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Run: 340B OPAIS Registration and Contract Pharmacy Reconciliation Log

Use this log to reconcile 340B OPAIS records against active contract pharmacy agreements, site addresses, and program documentation before recertification or...

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Inspection Setup and Scope

Enter the reconciliation period covered by this log.
Record the covered entity name and OPAIS identifier used for the review.
Select all contract pharmacies reviewed in this inspection.
Confirm that OPAIS records, active contracts, and site address documentation are available.

OPAIS Registration Accuracy

Confirm the legal entity name in OPAIS matches the current covered entity record.
Confirm the OPAIS site address matches the physical address of the active covered entity location.
Verify that the listed contact name, phone number, and email address are current for program administration.
Confirm the entity remains active and properly registered in OPAIS for the review period.
Confirm any additions, terminations, relocations, or ownership changes are documented and reflected in the record set.
Attach a screenshot or export showing the current registration record.

Contract Pharmacy Reconciliation

Verify a current executed contract exists for each pharmacy reviewed.
Confirm the pharmacy name and location in OPAIS match the executed contract pharmacy agreement.
Verify the active dates in the record set match the current contractual status.
Confirm the pharmacy street address and service location are consistent across OPAIS and contract documents.
Verify terminated or inactive contract pharmacies are not listed as active in internal records or OPAIS.
Describe any mismatches, missing records, or unresolved exceptions found during reconciliation.

Program Controls and Recertification Readiness

Confirm the annual HRSA recertification timeline has been reviewed and assigned to the responsible owner.
Verify there is a documented process for updating OPAIS when sites or contract pharmacies change.
Confirm reconciliation workpapers, contracts, and OPAIS evidence are retained according to policy.
List any corrective actions, owners, and due dates for unresolved discrepancies.
Inspector confirms the reconciliation was completed and reviewed.

Evidence and Notes

Attach screenshots, exports, or supporting documents used in the reconciliation.
Record any additional observations, clarifications, or follow-up items.
Enter the date and time the reconciliation review was completed.

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