Labman tqm -++


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Labman tqm -++

  1. 1. 1
  2. 2. Appreciate the importance of TQM in the laboratory settingLearn the different Quality System Essentials (QSE) and their importance in providing quality health services to the best level 2
  3. 3. 3
  4. 4. Essential to all aspects of health care are laboratory results that are: accurate reliable timely 4
  5. 5. Achieving a level of quality meansaccepting a 1% error rate 5
  6. 6. In France a error rate would mean everyday14 minutes without water or electricity50,000 parcels lost by postal services22 newborns falling from midwives’ hands600,000 lunches contaminated by bacteria3 bad landings at Orly Paris airport 6
  7. 7. Result of error 7
  8. 8. timepersonnel effort patientoutcomes 8
  9. 9. unnecessary treatment; treatmentcomplicationsfailure to provide the proper treatmentdelay in correct diagnosisadditional and unnecessary diagnostictesting 9
  10. 10. coordinated activities to direct andcontrol an organization with regard toquality (ISO,CLSI) ALL aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system 10
  11. 11. Reporting Patient/Client Prep Sample Collection Personnel Competency Test Evaluations •Data & Laboratory Management •Safety •Customer Service Sample Receipt and Accessioning Record Keeping Sample Transport Quality Control Testing 11
  12. 12. THE PATIENT Test selection Sample Collection Preexamination Phase Sample Transport Laboratory Analysis Examination Phase Report Transport Report Creation Result Interpretation Postexamination Phase 12
  13. 13. The entire process of managing asample must be considered:• The beginning: sample collection• The end: reporting and saving of results• All processes in between 13
  14. 14. Laboratory tests are influenced by:laboratory environmentknowledgeable & competent staffreagents and equipmentquality controlcommunicationsprocess managementoccurrence managementrecord keeping 14
  15. 15. Organization Personnel EquipmentPurchasing Process Information & Control Management InventoryDocuments & Occurrence Assessment Records Management Facilities Process Customer &Improvement Service Safety 15
  16. 16. Responsibilities Authorities Quality Policy Provision Communication ofResources 16
  17. 17. human resourcesjob qualificationsjob descriptionsorientationtrainingcompetency assessmentprofessional developmentcontinuing education 17
  18. 18. safe working environmenttransport managementsecuritycontainmentwaste managementlaboratory safetyergonomics 18
  19. 19. acquisitioninstallationvalidationmaintenancecalibrationtroubleshootingservice and repairrecords 19
  20. 20. vendor qualificationssupplies and reagentscritical servicescontract reviewinventory management 20
  21. 21. quality controlsample managementmethod validationmethod verification 21
  22. 22. confidentialityrequisitionslogs and recordsreportscomputerized laboratoryinformation systems (LIS) 22
  23. 23. creation collectionrevisions and review review storagecontrol anddistribution retention 23
  24. 24. complaintsmistakes and problemsroot cause analysisdocumentationimmediate actionscorrective actionspreventive actions 24
  25. 25. INTERNAL EXTERNAL Quality Proficiency Indicators Testing (EQA)Audit Program InspectionsAudit Review Accreditations 25
  26. 26. opportunities for improvement (OFIs)stakeholder feedbackproblem resolutionrisk assessmentpreventive actionscorrective actions 26
  27. 27. customer group identificationcustomer needscustomer feedback 27
  28. 28. ImplementingQuality Management an Laboratory 28
  29. 29. 29
  30. 30. Organizatio Personnel Equipment nPurchasing Information Process & Management Control InventoryDocuments Occurrence & Assessment Managemen Records t Customer Facilities Process Service &Improvement Safety 30
  31. 31. 31
  32. 32. Walter W. Edwards Shewhart Deming 1891-1967 1900-1993 Joseph Juran Philip Crosby Robert Galvin1904-2008 (103 years) 1926-2001 b. 1922 32
  33. 33. Innovator Date CycleWalter A.Shewhart 1920s Statistical Process ControlW. Edwards Deming 1940s Continual ImprovementJoseph M. Juran 1950s Quality ToolboxPhilip B. Crosby 1970s Quality by RequirementRobert W. Galvin 1980s Micro Scale Error Reduction 33
  34. 34. ISO CLSIInternational Organization Clinical and Laboratory for Standardization Standards Institute (formerly known as NCCLS) Guidance for quality in Standards, guidelines, andmanufacturing and service best practices for quality in medical laboratory testing industriesBroad applicability; used Detailed; applies by many kinds of specifically to medical organizations laboratoriesUses consensus process in Uses consensus process in developing standards developing standards 34
  35. 35. ISO 9001:2000 Quality ManagementSystem RequirementsModel for QA in design, developmentproduction, installation, and servicingISO/IEC 17025:2005 Generalrequirements for the competence oftesting and calibration laboratoriesISO 15189:2007 Quality managementin the clinical laboratory 35
