PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CH. 27]
Reporting of Communicable and Noncommunicable Diseases
[30 Pa.B. 2715] The Department of Health (Department), with the approval of the State Advisory Health Board (Board), proposes to amend Chapter 27 (relating to communicable and noncommunicable diseases). The proposed amendments are to read as set forth in Annex A.
A. Purpose of the Proposed Amendments
Most of the regulations in Chapter 27 were originally promulgated in 1959. Since that time, there have been dramatic changes in society, technology and the environment which necessitate a review and revision of these regulations. Where once outbreaks of disease could be held within geographical boundaries, today, the speed of air travel and the global economy are fostering the worldwide spread of life-threatening pathogens. Persons infected in one place can be on the other side of the world by the time symptoms appear. New infectious agents are emerging which require new prevention and control techniques. New conditions are becoming recognized which benefit from early detection and treatment. Disease outbreaks continue to occur, antibiotic resistance of some diseases is spreading, and previously controlled agents are in resurgence. Although more exotic diseases like Group A streptococcus (flesh eating bacteria), the hantavirus and the ebola virus receive most of the attention from the media, other infectious diseases continue to pose public health problems. For example, there have been recent outbreaks of cryptosporidiosis, E. coli 0157:H7, Salmonella enteritidis, hepatitis A and shigellosis. There are strains of multidrug resistant tuberculosis, which reduces the ability to treat the disease, and there have been recent reports from Japan of evidence of resistance of Staphylococcus aureus to the drug, Vancomycin, long considered the last line of defense. This Commonwealth is not immune from these public health threats. A few examples of threats to the public health within this Commonwealth over the past few years include a 1996-1997 outbreak of cyclospora caused by Guatemalan raspberries, ongoing Salmonella enteritidis outbreaks caused by, among other things, infected eggs; rabies outbreaks from 1991 to the present; a shigellosis outbreak in 1996, spread from Ohio to this Commonwealth; multidrug resistance to tuberculosis; and the ongoing epidemic of Lyme disease. The Department has chosen to revise the regulations to ensure that the disease control and prevention needs of changing diseases and conditions and current health care priorities are adequately addressed.
B. Requirements of the Proposed Amendments
CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES The Department proposes to delete from its regulations all unnecessary clinical references; superseded public health methods and practices; currently reportable diseases and conditions which, in its opinion, no longer need to be reported; and outdated scientific or technical references and information. In the place of the deleted material, the Department is proposing to add state-of-the-art public health practices and methods; new reportable diseases, infections and conditions that the Department, with the approval of the Board, considers necessary to protect the public health of this Commonwealth; and current scientific or technical information and references. The following is a discussion of the major amendments, additions and deletions that are being proposed.
Subchapter A. General Provisions
Subchapter B. Reporting of Diseases, Infections and Conditions.
The current regulations contain several lists of reportable diseases and conditions in two different subchapters. Section 27.2 (relating to reportable diseases) in Subchapter A contains a list of reportable diseases. This list is not exclusive, however. It is supplemented by separate sections in both Subchapter A, and in Subchapter B. For example, § 27.4 (relating to noncommunicable diseases and conditions) in Subchapter A sets out specific reporting requirements for lead. Section 27.22 (relating to reporting laboratory results indicative of certain infections or conditions) in Subchapter B contains a separate list of diseases reportable solely by laboratories.
The Department is proposing to include all the specific reporting requirements in Subchapter B, which it is proposing to retitle, ''Reporting of Diseases, Infections and Conditions.'' In that subchapter, the Department proposes to break up the listings of reportable diseases, infections and conditions by the individuals and entities which are to report them, and proposes to include specific time frames within which these diseases, infections and conditions are to be reported. The Department is proposing to include in Subchapter A only general provisions relating to reporting.
Subchapter A. GENERAL PROVISIONS Section 27.1. Definitions.
Several terms used in the current regulations are outdated or inadequately defined. The Department proposes to replace outdated terms with language that reflects state-of-the-art public health practices and methods, add new terms used by public health professionals, and clarify existing definitions of terms.
The Department proposes adding the terms ''ACIP,'' ''caregiver,'' ''case,'' ''case report form,'' ''central office,'' ''child,'' ''clinical laboratory,'' ''district office,'' ''health care facility,'' ''health care practitioner,'' ''health care provider,'' ''infectious agent,'' ''local health department,'' ''medical record,'' ''modified quarantine,'' ''physician'' and ''segregation'' to further clarify the regulations. The definitions of these terms are self-explanatory.
Additionally, the Department proposes adding a definition of the term ''child care group setting'' to further clarify proposed §§ 27.76 and 27.77 (relating to exclusion and readmission of children and staff in child care group settings; and immunization requirements for children in child care group settings). The Department also proposes adding a definition of the term ''operator'' to further clarify the definition of ''child care group setting.''
The Department also proposes to add a definition of the term ''local morbidity reporting office (LMRO)'' to further clarify proposed §§ 27.41a, 27.42a and 27.43a (relating to reporting by local morbidity offices). The proposed definition describes the various types of offices that may be designated by the Department to receive case reports on a local basis. The Department is also proposing revisions to the existing definitions of ''local health officer'' and ''local health authority'' to clarify the differences between a local health authority and a local health department, and to more fully explain what the responsibilities of a local health officer are. These clarifications are important to an understanding of the reporting requirements, and of the disease prevention and control responsibilities of these entities.
