RULES AND REGULATIONS
Title 28--HEALTH
AND SAFETY
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 27 AND 211]
Reporting of Communicable and Noncommunicable Diseases
[32 Pa.B. 491] The Department of Health (Department) and the State Advisory Health Board (Board) adopt amendments to Chapters 27 and 211 (relating to communicable and noncommunicable diseases; and program standards for long-term care nursing facilities) to read as set forth in Annex A.
A. Purpose and Background
The Department's regulations relating to communicable and noncommunicable diseases in Chapter 27 were first promulgated in 1959. Since that time, there have been dramatic changes in society, technology and the environment that make revision of these regulations a necessity. 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, within the past several years there have been 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 in recent years there have been 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 that spread from Ohio to Pennsylvania; multidrug resistance to tuberculosis; and the ongoing epidemic of Lyme disease. More recently, concerns relating to the possibility of bioterrorism and the Commonwealth's response have arisen. 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.
The Department, with the approval of the Board, published a proposed rulemaking at 30 Pa.B. 2715 (May 27, 2000), and provided a 30-day public comment period. One commentator raised an issue regarding the telephone number for contacting the Department listed in the proposed rulemaking. The number did not work, and the commentator requested that the public comment period be extended for 1 week. The Department chose not to extend the comment period since the commentator did manage to contact the Department by telephone and provide written comments, and an accurate address for the submission of comments was included in the regulations.
The Department received many comments to the substance of the proposed rulemaking as well. The comments and the Department's responses to them appear in the summary of this final rulemaking.
If a section is not mentioned in the summary, no comments were received on that section, and it was adopted as proposed.
B. Summary
CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES
Subchapter A. GENERAL PROVISIONS General Comments
Several of the general comments that the Department received involved the manner in which the Department requires reporting to be done.
Comment
These reporting requirements would require a separate system that would duplicate, and be less comprehensive and less current as a health promotion tool than the existing reporting system in place for child care centers and group homes regulated by the Department of Public Welfare (DPW), using a child health assessment form, no. CY51. This form uses a Nationally recommended routine preventive health services schedule, including vision, hearing, anemia, growth and lead, health history and physical examination findings as well as documentation of vaccinations. This form should not be duplicated or supplanted by any form or reporting requirements developed by the Department. In doing so, would lessen the effectiveness of the more comprehensive system in place in DPW licensed facilities.
Response
The Department has not changed the proposed rulemaking in response to this comment. The Department is the State agency responsible for disease control and prevention throughout this Commonwealth, and has the authority to require reporting of those diseases, infections and conditions that it, with the review and approval of the Board, determines should be reported to the Department to carry out this responsibility. See generally, the Disease Prevention and Control Law of 1955 (act) (35 P. S. §§ 521.1--521.21). DPW, as the licensing agency for certain facilities, has certain statutory responsibilities, which differ from those of the Department. The information the two agencies gather is different. The Department does not require reporting of vision, hearing, anemia and growth data through its communicable and noncommunicable disease regulations, nor of complete health histories or physical examinations, since the Department is not responsible as part of its disease prevention and control function for the healthy growth and development of each individual within a licensed facility. The Department is responsible for the health and welfare of all the citizens of this Commonwealth. The list of reportable diseases, infections and conditions that the Department determines should be reported, the information included in those reports, and the manner in which the reporting is to be done, are driven by this broader role.
Comment
The reporting requirements are burdensome, since a reporter is first required to determine the appropriate local agency for a patient's residence, or which agency is able to intervene. Then when reporting is made to the Department, the point of submittal differs by the disease being reported. The Department should review the process and explain why this system is necessary.
Response
The Department made some changes to the regulations based on these comments.
The Department will not require, at this point, that all reports be made electronically, and to one location within the Department, given the cost and technological issues involved. The Department has added language to the regulations stating its intent to phase in electronic reporting for all reporters as it implements components of the National Electronic Disease Surveillance System (NEDSS). See § 27.4(b) (relating to reporting cases). At the time this occurs, reports will be made to one location within the Department, or to the appropriate local morbidity reporting office (LMRO).
The Department intends to begin piloting its modifications to NEDSS in several of its health districts in the fall of 2001. As the Department becomes ready to implement its electronic system for the reporting of various diseases, the Department will notify in writing all reporters who are licensed in this Commonwealth (for example, hospitals, physicians, nurses, day care centers, drug and alcohol abuse treatment facilities), and will also publish notice of this requirement in the Pennsylvania Bulletin. Notice will be given at least 6 months in advance of the date on which electronic reporting is to occur.
