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PA Bulletin, Doc. No. 00-930a

[30 Pa.B. 2715]

[Continued from previous Web Page]

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

   The Department is proposing to apply the requirements of the regulations under this heading to children and staff in schools and child care group settings. Because staff are present along with the children, attempts to prevent and control the spread of diseases, conditions and infections in schools and child care group settings would not be effective if staff were allowed to attend while children with the same symptoms were not. The term ''staff'' is intended to include all individuals that may work in schools, including volunteers.

Section 27.71.  Exclusion of pupils and staff for specified diseases and infectious conditions.

   The Department proposes to amend this section to clarify that any case of a listed communicable disease should be excluded from attending school until the case is no longer infectious.

   The Department is also proposing to update the criteria for readmission and the period of exclusion for each listed disease. Further, the Department proposes to add specific criteria for readmission to schools and child care group settings for pupils and staff with ringworm and with tuberculosis. The criteria relating to tuberculosis are based on current medical practice and are consistent with the Department's Policy on Infectiousness of Tuberculosis Patients.

Section 27.72.  Exclusion of pupils and staff showing symptoms.

   The Department proposes to amend this section to include basic clinical symptom criteria to be used by school officials to determine whether or not a pupil or staff member should be excluded from attending school until a clinical diagnosis is made of his or her illness. The Department also proposes to require schools to maintain a record of each exclusion, and the reasons for that exclusion, and to then use the record to make a determination of when unusual rates of absenteeism occur. The Department proposes to publish periodically in the Pennsylvania Bulletin what constitutes an unusual rate of absenteeism.

Section 27.73.  Readmission of excluded pupils and staff.

Section 27.74.  Readmission of exposed or isolated pupils and staff.

Section 27.75.  Exclusion of pupils and staff during a measles outbreak.

   The Department proposes to amend these sections to make them applicable to staff in schools. Disease can be spread by the staff as well as by the children. The Department also proposes to add language in § 27.73(b) requiring a physician's determination that the illness is either resolved, noncommunicable or in a noncommunicable state, when the symptoms of the illness are rash with fever or behavioral change, or a productive cough with fever.

Section 27.76.  Exclusion and readmission of children and staff in child care group settings.

   This section would be new. It would apply the requirements in proposed §§ 27.71--27.75, which pertain to communicable diseases in children and staff attending schools, to child care group settings, except that the readmission of children and staff in child care group settings would be contingent upon a physician verifying that the criteria for readmission, set forth in the proposed section, have been satisfied. This section differs from proposed § 27.73 (relating to readmission of excluded pupils and staff), because it makes readmission contingent upon a physician, rather than a school nurse, being satisfied that the condition for which the person was excluded is not communicable.

   The Department proposes to include conditions and circumstances, in addition to those that would be set forth in § 27.71 (relating to exclusion of pupils and staff for specified diseases and infectious conditions), for which a child or staff person in a child care group setting shall be excluded. Readmission criteria are also proposed. The Department also proposes to require that the caregiver at the child care group setting provide for instruction of the staff regarding exclusion and screening criteria, and instruction of parents and guardians in exclusion criteria, and that they are to notify the caregiver within 24 hours after it is determined or suspected that a child has an illness or a condition for which exclusion is required. The caregiver would also be required to have staff screen the children each day, at the time the child is brought to the child care group setting, for the presence of conditions requiring exclusion. The Department considers it necessary to impose these requirements on child care group settings because child care group settings have a population highly susceptible to disease.

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

   This section would be new. It would set forth the responsibilities of a caregiver in a child care group setting with respect to ensuring compliance with immunization standards. The proposed section would authorize the caregiver not to accept or retain a child 2 months of age or older after specified time periods if the child had not received the appropriate immunizations, if the verifications specified in the section were not received by the caregiver, or if a religious objection to the requirements has not been raised in writing. The caregivers would be required to obtain immunization data from all enrolled children and maintain up-to-date immunization records on the children. The records would need to identify which children were properly immunized, which were under-immunized, and which were exempt from immunizations.

   The section would also provide an exemption from immunization requirements if the parents or guardian of the child were to object in writing. Further, if the setting is a kindergarten, elementary school or high school, the proposed regulations would not apply. The proposed regulations would also not apply if the child were known by the caregiver to be 6 years of age or older, or to attend a kindergarten, elementary school or high school. The requirements would also not apply in a child care group setting where the caregiver does not serve as a caregiver for at least 40 hours during at least 1 month. The requirements of subsection (a), pertaining to caregiver responsibilities, would not apply during a month the caregiver did not serve as a caregiver for at least 40 hours.