  36. 36. HS1-A2 A Quality Management System Modelfor Health Caredescribes quality system model, 12 essentialsaligns to ISO 15189 and parallels ISO 9000applies to all health care systemsGP26-A3 Application of Quality ManagementSystem Model for Laboratory Servicesdescribes laboratory application of quality system modelrelates the path of workflow to the quality system essentialsassists laboratory in improving processesrelates to HS1-A2 and ISO 15189 36
  37. 37. 37
  38. 38. describe organizational elementsneeded for a quality managementsystemdiscuss management roles andresponsibilities in a quality systemexplain the process forimplementing, maintaining, andimproving the laboratory qualitymanagement system
  39. 39. Leadership, Managerial RolesOrganizational Structure Planning Process Implementation Monitoring: Maintenance and Improvement 39
  40. 40. exercising responsibleauthority, whileproviding motivationand visioninfluencing andencouraging staffto good performance
  41. 41. establish a working structure thatensures sufficiency at all parts in thelaboratory work flowdesignate responsibilities and roles;develop an organization chartdesignate a Quality Managerallocate sufficient resources 41
  43. 43. ISO 15189 requirementhas responsibility and authority tooversee compliancereports directly to the decision-makinglevel of laboratory management
  44. 44. monitor quality management systemassure compliancereview all recordsconduct, coordinate auditsinvestigate deficiencies
  45. 45. approaches varywith local situationmany factorsinfluencestarting pointinclude all qualityelements in planmay implement instepwise process
  46. 46. Keep in mindcommunicate, betransparentset feasibletimelinesdevelop realistic,measurableobjectivesset priorities,proceed stepwise
  47. 47.  determine the gaps, using quality management systems checklist — GAP ANALYSIS — develop a task list prioritize by: – quick fixes first – determine what would have the greatest positive impact
  48. 48. test orderingsample managementtraining level (competence)of technical staffquality controlanalytical processrecording and reportingresults
  49. 49. a document describing the qualitymanagement system of an organizationessentialorganizational stepmanagementresponsibility 49
  50. 50. communicates informationserves as a framework formeeting quality systemrequirementsdemonstrates management’scommitment to quality
  51. 51. communicates quality policyneeds management approvalrequires updating
  52. 52. having management commitmentunderstanding the benefits of a qualitymanagement systemengaging staff at all levelsstriving tocontinually improvehaving realisticexpectations 52
  53. 53. 53
  54. 54. assign responsibility for implementationallocate resourcesdevelop and distribute a quality manualimplement quality systemmonitor compliance with qualitymanagement system requirements 54
  55. 55. • Spend time today to gain rewards tomorrow: – quality results – efficiency – professional, personal satisfaction – peer recognition 55
  56. 56. 56
  57. 57. relate how facility design impacts theefficiency and safety of laboratoryworkersdescribe practices to prevent or reduceriskslist personal protective equipment (PPE)that should be used routinelydescribe steps to take in response toemergencies
  58. 58. loss of staff confidenceloss of reputationloss of customersincreased cost --- litigation, insurance Negligence of laboratory safety is costly! 58
  59. 59. 59
  60. 60. All diagnosticand health carelaboratoriesmust be designedand organized forBiosafety level 2or above 60
  61. 61. path followed by the sample• reception and registration of patients• sampling rooms• dispatch between different laboratories• analysis of samples report delivery, filing service rooms 61
  62. 62. Common room, stairs to offices Gynaecological samplesBlood clotting Wash room Blood samplesHematologyBiochemistry Disinfection Bacteriology 62
  63. 63. 63
  64. 64. no unauthorized personsno friendsno childrenno animals 64
  65. 65. 65
  66. 66. Common room, stairs to offices Gynaecological samples collection Blood clotting Blood samples Hematology collection WashBiochemistry room Patient Reception Disinfection Bacteriology 66 ENTRANCE
  67. 67. Common room, stairs to offices Gynaecological samples collectionBlood clotting Blood samplesHematology collection WashBiochemistry room Sample Reception Disinfection Bacteriology ENTRANCE 67
  68. 68. MainDoor 68
  69. 69. Common room, stairs to offices Gynaecological samples Blood collection clotting BloodHematology samples collection WashBiochemistry room Waste Reception Disinfection Bacteriology 69
  70. 70. high ceiling with good ventilationwalls and ceiling use washable, glossy paint easy to clean and disinfectfloor easy to clean and disinfect 70
  71. 71. non-porous covering, easy toclean, resistant to chemicals anddisinfectantno wood, no steel 71
  72. 72. daily • bench tops • floorsweekly • ceilings, wallsothers • refrigerators, freezers, storage areas 72
