2.1.5 Is a policy that lists types of specimens that the facility may choose to exclude from routine submission to the pathology department for examination? 2.1.6 Are extra-departmental consultations documented, and records of these consultations maintained in the pathology department? 2.1.7 When extra-departmental cases are submitted to the laboratory for consultation, are they accessioned according to the standard practices of the laboratory and is a documented report prepared, with a copy sent to the originating pathologist? 2.1.8 Is there a policy defining the handling of original slides/blocks for consultation? 2.1.9 When slides/blocks are sent to another facility for consultation, is this documented? 2.2 Specimen Examination 2.2.1 Are there specific policies and procedures for the safe handling of tissues that may contain radioactive material? 2.2.2 Are primary specimen containers labelled with at least two identifiers? 2.2.3 Are there procedures for handling specimens? 2.2.4 Are gross specimens retained for at least 8 weeks after the final reports are signed and results reported? 2.2.5 Are all macroscopic tissue gross examinations performed by a pathologist or under the supervision of a qualified pathologist? 2.2.6 Are there defined procedures if gross examinations are performed by laboratory personnel other than a pathologist? 2.2.7 Does a qualified pathologist do periodic evaluation of the non-pathologist gross examinations? 2.2.8 Are surgical tissue diagnoses made by a pathologist? 2.2.9 Are there instructions available for the proper dissection, description and histological sampling of various specimen types? 2.2.10 Are slides of sufficient quality for diagnosis?
2.2.11 Is documented evidence of daily review of the technical quality of histological preparations by the pathologist? 2.3 INTRA-OPERATIVE CONSULTATION (RAPID DIAGNOSIS) 2.3.1 Are frozen sections, touch and scrape preparations adequate for intra-operative diagnosis? 2.3.2 Are the results of intra-operative surgical consultations signed by the pathologist who made the diagnosis? 2.3.3 If verbal reports are given, does the pathologist speak directly to the surgeon? 2.3.4 Are the patient’s identification checked and confirmed before delivery of any verbal report? 2.3.5 Are all intra-operative consultation reports made a part of the final surgical pathology report? 2.3.6 Is all frozen section, touch and scrape preparation slides permanently stained, mounted, properly labelled and retained with the rest of the slides from the case? 2.3.7 Is the residual frozen tissue routinely processed into paraffin, and a histological section prepared and examined for comparison with the frozen section interpretation? 2.3.8 Is there a documented procedure for the routine decontamination of the cryostat at defined intervals, and decontamination records are evident? 2.4 REPORTS 2.4.1 Is there a policy regarding the communication and documentation of significant surgical pathology findings? 2.4.2 Do surgical pathology reports include gross descriptions that contain type, number, dimensions and/or weight of the specimens, measurements and extent of gross lesions and other information essential to the diagnosis? 2.4.3 Do gross descriptions include a summary noting block and slide designations for special sections? 2.4.4 Do gross descriptions and microscopic findings support the pathologic diagnosis?
5.2.7 Has the laboratory validated new antibodies prior to use in patient diagnosis? 5.2.8 Are new lots of antibody and detection system reagents tested in parallel with old lots? 5.2.9 Are the immunohistochemical stains produced of acceptable technical quality? 5.3 Fluorescence and Non-Fluorescence Hybridization (FISH, ISH) 5.3.1 Is there documentation of validation of commercially available ISH and FISH probes used? 5.3.2 Is there documentation of validation of probes that are developed in-house? 5.3.3 Are there documented procedures for scoring results, including the number of cells scored? 5.3.4 Are quantitative and semi-quantitative analyses scored according to these procedures? 5.3.5 Are control loci (internal or external) used with and documented for each FISH analysis? 5.3.6 Are photographic or digitized images retained for documentation of all FISH assays? 5.3.7 Is the morphologic interpretation and correlation of results performed by a qualified pathologist as appropriate for hybridization studies? 5.3.8 Are interpretations of in situ hybridization results provided in the report? 5.4 Predictive Markers 5.4.1 For immunohistochemical and FISH/ISH tests that provide independent predictive information, does the patient report include information on: 5.4.1.1 specimen processing 5.4.1.2 antibody clone/probe 5.4.1.3 scoring method used 5.4.2 For immunohistochemical and FISH/ISH tests that provide independent predictive information, does the laboratory (at least annually) compare its patient results with published benchmarks, and evaluate
6.2.4 Is a preliminary report of the gross pathology finding issued within 72 hours? 6.2.5 Is the final autopsy report produced within: 6.2.5.1 30 days – routine cases 6.2.5.2 90 days – complicated cases 6.5.6 Descriptions: 6.2.6.1 clear and concise 6.2.6.2 pertinent findings described 6.2.7 Do the descriptions support the diagnosis? 6.2.8 Are microscopic descriptions in the report clear and concise? 6.2.9 Do microscopic descriptions support the diagnosis? 6.2.10 Does the report include a summary noting block and slide descriptions to allow identification of the source of specific microscopic sections? 6.2.11 Does the final autopsy report contain sufficient information so that a physician may ascertain the patient’s major disease processes and probable cause of death? 6.2.12 Are autopsy records organized and available for review? 6.2.13 Are data from the final report entered into a database that allows for prompt retrieval of cases according to diagnosis? 7.0 ELECTRON MICROSCOPY 7.1 QUALITY MANAGEMENT 7.1.1 Do requisitions include sources of tissue and appropriate clinical data? 7.1.2 Are electron microscopy fixatives easily accessible to collection areas? 7.1.3 Is the identity of every specimen maintained through each step in processing? 7.1.4 Are blocks identified adequately? 7.1.5 Are sections of embedded tissue reviewed by the pathologist or designate to ensure that appropriate areas are selected for electron microscopic examination? 7.1.6 Are one micron sections reviewed by the pathologist or designate to ensure that appropriate areas have been selected?