Physician-owned, multi-specialty managed care organizations are becoming fierce competitors in the health care market. Patient identification, as an aspect of provider compliance, has been under scrutiny by insurance carriers and the Centers for Medicare and Medicaid Services (CMMS). Low compliance in this area can adversely affect the organization’s financial health.
Standards set by the Advisory Committee on Immunization Practices (ACIP), American Academy of Pediatrics (AAP), National Childhood Vaccine Injury Act of 1986 (NCVIA), the National Vaccine
Injury Compensation Program (NVICP), and the Vaccine Adverse Events Reporting System (VAERS) call for documentation of immunization as a vital aspect of patient care and record keeping.
Internal audits of physician-owned managed care organizations, however, have revealed inconsistent use of pediatric documentation forms and documenting style. Anecdotal evidence suggests that there are differences in documenting styles among pediatricians and nurses. The purpose of pediatric documentation is to help ensure that persons in need of vaccine receive them and that adequately vaccinated patients are not over-immunized.
Moreover, if an adverse event does occur, the provider has documentation.The purpose of this study is to determine immunization documentation compliance, provider knowledge, and the barriers to pediatric immunization in a New York multi-specialty managed care organization (MCO). The study examines compliance by professional category according to Standard Nine, Vaccine Practice Office. Standard Nine is the legal framework for immunization providers, which ensures accurate record keeping of vaccinations.
Based on the purpose of the study, the research questions are as follows:
1. How compliant are providers based upon current federal, state, and local standards?
2. How knowledgeable are the providers about pediatric documentation standards?
3. What are the barriers that prevent providers from providing appropriate documentation based upon federal criteria?
As background, it is useful to start with the definitions of vaccine and immunization. “A vaccine is a suspension of live (usually attenuated) or inactivated microorganisms (e.g., bacteria) or fractions thereof administered to induce immunity and prevent infectious disease of its sequelae” (Morbidity and Mortality Weekly Report, 2002, p. 41). “An immunization is a more inclusive term denoting the process of inducting or providing immunity artificially by administering an immunobiologic. Immunization can be active or passive” (MMWR, 2002, p. 41). Adequate immunization protects children against several diseases that killed or disabled many children in past decades (Centers for Disease Control, 1999).
In New York, the following vaccines are included in the immunization schedule: Hepatitis B, Diptheria-Tetanus-Pertussis (DTP), Haeomophilus influenza type b, Polio, Measles-Mumps-Rubella (MMR), and Varicella (New York State Department of Health, 2000). Purified protein derivative (PPD), also known as targeted tuberculin testing, is also considered an immunization in the present study.
The rationale for this decision, made by MCO’s director, is that, if other primary immunizations were initially administered prior to the PPD, the PPD would then be considered an immunization. Second, public health data suggested that the incidence of tuberculosis (TB) was on the rise in certain demographic areas (New York State Department of Health, 2000) in which some of the centers were located (primarily Manhattan and the Bronx). This is supported by descriptive data, provided by (New York City Health Department, 1999) on cohorts of foreign-born nationals, whose countries of origin a high prevalence of TB. Children, especially those younger than 5 years of age, who have had a positive tuberculin skin test, are likely to have the active disease, with the potential for dissemeninated TB (CDC, 2000). It appeared reasonable to the senior management, as a prevention strategy, to screen children for TB. Targeted tuberculin testing is a strategic component of TB control that identifies the need for treatment (CDC, 2000).
Modern vaccines are safe and effective (CDC, 1999). However, some adverse events have been reported following the administration of vaccines (CDC, 1999). These events can range from frequent, minor, local reactions to extremely rare, severe, systemic illness (CDC, 1999). NVICP, established by the National Childhood Vaccine Injury Act of 1986, enabled compensation to be paid on behalf of a person who was injured or died as a result of receiving a vaccine. The law establishing the program also created a vaccine injury table, which lists the vaccines covered by the program and the injuries, disabilities, illnesses, and conditions.
As noted above, the purpose of documenting patient immunizations is to help ensure that persons in need of vaccine receive them and that adequately vaccinated patients are not over-immunized, increasing the risk for hypersensitivity.
Health care providers who administer one or more of vaccines covered by NVICP are required to ensure that the permanent medical record of the recipient states: (a) the date the vaccine was administered; (b) the vaccine manufacturer; (c) the vaccine lot number; and (d) the name, address, and the title of provider administering the vaccine.
