Occupational Health: Vaccinations in the Workplace Additional Questions & Answers: Ruth M. Carrico, PhD, FNP-C, CIC

Occupational Health: Vaccinations in the Workplace Additional Questions & Answers: Ruth M. Carrico, PhD, FNP-C, CIC Healthcare Professionals (HCPs)/Facilities Please provide guidance regarding requiring HCPs who refuse influenza immunization and prefer to wear surgical masks while in the healthcare facility throughout the entire "influenza season." This is certainly a controversial issue. But, the most important thing to remember is that the requirement for influenza vaccination and mask wearing is a patient safety issue. Approaches are often institutional policy, so that obligates conformance, even if there is disagreement among the masses. When those institutional policies have been made, it signals that those responsible for policy development have determined that the data are significant and, therefore, the policy mandates have occurred. Many professional societies have also come forward agreeing with this decision. Beyond the policy, there is also an ethical component to the discussion regarding the ethical responsibility a healthcare worker has to prevent illness in those they are responsible to protect. Can you talk about the CMS flu requirements a little more? CMS is requiring reporting of healthcare worker influenza immunization. The purpose is to identify and share immunization rates among facilities as part of HospitalCompare. Categories of personnel and contraindications can be compared across facilities with the purpose of improving rates and driving accountability. How can we advise healthcare facilities that do not have a vaccination policy in place for their workers? If the healthcare facility receives federal funding for the provision of patient care (e.g., Medicare/Medicaid), then CMS standards require an immunization program be in place. The same is true for accreditation standards that outline care expectations in acute and long term care facilities. As with any program, there needs to be written guidance. This provides the prescriber authorizing use of the vaccine (a licensed healthcare provider must be the prescribing authority for any vaccine or medication administered or provided by the Occupational Health Department) with the ability to ensure consistent application of best practice guidelines. Therefore, every facility that employs healthcare workers, has volunteers or students, and has licensed independent providers caring for patients, should have a vaccination policy. CDC guidelines provide an excellent basis for provision of this program that focuses on protection of the patient, the healthcare worker, visitors, and the community. What are strategies to overcome hesitancy at a health department to mandate all HCP vaccines? The existing CDC recommendation, articulated in the 2011 MMWR (2011b) should be the marching orders for the local health department. They represent public health at the local level. The CDC 1

guidelines are the de facto standard of practice and should be recognized as such. Healthcare facilities and their respective occupational health programs use these guidelines as the framework for the norm, so it stands to reason that local public health would be in sync. Centers for Disease Control and Prevention (2011b). Immunization of Health-Care Personnel. Recommendations of the Advisory Committee on Immunization Practices (ACIP)]. MMWR 2011;60(No.7):1-46. Who should keep records of immunization, onsite or with a consulting occupational health service? The employer is responsible for maintaining records of hepatitis B vaccination (OSHA). A contractor should maintain records of what has been provided as documentation of their services. It can be a contractual decision, but the employer must be able to provide results back to the employee upon request and the records must be maintained for 30 years. Therefore, it seems more reliable that the employer would at least maintain a copy of those records. This would also be helpful if prompt action is needed in the event an exposure situation occurs. Is it necessary for a 19 year old nursing student to come to the health department for polio vaccine if she had titers for all vaccine-preventable diseases and her polio titers were low? Polio immunization is not included in the CDC recommendation for healthcare worker immunization. There are many other situations that may impact this decision including whether or not the individual is an immigrant or refugee, whether they have or are traveling to one of the few countries where polio has been identified, or if there is evidence the individual never received primary immunization against polio. These situations are unlikely, so a general answer would be that polio is not indicated, even if titers are low. Remember that circulating evidence of immunity can wane over time, but that does not mean that cellular memory is gone. It is that cellular immunity that can respond in the event exposure to the infection occurs, leading to antibody production and subsequent protection against the disease. Do you have any guidance for restrictions from work following receipt of live vaccines? Are there special precautions for immunocompromized patients, newborns, or others? There are no work restrictions for HCPs who have recently received the MMR vaccine. If the HCP develops a vaccine-related rash after vaccination with varicella vaccine (and the current zoster vaccine), they should avoid contact with persons without evidence of immunity to varicella who are at risk for severe disease and complications until all lesions resolve (e.g., are crusted over) or, if they develop lesions that do not crust (macules and papules only), until no new lesions appear within a 24- hour period. (CDC, 2011; pps. 12,15,19,23). When the live attenuated influenza vaccine (LAIV) was available, the CDC guidance indicated that those directly responsible for care of a patient in the hospital following bone marrow transplant should be vaccinated with another influenza vaccine and not LAIV. If LAIV becomes available again, the prescribing information and current ACIP seasonal influenza vaccination guidelines should be reviewed to see if that has changed. There are no recommendations for work restriction for other live virus vaccines such as oral typhoid and yellow fever. 2

