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RULES AND REGULATIONS

Title 28—HEALTH AND SAFETY

DEPARTMENT OF HEALTH

[ 28 PA. CODE CHS. 23 AND 27 ]

School Immunizations; Communicable and Noncommunicable Diseases

[40 Pa.B. 2747]
[Saturday, May 29, 2010]

 The Department of Health (Department), with the approval of the State Advisory Health Board (Board), amends Chapter 23, Subchapter C (relating to immunization) and § 27.77 (relating to immunization requirements for children in child care group settings) to read as set forth in Annex A.

A. Purpose and Background

 The final-form rulemaking amends immunization requirements that children seeking to enter and attend school in this Commonwealth shall meet, and is based upon recommendations of the Advisory Committee on Immunization Practices (ACIP), an advisory committee of the Centers for Disease Control and Prevention (CDC).

 The final-form rulemaking is intended to control the spread of diseases in schools, which are known to be ideal settings for the transmission of communicable diseases. Requiring immunity before a child enters school in 1st grade or kindergarten, or before the child is permitted to attend a school in this Commonwealth, protects that child before entering an environment which readily lends itself to the transmission of disease. Further, ensuring that children are appropriately immunized carries with it advantages for the public as a whole, including other high-risk populations, as well as for the child. There is less chance of other persons contracting a highly infectious disease if children are vaccinated and less chance of outbreaks of contagious diseases occurring.

 The final-form rulemaking combines the immunization requirements in § 23.83 (relating to immunization requirements) for school entry into kindergarten or 1st grade with immunization requirements for school attendance in all grades and adds two new immunization requirements for entry into the 7th grade. The Department reviewed the recommendations of the CDC's ACIP and determined that certain ACIP recommendations serve to meet the needs of the Commonwealth with respect to requirements for school immunizations. The final-form rulemaking requires that students be immunized with the hepatitis B vaccine (previously required for entry into either kindergarten or 1st grade and entry into the 7th grade) before entering school. The final-form rulemaking requires that students entering the 7th grade be immunized with the tetanus, diphtheria and acellular pertussis (TdaP) vaccine, if at least 5 years has elapsed since their last tetanus and diphtheria-containing immunization. The final-form rulemaking also requires that children entering the 7th grade be immunized with the meningococcal conjugate vaccine (MCV).

 The final-form rulemaking also institutes ACIP recommendations regarding an additional dose requirement for mumps vaccine and for varicella vaccine. The existing requirement for varicella immunity upon school entry and for entry into the 7th grade will now be an all-grades requirement.

 Further, the final-form rulemaking also clarifies what immunization requirements apply to children under 5 years of age attending child care group settings located in a school. The final-form rulemaking also makes it clear that children in a school district operated prekinder- garten program, early intervention program operated by a contractor or subcontractor (this includes districts, intermediate units and private vendors) and private academic preschool are required to obtain age-appropriate immunizations as a condition of attending those programs.

 Finally, the final-form rulemaking adds a 4-day grace period for vaccine administration, also in accordance with recommendations of the ACIP, and amends the Department's requirements for school reporting of immunizations in § 23.86 (relating to school reporting).

 The Department published the proposed rulemaking at 38 Pa.B. 750 (February 9, 2008) and provided a 30-day public comment period. Because the title of the proposed rulemaking failed to include reference to school immunization and only mentioned communicable and noncommunicable diseases, and this could have created confusion among potential commentators, the Department extended the public comment period an additional 2 weeks. (See 38 Pa.B. 1150 (March 8, 2008).) The Department received comments from two commentators and from the Independent Regulatory Review Commission (IRRC). The comments and the Department's responses appear in the summary of this final-form rulemaking.

B. Summary

General comments

 IRRC and one commentator raised the question of whether the Department could simply adopt the ACIP's recommendations regarding vaccinations by reference and avoid the need for the Department's updating of regulations every time the ACIP makes a change to its recommendations. If the Department chose not to do so, IRRC recommended that the Department carefully consider the commentator's other recommendations and warned that IRRC would review the Department's responses in determining whether or not the regulation met the criteria in section 5.2 of the Regulatory Review Act (71 P. S. § 745.5b).

 The Department considered this particular comment with regard to the ACIP's recommendations on several previous occasions, and after reviewing its previous responses, will not revise the regulations as the commentator has requested.

 In determining what immunizations to require for school attendance, the Department reviews the ACIP's guidelines and recommendations. The Department does not, however, typically or uniformly accept or adopt the ACIP's recommendations, either for the immunizations the Department will require or for the standards applicable to those immunizations. The ACIP's recommendations are helpful and often definitive but may not take into consideration issues that may be important to the adopting state jurisdiction. Because the ACIP's recommendations are based on the purely public health reason of protecting children from every possible disease, the ACIP does not take into account the possibility of community reaction, nor should it. Practitioners, too, seeking to recommend the best health practices to their patients, are not constrained by the need to accept and review public comment regarding the efficacy and necessity of obtaining a particular vaccine. The Department, through these regulations, however, is in the position of mandating that a child obtain a particular disease vaccine or be denied access to the educational system for some period of time. To that end, the Department will allow for the public to review and present its concerns regarding a mandate such as this. To have adopted the ACIP recommendations without further review would have mandated the provision of human papillomavirus (HPV) to all boys and girls attending school without allowing for public comment. Regardless of one's position with respect to the efficacy of, and necessity for, receiving this vaccine, it shall be acknowledged that this particular vaccine has given rise to some controversy and concern in the public. In addition, there are groups of individuals who strongly disagree with immunization of children. Regardless of one's view of this issue, in the context of a regulation that requires immunizations for school attendance, rather than recommending them for personal health reasons, these persons, too, should have a meaningful opportunity to voice their concerns.

 Adopting ACIP recommendations upon their issuance would raise other issues. Some immunizations for diseases that are not prevalent in this Commonwealth would involve unnecessary cost to patients. For example, with respect to the hepatitis A vaccine, although the ACIP is careful to recommend vaccination against hepatitis A in states that are considered to be at high risk, a simple adoption of ACIP requirements would be insufficient to fully explain to the regulated community, that is, children, parents and guardians, and schools, whether the immunization is or is not required. These persons are unlikely to know that this Commonwealth is, in fact, not considered to be a high risk state for this disease due to low prevalence of hepatitis A disease. This would necessitate additional guidance from the Department in some form.

 While the issuance of additional guidance does not, at first glance, appear to be overly burdensome, it is not the effect on the Department that raises the issue here. The Department attempts to make its school immunization regulations as simple as possible to aid schools and school nurses in their responsibilities to make certain only children who are appropriately vaccinated are attending schools. To this end, the Department attempts to limit the number of communications with respect to existing requirements. The ACIP issues recommendations three times a year, however, and adopting ACIP recommendations wholesale would require schools and school nurses to review children for the appropriate vaccine requirements at least 3 times each year to ensure compliance with recommended changes.

 Adopting the ACIP's recommendations, without being able to review and affirmatively accept each one, with whatever modifications deemed necessary, would inhibit the flexibility needed by the Department to apply its and the Board's expertise to the question of what immunizations are appropriate as a condition of school attendance. This requires a balancing of the importance of the immunization to children in this Commonwealth preventing morbidity and mortality, versus the burden the requirements would place upon schools, parents and the community.

