[32 Pa.B. 491]
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This section should be deleted, since a separate section for standards is not required. Diagnostic tests for all diseases should be done following standard or approved test procedure, including using Food and Drug Administration approved tests when applicable.
The Department has not changed the proposed regulation in response to this comment. The act requires that the standard or approved test procedures for each of the sexually transmitted diseases be a test approved by the Department, and that if a laboratory test is part of the approved procedure, it should be done in a laboratory approved by the Department to make the tests. See 35 P. S. § 531.12.
Section 27.97. Treatment of minors.
This section includes language from section 14.1 of the act (35 P. S. § 521.14a) and section 3 of the act of February 13, 1970 (P. L. 19, No. 10) (35 P. S. § 10103), both of which provide for a minor to give effective consent for certain medical and health services without the consent of any other person. Section 14.1 of the act and section 5 of the act of February 13, 1970 (35 P. S. § 10105) also state that a physician who provides treatment under the given circumstances is not liable for properly administering appropriate treatment to the minor.
The Department should add language to this section defining health services to include venipuncture and clinical laboratory testing. The section should also state that a laboratory may not be sued or held liable for venipuncture or testing services if the minor consents.
The Department has not changed the proposed regulation in response to this comment. Under statute, a minor can give consent for ''medical and health services to determine the presence of or to treat pregnancy, and venereal disease and other diseases reportable under the [act] . . . .'' (35 P. S. § 10103). Since neither the Department nor local health authorities enforce this statutory provision, it is up to the individual health care provider to determine whether the phrase, ''to determine the presence of'' would include venipuncture and laboratory testing, so that consent of a minor would be sufficient. The Department cannot provide clinical laboratories with immunity through regulation. Only the General Assembly can grant immunity, which it has done in this case to physicians who act appropriately under the statute, and provide appropriate treatment. See 35 P. S. §§ 521.14a and 10105. The legislature has not seen fit to extend that immunity to clinical laboratories.
This section raises serious concerns. The regulations the Department is amending allow for consent for treatment for venereal disease, however, these regulations broaden it to all communicable diseases. A minor could give consent to a cancer workup without parental consent. The Department must be cognizant of parental rights. There should be further legal review of this section.
Further legal review is unnecessary. The General Assembly has already directed through the act of February 13, 1970 (P. L. 19, No. 10) (35 P. S. §§ 10101--10105) that a minor may consent to medical and health services for pregnancy, sexually transmitted diseases, and other diseases reportable under section 3 of the act of February 13, 1970, or when an attempt to secure consent would result in delay of treatment which would increase the risk to the minor's health under section 4 of the act of February 13, 1970 (35 P. S. § 10104). The regulation tracks these statutes. The Department has not changed the proposed rulemaking.
Section 27.98. Prophylactic treatment of newborns.
This section requires the application of certain medications to the eyes of a newborn child, unless the parent or guardian objects for religious reasons.
The Department should add ''or if in the opinion of the attending physician treatment is not advisable,'' before the phrase ''prophylactic treatment shall be withheld.''
The Department agrees with the comment. The addition of the language is necessary to take into account the health and safety of the newborn. The Department has added the language to the regulation.
Section 27.99. Prenatal examination for hepatitis B.
Subsection (a) requires a pregnant woman to undergo immunologic testing for the presence of hepatitis B antibodies, but permits her to object to the testing on religious grounds. Subsection (b) requires that, if the mother tests positive for hepatitis B surface antigens, the baby receive prophylactic treatment, and again provides a religious exemption.
The Department should delete the religious exemption from subsection (b). No parent has ever expressed a religious objection to treating the infant for exposure to its mother's hepatitis B to prevent chronic disease in the infant. It seems unlikely that this could be challenged in court.
The Department has not changed the proposed regulation in response to this comment. The fact that the commentator is not aware of the challenge of any parent or guardian to this treatment of the newborn does not mean that a parent or guardian does not have the right to reject medical care for the child. The Department must take that right into account in writing its regulations, and cannot mandate the treatment of the infant in this instance. The regulation does not prevent the hospital or attending physician from challenging the objection of the parent or guardian in a court of law, if they feel it is necessary to do so.
Subchapter E. SELECTED PROCEDURES FOR PREVENTING DISEASE TRANSMISSION.
Section 27.151. Restrictions on the donation of blood, blood products, tissue, sperm and ova.
This section sets standards for the donation of certain materials from the human body.