   This section would also require the immunization status of all children in child care group settings to be reported to the Department annually. The reporting of the immunization status of children would allow the Department to monitor compliance with immunization requirements. Reporting also would allow for onsite quality assurance reviews and prompt responses to reports of disease occurrence by the Department. The imposition of immunization requirements in school students has effectively eliminated large and extended disease outbreaks in schools. The Department has the same expectations for child care group settings if the provisions of this proposed section are followed and noncompliant enrollees are identified and excluded from child care group settings.

   Subsection (b) would also set forth the standards for immunization which children enrolled in a child care group setting would be required to meet. These standards are standards which were developed by the CDC's Advisory Committee on Immunization Practices (ACIP). Subsection (c) would provide for the Department to publish a notice containing a list of all publications containing ACIP recommendations issued under these standards.

   Lastly, the section would provide the Department or local health department with the ability to exclude an individual who is susceptible to a disease set forth in the regulation from a child care group setting when that disease is identified within such a setting, and from any child care group setting which is determined to be at high risk for the transmission of that disease. This, too, is intended to protect a particularly vulnerable part of the population from the spread of serious disease.

Subchapter D.  SEXUALLY TRANSMITTED DISEASES, TUBERCULOSIS AND OTHER COMMUNICABLE DISEASES

Section 27.81.  Examination of persons suspected of being infected.

Section 27.82.  Refusal to submit to examination.

Section 27.83.  Court ordered examinations.

   The Department proposes to make minor revisions to these sections. The revisions would more closely reflect the language of the sections of the act which deal with these issues, and changes the term, ''venereal disease,'' to ''sexually transmitted disease,'' as has already been discussed.

   Section 27.81 permits the Department or a local health authority to require a person which either suspects of having a sexually transmitted disease to undergo a medical examination. The Department proposes adding language which requires a local health authority which is not an LMRO to consult with and receive approval from it prior to taking action. This language would ensure that local health authorities with less experience than LMROs do not restrict a person's liberty without good cause.

Section 27.84.  Examination for sexually transmitted disease of persons detained by police authorities.

   The Department proposes to amend this section to clarify its authority and the authority of local health authorities under sections 7 and 8 of the act (35 P. S. §§ 521.7 and 521.8) (relating to examination and diagnosis of persons suspected of being infected with sexually transmitted disease, tuberculosis, or any other communicable disease, or of being a carrier and venereal disease). Under these sections, the Department and local health authorities have the authority to pursue a judicial action for enforcement if a person detained by police authorities, for certain purposes, refuses to permit an examination or to provide a specimen for a laboratory test for a sexually transmitted disease. The proposed amendments would add language to this section to clarify that fact.

Section 27.85.  Diagnosis and treatment of sexually transmitted disease.

   The Department proposes to make minor revisions to this section to delete references to the act, and to replace the term, ''venereal disease,'' with ''sexually transmitted disease.''

Section 27.86.  (Reserved).

   The Department proposes to delete this section, which prohibits the sale of remedies for the treatment of venereal disease, except under a physician's prescription. The provisions of the section are contained in section 10 of the act (35 P. S. § 521.10). Repetition in the regulations would serve no purpose. The Department is not the enforcing agency.

Section 27.87.  Refusal to submit to treatment for communicable diseases.

   The Department proposes to amend this section to clarify its authority under section 11 of the act (35 P. S. § 521.11) (relating to persons refusing to submit to treatment for sexually transmitted diseases, tuberculosis, or any other communicable disease) to order persons to complete therapy if they are infected with a communicable disease which may be significantly reduced in its communicability if that therapy is continued. This provision is of particular importance in cases of tuberculosis, which require that an individual complete the drug therapy to render the tuberculosis noncommunicable.

   The Department also proposes the addition of language which requires a local health authority which is not an LMRO to consult with the Department and receive Department approval before taking any action under this section.

Section 27.88.  Isolation and quarantine in appropriate institutions.

   The Department is proposing that this section be amended to remove references to jails. The Department proposes broadening the term to permit the Department to order isolation or quarantine in institutions where movement is restricted. This would permit the Department to place the individual in the type of institution which would best serve the individual's medical needs.

Section 27.89.  Examinations for syphilis.

   The provisions of 23 Pa.C.S. §§ 1101--1905 (relating to Marriage Law) pertaining to premarital syphilis testing were deleted in June of 1997. Accordingly, the Department proposes to delete the requirement for premarital syphilis testing from the regulations.

   The Department proposes to retain the syphilis prenatal testing requirements which are currently set forth in § 27.94. The Department proposes to update the syphilis prenatal testing requirements and to move them from § 27.94 to this section. The Department proposes deleting § 27.94 since it would no longer be necessary.

