EFI ACCREDITATION PROGRAM. INSTRUCTIONS TO APPLICANT - PACKET A and C: APPLICATION FOR ACCREDITATION AND RENEWAL OF ACCREDITATION

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1 EFI ACCREDITATION PROGRA INSTRUCTIONS TO APPLICANT - PACKET A and C: APPLICATION FOR ACCREDITATION AND RENEWAL OF ACCREDITATION Please read all instructions carefully and review the enclosed EFI standards thoroughly before completing the application. See the Accreditation Procedure anual, published on the EFI accreditation site: (quick links Accreditation, Download files, Procedure anual), for full details of the accreditation process procedures. N.B. Provide your EFI laboratory number and application date at the top of each page of packet A/C. For application to Packet C Please note accreditation will be suspended 6 months after the expiring date of the certificate if packets have not been received within the appropriate time frame. Please ensure your packet is submitted in time to allow for completion of the inspection and any corrective actions prior to the expiring date. Cover Page PA/C-1-2 Complete the cover pages and append it to the front of the application. Provide the names of the Director, and Co-Director(s), if applicable, the laboratory, department and institution, as they should appear on the accreditation certificate. ark all accreditation categories and accreditation techniques for which you are seeking accreditation. A matrix of accreditation categories and required techniques can be found in the table on page IA/C-4 of these instructions. The agreement must be dated and signed by the Director/s on PA/C-1. Submit an organogram of the laboratory with positions and names of persons at the staff and supervisory levels (addendum #1). If the laboratory is part of a larger department, an overview of the department must also be provided (addendum #2). Director/Co-Director Qualifications (Standard B1.1) PA/C-3 As described in section B1.1 of the EFI standards, accreditation of a laboratory requires the laboratory to be directed by an individual (or individuals) who meet certain requirements of academic degree and training and/or experience. While titles may vary locally (e.g. Director, Head, anager etc), the terms Director and Co-director will be used in reference to this/these individual/s throughout the accreditation process. The term Director will be used by EFI to denote the individual with the main scientific/clinical responsibility for the laboratory. Where there is more than 1 individual employed with the necessary qualifications and experience and with similar levels of responsibility these may be referred to as either Director or Co-Director appropriate to the organization of the laboratory. The director/co-directors must establish competency of staff and provide adequate supervision and participation in laboratory activities at a time level commensurate with the laboratory s workload. Provide information on any new director or co-directors and director or co-director who has left the laboratory since the last packet submitted. Page PA/C-3 must be completed for all individuals designated as Director or Co-Director. Provide a detailed description of the duties of each individual in addendum #3. CV s (addendum #4) must be submitted and must include details of qualifications and training in H&I. A list of publications must be submitted (addendum #5). Where more than one Director/Co-Director is employed, use a copy of PA/C-3. As detailed in standard Standard B1.1 the Director/Co-Directors must be informed of and comply with all relevant national legislation. The Director/Co- Directors must be able to demonstrate that the laboratory operates according to national legislation and relevant regulations (e.g. regulations governing transplantation activities, health and safety, national licensing or registration staff etc). Instructions to Packet A and C based on the Standards version 6.2. Effective 1 st October IA/C - 1