Current health care policies and practices in all settings result in the failure to deliver vaccines on schedule to many vulnerable preschool-age children. This is evidenced in the recent resurgence of measles and measles-related childhood mortality, which may be a precursor to other vaccine-preventable disease outbreaks (MMWR, 1998). This failure is due primarily to barriers that impede vaccine delivery and missed opportunities during clinic visits (Chu, Luman, McCauley, Pickering, & Stockley, 2002). Chu et al. (2002) identified missed “well child” visits as the greatest barrier to complete immunization. In this regard, Brayden and France (2001) believe that changes in policies and practices can immediately improve coverage. The system should be “user-friendly,” family-centered, and culturally sensitive and should include comprehensive primary health care that can provide rapid, efficient, and consumer-oriented services to the users (i.e., children and their parents).
The results of the study indicate that there were differences between the nurses (RNs and LPNs) and pediatricians in regards to pediatric documentation (Jacquescoley, 2004). Overall, providers were compliant, but there were differences in provider signature, provider title, and administration site. For provider signature, RNs were less compliant than pediatricians, who were less compliant than LPNs. Several factors contribute to this difference. Some centers with large patient populations had one nurse manager or a nurse clinician overseeing various specialties, as well as center responsibilities, which left no time for consistent audit of the charts.
The LPN(s), depending on the center, were responsible for the administration and documentation of the immunization. This is in contrast to other centers, such as smaller ones or ones in which no nurse was available to the pediatric department, where the physician was the primary administrator and documenter of the vaccinations. Additionally, urgent child-care visits could be another factor due to triaging the patient properly, even though the providers in this study did not indicate that this was a barrier to immunizations. Depending on how many nurses are available to triage a patient, when a patient arrives with an emergency, the schedule changes for that department to accommodate that emergency (Jacquescoley, 2004).
Triaging a patient properly also was noted as a significant barrier to immunizations in nurse shift work, due to time constraints because triage took away from their time due to excessive paperwork caused by the urgent child visit (Fitzpatrick, Roberts, & White, 1999). Further, urgent child-care visits are considered as an opportunity for missed immunizations (Black, Lieu, Ray, Ray, Shinefield, & Udovic, 1998). Missed immunizations also were identified as the greatest barrier to complete immunizations in a study in Cook County, Illinois (Smith, Connery, Frintner, Knudsen, Outlaw, Smith, & Weingart 1999). With all this activity, it is possible that the nurse simply forgot to sign his or her name to the chart. This observation was also noted in the
Richards and Sheridan (1999) study.
The results in regard to provider title warrant concern. LPNs and RNs had very low compliance compared to pediatricians. This disparity could be attributed to the demographic composition of both nurse groups, compared with the pediatricians. However, demographic data was not collected in the questionnaire, which was one of the limitations of this study.
In regard to administration site, RNs were less compliant than LPNs or pediatricians. There are two factors that may account for this. During site visits, a determination was made that procedures varied widely among centers as to the documentation of immunizations in patient charts. Five centers utilized a separate vaccine log, while the remaining centers did not. The purpose of the log was to track manufacturers and lot numbers of vaccines. It also was determined that various immunization forms were being utilized to record the immunizations. In most cases, the progress note clearly identified what immunizations were to be administered. The physical form also was utilized for this purpose, but was less prevalent compared to the progress notes. The most prevalent form group wide appeared to be the American Academy of Pediatrics Vaccine Administration Record (1992, revised 1997). This form was adopted to cater to center and division needs throughout the group. Responses from physicians, registered and licensed nurses, varied between “always”, “sometimes,” and “never” concerning the site, title of provider, signature, and vaccine lot number. From an analysis of the data at the various centers, it was determined that various forms were being utilized. The following is a list of the forms in which the documentation was included: (a) Immunization Tracking Form (Blue Test Schedule); (b) Immunization Form-Academy of American Pediatrics;
(c) Immunization Form-Academy of American Pediatrics (Center Specific);
(d) Immunization Form- Academy of American Pediatrics (Division Specific);
(e) Immunization Tracking Form (Dates Only); (f) Well Child; (g) Photocopies of patient immunization records from other providers; and (h) New York City Department of Health Form.
Finally, there was recall bias in this study (Jacquescoley, 2004). Recall bias occurs when knowledge is ascertained from study participants who gather information for a specific purpose. As a result, responses given on the questionnaire may have influenced the reporting. Recall bias could result in a biased estimate of effect. This could affect the study when attempting to generalize the results.
As noted above, this study had some limitations. The questionnaire did not address demographic information. This information could have shed more light on the differences between the groups in terms of knowledge and barriers. In a study that examined vaccination beliefs and practices of pediatricians who provide care for low-income children, it was determined that demographic information was useful (Smith et al., 1999). Further, the sample size was not large enough to make the results generalizable to other nurses and pediatricians (Cheadle et al., 2002).
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