IBTS DIAG GDE 0001 - Irish Blood Transfusion Service

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IBTS/DIAG/GDE/0001 Ver. 2 Page 3 of 41TITLE:IBTS PRIMARY SPECIMEN AND USER MANUALDIAGNOSTICS / COMPATIBILITY LABORATORIESCONTENTSPAGE1.0 Introduction ………………………………………………………………………………. 5-62.0 Guide to Using this Manual ……………………………………………………………... 63.0 Quality Policy ……………………………………………………………………………. 64.0 General Information ……………………………………………………………………... 7 - 104.1 Laboratory Directors … …………………………………………………………… 74.2 IBTS Laboratory Personnel –Medical/Medical Scientific ………..…………………… 74.3 Service Operating Times ………………………………………………………….. 74.4 Specimen Scheduling ……………………………………………………………… 7-84.5 Diagnostics/Compatibility Laboratories Contact Details …………………………… 84.6 Contacting the Diagnostics/Compatibility Laboratory with an Urgent Request forEmergency Services……………………………………………………………….. 84.6.1 Routine Hours ……………………………………………………………………… 84.6.2 Out of Hours ……………………………………………………………………… 94.6.3 Procedure to be Followed for Urgent Request ……………………………………… 94.7 Service Fees and Charges ……................................................................................... 105.0 Laboratory Request Forms, Specimen Bottles and Containers …………………………… 10 - 165.1 General Information Re: Specimen Collection...……………………………..………… 105.2 Categories of Request Forms available at the IBTS Diagnostics Laboratory …………….. 105.2.1 Process for Ordering the IBTS Request Forms ………………………………………… 105.3 Completion of Request Forms …………………………………………….. 115.4 Labelling the Specimen ……………………………………………………………….. 11-125.4.1 Mandatory Requirements ……………………………………………………………… 115.4.2 Labels on Specimen Bottles ……………………………………………………………. 125.4.3 Requirement to sign the declaration …………………………………………………… 125.5 Exceptions ……………………………………………………………………………… 125.6 Quality of Blood Specimens (Vis-à-Vis Condition and Timing) ……………………….. 135.6.1 Timing of Specimen Collection in Relation to Previous Transfusions ………………….... 135.6.2 Crossmatching Requests, Reference Specimens ………………………………………… 135.7 Non-Conforming Specimen Bottles, Forms or Specimen Quality Issues........................... 13-165.7.1 Specimens: Condition/Documentation and Appearance/Quality Issues………………… 145.7.2 Specimen Request Form Issues ………………………………………………………… 155.7.3 General Information Re: Specimens and Forms …............................................................ 166.0 Delivery, Packaging, Storage and Transport Requirements of Diagnostic Specimens ……... 16 - 176.1 Specimen Delivery ……………………………………………………………………… 166.2 Specimen Packaging and Transport ……………………………………………………… 166.2.1 International Carriage of Dangerous Goods by Road ……………………………………. 166.2.2 Universal Packaging Procedure for the Transport of Diagnostic Specimens ……....…… 176.2.3 Disposal of Waste Material Used in Specimen Collection ……………………………….. 176.3 Storage of Specimens …………………………………………………………………….. 176.4 Delivery of Routine Diagnostic Specimens:-Out of Hours ……………….………….…… 177.0 External and Internal Quality Assessment Programmes ……………………………………… 187.1 External Quality Assessment Programmes ………………………………………………. 187.2 Internal Quality Assessment Programmes ……………………………………………… 187.3 Outcome of a Major Non-Conformance …………………………………………………. 18
IBTS/DIAG/GDE/0001 Ver. 2 Page 4 of 418.0 Laboratory Tests and Services .....................................................................................................19 - 298.1 Services Provided by the IBTS Diagnostics Laboratories ………………… …… 198.1.1 Test Profiles and Turnaround Times …………………………………………………….. 19 - 268.2 Provision of Blood/Blood Components …………………………………………………. 278.2.1 Provision of Red Cells (Stock)……………………………………………………………. 288.2.2 Provision of Platelet Components ……………………………………………………… 288.2.3 Provision of Rare Donor Red Cells from International Rare Blood Programmes ……… 288.3 Consultancy and Pathology Services ……………………………………………………… 288.4 Haemovigilance Advisory Service …………………………………. 298.5 Repeat Examination due to Analytical Failure or Further Examination of the PrimarySpecimen ………………………………………………………………………………….. 298.5.1 Repeat Examination due to Analytical Failure …………………………………………… 298.5.2 Further Examination of the Primary Specimen …………………………………………… 298.5.3 Referring specimens to an external laboratory for further investigations ………………298.6 External Laboratory Testing ……………………………………………………………… 299.0 Reporting of Test Results ………………………………………………………………………… 30 - 319.1 Approval of Test Results and Issuing Reports ……………………………………………. 309.2 Issuing Reports on Critical Specimens where the Results are delayed …………………… 309.3 Reporting of Results by Fax ………………………………………………………………. 309.4 Telephoned Results ………………………………………………………………………... 319.5 Archiving of Patients Records …………………………………………………………….. 3110.0 Review and Assessment of Customer Satisfaction ……………………………………………... 31 - 3210.1 Service Level Agreements……………………………………………………………… 3110.2 Customer Complaints ……………………………………………………………………... 3210.3 Quality Management Review………………....………………………………………….. 3210.4 Customer Liaison ………………………………………………………………….. 3210.5 Hospital Transfusion Committees……………………………………………………….. 3210.6 Continuous Improvement ………………………………………………………………….. 3211.0 Traceability and reporting of Serious Adverse Reactions (SARs) andSerious Adverse Events (SAEs) ……………………………………………………………….....33 - 3411.1 Traceability ………………………………………………………………………………. 3311.2 Serious Adverse Reactions and Serious Adverse Events………………………………….33 - 3412.0 Guidelines: Medical/Scientific …………………………………………………………………… 35 - 3812.1 Ante-Natal Guidelines …………………………………………………………………….. 3512.1.1 Specimens for Quantitation (AntiD/c)………………………………………………….. 3512.1.2 Ante-Natal Specimens for Antibody Titration …………………………………………… 3612.2 Guidelines for the Collection of Specimens from Previously Transfused Patients …….... 3712.3 Guidelines for the Storage of Specimens: Pre Testing ……………………………………. 3712.4 Guidelines for Storage of Examined Specimens for Archive and Look Back Purposes ….. 3712.5 Guidelines for Processing Specimens with Special Requirements Outside of theRoutine Working Day ……………………………………………………………………... 3812.5.1 Non Compliance with the Turnaround Times …………………………………………….. 3813.0 Index of Tests and Services Provided ……………………………………………………………. 39 - 4113.1 Tests……………………………………………………………………………………… 39 - 4013.2 Services ……………………………………………………………………………………. 41
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IBTS DIAG GDE 0001 - Irish Blood Transfusion Service

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