary studies to be reported at the same time as the primary diagnosis. These are often later and putting them all in the same synoptic causes a lot of problems with lab information systems. Clinicians order ancillary tests that are sometimes not needed. The lab is then obligated to perform and report the tests as requested. Since the timing of the ancillary study results is different, it would be difficult to integrate one-time synoptic report, but all result should be in one integrated report. Many ancillary studies (molecular and cytogentic) may not change the interpretation and the final diagnosis, and are reported in an EHR that should be linked and readily accessible by the clinician. Release of the final report should not be delayed for addition of these studies, nor should numerous addendums or amendments be issued which do not alter the substance of the interpretation as long as those results are available elsewhere. Agree that non-availability of ancillary studies at the time of synoptic report should not hold up report If current standard of care includes those studies a note should be added to report after discussing with clinician, oncologist. The need for a follow-up report that includes the ancillary studies not completed should be addressed.

Key Question 2 Considering the possible ancillary studies that could be ordered on a bone marrow specimen, which ones are required on a synoptic report if completeness is the outcome of interest? Statement 6: If results for an ancillary study are not available at the time the report is issued, pending status should be explicitly stated. Agree: 79 Disagree: 5 4/21/2014 A supplemental correlative report should be issued for all pending studies. Many ancillary studies are not ordered until after the BM is signed out so this should not be the only source of pending test information This is dictated currently in a comment and is sufficient. A synoptic is not necessary. Commented upon previously. I think it is too tedious and error-prone if each stain should be documented in the synoptic. Rather, for instance, "IHC: performed / not performed / pending / performed & some stains pending" format may be more desirable. Similar approach to listing flow, cytogenetics, FISH, molecular, other studies... 4/28/2014 Do not believe in "pending". Individual reports can be issued, and a summary report should be generated when all results are available. It is of note that in our institution cytogenetic reports routinely done on bone marrows are not incorporated in hematopathology report due to longer turnaround time. However final diagnosis requires cytoegentics in cases such as suspected MDS since 50% of time they have abnormal findings but morphology may not be definitive. Either in the diagnostic line or comment. Is there a provision for a preliminary written report? Completeness to me is what is necessary to make the diagnosis, not, e.g. the full karyotype and molecular tests that may add or may not add to care. See my comment to the previous question 5/12/2014 Useful to have pending status (or "not performed" if appropriate) so in the future it's clear if such results exist to incorporate into clinical decision making. 5/12/2014 Clinicians sometimes order ancillary tests independently of their submission of the morphology specimen to different sites, without indicating what was done. While it is a very desirable goal to include the information on pending tests, and one that we do on specimens that originate at our medical center, to make this a synoptic requirement would be onerous. A compromise position would be to limit this to tests that the morphology pathologist ordered. If you mark it as simply "pending" and then sign the case out, your report will always say pending. This causes confusion. This may just be a verbiage issue, but I would prefer "Test pending as of (date/time). Please see additional results when they are available." I would agree that pending status should be stated for pertinent testing that may influence the outcome of the interpretation. However, not all testing falls in that category. Wording would also need to be adjusted so as not to expect pathologists to continue to search for ancillary testing (chimerism, send out molecular tests) and issue daily addendums as test results return.

Many of these are send outs and do not come back to the departments electronically. Definitely. It is an incomplete report when the follow up report is not completed and when the clinician is looking for it or when second opinion is requested.

Key Question #3: What sequence of results reporting should be followed? a. Considering the options available, is there an optimum report format that should be used if ease of use, error reduction, and fewer incompletes are the outcomes of interest? b. Is there an optimum presentation for the elements of the minimum data set if the outcomes of interest are clarity and ease of use?

