[32 Pa.B. 491]
[Continued from previous Web Page] Comments
How does the Department intend to communicate in a timely fashion that it has decided upon an exception?
The regulations do not address the question of what would occur if the Board affirmed or rejected the exception.
The Department removed language similar to this from other parts of the regulations. Did it intend to retain the language regarding exceptions in this section? How is it permissible to grant an exception without regulatory action?
Response
Because the Department has chosen not to adopt the proposed section, there is no need to respond to these comments.
Comment
The Department should consider incorporating the Morbidity and Mortality Weekly Report (MMWR), which would be a viable alternative toward authorizing an exception, if a regulation becomes outdated. Guidelines for documents that can be incorporated by reference are found in 45 P. S. § 727 (relating to matter not required to be published) and 1 Pa. Code § 3.41 (relating to matter not required to be published).
Response
The Department does consider the MMWRs relating to disease prevention and control, as well as other guidelines and recommendations from the Centers for Disease Control and Prevention (CDC) and its Council of State and Territorial Epidemiologists in making decisions concerning what diseases, infections and conditions to add to the list of reportable diseases. The Department is not, however, required by any entity to accept these recommendations and guidelines in their entirety. It is up to the Department, with the approval of the Board, to determine when and how to add diseases, infections and conditions to the list. See 35 P. S. § 521.16(a) and 71 P. S. § 536(a) with respect to the Department's authority to issue rules and regulations on communicable and noncommunicable diseases, declare diseases to be communicable, and to establish regulations for the prevention and control of disease. These decisions must be made on a state-by-state basis, since they depend upon the different populations of the state and their needs, and other characteristics of each state.
Subchapter B. REPORTING OF DISEASES, INFECTIONS AND CONDITIONS Section 27.21. Reporting of AIDS cases by physicians and hospitals.
This section states the requirements for physicians and hospitals reporting AIDS.
Comment
The Department erred in deleting requirements from its regulations that both hospitals and physicians report cases of AIDS. To only require reporting by physicians could lead to underreporting of AIDS cases.
Response
The Department agrees that both hospitals and physicians should report cases of AIDS. The deletion of the requirement relating to hospitals was inadvertent. The section has been revised accordingly.
Section 27.21a. Reporting of cases by health care practitioners and health care facilities.
This section lists the diseases, infections and conditions reportable by health care practitioners and health care facilities. This section also provides the time frames in which the disease, infection or condition must be reported.
The Department has made some minor changes to the list from the proposed rulemaking for the sake of accuracy. The Department has changed the term ''Legionnaire's disease'' to the more technically accurate ''Legionellosis.'' The Department has also deleted yellow fever from the regulations since yellow fever is an arbovirus, and there is no need to list it separately.
Comment
Under subsection (b)(1) (now subsection (a)(1)), a health care practitioner or a health care facility is not required to report if that health care facility or practitioner has already reported the case. The Department should clarify that a health care facility is also not required to report if its laboratory has reported previously. Currently, hospitals are not reporting if their laboratories are reporting. If the Department does not agree to this change, it should explain why duplicate reports are necessary, and how the benefits of this reporting outweigh the costs.
Response
The Department has not changed the proposed rulemaking in response to this comment. Reporting by practitioners and facilities as well as laboratories, what is referred to as the ''dual pathway'' of reporting, is not unique to this Commonwealth. It is the National standard for ensuring completeness of reports. Ideally, the practitioner or facility should make the initial case report. Historically, however, there has been significant noncompliance. Through the identification of practitioners and facilities in laboratory reports, the Department is able to contact practitioners and facilities and obtain from them a completed case report on a particular patient whose test result has been reported to the Department by a laboratory but for whom no report has been made by the provider. This approach is consistent with the CDC protocols and with protocols in other states. A more detailed explanation of why reporting from all possible reporting entities is necessary for a successful disease prevention and control program has been provided in the Department's response to general comments concerning reporting.
Comment
The Department's need for potentially overlapping information from facilities, practitioner, clinical laboratories and persons in charge of group facilities is unclear.
Response
The Department has not changed the proposed regulation in response to this comment. The Department is seeking overlapping information from providers, facilities and the public, to ensure that it obtains the widest variety and amount of information possible. The need for all relevant and available information, and the manner in which the Department resolves duplicate reports, has been discussed.
Comment
Does this section supersede § 211.1 (relating to reportable diseases in long-term care nursing facilities)?
Response
Section 211.1 is based on the requirements of this chapter. By this rulemaking, the Department is also amending § 211.1 to state that reportable diseases, infections and conditions are those diseases, infections and conditions listed in this section. The reporting requirements in § 211.1 do not eliminate the reporting requirements for a health care facility under Chapter 27.
