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quality control in clinical pathology


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quality control in clinical pathology

  2. 2. Quality Assurance in Healthcare• All management systems are now focused on getting the job done.• All promise more efficient and effective management• Some have been effective in making larger profits while others have been effective in providing a better service to the client
  3. 3. DEFENITIONQuality Control - QC refers to study of those errors which are the responsibility of the laboratory and the procedures used to recognize and minimize them.This study include all errors arising with in the laboratory b/w receipt of specimen and dispatch of the report.
  4. 4. Quality assurance: It is the sum total of all lab activities that are undertaken to ensure generation of accurate and reliable results.
  5. 5. The Quality Assurance Cycle Patient/Client Prep Sample Collection Personnel Competency Reporting Test Evaluations •Data and Lab Management •Safety •Customer Service Sample Receipt and AccessioningRecord Keeping Quality Control Sample Transport Testing
  6. 6. The Quality System Organizatio Personnel Equipment n Process Purchasing Control Information (QC & EQA) & & Inventory Specimen Management Management Documents Occurrence Assessment & Records Manageme nt Process Customer Facilities & Improvemen Service Safety t
  7. 7. Quality systemsObjectives To prevent risks To detect deviations To correct errors To improve efficiency To reduce costsHow : By establishing a quality manual defining Organizational structure – Staff Responsibilities Procedures and processes Resources Documentation
  8. 8. Factors influencing quality:Pre analytical Analytical Post analyticalRight Specimen Laboratory Recording professionalsRight collection Reagents InterpretationRight labeling Equipment Turnaround timeRight quantity Selection of test - Report to right SOP userRight transport RecordsRight storage Bio-Safety
  9. 9. Areas of Phlebotomy subject to QC• Patient preparation procedures• Specimen collection procedures Identification Equipment Puncture device Evacuated tubes• Labeling• Technique• Collection priorities• Delta checks
  10. 10. • Specimen rejection  mislabeled/unlabeled  improper transport temp. or container/medium  quantity not sufficient (QNS)  leaking  delay in transport (> 2 hrs unpreserved)  inappropriately received in fixative, or received dried up MUST COMMUNICATE WITH CARE TEAM
  11. 11. User manual• Example of QA documentation• Chart or type form• Contains information on minimum amount of specimens required, special handling desired, reference values, TAT etc.
  12. 12. Procedure Manual• Standardization purposes• Must be updated annually• Written in a special format – NCCLS• States laboratory policy and procedures that apply to each test in the lab
  13. 13. Information found in a Procedure Manual• Purpose of the procedure• Specimen type and collection method• Equipment and supplies required• Detailed step-by-step procedure• Limitations and variables of the method• Corrective actions• Method validation• Normal values and references
  14. 14. COMPONENTS OF QUALITY ASSURANCEInternal Quality control: IQC Nature: Concurrent performed by: lab staff Objective: Reliable results on a daily basisExternal quality assessment: EQA Nature: Retrospective to evaluate IQC Performed by: Independent agency Objective: Ensure inter laboratory comparability
  15. 15. IQC• Based on monitoring the test procedures.• Measurements on specially prepared materials• Repeated measurements on routine specimens.• Daily statistical analysis of data obtained• Eliminates differences in random and systematic errors between samples and standards
  16. 16. EQC• Evaluation by an outside agency of the performance by numerous laboratories of specially supplied samples.• National schemes are known as – NEQUAS(National External Quality Assessment Scheme).
  17. 17. STANDARDISATION• Encompass both materials and methods• Standard material/ reference preparation-• Used to calibrate an analytical instrument.• Reference method – Technique that is used in association with a reference preparation.• Working method – Intended to use in routine practice.
  18. 18. National Standard and Regulatory Agencies• World Health Organization(WHO)• Joint Commission on Accreditation of Healthcare Organizations (JCAHO)• College of American Pathologists (CAP)• Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)• National Committee for Clinical Laboratory Standards (NCCLS)• National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)
  19. 19. Clinical Hematology pathology QCHistopathology Cytology
  21. 21. Preanalytical phasecategory VariablesSample collection Patient identification, labeling Phlebotomy technique Volume Sample collection tubeSample Handling Storage Agitation, centrifugation TransportationPatient Factors Physiological variables Pathological states
  22. 22. Types of control materials• Assayed mean calculated by the manufacturer must verify in the laboratory• Unassayed less expensive must perform data analysis• “Homemade” or “In-house” pooled sera collected in the laboratory characterized preserved in small quantities for daily use
  23. 23. REFERENCE PREPARATION• Red Blood cells ACD/CPD added blood Red cells stabilized with gluteraldehyde Suitable sized particles• White Blood Cells Fixed & concentrated human blood. Turkey /Chicken red cells
  24. 24. • Hemoglobin standardized haemolysate• Platelet platelets separated by centrifugation (200g for 10) ,fixed by gluteraldehyde.