 In fact, the General Assembly has recognized the Department and the Board as authoritative on the issue of immunizations. In section 16(a)(6) of the Disease Prevention and Control Law of 1955 (35 P. S. § 521.16(a)(6)), section 2111(c.1) of The Administrative Code of 1929 (71 P. S. § 541(c.1)) and section 1303 of the Public School Code of 1949 (24 P. S. § 13-1303a(a)), the General Assembly authorized the Department, with the Board, without reference to the ACIP, to create a list of diseases against which children shall be immunized. To cede this authority to create a list of diseases to a Federal advisory committee that does not have rulemaking authority or responsibility, and whose recommendations are not subject to a rigorous rulemaking process prior to issuance, is not in accord with the General Assembly's direction to the Department. It is the Department's responsibility, with the approval of the Board and the necessary State regulatory review bodies, including the General Assembly, to determine when and how to add required immunizations to the list.

 The Department may review standards from groups with expertise in the matters the Department is seeking to regulate and may consult with those groups as well. In fact, the Department has done, and continues to do, just that in many areas falling under its purview. When, however, the General Assembly delegated a responsibility to the Department, the final execution of that responsibility rests with the Department under the law. Therefore, the Department may review and approve standards recommended by independent entities, but cannot, however, adopt future unspecified and unknown standards and guidelines.

 Then, too, there is a question as to whether it is beneficial to allow some time to pass before accepting an ACIP recommendation as a mandate for school attendance. There may be problems with a vaccine that the ACIP has not anticipated. The Department notes that, although the vaccine against the rotavirus was not recommended by the ACIP for the age group in question here, within 4 months of the ACIP's recommendation regarding that immunization, problems arose and children suffered severe injuries and death from twisting of the bowel, attributable to the vaccine. If this were to occur following the adoption of an immunization mandate for school attendance, the public's trust in State government to properly protect them could be irreparably damaged.

 The Department understands the concern that the regulatory process lags behind current thinking of the scientific community. The Department is willing, following the implementation of this final-form rulemaking, to invoke a stakeholder process to consider alternatives that may expedite the regulatory process, while at the same time preserving the Department's and the Board's careful review of proposed amendments to immunization requirements for school attendance.

 New vaccinations continue to be developed and recommendations of knowledgeable bodies change from day to day. What remains a constant, however, is the Department's commitment to protect the health and safety of the children of this Commonwealth by ensuring that it exercises its discretion and expertise to review recommendations and only require the most appropriate immunizations for school attendance in this Commonwealth. The fact that this may take some time only means that these vaccinations are not required for a child's attendance at school immediately upon their recommendation by the ACIP. It does not prevent a physician from recommending and offering the vaccination to his patients when the recommendations are issued. The Department would rather be cautious in the exercise of its discretion than create additional burden to the citizens of this Commonwealth by abdicating its responsibilities to take the most efficient and practical means necessary to prevent and control the spread of disease.

CHAPTER 23. SCHOOL HEALTH

Subchapter C. IMMUNIZATION

§ 23.83. Immunization requirements.

Subsection (a). Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school.

 IRRC noted that the proposed rulemaking did not specifically address whether the requirements of this subsection would apply to charter and cyber schools. The Public School Code of 1949 (24 P. S. §§ 1-101—27-2708), upon which the final-form rulemaking is based, in part, states that ''school directors, superintendents, principals, or other persons in charge of any public, private, parochial, or other school including kindergarten'' must ascertain whether the immunization has occurred. The statute is sufficiently broad enough to include cyber and charter schools, without the need for that statement appearing in this section. Since this section is being amended at this time, the Department, however, does not have an objection to adding language that would make it clear that persons in charge of cyber and charter schools should also ascertain whether a child is in compliance with the appropriate immunization requirements and that the immunizations required in § 23.83(b) for school attendance are also required for children in cyber and charter schools. Children in these educational settings are exposed to other children and placed at risk for contracting or spreading a vaccine-preventable disease. These children are able to participate in extra-curricular activities, just as children who attend ''regular'' schools do, and have regular contact with adults, who may be susceptible to contracting diseases like pertussis. The definition of ''attendance at school'' in § 23.82 and §§ 23.83(a) and (c) and 23.86(a) have been revised to include a reference to cyber and charter schools.

 IRRC recommended that the Department add language to subsection (a) specifically telling persons required by law to ascertain whether a child was in compliance with the appropriate immunization requirements how to make that determination. The commentator suggested that the Department add the language in § 27.77 and require that parents provide a written verification from a physician, the Department or a local health department be provided to the school. In the alternative, the commentator recommended that the Department include the language that the Department used with respect to proof of varicella immunity with each of the immunizations required.

 The Department has not revised this subsection as recommended. The language that appears in the Department's regulations regarding child care group settings was written because there was not a requirement prior to the adoption of those regulations in 2002 that a child care group setting require certain vaccinations or how that entity should verify vaccinations. Schools, however, are governed by the regulations of the Department and the Department of Education. (See 22 Pa. Code §§ 11.20 and 51.13 (relating to nonimmunized children; and immunization).) Section 23.85 (relating to responsibilities of schools and school administrators) discusses how schools are to carry out these responsibilities. Section 23.85(a) requires a school administrator to obtain a certificate of immunization from the child's parents or a history of the child's immunization and requires that the information be stored in a database. In general, the information is kept in the child's medical record; schools are required to keep medical records of students, independently of the Department's regulations regarding school immunizations. (See section 1402 of the Public School Code of 1949 (24 P. S. § 14-1402), regarding health services. While the need existed in the regulations regarding child care group settings to explain how vaccinations would be verified, that requirement is already in place regarding schools and does not need to be reiterated in this final-form rulemaking.

 Further, with respect to the language included with the varicella vaccine regarding verification of varicella immunity, the language could not be adopted for each immunization listed in subsection (b) because of the nature of the disease and the response of the public to that disease. Chickenpox (varicella) is often considered by parents to be a ''rite of passage'' of childhood, a disease that is not dangerous and need not be treated like a more ''serious'' disease would be, for example, like measles. Children with varicella are often not taken to the doctor's office. In addition, at the time the varicella regulation was first promulgated the vaccine had been relatively newly licensed in the United States. The Department, taking these circumstances into consideration, allowed for immunity to be verified in different ways and not simply by the recording of the administration of the vaccine. One way, for example, is through a statement of the parent that the child has had the disease. This language would not be applicable and the same considerations would not hold true, for instance, in the case of a disease like tetanus or diphtheria.

 IRRC suggested that the Department cross-reference section 1303 of the Public School Code of 1949 in subsection (a) to clarify the statutory exemptions and penalties involved.

 The Department added a cross-reference as recommended. With respect to the statutory exemptions, however, it should be noted that those are already included in § 23.84 (relating to exemption from immunization).

Subsection (b). Required for attendance.

 IRRC and one other commentator raised the question of combination vaccines. The commentator suggested that the Department use combination vaccines for several of the immunizations required. IRRC stated that the commentator made a compelling argument for the use of combination vaccines. IRRC requests that the Department explain why the proposed rulemaking did not include a requirement for combination vaccines.

 The commentator strongly urged the Department to encourage the use of combination vaccines when available and to encourage the use of the correct vaccine for diphtheria, tetanus and pertussis. According to the commentator, children under 6 years of age should receive five doses of DTaP and adolescents 11 years of age through 18 years of age should get one booster dose of TdaP based on the CDC guidelines. This would eliminate confusion between the two different vaccines.