   Additionally, to encourage prompt testing, the Department proposes to clarify that the first examination following a diagnosed pregnancy includes the visit when the pregnancy test is first positive. Also, in an effort to prevent congenital syphilis, the Department proposes to add a third trimester syphilis test on pregnant women in counties where the incidence of infectious syphilis is at a rate of syphilis occurring in the population for which the CDC has determined it is cost-effective to institute special precautions. The current rate established by the CDC is any rate above 2.0 per 100,000 population. The Department proposes to publish changes to this rate in the Pennsylvania Bulletin as necessary. The proposed addition of a syphilis test of a newborn or a stillborn in counties where the rate is above the CDC established rate would help to identify newborns and mothers with syphilis who were not found through prenatal testing. Finally, the proposed language regarding both the timing of syphilis testing after delivery, and timing of medical record entries of tests for syphilis on the medical records of both the newborn and the mother, would help to prevent their discharge without review of the test results. This is important since the blood taken at birth is an indicator of the infection status of both mother and child. Because only Philadelphia has a rate of syphilis above the current CDC established rate, these specific requirements presently apply only to Philadelphia. However, the standard would enable the Department to broaden a surveillance network to prevent congenital syphilis elsewhere in the event the established CDC rate is exceeded elsewhere.

Section 27.90.  (Reserved).

Section 27.91.  (Reserved).

Section 27.92.  (Reserved).

Section 27.93.  (Reserved).

   The Department proposes to delete §§ 27.90--27.93. These sections basically repeat the statutory requirements specific to premarital syphilis testing, which were deleted in June of 1997.

Section 27.94.  Prenatal examination for syphilis.

   The Department proposes to delete this section as it is including provisions for prenatal examinations for syphilis in proposed § 27.89 (relating to an examinations for syphilis).

Section 27.95.  Reporting syphilis examination information for births and fetal deaths.

   The Department proposes to make changes to this section to reflect the changes made in § 27.89.

Section 27.96.  Diagnostic tests for sexually transmitted diseases.

   The Department is proposing minor editorial changes to this section. In subsection (a), the Department is also proposing to replace the reference to itself as the agency approving tests to be used in diagnosing sexually transmitted diseases with a reference to the Food and Drug Administration (FDA). The FDA is the appropriate agency to approve these tests. Subsection (b) would specify that an individual may contact the Division of Clinical Microbiology of the Department's Bureau of Laboratories to obtain a list of approved tests.

Section 27.97.  Treatment of minors.

   The Department proposes to amend this section to clarify section 14.1 of the act (35 P. S. § 521.14a) (relating to treatment of minors). The proposed language would permit a person under the age of 21, who has consented to diagnosis and treatment for a sexually transmitted disease, to undergo the diagnosis and treatment without the consent of his parents. A similar consent provision is included in section 3 of the act of February 13, 1970 (P. L. 19, No. 10) (35 P. S. § 10103), which permits a minor to give effective consent for medical and health services to determine the presence of or to treat reportable diseases under the act, including sexually transmitted diseases.

Section 27.98.  Prophylactic treatment of newborns.

   The Department proposes to delete tetracycline ophthalmic ointment or solution as a prophylactic treatment of newborns since it is no longer the standard prophylactic treatment. A silver nitrate solution or an erythromycin ophthalmic ointment or solution is the standard prophylactic treatment of newborns.

Section 27.99.  Prenatal examination for hepatitis B.

   This section would be new. To reduce the risk of hepatitis B virus (HBV) infection, the Department proposes adding this section to require physicians to test pregnant women for HBV at or before the time of delivery, and if the results are positive, to provide the appropriate prophylaxis treatment to the newborn within 12 hours after birth. This section would also contain language providing for a religious objection to the test. HBV infection is a major public health problem throughout the world. Children born to HBV infected mothers are at especially high risk. Approximately 22,000 infants are born to HBV-infected mothers each year in the United States. Infants born to positive mothers have a 70% to 90% chance of becoming HBV-infected perinatally, and 85% to 90% of infants infected with HBV become chronic carriers. HBV-related acute and chronic liver disease causes about 5,000 deaths each year.

Subchapter E.  SELECTED PROCEDURES FOR PREVENTING DISEASE TRANSMISSION

   Subchapter E of the regulations currently identifies the procedures for treating each reportable disease, many of which are outdated. Accordingly, the Department proposes deleting Subchapter E, which includes §§ 27.101--27.146, and replacing it with a new Subchapter E, which would contain state-of-the-art public health procedures which would best prevent disease transmission. These state-of-the-art public health procedures would be in proposed §§ 27.151--27.164. These sections would all be new sections.

Section 27.151.  Restrictions on the donation of blood, blood products, tissue, sperm and ova.

