Inspecting Anatomic Pathology

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Marilynn Cook
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1 Inspecting Anatomic Pathology Managing the Inspection Process I. Introduction Conduct a brief interview with the AP Lab director and/or the section supervisor to pose some QM related questions. If the AP director happens to be the director of the entire lab and you are the team leader, you can use this opportunity to also assess the director's performance (in accordance with the TL Checklist), which may require a lengthier interview. If this lab has defined subspecialty divisions (e.g., molecular; EM; Autopsy etc) with their own separate physical lab space and subdivision directors, you should allocate min for an interview with the subdivision directors. Give your host a prepared list of items that you want to read on your own and the slides/reports that you want to review after the physical inspection of the lab. Here is a suggested list of slides/reports to review: At least one case, if a small lab volume, or 3-5 cases, if large volume, per 12 month period for each category listed below: Surgical pathology: o frozen sections with permanent follow up o small biopsies from major work areas (respiratory, GI, GU, GYN etc) o large specimens from major work areas including cancer diagnosis and correlation of various studies o hematopathology cases: lymph node and bone marrow o cases with consults o cases with IHC and mol path, if any (represent major markers utilized) o cases with routine histochemistry, if any (represent most commonly used stains) Cytology: o All gyn categories: unsat, neg, asc-us, LGSIL, HGSIL, positive o Non-gyn: neg and positive from major work areas (smear and FNA, if any utilized) Autopsy: o report and slides, including neuropath, if any utilized EM o report with photomicrographs and thick sections (appropriate correlations with other studies are made) This phase should take about hr. II. Physical Inspection Stop at each work station and apply the ROAD strategy; you can either memorize the elements of each component (what to Read,, and ) or have keywords written in advance on small reminder cards (a sample grid/table is shown towards the end of this document, in which you can enter your primary key words). Conduct your interaction (especially the asking ) with the workers that staff the station and not just the supervisor or Quality manager who may be tagging along. Conduct all of the and and most of the on site. However, some of the reading material and almost all of the post-analytical discovery items you can leave for later, after you have completed the physical tour/inspection of all work stations. Make notes of any finding that may constitute a deficiency, recommendation or controversy; alert your host regarding each one of those possibilities with a Page 1 of 10

2 promise to let him/her know the final verdict if uncertain before the summation conference. The physical inspection of an average cytology lab should be completed in about 1-2 hrs. III. Document Review Completing your reading and your post-analytical review of slides/reports. This should be completed in about 1-2 hrs. The checklist review: Go through the checklist items to mark any that you are considering for deficiency or recommendation and fill in the appropriate forms. Discuss controversial items with the team leader. Revisit any missed items in the lab. This phase should take approximately 1 hr or less. IV. Summation The pre-summation conference: Report to the Team leader as he/she instructs. The summation conference: Highlight lab s positive points before presenting deficiencies, if any; recommendations need not be presented. This should be completed in about 1-2 hrs. Page 2 of 10