Also, the Department proposes adding a definition of the term ''outbreak'' since the regulations set forth special reporting and investigative procedures for outbreaks. By defining the term, any possible confusion with respect to what is considered to be an outbreak would be eliminated, which would allow the Department to more quickly investigate outbreaks and implement the appropriate intervention strategies.
Further, the Department proposes to expand the term ''surveillance'' by including two definitions, ''surveillance of contacts'' and ''surveillance of disease,'' in these regulations. This would assist the Department to explain requirements for the continuing scrutiny of all aspects of occurrence and spread of disease that are pertinent to effective control of diseases. Communicable diseases may spread by means other than through persons and animals exposed to those communicable diseases. Therefore, it is important that the Department be able to supervise all aspects of the occurrence and spread of disease; not just supervise those individuals or animals exposed to the disease.
Finally, the Department proposes to replace the term ''venereal disease,'' which is an outdated term, with the more modern term ''sexually transmitted disease.'' The definition of ''sexually transmitted disease'' is broader than the current definition of ''venereal disease,'' which only includes five diseases. The proposed definition includes chlamydia trachomatis infections as well as the five diseases which have been covered by the term ''venereal disease,'' and would allow for the future addition of diseases by the Department.
Section 27.2. Specific identified reportable diseases, infections and conditions.
The Department is proposing to delete the specific listing of reportable diseases and conditions currently included in this section, and to include this listing with some additions and deletions, in proposed § 27.21a (relating to reporting of cases by health care practitioners and health care facilities). Proposed § 27.21a is included in proposed Subchapter B, which will contain all specific reporting requirements. Proposed § 27.2 would contain a general requirement that specified diseases, conditions and infections be reported to the Department or other appropriate entity within the time frames and in the manner required by the proposed regulations, in keeping with the Department's proposal to include in proposed Subchapter A all general provisions relating to reporting.
Section 27.3. Reporting outbreaks and unusual diseases, infections and conditions.
The Department proposes to amend this section to clarify the reporting time frames for outbreaks and incidents of unusual diseases, infections and conditions, including those not specifically reportable under Subchapter B, but which, nonetheless, pose a potential public health threat. This would allow the Department to more quickly investigate these situations and implement the appropriate intervention strategies.
Section 27.4. Reporting cases.
The Department proposes to rewrite this section to give the general rule on where case reports would be made. Under this general rule, case reports would be made to the local morbidity reporting office (LMRO) where the case resides, unless the residence of the case is unknown, another provision of the chapter were to direct otherwise, or the reporter were a clinical laboratory. Clinical laboratories would report to the appropriate office of the Department unless otherwise directed in the proposed rulemaking.
Subsection (b) would provide a comprehensive list of Department offices to which the proposed regulations require certain specific case reports to be made. The Department proposes to include this list for the ease of reference of the persons who would be utilizing the proposed regulations.
The Department proposes to delete current subsection (a), which requires reports of diseases and conditions to be made to those places where the Secretary can then most effectively determine and employ efficient and practical means to protect and promote the health of the residents of this Commonwealth, but which does not identify those places. The Department proposes to specifically set out where diseases and conditions are to be reported, including noncommunicable diseases and conditions, and to detail what information is to be included in those reports. See proposed §§ 27.21a, 27.22, 27.30, 27.31, 27.33 and 27.34.
Subsection (b), which discusses the reporting of lead cases, would also be redundant once the proposed regulations become final. The provisions of this subsection would be included in other portions of the proposed regulations, specifically in proposed §§ 27.22 and 27.34 (relating to reporting of cases by clinical laboratories; and reporting cases of lead poisoning).
Section 27.5. (Reserved).
The Department proposes to delete this section, which currently pertains to the Cancer Registry. The Department proposes to address that subject matter in § 27.31 (relating to reporting cases of cancer). This would locate all of the cancer reporting requirements in two sections of the proposed regulations, §§ 27.21a and 27.31.
Section 27.5a. Confidentiality of case reports.
This section would be new. This section would further clarify the confidentiality requirements for case reports set forth in section 15 of the Disease Prevention and Control Law of 1955 (act) (35 P. S. § 521.15) (relating to confidentiality of reports and records).
Section 27.6. Disciplinary consequences for violating reporting responsibilities.
This section would be new. In the past, the Department has been unable to conduct some disease investigations and implement the appropriate intervention strategies because certain entities and individuals have failed to report diseases, infections or conditions to the Department. To encourage compliance with the reporting requirements under this chapter, the Department proposes to add a section to inform laboratories, health care facilities and health care practitioners that violations of their reporting requirements may result in disciplinary consequences under their respective licensing statutes.
Section 27.7. Cooperation between clinical laboratories and persons who order laboratory tests.
This section would be new. The Department proposes adding this section to impress upon clinical laboratories and persons ordering laboratory tests the necessity of providing all demographic and other information the Department is requesting on the reporting form, whether the clinical laboratory is required to report electronically, or on paper. In the past, the Department has had great difficulty obtaining the necessary information from persons, including clinical laboratories. Recognizing that, at times, the individual requesting the test from the laboratory has failed to obtain all requested information from the subject, thus making it impossible for the laboratory to completely report to the Department, the Department proposes to require the laboratory to provide the necessary form to the individual requesting the test, and require the individual requesting the test to provide all information requested on that form. Failure to comply with these requirements could result in a recommendation for disciplinary action either against the laboratory or the individual requesting the test. See proposed § 27.6 (relating to disciplinary consequences for violating reporting responsibilities).
Section 27.8. Criminal penalties for violating the act or this chapter.
