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QMP-LS Home Ontario Laboratory Accreditation (OLA)

 
Frequently Asked Questions


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  • About OLA Accreditation

  1. What is OLA?

  2. What is accreditation?

  3. How does OLA’s program compare to the rest of Canada and the world?

  4. Who does OLA accredit?

  5. Are all medical laboratory test accredited?

  6. Can multiple laboratory sites be accredited simultaneously?

  7. Does our laboratory have to pay for OLA accreditation? 

  8. Who will receive the correspondence regarding accreditation?

  9. How do I apply for voluntary accreditation?

  10. How do I prepare for accreditation?

  11. How long is the term for accreditation?

  12. What is the scope of accreditation?

  13. If my laboratory now performs a new test or class of tests, can they be added to the scope 
    of accreditation?

  14. If my laboratory was sold to a new owner, is it still accredited?

  15. Will accreditation be granted by discipline or for the full extent of laboratory services?

  16. If my laboratory is ISO 9001 registered, will we automatically receive full accreditation?

  17. What is the ISO 15189 certificate?

  18. How does the ISO 15189 certificate differ from the ISO 9001 certification?

  19. How can I receive an ISO 15189 certificate?

  20. What is a Quality Management System?

  21. Are the criteria for an OLA certificate and an ISO 15189 certificate different?

  22. We have been accredited by the College of American Pathologists (CAP) through its Laboratory Accreditation Program (LAP). Do we automatically receive full OLA accreditation?

  23. What is external quality assessment?

  24. Which EQA providers can I use to meet OLA requirements for PT/EQA?

  1. What is OLA?

Ontario Laboratory Accreditation (OLA) is an accreditation body operated by the Ontario Medical Association, which accredits medical laboratories.

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  1. What is accreditation?

Accreditation is a process by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks (detailed in a scope of accreditation) in a reliable, credible and 
accurate manner.

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  1. How does OLA’s program compare to the rest of Canada and the world? 

OLA is Canada’s only English-speaking accreditation program aligned with Standards Council of Canada. Therefore, OLA is Canada’s only English-speaking accreditation program that leads to an ISO 15189 Certificate of accreditation to ISO 15189:2007 Medical laboratories—Particular requirements for quality and competence

Our accreditation requirements are augmented with the following additional standards: 

  • ISO 15190:2003 Medical Laboratories—Requirements for safety

  • ISO 22870:2006 Point-of-Care Testing (POCT)—Requirements for quality and competence

  • CSA Z902-04, Blood and Blood Components

For this reason, we call our accreditation OLA 15189PLUS™ throughout Canada and around the world.

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  1. Who does OLA accredit?

OLA accredits all medical laboratories licensed by the Ontario Ministry of Health and Long-Term Care (MOHLTC), all laboratories within the Province of Newfoundland and Labrador, and is voluntarily subscribed to by other laboratories within Canada and the Caribbean. A list of our accredited laboratories with the applicable scopes of accreditation can be found on the QMP–LS website at www.qmpls.org/ola/ola_accredited.htm. 

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  1. Are all medical laboratory tests accredited?

For our mandatory participants, all medical laboratory tests that are performed for the purpose of diagnosis, prophylaxis or treatment of patients are included. Voluntary laboratories can define which tests are included with their scope of OLA 15189PLUS™ accreditation. 

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  1. Can multiple laboratory sites be accredited simultaneously?

Laboratories belonging to the same corporate grouping (i.e. identical management, one Quality System) may be assessed together.

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  1. Does our laboratory have to pay for OLA accreditation?

This depends on the laboratory. If accreditation is mandatory, then the government regulator may pay. (Costs for licensed Ontario medical laboratories are paid for by the government. The Province of Newfoundland and Labrador pays costs for its medical laboratories.) Individual laboratories voluntarily applying for accreditation must pay for the accreditation assessment visits and pay administrative/maintenance fees.

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  1. Who will receive the correspondence regarding accreditation?

Correspondence is sent to the person with official designation from the laboratory to receive correspondence on behalf of the Owner/Operator, as well as the official Laboratory Director(s) as stated by the laboratory. Correspondence may also be copied to an assessment site coordinator. For laboratories in Ontario, Newfoundland and Labrador, the government may identify these individuals, e.g. for licensed Ontario medical laboratories, responsible individuals are identified through the MOHLTC laboratory licence.

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  1. How do I apply for voluntary accreditation?

