Are you ready for a Site Visit?

1. Are you ready for a Site Visit? Presented by: Beth Meadows, RN Wendy Holmes, RN

2. Background on the North Carolina Immunization Program (NCIP) ??? • The North Carolina Immunization Program (NCIP) works in conjunction with the federal vaccine supply program, called the Vaccines for Children (VFC) program, to provide vaccines to health care providers across the state who administer childhood immunizations • The NCIP and Vaccines for Children (VFC) Program provides vaccines to children whose parents or guardians may not be able to afford them NCIP 2011 State Immunization Conference

3. Background Cont… NCIP 2011 State Immunization Conference NCIP helps to ensure that all children have a better chance of getting their recommended vaccinations on schedule

4. Which Vaccines are Available? NCIP 2011 State Immunization Conference ACIP Recommended CDC approved

5. Who is enrolled in the program? NCIP 2011 State Immunization Conference Health Departments Federally Qualified Health Clinics/Rural Health Centers Private Physician Offices School-based Health Clinics Hospitals Youth Detention Centers

6. What is a Site Visit? ~ Formal quality assurance visit to enrolled providers. NCIP 2011 State Immunization Conference

7. Site Visit Objectives: NCIP 2011 State Immunization Conference Evaluate provider compliance with the NCIP and Vaccines for Children Program in both private and public healthcare settings Evaluate compliance with NC specific Immunization Laws and rules

8. Provider Agreement NCIP 2011 State Immunization Conference READ and HEED!!!!!

9. Site Visit Objectives: NCIP 2011 State Immunization Conference Evaluate provider compliance with the NCIP and Vaccines for Children Program in both private and public healthcare settings Evaluate compliance with NC specific Immunization Laws and rules

10. Provider Enrollment Who Should Sign the Provider Enrollment Form? Who Should Sign the VFC Provider Enrollment Form? Section 1928 (c) (1) (A) of the Social Security Act (42 U.S.C. 1396s (c) (1) (A) states that the following providers qualify to be VFC program-registered providers: those healthcare providers "licensed or otherwise authorized for administration of pediatric vaccines under the law of the State in which the administration occurs" (subject to section 333 (e) of the Public Health Service Act, which authorizes members of the Commissioned Corps to practice). The VFC statute follows state law in qualifying practitioners as VFC providers. The term “authorized for administration of pediatric vaccines” is intended to mean authorized to “prescribe” vaccines. Therefore, only providers authorized to prescribe vaccines under state law should be the official VFC program-registered providers. However, other providers authorized to administer vaccines can operate under the supervision of a prescribing VFC provider and should be listed on the Provider Enrollment Form. NCIP 2011 State Immunization Conference

11. NC Prescribing Authority SECTION .1000 - PRESCRIBING 21 NCAC 32B .1001 AUTHORITY TO PRESCRIBE • (a) A license to practice medicine issued under this Subchapter allows the physician to prescribe medications, including controlled substances, so long as the physician complies with all state and federal laws and regulations governing the writing and issuance of prescriptions. • (b) A physician must possess a valid United States Drug Enforcement Administration ("DEA") registration in order for the physician to supervise any other health professional (physician assistant, nurse practitioner, clinical pharmacist practitioner) with prescriptive authority for controlled substances. The DEA registration of the supervising physician must include the same schedule(s) of controlled substances as the supervised health professional's DEA registration. History Note: Authority G.S. 90-2(a); Eff. June 1, 2007. NCIP 2011 State Immunization Conference

12. Provider Agreements NCIP 2011 State Immunization Conference Type of Agreements Local Health Department Agreement Private Provider Agreement NCIR Provider Agreement Non-NCIR Provider Agreement

13. Coverage Criteria NCIP 2011 State Immunization Conference

14. Provider Level Compliance Site Visits • How we pick provider sites to visit? NCIP 2011 State Immunization Conference

15. Items needed for the site visit Include: • Un-interrupted meeting time with the vaccine contact staff • Past three months of vaccine temperature logs • Access to vaccine storage units, temporary and permanent storage • Access to the circuit breaker NCIP 2011 State Immunization Conference

16. Items Needed, Cont. NCIP 2011 State Immunization Conference Vaccine Information Statements (VISs) Borrowing and Replacement Forms Disaster Recovery Plan

17. Items Needed, Cont. NCIP 2011 State Immunization Conference Vaccine Information Statements (VISs)

18. Items Needed, Cont. NCIP 2011 State Immunization Conference Borrowing and Replacement Forms

19. Items Needed, Cont. NCIP 2011 State Immunization Conference Disaster Recovery Plan

20. Who Conducts the Visit? NCIP 2011 State Immunization Conference Regional Immunization Nurses Regional Program Consultants

21. Site Visit Process NCIP 2011 State Immunization Conference Scheduling Letter/Questionnaire

22. NCIR Review NCIP 2011 State Immunization Conference

23. NCIR Review NCIP 2011 State Immunization Conference

24. NCIR ReviewVaccine Transaction Summary By Provider NCIP 2011 State Immunization Conference

25. NCIR Review Vaccine Accountability Report NCIP 2011 State Immunization Conference

26. NCIR ReviewVaccine Usage Report NCIP 2011 State Immunization Conference

27. NCIR ReviewWasted/Expired Vaccine Report NCIP 2011 State Immunization Conference

28. Non-NCIR User NCIP 2011 State Immunization Conference Vaccine Administered Log Borrowing Reports Wasted/Expired Forms

