Legion Diagnostics

Recording lab director site visits

Record each lab director visit with what was reviewed, and see whether every site meets the CLIA rule of an on-site visit at least every 6 months.

CLIA requires the laboratory director of a moderate or high complexity laboratory to be on site at least once every 6 months, with at least 4 months between those visits, and to document each visit with evidence of what was done. Director site visits keep that record for every site and show where a visit is due. Open it from "Quality management", then "Director site visits".

What counts toward CLIA

A visit counts toward the 6-month requirement only when all of these are true:

  • it was on site, not remote
  • the visitor held the site's lab director designation on the visit date
  • it has at least one note, linked record or PDF describing what was done
  • it has been finalized by the director, if your visit policy requires a signature

The 6-month clock restarts at a counting visit only when it is at least 4 months after the previous one that restarted it. A visit sooner than that is still kept and shown, marked as less than 4 months after the last visit, but it does not move the due date.

Designations come from site licensure. When a site's lab director changes, its visit status is worked out again straight away: the new director's visits count from the day their designation starts, and for a site with no counting visit yet the clock starts on that day too. A site that is closed, performs only waived testing, or has no designated lab director has no visit requirement, and the table says which.

Remote visits and other visitors

You can record remote visits and visits by anyone else, such as a technical consultant or a site manager. They are part of the site's history but never count toward the CLIA on-site requirement, which the director cannot delegate. Your organization's own policy can choose to count them toward its internal schedule.

The site table

The page opens on one table with a row per site group. Its columns are:

  • "Site group", with a note when the site is closed or has no time zone set
  • "Lab director", or "Not designated"
  • "Status", the CLIA status, with your own policy's status underneath when it differs
  • "Last on-site visit", the last counting visit, which you can click to open
  • "Next due", the date the next counting visit is due or was due
  • "By month", one square per month of the period with a dot for each visit

The dot colors show whether a visit counted, came too soon, was remote, was by someone other than the director, or still needs to be finalized. The help icon beside "By month" explains each color, and pointing at a dot shows its date and visitor. Click a dot to open that visit. A site is marked:

  • "Visit due" when the next visit is due within the warning period (30 days by default)
  • "Overdue" when the due date has passed without a counting visit
  • "On time" otherwise
  • "Not required" when the site has no visit requirement

Status and next due are always as of today. The table follows the site group chosen in the header, including "All site groups". The "From" and "To" dates at the top set the period for the month squares: the last 12 months by default and up to 36 months. Search by site group name, click any column heading to sort, and use the filter beside "Lab director" or "Status" to narrow the table, for example to every site one director oversees. The table shows 25 rows per page; choose 50, 100 or 200 with "Rows per page".

Click a row to open that site's visits. The menu at the end of each row has "View visits" and "Record visit".

A site's visits

A site's page lists its visits in the period with the visit date, type, visitor, status, the number of links and the number of open tasks. Sort by any of these columns, filter by type or status, and search by visitor or note text. The breadcrumb at the top takes you back to the site table.

Each visit has one status badge, "Open" or "Finalized". Point at the badge to see whether the visit counts and, if it does not, why: for example that it has no notes, links or files yet, that it was remote, or that your policy needs it finalized.

Click "Record visit" at the top to add a visit to this site. Click a row, or "Edit" in the row's menu, to open a visit; for a finalized visit the menu says "Open". "Archive" in the same menu archives a visit entered by mistake. Archived visits are listed under "Archived" at the bottom of the page, where "Restore" brings one back. Archiving and restoring both ask for a reason, an archived visit stops counting, and a finalized visit cannot be archived until its signature is revoked.

The clock icon on each row opens the visit's audit trail: when it was created and edited, each note, link and file added or removed, when it was finalized, when a signature was revoked and why, and when it was archived or restored. You can download the audit trail as a PDF. Archived visits keep their audit trail too.

