POL:07:QP:010:03:NIBT PAGE: 1 of 4. Document Details Document Number: POL:07:QP:010:03:NIBT No. of Appendices: 4 Supersedes Number: 07:02:QP:010:NIBT

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1 POL:07:QP:010:03:NIBT PAGE: 1 of 4 POLICY DOCUMENT Document Details Document Number: POL:07:QP:010:03:NIBT No. of Appendices: 4 Supersedes Number: 07:02:QP:010:NIBT Document Title: INTERNAL QUALITY CONTROL POLICY ISSUE DATE: 2 AUGUST 2012 EFFECTIVE DATE: 13 AUGUST 2012 Document Authorisation Written By: Geoff Geddis, Quality Manager Signature: Date : Authorised By: Dr K Morris, Chief Executive Signature: Date : CROSS REFERENCES This Policy refers to the following documents: Doc Type Doc. No. Title APPENDIX 1 Quality APPENDIX 2 Transfusion Micro APPENDIX 3 Automated Serology APPENDIX 4 Reference Lab

2 POL:07:QP:010:03:NIBT PAGE : 2 of 4 Key Change from Previous Revision: New Format and revision to Microbiology appendix reflecting the introduction of NAT Donor ing. 1 STATEMENT NIBTS laboratories will for critical reagents perform batch acceptance tests. This will involve the testing of new batches of kits or reagents against a range of samples/reagents which will confirm the suitability of that kit or reagent for use. Acceptance testing to be carried out for each delivery regardless if the same lot number of reagents were previously received. NIBTS will, for each test or batch of tests performed, develop where available the application of internal quality control samples. These samples will be designed to provide appropriate to assure the on-going maintenance of the required standards for the test in question, these may either be positive/, qualitative (e.g. Blood Groups) controls or single samples which provide a basis for on-going monitoring of a particular test, for example microbiology screening tests. Where appropriate statistical analysis will be applied to the this may be by application of Statistical Process. of internal quality control tests will be reviewed at the time of release of and measured against the predefined acceptance criteria for that test. Only on satisfactory performance of quality control samples will each set of test or batch of test be released. 2 INTRODUCTION Quality is regarded of paramount importance at the Northern Ireland Blood Transfusion Services, this commitment is demonstrated by the development of quality management system, which will ensure the provision of safe application of blood products and services for both patients and donors. The integral part of any quality system is the application of appropriate internal quality control activities, such activities are particularly applicable within a laboratory environment. Within the individual laboratories of the a range of internal quality control processes are applied. It is the aim of the Northern Ireland Blood Transfusion Service to apply internal quality control tests to all critical testing processes.

3 POL:07:QP:010:03:NIBT PAGE : 3 of 4 3 RESPONSIBILITY Quality Manager the Quality Manager will ensure a policy for the implementation of Internal Quality is defined, reviewed, updated and relayed to all relevant staff Laboratory Managers are responsible for ensuring compliance with this policy and that the relevant appendix is updated to reflect any changes in testing within there laboratory. 4 POLICY 4.1 NIBTS laboratories will for critical reagents perform batch acceptance tests. This will involve the testing of new batches of kits or reagents against a range of samples/reagents which will confirm the suitability of that kit or reagent for use. Acceptance testing is to be carried out for each delivery regardless if the same lot number of reagents were previously received. NIBTS will, for each test or batch of tests performed, develop where available the application of internal quality control samples. These samples will be designed to provide appropriate to assure the on-going maintenance of the required standards for the test in question, these may either be positive/, qualitative (e.g. Blood Groups) controls or single samples which provide a basis for on-going monitoring of a particular test, for example microbiology screening tests. Where appropriate statistical analysis will be applied to the this may be by application of Statistical Process. 4.2 RESULTS of internal quality control tests will be reviewed at the time of release of and measured against the predefined acceptance criteria for that test. Only on satisfactory performance of quality control samples will each set of test or batch of test be released. Attached appendices 1-4 are the details of internal quality control material used within the NIBTS laboratories. Failures in internal quality control samples and should be noted and as appropriate reported to the quality department via the incident reporting procedures. It should be noted that individual processing of quality control material for each specific test will be addressed in the appropriate testing standard operation procedure. 4.3 HEALTH AND SAFETY Relevant Health and Safety information relating to control materials will be included in individual SOPs by reference to COSHH assessments.

