1. Principles of pre-analytic and
post-analytic test
management
Dr Varsha Shahane

2. Objectives
• To familiarize with selection , assessment and
incorporation of diagnostic tests
• To review principles of test evaluation and utilisation and
their effect on patient outcomes
• To describe major elements of requisition and test menu
formats
• To review principles of formatting of reports of test
results
• To review needs for record storage

3. Introduction
• Quality Assurance : refers to the systematic
activities implemented in a quality system so
that quality requirements for a product or service
will be fulfilled
• ‘PATH OF WORKFLOW’ - 3 phases of QA
cycle :
 Pre analytical
 Analytical
 Post analytical

5. • Level of Quality →minimize errors, minimize
resources waste, maximise efficacy
↓
Quality standard guidelines and regulatory
accreditation (NCCLS & CLIA guidelines)

6. (i) Pre analytical
• Requisition by physician
• Patient preparation
• Collection of specimen
• Handling of specimen
• Transportation
• Specimen receipt
• Storage of specimen
• Referral of specimens

7. Purposes of lab tests
• Screening
• Provisional diagnosis
• Differential diagnosis
• Final diagnosis
• Prognosis
• Treatment
• Monitor response to treatment
• Specific events (rape, antenatal, post
mortem)

8. CATEGORIZATION OF TESTS
• Waived tests : are those that have few steps
and have been shown to be accurate and
easy to perform eg –BSL, pregnancy tests,
urine dipstick tests, haemoglobin etc
• Non waived tests: are the moderately and
highly complex tests
• Screening tests : good sensitivity and
specificity, low cost and risk, confirmatory test
available and practical, presymptomatic
period detectable and treatable, high
prevalence of disease, increased morbidity
and mortality of disease

9. • Diagnostic tests : method well described
and easily reproducible, accurate,
established reference range, sensitivity
and specificity established after a wide
study.

10. FACTORS TO BE CONSIDERED BEFORE
PERFORMING TESTS
(i) Direct access testing [DAT]- patients are
health conscious
• No markups or kick backs
• Ethical or social issues attached to reports
• Usually waived
• Doctor X patient relationship 

11. (ii) Cost benefit analysis :
benefit/cost ˃ 1 is cost effective
(iii) To implement or discontinue the test – adequacy
and trained staff ?, kits available or not ?, test
volume too low, advanced technology, in vogue or
obsolete, reimbursed or not
(iv) Pareto principle : 80/20 rule
80% of total revenues generated by 20% of its
products –list all tests performed in the lab and rank
them according to the total annual revenues
produced by each test

12. Verification / validation of tests
• CLIA 1988 guidelines – verify the test and
periodically validate it
• Periodic evaluation of test utilisation and
appropriateness of test
• JCI – medical director of clinical and pathological
lab services should ensure an active policy for
monitoring and evaluation of quality and
appropriateness of services is provided
• Legal and ethical issues
• Professional and moral responsibility of doctor and
director

13. • Overutilisation of tests x
• Underutilisation of tests x
• Misutilisation of tests x
• Laboratory information and consulting
center : interpret, counsel, consult online
or by mail/fax
• Feedback to family doctors – improves
test order quality ( provide patient data to
lab- rationalise the test order)

14. REQUISITION
• Person ordering the test
• Referral from ( lab and person details)
• Name/ age / sex
• sample with source/ time
• date of collection, of reception
• LMP/any previous testing,treatment or
biopsy
• Any additional relevant information for
testing

15. SOPM –standard operating procedure
manual
• List of tests available
• Purpose of examination
• Principle of procedure
• Detailed instructions about preparation of
patient and collection of sample, also type
and volume of sample, timing of collection,
precautions, labelling, type of container,
additives, safe disposal of sample
• Clinical information

16. SOPM continued.....
• Equipment
• Calibration
• Procedure
• Controls
• Calculations
• Alert/ critical values
• Interpretation
• Safety precautions

17. Pre analytical loopholes
• Test requests
• Order entry errors
• Identification of patient
• Identification of specimen
• Evaluation of specimen adequacy
• Type of medium and/ preservative
• Transport delay
• Improper patient preparation

18. • Improper collection
• Wrong specimen container
• Incorrect storage
• Unlabelled/ mislabelled specimen
• Improperly/ incompletely filled form
• Specimen collected X test ordered

