April 19, 2011

Time Limits for Laboratory Accreditation Corrective Actions

The following information is to provide clear direction to ASCLD/LAB accredited laboratories and new applicant laboratories concerning the time limits for implementing corrective actions. 

When a nonconformity requiring corrective action is cited during an inspection (See Note), assessment or surveillance visit of a laboratory, the laboratory shall be informed in writing of a time limit by which corrective action shall be completed. 

Time limits allowed for corrective actions shall be in accordance with the following provisions:

Legacy Program

When a nonconformity requiring corrective action is cited during an inspection (See Note), assessment or surveillance visit of an accredited laboratory, the laboratory shall be informed in writing of a time limit by which corrective action shall be completed.

Time limits imposed shall be in accordance with the following provisions:

Legacy Program

• No later than 180 days (six months) calendar days from the date the Audited Inspection Report is provided to the laboratory

International Program – New Level 1 Corrective Action Requests

• No later than 180 days calendar days (six months) from the date the Full Assessment Report is provided to the laboratory

International Program – New Level 2 Corrective Action Requests

• On or before the next scheduled surveillance visit

International Program – Level 2 Corrective Action Requests Carried Over from Last On-Site Visit

• (If not completed on or before the Surveillance Visit) No later than 180 days calendar days (six months) from the date of the Surveillance Visit

In the event a laboratory fails to fully implement corrective actions within the time limit imposed, the Executive Director shall be notified by the appropriate Program Manager and the matter shall be referred to the Board of Directors for action.  The Board may extend the time limit or take any other action deemed appropriate.

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