[32 Pa.B. 491]
[Continued from previous Web Page] Response
The commentator misread the proposed regulation. The section, as proposed, does include a subsection (a). There is no need to relabel subsection (b) as subsection (a).
Comment
Proposed subsection (b)(2) requires that the LMRO report cases of certain diseases, infections and conditions to the Department on the same day any of the listed diseases are reported to it or it finds out about those diseases. The Department should delete hepatitis A and meningitis from subsection (b)(2) and should add the words ''food borne'' before the word ''botulism'' in that subsection.
Response
The Department agrees with this comment, and has made the recommended changes. An urgent response to reports of hepatitis A and meningitis is not necessary due to the manner in which these diseases are transmitted.
Comment
The Department should add the following diseases, infections and conditions to subsection (b)(2): arbovirus disease, haemophilus influenzae invasive disease in a child under the age of 15 years, and Legionnaire's disease. Because of the serious nature of these diseases, action to intervene must be taken to prevent and control their spread in less than 5 days.
Response
The Department agrees with this comment, and has revised subsection (b)(2) to include the recommended changes.
Comment
The Department should add smallpox to subsection (b)(2) due to the possibility of its use in a terrorist attack.
Response
The Department agrees with this comment, and has revised subsection (b)(2) to include smallpox.
Subchapter C. QUARANTINE AND ISOLATION Comment
The Department should clarify in the preamble how this subchapter applies to hospitals, or state in its regulations the circumstances under which health care facilities are required to contact local health officials to confer about matters relating to quarantine and isolation. Hospitals routinely adhere to standards relating to isolation of patients and transporting them without notifying the Department or local health authorities. The Department does not need to have routine matters reported to it by health care facilities.
Response
Subchapter C has been in place in the form now being amended since 1979. Section 27.67 (relating to movement of persons and animals subject to isolation or quarantine by action of a local health authority or the Department) has, over the last 20 or more years, required a health care facility to secure the permission of a local health authority or the Department before moving a person under isolation or quarantine. The only substantive change to this section is to include movement of animals under isolation or quarantine to its requirements, which should have little impact on hospitals. The remainder of the amendments to this section are intended to update the terms used in the section, for example, changing ''local health officer'' to ''local health authority.''
There is no need to clarify this subchapter. By law, the Department and local health departments are given broad authority by the General Assembly through the act to prevent and control the spread of disease. See 35 P. S. § 521.3 (relating to responsibility for disease prevention and control). This includes the imposition of disease control measures, including isolation and quarantine, and the ability to set requirements for those control measures, necessary to prevent and control the spread of disease. See 35 P. S. §§ 521.5, 521.7, 521.11 and 521.16(a)(3)(4) and (5) (relating to control measures; examination and diagnosis of persons suspected of being infected with venereal disease, tuberculosis, or any other communicable disease, or being a carrier; persons refusing to submit to treatment for venereal diseases, tuberculosis or any other communicable disease; and rules and regulations); see also 71 P. S. § 536(b) (providing the Department authority to establish and enforce quarantines to prevent the spread of disease) and 71 P. S. § 541(b) (providing the Department through the Board the ability to promulgate regulations for the health and protection of the people of the Commonwealth)).
While the Department recognizes that a health care facility has the responsibility for the individual patient, the Department has the responsibility for the safety and welfare of the entire public. It is necessary for the Department to be involved in matters relating to isolation and quarantine of persons with reportable diseases, regardless of whether these persons are currently in a health care facility, to ensure that the public's safety is considered as well as the patient's. Further, the Department has expertise in these matters which could benefit the health care facility.
If a disease, infection or condition is reportable under these regulations, the health care facility must report it as required under the regulations. The health care facility has no discretion in the matter. This requirement has also not changed over the years, although the list of diseases and the method of reporting may have changed somewhat. If the disease is one which requires isolation of the case or quarantine of the contacts, and the Department or a local health authority orders the isolation or quarantine, the health care facility must comply with the regulations and the Department or local health authority's orders regarding control measures, if any are issued, or be in violation of the law. The Department will, of course, be cognizant of the expertise of the hospital's infectious disease staff, and will work with them to ensure that proper control measures are taken, as it currently does.
Section 27.60. Disease control measures.
This section lists the disease control measures that the Department or a local health authority may take, including any disease control measure that the Department or a local health authority considers to be appropriate for the surveillance of disease, when it is necessary to protect the public health. Actions of local health authorities that are not LMROs are conditioned upon the approval of the Department.