The Department is providing reporters with the electronic application to be used to make reporting electronically easier and less costly. Further, reporters who may not have access to the Internet may still make initial reports of cases by telephone. When this occurs, the Department explains to the reporter how the complete report should be made. This will continue to occur. See § 27.4(c).
Paper reports of the listed diseases, infections and conditions will continue to be made by reporters, including laboratories, to one of the LMROs, which will consist of the Department's six district offices and the ten county and municipal health departments (local health departments), until the Department notifies reporters that reports must be made electronically.
The Department is currently encouraging electronic reporting by laboratories, because having laboratories report electronically is quicker than paper reporting and makes it easier for the Bureau of Epidemiology (Bureau) to review and disseminate important information to the various Departmental public health programs (the Department's TB program for example), the district offices, and the local health departments that utilize that information for case management and other services. The Department is aware that large National and regional laboratories performing testing for many states find it burdensome to sort Commonwealth reports for transmission to different locations within this Commonwealth. If electronic reporting is done by laboratories, however, the Department is requiring that those electronic reports be made to a single location in the Department.
The Department requires laboratories to report directly to it rather than to the LMROs because many of the laboratory's reports could be reports of repeat testing. Patients may also visit more than one provider and be tested multiple times. The laboratory has no way of knowing whether a test is the initial test a provider orders on a patient or a repeat test, or a repeat test ordered by a second provider. The Department, in the Bureau, is able, with software it possesses, to electronically match information in those reports with information from reports it already received and placed in its Statewide reporting databases. The Department can then identify multiple reports on the same individual and consolidate unduplicated useful information in one case record. Local health departments and the Department's district offices do not have this capability at the present time.
The Department is requiring all reports other than electronic laboratory reports to be made to LMROs for several reasons. For local health departments and the Department to provide follow-up services and information, the local health department or district office should have a relationship with the practitioner-reporter. This required contact by the reporter will enable the reporter to begin that relationship. From the standpoint of efficiency, the requirement will provide the information to enable and expedite case tracking and other services directly to the local health departments and Department staff that do the actual case investigation, follow-up, counseling, referral and partner notification.
Further, to require that all paper reports go to one office within the Department would be burdensome for that office, and would take too long to sort and redirect. Certain reports are time sensitive, for example, reports of diseases of the newborn. A child with maple syrup urine disease (MSUD) must be identified and treatment begun within 7 days of birth or serious impairment to or death of the child will occur. For this reason, the regulation requires those reports to be sent directly to the specific office within the Department with responsibility for managing that disease, infection or condition.
With respect to issues involving the requirement of multiple reporters, the Department requires reporting from all different types of reporters, including practitioners, facilities, laboratories, other providers and the public for several reasons. The Department does not want possible reporters to self-censor, based on their assumption that another person will make the report. That could lead to under-reporting, and jeopardize the ability of the public health system to positively impact the health of infected individuals and their contacts. If the Department and local health departments are unaware of cases, they will be unable to offer or provide follow-up, including counseling and referral information, and perform case investigation.
The Department also receives different information from different reporters. For example, a report by a laboratory is a confirmatory report of a disease or condition diagnosed by a health care practitioner. From heads of institutions the Department will receive information that is neither a diagnosis nor a confirmed report, but a suspicion that may help to identify a disease outbreak. The monitoring of the disease in the patient is dependent on receiving information from a practitioner as well as a laboratory, as is the monitoring of the disease in the population as a whole. Information relating to opportunistic infections, referrals, mode of transmission and treatment are not shared by a practitioner with the laboratory, and, therefore, the Department would not be able to obtain this type of specific information from laboratories if laboratories alone were to report. A provider would not release this type of information to a laboratory because of its confidential nature. A laboratory does not need to be aware of the mode of transmission of a disease or types of referrals made for the individual to perform its licensed function--conducting laboratory tests of specimens.
The more specific the information received by the Department from all reporters, the more likely it is that the Department will be able to match information obtained from other sources, sometimes incomplete, and obtain complete information on each reported case. The more complete the demographic picture of the individual whose results are being reported, the easier it is for the Department to track the disease in this Commonwealth for purposes of implementing prevention measures, including targeting funding to affected populations. Further, the more complete the information on a specific individual the Department obtains, the easier it becomes for the Department and local health departments to provide follow-up services to that individual. For example, with a case of infectious tuberculosis, the Department will provide treatment, including directly observed therapy, to ensure that the case is cured, and will also locate and test and treat contacts as necessary. In the case of sexually transmitted diseases, the Department and local departments locate and offer counseling and testing services to partners of individuals who test positive.
