[32 Pa.B. 3597]
[Continued from previous Web Page] Section 27.32d. Department authority to require complete reporting.
This section had been proposed as new § 37.32c, rather than § 27.32c, as a result of a typographical error. It is being renumbered for the reason previously discussed. It reiterates the Department's authority, contained in the act, to make complete investigations of communicable and noncommunicable diseases, infections and conditions, including outbreaks. This includes the Department's authority to review records of reporters as necessary.
Comment
The section is unclear and should be broken into two sentences.
Response
The Department has made the change suggested.
Comment
Although the Department's need for the information is understood, the Department did not implement the HIV regulations in a timely fashion. The Department should work with physicians and hospitals to develop the most effective and least disruptive means of collecting needed information. This same comment is applicable to § 27.32e (relating to record audits).
Response
The Department is cognizant of the need for cooperation and education. The Department currently conducts case investigations involving physicians and hospitals and always attempts to work with those entities to obtain their cooperation. The Department intends to continue that practice.
Comment
The Department should strike out ''all other persons or entities providing HIV services'' from this section, because only physicians or clinicians can make a diagnosis.
Response
As the Department has stated in its responses to comments on proposed § 27.32(a) (adopted as 27.32a(b)), the regulations do not require any person to make a diagnosis. No person should be making a diagnosis other than a person who, within the scope of that person's practice, is authorized to do so.
Section 27.32e. Record audits.
This section had been proposed as new § 27.32d. It is being renumbered for the reason previously discussed. It states that the Department will conduct record audits back to January 1, 2000, for the purposes of completing case investigations.
The Department has added the word ''to'' between the words ''chapter'' and ''ensure'' in subsection (b).
Comment
The Department should strike out ''all other persons or entities providing HIV services'' from subsection (a), because only physicians or clinicians can make a diagnosis.
Response
The Department has not changed the regulation in response to this comment. As the Department has stated in its responses to comments on proposed § 27.32(a) (adopted as § 27.32a(b)), the regulations do not require any person to make a diagnosis. As the Department has stated, it does not expect any person to make a diagnosis other than a person authorized to do so within the scope of that person's practice. If a diagnosis of AIDS is made, then it must be reported.
Comments
The Department should delete the proposed language stating that it will conduct audits back to January 1, 2000. This could create legal problems for providers who do not have consents permitting them to release this information. If the individual is in care, he will have periodic tests, which in the course of a year will cause him to be reported to the Department.
The proposed section violates the physician/patient privilege and ignores the need for patient consent.
Response
The Department has not changed the regulation in response to these comments. The audits will be done to collect information to complete HIV and CD4 T-lymphocyte case reports. The Department is instituting this requirement to allow it not only to track disease trends, but to complete case investigations and obtain information necessary to complete applications for Federal funding grants from the United States Department of Health and Human Services (HHS). One of the reasons the Department included this section, and § 27.32d, is that, in the past, the Department has had difficulty in securing cooperation from some providers. They have refused to allow the Department to review patient records to enable the Department to complete its case report files.
The Department's authority to conduct these record reviews without patient consent is clear in the act. Sections 3 and 5 of the act (35 P. S. §§ 521.3 and 521.5) give the Department and the local health departments the responsibility for the prevention and control of the spread of disease (section 3(a) and (b) of the act) and the authority to take any disease control measure necessary to protect the public health upon receipt of a report of a disease (section 5 of the act). Section 16 of the act (35 P. S. § 521.16) gives the Department, through the Board, the ability to promulgate whatever regulations are necessary to prevent and control the spread of disease. Further, section 2102(a) of The Administrative Code of 1929 (Code) (71 P. S. § 532(a)) gives the Department the authority to take the most efficient and practical means necessary for the prevention and suppression of disease. The reviews permitted by this section are necessary for locating cases of HIV and AIDS and controlling and preventing the spread of disease. Consequently, the Department is authorized by the act to promulgate regulations concerning those reviews and is not required to obtain patient consent to conduct those reviews. The fact that the information is HIV related information does not change this provision, since Act 148 includes an exception that allows the information to be provided to the departments for the purpose of disease control and prevention. See section 7(a) of Act 148.
