1. 1 Quality System Definition Organizational structure, resources, processes and procedures needed to implement quality management (ISO, NCCLS)

2. 2 Quality System Quality Assurance Quality Control

3. 3 Quality System Essentials Organization Personnel Equipment Purchasing and inventory Process control (validation, quality control, proficiency testing, specimen management) Organization Personnel Equipment Purchasing and inventory Process control (validation, quality control, proficiency testing, specimen management)

4. 4 Who is Responsible??? Lab Tech-The person who performs testing Supervisor-The person who is responsible for day- to-day activities, training, delegation of work Director-The person who is responsible for entire seamless operation, planning, and control of all activities Ministry of Health-Place responsible for infrastructure, man power, and resources. Lab Tech-The person who performs testing Supervisor-The person who is responsible for day- to-day activities, training, delegation of work Director-The person who is responsible for entire seamless operation, planning, and control of all activities Ministry of Health-Place responsible for infrastructure, man power, and resources.

5. 5 Lab Tech Must be trained to perform the tests Follow SOPs Must run QC samples Maintain all the record up to date Inform the Supervisor of any problems--- immediately Corrective actions taken by them must be noted down and any implications on other samples Must be trained to perform the tests Follow SOPs Must run QC samples Maintain all the record up to date Inform the Supervisor of any problems--- immediately Corrective actions taken by them must be noted down and any implications on other samples

6. 6 Supervisor Train the Lab tech for the assigned job Provide periodic training to the lab techs Prepare the controls and check the values Prepare and update the SOPs -easy to understand Keep record of Equipment Maintenance, problems, and repairs Keep records of training, SOPs, equipment, etc. Ensure all Lab tasks on time Train the Lab tech for the assigned job Provide periodic training to the lab techs Prepare the controls and check the values Prepare and update the SOPs -easy to understand Keep record of Equipment Maintenance, problems, and repairs Keep records of training, SOPs, equipment, etc. Ensure all Lab tasks on time

7. 7 QA and QC QC is that part of GLP which is concerned with sampling, specifications, testing and with in the organization, documentation,and release procedures which ensure that the necessary and relevant tests are carried out QC is that part of GLP which is concerned with sampling, specifications, testing and with in the organization, documentation,and release procedures which ensure that the necessary and relevant tests are carried out QA is the sum total of organized arrangements made with the object of ensuring that product will be of the Quality required by their intended use.

8. 8 QA and QC Operational laboratory techniques and activities used to fulfill the requirement of Quality All those planned or systematic actions necessary to provide adequate confidence that a test will satisfy the requirements for quality

9. 9 Quality Assurance Definitions Planned and systematic activities to provide adequate confidence that requirements for quality will be met (ISO) Includes IQC, EQA, pre-analytic phase, test standardization, post-analytic phase, management, and organization (WHO, 1992) Planned and systematic activities to provide adequate confidence that requirements for quality will be met (ISO) Includes IQC, EQA, pre-analytic phase, test standardization, post-analytic phase, management, and organization (WHO, 1992)

10. 10 The Quality Assurance Cycle Data and Lab Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Record Keeping Reporting Personnel Competency Test Evaluations Testing

11. 11 Pre-analytical stage Selection of the right patient and right sample at the right time in the right container selection and appropriate use of microbiological investigations Proper filling of request form Collection and transport of specimens Checks must be made when the specimen and request form reach the laboratory.

12. 12 Analytical stage Detailed procedure for receiving and examining different specimens. Reagent preparation and QC. Aseptic techniques and safe handling of infectious material. Preparation and QC of culture media. Inoculation, Reading and interpretation of cultures. Techniques used to identify pathogens. Antimicrobial sensitivity testing and QC of procedures and antibiotic discs. Cleaning and QC of equipment used the lab. Safe working practices. Disposal of specimens and cultures. Cleaning of glassware, plastic ware, etc. Sterilization procedures and their control.