2 As detailed in Standards C11.5 a Director may appoint designated individuals to sign reports if necessary. A policy defining who may act as designated individuals must be included in addendum #3. Technical Supervisor s Qualifications (Standard B1.2) PA/C-4 Requirements for the qualifications of Technical Supervisors are described in the EFI standards (B1.2). Page PA/C-4 is to be completed for the technical supervisor(s); a description of duties, CV and list of publications must also be submitted (addenda #3-5). Personnel and Continuing Education PA/C 5-7. List on pages PA/C 5-6 all personnel involved in the histocompatibility and immunogenetics activities of the laboratory. Include on page PA/C-5 information on the director(s), co-director(s), technical supervisor(s), technical personnel, etc. Include in the list of the non-technical staff on page PA/C-6 secretary(ies), computer programmer(s), administrator(s), etc. A summary of participation in educational activities (addendum #6) is required for Director(s), Co- Director(s), technical supervisor(s), and each member of the technical staff. odifications in the laboratory over last year (only applicable to Packet C) PA/C-7 Provide, in a separate addendum #7 description of any modifications in laboratory management, procedures or facilities either implemented or abandoned during the year previous to this application. Laboratory Activities PA/C 8-10 Provide data covering the year (1 January 31 December) previous to application. Accreditation techniques and accreditation categories - PA/C Sections VIII to XVII refer to accreditation techniques (typing, antibody screening and identification, crossmatch) and accreditation categories (renal, other solid organ, HSCT, chimerism, transfusion). Please fill in the tables and submit addenda (#8 to #20) as requested. Quality Assurance - PA/C A list of the Laboratory s SOPs is required (addendum #21). Note that SOP s should not be submitted unless requested. A copy of reports and required SOP s may be submitted in the local language and all other documents must be provided in English. Addenda #23 to #26 must also be provided. External Proficiency Test Results PA/C-20, PA/C-22 Accreditation of the techniques used is based on skills proven in the EPT program(s) by satisfactory performance for each of these techniques. In order to obtain accreditation, successful participation in external proficiency testing (EPT) programs must be documented. The EPT program shall be approved by EFI. Performance of the tests must be rotated among all technologists performing the technique. EPT samples must be processed in the same way as routine samples. Submit as addendum #22 a summary of all EPT results of your laboratory for the period covering 1 January till 31 December of the year previous to the application, including the annual certificate and details of the review and any corrective actions for all errors made. If necessary indicate your laboratory identification code as used in reports. Copies of raw data and submissions to EPT providers are not required for the packet but should be available for examination during on-site inspection if requested. Summarise your EPT results in the table on PA/C-22. Indicate the name of the Proficiency Testing Program, the technique(s) used, the number of tested specimens, the number of not tested specimens and the number of discrepancies. The current requirements for numbers of samples to be tested for each technique, the definition of consensus and the definition of discrepancies can be found on the EFI-website ( Instructions to Packet A and C based on the Standards version 6.2. Effective 1 st October IA/C - 2

3 Submission of Application Your laboratory is requested to return the completed packet A or Packet C and the required addenda as a paper hard copy in 4-fold to the EFI Accreditation Office. For the requested addenda use the enumeration as indicated on page PA/C-23. Please indicate in the column submitted if an addendum is present ( yes ); in case the requested addenda refer to an accreditation category not requested by your laboratory, state no. IPORTANT NOTE: Addenda should be clearly numbered and placed at the end of Packet C. When completing Packet C, do not change the Page numbers. If the space on one page is not sufficient then insert one or more pages with the same page number. Payment of the accreditation fee must be made in Euro and directly transferred to the bank account of the EFI Accreditation Office. Please indicate IBAN and BIC code. Processing of the application will not begin until payment has been received. The commissioner will review the received application materials and two inspectors will be appointed. If the application packet is incomplete, you will be contacted directly by the commissioner (or one of the inspectors). Since incomplete applications will delay the accreditation process, please review all materials carefully before submission. Please note that accreditation cannot be granted until all expenses relating to the inspection process are paid in full. The inspection checklist contains useful guidelines and will help you prepare for the inspection. Prerequisites This section provides guidance for applicants on specific requirements for accreditation in the different categories. Accreditation will only be granted for the technique(s) if skills have been proven by participation and satisfactory performance in relevant proficiency testing program(s), and if the techniques have been validated. The laboratory must participate in an EPT programme for every technique or combination of techniques used. For example if HLA typing is performed by PCR-SSP and PCR-SSO then both techniques must be assessed in an appropriate programme. The laboratory must keep records of the validation of all techniques and make these available to the Commissioner/Inspectors as required. To obtain accreditation in Antibody Screening, laboratories must have experience in the detection of HLA-antibodies. Services for renal transplantation require skills in antibody detection and identification. There is a choice in techniques to be used: CDC, Flow cytometry, ELISA and/or Bead array techniques. The laboratory must describe how newly introduced techniques have been validated (EFI standard C8.2.1) and when the validated technique has been or will be used to test EPT samples. For example, if the laboratory uses ELISA as a serological technique for HLA antibody detection and determination of antibody-specificities in addition to CDC, then ELISA tests for antibody detection and determination of antibody specificity must be part of the proficiency testing. Another example is, if the laboratory uses flow cytometry for the crossmatch in donor-recipient selection, then flow cytometry must be part of the proficiency testing exercise(s). An overview of requirements for various accreditation categories is presented below. To obtain accreditation for Organ Donor Typing, compliance with EFI standards and, in addition, compliance with regulations of the Organ Transplant Organization and national legislation are mandatory. To obtain accreditation for recipient typing in Renal Organ Transplantation, laboratories must have experience in HLA-A, B, DR typing either by CDC or by DNA technology at the 2-digit level, dependent on the techniques applied for routine testing and proven by satisfactory performance in proficiency testing program(s). For transplantation of non-renal solid organs, it is not mandatory to perform HLA- A, B, DR typing and antibody testing for each individual patient-donor combination. However, experience in these techniques is mandatory for these clinical applications because for some individual Instructions to Packet A and C based on the Standards version 6.2. Effective 1 st October IA/C - 3

