Accreditation Program Information - Medical Laboratory
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La version française suit l’anglais (cliquez ici) Diagnostics Accreditation Program Information Medical Laboratory Point-of-Care Diagnostic Testing Imaging Specimen Procurement Status: Current Version 5.6 Page 1 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Accreditation Canada Diagnostics 1500–393 University Ave Toronto, Ontario M5G 1E6 Canada 1-877-323-9540 / 416-323-9540 diagnostics@accreditation.ca https://diagnostics.accreditation.ca Status: Current Version 5.6 Page 2 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Preface .................................................................................................................................................................. 5 Who Is Accreditation Canada Diagnostics? ......................................................................................................... 5 Conflict of Interest and Impartiality ...................................................................................................................... 5 Accreditation Programs Offered by AC Diagnostics............................................................................................ 5 What is Accreditation? ......................................................................................................................................... 6 AC Diagnostics Credentials.................................................................................................................................. 6 The AC Diagnostics accreditation program ......................................................................................................... 7 AC Diagnostics Accreditation Cycle .................................................................................................................... 8 AC Diagnostics Steps to ISO 15189 Plus™ Accreditation ................................................................................... 9 French Language services ................................................................................................................................. 10 Fees..................................................................................................................................................................... 10 AC Diagnostics Information Through Electronic Subscription ......................................................................... 10 AC Diagnostics/IQMH Accreditation Requirements ........................................................................................... 11 ISO 15189 Plus™ Medical Laboratory ................................................................................................................ 11 Limited Checklists for Special Circumstances (Medical Laboratory Program) ................................................. 13 ISO 15189 Plus™ Diagnostic Imaging ................................................................................................................ 14 ISO 15189 Plus™ Specimen Procurement ......................................................................................................... 15 Other Supporting Documents............................................................................................................................. 16 Applicable to All Programs ............................................................................................................................ 16 Medical Laboratories and POCT ................................................................................................................... 16 AC Diagnostics Assessors ................................................................................................................................. 17 Medical Laboratory Accreditation Advisory Panel ............................................................................................. 17 Diagnostic Imaging Accreditation Decision Panel ............................................................................................. 17 AC Diagnostics Accreditation Process .............................................................................................................. 18 Sharing of Documentation and Correspondence............................................................................................... 18 Multi-Site Facilities ............................................................................................................................................. 18 Self-Assessment ................................................................................................................................................. 18 Pre-Visit Activities .............................................................................................................................................. 19 Notification ................................................................................................................................................... 19 Document Review ........................................................................................................................................ 19 Assessor Selection ....................................................................................................................................... 19 The Assessment ................................................................................................................................................. 20 Falsification of Documents or Records .......................................................................................................... 20 Categorization of Non-Conformances............................................................................................................ 20 Post-Visit Activities ............................................................................................................................................ 21 Corrective Actions ........................................................................................................................................ 21 Decision Making ........................................................................................................................................... 22 Certificate .................................................................................................................................................... 22 List of Accredited Facilities ................................................................................................................................ 22 Surveillance Assessments ................................................................................................................................. 