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Quality Manual Review
Confirmation of an upcoming peer assessment visit includes a self-assessment form for the laboratory quality manual. The completed form is returned to QMP–LS with a copy of the quality manual. The quality manual is returned during the peer assessment visit.
Accreditation Team Members
Accreditation teams consist of a team leader, an OLA staff technologist, and additional assessors as dictated by the size and scope of the laboratory. Teams are balanced to include physicians, scientists and medical laboratory technologists and to provide expert coverage for all disciplines involved. Teams include peers with the knowledge of laboratory operations and quality assurance practices, and who possess management skills and specialty expertise. All assessors receive advance training and certification. Laboratories receive the names of all team members prior to assessment visits and have the opportunity to reject a member based on defined conflict of interest guidelines.
The Peer Assessment Visit
The team leader conducts an opening meeting with laboratory staff to review the peer assessment visit purpose and agenda. Accreditation team members assess the laboratory according to pre-assigned tasks and each member completes the appropriate assessment tools (checklists) to determine conformance to program requirements. This process is detailed and comprehensive. At the conclusion of the visit, the team leader facilitates a summation meeting to review the findings and conclusions with administration, laboratory management and additional laboratory staff included by laboratory management. This verbal report outlines commendations and major/minor non-conformances.
Assessment Report
A formal report of the peer assessment visit is issued to the recipient facility within 30 days of the peer assessment visit, with a spreadsheet on which the laboratory 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 has two weeks in which to dispute findings based on errors of fact.
Major non-conformance
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Requirement not addressed by laboratory’s quality manual or operating procedures or
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Procedures are consistently NOT followed or
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Existing protocols fail to address requirement or
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Non-conformance directly impacts patient safety or
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Consistent/persistent incidence of non-conformance or
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Repeated incidence of non-conformance in the majority of sections of the
laboratory.
Minor non-conformance
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Isolated incident of non-conformance or
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Adherence to procedures is inconsistent (usually followed but sometimes not) or
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Existing protocols address requirement but are not necessarily followed.
Corrective Action
The facility must submit corrective actions to QMP–LS with supporting documentation within 90 days of the peer assessment visit. QMP-LS reviews the corrective action and corresponds with laboratory staff if further clarification/documentation is required. Laboratory corrective action documentation requiring review is shared with the OLA Advisory Panel and/or the appropriate QMP–LS Scientific Committee(s) for advice and determination of satisfaction in addressing outstanding issues.
Certificate Issue
Accreditation status is assessed following each peer accreditation assessment visit (Figure 4). Three options may result.
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5-year accreditation certificate issued
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2-year accreditation certificate issued
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Intent to withdraw accreditation declared
Initial accreditation certificates are issued only after conducting an initial peer assessment encompassing all activities and all premises associated with the scope of testing proposed for accreditation. Corrective action is required. (See “Corrective Action”). To maintain certificates of accreditation, laboratories must submit to ongoing surveillance of proficiency testing and conduct a self-assessment on all activities conducted in conjunction with the scope of testing in each discipline subject to accreditation. (See “Other Surveillance”).
Certificates issued by Standards Council of Canada require endorsement of the OLA Advisory Panel’s recommendation by Standards Council of Canada. (See “Agreement with Standards Council of Canada”).
The accreditation certificate includes either the QMP–LS and/or the Standards Council of Canada logo, laboratory name, address, unique identifier and license number, assessment date(s), issue date and expiry date with reference to the applicable version of the OLA requirements and conditions of accreditation.
| Figure
4: Recommendations for Certificate Issue, Based on Peer Assessment
Visit Follow-up |
| Scenario: |
QMP-LS Action: |
Follow-up |
| Laboratory
submits a response within 90 days of assessment. All major
non-conformances are resolved and action plan to address minor
non-conformances is acceptable. |
Issue 5-year
Accreditation Certificate |
Regularly
scheduled self-assessment and peer assessment visit occur. |
| Laboratory
submits a response within 90 days of assessment. Not all major
non-conformances are resolved, but the action plan to address major
and minor non-conformances is acceptable. |
Issue 2-year
Accreditation Certificate |
Within the
two years, a laboratory may apply to have a 2-year certificate
replaced with a 5-year certificate, provided evidence is submitted
substantiating all major non-conformances have been resolved.
In some cases, a repeat peer assessment visit at the laboratory’s
expense may be necessary. |
| Assessment
findings adversely affect patient care and/or laboratory does not
resolve all major non-conformances and/or does not submit an
acceptable action plan for all major and minor non-conformances
and/or there is conclusive evidence that the generally accepted
standard cannot be met. |
Recommend
Intent To Not Issue Certificate or To Withdraw Accreditation |
File
referred to Management and Conjoint Committee. |
Dispute Resolution
Laboratories have the right to appeal accreditation assessment and associated decision regarding accreditation status. Appeals must be submitted in writing, and are reviewed by a multi-disciplinary and impartial panel.
