EFI Standards: v 6.1 Tracking Document

Transcription

1 B1.1 A Director / Co-Director that must: B1.1 A Director that must: (B1.000) NEW B1.1.4 If a Co-Director is appointed, Standards B B1.1.3 apply. Comment from the EFI Commissioners. It is essential that the Co-Director has the same qualifications as the Director if this person is to share the running of the department. The standards have been modified to ensure that this is a clear requirement. B1.1.4-B1.1.5 (B2.000, B3.000) B1.1.5-B1.1.6 These Standards have been renumbered to accommodate the insertion of B B Hold a bachelor's degree or equivalent and have three years' experience in human histocompatibility testing under the supervision of a qualified Director / Co- Director B Hold a bachelor's degree or equivalent and have three years relevant experience in human histocompatibility and immunogenetics testing under the supervision of a qualified Director or Co-Director Comment from an EFI Member. If the Technical Supervisor is under the direct supervision of an appropriately qualified Director (or Co-Director), the length of service in H&I may be relaxed, depending upon the previous experience of this person. NEW D If an HLA typing is performed using DNA methods, it is acceptable to report an HLA serological assignment if required for the purposes of organ allocation. NEW th Finalised Maastricht, 10 May 2013 D The translation of alleles to serological equivalence must be performed according to a documented protocol. Comment from a Commissioner. For solid organ transplantation HLA matching and the definition of unacceptable HLA antigens requires antigen level resolution. The Standards Committee agreed that HLA Typing reports must be understood by our clinical colleagues when seen in association with antibody specificities, unacceptable antigens, and HLA matching requirements. This new standard allows a typing produced using molecular methods to be used to report at the antigen level of resolution to meet the requirements of organ allocation schemes. It is much safer for the type to be converted by trained staff within the

2 Existing Standard v 6.0 (v5.7 Reference) Proposed Change V6.1 H&I laboratory than to risk incorrect interpretation from a molecular type to a serological equivalent being performed by somebody unfamiliar with HLA. E1.1 (E0.100) For HLA Typing by Complement Dependent Cytotoxicity, each serum-cell combination must be recorded in a manner which indicates the percentage of cells killed. Numerical scores used should be: E1.1 For HLA testing by Complement Dependent Cytotoxicity, each serum-cell combination must be recorded in a manner which indicates the percentage of cells killed. Numerical scores used should be: Comment from Standards Committee Members. This standard relates to both crossmatching and HLA typing by CDC. The word typing has been replaced with testing to include both techniques. F1.4.2 (F1.230) The positive control must be from highly alloimmunised individuals and documented to react with HLA antigens. F1.4.2 The positive control must be either a validated monoclonal antibody, or sera from highly alloimmunised individuals and documented to react with HLA antigens Comment from EFI members about inconsistency between serological positive control reagent specifications. The Standards Committee agree that if a control reacts in the appropriate way, it is acceptable to use either a monoclonal antibody or serum from an alloimmunised individual(s). G4.1.1 (G3.100) Crossmatching must be performed prospectively, G4.1.1 Crossmatching must be performed prospectively, or may be omitted if Virtual Crossmatching is performed (G4.2). This Section of the G Standards has been revised to give more direct guidelines for the use of Virtual Crossmatching. G4.1.2 (G3.100) Or retrospectively, if omitted for patients Or retrospectively, if omitted for patients NEW G4.1.2 Prospective crossmatching must be performed for all living donor transplants This standard has been deleted. NEW G4.1.3 If the prospective crossmatch is omitted, a retrospective crossmatch must be performed. NEW G4.2 Virtual Crossmatching Finalised Maastricht, 10 May 2013 th G4.2.1 A transplant protocol for Virtual

3 Crossmatching must be agreed with the clinical transplant teams and documented. G4.2.2 There must be evidence that the eligibility of each patient has been evaluated when a virtual crossmatch has been performed. G4.2.3 The transplant protocol must include evidence that the clinical teams are aware of the possibility of errors in donor offer typing. G4.2.4 The Virtual Crossmatch result must be reported by the laboratory to the transplant clinician before the transplant proceeds. G4.2.5 Evidence that the Virtual Crossmatch was reported must be documented. G4.2.6 Patients are only eligible for virtual crossmatching if G There have been no potential sensitising events since the last serum sample screened. G must have been collected as defined in G2.3 G Sera must have been collected as defined in G2.3 G G At least two different samples must have been tested. must include at least one serum screening result obtained within the previous 3 months G At least two different samples must have been tested. G At least one serum screening result obtained within the previous 3 months must be included These standards have been renumbered. In some cases wording has been adjusted to make sense with the new standards. G must be tested by a technique of equivalent sensitivity to that used for G Sera must be tested for antibody specificity identification by a technique of at least

