not valid after july 26, 2019 · cap wsi: draft recommendations and strength of recommendations not...

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13.64% 21

9.09% 14

1.30% 2

9.74% 15

11.04% 17

5.84% 9

Q1 What is your occupation/role? (select all that apply)Answered: 154 Skipped: 3

Total Respondents: 154

# OTHER (PLEASE SPECIFY) DATE

1 CAP staff 7/15/2019 12:18 PM

2 Digital Pathology Project Manager 7/11/2019 5:36 PM

3 Imaging Research 7/2/2019 10:04 AM

4 Student 7/1/2019 6:30 PM

5 Head of the Department 6/30/2019 9:35 AM

6 Healthcare Innovation Centre 6/28/2019 11:40 PM

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QA/QCCoordinator

LaboratoryManager

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ANSWER CHOICES RESPONSES

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CAP WSI: DRAFT Recommendations and Strength of Recommendations

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7 Director of Informatics 6/28/2019 11:18 AM

8 Informatics director & research faculty 6/28/2019 10:48 AM

9 retired pathologist who also did clinical medicine 6/28/2019 10:44 AM

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DisclaimerThe information, data, and draft recommendations provided by the College of American Pathologists are presented for informational and publicfeedback purposes only.The draft recommendations and supporting documents will be removed on July 26, 2019.The draft recommendations along with the public comments received and completed evidence review will be reassessed by the expert panel in orderto formulate the final recommendations. These draft materials should not be stored, adapted, or redistributed in any manner.

43.79% 67

9.80% 15

4.58% 7

7.84% 12

0.65% 1

1.31% 2

3.27% 5

Q2 Which of the following best describes your practice setting? (selectone)

Answered: 153 Skipped: 4

Universityhospital/aca...

Voluntary,non-profit...

Proprietaryhospital

City/County/State hospital

Veteranshospital

Army/AirForce/Navy...

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11.76% 18

1.31% 2

1.96% 3

11.11% 17

2.61% 4

TOTAL 153


1 CAP staff 7/15/2019 12:18 PM

2 retired 7/13/2019 11:52 AM

3 Immunology research 7/1/2019 7:53 AM

4 Retired 6/29/2019 1:12 PM

Regional/local independent laboratory (except clinic or group practice and not owned by a national corporation(s))

Public Health, non-hospital

Clinic, group, or doctor office laboratory

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Q3 Draft Recommendation Statement 1Strong Recommendation - Thevalidation process should include a sample set of at least 60 cases for

one application (eg, H&E stained sections of fixed tissue, frozen sections,cytology, hematology) that reflects the spectrum and complexity of

specimen types and diagnoses likely to be encountered during routinepractice.Note: The validation process should include another 20 cases for

each additional application (eg, immunohistochemistry, special stains).(Statement reaffirmed)Draft Evidence Tables for Recommendation

1Explanatory Note: As outlined in the introduction of the 2013 guideline,“validation” refers to a process designed to demonstrate that new

technology or instrumentation performs as expected for its intended useprior to its application for patient care. This recommendation refers to the

initial validation of the hardware and software components of a wholeslide imaging (WSI) system that must function correctly in order forpathologists to render diagnostic interpretations by WSI. The key

question is whether the same pathologist makes the same interpretationof a given case regardless of whether the case is reviewed by WSI or

glass slides. The intent of this recommendation is to evaluate theperformance characteristics of the new technology. It is not intended to

validate, establish or test an individual pathologist’s diagnosticcompetency.The initial validation of the WSI system should be carried outby pathologists who have been trained and are technically competent inthe use of WSI system for making diagnostic interpretations. Following

systematic literature review, no evidence-based recommendations can bemade about the exact type of training required or the metrics used toassess technical competency of pathologists using WSI systems fordiagnostic purposes. Training varied from study to study and not all

studies explicitly stated what the training entailed. Training andcompetency, as well as the number of pathologists invited to complete

the validation process, is defined at the discretion of the laboratorymedical director. The expert panel plans to provide suggestions for

training as an additional resource (i.e., not part of the guidelinemanuscript). This will be made available on the CAP website upon

release of the guideline.Answered: 111 Skipped: 46

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75.68% 84

18.92% 21

5.41% 6

TOTAL 111

# COMMENTS DATE

1 ...60 cases for one application "and for each disease" 7/21/2019 7:48 PM

2 May add additional clarification: 1. The validation may be distributed among more than onepathologist. If there are numerous members of a group, is it recommended each participate ifpossible or better to concentrate on fewer members? 2. Concerning additional applications - Ifcases routinely contain "additional applications" (eg. IPOX for H. Pylori) would these qualify forvalidating the specific additional application as well. 3. Once the validation process is completed,additional validation is not necessary for pathologists and/or different locations for interpretation. Inother words, each microscope for conventional light microscopy does not require a separatevalidation comparing it to the digital format.

7/19/2019 12:16 PM

3 Agree with basic sentiment. However, I think the term "application" is a little vague. It is unclearwhat is an "application" and what is an "additional application" e.g. is neuropathology anapplication or an additional application? Are different special stains e.g. PAS, gram, the sameadditional application or does each need 20 cases to validate? Also for telepathology networks, dodifferent scanners from different institutions represent separate applications (needing 60 cases) oradditional applications (needing only 20 cases for validation)?

7/18/2019 3:42 PM

4 Agree with the "at least 60" cases of specific routine types of cases (Routine H&E; Frozens;cytology etc.) but recommend that Additional studies be "at least 30 cases" for additional types ofstudies. 30 is the minimal number considered statistically significant. Lower that 30 is problematicand most pathologists will prefer to perform at least 50 additional cases. 30 should be the absoluteminimum for the additional types of studies evaluated.

7/18/2019 1:45 PM

5 If the final document provides compelling evidence for this number of cases 7/18/2019 9:51 AM

6 Training needs must show conpetancy and documentation. Clarification of the type of samples thatare needed as dense chromatin patterns ( ie lymphnode may look different than open ie kidneythis also is true for IHC membranous,nuclear, cytoplasmic staining and varied expression ( highand low) assure WSI is providing an adequate scan.

7/17/2019 1:34 PM

7 1. Query: Draft Recommendation Statement Line 1 " at least 60 cases for one application": does itmean "per application"? 2. Validation of detectability of bacteria might be assigned a separatevalidation recommendation statement for the same system.

7/13/2019 8:48 PM

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8 At this moment I do not think it is necessary to consider the validation depending on a "relative"number of slides, since it may be according to the taste of the referees, if I like the number 20 itmay be that another likes the 40, 60 or 100. The pathology has always been learned, first bydrawings and graphics, then by black and white photographs and finally printed color photographs,now with digital photographs of high resolution and finally WSI. I believe that at the height oftemporality and the advancement of technologies, the quality of the digital image in WSI must beobserved more than the coincidence of intraobserver or interobserver diagnoses. The otherobservation is that if the Z plane is required in cytological smears with Papanicolaou or othercolorations in FNA cytological studies or imprints. Obviously it is very necessary that in addition tothe slide scanned very well, it requires the minimum knowledge of the use of the mouse and someother software tool to move in the WSI to study.

