Influenza & Pneumococcal Immunizations

1. Influenza & Pneumococcal Immunizations Guidance Training CFR 483.25(n) F334 1

2. Today’s Agenda • Regulation • Interpretive Guidelines • Investigative Protocol • Determination of Compliance • Deficiency Categorization 2

3. Training Objectives • Describe the intent of the Influenza and Pneumococcal immunization regulation • Describe and utilize the components of the investigative protocol • Identify compliance with the regulation • Appropriately categorize the severity of noncompliance 3

4. Influenza & Pneumococcal Immunizations Interpretive Guidelines 4

5. Interpretive GuidelinesComponents • Intent • Definitions • Overview • Provision of Immunizations 5

6. Interpretive GuidelinesIntent The intent of this requirement is to: • Minimize the risk of residents acquiring, transmitting, or experiencing complications from influenza and pneumococcal pneumonia by assuring that each resident is informed about the benefits and risks of immunizations and has the opportunity to be immunized. • Assure that the resident’s medical record reflects the provision of education about the benefits and risks of immunizations and the resident’s immunization status. 6

7. Interpretive GuidelinesDefinitions • Medical Contraindication • Precaution 7

8. Interpretive GuidelinesOverview Influenza & pneumococcal immunization program that promote health and well-being of long term care residents include: • Policies that reflects current immunization standards of practice. • Medical director involvement. • Physician approved policies. 8

9. Interpretive GuidelinesOverview continued • Vaccination schedules and mechanisms for recording and monitoring administration of both influenza & pneumococcal vaccines. • Education regarding the benefits and potential side effects of immunizations that allows the resident to make an informed choice including the refusal to be immunized. 9

10. Interpretive GuidelinesProvision of Immunizations Facilities are required to: • Educate • Document 10

11. Interpretive GuidelinesProvision of Immunizations Vaccination may be delayed or not given for clinical or other types of reasons such as: • Precaution is present (acute illness) • End stages of a terminal illness & receiving only palliative care • Medical contraindications for live attenuated influenza vaccine (LAIV) • Immunization status is current or resident refused. 11

12. Interpretive GuidelinesProvision of Immunizations Documentation • Documentation requirements for Influenza (§483.25(n)(1)(iv)) & Pneumococcal (§483.25(n)(2)(iv)) are the same. • Resident or resident’s legal representative educated • Resident did or did not receive immunization. 12

13. Interpretive GuidelinesProvision of Immunizations • Exceptions • Outside the influenza season (which is October 1-March 31) • Previously administered. 13

14. Influenza & Pneumococcal Immunizations Investigative Protocol 14

15. Investigative Protocol Components • Objectives • Use • Procedure 15

16. Investigative ProtocolObjectives • To determine if the facility’s immunization program has been implemented and effectively assures that residents are offered vaccines, and that residents or legal representatives receive related education; • To determine if education regarding the benefits and potential side effects of immunization(s) was provided to the resident or legal representative each time a vaccine was offered; and 16

17. Investigative ProtocolObjectives (con’t) • To determine if each resident received the influenza and/or pneumococcal immunization(s) unless medically contraindicated, refused, or already immunized, or because of circumstances outside of the facility’s control, such as vaccine production delays. 17

18. Investigative ProtocolUse Use for all surveys however sampling method dependent on time of year: • Within Influenza Season (Oct 1 thru Mar 31) • Outside Influenza Season Same resident sample is used for both pneumococcal & influenza immunizations. 18

19. Investigative ProtocolUse: Sample Selection Within Influenza Season (Oct 1-Mar 31) • Comprehensive review sample is used Outside Influenza Season • Select from list provided by facility’s immunization program coordinator 19

20. Investigative ProtocolProcedures: Pneumococcal Vaccine Determine the following: • The provision of education related to the vaccine; and • Either documentation of the administration of the vaccine; or • If not provided, documentation as to why the vaccine was not provided, such as medical contraindications, refusal, or vaccine was already given prior to admission. 20

21. Investigative ProtocolProcedures: Influenza Immunization Within Influenza season (Oct 1-Mar 31) Determine the following: • The provision of education related to the vaccine; and • Either documentation of the administration of the vaccine; or • If not provided, documentation as to why the vaccine was not provided. 21

22. Investigative ProtocolProcedures: Influenza Immunization Within Influenza season (Oct 1-Mar 31) If influenza vaccine unavailable demonstrate: • Ordered vaccine & know when it will become available to them. • Plans for when vaccines will be administered. • Determined residents eligible to receive and • Implemented education. 22

23. Investigative ProtocolProcedures: Influenza Immunization Outside of the Influenza season • Determine if during the previous influenza season: • Education related to the vaccine was provided; and • Either documentation of the administration of the vaccine; or • If not provided, documentation as to why the vaccine was not provided. 23

24. Investigative ProtocolProcedures Review Facility Immunization Program if: • Residents not immunized & not due to unavailability or refusal, or • Residents not evaluated for vaccination status, or • Residents not educated 24

25. Investigative ProtocolProcedures Immunization Policies & Procedures: • Resident education • Immunization implementation • Plan for unavailability or like issues • Tracking/Monitoring of vaccine status 25