Comment
There is considerable controversy over the appropriateness and need for isolation of some infections. Many reports and articles provide a different approach for different facilities. There is concern that a long-term care facility may find itself in conflict with the regulations, and be forced to accept the Department's interpretation of whether isolation was indicated, where and how much. Specifically the concern is with Methicillin resistant staphylococcus aureus (MRSA) and Vancomycin resistant enterococchi (VRE), which are not often seen. It should be assumed that the requirements for disease control measures with respect to these diseases do not apply, since they are not reportable diseases and conditions. Also, a long-term care facility may isolate a salmonella case, but not always with the practice of universal standard precautions.
The Department's statement that it has the discretion to implement the most appropriate disease control measures for the situation is not accurate. This statement gives all the authority to the Department to determine the isolation requirements without any recognition of a facility's systems. The long-term care industry is currently burdened with Department-imposed two-step tuberculin skin testing for all employees. Neither the CDC nor OSHA imposes this requirement. Since the Department is not reasonable with respect to these requirements, long-term care facilities have no confidence that the Department will be reasonable with respect to control requirements. The Department must give some recognition in this section for a health care facility's existing and regulatorily required infection control systems to prevent the future imposition of arbitrary and capricious measures.
Response
As discussed in response to general comments on this subchapter, the Department has statutory authority, regardless of existing systems within a health care facility, to require specific disease prevention and control measures as the Department's disease control experts find necessary to protect the fragile population resident in long-term care facilities. The Department and local health departments will work first within a facility's existing infection control systems, which should be adequate for most outbreaks and cases. If, however, additional precautions are necessary, the facility must comply with the Department's orders to remain compliant with the law.
With respect to MRSA and VRE mentioned by the commentator, although these diseases are not specifically listed as reportable within Chapter 27, if there is an outbreak of either, the outbreak is reportable. Upon being informed of the outbreak, the Department may take the steps it deems necessary to prevent and control the spread of disease. Further, these diseases are reportable under the Department's regulations relating to long-term care nursing facilities. See § 211.1(c).
With respect to the issue regarding tuberculosis, the regulations of the Division of Nursing Care Facilities are not in conflict with the recommendations of the CDC. The regulations require a two-step PPD testing procedure, as the CDC recommends. In interpreting its regulations, the Department requires that long-term care facilities have policies and procedures in place to address individual situations, which may satisfy the two-step PPD test requirement. If a long-term care facility has implemented appropriate policies and procedures and the facility's Medical Director is willing to document that a complete two-step PPD test is not required for an individual employee, the Department will consider that when determining if the facility has met the regulatory requirements. Accordingly, the Department is not in conflict with CDC recommendations, but merely requires that each situation be addressed individually by a medical professional to assure the health and safety of the residents in a long-term care facility.
Comment
The last sentence of this section requires an LMRO to receive approval from the Department before taking disease prevention and control measures. The Department should explain how this is to occur, and whether the requirement needs to be in writing.
Response
This section requires only a local health authority that is not an LMRO to obtain approval from the Department. This is intended to ensure that those local health authorities without experience in dealing with disease control measures have the benefit of the Department's expertise before taking action. The Department has changed the last sentence of the proposed regulation to use the term ''LMRO'' rather than ''local health department'' since that is consistent with the remainder of the Department's regulations on disease control. The Department will contact the local health authority by telephone, facsimile or in writing, depending upon the circumstances of the case and the urgency for action to be taken to control and prevent the spread of disease.
Section 27.67. Movement of persons and animals subject to isolation or quarantine by action of a local health authority or the Department.
This section requires certain actions to occur before persons or animals subject to quarantine or isolation by action of the Department or a local health authority can be moved from one place to another.
Comment
The Department should add the word ''person'' in front of the word ''animal'' in subsection (d).
Response
The Department agrees, and has revised the regulation.
COMMUNICABLE DISEASES IN CHILDREN AND STAFF ATTENDING SCHOOLS AND CHILD CARE GROUP SETTINGS This part of Subchapter C includes criteria for exclusion and readmission of children and staff in schools and in child care group settings, and lists the diseases and symptoms for which exclusion may occur. It also includes a section that requires exclusion from child care group settings if a child does not have the listed immunizations or immunities. The Department received several comments on the sections in this part of the subchapter. Several comments were directed at the substance of this part of the subchapter, rather than to a particular regulation.
Comment
The heading of this part of the regulations uses terms like ''children'' and ''staff'' while the sections in this part use the term ''pupils.'' The Department should review this part for consistency, and use terms consistently.