19. (ii) Analytical
• Actual performance of test

20. Analytic activities
• Specific reagents
• Test kits
• Proper patient information
• Proper interpretation- include disclaimers

21. Factors influencing analytic
activities
• Proficiency of personnel
• Stability, integrity and reliability of
reagents
• Equipment reliability
• Specificity and sensitivity of tests
• Use of appropriate controls
• Documentation
• Assessment

22. 3 components of Analytic phase
• Monitor, evaluate and maintain this phase
for ensuring reliability of results. This can
be done by :
 Equipment – reliability and maintainence
 Examination procedures
 Quality of examination procedure

23. a) Equipment
• Proper installation
• Calibration
• Validation
• Regular maintainence
• Train the operator
Reputed manufacturers - good
manufacturing practices (GMP),
annual maintainence contract
(AMC), simple to use, safe,
moderate running cost,
operation manual with trouble
shooters

24. b) Examination procedure
• Standard procedures
• In house – to be validated – references,
interlab comparisons, other references in
literature
• Review of all procedures periodically

25. c) Quality of examination
procedures
• Quality Control : Operational
techniques and activities used to fulfill
requirements of quality is called
Quality Control (QC)
• Quality assuranCe : Planned and
systematic actions to provide quality in
services is called Quality Asssurance
(QA)

26. 3 main aspects of QC
• ACCURACY
• ASSURANCE
• REPRODUCTIBILITY
Nowadays, there is large dependance on the
laboratories (labs) and hence increasing load
on technicians – errors ; On a global scale,
increasing demand for accreditation of labs
has further necessitated QC in labs.

27. • AIM : To assure the patient, doctor and
the laboratory personnel of the validity
and preciseness of ALL the tests
performed in the lab.

28. 2 types of QC
• Internal – the lab itself conducts these
processes, maybe once a week , to
ensure its credibility
• External – an outside agency or reference
lab monitors/ supervises the working of
the lab to test its quality. Once in 3-4
months.

29. QC program- DMPOIV
• Design : proper facilities, expertise,
prepare and maintain SOPM- standard
operating manual, daily performed tests
signed by director/ head of the lab
• Material : reagents, chemicals, media, kits,
sera, stains, all certified
• Process : Maintainence and calibration of
all equipment, SOPM.

30. • Output: check exceptionally high/low
values. Reference ranges are determined.
There should be baseline values of all
records
• Inspection and verification : is done by
government or professional groups,
medical director, lab consultant, chief lab
technician or scientist

31. (iii) Post Analytical
• Results and data review
• Reports
• Interpretation
• Communicate reports to physician
• Storage of specimen

32. Post analytic activities
Review and evaluate the following:
• Effectiveness of the corrective actions
• Procedures and policies to prevent recurrences
• Accuracy and completeness of results and
reports
• Disposition of unacceptable specimens
• Turnaround times
• Referral specimens and their reports
• Corrected reports

33. Contd.....
• Procedures for notification of test results
with statistics
• Assurance of confidentiality of patient
information

34. (a) Reporting of results
• Release of reports only to the authorized
person
• Timely release of provisional and final
report
• Any value which exceeds the normal limit
must be clearly published, understood and
conveyed verbally, electronically or printed
form - when, where, what and to whom
was reported - document it

35. • Result format –
 Name and address of lab
 Name of patient with gender
 Lab ID number
 Date and time of receipt of sample
 Type of sample
 Name of test requested with a brief
clinical background
 Result with the units
 The normal or reference range of
the test

36.  Interpretation and explanation of the value
of result
 Any disclaimer/s
 Value added textual comments
 Name of the person authorising the
release of the report
 Signature of the person releasing the
report

37. • Expected turnaround time – if delay, notify
the doctor
• Types of reports – standard paper,
electronic and web based
• Quality assessment and corrected reports-
monitor and evaluate its results
• If sample was unacceptable – prompt
communication

38. (b) Storage and retention of
samples
• Standard procedures
• Regulations for process and duration
• Records – duration

39. (c) Assessment of test results on
patient outcomes
• Patient’ s health – quality of life
• Financial outcomes
• Publications
• Discoveries
• Case studies – interventions
• Educational programs
• Formulate empirical line of treatment

40. Sequelae to the path of workflow
• Interact with teams of :
 Infectious disease clinicians
 Hospitalists
 Infection control epidemiologist
 Pharmacist
 Clinical case managers
 Nursing staff
 House keeping
 Cafeteria

41. Laboratory management –
good team work