Comment
The Department should move the following diseases from subsection (a)(2) (now subsection (b)(2)) which contains a listing of all diseases infections and conditions to be reported within 5 days, to subsection (a)(1) (now subsection (b)(1)) which contains a list of all diseases infections and conditions to be reported within 24 hours: animal bite, anthrax, arbovirus disease, enterohermorrhagic E. coli and legionellosis. With these diseases and conditions, action must be taken to prevent serious consequences to the individual within a shorter time frame than 5 days. With respect to anthrax, since there is the possibility of a bioterrorist attack using this disease as a weapon, it should be reported within a shorter time frame than 5 days.
Response
The Department agrees with the comments, and has moved these diseases and conditions from the list requiring reporting within 5 days to the list requiring reporting within 24 hours. See subsection (b)(1) and (2).
Comment
The Department should add the following diseases to the list of diseases that must be reported within 5 days: Creutzfeldt-Jakob disease; streptococcus pneumoniae drug resistant invasive disease; and staphylococcus aureus, Vancomycin-resistant (or intermediate) invasive disease.
This comment also applies to § 27.22 (relating to reporting of cases by clinical laboratories).
Response
The Department agrees with the comment, and has added these diseases to the list of diseases that must be reported within 5 days. See subsection (b)(2). That action is consistent with National reporting standards recommended by the CDC.
The Department has made similar revisions to § 27.22(b).
Comment
There is a concern that this section would require emergency management technicians (EMTs) to report cancer. While this would not include patients already diagnosed, it could be confusing to EMTs who do not know the complete history of the patient. Further, EMTs cannot diagnose cancer.
Response
It was not the Department's intention to require health care practitioners to perform diagnoses who cannot, within the scope of their licensure or training, diagnose diseases, infections or conditions. The diseases, infections and conditions listed in subsection (b), (proposed as subsection (a)), are only to be reported in accordance with subsection (a), (proposed as subsection (b)), and the remainder of the chapter. Cancer, which only certain specified health care practitioners and facilities are required to report (see § 27.31 (related to reporting cases of cancer)), would not be reportable by EMTs. Because this section has generated some confusion among commentators, the Department has rearranged subsections (a) and (b), and added language to clarify that if there are specific requirements in other sections for the reporting of certain diseases, those provisions must be read in addition to this section.
Further, the Department has added language to subsection (d) to clarify that health care practitioners as well as health care facilities are to look to § 27.31 (relating to reporting cases of cancer) to determine how to report cancer cases. The Department has also attempted to provide additional clarity by adding subsection (a)(4), as well as similar language to § 27.31(a) and (b), which states that only those facilities and practitioners actually providing services relating to the individual's cancer are required to report the case as a cancer case.
The Department has also revised the language in this section that requires reporting of identified diseases, infections and conditions to clarify the meaning of the word ''identify.'' A disease, infection or condition is reportable when it has been identified by symptoms, appearance of the individual or diagnosis. Consequently, a diagnosis is not needed to trigger a duty to report.
Comment
While Haemophilus influenzae should be reportable within 24 hours, the Department should delete the reference to ''type B invasive disease'' from the list of reportable matters. Many clinical laboratories do not conduct serotyping, and laboratories that do conduct serotyping may not have results for several days. Since action may need to be taken sooner than it would take the laboratory to conduct the serotyping, the Department should make Haemphilis influenzae reportable within 24 hours. This comment pertains to § 27.22(b)(1) as well.
Response
The Department agrees with this comment, and is deleting ''type B'' from the reference to Haemophilus influenzae in subsection (b), (proposed as subsection (a)).
Comment
All types of hepatitis should be reported, and should be reportable within 5 days of identification of the disease.
Response
The Department agrees that all forms of hepatitis should be reportable, and has revised the regulations to make hepatitis reportable within 5 days of the identification of the disease. The Department has divided reportable diseases into two categories, those reportable within 24 hours, and those reportable within 5 days, to eliminate some burden from those entities required to report. Only those diseases that need quick public health intervention are required to be reported within a 24-hour period. The Department agrees that hepatitis does not need to be reported within that time frame due to the manner of its transmission.
Comment
The regulation should require the reporting of chronic cases of hepatitis C as well as acute cases. More extensive reporting of hepatitis C cases is necessary so that reputable and inclusive data can be used to make an accurate assessment of the public health threat of hepatitis C to citizens of this Commonwealth. This issue should not be allowed to languish through a long regulatory process. This same comment is applicable to §§ 27.22 and 27.43a (relating to reporting of cases by clinical laboratories; and reporting by LMRO of outbreaks and selected diseases).