  25. 25. TEST PROCEDURES• Measurement of prepared materials.• Repeated measurement/Replicate testing.• Duplicate testing.• Short hand checking• Delta check• Daily statistical analysis.
  26. 26. Analysis of Control Materials• Need data set of at least 20 points, obtained over a 30 day period• Calculate mean, standard deviation, coefficient of variation; determine target ranges• Develop Levy-Jennings charts, plot results
  27. 27. Levy-Jennings Chart A graphical method for displaying control results and evaluating whether a procedure is in-control or out-of-control Control values are plotted versus timeGaussian distribution curve Cusum chart
  28. 28. ANALYSIS OF EQA DATA• Deviation index• Target value & bias• Youden XY plot - same analysis on two diff. control and plot on X & Y axis
  30. 30. Quality assurance in HISTOPATHOLOGYConcept of QC in histopathology lab is relatively youngIt may be due to,descriptive nature of report lack of objective numerical data Individual judgment and bias No uniformity of reporting pattern
  31. 31. QUALITY ASSURANCEThis make assessment and implementation of QC is more difficult in histopathology Even though we can implement QC in histopathologyit may be Pre analytical Analytical Post analytical
  32. 32. A good quality histological section is the starting point of an accurate histopathology resultAccording to CAP, 1. Preanalytical part - all process for generation of good section 2.Analytical part - interpretation of slide and accurate diagnosis 3.Post analytical part - proper dispatching of result, storage
  33. 33. Pre analytical All process up to submission of slidemajority errors occur in this stage Sample accession and identification errors  Avoided by barcode technology  Maintain a good referral form with all possible details and that should make available in sample collection area
  34. 34. Good fixation is very necessary for goodresultFixation problems are, Should be fixed immediately Volume of fixative Conc. & type of fixative Adequate time of fixation Space in the container It should be cut open for proper internal after grossing Leakage of fixative
  35. 35. Decalcification problem Should remove any traces of calcium salt from the tissue Always maintain  proper time  good decalcifying fluid  check end point of decalcification
  36. 36. Tissue processing and embedding Always maintain good quality reagent Periodical changing of processing fluid Maintain a appropriate treatment time If tissue processor used, Ensure complete working Use closed type processor Temp. of paraffin wax Use Tissue Teck system for embedding
  37. 37. Section cuttingUse good quality microtomeSharp knifeProper adjustment of anglePeriodic calibration of micrometerCryostat proper handling of sample correct temperature anti-roll plate position
  38. 38. Staining Control is used parallel with each batch of staining Maintain good quality of regent Standard operating procedure Filter stain regularly Special stains are done with suitable controls If automatic stainer used, check their working
  39. 39. Mounting and labelingUse appropriate good mounting media dilute DPX if it become very thick with xyleneLabel should be affixed with serial numberWriting should be legibleLabel ideally carry name of laboratoryPrefer to bar code labeling system
  40. 40. Analytical errors Assessment of analytical errors are not an easy taskMaintained by, Intradepartmental consultation ; review selected cases by colleague Comparison with other reports (cytology, frozen) RBRC © by same person – for precision © diff. person – for accuracy Slide transferring and examination between two institution
  41. 41. Post analytical QCInvolves, Report generation without any transcription error Double checking of printed report Counter signed by consultant pathologist Report dispatch to right person Storage of reported material Disposal of specimen Monitor TAT
  42. 42. EQC in histopathology*CAP and UK- NQAS – international programmerIn India,Indian College Of Pathology with collaborationwith Association of Pathologist in NorthAmerica(AIPNA) run EQC as a part of NABLaccreditationInter-Laboratory Quality Assessment Programefor Histopathology (ILQA-HP) under ILQA-Bangalore
  43. 43. EQA programme involvesScheme divided in to two categories asses pre analytical aspect asses analytical aspect
  44. 44. Pre analytical assessmentDone by sending a bit of formalin fixed tissue measuring made from a common source to each of participating lab They process ,cut and stain the tissue in their set up Stained section are send back for assessment
  45. 45. Analyses as, Stained section are examined by 5 experts & Score as , score 1 - unsatisfactory score 3 - average score 2 - poor score 4 - good score 5 - excellent Give mark as processing - 5 mark sectioning - 5 mark staining - 5 mark total 15 mark lab that mark below 3 will take immediate action
  46. 46. Analytical aspects,Section obtained in one common source is stained with H&E and distribute to lab along with all detailspathologist examine and report was returned to nodal centre for assessment
  48. 48. Cytopathology QCWill Require: Observation of technical procedures Review of QI program and indicators On-site microscopic review  standardization in reporting format