In subsection (a), the Department should add the words ''or suspected'' to the phrase ''a person known to be infected with the causative agent of a reportable disease . . . .''
The Department agrees with this recommendation, and has added the words ''or suspected of being'' to the regulation.
In subsection (b), the Department should add ''from a person known or suspected of being infected with the causative agent of a reportable disease'' before ''for donation'' and ''and'' before ''without obtaining.'' If the donor who has the infection is prohibited from donating, the receiving agency should also be prohibited from accepting the donation. Screening tests will prevent donations from persons with HIV, hepatitis B and C, but from none of the other diseases.
The Department agrees with the comment, and has added the recommended language ''from a person known or suspected of being infected with the causative agent of a reportable disease.''
Section 27.152. Investigation of cases and outbreaks.
This section states that the Department or a local health authority may investigate any case or outbreak that either believes is a potential threat to the public health. It also requires cooperation with the investigator from health care practitioners, facilities, other institutions and the public, provided that the representative presents documentation establishing that he is an authorized representative.
What type of documentation is required to establish that the person is an authorized representative of the Department or a local health authority? Is a name tag sufficient to meet this requirement?
An official form of Department or local health authority identification would be sufficient. Department staff have photo identification cards, but do not wear name tags. A letter bearing official signatures would also be sufficient. For example, Department staff will often carry a letter from the Secretary of Health on Department stationary when attempting to require compliance with a drug treatment regimen for tuberculosis. Any method which clearly establishes that the person performing the investigation is a representative of the Department or a local health authority is acceptable.
Section 27.153. Restrictions on food handlers.
This section limits the ability of persons with the listed diseases or conditions to work as food handlers.
The Department should reconcile the requirements of this section and of § 27.154 (relating to restriction on caregivers in a childcare group setting) with the CDC's Personnel Health Guidelines that specifically deal with the prevention of nonsocomial transmissions of selected infections. In particular, the Department should reconcile the differences with respect to hepatitis A and diarrhea.
The Department has not changed the proposed regulations to address this comment. The guidelines referred to by the commentator were crafted for hospital settings and are concerned with nosocomial transmissions of disease. The Department sees no conflict between its regulations, drafted to meet more general public health requirements, and those guidelines. The Department is available to provide guidance on these issues as is necessary.
The use of the term ''diarrhea'' in this section and § 27.154 is outdated. That term should be replaced with the term ''gastroenteritis.''
The Department has not changed the proposed regulation in response to this comment. The term ''diarrhea'' most accurately describes the symptom with which the Department is concerned. The term ''gastroenteritis'' is a general description of a variety of illnesses, and does not convey the need for a demonstrative symptom which may be measured.
The Department should add ''or paratyphi'' after ''typhi'' in paragraph (4). The same revision should be made to § 27.154 and § 27.155 (relating restrictions on health care practitioners).
The Department agrees that paratyphi should be added to paragraph (4) of each of these three sections. The Department has revised all three sections accordingly.
Section 27.154. Restrictions on caregivers in a child care group setting.
This section limits the ability of persons with the listed diseases or conditions to work as caregivers in a child care group setting.
Diarrhea should be deleted from the list of conditions that require physician approval for readmission to the child care group setting. A physician will determine whether there has been resolution of the condition by asking the patient if the symptoms have subsided. A child care operator can do this as well as a physician. The requirement for readmission should be retained, but physician approval should not be required.
The Department has not changed the proposed regulation to address this comment. The Department has addressed the comment in its response to a similar comment on § 27.76.
Section 27.155. Restrictions on health care practitioners.
This section limits the ability of persons with the listed diseases or conditions to work as health care practitioners.
The Department should provide education sessions regarding disease reporting across this Commonwealth. There are differences in how various local health authorities and other health departments work with health care practitioners and health care facilities in disease reporting, the presence or absence of a county health department dictates the way diseases are reported, and special requirements for certain diseases exist. It would be beneficial for the Department to discuss its plans regarding electronic reporting, to review the forms required, and to provide contacts and telephone numbers for each county as appropriate.
The Department agrees that education regarding disease reporting would be beneficial, to reacquaint practitioners and facilities with disease reporting requirements. The Department will provide a list of LMROs, which will include the county/municipal health departments, upon request. A more detailed discussion of the Department's plans regarding electronic reporting is included in its response to the general comments on these regulations.
The Department should include a hospital-based infection control practitioner on the Department's task forces or on the Board to ensure that the perspective of health care facilities are considered and addressed.
