PAP. Interlaboratory Comparison Program in Cervicovaginal Cytopathology (PAP) YEAR END SUMMARY REPORT. Anatomic Pathology Programs

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1 2005 PAP Interlaboratory Comparison Program in Cervicovaginal Cytopathology (PAP) Surveys and Educational Anatomic Pathology Programs YEAR END SUMMARY REPORT 2005 College of American Pathologists. The College does not permit reproduction of any substantial portion of the material in this Report without its written authorization. The College hereby authorizes participants in the program to use the material in this Report solely for educational purposes within their own institutions. The College prohibits use of the material in the Report - and any unauthorized use of the College s name or logo - in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Data from this program do not necessarily indicate the superiority or inferiority of instruments, reagents, or other materials used by participating laboratories. Use of these data to suggest such superiority or inferiority may be deceptive and misleading. The College will take all steps open to it under the law to prevent unauthorized reproduction of substantial portions of the material in this Report, deceptive use of any such material, and any unauthorized use of the College s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.

2 Image 1: Classic koilocytic changes seen in LSIL was not problematic in mock PT (ThinPrep ) Image 2: Cases demonstrating binucleation and nuclear enlargement without koilocytic features. These cases were problematic in mock PT. (ThinPrep ) Image 3: Inflammatory changes may cause enlarged nuclei with degenerative features as seen in this image. These cases may be interpreted as LSIL in mock PT. (ThinPrep ) Image 4: Differentiation of LSIL from HSIL is problematic in cases with classic koilocytes and rare single, atypical metaplastic type cells.

3 TABLE OF CONTENTS Participant profiles in the PAP Program Overview. 1 Slide selection for the PAP program. 2 Interpretive Menu. 2 PAP criteria for slide grading/validation 3 Mock Proficiency Testing 4 Limitations of educational and proficiency slide testing. 5 Criteria and importance of recognizing the unsatisfactory preparation... 5 Discussion of Sensitivity Rates and Trends. 6 Conclusion. 7 General and Committee References. 8 Table 1 Total Laboratory Interpretations and Concordance Rates (to Series) by Reference Diagnosis 10 Tables 2a-2k -Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated Conventional Slides 11 Tables 3a-3k -Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated ThinPrep Slides.. 15 Tables 4a-4k -Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated SurePath Slides.. 19 CYTOPATHOLOGY COMMITTEE Dina R. Mody MD, Chair David C. Wilbur MD (Vice Chair) Joel S. Bentz MD Barbara Dubray Benstein SCT(ASCP) PhD (Consultant) George G. Birdsong MD Christine Noga Booth MD Karen M. Clary MD Amy C. Clayton MD Camilla J. Cobb MD Terence J. Colgan MD Teresa Marie Darragh MD Barbara S. Ducatman MD Michael Ross Henry MD Jonathan H. Hughes MD,PhD Ann T. Moriarty MD Margaret H. Neal MD Marianne Unger Prey MD Andrew A. Renshaw MD Mary R. Schwartz MD Tamela M. Snyder MD William D. Tench MD Theresa M. Voytek MD Nancy A. Young MD Sue Zaleski MA,HT(ASCP),SCT (Consultant) Front cover image: High Grade Squamous Intraepithelial Lesion on ThinPrep Pap test. The syncytial fragment demonstrates metaplastic cells with small irregular, hyperchromatic nuclei.