4 POL:07:QP:010:03:NIBT PAGE : 4 of 4 5 EQUALITY SCREENING OUTCOME This policy has been drawn up and reviewed in light of the statutory obligations contained within Section 75 of the Northern Ireland Act (1998). In line with the statutory duty of equality this policy has been screened against particular criteria. If at any stage of the life of the policy there are any issues within the policy which are perceived by any party as creating adverse impacts on any of the groups under Section 75 that party should bring these to the attention of the Head of HR& Corporate Services. 6 TRAINING REQUIREMENTS All Laboratory staff involved in testing samples must read and understand this policy.

5 Ref:POL:07:QP:010:03:NIBT APPENDIX 1 Department: QUALITY CONTROL Factor VIII assay Factor VIII assay Fibrinogen assay Full Blood Counts Low level leucocyte level CD34 determination British Standard For Blood Coagulation FVIII Concentrate Human. Calibration Plasma International Standard for Fibrinogen E check low, normal and high controls Leucocyte Combi Kit (1 high + 1 low platelet control, 1 high + 1 low red cell control Stem Cell Kit NIBSC Specified level +/- 10% Instrumentation Specified level +/- Laboratory 10% NIBSC Specified level +/- 10% Sysmex Becton Dickinson Becton Dickinson As per manufacturer defined range As per manufacturer defined range As per manufacturer defined range On completion of each test run On completion of each test run On completion of each test run Daily Daily On completion of each batch of tests Hemolysis testing Sterility checks on components Page 1 of 2 Plasma Low Hb/control (1x low, 1 x norm, 1x high) Spiked BTA Bottles (1 x anaerobic, 1 x aerobic, 1 x paediatric) Hemocue Ltd Bottles Biomerieux Organisms Oxoid As per manufacturer defined range Bottle positive in defined time (dependant on organism) Before commencing each batch of tests Weekly

6 Ref:POL:07:QP:010:03:NIBT APPENDIX 1 Latex Agglutination Stock organism stock organism Catalase Stock organism Organism Oxoid / test result as appropriate With each batch of tests Organism Oxoid test result With each batch of tests Oxidase Dryslide Stock organism Organism Oxoid test result With each batch of tests Sterility Checks on Bone Environmental Monitoring for Cord Blood and Stem Cell Clean Rooms Environmental Monitoring for Hospital Services Settle Plates and Bottles in Cabinet during inoculation and plating Settle Plates in cabinet during plating of samples Settle Plates in cabinet during plating of samples Settle plates Fanin Healthcare TSA/Thioglycollate bottles Ulster Anaesthetics Settle plates Fanin Healthcare Settle plates Fanin Healthcare No growth No growth No growth With each batch of tests With each batch of tests With each batch of tests Bacteriology testing of platelets and blood products Settle Plates in cabinet during inoculation Settle plates Fanin Healthcare No growth With each batch of tests Page 2 of 2

7 APPENDIX 2 Department: TRANSFUSION MICROBIOLOGY Page 1 of 2 NAT HIV, HBV, HCV HTLV, HIV, HB s Ag, HCV, Syphillis, CMV, Rubella Kit controls provided by Manufacturer Manufacturer As defined by manufacturer HIV Screening BWS for anti-hiv 1 NIBSC within HIV Screening BWS for anti-hiv 2 (99/674-WIL) HBsAg Screening HBsAg Screening NIBSC BWS for HBsAg 0.2 IU/ml Monitor for HBsAg 0.05IU/ HCV Screening BWS for anti-hcv (0 1 in 8 dilution for use with Abbott PRISM. NIBSC NIBSC NIBSC NIBSC within within within within Before acceptance of tests, this Is normally automated Ongoing analysis test too strong so only used as a monitor test test. Too strong so used as a monitor. test test. Syphilis screening CMV screening Rubella screening Anti-syphilis QC2 QCRSYPHQC Anti CMV QC1 QCRCMVQC1 Anti-rubella QC1 QCRRUBQC1 HPA HPA HPA within within within test. test. test.