3 Conducting the Physical Inspection I. Pre-analytic Work Stations Specimen receiving and accessioning Grossing station Tissue processing Embedding and sectioning/slide preparation Staining of slides: H&E, histochemistry, IHC/molecular, EM Inspection Subjects Personnel: clerks, technicians, grossing staff (pathologist/resident/other) Equipment: slide and block printer, fume hood, cryostat, histobath, tissue processor, paraffin/plastic/other embedding, water bath, microtomes, automated strainers, thermal cyclers, microwave oven, other accessories Reagents: fixatives, volatiles, staining chemicals, antibodies, probes Environment/safety: work space, fire-fighting equipment, personal protective equipment, spill/contamination immediate response devices, ergonomics Quality Control: proper ID, cross-contamination, equipment maintenance logs, temp logs Read/Review a sampling of: Surgical specimen handling and retention policies and procedures Sub-optimal specimen policies and records/logs Histology QC policies and procedures Records of daily review of histologic slide quality Non-pathologist performance evaluations Documentation of non-pathologist personnel education and experience (competence) Instrument/equipment maintenance logs and repair records Cryostat decontamination records Microwave reproducibility and ventilation checks Function check records for instruments/equipment Pipette/dilutor checks Records of traceability to NIST standards temperature logs Lab/autopsy room chemical and physical safety records, policies and procedures IF policy/ procedure and QC records FISH/ISH policies/procedures and QC records IHC policies/ procedures and QC records Predictive markers (e.g. ER/PgR) policies and procedures Buffer ph records Batch control records FNA policies and procedures (items relevant to FNA: inspect under SP only if FNA material is processed as SP, otherwise under Cytology) Sampling of primary specimen containers (labeling; concordance with the requisition form) Sampling of tissue blocks (identification) Sampling of slides (labeling, quality) Sampling of reagents (expiration date) Instruments/equipment (clean and well-maintained) Posting of lab/autopsy safety policies Space, storage, cleanliness, ventilation, outlets, sinks, lighting are all sufficient Page 3 of 10 What is your course of action when you receive mislabeled or sub-optimal specimens?

4 How does your laboratory ensure specimen identity throughout processing and examination? How does your laboratory ensure quality testing when non-pathologists assist in gross examinations? How do you ensure there is no cross-contamination of specimens? Does your laboratory exclude any specimen types from routine submission to the pathology department? IHC/Mol: How does your laboratory validate new antibodies? IHC/Mol: How does your laboratory validate new reagent lots? IHC/Mol: What do you do to minimize background or nonspecific staining? Do you monitor formaldehyde/xylene exposure? Show me evidence of your compliance with chemical safety standards. II. Analytic Follow the trail of one specimen from receipt to complete staining If problems are identified during the review of instruments and equipment, or when asking questions, further evaluate the laboratory's responses, corrective actions and resolutions Work Stations Stained slide trays holding areas Pathologists reviewing posts (microscopy: light, IF and EM) Image analyzers, if used Frozen section processing and examination area Inspection Subjects Personnel: pathologists, pathology residents/fellows, molecular scientists Equipment: microscopes (light, IF and EM), image analyzer Reagents: markers, slide/lens cleaners Environment/safety: work space, fire-fighting equipment, personal protective equipment, spill/contamination immediate response devices, ergonomics Quality Control: proper patient/slide ID, prospective peer review, correlation with clinical history, correlation with other studies if available Read/Review a sampling of: Policies and procedures (gross examinations, frozen sections, touch preps, scrape preps) Frozen section (F/S) (intra-operative consultation) preliminary/verbal report records Final F/S reports IHC/FISH/ISH: antibody/probe validation records HER2, ER, PgR proficiency testing policy HER2, ER, PgR proficiency testing records Review of HER2, ER and PgR assay validation studies Sample of slides from previously processed frozen section cases (quality of sectioning and staining) If ongoing, observe handling and processing of F/S specimens, reporting format and timing Sample of slides representative of most commonly used histochemical stains (quality) Sample of slides representative of most commonly used immunohistochemical/molecular stains (quality) Photographic facilities Page 4 of 10

5 Is the work area sufficient for you to perform your duties safely and accurately? What is your laboratory's course of action regarding residual frozen tissue? If F/S verbal reports only are provided, how do you ensure that the surgeon accurately understood your communication? IHC/Mol: How does you distinguish non-specific false-positive staining from endogenous biotin? What is your course of action if a DNA probe does not produce an internal control signal? What is your laboratory's course of action when negative HER2 and/or negative ER/PgR by IHC results are obtained and the fixation was not appropriate? How does your laboratory ensure the safe handling of suspected CJD tissues? If problems are identified during the read, observe and ask sessions, further evaluate the laboratory's responses, corrective actions and resolutions Review samples of final surg path reports with relevant slides and clinical history for evidence of adherence to processing and QA policies Page 5 of 10