 The Department supports the commentator's position that combination vaccines are preferable because of the reduction in cost by eliminating multiple visits, stocking and storing multiple vaccines and stress on the child. The Department's existing regulations neither encourage nor discourage the use of combination vaccines; it should be noted that many vaccines are not available in this Commonwealth or United States as single antigen vaccines. The Department believes that health care professionals, if they have single antigen vaccines available to them, will take these issues into consideration in deciding which vaccine to use. Given the concern expressed by commentators, however, the Department has decided to revise this subsection to add language acknowledging that a combination vaccine is an acceptable vaccine for purposes of school attendance, as well as a single antigen vaccine. The Department added this language even in situations when a combination vaccine currently does not exist to anticipate the continuing development of these vaccines. The Department agrees with the commentators and strongly encourages the use of combination vaccines when appropriate and available.

 The Department cannot, however, state that single antigen vaccines will not be considered acceptable for school attendance. In some instances, for example, in the case of the hepatitis B vaccine, a combination vaccine is not presently available for school age children. There is a combination vaccine for hepatitis B available; it is, however, only licensed for children 18 years of age and older. In addition, because single antigen vaccines are still given in many other countries, there are children coming to school in this Commonwealth with single antigen measles and mumps vaccines that should be counted as valid doses. If regulation requires that only combination vaccines are counted as valid doses, these children would have to be revaccinated unnecessarily at additional cost.

 With respect to the comment regarding the differences between TdaP and DTaP, the level of specificity the commentator is recommending in final-form rulemaking regarding TdaP and DTaP goes beyond what the Department feels is appropriate for regulation in this area, given the possible encroachment on professional judgment resulting from a regulation such as this. The Department is not in a position to substitute its regulatory authority for the professional judgment and knowledge of a health care practitioner. The Department believes that health care practitioners following accepted standards of practice and exercising their professional judgment do not need to be instructed by the Department through regulation of which vaccine to administer and when.

 One commentator stated that the commentator felt that it would be more beneficial for the Department to require TdaP and MCV for entry into the 8th grade than the 7th grade. This would allow additional time for students to become vaccinated and prevent exclusion of those students who fail to obtain the required vaccinations. The commentator based this recommendation on the fact that out of a class of 500 6th graders in what the commentator classified as a middle class school district there were only 100 students who received the MCV and 176 who received the TdaP. Further, as a school nurse, the commentator sent letters to parents explaining the Department's proposed rulemaking which would require those vaccinations and did not receive a significant response.

 The Department considered this comment and did not revise this subsection. The Department is unable to draw a conclusion from the parents' lack of response to the commentator's letter. Further, the vaccinations in question were not required for entry into 7th grade at the time the commentator informally surveyed the 6th grade class and sent a letter to parents.

 In addition, in 2007, in preparation for the eventual implementation of this final-form rulemaking, the Department itself conducted a survey of 160 schools in selected school districts, including Philadelphia and Allegheny Counties. The survey showed that 11% of 7th graders had, at that point, received the MCV, while 16% received the TdaP, without the existence of a requirement that children have these vaccines for entry into the 7th grade. In setting entry into the 7th grade as the time in which children are required to have the MCV and the TdaP, the Department is following the ACIP guidelines with respect to those vaccinations. Nothing in its study or the commentator's informal survey leads the Department to the determination that to implement the vaccination in accordance with the ACIP requirements would be improper or would create hardship on students. It should also be noted that the health departments of Allegheny and of Philadelphia Counties require meningococcal vaccine for school students. The health departments of Allegheny and of Philadelphia Counties are local health departments with the authority to promulgate their own regulations, so long as those regulations are more stringent than those of the Department (See section 16(c) of the Disease Prevention and Control Law of 1955 (35 P. S. § 521.16(c)).) As of the 2009-2010 school year, the Allegheny County Health Department requires the vaccine for students entering 7th through 12th grades; as of the 2008-2009 school year, the Philadelphia Department of Public Health requires students entering 6th grade to have the vaccine.

 Questions were also raised concerning the cost of the MCV to families whose children will now be required to obtain this vaccine before entering the 7th grade. Certain insurance plans are required to cover provision of the MCV, since it is a recommendation of the ACIP, and was included in a notice published by the Department in accordance with the Childhood Immunization Insurance Act (40 P. S. §§ 3501—3508) and its accompanying regulations in 31 Pa. Code §§ 89.801—89.809 (relating to childhood immunization insurance). In addition, the vaccine is covered for vaccine-eligible children enrolled in the Federal Vaccines for Children Program. (See section 1928 of the Social Security Act (42 U.S.C.A. § 1396s).) Lastly, for children not covered by either of these programs, the Department makes vaccine, which it obtains through a Federal grant, available through ''catch-up'' programs at schools and through its State health centers. It has done so in the past with respect to hepatitis B vaccine and varicella vaccine and will do so with respect to the MCV, TdaP and the second dose of varicella.

 In connection with cost concerns, an issue has also been raised regarding the College and University Student Vaccination Act (act) (35 P. S. §§ 633.1—633.3). The College and University Student Vaccination Act requires students entering college and living in dormitories to have a one-time vaccination against meningitis. Concerns were raised that students required to receive the MCV in 7th grade under the Department's regulations would then be forced to have a booster shot prior to entering college to comply with the College and University Student Vaccination Act. Under the ACIP recommendations, MCV is specifically recommended for children 11 or 12 years of age and is only recommended for 13 years of age through 18 years of age if not previously vaccinated. (See 58 MMWR 1042 (September 25, 2009).) Secondly, booster shots are only recommended for children who remain at increased risk after 5 years. The recommendations specifically state that persons whose only risk factor is living in on-campus housing are not recommended to receive an additional dose. (See 58 MMWR 1042 (September 25, 2009).) Therefore, under these recommendations, there would not be a requirement for an additional vaccine at college entry if the child is vaccinated in the 7th grade. It should also be noted that, depending upon the child's insurance coverage and age at the entry to college, there is a greater possibility of the vaccine being covered by private insurance or a government program for the child if it is received at entry into 7th grade than at entry into college.

 IRRC and one other commentator asked whether the Department had considered adding requirements for immunization for hepatitis A, rotavirus, haemophilus influenzae type b and HPV to its list of diseases against which children must be immunized prior to school attendance or entry. The Department has not changed the final-form rulemaking in response to this comment.

 The Department did consider the addition of hepatitis A to the list. It determined against including that requirement, since this Commonwealth is not considered a high risk state for that disease.

 The Department began consideration of what action to take with respect to vaccination for HPV when that vaccination became licensed several years ago. The Department formed the Cervical Cancer Task Force to discuss and make recommendations regarding that particular vaccination. At this time, there has not been a recommendation for the addition of HPV to the list.

 The Department has not added haemophilus influenzae type b or rotavirus to the list since this final-form rulemaking deals with school attendance. Typically, children begin school at 5 years of age and rotavirus and HIB are vaccines licensed for children under 5 years of age .

 One commentator also requested that the Department give preference to the injectible inactivated polio vaccine, since the oral polio vaccine is no longer considered the standard of care.

 The Department has not revised this subsection. Oral polio vaccine is no longer available in the United States. The Department will, however, continue to take into consideration the possibility that children coming from other countries may have had the oral vaccine. The subsection must allow for this to be counted as a dose. Further, the Department relies upon health care practitioners to follow the standard of care demanded by their professional judgment and licensure requirements.