  73. 73. 73
  74. 74. 74
  75. 75. 75
  76. 76. 76
  77. 77. 77
  78. 78. physicalchemicalbiological 78
  79. 79. needles, syringes Bites,scratchesanimal or brokenparasites Accidents, glass, sharps injuries Aspiration Spills, through sprays pipettes 79
  80. 80. 80
  81. 81. do not recap needles always use puncture- resistant, leakproof, sharps containers always use specific waste disposal containersnever directly handle broken glass 81
  82. 82. 82
  83. 83. Do you see anything wrong? 83
  84. 84. Do NOT reuse disposable injection equipment 84
  85. 85. separate cabinets for storage spill containment cabinet hazardous waste storage flammable liquids storage 85
  86. 86. 86
  87. 87. aerosols and droplets ocular invasion inhalation ingestion skin penetration 87
  88. 88. 88
  89. 89. 89
  90. 90. laboratory’s greatest assetcritical to qualitypartners in public healthqualified professionals 90
  91. 91. Job DescriptionsPerformance Orientation Appraisal Personnel ManagementContinuing TrainingEducation Competency Assessment 91
  92. 92. Motivated employees are more committed to their work praise recognition bonuses benefits flexible time 92
  93. 93. “Laboratory Management shall have job descriptions that define qualifications and duties for all personnel.” ISO 15189:2007 93
  94. 94. Qualified New Employee Job DescriptionOrientation Task-specific Training Retraining Competency Assessment Competency Recognition 94
  95. 95. 95
  96. 96. • Direct Observation Technologist Name Technologist Title checklists Procedure for Evaluation Date Evaluator Evaluation Procedure item Accept Partial No Comment• Indirect Observations Read procedure manual – monitoring records Equipment set up appropriately – re-testing Work area neat – case studies Reagent preparation Perform task accurately Perform task timely Other: Specify 96
  97. 97. • use standard forms• date and keep confidential
  98. 98. Training Continuing Education 98
  99. 99. competencies adherenceprofessional to policy behavior Performance Appraisal observationpunctuality to safety customer service communication 99
  100. 100. Training Records Performance Appraisal Competency Assessment John Smith Competency Assessmen CONFIDENTIAL 100
  101. 101. 101
  102. 102. Test results Variation/ TimePerformance high level Lowers Lengthens repair costs lifespan 102
  103. 103. Increases safety Reducesinterruption of services Greater customer satisfaction 103
  104. 104. easy to uselanguagewarrantysafetywill it fit? 104
  105. 105. wiring diagramssoftware informationparts listoperator manualinstallation bymanufacturertrial period 105
  106. 106. confirm vendor’s responsibilities inwritingestablish checklist 106
  107. 107. when possible, have manufacturerinstall and set updo not attempt touse prior to properinstallationverify packagecontentscopy software,if part of system 107
  108. 108. Inventory Record OperatingCalibration Verification Procedures Maintenance Program Train ALL Operators 108
  109. 109. • perform initial calibration – use calibrators or standards – follow manufacturer’s instructions• determine frequency of routine calibrations 109
  110. 110. Test known samples, analyze data Establish stability for temperature- controlled equipment NEW ValidateEQUIPMENT performance with parallel samples 110
  111. 111. routine cleaningadjustment,replacement ofequipment parts 111
  112. 112. Monitor instrument parameters: – periodically, daily, weekly, monthly – after major instrument repair Examples: – incubator temperatures – wavelength calibration – autoclave temperature chart 112
  113. 113. instrument type, model number,serial numberlocation in laboratorydate purchasedmanufacturer andvendor contact infowarranty, spare parts 113
  114. 114. What is the source of the problem?• Sample?• Reagent?• Water, Electricity ?• Equipment? 114
  115. 115. 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 115
  116. 116. Do NOT use equipment that does not function properly WARNING OUT OF ORDER DO NOT USE
  117. 117. • manufacturers laboratory must schedule routine manufacturer’s maintenance warranty may require repair handled by manufacturer• in-house biomedical service technicians
  118. 118. date problem occurred, equipmentremoved from servicereason for breakdown or failurecorrective actionstakendate returned to usechange in maintenance or in functionchecks 118
  119. 119. Example of logbook 1 119
  120. 120. Example of logbook 2 120
  121. 121. Example of logbook 3 121
  122. 122. 122
  123. 123. Minimize wasteSupplies andreagents always Stay withinavailable Quality budget Maintained 123
  124. 124. balance between stockavailabilityand expiration dates Expiry In- Date stocklife-span of laboratoryreagents varies 124
  125. 125. define criteria for supplies and services tobe purchaseduse information from other laboratoriesevaluate before purchase and afterreceipt 125
  126. 126. Understand government requirementsNegotiate Review Contracts prices Assure reliable availability, delivery Determine payment mechanisms 126
