1. 1 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000

2. 2 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 3. Essential to all aspects of health care are laboratory results that are: accurate reliable timely 3 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 4. Achieving a level of quality means accepting a error rate1% 4 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 5. 5 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 6. unnecessary treatment; treatment complications failure to provide the proper treatment delay in correct diagnosis additional and unnecessary diagnostic testing 6 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 7. coordinated activities to direct and control an organization with regard to quality (ISO,CLSI) ALL aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system 7 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 8. 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 8Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 9. THE PATIENT Test selection Sample Collection Sample Transport Laboratory Analysis Examination Phase Report CreationReport Transport Preexamination Phase Result Interpretation Post examination Phase 9Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 11. human resources job qualifications job descriptions orientation training competency assessment professional development continuing education 11 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 12. safe working environment transport management containment security waste management laboratory safety ergonomics 12 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 13. acquisition installation validation maintenance calibration troubleshooting service and repair records 13 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 14. quality control sample management method validation method verification Process Control 14 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 15. confidentiality requisitions logs and records reports Information Management computerized laboratory information systems (LIS) 15 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 16. creation revisions and review control and distribution Documents Records collection review storage retention 16 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 17. complaints mistakes and problems documentation root cause analysis immediate actions corrective actions preventive actions Occurrence Management 17 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 18. INTERNAL Quality Indicators Audit Program Laboratory Assessment EXTERNAL Proficiency Testing (EQA) Inspections AccreditationsAudit Review 18 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 19. customer group identification customer feedback customer needs Customer Service 19 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 20. Implementing Quality Management an Laboratory 20 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 21. Standards Organizations 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 22. exercising responsible authority, while providing motivation and vision influencing and encouraging staff to good performance Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 23. Organizational Structure 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 24. LABORATORY DIRECTOR CHARGE TECHNOLOGIST ASSISTANT CHARGE TECHNOLOGIST TECHNOLOGIST QUALITY MANAGER NURSING DIRECTOR NURSING HOSPITAL DIRECTOR 24Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 25. Quality Manager ISO 15189 requirement has responsibility and authority to oversee compliance reports directly to the decision-making level of laboratory management Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 26. Quality Manager Responsibilities monitor quality management system assure compliance review all records conduct, coordinate audits investigate deficiencies Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 27. Gap Analysis: Common Problems Identified test ordering sample managementtraining level (competence) of technical staff quality control analytical process recording and reporting results Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 28. FACILITIES AND SAFETY 28 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 29. Learning Objectives 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 30. Effects of Laboratory Accident loss of staff confidence loss of reputation loss of customers increased cost --- litigation, insurance Negligence of laboratory safety is costly! 30 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 31. is responsible for quality and safety 31 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 32. Laboratory Design 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 33. Blood clotting Hematology Biochemistry Wash room Bacteriology Gynaecological samples Blood samples Common room, stairs to offices Disinfection Laboratory Design 33 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 34. Registration Desk 34 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 35. Blood clotting Hematology Biochemistry Wash room Bacteriology Gynaecological samples collection Blood samples collection Common room, stairs to offices Disinfection Waste Reception 35Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 36. Premises high ceiling with good ventilation use washable, glossy paint easy to clean and disinfect walls and ceiling floor easy to clean and disinfect 36 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 37. Benchtops non-porous covering, easy to clean, resistant to chemicals and disinfectant no wood, no steel 37 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 38. Scheduled Cleaning daily bench tops floors weekly ceilings, walls others refrigerators, freezers, storage areas 38 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 39. General Safety Equipment fire safety PPE waste disposal 39Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 40. Standard Safety Practices 40 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 41. Standard Safety Practices 41 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 42. Safety Signs 42 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 43. Laboratory Hazards physical chemical biological 43 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 44. Physical Hazards 44 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 45. do not recap needles always use puncture-resistant, leakproof, sharps containers always use specific waste disposal containers never directly handle broken glass 45 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 46. 46 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 47. Do you see anything wrong? 47 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 48. Do NOT reuse disposable injection equipment 48 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 49. separate cabinets for storage spill containment cabinet hazardous waste storage Chemical Hazards flammable liquids storage 49 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 50. Material Safety Data Sheet 50 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 51. aerosols and droplets Biological Hazards ocular invasion inhalation ingestion skin penetration 51 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 52. Laboratory Fire Safety 52 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 53. 