Quality System (Veterinary Medicine, BeniSuef University) PDF

QUALITY SYSTEM ( A DEGREE OF EXCELLENCE) Faculty of Veterinary Medicine, BeniSuef University The main objective of a Laboratory is to provid accurate test results. This is only occur by : ◦Monitoring and Evaluation of Laboratory Performance continuously. ◦Implementation and Follow- up of cor...

QUALITY SYSTEM ( A DEGREE OF EXCELLENCE) Faculty of Veterinary Medicine, BeniSuef University The main objective of a Laboratory is to provid accurate test results. This is only occur by : ◦Monitoring and Evaluation of Laboratory Performance continuously. ◦Implementation and Follow- up of corrective actions.  If you want to open a lab with credibility in results you should apply steps of QUALITY SYSTEM. The establishment of (Robust testing system) is essential to the success of lab. Services and treatment program  TO apply the quality system you should have correct data on the patient and provide reagents to do tests and get results. IF you get the certificate of quality, that means you have reached a degree of EXCELLENCE (everything is perfect 100%)  Quality procedures : Internal Q.C and external Q.C N.B: These 2 items are complementary with each other , they should be present to achieve Q.A Internal Q.C : ◦Internal Q.C : depends on the presence of a supervisor (doctor) who monitors everything in the lab. ◦Include (persons (patient), sample, instrumentation, document control(computerized data – sample label – permanent database on computer)difficult to be lost, Reagent control (stable- sufficient- good quality), and corrective action ◦TIME: every day (daily)  external Q.C : ◦external Q.C: depends on the presence of a COMMITTEE that comes to the lab to give a Certificate of quality which is important to ensure the lab is performing to an external standard. ◦TIME: from time to time (long term) N.B: √EQA results evaluate performance of the laboratory against other laboratories participating in the same program √EQA results should be formally documentd oithin the  QUALITY ASSURANCE = Quality control (internal) + Quality control (external) ◦Quality Control(Q.C): refers to operational techniques that must be included during each assay run to vertify that the requirements for quality are met with. ◦Quality assurance(Q.A) : refers to all those planned and systematic activities to provide confidence that the results given out by the lab are correct. ◦The aim of Q.C is simply to ensure that the results generated by the test are correct. ◦Q.A is more common that the right test is carried out on the right specimen and the right result and right interpretation is delivered to the right person at the right time. THE PURPOSE of Q.A is the maintenance of overall quality of patient results. All factors that affect the test results divided into 3 parts : Pre-clinical Analytical Post- analytical 1- Control of Pre-analytical variables: ☺At the level of patient: Patient preparation. Patient Identification: get data of patients for labeling of specimens and good documentation system (on computer) Test conducted: appropriate test should be requested and performed (correct sample acc to required test) Laboratory logs: entry of patient & test details in lab registers & computers.  1- Control of Pre-analytical variables: ☺At the level of specimen: (safety precautions for all specimens) Sample collection: suitable clean and dry container – Anti coagulant. Sample Transportation: critical for some tests (precautions of temp ,…) Sample preservation: put sample on suitable anti-coagulant or refrigerator or freezer. Sample separation: by monitoring centrifuge performance or container used for sample storage. 2- Control of Analytical variables: Reliable analytical methods are obtained through careful process of: Selection (location of the lab) Evaluation Implementation Maintenance Control Factors influencing analytical variables: 1. proficiency of personnel: the person who works in your lab should have (Education, Training, Competence, Adequate number, Supervision and Motivation) 2. Reagents stability, integrity and efficiency: should be stable, Efficient, desired quality, continuously available, cost-effective. 3. Equipment reliability: Meet technical needs, compatible, validated, user, cost-effective, Maintenance friendly. 4. Specificity & Sensitivity of selected test: specific, sensitives, cost-effective, interpretable. 5. Documentation: All the written policies, plans, procedures, instructions and records, Q.C procedures. 6. Use of appropriate controls: Internal (national), External (international) 3- Factors of Post-Analytical variables: Right recording and reporting. Right interpretation. Report to right user.  Reporting Results All data entry vertified by A supervisor and reviewed by management for final interpretation and release of results. In the event that a report has been sent out and needs correction, a new report is issued with an updated report written on it. (according to the data present on your computer) The old report remains in the patient file.  House keeping Surface decontamination (sterilization) of instruments and benchtops. Disposal of waste products. Cleaning with detergents Monitoring of fridge and freezer and incubator temperatures. * Objective of quality in lab:- ◦1- Reduce Morbidity ◦2- Reduce Mortality ◦3- Reduce economic loss ◦4- Ensure Credibility in lab ◦5- Generate Confidence in lab results ◦6- Corrective Results * Consequences of poor quality:- ◦- Inappropriate action : ◦ 1- Over Treatment 2- Mis Treatment 3- Over investigation ◦- Inappropriate inaction : ◦ 1- Mis Treatment 2- Lake or Loss of investigation 3- Lake or No treatment ◦- Delayed action ◦- Loss of Cerdibility of laboratory ◦- Legal action HOW TO IMPLEMENT Q.C PROGRAM: ◦ Putting of plan for good quality ◦ Assign Responsibility for monitoring and reviewing ◦ provide every thing in your lab with good amount as : Reagents to work continuously ◦ Provide Equipments ◦ Obtain Control material ◦ Good Train Staff ◦ Establish and Implement the corrective action ◦ Collection of data and control data ◦ Establish and maintain system for documentation (All data of patient saved on computer).