4 2005 Interlaboratory Comparison Program in Cervicovaginal Cytopathology (PAP) Year End Summary Report Participant profiles in the PAP Program Overview The 2005 Interlaboratory Comparison Program in Cervicovaginal Cytopathology (PAP) is a quality improvement program using glass slides mailed to laboratories. The program started in 1989 with 207 laboratories In 2005, enrollment was as follows: PAPC PAPM PAPK PAPJ Laboratories Participants 2,127 5,640 1, The College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) requires all laboratories performing gynecologic cytology to enroll in the PAP or an approved alternative program was the first year for a CLIA 88 (Clinical Laboratory Improvement Amendments of 1988) mandated gynecologic cytology proficiency test (PT), without penalty, administered by the Midwest Institute for Medical Education (MIME). The CAP will be offering its own PT test in 2006 and in preparation for the PT events of 2005 and 2006, one of the 2005 mailings was a mock PT test. Participating laboratories were profiled via a demographics questionnaire distributed with the second 2005 (PAPB) mailing. Although all types of cytology laboratories participate, hospital laboratories constitute the largest proportion. Other participants include independent and government labs (including military, state, city, county, and public health hospitals/labs), academic, office/group practices, and international hospitals/laboratories. The majority of reporting laboratories (58.7%) examine fewer than 10,000 cytopathology cases per year. In contrast, a small minority (10.3%) reviews more than 50,000 cytopathology cases per year. Of those responding, 15.4% did not examine any conventional slides, 27.7 % did not examine any ThinPrep slides and 71.2% did not examine SurePath preparations. Of those utilizing ThinPrep Pap tests, 37.7% reported that the technique had been used for over 5 years, while 10.5% had implemented use within the last year. Likewise, of responding labs that use SurePath Pap tests, 6.2% had used this technique for over 5 years while 30% had used it for less than one year. A significant percentage of enrolled laboratories that responded (55%) had pathologists qualified in cytopathology by the American Board of Pathology. Seventy-one percent of laboratories responded that they employ full time cytotechnologists trained in ThinPrep cytology, and 48% employ part time cytotechnologists so trained. Thirty-eight percent of laboratories employ full time cytotechnologists trained in SurePath cytology, and 24% of laboratories employ part time cytotechnologists with SurePath training. 1

5 Slide selection for the PAP program Participants generously contribute slides to the program. Submitted slides with a diagnosis of low grade squamous intraepithelial lesion (LSIL) or higher must be confirmed by biopsy. The slides and accompanying clinical information are reviewed by a minimum of three experienced cytopathologists from the Cytopathology Resource Committee. The slides must be judged to be of good technical quality and an excellent example of the reference interpretation in order to be accepted into the program as an educational slide. Furthermore, the three reviewers must agree on the exact target interpretation and this must agree with the stated biopsy interpretation (if LSIL or higher). Interpretive Menu The PAP program enrollees received three slidesets in 2005; two were composed of five educational cervicovaginal cytology glass slides. The third slide set consisted of ten graded slides and was considered a Mock Proficiency Test (PT). The coded answer sheets have interpretive menus using modified Bethesda System terminology. Referenced slides are placed into one of three selection series: the 000 series for unsatisfactory slides, the 100 series for negative, infectious and reparative conditions, and the 200 series for epithelial abnormalities and carcinoma. This system was maintained in 2005 for LAP purposes. The Mock PT had a separate scoring grid for participants. See the following Interpretive Menu chart for 2005: Interpretive Menu for 2005 PAP Program Selection Series Code Interpretation 000 Series 001 Unsatisfactory for evaluation 100 Series 101 Negative for intraepithelial lesion or malignancy, NOS 111 Fungal organisms consistent with Candida 113 Trichomonas vaginalis 115 Cellular changes consistent with Herpes simplex virus 120 Reparative changes 200 Series 201 Low grade squamous intraepithelial lesion (LSIL) 211 High grade squamous intraepithelial lesion (HSIL) 221 Squamous cell carcinoma 225 Adenocarcinoma 226 HSIL/Carcinoma, Not Otherwise Specified (NOS) PAP criteria for assessing participant responses In all the PAP programs (PAPC, PAPM, PAPK and PAPJ), laboratory responses are graded based on the selection series. Therefore, a correct/concordant response means 2

6 that the answer for the slide was in the correct selection series. For example, an interpretation of reparative change on a slide with a target/reference interpretation of NILM-NOS would be graded as correct/concordant since both answers are in the 100 selection series. An incorrect/discordant response means that it is in the wrong selection series. For example, a response of reparative change on a slide with a reference interpretation of adenocarcinoma is considered a false negative (FN) response, and would be registered as a discordant/incorrect response. Similarly, a response of LSIL on a slide with a reference diagnosis of NILM-NOS is a false positive (FP) interpretation and would also be registered as a discordant/incorrect response. On the other hand, discrepant interpretations within a selection series (for example LSIL versus HSIL responses) are considered minor discrepancies and recognized as concordant/correct responses. (This system was maintained in 2005 for LAP purposes, the Mock PT had a separate scoring grid for participants.) PAP criteria for slide grading/validation All the PAP programs field validate slides for acceptance into graded sets. Validation criteria are as follows: 1. At least 20 participants must submit a correct response on the slide for the following reference diagnoses: Negative for Intraepithelial Lesion or Malignancy, Reparative Changes, Low Grade Squamous Intraepithelial Lesion, High Grade Squamous Intraepithelial Lesion and HSIL/Carcinoma, Not Otherwise Specified (NOS). 2. The percentage of participant responses in the correct selection series must be at least 90%. 3. The standard error of this percentage must be, at most, 0.05 (SE 0.05). These requirements ensure: 1) a large enough group of responses/interpretations are used to determine field-validated response; 2) close agreement within that group; and 3) agreement is statistically significant. For example, if a slide has a reference interpretation of reparative changes (100 series) and the number of correct participant responses is exactly 20, then at least 95% of participant interpretations must be in 100 series to achieve the standard error requirement. If participants agree with the this series only 90% of the time, the group must contain at least 36 members to achieve the standard error requirement of Slides that have not obtained or retained validated status are designated as educational slides. Measuring laboratory proficiency in the PAP educational program In 1996, the PAP developed a measurement of laboratory proficiency through the introduction of a grading (or validation) system for slides (see below). This system 3