26. Influenza & Pneumococcal Immunizations Determination of Compliance 26

27. Determination of Compliance • Synopsis of regulation • Criteria for compliance • Noncompliance for F334 27

28. Determination of Compliance Synopsis of Regulation The influenza & pneumococcal vaccination requirement has five aspects: • The resident is provided education regarding the benefits & potential side effects of the vaccinations; • The facility must determine if a resident is eligibility to receive the vaccinations. • The resident, or the resident’s legal representative, has the right to refuse the vaccinations. 28

29. Determination of ComplianceCriteria for Compliance • Each eligible resident is administered the influenza & pneumococcal vaccine (unless refused or contraindicated or the resident has already been immunized); and • The facility must document that education was provided and that the resident either received the vaccine(s) or, if not received, that the vaccine(s) was (were) refused or medically contraindicated or the resident had already been immunized. 29

30. Determination of ComplianceCriteria for Compliance The facility is in compliance with this requirement: • If each resident receives education regarding the benefits & potential side effects of the vaccine(s); • If each resident has been evaluated for eligibility to receive the vaccines(s); • If each resident is offered, unless medically contraindicated or already vacinated, an influenza vaccine October 1 through March 31 annually, & a pneumococcal vaccine; 30

31. Determination of ComplianceCriteria for Compliance • If the resident has the opportunity to refuse; and • If the record includes documentation that indicates, at a minimum: • The resident was provided education regarding the benefits & potential side effects; and • That the resident received the immunizations, refused the vaccination(s), or did not receive the vaccine(s) because of already being immunized, or as a result of a medical contraindication, unavailability, or a precaution that delayed the administration & a later date for administration has been planned. 31

32. Determination of ComplianceCriteria for Compliance If the facility is not in compliance with each of these aspects of the requirement, cite F334. 32

33. Determination of ComplianceNoncompliance for F334 Noncompliance for F334 may include, but is not limited to, one or more of the following: • An eligible resident did not receive either the influenza and/or the pneumococcal vaccines without a valid reason. • The facility did not evaluate to identify potential medical contraindications to the vaccines. • The facility administered either of the vaccines to a resident who had refused them. • The facility administered the vaccines(s) to a resident who had an identified precaution, such as moderate or severe acute illness with or without fever, without physician involvement and.or approval. 33

34. Determination of ComplianceNoncompliance for F334 con’t • The facility administered the vaccines(s) to a resident who had an identified precaution, such as moderate or severe acute illness with or without fever, without physician involvement and/or approval. • The facility failed to provide the pertinent information regarding the immunizations to the resident; 34

35. Determination of ComplianceNoncompliance for F334 con’t • The facility failed to document that the resident or resident’s legal representative was provided education regarding the benefits and potential side effects of the influenza and, as applicable, the pneumococcal immunization; and • The facility failed to document that the resident either received the vaccine(s) or did not receive the vaccine(s) due to medical contraindications or refusal. 35

36. Determination of CompliancePotential Tags Related requirements that may be considered: • 42 CFR 483.20(b), F272, Comprehensive assessments • 42 CFR 483.65, F441, Infection control program • 42 CFR 483.75(i)(2), F501, Medical Director 36

37. Influenza & Pneumococcal Immunizations Deficiency Categorization 37

38. Deficiency CategorizationSeverity Determination The key elements for severity determination are: • Presence of harm or potential for negative outcomes because of lack of appropriate treatment • Degree of harm (actual or potential) related to the non-compliance • The immediacy of correction required 38

39. Deficiency CategorizationSeverity Determination Levels • Level 4: Immediate Jeopardy to resident health or safety • Level 3: Actual Harm that is not Immediate Jeopardy • Level 2: No actual harm with potential for more than minimal harm that is not immediate jeopardy • Level 1: No actual harm with potential for minimal harm 39

40. Deficiency CategorizationSeverity Level 4: Immediate Jeopardy Examples of avoidable negative outcomes: • A resident who is not eligible to receive the vaccine due to medical contraindications is administered the vaccine and experiences a life threatening reaction, such as anaphylactic shock. • Residents who were eligible to receive vaccines did not receive them as a result of the facility’s failure to have any program for vaccinating residents. 40

41. Deficiency CategorizationSeverity Level 3: Actual Harm that is not IJ Examples of avoidable negative outcomes: • A resident who was not eligible to receive the vaccine due to medical contraindications receives the vaccine & experiences a reaction that is not life threatening, but requires treatment. • Because of an unwarranted delay in administering the influenza vaccine despite its availability, an eligible resident who has agreed to receive the influenza vaccine develops influenza. 41

42. Deficiency CategorizationSeverity Level 2: No Actual Harm with Potential for more than Minimal Harm that is not IJ Examples of avoidable negative outcomes: • An eligible resident did not receive the vaccine, but did not develop symptoms of influenza. • An eligible resident received two doses of the pneumococcal vaccine, due to a failure to document the receipt of the first does, but did not experience any untoward reactions. • The staff did not asses for medical contraindications prior to providing the vaccine(s), but there were not reactions to the vaccine. 42

43. Deficiency CategorizationSeverity Level 1: No Actual Harm with Potential for Minimal Harm Examples of avoidable negative outcomes: • The facility failed to document that information/education was provided to the resident prior to administering the immunizations. 43