 IRRC raised the question that the Department continually uses the phrase ''properly spaced dose'' in subsection (b) without explaining where the definition of ''properly spaced dose'' is to be found. The commentator recommended that the Department include the standard in the final-form rulemaking.

 The Department has not revised the regulation. This language is not new to the school immunization regulations, although it does appear in the new language regarding mumps, hepatitis b, and varicella. (See subsection (b)(6)—(8)). Physicians and other health care practitioners who have worked with these regulations have never raised a question as to its meaning prior to this time. The term ''properly-spaced dose'' refers to the standard of practice followed by practitioners whose license permits them to administer vaccinations and is unique to each vaccine series. Practitioners determine appropriate dosing by reference to guidelines developed by their medical associations and other experts in the field of immunizations. The Department does not have the authority to define the standard of practice for licensed practitioners.

 Further, within the context of the regulations, the term, ''properly-spaced dose'' is intended to identify which doses may be counted by the Department for audit purposes and for record checking. From the Department's perspective, a dose which is not a ''properly-spaced'' dose under the CDC's guidelines means that the Department will not count that dose towards the number of children receiving vaccinations, which is required to be reported to the CDC. The information may also be used in the event of an outbreak of a vaccine reportable disease. In that case, a child not having received properly-spaced doses (given at too early of an age or at less than a minimum interval between doses for that vaccine) may need to be excluded from attendance by the school. These regulations, however, do not provide for punitive action against either the school or the practitioner.

Subsection (b)(1). Diphtheria.

Subsection (b)(2). Tetanus.

 One commentator recommended that the language for diphtheria and tetanus be changed from requiring one dose on or after the 4th birthday to the final dose being administered at 4 years of age. This is intended to clarify that the initial three doses have already been given and that the booster shot should be administered at 4 years of age.

 The Department agrees that the language of the paragraphs should be changed to reflect that the three initial doses should occur prior to the 4th birthday. The Department believes that the language suggested by the commentator, that the final dose be given ''at 4 years of age'' is too restrictive, and could be read to mean that the dose must be given on the 4th birthday. Therefore, the Department has revised the paragraph to read ''The fourth dose shall be administered on or after the 4th birthday.'' This takes into consideration the commentator's concern that the paragraphs lack clarity regarding when the first three doses may be given and requires that the fourth and final dose be given on or after the child turns 4 years of age.

Subsection (b)(4). Measles (rubeola).

Subsection (b)(5). German measles (rubella).

 IRRC questioned the Department's removal of the requirement in subsection (b)(4) and (5) that serological evidence showing antibodies to rubeola (subsection (b)(4)) or rubella (subsection (b)(5)) determined by the hemagglutination inhibition test or a comparable test be the specific type of testing used as an alternative to evidence of vaccination. The Department has changed that requirement to allow acceptance of ''laboratory testing'' as evidence of immunization. IRRC recognized that, as the Department stated in the preamble to proposed rulemaking, the Department's intention was to allow for changing technology to be recognized, but questioned whether the requirement had now become too broad. IRRC asked what type of laboratory testing the Department would accept and whether the testing procedure and laboratory would be required to be approved or accredited by an appropriate medical authority.

 It is the Department's intent to allow for the most current testing to be utilized, and the language that has been removed from these paragraphs would have prevented that from occurring. In considering this comment, the Division of Immunization sought the advice of the Department's Bureau of Laboratories (BOL). There are numerous tests on the market for detection of Rubella and Rubeola antibodies. The majority are enzyme linked immunoabsorbent assay tests, although there are other methods available. These tests could all be considered ''comparable'' to the hemagglutination inhibition test. Use of any of these tests would require licensure for nonsyphilis serology under The Clinical Laboratory Act (35 P. S. §§ 2151—2165) and certification for general immunology under the Federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).

 Under the CLIA requirements, a laboratory offering one or more of these tests would require a CLIA certificate of compliance (the agency inspecting the laboratory would be the CLIA state agency, which in the Commonwealth is the BOL) or a certificate of accreditation (the agency inspecting the laboratory would be a Federally-approved accrediting agency). CLIA certified and state permitted laboratories are inspected at least every 2 years. In addition, laboratories shall participate regularly and successfully in an external proficiency testing program (usually three times per year). The Department has revised subsection (b)(4) and (5) to clarify that the laboratory performing the testing must have the appropriate certification.

 Once a laboratory meets these requirements, it may perform testing to determine immunity for rubella and rubeola without any additional approvals by the Department.

Subsection (b)(8). Chickenpox (varicella).

 IRRC asked the Department to clarify how it determined that the school year 2010-2011 allowed a reasonable amount of time for children to meet the requirement for the two dose varicella vaccine.

 In choosing the time frames for varicella compliance in the proposed rulemaking, the Department drew on its experience in phasing in vaccine requirements. The Department did not wish to delay an unduly long period of time in creating an all grades requirement, since there is a need for a second dose to ensure that children are appropriately immunized, and not either contracting or spreading a serious disease. The varicella vaccine has been licensed since 1995 and a one dose requirement of the vaccine for school attendance has been in place since 2001. Most children, therefore, already have received one dose of the vaccine. Further, the recommendation for a second dose of varicella was issued by the ACIP in 2007 and many doctors are already giving the second dose as a result of these recommendations. Because the school immunization regulations of the Department and the Department of Education provide that a child may attend school so long as he has one dose and then receives subsequent doses within an 8 month provisional period, the Department did not believe that the proposed amendment would cause hardship to children by causing their immediate exclusion from school. (See § 23.83(e) and 22 Pa. Code §§ 11.20 and 51.13.)

 After a request to allow additional time for school nurses and for children, parents and guardians to prepare to administer the new vaccine requirements, however, and given that the final-form rulemaking will most likely not be effective until the very end of school year 2009-2010, making that preparation more difficult for schools, the Department has agreed to delay implementation of this final-form rulemaking until school year 2011-2012. This will provide ample time for schools to make families aware of the new immunization requirements and will provide ample time for families to obtain the required immunizations before the school year starts in the fall of 2011. Because of this change in implementation date, the Department has removed the phase-in requirements for varicella from the final-form rulemaking.

 IRRC also recommended adding the qualifier ''or older'' to proposed subsection (b)(8)(i)(A), which required the first dose of the vaccine to be administered at 12 months of age, since the existing regulation contained that language. The Department agrees and has revised subsection (b)(8)(i)(A) to include the recommended language.

 IRRC requested that the Department explain the difference between subsection (b)(8)(i)(B) and (C).

 The Department revised the regulation to remove the phase-in requirement and deleted subsection (b)(8)(i)(B) and (C). Children attending school will be required to have two properly-spaced doses of varicella vaccine, the first dose administered at 12 months of age or older.

§ 23.83. Immunization requirements.

Subsection (e). Prekindergarten programs, Early Intervention programs' early childhood special education classrooms and private academic preschools.

 The Department sought the expertise of the Department of Public Welfare (DPW) and the Department of Education with respect to the language included in this subsection. The DPW's Office of Childhood Development and Early Learning provided clarification regarding the types of programs and the age of the children that are intended to be covered by this subsection. The Department revised the language and title of the subsection to reflect those clarifications.

Subsection (f). Grace period.

 IRRC requested that the final-form rulemaking explain who will monitor the 4-day grace period and what the consequences are for exceeding it.