7/13/2019 6:35 PM

9 Training expectations should be outlined and number of cases per type at 60 is a little excessive. 7/12/2019 3:30 PM

10 Additional for IHC should be clearly defined - is it by tumor type (may be difficult to achieve 20 forrare tumors) or general for IHC?

7/11/2019 8:29 PM

11 Requires clarification on "60 cases". Some cases may have one H/E stained slide and diagnosiswhile others may have numerous. Perhaps consider 60 diagnosis related to review of designatedslide(s). Eg. 60 separate GI polyps or 50 polyps and ten breast biopsy cases which may containnumerous slides for each.

7/10/2019 3:24 PM

12 Probably should explicitly require testing the SYSTEM from receipt to final report in a finalworkflow format to understand how WSI may play with all the other ways pathologists work andinterplay with EHRs.

7/2/2019 12:45 PM

13 If you are using WSI for primary diagnosis, you can start with H&E and add 20 frozen cases ontop; however, if you are starting with frozen sections, it is impractical and inhibitory to do 60 frozencases. That number should be reduced to 30, otherwise, the faculty will not go through the hassle(speaking from experience).

7/2/2019 10:18 AM

14 Instead of a fixed number of 60 cases, can atleast 10% of the laboratory’s workload be fixed forvalidation of each of H&E, frozen section, Cytology and haematology, in large labs? This wouldalso train the pathologist in interpretation on WSI.

6/28/2019 9:59 PM

15 I would double the number of slides to review, see below. 6/28/2019 4:35 PM

16 Training plan requirements should be defined and competency of training documented. 6/28/2019 2:03 PM

17 After using WSI for diagnostic for 3 years,it is strongly recommended to produce a step-by-stepvalidation. In my experience, cases that use high-magnification (like hematopathology) are goingto challange the system beyond expectation. Also, pathologies that use micrometer movements(like cytology or microbiology) are also beyond the reach. Finally, immunohistochemistry receive astrong impulse with WSI, and its usage should be encouraged.

6/28/2019 1:28 PM

18 The categories of application are too broad and therefore 60 cases is far too few to identifypotential problems within the broad range of specific scenarios within each application. Inparticular, for surgical pathology cases, the validation should separately address resection versusbiopsy specimens and should be stratified by major subspecialty, as the potential forerrors/problems is different between these specimen types (resection/biopsy) and specialty areas.A colon biopsy digital slide and an endocervical curettage digital slide have different possibleproblems. Testing only 60 cases of all surgical pathology specimens is not likely to capture enoughdiversity of the routine practice. A better strategy is for each practice or institution to self-identifythe major types of specimens they encounter and then evaluate at least 60 cases of each type.This could translate to several hundred cases for the validation. This comment comes from ourinstitution's experience in validating digital slides across a large array of specialties.

6/28/2019 11:58 AM

19 How will CAP ensure that pathologists are technically competent to use Shole a life imaging. 6/28/2019 11:44 AM

20 The validation set should be 40 specimens. If carefully selected, 40 specimens should be morethan enough.

6/28/2019 11:14 AM

21 "20 cases" doesn't specify the proportion of high/low or positive/negative in the case of IHC forexample. Also, it's not clear whether all IHC is covered under a single set of 20 or if different stainsshould be tested separately -- for example, should ER/PR, Her2, and PD-L1 be treated the same?More clarity is needed.

6/28/2019 11:01 AM

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22 It's good that the issue of IHC and special stains are going to be addressed in the newrecommendation ...With our limited experience I feal the number of case for IHCs especially whichhad predictive and prognostic implications like CerB2, Ki-67 should be high ...I.e. 60 (similar toCAP recommendation for validation of IHC in diagnostic labs) Reason :might over interpretmembranous staining of cerbB2 on digital platforms if not properly trained

6/28/2019 10:42 AM

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73.87% 82

19.82% 22

6.31% 7

Q4 Draft Recommendation Statement 2Strong Recommendation - Thevalidation study should establish diagnostic concordance between digital

and glass slides for the same observer (ie, intraobserver variability). Ifconcordance is less than 95%, laboratories should investigate and

attempt to remedy the cause. (Statement updated)Answered: 111 Skipped: 46

TOTAL 111

# COMMENTS DATE

1 How do you define diagnostic concordance? Is it benign versus malignant? How about gradingtumors (eg. prostate grading 3+4=7 vs. 4+3=7 on borderline tumors with near equal percentagesof patterns 3 and 4)?

7/19/2019 12:16 PM

2 95% is an adequate standard, but certainly need to understand reasons if lower e.g. case type,specialty etc.

7/19/2019 10:25 AM

3 Agree, however, the phrase "diagnostic concordance" should be clearly defined. 7/18/2019 3:42 PM

4 5% error rate is way too high. Most studies for routine mix of cases in surgical pathology and/orcytology would expect less than 1% error rate. In the literature 5% is often used for frozen sectionsbecause correlation with the fixed permanent H&E sections of the frozen section block may revealadditional lesions deeper in the paraffin block. 5% is way too high an error rate for reviewing thesame slide via two different methodologies. >98 or 99% should be the expectation for re-readingthe same exact slide. Also there needs to be BOTH intra-observer and inter-observer correlationstudies performed.

7/18/2019 1:45 PM

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5 I think that putting in a specific number is an important step forward. However, 95% may not be arealistic expectation for applications that are known to have high intraobserver variabilityregardless of the use of WSI. For instance, in my practice we sign out cervix biopsies inassociation with a national lab, for which WSI is sometimes used. Trying to get 95% agreement oncervix biopsies might not be possible. The 95% figure should be couched in such a way as tomake it clear that this benchmark is intended for a group of cases that would come out of a typicallab on a typical day - in other words cases that are very straightforward with a high likelihood ofconcordance for which discrepancies are likely to be attributable to WSI technology rather thanunderlying case difficulty.

7/17/2019 1:45 PM

6 This may be too aggressive since manual to manual concordance for FDA approval is only 93% 7/17/2019 1:34 PM

7 Diagnostic concordance needs to be defined. I think a distinction between major and minordiagnostic concordance should be differentiated. Not sure 95% should be the recommendation.95% is the mean of the studies, not a minimum to validate the procedure. The concordancevalidation should be based on what the diagnostic concordance (intraobserver variablitiy) wouldbe for someone reviewing slide cases with a 2 week washout (data not provided).

7/15/2019 2:02 PM

8 Less than 97% 7/13/2019 10:32 PM

9 Validation of detectability of bacteria might be assigned a separate validation recommendationstatement for the same system.

7/13/2019 8:48 PM

10 I think that the quality of the digital image in WSI must be observed more than the coincidence ofintraobserver or interobserver variability in diagnoses. If that option is considered, the validationshould be analyzed with lesions as basic as an intradermal nevus, a cut of skeletal muscle (withvisible striations), or the identification of Barr chromatin in a cytological smear, because if it ariseswith diagnoses Difficulties posed by the use of immunohistochemistry or molecular biology there ismuch interobserver variability by subjectivity.