  127. 127. Assign responsibility Maintaininventory system Analyze in all storage needs areas INVENTORY CONTROL Establish Establish system for minimum stockreceiving, storing needs Develop forms and logs 127
  128. 128. listing all tests in the laboratoryidentifying all supplies needed foreach testusing available information toestimate usage 128
  129. 129. Unit of count Storage Usage/ space, month (quantification)conditions Item Description Order lead time/ Priority delivery Level time 129
  130. 130. consumption-based methodmorbidity-based method 130
  131. 131. based on actual usagemust 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 131
  132. 132. 90807060 Slides5040 Immersion Oil3020 Collection10 containers 0 1st 2nd 3rd 4th Qtr Qtr Qtr Qtr 132
  133. 133. based on actual number of episodesmust take into account:• population size• disease incidence• accuracy of morbidity data• treatment guidelines 133
  134. 134. 180160140120 Influenza100 Diarrhea 80 TB 60 4020 0 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr 134
  135. 135. 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.
  136. 136. Includes:  name and signature  date of receipt  quantity  date of expiry  minimum stock  stock balanceOther information: – shelf number – destination 136
  137. 137. 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 137
  138. 138. Use clearly visible dating labelsdate openeddate expired 138
  139. 139. Assign responsibility MaintainUpdate Inventory inventory systemrecords Control in all storage areas Conduct weekly physical counts 139
  140. 140. advantages• exact current state of stock• management of expiration dates• makes inventory tasks easier drawbacks• on-site computer is needed• requires trained staff 140
  141. 141. 141
  142. 142. The result of any laboratoryexamination is only as good asthe sample received in thelaboratory. 142
  143. 143. 143
  144. 144. Laboratory HandbookPolicies & Practices 144
  145. 145. • 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 145
  146. 146.  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 146
  147. 147. Provide sample Provide appropriatecollection information What- When- How containers and supplies Define a goodAssess all samples - labeling system preexamination
  148. 148. • patient ID• tests requested• time and date of sample collection• source of sample, when appropriate• clinical data, where indicated• contact information of requesting physician 148
  149. 149. • patient preparation• patient identification• type of sample required• type of container needed• labeling• special handling• safety precautions 149
  150. 150. patient’s namepatient’s unique ID numbertest orderedtime and date of collectioncollector’s initials 150
  151. 151. delays in reporting test resultsunnecessary re-draws/re-testsdecreased customer satisfactionincreased costsincorrect diagnosis / treatmentinjury and death 151
  152. 152. • Verify –completeness of test request –appropriateness of sample –information on label• Record in register or log• Enforce sample rejection criteria 152
  153. 153. Labeled samples, Spilled urine sample,completed requisitions a cause for rejection 153
  154. 154. inform authorized personrequest another samplerecord rejected samplesretain rejected samplebased on preset criteriaextraordinary circumstances mayrequire testing suboptimal samples 154
  155. 155. date and time of collectiondate and time of receiptsample typepatient namedemographics as requiredlaboratory assigned identificationtests to be performed 155
  156. 156. Handle all samples as if infectious 156
  157. 157. • set policy for sample disposal• compliance with local and country regulations• disinfection procedures 157
  158. 158. – temperature– preservation of sample– special transport containers– time limitations 158
  159. 159. New Classification in 2005: based on two transport categoriesCategory A: infectious substances capable ofcausing • permanent disability • life-threatening or fatal disease to humans or both human and animalsPackaging: most durable triple packaging with fulldangerous goods documentationTraining of transport staff 159
  160. 160. Category B: infectious substancesnot included in Category A less stringent triple packaging no dangerous goodsdocumentation required 160
  161. 161. 161
  162. 162. Quality Control (QC) is part of qualitymanagement focused on fulfilling qualityrequirements ISO 9000:2000 (3.4.10)QC is examining ―control‖ materials ofknown substances along with patientsamples to monitor the accuracy andprecision of the complete examination(analytic) process. 162
  163. 163. The goal of QC is to detect errorsand correct them before patients’results are reported. 163
  164. 164. Measure the quantity of a particularsubstance in a sample.Measurements should be bothaccurate and precise 164
  165. 165. Examinations that do not havenumerical results growth or no growth positive or negative reactive or non- reactive color change 165