Response
The Department has added language to the regulation to clarify that it is requiring the reporting of all cases of hepatitis C, chronic as well as acute. The Department looks at all reported cases of hepatitis C to resolve whether an individual is an acute or chronic case. It makes this assessment by determining whether the individual also has clinical symptoms. An individual who has both a positive laboratory serology and presents with clinical symptoms is an acute case. An individual whose laboratory tests show that he is positive for hepatitis C, but who has no clinical symptoms, is a chronic case. Since an intervention message can be life-saving for persons with chronic hepatitis C, information regarding the need to practice safe sex and to get vaccinated for hepatitis A and B as well as other information relating to the disease will be given by the Department to each individual reported with hepatitis C.
Comment
The Department should delete hepatitis, viral, including type A and type E, from proposed subsection (a)(1) (now subsection (b)(1)) which requires reporting within 24 hours. All other types of hepatitis are reportable within 5 days. References to type G should be deleted from the proposed subsection (a)(2) (now subsection (b)(2)) listing of diseases reportable within 5 days, since it does not exist. Hepatitis, non-A and non-B should be added to the 5 day list in proposed subsection (a)(2). These same comments apply to § 27.22(b).
Response
The Department agrees with the comments, and has revised the references to hepatitis in this section. The Department has deleted all references to hepatitis from what is now subsection (b)(1), which requires reporting within 24 hours. The regulations require that hepatitis, viral, all types, is reportable within 5 days of its identification by symptom, patient appearance or diagnosis. See subsection (b)(2).
The Department has made similar revisions to § 27.22(b).
Comment
The Department should require HIV reporting. The Legislature contemplated reporting of HIV infection under section 7(a)(9) of the Confidentiality of HIV-Related Information Act (35 P. S. § 7607(a)(9)). The Department should also explain what type of HIV reporting it favors; most persons appear to favor a unique identifier system of reporting.
Response
The Department has chosen to promulgate regulations relating to HIV separately. The revisions to Chapter 27 included in this final-form rulemaking have been under consideration by the Department and various stakeholder groups for the past 10 years. The Department was anxious to proceed with the amendments, and did not wish to delay them while important consideration and public discussion was given to the question of when and how HIV should be made reportable. The Department neither wished to rush the process involving the promulgation of regulations relating to HIV reporting, nor to delay this general rulemaking concerning communicable and noncommunicable diseases.
Further, the importance of the promulgation of regulations relating to HIV reporting warranted a separate rulemaking so that attention could be focused on that issue. Therefore, the Department has proposed separate regulations on that topic. The regulations that would require reporting of certain HIV tests, CD4 T-lymphocyte counts below certain levels, and perinatal exposure of newborns to HIV by name, were published as proposed at 31 Pa.B. 2126 (April 21, 2001). A 30-day public comment period was provided.
Comment
With respect to the requirements for reporting phenylketonuria, MSUD, hypothyroidism and sickle cell hemoglobinopathies, the Department should explain why it is using both the phrase ''up to 5 years'' and ''up to 60 months'' in relation to the age of the child in whom the disease should be reported.
Response
The Department agrees that this language should be changed, and is revising the regulation to state that these diseases are reportable in children under 5 years of age.
Comment
The Department should include smallpox in the list of diseases that must be reported within 24 hours. The threat of bioterrorism requires the reintroduction of smallpox into the list.
Response
The Department agrees with the recommendation, and has added smallpox to subsection (b)(1).
Comment
The statement in the preamble to the proposed regulations that it is not clear that chickenpox can be prevented by vaccination is outdated. This vaccine is now recommended universally for children and other persons not known to be immune.
Response
The Department agrees that the statement is no longer correct. The Department has promulgated regulations that include chickenpox (varicella) in the list of diseases for which immunization is required for school entry and attendance. These provisions will be effective for the 2002-2003 school year.
Comment
Does the Department distinguish between occurrence of the chickenpox disease and postvaccination cases?
Response
The Department does not distinguish between wild virus chickenpox and postvaccination cases.
Comment
The Department should remove required reporting of chickenpox (varicella) until it decides that reporting is warranted based on trends in information reported by clinical laboratories. The 3-year time frame presupposes that cases will need to be reported by health care facilities and practitioners. The Department should wait until chickenpox (varicella) immunity is required in schools.