   The Department proposes prohibiting persons known to be infected with the causative agent of a reportable disease from donating blood, blood products, tissue, sperm or ova for use in other human beings. The Department also proposes language which would prohibit the receipt of blood, blood products, tissue, sperm or ova for donation without laboratory evidence showing the absence of hepatitis B, hepatitis C, HIV and other diseases and infections, which the Department may specify through notice in the Pennsylvania Bulletin. The Board would then have 90 days to approve the additions to the list. If the Board does not act within the 90-day period, the changes would expire. This would give the Department flexibility to add dangerous diseases and infections as they become known, and would help to prevent the transmission of reportable disease, infections and conditions through blood, blood products, tissue, sperm or ova.

Section 27.152.  Investigation of cases and outbreaks.

   The Department proposes adding a section to clarify the authority of the Department and local health authorities under sections 3 and 5 of the act (35 P. S. §§ 521.3 and 521.5) (relating to responsibilities and measures for disease prevention and control) to investigate any case or outbreak of disease judged by the Department or local health authority to be a potential threat to the public's health. Specifically, the proposed language would prohibit any person from interfering or obstructing an investigation by the Department or local health authority and would authorize the Department or local health authority to conduct a confidential review of medical records during the course of its investigation. This proposed language would ensure that the Department or local health authority is able to conduct a complete disease investigation.

Section 27.153.  Restrictions on food handlers.

Section 27.154.  Restrictions on child care group setting caregivers.

Section 27.155.  Restrictions on health care practitioners.

   The Department proposes in these sections to place restrictions on food handlers, child care group setting caregivers and health care practitioners with amebiasis, enterohemorrhagic E. coli, shigellosis, typhoid or paratyphoid fever, hepatitis A, viral hepatitis, or jaundice of an unspecified etiology, or diarrhea. The Department considers it necessary to place restrictions on these specific types of individuals because of their potential to spread a reportable disease, infection or condition to many people.

Section 27.156.  Special requirements for amebiasis.

Section 27.157.  Special requirements for enterohemorrhagic E. coli.

Section 27.158.  Special requirements for shigellosis.

Section 27.159.  Special requirements for typhoid and paratyphoid fever.

   The Department proposes in these sections to restrict household contacts of laboratory confirmed cases of amebiasis, enterohemorrhagic E. coli, and shigellosis, from working as food handlers, from attending or working in child care group settings, or from providing direct patient care, until the required laboratory tests for these diseases are confirmed negative. The Department proposes placing similar requirements on both symptomatic and asymptomatic contacts of typhoid or paratyphoid fever. Chronic carriers of typhoid or paratyphoid fever would also be excluded from these activities until laboratory tests are confirmed negative. The Department proposes these special requirements because these diseases are easily communicable by food handlers, persons working in or attending child care group settings and persons providing direct patient care.

Section 27.160.  Special requirements for measles.

   An effective way to reduce secondary cases of measles is to identify cases early, define the zone of risk, identify the susceptible individuals, and exclude the susceptible individuals from the setting. Accordingly, the Department proposes setting forth special procedures that are to be followed during a measles outbreak in a child care group setting and which would minimize person-to-person exposure. These procedures are recommended by both the ACIP and the CDC. The procedures also would be consistent with measle outbreak procedures in other types of settings.

Section 27.161.  Special requirements for tuberculosis.

   The Department proposes adding this section to set forth the appropriate isolation requirements for persons infected with tuberculosis and their close contacts. The procedures would include requiring close contacts to have a Mantoux tuberculin skin test or chest X-ray, or both. These requirements are based on current medical practice. This proposed section would replace § 27.142, which pertains to tuberculosis, and which the Department is proposing to delete.

Section 27.162.  Special requirements for animal bites.

   The Department proposes adding this section to set forth the procedures for addressing animal bites to humans, including the quarantine and euthanasia of the animal and subsequent laboratory testing of brain tissue. The Department considers these special requirements necessary to ensure that the Department is able to conduct a complete investigation to determine whether or not the animal is infected with rabies, and to spare persons who have been bitten from undergoing costly and painful treatment that may prove to be unnecessary.

Section 27.163.  Special requirements for psittacosis.

   The Department proposes to require that Chlamydia psittaci contaminated buildings be appropriately decontaminated prior to either reoccupancy or reuse. The Department proposes adding this section to respond to the public health need to decontaminate buildings of Chlamydia psittaci, a need that is currently unaddressed.

Section 27.164.  Special requirements for close contacts of cases of plague, pharyngitis or pneumonia.

   The Department proposes to require close contacts of cases of plague, pharyngitis and pneumonia to take certain precautions to prevent the spread of these diseases.

Subchapter G.  MISCELLANEOUS PROVISIONS

IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS

Section 27.191.  Importation of animals and animal products during a public health emergency.

   The current regulations authorize the Department to place restrictions on the importation of rabbits, hares or rodents during a public health emergency. Since disease may be spread by animals other than rabbits, hares and rodents, the Department proposes replacing all references to ''rabbits, hares or rodents'' in this section with ''animals and animal products.'' Because animals and animal products frequently serve as vehicles for disease, the Department's authority to place restrictions on these items is important for its disease prevention and control function.