4 patients these tests might be indicated due to the local protocol and/or regulations of the Organ Exchange Organization. To obtain accreditation in unrelated Haematopoietic Stem Cell Transplantation experience in DNA based typing at the level of high resolution class II (HLA-DRB1*) as defined in standard D1.4 - D is mandatory. High resolution typing for class I is mandatory if required by the local transplant protocol. To obtain accreditation for related Haematopoietic Stem Cell Transplantation the laboratory must be able to type at the level of high resolution for class II &/or class I to establish the degree of matching meets that required by the transplant protocol if identity by descent cannot be proven. Laboratories applying for accreditation of high resolution DNA typing must be able to report EPT results at the high resolution level on HLA-A*, B*, C* and DRB1*, DQB1* alleles (exon 2+3 for class I and exon 2 for class II) as listed in the most recent IGT/HLA database ( If the laboratory is not able to perform high resolution typing there is the possibility to subcontract these services to EFI accredited laboratories. HLA typing for Disease Association may be done with any appropriate technique dependent on the level of resolution required for the allele(s) under investigation. Laboratories applying for accreditation for Transfusion purposes must comply with the standards relating to HLA and/or HPA and/or HNA testing as appropriate to the range of services provided. Laboratories providing services to support platelet refractory patients must have proven experience in low resolution class I typing and in antibody specificity determination or crossmatching. Requirements for EFI accreditation categories Low resolut ion Organ Transplantation - Recipient Typing High resolution class II High resolution class I - Antibody Screening - Antibody Identification - Donor Typing - Cross-atching HSCT - Donor Registry Typing - Related Donor Typing #1 #1 - Unrelated Donor Typing - Cord Blood Typing - Cross-atching Disease association studies antibody detection Transfusion - Platelet refractoriness #2 - Transfusion related Acute Lung Injury specificity testing = andatory #1 = andatory if necessary to determine required degree of matching where identity by descent not proven #2 = andatory unless crossmatching is performed as an alternative Inspection Instructions to Packet A and C based on the Standards version 6.2. Effective 1 st October IA/C - 4

5 The on-site inspection will be performed by two inspectors. ost inspections can be completed in a single day. To facilitate a thorough evaluation, please have all records readily available and designate at least one individual to assist the inspectors in accessing the necessary information. The procedures (as detailed in addendum #21) should be readily available for the inspectors to consult as they choose. Staff involved during the inspection can be expected to include the Director/Co-director, technical supervisors and any quality assurance officer as well as staff performing routine tasks throughout the laboratory. On the day of on-site inspection the inspectors will need to observe the processing and testing of routine samples and may request testing of a specific sample which they provide. All testing performed on the day of inspection must be according routine practice. The inspectors must complete the inspection checklist. The inspection checklist has to be signed by both inspectors and signed by the representative of the laboratory to confirm that findings have been communicated/agreed. A copy of the checklist remains in the laboratory. At the end of the inspection, an exit interview will be conducted to summarize the items that will be part of the inspectors report to the commissioner. After receipt of the inspector report the Commissioner will send a report to the laboratory detailing any findings and required corrective action. The laboratory must take the necessary corrective actions and report back to the Commissioner with supporting evidence in a short time not more than 4 weeks. Upon receipt of satisfactory actions the Commissioner will recommend accreditation of the laboratory. In case of severe deficiencies, an interim inspection might be imposed by the commissioner to determine if all the deficiencies have been fully corrected. The inspection questionnaire should be completed on the web by the laboratory immediately after the inspection ( In case items in the EFI Standards or the inspection process give rise to questions or proposals for a change, they should be reported to the Accreditation Office by completing the form on page PA/C-24 (update of standards); your input is highly appreciated. Instructions to Packet A and C based on the Standards version 6.2. Effective 1 st October IA/C - 5