Inspecting Cytopathology

Transcription

1 Inspecting Cytopathology Managing the Inspection Process I. Introduction Conduct a brief interview with the Lab director and/or Cytology supervisor to pose some QM related questions. 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. 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, Observe, Ask and Discover) 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 Ask and Observe and most of the Discover 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 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: o Go through the checklist items to mark any that you are considering for deficiency or recommendation and fill in the appropriate forms. o Discuss controversial items with the team leader. o Revisit any missed items in the lab. o 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. Page 1 of 6

2 Conducting the Physical Inspection I. Pre-analytic Work Stations Specimen receiving and accessioning Preparing and labeling of slides Staining of slides Inspection Subjects Personnel: clerks, technicians Equipment: slide printer, smear maker/concentrator, stainer Reagents: fixatives, volatiles, staining chemicals Environment/safety: work space, fire-fighting equipment, personal protective equipment, spill/contamination immediate response devices, ergonomics Quality Control: proper ID, cross-contamination Read/Review a sampling of: GYN and Non-GYN specimen collection and handling policies and procedures including specimen rejection criteria Gynecologic cytopathology policies and procedures Non-gynecologic cytopathology policies and procedures Stain policies and procedures (promptly retrievable?) Records of daily review of technical quality of cytologic preparations with corrective action of unacceptable stain quality Instrument policies and procedures Instrument maintenance logs and repair records Validation data with documented review and approval Slide handling policies and procedures Hazardous waste disposal policy Formaldehyde/xylene monitoring procedure and records of monitoring Observe Delivery, receipt, accessioning and labeling of specimens Follow a slide through automated staining, cover-slipping and automated screening. Determine if practice matches procedure. Sampling of stains/reagents (labeling; expiration date) Sampling of slides (labeling) Instrument records (promptly retrievable) Slide storage area (organized, accessible, slides easily retrieved) Use of Papanicolaou stain Space and utilities are sufficient Ask What is your course of action when you receive unacceptable cytopathology specimens? When do you label FNA slides? What identifiers are placed on the slides and containers? What procedures do you have in place to prevent errors in ID, site and testing? What criteria do you use to identify rejected or unsatisfactory specimens? Who performs the daily review of the quality of cytological preparations? What is your course of action when stain quality is unacceptable? How frequently do you change stains? Under what circumstances do you filter stains? How do you assign expiration dates for laboratory-prepared stains and solutions? If you extend expiration dates, how do you do so? What procedures are in place to prevent cross-contamination during staining? Page 2 of 6

3 II. Analytic Discover Review records or specimen log for unsatisfactory specimens. Determine if the quality of the specimens follows defined criteria. Follow a specimen from accessioning through labeling and staining. Determine consistency in labeling and processing (smear prep, concentration, staining with Pap and other stains, if any). Work Stations Cytotechnologists /pathologists screening/reviewing posts Image analyzers, if used Inspection Subjects Personnel: cytotechnologists, cytology supervisor, cytopathologists Equipment: microscopes, 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 histology if available Read/Review a sampling of: Instrument policies and procedures, maintenance logs and repair records Instrument validation data with documented review and approval Section director's/technical supervisor's qualifications and job description Supervisor's/general supervisor's qualifications and job description Cytotechnologist's qualifications and job description Workload reporting policies and procedures Records of workload recording for each individual with supervisory review Observe Follow a slide through automated staining, cover-slipping and automated screening. Determine if practice matches procedure. Sampling of slides (labeling) Instrument records (promptly retrievable) Slide storage area (organized, accessible, slides easily retrieved) Space, ergonomics and utilities are adequate Ask How does your laboratory perform ongoing monitoring of screening instrumentation? What corrective action do you take when tolerance limits are exceeded? How do you handle workload when the screening instrument is down? How many cases do you use to validate the accuracy of your screening instrument? How do you identify slides that have not successfully been processed by the automated screening instrument? What is the process for performance monitoring of cytotechnologists? Under which circumstances do you require prospective peer review? How do you obtain relevant clinical information? When is it necessary to check for related histology? Page 3 of 6 Discover Review a sampling of rescreening records. Determine if the rescreening was performed by a qualified individual, results are not reported until the rescreen is complete and 10% of cases are rescreened. Review several cytotechnologists' workloads for a selected period. Ensure staff has not exceeded daily acceptable workload limits and that the individual workload has been reassessed at least every six months.