Any laboratory can apply for accreditation. Staff in a laboratory interested in voluntary accreditation should first acquire and become familiar with the OLA requirements. Visit the website for QMP–LS’ partner organization, the Institute for Quality Management in Healthcare (IQMH), at www.iqmh.org to purchase the OLA requirements. When ready, laboratory administration formally applies for voluntary accreditation by OLA. OLA requires a self-assessment to determine the laboratory’s readiness for accreditation.

Upon receipt of the application fee and completed application, OLA issues customized assessment checklists to use for a formal self-assessment. Afterward, laboratories submit the results to OLA in a self-exception report. (See “What is a Self-Assessment?”).

Note: Up to one year is allowed to transpire between the request for the initial self-assessment and receipt of the laboratory’s self-exception report, until the application expires.

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  1. How do I prepare for accreditation?

OLA issues a customized assessment checklist to each laboratory undergoing an assessment. Using this customized checklist, your laboratory can carry out a mock assessment. It is recommended that you do not assess your own department.

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  1. How long is the term for accreditation?

Depending on the findings of the assessment, accreditation could be for two years or four years.

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  1. What is the scope of accreditation?

A scope of accreditation lists the classes of tests, the number of tests, and the names of the tests included in accreditation.

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  1. If my laboratory now performs a new test or class of tests, can they be added to the scope of accreditation?

Yes. When OLA is notified of additional tests to an accredited laboratory’s test menu, a questionnaire will be provided. A surveillance visit may be necessary in order to expand the scope of accreditation.

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  1. If my laboratory was sold to a new owner, is it still accredited?

If the laboratory is sold to a new owner, this may result in a surveillance assessment visit within six months.

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  1. Will accreditation be granted by discipline or for the full extent of laboratory services?

Accreditation is granted for the full extent of laboratory services as covered by the scope of accreditation.

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  1. If my laboratory is ISO 9001 registered, will we automatically receive full accreditation?

ISO 9001:2008 will not replace the accreditation assessment or automatically ensure full accreditation. ISO 9001:2008 registration will go a long way in ensuring that a laboratory meets the OLA quality system requirements. However, accreditation criteria defined in the comprehensive OLA requirements encompass both the managerial and technical clauses of ISO 15189. Medical laboratories accredited to ISO15189:2007 are recognized as meeting the management system principles of ISO 9001:2008.

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  1. What is the ISO 15189 certificate?

ISO 15189 is an international accreditation standard for medical laboratories. Laboratories accredited to ISO 15189 demonstrate that they meet comprehensive international standards for quality and competence. Accreditation bodies around the world have signed an International Laboratory Accreditation Cooperation (ILAC) arrangement that fosters laboratory recognition of quality, competence and capability through ISO 15189 accreditation. These accreditation bodies are evaluated to ensure rigorous conformity assessment standards are met. Only those accreditation bodies that are part of the ILAC recognition arrangement may issue an ISO 15189 certificate. OLA’s partnership with Standards Council of Canada (SCC) makes an ISO 15189 certificate from SCC possible for OLA accredited laboratories.

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  1. How does the ISO 15189 certificate differ from the ISO 9001 certification?

Medical laboratories accredited to ISO15189:2007 are recognized as meeting the management system principles of ISO 9001:2008. Confusion exists about the differences between certification/
registration to the quality systems standard, ISO 9001 Quality Management Systems—Requirements and accreditation, and to ISO 15189. Certification or registration to ISO 9001 acknowledges that an organization’s operations comply with quality management system requirements. Accreditation is a process by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks. Laboratory accreditation to ISO 15189 provides assurance that an effective quality management system is in place, but it also demands technical competence.

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  1. How can I receive an ISO 15189 certificate?

OLA has an agreement with Standards Council of Canada (SCC). OLA conducts the assessment and recommends that the SCC issue an ISO 15189 certificate. Laboratories must declare their intent to receive an ISO 15189 certificate from SCC, in advance.

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  1. What is a Quality Management System?

A Quality Management System is a program developed to support efficient and effective, high quality and appropriate laboratory services. It involves comprehensive and coordinated efforts designed to meet quality objectives, and direct and control an organization with regard to quality. It includes a quality (management) system, assessment and improvement, quality assurance and quality control.

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  1. Are the criteria for an OLA certificate and an ISO 15189 certificate different?

The assessment standard for an OLA certificate and an ISO 15189 certificate are not different. SCC requires documentation from OLA stating that a laboratory has declared its intent for an ISO 15189 certificate, evidence that the standard is met, and a recommendation from OLA to issue an ISO 15189 certificate. 