7/13/2019 6:35 PM

11 "diagnostic concordance 95% or greater.... ...what constitutes diagnostic concordance? Exact Dxmatch?

7/11/2019 10:59 AM

12 Don't really disagree just checking to flag comments. 60 cases is hardly going to get a robust 95%threshold although I forget my statistics from yesteryear. Draft evidence tables are very interesting- published data appears to be just <95% and presumably being done by groups interested inWSI. Draft evidence tables need to include a review/data on glass slide to glass slideconcordances. For all we know WSI is better than glass although I doubt as I suspect we don'tknow how pathologists work or think still.

7/2/2019 12:45 PM

13 Include concordance criteria for inter-observer variability as well 7/2/2019 11:34 AM

14 Again we are lumping frozen with routine H&E. I think the threshold for frozen should be lower, asthe inter-observer variability tends to be higher.

7/2/2019 10:18 AM

15 Imaging and sensor technology has come along way since 2013. Concordance rate should be atleast 97%. Anything less compromises patient care/standards. This is human error vs technology.

7/1/2019 4:05 PM

16 Different imaging techniques have different sensitivities 6/30/2019 7:36 PM

17 If concordance is less than 100% then laboratories should investigate and attempt to remedycause. Note, a 5% error rate is completely unacceptable

6/29/2019 7:34 AM

18 The pathologist to refrain from reporting on WSI till an intra observer concordance of >95% isdemonstrated.

6/28/2019 9:59 PM

19 There should be 95% concordance with the glass slides seen 2 weeks apart to establish thatindividual’s self concordance rate.

6/28/2019 7:29 PM

20 In our current practice, the concordance rate is close to 100%. I believe that 95% is too low, andshould be higher around 98%. To achieve this, it would be better to double the number of theprevious point.

6/28/2019 4:35 PM

21 As previously stated, validation should be art of the training, and disease-specific or sample-specific, like the structure to have specialist in different topics of surgical pathology

6/28/2019 1:28 PM

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22 2 points: 1.) The diagnostic concordance rate should be measured within each major specimentype (colon biopsies, thyroid resections, hysterectomies) and not just the overall concordance of allcases combined, which may miss major problems in the system if they are confined to certainspecimen types. An overall concordance rate is therefore potentially misleading. 2.) Diagnosticconcordance is not the only measure of validity. The study should also include the rate ofconversion to glass slide review due to any of a variety of technical limitations in the digital slide(areas of blurred image, missing tissue, inability to evaluate to overlapping cells due to loss of Z-dimension fine focus). Validation should require that the system does not result in more than 1%conversion rate to glass slides within any major type of specimen.

6/28/2019 11:58 AM

23 I think the definition of cases has to be elaborated. It is not unusual for tertiary care centers to get10-15 part cases with 100 plus blocks or resection specimens with 40plus blocks. The purpose isnot just accurate diagnosis but accurate report. I also don’t think the whole slide imaging will workwell for cytology . Sometimes we make diagnosis on 2-3 cells . Validation must include allscenarios.

6/28/2019 11:44 AM

24 How is concordance defined? 6/28/2019 11:40 AM

25 The word "diagnostic" is unclear. There are some diagnostic tasks in which intraobserverconcordance is less than 95% on glass alone following a washout period (see recent paper byRakha et al e.g.). If left ambiguous, Kappa should probably be reported instead ofaccuracy/concordance.

6/28/2019 11:01 AM

26 Some papers had used non-inferiority cut off of 4% .....I.e 96% Otherwise okay with cut off of 95% 6/28/2019 10:42 AM

27 95% means it's wrong 5% of the time. It's not adequate. 6/28/2019 9:39 AM

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72.97% 81

17.12% 19

9.91% 11

Q5 Draft Recommendation Statement 3Strong Recommendation - Awashout period of at least 2 weeks should occur between viewing digital

and glass slides.(Statement reaffirmed)Answered: 111 Skipped: 46

TOTAL 111

# COMMENTS DATE

1 A 2 week washout may not always be enough. A 2 week washout period might be acceptable forroutine primary diagnosis applications; however, complex cases such as consultation casesinvolve more difficult and memorable cases, which require longer washout periods.

7/19/2019 10:25 AM

2 4 weeks would be more realistic. Even then, many pathologists will 'remember' the patterns seen,particularly of more unique or unusual cases. "At least Four weeks" would be a better timeframe tominimize 'recall' impact on the process. Correlation studies need not be rushed....it is moreimportant to get this critical new methodology implemented safely to optimize patient care.

7/18/2019 1:45 PM

3 Please define or clarify "washout period". Some histology or special stains fades with time on theslides, thus WSI scanning should be performed ASAP after the slides have been stained.

7/18/2019 12:32 PM

4 Washout period should be longer, at least 4 weeks 7/18/2019 11:05 AM

5 If the final document provides compelling evidence that 2 weeks as a minimum provides washoutsufficient to mitigate bias. It would surprise me if that were the case.

7/18/2019 9:51 AM

6 You answered my major question with this recommendation, because I can remember a slidewithin a few days.

7/18/2019 8:34 AM

7 In my experience, 2 weeks is too long. It is a barrier to adoption that does not serve ademonstrable purpose. If the cases are typical and easy, pathologists will forget them very quickly.If the cases are unusual, challenging, or interesting they will still remember them 2 weeks later. Ithink a shorter washout of a few days (2-3) would work just as well and make validation mucheasier to organize.

7/17/2019 1:45 PM

8 Fluorescence staining cannot be read in two weeks 7/13/2019 10:32 PM

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9 Ability to recall particular section have to do with individual's visual memory, workload, age anduniqueness of the case. I would like to know what the washout period for reviewing lightmicroscopy slides???

7/13/2019 8:48 PM

10 I do not consider it necessary because of the preceding comments. The period can be 3 days, aweek or 1 month or 1 year and the same results would always be obtained.

7/13/2019 6:35 PM

11 Is a two week washout period long enough? 7/13/2019 11:54 AM

12 Not sure what his means? 7/12/2019 3:30 PM

13 This restriction may result in needless prolongation of TAT. I do not see why a trained Pathologistcould not review digital and glass slides concurrently if necessary depending on the cases beingreviewed.

7/12/2019 3:06 PM

14 I don*t see the point in this, the validation purpose is to be made aware of differences andcompare how features appear on image vs slide. In most cases the diagnos will be the same butwith a wash out period you might loose the opportunity to calibrate your assessment of details.

7/12/2019 3:22 AM

15 The digital pathology slides should be reviewed first and then after a 2 week period the glassslides reviewed. *Reason, some pathologist can remember viewing the glass slide when they go tovalidate the digital pathology image. Since the guidelines are about validating digital pathology thefocus should be on what happens when reviewing the digital image. If one reviews the digitalimage first, one can also validate the digital pathology workflow.

7/11/2019 5:54 PM

16 Purpose of washout period? 7/11/2019 10:59 AM

17 In my opinion is not need a washout period of 2 weeks. One week is enough 7/11/2019 3:21 AM

18 Increase wash period of 30 days 7/9/2019 3:14 PM

19 2 weeks is way too short for a real washout especially if trying to do any kind of mix with difficultborderline/judgement type cases to really test the system.