DISPOSITION OF EFFECTS AND REMAINS OF INFECTED PERSONS

Section 27.203.  Preparation for burial or transportation of deceased human bodies.

   The Department is proposing to delete and replace the provisions of this section with a general statement requiring that appropriate precautions be taken. These precautions will change as accepted practice standards change.

Section 27.205.  (Reserved).

   The Department proposes to delete this section, which pertains to standards for transferring the body of a person who has died of certain diseases. The Department finds this section to be unnecessary.

C.  Who is Affected by the Proposed Amendments

   The proposed amendments will impact on health care providers, health care practitioners, clinical laboratories, health care facilities and child care group settings in this Commonwealth. They will be required to comply with the updated disease reporting procedures, which are not significantly different from current reporting requirements. Additionally, every citizen in this Commonwealth will be affected by the proposed amendments, as each will benefit from a reduced risk of exposure to, and resulting morbidity and mortality from infection with the more than 47 reportable disease, infections and conditions.

D.  Cost and Paperwork Estimates

   The proposed amendments will have no measurable fiscal impact on this Commonwealth, local government, the private sector or the general public because the disease reporting system already exists in this Commonwealth. In fact, the application of Nationally accepted state-of-the-art public health practices and communicable disease prevention and control strategies within this Commonwealth should create savings in related health care costs each year. The regulated community and local governments will see a benefit directly proportional to the numbers and types of disease cases prevented, thereby reducing community health care costs. This Commonwealth will also benefit in an amount directly proportional to the numbers and types of disease cases and disease outbreaks prevented, thereby greatly reducing State government health care costs.

   The proposed amendments are essentially a fine-tuning of an already existing disease reporting system in this Commonwealth and will not result in additional paperwork. Newly listed reportable diseases, infections and conditions will be reported and investigated in a similar manner to currently listed diseases, infections and conditions using national case-definitions and investigation forms provided by the CDC.

E.  Statutory Authority

   The Department's overarching authority to promulgate these regulations is found in the act. Section 16(a) of the act (35 P. S. § 521.16(a)), gives the Board the authority to issue rules and regulations on a variety of issues relating to communicable and noncommunicable diseases, including the following: which diseases are to be reported; the methods of reporting diseases; the contents of reports and the health authorities to whom diseases are to be reported; 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; requirements for the prevention and control of disease in public and private schools; requirements for the treatment of venereal disease, including patient counseling; and any other matters the Board may deem advisable for the prevention and control of disease and for carrying out the provisions and purposes 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.

   There is also Legislative authority for specific provisions of the proposed regulations in other statutes. The Administrative Code of 1929 (71 P. S. §§ 51--720.13) (code), contains several pertinent provisions. First, section 2102(g) of the code (71 P. S. § 532(g)), provides general authority for the Department to promulgate its regulations.

   Section 2106(a) of the code (71 P. S. § 536(a)), provides the Department with additional authority to declare diseases to be communicable, and to establish regulations for the prevention and control of disease. Section 2106(b) of the code provides the Department with the authority to establish and enforce quarantines to prevent the spread of disease, and section 2106(c) of the code gives the Department the authority to administer and enforce the laws of this Commonwealth with respect to vaccination and other means of preventing the spread of communicable disease.

   Section 2111(b) of the code (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. That section further provides that the regulations of the Board shall become the regulations of the Department.

   Section 2111(c.1) of the code, also 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 any public, private, or parochial school, including kindergarten. The section requires the Secretary to promulgate the list, along with any rules and regulations necessary to insure the immunizations are timely, effective and properly verified. The regulations that primarily carry out this responsibility are in Chapter 23, Subchapter C (relating to immunizations).

   Other statutes speak to the Department's authority to promulgate regulations in relation to specific diseases, infections or conditions. The Newborn Child Testing Act (35 P. S. §§ 621--625), provides the Department with the authority to promulgate regulations listing reportable diseases and conditions in the newborn child, and setting out the operation of a program of screening, follow-up, assessment and diagnosis of newborn children for these reportable diseases and conditions. See section 3 and 5 of the Newborn Child Testing Act (35 P. S. §§ 623 and 625). The Pennsylvania Cancer Control, Prevention, and Research Act (35 P. S. §§ 5631--5637), authorizes the Department to create a cancer registry to which persons in charge of hospitals and laboratories must report cases of cancer in accordance with rules and regulations adopted by the Department with the advice of the Pennsylvania Cancer Control, Prevention and Research Advisory Board. See section 6(b) of the Pennsylvania Cancer Control, Prevention and Research Act (35 P. S. § 5636(b)). This Legislation has been impacted by Federal legislation which was enacted in 1992, and which requires complete reporting of cancer cases to be made by all health care practitioners, and all hospitals or other facilities providing screening, diagnostic or therapeutic services to patients with respect to cancer. See 42 U.S.C.A. §§ 280e and 280e-1--280e-4). Finally, what is known as the ''Turtle Law'' the act of March 3, 1972 (P. L. 102, No. 37) (35 P. S. §§ 1071--1077), provides the Department with the authority to prohibit a person from bringing, causing to be brought, or transporting any live turtle into this Commonwealth, unless the turtle or lot of turtles is accompanied by a permit issued by the Department or another agency authorized by the Department to issue a permit. The permit may only be issued if there is adequate biological proof that the turtles are free from salmonella. The same permit is required when the turtles originate within this Commonwealth.