 The implementation of a 4-day grace period for the provision of doses of vaccine was instituted by the Department through a final-form rulemaking published at 32 Pa.B. 1305 (March 9, 2002). The grace period was intended to allow for the acceptance of vaccinations as valid that were given at a time less than or equal to 4 days prior to the minimal interval or age limit for a valid dose of vaccine administration. A vaccine given outside this grace period would result in that dose being considered an invalid dose and could result in a child not having the necessary immunizations for the purpose of school attendance. A vaccine counted as an invalid dose could cause the child to be excluded from school if he did not meet the requirements for provisional admission. (See § 23.85 and 22 Pa. Code §§ 11.20 and 51.13.)

 With respect to monitoring, the Department does random school audits and checks for compliance with dosage requirements. School nurses and administrators are also aware of these requirements and monitor the immunization status of children.

§ 23.85. Responsibilities of schools and school administrators.

 The Department received comments on this section, although it did not propose substantive changes to this section. This section previously allowed provisional admittance if a child had received one dose of each antigen of a vaccine. Since a vaccine like the MCV only requires one dose to complete the vaccine, concerns were raised that it was possible that a child failing to receive either the MCV or TdaP by school entry in school year 2010-2011 would be excluded immediately without a provisional period allowed.

 In response to these concerns, the Department added language to this section to clarify that a child may be provisionally admitted to school in a situation in which he needs a single dose vaccine (like the MCV or TdaP) as well as when the child is missing a multiple vaccine series, even if the child fails to obtain the necessary dose of the single dose vaccine. The Department also changed the effective date of the final-form rulemaking to August 1, 2011, so that it will be implemented for school year 2011-2012 in the hopes that this will limit the number of children needing provisional admittance for failure to obtain these vaccines.

§ 23.86. School reporting.

 Although the Department did not receive comments on this section, in reviewing the proposed rulemaking, the Department determined that nonsubstantive changes were necessary in subsection (d)(6) and (7). The Department amended these paragraphs to mirror language in earlier paragraphs. The Department also amended subsection (e)(3) to clarify that the paragraph does not require reporting on antigens given to each individual child, but, rather requires reporting on the number of doses of each individual antigen given in each grade level.

CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES

Subchapter C. QUARANTINE AND ISOLATION

Communicable Diseases in Children and Staff Attending Schools and Child Care Group Settings

§ 27.77. Immunization requirements for children in child care group settings.

 One commentator recommended that the fourth dose of necessary vaccines should be given between 4 years of age and 6 years of age, since this reflects the recommendations of the ACIP, the American Academy of Pediatrics and the American Academy of Family Practitioners. The commentator noted that this would alter the language in § 27.77(d)(1)(i) and (ii).

 The Department did not made changes in response to this comment. This final-form rulemaking is not intended to set out general rules of medical practice for the provision of immunizations to children. The Department's authority in promulgating this final-form rulemaking is to set out a list of diseases against which children must be immunized for entry to and attendance at school. Therefore, the regulations are written to set out requirements for school attendance.

 Because the age of children attending a school-based setting is changing, and many children younger than the typical age for school entry at kindergarten (5 years of age), are found in school-based settings, the Department found it necessary to clarify its regulations regarding immunizations for children. This could, potentially, create confusion with the Department's separate set of regulations promulgated under a different authority addressing the issue of children in child care group settings. See § 27.77. To ensure that confusion does not continue, the Department also revised § 27.77(d) to ensure that children attending kindergarten, elementary or higher school who are 5 years of age or older are not subject to those child care group setting requirements and are required, even in a child care group setting, to receive the immunizations in Chapter 23, Subchapter C.

C. Cost and Paperwork Estimate

1. Cost

a. Commonwealth

 The Commonwealth will incur some costs for the purchase of TdaP and MCVs, as well as additional Td, hepatitis B and varicella vaccines, and the mumps containing vaccine (MMR), through the expenditure of Federal immunization grant funds. The Commonwealth will also incur costs through the Medical Assistance Program, which pays for administering the vaccines for eligible persons. The Department makes vaccines available at no cost to private providers enrolled in the Vaccines for Children (VFC) Program for children through 18 years of age who have no insurance, who are Medicaid eligible or who are Alaskan Native or American Indian. In addition, VFC Program vaccines are also made available to other public clinic sites (Federally qualified health centers and rural health clinics) for the same population and also for underinsured children through 18 years of age. Vaccines are made available to schools at no cost through the Department's School Based Catch-Up Program for students who do not have a medical home or are unable to seek the immunization through a public clinic site. The Commonwealth will realize savings, however, based on the amount of funds that will not be needed to control the outbreak of vaccine preventable diseases.

 The inclusion of a grace period into the final-form rulemaking adds no cost for the Commonwealth, including either the Department or the Department of Education. The 4-day grace period is intended to allow a vaccine dose administered 4 days before the minimum interval between doses or before the appropriate age is reached to be counted as a valid dose. Since there is no scientific basis for taking a position that a vaccine must be given with a strict interval between doses or at an exact age or the vaccine is ineffective or unsafe, the grace period would merely allow schools to accept vaccines provided within this period for purposes of determining compliance with the Department's regulations regarding school attendance.

b. Local Government

 There will be no fiscal impact on local governments. Local governments may see a slight cost savings, since they do bear some of the cost of disease outbreak investigations and control measures. The Department addresses the potential impact of final-form rulemaking on school districts, which may be considered to be local government, under the heading of ''regulated community.''

c. Regulated Community

 Families whose children's vaccinations are covered by their insurance plans (public or private) under State law will not see out-of-pocket costs for the added vaccines. Families whose insurance plans do not cover these vaccinations, or who do not have insurance, will need to seek other assistance to pay for the vaccines or pay out-of-pocket. In general, there is other assistance provided for vaccinations from the Department, if a third party payer is not available. The Department, through its State health centers, provides vaccinations. The Department also provides vaccines to providers for certain eligible children through the VFC Program and to schools through its School Based Catch-Up Program. The savings in prevention of childhood illness outweigh the minimal cost of the vaccine.

 The inclusion of a grace period does not add costs for school districts. School districts currently decide which children are appropriately immunized and which are not appropriately immunized and so are to be excluded from attendance. The inclusion of a 4-day grace period, which is intended to allow a vaccine dose administered 4 days before the minimum interval between doses or before the appropriate age is reached to be counted as a valid dose, will now be taken into consideration in making this determination. This final-form rulemaking does not add significantly to the cost of determining whether children are appropriately immunized, since the recommendation for a waiver period has been in place since the Department published a final-form rulemaking in 2002.

 The final-form rulemaking adds two additional immunizations for school officials to review, two additional vaccine doses to account for (two doses of varicella and two doses of mumps) and may increase the amount of follow-up needed to ensure that provisionally enrolled students in all grades receive the necessary doses in the series for all required immunizations prior to the expiration of the 8-month provisional enrollment deadline. Provisional enrollment allows for a child who has not had all the required vaccine doses described in § 23.83 to continue attendance at school if he has had at least one dose of each required vaccine and there is a plan for that child obtaining all required immunizations or, in the case of a multiple dose vaccine, that, although the child lacks any dose, there is a plan in place to receive the required dose. (See § 23.85(e).) A child provisionally admitted to school shall have completed the immunizations required under § 23.83 within an 8-month period from the date of his provisional admission or the school administrator may neither admit the child to school nor permit the child's continued admission. (See § 23.85(e).) Again, the savings in the prevention of an outbreak of a childhood illness in a school district outweighs the minimal cost in staff time to review two additional immunizations and to follow-up on provisional enrollments.