24 Scheduled surveillance assessments ............................................................................................................ 24 Unscheduled surveillance assessments ........................................................................................................ 24 Proficiency Testing Surveillance for Medical Laboratories ............................................................................... 25 Status: Current Version 5.6 Page 3 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Rights and Obligations of Accreditation Clients................................................................................................ 26 Scope Additions ................................................................................................................................................. 27 Appeals ............................................................................................................................................................... 27 Complaints.......................................................................................................................................................... 27 Suspension of Accreditation or Reduction of Scope ......................................................................................... 27 Withdrawal .......................................................................................................................................................... 27 Transfer............................................................................................................................................................... 28 Cross-Frontier Accreditation .............................................................................................................................. 28 Accreditation Symbol ......................................................................................................................................... 29 Confidentiality..................................................................................................................................................... 29 Definitions........................................................................................................................................................... 30 Status: Current Version 5.6 Page 4 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
PREFACE This document provides a complete description of the accreditation programs offered by Accreditation Canada Diagnostics (formerly IQMH, Centre for Accreditation) for use by potential and existing clients. Who Is Accreditation Canada Diagnostics? On October 7, 2019, the Institute for Quality Management in Healthcare (IQMH) became a controlled affiliate of Accreditation Canada (AC). Today, an integrated business operating model has been developed to further separate operations. The IQMH Centre for Accreditation is now a part of Accreditation Canada under a new name, AC Diagnostics, and has been rebranded. Our accreditation services have achieved world-wide recognition: Accreditation Canada is a signatory to the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) for Medical Testing (ISO 15189). Our organization is regularly evaluated to ensure we meet the requirements of ISO/IEC 17011 Conformity assessment – requirements for accreditation bodies accrediting conformity assessment bodies. This achievement demonstrates that we meet rigorous international standards for quality and competence. CONFLICT OF INTEREST AND IMPARTIALITY We are committed to maintaining the trust that stakeholders and clients have in our accreditation services. Impartiality is ensured with the self-declaration of any conflicts of interest by all staff, assessors and advisors. Advisors consist of professionals of stature who have broad knowledge of operations, quality assurance practices, management skills, and who represent a cross-section of practitioners. No single party predominates. AC Diagnostics activities are conducted impartially. Accreditation decisions are based on objective evidence and made impartially with independent oversight. See the AC Diagnostics Impartiality and Operating Principles Policy posted on our website ACCREDITATION PROGRAMS OFFERED BY AC DIAGNOSTICS SERVICE ACCREDITATION PROGRAM NOTES Voluntary program for medical laboratory accreditation throughout the world. ISO 15189 Plus™ Mandatory program for all medical laboratories and Medical Laboratories their specimen collection centres in the following Medical Laboratory Canadian Provinces: • Ontario (modified program) • Newfoundland and Labrador • New Brunswick ISO 15189 Plus™ Voluntary program for providers of specimen Specimen Procurement procurement services who are not connected to a Specimen Procurement licensed medical laboratory. Mandatory program for all facilities in Ontario engaged Echocardiography Quality Echocardiography in adult echocardiography diagnostic testing. Contact Improvement (EQI) Program eqi@acdiagnostics.ca for more information. ISO 15189 Plus™ Voluntary program for providers of diagnostic imaging Diagnostic Imaging Diagnostic Imaging services. ISO 15189 Plus™ Voluntary program for providers of point-of-care testing Point-of-Care Testing Point-of-Care Testing services. Status: Current Version 5.6 Page 5 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
WHAT IS ACCREDITATION? Accreditation is the evaluation of processes to ensure quality and competence, through conformance to an acknowledged standard. Clients accessing services such as medical laboratory testing, medical specimen procurement, point-of-care testing, echocardiography and diagnostic imaging expect reliability and high quality. Accreditation elevates the confidence of patients, healthcare providers, facility administration, government and of all those working in the accredited service. ISO 15189 is the standard of choice for the accreditation of medical diagnostic facilities. It requires standardized processes and procedures for both quality system and technical requirements. It sets up a no-blame environment that drives continual improvement, establishes an interface with users and ensures the reliability and accuracy of test results. AC Diagnostics accreditation programs assess the ability of a facility to perform diagnostic testing with formal recognition of this competence through accreditation to our ISO 15189 Plus™ requirements. It also provides facilities with the tools they need to standardize their processes, address diminishing resources, mitigate risk and drive continual quality improvement; ultimately improving patient safety. Accreditation elevates confidence in the healthcare system. AC DIAGNOSTICS CREDENTIALS