CONFORMANCE MONITORING
To retain accredited status for a full five year term, a laboratory is expected to continue to meet the standards under which it was accredited. The principal means by which ASCLD/LAB monitors conformance are the Annual Report, results of annual surveillance visits, proficiency testing reports submitted by approved test providers, and special interim assessments if needed.
Any information suggesting nonconformance with the standards by an accredited laboratory will be addressed by the Board on a case-by-case basis. Upon receipt of such information, the Board will consider the information and determine if an investigation or a special interim assessment should be required. The laboratory director shall be notified of any sanctions under consideration and will have the right to make representations in person at any subsequent meeting in which conformance issues concerning that laboratory are considered. The Board will decide what, if any, sanction will be imposed.
ANNUAL REPORT
Within thirty calendar days following the laboratory’s accreditation anniversary date, the director of an accredited laboratory is required to submit an Annual Report based on a self-evaluation of the laboratory's status with respect to all accreditation requirements during the previous calendar year. Instructions for completing and submitting the annual audit report may be found in the ASCLD/LAB-International Program Overview Document in Appendix A - ASCLD/LAB-International Surveillance Activities and Visits.
OTHER LABORATORY REPORTING
In addition to the Annual Report, an accredited laboratory shall notify and inform ASCLD/LAB in writing without delay of significant changes relevant to accreditation, in any aspect of the laboratory's status or operation, or instances of non-conforming work requiring customer notification
ANNUAL SURVEILLANCE VISITS
During the five-year accreditation period, an annual surveillance visit will be made to each accredited laboratory. Detailed information concerning annual surveillance visits may be found in the ASCLD/LAB-International Program Overview document in Appendix A - ASCLD/LAB-International Surveillance Activities and Visits.
PROFICIENCY TESTING
The Board has adopted a comprehensive Proficiency Review Program and established a Proficiency Review Committee (PRC) for each of the accredited disciplines. These committees are responsible for reviewing the external proficiency test reports received from approved test providers for each of the accredited laboratories. The PRCs work under the direction of the Board through the ASCLD/LAB Proficiency Test Program Manager and serve as the initial contact with laboratories in evaluating apparent proficiency testing inconsistencies. ASCLD/LAB-International accredited laboratories must abide by the terms and conditions of the ASCLD/LAB Proficiency Review and Testing Program in order to retain accreditation. Failure to do so could adversely impact the laboratory’s accredited status and result in a Board imposed sanction.
SPECIAL INTERIM ASSESSMENTS
When information comes to ASCLD/LAB which indicates that an accredited laboratory has failed to remain compliant with the requirements under which the laboratory was accredited, a special interim assessment may be initiated. The scope of the assessment will be determined by the Board, based on the nature of the concerns brought to the Board's attention. A laboratory may be required to provide relevant documentation to the assigned Lead Assessor prior to their visit to the laboratory. The findings of the assessment team will be reported to the Board and the laboratory director and/or parent organization.
In addition to the annual surveillance visits, a laboratory may elect to seek a special interim assessment for various reasons. The laboratory must submit a new application which includes all of the required application documents.
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