Section 27.1. Definitions.
This section explains the terms used in Chapter 27.
The Department has revised the proposed definition of ''LMRO--local morbidity reporting office'' to match the language proposed for this term at 31 Pa.B. 2126 (April 21, 2001). The Department believes that the offices receiving reports should be limited to those local health authorities with the greatest experience in this area. These include only the Department's six district offices and the ten local health departments.
Comment
There are many different definitions of the term ''child'' used in this Commonwealth. The Department should explain why it has defined ''child'' as a person 15 years of age or younger.
Response
The Department took its definition of ''child'' from the definition of ''child'' used by DPW in its definition relating to day care (see 55 Pa. Code Chapters 3270--3290). The Department has since been informed by the DPW that DPW's definition of ''child'' may change during the revision of DPW's regulations on these topics. The Department has, therefore, reviewed its definition, and has determined that it would be more appropriate in the context of these regulations to define a child as a person under 18 years of age. When the regulatory context requires a different age limit, for example, in the area of newborn screening, the language of the regulation will reflect that fact.
Comment
The definition of ''child care group setting'' properly encompasses all types of group care in this Commonwealth, since group care among young children increases their exposure to and risk of contracting a communicable disease. By defining this term broadly, the Department has appropriately addressed that risk. However, the definition should be adjusted to account for the practical limitations of checking vaccination status in settings where group care is transient and infrequent, for example, in day care provided during church services, court proceedings, in shopping malls and other temporary settings. The Department should modify the regulations to apply where four or more children unrelated to the operator receive care for 10 or more hours in any week, or for 40 or more hours in any month.
Response
The Department has not changed the definition. It was not the Department's intention to capture all the types of care settings discussed by the commentator through its regulations relating to immunization in child care group settings. The Department has included in § 27.77 (relating to immunization requirements for children in child care group settings) a provision which states that a caregiver who does not serve as a caregiver for at least 40 hours in at least 1 month is not covered by the regulation. See § 27.77(d)(iii).
Comment
The definition of ''communicable disease'' is broad. Does this mean that if a disease is not listed in the regulations, it will not be regulated? Can a facility determine its own procedures for control of a nonlisted disease?
Response
The definition of ''communicable disease'' is intended to be broad; the definition is taken from the act, which defines the term broadly. The Department has revised the definition to clarify it, and to make it clear that it is not the act of transmission that makes the disease communicable, but that fact that it is capable of being transmitted to a susceptible host.
If the disease is not listed in the regulations as a reportable disease (defined by the act as any communicable disease made reportable by regulation), it still comes under the act and regulation if there is an outbreak of that disease. A nonlisted disease becomes reportable if an outbreak of that disease occurs. ''Outbreak'' is defined as ''any unusual increase in the number of cases of a disease, infection or condition, whether reportable or not as a single case, above the number of cases that a person required to report would expect to see in a particular geographic area or among a subset of persons (defined by a specific demographic or other features).'' See § 27.1 (relating to definitions).
With respect to the question concerning control procedures for a nonlisted disease, if there is not an outbreak of the nonlisted disease, the Department will most likely not be involved in the matter (unless requested to do so by the facility). If an outbreak is reported, the Department will be involved in the investigation, and will provide recommendations regarding disease control and prevention.
Comment
The definition of ''health care facility'' is not clear. It contains a provision excluding an office used primarily for the private practice of a health care provider where no clinically related health care service is offered. The Department should add a definition of ''clinically related health care service'' to clarify the definition.
Response
The Department's intention was to use the definition of ''health care facility'' from the Health Care Facilities Act (35 P. S. §§ 448.101--448.904b). It has revised the definition to reflect the definition applicable to Chapter 8 of that statute (35 P. S. §§ 448.801--448.821) (relating to licensure of health care facilities). The phrase, ''clinically related health care services,'' was in the definition of ''health care facility'' used in the certificate of need provisions in Chapter 7 of that statute (35 P. S. §§ 448.701--448.712), which sunset in December of 1996. The Department has deleted that phrase from the definition in this section, and has revised the definition to reflect the language in Chapter 8 of the Health Care Facilities Act. The Department has expanded that definition to include drug and alcohol abuse treatment facilities as health care facilities for the purposes of these regulations. The client population in drug and alcohol abuse treatment facilities is particularly susceptible to certain communicable diseases, for example, tuberculosis. The need to control the spread of disease in this population is acute.