7/2/2019 12:45 PM

20 A washout period of two weeks is good for a busy practice, but a dedicated number of reads/casessigned out should accompany the two weeks. " A washout period of at least 2 weeks and 500cases must occur between the glass slide and WSI review"

7/1/2019 4:05 PM

21 Washout should be at least 4 weeks between viewing digital and glass slides. Pathologistsremember cases, 2 weeks is not long enough for a washout for this type of validation.

7/1/2019 12:09 PM

22 should be resolved in 1 week or less 6/30/2019 7:36 PM

23 A washout period of at least 3 months should occur between viewing digital and glass slides. Note,unless the pathologists involved are demented they will remember 2 week old diagnoses

6/29/2019 7:34 AM

24 4weeks would be ideal as interesting and tough cases could still be remembered by us and ifincluded, even blindly, could be biased.

6/28/2019 9:59 PM

25 1 week 6/28/2019 7:49 PM

26 4 week washout period 6/28/2019 1:01 PM

27 In our institutional experience, 2 weeks washout is not enough time for an honest appraisal. 4weeks at a minimum is advised.

6/28/2019 11:58 AM

28 4 weeks or more We sign out cases and present them in Tumor Board 2 weeks later and yetremember the case

6/28/2019 11:44 AM

29 Most of the cases included for this validation will include complex specimens and pathologistshave a great recall of cases, even if routine. A wash out period will likely not make a significantdifference. Pathologists take (and are expected to take) validations honestly and critically. Washout period will only lengthen the validation process without improving the strength of the validation.

6/28/2019 11:14 AM

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94.68% 89

3.19% 3

2.13% 2

Q6 1. All pathology laboratories implementing WSI technology for clinicaldiagnostic purposes should carry out their own validation studies. –

Reaffirmed as a GPSAnswered: 94 Skipped: 63

TOTAL 94

# COMMENTS DATE

1 In the whole world there are good and regular pathologists, so the results will surely be variable.What should be validated is the quality of the image and that the softwares (of any company) in auniversal and free way have a mandatory conversion to DICOM automatically

7/13/2019 11:10 PM

2 This should be a standard expectationfor operations not GPS 7/12/2019 3:38 PM

3 Validation to be confirmed by CAP inspector 6/29/2019 1:14 PM

4 There should be very clear set minimal requirements 6/28/2019 11:05 AM

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90.43% 85

9.57% 9

0.00% 0

Q7 2. Validation should be appropriate for and applicable to the intendedclinical use and clinical setting of the application in which WSI will be

employed. Validation of WSI systems should involve specimenpreparation types relevant to intended use (eg, formalin-fixed paraffin-embedded tissue, frozen tissue, immunohistochemical stains, cytology

slides, hematology blood smears). – Reaffirmed as a GPS Note: If a newintended use for WSI is contemplated, and this new use differs materiallyfrom the previously validated use, a separate validation for the new use

should be performed.Answered: 94 Skipped: 63

TOTAL 94

# COMMENTS DATE

1 Please include "immunofluorescence studies" in the intended use section, as these are nowbecoming available.

7/18/2019 8:59 AM

2 Always keeping in mind that it is time to have a language - universal format, such as DICOM 7/13/2019 11:10 PM

3 Guidelines need to be suggested to bridge existing gaps of knowledge 7/13/2019 8:55 PM

4 Clarify if "materially different" refers to a different specimen preparation type 7/2/2019 11:44 AM

5 Sample number for each of those new validation should represent the complexity of the work andat least 10% of the volume.

6/28/2019 10:08 PM

6 The categories of the application should be defined more specifically. Each institution/practiceshould self-identify what are the major types of specimens in their practice and the validationshould be targeted to each of those major specimen types and evaluated for the major types ratherthan lumped together as a single system-wide validation.

6/28/2019 12:05 PM

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7 Cytologya nd hematology slides should be excluded from this group 6/28/2019 11:46 AM

8 If I validate using only prostate FFPE tissue, can I make a primary diagnosis using ovarian FFPEtissue? In other words, does the tissue of origin or disease process factor into the validation?

6/28/2019 11:42 AM

9 As stated earlier, I think there may be too much ambiguity here. In my view, more guidance than"differs materially" should be provided.

6/28/2019 11:07 AM

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98.94% 93

1.06% 1

0.00% 0

Q8 3. The validation study should closely emulate the real-world clinicalenvironment in which the technology will be used. – Reaffirmed as a GPS


TOTAL 94

# COMMENTS DATE

1 Applicable examples! 7/13/2019 8:55 PM

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87.23% 82

6.38% 6

6.38% 6

Q9 4. The validation study should encompass the entire WSI system. –Reaffirmed Note: It is not necessary to validate separately each individual

component (eg, computer hardware, monitor, network, scanner) of thesystem nor the individual steps of the digital imaging process.


TOTAL 94

# COMMENTS DATE

1 validate the clinical-morphological result of the WSI system 7/21/2019 8:00 PM

2 Agree it should be based on diagnostic outcome; otherwise, it becomes ridiculously difficult. 7/18/2019 8:36 AM

3 Clarification if a component change - should you reevaluate- suggest providing samples. Monitorsshould be removed from the list.

7/17/2019 1:44 PM

4 Discussion is needed about changing elements within a "validated" entire WSI system 7/15/2019 12:25 PM

5 If I change a computer or an imager, do I have to revalidate? 7/15/2019 9:42 AM

6 In some cases as in cytology, the validation requires a z-Stack WSI for focusing, and not allscanners provide it, and and the Universal DICOM image should be mandatory.

7/13/2019 11:10 PM

7 Specify if additional or repeated validation is needed when one or more individual WSI systemcomponent(s) change (e.g. outdated monitor or same scanner with larger capacity)

7/2/2019 11:44 AM

8 Removing monitor from the list. A quality monitor with specific specs will make a difference 7/1/2019 4:10 PM

9 It is necessary to validate separately each individual component.... 6/29/2019 7:36 AM

10 Laboratories should provide evidence from the manufacturer that each system like monitor,scanner, network have been validated by the manufacturer

6/28/2019 10:08 PM

Agree aswritten


Disagree(include...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Agree as written



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11 it is necessary to measure and validate individual components. It is a whole different story. monitoris an issue, as the chair and pathology vision impairment, with a high frequency of us working tillour 70's. Microscope eyepieces eliminate different vision problems, that appeand when you mustsee images at 50 to 60 cm distance. Reading glasses are not enough.

6/28/2019 1:34 PM

12 If the system has a high rate of diagnostic concordance but a significant subset of cases fail todigitally scan correctly and require conversion to glass slide review, then that is not a successfulsystem. The validation study needs to include a measurement of the rate of conversion to glassslide review.

