Policy on Disclosure of Substantive Non-compliance

One of the stated objectives in each of the ASCLD/LAB accreditation programs is “To offer to the general public and to users of laboratory services a means of identifying those laboratories which have demonstrated that they meet established standards.”

To identify the laboratories which meet the established standards, ASCLD/LAB provides each accredited laboratory with a certificate of accreditation which designates the disciplines for which the laboratory is accredited and the laboratory is included on a list of accredited laboratories which is published on the ASCLD/LAB website, www.ascld-lab.org.

Once accredited, a laboratory is required to remain compliant with the standards of the accreditation program through each accreditation cycle. In the ASCLD/LAB Legacy program, an accredited laboratory “must have a written procedure which it uses to initiate a review and to take corrective action when the laboratory has an indication of a significant¹ problem with a technical procedure or the work of an analyst.” In the ASCLD/LAB-International program, an accredited laboratory “shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer.”

Legacy accredited laboratories are also required to report substantive1 occurrences of non-compliance with Essential criteria on its Annual Accreditation Audit Report to ASCLD/LAB. “Substantive” is defined as potentially having a significant bearing on the quality of the work of the laboratory, even if for a short period of time. Annual reports in the International program must include a summary of any nonconforming work events, and the actions taken, that have occurred since the last on-site visit, and a summary of any other substantive corrective actions (see Level 1 definition)² completed (or in process) since the last on-site visit.

In keeping with the stated objective of “identifying those laboratories which meet established standards”, the ASCLD/LAB Board has determined that, as an accrediting body, we must be timelier in reviewing instances of significant non-compliance. To further this objective, all accredited laboratories must disclose to ASCLD/LAB all substantive occurrences of non-compliance within 30 calendar days of determining that the non-compliance has occurred.

In the Legacy program, the requirement to disclose substantive occurrences of non-compliance is limited to Essential criteria. In the International program, the requirement to disclose is applicable to any requirement when the non-conformity fits the Level 1 definition.
Disclosure of such occurrences must be in writing to the Executive Director and must include a summary of the occurrence(s) and a statement of actions taken or being taken by the laboratory to: (1) determine the root cause of the problem, (2) determine who may have been impacted by the occurrence(s), (3) notify those who are potentially impacted by the occurrence(s), and (4) appropriately correct and/or eliminate the cause of the occurrence(s).

¹For the purpose of this policy, the words substantive and significant are synonymous.

²Level 1 - The nature or cause of the non-conformity directly affects and has a fundamental impact on the work product of the laboratory or the integrity of evidence.



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