1. CL 400
SESSION 3

2. LABORATORY DIAGNOSTIC TEST
Is a diagnostic test which is performed on a clinical specimen (blood, stool, tissue, body fluid, urine etc) in order to obtaining information about the health of a patient as pertaining to the diagnosis, treatment, and prevention of disease. There are three stages of Diagnostic test.

3. STAGES OF DIAGNOSTIC TESTS
Pre analytical stage
Analytical stage
Post analytical Stage

4. PRE ANALYTICAL STAGE
Pre analytical stage is vital to the success of any diagnostic test. It involves
Patient preparation (e.g. patient educations, patient history to identify contraindications to a specific test, to elicit fears of the patient, previous medications, previous test, dietary restriction in studies requiring fasting etc),

5. PRE ANALYTICAL STAGE
Patient Identification (e.g the patient should be asked to state his/her full name then be verified by checking the identification band and requisition form),
Specimen Collection (Specimen collection must follow Standard Operation Procedure. Each specimen is collected different from another in terms of timing, volume, site of collection, container used etc)

6. PRE ANALYTICAL STAGE
Specimen transportation (The specimen must get into the Laboratory for testing as soon as possible in an acceptable state for examination, infectious specimen must be transported in a triple transport container. Use transport media such as Cary –Blair, Amies or Stuart Transport media where necessary.

7. ANALYTICAL STAGE
Involves the testing of the specimen. For quality Laboratory results, Quality Assurance both Internal and External of the tests must be adhered.

8. POST ANALYTICAL STAGE
This stage involves reporting tests results. In order to be clinically usefully, the results must be reported timely.

9. A GENERAL CLINICAL SPECIMEN FLOW
Request
Collection of specimen
Transport
Reception
Macroscopic and Microscopic examination,
Antibody and antigen detection (Serological tests): Other rapid tests e.g. FBP, clinical chemistry etc

10. A GENERAL CLINICAL SPECIMEN FLOW
7. Cultivation and Isolation
8 Identification: Antimicrobial sensitivity testing
9. Further Identification; typing;toxin production; further sensitivities

11. TOTAL QUALITY MANAGEMENT (TQM)
The Quality of the Final Report of a Clinical laboratory depends on Total Quality Management (TQM)
TQM refers to all areas of Laboratory Practice that most influence how a laboratory service functions and uses its resources to provide a quality and relevant service.

12. TOTAL QUALITY MANAGEMENT
TQM can include the following:
The correct use of the Laboratory in the community Health Care.
Providing a quality service to patients and those requesting tests
Management of finance, equipment and supplies.
Staffing of the Laboratories, training and competence of staff
Quality Assurance to Obtain quality laboratory results
Continuing improvement oin quality

13. CORRECT USE OF THE LABORATORY IN HEALTH CARE
Selecting those investigations that are needed in curative health care, surveillance and rapid investigation of epidemics, health protection, health education, health promotion and health planning only.
Deciding whether those investigations that are needed can be affordable and reliable

14. CORRECT USE OF THE LABORATORY IN HEALTH CARE
Assessing whether those requesting laboratory test have sufficient training and experience to understand the meaning of test results and the limitations of laboratory tests.
To review the value of tests performed so that the outdated tests can be replaced by tests that are more cost-effective, rapid, informative, easier to perform, and that new technologies are introduced.

15. CORRECT USE OF THE LABORATORY IN HEALTH CARE
Monitoring the impact and cost effectiveness of Laboraqtory practice

16. PROVIDING A QUALITY SERVICE
Reliable with tests performed using SOPs
Accessible and Available
Professional (Laboratory staff knowing their job, presenting clear and informative reports and confidentially.
User friendly

17. PROVIDING A QUALITY SERVICE
Dependable by laboratory staff arriving at work timely and all laboratory supplies available all the times.
Flexible, to allow the introduction of new technologies in respond to the needs of users and changing health strategies.

18. MANAGEMENT OF FINANCES, EQUIPMENT, AND SUPPLIES
Good management of laboratory finances, equipment and supplies are important functions of TQM because they help to keep financial records, estimating laboratory operating costs and the ways of controlling them. Effective equipment management policy enables the equipment to last longer.

19. QUALITY ASSURANCE (QA) AND QUALITY CONTROL (QC)
Immediate and long term clinical, public health and health planning decisions are based on the results of laboratory test results. Incorrect, delay or misinterpreted tests results can have serious consequences for patients and community hence a need for QA and QC

20. QA AND QC
The purpose of QA in laboratory practice is to provide tests results that are:
Relevant
Reliable
Timely
Interpreted correctly

21. QA AND QC According to WHO Quality Assurance is defined as:
The total process where by the total quality of Laboratory reports can be guaranteed.

