The following are the requirements for pathology services:
- Pathology services must be performed by qualified pathologists in accordance with federal standards in anatomic pathology and licensed in the state in which they provide care.
- Pathology services must provide reports of external quality assurance programs quarterly.
- A "wet read" of a preliminary cancer, melanoma and significant diagnosis should be provided to the ordering clinicians within 24 hours of receiving the specimens at the testing institutions.
- Consultations regarding the medical significance of the laboratory results or data provided.
- Mandatory second pathologist review when indicated by current standard of care (such as any malignancy, high-grade dysplasia in Barrett's, any dysplasia in IBD, and others).
- Retrospective review of two percent of all cases, randomly selected, or selected by organ system for systemic review.
- Mandatory review of any outside pathology materials upon which a definitive therapy is planned within a referral institution.
- Pathology department must utilize a specific set of preferred consultants who are recognized experts within each subspecialty.
- All gross specimens must be retained until at least two weeks after the final reports are signed and results reported to the referring physician.
- Intradepartmental consultations must be included in the patient's final report, or filed separately.
- The results of surgical consultations must be documented and signed by the pathologist who made the diagnosis.
- Statistical reports on turnaround time are required for the following categories of pathology specimens:
- Routine, such as Pap smears.
- Advanced, such as molecular pathology, flow cytometry and fluorescence in situ hybridization (FISH).