Hepatitis B If you wait until hepatitis B exposure to vaccinate, do you have them sign a declination as you are not vaccinating within 10 days of hire? According to OSHA Bloodborne Pathogens Standard, hepatitis B vaccination shall be made available after the employee has received training regarding risk and within 10 working days of the initial assignment unless they have been previously vaccinated, have demonstrated antibodies to hepatitis B, or have a contraindication to receiving the vaccine. The employer must provide access to the vaccine or have a signed declination form. The OSHA standard also addresses development of an exposure control plan where the facility identifies those healthcare workers deemed at risk for exposure. Occupational Safety and Health Administration (OSHA). (1991, revised 2001). bloodborne pathogens standard CFR 1910. 1030. Are titers necessary for healthcare workers who have proof of receiving the recommended doses for the vaccinations (3 doses of hepatitis B or 2 doses of MMR for example)? CDC recommendation is that healthcare personnel who have received the hepatitis B vaccine should be tested to ensure that the vaccine provided immunity. This involves testing for presence of sufficient antibodies (e.g., 10 IU/ml). For those with documentation of receipt of two doses of MMR vaccine, the recommendation is that antibody testing not be done. If you do test and results are negative or equivocal for any of the three antigens (e.g., measles, mumps, or rubella), you do not need to revaccinate. (CDC, 2011b; pps. 15, 19). The thought is that the vaccine has an effectiveness of 95%, which is greater than the sensitivity and specificity of the test. In short, trust that the appropriate number of vaccines, spaced appropriately (e.g., 28 days apart in the adult recipient), produces the desired immunity. Is having a 3-dose series of hepatitis B sufficient to be being immune, or do we have to test them with a titer to show immunity? CDC recommendation is that healthcare personnel who have received the hepatitis B vaccine should be tested to ensure that the vaccine provided immunity. This involves testing for presence of sufficient antibodies (e.g., 10 IU/ml). If antibody testing is insufficient following completion of a 3-dose series appropriately spaced (e.g., 0, 1, 6 months), then administer another 3-dose series and test again. If still negative or insufficient antibodies, test for the hepatitis B surface antigen. If positive, this indicates hepatitis B chronic infection may be present and that person will not develop antibodies. Instead, they represent an exposure risk to their patients and should be appropriately counseled and their job activities evaluated for infection transmission opportunities. Centers for Disease Control and Prevention (2011b). Immunization of Health-Care Personnel. Recommendations of the Advisory Committee on Immunization Practices (ACIP)]. MMWR 2011;60(No.7):1-46. Chronic dialysis outpatients are tested for hepatitis B each time they are admitted to the hospital. Explain the rationale and how long this patient population remains immune post-vaccination. Patients with end-stage renal disease, including patients requiring dialysis, have an impaired immune response to the hepatitis B vaccine. Those patients have lower seroconversion rates compared with individuals with normal renal function. In addition, even after patients with impaired renal function 3

receive the complete hepatitis B vaccine series, titers are low and decline logarithmically over time. It is presumed that their immunocompromised states results in impaired efficacy of the hepatitis B vaccine. Consequently, they are evaluated frequently for immunity and revaccinated in accordance with their titer results. Can you address the issue of a positive titer post completion of hepatitis B vaccine and then randomly drawn titer is negative. Is the once positive, always positive rule correct? Circulating antibodies can be lost over time, but it is possible that immune memory is retained. Therefore, a negative titer can be perplexing. The way to bring clarity is to always test for presence of the antibody 30-60 days after completion of the series. If insufficient antibodies are found (e.g., <10 IU/ml), then repeat the series and test again 30-60 days after completion of that second series. Once sufficient numbers of antibodies have been detected there is no need to test again and the individual is deemed as protected for the future. If an HCP has documentation of three doses of hepatitis B shots, does it prove immunity? Receipt of 3 doses of vaccine only shows that the vaccines were given. It does not show whether or not they actually worked to produce antibody protection. Testing for presence of the hepatitis B antibody should be done 30-60 days after completion of the series. Is it appropriate for employee health, which is part of Human Resources, to know the status of the hepatitis B antigen? If the titer of antibodies came back negative, wouldn't we just educate them on precautions, as that positive hepatitis B status really shouldn't be known to us legally? Your point demonstrates why the employee health record must remain separate from other employment records. The job of the occupational health program is to ensure safety of the patient and safety of the healthcare worker. If the individual receives 2 complete 3-dose series of the hepatitis B vaccine and antibody tests are conducted within 30-60 days following completion of each of those series, and are still insufficient (e.g., <10 IU/ml), the individual should be tested to see if they are chronically infected. This is determined by use of hepatitis B surface antigen testing. If that is positive, the healthcare worker is infected and should be made aware. They should be educated regarding their ethical responsibilities to prevent exposure to others and prompt reporting if such an event occurs (e.g., an infected scrub technician who is cut during a procedure and exposes the surgical patient to their infected blood). It is the ethical and legal responsibility of the occupational health program to protect the patients that are served by that healthcare facility, just as it is their responsibility to protect the healthcare worker through provision of an immunization program, access to personal protective equipment, as well as other environmental and administrative protections. Being in the occupational field, I travel to sites often to administer hepatitis B vaccines. How you would you recommend me storing them en route? Follow the vaccine storage and handling recommendations from CDC, which tell us to maintain appropriate temperatures for vaccines at all times. When vaccines are stored outside those ranges, they begin to lose potency. If you are traveling, you should have a carrier that is specifically designed for transporting vaccine. How long you will have the vaccine away from its refrigerated/frozen storage unit determines the type of vaccine transport container you need. For example, if vaccine is going to be out of the refrigerator/freezer for hours, it may be prudent to have a transport container that can be 4