Accreditation Canada is now a signatory (ISO 15189) to the Mutual Recognition Arrangement (MRA) of the International Laboratory Accreditation Cooperation (ILAC) and its regional Asia Pacific Accreditation Cooperation (APAC). ISO 15189 Plus™ certificates granted under this MRA are recognized world-wide. They provide recognition of competence and underscore the facility’s experience, superior technical competence and reliability. Our signatory status with the APAC MRA is a working arrangement that assists facilitation of international trade and acceptance of testing results. To achieve this important international status, AC Diagnostics maintains the processes of IQMH, Centre for Accreditation and has carefully aligned its accreditation processes with ISO 17011:2017 Conformity Assessment – Requirements for accreditation bodies accrediting conformity assessment bodies, ILAC and APAC policies and guidelines for assessment, assessor qualifications, training and competence. AC Diagnostics undergoes international peer evaluation on a regular basis to maintain its MRA signatory status. As part of the Mutual Recognition Arrangement, AC Diagnostics recognizes medical testing performed in the accredited laboratories of other economies with signatory status as equivalent. More information and the complete list of signatories can be found at www.ilac.org and at www.apac.org. Status: Current Version 5.6 Page 6 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
THE AC DIAGNOSTICS ACCREDITATION PROGRAM 1. IMPLEMENTATION OF AN ISO QUALITY MANAGEMENT SYSTEM AC Diagnostics (formerly IQMH Centre for Accreditation) embraces the quality principles of the International Organization for Standardization (ISO). An ISO quality management system provides facility management with a systematic set of tools in order to document processes and procedures, control documents and measure progress with quality indicators, occurrence management, internal audits and management reviews. Utilization of these tools of self-analysis promotes continual improvement. In addition, the implementation of a quality management system provides a solid base and infrastructure on which to add efficiency initiatives such as LEAN. 2. ASSURANCE OF TECHNICAL COMPETENCE The AC Diagnostics/IQMH accreditation program requisites contain management requirements and very specific technical requirements to ensure overall competence in performing the service. AC Diagnostics assessment teams are composed of peers carefully selected to mirror the entire scope of the services and provide the right technical expertise. 3. RISK REDUCTION An effective quality management system reduces risk and improves patient safety through the implementation of tools to measure and mitigate risk. 4. STAFF CONFIDENCE A quality management system can foster healthcare reform and provide an environment in which staff can perform their best. Staff contribution, involvement and professionalism are encouraged, and morale is improved. The implementation of the accreditation requirements, particularly the quality management system requirements, will present many new learning opportunities for staff, and new career paths such as quality manager positions will emerge. The process provides excellent validation of the quality of the service. Additionally, participating as a peer assessor will develop another set of valuable tools for individual growth and professional development. 5. IMPROVED COMMUNICATION Clear documentation of processes and procedures results in improved communication and reduced variability. 6. INTERNATIONAL RECOGNITION AC Diagnostics accreditation is recognized world-wide as a mark of excellence, fostering competitiveness and assisting facilities in expanding their business model. 7. ASSESSMENTS BY PEERS AC Diagnostics accreditation assessments are carried out by a team of trained, certified peers. 8. DEMONSTRATES A COMMITMENT TO QUALITY AND ACCOUNTABILITY Investment in a structured accreditation program demonstrates a solid commitment by management to provide the best quality service and accountability to patients, accreditors and regulators. This is a clear sign that its service can be trusted. 9. SUSTAINMENT OF GAINS The AC Diagnostics program cycle encourages continuous review and maintenance of documentation and processes. Momentum is never lost. 10. CULTIVATION OF FRESH IDEAS The AC Diagnostics accreditation process provides an opportunity for a service to be scrutinized by different eyes, providing different perspectives to cultivate fresh ideas to improve the overall system. In addition, volunteering as an assessor provides a unique opportunity to observe alternative approaches. Status: Current Version 5.6 Page 7 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
AC DIAGNOSTICS ACCREDITATION CYCLE AC Diagnostics accreditation is a four-year cycle with a surveillance assessment every two years and a certificate that is valid for four years. New AC Diagnostics applicants submit a self-assessment within a year of application to determine readiness for assessment. The initial assessment visit can occur in as little as four months after completion of the self-assessment. It will take about five months after the initial assessment to correct any non-conformances identified and for AC Diagnostics to issue an accreditation certificate. Dates are mutually agreed upon, and clients are notified of any delay. New applicants receive a surveillance visit about one year after the issuance of their certificate. This visit is optional for medical laboratories but mandatory for all other programs. New medical laboratory clients may find it useful for improvement of their quality system. A surveillance assessment will occur two years after the initial visit. Full reassessment will occur in another two years. Thereafter, full scope assessments and surveillance assessments will alternate every two years. Additional unscheduled focused surveillance assessments may be required during the four-year accreditation cycle (relocation, poor performance, reopening, request from regulator, etc.). Status: Current Version 5.6 Page 8 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