Comment
The definition of ''local health authority'' does not include a sanitary board. Unless sanitary boards fall under some other definition, they should be included here.
Response
The Department agrees, and has added language to the definition of ''local health authority'' to include sanitary boards.
Comment
The Department should add language to the definition of ''local health department'' stating that the Department will revise the list when a local health department is closed, as well as when one is established. This language should then be moved to § 27.4 (relating to reporting cases), since the provision is a substantive one.
Response
The Department agrees that its list of local health departments should be revised when local health departments are closed, as well as when they are established. The Department is removing the language from the regulation altogether, however, as the Department's intention to maintain this list need not be included in the regulations. The Department will maintain a list of local health departments and will update the list when any change occurs.
Comment
The definitions of ''modified quarantine,'' ''segregation'' and ''surveillance of contacts'' appear in two places in the regulations. They are repeated at 30 Pa.B. 2730 and 2731.
Response
The definitions of these terms were not repeated. They were bracketed at 30 Pa.B. 2730 to identify language that the Department was proposing to remove from the definition of ''quarantine,'' which had included definitions for all three terms. The Department has revised the definition of ''quarantine'' to remove definitions for ''segregation,'' ''modified quarantine'' and ''surveillance.'' The Department has separately defined ''segregation'' and ''modified quarantine,'' and has added a definition for ''surveillance of disease.'' These changes are made because of the importance of each term in performing disease control.
Comment
The term ''surveillance'' has two different meanings. One meaning appears in the context of surveillance of disease, the other in the context of surveillance of contacts. The Department should change the term ''surveillance of contacts'' to ''monitoring of contacts'' to take these differences into account.
Response
The Department agrees and has amended this section accordingly.
Comments
The definition of ''health care practitioner'' as written will include first responders, emergency medical technicians, prehospital registered nurses and paramedics. The training provided to these individuals will not necessarily prepare them to diagnose the diseases listed in the regulations. There will need to be a revision to training requirements to allow them to do this. Since patients are taken to hospitals, staff in emergency rooms will handle this reporting more appropriately. The Department should exempt persons identified in the Emergency Medical Services Act (35 P. S. §§ 6921--6938) from being required to report, or should provide immunity from the reporting requirements.
What does the Department expect in reports from laypersons? Can reports be based on symptoms and suspicions, rather than identification?
Response
Neither the act nor the regulations condition reporting solely based on diagnosis of disease. It is not the Department's intention to require layperson, or health care practitioners who are not trained or permitted by the scope of their practice, to make diagnoses. The act requires that knowledge or suspicion of a disease be reported. See 35 P. S. § 521.4 (relating to reports). If a first responder, emergency medical technician, prehospital registered nurse or paramedic has reason to believe, through symptoms or for other reasons, that an individual has a reportable disease or condition, those individuals are required to report. A report from a layperson could include that person's observations of the physical state of the individual, or could be a relating of the person's concerns that the individual is exhibiting something unusual that should be reported to the Department. The Department will then ask the layperson questions designed to elicit information which will allow the Department to make a determination of what further action is necessary, if any.
As previously discussed, the Department intentionally drafted these regulations to require reporting from as many types of individuals as possible, even when reporting could be duplicative.
Comment
Does a certified nurse's aide (CNA) have to report communicable diseases?
Response
A CNA is required to report the listed diseases, infections and conditions to the same extent that any member of the public is required to report.
Comment
The Department should define the terms ''pupil,'' ''school,'' ''school employee'' and ''child care provider.''
Response
The Department has replaced the term ''pupil'' with the term ''child'' or ''children'' throughout Chapter 27. Child is defined in the regulations. The Department has been unable to locate the terms ''school employee'' or ''child care provider'' in the regulations. The Department has not defined the term ''school'' since this is a term used throughout the Public School Code of 1949 (24 P. S. §§ 1-101--26-2606-B), and the regulations promulgated under that statute by both the Department (see Chapter 23 (relating to school health)) and the Department of Education (see 22 Pa. Code (relating to education)).