The members of the Board are appointed by the Governor, and, by statute, must fall within certain specified categories. The Board is to be comprised of 13 members, including the Secretary of Health, five of whom must be physicians, one a dentist, one a pharmacist, one a registered nurse and one an engineer. See section 448 of The Administrative Code of 1929 (71 P. S. § 158). The Department agrees that an individual with experience in facility-based infection control could be an asset to the Board, and will consider recommending such an individual to the Governor for appointment once an appropriate vacancy occurs.
The Department does, however, have doctorate level staff, including physicians, with expertise in infectious disease control. These persons do discuss issues with hospitals and their infectious disease staff.
Is there a more comprehensive way to describe a potentially infectious case of diarrhea versus a 1 day condition due to a known strain of influenza than the language in paragraph (6)? Paragraph (6) also suggests that an evaluation by a physician is necessary for readmission to work as a health care practitioner. The Department may wish to consider defining the term ''resolved.''
The Department's intent was to address only potentially infectious diarrhea in this section, and in §§ 27.153 and 27.154. Therefore, the Department has changed the listed condition to ''persistent diarrhea'' to clarify this intent.
Section 27.158. Special requirements for shigellosis.
This section prohibits household contacts of persons with shigellosis who have certain employment that could expose others to the disease from performing that work until the requirements of the section are met.
The Department should define the term ''household contact'' or provide examples.
The Department has added a definition of ''household contact'' to the definition section of the regulations. The term is intended to apply to any person living in the same residence as a case, whether or not the individual is related.
Section 27.161. Special requirements for tuberculosis.
This section includes standards for the isolation of persons with tuberculosis, and requirements for testing close human contacts of that person.
Subsection (b) defines a close human contact as a person who spends a substantial amount of time with the person who has infectious tuberculosis. The term ''substantial'' should be deleted, and a specific time frame included.
There are no definite guidelines published by the CDC on time frames for determining who is a ''close contact.'' Further, what constitutes ''substantial'' could differ depending upon who the other individuals are and the circumstances surrounding the case. For example, a young child is more susceptible to contracting tuberculosis than an older person, and less time in contact with the infected individual could be necessary for a child to contract the disease. Therefore, it would be impossible to specify a definite time frame in the regulations. ''Substantial,'' as used in this section, means anything more than casual contact. However, the Department must be able to determine who are close human contacts and who are casual contacts on a case-by-case basis, based on the characteristics of the individuals and the circumstances surrounding the contact.
Subchapter F. MISCELLANEOUS PROVISIONS
Section 27.183. Occurrence of psittacosis.
This section requires certain disease prevention and control measures to occur when a case of psittacosis is found in humans or in birds.
The Department should add a subsection (c) that states:''A bird with psittacosis that has been placed under quarantine may not be sold or removed from its isolation quarters until it has been treated for at least 7 days. After 7 days, it may be sold, but the buyer must be made aware in writing with a signed receipt of the significance of psittacosis and the signs and symptoms for which to look. The signed receipt paperwork will include a copy of any documents provided to the new owner, and will be maintained at the place of sale for 6 months after the sale of the quarantined bird. The duration of additional treatment necessary must be established at the time of sale, and a supply of medicated feed sufficient for the duration of the treatment must be provided to the new owner.''
The Department agrees with this recommendation, and has added the language. This requirement is a National practice standard relating to psittacosis, and has been added to the CDC's compendium on psittacosis.
Section 27.201. Disposition of articles exposed to contamination.
This section includes requirements for the disposition of bedding, clothing or other articles that have been exposed to contamination from specific communicable diseases.
The Department should explain why it has deleted certain diseases and added others to this section.
The Department should retain references to smallpox (variola, varioloid) in this section, since there is the possibility of a bioterrorist attack using this infectious agent.
The Department agrees with the latter comment, and has reinstated references to smallpox (variola, varioloid) into this section. Because the Department is not deleting any diseases from the section, no further response to the first comment is necessary.
The Department should explain or reference what a proper precaution to be taken is when there is a transmission of articles that have been contaminated.
Appropriate precautions to be taken to decontaminate articles exposed to smallpox, plague or anthrax so that they may be safely transmitted from one person to another depend upon the circumstances of the case, including the type of disease involved and the manner in which it is spread. The Department and local health authorities do not expect individuals to determine what these appropriate precautions are. The Department will make recommendations concerning what type of precautions are necessary on a case by case basis.
Section 27.202. Lease of premises occupied by a person with a communicable disease.
This section includes requirements for renting out a room, house or part of a house in which a person with a communicable disease has been.