AC DIAGNOSTICS STEPS TO ISO 15189 PLUS™ ACCREDITATION STEP 1: REQUEST INFORMATION Contact AC Diagnostics via email: accreditation@acdiagnostics.ca or by telephone: 416-323-9540/1-877-323-9540 to request preliminary information about accreditation. Our staff will be pleased to explain the process, the requirements and the fee structure. STEP 2: SUBMIT AN ADMINISTRATION FEE AND APPLICATION FORM Interested facilities must request an application through our website (https://diagnostics.accreditation.ca/Shop) and submit an initial non-refundable application fee of $200.00. Potential clients will be provided with an application form. This document is reviewed by AC Diagnostics staff in order to determine suitability for ISO 15189 Plus™ assessment. STEP 3: PURCHASE THE AC DIAGNOSTICS/IQMH ACCREDITATION REQUIREMENTS (ANY TIME PRIOR TO SELF ASSESSMENT) The AC Diagnostics/IQMH Accreditation Requirements are available for purchase upon request through our website (https://diagnostics.accreditation.ca/Shop) in English for diagnostic imaging and English and French for medical laboratory, point- of-care testing and specimen procurement. It is essential to understand the scope of our ISO 15189 Plus™ program prior to committing to an assessment. ISO 15189 Plus™ accreditation requires facilities to meet a number of rigorous standards, all of which have been incorporated into the Accreditation Requirements along with valuable guidance information. STEP 4: RECEIVE A PROPOSAL FOR ACCREDITATION AND SUBMIT A SIGNED STATEMENT OF INTENT Following review of the information provided in the application form and discussion with the potential client, AC Diagnostics may provide a proposal for accreditation which will include a pricing estimate and a Statement of Intent for completion. Submission of a completed Statement of Intent indicates the accreditation client’s agreement with their rights and obligations. STEP 5: RECEIVE A SELF-ASSESSMENT AND SUBMIT FINDINGS Clients will receive a Self-Assessment Notification. The applicant has one year from the date of submission of the Statement of Intent to complete and submit a self-assessment against the Accreditation Requirements. AC Diagnostics provides electronic tools to aid in this task. A conformance rate of 85% is needed to proceed. STEP 6: RECEIVE AN ASSESSMENT VISIT Upon successful completion of the self-assessment, an assessment visit is initiated. The planning phase is generally four months. Visit dates are scheduled in consultation with the facility. The length of the visit depends on the size and scope of the diagnostic service; generally assessment visits are two to five days in length. STEP 7: SUBMIT CORRECTIVE ACTIONS Facilities have 90 days following the assessment to submit corrective actions (along with evidence) to address any non-conformances identified by the assessment team. STEP 8: SUBMIT FEES AND RECEIVE CERTIFICATE Upon confirmation by the AC Diagnostics Advisory/Decision Panel that all non-conformances have been suitably addressed, the facility will receive an accreditation certificate. Follow-up will include a mid-cycle surveillance assessment. An initial one-year surveillance assessment is available by request. Status: Current Version 5.6 Page 9 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
FRENCH LANGUAGE SERVICES The AC Diagnostics accreditation program for medical laboratories, specimen procurement and point-of-care testing is available in English and French. The language of preference must be conveyed at the time of application; all correspondence will be in the language of choice. Currently, the AC Diagnostics accreditation program for diagnostic imaging is available in English only. FEES AC Diagnostics ISO 15189 Plus™ Accreditation services are paid for directly by clients, on a cost-recovery basis. Applicants pay a non-refundable $200.00 CAD application fee to cover the administrative costs associated with opening of the client file. Facilities pay all direct costs and an administration fee associated with accreditation assessments. Costs include staff and assessor travel, insurance, visas as well as labour associated with application, self-assessment and documentation review, coordination and preparation for the visit, assessment and follow-up activities. Upon issue of an accreditation certificate, accredited services pay an annual maintenance fee. This annual fee is invoiced on the anniversary date of certificate issue, until such time that the certificate expires or is withdrawn. A minimum fee of $500 CAD applies when an application for accreditation scope addition is processed. Note: For those medical laboratories whose participation is mandated by government (e.g. Provinces of Ontario, New Brunswick and Newfoundland & Labrador), cost for a package of services and payment terms are negotiated between AC Diagnostics/IQMH and the government regulator. Laboratories may be responsible for fees associated with scope addition requests as well as unscheduled surveillance assessments (e.g. factors may include relocation, poor performance, reopening, as directed by regulator, etc.). Contact accreditation@acdiagnostics.ca for more information or to obtain a pricing estimate. AC DIAGNOSTICS INFORMATION THROUGH ELECTRONIC SUBSCRIPTION All interested individuals are encouraged to subscribe to the AC Diagnostics subscription service to receive email notifications about news, offers, educational articles and important announcements. Learn more: https://diagnostics.accreditation.ca/ess. Status: Current Version 5.6 Page 10 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
AC DIAGNOSTICS/IQMH ACCREDITATION REQUIREMENTS The IQMH Accreditation Requirements and Guidance Information used by AC Diagnostics are available for purchase by any interested parties at https://diagnostics.accreditation.ca/Shop. Once an application for accreditation is submitted, that facility will receive additional enhanced access to the requirements and guidance information through QView™, our password-protected web portal. This will include automatic updates of new versions of the requirements. The principle international standards on which our programs are based are: • ISO 15189: Medical laboratories —Requirements for quality and competence • ISO 15190: Medical laboratories – Requirements for safety • ISO 22870: Point-of-care testing (POCT) – Requirements for quality and competence For each program, the applicable requirements necessary to issue an accreditation certificate have been defined and extensive guidance has been provided for each requirement. The AC Diagnostics/IQMH Accreditation Requirements and Guidance Information include not only the applicable clauses of the appropriate international standards, but also: • Additional Canadian Statutes and Regulations (for laboratories located outside Canada, local regulations apply) • Provincial Statutes and Regulations • Health Canada Guidelines • Standards and guidelines achieved through consensus by international, North American, Canadian and provincial associations, federations, organizations and regulatory bodies. Because of the extra rigour of our requirements, our programs are brand named ISO 15189 Plus™. Each accreditation requirement has an accompanying reference source. Accompanying each requirement “What To Look For” guidance information that explains the intent of the requirement and provides insight into its application. Usually, this guidance information is phrased as a question, and may include an indication of documents and records required as evidence to meet the requirements. A review of requirements occurs every year. Supporting reference sources are reviewed, updated and their impact (if any) on the wording of requirements is assessed to determine the necessity for a new version of the requirements. At minimum, a new version of the requirements is released once every three years. Any client may offer suggestions regarding the suitability of a requirement at any time; ongoing feedback is recorded and reviewed regularly. The Accreditation Advisory Panel investigates and addresses challenges as needed. Accreditation is the tide that raises all ships. Status: Current Version 5.6 Page 11 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