 No additional cost will be added to the regulated community by the deletion of the requirements that the hemagglutination test or a comparable test be used to show a history of immunity to measles or German measles and that a more current test be used. Even without an amendment to the regulations, there would be a cost associated with choosing this particular method of showing immunity—the cost of the hemagglutination test. Since the final-form rulemaking does not prohibit that particular test from being used in the future, no cost beyond that of the hemagglutination test would be incurred and the cost of the final-form rulemaking in this regard remains stable. Future tests may, in fact, decrease in price, which would provide a cost savings for affected persons. Further, use of this method of proving immunity is not required.

 Lastly, no additional cost is added by the Department's clarification regarding children in child care group settings located in schools. The requirements for attendance at school and school reporting do not apply to those children. The regulations that apply are those immunization requirements that are already in place that deal with child care group settings in § 27.77.

d. General Public

 The general public will not see an increase in cost. The general public will see a decrease in costs resulting from a reduction in medical treatment needed to treat the disease and a reduction in the loss of work to stay home with a sick child. The general public may see a benefit in the reduction of vaccine preventable diseases, such as pertussis, chickenpox, mumps and meningitis. Since the school environment is conducive to the contracting and transmission of diseases among children with no immunity, failure to immunize properly not only puts children at risk for contracting these debilitating diseases, it also places the public at risk since these diseases are then easily spread by staff and children outside the school setting and into the general public.

2. Paperwork Estimates

a. The Commonwealth and the Regulated Community

 Schools will be required to report in accordance with the new reporting requirements, which require them to report the number of doses of individual antigens that have been administered to students. The Department will need to review and include those new reported numbers in its report to the CDC. Schools are currently required to report immunization coverage status for their students to the Department for the Department to satisfy CDC requirements regarding reporting of immunizations. The additional paperwork requirements for the Commonwealth, including both the Department and the Department of Education, and the regulated community would be minimal, however, since school districts already complete this annual report regarding the number of immunizations and follow up on provisional enrollment. School nurses, who perform recordkeeping and reporting requirements in the schools, currently maintain and report this information. The CDC, however, is in the process of changing these requirements. The Department will provide reporting forms to schools, as it currently does, and the reports will be sent to the same Department office as the current reports. Schools also have the option of electronic reporting.

b. Local Government

 There is no additional paperwork requirement for local government. The Department included school districts, which may be considered to be local government, under the heading of ''regulated community.''

c. General Public

 There is no additional paperwork requirement for the general public.

D. Statutory Authority

 The Department obtains its authority to promulgate regulations regarding immunizations in schools from several sources. Generally, the Disease Prevention and Control Law of 1955 (act) (35 P. S. §§ 521.1—521.21) provides the Board with the authority to issue rules and regulations on a variety of matters regarding communicable and noncommunicable diseases, including what control measures are to be taken with respect to which diseases, provisions for the enforcement of control measures, requirements concerning immunization and vaccination of persons and animals, and requirements for the prevention and control of disease in public and private schools. (See section 16(a) of the act.) Section 16(b) of the act gives the Secretary of the Department the authority to review existing regulations and make recommendations to the Board for changes the Secretary considers to be desirable.

 The Department also finds general authority for the promulgation of its regulations in The Administrative Code of 1929 (71 P. S. §§ 51—732). Section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)) gives the Department this general authority. Section 2111(b) of The Administrative Code of 1929 (71 P. S. § 541(b)) provides the Board with additional authority to promulgate regulations deemed by the Board to be necessary for the prevention of disease and for the protection of the lives and the health of the people of this Commonwealth. Section 2111 of The Administrative Code of 1929 further provides that the regulations of the Board shall become the regulations of the Department.

 The Department's specific authority for promulgating regulations regarding school immunizations is found in The Administrative Code of 1929 and in the Public School Code of 1949. Section 2111(c.1) of The Administrative Code of 1929 provides the Board with the authority to make and revise a list of communicable diseases against which children are required to be immunized as a condition of attendance at public, private or parochial schools, including kindergarten. The section requires the Secretary to promulgate the list along with rules and regulations necessary to insure the immunizations are timely, effective and properly verified.

 Section 1303 of the Public School Code of 1949 provides that the Board will make and review a list of diseases against which children shall be immunized, as the Secretary may direct, before being admitted to school for the first time. The section provides that the school directors, superintendents, principals or other persons in charge of public, private, parochial or other schools including kindergarten, shall ascertain whether the immunization has occurred, and certificates of immunization will be issued in accordance with rules and regulations promulgated by the Secretary with the sanction and advice of the Board.

E. Effectiveness/Sunset Dates

 The final-form rulemaking will become effective on August 1, 2011. This will allow parents, guardians and schools time to become familiar with the requirements, prepare for their implementation and obtain the required vaccinations prior to the effective dates. No sunset date has been established. The Department will continually review and monitor the effectiveness of these regulations.

F. Regulatory Review

 Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on October 21, 2006, the Department submitted a copy of the notice of proposed rulemaking, published at 38 Pa.B. 750, to IRRC and to the House Health and Human Services Committee and the Senate Public Health and Welfare Committee (Committees) for review and comment.

 Under section 5(c) of the Regulatory Review Act, IRRC and the Committees were provided with copies of the comments received during the public comment period, as well as other documents when requested. In preparing the final-form rulemaking, the Department has considered all comments from IRRC, the Committees and the public.

 Under section 5.1(j.2) of the Regulatory Review Act (71 P. S. § 745.5a(j.2)), on April 21, 2010, the final-form rulemaking was approved by the Committees. Under section 5.1(e) of the Regulatory Review Act, IRRC met on April 22, 2010, and approved the final-form rulemaking.

G. Contact Person

 Questions regarding this final-form rulemaking should be submitted to Heather Stafford, Director, Division of Immunization, Department of Health, 625 Forster Street, Harrisburg, PA 17108, (717) 787-5681 within 30 days after publication in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the final-form rulemaking may do so by using the previous phone number or address. Speech or hearing impaired persons may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT). Persons who require an alternative format of this document should contact Heather Stafford so that necessary arrangements may be made.

Findings

 The Department finds that:

 (1) Public notice of intention to adopt the final-form rulemaking adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202) and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.

 (2) A public comment period was provided as required by law and all comments were considered.

 (3) The adoption of final-form rulemaking in the manner provided by this order is necessary and appropriate for the administration of the authorizing statute.

Order

 The Department, acting under the authorizing statute, orders that:

 (1) The regulations of the Department, 28 Pa. Code Chapters 23 and 27, are amended by amending §§ 23.82, 23.83, 23.85, 23.86 and 27.77 to read as set forth in Annex A. (Editor's Note: Section 23.85 was not proposed to be amended at 38 Pa.B. 750.)

 (2) The Secretary of Health shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.

 (3) The Secretary of Health shall submit this order, Annex A and a Regulatory Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for their review and action as required by law.

 (4) The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

 (5) This order shall take effect August 1, 2011.

EVERETTE JAMES, 
Secretary

 (Editor's Note: For the text of the order of the Independent Regulatory Review Commission relating to this document, see 40 Pa.B. 2493 (May 8, 2010).)

Fiscal Note: 10-181. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 28. HEALTH AND SAFETY

PART III. PREVENTION OF DISEASES

CHAPTER 23. SCHOOL HEALTH

Subchapter C. IMMUNIZATION

§ 23.82. Definitions.