plugged in to an outlet or the car cigarette lighter. For shorter durations, a container that has designated cold or frozen packs may be indicated. When in doubt, contact your state immunization program for assistance in decision-making. They can also recommend reasonably priced transport units. What are your recommendations regarding those reporting hepatitis B "non-responder" and giving a dialysis dose? Several studies have offered options that may help non-responders demonstrate antibody production. These include increased dosing, decreasing intervals between doses, and administration intradermally. However, these are all off label uses of the vaccine and outside current CDC guidelines. MMR and Varicella If an employee (with no vaccine records) had an equivocal titer for mumps and gets a MMR vaccine, can they recheck a titer 30-60 days later instead of a 2nd dose? Effectiveness of MMR vaccine for prevention of mumps after one dose of MMR vaccine is 80-85%. Factor that with the possibility of a false negative or even an equivocal result after testing, and it seems to make more sense to follow the recommendation and give the individual 2 doses of MMR vaccine separated by at least 28 days. One dose could provide protection, but there is a definite value to the time spent by the Occupational Health staff in obtaining the specimen, monitoring results, and communicating back to the healthcare worker. (CDC, 2011; p. 15) With regards to MMR vaccination, what is the best approach for an individual who works as a child care provider who has documented a 2 dose vaccination and a negative either measles or mumps titer years after vaccination? The CDC guidelines recommend that the negative titers be ignored if you have documentation of receipt of two doses of the vaccine that were appropriately spaced (e.g., 28 days between doses for the adult recipient). If negative Rubella titer, should you give 2 MMR vaccines or 1 MMR vaccine? Adequate rubella vaccination for HCPs consists of 1 dose of MMR vaccine. (CDC, 2011; p. 18) Can you say more about switching the MMR vaccine back and forth from freezer to refrigerator? The MMR vaccine is to be stored in either the freezer or the refrigerator. The goal is to ensure that vaccine can be monitored for expiration dates and standardized administration procedures. It may be helpful to employees responsible for the vaccine to have designated places for the vaccine. Consequently, moving doses of that vaccine from refrigerator to freezer may be a confusing situation promoting error. Further, it is easy to confuse boxes of varicella and MMR as they are similarly packaged. Varicella must be maintained in the freezer so processes that enable error in vaccine storage should be avoided. Aim for consistent approaches to handling of vaccine in an effort to prevent error. Do you recommend testing employees retroactively under the new guidelines (e.g., titers for MMR, varicella)? 5