ISO 15189 Plus™ Medical Laboratory Requirements for the medical laboratory accreditation program are based on the following standards: • ISO 15189 Medical laboratories — Requirements for quality and competence • ISO 15190 Medical laboratories — Requirements for safety • ISO 22870 Point-of-care testing (POCT) — Requirements for quality and competence • CSA Z902 Blood and Blood Components • CSA Z316.7-12 (R2017) Primary Sample Collection Facilities and Medical Laboratories — Patient Safety and Quality of Care – Requirements for transporting, and Storing Samples Requirements for accreditation are grouped into sections for ease of preparation and assessment: • Organizational Structure, Personnel Policies and Training, and Management • Quality Management System • Physical Facilities • Equipment, Reagents and Supplies • Pre-Examination Process • Examination Process • Quality Assurance • Post-Examination Process (Reporting) • Laboratory Information System • Safety • Point-of-Care Testing Discipline-specific technical detail is incorporated within the requirements as “What To Look For” guidance, and represents application of the requirements to individual discipline practice. This discipline specific information encompasses key details that the peer assessors will consider, but it should not be considered all-inclusive. Individual assessors apply their own knowledge and expertise when assessing whether a laboratory meets requirements. Discipline-specific guidance is provided for the following: • Anatomic Pathology • Chemistry • Cytogenetics • Cytopathology • Hematology • Flow Cytometry • Maternal Serum Screening • Microbiology • Molecular Diagnostics • Transfusion Medicine Status: Current Version 5.6 Page 12 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Limited Checklists for Special Circumstances (Medical Laboratory Program) A limited accreditation checklist is a list based on the AC Diagnostics/IQMH Accreditation Requirements that has been customized to meet specific needs during an assessment. All requirements included on limited checklists are pulled from the overall Requirements and Guidance Information; they are simply shortened lists to aid in consistency of application in special circumstances. One or more of the following limited checklists may be used during an assessment: NAME OF CHECKLIST SELECTION OF REQUIREMENTS FOR THE ASSESSMENT OF... Limited Laboratory Information System (LIS) Laboratory information systems that are managed off-site. Limited Microbiology Laboratories that plant and/or incubate specimens only. Limited Molecular Diagnostics PCR-based methodologies in areas other than molecular genetics. Selected requirements for sites who perform frozen sections only Limited Frozen Sections (without a full Pathology laboratory) Organizational, personnel and quality system requirements in Limited Quality Management System (QMS) secondary sites of multi-site organizations. Specimen Collection Centre Specimen collection centres managed by a laboratory. Transfusion practices in facilities that don’t perform transfusion Blood Component Dispensing medicine testing but play a role in the transfer of blood components from a supplier laboratory to patients within their facility. Selected safety requirements to be assessed in each area of a Limited Safety facility with multiple testing areas. Status: Current Version 5.6 Page 13 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
ISO 15189 Plus™ Diagnostic Imaging ISO Standard 15189 is used around the world for Diagnostic Imaging assessment. Requirements for the Diagnostic Imaging accreditation program are based on the following standards: • ISO 15189 Medical laboratories — Requirements for quality and competence • ISO 15190 Medical laboratories — Requirements for safety • ISO 22870 Point-of-care Testing (POCT) - Requirements for Quality and Competence where applicable • CSA Z314 Decontamination of reusable medical devices. Requirements for accreditation are grouped into sections for ease of preparation and assessment: • Organizational Structure, Personnel Policies and Training, and Management • Quality Management System • Physical Facilities • Equipment, Reagents and Supplies • Pre-Examination Process • Examination Process • Quality Assurance • Post-Examination Process (Reporting) • Information System including Picture Archiving Communications Systems • Safety • Point-of-Care Testing (Limited) Modality-specific technical detail is incorporated within the requirements as “What To Look For” guidance, and represents application of the requirements to individual modality practice. This modality specific information encompasses key details that the peer assessors will consider, but it should not be considered all-inclusive. Individual assessors apply their own knowledge and expertise when assessing whether a facility meets requirements. Modality-specific guidance is provided for the following: • Bone Densitometry • Computed Tomography Scanning • General Radiography • Interventional Radiography • Mammography • Magnetic Resonance Imaging • Nuclear Medicine • Position Emission Tomography • Telemammography • Teleradiology Status: Current Version 5.6 Page 14 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