4 III. Post-analytic Work Stations Cytotechnologists /pathologists screening/reviewing posts Computers (Lab/Hospitals Information System) Inspection Subjects Personnel: cytotechnologists, cytology supervisor, cytopathologists 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 diagnostic statistics, retroactive peer review, intra -and inter-institutional peer review, proficiency/educational surveys, cyto-histo correlation Read/Review a sampling of: 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 Observe Entering and retrieving reports via the lab information system (computer/chart) Page 4 of 6 Ask What type of remedial training do you provide when an individual has an unacceptable score on PT? How are disparities between histological and cytological findings addressed? Under what circumstances do you issue an amended report? How do you document intra-departmental and extra-departmental consultations? If cases are resulted at different locations, how do you ensure that the testing laboratory name and address are correct on the final report? For slides retained for different periods of time, how does your laboratory ensure that the slides are retained for the defined time period? If using off-site storage, how do you ensure that slides are stored appropriately? What is the laboratory's process for follow-up or investigation of significant results? What is your course of action when you are unable to obtain histological reports or material when reporting gynecologic cases with HSIL? What is your process for correlating gynecologic cytopathology findings with clinical information? How do you educate providers that the Pap test is a screening test with false negative results? What is your process for correlating non-gynecologic cytopathology findings with histological and clinical information? How does your laboratory dispose for infectious specimens and contaminated

5 material? Have you had any complaints of noxious fumes in the work area? Have you had any employee complaints of skin rash or difficulty breathing while working in the laboratory? Discover Review lab s quality management plan and note whether there is adequate monitoring of the 3 phases of the process Sample actual performance data such as turn-around-time, histo-cyto correlation, error Management etc to verify compliance with established thresholds and evidence of corrective and Preventive actions when there is lack of compliance Select an example of unacceptable inter-laboratory comparison results (if applicable) and follow documentation from original testing to retesting and remedial training, if necessary. Determine if practice matches documented policies and procedures. Review a randomly selected representative sample of cases (example: 1-2 cases from each diagnostic category, from each of the previous two years since last inspection) using the table below to guide selection: Gynecologic Cases Unsatisfactory Negative / Reactive Atypical squamous cells HPV / LGSIL HGSIL / POS Non-Gynecologic Cases (including FNA's) From each commonly targeted organ/tissue Negative / Reactive Suspicious / Positive Cases should be selected by the laboratory pathologist and/or cytopathology supervisor in a random manner that may be defined by the inspecting Team Leader (e.g. the first 1-3 negative and abnormal cases in each specimen category from a certain date or week). The following are core elements of the on-site review: Evaluate slides for proper labeling, quality of technical preparation and specimen adequacy Determine if significant cells have been identified Compare slides with the diagnostic report for completeness and clarity of diagnostic terminology 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. Page 5 of 6

6 The Cytology Laboratory: Personalized Quick Reference Keyword Table Work station (phase): activities Pre-analytical - specimen receipt, ID, accessioning and labeling - conventional smear prep, fluid-based prep, cell block - staining Pap - staining other Analytical - cytotech screening - image analysis - supervisory review - pathologist review Component (Item ) Read Observe Ask Discover Personnel Equipments Reagents Environment Q A Personnel Equipments Reagents Environment Q A Post-analytical - final report - transmission - verbal notification of significant findings - look-backs - correlation with histology - consultation/ peer reviw Personnel Equipments Reagents Environment Q A Page 6 of 6