Healthcare Personnel Immunization. Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases University of Louisville

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Healthcare Personnel Immunization Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases University of Louisville

Disclosures Funding provided by the U. S. Department of Homeland Security, Science & Technology Directorate, through a technology development and deployment program managed by The National Institute for Hometown Security.

Objectives Identify current immunizations recommended by the CDC ACIP for inclusion in a healthcare personnel immunization program applicable for any healthcare setting Identify specific areas of risk for safe vaccine handling and management Discuss available resource regarding safe vaccine handling, management, administration, and program evaluation

ACIP Recommendations Hepatitis B Measles-Mumps-Rubella Varicella Tetanus-Diphtheria-acellular Pertussis (tdap) Influenza (TIV or QIV; IM/ID; or LAIV) Meningococcus (for special populations) CDC. Immunization of Health-Care Personnel: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR November 25, 2011; 60(No. RR-07); 1-45

Comprehensive Immunization Program Selecting the correct vaccines for the program Selecting the correct vaccines for the HCP Storing Handling Administering Educating Monitoring Improving

Evaluating Existing Practices Survey of APIC Infection Preventionists IRB approval University of Louisville Web-based survey 38 questions 93 response items

Evaluating Existing Practices Survey questions targeted Program management Vaccines included in the program Processes for handling vaccine Training of administering personnel Application of knowledge Overall quality of the program

Methods Survey of APIC Infection Preventionists IRB approval University of Louisville Web-based survey 38 questions 93 response items Aims Evaluate current healthcare worker immunization practices in US healthcare facilities Evaluate current vaccine handling and management practices in employee/occupational health departments in US healthcare facilities

Results 10,930 eligible respondents 1006 respondents (9.2% response rate) Acute Care Hospital 56.3% Long Term Care 9.0% Ambulatory Care/Surgery Center 11.4% Behavioral Health 2.7% Public Health 2.5% Critical Access 6.3% Home Health 0.9% Other 10.9%

Variable Number Percent Current employment Setting Acute Care Hospital 517 56.3 Long Term Care Facility 83 9.0 Ambulatory Care/Ambulatory Surgery Center 105 11.4 Behavioral Health Facility 25 2.7 Public Health 23 2.5 Academia 0 0.0 Critical Access Hospital 58 6.3 Home Health 8 0.9 Other 100 10.9

Variable Facility Licensed Bed Size Number Percent 0-50 259 29.1 51-99 117 13.1 100-200 204 22.9 201-300 117 13.1 301-500 115 12.9 >500 79 8.9

Gender Age Group Variable Number Percent Male 44 4.8 Female 865 95.2 20-30 20 2.2 31-40 90 9.9 41-50 212 23.3 51-60 424 46.5 >60 165 18.1

Variable Number Percent Current Job Domain Occupational/Employee Health Professional 75 8.2 Infection Preventionist 604 65.9 Other 237 25.8 Years Worked in this Specialty 0-1 85 9.3 2-5 254 27.7 6-10 197 21.5 11-20 216 23.5 >20 166 18.1 Targeted Population Adult 328 92.9 Pediatric/Neonates 25 7.1

Median: 47.6% Minimum Passing Score, 70%

Significant Findings: Program Management 40.2% CIC 2.4% COHN/COHN-S 95% either completely or partially responsible for the immunization program in their facility 45.9% indicated they developed vaccine policy with assistance of others (not physician) 27.2% develop vaccine policy with assistance of physician 86.1% listed CDC/ACIP/Public Health as resources for their programs

Significant Findings: Vaccines Provided The following were provided to at least some personnel in their facilities Hepatitis B 99% Influenza 99% Tdap 74% MMR 73% Varicella 62% Meningococcal 30%

Significant Findings: Monitoring of Immunization Rates 70% collect data regarding at least some vaccines administered 28% reported collecting data regarding vaccine administration errors 53% collect data regarding vaccine refusals, exemptions, and/or contraindications

Significant Findings: Vaccine Handling 51% use a refrigerator type specifically contraindicated by CDC guidance 20% use calibrated thermometers 28% report having to discard vaccine due to unsuitable storage temperature events 58% maintain redundant power to the vaccine refrigerator 31% use temperature-stabilizing strategies 2% use a vaccine refrigerator to maintain cold chain when vaccines administered outside the office (e.g., mobile carts)