Response
The Department has not changed the proposed rulemaking in response to this comment. The Department believes that reporting of varicella is warranted now. As stated previously, the Department's regulations requiring immunity from chickenpox as a condition of school entry and in the seventh grade will be in place for the beginning of the 2002-2003 school year.
Comment
Chickenpox (varicella) should be added to the list of reportable diseases, however, there should not be a 3-year delay for reporting by practitioners. Laboratories will not have data to provide, since a primary care provider rarely, if ever, requires a laboratory test for the disease. School nurses and child care programs could report the disease, since often only the most severe cases are seen by physicians.
Response
The Department has not changed the proposed rulemaking in response to this comment. Laboratories are already reporting this disease on a voluntary basis. Sentinel surveillance systems are already ongoing in schools and day care centers, and with physicians. Sentinel surveillance for varicella involves polling approximately 2,000 sites Statewide on a monthly basis to gather information on ongoing incidence, morbidity and mortality of varicella. As varicella vaccine usage increases, the Department will monitor disease incidence using this system until the numbers of cases of varicella are at a more manageable level for individual case reporting. The Department anticipates that this will be within a 3-year period from the effective date of these regulations, which will coincide with a 3-year period from the effective date of the varicella immunization requirements. The Department, in setting a 3-year delay in reporting for health care practitioners (which includes school nurses) is attempting to alleviate what could become a burden for health care practitioners, and what could, if reporting were immediately required, cause them to have to report tens of thousands of cases a year. The Department's expectation is that within 3 years of the regulations regarding school immunizations and immunity being in place, this number will drop to less than 1,000 annually.
Comment
The Department should add to subsection (c) a requirement that a child care group setting that enrolls more than 12 children is to report to the LMRO any unusual increase in the number of absentees.
Response
The Department agrees that such a requirement would aid it in its responsibilities to prevent and control the spread of disease, and has added the recommended language to subsection (c).
Section 27.22. Reporting of cases by clinical laboratories.
This section addresses reporting requirements for clinical laboratories. It includes the list of diseases, infections and conditions reportable by laboratories and the time frames in which laboratories are required to report.
Comment
The Department should delete language from the regulation that limits the reporting of arboviruses to the Eastern, Western and St. Louis arboviruses. The Department should add references to West Nile and Equine as well. Arboviruses can appear in unexpected places, as the West Nile outbreak in New York City shows. Any arboviral case could lead to the need for mosquito control efforts and other public actions.
Response
The Department agrees with the comment. Since the Department's intention is to require the widest reporting possible, it has deleted all references limiting reporting to certain types of arboviral diseases, thereby requiring the reporting of all arboviruses.
Comment
The Department should add language that would permit either the referring laboratory or the laboratory performing the test to report the results. This would ensure that the Department receives a report that contains the most complete information. It will also eliminate duplication. The referral laboratory may not have all the demographic information requested by the Department. If the Department chooses not to revise this section, it should explain why duplicate reports are necessary and how the benefits outweigh the costs.
Response
The Department has not changed the proposed rulemaking in response to this comment. Because the Department needs all the information on a case it can obtain, both the ''primary'' and the ''referral'' laboratory are required to report. The necessity for reporting from all possible reporters has already been discussed in detail.
Comment
The Department should explain why it has made decisions to delete or add specific diseases.
Response
The Department will respond to this comment in its responses on the specific requests for additions or deletions to the list of cases reportable by clinical laboratories.
Comment
The Department should add CD4 T-lymphocyte counts of 500 cells per microliter or less to the list of reportable diseases in subsection (b).
Response
The Department has not added this requirement to these regulations. The Department, in a separate rulemaking, published at 31 Pa.B. 2126 is proposing to add a requirement for reporting of laboratories, practitioners, and other entities of CD4 T-lymphocyte cell counts of less than 200 cells per microliter or which are 14% or less of total T-lymphocyte cells. Chapter 27 will be amended again when the Department acts to adopt that proposed rulemaking.
The Department has not proposed the reporting of CD4 T-lymphocyte cell counts of less than 500 cells per microliter because there is not a National consensus on reporting at that level.
Comment
The Department should add the following diseases to the list of diseases reportable by laboratories: cryptosporidiosis; histoplasmosis; meningitis; toxoplasmosis and yellow fever. Arboviruses should be listed in the same manner as in § 27.21a.
Response
The Department agrees and has amended this section to require reporting of cryptosporidiosis, histoplasmosis and toxoplasmosis by laboratories. This comports with the National standard for reporting.