53 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 54. Laboratory Staff laboratorys greatest asset critical to quality partners in public health qualified professionals 54 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 55. Personnel Management Job Descriptions Orientation Training Competency Assessment Continuing Education Performance Appraisal 55 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 56. Orientation Competency Assessment Task-specific Training Competency Recognition Job Description Qualified New Employee Retraining 56Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 57. 57 58. Reduces interruption of services Increases safety Greater customer satisfaction Equipment Management Benefits 58Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 59. Selecting and Acquiring Equipment easy to use language warranty safety will it fit? 59 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 60. Negotiating Equipment Acquisition wiring diagrams software information parts list operator manual installation by manufacturer trial period 60 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 61. Before Equipment Installation confirm vendors responsibilities in writing establish checklist 61 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 62. Equipment Installation 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 63. After Equipment Installation Inventory Record Calibration Verification Operating Procedures Maintenance Program Train ALL Operators 63 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 64. perform initial calibration use calibrators or standards follow manufacturers instructions determine frequency of routine calibrations Equipment Calibration 64 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 65. Performance Evaluation Test known samples, analyze data Establish stability for temperature- controlled equipment Validate performance with parallel samples NEW EQUIPMENT 65 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 66. Preventive Maintenance routine cleaning adjustment, replacement of equipment parts 66 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 67. Function Checks Monitor instrument parameters: periodically, daily, weekly, monthly after major instrument repair Examples: incubator temperatures wavelength calibration autoclave temperature chart 67 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 68. Create an Equipment Inventory Log instrument type, model number, serial number location in laboratory date purchased manufacturer and vendor contact info warranty, spare parts 68 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 69. Troubleshooting What is the source of the problem? Sample? Reagent? Water, Electricity? Equipment? 69 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 70. When in-house efforts fail: 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 71. manufacturers laboratory must schedule routine manufacturers maintenance warranty may require repair handled by manufacturer in-house biomedical service technicians Service and Repair Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 72. Recording Problems 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 73. Example of logbook 1 73 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 74. Example of logbook 2 74 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 75. Example of logbook 3 75 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 76. PURCHASING AND INVENTORY 76 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 77. Benefits of an Inventory Management Program Quality Maintained Minimize waste Stay within budget Supplies and reagents always available 77 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 78. Inventory Management Challenges balance between stock availability and expiration dates life-span of laboratory reagents varies In- stock Expiry Date 78 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 79. Establish a System to Qualify and Select Vendors define criteria for supplies and services to be purchased use information from other laboratories evaluate before purchase and after receipt 79 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 80. Determine payment mechanisms Negotiate prices Review Contracts Understand government requirements Assure reliable availability, delivery Purchasing Considerations 80Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 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 How to Implement Inventory Control 81Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 82. Analyze Needs listing all tests in the laboratory identifying all supplies needed for each test using available information to estimate usage 82 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 83. Quantification: How? consumption-based method morbidity-based method 83 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 84. Quantification: Consumption-Based 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 85. 0 10 20 30 40 50 60 70 80 90 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr Slides Immersion Oil Collection containers 85 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 86. Quantification: Morbidity-Based based on actual number of episodes must take into account: population size disease incidence accuracy of morbidity data treatment guidelines 86 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 87. 0 20 40 60 80 100 120 140 160 180 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr Influenza Diarrhea TB 87 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 88. Inventory Control: Documentation 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. Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 89. Includes: name and signature date of receipt quantity date of expiry minimum stock stock balance Other information: shelf number destination 89 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 91. Use clearly visible dating labels date opened date expired 91 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 92. Continuous Monitoring of Inventory Inventory Control Assign responsibility Maintain inventory system in all storage areas Conduct weekly physical counts Update records 92 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 93. Computerized Stock Management advantages exact current state of stock management of expiration dates makes inventory tasks easier drawbacks on-site computer is needed requires trained staff 93 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 94. 94 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 95. The result of any laboratory examination is only as good as the sample received in the laboratory. 95 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 96. 96 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 97. Components Laboratory Handbook Policies & Practices 97 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 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 Laboratory Handbook 98 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 99. Laboratory Handbook 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 Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000 100. Define a good labeling systemAssess all samples - preexamination Provide sample collection information What- When- How Provide appropriate containers and supplies The Laboratorys Responsibilities Compiled By SIGMA DIAGNOSTICS YAMUNA NAGAR 135001, HARYANA, INDIA 93551-24000, 93150-24000