CL 400 SESSION 3

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.

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

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),

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)

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.

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

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

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

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

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.

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

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

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.

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

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

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.

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.

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

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

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.

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

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.

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

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

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

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

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.

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

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

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

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

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

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)

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

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

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

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

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

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

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.

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.

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.

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

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

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.