• Ultrasound ISO 15189 Plus™ Specimen Procurement Requirements for specimen procurement accreditation are based on the following standards: • ISO 15189 Medical laboratories — Requirements for quality and competence • ISO 15190 Medical laboratories — Requirements for safety • CSA Z316.7-12 (R2017) Primary Sample Collection Facilities and Medical Laboratories — Patient Safety and Quality of Care – Requirements for transporting, and Storing Samples The requirements encompass selected management and technical issues from the medical laboratory program: • Organizational Structure, Personnel Policies and Training, and Management • Quality Management System • Physical Facilities • Equipment, Reagents and Supplies • Pre-Examination Process • Laboratory Information System • Safety ISO 15189 Plus™ Point-of-Care Testing Requirements for the point-of-care testing accreditation program are based on the following standards: • ISO 15189 Medical laboratories — Requirements for quality and competence • ISO 22870 Point-of-care testing (POCT) — Requirements for quality and competence The requirements encompass selected management and technical issues from the medical laboratory program: • Organizational Structure, Personnel Policies and Training, and Laboratory Management • Quality Management System • Point-of-Care Testing For information regarding the Echocardiography Quality Improvement Program (EQI), contact eqi@acdiagnostics.ca Status: Current Version 5.6 Page 15 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Other Supporting Documents Applicable to All Programs Position Statement – Accreditation Impartiality and Operating Principles Position Statement – Accreditation Service Provision Position Statement – Categorization of Non-Conformances Position Statement – Use of Symbol and Claims of Accreditation Status Position Statement – Extension of Certificate Expiration Date Position Statement – AC Diagnostics Participation in ILAC and APAC Position Statement – Transfers of Accreditation to AC Diagnostics Medical Laboratories and POCT Position Statement – Inter-laboratory Comparison Surveillance in Accreditation Position Statement – Traceability Accreditation Requirements All of these documents can be found at https://diagnostics.accreditation.ca/Resources. Status: Current Version 5.6 Page 16 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
AC DIAGNOSTICS ASSESSORS Training, certification and recertification of assessors are based on the following seven competencies. • Familiarity with the AC Diagnostics/IQMH Requirements and Guidance Information and values • Knowledge of the accreditation assessment process and procedures • General knowledge of quality management systems • Knowledge of risk based assessment techniques • Specific technical knowledge • Assessment information gathering techniques • Ability to identify, record and classify the degree of conformance to the accreditation requirements • Interpersonal skills to conduct assessments according to program values To qualify as a Team Leader, an individual must: • Meet the basic selection requirements for technical assessors • Have completed at least three assessment visits • Possess demonstrated knowledge of quality management systems; i.e., demonstrated during previous three assessments as a team member. • Demonstrate the following interpersonal skills, through three positive assessment evaluations: o Diplomacy o Open- mindedness o Ability to react effectively to stressful situations o Communication and public speaking o Respectfulness ADVISORY PANEL The Laboratory Accreditation Advisory Panel consists of professionals of stature who have broad knowledge of diagnostic operations, quality assurance practices, management skills, and who represent a cross-section of practitioners. Further advice is sought from additional experts as necessary. The panel reviews and approves operational policy, accreditation requirements, and recommends the issue of accreditation certificates for the medical laboratory program. Government and AC Diagnostics representatives are ex-officio members without voting rights. DIAGNOSTIC IMAGING ACCREDITATION DECISION PANEL This decision panel reviews and approves accreditation requirements, recommends the issue or withdrawal of accreditation certificates, reviews appeals, complaints and scope additions, and approves unscheduled surveillance visits for the Diagnostic Imaging accreditation program. Status: Current Version 5.6 Page 17 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
AC DIAGNOSTICS ACCREDITATION PROCESS Sharing of Documentation and Correspondence On enrolment, each facility is given a unique identification code, which remains associated with that file indefinitely. Correspondence is offered in the language of choice (English or French). Official correspondence between facility contacts and AC Diagnostics is considered confidential and is conducted in writing but may be delivered electronically. The individual named by the facility as designated correspondent receives all official communication, although technical correspondence may be delegated to the director(s), regional consultant, and/or site coordinator. When accreditation may be in jeopardy, the chief executive/owner/operator is informed. Information may be shared with a Regulator as applicable. Multi-Site Facilities Multi-site corporations may qualify for a single assessment of their accredited facilities in which the application of shared management services and the quality management system are verified at each site. Team members visit all premises of the facility from which one or more key activities are performed and which are covered by the scope of accreditation. Some conditions apply to address travel and duration of the visit(s). Individual accreditation certificates are awarded to each site. Examples of multi-site arrangements include: 1. Corporations with multiple diagnostic testing sites 2. Hospitals or medical laboratories that operate off-site specimen collection centres 3. Hospitals, medical laboratories or diagnostic imaging services that offer point-of-care testing off-site Self-Assessment Initial self-assessments are intended to assist applicants in determining the degree to which they meet accreditation requirements and if they are ready for accreditation assessment. Applicants perform self-assessments and report their findings in exception reports. Detailed instructions and a customized checklist are provided with notification. Self-assessment exception reports are reviewed at AC Diagnostics. Following review, applicants are advised if the findings indicate applicants are ready for their initial assessment visit. If you can’t describe what you are doing as a process, you don’t know what you’re doing. Deming Status: Current Version 5.6 Page 18 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Pre-Assessment Activities Notification Facilities receive written notification (120 days) of each pending accreditation assessment visit or surveillance assessment. This includes reassessment visits and scheduled surveillance assessments. AC Diagnostics Staff Technologists and facility leadership set mutually agreeable dates for assessments. Facilities receive the names of all team members prior to the assessment and have the opportunity to reject members based on defined conflict of interest