1. 1 Program Managers’ Meeting New Orleans, Louisiana November 19, 2008 OMB Circular A-133 Immunization Compliance Supplement

2. 2 Discussion Topics  OMB Circular A-133  Immunization Compliance Supplement  Compliance Supplement Changes  Challenges Revisited  Links and POCs

3. 3 OMB Circular A-133 Issued pursuant to federal law (P.L. 98-502 and P.L. 104-156) Subtitle: Audits of States, Local Governments, and Non- Profit Organizations Threshold = $500,000 Frequency = annual (in some cases, biennial)

4. 4 OMB Circular A-133 A-133 internal control provisions require auditors to plan and perform “testing of internal control … relevant to compliance requirements for each major program.” Major programs are determined using a four-step approach described in OMB Circular A-133, §.520. Not all major programs need to be audited every year, e.g., low-risk major program.

5. 5 Immunization Compliance Supplement Sets forth internal control audit requirements for major programs as defined in OMB Circular A-133, §.520. Changes reviewed/approved through ISD, PGO, HHS, and OMB. Consists of four sections: IProgram Objectives IIProgram Procedures IIICompliance Requirements IVOther Information Minor (non-substantive) changes to sections I and II. Significant changes to section III, sub-section N. Special Test and Provisions; and to section IV.

6. 6 Compliance Supplement Changes ( Section III, Sub-Section N. Special Tests and Provision) Old Audit ProceduresNew Audit Procedures 1.Control, Accountability, and Safeguarding of Vaccine a.Test a sample of inventory records to ensure proper recording of receipt, transfer, and usage of vaccine. b.Review storage of vaccine for proper safeguarding including risks of loss from theft, expiration, or improper storage temperature. 1.Control, Accountability, and Safeguarding of Vaccine a.Determine if the grantee has a written procedure for overseeing vaccinating providers that provides for sampling of provider’s inventory records and assessment of storage procedures. b.Determine if the grantee sampled the provider’s inventory records to ensure proper recording of receipt, transfer, and usage of vaccine. c.Determine if the grantee reviewed the provider’s storage of vaccine for proper safeguarding, including risks of loss from theft, expiration, or improper storage temperature. d.Determine if necessary follow-up procedures were followed if any deficiencies were identified.

7. 7 Compliance Supplement Changes ( Section III, Sub-Section N. Special Tests and Provision) Old Audit ProceduresNew Audit Procedures 2.Record of Immunization a.Obtain an understanding of how the vaccination records are maintained. b.Test a sample of vaccinations to ascertain if the required records were maintained. 3.Monitoring For-Profit Subrecipients –Assigned responsibility to grantees, as pass through entities, for “establishing requirements as necessary to ensure compliance by for-profit subrecipients.” 2.Record of Immunization a.Determine if the grantee has a written procedure for ensuring that the required information has been recorded for vaccine recipients. b.Determine if the grantee tested a sample of vaccination records to ascertain if the required information was maintained. c.Determine if the grantee took any follow-up action if the required records and information were not maintained. 3.Monitoring For-Profit Subrecipients –Deleted

8. 8 Compliance Supplement Changes ( Section IV, Other Information) Old ProcedureNew Procedure “The value of vaccine received by the States and its subrecipients as well as grant funds shall be included in the total expenditures of CFDA 93.268 when determining Type A programs. The value of vaccine shall be included with grant funds on the Schedule of Expenditures of Federal Awards.” “After the end of each month and after the end of each Federal fiscal year, CDC advises each grantee of the value of all federally funded vaccine that was distributed, in lieu of cash, directly to the grantee and/or on behalf of the grantee to vaccinating providers located in the grantee’s geographical area. The annual dollar value of federally funded vaccine should be treated by the grantee as a grant expenditure for purposes of determining audit coverage and reporting on the Schedule of Expenditures of Federal Awards. Vaccinating providers and vaccinated individuals are not considered subrecipients; therefore, the value of vaccine received is not a grant expenditure for purposes of determining audit coverage and reporting for those entities.”

9. 9 Challenges Revisited Complying with the “old” immunization compliance supplement was difficult under “new” operating procedures for funds management and centralized vaccine distribution. Most issues addressed by updating section IV of the compliance supplement. Some of the resolved issues included: –With DA vaccine no longer obligated to grantees, should DA vaccine be included as part of the value of vaccine received? If yes, where would auditors/grantees get value of vaccine received data? –Are vaccinating providers (LHDs and private providers) considered subrecipients? If yes, how would the provisions of A-133 apply given centralized vaccine distribution. If no, how would auditors/grantees account for vaccine shipped directly to vaccinating providers? –Should the value of DA vaccine shipped directly to vaccinating providers be included as a grant expenditure for purposes of determining audit coverage as a major program? –Should the value of DA vaccine shipped directly to vaccinating providers be included in the Schedule of Expenditures of Federal Awards (SEFA)?

10. 10 Links and POCs Links –OMB Circular A-133 http://www.whitehouse.gov/omb/circulars/a133/a133.pdf –Immunization Compliance Supplement http://www.whitehouse.gov/omb/circulars/a133_compliance/08/hhs.pdf POCs –OMB Circular A-133 Gary KoontzDalton LeonardProcurement and Grants Office (770) 488-2842(770) 488-2816 gck0@cdc.govkel9@cdc.gov –Immunization Compliance Supplement Victor Negron Program Operations Branch, Immunization Services Division (404) 639-6221 vmn1@cdc.gov