29. Day of the Visit- Assessment NCIP 2011 State Immunization Conference VIS’s/temps, etc. Storage units Circuit Breaker

30. Day of the Visit- Assessment NCIP 2011 State Immunization Conference VIS statements for all vaccines administered Past three months temperature logs for the refrigerator and freezer Access to all vaccine storage units, including those used for temporary storage Clear assess to circuit breaker

31. Day of the Visit, Feedback NCIP 2011 State Immunization Conference All findings will be reviewed with the vaccine contact Areas that need improvement will be discussed Education will be provided to improve vaccine services Follow up recommendations/requirements will be reviewed

32. Provider Improvement Plan NCIP 2011 State Immunization Conference Summary of out of compliance items will be provided Providers have thirty days to submit a corrective action plan to the NCIP

33. Remember: NCIP 2011 State Immunization Conference We are EDUCATORS not AUDITORS

34. Common Site Visit Questions 34 NCIP 2011 State Immunization Conference

35. Do I have to complete the site visit? NCIP 2011 State Immunization Conference Yes!!!!!! Item #(17)Provider Agreement: Allow periodic VFC Site Visits or inspection of vaccine supplies and records as requested by the Immunization Branch

36. How often are visits done? NCIP 2011 State Immunization Conference Every other year (or more often as needed).

37. How Long Do the Visits Take? NCIP 2011 State Immunization Conference Approximately 1-3+ hours

38. What are you looking for in my Fridge/Freezer? 38 NCIP 2011 State Immunization Conference

39. Vaccine Storage Equipment This is an improper way to store vaccine. There are many reasons why this is unacceptable but the main reason is improper/poor air circulation. This provider will be required to purchase additional refrigerator space to allow air circulation. Problems with Household Combination • For food/ beverage storage • Temperature fluctuations • Inadequate usable space 39 NCIP 2011 State Immunization Conference

40. Vaccine Storage Equipment • Phase out interior freezer by 12/31/2009(requirement) • Any size unit with interior freezer • Day storage only • Temperatures 2 X daily Phase out units with interior freezers, regardless of size. This is effective December 31, 2009 (requirement) 40 NCIP 2011 State Immunization Conference

41. Vaccine Storage Practices Diluents Water Bottles Water Bottles Diluents 41 NCIP 2011 State Immunization Conference

42. Vaccine Ordering and Inventory Management • Label shelves/trays • Mark multi-dose vials • Date open • Doses used 42 NCIP 2011 State Immunization Conference

43. Site Visit Requirements Appropriate Refrigerator/Freezer Distinguish private/state Biological specimens Jugs of water – refrigerator Ice packs - freezer Certified calibrated thermometer (middle with vaccine) 43 NCIP 2011 State Immunization Conference

44. Site Visit Requirements Appropriate Refrigerator/Freezer No food Vaccine not in door Proper air circulation MMR in the freezer Properly rotate vaccine Do not pre-draw “DO NOT DISCONNECT” signs on the outlet and circuit breaker 44 NCIP 2011 State Immunization Conference

45. Site Visit Requirements Temperatures log Checked and documented in a.m. & p.m. Temperatures maintained Written documentation of action taken 45 NCIP 2011 State Immunization Conference

46. Why do you need to see our Vaccine Information Statements? Ensure you are using the appropriate VIS for each dose of vaccine you administer Ensure you provide a current VIS for each dose of vaccine given Review our providers responsibilities regarding the use of VIS’s 46 NCIP 2011 State Immunization Conference

47. VIS FACT • According to CDC, every time one of these vaccines is given — regardless of what combination vaccine it is given in — regardless of whether it is given by a public health clinic or a private provider — regardless of how the vaccine was purchased — and regardless of the age of the recipient — the appropriate VIS must be given out prior to the vaccination. 47 47 NCIP 2011 State Immunization Conference

48. VIS FACT • Use of the VIS is mandatory! • Before a healthcare provider vaccinates a child or an adult with a dose of any vaccine containing diphtheria, tetanus, Pertussis, measles, mumps, rubella, polio, hepatitis A, hepatitis B, Haemophilus influenzae type b (Hib), influenza, pneumococcal conjugate, meningococcal, rotavirus, human papillomavirus (HPV), or varicella (chickenpox) vaccine, the provider is required by the National Childhood Vaccine Injury Act (NCVIA) to provide a copy of the VIS to either the adult recipient or to the child’s parent/legal representative. 48 48 NCIP 2011 State Immunization Conference

49. What else are you looking for? Vaccine Administration Practices Administration fee(s) to non-Medicaid VFC eligible patients Patient is unable to pay administration fee Office fee for an immunization only visit Prerequisite (i.e. physical exam) prior to an immunization only visit 49 NCIP 2011 State Immunization Conference

50. Site Visit Requirements– Vaccine Schedule 50 NCIP 2011 State Immunization Conference