Significant Findings: Training Questions focused on vaccine storage, handling, administration, adverse events reporting, and personal immunization history of the respondents 47% received training on vaccines, their storage, handling, management, and administration 16% said policies specifically addressed the cold chain Competency assessments are included in the job for 18% Training regarding adverse events occurred among 47% 63% said they never used VAERS to report an adverse event

Significant Findings: Overall Program Quality Recall the scoring slide 80% of respondents agreed or strongly agreed that vaccines were always stored in a manner safe for administration 66% agreed or strongly agreed that they were confident in their knowledge regarding handling and maintenance 47% felt their training had been adequate

Median: 47.6% Minimum Passing Score, 70%

Program Management Standing orders written in collaboration with someone with knowledge in vaccines Clear understanding of contraindications to specific vaccines and how that differs from precautions and warnings Program evaluation with clear metrics for improvement Ability to handle and manage vaccines safely, adequately and consistently

Processes for Handling Vaccine Maintenance of cold chain Routine storage Temperature monitoring Stabilization of temperatures Safe injection practices Diluents

Training of Administering Personnel Standing orders or protocols Techniques for administering vaccines (IM, SQ, ID, IN) Skill validation Vaccine information to recipients (VIS)

Application of Knowledge Able to select the correct vaccine administer the correct vaccine reschedule for next doses handle and manage vaccine in all settings educate vaccine recipients recognize breaches in the process correct breaches immediately correct the process to prevent reoccurrence

Overall Quality of the Program Monitoring gap between current practice and ideal practice Development of evaluative metrics and processes Identification of performance improvement activities, including improving immunization rates Reporting of results across the facility

Addressing the Gaps Lack of knowledge regarding available resources Incongruence with CDC recommendations Lack of existing training and resource materials for healthcare facility-based healthcare personnel immunization program

Healthcare Personnel Immunization Toolkit Electronic toolkit www.infectionpreventiontools.com Contains information from CDC, newly developed checklists, sample policies, sample monitoring processes, skill validations, sample job descriptions, FAQs, and web links for access to dynamic support materials

The Pink Book Complete information regarding vaccines Tools and Resources Focused on public health but applicable to IPs

Healthcare Personnel Verification of immunity Laboratory confirmed immunity or disease Documentation of vaccine series receipt with appropriate spacing Immunization does not preclude need for PPE use Maintenance of records

Current Recommendations: Hepatitis B 3-injection series hepatitis B immunization Administered in deltoid muscle Injections given at 0,1,5 month intervals Verify immunity 30-60 days after 3rd injection -check hepatitis B antibody (anti-hbs 10 iu/ml). If non-immune, repeat series, if still nonimmune check HBsAg Give employee information regarding dates of vaccine and results of antibody test

Current Recommendations: Hepatitis B Caveats Can provide on an accelerated schedule Consider underlying health condition of individual employee (e.g., on dialysis or advanced HIV) What about new employees with evidence of immunization but no titers? Titer, challenge, titer Challenge, titer Wait until exposure then titer

Hepatitis B HCW reports an injury involving source patient blood or body fluid Direct appropriate first aid Instruct HCW to notify EH Instruct HCW to complete occurrence report Confirm exposure 1 Most important step is to determine true exposure to blood/opim Blood to blood contact Contact with other potentially infectious material (OPIM) in a manner that allowed contact with HCW mucous membranes Contact with unknown fluid in same manner Confirmed exposure 1 Yes No Followup with EH Has HCW ever demonstrated antibodies to Hepatitis B? No Yes Stop Instruct employee to followup with EH Order Hepatitis B surface antigen on source Source unknown Results obtained Negative source HBsAg Stop Instruct employee to followup with EH for immunization or testing for HBsAg carrier state Positive source HBsAg Preventing Secondary Transmission 2 No unprotected sex No tissue/blood donation Continue precautions until serial testing completed and results negative 1 dose IM Hepatitis B vaccine (1 cc) HBIG IM 0.06 mg/kg weight of HCW. Ideal timing for HBIG is within 48 hours of exposure but can be given up to 7 days post exposure -Instruct employee to followup with EH -Test for Ag and Ab in 12 weeks -Discuss secondary transmission prevention 2 Additional Comments Instruct HCW to report signs of fatigue, malaise, or viral syndrome during first 30 days post exposure Ruth Carrico PhD RN CIC University of Louisville School of Medicine Ruth.carrico@louisville.edu 3/15