   Several statutes provide the Department with authority to command disease prevention and control measures within certain institutions. Section 803 of the Health Care Facilities Act (35 P. S. § 448.803), provides the Department with the authority to promulgate regulations relating to the licensure of health care facilities, and allows the Department to require certain actions relating to disease control and prevention to occur within health care facilities. Articles IX and X of the Public Welfare Code (62 P. S. §§ 901--922 and 1001--1059), which provide the Department with the authority to license inpatient drug and alcohol abuse treatment facilities, play the same role with respect to the Department's ability to require certain disease prevention and control methods in those facilities.

   The Public School Code of 1949 (24 P. S. §§ 1-101--26-2606-B) provides the Department with additional authority for disease prevention and control actions taken within schools. Section 1421(c)(2) of the Public School Code of 1949 (24 P. S. § 14-1421(c)(2)), provides the Secretary of the Department, in consultation with the Secretary of the Department of Education, with the authority to promulgate rules and regulations implementing the school health program. The requirements of the school health program are in Article XIV of the Public School Code of 1949 (24 P. S. §§ 14-1401--14-1422), and provide, among other things, that pupils are released from compulsory attendance when they are prevented from attending by the health laws of this Commonwealth, section 1417 of the Public School Code of 1949 (24 P. S. § 14-1417), that no persons having any form of tuberculosis in a transmissible stage shall be a pupil, teacher, janitor or another employe in a school, unless it is a special school. See section 1418 of the Public School Code of 1949 (24 P. S. § 14-1418). Section 1303a of the Public School Code of 1949 (24 P. S. § 13-1303a), provides that the Board will make and review a list of diseases against which children must be immunized, as the Secretary of the Department 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 a public, private, parochial or other school including kindergarten, must ascertain whether the immunization has occurred, and certificates of immunization will be issued in accordance with rules and regulations promulgated by the Secretary of the Department with the sanction and advice of the Board. Again, most of the regulations carrying out these responsibilities are in Chapter 23 (relating to school health).

F.  Effective/Sunset Dates

   The proposed amendments will become effective upon final publication in the Pennsylvania Bulletin. No sunset date has been established. The Department will continually review and monitor the effectiveness of these regulations.

G.  Regulatory Review

   Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on May 17, 2000, the Department submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.

   Under section 5(g) of the Regulatory Review Act, if IRRC has objections to any portion of the proposed amendments, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by that portion of the proposed amendments to which an objection is made. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the amendments by the Department, the General Assembly and the Governor of objections raised.

H.  Contact Person

   Interested persons are invited to submit written comments, suggestions or objections regarding the proposed amendments within 30 days following publication to James T. Rankin, Jr., D.V.M., M.P.H., Ph.D., Director, Division of Communicable Disease Epidemiology, Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 783-3350, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding the proposed amendments may do so by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984[TT]. Persons who require an alternative format of this document may contact Dr. James Rankin so that necessary arrangements may be made.

ROBERT S. ZIMMERMAN, Jr.,   
Secretary

   Fiscal Note:  10-156. No fiscal impact; (8) recommends adoption.

Annex A

TITLE 28.  HEALTH AND SAFETY

PART III.  PREVENTION OF DISEASES

CHAPTER 27.  COMMUNICABLE AND NONCOMMUNICABLE DISEASES

Subchapter A.  GENERAL PROVISIONS

§ 27.1.  Definitions.

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

   ACIP--The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, United States Department of Health and Human Services.

*      *      *      *      *

   Caregiver--The entity or individual responsible for the safe and healthful care or education of a child in a child care group setting.

*      *      *      *      *

   Case--A person or animal that is determined to have or suspected of having a disease, infection or condition.

   Case report form--The form designated by the Department for reporting a case or a carrier.

   Central office--Department headquarters located in Harrisburg.

   Child--A person 15 years of age or younger.

   Child care group setting--The premises in which care is provided at any one time to four or more children, unrelated to the operator.

   Clinical laboratory--A laboratory for which a permit has been issued to operate as a clinical laboratory under The Clinical Laboratory Act (35 P. S. §§ 2151--2165).