The Department has revised the reference to arboviruses in this section to require reporting of all arboviruses, as it has in § 27.21a(b)(1). Since yellow fever is a mosquito-borne disease, and is covered by the term ''arbovirus,'' there is no need to add it specifically to the list. Similarly, the regulation requires the reporting of meningococcal infections by laboratories, rather than meningitis. Meningitis is a clinical diagnosis, and is required to be reported by health care practitioners and health care facilities in § 27.21a.
Comment
The Department should delete synctial virus from the list of diseases required to be reported by clinical laboratories. Local health authorities will be inundated with reports, and the Department did not provide a reason in its preamble to proposed rulemaking for including this disease.
Response
The Department has not changed the proposed regulation in response to this comment. Since this section requires reporting of synctial virus by laboratories, and not by health care practitioners and facilities, the Department does not expect to be inundated by reports. This requirement will allow the Department to identify outbreaks of disease once the use of the new vaccine for this virus is widespread.
Comment
The Department should remove references to unusual clusters of isolates from subsection (b) since the term ''unusual'' may mean something different depending on the disease.
Response
The Department has not changed the proposed regulation in response to this comment. The term ''unusual'' may mean different things depending on different diseases. For example, a laboratory may notice that it has positive results for E. coli 0157:H7 from tests on several different specimens, and this does not usually occur. This unusual grouping of test results could be indicative of an outbreak. The Department does not want to lose an opportunity to intervene to prevent and control the spread of disease.
Comment
The Department should add the following language to subsection (c): ''the report shall include the source of the specimen (such as, serum, CSF, stool, wound); the results; the range of normal values for the specific tests.''
Response
The Department agrees that this additional information would be valuable to it in its disease prevention and control function. It has added the recommended language to subsection (c), with the exception of the test results, since that data element is already included in the regulation.
Comment
The Department should adopt a unique identifier system for all reporting. There is a concern with respect to the confidentiality of information reported to the Department, particularly with cancer information and lead test results. A unique identifier system would permit the Department to carry out its responsibilities while protecting the information.
Response
The Department has not changed the proposed rulemaking to address this comment. The Department cannot fulfill its disease prevention and control functions, which include follow up with individuals to ensure that medication is being taken, treatment being followed and contacts being notified, without obtaining the name and identifying information of the individual about whom the report is made. The Department has had information reported to it under the act since 1955 by name of the individual without major issues surrounding confidentiality.
The act requires the Department and local health departments to keep confidential the information they collect under the act. The act prohibits the Department from releasing information secured under the statute, even in the face of a subpoena, with few exceptions. Section 15 of the act (35 P. S. § 521.15) provides as follows:
State and local health authorities may not disclose reports of diseases, any records maintained as a result of any action taken in consequence of such reports, or any other records maintained pursuant to this act or any regulations, to any person who is not a member of the department or a local board or department of health, except where necessary to carry out the purpose of the act. (35 P. S. § 521.15).The Supreme Court of the Commonwealth has stated that the purpose of the act is to aid the Department and local health departments to prevent and control the spread of disease. See Commonwealth v. Moore, 584 A.2d 936, 940 (Pa. 1991). In Moore, the Supreme Court held that release of information collected under the act to aid a criminal prosecution did not carry out the purpose of the act. The Department may disclose aggregate information on disease cases for research purposes, but will only do so without including case-identifying information. The Department will disclose identifying information with a valid consent from the individual whose information is being requested.
Because the Department and local health departments take the responsibility to protect all information reported under the act very seriously, they have, on several occasions, engaged in litigation in State and Federal court to prevent the release of information reported under the act. The Department has no reason to abdicate this responsibility to maintain the confidentiality of this information.
With respect to cancer reporting, this type and level of cancer reporting is required by the Federal Cancer Registries Amendment Act of 1992.
Comment
Subsections (d), (e) and (k), which require reporting of diseases and conditions of the newborn, sexually transmitted diseases (STDs), lead levels and tuberculosis test results to separate places within the Department (and in the case of tuberculosis, to Allegheny and Philadelphia Counties when the patient resides there), should be deleted. All reports should be made to a single location within the Department.
Response
The Department agrees that a single reporting location should be developed for electronic laboratory reporting, but is unwilling to do so for paper reporting at this time. The Department is, therefore requiring that all laboratory reports that are made electronically be made to the Department's Division of Infectious Disease Epidemiology, with the exception of newborn screening, lead and cancer. The Department intends to phase in electronic reporting by all reporters as has already been discussed.
