Inspection Guide for WMDA reviewers

Transcription

1 WMDA Review and Inspection of Unrelated Volunteer Donor and Umbilical Cord Blood Registries Providing Hematopoietic Progenitor Cell to International Patients for WMDA Accreditation Guidelines for Reviewers Edition I, October 2014 Prepared by WMDA Accreditation Steering Committee Page 1 of 12

2 Table of Contents 1.0 Introduction page Qualification and Training of Reviewers page Review Process page Documentation page On- site inspection page Final Report and Decision page Evaluation of Review/Inspection System page 11 Appendix 1. WMDA Standards and Guidance page 12 Appendix 2. Application Forms page 12 Appendix 3. On- Site Inspection Checklist page 12 Appendix 4. Final Report Format page 12 Appendix 5. References page 12 Page 2 of 12

3 1.0 Introduction The WMDA standards are aimed at enhancing the quality of Registries assisting the grafting physician responsible for patient treatment in the international search for an unrelated donor for their patient. This document briefly describes the accreditation process. Qualification and subsequent accreditation of individual Registries by the WMDA is an indication that these Registries are committed to follow WMDA Standards. These standards promote the quality of procedures necessary to obtain, in the shortest possible time, the appropriate quality and quantity of hematopoietic stem cells of the best- unrelated donor suitable for engrafting a patient while protecting the anonymity, health and well being of the volunteer donors. The benefits of WMDA qualification/accreditation include: Internal review. Preparation of a qualification/accreditation package provides a structured approach for registries to comprehensively review and compare their practices, policies and procedures to an international standard. External review. The review of a qualification/accreditation package provides a comprehensive external review by individuals experienced in registry operations. The report of the review committee, including areas requiring improvement, can serve as a template for change. Indication of quality. The fact that a registry is qualified/accredited demonstrates its attention to quality and compliance with internationally accepted standards. Qualification/accreditation should reduce barriers to donor access by ensuring that the registry has the process and procedures needed to provide a sufficient quality and quantity of hematopoietic stem cells from a healthy donor in an appropriate time frame. Standardization. Establishing a process of Registry accreditation means that a minimum set of standards has been created by the international registry community. This helps transplant physicians and competent authorities feel more assured that donor selection, product collection and manufacturing practices have a set of minimum standards by which all registries operate. Compliance with national regulatory entities. National regulatory authorities may use WMDA qualification/accreditation to meet their requirements for the national registry. Compliance with regulatory entities in countries where products are exported or imported. National regulatory authorities, concerned about the quality of products imported from abroad may accept WMDA qualification/accreditation of those registries to address their requirements. In addition, national regulatory authorities, concerned about the appropriate use of products exported to abroad, may accept WMDA qualification/accreditation of those registries to address their requirements. Page 3 of 12

4 Registries follow a two- step process. The first- time application, in which documents are reviewed but no on- site inspection is performed, results in WMDA qualification status. During the review, the focus is compliance with key benchmark standards. Following a period of no more than 5 years, the second step involves a review of documentation and an on- site inspection. This results in WMDA accreditation, effective for 4 years before it must be renewed. An annual self- evaluation is also required of qualified and accredited registries with the results of that evaluation submitted to the WMDA for review every second year. The process of qualification/accreditation is overseen by the WMDA Accreditation Committee and its Accreditation Steering Committee leadership, with the support of the WMDA Office. The Accreditation Committee is a committee of the WMDA Board and reports to it. 2.0 Qualification and Training of Reviewers 2.1 Education and Experience Reviewers are unpaid volunteers who are a member of the WMDA or affiliated with a WMDA member registry. The reviewers should have a level of training as described in 2.2 and have the necessary education and experience, at least three years experience in some aspect of registry operations. 2.2 Training The WMDA has established a training programme for reviewers. For new reviewers: The reviewers have taken and passed a written exam on accreditation and prior to participation on a review committee as a trainee. After this exam the reviewer participates as a trainee in a document- based review. For continuing training and continuous development: The reviewers must attend reviewer workshops and accreditation meetings at a minimum as documented by attendance records. Also, the WMDA offers web- based continuing education programs. 2.3 Responsibilities The role of the reviewer is to verify the compliance of the registry with the WMDA Standards. The reviewers sign a conflict- of- interest form regarding the registry under review. Reviewers may not accept any payment or gifts from that registry during the review process other than reimbursement of expenses incurred and customary hospitality. Reviewers participating in site visits must perform the review in a cost conscious and timely fashion. Reviewers must behave in a courteous and professional manner during the inspection. Page 4 of 12