Response
The Department agrees with the comment. It has amended the proposed regulations to use the terms ''child'' and ''children'' rather than ''pupil,'' and the phrase ''staff having contact with children'' rather than ''staff.''
Comment
A physician or school nurse should not have to verify that criteria for readmission have been satisfied unless there is a question on the part of the school or child care group setting regarding whether the criteria have been satisfied. The criteria specified by the Department for readmission are very clear for most conditions, and to require a doctor or nurse to verify them would be a waste of time and resources. For example, physicians can do no more to ascertain the status of the child than a caregiver, who would ask the parents about whether the first crop of vesicles of chickenpox developed, and whether all the lesions have dried and crusted. Physicians and parents do not have to interact to confirm this status.
The times when a health professional needs to be included are clearly stated in the readmission criteria for conditions where the involvement is appropriate. When negative culture tests are required, the tests require involvement of a health professional as stipulated in the exclusion criteria.
Response
The Department has not changed the proposed regulations in response to this comment. The disease situations listed in this portion of the regulations that require verification for readmission to a school or group child care setting by a physician or a school nurse are situations that pose serious medical consequences to the individual with the disease, and to those exposed to the disease, if the individual remains communicable. Where the regulations require verification by physicians or school nurses for readmission, that verification is necessary to prevent and control the spread of disease.
Comment
Nonpublic schools do not have full-time school nurses. There are no school nurses functioning in many nonpublic schools. If no other type of personnel is assigned to perform this function, how can children be readmitted?
Response
The Department has not changed the proposed rulemaking in response to this comment. Whether a school is public or nonpublic does not change the risk to children exposed to a communicable disease. Further, although a school nurse may not be stationed daily at a nonpublic school, school nurses are available from the district. If one is not due for a visit at the time readmission criteria must be verified, the private school may request that one come to the private school for that purpose. The law requires that the school district make health services available to public and private school children. See 24 P. S. § 14-1402(a). School nurses are made available to nonpublic schools by the school district (id. at (a.1); and § 23.51 (relating to children to be provided school nursing services)). The number of school nurses to be provided within a school district is calculated based on the number of private and public school children within that district. See 24 P. S. § 14-1402(a.1). Therefore, by law, there must be access to school nurse services by children of private schools. Further, as the regulations state, in the absence of a school nurse, a physician's certificate is acceptable.
Comments
To require verification by a school nurse is a problem, because public schools do not have school nurses in every building every day. Further, the function of a school nurse is to focus on children, not the employees of the school.
Given the concern over lack of school nurses, why is verification of the criteria for readmission limited to a school nurse or a physician? Would verification from other medical personnel meet the requirements?
Response
The Department has not changed the proposed regulations in response to these comments. As is the case with private schools, if a school nurse is not present in a particular building, the school nurse may be sent for to verify readmission criteria. Again, a physician's verification need not be reverified by a school nurse. Lastly, Article XIV of the Public School Code of 1949 (24 P. S. §§ 14-1401--14-1422), which addresses school health services, includes requirements for the health of school staff. See 24 P. S. § 14-1418. If the staff in contact with children have a communicable disease of the type listed in the regulations, the health of the children with whom that staff are in contact could be compromised. To prevent and control the spread of disease within the school community, the health of all members of that community must be monitored. Infected staff can infect children.
Comment
The Department should reconcile the exclusionary language in this part of the regulations with the CDC's Personnel Health Guidelines which were published on September 8, 1997.
Response
The Department has not changed the proposed regulations in response to this comment. The guidelines to which the commentator refers are guidelines for hospital-based infection control. The Department's requirements are broader in this particular part of the regulations, in that they are directed toward prevention and control of the spread of disease in schools and child care group settings. The difference in setting requires a different approach. Individuals in a hospital setting are exposed to more virulent and different types of infections and are more likely to be in a fragile state susceptible to transmission of disease.
Comment
The Department should change the language of §§ 27.71--27.75 to read ''children in child care and pupils in schools,'' and add the words ''child care group settings'' and ''caregiver'' to the sections. The reference to §§ 27.71--27.75 in § 27.76 (relating to exclusion and readmission of children, and staff having contact with children, in child care group settings) would then be unnecessary.
Response
The Department has not changed the proposed regulations in response to this comment. The Department is satisfied with the language in § 27.76 that expressly applies §§ 27.71--27.75 to child care group settings, with appropriate modifications.