Current Recommendations: Measles (Rubeola), Mumps and Rubella Transmitted through the air (rubeola) and droplets (rubella and mumps) Immunization indicated for persons born after 1957 without documentation of either receipt of 2 doses on or after 1st birthday, physician diagnosed case, or laboratory evidence of immunity Persons born before 1957 may be immune but should provide the same level of confirmatory information (potential for involvement in outbreak)

Current Recommendations: Measles (Rubeola), Mumps and Rubella Immunization by administering 0.5 ml MMR vaccine subcutaneously (live virus vaccine) 2 dose series provides immunity to rubeola and mumps 1 dose provides immunity to rubella NOT to be given during pregnancy or if individual attempting pregnancy No need to test after vaccine series Post exposure IG + Vaccine

Measles Patient identified with suspected or confirmed measles Place patient in airborne precautions in a negative pressure airborne infection isolation room Notify IP Continue patient isolation for at least 4 days after appearance of rash Yes, patient mgmt Confirm diagnosis* No Stop Yes, HCW follow-up Notify Health Department Complete documentation and reports as necessary Notify Employee Health Confirm diagnosis* Clinical: Generalized rash > 3 days T > 101 degrees F Cough, coryza, and conjunctivitis Lab: Measles IgM + Significant increase in measles antibody level Isolation of measles virus Assess if HCW exposed. Did the HCW spend any time in an enclosed airspace (e.g. face-to-face contact, same room or in an airspace supplied by same HVAC, or up to 2 hours later) with an infected patient for any length of time during 5 days before to 4 days after onset of rash in the patient. No Stop Yes Evidence of Immunity written documentation of vaccination with 2 doses of live measles or MMR vaccine administered at least 28 days apart, laboratory evidence of immunity, laboratory confirmation of disease. Birth before 1957 likely to be immune but evidence or immunization still required ICP and involved areas generate linelist of exposed HCW Evaluate HCW for exposure, including students, medical staff, etc. Susceptible Immune Stop Restrict exposed HCW from work for days 5-21 Consider immunization ( within 72 hours of exposure) or immunoglobulin (within 6 days of exposure) Monitor HCW. Exclude exposed, susceptible HCW from work at day 5 until day 21 after exposure No symptoms Stop Symptomatic Refer for medical evaluation and restrict from work for an additional 4 days after appearance of rash Complete documentation and reports as necessary Complete documentation and reports as necessary Ruth Carrico PhD RN CIC Ruth.carrico@louisville.edu 3/15

Patient identified with possible mumps Place patient in droplet precautions Notify ICP Continue droplet precautions for at least 9 days after onset of symptoms Yes, patient mgmt Confirm diagnosis* No Stop Yes, HCW followup Notify Health Department Complete Documentation and reports as necessary Notify Employee Health Confirm diagnosis* Clinical: acute onset of unilateral or bilateral tender swelling of parotid or slalivary gland for >2 days Lab: Mumps virus culture +, significant rise in IgG mumps antibody or IgM mumps antibody + Assess if HCW exposed. Did the HCW have direct of droplet contact to oral or nasal mucous membranes or with respiratory secretions of infected patient Yes No Stop Immunity** (any of the following) written documentation of vaccination with 2 doses of live mumps or MMR vaccine administered at least 28 days apart; laboratory evidence of immunity, laboratory confirmation of disease, or birth before 1957 IP and involved area(s) generate linelist of exposed HCW Evaluate HCW for exposure, including students, medical staff, etc. Immune** Stop Birth before 1957, although natural disease likely, still requires evidence Non-immune Test for mumps antibody. If negative, restrict from work for 12th-25th day after exposure positive mumps antibody Stop Consider immunization (effective within 72 hours of expoosure) or immunoglobulin Monitor HCW No Symptoms Stop Symptomactic Ruth Carrico PhD RN CIC University of Louisville School of Medicine 3/15 Refer for medical evaluation and restrict from work for 5 days after onset of symptoms Complete documentation and reports as necessary Complete Documentation and reports as necessary

Current Recommendations: Varicella 2 dose vaccine series (28 days apart) Varicella vaccine 0.5 ml subcutaneously Varicella zoster vaccine at age 60 primarily to prevent post-herpetic neuralgia (0.65 ml) Both vaccines are live and both must remain frozen until immediately before dilution and administration Serology poor at verifying vaccine-induced immunity

