All Clinical Laboratories Letters (ACLL)
Deemed Status / Accrediting Organizations (AO)
Section 1223 of the California Business and Professions Code (BPC) allows the California Department of Public Health to approve private, non-profit accrediting organizations to inspect clinical laboratories operating in California or laboratories outside California processing specimens originating in California for the purpose of deeming them to meet the requirements of California clinical laboratory law for licensure or registration. Laboratories can choose licensure or registration by the department, or certification of deemed status issued by the department to laboratories deemed by a private non-profit accrediting organization approved by the department.
The requirements for accrediting organizations and the requirements for laboratories that choose deemed status are listed in BPC §1223. Please refer to
BPC §1223 for the complete statute. More detailed information on interpretation and implementation is made available in All Clinical Laboratories Letters (ACLL).
An ACLL is a letter from Laboratory Field Services (LFS) to facilities licensed or registered by the department to address the standards the department is imposing, allow the public to observe which California laws are more stringent than federal standards, or specify which accrediting organizations have been approved to conduct inspections. Public comment on an ACLL will be received and considered by the department for 30 days after posting online. The ACLL becomes final 45 days after posting online, after which time it has the force of regulations. Please address your comments to LFS at LFSaccorg@cdph.ca.gov and refer to the ACLL by number in the subject line.