5 3.0 Review Process The process is initiated by the receipt of a letter of intent submitted by a registry. This letter requests a specific date for submission of their application for qualification/accreditation. The WMDA office confirms the date and identifies a review team with the approval of the WMDA Accreditation Steering Committee. 3.1 Composition of review team. The review team will consist of two experienced reviewers and a trainee reviewer. One of the team will be designated as the leader and will be responsible for completing all assignments following an established time line. 4.0 Review of Documentation The registry submits an application, which includes standard operating procedures, policies, forms, and other documents to demonstrate the registry s compliance with WMDA Standards. Assessment by other accrediting and/or regulatory bodies is accepted to cover various specific areas of registry activities. For example, JACIE accreditation of transplant centres will meet the requirement for registry oversight of its affiliated transplant centres. Page 5 of 12

6 This application is reviewed by individual members of the review team. A list of deficiencies and a request for more information is compiled, discussed, and submitted to the registry prior to the on- site inspection. The request for more information is provided to the registry within 1.5 months of the receipt of the application. 5.0 On- Site Inspection The inspection will occur usually within one month after the request for additional information. The inspection dates will be scheduled with the registry. Two experienced people will serve as reviewers. The inspection will focus on an audit of the system proceeding from donor/cord blood search to further confirmatory/validation testing to work- up and collection and finishing with donor follow- up. Quality management will also be assessed. The on- site inspection will take days. 5.1 Preparation The registry will provide information as to what files are to be found on- site. This will vary from registry to registry. For example, a registry may serve as a donor centre and will have files related to donor recruitment on site while other registries may work with independent donor centres and will not have these files on site. In the latter case, the WMDA will evaluate audits that the registry conducts of its donor centres. Deficiencies identified during the review of documentation as well as deficiencies from any prior review/inspection will be further evaluated during the inspection. A plan for the inspection will be sent to the registry in advance. Address any issues from the pre- inspection review that require specific investigation during the inspection and any relevant issue notices during the document review of the registry to ensure that it is discussed during the inspection. Checklists guide the process. Prior to the inspection, the reviewers should familiarize themselves with the registry to be inspected. This should include at least: Review of the document application submitted by the registry. The reviewers should bring a copy of the application with them to the on- site inspection. A review of the reports from previous inspections. Significant changes. A review of the follow- up action (if any) arising from previous inspections. Information about the available files at the registry. In the evening before the inspection, the reviewers should meet to discuss the plan for the inspection and identify areas that might require extra attention. Page 6 of 12

7 5.2 Inspection During the Inspection Reviewers should strive to create a positive atmosphere during the inspection. A reviewer should be aware of his/her influence on the decision making process. The reviewer should answer questions but avoid the role of consultant. However, the task of a reviewer is not entirely limited to the disclosure of deficiencies; he/she should connect an observation with educational and motivating elements. Reviewers may disturb the normal work patterns within a registry. Therefore, the reviewers should take care not to put the provision of hematopoietic stem cells at risk, and should carry out their work in a careful and planned way. Reviewers will, while conducting the inspection, have access to confidential information and should handle it with integrity and great care. An outline of the audit programme: Opening meeting: introductions, plan for day. o Reviewers introduce themselves and sign a registry- provided confidentiality document. The reviewers explain the purpose and scope of the inspection. Plan for the day will be sent in advance to the registry and will depend on the tasks performed and files held at the registry. Reviewers describe the system audit process and review the plan with the group. There may be some general questions at this time. o The registry presents the management structure of the registry (organizational chart). Staff members are introduced to the reviewers TIP: look during the opening meeting to see if the registry staff is feeling comfortable, if they look defensive and whether they feel that the inspection is valuable or not necessary. Rapid registry tour: The purpose of this tour is to provide an overall assessment of the registry facilities and the general organization of the registry. The details of registry operations should not be covered at this time. Usually one member of the registry will accompany the reviewers during the day. This is usually the quality manager of the registry. If the language of the registry is not English, a member of the registry fluent in English should accompany the reviewers. The goal of the tour is familiarization of the registry. Search process. Reviewers will meet with one staff member who handles international search requests. If there are several staff members who handle this stage, the reviewers may randomly select one to interview. This meeting takes place at the workstation of the staff member. The reviewers will ask questions about the search process, will ask to see current files being worked on by the staff member, may ask to see a relevant SOP, form or guidance. Reviewers may solicit information on training. Page 7 of 12