Comment
The Department should make immunization delivery a reportable event, as the city of Philadelphia has done. This would allow future implementation of a Statewide immunization system, or registry. The language allowing for this should permit all health care providers or insurers to report, and should include immunity for violations of privacy and confidentiality of medical records.
Response
The Department is taking this comment into consideration. However, given the many serious issues surrounding the actual development and implementation of a registry process, more time is needed to consider the possibility of a registry, and how it would be implemented. For example, issues concerning whether persons other than the Department would have access to the registry, how that access would occur, whether or not patient consent to be a part of the registry must be obtained, and how registration would occur, must be taken into account. More public comment should be invited than is possible at this stage in this rulemaking process. Further, the Department could not create immunity for providers and insurers from privacy and confidentiality laws, without having the statutory authority to do so. If the Department decides to pursue implementation of reporting of immunization delivery, the most appropriate way to do so is through separate rulemaking.
Section 27.71. Exclusion of children, and staff having contact with children, for specified diseases, infections and conditions.
This section requires exclusion of children, and staff persons who have contact with children, from school when a physician or school nurse suspects that individual of having any of the communicable diseases, infections or conditions listed in the section.
The Department has made a revision in paragraph (5), with respect to the exclusionary requirements for rubella. The proposed rulemaking had changed the number of days from the onset of rash from four to seven. The number should have remained four.
Comment
The Department should add Neisseria meningitidis to the list of diseases for which children and staff having contact with children are excluded. The exclusion should last until the person is made noninfective by a course of rifampin or other drug which is effective against the nasopharyngeal carriage state of this disease, or until otherwise shown to be noninfective. This requirement is included in child care group settings, but is missing from this regulation relating to schools.
Response
The Department agrees with this comment, and has added the disease to the regulation.
Comment
The Department should clearly define what adults are affected by these sections. What does contact with pupils mean? Does a staff person who has contact with pupils mean only teachers and administrators, or does it also include custodians, cafeteria workers and bus drivers? The Department should develop a definition of ''school employee'' that indicates who is to be excluded from the definition, and who included in it. The Department could define a ''school employee'' as an individual employed by a school. This definition would include an independent contractor or employee, and would exclude an individual with no direct or routine interaction with students.
Response
The Department's use of the phrase, ''staff having contact with children,'' is meant to include all persons present in the school to perform duties for the school--volunteers, employees and independent contractors--who come into contact with children. To clarify this for the public, the Department has added language to the regulations referencing volunteers, along with a general definition of ''volunteer'' in § 27.1.
Further, the Department has intentionally used the phrase ''having contact with children'' and has not qualified the contact as routine or indirect. The regulations include every person performing duties for the school, paid or unpaid, who has any contact with children. Even a nonroutine or indirect contact of an infected person with a very young child, depending upon the circumstances of that contact, can and has caused severe illness in the child. If the school has knowledge of or a suspicion that the person has one of the diseases, infections or conditions included in the regulations, that person is to be excluded. This is necessary to prevent transmission of illness between staff, including volunteers, and the children. The illness in some cases, may result in death or serious disability.
Comment
It is not clear if volunteers are meant by the Department's use of the phrase ''staff having contact with children,'' although the preamble to proposed rulemaking did say that they were. The regulations do not include the word ''volunteer.'' Volunteers should not be included in these regulations, since these people are present at the school at different times throughout the school year. It would be difficult for school personnel to medically monitor these persons and comply with exclusion and readmission requirements that are more appropriately directed to students and to school employees. The Department should eliminate any requirement that volunteers be covered, but should include language that emphasizes the ability of the school staff to exclude these volunteers if a health risk is present.
Response
The Department has explained why volunteers are covered in prior responses to comments. The requirement under the regulations is, as the commentator has suggested, to exclude these persons if the school believes there is a health risk present. Once excluded, the individual cannot be readmitted unless the requirements of the regulation are followed.
Comment
Specific time frames for readmission are not mentioned under these diseases. If a specific time frame is satisfied, is it necessary to incur the expense of an additional doctor's visit? Wouldn't verification by a nurse or physician's assistant be satisfactory? This is more easily obtained and less expensive.
Response
The Department has not changed the proposed regulation in response to this comment. The text following most of the diseases listed in this section does include specific time frames for readmission running from a specific event in the course of the disease. The Department has provided a time frame for readmission for the remainder of the listed diseases predicated upon a specific event readily ascertainable which occurs in the course of the disease.
With respect to the comment asking whether verification of readmission criteria by a nurse or physician's assistant would be sufficient, the Department has already explained its reasons for requiring verification by a school nurse or physician in its response to general comments on this portion of the regulations relating to requirements for schools and child care group settings.