The Department is addressing paper reporting by changing the requirement in subsection (e) that laboratories making paper reports send the report to the county or municipal department of health where the patient resides. Section subsection (d) now requires the laboratory to send paper reports to the LMRO where the case was diagnosed or identified. This is in keeping with the Department's revisions to requirements for health care providers and practitioners who report on paper. The Department has, therefore, deleted proposed subsection (k), which would have required laboratories to report tuberculosis to either Philadelphia or Allegheny County, depending upon where the case resided, or as a default, to the Division of Tuberculosis and Sexually Transmitted Diseases.
The Department has also made changes to § 27.33 (relating to reporting cases of sexually transmitted diseases). The Department has revised that section to delete special reporting requirements for syphilis, and to require paper reports of sexually transmitted diseases to be sent to the LMRO where the case is diagnosed or identified (see § 27.33(b)) and electronic reports to be sent to the Division of Infectious Disease Epidemiology, Bureau of Epidemiology (see § 27.33(c)). The Department has deleted the reference to § 27.33 from subsection (e).
Comment
The Department should add language that would require laboratories that cannot perform serotyping to mail isolates of salmonella (subsection (f)), Neisseria meningitides (subsection (g)), E. coli isolates (subsection (h)), and H. influenzae isolates (subsection (i)) to the Department. All other laboratories should be exempted from that requirement as they can conduct the serotyping themselves. This would eliminate the need to send a potentially biohazardous specimen through the mail.
Response
The Department has not changed the proposed regulation in response to this comment. The only laboratories that can perform the level of serotyping required by the Department for its disease investigation and surveillance are National reference laboratories, which obtain the necessary reagents from the CDC to perform this testing. However, a commercial National reference laboratory may not be able to perform all the required tests on the specimen. The only laboratory within this Commonwealth that can perform the level of serotyping needed by the Department to conduct its disease surveillance and investigation is the Department's State laboratory operated by its Bureau of Laboratories. The Bureau of Laboratories also maintains the isolates so that the Department can match up disease strains and pinpoint outbreak sources. This enables the Department to control the spread of the disease. Further, the Department does not charge the person submitting the specimen; it does this testing as a public health service.
Section 27.23. Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.
This section requires individuals in charge of certain types of group facilities to report diseases, infections and conditions.
Comment
The language of this section appears to require the same level of reporting for persons in charge of group facilities as is required of health care practitioners and health care facilities. Individuals in charge of group facilities do not diagnose, or treat or examine patients. Does this section intend schools and child care providers to become mini health clinics? What does the Department expect from layperson's reports? Can reports be based on symptoms and suspicions, rather than identification?
Response
As the Department has explained in response to comments on § 27.21a, the Department does not intend to require diagnosis of a disease, infection or condition by those individuals who are not, by training and experience, capable of performing diagnoses, or who are not, by the scope of their licensure, permitted to diagnose. The act and regulations require reporting, not only of a diagnosed case, but also of a suspected case, based on symptoms, appearance and the circumstances surrounding the suspected case. The Department does not expect a layperson to be as aware of diseases, infections and conditions as a health care practitioner or facility, and has changed the language of this section to clarify that. The Department has explained how reports from laypersons are handled in its response to comments on the definition of the term ''health care practitioner'' in § 27.1.
Comment
Why is the phrase, ''except as otherwise set forth in this section'' needed here?
Response
The phrase was included because the section, as proposed, would have required individuals in charge of certain group facilities to report in the same manner as health care practitioners are required to report under § 27.21a. Some of the diseases listed in § 27.21a are reported in a unique manner, however. Lead poisoning, for example, is reported directly to the Division of Maternal and Child Health, rather than to an LMRO. Because the Department has revised this section by deleting the statement that reports are to be made in accordance with § 27.21a, the phrase is no longer necessary. The Department has deleted it from the regulation.
Section 27.25. (Reserved).
This section, which is being deleted by the Department, required licensed health care practitioners other than physicians, including nurses, chiropractors and optometrists, to report the knowledge or suspicion of a communicable disease.
Comment
The Department states that it is deleting this section because it is including the requirements of the section in § 27.21a. The regulations do not say who is to report. This should be clarified.
Response
Section 27.21a clearly states that health care practitioners and health care facilities are to report the listed diseases, infections and conditions. The Department has defined ''health care practitioner'' broadly to include the individuals listed in repealed § 27.25. The Department believes that no further clarification is necessary, and has deleted the regulation, as proposed.
Section 27.30. Reporting cases of certain diseases in the newborn child.
This section requires that reports of MSUD, PKU, primary congenital hypothyroidism and sickle cell hemoglobinopathies be made to the Department's Division of Maternal and Child Health.
Comment
This section should be deleted, since all reports should be made to one central location within the Department.