8 o Check the search requests (maximum 5, cord blood/donors) received at the moment of inspection OR o Check the search requests (maximum 5, cord blood/donors ) received in the last month Confirmatory typing/verification typing process. Reviewers meet with one staff member who handles international requests. There may be a separate staff member handling requests for cord blood typing. If so, meet separately with this second individual. This meeting takes place at the workstation of the staff member. The reviewers will ask questions about the process, will ask to see current files being worked on by the staff member, may ask to see a relevant SOP, form or guidance. Reviewers may solicit information on training. o Check CT (maximum 3) requests received and completed for donors/cord blood o Check CT (maximum 3) requests received and not completed o If no files are available, check the audit report of the donor centre during the quality management review Work- up/collection process. Reviewers meet with one staff member who handles the international work- up/collection stage. There may be a separate staff member handling requests for cord blood typing. If so, meet separately with this second individual. This meeting takes place at the workstation of the staff member. The reviewers will ask questions about the process, will ask to see current files being worked on by the staff member, may ask to see a relevant SOP, form or guidance. Reviewers may solicit information on training. o Check HPC donations (maximum 3) proceeded to work up o Check HPC donations (maximum 3) that did not proceed to work- up o Or check audit report of the donor/collection centre covering work- up/collection/cord blood bank during the quality management review o Check one cord blood shipment for international patient Quality management, donor follow- up, S(P)EAR, audits of other entities, training. Reviewers meet with the quality manager and any other individuals familiar with the areas being audited. This meeting takes place in a conference room. The reviewers will ask questions about several areas and will request various random documents and files for review. o Donor follow- up, long term and short term. The reviewers will ask questions about the process, will ask to see random files, and may ask to see a relevant SOP, form or guidance. o S(P)EAR. The reviewers will ask questions about the process, will ask to see random files, and may ask to see a relevant SOP, form or guidance. o Internal and external audits of associated entities (Collection Centres, Donor Centres, Cord Blood Banks, Transplant Centres, testing laboratories (IDM, blood Page 8 of 12

9 group, HLA)). The reviewers will ask questions about the process, will ask to see random audits, and may ask to see a relevant SOP, form or guidance. It is understood that the contents of a specific audit report can remain confidential; however, the reviewers should be able to see report in a general way and may ask for documentation on follow- up of corrective action. o Training. Reviewers will ask questions about the process and may ask to see training records of specific staff. o Quality management. The reviewers will ask questions about the process, may ask to see complaints/corrective actions, and may ask to see a relevant SOP, form or guidance. Versions of documents observed by reviewers during the day are reviewed with manager to examine whether these versions are the correct ones for the date of the activity. o IT. Any IT questions may be asked at this time. Additional questions. Reviewers pose additional final questions to any of the staff they have talked to during the day and the registry has the opportunity to clarify or correct. Reviewers complete checklists and draft inspection report. Final group meeting: findings. The reviewers meet with senior registry staff and/or others to verbally share their general observations made during the on- site inspection. Reviewers thank staff. The deficiencies, observed during the inspection should be described clearly. An indication should be given verbally of the seriousness of the deficiency. Deficiencies should be reported with reference to the WMDA standards. A written report is not provided at this time. Reviewers complete inspection report prior to departure. Tips: Performing an interview with a staff member of the registry is difficult, especially when English is not one s first language. If asking questions to a staff member of the registry it is important to be an effective interviewer, using the following approaches: - Observe; silence is OK - Asking questions in an unbiased way - Ask more questions: when do you do this, how do you do this - Recognize the message behind the words - Repeat or summarize the response Besides asking questions, take an active listening attitude: - Listen to non- verbal reactions - Summarize by saying: is it right that - Empathize Page 9 of 12