This section would be new. It would reiterate the language in sections 19 and 20 of the act (35 P. S. §§ 521.19 and 521.20) which provide for the imposition of criminal penalties and fines on persons who violate the act or regulations promulgated thereunder. The Department proposes to include the criminal penalties and fines in this regulation to emphasize the importance of complying with the requirements of this chapter.
Section 27.9. Authorized departures from the regulations.
This section would be new. It would allow the Department to authorize an exception to any regulation in this chapter if the requirement of the regulation is not also a statutory requirement. An exception would be permitted if the regulatory standard would become outdated due to medical or public health developments, and if the exception would be determined by the Department to be necessary to protect the health of the people of this Commonwealth. For the exception to remain in effect, it would then need to be approved by the Board within a 90-day period. If the Board were to fail to approve the exception within this time period, the exception would expire. This proposed section is intended to allow the Department the flexibility to meet changing public health needs.
Subchapter B. REPORTING OF DISEASES, INFECTIONS AND CONDITIONS Early in 1994, the Department assembled an expert committee comprised of Department staff from each of the Department's program areas to review and revise these regulations. The committee met a total of 14 times over a 2-year period and determined which diseases and conditions should be modified, deleted or added to the list of reportable diseases and conditions. The committee's proposed changes to the list of reportable diseases are described in the following. The Department is also proposing to use more accurate terminology for what is reportable. Therefore, although infections and conditions must currently be reported to the Department, the Department is proposing to add these words to the title of Subchapter B to more accurately describe the scope of reporting required by the act and the proposed regulations.
In reviewing the structure of the regulations, the Department also decided that it would propose doing away with a general list of reportable diseases and conditions, and specify in each relevant section which diseases, conditions and infections are to be reported by the entities identified in the section.
GENERAL Section 27.21. Reporting of AIDS cases by physicians.
The Department is proposing to move the current requirements of this section to other, more relevant sections. The Department is proposing to add a separate section setting forth reporting requirements of all health care practitioners, including physicians. This proposed section, § 27.21a, would include in its provisions the current requirement that when a physician treats or examines a person suffering from, or who the physician suspects of having, a reportable disease, the physician is to make a report of that disease or condition. The Department is not proposing to include, in the relevant provisions of § 27.21a, language which requires a physician to report when a person the physician treats is suspected of being a carrier or when the person is affected asymptomatically. The current provisions of § 27.21 which include the manner in which reports are to be made, and to what place, would be included in § 27.4 which would set out how cases are to be reported. The current provisions which discuss how venereal diseases are to be reported would be included in § 27.33 (relating to reporting cases of sexually transmitted disease). Lastly, because of changes in Federal law, physicians will now be required to report cases of cancer, and those requirements would be set out in § 27.31.
Reporting cases of AIDS is a reporting responsibility which would fall solely upon the physician under these proposed regulations. The current regulations require reporting of AIDS by hospitals and physicians. The Department is proposing adding language to this section which would require physicians to report cases of AIDS within 5 work days.
Section 27.21a. Reporting of cases by health care practitioners and health care facilities.
The Department is proposing to include in this section the list of diseases, infections and conditions which must be reported by health care practitioners and health care facilities. The Department is proposing to categorize the list of diseases, infections and conditions by the time frame within which each disease, infection and condition must be reported. The Department includes those which it proposes must be reported within 24 hours of identification in proposed subsection (a)(1). Those which the Department proposes be reported within 5 work days, it includes in proposed subsection (a)(2).
The Department is also proposing to make the following modifications to the general list currently set out in § 27.2 (relating to specific identified reportable diseases, infections and conditions) for the following reasons:
AIDS
The Department proposes excluding AIDS from the list of diseases, infections and conditions it proposes to make reportable in this section. The proposed reporting requirements of this section apply to all health care practitioners and health care providers. The Department proposes to change the current requirement that AIDS be reported by hospitals and physicians, and to make AIDS reportable only by physicians. To do this, it would be necessary to delete AIDS from this section and create a separate section requiring only physicians to report cases of AIDS. The Department proposes to set out this physician reporting requirement in § 27.21 (relating to reporting of AIDS cases by physicians).
Arbovirus Disease
The Department has determined that arbovirus disease (AD) should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. AD is transmitted by a mosquito insect vector. Examples of AD include, Eastern equine encephalomyelitis, Saint Louis encephalitis, Venezuelan equine encephalomyelitis, Western equine encephalomyelitis and yellow fever. An outbreak of AD is a Nationally reportable condition.
Chancroid
The Department has determined that chancroid should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Chancroid is a sexually transmitted disease characterized by painful genital ulceration caused by Hemophilus ducreyi that is probably present in this Commonwealth. This is a Nationally reportable condition.
Chickenpox (varicella)
The Department has determined that chickenpox should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of diseases, infections and conditions reportable by health care providers. Between 1970 and 1984, when chickenpox was last reportable, an average of 2,443 cases were reported each year. In 1973, there was a chickenpox outbreak of 7,315 cases. Therefore, outbreaks of chickenpox, especially within group settings, may be controlled if cases are identified and appropriate intervention strategies are implemented. Additionally, by reporting chickenpox cases, the efficacy of the new chickenpox vaccine can be measured. It is not yet clear that chickenpox can be prevented by a new vaccine. For reporting by health care providers to provide the Department with information which will be useful in determining the efficacy of the vaccine, the Department is proposing to obtain 3 years of reporting data from laboratories before requiring health care providers to report chickenpox.