   Communicable disease--An illness [due to an infectious agent or its toxic products which is transmitted, directly or indirectly, to a susceptible host from] which is capable of being spread to a susceptible host through the direct or indirect transmission of an infectious agent or its toxic product by an infected person, animal or arthropod, [or through the agency of an intermediate host, or a vector] or through the inanimate environment.

   Communicable period--The time during which [the] an etiologic agent may be transferred directly or indirectly from an infected person to another person, or from an infected animal to a person.

   Contact--A person or animal known to have [been in] had an association with an infected person or animal [as to have had an opportunity of] which presented an opportunity for acquiring the infection.

   [County morbidity reporting area--A county so designated by the Board wherein initial reports for communicable and noncommunicable diseases are to be reported to the State health center of the Department.]

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   District office--One of the district headquarters of the Department located within this Commonwealth of Pennsylvania.

   Health care facility--

   (i)  A facility providing clinically related health services, including a general, chronic disease, or other type of hospital, a home health care agency, a long-term care nursing facility, a cancer treatment center using radiation therapy on an ambulatory basis, an ambulatory surgical facility, a birth center, and an inpatient drug and alcohol treatment facility, regardless of whether the health care facility is operated for profit, nonprofit or by an agency of the Commonwealth or local government.

   (ii)  The term does not include:

   (A)  An office used primarily for the private practice of a health care practitioner where no clinically related health service is offered.

   (B)  A facility providing treatment solely on the basis of prayer or spiritual means in accordance with the tenets of any church or religious denomination.

   (C)  A facility conducted by a religious organization for the purpose of providing health care services exclusively to clergy or other persons in a religious profession who are members of a religious denomination.

   Health care practitioner--An individual who is authorized to practice some component of the healing arts by a license, permit, certificate or registration issued by a Commonwealth licensing agency or board.

   Health care provider--An individual, a trust or estate, a partnership, a corporation (including associations, joint stock companies and insurance companies), the Commonwealth, or a political subdivision, or instrumentality (including a municipal corporation or authority) thereof, that operates a health care facility.

   Infectious agent--An organism, such as a virus, bacterium, fungus or parasite, that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease.

   Isolation--The separation for the [period of communicability] communicable period of an infected [persons] person or [animals] animal from other persons or animals, in [places and under conditions that prevents] such a manner as to prevent the direct or indirect transmission of the infectious agent from infected persons or animals to other persons or animals who are susceptible or who may spread the disease to others.

   LMRO--Local morbidity reporting office--An office designated by the Department to receive initial case reports on a local basis, including the primary office of a local health department, any other local health authority designated by the Department as an LMRO, and a State health center in the absence of a local health department.

   [Local board--The board of health or the department of public health of a municipality of the first class, a county department of health or a joint county or joint municipal department of health.]

   Local health authority--[The appropriate local health officer, local board or district director of the area] A county or municipal department of health, or board of health of a municipality that does not have a department of health. The term does not include a sanitary board.

   Local health department--Each county department of health under the Local Health Administration Law (16 P. S. §§ 12001--12028), and each department of health in a municipality approved for a Commonwealth grant to provide local health services under section 25 of the Local Health Administration Law (16 P. S. § 12025). The Department will maintain a list of local health departments and revise the list when new local health departments are established.

   Local health officer--[The head of a local board] The person appointed by a local health authority to head the daily administration of duties imposed upon or permitted of local health authorities by State laws and regulations.

   Medical record--An account compiled by physicians and other health professionals including a patient's medical history; present illness; findings on physical examination; details of treatment; reports of diagnostic tests; findings and conclusions from special examinations; findings and diagnoses of consultants; diagnoses of the responsible physician; notes on treatment, including medication, surgical operations, radiation, and physical therapy; and progress notes by physicians, nurses and other health professionals.

   Modified quarantine--A selected, partial limitation of freedom of movement determined on the basis of differences in susceptibility or danger of disease transmission which is designated to meet particular situations. The term includes the exclusion of children from school and the prohibition, or the restriction, of those exposed to a communicable disease from engaging in particular activities.

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   Operator--The legal entity that operates a child care group setting or a person designated by the legal entity to serve as the primary staff person at a child care group setting.

   Outbreak--An unusual increase in the number of cases of a disease, infection or condition, whether reportable or not as a single case, above the number of cases that a person required to report would expect to see in a particular geographic area or among a subset of persons (defined by a specific demographic or other features).

   Physician--An individual licensed to practice medicine or osteopathic medicine within this Commonwealth.

   Placarding--The posting on a home or other building of a sign or notice warning of the presence of communicable disease within the structure and the danger of infection therefrom.