10 - React that the situation is understood In an interview it is important to ask open questions. Open questions are questions starting with WHEN, WHAT, HOW and WHO. Be careful with the questions starting with WHY, because that might frighten the staff member. Example question: what do you do when a donor is not available for verification request? If the staff member is silent, it might be that they have not fully understood your question. You can check if they have understood your question, but do not push them to the answer you would like to hear. For example, don t ask: do you know that search requests need to be handled within 24 hours? It is also important that you ask more questions, if you do not fully understand the response. Keep in mind what you would like to know and ask more questions. If you would like to write your final written report it is important that the report is complete and correct. Avoid leading questions where the staff member is driven in a direction. For example, don t ask: When you are initiating a CT request, do you certainly use EMDIS? The checklists include possible questions the reviewer might ask of the registry staff. These questions are not required, but may be asked to help the reviewer familiarise themselves with a certain process, in order to successfully complete the checklist. In summary: - Take care for comfortable circumstances (good atmosphere, good seats) - Be clear about the length of the interview 5.3 Inspection After the Inspection A written inspection report (proposed format) should describe the scope and observations arising from the inspection. The report on the audit should be at least drafted, preferably finalized, before the reviewers depart. The report should contain a reference to the WMDA Standards with suggestions to the registry. The conclusions should clearly identify deficiencies, classifying them as critical, major, observation of concern, suggested improvements or comment. Find below the definitions: Critical issue - Has a high probability of resulting in patient or donor risk, adverse reaction, injury or death. Could result in a product recall or may be a serious violation of WMDA Standard. Action must be taken immediately to eliminate the cause of these non- compliances. A critical issue will also be raised if a major issue Page 10 of 12

11 has not been corrected in the agreed time period. A critical issue may require a further visit from a reviewer after it has been corrected by the Registry. Major issue - Has potentially serious implications upon product quality and could lead to "out of specification" situations, or close to failure. Initial impact may not be associated with immediate patient safety, but could be affected long term. Usability of product could be impaired. It will also be deemed necessary to raise a major issue when it is identified during the audit process that the documented procedures are not being followed. A major issue will be raised for any action that will require attention prior to the next scheduled site visit. Observation of Concern - Cannot be ignored but has an extremely low probability of product failure and unlikely to affect patient safety. As a general rule, these will be checked at the next audit, but this will be at the discretion of the review subcommittee. Depending on the issues identified, it may be felt that the issue cannot wait until the next site visit. In these cases, the issue should be resolved as soon as possible. If action has not been taken, the issue will be raised again but shown as a major issue. Suggested Improvements This allows the reviewer the opportunity to highlight any suggestions of improvement identified during the audit. Comments Any further information that does not fit into the previous categories. These deficiencies, improvements and comments are incorporated into the final report. 6.0 Completion of Final Report and Decision Regarding Qualification/Accreditation The review team will compile their final report, including their observations from review of submitted documentation as well as the on- site inspection. This report and their recommendations will be forwarded to the Accreditation Committee and discussed with the review team leader during a conference call. During that call, a decision is made regarding approval of qualification/accreditation. If the Accreditation Committee is not unanimous or votes for disapproval, the report and vote will be sent to the executive committee of the board for a decision on how to proceed. 7.0 Evaluation of Review/Inspection System 7.1 System Performance. Benchmarks evaluated annually include: Number of reviews/on- site inspections each year Number of registries qualified/accredited each year Page 11 of 12

12 Average time from receipt of application to final report/decision 7.2 Reviewer Training and Performance. Benchmarks evaluated include: Completion of training by each reviewer (initial training, continuing training) Number of reviews performed by each reviewer Evaluation of performance of each reviewer Average time for completion of reports by each reviewer Reviewers who no longer qualify (or state as reviewers who need to undergo additional training to retain their status) 7.3 External Evaluation. The WMDA accreditation programme should work towards periodic evaluation by an external body (like ISQUA). Appendix 1. WMDA Standards and Guidance WMDA Standards Guidance WMDA Standards Appendix 2. Application Forms Application table Letter of Intent for WMDA Accreditation Instructions how to prepare the application package Appendix 3. On- Site Inspection Checklist Being updated Appendix 4. Final Report Format Being updated Appendix 5. References Hurley, C.K., C. Raffoux on behalf of the World Marrow Donor Association World Marrow Donor Association international standards for unrelated hematopoietic stem cell registries. Bone Marrow Transplantation 34: Hurley, C.K., L. Foeken, M. Horowitz, B. Lindberg, M. McGregor, N. Sacchi on behalf of the WMDA Accreditation and Regulatory Committees. Standards, regulations, and accreditation for registries involved in the worldwide exchange of hematopoietic stem cell donors and products Bone Marrow Transpl 45: [Current standards, accreditation documents] Inspection of Tissue and Cell Procurement and Tissue Establishments, Guidelines for Competent Authorities, European Union Standards and Training in the Inspection of Tissue Establishments (EUSTITE) Edition II, May 2008 Page 12 of 12