微生物檢驗品管

1. 微生物檢驗品管 高雄長庚檢驗醫學科微生物組　簡春治

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

3. QA can be seen as the sum of QC, IQA and EQA QA = QC + IQA + EQA IQA: Internal quality assessment EQA: External quality assessment

4. Quality System Model In the laboratory

5. Quality assurance (QA) • is the total process whereby the quality of laboratory reports can be guaranteed. • It has been summarized as the: 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.

6. Attributes of a QA plan • Planned,systematic, and ongoing Comprehensive • Based on indicators and criteria with consensus approval • Routine surveillance and analysis of data • Documentation of problem identification and resolution • Continuous activity to ensure that quality performance is sustained • Integrated and interdepartmental

7. Quality and Improvement procedure • Objectives • Consensus • Quality indicators • Data analysis and strategies for improvement • Documentation

8. Quality management organization

9. 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.

10. 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

11. QC covers that part of QA, which primarily concerns the control of errors in the performance of tests and verification of test results • QC must cover all aspects of every procedure within the department • It must be practical,achievable,andaffordable

12. 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

13. 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

14. 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 Sterilization ampules, Occult blood, Biochemical reactions • Opacity tube standards: McFarland std tubes

15. Specimen vs. Diagnosis

16. Quality assurance in Microbiology Lab •  Quality control • Standard operating procedures (SOPs) • Pre-analytical stage • Analytical stage • Post-analytical stage • Facilities • Staff and qualifications • External quality assessment (EQA) • Internal quality assessment (IQA)

17. Pre-analytical stage-1 • Each specimen must be accompanied by a request form which details: • Patient's name, age, gender, occupation, outpatient or inpatient number, ward or health center. • Type and source of specimen, date and time of collection. • Investigations required. • Clinical note summarizing the patient's illness, suspected diagnosis and information on any antimicrobial treatment that may have been started at home or in the hospital.

18. Pre-analytical stage-2 • Collection and transport of specimens • the quality of the specimen submitted • timing of specimen • the suitability of sampling method and transport • use of transport media

19. Analytical stage -1 • The following should be incorporated in the microbiological SOPs covering the analytical stage:a) Detailed procedure for examining different specimens.b) Staining techniques and QC of stains.c) Aseptic techniques and safe handling of infectious material.d) Preparation and QC of culture media and preservation of stock strains.

20. Analytical stage • Fellow SOP • Control of stains and reagents • Control of Equipment

21. Analytical stage -2 e) Inoculation of liquid and solid media. f) Reading and interpretation of cultures. g) Techniques used to identify pathogens. h) Antimicrobial sensitivity testing and QC of procedures and antibiotic discs. i) Cleaning and QC of equipment used in microbiology laboratory.

22. Analytical stage -3 j) Immunologic techniques and QC of antigen and antibody reagents. k) Safe working practices. l) Disposal of specimens and cultures. m) Cleaning of glassware, plastic ware, etc. n) Sterilization procedures and their control.

23. Post-analytical stage 1. SOP needs to include reporting and verifying of microbiological test results, interpreting test reports correctly, taking appropriate action when a result has serious implications for a patient or public health. 2. Turn around time ─ no delay

24. Equipment-1 (1)Incubator the percentage of CO2 temperature (2)BACTEC 9240 ---noninvasive fluorescent detection system 溫度 燈號 (3)Anaerobic chamber anaerobiasis humidity temperature the pressure of gas (4) TemperatureIncubator Refrigerator deep Freezer autoclave

28. Equipment-2 (5)Biosafety cabinet air flow (done by specialist) change HEPA filter UV light (6)Microscop clean adjust (7) Centrifuge (8) VITEK

29. Process and process improvement • Pre-analytical • Specimen collection, transport, receiving • Analytical • Culture media and reagent • Antimicrobial Susceptibility • Post-analytical • Preliminary result report • Critical result report and notification • Delayed result report

30. Process –Analytical • Culture media • Commercial media • In-house media

31. Process – Analytical • Media Preparation • Record amount • Lot number • Preparation date • Preparer • Expiration date

32. Process – Analytical • Commercial media • Test by the manufacture • 可不做sterility 及performance test • 注意批次(lot) ,過期日期及是否污染等外觀 • 特殊功能培養基 : 如chocolate agar及selective media for pathogenic Neisseriae及CCFA必須每一新批次皆要測試後才能用 • Mueller-Hinton agar,Mueller-Hinton BAP :以 E. faecalis ATCC29212測thiamine含量,SXT抑制圈應>=20mm

33. 進貨/泡製記錄表

34. 品管記錄表

35. Process – Analytical • In-house media • 每新配製一批media皆需進行sterility 及performance test • 以塑膠袋密封,標示配製日期有效期限及品名 • Performance test 操作時機 • 新一批次配製時 • 舊批次使用三個月後,每三個月操作一次

36. Process – AnalyticalMicrobiology QC • Check: • Sterility • Ability to support growth • Selective or inhibitory characteristics of the medium • Biochemical response • Frequency • 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

37. 品管記錄表

38. Process – Analytical • Reagent • 染色試劑 • 泡製試劑 • 商品化試劑 • 抗血清試劑

40. Process – AnalyticalStains, Reagents, Antisera • Label the containers • Contents • Concentration • Date prepared • Placed in service • Expiration date/ shelf life • preparer

41. Process – AnalyticalStains • 每次新配製的染色試劑需記錄配製時間 • Gram stain : 每週QC • Acid-fast Stain : 每日QC • Fluorochrome Stain : 每次QC

42. STAINS-1

43. 泡製試劑

44. 商品化試劑

46. 商品化試劑-1

47. 抗血清試劑 (1)Salmonella , Shigella antiserum (2)S.pneumonia , H. influenzae b使用時需同時操作藥組中所附之Positive control 及Negative control (3)Staphaurex plus(latex agglutination test) (4)品管頻率 : 開封時/每六個月

48. 鑑定套組品管

49. Antimicrobial Susceptibility Q.C (1)Disk Diffusion Method (2)MIC Method( Vitek system) (3) Two Endpoint-determining Method ( Agar Dilution Method ) (4)Agar Dilution Method

50. Disk Diffusion Method