quality control in clinical pathology
DESCRIPTION
quality control set upTRANSCRIPT
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
•Data and Lab Management•Safety•Customer Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Record Keeping
ReportingPersonnel CompetencyTest Evaluations
Testing
Purchasing & Inventory
AssessmentOccurrence Manageme
nt
Information Management
Process Improvemen
t
Customer Service
Facilities & Safety
The Quality System
Organization
Personnel Equipment
Documents & Records
Process Control (QC & EQA) & Specimen
Management
Quality systems
ObjectivesTo prevent risksTo detect deviationsTo correct errorsTo improve efficiencyTo reduce costs
How : By establishing a quality manual defining
Organizational structure – StaffResponsibilities Procedures and processesResourcesDocumentation
Factors influencing quality:
Pre analytical Analytical Post analytical
Right Specimen Laboratory professionals
Recording
Right collection Reagents Interpretation
Right labeling Equipment Turnaround time
Right quantity Selection of test - SOP
Report to right user
Right transport Records
Right storage Bio-Safety
Areas of Phlebotomy subject to QC
• Patient preparation procedures• Specimen collection procedures
IdentificationEquipmentPuncture deviceEvacuated tubes
• Labeling• Technique• Collection priorities• Delta checks
• Specimen rejection
mislabeled/unlabeled improper transport temp. or container/mediumquantity not sufficient (QNS) leakingdelay 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
Internal Quality control: IQCNature: Concurrentperformed by: lab staffObjective: Reliable results on a daily basis
External quality assessment: EQANature: Retrospective to evaluate IQCPerformed by: Independent agencyObjective: Ensure inter laboratory comparability
COMPONENTS OF QUALITY ASSURANCE
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)
QC
Hematology
Cytology
Clinical pathology
Histopathology
QC IN HEAMATOLOGY
Preanalytical phase
category Variables
Sample collection Patient identification,labelingPhlebotomy techniqueVolume Sample collection tube
Sample HandlingStorage
Agitation, centrifugation
Transportation
Patient Factors Physiological variablesPathological states
Types of control materials• Assayed
mean calculated by the manufacturermust verify in the laboratory
• Unassayedless expensivemust perform data analysis
• “Homemade” or “In-house” pooled sera collected in the laboratory characterizedpreserved 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 Analytical Post analytical
Pre 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 knifeProper adjustment of anglePeriodic calibration of micrometerCryostat proper handling of sample correct temperature anti-roll plate position
Staining
Control is used parallel with each batch of staining
Maintain good quality of regentStandard operating procedure Filter stain regularlySpecial 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
xyleneLabel should be affixed with serial numberWriting should be legibleLabel ideally carry name of laboratoryPrefer to bar code labeling system
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
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
proceduresReview of QI program and
indicatorsOn-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 failureDocumented 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 yearsFNA slides 10 yearsReports 10 yearsAccession logs / worksheets 2 yearsMaintenance records 2 yearsQC / 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 negativePerformed by individual qualified to be supervisor (3 years experience)Must include both high risk and randomly selected
casesCases not reported until rescreening completePathologists 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 slide2.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 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
analysis
Performed person should be well trainedMaintain good quality reagents for chemical
examination with suitable controlMicroscopy recheck if neededMaintain an uniformity in reporting
Microscopic UA
Correlate with cloudiness and other findingsQuality 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 –
THANK YOU