Section 27.72. Exclusion of children, and staff having contact with children, for showing symptoms.
This section requires exclusion of children and of staff having contact with children who are showing the symptoms listed.
Comments
The Department is to be commended for including language that is consistent with currently published National standards.
The Department should include diarrhea as a symptom permitting temporary exclusion of a pupil or staff person from a school or college to the extent the person may represent a communicable disease risk. The language would then be consistent with §§ 27.76(a)(3), 27.154(6) and 27.155(6) (relating to exclusion and readmission of children, and staff having contact with children, in child care group settings; restrictions on caregivers in a child care group setting; and restrictions on health care practitioners).
Response
The Department agrees with the latter comment and has added persistent diarrhea as a symptom for which exclusion is required.
Comment
A child who has a fever or is vomiting would have to be excluded under this section. This would require a child to be seen by a physician or school nurse whenever they have an upset stomach to be readmitted.
Response
The symptoms chosen by the Department to require exclusion were intended to be those that could be associated with a serious communicable illness of a child. For example, the Department requires exclusion of a child for a fever when the fever is equal to or greater than 102° F. The Department has changed the regulation to require exclusion for persistent vomiting rather than a single incident of vomiting for the reason raised by the commentator.
Comments
It is not practical to expect schools to keep abreast of what constitutes an unusual rate of absenteeism as published in the Pennsylvania Bulletin.
The term ''periodically'' in subsection (b), which states that the Department will periodically determine and publish what increase constitutes an unusual rate of absenteeism, is unclear. Will this be quarterly, annually or monthly? The Department should establish a time frame and say where the information will be published.
Response
The Department has deleted this statement from the regulation. A school may determine itself what constitutes an unusual rate of absenteeism, by a review of its records relating to absenteeism.
Comment
Subsection (b) requires schools to maintain records of exclusion of staff and students. This language is broad. Does a school have the authority to determine what an unusual rate of absenteeism is, and how often would it review its records to determine this rate? Development of guidelines and forms by the Department would be helpful to assist in these new recordkeeping duties. Will school districts be required to submit reports to the Department? The language implies this, but does not require it. The Department should clearly state that schools must submit the information, and specify the reporting process
Response
The regulation neither requires a school to submit records of exclusion or rates of absenteeism to the Department, nor specifies regular review periods for the records. The Department does not want this information reported on a regular basis. The Department expects that when a school notices something unusual occurring with respect to the number of children being excluded or absent, the school will review its records, and notify the Department through the disease reporting process. There are no special forms for this report.
As stated previously, the Department, through this chapter, intends to obtain the widest variety of information available on possible outbreaks of disease. One possible avenue for this information is through absenteeism rates at schools. If the school fails to notice something unusual, it is possible that the Department could locate the outbreak through other reporting sources. It is also possible, however, that information from a school could provide the Department with early warning of a problem in the community.
Section 27.73. Readmission of excluded children, and staff having contact with children.
This section sets standards for readmission into a school of children, and staff having contact with children, who were excluded under §§ 27.71 and 27.72.
Comment
The first part of subsection (a) should be deleted, since the exclusion criteria that require health professional decision making are already included in the criteria for the specific conditions and symptoms.
Response
The Department has not changed the proposed regulation based on this comment. The Department believes the language is necessary for the clarity of the section.
Section 27.74. Readmission of exposed or isolated children, and staff having contact with children.
Section 27.75. Exclusion of children, and staff having contact with children, during a measles outbreak.
The Department received no comments on §§ 27.74 and 27.75. The Department has, however, revised these sections consistent with revisions it has made to other sections in Subchapter C. The Department has added language to both of these sections to ensure that volunteers are covered by their provisions, and has clarified that the Department is concerned with all staff having contact with children, as it has in the other sections in this part of Subchapter C.
Section 27.76. Exclusion and readmission of children, and staff having contact with children, in child care group settings.
This section includes exclusion and readmission criteria for children and staff in child care group settings.
Comment
How will staff and management in a child care group setting be able to screen and diagnose children for exclusion? How will they be able to report at the same level as a health care facility?
Response
The regulations do not require management and staff to diagnose diseases, infections and conditions. If management or staff suspect that a child in the child care setting has one of the diseases, infections or conditions listed in the regulations for which a child or staff person must be excluded, or is showing signs and symptoms of that disease, infection or condition, or if the parent or guardian makes the child care group setting aware that the child has a disease, infection or condition for which the child must be excluded, then the child should be excluded. The same reasoning should be applied to staff. Readmission is contingent upon verification from a physician that the criteria for readmission have been satisfied.