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  1. We have been accredited by the College of American Pathologists (CAP) through its Laboratory Accreditation Program (LAP). Do we automatically receive full 
    OLA accreditation?

We recognize that the CAP program is comprehensive and rigorous. While CAP accreditation will help participants prepare for OLA assessment, CAP/LAP accreditation will not automatically ensure OLA accreditation because both the assessment process and the individual requirements for accreditation
are different.

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  1. What is external quality assessment?

External quality assessment (EQA) is a process in which laboratories participate in an interlaboratory comparison to determine the performance of the laboratory. It is synonymous with proficiency testing, and is required for accreditation.

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  1. Which EQA providers can I use to meet OLA requirements for PT/EQA?

Formal programs known to meet OLA’s criteria are published on the OLA section of the QMP–LS website. EQA provided by QMP–LS also meets OLA’s criteria. When formal interlaboratory comparison programs are not available, accredited laboratories are expected to find an alternative such as split-sample testing.

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  1. Which international and national standards apply?

  2. Are OLA accreditation requirements based on ISO 15189? 

  3. Where are the OLA requirements?

  4. Do all requirements apply to my laboratory?

  5. Is OLA open to suggestions for changes to the requirements?

  6. How often are the OLA requirements reviewed and revised?

  7. How will updates to the requirements be communicated to laboratories?

  8. What is the significance of guidance information?

  9. Will the OLA requirements apply to my province or country?

  10. Why do small rural laboratories need to meet the same requirements as large teaching hospitals?

  1. Which international and national standards apply?

During the training of the assessors, the following standards are used:

  • ISO/IEC 17011:2004 Conformity assessment—General requirements for accreditation bodies accrediting conformity assessment bodies

  • ILAC-G11:07/2006 ILAC Guidelines on Qualification and Competence of Assessors and Technical Experts

  • ILAC-G3:1994 ILAC Guidelines for Training Courses for Assessors Used by Laboratory Accreditation Schemes

During the laboratory accreditation assessment process, the following standards apply:

  • ISO 15189:2007 Medical laboratories—Particular Requirements for quality and competence

  • ISO 15190:2003 Medical laboratories—Requirements for safety

  • ISO 22870:2006 Point-of-care testing (POCT)—Requirements for quality and competence

  • Canadian Standards Association CAN/CSA-Z902-04 Blood and blood components March 2004

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  1. Are OLA accreditation requirements based on ISO 15189? 

Yes, OLA’s requirements for accreditation include all clauses of ISO 15189:2007 Medical Laboratories—Particular Requirements for Quality and Competence.

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  1. Where are the OLA requirements?

Laboratories accredited by OLA have an electronic account set up from which they are able to access OLA requirements. The requirements are also available to other laboratories for a fee. Once the fee is paid, an electronic account is created in QView™ (the password-protected document server on the QMP–LS website) for access to the OLA requirements. Visit the Institute for Quality Management in Healthcare (IQMH) website at www.iqmh.org to purchase the OLA requirements

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  1. Do all requirements apply to my laboratory?

Accreditation requirements universally apply to almost every medical laboratory, with rare exceptions.

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  1. Is OLA open to suggestions for changes to the requirements?

Yes. Feedback is collected for the review of requirements and guidance information. Feedback can be sent to OLA through the following link: www.qmpls.org/ola/ola_feedback.html or an email can be sent to ola@qmpls.org.

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  1. How often are the OLA requirements reviewed and revised?

OLA requirements are updated at a minimum of once every three years. Annually, feedback and changes to reference sources are reviewed in regards to any requirements or guidance information that may need to 
be updated.

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  1. How will updates to the requirements be communicated to laboratories?

All accredited laboratories and applicant laboratories have access to requirement updates, which are posted in QView™ (the password-protected document server) on the QMP–LS website.

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  1. What is the significance of guidance information?

For each requirement, guidance information provides insight into how to apply the requirement. Often, its application within a specific discipline is clarified. It is intended for use by laboratory personnel when preparing for an assessment and for OLA assessors during an assessment visit.

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  1. Will the OLA requirements apply to my province or country?

OLA requirements apply to any laboratory accredited by OLA. Individual requirements that may be specific to an individual country, province or region are identified. 

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  1. Why do small rural laboratories need to meet the same requirements as large teaching hospitals?

All patients deserve the same high standards of health-care delivery, regardless of their location.

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  1. How much does an accreditation assessment visit cost?