8 APPENDIX 2 Page 2 of 2 Pre batch acceptance HBsAg Panel of 10 pos diluted NMRU within HIV antibody Panel of 7 pos diluted NMRU within HCV antibody Panel of 10 positives within native plasma CMV antibody Panel of 10, the within same panel as for HCV but not all CMV positive The number of positive samples varies as the panel is changed. With pre-batch acceptance screening a sample of plasma from a NIBTS discarded unit is tested 20 times to show reproducibility of the assay. With pre-batch acceptance screening 10 random donor samples are retested in tandem to show predictive specificity.

9 APPENDIX 3 Department: AUTOMATED SEROLOGY Galileo automated Blood grouping Galileo automated Red cell Antibody screening Galileo automated Genotypes / Phenotypes Galileo automated red cell antibody screening Galileo QC Blood Grouping assay. and controls on each plate Galileo QC Genotype assay and controls on each plate Immucor Galileo reagents Immucor Galileo reagents. Immucor Galileo reagents Immucor Galileo reagents. All to be qualified by Galileo control must be 3+ and. Any differences from this criteria and the screening plate will automatically fail. All to be qualified by Galileo control must be 3+ and. Any differences from this criteria and the screening plate will automatically fail. Before commencement of Blood Grouping At time of testing Before commencement of Genotyping At time of testing printed, reviewed and signed. Immediate stored in Galileo and ultimately archived. printed reviewed and signed Immediate stored in Galileo and ultimately archived. Page 1 of 4

10 APPENDIX 3 Galileo automated weak D test Galileo automated IgM group O high titre test. and controls on each plate and controls. Immucor Galileo reagents. ALBAcheck high titre and controls antisera with Immucor A 1 rr and B rr cells. control must be 3+ and. Any differences from this criteria and the screening plate will automatically fail. control must be positive and. At time of testing At time of testing Immediate stored in Galileo and ultimately archived. Immediate stored in Galileo and ultimately archived. Page 2 of 4

11 APPENDIX 3 Manual antibody identification (Tube serology) and control per red cell test panel control: ALBAcheck weak anti-d 0.3 iu / ml with heterozygous R1r cell provided by NIBTS Reference lab. control must be positive and. At time of testing before panel is read. recorded on investigation sheet and accompanying QC sheet. Manual red cell antibody titration and controls per cell washer. control: AB serum with same R1r cell. control: ALBAcheck weak anti-d 0.3 iu / ml with heterozygous R1r cell provided by NIBTS Reference lab. control must be positive and. At time of testing before titration panel is read. recorded on investigation sheet and accompanying QC sheet. Manual Genotyping / phenotyping tests control: Cell heterozygous for the antigen being tested e.g. Kk. With relevant antisera control Cell homozygous for the antigen being tested eg kk with relevant antisera control: AB serum with same R1r cell. Commercial antisera and red cell panels. Cells also provided by NIBTS Ref lab. control must be positive and. At time of testing before typing is read. recorded on investigation sheet and accompanying QC sheet. Page 3 of 4

12 APPENDIX 3 Direct Coombs test and controls per cell washer. control: ALBAcheck weak anti-d 0.3 iu / ml with heterozygous R1r cell provided by NIBTS Reference lab. control must be positive and. At time of testing before titration panel is read. recorded on investigation sheet and accompanying QC sheet. Cell washer QC Sensitised red cells with AHG reagent control: AB serum with same R1r cell Commercial AHG reagent with sensitised cells provided by NIBTS ref lab Sensitised cells must be positive At time of testing. recorded and reviewed. Page 4 of 4