 The following words and terms, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

Ascertain—To determine whether or not a child is immunized as defined in this subchapter.

Attendance at school—(i) The attendance at a grade, or special classes, kindergarten through 12th grade, including public, private, parochial, vocational, intermediate unit and home education students and students of cyber and charter schools. (ii) The term does not cover the attendance of children at a child care group setting, defined in § 27.1 (relating to definitions), located in a public, private, or vocational school, or in an intermediate unit.

Certificate of immunization—The official form furnished by the Department. The certificate is filled out by the parent or health care provider and signed by the health care provider, public health official or school nurse or a designee. The certificate is given to the school as proof of immunization. The school maintains the certificate as the official school immunization record or stores the details of the record in a computer data base.

Department—The Department of Health of the Commonwealth.

Immunization—The requisite number of dosages of the specific antigens at the recommended time intervals under this subchapter.

Record of immunization—A written document showing the date of immunization—that is, baby book, Health Passport, family Bible, other states' official immunization documents, International Health Certificate, immigration records, physician record, school health records and other similar documents or history.

Secretary—The Secretary of the Department.

§ 23.83. Immunization requirements.

 (a) Duties of a school director, superintendent, principal or other person in charge of a public, private, parochial or nonpublic school. Each school director, superintendent, principal, or other person in charge of a public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, and special education and home education programs, cyber and charter schools, shall ascertain that a child has been immunized in accordance with the requirements in subsections (b), (c) and (e) prior to admission to school for the first time, under section 1303 of the Public School Code of 1949 (24 P. S. § 13-1303a) regarding immunization required; penalty.

 (b) Required for attendance. The following immunizations are required as a condition of attendance at school in this Commonwealth:

 (1) Diphtheria. Four or more properly-spaced doses of diphtheria toxoid, which may be administered as a single antigen vaccine or in a combination form. The fourth dose shall be administered on or after the 4th birthday.

 (2) Tetanus. Four or more properly-spaced doses of tetanus toxoid, which may be administered as a single antigen vaccine or in a combination form. The fourth dose shall be administered on or after the 4th birthday.

 (3) Poliomyelitis. Three or more properly spaced doses of either oral polio vaccine or enhanced activated polio vaccine, which may be administered as a single antigen vaccine, or in a combination form. If a child received any doses of inactivated polio vaccine administered prior to 1988, a fourth dose of inactivated polio vaccine is required.

 (4) Measles (rubeola). Two properly-spaced doses of live attenuated measles vaccine, the first dose administered at 12 months of age or older, or a history of measles immunity proved by laboratory testing by a laboratory with the appropriate certification. Each dose of measles vaccine may be administered as a single antigen vaccine or in a combination form.

 (5) German measles (rubella). One dose of live attenuated rubella vaccine, administered at 12 months of age or older or a history of rubella immunity proved by laboratory testing by a laboratory with the appropriate certification. Rubella vaccine may be administered as a single antigen vaccine or in a combination form.

 (6) Mumps. Two properly-spaced doses of live attenuated mumps vaccine, administered at 12 months of age or older or a physician diagnosis of mumps disease indicated by a written record signed by the physician or the physician's designee. Mumps vaccine may be administered as a single antigen vaccine or in a combination form.

 (7) Hepatitis B. Three properly-spaced doses of hepatitis B vaccine, unless a child receives a vaccine as approved by the Food and Drug Administration for a two-dose regimen, or a history of hepatitis B immunity proved by laboratory testing. Hepatitis B vaccine may be administered as single antigen vaccine or in a combination form.

 (8) Chickenpox (varicella). One of the following:

 (i) Varicella vaccine. Two properly-spaced doses of varicella vaccine, the first dose administered at 12 months of age or older. Varicella vaccine may be administered as a single antigen vaccine or in a combination form.

 (ii) Evidence of immunity. Evidence of immunity may be shown by one of the following:

 (A) Laboratory evidence of immunity or laboratory confirmation of disease.

 (B) A written statement of a history of chickenpox disease from a parent, guardian or physician.

 (c) Required for entry into 7th grade. In addition to the immunizations listed in subsection (b), the following immunizations are required at any public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate unit, special education and home education programs, and cyber and charter schools as a condition of entry for students entering the 7th grade; or, in an ungraded class, for students in the school year that the student is 12 years of age:

 (1) Tetanus and diphtheria toxoid and acellular pertussis vaccine (TdaP). One dose if at least 5 years have elapsed since the last dose of a vaccine containing tetanus and diphtheria as required in subsection (b). TdaP may be administered as a single antigen vaccine or in a combination form.

 (2) Meningococcal Conjugate Vaccine (MCV). One dose of Meningococcal Conjugate Vaccine. MCV may be administered as a single antigen vaccine or in a combination form.

 (d) Child care group setting. Attendance at a child care group setting located in a public, private or vocational school, or in an intermediate unit is conditional upon the child's satisfaction of the immunization requirements in § 27.77 (relating to immunization requirements for children in child care group settings).

 (e) Prekindergarten programs, Early Intervention programs' early childhood special education classrooms and private academic preschools. Attendance at a prekindergarten program operated by a school district, an early intervention program operated by a contractor or subcontractor including intermediate units, school districts and private vendors, or at private academic preschools is conditional upon the child's satisfaction of the immunization requirements in § 27.77.

 (f) Grace period. A vaccine dose administered within the 4-day period prior to the minimum age for the vaccination or prior to the end of the minimum interval between doses shall be considered to be a valid dose of the vaccine for purposes of this chapter. A dose administered greater than 4 days prior to minimum age or interval for a dose is invalid for purposes of this regulation and shall be repeated.

§ 23.85. Responsibilities of schools and school administrators.

 (a) The administrator in charge of a school shall appoint a knowledgeable person to perform the following:

 (1) Inform the parent, guardian or emancipated child at registration or prior to registration, if possible, of the requirements of this subchapter.

 (2) Ascertain the immunization status of a child prior to admission to school or continued attendance at school.

 (i) The parent, guardian or emancipated child shall be asked for a completed certificate of immunization.

 (ii) In the absence of a certificate of immunization, the parent, guardian or emancipated child shall be asked for a record or history of immunization which indicates the month, day and year that immunizations were given. This information shall be recorded on the certificate of immunization and signed by the school official or the official's designee, or the details of the record shall be stored in a computer database.

 (b) If the knowledgeable person designated by the school administrator is unable to ascertain whether a child has received the immunizations required under § 23.83 (relating to immunization requirements) or under subsection (e) or is exempt under § 23.84 (relating to exemption for immunization), the school administrator may admit the child to school or allow the child's continued attendance at school only according to the requirements of subsections (d) and (e).

 (c) The parent or guardian of a child or the emancipated child who has not received the immunizations required under § 23.83 shall be informed of the specific immunizations required and advised to go to the child's usual source of care or nearest public clinic to obtain the required immunizations.

 (d) A child not previously admitted to or not allowed to continue attendance at school because the child has not had the required immunizations shall be admitted to or permitted to continue attendance at school only upon presentation to the school administrator or school administrator's designee of a completed certificate of immunization or immunization record, upon submission of information sufficient for an exemption under § 23.84, or upon compliance with subsection (e).

 (e) Provisional admittance to school.