  2. During an accreditation visit, are the staff assessed as well as the laboratory?

  3. Will my laboratory know when an accreditation assessment visit will occur and who is coming?

  4. Who sets up the accreditation assessment visit?

  5. Can the findings of a self-assessment lead to an accreditation visit?

  6. Will OLA leave a printed report at the accreditation assessment visit?

  7. Who exactly will assessors speak to and will assessments involve laboratory clients?

  8. How quickly are certificates of accreditation issued?

  9. What if I disagree with a decision or a report issued about my laboratory?

  10. How long does a laboratory have to correct non-conformances?

  11. Do all non-conformances need correction before an accreditation certificate is issued?

  12. What is a corrective action?

  13. What is a minor non-conformance?

  14. What is a major non-conformance?

  15. What is an assessment visit?

  16. What is an assessment report?

  17. What is a surveillance visit? 

  18. What is a self-assessment?

  19. Who makes the decision if my laboratory receives an OLA certificate?

  1. How much does an accreditation assessment visit cost?

The charge for an accreditation assessment visit includes labour and travel expenses for OLA staff and assessors plus an administration fee. For additional information on the cost of accreditation, contact ola@qmpls.org.

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  1. During an accreditation visit, are the staff assessed as well as the laboratory?

During an accreditation assessment visit, performance of individual staff members is not assessed. It is the organization’s competence to carry out specific tasks, as detailed in the scope of accreditation, which is assessed.

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  1. Will my laboratory know when an accreditation assessment visit will occur and who is coming?

Yes, laboratories are notified via mail as well as through electronic means QView™ (the password-protected document server on the QMP–LS website) of a pending accreditation assessment visit, usually four months in advance. Visit dates are scheduled in consultation with the laboratory. To maintain transparency, the selected team member names are provided to the laboratory in advance to ensure conflicts are avoided.

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  1. Who sets up the accreditation assessment visit?

An OLA staff technologist telephones the laboratory to identify who will coordinate the assessment visit within the facility.

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  1. Can the findings of a self-assessment lead to an accreditation visit?

The purpose of a self-assessment is to ensure ongoing compliance with accreditation requirements. These and other surveillance activities (e.g. changes in laboratory location, ownership and menu of tests, performance in proficiency testing/external quality assessment) may prompt an assessment visit if they give cause for concern that the standard is not being met.

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  1. Will OLA leave a printed report at the accreditation assessment visit?

No. A formal written summary of the findings (assessment report) is mailed to the laboratory within 14 days of the assessment visit. A comprehensive verbal summary is provided at the visit summation meeting.

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  1. Who exactly will assessors speak to and will assessments involve laboratory clients?

Assessors will look for objective evidence that processes are in place to ensure requirements are met (including the assurance that client concerns are addressed by means of an interview with these clients). They may ask to speak with responsible laboratory personnel.

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  1. How quickly are certificates of accreditation issued?

OLA’s goal is to issue accreditation certificates within five months of the accreditation assessment visit.

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  1. What if I disagree with a decision or a report issued about my laboratory?

Laboratories have the right to appeal accreditation assessment findings and associated decisions regarding accreditation status. Appeals must be submitted in writing, and are reviewed by a multi-disciplinary and impartial panel.

The intent of the accreditation program is to ensure the provision of quality laboratory services. In the event that a laboratory does not meet accreditation requirements, OLA will not issue a certificate. In addition, a recommendation to deny or to withdraw accreditation may be made to a government regulator, who may have an appeal mechanism.

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  1. How long does a laboratory have to correct non-conformances?

Laboratories have 90 days from the visit to correct major non-conformances and submit an acceptable action plan to address minor non-conformances.

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  1. Do all non-conformances need correction before an accreditation certificate is issued?

Non-conformances are categorized as either major or minor. All major non-conformances must be resolved prior to issuance of a 4-year certificate. If any major non-conformance is outstanding, but there is a satisfactory action plan to address it, a 2-year certificate may be issued. Acceptable action plans to address minor non-conformances must be submitted prior to certificate issue, and ongoing followup reported at the next self-assessment.

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  1. What is a corrective action?

Corrective action is submitting a description with supporting evidence to OLA that shows how non-conformances were corrected, or action plans to correct non-conformances.

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  1. What is a minor non-conformance?

A minor non-conformance refers to the following types of findings:

  • An isolated incident of non-conformance

  • Inconsistent adherence to procedures (usually followed, but sometimes not)

  • Not always following the laboratory’s existing protocols to address the requirement 

Note: If on a subsequent assessment visit, a repeated minor non-conformance occurs for exactly the same reason, then that repeated minor non-conformance is categorized as a major non-conformance.