Statement 7: A synoptic report should comprise a diagnosis section, a section for supporting studies including ancillary data that are critical for diagnosis, and interpretative comment. Key morphologic descriptors should be in the synoptic portion of the report and may be included in the diagnosis section if critical or a component of the disease classification. The diagnosis section should head the synoptic report. Agree: 78 Disagree: 7 4/21/2014 Most ancillary studies (cytogenetics and Molecular) will not be available at time of sign out. A second comprehensive report is a better solution. I agree that the diagnostic section should head the synoptic report. I sometimes receive outside reports with the diagnostic evaluation buried in the text, or at the end. It's a struggle to find the "bottom line" conclusion on these reports. I can't imagine how a clinician makes sense of these reports. I, for one, prefer for the interpretive comment to immediately follow the diagnostic line. 4/28/2014 Too much micromanagement I do strongly agree that all information obtained during bone marrow procedure including aspirate, flow, immunostain and cytogenetic needs to be incorporated to reach final diagnosis. Hematopathologists are trained to know limitation of each in terms of sample adequacy and need to additional studies to reach final diagnosis. For example if flow cytometry result for palsma cells is used by hematologist. Percentage of plasma cells may be erroneous related to porr invitro viability of plasma cells. Immunostain is required for that percentage. As for monoclonality flow cytoemtry is more sensitive in this regards and other data such as IFE has the most sensitivity for this. Therefore incorporation of this data is required to explain possible discrepancies in results and at the same time decrease need for extra immunostains and therefore decrease cost. Do NOT duplicate stuff - so do not have a diagnosis section and then report the diagnosis in a synoptic function. There are almost no morph descriptors that are a diagnosis and therefore have no business being in a synoptic report, e.g. is it AML or not and if so what are cytogenetics; % blasts belong in a footnote. Why not just bite the bullet and make the whole report synoptic? 5/05/2014 If reporting format is as optimum as it could be, then nothing will be missed with regard to diagnosis and key ancillary studies one could do. 5/12/2014 Would be nice to have the Dx at the top of the report. We can't do this at our institution for some reason. Any report should include the key sections of clinical information, CBC, bone marrow diff

data, morphology, and as required immunophenotype, cytogenetics, FISH, molecular. Not actually sure how a synoptic report is going to be different other than including check boxes for data that may or may not be relevant to the case Significant or unusual morphologic abnormalities should be explained in the interpretive section. 5/12/2014 Keep the final diagnosis statement uncluttered from microscopic morphology details and ancillary information or the goal of finding the diagnosis will be lost in the name of "complete" synoptic reporting. The final diagnosis should definitely lead the report. I'm not sure I agree or disagree. I need to see an example. This could be great or awful as described. Synoptics, if not designed well, will not be used. I hope you have a pathology informaticist working with you.

Key Question #3: What sequence of results reporting should be followed?

a. Considering the options available, is there an optimum report format that should be used if ease of use, error reduction, and fewer incompletes are the outcomes of interest? Statement 8: The following elements should be considered for formatting and data presentation of synoptic reports:

• Electronic data integrity • Font: serif, size consistency, font consistency • Adequate use of white space

Expert Panel Discussion: The use of images, tables, bold face, bullets, etc. can enhance presentation but is problematic when data are transmitted across interfaces. While the synoptic reporting section should not include tables, bullets, and other formatting not conducive to electronic data integrity, these items can be used in a more comprehensive summary report that has validated data transmission, eg, PDF formats. Agree: 74 Disagree: 9 4/21/2014 This one is going to be difficult to achieve due to various types of IT systems and interfaces. SERIF?? I think, hope and pray you mean SANS SERIF font. Who needs useless flourishes on their letters? ARIAL, CALIBRI, HELVETICA are all OK. Times New Roman is NOT appropriate for the medical record. Each test type or sample type should get their own paragraph and heading such as: PERIPHERAL BLOOD: ASPIRATE: BIOPSY AND CLOT SECTION: IMMUNOHISTOCHEMISTRY: FLOW CYTOMETRY: CYTOGENETICS: MOLECULAR STUDIES: They should simply be dictated in a diagnostic field, with ancillary studies in a comment in clean, short, paragraphs. Sequence of results reporting: Diagnosis first, followed by comment/note, then up to discretion of pathologist/lab. This implies that there should be two reports: One that is easily readable but not electronically transmissible and one that transmits with integrity but is not necessarily readable. One easily readable report should serve both purposes. 4/28/2014 Too much Micromanagement This is fluff -- everything goes across interfaces now and pdf is an afterthought that requires multiple clicks to get to so discourage. Often, formatting does not transmit intact from LIS to EMR (in fact, in my experience, that is the rule rather than exception) so all efforts to adhere to a stylistic format would likely be futile as the final report on the clinician end would not reflect any of the changes. The electronic world is here and we have to have reports that move data across interfaces. Beautifully formatted reports do not look so great when scanned in and are difficult to retrieve. In the bigger scheme of things, we should migrate to the synoptic report parameters being data elements that can be retrieved and studied. 5/05/2014 EMR's may be the law of the land, but that doesn't make them good for patient care, efficiency

of reporting, or anything else relevant to clinical practice. They needn't be allowed to drive how we do our reporting. 5/12/2014 This is micromanagement. Pathologists need to work with their LIS group to figure out how data crosses interfaces, and work to make reports that remain understandable after crossing through interface. I have no idea what "font" our reports are in, and the font that is used in the LIS is different from the one in our HIS- which is what the patient would see. But, I do know that all formatting (bold, italics, different fonts) are all wiped out in the interface anyway. Summary and synoptic sections should be components of the same report, not separate reports. 5/19/2014 This is a vague guideline that is not about the elements of the report but on technical features of interfacing (e.g. HL7). What is "adequate use of white space" to be in compliance? Remove or retool this guideline. Ex. Construct of the synoptic report so that it maintains electronic data integrity when crossing interface to consumers' LIS or EHR platforms. I would not encourage the use of PDF formats. While these maintain the visual, you are losing all hope of having this data populate an EHR as discrete elements when you use PDF. RTF is a better option (or PDF combined with RTF). Comprehensive summary report" Would that be a reiteration of the synoptic report with pending studies all completed with further interpretation is indicated?