  166. 166. Results are expressed as anestimate of the measured substance―trace amount‖, ―moderate amount,‖or ―1+, 2+, or 3+‖ number of cells per microscopic field titers and dilutions in serologic tests 166
  167. 167. Establish include written corrective policies and actions proceduresReview QC Train QC Program all staff data Steps Assure complete documentation 167
  168. 168. material that contains the substance being analyzed include with patient samples when performing a testused to validate reliability of the test system run after calibrating the instrument run periodically during testing 168
  169. 169. 169
  170. 170. Calibrators ControlsA substance with a specific A substance similar toconcentration. patients’ samples that has an establishedCalibrators are used to set concentration.(calibrate) the measuringpoints on a scale. Controls are used to ensure the procedure is working 1 2 3 4 5 properly. 1 2 3 4 5 170
  171. 171. appropriate for the diagnostic samplevalues cover medical decision points similar to test sample (matrix) available in large quantity; ideally enough for one year can store in small aliquots 171
  172. 172. may be frozen, freeze-dried, or chemically preserved requires very accuratereconstitution if this step is necessary 172
  173. 173. commercially prepared made ―in house‖ obtained from anotherlaboratory, usually central or reference laboratory 173
  174. 174. Target value predetermined ASSAYED Verify and use Target value not predeterminedUNASSAYED Full assay required before using In-house pooled sera“IN-HOUSE” Full assay, validation 174
  175. 175. • values cover medical decision points• similar to the test sample• controls are usually available in high, normal, and low ranges 175
  176. 176. obtain control materialrun each control 20times over 30 days 3SDcalculate mean and 2SD+/-1,2,3 Standard 1SDDeviations Mean 1SD 2SD 176
  177. 177. Variability is a normal occurrence when a control is tested repeatedly Performance Operator Environmental characteristics oftechnique conditions the measurement 177
  178. 178. Although variable, sets of data aredistributed around a central value F r e q u e n c y Measurement 178
  179. 179. Mode the value which occurs with the greatest frequencyMedian the value at the center or midpoint of the observationsMean the calculated average of the values 179
  180. 180. Not all central values are the same. Mean Mode F Median r e q u e n c y Measurement 180
  181. 181. Symbols Used in Calculations∑ is the sum of (add data points)n = number of data pointsx1 - xn = all of the measurements (1 through n)__X represents the mean 181
  182. 182. Quality Control is used to monitorthe accuracy and the precision of the assay. What are accuracy and precision? 182
  183. 183. The closeness of measurementsto the true valueThe amount of variation in themeasurementsThe difference between theexpectation of a test result and anaccepted reference value 183
  184. 184. Accurate Preciseand Precise but Biased ImpreciseAccurate = Precise but not Biased 184
  185. 185. For a set of data with a Xnormal distribution, a Frequencyrandom measurement willfall within: 68.2%+ 1 SD 68.3% of the time 95.5% 99.7%+ 2 SD 95.5% of the time -3s- 2s -1s Mean +1s +2s +3s+ 3 SD 99.7% of the time 185
  186. 186. Graphically Representing Control Ranges 186
  187. 187. assay control material at least 20 datapoints over a 20-30 day periodensure procedural variation isrepresentedcalculate mean and + 1, 2 and 3 SD 187
  188. 188. Draw lines for Mean and SDs (calculated from 20 controls) Chart name: Lot number:196.5 +3SD194.5 +2SD192.5 +1SD190.5 MEAN188.5 -1SD186.5 -2SD184.6 -3SD Days 188
  189. 189. Number of ControlsInterpretation depends on number of controls run with patients’ samples.Good: If one control: accept results if control is within ± 2SD unless shift or trendBetter: If 2 levels of controls apply Westgard multirule system 189
  190. 190. : variation in QC resultswith no pattern- only a cause forrejection if outside 2SDs. : not acceptable,correct the source of errorExamples:– shift–control on one side of the mean 6 consecutive days– trend–control moving in one direction– heading toward an ―out of control‖ value 190
  191. 191. Levey-Jennings Chart Shift196.5 +3SD194.5 +2SD192.5 +1SD190.5 MEAN188.5 -1SD186.5 -2SD184.6 -3SD Days 191
  192. 192. Levey-Jennings Chart Trend196.5 +3SD194.5 +2SD192.5 +1SD190.5 MEAN188.5 -1SD186.5 -2SD184.6 -3SD Days 192
  193. 193. If QC is out of control• STOP testing• identify and correct problem• repeat testing on patient samples and controls after correction• Do not report patient results until problem is solved and controls indicate proper performance 193
  194. 194. Solving out-of-control problems identify problemrefer to establishedpolicies and proceduresfor remedial action 194
  195. 195. • degradation of reagents or kits• control material degradation• operator error• failure to follow manufacturer’s instructions• an outdated procedure manual• equipment failure• calibration error 195