The Department has deleted from this section language that requires these places to be cleaned to the Department's satisfaction. What is the standard of cleanliness that must now be met?
The Department agrees that the original standard provided more guidance than the proposed regulation, and has retained the language it had proposed to delete from this section.
Section 27.203. Preparation for burial or transportation of deceased human bodies.
This section requires persons handling deceased human bodies to take appropriate precautions to prevent the spread of communicable diseases.
The statement that appropriate precautions should be taken is vague. The Department should give examples of appropriate precautions in the final form regulations.
The Department agrees that there is a need for more explicit standards in this section, and has retained the language it had proposed to delete.
CHAPTER 211. PROGRAM STANDARDS FOR LONG-TERM CARE NURSING FACILITIES
Section 211.1. Reportable diseases.
This section lists communicable diseases that long-term care nursing facilities are required to report. The Department is amending this section as has been previously discussed in commentary on § 27.21a.
C. Affected Persons
The amendments impact on health care providers, health care practitioners, clinical laboratories, health care facilities and child care group settings in this Commonwealth. The amendments also impact on local health authorities, including the ten county/municipal health departments. These entities shall comply with the updated disease reporting procedures, which are not, however, significantly different from current reporting requirements.
Additionally, every citizen in this Commonwealth is affected by the amendments as each will benefit from a reduced risk of exposure to, and resulting morbidity and mortality from, infection with the more than 50 reportable diseases, infections and conditions.
All reporters will be affected by the Department's phasing in of an electronic reporting system. Reporting electronically will make reporting easier and more efficient, and, since reporting software and training will be provided at no cost to the Department, will not increase reporting costs for providers.
D. Cost and Paperwork Estimate
The amendments will have no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public because the disease reporting system already exists in this Commonwealth. In fact, the application of Nationally accepted state-of-the art public health practices and communicable disease prevention and control strategies within this Commonwealth should create savings in related health care costs each year. The regulated community and local governments will see a benefit directly proportional to the numbers and types of disease cases prevented, thereby reducing community health care costs. This Commonwealth will also benefit in an amount directly proportional to the numbers and types of disease cases and disease outbreaks prevented, thereby greatly reducing State government health care costs.
The amendments fine-tune an already existing disease reporting system in this Commonwealth and will not result in additional paperwork. Newly listed reportable diseases, infections and conditions will be reported and investigated in a manner similar to the reporting and investigation of currently listed diseases, infections and conditions, using National case-definitions and investigation forms provided by the CDC.
E. Statutory Authority
The Department's overarching authority to promulgate these regulations is found in the act. Section 16(a) of the act gives the Board the authority to issue rules and regulations on a variety of matters relating to communicable and noncommunicable diseases, including the following: the diseases that are to be reported; the methods of reporting diseases; the contents of reports; the health authorities to whom diseases are to be reported; the control measures that are to be taken with respect to different diseases; the enforcement of control measures; the immunization and vaccination of persons and animals; the prevention and control of disease in public and private schools; the treatment of sexually transmitted diseases, including patient counseling; and any other matters the Board may deem advisable to address for the prevention and control of disease and for carrying out the provisions and purposes of the act. Section 16(b) of the act gives the Secretary of Health the authority to review existing regulations and make recommendations to the Board for changes the Secretary considers to be desirable.
There is also legislative authority for specific provisions of the regulations in other statutes. First, section 2102(g) of The Administrative Code of 1929 (code) (71 P. S. § 532(g)) provides general authority for the Department to promulgate its regulations.
Section 2106(a) of the code (71 P. S. § 536(a)) provides the Department with additional authority to declare diseases to be communicable, and to establish regulations for the prevention and control of disease. Section 2106(b) of the code (71 P. S. § 536(b)) provides the Department with the authority to establish and enforce quarantines to prevent the spread of disease, and section 2106(c) of the code gives the Department the authority to administer and enforce the laws of the Commonwealth with respect to vaccination and other means of preventing the spread of communicable disease.
Section 2111(b) of the code (71 P. S. § 541(b)) provides the Board with additional authority to promulgate regulations deemed by the Board to be necessary for the prevention of disease, and for the protection of the lives and the health of the people of this Commonwealth. That section further provides that the regulations of the Board shall become the regulations of the Department.
