Pathologists’ histopathologic evaluation of slides are entered into the Micropathology Data Collection System (MDCS or MicroPath). The pathologist’s observations are either entered directly by the pathologist as observations are made or written on a form and entered into the system by the data technicians. Standardized terminology from the Pathology Code Table (PCT) is used to describe lesions. Data are entered by choosing the organs, sites, morphologies, and qualifiers from a menu on the computer screen.
For each test, the pathologist provides a list of observations, from which a study-specific dictionary is built; this dictionary is stored, and a shortcut is assigned to each observation. Consequently, the shortcut may be used alone each time an observation is entered. Data are stored and may be reviewed either on the screen or from a printout. The study pathologist can review and change diagnoses at any time during the evaluation of a study.
TPA’s data technicians have over 20 years of cumulative experience entering these data, as well as original histopathology data, into the MicroPath system; their knowledge of both data entry procedures and pathology terminology is extensive. They are also experienced and skilled at entering data into data collection systems other than MicroPath.
Upon completion of histopathologic evaluation and data entry, a draft pathology report of the results, interpretation, and evaluations with respect to species and dose groups is prepared. TPA’s pathologists are experienced and skilled report writers and have full understanding of and an appreciation for, NCTR and NTP reporting requirements.
Generally, the format of the final report is tailored to fulfill the specific needs of the client. For each of our clients, TPA final pathology reports are structured to permit easy incorporation of the pathology findings into technical reports and in many cases, directly into publications and presentations.
The protocol is reviewed for required tissues and any memos for procedure changes. Verification is performed to ensure that all codes are properly recorded, required signatures and dates are in the proper locations, early death animals have a probable cause of death, found-at-trim lesions have initials and date, error codes are in the proper sequence, page numbering is correct, notes are signed and dated, and the animal’s condition is marked. Verification is performed to ensure there are no strikeovers or misspellings and that all TGLs have either a color or morphology.
MicroReviews are printed after each data entry session and compared to the pathologist’s worksheet. Any differences on the microreview are tagged. All TGLs and protocol required tissues are accounted for. Any data entry corrections are made and rechecked. Once all data points have been verified, the microreview can be filed in the study file.
Data points in the reports are verified using validated reports from GPS, Pathology Tracking System or MicroPath before distribution. Corrections needed are made and rechecked. After all data points have been verified, the report can be distributed. A copy is kept in the study file in data services.
Using the pathology reports or validated access reports, all data points are verified in any table, graph or other extraneous data as requested. Any corrections are made and rechecked. Once all data points have been verified, the report is distributed.
Using pathology reports and validated MS Access reports, all statements are verified against the data. The narrative is reviewed for grammatical correctness, spelling errors, referenced quotes, correct study titles and treatment groups, as well any other miscellaneous information. Discrepancies are discussed with the study pathologist and any necessary corrections are made. Once all discrepancies have been resolved, the reports are ready for distribution.
Various Quality Control reviews are performed on log books, SOP books, protocol books, oven temperature records, block and slide shipments, forms filed in block and slide and any other necessary materials. Discrepancies are documented in a memo and distributed to the laboratory supervisor or its designee for correction or clarification. Also, a copy of the memo is distributed to the study pathologist (if applicable), Program Manager, TPA Quality Assurance Manager and placed in the study file.