6/28/2019 12:05 PM

13 It's very much important to validate the other components like monitors(no clear recommendationwhether pathologist needs medical grade monitors), computer hardware and network (as thesystem specification has impact on the time required for image retrieval n viewing).....Difficult forhospital administration to convience especially in developing countries like us in India....So thisissue should be addressed....I know it's difficult to set up gold standards for this ,but minimumrequirements should be addressed in the guidelines

6/28/2019 11:09 AM

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92.55% 87

6.38% 6

1.06% 1

Q10 5. Laboratories should have procedures in place to address changesto the WSI system that could impact clinical results. – Revised


TOTAL 94

# COMMENTS DATE

1 These need to follow the CAP checklist recommendation and all changes w/validation need to bedocumented and be able to be archived.

7/17/2019 1:44 PM

2 The translation into a universal language of the image in medicine as happened in Radiology withDiagnostic Imaging (DICOM) must happen in Pathology. "The image is the image", the image isnot a code or file format or a file extension

7/13/2019 11:10 PM

3 Proposesal for procedues! 7/13/2019 8:55 PM

4 It is hard to write a procedure for what if's. YOu end up with a nonvalued add generic procedurethat does not provide any QC.

7/12/2019 3:38 PM

5 Appropriate re-validation must also be included depending on the change made. 7/8/2019 3:03 PM

6 Specify if RUO systems can be validated for clinical use 7/2/2019 11:44 AM

Agree aswritten


Disagree(include...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Agree as written



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88.42% 84

9.47% 9

2.11% 2

Q11 6. A pathologist(s) adequately trained to use the WSI system mustbe involved in the validation process. – Reaffirmed as a GPS


TOTAL 95

# COMMENTS DATE

1 All pathologist requires validation on the WSI system before rendering primary diagnosis. They donot have to be included in the "original" validation process. Consider rewording to ..must beinvolved in "a" validation process. Once a pathologist is validated it is not necessary to re-validatefor each location where one may render primary diagnosis.

7/19/2019 12:23 PM

2 There should be a minimum of three pathologists involved in the validation process; intra-observerand inter-observer validation studies.

7/18/2019 1:49 PM

3 "Adequately trained" should be left vague for maximum flexibility 7/17/2019 1:55 PM

4 Clarification of adequately trained - Who is responsible and does it need to be documented. 7/17/2019 1:44 PM

5 Adequate, please define 7/13/2019 10:51 AM

6 ...adequately trained (as determined by the laboratory medical director)... 7/5/2019 9:23 PM

7 well the whole point is to implement a new method so need digital virgins to really test and see if itworks.

7/2/2019 12:47 PM

8 ALL/each pathologist viewing WSI must complete the validation process 7/1/2019 4:10 PM

9 I agree but what is the definition of "adequately trained" - this needs to be defined. They should berequired to take and pass an initial training at minimum, and that should be documented.

7/1/2019 12:23 PM

10 WSI is still an evolving technology in countries like asia. So it’s difficult to find trained pathologiststo be a part of validation. Even in country like US and centres like MSKCC, WSI is not routinelyused for primary diagnosis. If an application specialist confirms that the pathologist is confidentenough to use the Image management system, that should be enough.

6/28/2019 10:08 PM

11 All pathologist who are going to use WDI should be involved in validation. 6/28/2019 11:46 AM

Agree aswritten


Disagree(include...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Agree as written



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12 But the real world fact is that actual training of the pathoLogist on digital platform starts when theyactually start using the system installed in their own department......So is it mandatory for thescanner companies to ensure training of pathologist before they actually start the validation....Confusing statement....Even I m confused

6/28/2019 11:09 AM

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90.63% 87

8.33% 8

1.04% 1

Q12 7. The validation process should confirm that all of the materialpresent on a glass slide to be scanned is included in the digital image. –

Reaffirmed as a GPSAnswered: 96 Skipped: 61

TOTAL 96

# COMMENTS DATE

1 Suggest that CAP comment that there may be special circumstances that require the pathologistto refer to the glass slide. Capturing all material does not garentee the ability to have all informationrequired to make the diagnosis.

7/19/2019 10:25 AM

2 Some softwares do not scan the entire slide and may omit small chunks of tissue at the peripheryconsidering it as junk. At least a low mag image of the whole slide should be provided to thepathologist, to ensure that the entire slide content are reviewed, and leave it to discretion ofpathologist whether to further scan and examine the "redundant/junk" material.

7/18/2019 8:59 AM

3 This is a potentially problematic requirement. For instance, if immunohistochemistry is beingvalidated, and you want to use 60 consecutive cases, what do you do if some of your negativeIHC cannot be scanned because the WSI machine cannot find a focal plane? I ran into thisproblem personally. Is it acceptable to discard such cases and add new consecutive cases that willscan successfully? This needs clarification, especially if we are supposed to aim for 95%concordance.

7/17/2019 1:55 PM

4 Specify if archival slides can be used and recommend maximum age of slides 7/2/2019 11:44 AM

5 The validation process should confirm that the digital image includes the entirety of the clinicallyrelevant material intended to be imaged from the physical sample. **Consider this rewording asbeing more specific about what the goal of the imaging is as well as potentially being applicable toupcoming ex vivo imaging techniques.**

7/2/2019 10:15 AM

6 Different imaging techniques may impact the material 6/30/2019 7:37 PM

7 May not be applicable for systems which have manual mode of identification of AOI. 6/28/2019 10:08 PM

Agree aswritten


Disagree(include...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Agree as written



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8 How about the label and the system to link it with filename and any measure to avoid mismatchexamination? Errors will occur, beyond any expectation. We must include QA mechanism

6/28/2019 1:34 PM

9 The validation process should also document the incidence of digital slides that fail to detect all ofthe material on the glass slide due to a variety of technical issues. If that rate is more than 1% orso, then the system is not valid and the lab needs to investigate. Thus, the metric of tissuedetection failure, as defined by the rate of conversion to glass slide review, must be measured andevaluated.

6/28/2019 12:05 PM

10 Might be useful to establish whether rescans count as a failure or a success. For example,automated tissue finders in some scanners can fail, but access and review of the macro imagemay alleviate this issue (recent JPI article).

6/28/2019 11:07 AM

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96.88% 93

2.08% 2

1.04% 1

Q13 8. Documentation should be maintained recording the method,measurements, and final approval of validation for the WSI system to be

used in the clinical laboratory. – Reaffirmed as a GPSAnswered: 96 Skipped: 61

TOTAL 96

# COMMENTS DATE

1 Remove clinical laboratory from the statement. 99% of this work falls in the AP laboratory, make itgeneric AP an Clinical are seperated in most practices.

7/12/2019 3:38 PM

2 Add - for the lifetime of the digital scanner 7/1/2019 12:23 PM

Agree aswritten


Disagree(include...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Agree as written



25 / 42


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87.23% 82

6.38% 6

6.38% 6

Q14 9. Pathologists should review cases/slides in a validation set inrandom order. This applies to both the review modality (ie, glass slides or

digital) and the order in which slides/cases are reviewed within eachmodality. – Revised


TOTAL 94

# COMMENTS DATE

1 I don't believe this is necessary 7/18/2019 12:44 PM

2 May be overkill on the randomness required as this is time-consuming and could cause errors dueto logistics

7/17/2019 5:57 PM

3 I believe it is acceptable if a lab wants to have pathologists look at the glass slides first before thescanner arrives. I especially think this should be flexible if the 2 week washout period is going tobe expected. In my opinion random ordering doesn't improve the validation enough to make theinconvenience / barrier to implementation justifiable.