Response
The Department has discussed the issue of reporting to a central location in its response to general comments on the reporting of cases. However, when electronic reporting for practitioners and facilities as well as laboratories is instituted, § 27.30 is unlikely to be repealed. There are additional considerations with respect to reporting results of metabolic disease testing in the newborn that necessitate continued reporting of these diseases directly to the Division of Maternal and Child Health. If these diseases were reported to a central location within the Department, that location would have to sort these reports out of reports of each of the 52 reportable diseases, infections and conditions, and route them to the Division of Maternal and Child Health. The delay in time that this would cause could be dangerous for the children involved. There is a need for speed in reporting these diseases to the Division, which is responsible for follow-up and referral of children with these conditions. MSUD, for example, within the space of 7 days, can cause severe mental retardation or death.
Comment
Expanding reporting to the four diseases included in the regulations, MSUD, PKU, sickle cell hemoglobinopathies and congenital hypothyroidism is supported, however the regulation should be expanded to include all diseases for which tests are conducted by Neogen, Inc., a company offering an expanded testing panel which is currently used by most birthing hospitals. It is in the epidemiological interest of the Department to monitor the frequency of these diseases for their possible addition to the newborn screening program.
Response
The Department has not changed the proposed rulemaking in response to this comment. The expansion of diseases and disorders reported to the Department's newborn screening program is cautiously and carefully considered on a condition-by-condition basis, based on criteria adopted by the Department and recommended by the Council of Regional Networks for Genetic Services. Before adding diseases and conditions to the list, the Department considers demographic information, the genetic composition of the population, available methodologies, outcomes and economics. The Department will screen for only those conditions for which effective intervention and treatment is available and accessible to all affected newborns. The Department also considers the impact of the required reporting on the program's capacity for follow-up and treatment. A follow-up system must be in place, or able to be put in place, that will ensure that any positive or potentially positive result for a newborn is pursued through to resolution.
The Department does continually review the newborn screening program and the list of diseases and conditions included in that program, and evaluates the need for expansion. At 31 Pa.B. 2271 (April 28, 2001), the Department published proposed rulemaking in which it proposed to add two conditions to the list--galactosemia and congenital adrenal hyperplasia. That rulemaking, upon becoming final, will amend these regulations relating to communicable and noncommunicable diseases as well, to add the two conditions to the list of reportable diseases, infections and conditions. Questions concerning the appropriateness of including diseases and conditions on the list of diseases and conditions for which newborn screening is done are more appropriately addressed through discussion on that rulemaking.
Section 27.32. (Reserved).
This section, which is being deleted, required reporting of AIDS by hospitals and physicians.
Comment
The Department should not delete the section, which includes the requirement that AIDS be reported by hospitals, health care facilities and institutions. Hospitals as well as health care practitioners should be required to report AIDS.
Response
As the Department has stated earlier in its response to comments on proposed § 27.21, the deletion of a requirement that hospitals report cases of AIDS was an oversight, and the Department has reinstated that requirement in § 27.21. The Department's regulations never required that institutions report AIDS.
§ 27.33. Reporting cases of sexually transmitted disease.
This section specifies how health care practitioners and health care facilities are to report cases of sexually transmitted diseases.
This section has been revised in response to general comments that all diseases, infections and conditions should be reported in the location where the individual is, rather than where the individual resides. The Department has changed this section to require that all reports of sexually transmitted diseases be made to the LMRO where the case is diagnosed or identified. This will simplify disease reporting.
Section 27.34. Reporting cases of lead poisoning.
This section includes specific requirements for reporting cases of lead poisoning. The Department has changed the language of the section to clarify its intent that clinical laboratories report elevated blood lead levels (not lead poisoning) as defined by the NIOSH, in persons 16 years of age or older. Currently, that definition is a venous blood lead level of 25 micrograms per deciliter (µg/dL) or higher. The Department will publish updates of this definition in the Pennsylvania Bulletin within 30 days of its notification by NIOSH. See § 27.34(a)(3).
Comment
Reporting of all childhood lead testing analyzed by a clinical laboratory, regardless of the result, is supported. This will give the Department sufficient information to develop appropriate lead testing protocols for this Commonwealth. Reporting by the laboratory is also supported, since all venous and capillary lead testing is done by laboratories.
Response
The Department agrees.
Comment
The requirement that a clinical laboratory report blood lead tests performed on pregnant women should be deleted from subsection (a). A laboratory has no way of knowing whether a specimen for testing is from a pregnant woman. This information is more appropriately reported by health care practitioners, who have access to it.