7 utilizes laboratory responses only and three simplified diagnostic categories, in contrast to the CLIA 88 mandated scoring system which tests individuals and uses a four category system. Similar to other CAP proficiency testing programs, such as in hematology and chemistry, a laboratory must have a cumulative score of 90% or greater on 20 validated slides in the two-year cycle to obtain a satisfactory or passing cumulative score. Conventional, ThinPrep, and SurePath slides are currently available for use in graded sets. Currently, when a laboratory accredited by the CAP Laboratory Accreditation Program receives a failing score (less than 90% correct within two consecutive calendar years) in the graded PAP program, a letter is sent to the medical director. The director must implement a plan of corrective action and present evidence that the problem has been resolved. If the ensuing response is acceptable, the file is closed. These laboratories are sent a graded slide set in their next mailing to give them an opportunity to bring their grade up to 90%. Mock Proficiency Testing Sixteen years ago, CLIA 88 mandated national proficiency-testing (PT) for individual cytotechnologists and pathologists. Scoring for this differs substantially from the PAP assessment. In 1992, CLIA proposed four response categories: unsatisfactory, normal or benign changes, low-grade squamous epithelial lesion (LSIL), and high-grade squamous epithelial lesions (HSIL) and carcinoma. Both pathologists and cytotechnologists must score at least 90, and the scoring system rewards or penalizes participants in proportion to the degree of variance from the target interpretation with the penalty weighted in proportion to the severity of the lesion. However, the penalty system is more severe for pathologists than cytotechnologists. For the Mock PT exercise, participants were graded according to the scoring grids for either pathologists (technical supervisors) or cytotechnologists (See scoring grid on next page). Thus, cases had to be coded as follows: Category A - Unsatisfactory cases, the 000 series Category B - NILM cases, including all 100 series cases Category C - LSIL (201 only) Category D - HSIL and above, all other 200 series cases In order to fulfill CLIA mandates,the Mock PT was an exercise for individuals and not for overall laboratory performance. 4

8 CLIA 88 Grading System by Participant Type Pathologist (Technical Supervisor) 10 Slide Test Correct Response Examinee Response A -UNSAT B -NEGATIVE C -LSIL D HSIL A -UNSAT B -NEGATIVE C -LSIL D -HSIL Cytotechnologist 10 Slide Test Correct Response Examinee Response A -UNSAT B NEGATIVE C -LSIL D-HSIL A -UNSAT B -NEGATIVE C -LSIL D -HSIL Limitations of educational and proficiency slide testing Both educational and proficiency testing programs of cervicovaginal cytology preparations will identify only screening and/or interpretive discrepancies. Sampling errors, which occur when a patient truly has an abnormality, but the specimen lacks abnormal cells may represent the majority of false-negative discrepancies in actual practice. However, neither type of testing program can assess sampling discrepancies. Criteria and importance of recognizing the unsatisfactory preparation The PAP program continues to circulate unsatisfactory conventional smears and liquidbased preparations (response category 001). The 2001 Bethesda System criteria for an unsatisfactory preparation include any of the following: A slide that is broken and cannot be repaired Scant squamous epithelial component, defined as less than: o 8,000 12,000 well preserved and well visualized squamous epithelial cells for conventional slides o 5,000 well preserved and well visualized squamous epithelial cells for liquidbased slides 5

