PWS Appendix 1.pdf

Appendix 1: Historical and Estimated Workload

Historical and Estimated Workload

The total number of studies per fiscal year (2010 – 2024) with time spent in Pathology are shown in Figure 1. Individual studies may take anywhere from a few hours to thousands of hours per year. Time spent on studies includes time spent preparing for the studies, including consultation and developing estimates for time and supplies. At any given time, pathology services may be performed for 10-15 different studies.

Table 1 shows the pathology workload at NCTR by year from November 2014 through July 2024. The years (2015 – 2024) follow contract periods and are not all full years (2015 represents 10 months and 2016 represents 8 months). The Necropsy/Histology category represents traditional pathology from necropsy of animals through reading slides and archiving study materials. The Special Procedures category includes a wide variety of immunohistochemistry (IHC) tests, photomicrography, scanned slides, and vaginal smears. The Clinical Pathology category includes the number of animals for which some type of clinical analysis was done and the different types of analyses. The Data Services category contains the number of Micropath data entries (or cases entered into the database system from pathologists’ notes), the total number of times databases were updated to verify data, and the total number of draft and final reports completed. Figures 2 – 8 are based on the data in Table 1.

Figure 1. Number of studies supported by the pathology contract during fiscal years 2010 through 2024.

0 10 20 30 40 50 60 70 80

Number of Studies per Year

Table 1. Historical Pathology Workload at NCTR from November 2014 through July 2024a.

2015* 2016** 2017 2018 2019 2020*** 2021 2022 2023 2024

Necropsy/Histology

Animals Necropsied 800 1,540 1,385 1,109 798 698 1150 985 574 793

Tissue Only Received - - - - - 605 456 516 664 713

Laboratory Process Complete 1,761 2,705 1,371 932 771 305 5,577 696 4,736

Cases Assigned 1,855 872 1,394 968 741 193 823 1,099 788 789

Block & Slide Archived 2,070 2,098 1,924 1,123 847 572 969 541 671

Wet Tissue Archived 805 1,107 1,309 896 536 459 259 327 211

Cassettes Trimmed 18,784 14,292 9,895 6,804 4,406 2065 5,072 5,200 3,755

Cassettes Processed 31,988 14,793 14,235 8,824 5,341 2292 5,305 5,585 4,342

Blocks Embedded 31,400 12,545 14,455 8,859 5,522 2523 5,758 5,847 4,646

Blocks Sectioned 31,923 14,118 13,608 5,902 5,521 2301 5,014 5,419 3,374

Slides Stained (H&E) 35,773 16,205 15,850 7,399 6,633 6,692 2569 4,920 5,845 7,616

Unstained Sections - - - - - 17,883 22679 55,269 6,934 6,488

Special Stains - - - - - 288 - - 250

Special Procedures

Immunohistochemistry 2,449 512 2,989 2,644 2,410 2,080 1008 1,627 1,955 1,849

Photomicrographs - - - - - 215 215 675 990 1,042

Scanned Slides - - - - - 487 145 641 1,224 3,816

Vaginal Smears 10 210 424 150 - - 30 30 - -

Clinical Pathology

Animals 934 3,325 2,096 2,157 1,211 411 143 - -

Blood Collections - - - - - - 112 597 aPTT - - - - - - - 53

Hematology (CBC's) 621 2,072 1,282 1,415 789 629 206 143 62

2015* 2016** 2017 2018 2019 2020*** 2021 2022 2023 2024

Bone Marrow Collection - - - - - - - 71 147

Bone Marrow Stain - - - - - - - 36

ELISA - 672 84 4,330 4,030 173 340 136 356

RIA - 302 - - - - - - -

Urinalysis 2,725 524 802 - - 26 - 130 -

Chemistries 9,564 18,249 23,800 17,650 9,743 3761 6,926 3,625 1,940

Sperm Counts - - - 163 - - 107 6 -

Sperm Motility - - - - - 53 - 46 53

Sperm Morphology - - - - - - - 20 22

Reticulocytes 408 317 284 247 16 63 73 23

Samples Collected - - - - - 133 - 486 88

Samples Collected and Frozen 180 2,131 1,745 1,630 991 233 809 50 120

Coagulation 1,165 1,068 1,068 1,664 2,194 - - 5 5

Data Services

Micropath Data Entry 1,350 1,367 1,054 1,121 881 840 500 932 621 488

Database Update Total 109 121 26 90 84 34 299 169 188 213

Total Draft/Final Pathology Report 22 13 38 52 49 21 19 10 40 21 a Years represent contract periods rather than calendar years as follows:

2015*: November 2014 – August 2015 (10-month period) 2016**: September 2015 – April 2016 (8-month period) 2017: May 2016 – April 2017 2018: May 2017 – April 2018 2019: May 2018 – April 2019 2020***: May 2019 – July 2020 (14.5-month period, not all data were available) 2021: July 16, 2020 – July 15, 2021 2022: July 16, 2021 – July 15, 2022 2023: July 16, 2022 – July 15, 2023 2024: July 16, 2023 – July 15, 2024

Figures 2 and 3 show the numbers of animals and cassettes, respectively, processed quarterly through pathology at NCTR from November 2015 through July 2024. The data are separated into two graphs due to the scale of the numbers – animal (or case) numbers are approximately ten times lower than the numbers of cassettes processed. Clinical Chemistries are included in Figure 3 because the data fit the scale of this graph better than that of other graphs.

Figure 4 shows the numbers of Special Procedures performed yearly in pathology at NCTR from November 2015 through July 2024.

Figures 5 and 6 show the numbers of clinical pathology samples processed monthly by pathology at NCTR from November 2015 through July 2024. The tests are divided into two graphs due to the large number of types of tests and to the differences in the scales of the two graphs.

Figures 7 and 8 show the numbers of studies for which Data Management services were provided from November 2015 through July 2024 for pathology at NCTR. The data are shown on separate graphs due to the large scale of the numbers of animals for which data was entered from pathologists’ notes (Micropath Data Entry; Figure 7) compared to the other data management tasks. Database updates included periodically running reports to ensure that data were captured properly.

Figure 8 also shows the number of studies for which Draft or Final Pathology Reports were completed. The draft reports must go through NCTR’s QAU audit prior to being finalized. The Pathology Reports are not considered Final until they have been signed by the study director, so multiple rounds of edits may be required prior to finalizing the reports.

Figure 9 shows the hours used yearly for all pathology contract work at NCTR from May 2016 through July 2024. While the hours vary somewhat from year to year, depending on the number and needs of the research protocols each year, there has been a noticeable decrease in workload over this time period. The spike in 2020 is due to the extended time for that contract period of performance. The workload is not expected to increase over the next contract period of performance.

Figure 10 shows the monthly purchasing workload from October 2020 to December 2024.

Figure 1. Historical number of animals processed through pathology services contracts at NCTR. “Laboratory Process Complete” refers to slides going to the pathologist for evaluation from the lab. “Cases Assigned” refers to the number of cases (each case represents one animal) assigned to a pathologist for slide reading. “Cases Archived Block & Slide” refers to the number of cases (animals) archived in the block and slide archive. “Wet Tissue Archived” refers to the number of wet tissues (animals) archived in the wet tissue archive. Years are defined in Table 1 footnotes.

Figure 2. Historical numbers of cassettes processed through pathology services contracts at NCTR. Cassette/block/slide numbers are not directly related to number of tissues, since each may contain multiple tissues. Clinical chemistries are included on this graph due to scale. Years are defined in Table 1 footnotes.

Figure 3. Historical numbers of immunohistochemistry, mammary whole mounts, and vaginal smear analyses performed through pathology services contracts at NCTR. Years are defined in Table 1 footnotes.

Figure 4. Historical numbers of animals from which samples for clinical pathology were taken, enzyme-linked immunosorbent assays (ELISA), radioimmunoassays (RIA), and urinalyses performed through pathology services contracts at NCTR. Years are defined in Table 1 footnotes.

Figure 5. Historical numbers of hematology (CBC’s) analyses, sperm counts, reticulocyte counts, samples collected and frozen, and coagulation analyses performed through pathology services contracts at NCTR.

Years are defined in Table 1 footnotes.

Figure 6. Historical number of cases (animals) entered into the Micropath database from pathologists’ notes at NCTR. Years are defined in Table 1 footnotes.

Figure 7. Historical numbers of studies for which pathology data management tasks were performed at NCTR. Years are defined in Table 1 footnotes.

Figure 8. Historical total yearly pathology hours used at NCTR. Years are defined in Table 1 footnotes. Hours for 2020 are for a 14.5-month period.

10000

20000

30000

40000

50000

60000

70000

80000

2017 2018 2019 2020*** 2021 2022 2023 2024

Pathology Hours

Figure 10. Monthly purchasing workload from October 2020 to December 2024. Purchase card (Pcard) requisitions and lines for reconciliation are measured on the right y-axis, and equipment requisitions are measured on the left y-axis.