  196. 196. • microscopic examinations• dipsticks• serologic procedures• microbiological procedures• any reaction that produces non-numeric results 196
  197. 197. built-in controlscontrol materials thatmimic patient samples reference organisms 197
  198. 198. integrated into the design of atest kit deviceautomatically run with each testperformedassess certain aspects of kitperformancemay not assess entire testingprocess 198
  199. 199. reference strainsin-house developed strainspredictable reactionsin stains and mediaensure media,reagents and supplieswork as intended 199
  200. 200. ATCC-American Type CultureCollectionNTCC-National Type CultureCollection (UK)CIP- Pasteur Institute Collection(France) 200
  201. 201. use established procedure forpreparation or reconstitutionlabel: content, concentration, dateprepared and placed inservice, expiration, initialsstore appropriately 201
  202. 202. check with known organisms or cellsexamine for crystal shards or forprecipitationexamine for contaminants such asbacteria and fungi Left: Wright stain Right: Gram stain 202
  203. 203. verify performance of all mediain-house prepared: all batchescommercially prepared: new lot only MacConkey Agar QC Left: non-lactose fermenter Right: lactose fermenter 203
  204. 204.  out-dated  dried-out  contaminatedHuman blood should not be used because: too much batch to batch variationmay include inhibitory substances, including antimicrobialsmay contain biohazards (e.g., hepatitis virus) 204
  205. 205. 205
  206. 206. Documents and Records—How do they differ?Documents Records communicate  capture information information via on worksheets, policies, processes, forms, labels, and and procedures charts need updating  permanent, do not change RECORDS 206
  207. 207. Why do laboratories need tomanage documents and records? To find information whenever it is needed! 207
  208. 208. Information is the major productof the laboratory. 208
  209. 209. Policies Laboratory DocumentsProcedures Processes 209
  210. 210. Policies - The ―WHAT TO DO‖A written statement of overall intentions anddirections defined by those in the organizationand endorsed by management.‖ (CLSI HS1-A3) Processes - The ―HOW IT HAPPENS‖A ―set of interrelated or interacting activitiesthat transform inputs into outputs.‖ (ISO 90004.3.1) Procedures - The ―HOW TO DO IT‖Standard operating procedures (SOP) 210
  211. 211. “How to do it”“How it happens”“What to do” 211
  212. 212. Documents are the communicators of the quality management systemVerbal instructions often are:• not heard• misunderstood• quickly forgotten• difficult to follow 212
  213. 213. Why are documents important?• essential guidelines for laboratory• quality manual• SOPs• reference materials• required by formal laboratory standards 213
  214. 214. Documents are a reflection of the laboratory’s organization and its quality management. A good rule to follow is: ―Do what you wrote and write what you are doing.‖ 214
  215. 215. Good Documents are:• clear• concise• user-friendly• explicit• accurate• up-to-date 215
  216. 216. Documents for work processes shouldbe accessible to staff at the work site• instructions on handling incoming samples• SOPs for each test• quality control charts and trouble-shooting instructions• safety manuals and precautions 216
  217. 217. Standard Operating Procedures (SOPs) are documents that: describe how to perform a test using step-by-step instructions written SOPs help ensure: – consistency – accuracy – quality 217
  218. 218. A Good SOP• provides detailed, clear, and concise direction for testing techniques• is easily understood by new personnel• is reviewed and approved by management• is updated on a regular basis 218
  219. 219. Standardized SOP Format • Computerized procedure • Standardization: – Header – Version/chapter/reference – Author/reader/validator – Recipients – Version date/Application date – Typical outline • Updating and storage of different versions is easy
  220. 220. Complete Standardized HeaderUse at the top of the first page only 220
  221. 221. Reduced Standardized Header• other pages of every procedure• use at the top of all other pages 221
  222. 222. When Preparing SOPs determine procedure to useestablish assessmeans for scientificupdating validity gather all include documents each step
  223. 223. Suggested Outline for SOPs• Title: Name of Test• Purpose: Medical use• Instructions: – Preexamination – Examination – Postexamination• References to verify the method is established• Author’s name• Approval signature(s)–initial and date 223
  224. 224. Do not rely solely on manufacturer product inserts Inserts do not provide specific information for test sites, such as:• materials required, but not in kit• specific safety requirements• external quality control requirements 224