  49. 49. Cytopathology QC• General Elements of QI Technical and procedural (QC) Professional/diagnostic activities of cytotechnologists and pathologists (QI) Quality of the diagnostic report (QC/QI)
  50. 50. Specimen Collection and Receipt • Specimens properly identified • Instructions available for preferred specimen collection/preparation • Requisition: complete data requested including date, source, physician, LMP, pertinent clinical information, etc. • Criteria for specimen rejection and notification of unacceptable specimens
  51. 51. Cytology Stains Stains labeled and dated Cytology stains: new requirement for annual inventory to ensure proper storage and quality (many stains do not expire) Papanicolaou stains filtered or replaced regularly Papanicolaou stain prepared with good reagent Regular monitoring of stain characteristics
  52. 52. Instrumentation• Evidence of active review of results of instrument maintenance and function (II)• Automated instruments (Phase II) – Documentation of adherence to manufacturer- recommended protocol for implementation – Documentation of appropriate technical and interpretive training – Written procedure to verify diagnostic & adequacy performance of screening instrument
  53. 53. Instrumentation• Automated screening systems If tolerance limits exceeded, is there documentation of corrective action? Documented procedure for handling workload during instrument failure Documented procedure for handling slides not successfully processed “Negative” slides subject to 5 year retro review
  54. 54. On-Site Microscopic Review • Not meant to be comprehensive rescreen or competency review, but a means of facilitating evaluation of overall procedures • 10 -15 case review recommended including: > Unsatisfactory > Reactive > Positive for all abnormality reported “Must have written criteria”
  55. 55. On-Site Microscopic Review • Evaluate adequacy, technical quality, labels • Determine if significant cells identified • Compare with written interpretive report • Check requisition for complete information • Discrepancies analogous to PAP program • Team leader should discuss significant discrepancies with laboratory director • Record specimen category & discrepancies
  56. 56. Cytopathology Reports• Name/unique identifier/accession number• Birth date / age• Physician / clinic• Anatomic source / type of specimen• Collection, receipt, and reporting dates• Description of specimen on receipt• Interpretation (descriptive terminology)• Space for comments / recommendations
  57. 57. Retention GuidelinesALL slides 5 yearsFNA slides 10 yearsReports 10 yearsAccession logs / worksheets 2 yearsMaintenance records 2 yearsQC / QA records 2 yearsService / repair records instrument life
  58. 58. Slide Storage• Stored in accessible manner• Documented policy for protecting and preserving the integrity of original slides• Policy to ensure defined handling and documentation of referral, transfer, receipt of original slides for availability• Documentation when material is loaned to programs such as PAP (including receipt)
  59. 59. Cytopathology Quality Improvement • Correlation with clinical findings • Reconciliation of Disparities • Documentation of consultations • Documentation of technical quality • Participation in PAP program or CLA- approved alternative program
  60. 60. Pap Rescreening• Laboratory must rescreen a minimum of 10% of each cytotechnologist’s initially judged as negative Performed by individual qualified to be supervisor (3 years experience) Must include both high risk and randomly selected cases Cases not reported until rescreening complete Pathologists exempt (but rescreening advised)
  61. 61. EQA IN CYTOLOGY1. Exchange of slide programme A set of gynecological and nongynecologicalsmears are distributed to diff. lab rechecking or reassessment of slide2.Laboratory accreditation and certification Indian Academy of cytologist
  62. 62. Accreditation of IAC is based on, Workload Staff pattern Report generation and methodology Screening of specimen Diagnostic verification Follow-up Filing of report and slide Continuing education
  64. 64. QA in CLIP > Still in dormant state > Require great attention > International and national agency should come forward
  65. 65. QC in urine analysisSpecimen Collection  First morning voiding (most concentrated)  Record collection time  Type of specimen (e.g. “clean catch”)  Analyzed within 2 hours of collection  Free of debris or vaginal secretions
  66. 66. analysisPerformed person should be well trainedMaintain good quality reagents for chemical examination with suitable controlMicroscopy recheck if neededMaintain an uniformity in reporting
  67. 67. Microscopic UACorrelate with cloudiness and other findingsQuality control – Consistent volume – Centrifugation – Well mixed fresh specimen – Microscopy (wet mount, use low light)
  68. 68. Accreditation Bodies• College of Pathologists (CAP) , USA• Joint Commission on Accreditation of Hospitals (JCAHO), USA• Clinical Pathology Accreditation (CPA), UK Ltd• National Association of Testing Authorities (NATA), Australia• Department of Standards (DSM) Malaysia –
  69. 69. THANK YOU