Comment
The Department should simplify the definition of ''outbreak.'' An outbreak should be defined as the excess of the expected incidence of disease within a particular geographic area or population in a specified time period. This definition comes from the Epidemiological Handbook published by the Association of Professionals in Infection Control and Epidemiology (APIC).
Response
The Department disagrees with this comment. The definition of ''outbreak'' used by the Department in its regulations is the definition of the American Public Health Association (APHA) and is a more universally accepted definition for this term. The Department has not changed the definition.
Comment
The definitions of ''communicable disease,'' ''isolation,'' ''local health officer,'' ''quarantine'' and ''reportable disease'' differ from the definitions of these terms included in the act. The Department must explain why these definitions have been changed.
Response
The Department has not changed its regulation in response to this comment. Since the statute was enacted in 1955, the meanings of these terms have been refined by public health practice. The Department has updated the language used in the statute, to clarify the meaning of these terms, but has not substantively changed them.
Comments
The definition of the term ''isolation'' should be clarified since it appears that the language could be interpreted to require isolation of any patient or resident with a communicable disease.
The Department should include the factors and situations used in determining whether the patient, resident or animal should be separated, and what degree of separation is required. This should be done in § 27.61 (relating to isolation) and not in the definition of the term ''isolation'' in this section.
Response
The Department has not changed the proposed definition of ''isolation.'' The purpose of § 27.61 is to enable the Department or a local health authority to isolate a patient or resident with a communicable disease, depending upon the circumstances of the case. Whether isolation will occur, and what form it will take depends on the nature of the diagnosed disease, the characteristics of the individual (including how the individual is complying with disease control requirements), and the type of facilities available. However, a general determination of what control measures are necessary, not just decisions of how isolation would be effected, is based upon these considerations. Therefore, the Department has changed the language of § 27.60 (relating to disease control measures) to include the relevant considerations, rather than § 27.61, which relates specifically to isolation.
Section 27.3. Reporting outbreaks and unusual diseases, infections and conditions.
This section requires the reporting of outbreaks of disease, and the incidence of any unusual disease, infection or condition by any person who suspects a public health emergency.
Comment
Is reporting of an unusual disease, infection or condition required when it is suspected or when there is a microbiological or other test, such as sputum smear, confirming the presence of the disease or infection? The Department should provide specific instructions with respect to reporting these matters.
Response
The Department has not changed the proposed rulemaking. This section specifically requires reporting of an unusual disease, infection or condition whenever a person suspects a public health emergency. The existence of a confirmatory laboratory report or other test is not required. This section is intended to reach anyone who may suspect that a public health emergency is occurring, regardless of whether that person has access to confirmatory test results. The instructions on how to report are included in § 27.4.
Section 27.4. Reporting cases.
This section explains generally how and where reporting of diseases is to occur.
Comment
Will the Department provide health care facilities and health care practitioners with a list of address or phone number changes if there is a move of the locations to which diseases and conditions are to be reported? Will the Department notify individuals of the changes?
Response
The Department will provide a list of addresses and telephone numbers for the LMROs and the specific Department offices to which certain specified diseases are to be reported. The Department will publish this list in the Pennsylvania Bulletin, and update it when it becomes necessary. The Department will also provide the list upon request.
Subsection (d), proposed as subsection (b), does contain the official names of the offices in the Department to which reports may be made. Individual regulations relating to specific diseases, infections or conditions specify to which of these offices the report is to be made. Although the names of the specific offices may change, the Department address, P. O. Box 90, Harrisburg, PA, will not.
Comment
Subsection (a) requires health care facilities and health care providers to report cases to the local health authority where the individual resides. It is easier to report to the local health authority where the practitioner or facility is, rather than to determine to which local health authority to report. The local health authority then determines where to report. This is currently being done.
Response
The Department agrees, and has changed the regulation as recommended.
For clarification, subsection (a) refers to LMROs, and not local health authorities. An LMRO includes county/municipal health departments and the Department's six district offices, excluding all other local health authorities.
Comment
Clinical laboratories reporting electronically should be sending all reports, except cancer reports, to a central location. Proposed subsection (b)(2)--(7) which requires reporting to specified offices within the Department, should be deleted.