Patient identified with possible VZV infection Chickenpox (Varicella) Ruth Carrico PhD RN University of Louisville School of Medicine 3/15 Chickenpox (varicella) Place patient in airborne and contact precautions in a negative pressure room. Herpes zoster (shingles) use standard precautions unless disseminated disease. If so, use airborne and contact precautions Notify IP for varicella and disseminated zoster Continue patient isolation until all lesions are completely crusted Yes, patient mgmt Confirm diagnosis* No Stop Yes, HCW follow-up Complete documentation and reports as necessary Notify Employee Health *Confirm diagnosis Clinical: diffuse maculo-papulo vesicular rash Lab: isolation of VZV, DFA+ VZV, PCR+, significant increase in VZV IgG Assess if HCW exposed. Did the HCW have unprotected physical contact with lesions or share air space with infected patient for more than several minutes No Stop Yes IP and involved areas generate linelist of exposed HCW **Immunity (any of the following) Diagnosed VZV or zoster by healthcare provider Laboratory evidence of VZV antibody or documentation of disease Written documentation of 2 doses of varicella vaccine Diagnosis or verification of history by healthcare provider Evaluate HCW for exposure, including students, medical staff, etc. Immune** Stop < 72 Hours Non-immune** > 72 Hours Administer varicella vaccine (immunocompetent adults) Restrict exposed HCW from work for days 10-21. Test for VZV antibody Vaccinate, if possible. If VZV antibody is positive, HCW may return to work No Symptoms Observe HCW for infection / lesions (incubation period 10-21 days), or vaccine associated lesions (5-26 days after vaccination) Symptomatic Refer for medical evaluation and furlough for duration of symptoms Complete documentation and reports as necessary Complete documentation and reports as necessary

Current Recommendations: tdap Substitute one dose for tetanus-containing vaccine Goal is to prevent illness in the infant and child Unsure of durability of the immunization Now administered with each pregnancy 0.5ml administered intramuscularly

Pertussis Patient identified with possible pertussis Place patient in droplet precautions Notify IP Continue droplet precautions for 5 days after initiation of effective therapy or until 3 weeks after cough onset, if no effective antimicrobial treatment given. Yes, patient mgmt Confirmed diagnosis*. No Stop Yes, HCW follow-up Complete documentation and reports as necessary Notify Health Department Assess if HCW exposed and unimmunized: Did HCW have direct unprotected contact exposure to droplets or oral or nasal secretions from patient, face-to-face contact >5 minutes, in the same room for > 1 hour or (e.g.. intubation, unprotected cough to face) No Stop Confirm diagnosis* Clinical: cough >2 weeks plus paroxysm, inspiratory "whoop" or post-tussive vomiting Lab: B. pertussis isolated or B. pertussis PCR + Yes Notify Employee Health. Immunize employee if not previously done IP and involved areas generate linelist of exposed HCW Restrict exposed and unimmunized HCW from work until 20 days after last exposure only if they refused or are unable to take post exposure prophylaxis Provide prophylaxis to exposed and unimmunized HCW and refer non employees in accordance w/ facility policy Monitor HCW for 21 days after exposure No Symptoms Stop Symptomatic Restrict from work for 5 days after effective treatment Complete documentation and reports as necessary Complete documentation and reports as necessary Ruth Carrico PhD RN CIC Ruth.carrico@louisville.edu 3/15

Current Recommendations: Influenza Currently an annual vaccine Traditionally trivalent, now quadrivalent Given IM, ID or intranasal Intranasal is live attenuated High dose vaccine for immunocompromised and those 65 and older Even poor match of vaccine to circulating strains prevent hospitalizations and mortality

Current Recommendations: Meningococcus Special situation vaccine Focus on those handling pure culture in the lab Currently addresses serotypes C,W,Y-135 New vaccine FDA approved for serotype B If vaccine given to healthcare worker, discussion regarding booster every 5 years. Conjugated and polysaccharide vaccines. 0.5 ml intramuscular for the conjugated and 0.5 ml subcutaneously for the polysaccharide.

Conclusions Vaccine handling and management Which vaccines need to be provided (Hint: All CDC recommendations) Spacing, administration, documentation Exposure situations