4 crossmatching equivalent sensitivity to that used for crossmatching NEW G4.3 Virtual Crossmatching for Unsensitised Patients NEW G4.3.1 A prospective crossmatch may be omitted for patients: G Who test consistently negative for the presence of HLA-specific antibodies, as relevant for the transplant protocol. G who test consistently negative for the presence of HLA-specific antibodies, as relevant for the transplant protocol (G4.2.1). These Standards have been renumbered G (G3.120) for whom there must be evidence that the laboratory maintains a record of potentially sensitising events G for whom there must be documented evidence that the laboratory maintains a record of potentially sensitising events NEW G4.4 Virtual Crossmatching for Sensitised Patients NEW G4.4.1 The prospective crossmatch may be omitted in carefully selected HLA immunised recipients in whom acceptable and/or unacceptable mismatches have been clearly defined and documented. NEW G4.4.2 If a prospective crossmatch is omitted from an alloimmunised recipient, the method of antibody identification must rely on single antigen technology. NEW G4.4.3 The Virtual crossmatch must include data from single antigen testing performed on a sample collected within the last 3 months. NEW G4.4.4 Patients are ineligible for virtual crossmatching if they have antibodies against

5 specificities for which the donor has not been typed. NEW G4.5 Retrospective Crossmatching G4.2 If retrospective crossmatches are performed according to G4.1.2 G4.5.1 If retrospective crossmatches are performed according to G4.1.3 This standard has been re-numbered and the reference updated. G4.2.1 to G4.4.3 G to G4.7.3 These standards are unchanged but renumbered to accommodate the new inserted standards. I4.4 Unrelated Cord Blood Unit Typing at Transplant Centre for Donor Selection Unrelated Cord Blood Unit Typing for Donor Selection I4.4.1 Verification typing must: Verification typing must be performed Comments were received from EFI members stating that this typing is rarely performed by the laboratory affiliated with the transplant centre due to lack of available sample. This standard has been simplified for clarity. I be performed by the transplant centre, or, if not possible, be performed by the transplant centre, or, if not possible, I by the laboratory designated by the Cord Blood Bank. by the laboratory designated by the Cord Blood Bank. These standards have been deleted I Include as a minimum requirement I Including as a minimum requirement This standard has been re-numbered and the wording has been adjusted to accommodate the changes to I4.4.1 Standards. I to I I to I These standards are unchanged but renumbered to accommodate the deleted standards. NEW K1.4 The clinically relevant HLA loci and alleles must be documented for each disease association service provided. Comment from an Inspector that some laboratories are not testing all clinically relevant loci for Disease Association

6 L6.1 optimal electrophoretic conditions must be determined L6.1 electrophoretic conditions must be documented. L6.1.1 acceptable ranges must be established acceptable ranges must be established L6.1.2 use of these parameters must be documented use of these parameters must be documented Studies (eg, not testing for DQA1* in celiac disease). The standard has been created to stress that if this service is required, all clinically relevant loci must be tested. Comment from an Inspector. This standard is outdated as laboratories mostly use electrophoretic conditions recommended by the manufacturer. As long as conditions are documented, that is sufficient. L6.1.1 and L6.1.2 have been deleted. L Each assay should include a DNA of known type Each assay should include a DNA of known type Comment from an Inspector this standard refers to forward SSO techniques which are no longer in common use. It is outdated and has been deleted. M Functional checks for laser-based instruments The laboratory must: M Record the current input (amps) and laser light output (milliwatts) at the normal operating wavelength, measured after the laser has peaked and normal operating power has been set Functional checks for laser-based instruments The laboratory must: Record the current input (amps) and laser light output (milliwatts) at the normal operating wavelength, measured after the laser has peaked and normal operating power has been set Comment from a Commissioner. This standard was introduced to ensure that lasers remained aligned in first generation Flow Cytometers. The data is not always available or accessible for modern instruments. It was agreed that this standard is outdated, and it has been deleted. M Define other pertinent regular function checks and document them. Define other pertinent regular function checks and document them.