6 III. Post-analytic Work Stations Pathologists reviewing posts Computers (Lab/Hospitals Information System) File, including blocks and slides, storage locations Inspection Subjects Personnel: pathologists, pathology residents/fellows, molecular scientists Equipment: computers, printers Reagents: Environment/safety: work space, fire-fighting equipment, personal protective equipment, spill/contamination immediate response devices, ergonomics Quality Control: patient/slide ID error management, TAT, annual statistics, retroactive peer review, intra -and inter-institutional peer review, proficiency/educational surveys, cyto-histo-mol -EM correlation, F/S vs final dx, significant result communication; fidelity of report transmission to the clinical providers Read/Review a sampling of: Quality management program/policy in AP (as whole or for different sections) and sample of QM meeting minutes for evidence of compliance with policy Sampling of records of peer educational program participation Sampling of the following records: previous/current material review, intradepartmental consultations, extra-departmental consultations Sampling of documentation of communication of significant/unexpected findings Sampling of surgical pathology reports for completeness, including required CAP cancer protocol data elements, second pathologist review and ASR disclaimer, when appropriate FISH/ISH: Sampling of patient test reports Predictive markers: Sampling of patient reports for completeness, including ASCO/CAP scoring when applicable Predictive markers: Records of annual benchmark comparison Sampling of digital analysis/dna patient reports for completeness Specimen retention policies and procedures Policies pertinent to patient confidentiality (HIPPA) issues as it applies to requested reviews/duplicates of patients reports, slides, blocks etc Reporting policies and procedures Patient reports Statistical reporting policy Statistical records and annual summary Patient reports for pathologist review and interpretation of specific screening diagnoses 10% rescreening records Records of retrospective review and evidence of corrected reports, if applicable Records including evidence of annual review and investigation when the laboratory falls outside the 5th or 95th percentiles Records of employee participation and monitoring including individual's discrepancies and corrective action Patient reports on negative cases not reviewed by pathologist Interlaboratory comparison program policies and procedures Interlaboratory comparison program records including participation, retesting and remedial training, if applicable the process of entering and retrieving a report through the lab/hospital information system Storage and retrieval of records (organized, readily available) Page 6 of 10

7 Storage and retrieval of tissues, slides and blocks How does your laboratory participate in peer educational performance comparisons? Does your QM program include retroactive peer review? What is your laboratory's course of action when a significant disparity exists between the primary pathologist and the peer reviewer? What is your laboratory's course of action when a significant disparity exists between the initial intra-operative (F/S) consultation and final pathology diagnosis? How does your laboratory correlate the results of specialized studies with the morphologic diagnosis? How does your laboratory ensure prompt retrieval of cases according to diagnosis? Are the clinicians in your hospital (clients) satisfied with your TATs and methods of communication? How do you evaluate the long-term (annual) performance of the diagnostic pathologists? How do you handle diagnostic errors in AP? If problems are identified during the review of records, or when asking questions, further evaluate the laboratory's responses, corrective actions and resolutions Select a representative specimen and follow from receipt in the department through accessioning, grossing, processing, time reported and availability in the LIS Review slides, relevant stains and reports of representative cases from the previous two years. Suggested list is included in the introductory section (hand to the Lab Director or administrative supervisor at the beginning or during the introduction phase). The following are core elements of the review: o Evaluate slides for proper labeling, quality of technical preparation and specimen adequacy o Determine if the significant abnormalities have been identified and reflected in the report (including relevant other studies, correlations, consultations and communicsations) o Compare slides with the diagnostic report for completeness and clarity of diagnostic terminology (Scientifically Validate Data Elements) o Determine if the information provided with the requisition and included in the diagnostic report is complete and appropriate If, during the on-site review, there is believed to be a significant diagnostic discrepancy, the pathologist team leader should discuss this with the laboratory director. Interpretations may be considered discrepant if there is a significant diagnostic difference in interpretation. An example of this would be an interpretation of carcinoma, vs. melanoma or benign vs high - grade dysplasia/ invasive malignancy. Page 7 of 10