criteria. At notification, medical laboratories are reminded that participation in and satisfactory performance on formal inter- laboratory comparison, i.e., proficiency testing (PT) is required. AC Diagnostics provides a form in QView™, a password-protected web portal, on which facilities submit this information. Document Review Notification of an upcoming accreditation assessment includes a pre-visit questionnaire that requests the return of the following quality documentation. This quality documentation is reviewed by the Staff Technologist prior to the visit and shared with the assessment team members. • Quality manual • Assessment of staff skills procedure • Document control procedure • Record retention procedure • Investigation of non-conformities procedure • Internal audit procedure • One representative technical procedure from each technical testing area Assessor Selection Accreditation assessment teams consist of a Team Leader, a Staff Technologist, and additional assessors as dictated by the size and scope of the facility. Teams are balanced and may include physicians, physicists, nurses, scientists and technologists to provide expert coverage for all technical areas involved. These peer volunteers have the knowledge of diagnostic operations and quality assurance practices and possess management skills and specialty technical expertise. All receive advance training and certification. For each assessment, one member of the team is engaged to serve as the Team Leader. The Team Leader has the following duties (but may also serve as a technical assessor): • Leading the assessment team • Conducting the opening and summation meetings (remotely when appropriate) • Making decisions relating to the assignment of non-conformances • Representing the assessment team with the facility’s management • Assisting in the drafting of the final Summary Report, approval of the Summary Report • Review of submitted corrective actions • Review any appeals of cited non-conformances • Preventing and resolving conflicts • Providing guidance to technical assessors Status: Current Version 5.6 Page 19 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
The Assessment Regular accreditation assessments encompass all aspects of the defined scope of service. For medical laboratories, this includes specimen procurement and point-of-care testing managed by that laboratory. Program requirements are comprehensive and process-based. Assessments validate that quality management processes are in place and that technical operations meet individual requirements. Depending on the size and scope of the service, an accreditation assessment will be 1–5 days in length. The Team Leader conducts an opening meeting with facility staff to review the accreditation assessment visit purpose and agenda. This meeting may be conducted remotely in certain circumstances. Accreditation team members assess the diagnostic service according to pre-assigned tasks (e.g. interviews, observation, document review) and each member completes the appropriate assessment tools (checklists) to determine conformance to program requirements. This process is comprehensive and involves conversations with many levels of staff. Assessment may be conducted using remote technology where appropriate. The visit agenda is created after a comprehensive review of the scope of testing of the diagnostic service and a pre- visit questionnaire. Particular attention is paid to hours of operation. Visits encompass all activities and all premises associated with the scope of testing proposed for accreditation (with the exception of some surveillance assessments). The guidance provided to each assessor includes suggested sample sizes to ensure the assessor views a representative number of examples. Falsification of Documents or Records Falsification of documents and records on the part of a participant may include misrepresentation or fraudulent altering of a document or record when submitted as evidence to support conformance to an accreditation requirement. This may occur during an accreditation assessment, or during the corrective action review following an assessment, or during review of self-assessment reports. All suspected cases of falsification or failure to disclose evidence are investigated. The facility is informed in writing and no pending accreditation certificate will be issued until the dispute is resolved. Categorization of Non-Conformances Non-conformances are classified as either major or minor. Major non-conformance: • Non-conformance has the potential to directly impact patient or staff safety or a diagnostic examination*; or • Existing processes and procedures address a requirement but are not followed most of the time; or • Repeated incidence of non-conformance in the majority of sections of the service; or • Repeated incidence of non-conformance; or • Requirement not addressed by the facility (neither written nor in practice). * Any non-conformance that has the potential to directly affect a diagnostic examination result and/or the patient outcome is to be considered a potential risk to patient or staff safety and categorized as major. Minor non-conformance: • Adherence to policy/process or procedures is inconsistent (usually followed but sometimes not); or • The requirement is met in practice, but required documentation is missing or incomplete; or • If on a subsequent assessment, a repeated minor non-conformance occurs for exactly the same reason, then that repeated non-conformance is categorized as major. Assessment visits conclude with a formal summation meeting and a draft of the report may be left with the facility. Status: Current Version 5.6 Page 20 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Post-Assessment Activities A formal report of the accreditation assessment visit is issued to the facility within 14 days of the accreditation assessment, with a spreadsheet on which the facility management may submit any corrective action. It summarizes conformance and provides commentary to explain all incidences of non-conformance with the program requirements. Within two weeks of its receipt, the facility may appeal a cited non-conformance. Corrective Actions The facility must submit corrective actions with supporting documentation within 90 days of the accreditation assessment. Majors must be corrected, and acceptable action plans to correct the root cause of minors must be submitted. AC Diagnostics staff review the corrective actions and correspond with facility staff if further clarification/documentation is required. The investigation and follow-up of non-conformances is a critical component of an effective quality management system. Service providers must follow their own process for the investigation