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  1. What is a major non-conformance?

A major non-conformance refers to any of the following types of findings:

  • Requirement not addressed by laboratory’s quality manual or operating procedures 

  • Procedures are consistently NOT followed 

  • Existing protocols fail to address requirement

  • Non-conformance directly impacts patient safety 

  • Consistent/persistent incidence of non-conformance

  • Repeated incidence of non-conformance in the majority of sections of the laboratory

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  1. What is an assessment visit?

An assessment visit is an on-site visit within the laboratory. The assessment team, using the appropriate assessment tools (checklist), determines conformance to OLA requirements.

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  1. What is an assessment report?

A formal report of the accreditation assessment visit is issued to the recipient facility within 14 days of the accreditation assessment visit, with a spreadsheet on which the laboratory may submit any corrective action. The report summarizes conformance and provides commentary to explain all incidences of non-conformance to requirements. 

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  1. What is a surveillance visit? 

A surveillance assessment visit (focused) occurs one year after the initial issue of an 

ISO 15189 certificate by SCC, and may also be initiated upon:

  • New laboratory ownership or laboratory address

  • Issues with ongoing competency/proficiency

  • Request due to a potential threat to patient safety (from the facility or government regulator)

  • Addition of a class of tests to the test menu

  • Self-assessment findings that demonstrate no intent to implement corrective actions or that raise other concerns regarding patient care

  • Imminent expiry of a two-year certificate

Surveillance assessment visits will occur within six months of the change or request.

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  1. What is a self-assessment?

Self-assessments are intended to assist laboratories in determining the degree to which they meet accreditation requirements. Self-assessments ensure that:

  1. Laboratories continue to monitor their own conformance to accreditation requirements.

  2. OLA can identify the degree to which laboratories meet requirements and monitor corrective action plans.

  3. OLA can determine requirements that may be difficult to achieve.

OLA formally coordinates the self-assessment process by requiring that laboratories perform self-assessments and report their findings in exception reports. Ongoing followup to address non-conformances assessed at the last accreditation assessment must also be reported. Detailed instructions and a customized checklist are provided with the 120-day notification. Following a review of the self-assessment findings submitted, laboratories receive correspondence that confirms receipt, provides a summary of conformance and gives a formal record of non-conformances. 

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  1. Who makes the decision if my laboratory receives an OLA certificate?

To maintain objectivity, decisions on accreditation are made by persons who were and were not part of the OLA assessment team for your laboratory. 

First, the OLA staff technologist, team leader, and OLA Advisory Panel members review and assess the acceptability of your corrective actions and seek further evidence if necessary. If they still have concerns that your laboratory has not addressed non-conformances, they ask for an extensive review by the OLA Advisory Panel. Once a decision is made that corrective actions have satisfactorily addressed non-conformances, the OLA Advisory Panel with the Director, OLA recommend certificate issue.

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  1. Who are the OLA Assessors?

  2. How can I become an OLA assessor?

  3. Are OLA assessors paid?

  4. What will the OLA assessor look for?

  1. Who are the OLA Assessors?

OLA has a roster of more than 280 trained assessors who are physicians, scientists or medical laboratory technologists. Accreditation assessment visit teams consist of a team leader, and sufficient assessors to provide technical expertise for all disciplines involved. All OLA assessors receive advance training and certification, and are required to recertify annually.

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  1. How can I become an OLA assessor?

General information and an application to become an OLA assessor are available from the QMP–LS website www.qmpls.org/ola/ola_assessors.html. There is a screening process for all applications. Applicants must be laboratory physicians, laboratory scientists, or medical laboratory technologists, qualified to practice with at least four years’ experience in a laboratory or laboratory-related environment. A potential assessor will also have management or supervisory experience concurrent with “on the bench” experience. Experience teaching students or consulting for laboratories would also be advantageous for potential assessors.

Following a reference check a potential assessor may be asked to attend a training session.

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  1. Are OLA assessors paid?

OLA pays a professional fee for the time individuals serve as OLA assessors (assessment visits), at a predetermined rate. While on assigned OLA assessment visits, expenses for travel, meals and accommodation are paid by OLA.

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  1. What will the OLA assessor look for?

OLA assessors determine if laboratories conform to the OLA requirements. This is done by asking questions, observing individuals at work, and reviewing standard operating procedures and records.

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Ontario Laboratory Accreditation (OLA) Assessors


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