Appendix_8__Sample_approach_to_combined_QA-PWG.pdf

An example NTP Pathology Peer Review Process where QA pathologist conducts the QA and PWG

1. After a thorough review of the submitted data the lab establishes a tentative date for the Quality Assessment Pathology Review (QA), the Audit of Pathology Specimens (APS), and a Pathology Working Group (PWG) meeting in conjunction with NTP staff. Generally, a PWG is held in 4-5 months after receipt of the pathology data.

2. Once the data is received at the NTP Archives, the staff in the quality assessment unit prepare the Pathology Data Review (PDR) package. The PDR package then goes to the pathologist for generation of the draft PDR Report.

Copies of the Draft PDR Report are submitted to the NTP (depending upon the complexity of the submitted study this task takes approximately 2 months from receipt of the data package)

3. Occasionally we review a percentage of animals per dose group rather than all animals which is counter to what we do for all other NTP studies. For routine NTP chronic studies we evaluate all target tissues, incidence organs, potential inappropriate diagnoses, and possible duplicate diagnoses.

a) For routine NTP chronic studies a PDR meeting is arranged with Dr.

Malarkey and other NTP staff and the QA pathologist/PDR writer to discuss the findings of the PDR and any additional studies or evaluation that might/may be needed. Suggestions at the PDR meeting may be incorporated into the PDR report. Less time will be expended if the review process is truncated for some studies.

4. Next, the PDR report is generated from Section X and Attachments B and D of the PDR. The PDR defines;

a) Which tissues are to be included in the QA Review and which groups/specific animals are to be included in the review.

b) Designates specific animals to be included in the APS. Drafts of the PDR are sent to NTP. The PDR is used to set up the slide sets for the QA Review (all slides are pulled based upon the tissues and lesions identified in the PDR) and the APS (all residual wet tissues in jars and/or bags, slides and blocks for the random sample of 10% animals in each dose group, those from any animals with discrepancies identified in the PDR Report, and all tissue jars are to be inventoried).

5. Next, a QA team (consisting of two pathologists), an APS team (consisting of one pathologist and two QA technicians) and the PWG participants (pathology experts) are selected.

6. Both the APS and QA teams proceed to the histology/necropsy lab to begin the APS and two pathologists, and the second technician set up to do the QA review, and the slide count/slide block match for the APS. Immediately after the QA review the SP and QA pathologists meet to discuss any discrepancies in diagnoses or terminology (It typically takes both teams one full week to complete their tasks).

7. Once the QA and APS are completed, the team writes their reports and the PWG

Chairperson, Dr. Shackelford, and the two QA pathologists decide on what lesions in specific animals need to be brought to the PWG. Once decided on, the PWG tables are generated and submitted to have specific tissues with lesions pulled and ready (It generally takes ~ one week for the QA pathologists to write the QA narrative and the PWG Chairperson to set up the PWG.)

8. The PWG Chairperson and both QA pathologists:

a) Finish setting up the PWG

b) Hold the PWG with the SP(s), QA(s), an NTP pathologist, and any invited pathology experts and observers. To begin the PWG the study scientist for the study in question gives a 10-15 minute introduction about the study (what was done, why it was done, the results of the study and answers any questions that the attendees may have). Next the PWG Chairperson passes the specific slides for review around for all participants to view. Once all slides have been reviewed and all issues of importance have been discussed the PWG ends (This generally takes 1-2 days).

9. Once back at the office the PWG Chairperson writes a Chairperson’s Report and submits a draft to NTP and the study pathologist(s) for review. From beginning the PDR to delivering the final PWG report usually takes about 4-5 months. This is compares with about 18 months for the standard NTP study.