7/17/2019 1:55 PM

4 method should be clarified - sorry to say some people dont know what that means. 7/17/2019 1:44 PM

5 it is not necessary, because it does not depend on the pathologists but on the ability of the image"to show itself as it is" to the pathologist. I return to my point of view: The validity depends on thesharpness of the image, that is, the resolution; just to give some examples: Of the ability todistinguish or not the finely granular acidophilic aspect of the cytoplasm of the cells of Hurtle(mitochondria), different from eosinophilic cytoplasm with coarse granules (representingphagolysosome aggregates) in the granular cell tumor. Other examples: The validation dependson the ability to show the appearance of the granular chromatin (Salt-and-pepper chromatin)described in some neuroendocrine tumors, to clearly capture the Barr chromatin, as well as theacidophilus nucleolus and the fine brown microgranules of the malignant melanoma, amongothers.

7/13/2019 11:10 PM

6 Not sure that this will change the outcome of the study. 7/12/2019 3:09 PM

Agree aswritten


Disagree(include...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Agree as written



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7 While I agree with the intent of this statement, I wonder about how practical this will be. Taken tothe logical conclusion, it may be quite challenging if a lab is using the same set of cases formultiple pathologists. It seems like this require a major record keeping and slide sorting effort inorder to ensure that each pathologist is given a randomly ordered set of cases which is alsorandomly assigned to review modality which is also unique to each person. Would it be acceptablefor there to be a set of 30 cases which are designated to be glass review first for all participantsand another which set of 30 which are digital review first for all participants and then have thecases presented in a different random order for each participant?

7/5/2019 3:29 PM

8 The 2 week washout period should allow sufficient time such that the diagnosis by case/slidecould be memorized.

7/2/2019 1:23 PM

9 I am not sure that this necessary and it would add some complexity to the process. 7/2/2019 10:21 AM

10 Randomization between slide/image reads not necessary 6/28/2019 1:06 PM

11 Provided there is a wash off period this statement does not make relevance n might be modified tosimple language ...Little complicated

6/28/2019 11:09 AM

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76.34% 71

23.66% 22

0.00% 0

Q15 How feasible is it to implement this guideline?Answered: 93 Skipped: 64

TOTAL 93

# COMMENTS ABOUT THE FEASIBILITY OF IMPLEMENTING THE GUIDELINE: DATE

1 These guidelines are most reasonable for medium to large pathology practices. Even smalllaboratories with 1 to 2 pathologist should be able to implement these guidelines without difficulty.They will most likely be partnering with medium to large laboratory.

7/18/2019 1:57 PM

2 The guideline was already blocking implementation excessively. This version seems to be makingvalidation even harder. I think that the barriers should be lowered, not raised. I like the idea ofsetting a specific numerical benchmark (95%) in theory, but this absolutely has to be flexible sothat people don't end up deciding that WSI is unworkable if they can't hit 95% despite optimizingthe WSI equipment.

7/17/2019 2:12 PM

3 Validation concordance difficult to meet 7/17/2019 1:47 PM

4 The guidelines, while simpler, will be more universal. 7/13/2019 11:37 PM

5 Guidelines are good. However, with regard the current computational power in general hospitalsettings, glass slide is still the better way of diagnosis. None of the pilot study really can representthe real practice settings. It is at the best represent a testing setting.

7/13/2019 11:00 AM

6 The requirement to have a pathologist well trained in digital pathology and WSI diagnosis beforeyou implement the system might hinder many labs from going digital. I also think it is important toseparate the validation of the system and the validation of the individual pathologist

7/12/2019 3:27 AM

7 An important barrier is the assessment of a proper training in WSI applications for a pathologist.Various types of courses and information, technology, and WSI systems are available and theprocess to implement them and/or be trained for that specific equipment may vary.

7/5/2019 4:01 PM

8 I believe that the majority of this is feasible, but I have concerns about the practicality of GPSstatement #9 - see separate comment.

7/5/2019 3:42 PM

9 The more restrictive and cumbersome the guidelines are, the less likely people would want toadopt WSI.

7/2/2019 10:24 AM

All of it isfeasible to...

Parts of itare feasible...

None of it isfeasible to...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


All of it is feasible to implement.

Parts of it are feasible to implement.

None of it is feasible to implement.

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10 There is hardly any other alternatives...Recently RCPATh n DPS guidelines were publishedotherwise no alternative option

6/28/2019 11:39 AM

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16.13% 15

6.45% 6

19.35% 18

26.88% 25

24.73% 23

12.90% 12

13.98% 13

Q16 What barriers might impede adoption of the final guideline? (Chooseall that apply.)Answered: 93 Skipped: 64

Disagreementwith the dra...

Disagreementwith how the...

Too burdensome

Lack ofsupport from...



There is notenough evide...

Lack ofresources...

Lack ofexpertise wi...

Whole slideimaging...

Do not wish togive up...


0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Disagreement with the draft recommendations

Disagreement with how the guideline was developed

Too burdensome

Lack of support from administration

Lack of support from other members of the medical team

Lack of support from the community (others outside your institution e.g., patients, industry, the digital pathology community)

There is not enough evidence that digital pathology is safe for clinical use

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44.09% 41

38.71% 36

29.03% 27

11.83% 11

13.98% 13



1 None 7/19/2019 10:30 AM

2 The entire validation process for some applications (such as remote from home telepathology)may be too burdensome to fully implement. I suggest adding any specific guidelines fortelepathology validation.

7/18/2019 3:48 PM

3 I do not think there are problems with the guideline. There are problems with WSI. It is too slowand currently takes too much time to implement. There is no reimbursement for use. Mouse orkeyboard driven interfaces are too clumsy for clinical use.

7/18/2019 8:42 AM

4 Complete retooling and realignment of the histology work flow. 7/15/2019 10:14 AM

5 That they take into account some new opinions, perhaps some of the ones that I have written, thatwould simplify the handling and a universal language useful for telepathology with WSI withoutborders, for the benefit of the patients.

7/13/2019 11:37 PM

6 Lack of full integration with current Laboratory Information systems (LIS). Current LIS arelaboratory workflow-centred and current DPS are case-centred. I had to juggle between twosystems and screens to report a case. Incompatibility issues often cause hanging of one or theother systems. An encompassing Patient Report Centred Information system is needed to simplifythe process of reporting, and separate the technical laboratory data from the pathologist deskstation that is concerned with three sets of date: patient bio-data and clinical context, WSI andSpecial requests and Report.

7/13/2019 9:10 PM

7 None 7/12/2019 11:07 PM

8 Lack of guidelines for viewing slides and rendering diagnoses remotely. 7/10/2019 6:51 PM

9 People can come up with all kinds of excuses to not follow a guideline. I would say that the #1barrier to implementation is ignorance of Whole Slide Imaging and its pitfalls. If someoneunderstands the pitfalls, then he/she understands why it is important to follow the guidelines.