Cryptosporidiosis
The Department has determined that cryptosporidiosis should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Cryptosporidiosis is caused by the protozoan cryptosporidium parvum and characterized by diarrhea, abdominal cramps, loss of appetite, low-grade fever, nausea and vomiting. The disease may be prolonged and life-threatening in severely immunocompromised persons. This is a Nationally reportable condition.
Enterohemorrhagic E. coli
The Department has determined that enterohemorrhagic E. coli should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Large outbreaks of E. coli 0157:H7 bacteria have been reported in the United States, including a 1993 outbreak linked to undercooked hamburgers with more than 600 reported cases and four deaths. In 1996, more than 6,000 schoolchildren in Japan developed E. coli 0157:H7 infection from eating contaminated radish sprouts. In August of 1997, 25 million pounds of ground beef patties were recalled by the United States Department of Agriculture because they had been epidemiologically linked to a disease outbreak of E. coli 0157:H7. This is a Nationally reportable condition.
Granuloma Inguinale
The Department has determined that granuloma inguinale (GI) should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. GI is a slowly progressive ulcerative disease of the skin and lymphatics of the genital perianal area caused by infection with Calymmatobacterium granulomati, a bacteria that is most likely present in this Commonwealth.
Hantavirus Pulmonary Syndrome
The Department has determined that hantavirus pulmonary syndrome (HPS) should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. HPS is a rare but serious acute lung disease caused by hantavirus infection. In June of 1993, the first cases in the United States were diagnosed in the Southwest. On November 25, 1997, HPS was diagnosed, post-mortem, in a resident of this Commonwealth who presumably acquired the fatal condition from infected rodents in Northeastern Pennsylvania. In addition, an ongoing retrospective review of unexplained deaths lead to the diagnosis of a March 1997 unexplained death in a Commonwealth citizen as also being caused by HPS. HPS is a Nationally reportable condition.
Hemorrhagic Fever
The Department has determined that hemorrhagic fever (HF) should be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. HF is an often fatal viral disease with an early high fever with subsequent vascular and neurological symptoms. Most HF is caused by Biosafety Level 4 (spacesuit isolation) viruses for which neither treatment nor vaccination is available. Examples of HF include: Argentina HF (Junin virus), Bolivian HF (Machupo virus), Brazilian HF (sabia virus), Congo-Crimean HF (CCHF virus), ebola HF (ebola virus-Sudan, Zaire, Reston), HF with renal syndrome (hantavirus: Hantaan, Seoul, Puumala viruses), Lassa fever (Lassa virus), Marburg HF (Marburg virus-Kenya) and Venezuelan HF (Guanarito virus). An outbreak of HF is a Nationally reportable condition.
Hepatitis, viral, including types A, E, B, C, D and G
Currently, the Department requires the reporting of the following types of hepatitis: hepatitis A; hepatitis B; and hepatitis non-A and hepatitis non-B (NANB). Because hepatitis C cases constitute a large majority of the NANB cases, the Department proposes to make newly identified specific types of viral hepatitis reportable: hepatitis C, hepatitis E and hepatitis G. Adding these types of hepatitis is important so that disease specific trends can be followed within this Commonwealth and the Nation.
Influenza
The Department has determined that influenza (flu) needs to be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Flu is a highly contagious disease of the respiratory tract caused by influenza A and B viruses, which, in some people, can cause severe illness or death. It is estimated that more than 10,000 Americans die of flu each year. The Hong Kong avian influenza (H5N1) outbreak, which could have been the start of the next influenza pandemic, emphasizes the need to make confirmed laboratory cases of flu reportable in this Commonwealth.
Kawasaki Disease
The Department has determined that Kawasaki disease (KD) no longer needs to be a reportable disease or condition in this Commonwealth and proposes that it be excluded from the list of reportable diseases, infections and conditions. KD is an acute febrile, self-limited, systemic vasculitis of early childhood that is believed to be caused by a bacterial toxin secreted by staphylococcus aureus, or group A streptococcus. In the Department's opinion, public health intervention is no longer warranted and the small number of cases of KD in this Commonwealth does not justify keeping it as a reportable condition. Further, KD is not a Nationally reportable condition.
Lead Poisoning
Currently, requirements on reporting of lead poisoning and toxicity appear in several different places in the regulations, and do not appear in others. Although lead poisoning and toxicity is listed as a disease or condition to be reported by persons in charge of laboratories, it is not listed as a reportable disease in the general reporting section. The requirement that lead levels be reported is currently contained in § 27.4(b), which only requires reporting at very high lead levels.
To clarify requirements of reporting, the Department is now proposing to include lead poisoning both in the proposed amendments to this section and in the list of diseases and conditions which must be reported by clinical laboratories. See proposed § 27.22 (relating to reporting of cases by clinical laboratories).
Lead poisoning is a Nationally recognized public health problem which causes mental retardation in either children consuming leaded paints, or in workers exposed to lead at their work site. One of the National objectives for the Year 2000 is the elimination of lead exposures that cause workers to have blood lead levels higher than 25 micrograms per deciliter (µg/dL). The Department's goal is to reach childhood blood levels of 0 µg/dL. The proposed changes to Chapter 27 concerning blood lead levels would assure that the Department is in compliance with current policy statements on elevated blood lead levels by the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health.
Leprosy (Hansen's Disease)
The Department has determined that leprosy needs to be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Leprosy is a chronic bacterial disease of the skin, peripheral nerves and the upper airway caused by Mycobacterium leprae. The current ability of persons to rapidly and freely travel from the tropics, like Hawaii, to this Commonwealth, makes leprosy a potential problem in this Commonwealth. Leprosy is a Nationally reportable condition.
