U. S. Department of Health and Human Services

APRIL 2006 93.268 IMMUNIZATION GRANTS State Project/Program: IMMUNIZATION PROGRAM / AID TO COUNTY FUNDING U. S. Department of Health and Human Services Federal Authorization: Public Health Service Act, Section 301, 42 U.S.C. 241, and Section 317, 42 U.S.C. 247b, as amended; Health Services and Centers Amendments of 1978, Public Law 95-626; Omnibus Budget Reconciliation Act of 1981, as amended, Public Law 97-35; Preventive Health Amendments of 1984, Public Law 98-555; Social Security Act, Section 1928. State Authorization: N. C. Department of Health and Human Services Division of Public Health Agency Contact Person Program Gary Walker Immunization Branch 1917 Mail Service Center Raleigh, NC 27699-1917 (919) 707-5556 Gary.Walker@ncmail.net Agency Contact Person - Financial Frances Dreps Budget Officer (919) 707-5071 Frances.Dreps@ncmail.net N. C. DHHS Confirmation Reports: SFY 2006 audit confirmation reports for payments made to Counties, Area Programs, Councils of Government and District Health Departments will be available by around late August to early September at the following web address: http://www.dhhs.state.nc.us/control/ At this site, page down to Letters/reports/forms for ALL Agencies and click on Audit Confirmation Reports (State Fiscal Year 2005-2006). Additionally, audit confirmation reports for Nongovernmental entities receiving financial assistance from the DHHS are found at the same website except select Non-Governmental Audit Confirmation Reports (State Fiscal Years 2003-2005). The auditor should not consider the Supplement to be safe harbor for identifying audit procedures to apply in a particular engagement, but the auditor should be prepared to justify departures from the suggested procedures. The auditor can consider the Supplement a safe harbor for identification of compliance requirements to be tested if the auditor performs reasonable procedures to ensure that the requirements in the Supplement are current. The grantor agency may elect to review audit working papers to determine that audit tests are adequate. I. PROGRAM OBJECTIVES The objectives of the National Immunization Program are focused on achieving the Healthy People 2010 Objectives which include the following immunization objectives: (1) Reducing indigenous cases of vaccine-preventable diseases (VPDs) to zero cases of diphtheria and tetanus among people aged 25 and younger; zero cases of polio, measles, rubella, and congenital rubella syndrome among people of all ages; 500 cases of mumps among people of all ages; and, 1,000 cases of pertussis among people of all ages by the year 2010; (2) ensure that 90% of children complete by age 2 the vaccine series recommended by the Advisory Committee on Immunization Practices (ACIP); (3) Increase immunization levels for pneumococcal and B-4 93.268-2 1

influenza to at least 60 percent among non-institutionalized high-risk populations as defined by the ACIP. The Immunization Grants are administered to assist States and communities in establishing and maintaining preventive health service programs to immunize individuals against vaccinepreventable diseases. (Authorization: PHS ACT, SECT 317) The Omnibus Budget Reconciliation Act (OBRA) created the Vaccines for Children (VFC) program as Section 1928 of the Social Security Act Title XIX. The creation of this program (in October 1, 1994) marks the first time private providers could receive publicly purchased vaccine. (Authorization OBRA 1993, Social Security Act, Title XIX, Section 1928, 42 U.S.C. 1396s) II. PROGRAM PROCEDURES To achieve these objectives, Centers for Disease Control and Prevention (CDC) has identified the following areas of activity for programmatic emphasis: (1) improvements in the quality and quantity of vaccination-delivery services; (2) reduction in vaccine cost as a barrier for needy parents; (3) increases in community participation, education and partnerships; (4) improvements in monitoring of disease and vaccine coverage; (5) improvements in vaccines and vaccine use. The Secretary of the Department of Health and Human Services (HHS) allocates funds to a State upon submission of an application by a State and approval of that application. The application must include a State plan for meeting the program objectives and must (1) include annual program objectives for each of the specified program components; (2) be based on CDC s Immunization Program Performance Guidelines; (3) address methods of operation, including specific action steps to achieve the related objectives; (4) include a detailed budget and budget justification for each program component; (5) have a description of the State s total vaccine needs by individual vaccine with funding allocation needs specified among 317, VFC and other funding sources. The Department provides vaccines required by law (and other selected vaccines recommended by the ACIP) to public and private health care providers in accordance with 15A NCAC 19A.0502 which are outlined below in the requirements section. The Immunization Grants are administered by the North Carolina Department of Health and Human, Services, Division of Public Health, Women s and Children s Health Section, Immunization Branch, 1917 Mail Service Center, Raleigh, North Carolina, 27699-1917. The State of North Carolina also provides funding to assist local health departments to increase their immunization rates. Federal funding provides approximately 70% of the Aid to County support while 30% comes from the State. (G.S. 130A-152; (c1); Session Laws 1993, c.561, so.109) III. COMPLIANCE REQUIREMENTS A. ACTIVITIES ALLOWED OR UNALLOWED 1. Federal Immunization funding must be spent only for immunization programs. Subrecipients/vaccine providers will impose no charge for the cost of vaccine. B-4 93.268-2 2

