quality control set up

1. QUALITY CONTROL IN
PATHOLOGY
QUALITY CONTROL
IN
PATHOLOGY

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. 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.

4. Quality assurance:
It is the sum total of all lab activities that are
undertaken to ensure generation of accurate
and reliable results.

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 Accessioning
Record Keeping
Quality Control Sample Transport
Testing

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. 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

8. 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

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. • 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. 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. 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. 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. 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

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. 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. 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. 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. Clinical
Hematology
pathology
QC
Histopathology Cytology

20. QC IN HEAMATOLOGY

22. 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

23. 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

24. 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

25. • Hemoglobin
standardized haemolysate
• Platelet
platelets separated by centrifugation
(200g for 10') ,fixed by gluteraldehyde.

26. TEST PROCEDURES
• Measurement of prepared materials.
• Repeated measurement/Replicate testing.
• Duplicate testing.
• Short hand checking
• Delta check
• Daily statistical analysis.

27. 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

28. 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

29. 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. QUALITY CONTROL IN
HISTOPATOHLOGY

31. 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

32. 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

33. 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

34. 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

35. 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

36. Decalcification problem
Should remove any traces of calcium salt from
the tissue
Always maintain
 proper time
 good decalcifying fluid
 check end point of decalcification

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. EQA programme involves
Scheme divided in to two categories
asses pre analytical aspect
asses analytical aspect

45. 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

46. 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

47. 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

49. QUALITY CONTROL IN
CYTOLOGY

50. Cytopathology QC
Will Require:
Observation of technical
procedures
Review of QI program and
indicators
On-site microscopic review
 standardization in reporting
format

51. 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)

52. 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

53. 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

54. 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

55. 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

56. 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”

57. 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

58. 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

59. 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

60. 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)

61. 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

62. 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)

63. 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

64. 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

65. QUALITY CONTROL IN
CLINICAL PATHOLOGY

66. QA in CLIP
> Still in dormant state
> Require great attention
> International and national agency
should come forward

67. 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

68. 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

69. Microscopic UA
Correlate with cloudiness and other findings
Quality control
– Consistent volume
– Centrifugation
– Well mixed fresh specimen
– Microscopy (wet mount, use low light)

70. 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 –

72. THANK YOU