COMPLIANCE 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 compliance are the Annual Accreditation Audit Report filed by the laboratory director, proficiency testing reports submitted by approved test providers and interim inspections. Any information suggesting non-compliance 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 an interim inspection should be required. The laboratory director shall be notified of any sanctions under consideration and has the right to make representations in person at any subsequent meeting in which compliance issues concerning that laboratory are considered. The Board will decide what, if any, sanction will be imposed.
DOCUMENTATION OF COMPLIANCE
It is the laboratory’s responsibility to generate and maintain documentation of compliance with the standards and criteria of the accreditation program through each accreditation cycle. Once a laboratory becomes accredited, the laboratory must maintain documentation to demonstrate compliance with ASCLD/LAB requirements such as proficiency testing, testimony monitoring, training and competency testing throughout the period of accreditation. Once the laboratory has been granted renewal of accreditation, the laboratory may, in accordance with the agency’s regulations and the prevailing laws, dispose of documentation of compliance which was generated prior to the date of the last inspection.
ANNUAL ACCREDITATION AUDIT REPORT
On or about the laboratory’s accreditation anniversary, directors of accredited laboratories are required to submit to the ASCLD/LAB an Annual Accreditation Audit Report (Appendix 6) based on a self-evaluation of the laboratory's status with respect to all criteria during the previous calendar year. Whenever a laboratory finds that an essential criterion should be scored “NO” on the report, a statement must be attached to the report which explains the reason for the score and steps taken to bring the laboratory into compliance with the standard. Separate statements are required for any significant changes made in the laboratory during the previous year or for significant changes that have not been reported since the laboratory was accredited. Changes which must be reported are listed on the report form (Appendix 6).
Laboratories which have been accredited to an earlier version of the manual will not be required to be in compliance with new versions. However, laboratories are required to conduct their annual audit using the standards and criteria from the version of the accreditation manual which is in effect at the time of the audit and report in the Annual Accreditation Audit Report steps that are being taken to come into compliance with the current version of the manual.
PROFICIENCY TESTING
The Board has adopted a comprehensive Proficiency Testing and 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 Quality Manager and serve as the initial contact with laboratories in evaluating apparent proficiency testing inconsistencies. The Proficiency Testing and Review Program is provided with this manual as Attachment 1.
INTERIM INSPECTIONS
When information comes to the Board which indicates that an accredited laboratory has failed to remain compliant with the standards under which the laboratory was accredited, an interim inspection may be initiated by Board action. The scope of the inspection 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 inspection team prior to their visit to the laboratory. The findings of the inspection team will be reported to the Board and the laboratory director and/or parent organization.
DISCLOSURE OF NON-COMPLIANCE
Once accredited, a laboratory is required to remain compliant with the standards of the accreditation program through each accreditation cycle. Accredited laboratories are required to report substantive occurrences of non-compliance with Essential criteria on the Annual Accreditation Audit Report. “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. As an accrediting body, ASCLD/LAB is obligated to be timely in reviewing instances of significant non-compliance by an accredited laboratory. To further this objective, all accredited laboratories must disclose to ASCLD/LAB all substantive occurrences of non-compliance with any Essential criteria within thirty (30) calendar days of determining that the non-compliance has occurred. 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).
|
