Accreditation Program Information - Medical Laboratory

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Accreditation Program Information - Medical Laboratory
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Diagnostics

Accreditation Program Information

                                                         Medical Laboratory

 Point-of-Care                                                                                                    Diagnostic
   Testing                                                                                                         Imaging

                                                   Specimen Procurement

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© 2020 AC Diagnostics
Accreditation Program Information - Medical Laboratory
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

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© 2020 AC Diagnostics
Accreditation Program Information - Medical Laboratory
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

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© 2020 AC Diagnostics
Accreditation Program Information - Medical Laboratory
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

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© 2020 AC Diagnostics
Accreditation Program Information - Medical Laboratory
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.

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Accreditation Program Information - Medical Laboratory
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.

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© 2020 AC Diagnostics
Accreditation Program Information - Medical Laboratory
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.

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Accreditation Program Information - Medical Laboratory
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.).

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Accreditation Program Information - Medical Laboratory
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.

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Accreditation Program Information - Medical Laboratory
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.

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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.

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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

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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.

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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

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•       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

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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.

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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.

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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

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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

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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.

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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.

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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

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