13 APPENDIX 4 Department: REFERENCE LABORATORY A A 2 Cell B Cell B Cell B A 1 Cell A 2 Cell A,B O Cells A 1 Cells A 1 A 2 Cells O R 1 r Cells D A 1 rr Cells O r r Cells C O r r Cells O r r Cells E O r r Cells c O r r Cells O R 1 R 1 Cells e O r r Cells O R 2 R 2 Cells O R 1 R 1 Cells C w O R 1 R 1 Cells Kk Cells K kk k Kk Cells KK Cells Kp(a+b+) Cells Kp a Kp(a-b+) Cells Kp(a+b+) Cells Kp b Kp(a+b-) Js(a+b+) Js a Js(a-b+) Js(a+b+) Js b Js(a+b-) Page 1 of 3 Internally produced reagents Internally produced reagents Internally produced reagents Internally produced reagents Internally produced reagents Commercial panel. KK cells if available Commercial panel. Kp(b-) IF available IF available. Panel Cells Panel Cells. IF available

14 APPENDIX 4 Fy a Fy b Jk a Jk b M N S s P 1 Fy(a+b+) Fy(a-b+) Fy(a+b+) Fy(a+b-) Jk(a+b+) Jk(a-b+) Jk(a+b+) Jk(a+b-) M+N+ M-N+ M+N+ M+N- S+s+ S-s+ S+s+ S+s- P 1 + w P 1 - Le(a+b-) Le(a-b+) Lu(a+b+) Lu(a-b+) Lu(a+b+) Lu(a+b-) Co(a+b+) Co(a-b+) Co(a+b+) Co(a+b-) Le(a-b+) Le(a+b -) Wr(a+) Wr(a-) Phenotyping Anti-Le a Phenotyping Anti-Lu a Phenotyping Anti-Lu b Phenotyping Anti-Co Phenotyping Anti-Co b Le b Wr a V w + V w V w - Page 2 of 3 Panel cells. IF available Panel cells. IF available Panel cells. IF available IF available. Panel cells IF available. Panel cells

15 APPENDIX 4 HPA-1a Pak-12 EIA Kit HPA-1a + platelets HPA-1a - platelets Anti-HPA-1a Inert plasma Pak-12 EIA Kit Anti-HPA-1a Validation Anti-HPA-5b Indirect Antiglobulin Weak Anti-D v. O s R 1 r cells Indirect Antiglobulin AB serum v. O s R 1 r cells Enzyme s Weak Anti-D v. enzyme treated O R 1 R 1 cells Enzyme s AB Serum v. enzyme treated O R 1 R 1 cells Manual DiaMed LISS IAT Manual DiaMed enzyme Capture-R Capture-P ZZAP cells Coomb s Washers One positive control per panel One positive control per panel Anti-Fy a. Fy b, -s, -k Sensitised cells v. AB serum Supplied Kit s sample O.D. compared to control DiaMed HPA-1a Typing Kit Supplied Kit s sample O.D. Pak-12 EIA Kit compared to control NIBSC Standards Antibodies must be detectable for Pak-12 EIA (1:2 dilution) Kit validation Commercial reagent Commercial antiserum + in-house cells Commercial reagent Commercial antiserum + in-house cells Commercial reagent Commercial antiserum + in-house cells Commercial reagent Commercial antiserum + in-house cells Commercial Coomb s vs. DiaMed panel R 1 R 1 cell Commercial Coomb s vs. DiaMed enzyme panel R 1 R 1 cell Supplied Kit Reagents recorded and reviewd recorded and reviewd Supplied Kit Reagents Commercial Reagents Cells must be with all reagents prior to use In-house reagents Cells must be positive in all positions Capture-R kit Capture-P kit In-house cells and commercial reagents Commercial antiserum + in-house cells Page 3 of 3