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 audit review. It helps catch mismatches, stale contacts, and missing evidence before they become findings.
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Built for: 340b Covered Entities · Hospitals And Health Systems · Federally Qualified Health Centers · Outpatient Clinics · Contract Pharmacy Networks
Overview
This template is a reconciliation log for 340B covered entities that need to verify OPAIS registration details against active contract pharmacy agreements and internal program records. It is built to document the reporting period, confirm the covered entity name and OPAIS ID, compare registered site addresses and contacts, and record whether each contract pharmacy listed in OPAIS matches the executed agreement on file.
Use it when you are preparing for annual recertification, onboarding or terminating a contract pharmacy, updating a site address, or cleaning up stale program records after an organizational change. It is also useful when compliance, pharmacy, and legal teams need a shared record of what was checked, what did not match, and who owns the correction. The evidence section gives you a place to attach screenshots, exports, and supporting documents so the review is traceable.
Do not use this log as a substitute for legal review of 340B eligibility, contract language, or HRSA reporting obligations. It is a control document, not a policy manual. If your organization is not maintaining active contract pharmacy relationships, or if the review is only about general inventory or dispensing operations, this template is not the right fit. Its purpose is narrow: confirm that OPAIS, contracts, and internal documentation are aligned before a discrepancy becomes a compliance issue.
Standards & compliance context
- This template supports 340B program governance by creating a documented control for matching OPAIS records to executed contract pharmacy agreements and internal source documents.
- It aligns with common compliance management practices used in healthcare programs that rely on controlled records, change tracking, and evidence retention.
- The log helps prepare for HRSA review and internal audit by showing that registration data, pharmacy status, and corrective actions were checked on a defined schedule.
- If your organization uses formal quality or compliance systems, the reconciliation and sign-off fields can be mapped to document control and corrective action workflows.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Inspection Setup and Scope
This section defines exactly what period, entity, and pharmacy list are being reviewed so the reconciliation has a clear boundary.
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Reporting period documented
Enter the reconciliation period covered by this log.
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Covered entity name and OPAIS ID verified
Record the covered entity name and OPAIS identifier used for the review.
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Contract pharmacy list included in scope
Select all contract pharmacies reviewed in this inspection.
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Source records available for review
Confirm that OPAIS records, active contracts, and site address documentation are available.
OPAIS Registration Accuracy
This section checks whether the public registration data matches the covered entity's current legal and operational records.
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Covered entity legal name matches OPAIS
Confirm the legal entity name in OPAIS matches the current covered entity record.
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Registered site address matches active location
Confirm the OPAIS site address matches the physical address of the active covered entity location.
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Authorized contact information is current
Verify that the listed contact name, phone number, and email address are current for program administration.
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Entity type and registration status are active
Confirm the entity remains active and properly registered in OPAIS for the review period.
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Recent registration changes documented
Confirm any additions, terminations, relocations, or ownership changes are documented and reflected in the record set.
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Evidence of OPAIS screenshot or export attached
Attach a screenshot or export showing the current registration record.
Contract Pharmacy Reconciliation
This section verifies that each active pharmacy listing is backed by an executed agreement and correct status dates.
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Active contract pharmacy agreement on file
Verify a current executed contract exists for each pharmacy reviewed.
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Contract pharmacy listed in OPAIS matches executed agreement
Confirm the pharmacy name and location in OPAIS match the executed contract pharmacy agreement.
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Contract effective date and termination date are accurate
Verify the active dates in the record set match the current contractual status.
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Pharmacy address and service location match records
Confirm the pharmacy street address and service location are consistent across OPAIS and contract documents.
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Terminated or inactive pharmacies removed from active list
Verify terminated or inactive contract pharmacies are not listed as active in internal records or OPAIS.
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Reconciliation exceptions documented
Describe any mismatches, missing records, or unresolved exceptions found during reconciliation.
Program Controls and Recertification Readiness
This section confirms the organization has a repeatable process for updates, retention, and corrective action before recertification.
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Annual recertification calendar reviewed
Confirm the annual HRSA recertification timeline has been reviewed and assigned to the responsible owner.
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Change management process in place for site or pharmacy updates
Verify there is a documented process for updating OPAIS when sites or contract pharmacies change.
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Supporting documentation retained for review
Confirm reconciliation workpapers, contracts, and OPAIS evidence are retained according to policy.