2. Subrecipients/vaccine providers will not deny administration of a federally procured vaccine to a child because the child s parent/guardian is unable to pay the administration fee. 3. Provide all vaccines needed during a visit unless a specific contraindication exists to one or more of the vaccines 4. Impose no condition as a prerequisite to receiving vaccine (15A NCAC 19A.0502) 5. Report adverse vaccine reactions through the Vaccine Adverse Event Reporting System (VAERS) (15A NCAC 19A.0502) 6. Provide the latest edition of the applicable of the Vaccine Information Statement (VIS) to the parent, guardian, or person standing in loco parentis for each dose of vaccine administered; document this action within the patient s permanent medical record; retain the documentation for a period of 10 years following the end of the calendar year in which the vaccine dose was administered, or for 10 years following the recipient s age of majority, whichever is longer; upon request, furnish copies of the documentation to the local health department or the Department. Keep a record of the vaccine manufacturer, lot number, and date of administration for each dose of vaccine administered (15A NCAC 19A.0502) 7. Screen all patients 0-18 years of age to determine the VFC eligibility and retain such information for a period of 3 years following the date the vaccine was administered. Document the VFC status on the first visit and when VFC eligibility changes (authorization: Provider Agreement) 8. Submit an Annual Provider Profile on forms approved by the Immunization Branch (authorization: Provider Agreement) 9. Ensure a vaccine disaster recovery plan is completed, posted, and read by current and new staff (authorization: Provider Agreement) 10. Store vaccine on hand according to the most recent UCVDP Minimum Required Vaccine Ordering, Handling, and Storage procedures (most current policy available from the contact person listed above) 11. Return all spoiled or expired vaccine to the Immunization Branch. B. ALLOWABLE COSTS/COST PRINCIPLES All grantees that expend State funds (including federal funds passed through the N. C. Department of Health and Human Services) are required to comply with the cost principles described in the N. C. Administrative Code at 09 NCAC 03M.0201. E. ELIGIBILITY Children 0-18 years of age and younger are eligible to receive State supplied vaccine at no charge. Eligible agencies have been determined to be local and/or district health departments who have signed a consolidated contract and agreed to the terms of the contract addenda. (VFC Operations Guide 1999, US. Department of Health and Human B-4 93.268-2 3