Certificate of Accreditation and Accompanying Scope of Accreditation
An accreditation certificate is issued with a scope of accreditation, which lists the classes of tests and licensed tests covered by the certificate. The accreditation certificate includes the QMP–LS logo, laboratory name, address, unique identifier and license number, assessment date(s), issue date and expiry date with reference to the applicable version of the OLA requirements and conditions of accreditation. The Managing Director of QMP–LS signs the accreditation certificate. A change in the laboratory name and deletions to the testing menu prompt issue of a revised accreditation certificate and a revised scope. Accredited laboratories are reminded that the certificate of accreditation applies only to the scope of testing at the time of assessment. Claims that accreditation extends to additional testing or other unauthorized references to the accreditation symbol may result in withdrawal of accreditation.
List of Accreditation Certificates
Granted
Ontario’s Ministry of Health and Long-Term Care Laboratory Licensing and Inspection Service maintains a registry of all Ontario licensed medical laboratories subject to accreditation. QMP–LS maintains a list of all laboratories that voluntarily submit to and are granted accreditation, along with the current status of accreditation and the applicable scope of testing. This list
will be publicly available on the QMP–LS web site at
www.qmpls.org.
The Reassessment Visit
Following the initial peer assessment visit and issue of a 5-year accreditation certificate, subsequent assessments will occur to renew accreditation. This regularly scheduled subsequent assessment is called a “reassessment visit”.
The Surveillance Assessment Visit
A surveillance assessment visit (focused) may be initiated upon:
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New laboratory ownership or laboratory address
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Request due to a potential threat to patient safety (from the facility or government regulator)
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Addition of a class of tests to the test menu
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Self-assessment findings that demonstrate no intent to implement corrective actions or that raise other concerns regarding patient care
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Imminent expiry of a 2-year certificate
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Participation and performance in proficiency testing is unsatisfactory and corrective action is not taken
Surveillance assessment visits will occur within six months of the change or request.
Other Surveillance
Participation in and performance on proficiency testing (external quality assessment) is monitored on an on-going basis. Laboratories holding accreditation certificates must participate in formal inter-laboratory comparison schemes, where available and appropriate, for all classes of tests provided by the laboratory. Laboratories must also demonstrate that corrective actions identified through these activities are carried out when necessary.
The Self-assessment
Self-assessments are required to initiate and maintain accreditation (see “Application”). Self-assessments ensure that:
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Laboratories continue to monitor their own conformance to accreditation requirements.
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QMP–LS can identify the degree to which laboratories continue to meet requirements and implement previous peer assessment corrective action plans.
OLA formally coordinates the self-assessment process by requiring that laboratories perform self-assessments and report their findings in exception reports. Detailed instructions and a customized checklist are provided with the 120-day notification. Self-assessment exception reports are reviewed at QMP–LS. Following review, laboratories receive correspondence that confirms receipt of reports and provides a summary of conformance. Correspondence is initiated regarding any discrepancy in previously submitted corrective action plans. Submitted reports are retained in accreditation files, and details of self-assessments are reviewed during the next scheduled accreditation peer assessment visits.
Fees
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Applicants pay a non-refundable $200.00 CAD application fee to cover the administrative costs associated with opening of the laboratory file and preparation of the customized checklist.
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Participants pay all direct costs associated with peer assessment visits (inclusive of travel plus staff and volunteer labour associated with set-up, on-site assessment and follow-up).
Approximate Mean = $6,000 CAD
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A 30% administration fee is added to cover staff and volunteer labour associated with file review and self-assessment review, office supplies and postage/courier charges incurred by QMP–LS.
Approximate Mean = $1800 CAD
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If the applicant wishes the certificate to be issued by Standards Council of Canada (See “Agreement with Standards Council of Canada”), additional fees apply.
Accreditation Requirements and Guidance Information
Program requirements are based on the Canadian national standard CAN/CSA Z15189-03 Medical Laboratories - Particular requirements for quality and competence. Their development was aided by cross-referencing this standard to generally accepted principles of good practice in Ontario:
Standards and guidelines achieved through consensus by international, North American, Canadian and provincial associations, federations, organizations and regulatory bodies.
Each requirement has an accompanying reference source. All requirements applicable only to licensed Ontario laboratories are identified.
Additional good practice recommendations are included with the requirements.
The requirements are organized into 10 universal sections that apply to all disciplines of laboratory practice, plus a stand-alone section for point-of-care testing.
Accompanying each requirement and good practice recommendation is “What To Look For” guidance information that explains the intent of the requirement and provides insight into its interpretation. Usually, this guidance information is phrased as a question, and may include an indication of documents and records required to meet the requirements. 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.
Revisions/Review of the Requirements
A regular review of requirements occurs every two years. Any laboratory may offer suggestions regarding the suitability of a requirement at any time, ongoing feedback is recorded and reviewed regularly. The Accreditation Advisory Panel investigates challenges as needed.
Cost
OLA
Requirements Order Form 
OLA
Educational
Activities & Tools
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