22. QA AND QC Quality Assurance has been summarized as the
Right results at the
Right Time, on the
Right patient, with results interpretation based on
Correct reference data, and at the
Right Price

23. Quality Control (QC)
Quality Control covers that part of Quality Assurance which primarily concerns the control of errors in the performance of tests and verifications of test results. QC must be practical achievable and practical.

24. Quality Control (QC) There are two groups of Quality Assurance
External Quality control(EQA) and
Internal Quality control(IQA)

25. External Quality control(EQA) scheme
EQA assesses the past performance hence must never be a substitute of Internal Quality Assurance.

26. INTERNAL QUALITY CONTROL (IQA)
IQA is performed before testing the specimen.
It assess the performance of the machine or the procedure which is used.
The aim of performing IQA is to ensure that the final test results are correct and clinically useful

27. Quality Control (QC)
Errors can lead to incorrect test results. The purpose of QA is to detect errors at an early stage before they lead into incorrect test results. Errors can happen in Pre- analytical stage, Analytical stage and post analytical stage

28. Quality Control (QC) Implementation of QA requires:
Preparation and use of Standard Operating Prosecutes(SOPs)
System for monitoring test results so that they reach to those who are treating the patients timely to influence clinical and public decision making.
Policies of work(i.e decision that area taken to enable the laboratory to operate reliably, effectively and in a harmony with other departments in a Hospital.

29. STANDARD OPERATING PROCEDURES (SOPs)
Is a set of step-by-step instructions which help workers to carry out routine operations.

30. REASONS FOR HAVING SOPS
To improve and maintain the quality of laboratory service to patients and identify problems associated with poor work performance.
To provide laboratory staff with written instructions to perform tests consistently to an acceptable standards
To prevent changes in performance of tests
To make clinical and epidemiological interpretations of tests results easier by standardized specimen collections techniques, test methods and test reporting.
To promote safe laboratory practice

31. STANDARD OPERATING PROCEDURES (SOPs)
To make clinical and epidemiological interpretations of tests results easier by standardized specimen collections techniques, test methods and test reporting.
To promote safe laboratory practice

32. IMPORTANT FEATURES OF SOPS
SOPs must be:
Applicable and achievable in the laboratory where they will be used
Clear written and easy to understand and follow
Kept up to date using appropriatae technologies

33. PREPARING SOPs
SOPs must be written and implemented by a qualified experienced Laboratory Officer and followed exactly by all members of staff.
All SOPs must have a similar format with importations presented under separate headings

34. PREPARING SOPs
Each SOP must be given a title and an identification number and signed by an authorized person and date of preparation.
The SOP must include a list of staff who are able to perform the test(under supervised and supervised)

35. SOP HEADING
State the main reason(s) for performing the test Example to detect, identify and quantify malaria parasites in person with suspected malaria.
Indicate any limitation of the test

36. PRINCIPLE OF THE TEST
Example microscopic examination of stained thick blood film for malaria parasites

37. SPECIMEN
It should state the specimen required and how to collect it including:
Volume require
Container and its preparation
Use of any anticoagulant or stabilizer/ preservatives
Collection procedure for adults and children with health and safety notes
Laboratory

38. SPECIMEN How container should be labeled
Stability of specimens and requirement for storage and transport
Time within which the specimen should reach the

39. EQUIPMENT
List the items of equipment needed to perform the test such as microscope, centrifuge, incubator, calorimeter water bath etc.

40. REAGENT AND STAINS
List all reagents, stains, reagent strips etc needed to perform the test.

41. CONTROLS
List controls and source(s) to be used in the test e.g positive and negative controls in selorogical tests, control sera in clinical chemistry, positive and negative controls in urine tests etc.

42. METHOD OF TEST
Describe in a numbered sequence on how to perform the test. For quantitative tests include details of calibration, use of graph or factor and calculations. Describe how to control the procedure and the safety measures which apply. A fully safety procedure should be included in a separate appendix.

43. REPORTING RESULTS/INTEPRETATION
State how the test should be reported including
Units to be used and format of reporting(Explain any Abbreviations)
Actions to take if results is seriously abnormal or unexpected e.g. need for verification, additional testing, and or immediate notification of the result
Accepted reference range for a quantitative test
Give target turn-round ti me for issuing the report
Interpretation comments which should accompany the test.

44. SOURCES OF ERROR
Summarize the important and commonest causes of an incorrect test result.
Example sample not mixed well, Smear too thick, Sample hemolyzed, clots in ant coagulated sample

45. REFERENCE
List the main source of in formations contained in the SOP

46. IMPORTANT
SOPs must be kept up to date and reviewed at least annually. Any amendments must be authorized, referenced, dated signed and brought to attention of all members of staff.