Recording a visit

Click "Record visit", check the site group, and enter:

  • whether the visit was "On-site" or "Remote"
  • the visitor, the visit date and, if you like, the start and end time
  • the lab areas visited
  • who attended, from your organization's members or by name with an optional role
  • a first note on what was reviewed or done, if you have one now

Click "Save visit". The visit opens in a panel on the right with four sections you can collapse:

  • "Visit details" holds everything above and can be changed while the visit is open. The site group is set when the visit is started and does not change. Click "Save" after changing it.
  • "Links" is one list of what documents the visit. Click "Add" to link a record the director covered, for example a QC review, an SOP or a quality event, or to upload a PDF such as a signed form or a sign-in sheet (up to 25 MB each).
  • "Tasks" lists follow-up work raised from the visit. Click "New task" to create one. It is filed under the visit's site group, shows in the assignee's My Queue and links back to the visit. The assignee must belong to that site group.
  • "Notes" lists each note on its own with who wrote it and when. Click "Add" beside the heading to write one. You can edit or remove your own notes while the visit is open.

CLIA asks for evidence of what was done, so an open visit counts once it has a note, a linked record or a PDF, unless your policy requires the director to finalize it. A closed site's visits stay readable, but nobody can record or change visits there until the site is reopened.

QC director reviews

When a site has QC director reviews around the visit date, the "Links" section lists them at the top, with drafts marked, so you can link the ones the director went over with "Link". From a QC director review you can also click "Add to site visit". It lists the open visits at that site within 60 days of the review, so you can add the review to one of them, or click "Start a visit" to record a new one.

Finalizing

Finalizing is the designated lab director signing the visit. Only the visitor can finalize a visit, and only when they were the site's designated lab director on the visit date and the visit has a note, link or PDF. Save any changes first. Visits by anyone else can never be finalized, and the "Finalize" button says why when it is unavailable. Finalizing is optional unless your visit policy requires a signature; then only finalized visits count.

A finalized visit is locked: its details, notes, links and files no longer change and no new tasks can be linked to it. Its existing tasks can still be opened and worked, and "View signature" shows who signed and when. If something needs correcting, the director who signed or a Primary Site Administrator can click "Revoke signature" and give a reason. The visit opens for changes again, and the revoked signature and the reason stay in its audit trail. Finalize it again when it is correct.

Reminders

When a visit is due or overdue, the site's designated lab director gets a reminder in My Queue, or the organization's Primary Site Administrators when the site has no director with an account. The reminder closes when a counting visit is on record. Closing a site pauses its reminders, and reopening it brings them back.

Your site visit policy

Your organization can set a stricter internal schedule than CLIA. People who manage access control set it in organization settings, on the site groups page, under "Director site visit policy". The top of the director site visits page shows the current policy, for example "Policy: lab director on site every 6 months", and for people who can change it, a link to where it is set. You can set:

  • "Visit at least every (months)", from 1 to 6
  • "Flag as due (days before)", from 1 to 90 (30 by default)
  • whether remote visits count toward your policy
  • whether visits by someone other than the designated lab director count toward your policy
  • the director's signature: "Optional", "Required for on-site visits" or "Required for every visit by the director"

Your policy can be stricter than CLIA but never looser, and remote visits and other visitors only ever count toward your own policy. A site group can also have its own schedule of up to 6 months: on the site groups page, select the site group, click "Actions", then "Visit policy…". The dialog shows the cadence the site follows now, and you can choose a number of months or go back to the organization's cadence. Each change needs a reason and is listed in the policy history. The CLIA status and your policy's status are shown side by side, and reminders follow whichever is due first.

Inspection readiness

Director visits with a note, link or PDF can be linked as evidence on an inspection checklist, and the AI evidence suggestions offer a site's counting visits for the requirement that the director be on site. The readiness view for a site group also notes any stretch of more than 6 months without a counting visit, any visit that came less than 4 months after the previous one, and a visit that is due or overdue.

Site licensure shows each site's last on-site director visit and when the next is due, so you can see it beside the site's designations.

Getting help from the AI assistant

The AI assistant can help you work with visits, for example by drafting notes or finding records to link. Finalizing a visit, and revoking its signature, are always done in the app by the people allowed to sign.

Who can see and record visits

Viewing and recording visits are permissions in access control. By default they go to Lab Directors and Primary Site Administrators, and can be granted to anyone else. You see visits only for the site groups you belong to.