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quality control in clinical pathology

This document discusses quality control in pathology, with a focus on histopathology. It defines key terms like quality control, quality assurance, and defines the goals of a quality system. It outlines the quality assurance cycle and different factors that can influence quality, including pre-analytical, analytical, and post-analytical phases. Specific areas of quality control in histopathology are discussed, including sample collection and handling, tissue processing, section cutting, and staining. Maintaining standards and addressing errors at each step of the histopathology process is important for accurate diagnosis.

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QUALITY CONTROL IN PATHOLOGY QUALITY CONTROL IN PATHOLOGY
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
DEFENITION Quality 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.
Quality assurance: It is the sum total of all lab activities that are undertaken to ensure generation of accurate and reliable results.
The Quality Assurance Cycle Patient/Client Prep Sample Collection Personnel Competency Reporting Test Evaluations •Data and Lab Management •Safety •Customer Service Sample Receipt and Accessioning Record Keeping Quality Control Sample Transport Testing
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
Quality systems Objectives  To prevent risks  To detect deviations  To correct errors  To improve efficiency  To reduce costs How : By establishing a quality manual defining  Organizational structure – Staff  Responsibilities  Procedures and processes  Resources  Documentation
Factors influencing quality: Pre analytical Analytical Post analytical Right Specimen Laboratory Recording professionals Right collection Reagents Interpretation Right labeling Equipment Turnaround time Right quantity Selection of test - Report to right SOP user Right transport Records Right storage Bio-Safety
Areas of Phlebotomy subject to QC • Patient preparation procedures • Specimen collection procedures Identification Equipment Puncture device Evacuated tubes • Labeling • Technique • Collection priorities • Delta checks
• 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
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.
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
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
COMPONENTS OF QUALITY ASSURANCE Internal Quality control: IQC Nature: Concurrent performed by: lab staff Objective: Reliable results on a daily basis External quality assessment: EQA Nature: Retrospective to evaluate IQC Performed by: Independent agency Objective: Ensure inter laboratory comparability
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
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).
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.
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)
Clinical Hematology pathology QC Histopathology Cytology
QC IN HEAMATOLOGY
Preanalytical phase category Variables Sample collection Patient identification, labeling Phlebotomy technique Volume Sample collection tube Sample Handling Storage Agitation, centrifugation Transportation Patient Factors Physiological variables Pathological states
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
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
• Hemoglobin standardized haemolysate • Platelet platelets separated by centrifugation (200g for 10') ,fixed by gluteraldehyde.
TEST PROCEDURES • Measurement of prepared materials. • Repeated measurement/Replicate testing. • Duplicate testing. • Short hand checking • Delta check • Daily statistical analysis.
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
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
ANALYSIS OF EQA DATA • Deviation index • Target value & bias • Youden XY plot - same analysis on two diff. control and plot on X & Y axis
QUALITY CONTROL IN HISTOPATOHLOGY
Quality assurance in HISTOPATHOLOGY Concept of QC in histopathology lab is relatively young It may be due to, descriptive nature of report  lack of objective numerical data  Individual judgment and bias  No uniformity of reporting pattern
QUALITY ASSURANCE This make assessment and implementation of QC is more difficult in histopathology Even though we can implement QC in histopathology it may be Pre analytical Analytical Post analytical
A good quality histological section is the starting point of an accurate histopathology result According 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
Pre analytical All process up to submission of slide majority 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
Good fixation is very necessary for good result Fixation 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
Decalcification problem Should remove any traces of calcium salt from the tissue Always maintain  proper time  good decalcifying fluid  check end point of decalcification
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
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
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
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
Analytical errors Assessment of analytical errors are not an easy task Maintained 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
Post analytical QC Involves,  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
EQC in histopathology *CAP and UK- NQAS – international programmer In India, Indian College Of Pathology with collaboration with Association of Pathologist in North America(AIPNA) run EQC as a part of NABL accreditation Inter-Laboratory Quality Assessment Programe for Histopathology (ILQA-HP) under ILQA- Bangalore
EQA programme involves Scheme divided in to two categories asses pre analytical aspect asses analytical aspect
Pre analytical assessment Done 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
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
Analytical aspects, Section obtained in one common source is stained with H&E and distribute to lab along with all details pathologist examine and report was returned to nodal centre for assessment
QUALITY CONTROL IN CYTOLOGY
Cytopathology QC Will Require: Observation of technical procedures Review of QI program and indicators On-site microscopic review  standardization in reporting format
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)
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
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
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
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
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”
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
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
Retention Guidelines ALL slides 5 years FNA slides 10 years Reports 10 years Accession logs / worksheets 2 years Maintenance records 2 years QC / QA records 2 years Service / repair records instrument life
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)
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
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)
EQA IN CYTOLOGY 1. Exchange of slide programme A set of gynecological and nongynecological smears are distributed to diff. lab rechecking or reassessment of slide 2.Laboratory accreditation and certification Indian Academy of cytologist
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
QUALITY CONTROL IN CLINICAL PATHOLOGY
QA in CLIP > Still in dormant state > Require great attention > International and national agency should come forward
QC in urine analysis Specimen 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
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
Microscopic UA Correlate with cloudiness and other findings Quality control – Consistent volume – Centrifugation – Well mixed fresh specimen – Microscopy (wet mount, use low light)
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 –
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