Clarification of CLIA Lab Director Responsibilities  

There has been an announcement by CAP regarding its lab accreditation requirements and the duties of the clinical laboratory director under CLIA. The individual named as the laboratory director on the CLIA certificate is required to personally sign each procedure before they are put into use and after any changes or revisions. We have reprinted below the advisory from CAP.

Dear CAP Accreditation Participant:

With the July 2011 CAP Accreditation Checklists release, two significant revisions to policy and procedure review will be published:

1. The responsibility for review of new and/or substantially revised policies and procedures will be restricted to the Laboratory Director whose name appears on the CLIA certificate. Per CLIA requirements these responsibilities can not be delegated.
2. The responsibility for annual review of policies and procedures by the Laboratory Director, or designee will be required once every two years instead of annually.

CMS Announces that Physician Signature Requirement on Lab Requisitions Will Be Shelved

CMS had previously announced their intent to enforce a requirement for a physician or other ordering health care practitioner signature on all clinical laboratory requisition forms beginning April 1, 2011. After hearing great protest from the clinical laboratory community a delay had been announced and CMS indicated that they would undertake an educational effort with the medical community.

On March 31st CMS announced that they will not implement this policy. They indicated the confusion in the medical community and the difficulty in compliance.