7/8/2019 3:07 PM

10 I wonder if some labs which have used wsi for a long time prior to the guideline may considerthemselves “grandfathered” and not have carefully documented an initial evaluation.

7/5/2019 9:28 PM

11 I believe the biggest hurdle will revolve around insurance reimbursement. 7/1/2019 4:15 PM

12 Very limited involvement of the pathologists from asian/developing countries....Which is a hugemarket for digital pathology companies in future Being involved in implementation of digitalpathology in one of leading academic centre in India.,,making this comment... ..As Every try toreplicate us, what we do at our center in India n hence pAthologist from india sud be involved inframing these guidelines as many centres are going to adopt digital pathology with very littleconcept of proper validation .....Will have more acceptability if our problems are also addressed..things are different for asian n African countries

6/28/2019 11:39 AM

13 I don't know. 6/28/2019 11:09 AM

Lack of resources (funding, equipment, space, etc.)

Lack of expertise with whole slide imaging

Whole slide imaging workflow is cumbersome and slows me down

Do not wish to give up personal autonomy to follow the guideline


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51.61% 48

15.05% 14

44.09% 41

31.18% 29

44.09% 41

44.09% 41

17.20% 16

12.90% 12

Q17 What facilitators might assist in your adoption of the final guideline?(Please select your top 3 facilitators.)




1 Guidlines for validation are different from adoption. The guidelines are fine but at its core, WSI isstill not ready to replace the microscope. If it didn't slow me down, I'd be happy to use it.

7/18/2019 8:42 AM

2 Note the strong distinction between the guideline and the acceptance and adoption of WSI 7/15/2019 12:28 PM

3 I believe that once the guidelines are finished, they should be translated into all languages. 7/13/2019 11:37 PM

If there weredata readily...

If leaders ofthe medical...

If there weretools to hel...

If we areforced to...

If we findthat peer...

If othertrusted...

If we know andtrust the...


0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


If there were data readily available that I could use to convince others that whole slide imaging would be beneficial for ourinstitution/practice

If leaders of the medical staff discussed adoption/adaption of the guideline for our practice setting

If there were tools to help implement the guideline

If we are forced to comply with the guideline by administration or an accreditation body

If we find that peer institutions/practices adopt the guideline

If other trusted organizations endorse the guideline

If we know and trust the members of the panel members and/or organizations who developed the guideline


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4 It is not uncommon to find out that the most electronic system for pathology are way behind thestate of arts the current technology at.

7/13/2019 11:00 AM

5 If the guidelines included a statement regarding remote access to slides and the ability to diagnosecases from outside the laboratory.

7/10/2019 6:51 PM

6 If vendors provided resources and references (peers in the area) to help guide WSI validation 7/2/2019 11:50 AM

7 If the organizations would provide a standard set of cases for validation purposes. 7/2/2019 10:24 AM

8 In our country, biggest challenge to adopting is the cost of the scanners and storage. 6/28/2019 10:12 PM

9 Do not think it would be that an unease implementation 6/28/2019 4:53 PM

10 I am not aware of any surgical pathologist in the US who is a well-recognized expert who currentlyuses digital slides for primary diagnosis and who advocates this publicly. It is the opposite. EveryUS surgical pathologist who is a well-recognized expert who has been asked at the major USnational pathology professional meetings if they endorse digital pathology has said that theyrecognize its value in education and research but that they personally do not use it at the currenttime and are not intending to. This is a major message to the broader pathology community.

6/28/2019 12:10 PM

11 D 6/28/2019 11:47 AM

12 I don't think the barriers to adoption are possible to solve by modifying the guidelines, which arequite reasonable.

6/28/2019 11:43 AM

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Q18 Please provide any general comments or concerns in the spacebelow:


# RESPONSES DATE

1 If possible, the guidelines should indicate that once a system is validated, it is not necessary tovalidate each microscope in the same or different setting/laboratory.

7/19/2019 12:27 PM

2 This response is the official recommendation of the Mayo Clinic Digital Pathology Oversight Groupon behalf of the Rochester, Florida, and Arizona Mayo Clinic Campuses.

7/19/2019 10:30 AM

3 Well thought out guidelines with only minor recommendations. Even with the recommendationsprovided as written, individual laboratories could perform more than required (e.g. 100 vs 60 and30 additional vs 20 additional); intra-observer AND inter-observer correlation; 4 week wash outperiod, etc. The main concern is an "accepted" error rate of 5% for reading the same slide via twomethodologies. This must be addressed and narrowed. 99% or at minimum >98% agreementshould be the goal. Thank you for the chance to review and comment.

7/18/2019 1:57 PM

4 None 7/18/2019 9:53 AM

5 I am finishing a study that shows a very low rate of adoption of WSI and Telepathology servicesamong my colleagues due to lack of technical expertise, reimbursement, institutional support, andlack of advantage over the 19th century microscope.

7/18/2019 8:42 AM

6 From the beginning these guidelines have been more specific and strict than typical CAP checklistitems, at least for AP. It seems this version will be even more so. I urge the guideline writers tothink about these guidelines as if they were checklist items so that labs would have moreautonomy and flexibility.

7/17/2019 2:12 PM

7 Unfortunately WSI has limited usage in institutions and their is poor uptake. 7/17/2019 1:47 PM

8 My name is Hugo Góngora Jara, Head of Department and Instructor of Residents of the PathologyService of the Dr. Enrique Vera Barros Regional Hospital, in La Rioja. Argentina, Professor ofMorphological Sciences (including Histology) and Associate Professor of Pathology) at the HéctorA. Barceló University (University Institute of Health Sciences, H.A. Barceló Foundation), I mentionit to emphasize that my opinions are my own. Consider another important point: The imagesshould be scanned up to 400X to be able to observe all the cellular details, it is a matter of time forstorage in Petabytes is something normal in a desktop PC, as everything evolves in Technologies.

7/13/2019 11:37 PM

9 I hope we are not forced to use imaging in our daily diagnostic work. Sounds cool but not so goodfor the safety of our patients

7/13/2019 11:00 AM

10 agree 7/12/2019 3:37 PM

11 The greatest benefit of WSI would be the ability to review and diagnose cases remotely over asecure connection. I would be far more inclined to implement WSI in my laboratory if the aboveguidelines outlined specific steps for coupling WSI with an approved remote system that wouldallow pathologists to view slides and make diagnoses from any location that could support asecure connection.

7/10/2019 6:51 PM

12 There is a need to update guidelines for glass vs digital storage. It should be one or the other, notboth. Is there a need to write guidelines for using WSI and applying it against a CPT Code?