The Department has revised subsection (b)(3) to clarify that the child care group setting must ensure that the condition which required exclusion has been resolved before the child may be readmitted.
Comment
Diarrhea should be deleted from the list of conditions that require physician approval for readmission to the child care group setting. A physician will determine whether there has been resolution of the condition by asking the patient if the symptoms have subsided. A child care operator can do this as well as a physician. The requirement for readmission should be retained, but physician approval should not be required.
Response
The Department has changed the wording of subsection (a)(3) to require physician approval only if persistent diarrhea occurs. Since persistent diarrhea is most likely an indication of disease, unlike the incidence of sporadic diarrhea, the Department believes that a physician's approval is necessary to determine the nature of the disease and its resolution. Further, physician verification is required under this subsection when diarrhea is coupled with other symptoms or circumstances. Both together are evidence of serious illness, rather than a minor stomach condition.
Comment
The requirement in subsection (a)(3) that a person be excluded for diarrhea when associated with an identified bacterial or parasitic pathogen is too broad. Children and staff who are carriers of Giardia lamblia do not need to be excluded from child care. Similarly, asymptomatic children with salmonella other than s. typhi in their stools do not need to be excluded.
Response
The Department has not changed the proposed regulation in response to this comment. The presence of a bacterial or parasitic pathogen is only cause for exclusion under subsection (a) when it is coupled with persistent diarrhea. (The Department has changed the term ''diarrhea'' to ''persistent diarrhea'' to evidence a serious illness, as has been discussed.) Therefore, asymptomatic children would not be excluded under this provision; the only children who would be excluded would be children who had a persistent symptom. The persistent symptom, diarrhea, particularly when it occurs among very young children, can easily transfer infection by hand-to-mouth contact.
Comment
Subsection (a)(8) should say ''influenzae'' rather than ''influenza.'' However, there is no reason to exclude children or staff members from a child care group setting for H. influenzae disease.
Response
The Department agrees, and has deleted the text of proposed subsection (a)(8). Cases are no longer infectious 24 hours after antimicrobial treatment begins. At that time, the child would pose no threat of infection to other children. Prior to treatment, the child will be obviously ill, and will either be kept home by parents or guardians, or will fall under another exclusionary provision of the regulations.
Comments
Subsection (b)(3) requires a caregiver to screen every child for the presence of a condition that requires exclusion. This would require the caregiver, or a school perhaps, to screen for all diseases listed as well as symptoms. This is unreasonable, burdensome, costly and time consuming. This would require a child to be subjected to a daily medical examination. How would this be administered?
Does this mean a caregiver would have to screen a child every day for the presence of an exclusionary disease, or only if the child is suspected of having a disease?
The Department should clarify whether the caregiver is required to make an accurate diagnosis of the child's condition, or is to screen for symptoms of the child's condition.
Response
This subsection does not apply to schools. This subsection applies when children are returned to a child care group setting following an exclusion under the regulations. The Department realizes that the proposed paragraph reads otherwise, and has revised it so that it clearly applies only when a child is returned to a group care setting following an exclusion.
Comment
How will the caregiver report the presence of an exclusionary disease to the Department? Is there a form required by the Department? The Department must fully explain how to report.
Response
This section deals with exclusion and readmission of children and staff having contact with children in a child care group setting. Child care group settings are required to report diseases, infections and conditions under § 27.23. Reporting is done in accordance with § 27.4. The time frames in which reports must occur are included in § 27.21a. Further discussion concerning case reporting is included in the Department's responses to comments on § 27.4.
A person who has a question concerning the appropriate reporting requirements may call the Department's district office or the local health department in the area in which the person is located.
Section 27.77. Immunization requirements for children in child care group settings.
This section requires children in child care group settings to have certain immunizations, and sets standards for excluding those children from the setting for failure to obtain those immunizations.
Comment
The DPW governs the development, implementation and enforcement of regulations in this area. Operators of child care group settings will take the information provided by the Department relating to disease control and prevention in an effort to improve quality of care. The Department's regulations, however, conflict with standards being followed by home-based providers in the area of procedures involving matters such as communicable diseases.