of non-conformities and use the procedures and related forms they have created for this purpose. The AC Diagnostics corrective action form is not intended to replace a facility’s own process for quality improvement; rather, it is a means to facilitate communication with AC Diagnostics. Major Non-Conformances – The facility must show full evidence of root cause investigation and corrective action. A detailed description of the root cause analysis and corrective action must be provided along with evidence to substantiate it. Many corrective actions will require the facility to modify or create new procedures. Copies of those approved procedures must be provided as evidence. The facility must also demonstrate that where procedures were modified or created, staff were informed of the change and trained appropriately. Communication means and, if possible, samples should be included in the submitted corrective actions. Other corrective actions may require simple actions, e.g. the removal of obsolete documents, creation of forms and completing them to create records, labelling, clearing of cluttered passageways and posting of signage. Substantiating documentation may include samples or photographs. Where a problem is deemed to be systemic, the process for corrective action will include an investigation to determine the underlying root cause(s) of the problem. Corrective action(s) for systemic problems must describe immediate remedial actions, but also describe ongoing plans to prevent recurrence of similar non- conformances. In most cases, it will be appropriate to implement a means to monitor the effectiveness of the corrective action over time. How this will be done and in what timeline(s) should be explained in the submitted corrective actions. Minor Non-Conformances - At minimum, a detailed action plan must be submitted that substantiates minor non- conformances will be corrected by the next assessment activity (i.e., within two years). Those plans must identify the root cause and what will be done to resolve the issue and the expected completion date. The Staff Technologist may ask for supporting evidence to substantiate the action plans. If a minor is corrected by the facility, the supporting evidence to substantiate it is required to close the non-conformance. On receipt of the corrective action form and supporting evidence, the Staff Technologist, Team Leader, one Accreditation Advisory Panel member (or one member of the Diagnostic Imaging Accreditation Decision Panel) and the Managing Director conduct an initial review. The goal of the review is to determine if: 1. The actions address the causes and not just the symptoms of the issue 2. Corrective actions for major non-conformances are sufficient and effective; 3. Action plans for minor non-conformances not corrected are adequately documented to provide assurance that the requirement in question will be fulfilled in a timely manner, and before the next assessment activity; 4. Appropriate follow-up is included, where necessary. AC Diagnostics staff will correspond with the facility if further clarification or documentation is needed to provide confidence in the corrective actions taken. When further information is requested, a deadline is provided to the facility management (usually two weeks). In some cases, additional clarification will be needed but the total time frame allowed for seeking clarification and additional documentation from the facility is 45–60 days. Following the receipt of follow-up information and documentation, if any one of the reviewers believes that any major non-conformance is not corrected, the Accreditation Advisory Panel conducts an extensive review. Status: Current Version 5.6 Page 21 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
Decision Making Decisions on accreditation are taken by competent persons different from those who carried out the assessment. Staff Technologists, Team Leaders, Advisory or Decision Panel members review and assess the acceptability of corrective actions. Advisory/Decision panel members recommend certificate issue. The entire file is reviewed and accreditation is awarded by the Managing Director. Three options may result. • Accreditation certificate issued • Intent to withdraw accreditation or not grant declared • Intent to reduce the scope of accreditation declared Initial accreditation certificates are issued only after conducting an initial accreditation assessment visit encompassing all activities and all premises associated with the scope of testing proposed for accreditation. Corrective action is required. To maintain certificates of accreditation, facilities must submit to all assessment visits and to ongoing surveillance of proficiency testing. All non-conformances must be addressed prior to certificate issue. Major non-conformances must be resolved and acceptable action plans submitted for minor non-conformances. Follow-up will occur on all non-conformances at the next assessment. If a minor non-conformance is still outstanding it will be classified as a major non-conformance to ensure it is subsequently resolved. Certificate An accreditation certificate is issued with a scope of accreditation, which lists the classes of examinations or modalities, and examination details. The accreditation certificate includes the name and logo of the accreditation body, the accreditation symbol, facility name, address(es), unique identifier(s), assessment date(s), issue date and expiry date with reference to the applicable version of the accreditation requirements, ISO standards, scope and conditions of accreditation. The Managing Director signs the accreditation certificate. A change in the facility name prompts issue of a revised accreditation certificate and a revised scope without reassessment. Addition of classes of tests or modalities may prompt reassessment before a new certificate and scope can be issued. Other changes in ownership and location may require a surveillance assessment before a new certificate and scope can be issued. Applicants designate the applicable scope under assessment and may choose to suspend, withdraw or reduce their scope at any time – unless the accreditation is mandated by a regulator. LIST OF ACCREDITED FACILITIES AC Diagnostics maintains a list of all facilities that are granted accreditation, along with the current status of accreditation and the applicable scope. https://diagnostics.accreditation.ca/Diagnostics-Assessment-Programs/Medical-Laboratory/Accredited-Facilities Status: Current Version 5.6 Page 22 of 30 File name: Master - AC Diagnostics Accreditation Program Information - Authorized by:French Approver Version Date: 2021-04-06 FR © 2020 AC Diagnostics
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