7/9/2019 3:21 PM

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13 Overall I found this update to be very good and useful. I have two specific comments not related tothe content of the statements themselves: 1. I found the introduction to the Good PracticeStatements to be confusing. It says that a "GPS is a recommended action where there is a 'highlevel of certainty that the recommendation will do more good than harm (OR THE REVERSE)...' ".I don't understand what the phrase "OR THE REVERSE" is intended to convey. If it means that therecommendation will do more harm than good that seems illogical and probably not what isintended. Are you trying to say that Not taking a recommended action will cause more harm thangood? That is clearly implied from a plain reading of the statement. I would suggest getting rid ofthe phrase "OR THE REVERSE", but if you intend on keeping this parenthetical phrase, pleasemake sure that an unambiguous example or re-phrasing is given. 2. A comment about themechanics of the survey. The comment boxes on the pages about the individual statements weremuch to small, only displaying maybe 30 characters and not expanding or allowing scroll bars.This made it very challenging to type more than a single sentence. Please make all commentboxes larger and enable scroll bars if needed. Thanks.

7/5/2019 3:42 PM

14 Include more specific guidelines for validating using computer assisted algorithms for quantitativeIHC.

7/2/2019 11:50 AM

15 We have tried to use these guidelines (in their earlier form) for frozen sections and they haveproved to be impractical.

7/2/2019 10:24 AM

16 As noted in minor edit, consider including wording in document that addresses ex vivo imagingtechniques which may become clinically relevant in the near future.

7/2/2019 10:17 AM

17 Need to keep up with technology as it evolves rapidly 6/30/2019 7:40 PM

18 Please provide clarity on retention period of the whole slide images and how to addressmedicolegal issues, if any.

6/28/2019 10:12 PM

19 I think I had already put my concerns..N apologies if i had crossed my limits ...But I tried to putacross hard facts ....If any further discussion is required from my end .... be free to contact me inmy email [email protected] Associate professor pathology tata memorial hospital Bestregards Dr Rajiv Kumar kaushal

6/28/2019 11:39 AM

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50.00% 43

25.58% 22

23.26% 20

1.16% 1

Q19 Indicate your level of adoption of WSIAnswered: 86 Skipped: 71

TOTAL 86

I am currentlyusing the...

I plan toadopt the...

I am notplanning to...

I am notplanning to...

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


I am currently using the techonology

I plan to adopt the technology in 12-24 months

I am not planning to adopt, but want to follow the technology

I am not planning to adopt

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6.45% 4

0.00% 0

3.23% 2

0.00% 0

32.26% 20

Q20 If your laboratory utilizes WSI, which scanner/platform is currentlybeing used?


3DHistech

Excilone

Hamamatsu

Huron

Leica (Aperio)

Mikroscan

Motic

Olympus

Omnyx

Optra

Roche(Ventana)...

Sakura


0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


3DHistech

Excilone

Hamamatsu

Huron

Leica (Aperio)

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1.61% 1

4.84% 3

1.61% 1

1.61% 1

0.00% 0

4.84% 3

1.61% 1

41.94% 26

TOTAL 62


1 Not applicable 7/18/2019 10:47 AM

2 Philips 7/18/2019 8:06 AM

3 Roche DP200 7/17/2019 1:48 PM

4 Phillips 7/15/2019 2:05 PM

5 Added: By having residents, we use digital images with a video microscope with the Axio-Visioncamera and a high resolution LED TV, so we are familiar with the digital image, so when wevisualize WSI placed in the network, we practically did not notice the difference.

7/13/2019 11:43 PM

6 Philips DPS 7/13/2019 9:16 PM

7 We don't have wsi 7/13/2019 11:01 AM

8 Philips 7/12/2019 4:03 PM

9 Philips 7/12/2019 3:28 AM

10 Philips UFS 7/11/2019 5:58 PM

11 Cellavision 7/6/2019 7:59 AM

12 Precipoint M8 7/5/2019 4:02 PM

13 Philips 7/2/2019 1:27 PM

14 don't know; not really using per se 7/2/2019 12:49 PM

15 Roche (Ventana DP200) (NOT BioImagene) 7/2/2019 11:51 AM

16 Previously used Aperio, have worked directly with beta testing, and currently practice real-time forintraop

7/1/2019 4:18 PM

17 Phillips 7/1/2019 1:35 PM

18 Hyperion 6/30/2019 7:41 PM

19 Philips 6/29/2019 12:26 AM

20 Philips Ultra fast scanner 6/28/2019 10:15 PM

21 Philips 6/28/2019 12:12 PM

22 Philips 6/28/2019 11:48 AM

23 Philips 6/28/2019 11:41 AM

24 Please allow uses to select more than 1. 6/28/2019 11:21 AM

25 no longer working in the field---retired, but have used 6/28/2019 10:49 AM

26 Philips 6/28/2019 10:00 AM

Mikroscan

Motic

Olympus

Omnyx

Optra

Roche (Ventana) (BioImagene)

Sakura


38 / 42


Not Vali

d Afte

r July

26, 2

019

29.69% 19

31.25% 20

4.69% 3

20.31% 13

67.19% 43

51.56% 33

42.19% 27

21.88% 14

17.19% 11

Q21 For which purposes does your laboratory currently use WSI? (Selectall that apply.)Answered: 64 Skipped: 93

Routinediagnostic...

Sendout/consulta...

Legal cases

Frozensections and...

Teaching

Research

Tumorboard/confer...

QuantitativeIHC

Special stains

Qualityassurance/qu...


0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Routine diagnostic applications (primary diagnosis)

Send out/consultations

Legal cases

Frozen sections and/or on-site cytology evaluation

Teaching

Research

Tumor board/conferences

Quantitative IHC

Special stains

39 / 42


Not Vali

d Afte

r July

26, 2

019

15.63% 10

10.94% 7



1 Tech-only: share images of reference lab staining services back to customers 7/19/2019 10:30 AM

2 NA 7/13/2019 11:01 AM

3 Just getting started with training. We’ll probably start with outside review cases. 7/12/2019 4:03 PM

4 Currently validating the Philips system for primary diagnosis and have already started thevalidation on 5 services.

7/11/2019 5:58 PM

5 Real-Time Telepathology 7/1/2019 4:18 PM

6 We used both CAP and RCPath guidelines for validation. RCPath guideline is more easy to adoptand builds confidence of pathologist on adoption to WSI.

6/28/2019 10:15 PM

7 Prediction of metastatic potential of breast cases based on morphometry and automated scoring 6/28/2019 11:12 AM

Quality assurance/quality improvement


40 / 42


Not Vali

d Afte

r July

26, 2

019


55.56% 40

44.44% 32

Q22 Do you currently validate concordance of WSIs to H&E glassslides?


TOTAL 72

Yes

No

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Yes

No

41 / 42


Not Vali

d Afte

r July

26, 2

019


76.92% 40

23.08% 12

Q23 If yes, do you use the guideline from the CAP and Laboratory QualityCenter entitled, "Validating Whole Slide Imaging for Diagnostic Purposesin Pathology," published in Archives of Pathology & Laboratory Medicine

in March 2013 [Arch Pathol Lab Med. 2013 Dec;137(12):1710-22.]?Answered: 52 Skipped: 105

TOTAL 52

Yes

No

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Yes

No

42 / 42


Not Vali

d Afte

r July

26, 2

019


not valid after july 26, 2019 · cap wsi: draft recommendations and strength of recommendations not...

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