13. 13 Post-analytical stage Recording test results Recording QC results Review test/QC results Result interpretation and reporting Data entry

14. 14 Quality Control Definitions Qualitative Quality Control Quantitative QC – How to implement  Selection and managing control materials  Statistical Analysis of QC data  Monitoring quality control data Definitions Qualitative Quality Control Quantitative QC – How to implement  Selection and managing control materials  Statistical Analysis of QC data  Monitoring quality control data

15. 15 What is Quality Control? Process or system for monitoring the quality of laboratory testing, and the accuracy and precision of results Routinely collect and analyze data from every test run or procedure Allows for immediate corrective action Process or system for monitoring the quality of laboratory testing, and the accuracy and precision of results Routinely collect and analyze data from every test run or procedure Allows for immediate corrective action

16. 16 Sources of QC Samples Appropriate diagnostic samples Obtained from:  Another laboratory Commercial product Appropriate diagnostic samples Obtained from:  Another laboratory Commercial product

17. 17 Designing a QC Program – Establish written Lab policies, Requisition forms, SOPs, Report forms, and Revisions and Corrective action plan Assure complete documentation and review Assure proper controls, standards, chemicals and storage Equipment control and maintenance Train all staff and periodic retraining Periodic Internal audits Establish written Lab policies, Requisition forms, SOPs, Report forms, and Revisions and Corrective action plan Assure complete documentation and review Assure proper controls, standards, chemicals and storage Equipment control and maintenance Train all staff and periodic retraining Periodic Internal audits

18. 18 Qualitative vs.Quantitative Qualitative test  determines whether the substance being tested for is present or absent Quantitative test  measures the amount of a substance present Qualitative test  determines whether the substance being tested for is present or absent Quantitative test  measures the amount of a substance present

19. 19 Qualitative QC Quality control is performed for both, system is somewhat different Controls available  Agglutination / precipitation controls : Blood Bank / Serology / Micro / Biochemistry / RPR/TPHA  Colour change: Dipstick technology, Pregnancy test Sterlization ampules, Occult blood, Biochemical reactions  Opacity tube standards: McFarland std tubes Quality control is performed for both, system is somewhat different Controls available  Agglutination / precipitation controls : Blood Bank / Serology / Micro / Biochemistry / RPR/TPHA  Colour change: Dipstick technology, Pregnancy test Sterlization ampules, Occult blood, Biochemical reactions  Opacity tube standards: McFarland std tubes

20. 20 Lab Chemicals and Supplies Check upon receipt -Correct order -Clear and legible label -Content -Expiry date -Storage conditions Label date received Enter in your inventory book Check upon receipt -Correct order -Clear and legible label -Content -Expiry date -Storage conditions Label date received Enter in your inventory book

21. 21 Stains, Reagents, Antisera, Media Bulk containers- Date of opening Prepared contents: Label containers  Contents  Concentration  Date prepared and expiration date/shelf life  Storage condition  Placed in service  Prepared by Bulk containers- Date of opening Prepared contents: Label containers  Contents  Concentration  Date prepared and expiration date/shelf life  Storage condition  Placed in service  Prepared by

22. 22 Microbiology QC: Media Preparation Record amount prepared Source Lot number Sterilization method Preparation date and Expiration date Prepared by Record amount prepared Source Lot number Sterilization method Preparation date and Expiration date Prepared by

23. 23 Microbiology QC Check: Sterility Ability to support growth Indicative, selective, or inhibitory characteristics of the medium Biochemical response Test QC organisms with each new batch or lot number Check for growth of fastidious organisms on media of choice – incubate at time and temp recommended RECORD Results on Media QC form Check: Sterility Ability to support growth Indicative, selective, or inhibitory characteristics of the medium Biochemical response Test QC organisms with each new batch or lot number Check for growth of fastidious organisms on media of choice – incubate at time and temp recommended RECORD Results on Media QC form

24. 24 Quality Control: Stains and Reagents Gram stain QC  Use gram positive and gram negative organisms to check stains daily Other :  Check as used – positive and negative reactions Gram stain QC  Use gram positive and gram negative organisms to check stains daily Other :  Check as used – positive and negative reactions

25. 25 Stock QC organisms Check for purity Organisms- maintained & must be adequate to check all media and test systems.  E. coli – MacConkey, EMB, susceptibility tests  Staphylococcus aureus – Blood agar, Mannitol, susceptibility tests  Neisseria gonorrhoeae – Chocolate agar, Martin- Lewis Check for purity Organisms- maintained & must be adequate to check all media and test systems.  E. coli – MacConkey, EMB, susceptibility tests  Staphylococcus aureus – Blood agar, Mannitol, susceptibility tests  Neisseria gonorrhoeae – Chocolate agar, Martin- Lewis