8 Digital Image Analysis I. Pre-analytic Read/Review a sampling of: Validation and calibration policies and procedures QC policies and procedures Specimen analysis policies and procedures DNA image analysis policies and procedures Documentation of operator and section director/technical supervisor education and experience Setting up and calibration of the image analyzer Sample of calibration materials (labeling) Sample of calibration slides (labeling) What is your course of action if imaging calibration is unacceptable? II. Analytic Select one or several occurrences in which calibration was out of range and follow documentation to determine if the steps taken follow the laboratory policy for corrective action Read Sampling of imaging validation/calibration records Sampling of DNA analysis QC records the actual process of generating and analyzing the image, if ongoing or possible How do you determine when imaging QC is unacceptable and corrective actions are needed? How does your laboratory ensure detection of DNA aneuploidy? III. Post-analytic Review representative case reports (correlations) and their respective image analysis work sheets Electron Microscopy I. Pre-analytic Read/Review a sampling of: EM policies and procedures EM maintenance and repair records EM safety policies and procedures Radiation leakage check records II. Analytic If ongoing, observe the process of specimen handling, labeling and accessioning the operation of ultramicrotomes (condition, safety) Read Sampling of EM calibration records Examine a sample of EM blocks (adequately identified) Examine a sample of EM slides and electron micrographs (quality, adequately identified) If ongoing or possible, observe the process of EM operation for diagnostic purposes (selection of the appropriate field, magnification etc) Page 8 of 10

9 III. Post-analytic How does your laboratory ensure specimen identity throughout testing? How does your laboratory ensure appropriate tissue areas are selected for EM examination? Select a representative EM sample and follow the entire process from specimen receipt to final result reporting Review representative case reports with applicable photomicrographs and thick sections (appropriate correlations with other studies are made) Autopsy I. Pre-analytic Read Sampling of autopsy consent policies and procedures Record retention policy Sampling of lab/autopsy room safety records, policies and procedures Autopsy room (clean, sufficient lighting and space) II. Analytic III. Post-analytical How does your laboratory identify cases that are subject to medical examiner and/or coroner jurisdiction? How does your laboratory ensure the safe handling of suspected CJD tissues? Read Sampling of autopsy room temperature checks/logs Sampling of scale/balance calibration records If some of the autopsy work is going to be performed by assistants or trainees, does the attending pathologist conduct a case review/pre-autopsy discussion? How does your laboratory ensure inactivation of hepatitis B virus when disinfecting tables, reusable instruments and aprons Read Sampling of the following records: intra- and extra-departmental consultations, peer reviews, documented autopsy teaching activities (e.g., clinic-pathological conference) How does your laboratory communicate important autopsy findings that were undetected clinically? How does your laboratory incorporate autopsy findings into the institution's QM plan? Review representative case reports and slides, including neuropath, if any utilized Page 9 of 10

10 The AP laboratory: personalized quick reference keyword table Work station (phase): activities Component (Item ) Read Pre-analytical - Specimen receipt, ID, accessioning and labeling - grossing - tissue process - embed/cut - stain - supervisory review Personnel Equipments Reagents Environment Q A Analytical - microscopy Light IF EM - I mage analysis - F/S reporting - notification of significant findings - consults Post-analytical - final report content - fidelity of transmission - correlation with other studies - extra-dept peer review - TAT - error tracking Personnel Equipments Reagents Environment Q A Personnel Equipments Reagents Environment Q A Page 10 of 10

CAP Companion Society Meeting at USCAP 2009 Quality Assurance, Error Reduction, and Patient Safety in Anatomic Pathology

CAP Companion Society Meeting at USCAP 2009 Quality Assurance, Error Reduction, and Patient Safety in Anatomic Pathology Core Components of a Comprehensive Quality Assurance Program in Anatomic Pathology