Section 2111(c.1) of the code also provides the Board with the authority to make and revise a list of communicable diseases against which children are required to be immunized as a condition of attendance at any public, private or parochial school, including kindergarten. The section requires the Secretary to promulgate the list, along with any rules and regulations necessary to ensure the immunizations are timely, effective, and properly verified. The regulations that primarily carry out this responsibility are in Chapter 23, Subchapter C (relating to immunization).
Other statutes speak to the Department's authority to promulgate regulations in relation to specific diseases, infections or conditions. The Newborn Child Testing Act (35 P. S. §§ 621--625) provides the Department with the authority to promulgate regulations listing reportable diseases and conditions in the newborn child, and setting out the operation of a program of screening, follow-up, assessment and diagnosis of newborn children for those reportable diseases and conditions. See 35 P. S. §§ 623 and 625. The Pennsylvania Cancer Control, Prevention, and Research Act (35 P. S. §§ 5631--5637) authorizes the Department to create a cancer registry to which persons in charge of hospitals and laboratories shall report cases of cancer in accordance with rules and regulations adopted by the Department with the advice of the Pennsylvania Cancer Control, Prevention and Research Advisory Board. See 35 P. S. § 5636(b). This legislation has been impacted by Federal legislation which was enacted in 1992, and which requires complete reporting of cancer cases to be made by all health care practitioners, and all hospitals or other facilities providing screening, diagnostic or therapeutic services to patients with respect to cancer. See 42 U.S.C.A. §§ 280e and 280e-1--280e-4. The act of March 3, 1972 (P. L. 102, No. 37) (35 P. S. §§ 1071--1077), known as the Turtle Law, provides the Department with the authority to prohibit a person from bringing, causing to be brought or transporting any live turtle into this Commonwealth, unless the turtle or lot of turtles is accompanied by a permit issued by the Department or another agency authorized by the Department to issue a permit. The permit may only be issued if there is adequate biological proof that the turtles are free from salmonella. The same permit is required when the turtles originate within this Commonwealth.
Several statutes provide the Department with authority to command disease prevention and control measures within certain institutions. Section 803 of the Health Care Facilities Act (35 P. S. § 448.803) provides the Department with the authority to promulgate regulations relating to the licensure of health care facilities, and allows the Department to require certain actions relating to disease control and prevention to occur within health care facilities. Articles IX and X of the Public Welfare Code (62 P. S. §§ 901--922 and 1001--1059), which provide the Department with the authority to license inpatient drug and alcohol abuse treatment facilities, play the same role with respect to the Department's ability to require certain disease prevention and control methods in those facilities.
The Public School Code of 1949 (24 P. S. §§ 1-101--26-2606-B), provides the Department with additional authority for disease prevention and control actions taken within schools. Section 1421(c)(2) of the Public School Code of 1949 (24 P. S. § 14-1421(c)(2)), provides the Secretary of Health, in consultation with the Secretary of Education, with the authority to promulgate regulations implementing the school health program. The requirements of the school health program are set out in Article XIV of the Public School Code, and provide, among other things, that pupils are released from compulsory attendance when they are prevented from attending by the health laws of the Commonwealth (24 P. S. § 14-1417), and that no persons having any form of tuberculosis in a transmissible stage may be a pupil, teacher, janitor or any other employee in a school, unless it is a special school. See 24 P. S. § 14-1418. Section 1303a of the Public School Code (24 P. S. § 13-1303a) provides that the Board will make and review a list of diseases against which children must be immunized, as the Secretary may direct, before being admitted to school for the first time. The section provides that the school directors, superintendents, principals or other persons in charge of any public, private, parochial or other school including kindergarten, shall ascertain whether the immunization has occurred, and certificates of immunization will be issued in accordance with rules and regulations promulgated by the Secretary with the sanction and advice of the Board. Most of the regulations carrying out these responsibilities are set forth in Chapter 23.
F. Effectiveness/Sunset Dates
These final-form regulations will become effective upon final publication in the Pennsylvania Bulletin. No sunset date has been established. The Department will continually review and monitor the effectiveness of these regulations.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on December 8, 1999, the Department submitted a copy of notice of proposed rulemaking published at 30 Pa.B. 2715 to IRRC and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee for review and comment.
In compliance with section 5(c) of the Regulatory Review Act, the Department also provided IRRC and the Committees with copies of all comments received, as well as other documentation.
In compliance with section 5.1(a) of the Regulatory Review Act (71 P. S. § 745.5a), the Department submitted a copy of the final-form regulations to IRRC and the Committees on November 26, 2001. In addition, the Department provided IRRC and the Committees with information pertaining to commentators and a copy of a detailed regulatory analysis form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
In preparing these final-form regulations, the Department has considered the comments received from IRRC, the Committees and the public.
