Create, sign out, reject, or amend a report#

The REPORT stage produces the final clinical report. Reports must be reviewed, approved, signed out, and, when necessary, amended or rejected with a clear audit trail.

Before you start#

  • Confirm that you have the LaboratorySupervisor or MedicalDirector role, as appropriate for the action. Only LaboratorySupervisor can create and approve the PhenopacketReport; only MedicalDirector can sign it out.

  • The sample must be in the REVIEW or REPORT state with completed curation.

  • Your laboratory should have a standard operating procedure for report approval, sign-off, and amendment.

Create a report#

A report is created from the Approve Results action while the sample is still in the REVIEW lane (see Review and curate results), not from a separate action in the REPORT lane:

  1. In Reporter → Management, open the sample in the REVIEW lane and click Approve.

  2. Confirm or edit the auto-generated Report ID.

  3. Submit. Reporter blocks creation until every selected sample has been previewed and has a valid interpretation summary.

Submitting creates a PhenopacketReport, linked to the patient, biosample, and interpretations, and moves the sample to REPORT.

Approve a report#

Only the LaboratorySupervisor can perform the Approve action described above; this is what creates and hands off the report for the MedicalDirector’s sign-off. There is no separate approval step once the sample reaches the REPORT lane — from there, the next action is sign-off or rejection.

Sign out a report#

The MedicalDirector performs the final sign-off from the View Report dialog:

  1. Open the report and click Sign Off. This opens the Complete Pathologist Sign-Off dialog.

  2. Enter your Pathologist Signature / Credentials as free text (for example “Dr. John Doe, MD, PhD”). This is not a drawn or image signature; it is recorded as the report’s submitted_by value.

  3. Check the certification checkbox confirming that the results, variant classifications, and interpretations have been reviewed and verified against laboratory quality protocols and patient metadata. Both the signature text and the checkbox are required before Sign & Finalize Report becomes enabled.

  4. Click Sign & Finalize Report. Reporter sets the report status to FINAL and moves the sample to CLOSED. If the update fails partway through, Reporter automatically rolls the sample state and report status back rather than leaving the case in an inconsistent state.

A signed report is expected to be immutable. Any change after sign-off should follow the amendment process rather than editing the signed report directly.

Reporter does not currently deliver the signed report to the ordering physician or an EHR automatically from this dialog; a PDF of the report can be generated and downloaded from the console. Confirm your organization’s delivery process for getting the report to the ordering physician.

Reject a report#

If a report is not ready for sign-off, the MedicalDirector or LaboratorySupervisor can reject it:

  1. Open the report in the REPORT lane and click Reject.

  2. Confirm the rejection in the dialog (“Are you sure you want to reject this report?”).

  3. Reporter deletes the draft PhenopacketReport and returns the sample to REVIEW, where the MedicalTechnologist can revise the interpretation and resubmit for approval.

From the receiving side, a rejected sample simply reappears in the REVIEW lane with no report attached; there is no separate rejection-reason field recorded on the sample today, so communicate the reason for rejection to the review team directly (for example through the case notes or your team’s usual channel) until a structured rejection-reason field is available.

Amend or reissue a report#

Once a report is signed and the sample is CLOSED, the console does not currently expose a self-service reissue or amendment action from the Reporting pages. Follow your laboratory’s manual amendment procedure:

  1. Coordinate with your administrator or LaboratorySupervisor to open a controlled amendment.

  2. Clearly indicate that the new report supersedes the previous version.

  3. Preserve the original signed report and the reason for amendment in the audit trail.

Do not attempt to alter a CLOSED report’s content directly outside of an authorized amendment procedure.

Report version and audit requirements#

Each report version should record:

  • The author and approver identities.

  • The timestamps of creation, approval, sign-off, and amendment.

  • The interpretations and evidence included in the report.

  • The reason for any rejection or amendment.

Consult your organization’s compliance requirements for retention and audit review.

Roles and handoffs#

Action

Typical role

Result

Create and approve report

LaboratorySupervisor

Report enters REPORT stage.

Sign out report

MedicalDirector

Sample moves to CLOSED.

Reject report

MedicalDirector, LaboratorySupervisor

Draft report is deleted; sample returns to REVIEW.

Reissue / amend report

Administrator, LaboratorySupervisor

Handled outside the standard Reporting workflow via your laboratory’s manual amendment procedure.

Troubleshooting#

Problem

Possible cause

Action

Cannot create report

Sample has not been advanced from REVIEW, or role lacks permission.

Confirm the sample state and your assigned role.

Sign-off is disabled

Report is not yet approved or a required field is missing.

Complete the approval step and verify all required content.

Amendment is not allowed

Case is not configured for amendment or role lacks permission.

Contact your administrator or follow the manual amendment procedure.