Response
The Department has not changed the proposed regulation in response to this comment. Although the DPW may be the licensing agency for child care homes, the Department is the agency with the authority, delegated by the General Assembly, to prevent and control the spread of disease throughout this Commonwealth. The Department has the broad authority to take the necessary steps to prevent and control the spread of disease. The Department has worked and will continue to work with DPW to ensure that entities licensed by that agency are aware of reporting requirements.
Comment
There is no separate definition for schools or child care providers, rather, there is a single definition for child care group setting. Since the exemption provision in subsection (d) references schools, this implies that a child care group setting includes a school, unless specific exemptions are included in the language.
Response
Section 27.77 does not apply to schools. This is made clear under subsection (d). Regulations relating to exclusion of children from schools for failure to obtain immunizations already exist. See § 23.85 (relating to responsibilities of schools and school administrators) and 22 Pa. Code §§ 11.20 and 51.13 (relating to nonimmunized children; and immunization). There is no need to promulgate regulations twice on the same topic.
Comment
The documentation of vaccination status under subsection (a) would impose a heavy administrative burden on the child care group setting, and would require a level of expertise that cannot be met with the resources currently available to child care group settings. These settings do not have health professionals available to help with immunization record checks.
Response
The Department has not changed the proposed regulation in response to this comment. The Department must monitor to ensure that child care group settings are complying with the regulations, so that children within those settings are adequately protected from disease. The burden should be small on many child care group settings, since group child day care facilities licensed by DPW already are required to do health screening under DPW regulations, and report to DPW concerning vaccination status. See 55 Pa. Code §§ 3280.1--3280.221. These regulations require that a facility licensed by DPW conduct a health assessment of each child according to guidelines set by the American Academy of Pediatrics (AAP), and that a report be written that includes, among other things, a review of the child's immunization status according to AAP standards. See 55 Pa. Code § 3280.131(b), (c) and (d)(5). Therefore, child care group settings should have little difficulty in complying with the Department's regulations requiring documentation of a child's vaccination status.
Comment
The Department should consider using our software product to gather and track immunization information to other child care group settings not now under surveillance, as DPW does for its purposes.
Contrary to the Department's assessment in the preamble to proposed rulemaking of additional resources needed to implement the regulations, it will require additional resources to run immunization reviews in child care settings. The commentator is moving with DPW to require the full set of DPW's required forms from facilities. DPW has been working on this for years. Interfering with this careful groundwork and already operational system would be wasteful and regressive.
The commentator recommends that the Department and DPW work together collaboratively to develop, support and internalize existing systems of medical record checking that includes all recommended preventive health services (vaccinations and screening tests) as is now done by the commentator's software package.
Further, the child care facilities that must report under these regulations do not have resources available to perform these recording and reporting functions. Implementing the regulations will require the use of software that can apply complex decision rules about when vaccine should be received at varying ages, and that can track this information. The commentator has developed tools to help accomplish this.
Response
The Department declines to discuss the appropriateness of a particular software product in the context of its regulations. Any comment made by the Department could be viewed as circumventing the established bidding process for products and services, if one is instituted. The Department is currently incorporating a Statewide immunization information system into public clinic sites, and the information gathered through this regulation will be part of that system. This system will enable certain approved health care providers to easily access a child's immunization history, hopefully preventing unnecessary vaccinations, and facilitating the updating of a child's immunizations. For the present time, however, this immunization record will continue to be a paper record.
Comment
Subsection (a)(4) requires the caregiver to update certificates of immunization periodically. The term ''periodically'' is unclear. The Department should include a time frame.
Response
The Department is requiring certificates of immunization to be updated when new information regarding immunization is obtained. The Department has revised subsection (a)(4) to reflect this provision.
Comment
The Advisory Committee on Immunization Practices (ACIP) standards cited by the Department were superseded on January 1, 1999. New recommendations are made each January. The existing the DPW section references the existing standard, and therefore requires no revision.
Response
The Department has not changed the proposed regulation in response to this comment. The Department has accepted the standards in place on January 1, 1999, not the recommendations for immunization based upon those standards. Subsection (b)(2) states that the Department will deem an ACIP recommendation pertaining to the immunization of children to satisfy the standards of the subsection unless ACIP eliminates a standard and the recommendation is issued under the altered standards. This means that if ACIP recommends a new immunization in January of 2002, as long as that immunization meets the standards set in subsection (b)(1), children in child care group settings are required to have that immunization.
Subchapter D. SEXUALLY TRANSMITTED DISEASES, TUBERCULOSIS AND OTHER COMMUNICABLE DISEASES. Section 27.84. Examination for a sexually transmitted disease of persons detained by police authorities.