Listeriosis
The Department has determined that listeriosis needs to be made a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Listeriosis is caused by Listeria monocytogenes, which may produce any of several clinical syndromes, including stillbirth, newborn infection, meningitis, bacteremia or localized infections. Outbreaks of listeriosis are often determined to be a food borne illness.
Phenylketonuria
Primary Congenital Hypothyroidism in Children up to 5 Years or 60 Months of Age
Maple Syrup Urine Disease (MSUD)
Sickle Cell Hemoglobinopathies in Children up to 5 Years or 60 Months of AgeThe Department proposes to apply the reporting requirements of this section to four metabolic diseases of the newborn child. These four diseases, phenylketonuria (PKU) primary congenital hypothyroidism in children up to 5 years or 60 months of age, maple syrup urine disease (MSUD) and sickle cell hemoglobinopathies in children up to 5 years or 60 months of age, are the four metabolic diseases of the newborn child for which the Department screens in its Newborn Screening Program (NBS). Currently, only two of these four diseases are included in the regulations. The Newborn Child Testing Act (35 P. S. §§ 621--625) enacted in 1992, added sickle cell hemoglobinopathies and MSUD to the list for which newborn children are screened. See section 3(b) of the Newborn Child Testing Act (35 P. S. § 623(b)). As with lead poisoning, these two diseases were only included in the list currently set out in § 27.22. All four diseases would now appear in this section and in proposed § 27.22.
The Department proposes to add MSUD and sickle cell hemoglobinopathies to the list of diseases reportable to the Department because of the passage of the Newborn Child Testing Act, and because of the necessity of early detection of these diseases in children to prevent mental retardation, death and serious illness. The more quickly families and health care providers are aware of these conditions, the more quickly prophylactic measures can be taken to ameliorate serious harm to the child. Particularly with MSUD, and to a lesser extent with PKU, if the disease is not detected quickly, and treatment begun, severe mental retardation or even death can occur.
Therefore, the Department proposes to require persons other than laboratories to report to the Department cases of PKU primary congenital hypothyroidism in children up to 5 years or 60 months of age, MSUD and sickle cell hemoglobinopathies in children up to 5 years or 60 months of age within 5 days of being identified, and that clinical laboratories report within 24 hours. See proposed § 27.22. Given the necessary testing with some of these diseases, only a laboratory would be able to report these diseases in less than a 5 day time period.
The Department also proposes to narrow the cases of primary congenital hypothyroidism and sickle cell hemoglobinopathies which must be reported to those cases identified in children up to the age of 5 years or 60 months. This is not to say that the Department would not accept reports of these conditions in children over the age of 5 years; however, given the serious nature of these conditions during the early stages of a child's growth and development, the most beneficial action is taken to prevent death or serious illness or injury within the first 5 years of a child's life.
Reye's Syndrome
The Department has determined that Reye's syndrome (RS) no longer needs to be a reportable disease or condition in this Commonwealth and proposes that it be excluded from the list of reportable diseases, infections and conditions. RS is a frequently recognized hepatic and central nervous system complication of influenza B, and less commonly, influenza A virus infection. Again, in the Department's opinion, public health intervention is no longer warranted, and the small number of cases of RS, does not justify keeping it as a reportable condition. RS is also not a Nationally reportable condition.
Streptococcal Invasive Disease (Group A)
The Department has determined that streptococcal invasive disease (group A) should be a reportable disease or condition in this Commonwealth and proposes that it be added to the list of reportable diseases, infections and conditions. Streptococcal invasive disease may manifest as any of several syndromes, including pneumonia, bacteremia, or deep soft tissue infection (necrotizing fasciitis, or ''flesh eating bacteria''). This is a nationally reportable condition.
Tuberculosis
Since tuberculosis disease can be found in many parts of the body, such as the lungs, kidneys, and bones, the Department has determined that tuberculosis occurring in all sites of the body, including pulmonary and extra pulmonary tuberculosis disease, should be reportable in this Commonwealth. Accordingly, the Department proposes to replace the word ''forms'' with the word ''sites'' to clarify that tuberculosis disease in all sites of the body is reportable. The use of the word ''sites'' would not make tuberculosis infection reportable since it is not identified by site.
The Department is also proposing to include in this section the standards by which the health care practitioner and health care facility are to report cases. For example, the Department proposes to include in subsection (b) the requirement that a health care practitioner and health care facility be required to report a case when the practitioner or facility has treated or examined the person with the disease, infection and condition, or when the practitioner suspects the person of having a disease, infection or condition. Secondly, the Department proposes that a health care practitioner or health care facility would only need to report a case once. For example, if a practitioner or facility treats a person and reports a disease, and then laboratory testing confirms the case, the practitioner or facility need not report the disease again. This prevents duplicative reporting.
The Department also proposes to require school nurses to report unusual cases of absenteeism. This would give the Department early warning of outbreaks among a vulnerable population.
The Department also proposes, in subsection (b), that health care practitioners and health care facilities only report cases of influenza and chlamydia trachomatis infection after laboratory confirmation of the causative agent is obtained. It is important that these cases be confirmed by laboratory evidence to ensure accurate epidemiological reporting, and to prevent over-reporting of cases.
