CLIA designations and certificates for each site

Record a site’s test complexity, designate its CLIA positions from lab director to general supervisor, and track certificates and renewals.

Each site group is a CLIA-licensed site. Its licensure and designations record its test complexity, the people holding its CLIA positions, and its certificates. To open them, go to site staffing, click "Actions" on the site, then "Site licensure & designations".

Test complexity and required positions

Start with the site's highest test complexity, because it decides which positions the site must designate:

You can also record a Lab Manager and an Operations Lead. They help run the site but are not CLIA requirements. A site has one Lab Director and one CLIA License Holder, while the other positions can have several people. Each Technical Supervisor is designated for a specialty, which is fixed once set.

Designating people

For each position, click "Designate", pick the person and the date the designation starts, and add an optional note. The dialog suggests people based on their organization role, for example a member with the lab director role for Lab Director. To change a designation later, designate someone else, correct the start date, or end the designation, each with a reason.

The Lab Director designation also drives director site visits. When the Lab Director changes, the site's visit status is worked out again as soon as you save: the new director's visits count from the day their designation starts. If you can view director site visits, the dialog also shows the site's last on-site director visit and when the next one is due. People who manage access control can give a site its own visit cadence on the site groups page in organization settings: select the site group, click "Actions", then "Visit policy…". See Recording lab director site visits.

Changes collect in the dialog, marked as unsaved. Click "Save" to record them together. If you close the dialog with unsaved changes, it asks before discarding them.

Checks Legion Diagnostics makes

Legion Diagnostics checks that:

• every required position for the site's complexity has someone designated
• a high-complexity site has a Technical Supervisor for each specialty it tests in
• nobody directs more than five nonwaived sites in your organization, the CLIA limit

Missing positions show in the "Needs attention" list in site staffing and lower the site's inspection readiness.

Certificates

To record a certificate, click "Add certificate". It can be a CLIA certificate (Compliance, Accreditation, Registration, Waiver or PPM), CAP accreditation, a state license, or another certificate, with its number, issuing body, dates and the file itself (PDF, PNG or JPEG). Certificates save in their own dialogs. When a new certificate arrives, record a renewal and the old one moves to history. Reminders go to the Lab Director and Site Managers 90 days before a certificate expires. The CLIA numbers on current CLIA certificates are also what the "Your sites" report on the Benchmarks tab of Inspections uses to compare each site with similar labs; see CLIA deficiency benchmarks.

Designations also appear on each person's personnel record.