laboratory management and their guidelines.pptx

laboratory management and their guidelines.pptx

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3. Essential to all aspects of health care are laboratory results that are: accurate reliable timely 3

4. Achieving a 99% level of quality means accepting a error rate 1% 4

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6. unnecessary treatment; treatment complications failure to provide the proper treatment delay in correct diagnosis additional and unnecessary diagnostic testing 6

7. coordinated activities to direct and control an organization with regard to quality ALL aspects of the laboratory operation need to be addressed to assure quality ; this constitutes a quality management system 7

8. Preexamination Examination Postexamination Data & Laboratory Management Safety Customer Service Patient/Client Prep Sample Collection Sample Receipt and Accessioning Sample Transport Quality Control Testing Record Keeping Reporting Personnel Competency Test Evaluations 8

9. THE PATIENT Test selection Sample Collection Sample Transport Report Creation Report Transport 9

10. 10 The entire process of managing a sample must be considered: The beginning: sample collection The end: reporting and saving of results All processes in between

11. human resources job qualifications job descriptions orientation training competency assessment professional development continuing education 11

12. safe working environment transport management containment security waste management laboratory safety ergonomics 12

13. acquisition installation validation maintenance calibration troubleshooting service and repair records 13

14. quality control sample management method validation method verification 14

15. confidentiality requisitions logs and records reports computerized laboratory information systems ( LIS ) 15

16. creation revisions and review control and distribution collection review storage retention 16

17. complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions 17

18. INTERNAL Quality Indicators Audit Program EXTERNAL Proficiency Testing ( EQA ) Inspections Accreditations Audit Review 18

19. customer group identification customer feedback customer needs 19

20. Implementing Quality Management does not guarantee an ERROR-FREE Laboratory 20

21. ISO International Organization for Standardization CLSI Clinical and Laboratory Standards Institute (formerly known as NCCLS) Guidance for quality in manufacturing and service industries Standards, guidelines, and best practices for quality in medical laboratory testing Broad applicability; used by many kinds of organizations Detailed; applies specifically to medical laboratories Uses consensus process in developing standards Uses consensus process in developing standards 21

22. Leadership exercising responsible authority, while providing motivation and vision influencing and encouraging staff to good performance

23. establish a working structure that ensures sufficiency at all parts in the laboratory work flow designate responsibilities and roles; develop an organization chart designate a Quality Manager allocate sufficient resources 23

24. NURSING DIRECTOR NURSING HOSPITAL DIRECTOR 24

25. ISO 15189 requirement has responsibility and authority to oversee compliance reports directly to the decision-making level of laboratory management

26. monitor quality management system assure compliance review all records conduct, coordinate audits investigate deficiencies

27. test ordering sample management training level (competence) of technical staff quality control analytical process recording and reporting results

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29. relate how facility design impacts the efficiency and safety of laboratory workers describe practices to prevent or reduce risks describe steps to take in response to emergencies list personal protective equipment (PPE) that should be used routinely

30. loss of staff confidence loss of reputation loss of customers increased cost --- litigation, insurance Negligence of laboratory safety is costly! 30

31. Everyone 31

32. path followed by the sample reception and registration of patients sampling rooms dispatch between different laboratories analysis of samples report delivery, filing service rooms 32

33. Blood clotting Hematology Biochemistry Washroom Bacteriology Gynaecological samples Blood samples Common room, stairs to offices Disinfection 33 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR – 135001, HARYANA, INDIA 93551-24000, 93150-24000

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35. Blood clotting Hematology Biochemistry Washroom Bacteriology Gynaecological samples collection Blood samples collection Common room, stairs to offices Disinfection Waste Reception 35

36. high ceiling with good ventilation use washable, glossy paint easy to clean and disinfect walls and ceiling floor easy to clean and disinfect 36

37. non-porous covering, easy to clean, resistant to chemicals and disinfectant no wood, no steel 37

38. daily bench tops floors weekly ceilings, walls others refrigerators, freezers, storage areas 38

39. shower eye washer 39

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41. DO 41

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43. physical chemical biological 43