The Department also proposes to require that both health care facilities and health care practitioners report cases of cancer. The regulations currently prohibit a physician from reporting cancer cases. The Department is proposing to add this requirement because the 1992 Cancer Registries Amendment Act (42 U.S.C.A. §§ 280e and 280e-1--280e-4) requires assurances from states, applying for Federal grants as part of the National Program of Cancer Registries, that authorization under state law exists for the establishment of a statewide cancer registry. To comply with the 1992 Cancer Registries Amendment Act, the Department is proposing to amend this section to require health care practitioners and health care facilities to report cases of cancer.
Lastly, because the proposed definition of ''health care facility'' includes inpatient drug and alcohol abuse treatment facilities, the Department recognizes that this proposed section may pose a potential confidentiality problem, as it has in the past. The Department, therefore, has executed Qualified Service Organization Agreements with these facilities. These agreements would permit the drug and alcohol abuse treatment facilities to make reports of reportable diseases, infections and conditions within the scope of the law, and provide for adequate disease prevention and control while keeping the strict requirements of confidentiality for drug and alcohol abuse treatment clients in view.
Section 27.22. Reporting of cases by clinical laboratories.
The Department is proposing to substantially revise this section to remove those provisions dealing with reporting requirements specific to individual diseases, infections or conditions. The Department proposes to include these requirements in sections relating specifically to reporting those diseases, infections or conditions. See proposed §§ 27.30, 27.31, 27.33 and 27.34.
In subsection (a), the Department proposes to impose reporting time frames on clinical laboratories, except as noted otherwise in the chapter. The Department considers it necessary to impose these time frames to ensure the Department's receipt of the reports in sufficient time to generally enable the Department to prevent and control the spread of disease.
In subsection (b), the Department is proposing to include substantially the same list of diseases, infections and conditions to be reported as are included in proposed § 27.21a, although different time frames for reporting are proposed. The proposal would add certain diseases, including measles, mumps, pertussis, poliomyelitis, rubella and tetanus, to those which laboratories have been required to report. Reporting requirements for laboratories reporting chickenpox would take effect immediately upon publication in the Pennsylvania Bulletin.
Further, under the recommendation of the American Thoracic Society and the CDC, the Department is proposing to require in subsection (b) that laboratories report to the Department the results of drug susceptibility testing for tuberculosis. The reporting would enable the Department to be aware of drug-resistant tuberculosis and multidrug resistant tuberculosis as soon as possible.
In subsection (c), the Department proposes to clarify the types of information a clinical laboratory is required to report, and how a clinical laboratory is to report, including permitting a clinical laboratory to submit reports in an electronic format specified by the Department.
The Department also proposes to add language in subsection (j) which would permit the Department to make changes to the requirements in subsections (f)--(i). Those subsections would require a laboratory to submit isolates of certain specified diseases, infections, or conditions to the Department's Bureau of Laboratories for further testing within a specified time frame. The proposed language would also permit the Department to require clinical laboratories to submit isolates of reportable diseases other than those specified in subsections (f)--(i). The Department proposes to add language allowing it to alter these requirements based upon medical or public health developments when the change is determined by the Department to be necessary to protect the health of the people of this Commonwealth. The Board would then have 90 days to approve the change. If the Board failed to approve the change within the 90-day period, the change would expire. This would provide the Department with the ability to implement the most up-to-date laboratory procedures to effectively control and prevent the spread of diseases, infections or conditions.
Section 27.23. Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.
The Department proposes to delete the original provisions of this section. The provisions relating to school nurses would be contained in proposed § 27.21a. The Department is proposing to add language to this section which would require individuals in charge of institutions maintaining dormitories and living rooms, orphanages, and child care group settings to report all suspected cases of a reportable disease, infection or condition, except for cancer, to the local morbidity reporting office. This would provide the Department or local health authority with the opportunity to investigate, identify and respond to cases of a reportable disease, infection or condition in these settings.
Section 27.24. (Reserved).
The Department proposes to delete this section, which pertains to reporting by heads of institutions, since reports by heads of institutions would be addressed under proposed § 27.23 (relating to reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories). Because, under these proposed regulations, only physicians would be required to report cases of AIDS, the Department proposes deleting the current requirement in subsection (b) that hospitals are to report cases of AIDS.
Section 27.24a. Reporting of cases by veterinarians.
This section would be new. The Department proposes to add this section to require a veterinarian to report a case only if the veterinarian treats or examines an animal that the veterinarian suspects of having a reportable disease, infection or condition listed in proposed § 27.35 (relating to reporting of cases of disease in animals). The receipt of reports of certain diseases, infections or conditions in animals is important to the Department's disease prevention and control function because animals and animal products frequently serve as vehicles for transmission of disease to humans.
Section 27.25. (Reserved).
The Department proposes to delete this section, which pertains to reports by health care practitioners who are not physicians, as the requirement that other licensed health care practitioners report cases is included in proposed § 27.21a.
Section 27.26. (Reserved).
The Department proposes to delete this section, which pertains to the reporting of cases by persons such as owners of hotels, motels and other lodgings, as its requirements are included in proposed § 27.23 (relating to reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories).
Section 27.27. (Reserved).
The Department proposes to delete this section, which pertains to a physician revising the diagnosis of a disease or condition for which isolation or quarantine is required, as it is no longer necessary.
Section 27.28. (Reserved).
The Department proposes to delete this section, which pertains to reporting the occurrence of an unusual disease or group expression of illness. The requirements of this section would be included in proposed § 27.3 (reporting outbreaks and unusual diseases, infections and conditions).
DISEASES AND CONDITIONS REQUIRING SPECIAL REPORTING Section 27.30. Reporting results of metabolic disease testing in the newborn child.
