Pre analytic and postanalytic test management
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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.
![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 ](https://image.slidesharecdn.com/preanalyticandpostanalytictestmanagement-121122142838-phpapp01/85/Pre-analytic-and-postanalytic-test-management-10-320.jpg)
Pre analytic and postanalytic test management
- 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