This section tracks section 8(a) of the act (35 P. S. § 521.8(a)) and sets standards for requiring persons detained by police authorities to be tested for sexually transmitted diseases.
Comment
Subsections (a) and (b) state that if a person refuses to undergo an examination or submit a specimen, the Department or a local health authority may take judicial action to secure an appropriate remedy. What does the phrase ''appropriate remedy'' mean?
Response
The phrase, when taken in conjunction with the previous phrase, means that the Department or a local health authority may ask a court of competent jurisdiction for a variety of relief. It may petition, as provided for in sections 7 and 11 of the act (35 P. S. §§ 521.7 and 521.11), for an order requiring examination, and, if necessary, treatment. It may prosecute the individual under section 20 of the act (35 P. S. § 521.20). It may petition the court for any appropriate remedy to allow it to enforce the requirements of the act, which require an individual taken into custody and charged with a crime involving lewd conduct or a sex offense, or any person to whom the jurisdiction of a juvenile court attaches, to be examined for a sexually transmitted disease. See 35 P. S. § 521.8. The Department will determine the appropriate remedy to pursue, if any, depending upon the case. Since the matter would be before a court, the individual against whom the petition is filed would have the opportunity to challenge the Department's requested relief. The relief granted will ultimately be up to the court.
Section 27.87. Refusal to submit to treatment for communicable diseases.
This section sets out the actions the Department may take if a person refuses to submit to treatment for a communicable disease. It is based on section 11 of the act.
Comment
The Department should revise the second sentence of subsection (b), as it is long and complex.
Response
The second sentence of subsection (b) reads as follows: ''Upon the filing of a petition, the court shall, within 24 hours after service of a copy upon the respondent, hold a hearing without a jury to ascertain whether the person named in the petition has refused to submit to treatment.'' The Department believes that this sentence is clear as it is written.
Comment
Subsection (b) states that the Department or a local health authority may file a petition in the court of common pleas of the county in which the person resides asking the court to commit the person to ''an appropriate institution.'' What is ''an appropriate institution?''
Response
The type of institution appropriate for quarantining an individual will depend upon the person, the type of disease in question, and the availability of places to which the person may be committed. For example, for one case of multidrug resistant tuberculosis, when the individual involved was known to have drug and alcohol problems, the Department recommended to the court that the individual be sent to a drug and alcohol abuse treatment facility. The Department could recommend that the individual be placed in a hospital, or the individual's home, or some other type of institution, depending upon the circumstances and the available resources. The Department, or a local health authority, may recommend a type of institution for commitment, however, the court must approve that placement. The individual does have the opportunity before that court to object to the Department's or local health authority's recommendation. A copy of the petition must be served on the individual who is the subject of the petition. See 35 P. S. § 521.11(a.2).
Section 27.89. Examinations for syphilis.
This section includes standards for examinations for syphilis. Subsection (a) requires testing in the third trimester of pregnancy when the woman resides in a county where the annual rate of infectious syphilis is at a rate of syphilis occurring in a given population for which the CDC has determined it is cost-effective to require special precautions. Subsections (b) and (c) require testing of a woman who has had a live or stillbirth under the same circumstances.
The Department has added language to subsection (a)(1) to clarify that it is the person attending the pregnant woman who is to explain the importance of the syphilis test, and not the laboratory technician seeking to draw her blood.
Comment
In subsections (a)--(c), the Department has stated that it will publish in the Pennsylvania Bulletin, as necessary, the rate of syphilis at which the CDC determines it is cost-effective to require special precautions. What is the purpose of publishing the rate of syphilis? What criteria will be used to determine when it is necessary to publish the rate of syphilis?
Response
The purpose of publishing this rate in the Pennsylvania Bulletin is to alert health care providers that a syphilis test is required to be done in their county based on the rates at which the CDC has determined that it is cost-effective to require special precautions. To make it easier for physicians, the Department has stated in the section that, rather than publishing the rate determined by the CDC, the Department will publish a list of the counties in which that rate occurs. Reporting is only required in those counties where the annual rate of infectious syphilis is equal to or greater than the rate determined by the CDC.
At the present time, only Philadelphia has a rate of syphilis above the CDC-established rate. Therefore, these specific requirements will only apply to Philadelphia at the present time. This standard enables the Department to broaden surveillance to prevent congenital syphilis in the event the established CDC rate is exceeded elsewhere.
Section 27.96. Diagnostic tests for sexually transmitted diseases.
This section sets standards for tests used to determine the presence of a sexually transmitted disease.
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