   Quarantine--The limitation of freedom of movement of [persons] a person or [animals who have] an animal that has been exposed to a communicable disease, for a period of time equal to the longest usual incubation period of the disease, or until judged noninfectious by a physician, in [such] a manner [as] designed to prevent [effective contact with those not exposed] the direct or indirect transmission of the infectious agent from the infected person or animal to other persons or animals. The term does not exclude the movement of a person or animal from one location to another when approved by the Department or a local health authority under § 27.67 (relating to the movement of persons and animals subject to isolation or quarantine by action of a local health authority or the Department). [A quarantine may be complete or one of the following types:

   (i)  Segregation--The separation for special control or observation of one or more persons or animals from other persons or animals to facilitate the control of a communicable disease.

   (ii)  Modified quarantine--A selected, partial limitation of freedom of movement determined on the basis of differences in susceptibility or danger of disease transmission which is designed to meet particular situations. Modified quarantine includes, but is not limited to, the exclusion of children from school and the prohibition, or the restriction, of those exposed to a communicable disease from engaging in particular occupations.

   (iii)  Surveillance--The close supervision of persons and animals exposed to a communicable disease without restricting their movement.

   Regulation--A rule or regulation issued by the Board or an ordinance, rule or regulation enacted or issued by a local board.]

   Reportable disease, infection or condition--A [communicable ] disease, [declared] infection or condition, made reportable by [regulation; an unusual or group expression of illness which, in the opinion of the Department, may be a public health emergency; noncommunicable diseases and conditions for which the Department may authorize reporting to provide data and information which, in the opinion of the Board, are needed in order to effectively carry out those programs of the Department designed to protect and promote the health of the people of this Commonwealth, or to determine the need for the establishment of the programs.] § 27.2 (relating to specific identified reportable diseases, infections and conditions).

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   Segregation--The separation for special control or observation of one or more persons or animals from other persons or animals to facilitate the control of a communicable disease.

   Sexually transmitted disease--A disease which, except when transmitted perinatally, is transmitted almost exclusively through sexual contact.

   State health center (SHC)--The official headquarters of the Department in [each] a county, other than [those organized as county departments of health] a district office.

   Surveillance of contacts--The close supervision of persons and animals exposed to a communicable disease without restricting their movement.

   Surveillance of disease--The continuing scrutiny of all aspects of occurrence and spread of disease that are pertinent to effective control.

§ 27.2.  [Reportable] Specific identified reportable diseases, infections and conditions.

   [The Board declares the following communicable diseases, unusual outbreaks of illness, noncommunicable diseases and conditions to be reportable:

AIDS (Acquired Immune Deficiency Syndrome).
Amebiasis.
Animal bite.
Anthrax.
Botulism.
Brucellosis.
Campylobacteriosis.
Cancer.
Chlamydia trachomatis infections.
Cholera.
Diphtheria.
Encephalitis.
Food poisoning.
Giardiasis.
Gonococcal infections.
Guillain-Barre syndrome.
Haemophilus influenzae type b disease.
Hepatitis non-A non-B.
Hepatitis, viral, including Type A and Type B.
Histoplasmosis.
Kawasaki disease.
Legionnaires' disease.
Leptospirosis.
Lyme disease.
Lymphogranuloma venereum.
Malaria.
Measles.
Meningitis--all types.
Meningococcal disease.
Mumps.
Pertussis (whooping cough).
Plague.
Poliomyelitis.
Psittacosis (Ornithosis).
Rabies.
Reye's syndrome.
Rickettsial diseases including Rocky Mountain
   Spotted Fever.
Rubella (German Measles) and congenital rubella
   syndrome.
Salmonellosis.
Shigellosis.
Syphilis--all stages.
Tetanus.
Toxic shock syndrome.
Toxoplasmosis.
Trichinosis.
Tuberculosis--all forms.
Tularemia.
Typhoid.
Yellow Fever.]

   The diseases, infections and conditions set out in Subchapter B (relating to the reporting of diseases, infections and conditions) are reportable to the Department or the appropriate local health authority by the persons or entities in the manner and within the time frames set out in this chapter.

§ 27.3.  [Unusual or ill-defined diseases, illnesses or outbreaks] Reporting outbreaks and unusual diseases, infections and conditions.

   [The occurrence of outbreaks or clusters of an illness which may be of public concern, whether or not it is known to be communicable in nature, shall be reported to the local health officer of the municipality in which it occurs. In areas which have no local health officer, reports shall be made to the representative of the Secretary.]

   (a)  A person required to report under this chapter shall report an outbreak within 24 hours, and in accordance with the requirements of § 27.4 (relating to reporting cases).

   (b)  A person required to report under this chapter who suspects a public health emergency, shall report an unusual occurrence of a disease, infection, or condition not listed as reportable in Subchapter B (relating to reporting of diseases, infections and conditions) or defined as an outbreak, within 24 hours, and in accordance with the requirements of § 27.4.

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