These final-form regulations were deemed approved by the House Health and Human Services Committee and the Senate Public Health and Human Services Committee on December 17, 2001. IRRC met on December 20, 2001, and approved the regulations in accordance with section 5.1(e) of the Regulatory Review Act. The Attorney General approved the regulations on January 9, 2002.
H. Contact Person
Questions regarding these regulations may be submitted to: James T. Rankin, Jr., D.V.M., M.P.H., Ph.D., Director, Division of Communicable Disease Epidemiology, Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 787-3350. Persons with disabilities may submit questions in alternative formats such as audio tape, Braille or by using V/TT (717) 783-6514 for speech and/or hearing impaired persons or the Pennsylvania AT&T Relay Service at (800) 654-5984[TT]). Persons who require an alternative format of this document may contact Dr. Rankin at the address or telephone numbers listed in this preamble so that necessary arrangements may be made.
The Department and the Board find that:
(1) Public notice of the intention to adopt the regulations adopted by this order has been given under sections 201 and 202 of the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1201 and 1202), and the regulations thereunder, 1 Pa. Code §§ 7.1 and 7.2.
(2) A public comment period was provided as required by law and all comments were considered.
(3) The adoption of the final-form regulations in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutes.
The Department and the Board, acting under the authorizing statutes, order that:
(a) The regulations of the Department, 28 Pa. Code Chapter 27, are amended by adding §§ 27.5a, 27.6--27.8, 27.21a, 27.24a, 27.33--27.35, 27.41a, 27.42a, 27.43a, 27.60, 27.76, 27.77, 27.99 and 27.151--27.164; by amending §§ 27.1--27.4, 27.21--27.23, 27.29--27.31, 27.61, 27.65--27.69, 27.71--27.75, 27.81--27.85, 27.87--27.89, 27.95--27.98, 27.181, 27.183, 27.191, 27.192, 27.201, 27.202, 27.204 and 211.1; and by deleting §§ 27.5, 27.24--27.28, 27.32, 27.41--27.47, 27.51, 27.62--27.64, 27.86, 27.90--27.94, 27.101--27.146, 27.184 and 27.205 to read as set forth in Annex A.
(b) The Secretary of Health shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.
(c) The Secretary of Health shall submit this order, Annex A, and a Regulatory Analysis Form to IRRC, the House Committee on Health and Human Services and the Senate Committee on Public Health and Welfare for their review and action as required by law.
(d) The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.
(e) This order shall take effect upon publication in the Pennsylvania Bulletin.
ROBERT S. ZIMMERMAN, Jr.,
Fiscal Note: Fiscal Note 10-156 remains valid for the final adoption of the subject regulations.
(Editor's Note: For the text of a notice pertaining to this rulemaking, see 32 Pa.B. 539 (January 26, 2001).)
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES
Subchapter A. GENERAL PROVISIONS
§ 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
ACIP--The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, United States Department of Health and Human Services.
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Caregiver--The entity or individual responsible for the safe and healthful care or education of a child in a child care group setting.
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Case--A person or animal that is determined to have or suspected of having a disease, infection or condition.
Case report form--The form designated by the Department for reporting a case or a carrier.
Central office--Department headquarters located in Harrisburg.
Child--A person under 18 years of age.
Child care group setting--The premises in which care is provided at any one time to four or more children, unrelated to the operator.
Clinical laboratory--A laboratory for which a permit has been issued to operate as a clinical laboratory under the Clinical Laboratory Act (35 P. S. §§ 2151--2165).
Communicable disease--An illness which is capable of being spread to a susceptible host through the direct or indirect transmission of an infectious agent or its toxic product by an infected person, animal or arthropod, or through the inanimate environment.
Communicable period--The time during which an etiologic agent may be transferred directly or indirectly from an infected person to another person, or from an infected animal to a person.
Contact--A person or animal known to have had an association with an infected person or animal which presented an opportunity for acquiring the infection.
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District office--One of the district headquarters of the Department located within this Commonwealth.
Health care facility--
(i) A chronic disease, or other type of hospital, a home health care agency, a hospice, a long-term care nursing facility, a cancer treatment center using radiation therapy on an ambulatory basis, an ambulatory surgical facility, a birth center, and an inpatient drug and alcohol treatment facility, regardless of whether the health care facility is operated for profit, nonprofit or by an agency of the Commonwealth or local government.