The Department is proposing to delete the current language of § 27.30 and proposes to add language requiring that reports of the four reportable conditions in newborn children, PKU, primary congenital hypothyroidism, MSUD and sickle cell hemoglobinopathies, be reported to the Department's Division of Maternal and Child Health, in the Bureau of Family Health. This would require reports to go directly to the division of the Department which operates the program that provides diagnosis, follow-up and referral for treatment of children with one of these four metabolic conditions.
Section 27.31. Reporting cases of cancer.
Currently, only hospitals and laboratories are required to report cases of cancer. The Department proposes to add the requirement that all health care facilities and all health care practitioners, as defined in the proposed regulations, also be required to report cases of cancer. With the changes in technology and physician practice patterns, more patients than ever before are being diagnosed and treated for cancer outside the hospital setting. Reporting from nonhospital sources is critical for finding a significant percentage of melanoma, lymphocytic leukemia, and cancers of the eye, vulva, oral cavity and prostate. Reporting by nonhospital health care facilities and health care practitioners is necessary to assure complete reporting of all cancer cases and accurate calculation of cancer statistics for this Commonwealth. Also, these added reporting requirements are necessary for the Department to comply with the 1992 Cancer Registries Amendment Act which requires the Department to promulgate regulations that would provide for the complete reporting of cancer cases to the Statewide Cancer Registry by health care facilities and health care practitioners.
The Department also proposes to change the time frame in which health care facilities must report cases of cancer. The time frame would be changed from 90 to 180 days following inpatient discharge or outpatient treatment. Changing the reporting requirement from 90 to 180 days would provide the time necessary to collect additional information that is not always available within 90 days. Additionally, the 180 day reporting requirement would be consistent with reporting requirements of the American College of Surgeons Commission on Cancer, the accrediting agency for cancer programs; the North American Association of Central Cancer Registries, the standard setting organization for central cancer registry data collection; and the CDC in administration of the National Program of Cancer Registries.
Further, the Department proposes to add language to require health care practitioners to report cases of cancer within 5-work days of diagnosis. This language would make the reporting time frames consistent with the health care practitioner reporting time frames for other reportable diseases.
The Department also proposes to add language to ensure that the Department has access to all records maintained by health care facilities and health care practitioners which would identify cases of cancer, or establish characteristics of the cancer, treatment of the cancer, or medical status of an identified cancer patient. The added language is needed for the Department to comply with the Cancer Registries Amendment Act, which requires the Department to promulgate regulations that would provide for access by the Cancer Registry to all these records.
Section 27.32. (Reserved).
The Department is proposing to delete this section, which pertains to reporting cases of AIDS, because the reporting requirements are included in proposed § 27.21.
Section 27.33. Reporting cases of sexually transmitted disease.
This section would be new. In this section the Department lists the sexually transmitted diseases and infections that it proposes to make reportable. The term, ''sexually transmitted disease,'' is broader than the previously used, ''venereal disease,'' and would include chlamydia trachomatis infections.
Under proposed subsection (b), reports of cases of syphilis would be made reportable directly to the appropriate health authorities in Philadelphia and Allegheny counties for cases occurring in those counties. Each of these counties has a computerized registry of positive laboratory results for previously known syphilis cases reported in that county.
Section 27.34. Reporting cases of lead poisoning.
This section would be new. The Department proposes to add this section, and delete specific language concerning the reporting of lead poisoning and toxicity from § 27.22, to combine all the requirements for reporting of lead poisoning into one section. The current regulations contain lead reporting requirements in §§ 27.4, 27.22 and 27.117. The Department also proposes that § 27.117, which pertains to reporting and control measures for lead poisoning, be deleted as outdated and unnecessary. Section 27.117 is one of over 40 sections in the current regulations which includes specific information detailing how the spread of diseases is to be prevented. The Department proposes to include the necessary reporting information relating to lead poisoning in this section.
The Department also proposes to change the required blood levels for reporting for both children under the age of 16 and pregnant women, and for persons age 16 and older. Changes in the required levels would reflect current policy direction from the CDC. The Department proposes to require that all lead test results on venus and capillary blood specimens, including those at 0 micrograms per deciliter (µg/dL) and up, be reported to the Department. Reporting of all levels for children under the age of 16 and for pregnant women would allow the Department to carry out case management more effectively and to ensure that the appropriate medical and environmental follow-up services are provided to children and pregnant women in need of those services.
The Department also proposes that the blood lead level at which reports must be made to the Department for persons aged 16 and older be lowered to comport with CDC policy. That level would be changed from 40 µg/dL to 25 µg/dL. The Department is also attempting to avoid the necessity of continually amending the regulations to reflect continuing changes in policy by proposing to include language which would permit the Department to change the reporting level to comport with regulatory requirements or guidelines of Federal or environmental occupational health agencies by publishing a notice to that effect in the Pennsylvania Bulletin. The Board would then have 90 days to approve the change. If the Board did not act within the 90-day period, the change would expire. This would provide the Department with greater flexibility to meet current standards, and would eliminate the need to solely rely upon the cooperation of reporting entities for reporting test results consistent with national recommendations that precede regulatory changes.
The Department further proposes to set out in some detail the methods to be used to obtain all the necessary information required to be included on reporting forms submitted by the laboratories. The Department has had problems in the past obtaining all the information requested on the forms. The procedures in proposed subsections (g) and (h) would permit the laboratory to process the specimen in a timely manner when an incomplete report form is submitted to it. They would allow the laboratory to submit the incomplete report to the Department and return the incomplete report form to the specimen submitter. The person who submitted the specimen would be required to complete and return the report form to the laboratory within 14 days of the date of the letter returning the incomplete form. Under proposed subsection (h), the laboratory would then be required to send the completed form to the Department within 1 day.