Response
The Department has made some changes to the proposed rulemaking in response to this comment. The changes go beyond what type of reporting is required by laboratories, since this section addresses reporting of all reporters. Cases of cancer, AIDS, PKU, MSUD, hypothyroidism, sickle cell hemoglobinopathies and lead poisoning will still be reported to the particular office designated in the sections relating to reporting those matters. See, for example, § 27.33 (reporting cases of cancer). If and when the Department becomes ready to integrate reporting of these diseases, infections and conditions into its electronic disease surveillance system, the Department will publish notice of that fact 6 months before the change in reporting is to occur. Until that time, reports of these diseases infections and conditions will continue to be made to specific offices within the Department. The remainder of the reportable diseases, infections and conditions listed in Subchapter B (relating to reporting of diseases, infectious and conditions) will, however, either be reported to the LMRO where the case is diagnosed or identified, in the case of paper reports; or to the Division of Infectious Disease Epidemiology, in the case of electronic reporting by laboratories. The Department has therefore deleted proposed subsection (b)(3)--(5) in what is now subsection (d).
Comment
Proposed subsection (c) requires reporting to be done using the appropriate case format. The Department should explain what the case format is.
Response
Proposed subsection (c) is adopted as subsection (e). The Department, as part of a National effort, is developing a web-based disease reporting system with a generic report format that will capture disease specific information. However, providers will still be able to make initial reports by telephone if their financial considerations or lack of state-of-the-art reporting equipment so dictates. The Department provides paper case report cards to reporters. These cards, when returned to the Department, provide basic information regarding the case, and enable the Department to begin its case investigation.
Section 27.5a. Confidentiality of case reports.
This section states the general rule that all information gathered by the Department and local health departments under the act is confidential and will not be released, and also states the limited exceptions to that rule.
The Department received no comments on this section, but has added language to clarify that only those employees of the Department and local health departments who have a legitimate reason to view the information may do so.
Section 27.6. Disciplinary consequences for violating reporting responsibilities.
This section states that a licensed facility or practitioner who fails to comply with the regulations may be referred to the appropriate licensure board for disciplinary action.
Comments
The Department has no legislative authority to threaten that disciplinary action might be taken against a practitioner's license as a result of the practitioner's failure to report in any particular instance. The provision should be deleted.
The Department should modify its regulations to state that only a willful violation of the regulations or a demonstrated pattern of noncompliance will be reported to the appropriate disciplinary board, since the reporting requirements are complex.
Response
The Department has not changed the proposed rulemaking in response to these comments. The Department does not need specific legislative authority to refer a failure to comply with the law of the Commonwealth to a disciplinary board or licensing agency. The decision to take action is up to the disciplinary board or licensing agency. Further, these reporting requirements, with very little change, have been in place since 1955. The Department has written the regulation to apprise practitioners that the Department has the discretion to refer a practitioner's failure to satisfy reporting responsibilities to the appropriate licensure or disciplinary board. The Department's decision to do so would be based on all the circumstances involved in the case, including the nature of the violation, and whether it is part of a demonstrated pattern of noncompliance.
Comment
The language in the regulation that refers to disciplinary consequences against a physician who fails to report is troublesome. There is not sufficient detail in the regulations to understand under what circumstances disciplinary consequences would occur, whether there is an appeal process and what actions would be taken against physicians. If the Department wishes to increase reporting, it should establish a simple process for doing so that is available 24 hours-a-day, 7 days-a-week.
Response
As already stated, the regulations state that a physician's failure to report may be referred to the appropriate licensing board. That board, if it found sufficient reason to take action, would provide the necessary due process requirements. The Department itself cannot take disciplinary action against a physician. The Department does, however, have the authority under the act to institute a prosecution to fine someone who fails to comply with the act.
With respect to the comment regarding a continuous reporting system, the Department currently maintains on-call staff to respond as quickly as possible, 24 hours-a-day, 7 days-a-week, to reports of those diseases and infections that require immediate intervention. The Department's electronic reporting system will allow for 24-hour reporting of all diseases, infections and conditions even though the regulations do not require 24 hour reporting for all diseases, infections and conditions.
Comment
There should be a more aggressive educational approach toward improved physician reporting of diseases. Disciplinary action should not be taken against practitioners for failure to report. Subsection (c) should be deleted.
Response
The Department has not changed the proposed regulation in response to this comment. While the Department agrees that education is necessary, and is pleased with the commentator's willingness to aid in this undertaking, the Department believes it is important to underscore the necessity of prompt and complete reporting for every reportable disease and condition. Subsection (c) states that the Department may refer a practitioner's failure to report to the appropriate disciplinary board for action; it is not the Department's intention to do so unless the action is repeated and flagrant. It is up to the licensing boards, of course, to investigate and determine whether disciplinary action is necessary under the terms of the relevant statutes, for example, the Medical Practice Act of 1985 (63 P. S. §§ 422.1--422.45) and the regulations promulgated thereunder.