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Open corrective actions assigned
List any corrective actions, owners, and due dates for unresolved discrepancies.
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Inspector sign-off
Inspector confirms the reconciliation was completed and reviewed.
Evidence and Notes
This section captures the proof, context, and completion details that make the review defensible and easy to audit.
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Supporting evidence uploaded
Attach screenshots, exports, or supporting documents used in the reconciliation.
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Additional notes
Record any additional observations, clarifications, or follow-up items.
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Review completed date and time
Enter the date and time the reconciliation review was completed.
How to use this template
- 1. Enter the reporting period, covered entity name, OPAIS ID, and the full list of contract pharmacies that are in scope for the review.
- 2. Compare the OPAIS record to internal source documents and confirm that the legal name, active site address, contact details, entity type, and registration status are current.
- 3. Review each contract pharmacy agreement and verify that the pharmacy name, address, effective date, termination date, and service location match the OPAIS listing and executed file.
- 4. Document every mismatch, missing attachment, or inactive pharmacy that still appears on the active list, then assign an owner and due date for correction.
- 5. Confirm that recertification dates, change management steps, and supporting records are retained, then complete the inspector sign-off and review timestamp.
Best practices
- Use the legal entity name exactly as it appears in OPAIS and in the executed contract file to avoid false mismatches.
- Verify the service location and mailing address separately when a pharmacy has multiple locations or a centralized corporate address.
- Attach the OPAIS screenshot or export at the time of review so the evidence reflects the same record version you reconciled.
- Flag terminated or inactive pharmacies immediately and remove them from the active list only after the termination record is confirmed.
- Record the specific source document for every field you validate, such as the agreement, amendment, or internal registration record.
- Assign corrective actions to a named owner with a due date, not just a general note that an item needs follow-up.
- Keep the reconciliation cadence consistent so changes are caught before annual recertification or external review.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
Who should use a 340B OPAIS Registration and Contract Pharmacy Reconciliation Log?
This template is for 340B covered entities, compliance staff, pharmacy operations, and anyone responsible for maintaining OPAIS records and contract pharmacy files. It is especially useful for hospitals, clinics, and health systems that manage multiple service sites or pharmacy partners. If one team owns registration and another owns contract pharmacy oversight, this log helps keep both sides aligned.
How often should this reconciliation log be completed?
Many organizations run it on a monthly or quarterly cadence, then again before annual recertification or any material program change. The right frequency depends on how often sites open, close, relocate, or change pharmacy partners. At minimum, it should be updated whenever a covered entity address, authorized contact, or contract pharmacy arrangement changes.
What records should be compared in this template?
The log is built to compare OPAIS entries against executed contract pharmacy agreements, site address records, registration status, and internal program documentation. It also captures evidence such as screenshots or exports from OPAIS and notes for any exceptions. That makes it easier to prove what was reviewed and what was corrected.
Does this template help with annual recertification readiness?
Yes. The program controls section is designed to confirm that recertification calendars, change management steps, and corrective actions are in place before deadlines arrive. It does not replace the recertification process, but it helps identify missing documentation and unresolved discrepancies early enough to fix them.
What are the most common mistakes this log helps catch?
Common issues include a pharmacy still listed as active after termination, a site address in OPAIS that no longer matches the operating location, or outdated contact information that delays program notices. Teams also miss documentation gaps, such as an agreement on file without a matching effective date or missing evidence of a recent update. This template surfaces those non-conformances in one place.
Can this template be customized for multi-site health systems?
Yes. You can add rows for each covered entity location, separate contract pharmacies by site, or include internal owner fields for legal, compliance, and pharmacy operations. Multi-site organizations often add a status column for open, in review, corrected, or escalated so the log doubles as a workflow tracker.
How does this compare with ad hoc spreadsheet tracking?
Ad hoc tracking usually leaves gaps because one person updates OPAIS, another stores contracts, and no one confirms the records match. This template forces a structured reconciliation with evidence, exception notes, and sign-off, which makes review faster and more defensible. It also creates a repeatable audit trail instead of a one-time cleanup.
What should be attached as evidence?
Attach the current OPAIS screenshot or export, the executed contract pharmacy agreement, any amendment or termination notice, and supporting records that verify site address or contact changes. If a discrepancy is found, include the corrective action record and any follow-up confirmation. The goal is to show both the issue and the resolution.
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