The Department also proposes to add language to require the laboratory to notify the Department if the specimen submitter fails to return the information within the specified time periods. See proposed subsection (i). The Department could then recommend disciplinary action under proposed § 27.6 (relating to disciplinary consequences for violating reporting responsibilities). A laboratory that would fail to comply with the requirements in this may be subject to disciplinary consequences by the Department. See proposed subsection (j).
The Department has also proposed changing the reporting procedures, but only for reporting of results on children up to the age of 16 and on pregnant women. Laboratories reporting results on these persons, and which conduct more than 100 tests per month, would be required to report these results to the Department's Division of Maternal and Child Health electronically and in the format specified by the Department. Laboratories performing less than 100 tests per month would be able to choose to report either electronically or by paper.
Section 27.35. Reporting cases of disease in animals.
This section would be new. The Department proposes to add this section to clarify that any case of a listed zoonotic disease (a disease in an animal which is transmissible to humans), or any disease, infection or condition covered by proposed § 27.3, must be reported. The language of subsection (b) is intended to clarify that the Department only has authority with regard to the control and prevention of disease or infection in animals when the disease or infection is dangerous to humans.
REPORTING BY LOCAL MORBIDITY REPORTING OFFICES Section 27.41a. Reporting by local morbidity reporting offices of case reports received.
Section 27.42a. Reporting by local morbidity reporting offices of completed case investigations.
These sections would be new. The Department proposes to add these sections to clarify the reporting responsibility of the local morbidity reporting offices when a case report has been received and when a case investigation has been completed. The language in proposed § 27.42a also identifies the appropriate Department offices to which the completed case investigation reports would be submitted. These sections would make existing §§ 27.41 and 27.42 (relating to individual case reports and summary reports) of the current regulations obsolete. The Department proposes deleting those sections.
Section 27.43a. Reporting by local morbidity reporting offices of outbreaks and selected diseases.
This section would be new. The Department proposes to add this section requiring LMROs to report outbreaks and incidences of selected diseases by telephone to the appropriate Department office on the date that the reports are received. This would enable the Department to promptly conduct an investigation to identify the source of the outbreak or selected disease and implement procedures to prevent the further spread of the outbreak or selected disease. Proposed § 27.43a would make § 27.43 (relating to immediate reports by telephone or telegraph) of the current regulations obsolete. The Department proposes deleting that section.
Section 27.44. (Reserved).
Section 27.45. (Reserved).
Section 27.46. (Reserved).
Section 27.47. (Reserved).
These sections pertain to destination of reports, reports made to the Department, reports made to local health officers, and reports made by the Department back to local health boards, respectively. The Department proposes to replace them with §§ 27.41a, 27.42a and 27.43a, all of which relate to reports by local morbidity reporting offices. The Department proposes deleting §§ 27.44--27.47 since they would no longer be necessary.
REPORTING VIRAL HEPATITIS TO BLOOD BANKS Section 27.51. (Reserved).
This section requires health officers to report to blood banks cases of viral hepatitis. The Department proposes to delete this section. It is no longer necessary because blood banks now automatically test blood for viral hepatitis.
Subchapter C. QUARANTINE AND ISOLATION GENERAL PROVISIONS Section 27.60. Disease control measures.
This section would be new. The Department proposes to add a section which allows the Department or local health authority to direct isolation of a person or animal with a communicable disease or infection and to implement any other disease control measures that the Department or local health authority considers to be appropriate, including surveillance, segregation, quarantine or modified quarantine of contacts of persons or animals with a communicable disease or infection. This proposed section is important to the Department's disease control and prevention function, in that it would allow the Department the discretion to implement the most appropriate disease control measures for the situation. If the local health authority is not a local health department, it would be required to obtain approval from the Department prior to instituting disease control measures. This distinction between local health departments and boards of health takes into account the differing levels of experience and qualifications that different types of local health authorities may have.
Section 27.61. Isolation.
Section 27.65. Quarantine.
Section 27.66. Placarding.
Section 27.67. Movement of persons and animals subject to isolation or quarantine by action of a local health authority or the Department.
Section 27.68. Release from isolation and quarantine.
Section 27.69. Laboratory analysis.
The proposed amendments to these sections set forth the requirements for the isolation and quarantine of persons and animals by the Department or local health authorities. Proposed amendments to §§ 27.61 and 27.65--27.67 consolidate the isolation and quarantine requirements currently in §§ 27.62--27.64. The Department proposes deleting these sections from the regulations. The proposed amendments contain requirements necessary for disease control and prevention that may, if improperly used, unnecessarily impinge upon the rights of citizens of this Commonwealth. The Department is proposing, therefore, to add language requiring local health authorities without much experience in disease control or prevention, or whose qualifications in these areas may not be optimum, to seek the advice and approval of the Department before moving to take these actions.
Additionally, to prevent and control the spread of disease, the Department is proposing to amend these sections to apply quarantine and isolation requirements to animals. Frequently, animals are the vehicle to human exposure to disease. The only animals, however, over which the Department or a local health authority would have jurisdiction under these regulations are those animals which can expose humans to disease. For a list of relevant diseases, refer to proposed § 27.35 (relating to reporting cases of disease in animals).
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