9 Obscuring blood, inflammation, thick areas, poor fixation, air-drying artifact, contaminant, etc. that precludes interpretation of approximately 75% or more of the epithelial cells. PAP participants should use the Bethesda 2001 adequacy criteria to choose slide interpretations. Literature review demonstrates that patients with unsatisfactory slides are at greater risk for the later detection of squamous intraepithelial lesion than patients with a negative result. For CLIA 88 mandated PT, correct identification of Unsatisfactory for evaluation slides in testing events will be important to avoid failure. Discussion of Sensitivity Rates and Trends Sensitivity equals 1 minus the false negative (FN) rate. It is the ability of a test to detect the condition in question. For example, a pathologist FN rate of 5% would correspond to a screening/interpretative sensitivity of 95%. Only laboratory false negative responses are considered in these statistics (not sampling errors). True sensitivities would be lower if these sampling errors were also considered. Table 1 shows the total concordance rates by laboratories to the reference diagnosis for validated conventional, ThinPrep and SurePath slides for 2004 and Results are similar between the years, although there were many more unsatisfactory cases in 2005 for all three types of Pap test than previous years. Tables 2a-2k review the individual concordance rates of conventional smears with the reference category for various interpretations for both pathologists and cytotechnologists taking the Mock PT. The sensitivity for cytotechnologists was greater than for pathologists for every reference category except NILM/Herpes simplex virus for which the sensitivity was considerably higher for pathologists (Table 2e). The sensitivity to the reference category was above 90% for both cytotechnologists and pathologists for all diagnoses except for reparative changes for pathologists (Table 2f) and for cellular changes associated with Herpes simplex virus for cytotechnologists (Table 2e). The sensitivity to the reference category was greater than 95% for all interpretations except for those listed above, negative for intraepithelial lesion or malignancy (NILM), NOS and high grade squamous intraepithelial lesion (HSIL) for both groups, and low grade squamous intraepithelial lesion (LSIL) for pathologists. The lack of sensitivity for HSIL is particular problematic. For both groups, an answer of Category B (negative) in the face of HSIL would be an automatic failure under PT rules However, only pathologists are penalized for separating HSIL (category D) from LSIL (category C). Tables 3a-3k review the concordance with the reference category for ThinPrep slides for the mock PT stratified by pathologist and cytotechnologist. Once again, the sensitivity to reference category was higher for cytotechnologists than pathologist for all diagnoses except for reparative changes, in which there was a significant difference, and HSIL/Carcinoma, NOS. The sensitivity to reference category was less than 95% for 6

10 unsatisfactory (both groups), reparative changes (both groups), LSIL (pathologists only), HSIL (both groups), squamous carcinoma (pathologists only), and HSIL/Carcinoma, NOS (both groups). The sensitivity was below 90% to the reference series for reparative changes (only 71.4%) for cytotechnologists and for HSIL (88% for pathologists and 89% for cytotechnologists), and for HSIL/Carcinoma, NOS for cytotechnologists. There was much lower sensitivity to category D with HSIL by ThinPrep, both for pathologists and cytotechnologists, than with conventional slides. Thus, this might be a significant cause for failure in both groups. Furthermore, there was an extremely low sensitivity to reference category B (NILM) for reparative changes among cytotechnologists, who tended to overcall this lesion, possibly because of the grading scorecard. Tables 4a-4k review the concordance for SurePath slides with the reference category for the mock PT, stratified by the type of participant. As noted previously, the sensitivity was higher for cytotechnologists except for reparative changes and HSIL/Carcinoma, NOS. The sensitivity was less than 95% for HSIL (both groups) and cellular changes associated with herpes simplex virus (pathologists). The sensitivity was less than 90% to the reference category only for HSIL (82% for pathologists and 77% for technologists). Conclusion The PAP program has completed its seventeenth year. This year, the Year End Summary Report concentrates on the mock PT. If PT remains in its current form, the mock PT may predict future trends. The most disturbing trend is the lack of concordance to the reference category for HSIL for both pathologists and cytotechnologists. The performance was worst for SurePath for HSIL and best for conventional slides, with ThinPrep in an intermediate position. This may be associated with the failure rate for pathologists on both PT administered by MIME and the CAP Mock PT. Since many pathologists have had the most experience with conventional slides followed by ThinPrep and SurePath, perhaps these pathologists are still not familiar with the appearance of HSIL on ThinPrep and SurePath. This lack of HSIL concordance may also reflect the difficulty in clearly separating HSIL from LSIL. If PT were to reflect concordance to the 200 series (LSIL and higher), performance might be better. Further study and analysis as more data is available should help better define the issues. 7