Key Question #4: Which components required for correct coding and data repositories should be included in the report?

a. Coding b. Registries c. National guidelines (e.g. NCCN) d. Physician payment incentive requirements

Statement 9: No recommendation is made regarding the inclusion of coding terms in a synoptic report since coding terms are distinct from scientific terms and vary considerably among health authorities, payers, and different countries.

Agree: 77 Disagree: 5 4/21/2014 Most pathologists are not familiar with these types of information. While no recommendation should be made, these options should certainly be permitted. There should be no synoptic report required. this is stupid 4/28/2014 In the US, physicians and certified coders are responsible. Understand the hesitation for not including coding but we are required to code at our institution. A mention should be made to the effect that coding should be performed in accordance to institutional requirements. Suggest that these be relegated to pt. 4 or 6 font at max! 5/05/2014 Thank you for this element of sanity. 5/19/2014 At a minimum, since Meaningful Use requires use of SNOMED-CT for the problem list, diagnoses and some other items should be encoded into SNOMED-CT. This will assist with populating EHRs with the correct diagnosis electronically. Additional tests are performed based on morphology and sometimes do not correlate with the provided ICD9 codes and can be rejected by insurance.

Key Question #5: What clinical or laboratory information should be included in the report? Statement 10: Clinical and laboratory data required for a definitive diagnosis should be included in the synoptic report, along with its source(s), if applicable.

Expert Panel Discussion: Clinicians should transmit relevant clinical information. (eg, duration of cytopenias, organomegaly, pertinent drugs, history of malignancy/chemotherapy/ transplantation, etc.) The manuscript will include a table of examples. Since variability of data available to pathologists is high, the EP could not recommend that pathologist must search the electronic medical record in its entirety to find this information. The responsibility for transmitting relevant information is on the clinician submitting the specimens. It is important to record where or from whom certain information is derived. Agree: 71 Disagree: 6 4/21/2014 The lack of clinical information will have an impact on the number of data elements and ancillary studies obtained on a bone marrow sample. "If applicable" is the key word. Data is included in current reports. Synoptic not needed. Lacking the upfront communication, by the ordering physician, of clinical information that may be critically relevant to definitive diagnosis, every reasonable attempt should be made by the pathologist to obtain this information prior to finalization of the report. Merely placing this responsibility upon the head of the ordering physician does not ultimately serve the patient well. I very strongly agree that the responsibility for providing relevant clinical information lies with the clinician. This is a very serious issue with major implications regarding interpretative diagnostic errors caused by inadequate, incomplete, or erroneous information provided by the clinician to the pathologist. In some cases, even the electronic medical record contains erroneous information. There is simply no substitute for thorough accurate clinical histories provided by the clinician. I don't know how this can be enforced without taking draconian measures, such as holding the report until such information is provided. While I agree part of the responsibility for transmitting relevant information is on the clinician, there must be at least an equal responsibility on the part of the pathologist to ensure this is provided regularly. If necessary, feedback to the systems-based problem should address any lack of information that hinders assessment. Or, if only an infrequent case lacks clinical information it should at least be partly the pathologist's responsibility to identify a reasonable indication for the bone marrow if not provided or if inadequate. Key history in the report: main indication for bone marrow evaluation, relevant history of hematopoietic or lymphoid neoplasm, radiologic findings (if available), selected relevant laboratory results that impact the conclusion of the case. Agree and disagree - clinicians should provide pertinent clinical information. But if the clinician does not provide the data - the pathologist should gather the information needed - either through message to clinician or reviewing the EMR. Blind sign out of bone marrow cases without appropriate clinical information is as much on the pathologist as it is on the clinician. Again. A synoptic report for bone marrows is dumb. 4/28/2014 This would require a complete search of electronic medical record regardless. It's too much to ask for.