 (1) Multiple dose vaccine series. If a child has not received all the antigens for a multiple dose vaccine series described in § 23.83, the child may be provisionally admitted to school only if evidence of the administration of at least one dose of each antigen described in § 23.83 for multiple dose vaccine series is given to the school administrator or the administrator's designee and the parent or guardian's plan for completion of the required immunizations is made part of the child's health record.

 (2) Single dose vaccines. If a child has not received a vaccine for which only a single dose is required, the child may be provisionally admitted to school if the parent or guardian's plan for obtaining the required immunization is made a part of the child's health record.

 (3) Completion of required immunizations. The plan for completion of the required immunizations shall be reviewed every 60 days by the school administrator or the school administrator's designee. Subsequent immunizations shall be entered on the certificate of immunization or entered in the school's computer database. Immunization requirements described in § 23.83 shall be completed within 8 months of the date of provisional admission to school. If the requirements are not met, the school administrator may not admit the child to school or permit continued attendance after that 8 month provisional period.

 (f) A school shall maintain on file a certificate of immunization for a child enrolled. An alternative to maintaining a certificate on file is to transfer the immunization information from the certificate to a computer database. The certificate of immunization or a facsimile thereof generated by computer shall be returned to the parent, guardian or emancipated child or the school shall transfer the certificate of immunization (or facsimile) with the child's record to the new school when a child withdraws, transfers, is promoted, graduates or otherwise leaves the school.

§ 23.86. School reporting.

 (a) A public, private, parochial or nonpublic school in this Commonwealth, including vocational schools, intermediate units, special education and home education programs and cyber and charter schools, shall report immunization data to the Department by October 15 of each year, using forms provided by the Department.

 (b) The school administrator or the administrator's designee shall forward the reports to the Department as indicated on the reporting form provided by the Department.

 (c) Duplicate reports shall be submitted to the county health department if the school is located in a county with a full-time health department.

 (d) The school administrator or the administrator's designee shall ensure that the school's identification information, including the name of the school, school district, county and school address, is correct, and shall make any necessary corrections, prior to submitting the report.

 (e) Content of the reports must include the following information:

 (1) The month, day and year of the report.

 (2) The number of students attending school in each grade-level, or in an ungraded school in each age group, as indicated on the reporting form.

 (3) The number of doses of each individual antigen given in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (4) The number of students attending school who were classed as medical exemptions in each grade-level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (5) The number of students attending school who were classed as religious exemptions in each grade level, or in an ungraded school, in each age group, as indicated on the reporting form.

 (6) The number of students provisionally admitted in each grade level or, in an ungraded school, in any age group as indicated on the reporting form.

 (7) The number of students in each grade level who were denied admission because of the student's inability to qualify for provisional admission or, in an ungraded school, in each age group as indicated on the reporting form.

 (8) Other information as required by the Department.

CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES

Subchapter C. QUARANTINE AND ISOLATION

COMMUNICABLE DISEASES IN CHILDREN AND STAFF ATTENDING SCHOOLS AND CHILD CARE GROUP SETTINGS

§ 27.77. Immunization requirements for children in child care group settings.

 (a) Caregiver responsibilities.

 (1) Except as exempted in subsection (d), effective March 27, 2002, the caregiver at a child care group setting may not accept or retain a child 2 months of age or older at the setting, for more than 60 days, unless the caregiver has received a written objection to a child being vaccinated on religious grounds from a parent or guardian, or one of the following:

 (i) For all children not exempt under subsection (d)(1)(ii), an initial written verification from a physician, the Department or a local health department of the dates (month, day and year) the child was administered any vaccines recommended by ACIP. The verification must also specify any vaccination not given due to medical condition of the child and state whether the condition is temporary or permanent. The verification must show compliance with the vaccination requirements in subsection (b).

 (ii) For all children for whom vaccinations remain outstanding following the caregiver's receipt of the initial written verification, subsequent written verifications from a physician, the Department or a local health department as additional vaccinations become due. These verifications shall be prepared in the same manner as set forth in subparagraph (i), but need not repeat information contained in a previously submitted verification. The verifications must demonstrate continuing compliance with the vaccination requirements in subsection (b).

 (2) If the caregiver receives a written verification under paragraph (1) explaining that timely vaccination did not occur due to a temporary medical condition, the caregiver shall exclude the child from the child care group setting after an additional 30 days unless the caregiver receives, within that 30-day period, written verification from a physician, the Department or a local health department that the child was vaccinated or that the temporary medical condition still exists. If the caregiver receives a written verification that vaccination has not occurred because the temporary condition persists, the caregiver shall require the presentation of a new verification at 30-day intervals. If a verification is not received as required, the caregiver shall exclude the child from the child care group setting and not readmit the child until the caregiver receives a verification that meets the requirements of this section.

 (3) The caregiver shall retain the written verification or objection referenced in paragraphs (1) and (2) for 60 days following the termination of the child's attendance.

 (4) The caregiver shall ensure that a certificate of immunization is completed and signed for each child enrolled in the child care group setting. The certificates shall be updated by the caregiver to include the information provided to the caregiver under subsection (a) when that additional information is received. The immunization status of each enrolled child shall be summarized and reported on an annual basis to the Department at the time prescribed by the Department and on the form provided by the Department.

 (b) Vaccination requirements. Each child enrolled in a child care group setting shall be immunized in accordance with ACIP standards in effect on January 1, 1999, governing the issuance of ACIP recommendations for the immunization of children.

 (1) The standards are as follows:

 (i) The immunization practice is supported by both published and unpublished scientific literature as a means to address the morbidity and mortality of the disease.

 (ii) The labeling and packaging inserts for the immunizing agent are considered.

 (iii) The immunizing agent is safe and effective.

 (iv) The schedule for use of the immunizing agent is administratively feasible.

 (2) The Department will deem an ACIP recommendation pertaining to the immunization of children to satisfy the standards in this subsection unless ACIP alters its standards for recommending immunizations for children by eliminating a standard set forth in this subsection and the recommendation is issued under those changed standards.

 (c) Notice. The Department will place a notice in the Pennsylvania Bulletin listing publications containing ACIP recommendations issued under the standards in subsection (b). The Department published the initial notice at 32 Pa.B. 539 (January 26, 2002), contemporaneously with the adoption of amendments to this chapter. The Department will update that list in a notice which it will publish in the Pennsylvania Bulletin within 30 days after ACIP issues a recommendation which satisfies the criteria of this section.

 (d) Exemptions.

 (1) This section does not apply to the following:

 (i) Children attending kindergarten, elementary school or higher school who are 5 years of age or older. These caregivers shall comply with §§ 23.81—23.87 (relating to immunization).

 (ii) A caregiver who does not serve as a caregiver for at least 40 hours during at least 1 month.

 (2) The requirement imposed by subsection (a), to not accept a child into a child care group setting without receiving an initial written verification or objection specified in subsection (a), does not apply during a month the caregiver does not serve as a caregiver for at least 40 hours.

 (e) Exclusion when disease is present. Whenever one of the diseases in § 27.76 (relating to exclusion and readmission of children, and staff having contact with children, in child care group settings) has been identified within a child care group setting, the Department or a local health department may order the exclusion from the child care group setting or any other child care group setting which is determined to be at high-risk of transmission of that disease, of an individual susceptible to that disease in accordance with public health standards as determined by the Department.

[Pa.B. Doc. No. 10-984. Filed for public inspection May 28, 2010, 9:00 a.m.]



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