(ii) The term does not include:
(A) An office used primarily for the private practice of a health care practitioner.
(B) A facility providing treatment solely on the basis of prayer or spiritual means in accordance with the tenets of any church or religious denomination.
(C) A facility conducted by a religious organization for the purpose of providing health care services exclusively to clergy or other persons in a religious profession who are members of a religious denomination.
Health care practitioner--An individual who is authorized to practice some component of the healing arts by a license, permit, certificate or registration issued by a Commonwealth licensing agency or board.
Health care provider--An individual, a trust or estate, a partnership, a corporation (including associations, joint stock companies and insurance companies), the Commonwealth, or a political subdivision, or instrumentality (including a municipal corporation or authority) thereof, that operates a health care facility.
Household contact--A person living in the same residence as a case, including a spouse, child, parent, relation or other person, whether or not related to the case.
Infectious agent--Any organism, such as a virus, bacterium, fungus or parasite, that is capable of being communicated by invasion and multiplication in body tissues and capable of causing disease.
Isolation--The separation for the communicable period of an infected person or animal from other persons or animals, in such a manner as to prevent the direct or indirect transmission of the infectious agent from infected persons or animals to other persons or animals who are susceptible or who may spread the disease to others.
LMRO--Local morbidity reporting office--A district office of the Department or a local health department.
Local health authority--A county or municipal department of health, or board of health of a municipality that does not have a department of health. The term includes a sanitary board.
Local health department--Each county department of health under the Local Health Administration Law (16 P. S. §§ 12001--12028), and each department of health in a municipality approved for a Commonwealth grant to provide local health services under section 25 of the Local Health Administration Law (16 P. S. § 12025).
Local health officer--The person appointed by a local health authority to head the daily administration of duties imposed upon or permitted of local health authorities by State laws and regulations.
Medical record--An account compiled by physicians and other health professionals including a patient's medical history; present illness; findings on physical examination; details of treatment; reports of diagnostic tests; findings and conclusions from special examinations; findings and diagnoses of consultants; diagnoses of the responsible physician; notes on treatment, including medication, surgical operations, radiation, and physical therapy; and progress notes by physicians, nurses and other health professionals.
Modified quarantine--A selected, partial limitation of freedom of movement determined on the basis of differences in susceptibility or danger of disease transmission which is designated to meet particular situations. The term includes the exclusion of children from school and the prohibition, or the restriction, of those exposed to a communicable disease from engaging in particular activities.
Monitoring of contacts--The close supervision of persons and animals exposed to a communicable disease without restricting their movement.
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Operator--The legal entity that operates a child care group setting or a person designated by the legal entity to serve as the primary staff person at a child care group setting.
Outbreak--An unusual increase in the number of cases of a disease, infection or condition, whether reportable or not as a single case, above the number of cases that a person required to report would expect to see in a particular geographic area or among a subset of persons (defined by a specific demographic or other features).
Physician--An individual licensed to practice medicine or osteopathic medicine within this Commonwealth.
Placarding--The posting on a home or other building of a sign or notice warning of the presence of communicable disease within the structure and the danger of infection therefrom.
(i) The limitation of freedom of movement of a person or an animal that has been exposed to a communicable disease, for a period of time equal to the longest usual incubation period of the disease, or until judged noninfectious by a physician, in a manner designed to prevent the direct or indirect transmission of the infectious agent from the infected person or animal to other persons or animals.
(ii) The term does not exclude the movement of a person or animal from one location to another when approved by the Department or a local health authority under § 27.67 (relating to the movement of persons and animals subject to isolation or quarantine by action of a local health authority or the Department).
Reportable disease, infection, or condition--A disease, infection, or condition, made reportable by § 27.2 (relating to specific identified reportable diseases, infections and conditions).
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SHC--State Health Center--The official headquarters of the Department in a county, other than a district office.
Segregation--The separation for special control or observation of one or more persons or animals from other persons or animals to facilitate the control of a communicable disease.
Sexually transmitted disease--A disease which, except when transmitted perinatally, is transmitted almost exclusively through sexual contact.
Surveillance of disease--The continuing scrutiny of all aspects of occurrence and spread of disease that are pertinent to effective control.
Volunteer--A person who provides services to a school or child care group setting without receiving remuneration.
§ 27.2. Specific identified reportable diseases, infections and conditions.
The diseases, infections and conditions in Subchapter B (relating to the reporting of diseases, infections and conditions) are reportable to the Department or the appropriate local health authority by the persons or entities in the manner and within the time frames set out in this chapter.