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45. do not recap needles always use puncture-resistant , leakproof , sharps containers always use specific waste disposal containers never directly handle broken glass 45

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48. Do NOT reuse disposable injection equipment 48

49. separate cabinets for storage spill containment cabinet hazardous waste storage flammable liquids storage 49

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51. aerosols and droplets ocular invasion inhalation ingestion skin penetration 51

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54. laboratory’s greatest asset critical to quality partners in public health qualified professionals 54

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56. Orientation Competency Assessment Task-specific Training Competency Recognition Job Description Retraining 56

57. EQUIPMENT 57

58. Reduces interruption of services Increases safety Greater customer satisfaction 58

59. easy to use language warranty safety will it fit? 59

60. wiring diagrams software information parts list operator manual installation by manufacturer trial period 60

61. confirm vendor’s responsibilities in writing establish checklist 61

62. when possible, have manufacturer install and set up do not attempt to use prior to proper installation verify package contents copy software, if part of system 62

63. Maintenance Program 63

64. perform initial calibration use calibrators or standards follow manufacturer’s instructions determine frequency of routine calibrations 64

65. Test known samples, analyze data Establish stability for temperature- controlled equipment Validate performance with parallel samples NEW EQUIPMENT 65

66. routine cleaning adjustment, replacement of equipment parts 66

67. Monitor instrument parameters: periodically, daily, weekly, monthly after major instrument repair Examples: incubator temperatures wavelength calibration autoclave temperature chart 67

68. instrument type, model number, serial number location in laboratory date purchased manufacturer and vendor contact info warranty, spare parts 68

69. What is the source of the problem? Sample? Reagent? Water, Electricity? Equipment? 69

70. call manufacturer or other technical expert look for options to continue service obtain back-up instrument from central stores or manufacturer refer sample to nearby laboratory 70

71. manufacturers laboratory must schedule routine manufacturer’s maintenance warranty may require repair handled by manufacturer in-house biomedical service technicians

72. date problem occurred, equipment removed from service reason for breakdown or failure corrective actions taken date returned to use change in maintenance or in function checks 72

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77. Quality Maintained Minimize waste Stay within budget Supplies and reagents always available 77

78. balance between stock availability and expiration dates life-span of laboratory reagents varies In- stock Expiry Date 78

79. define criteria for supplies and services to be purchased use information from other laboratories evaluate before purchase and after receipt 79

80. Determine payment mechanisms Understand government requirements Assure reliable availability, delivery 80

81. INVENTORY CONTROL Assign responsibility Analyze needs Establish minimum stock needs Develop forms and logs Establish system for receiving, storing Maintain inventory system in all storage areas 81

82. listing all tests in the laboratory identifying all supplies needed for each test using available information to estimate usage 82

83. consumption-based method morbidity-based method 83

84. based on actual usage must take into account: health-supplies actually used waste: expired or spoiled supplies supplies out of stock for more than 15 days during any time of year 84

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86. based on actual number of episodes must take into account: population size disease incidence accuracy of morbidity data treatment guidelines 86

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88. Maintain records: date received lot number pass or fail acceptance criteria date placed in service or disposition May be useful to keep records in stockroom.

89. Includes: name and signature date of receipt quantity date of expiry minimum stock stock balance Other information: shelf number destination 89

90. inspect new orders at time of delivery verify contents check integrity record date each item received record expiration date store new shipment behind existing shipment create or update records 90

91. Use clearly visible dating labels date opened date expired 91

92. Inventory Control Assign responsibility Maintain inventory system in all storage areas Conduct weekly physical counts Update records 92

93. advantages exact current state of stock management of expiration dates makes inventory tasks easier drawbacks on-site computer is needed requires trained staff 93

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97. Laboratory Handbook Policies & Practices 97

98. contains information needed by those who collect samples available to all sample collection areas must be understood by all laboratory staff referenced in the quality manual 98

99. name and address of laboratory contact names and telephone numbers hours of operation list of tests that can be ordered sample collection procedures sample transport procedures expected turn around times (TAT) how urgent requests are handled 99

100. Define a good labeling system Assess all samples - preexamination Provide sample collection information What- When- How Provide appropriate containers and supplies