11 General and Committee References 1. Clinical Laboratory Improvement Amendments of 1988; Final Rule (42 CFR Part 405, et al). Federal Register, Feb. 28, Ransdell JS, Davey DD, Zaleski S. Clinicopathologic correlation of the unsatisfactory Papanicolaou smear. Cancer Cytopathol. 1997; 81: Davey DD, Nielsen ML, Frable WJ, Rosenstock W, Lowell DM, Kraemer BB. Improving accuracy in gynecologic cytology: results of the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Pathol Lab Med. 1993; 117: Nielsen ML. Cytopathology laboratory improvement programs of the College of American Pathologists. Laboratory accreditation program (LAP) and performance improvement program in cervicovaginal cytology (CAP PAP). Arch Pathol Lab Med. 1997; 121: Woodhouse SL, Stastny J, Styer P, Kennedy M, Praestgaard AH, Davey DD. Interobserver variability in subclassification of squamous intraepithelial lesions: results of the College of American Pathologists interlaboratory comparison program in cervicovaginal cytology. Arch Pathol Lab Med. 1999; 123: Davey DD, Woodhouse SL, Styer P, Stastny J, Mody D. Atypical epithelial cells and specimen adequacy: current laboratory practices of participants in the College of American Pathologists interlaboratory comparison program in cervicovaginal cytology. Arch Pathol Lab Med. 2000; 124: Jones BA, Davey, DD. Quality management in gynecologic cytology using interlaboratory comparison. Arch Pathol Lab Med. 2000; 124: Colgan TJ, Woodhouse SL, Styer PE, Kennedy M, Davey DD. Reparative changes and the false-positive/false-negative Papanicolaou test: a study from the College of American Pathologists interlaboratory comparison program in cervicovaginal cytology. Arch Pathol Lab Med. 2001;125: Solomon D, Davey D, Kurman R, Moriarty A, O Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T, Young N., The 2001 Bethesda system. JAMA. 2002; 287: Renshaw AA, Davey DD, Birdsong GG, Walsh M, Styer PE, Mody DR, Colgan TJ. Precision in gynecologic cytologic interpretation: A study from the College of 8

12 American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Pathol Lab Med. 2003; 127: Renshaw AA, Young NA, Birdsong GG, Styer PE, Davey DD, Mody DR, Colgan TJ. Comparison of Performance of Conventional and ThinPrep Gynecologic Preparations in the College of American Pathologists Gynecologic Cytology Program. Arch Pathol Lab Med. 2004; 128: Renshaw AA, Mody DR, Lozano RL, Volk EE, Walsh MK, Davey DD, Birdsong GG. Detection of adenocarcinoma in situ of the cervix in Papanicolaou tests. Arch Pathol Lab Med. 2004; 128: Davey DD, Neal MH, Wilbur DC, Colgan TJ, Styer PE, Mody DR. Bethesda 2001 implementation and reporting rates: 2003 practices of participants in the College of American Pathologists interlaboratory comparison program in cervicovaginal cytopathology. Arch Pathol Lab Med 2004; 128: Gagnon MB, Inhorn S, Hancock J et al. Comparison of cytology proficiency tesing glass slides vs. virtual slides. Acta Cytol 2004; 48: Renshaw AA, Dubray-Benstein B, Haja J, Hughes JH. Cytologic features of lowgrade squamous intraepithelial lesion in ThinPrep Papanicolaou test slides and conventional smears. Arch Pathol Lab Med 2005; 129: Renshaw AA, Wang E, Mody DR, Wilbur DC, Davey DD, Colgan TJ. Measuring the significance of field validation in the College of American Pathologists Interlaboratory Comparison Program in cervicovaginal cytology: how good are the experts? Arch Pathol Lab Med. 2005; 129: Snyder TM, Renshaw AA, Styer PE, Mody DR, Colgan TJ. Altered recognition of reparative changes in ThinPrep specimens in the College of American Pathologists Gynecologic Cytology Program. Arch Pathol Lab Med. 2005; 129: Renshaw AA, Mody DR, Wang E, Wilbur D, Colgan TJ. Measuring the significance of participant evaluation of acceptability of cases in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Pathol Lab Med 2005; 129: Renshaw AA, Walsh M, Blond B, Moriarty A, Mody D, Colgan TJ: Robustness of validation criteria in the College of American Pathologists Interlaboratory Comparison Program in Cervicovaginal Cytology. Arch Pathol Lab Med. (In press) 9