This should be optional. Some of these data depend on clinician input and hence is not controlled by the pathologist Yes, completely agree with this. Relevant laboratory data may have a major bearing on the interpretation of the report. If any abnormality is discovered in bone marrow, clinical information is required to diagnose bone marrow as primary source of disease and that requires exclusion of secondary causes. This is going to be institution dependent and how well EHRs work so hard to mandate. Also seriousness of dx will drive. The recommendations should allow us to REJECT any sample that does not include all relevant history. If available of course. We rarely get the information we need and do not have time to look up each patient in the EMR and sift through the volumes of data available. We obviously need to have an option for unavailable data. Of course this also influences the specificity and certainty of the diagnostic information that can be put into the report. Oftentimes the type of information in the diagnostic section of these types of reports would not fit into a synoptic based report. Not sure the source needs to be included. That could be cumbersome. However, I do usually notate if the information comes directly from the patient and not the EMR. We may not like it that our clinicians fail to give us data, but as consulting physicians we are obligated to collect all relevant info to arrive at a correct diagnosis. With some groups we have a history sheet that uses circles to fill out and our clinicians used it. We have not used it for marrows as they are clear for the indication or so complex that we need to look at the detailed history. I understand why the committee took this stance, but the pathologist should include all the data used to influence the diagnosis. Otherwise we can just have technologists do the report. 5/05/2014 Strongly agree. 5/12/2014 As long as the synoptic report is not too long, maybe we'll have time to talk to our clinician colleagues and figure out the clinical concerns and history in each case. Pathologists undoubtedly need this clinical information to make the correct diagnosis. We have an EMR-linked method for clinicians to submit that data. However, a summary (1-2 prose sentences) is in the morphologic report, NOT the full set of data from the request form. We also do not record from where we obtained the 1-2 sentences. This seems onerous. I would like to see if the patient has constitutional symptoms (B symptoms - fever, weight loss, chills) documented in the synopsis. Pathologists reviewing material from patients seeking second opinions, in consultation settings or reference labs don't have access to the patient's EMR. General Comment: Thank you for organizing this Bone Marrow Synoptic Reporting. 5/19/2014 We also do not record from where we obtain clinical and pertinent lab data and it does seem onerous; we generally rely on the requisition. Next, please write a synoptic requisition! However, pathologists should REQUIRE necessary clinical information up front. With the advent of CPOE for anatomic pathology specimens, these should be in the form of required ask-at-order prompts at the time of order. A meaningful report is only possible with relevant clinical data and this also prevents unnecessary tests. eg. A simple indication of R/O CML versus H/O CML makes a difference in tests ordered. A designation of just CML does not help the pathologist. Sure, but we should make an effort to find out relevant clinical information, when available, like

CBC results for example. The pathologist and clinician needs to be on same frequency. I feel we all should try to achieve this relationship as this makes getting relevant information and pre vinous clinical information necessary for making diagnosis.

GENERAL COMMENTS 4/28/2014 Suggestions regarding the process and content of the project:

1) The “open comment” survey only surveys opinions on the material that is presented. It does not, however, allow for general comments on topics other than those listed. Which leads me to my main point –

2) I think that there is an assumption missing in the reporting and it is perhaps so fundamental as to be overlooked. It is the question of sample “ADEQUACY”. The sample adequacy precedes any questions of results but is critical in evaluation of bone marrow samples. I read 2000-3000 bone marrows per year and while this is a significant, I find that issues of quality are present in a significant percentage of cases. In most cases, the sample is inadequate due to hypocellularity or lack of marrow elements in an aspirate smear. However, limited size, or artifact will often limit samples of core biopsies. Even PB smears can be inadequate due to cell lysis or inappropriate staining.

Per #2 above, I would suggest that an adequate statement be considered in addition to the other standards. I would suggest that like the Bethesda system for cytology, adequacy be reported as “ADEQUATE”, “INADEQUATE” or “SAMPLE LIMITED BY…..(artifact)”. This would not preclude a diagnosis if a single sample portion (such as aspirate smears was considered inadequate” but would address issues if, for example, a protocol required results of a smear count, which were not present. Likewise, in any case where a diagnosis is present, regardless of how limited the sample, results would be reported as “DIAGNOSIS; sample limited by (artifact)”. I believe that this issue is critical as it could also account for incomplete or inaccurate results which may be present within a synoptic reporting system, but would still allow for proper synoptic reporting (e.g. inadequate is not the same as an empty result field). This comment is not directly related to the above statement but there was no other option for a more general comment. Leukemia is the most common cancer of the pediatric population; therefore protocols for synoptic reporting of bone marrow findings should take into consideration any particularities that may be of special significance in children and not necessarily apply to the adult population. As a matter of fact, the CAP recognizes the special needs of reporting pediatric tumors in cases of non-hematologic neoplasia by providing a whole section of separate cancer protocols for the pediatric population. Even though hematopathologists with extensive experience in the realm of pediatric leukemia may be a good resource for this particular task, it is reasonable to state that a pathologist with double board certification in hematopathology and pediatric pathology represents the optimal choice and should be included in the panel of experts.