  225. 225. Job Aids• shortened version of SOPs• hand written or printed• visible location at testing site• useful tool to assure all testing steps are correctly performed 225
  226. 226. Job Aids 226
  227. 227. Document Controlassures that the ensures availability most current when needed version is used
  228. 228. Document Preparation and Control ProcessPreparation Issue Distribution Review Revision Approval 228
  229. 229. Common Document Control Problems• outdated documents• too many documents are distributed and the system cannot be maintained• lack of control of documents of external and internal origin 229
  230. 230. Sample log book or register Patient test Workbooks reports Worksheets EQA / Instrument PT printoutsrecords Quality control Maintenance data records 230
  231. 231. Personnel records Critical Internalcommunications audits results External Customer audits feedback results User Continuous surveys improvement 231
  232. 232. Test Report Contents ISO 15189• test identification • primary sample type• laboratory identification • results (SI units)• patient unique • biological reference identification and intervals location• name and address of • interpretive comments requestor • person authorizing• date and time of release, with signature collection when possible• time of receipt in lab • note if reporting a• date and time of release corrected result of report
  233. 233. 233
  234. 234. The test result is the finalproduct of the laboratory. Quality Lab Report 234
  235. 235. Establish processes for managing data Paper- Quality Lab Report based ID 0905120047 Patient  accessible information  accurate  timely  secure  confidentialElectronic  private 235
  236. 236. Unique identifiers samples, Effective patients Standardized communication request formsEffectivereporting Important Logs, systems worksheets elements Confidential Checking Data processes protection 236
  237. 237. safeguard a patient’s privacy assure laboratory data confidentiality 237
  238. 238. Paper-based systems• use durable materials for recording• store records properly Computerized systems• schedule regular backup of data 238
  239. 239. Data incomplete Computer ID systems insufficient incompatible CommonTransmission Problems Forms errors inadequate Data Archiving organized poor poorly 239
  240. 240. Error Integrate reduction QC with other sites Data Financial retrievalmanagement options Detailed, Access legible control reports Track, Track analyze reports trends 240
  241. 241. Training: time and money Adapting Back-up to a newrequirements system Costs: purchase and maintenance 241
  242. 242. 242
  243. 243. Any event that has a negative impacton an organization, includespersonnel, product, equipment, orthe environment. 243
  244. 244. • proficiency testing error• no action on out of range controls• false negative result• late reports• missing reports• complaints• laboratory accident 244
  245. 245. individual equipment responsibilities not properly unclear maintained no written procedures QC, EQA Common written procedures notperformed CAUSES not followed of Error test kits training not stored transcription not done properly errors or checks not completed not done 245
  246. 246. THE PATIENT Test selection Sample Collection Preexamination Phase Sample Transport Laboratory Analysis Examination Phase Report Transport Report Creation Result Interpretation Postexamination Phase 246
  247. 247. wrong sample collectedsample mislabeled orunlabeledsample transportedinappropriatelyreagents or test kitsdamaged by improperstorage 247
  248. 248. incorrect timing of test results reported when control results out of range improper dilution and pipetting of sample or reagentsreagents stored inappropriately 248
  249. 249. transcription error in reportingreport illegiblereport sent to the wronglocationreport not sent 249
  250. 250. AwarenessCommunicate Investigate ACTION 250
  251. 251. How are occurrences detected? Customer satisfaction Accreditation Monitoring Certification complaints Management Seeking Review Internal OFIs audits External Quality audits indicators PT / EQA 251
  252. 252. Learn from the event and avoid its recurrencePreventive actions Corrective actionsSee thepotential EVENTevent andplan toavoid it Remedial actions Address the event and its consequences 252
  253. 253. 254
  254. 254. • learn ―where we are‖ in terms of quality management• measure gaps• need information for: planning and implementation monitoring continuous improvement 255
  255. 255. Attention to detailCommunicate effectively Trained Important Skills for Auditors Technical/ Quality management Diplomatic expertise 256
  256. 256. Continuousmonitoring is the key element to success in theQuality System 257
  257. 257. ―It isn’t what you find…it’s what you doabout what you find.‖ -Philip Crosby 258
  258. 258. EQA MethodsProficiency Rechecking On-site Testing Retesting Evaluation 259
  259. 259.  comparison among different testsites early warning for systemic problems objective evidence of testing quality areas that need improvement training needs 260