Response
The Department agrees, and has changed subsection (a) to remove the proposed requirement that clinical laboratories report blood lead results on pregnant women. The Department has included in subsection (a) all requirements for clinical laboratories, and has revised subsection (b) to require health care practitioners and health care facilities to make reports on blood lead levels in pregnant women, since these entities would have access to that information. Subsection (b) also requires that health care practitioners and health care facilities report all blood lead levels, both venous and capillary, on persons under 16 years of age.
Comment
As with newborn screening reporting, all reports of lead poisoning should be sent to one clearinghouse within the Department. This would make it easier for persons and facilities required to report.
Response
The Department has not changed the proposed regulation to address this comment. The Department has addressed the issue of reporting to a central location in its response to general comments on these regulations. Further, the Department currently has in place, and is refining, an electronic system for reporting blood lead levels. When, in the development of its electronic disease surveillance system, the Department finds that it is more efficient and cost effective to include lead reporting within that system, the Department will do so upon 6 months notice to reporters. See § 27.4(b).
Comment
In subsection (a), the Department uses the term ''persons under 16 years of age'' rather than the term ''child,'' which includes anyone 15 years of age and under. The Department should use the term ''child'' in this regulation.
Response
The Department has not changed the proposed regulation to address this comment. Because the Department has revised the definition of the word ''child'' to include persons under 18 years of age, use of the word ''child'' in this section, without any qualifying language, would not be accurate. According to the CDC protocols, reportable lead levels for persons under 16 years of age, and for pregnant women, differ from those reportable for persons 16 and older. This is because the susceptibility to lead poisoning is different in persons of different ages, and lead poisoning is an extreme hazard for pregnant women.
Comments
Subsection (e) provides for referral of a physician under whose authorization blood is collected for a blood lead test to the appropriate licensing board for disciplinary action if the physician fails to provide the necessary demographic information to the laboratory along with the specimen. This subsection is a cause for concern, and should be deleted.
Subsection (h) should be deleted. Subsection (h) requires that a clinical laboratory follow certain procedures to attempt to obtain information necessary for the laboratory's report to the Department when certain information is not included with the specimen. The laboratory has the responsibility to provide a submission form to the person ordering the test that solicits certain information. The responsibility for providing that information belongs to the person ordering the test. Because there are criminal penalties associated with failure to properly report information, as well as the possibility of licensure sanctions, including revocation of a license, a laboratory should not be required to follow the burdensome procedures included in this subsection.
Response
The Department has reconsidered proposed subsections (h) and (i), and has decided that, as proposed, they would place too great a burden upon the clinical laboratory to obtain information from the specimen submitter. It has deleted those proposed subsections. Proposed subsection (e) would have been redundant since, if a physician fails to comply with the regulations on an ongoing basis, the Department may choose to refer the physician for disciplinary action under § 27.6. The Department has deleted proposed subsection (e) as well.
Comment
Subsection (i) requires the laboratory to notify the Department of its inability to obtain information from the specimen submitter as required in subsection (h), and includes in paragraphs (1)--(5) the information the laboratory must provide to the Department with this notice. Paragraph (5) requires the laboratory to provide any other information requested by the Department. This paragraph should be limited to any other information necessary to complete the reporting form.
Response
Since the Department has deleted proposed subsections (h) and (i), no further response to this comment is necessary.
Comment
Subsection (j) provides that a laboratory may be subject to revocation of its license for failure to comply with the subsection, or may be subject to other disciplinary action. To what other disciplinary action does this refer?
Response
Because § 27.6 adequately addresses these issues, the Department has deleted proposed subsection (j) as redundant. Under § 27.6, a clinical laboratory that fails to comply with these regulations may be subject to restrictions being placed upon its permit to operate, or revocation of its license under the Clinical Laboratory Act (35 P. S. §§ 2151--2165). Further, a laboratory that fails to comply with the act and regulations may be subject to penalties in accordance with section 20 of the act (35 P. S. § 521.20) and § 27.8.
§ 27.41a. Reporting by local morbidity reporting offices of case reports received.
§ 27.42a. Reporting by local morbidity reporting offices of completed case investigations.
These sections explain how LMROs are to report.
The Department has revised the proposed sections to reflect its changes to the proposed definition of ''LMRO.''
Section 27.43a. Reporting by local morbidity reporting offices of outbreaks and selected diseases.
This section explains how LMROs are to report. The Department has also revised this section to reflect its changes to the proposed definition of ''LMRO.''
Comment
The Department should review this section, and explain why various diseases have and have not been included in the section.
Response
The Department will address this comment in its response to comments on particular diseases.
Comment
There is no subsection (a) in this section, therefore, the Department should label subsection (b) as subsection (a).
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