Change in Laboratory Director for Certificate of

6016.1.1 - Change in Laboratory Director for Certificate of Accreditation Laboratories (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Once a laboratory becomes accredited by an Accreditation Organization (AO) (as indicated by the confirmation checkmark in the ASPEN Web Form CMS-116 on the AO Info tab), and the laboratory pays all CLIA fees, the certificate type will change from a Certificate of Registration to a Certificate of Accreditation (CoA). From this point on, the AO will be responsible for the qualification and entry of laboratory director changes into the CLIA Data System. Example 1: A SA receives an initial application for a Certificate of Accreditation and the laboratory has marked one of the approved accrediting organizations as the AO to which they have applied for accreditation for CLIA purposes. Does the indicated AO qualify the laboratory director and enter the name and title into the ASPEN Web CLIA 116? Response: No. Initial applications are entered by SA personnel. This includes performing the qualification of the laboratory director and entry of the name and title. Example 2: The laboratory has been entered into the ASPEN Web CLIA 116, has paid its registration fee and received its Certificate of Registration. The laboratory has now requested to change the director. Does the AO indicated on the initial application qualify and enter the new laboratory director? Response: No. The SA remains responsible for qualifying any laboratory director and entering the name and title changes while the laboratory holds a Certificate of Registration. The SA should send a replacement Certificate of Registration after making the changes. Example 3: The laboratory holds a Certificate of Compliance. The laboratory has requested a change in certificate type to a Certificate of Accreditation. Does the AO indicated on the request for the certificate type change (also known as a status change) qualify and enter the laboratory director? Response: No. The request for a status change is treated the same way as an initial application. Example 4: Due to state laboratory licensing laws, the laboratory needs to know when a change in laboratory director is entered by an AO so that it can qualify the new laboratory director per state regulations. Is there a report the laboratory can access to monitor such changes? Response: Yes. There is a nationwide report in ASPEN Web CLIA 116 that can be accessed by date range. CASPER report 104 can also be used. Remember that due to the overnight upload of data from ASPEN to CASPER, the information in CASPER will be a day behind the report in ASPEN, which shows real time data. The advantage to CASPER report 104 is that it can be accessed for an individual state or region. Example 5: When a CoA laboratory sends in a Form CMS-116 with requested changes, including a laboratory director change, to the SA, is the Form CMS-116 forwarded to the AO or CMS? Response: Neither. The SA keeps the Form CMS-116 as documentation of the requested changes and notifies the laboratory that changes other than specialties and laboratory directors will be performed by the SA personnel, but that any changes to specialties and laboratory director should be handled by the laboratory’s AO and the laboratory should use whatever form of documentation the AO requires to submit those changes. The AO’s do not use government forms. Example 6: Can the AOs change the demographic information associated with the laboratory in ASPEN Web CLIA-116? Response: No. While the demographic information is visible to the laboratory’s confirmed AO, the AO user is restricted from entering changes to those fields. Example 7: Will a revised certificate be automatically generated if my SA personnel make a change to the laboratory director on a Certificate of Accreditation while it is still under its registration certificate? Response: No. The CLIA Data System is programmed to do that only for AO users because they do not have access to that field in ASPEN Web CLIA 116. Remember AO users can’t make laboratory director changes while the laboratory is still under a Certificate of Registration. If a laboratory requests a revised certificate, the SA will process the request, and the revised certificate will be issued to the laboratory once the appropriate fees are paid. Example 8: If a CoA laboratory fails to notify an SA about a laboratory director change as required by state licensure requirements, will an alert be sent to the SA? Response: No. The ASPEN Web CLIA 116 does not feature alerts, but the new Director Change search function on the ASPEN Web CLIA 116 search page or CASPER report 104 will allow the SA to find CoA laboratories that have had laboratory director changes. (Also see Example 4) Example 9: Will the AO attach the Laboratory Director qualifications in the ASPEN Web CLIA 116? Response: No. The AO does not have the security rights to save attachments to the ASPEN Web CLIA 116 record. The documentation used by the AO for the laboratory director qualification will be maintained by the AO in accordance with its own standards.