  260. 260. • important for improvement• a measure of laboratory performance 261
  261. 261. ISO/IEC Guide 43-1:1997“Proficiency testing schemes (PTS) are interlaboratory comparisons that are organized regularly to assess the performance of analytical laboratories and the competence of the analyticalpersonnel.” 263
  262. 262. PT organization Laboratory /provider Analyze PT samples sent regularly Return results Evaluation ReceivePT performance PT report report Corrective Actions 264
  263. 263. ISO 15189 PT PatientLaboratory 1 sample sample Laboratory 2 Analyze same manner with same personnel Final PT report Improvement No discussion received between labs 265
  264. 264. Information received from PTparticipation must be directedtoward improvement in thelaboratory to receive the fullvalue. 266
  265. 265.  PT results are affected by variables not related to patient samples PT will not detect all problems in the laboratory PT may not detect problems with pre- and post examination procedures 267
  266. 266.  tested by reference laboratory performed on dried blood spots or serum not blinded statistically significant primarily used to assess HIV rapid testing 268
  267. 267. EQA Take Corrective Action Identifyproblems 271
  268. 268. ISOCLSICENWHO 272
  269. 269. worlds largest developer and publisher ofstandards are applicable internationalto many kinds of standardsorganizations includingclinical and public healthlaboratories 273
  270. 270. global, nonprof it, standards- developingpromotes the development organizationand use of voluntaryconsensus standards andguidelines within thehealth care community 274
  271. 271. national standards bodies in the Europeangeneral terms include Economicopenness and Community andtransparency, consensus, associatedand integration countries 275
  272. 272. has developed several standards fordisease-specific diagnosticlaboratories, such aspolio, tuberculosis, influenza, measles 276
  273. 273. Accreditation Body Standards Assessors User laboratory 278
  274. 274. Approved Knowledgeable Certification and Accreditation Bodies Standards- basedCompetent staff Objective 279
  275. 275. Where is your Laboratory? Reference Laboratory Laboratory Laboratory Accreditation CertificationLicensure 280
  276. 276. not one to be taken lightly or without forethought commitment planning Requirements knowledge resources 281
  277. 277. Accreditation does not guarantee success,it is only one step along the quality journey QUALITY MANAGEMENT ERROR CUSTOMER REDUCTION SATISFACTION CONTINUAL IMPROVEMENT ACCREDITATION 282
  278. 278. Accredited laboratories tend to: perform better on proficiency testing are more likely to have a working quality management system 283
  279. 279. 2010 2007 MAINTAINEDPRIMARY 2009 MAINTAINED 2008 It is an ACHIEVEMENTMAINTAINED to maintain accreditation 284
  280. 280. It is an accomplishment to receive accreditation 2007 PRIMARY 285
  281. 281. 286
  282. 282. Philip CrosbyFour Absolutes of Quality Management 1979 287
  283. 283. 288
  284. 284. Requires:• commitment from all staff• planning• knowledge of monitoring tools• resources 289
  285. 285. Laboratory Public Health CommunityPatients Physicians Health care provider 290
  286. 286. Good customer service provides:• valuable information for best patient care• valuable information to improve surveillance• professional image of laboratory 293
  287. 287. complaint monitoring interviews, qualityfocus groups indicators MONITORsatisfaction internal surveys audit management review 294
  288. 288. Complaints Actual dissatisfied customers! 295
  289. 289. Monitoring Conductingquality indicators internal audits Reviewing by management ACTION 296
  290. 290. planned analyzedin a timely organized manner Successful surveys no leading questions, pre-tested unbiased 297
  291. 291. An activeQuality Management System ensures Laboratories Meet ALL Client Requirements 298
  292. 292. 299
  293. 293. W. Edwards Deming 14 Points for Quality Two points address continual improvement:• create constancy of purpose for improvement• improve constantly and forever 300
  294. 294. PlanAct Do Check 301
  295. 295. Continual Improvement(ISO 15189:2007) develop plan for identify improvement potential sources of error adjust the implement action plan and modify the system review the effectiveness of action 302
  296. 296. LeanOptimizingspace,time, andactivity toimprove thephysical paths ofworkflow. 303
  297. 297. Organized processes to assist in decision making for continual improvement: control define measure analyze improve 304
  298. 298. • indicate performance• determine quality• highlight concerns• identify areas needing further study• track changes over time 305
  299. 299. Use an indicator only as long as it provides useful information. Don’t get tied to your indicators. 306
  300. 300. Use an indicator only as long as it provides useful information. Don’t get tied to your indicators. 307
  301. 301. 308
  302. 302. 309