CDC recommendations are designed to protect patients and the healthcare workers that care for them. Consequently, it is prudent to know who is immune and who is not. If healthcare workers are unable to provide documentation of immunization, the occupational health program can approach this in several ways. They can obtain titers on employees and provide immunization based upon those results, or they can be assumed to be non-immune and provided with the complete series of vaccines. This decision is likely to be made based upon costs of tests versus the vaccine, time spent in notifying and chasing down the employees, and time spent following test results. Having a standardized way of approaching this is likely to be the most cost and time effective. Ignoring the situation should not be an option and not be the occupational health program choice. If the MMR or varicella vaccine schedule is not given at 30 day interval, let s say 5 months later, is that still acceptable? Yes. Administer that second dose as soon as you can. No need to start the series over. If a person has had the shingles vaccine and has documentation, do they need varicella vaccine? The shingles vaccine should not be used instead of the varicella vaccine, and vice versa. If the healthcare worker has received the shingles vaccine, they do not routinely need the varicella vaccine as well. Please emphasize need for lab confirmation for varicella as other similar appearing rash illnesses are being reported that do not test positive for chickenpox. Thus, a clinically diagnosed patient may remain a reservoir for the disease without vaccine. Your point is that care for any patient should be guided by information. First, it is noteworthy that histories of chickenpox are notoriously unreliable, thus the CDC recommends that the question not even be asked. If a patient is being treated for a rash, then it is important to make efforts to determine the cause so appropriate treatment can be provided. In addition, it is important that consideration be given as to the etiology of the rash and its impact on the patient and other healthcare personnel through transmission. This is the basis for testing and ensuring immunity for healthcare personnel. It is no longer acceptable to ask the healthcare worker if they have had a particular infection (e.g., measles, mumps, chickenpox) because an adequate diagnosis may not have been made and/or the healthcare worker s memory may be faulty. Trust the CDC process and test/immunize according to the guidelines. If patient had one varicella vaccine we draw titers, but are you suggesting we just give another dose? Adolescents and adults require 2 doses to achieve seroconversion rates similar to those seen in children after 1 dose. A study of adults who received 2 doses of varicella vaccine 4 or 8 weeks apart and were exposed subsequently to varicella in the household estimated an 80% reduction in the expected number of cases. (CDC, 2011; p. 22) Other How far back should we accept titers? If you have titers demonstrating immunity to measles, mumps, rubella, varicella, or hepatitis B, then there are no guidelines to provided additional doses of vaccine. A possible exception to this could occur in the event of a public health emergency. 6

In what month or season is there more pertussis? Pertussis is seen all year around, but more frequently during the fall and winter. How should unused or expired vaccines be disposed of? First, sequester the vaccine so it cannot be inadvertently administered. Then, contact the company from which the vaccine was originally ordered (e.g., the vaccine company or a distributor). Sometimes, there is an opportunity to return vaccine for credit. If that is not an option, speak with the pharmacy regarding location of a container designated for pharmaceutical waste. Do not withdraw vaccine and squirt it into the garbage or sanitary sewer, or throw it into the garbage. For regulations specific to your state, contact your local health department. If the spacing is too long between dosing, do you start over? Typically, no. A vaccine given too early may impact the immune response, but the CDC guideline (2011b) specifically mentions that restarting a series is not necessary (pp. 6, 16, and 23). This is also addressed in the CDC general immunization recommendations (CDC, 2011a, p. 10: With exception of oral typhoid vaccine, an interruption in the vaccination schedule does not require restarting the entire series of a vaccine or toxoid or addition of extra doses. How do you best dispel myths about HPV vaccine because it is a newer vaccine (less than 10 years old)? Every vaccine has to ensure tremendous amounts of scrutiny regarding safety and effectiveness before it is released for public use. The Food and Drug Administration (FDA) and the Advisory Committee on Immunization Practices (ACIP) review the data carefully before licensing and establishing the recommendations for use. Once a vaccine is available for use and is included in the immunization schedule, it is considered safe for use and safety is monitored on an ongoing basis. Newer vaccines have been subjected to even greater scrutiny than their older counterparts, so just being new does not mean is has not been rigorously studied and evaluated for safety. HPV is a critical vaccine as it is instrumental in preventing cancer. Therefore, every effort should be made to educate parents so they can clearly see the value of this vaccine for their child s future. Does Flublok work just as well for those with allergies to eggs? During the 2012-2013 flu season, Flucelvax and Flublok were both approved by the FDA as vaccines that are safe to use in patients with egg allergies. Both are prepared using a development technique that does not involve inoculation of chicken eggs so they contain no egg proteins. FDA approval requires that the companies demonstrate that they are at least as good as what is currently available (non-inferiority). Head to head comparisons with other types of influenza vaccine may be available in the future with some history, especially during influenza seasons with heavy disease incidence. What is your take on the new CDC recommendations of ensuring documentation of three vaccines and a titer only to ensure immunity? If there is no documentation of either, are we to offer the series again? The goal is to vaccinate and ensure immunity. Therefore, administer the 3-dose series of hepatitis B vaccine, then test for presence of sufficient antibodies (e.g., 10 IU/ml) 30-60 days after completion of 7

the series. If insufficient antibodies, repeat the 3-dose series and check again for antibodies 30-60 days later. If still negative, test for presence of chronic infection by drawing a hepatitis B surface antigen. Resources Centers for Disease Control and Prevention (2011a). General Recommendations on Immunization. MMWR 2011; 60(No.2):1-60. Available from https://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf Centers for Disease Control and Prevention (2011b). Immunization of Health-Care Personnel. Recommendations of the Advisory Committee on Immunization Practices (ACIP)]. MMWR 2011;60(No.7):1-46. Available from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm Centers for Disease Control and Prevention (2016). Vaccine Storage & Handling Toolkit. June 2016. Available from https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf Occupational Safety and Health Administration (OSHA). (1991, revised 2001). bloodborne pathogens standard CFR 1910. 1030. Available from https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=standards 8