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Primary Specimen & User Manual - Irish Blood Transfusion Service

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IBTS/DIAG/GDE/0001 Ver. 1 Effective Date: 02 / 04 / 2009 Page 3 of 35<strong>Irish</strong> <strong>Blood</strong> <strong>Transfusion</strong> <strong>Service</strong>8.0 Laboratory Tests and <strong>Service</strong>s .....................................................................................................17 - 258.1 The <strong>Service</strong>s Provided by the IBTS Diagnostics Laboratories ……………………… 178.1.1 Test Profiles and Turnaround Times …………………………………………………….. 18 - 228.2 Provision of <strong>Blood</strong>/<strong>Blood</strong> Components …………………………………………………. 238.2.1 Provision of Red Cells (Stock)……………………………………………………………. 238.2.2 Provision of Platelet Components ……………………………………………………… 248.2.3 Provision of Rare Donor Red Cells from International Rare <strong>Blood</strong> Programmes ……… 248.3 Consultancy and Pathology <strong>Service</strong>s ……………………………………………………… 248.4 Haemovigilance <strong>Service</strong> …………………………………………………………………. 248.5 Repeat Examination due to Analytical Failure or Further Examination of the <strong>Primary</strong><strong>Specimen</strong> ………………………………………………………………………………….. 258.5.1 Repeat Examination due to Analytical Failure …………………………………………… 258.5.2 Further Examination of the <strong>Primary</strong> <strong>Specimen</strong> …………………………………………… 258.5.3 Referring specimens to an external laboratory for further investigations ……………… 258.6 External Laboratory Testing ……………………………………………………………… 259.0 Reporting of Test Results ………………………………………………………………………… 25 - 269.1 Approval of Test Results and Issuing Reports ……………………………………………. 25 - 269.2 Issuing Reports on Critical <strong>Specimen</strong>s where the Results are delayed …………………… 269.3 Reporting of Results by Fax ………………………………………………………………. 269.4 Telephoned Results ………………………………………………………………………... 269.5 Archiving of Patients Records …………………………………………………………….. 2610.0 Review and Assessment of Customer Satisfaction ……………………………………………... 27 - 2810.1 <strong>Service</strong> Level Agreements……………………………………………………………… 2710.2 Customer Complaints ……………………………………………………………………... 2710.3 Quality Management Review………………....………………………………………….. 2710.4 Annual <strong>User</strong> Symposium ………………………………………………………………….. 2810.5 Hospital <strong>Transfusion</strong> Committees……………………………………………………….. 2810.6 Continuous Improvement ………………………………………………………………….. 2811.0 Traceability and reporting of Serious Adverse Reactions (SARs) andSerious Adverse Events (SAEs) ………………………………………………………………......28 - 3011.1 Traceability ………………………………………………………………………………. 2811.2 Serious Adverse Reactions and Serious Adverse Events…………………………………. 29 - 3012.0 Guidelines: Medical/Scientific …………………………………………………………………… 30 - 3312.1 Ante-Natal Guidelines …………………………………………………………………….. 3112.1.1 <strong>Specimen</strong>s for Anti-D Quantitation ……………………………………………………….. 3112.1.2 Ante-Natal <strong>Specimen</strong>s for Antibody Titration …………………………………………… 3112.2 Guidelines for the Collection of <strong>Specimen</strong>s from Previously Transfused Patients …….... 3212.3 Guidelines for the Storage of <strong>Specimen</strong>s: Pre Testing ……………………………………. 3212.4 Guidelines for Storage of Examined <strong>Specimen</strong>s for Archive and Look Back Purposes ….. 3212.5 Guidelines for Processing <strong>Specimen</strong>s with Special Requirements Outside of theRoutine Working Day ……………………………………………………………………... 3312.5.1 Non Compliance with the Turnaround Times …………………………………………….. 3313.0 Index of Tests and <strong>Service</strong>s Provided ……………………………………………………………. 34 - 3513.1 Tests……………………………………………………………………………………… 34 - 3513.2 <strong>Service</strong>s ……………………………………………………………………………………. 35

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