26. 26 Detecting Errors Medium contaminated: Check Autoclave No Growth of control organism: -Check culture medium, preparation method, Sterility method, viability of organisms Gram + are Gram -: Check stain solutions Medium contaminated: Check Autoclave No Growth of control organism: -Check culture medium, preparation method, Sterility method, viability of organisms Gram + are Gram -: Check stain solutions

27. 27 Detecting Errors Many organisms have predictable antimicrobial test results  Staphylococcus spp. are usually susceptible to vancomycin  Streptococcus pyogenes are always susceptible to penicillin  Klebsiella pneumoniae are resistant to ampicillin Many organisms have predictable antimicrobial test results  Staphylococcus spp. are usually susceptible to vancomycin  Streptococcus pyogenes are always susceptible to penicillin  Klebsiella pneumoniae are resistant to ampicillin

28. 28 Sources of Error Unusual pattern Purity check  rule out error by checking identification of organism  repeat antimicrobial susceptibility test Report if repeat testing yields same result, or refer the isolate to a reference laboratory for confirmation Unusual pattern Purity check  rule out error by checking identification of organism  repeat antimicrobial susceptibility test Report if repeat testing yields same result, or refer the isolate to a reference laboratory for confirmation

29. 29 Error rates in the total testing process (American College of Pathology)

30. 30 Classification of errors in laboratory practice

31. 31 QC IN BLOOD GROUP SEROLOGY To ensure safety by providing a good and uniform quality and minimizing errors. Staff training, assessment of staff capability, equipment maintenance and calibration is important. Errors : 2 major categories  Errors of organization due to incorrect identification of samples or mistaken in transcription or in filing of results  Technical errors due to poor quality of equipment, reagent or performance of the test. To ensure safety by providing a good and uniform quality and minimizing errors. Staff training, assessment of staff capability, equipment maintenance and calibration is important. Errors : 2 major categories  Errors of organization due to incorrect identification of samples or mistaken in transcription or in filing of results  Technical errors due to poor quality of equipment, reagent or performance of the test.

32. 32 Cont.. General approach in QC- to compare ABO- and Rh-typing results with previous data.This will disclose errors of both categories. Based upon internal QC and external QC. Internal quality control are subdivided into:  Control for equipment  Control for reagents  Control for techniques General approach in QC- to compare ABO- and Rh-typing results with previous data.This will disclose errors of both categories. Based upon internal QC and external QC. Internal quality control are subdivided into:  Control for equipment  Control for reagents  Control for techniques

33. 33 QC FOR EQUIPMENT

34. 34

35. 35 Quality control for reagents Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) by FDA Color codes by the FDA: Blue for anti-A Yellow for anti-B Green for AHG  Use according to manufacturer's instruction  The new reagent has to be assessed & confirmed satisfactory  The appearance each reagent has to be checked each day  The reactivity and specificity has to checked each new lot Select the reagent with high specifications- reference preparation has been established for ABO, Rh and anti-human globulin (AHG) by FDA Color codes by the FDA: Blue for anti-A Yellow for anti-B Green for AHG  Use according to manufacturer's instruction  The new reagent has to be assessed & confirmed satisfactory  The appearance each reagent has to be checked each day  The reactivity and specificity has to checked each new lot

36. 36 Quality control of technique Provided the quality of equipment and reagents fulfill the requirement, false result are due to technique itself, either inadequate method or operational errors(inaccurate performance or incorrect interpretation)

37. 37

38. 38

39. 39 Quality Control – Quantitative Tests How to implement a laboratory quality control program?

40. 40 Implementing a QC Program – Quantitative Tests Select high quality controls Collect at least 20 control values over a period of 20-30 days for each level of control Perform statistical analysis Develop Levey-Jennings chart Monitor control values using the Levey-Jennings chart and/or Westgard rules Take immediate corrective action, if needed  Record actions taken Select high quality controls Collect at least 20 control values over a period of 20-30 days for each level of control Perform statistical analysis Develop Levey-Jennings chart Monitor control values using the Levey-Jennings chart and/or Westgard rules Take immediate corrective action, if needed  Record actions taken

41. 41 Selecting Control Materials: Calibrators Have a known concentration of the substance (analyte) being measured Used to adjust instrument, kit, test system in order to standardize the assay Sometimes called a standard, although usually not a true standard This is not a control Have a known concentration of the substance (analyte) being measured Used to adjust instrument, kit, test system in order to standardize the assay Sometimes called a standard, although usually not a true standard This is not a control