Comment
This section does not contain disciplinary consequences for child care group settings.
Response
The Department agrees that language relating to child care group settings parallel to that for other licensed facilities and practitioners should be included in the regulation. The Department has added that language stating that the Department may refer the child care group setting to the appropriate licensing agency for appropriate action. The decision to take action would then be up to that licensing agency.
Comment
Will there be an expected order of reporting, so that one person reports first, another reports second, and so on? If one report is filed, does every other person connected with that case have to file a report? Who is required to file what reports?
Response
Who is required to report what is clearly set out in the Department's regulations. The reporting responsibilities in the Department's regulations are categorized by the type of person or entity that is required to report them. For example, § 27.22 (relating to reporting of cases by clinical laboratories) lists the diseases, infections and conditions clinical laboratories are required to report. Section 27.21a (relating to reporting of cases by health care practitioners and health care facilities) lists the diseases, infections and conditions health care practitioners and facilities are required to report.
The Department has already addressed why multiple reports of the same case are required when multiple persons have knowledge of the case.
Comment
Do reporting practitioners have to communicate to other involved health care practitioners that a report has been made? Do reporting practitioners have to report the findings in a timely manner to other health care practitioners that need to know the information?
Response
The Department's regulations do not require reporting to any entity other than the Department or an LMRO.
Comment
A clinical laboratory must rely upon information provided by other individuals to comply with the regulations. Information that is not provided to the laboratory when solicited will result in a failure to comply with the regulations. The Department should add the following language ''unless due to circumstances beyond the control of the clinical laboratory,'' to the end of subsection (a).
Response
The Department agrees that the clinical laboratory should not be responsible in situations when the solicited information is not forthcoming. The Department has added the recommended language to subsection (a).
Section 27.7. Cooperation between clinical laboratories and persons who order laboratory tests.
This section requires laboratories to give a person requesting a laboratory test a form on which information necessary for the laboratory to complete a case report can be provided to the laboratory. The section also requires the person ordering the test to provide the laboratory with the information solicited by the form that the person ordering the test currently has or may readily obtain at the time the test is ordered.
Comment
The Department should clarify who ''the person requesting the test'' is. Is there a difference between the person ordering the test, and the person requesting the test. The Department should use one term or the other. In a long term care setting, the person who orders the test is the doctor, however, a nurse fills out the requisition for the test.
Response
Nurses as well as doctors have reporting responsibilities under the act and these regulations. This section, however, does not focus on reporting responsibilities, but, rather, states requirements for what information should be included with the order for the test. The person ordering the test must provide the necessary information to the laboratory so that it, in turn, can fulfill its reporting responsibilities to the Department. If, to do this, the staff of the facility or office must provide information, or fill out the form, then they should do so. It is, however, the responsibility of the person ordering the test to ensure the necessary information is present. In the example presented by the commentator, this would be the doctor who orders the test, not the nurse or other person who prepares the form requesting the test. The Department has changed the regulation to clarify this.
Comment
If the laboratory is to provide the appropriate laboratory requisition slips, who is responsible for obtaining them? In a long-term care setting, the long-term care provider contracts with a laboratory for services and has no control over the laboratory. Frequently results are delayed in reporting and real and potential problems in communications exist between the laboratory and the long-term care provider. The regulations should take these concerns into account.
Response
The Department has not changed the proposed regulation in response to this comment. The question of who is responsible for obtaining laboratory slips and communications between a laboratory and a health care practitioner should pose no problems in reporting. The health care practitioner or facility required to report is to do so as soon as there is a clinical determination that a reportable disease, infection or condition exists. There is no need to wait for laboratory confirmation of the disease, infection or condition.
Section 27.8. Criminal penalties for violating the act or this chapter.
This section reiterates the penalties for violation of the act and regulations included in sections 19 and 20 of the act (35 P. S. §§ 521.19 and 521.20).
Comment
This section includes penalties for persons with tuberculosis and other communicable diseases who fail to comply with the act and regulations. These penalties will not serve as a deterrent against leaving facilities, particularly if a person is destitute or homeless. This section is not enforceable, or in the best interests of quality care. A hospital cannot detain these people, and local law enforcement will not take any action.
