The document discusses principles of pre-analytic, analytic, and post-analytic test management. It covers test selection and evaluation, requisition and test menu formats, and report formatting. The three phases of quality assurance - pre-analytic, analytic, and post-analytic - are described in detail, including factors influencing each phase like specimen handling, equipment calibration, and report review. Quality control procedures are also outlined to ensure test accuracy and reproducibility.

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