42. 42 Selecting Control Materials: Controls A control also has a known amount of an analyte but is used to monitor the precision and accuracy of an assay method once it has been calibrated.  Use 2 or three levels of controls  Include with patient samples when performing a test Used to validate reliability of the test system A control also has a known amount of an analyte but is used to monitor the precision and accuracy of an assay method once it has been calibrated.  Use 2 or three levels of controls  Include with patient samples when performing a test Used to validate reliability of the test system

43. 43 Control Materials: Important Characteristics Values cover medical decision points Similar to the test specimen (matrix) Available in large quantity Stored in small aliquots Ideally, should last for at least 1 year Often use biological material, consider bio- hazardous Values cover medical decision points Similar to the test specimen (matrix) Available in large quantity Stored in small aliquots Ideally, should last for at least 1 year Often use biological material, consider bio- hazardous

44. 44 Managing Control Materials Sufficient material from same lot number or serum pool for one year’s testing- preserved and stabilized May be frozen, freeze-dried -Requires very accurate reconstitution if this step is necessary Always store as recommended by manufacturer Sufficient material from same lot number or serum pool for one year’s testing- preserved and stabilized May be frozen, freeze-dried -Requires very accurate reconstitution if this step is necessary Always store as recommended by manufacturer

45. 45 Types of Control Materials Assayed  mean calculated by the manufacturer  must verify in the laboratory Un-assayed  less expensive  must perform data analysis “Home made” or “In-house”  pooled sera collected in the laboratory  characterized  preserved in small quantities for daily use Assayed  mean calculated by the manufacturer  must verify in the laboratory Un-assayed  less expensive  must perform data analysis “Home made” or “In-house”  pooled sera collected in the laboratory  characterized  preserved in small quantities for daily use

46. 46 Microbiological investigations are important in: diagnosis, treatment, and surveillance. Test reports must be relevant, reliable, timely, and interpreted correctly. Must ensure right result, at the right time, on the right specimen, from the right patient, with the result interpretation based on correct reference data, and at the right price.

47. 47 Equipment Select equipment and assure appropriate use Provide for installation and initial calibration Set up mechanisms for maintenance, service, and repair, including timetables Require routine calibration Provide information for troubleshooting Regularly review all documentation Select equipment and assure appropriate use Provide for installation and initial calibration Set up mechanisms for maintenance, service, and repair, including timetables Require routine calibration Provide information for troubleshooting Regularly review all documentation

48. 48 Purchasing and Inventory Define criteria for products and services to be purchased Establish a system to receive, inspect, accept, store and inventory incoming materials Assess and maintain inventory Establish a system to connect materials to appropriate patients, activities, or records Define criteria for products and services to be purchased Establish a system to receive, inspect, accept, store and inventory incoming materials Assess and maintain inventory Establish a system to connect materials to appropriate patients, activities, or records

49. 49 Monitoring procedures to be performed. When they should be performed. Records results of control procedure. Describes limits of results for control procedure. Describes action required if results are outside set limits. Records remedial action taken. Details of servicing and maintenance procedures required. Central to any control scheme is a system of documentation involving:

50. 50 Record all QC records on Q form Report all “out of control” results to supervisor. Monthly review of QC records. Retain QC records for 2 years. Repeat out of control results. Don’t test patient specimens until QC problem is solved. Don’t report pt results till test is repeated and determined to be in control. Quality Control Records.

51. 51 Summary Every one is responsible for Quality of laboratory results Qualitative QC - In all areas of Medical laboratory Quantitative QC - Qualitative QC plus determine the control values Control materials - Reliable source, stable, and enough to last for a year, Every one is responsible for Quality of laboratory results Qualitative QC - In all areas of Medical laboratory Quantitative QC - Qualitative QC plus determine the control values Control materials - Reliable source, stable, and enough to last for a year,

52. 52 Accreditation Basics System to show a healthcare facility has reached standard required to carry out prescribed function. Three Elements: 1. Assessment Board 2. Set of Standards 3. Assessment Process – assessors and system of registration and inspection System to show a healthcare facility has reached standard required to carry out prescribed function. Three Elements: 1. Assessment Board 2. Set of Standards 3. Assessment Process – assessors and system of registration and inspection

53. 53 Sources of Laboratory QA Guidance and Information World Health Organization (WHO) International Organization for Standardization (ISO) NCCLS CDC guidelines Professional & accrediting organizations National standards & regulations