§ 27.3. Reporting outbreaks and unusual diseases, infections and conditions.
(a) A person required to report under this chapter shall report an outbreak within 24 hours, and in accordance with § 27.4 (relating to reporting cases).
(b) A person required to report under this chapter who suspects a public health emergency, shall report an unusual occurrence of a disease, infection or condition not listed as reportable in Subchapter B (relating to reporting of diseases, infections and conditions) or defined as an outbreak, within 24 hours, and in accordance with § 27.4.
(c) Any unusual or group expression of illness which the Department designates as a public health emergency shall be reported within 24 hours, and in accordance with § 27.4.
§ 27.4. Reporting cases.
(a) Except for reporting by a clinical laboratory, a case is to be reported to the LMRO serving the area in which a case is diagnosed or identified unless another provision of this chapter directs that a particular type of case is to be reported elsewhere. A clinical laboratory shall make reports to the appropriate office of the Department.
(b) Upon the Department's implementation of its electronic disease surveillance system for certain types of case reports, persons who make those reports shall do so electronically using an application and reporting format provided by the Department. At least 6 months in advance of requiring a type of case report to be reported electronically, the Department will publish a notice in the Pennsylvania Bulletin announcing when electronic reporting is to begin.
(c) This section does not prohibit a reporter from making an initial report of a case to the Department or an LMRO by telephone. The reporter will be instructed on how to make a complete case report at the time of the telephone call.
(d) Department offices to which this chapter requires specified case reports to be filed are as follows:
(1) Cancer Registry, Division of Health Statistics, Bureau of Health Statistics and Research.
(2) Division of Infectious Disease Epidemiology, Bureau of Epidemiology.
(3) HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology.
(4) Division of Maternal and Child Health, Bureau of Family Health.
(e) A case shall be reported using the appropriate case report format. Information solicited by the case report form shall be provided by the reporter, irrespective of whether the report is made by submitting the form directly in hard copy or by telecommunication or electronic submission. An appropriate case report form or format may be procured from the office to which the type of case is reportable.
§ 27.5. (Reserved).
§ 27.5a. Confidentiality of case reports.
Case reports submitted to the Department or to an LMRO are confidential. Neither the reports, nor any information contained in them which identifies or is perceived by the Department or the LMRO as capable of being used to identify a person named in a report, will be disclosed to any person who is not an authorized employe or agent of the Department or the LMRO, and who has a legitimate purpose to access case information, except for any of the following reasons:
(1) When disclosure is necessary to carry out a purpose of the act, as determined by the Department or LMRO, and disclosure would not violate another act or regulation.
(2) When disclosure is made for a research purpose for which access to the information has been granted by the Department or an LMRO. Access shall be granted only when disclosure would not violate another act or regulation. The research shall be subject to strict supervision by the LMRO to ensure that the use of information disclosed is limited to the specific research purpose and will not involve the further disclosure of information which identifies or is perceived as being able to be used to identify a person named in a report.
§ 27.6. Disciplinary consequences for violating reporting responsibilities.
(a) Failure of a clinical laboratory to comply with the reporting provisions of this chapter may result in restrictions being placed upon or revocation of the laboratory's permit to operate as a clinical laboratory, as provided for in the Clinical Laboratory Act (35 P. S. §§ 2151--2165) unless failure to report is due to circumstances beyond the control of the clinical laboratory.
(b) Failure of a Department licensed health care facility to comply with the reporting provisions of this chapter may result in restrictions being placed upon or revocation of the health care facility's license, as provided for in the Health Care Facilities Act (35 P. S. §§ 448.101--448.904b).
(c) Failure of a health care practitioner to comply with the reporting provisions of this chapter may result in referral of that matter to the appropriate licensure board for disciplinary action.
(d) Failure of a child care group setting to comply with the reporting provisions of this chapter may result in referral of that matter to the appropriate licensing agency for appropriate action.
§ 27.7. Cooperation between clinical laboratories and persons who order laboratory tests.
To facilitate the reporting of cases by clinical laboratories, the following is required:
(1) When a clinical laboratory is requested to conduct a test which, depending upon the results, would impose a reporting duty upon the clinical laboratory, the clinical laboratory shall provide to the person who orders the testing, a form that solicits all information which is required for completion of the applicable case report form.
(2) A person who orders testing subject to paragraph (1) shall, at the time of ordering the test, provide the clinical laboratory with the information solicited by the form which that person either possesses or may readily obtain.
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