Services, Public Health Service, CDC). Detail for eligibility can be found at NCAC T15A: 19A.401. I. PROCUREMENT All grantees that expend federal funds (received either directly from a federal agency or passed through the N. C. Department of Health and Human Services) are required to conform with federal agency codifications of the grants management common rule accessible on the Internet at http://www.whitehouse.gov/omb/grants/chart.html. All grantees that expend state funds (including federal funds passed through the NC Department of Health and Human Services are required to comply with the procurement standards described in the North Carolina General Statutes and the North Carolina Administrative Code, which are identified in the North Carolina Agency publishing manual accessible on the internet at: http://www.doastate.nc.us/pandc/agpurman.htm#p6 Nongovernmental subrecipients shall maintain written Procurement policies that are followed in procuring the goods and services required to administer the program. J. PROGRAM INCOME Effective March 1, 1999, the Division shall require as part of agreements with immunization program providers that the provider pay the cost of vaccine provided to replace vaccine provided under the program that has been wasted by the provider due to the provider s failure to properly store, handle, or rotate vaccine inventory (NC Senate Bill 1366, Section 12.52 (d). Funds received from providers shall be retained by the Division and used to provide technical assistance to providers and to enhance overall program efficiency. Audit Objective - Determine whether program income is correctly recorded and used in accordance with the program requirements. Suggested Audit Procedures 1. Identify Program Income a. Review the laws, regulations, and the provisions of contract or grant agreements applicable to the program and ascertain if program income was anticipated and, if so, the requirements for recording and using program income. b. Inquire of management and review accounting records to ascertain if program income was received. 2. Recording of Program Income - Perform tests to verify that all program income was properly recorded in the accounting records. 3. Use of Program Income - Perform tests to ascertain if program income was used in accordance with the program requirements. L. REPORTING B-4 93.268-2 4

Subrecipients must report electronically by the 10th day of each month immunization data from the population served by the local department. This data includes name, date of birth, social security (if available), vaccine given and dose number. N. SPECIAL TESTS AND PROVISIONS Consolidated Contract with Local Health Departments/Districts History Three divisions in DHHS can be traced back to a single division under the auspices of the former Department of Human Resources. These Divisions are Community Health Services, Epidemiology and Women s and Children s Health Services. [The Division of Environmental Health in the Department of Environment and Natural Resources was also a part of the former Division of Health Services.] Administrative staff in this former Division of Health Services developed a single contract document to manage all funds both State and federal, the Division allocated to local health departments across the State. This document, as amended, is still in use as the Consolidated Contract. This Contract sets forth the more general requirements of the funding relationship between the State and local public health agencies. The respective requirements are detailed under headings including: Work to Be Performed; Funding Stipulations; Fiscal Control; Responsibilities of the State; and Compliance. More specific information is set out in a document called the Contract Addendum which details each program s outcome objectives (which may or may not be negotiable at the beginning of each fiscal year) that each local health department must achieve in exchange for the funding. A third part of the system is the Budgetary Guidance which is sent annually from each of the Divisions to all health departments being allocated funds from specific sources, i.e., State appropriations or federal grant funds. This Guidance indicates the amount of the allocated funds and their respective sources. Each health department will be able to provide an auditor with a copy of the Consolidated Contract for the particular year being audited, as well as, copies of the Budgetary Guidance, Contract Addenda, expenditure reports and any activity reports for each pot of money received. If the health department cannot provide these documents, they are available from the respective public health Divisions mentioned above. Conflicts of Interest The North Carolina General Assembly enacted legislation (Chapter 321, Section 16, 1993 Session Laws) requiring each private, not-for-profit entity, as a prerequisite to the receipt of funding from the State, to formally adopt a policy that addresses conflicts of interest that might arise involving the entity s management, employees, and/or board members. All non-state entities (except those entities subject to the audit and other reporting requirements of the Local Government Commission) that receive, use or expend State funds (including federal funds passed through the N. C. Department of Health and Human Services) are subject to the financial reporting requirements of G. S. 143-6.2 for fiscal years beginning on or after July 1, 2005. These requirements include the submission of a Notarized Conflict of Interest Policy (see G. S. 143-6.2(b1)) and a written statement (if applicable) that the entity does not have any overdue tax debts as defined by G. S. 105-243.1 at the federal, State or local level (see G. S. 143-6.2(b2)). All non-state entities that provide State funding to a non-state entity (except any non-state entity subject to the audit B-4 93.268-2 5

and other reporting requirements of the Local Government Commission) must hold the subgrantee accountable for the legal and appropriate expenditure of those State grant funds. Suggested Audit Procedures It is suggested that Section B. FUNDING STIPULATIONS of the Consolidated Contract be reviewed by the auditor before beginning an audit. The fourteen items of this Section, as applicable, describe much of the detailed information the auditor may be seeking during a review of these programs. B-4 93.268-2 6