Further, it is unclear whether these incidents should be brought to the attention of the State or a local health department. The Department should provide guidance about what is to be done when a person leaves a facility against advice.
Response
The Department has not changed the proposed regulation to address this comment. This section reiterates penalties for violations of the act and regulations that are contained in sections 19 and 20 of the act. The Secretary of Health is given broad powers to enforce the law and these regulations, particularly the law and regulations relating to quarantine:
He may issue warrants to any sheriff, constable or policeman to apprehend and arrest such persons who disobey the quarantine orders or regulations of the department of health. Every warrant shall be forthwith executed by the officer to whom directed, who shall make due return of the execution thereof to the [Secretary]. (71 P. S. § 1402).Although the Department has not in recent history sought imposition of these statutory penalties, and agrees that illness should not be criminalized, it has used the threat of penalties to obtain cooperation from individuals who have been and could continue to be noncompliant with treatment and control measures. This has been done with the cooperation of law enforcement officials, who are required, by law as discussed previously, to cooperate with the Secretary in these matters.
It is not the Department's intention to make the facility responsible for detaining a patient. It is the Department or local health department that is responsible for ensuring patient compliance. If the facility is within the geographic area over which a local health department has jurisdiction, it should call that local health department regarding these incidents. The facility, when in doubt, may always call the Department, which can determine where jurisdiction lies. Intervention by the departments after notification at the earliest possible time of all suspected and confirmed cases of tuberculosis will provide the departments the opportunity to take necessary action, including petitioning courts for aid, if necessary, to detain noncompliant patients. The act gives the Department, or, depending upon the location of the patient, the local health department, the authority to take action when a patient refuses to be tested for a communicable disease, or is noncompliant with the orders of the Department or local health departments regarding the treatment and control of that disease. See sections 7 and 11 of the act (35 P. S. §§ 521.7 and 521.11). When an individual agrees to treatment at a particular facility, or is court-ordered to treatment in a particular facility recommended by the Department, the Department pays the facility according to contracts it has with that facility. The Department has, on occasion, provided funds for security to enforce the quarantine.
Comment
There is concern about the extended period of time acute care hospitals are used essentially to house tuberculosis patients that require isolation or are noncompliant. The payer may determine that this is not medically necessary, so that hospitals are not getting reimbursed at the level needed to care for these patients. The Department should develop alternative placement arrangements for patients who no longer require hospital services. The Department should also address reimbursement issues with governmental and commercial payers.
Response
As stated previously, with respect to individuals with whom the Department is involved, the Department contracts with facilities for the provision of care at a rate agreed upon in the contract. The Department relies upon its contracted tuberculosis consultant physicians to advise upon the time limitations of the quarantine. Any hospital that does not wish to provide these services need not enter into a contract with the Department. If hospitals are unhappy about third-party reimbursement rates, for example, Medical Assistance rates, hospitals must address those issues with the responsible agencies, not the Department. These regulations are not an appropriate venue for those conversations. If a hospital has an issue with anything done by a local health department with respect to tuberculosis, the issue should be addressed with that health department.
Comment
The Department must believe that there is considerable lack of compliance to justify criminal penalties. The regulations must be very specific concerning who is to take what action and how the action is to occur, since failure results in criminal penalties.
Response
The Department has not changed the proposed rulemaking to address this comment. The referenced penalties are all taken from the act. The requirements for reporting are carefully defined in the act and regulations. Since most of these requirements have existed for 50 years, compliance should not be difficult. The Department is currently considering how to provide educational sessions for persons who believe a ''refresher'' course in reporting would be useful.
Section 27.9. Authorized departures from the regulations.
The proposed section stated that the Department could decide against enforcing a provision of the regulations when it determines, with the agreement of the Board, that the provision is outdated, and that waiving the provision would be necessary to protect the health of the people of this Commonwealth.
Comment
The Department can only amend regulations by promulgating new rulemaking. The Department should add language to state that if the Board affirms, the Department will amend the regulations, or should explain its statutory authority for amending regulations without going through the regulatory process.
Response
The Department has not adopted the proposed section. The provision was not intended to allow the Department to amend its regulations without rulemaking. The Department was only announcing its intention to, upon the approval of the Board, cease enforcing certain regulations that are not parallel to a statutory requirement, when those regulations are outdated.
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