13 TABLE 1 Interlaboratory Comparison Program in Cervicovaginal Cytopathology (PAP) Total Laboratory Interpretations and Concordance Rates (to Series) by Reference Diagnosis Validated Conventional, ThinPrep, and SurePath Slides for Conventional ThinPrep SurePath Reference Diagnosis N % N % N % N % N % N % Unsatisfactory Negative for intraepithelial lesion or malignancy 2, , Fungal organisms c/w Candida Trichomonas vaginalis 1, Cellular changes c/w Herpes simplex virus Reparative changes Atrophic vaginitis Low grade squamous intraepithelial lesion 1, High grade squamous intraepithelial lesion 2, , Adenomacarcinoma in situ Squamous cell carcinoma 1, Adenocarcinoma, not otherwise specified 1, HSIL/Carcinoma, not otherwise specified Total 12, , , , ,

14 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated Conventional Slides Table 2a Reference Diagnosis: Unsatisfactory for evaluation Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 2b Reference Diagnosis: Negative for intraepithelial lesion or malignancy, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 2c Reference Diagnosis: Fungal organisms consistent with Candida Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 11

15 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated Conventional Slides Table 2d Reference Diagnosis: Trichomonas vaginalis Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 2e Reference Diagnosis: Cellular changes consistent with Herpes simplex virus Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Reference Diagnosis: Reparative changes Table 2f Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 12

16 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated Conventional Slides Table 2g Reference Diagnosis: Low grade squamous intraepithelial lesion Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 2h Reference Diagnosis: High grade squamous intraepithelial lesion Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 2i Reference Diagnosis: Squamous cell carcinoma Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 13

17 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated Conventional Slides Table 2j Reference Diagnosis: Adenocarcinoma, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 2k Reference Diagnosis: HSIL/Carcinoma, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 14

18 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated ThinPrep Slide1 Table 3a Reference Diagnosis: Unsatisfactory for evaluation Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 3b Reference Diagnosis: Negative for intraepithelial lesion or malignancy, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 3c Reference Diagnosis: Fungal organisms consistent with Candida Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 15

19 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated ThinPrep Slides Table 3d Reference Diagnosis: Trichomonas vaginalis Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 3e Reference Diagnosis: Cellular changes consistent with Herpes simplex virus Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Reference Diagnosis: Reparative changes Table 3f Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 16

20 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated ThinPrep Slides Table 3g Reference Diagnosis: Low grade squamous intraepithelial lesion Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 3h Reference Diagnosis: High grade squamous intraepithelial lesion Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 3i Reference Diagnosis: Squamous cell carcinoma Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 17

21 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated ThinPrep Slides Table 3j Reference Diagnosis: Adenocarcinoma, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 3k Reference Diagnosis: HSIL/Carcinoma, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 18

22 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated SurePath Slides Table 4a Reference Diagnosis: Unsatisfactory for evaluation Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 4b Reference Diagnosis: Negative for intraepithelial lesion or malignancy, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 4c Reference Diagnosis: Fungal organisms consistent with Candida Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 19

23 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated SurePath Slides Table 4d Reference Diagnosis: Trichomonas vaginalis Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 4e Reference Diagnosis: Cellular changes consistent with Herpes simplex virus Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Reference Diagnosis: Reparative changes Table 4f Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 20

24 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated SurePath Slides Table 4g Reference Diagnosis: Low grade squamous intraepithelial lesion Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 4h Reference Diagnosis: High grade squamous intraepithelial lesion Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 4i Reference Diagnosis: Squamous cell carcinoma Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 21

25 2005 Pap Mock PT Program Individual Participant Interpretations for Slides in Each Reference Diagnosis Validated SurePath Slides Table 4j Reference Diagnosis: Adenocarcinoma, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % Table 4k Reference Diagnosis: HSIL/Carcinoma, NOS Category A (Unsat) % % Category B (Negative) % % Category C (LSIL) % % Category D (HSIL+) % % No response % % Total % % 22

26 NOTES

27 Image 5: HSIL. Small metaplastic cells in a liquid based preparation (LBP) may be overlooked if participants are not experienced in the interpretation of LBP. If overlooked, an automatic failure ensues with PT. (ThinPrep ) Image 6: HSIL cases with many cells demonstrating nuclear enlargement and coarse chromatin patterns are easily identified. (ThinPrep ) Image 7: Herpes simplex usually performs well in the CAP interlaboratory comparison program, but performance was not as strong in the mock PT. (ThinPrep ) Image 8: Repair is historically difficult to validate and shows low sensitivity in mock PT. (ThinPrep )

28 College of American Pathologists 325 Waukegan Road Northfield, Illinois , option 1 #