Further, since section 4 of the act (35 P. S. § 521.4) places reporting responsibilities on certain persons, and section 16(a) and (b) of the act (35 P. S. § 521.16(a) and (b)) give the Department the authority to promulgate regulations to effectuate these reporting requirements, the Department has the authority to review these records to ensure that reporting is occurring appropriately. The regulation, therefore, clearly states the Department's authority to conduct these types of reviews of patient records. This should eliminate the occasional lack of cooperation on the part of providers.
Comment
The Department should not limit its ability or the ability of local health departments to obtain information by placing a time limitation on its back auditing. It should delete from subsection (a) the reference to January 1, 2000.
Response
In considering the interests of providers as well as the need for information, the Department has determined that reviewing information back to January 1, 2000, will sufficiently serve its purpose.
Comment
What are the ''special reports'' referenced by the Department in subsection (b)?
Response
By the term ''special reports,'' the Department means reports that are not specifically disease reports but, rather, are intended to help the Department prevent, track, and control the spread of disease in a particular situation or that will enable the Department to monitor reporting practices. For example, several years ago the Department received reports of needle stick injuries in a particular county caused by adolescents surreptitiously sticking other persons with needles and raising concern of potential exposures to blood-borne diseases. The Department requested that the provider who initially made the report respond to a report form developed by the Department with regard to these specific incidents, including a time line and other questions relating to the potential exposures.
As another example, the Department could request that certain providers respond to a given set of ICD-9 codes with a listing of all cases matching those codes and the dates, if any, that the case was reported to the Department. This would enable the Department to determine if reporting by those specific providers was complete.
Several commentators made general comments that were not associated with any section or regulatory provision.
Comments
The effective date is unrealistic given the publicity and training that needs to be accomplished.
It will be hard for reporters to be prepared to report by January 1, 2002. There will be limited staff available to implement these requirements. The Department should adjust implementation accordingly.
Response
The Department has changed the regulation. The Department had originally proposed a January 1, 2002, implementation date for reporting; however, the promulgation of these regulations was dependent upon the promulgation of final rulemaking relating to communicable and noncommunicable diseases. Those regulations were effective on January 26, 2002, therefore, the Department could not keep to the proposed implementation date. The implementation date for reporting will be 90 days after the effective date of these regulations. The Department's operational plan includes time for training and education of providers. The Department is prepared to deal with issues that arise during that phase of the process.
Comment
The use of the term ''public health intervention'' in the preamble to the proposed regulations is neither defined nor described in regulatory language and so is open to broad interpretation. Interventions should be specifically designed using best practice models and described in detail in regulatory language. These should only be implemented as a last resort after a clinician has exhausted all other avenues of contacting an individual, not as a first step as the regulations suggest. Community-based organizations should be included in these interventions.
Response
The Department has not changed the regulations in response to this comment. The term ''public health intervention'' does not appear in the regulations and only appears in the preamble to proposed rulemaking in language discussing the Department's reasons for requiring the reporting of low CD4 T-lymphocyte counts that may ultimately prove not to be connected to HIV or AIDS. The Department has not included descriptions of ''best practices'' for public health interventions in the regulations. Public health practices change with changing science and the development of new and more effective methodologies for preventing and controlling the spread of disease. The Department will not tie itself to practices which might become outmoded. The Department consistently acts within CDC guidelines in carrying out its public health function.
With respect to the manner in which the Department will interact with private providers in the context of HIV cases, the Department has said that it will not directly contact the individual. The Department will use the provider as the point of contact, and will not intervene in the case without offering its services to the infected individual through the auspices of the provider.
Comment
The Department should add a penalty for those reporters who do not report in violation of the regulations. Allegheny County Health Department makes failure to report a summary offense and a civil penalty of up to $300.
Response
The Department has not changed the regulation in response to this comment. This rulemaking is a part of the Department's communicable disease regulations and is being promulgated under the act. The act includes the same $300 penalty and summary offense referenced by the commentator for any violation of the act or regulations promulgated under the act. Section 20 of the act (35 P. S. § 521.20). For the Department to impose an additional penalty would require action on the part of the General Assembly.
Comment
The discrepancy between this rulemaking and the rulemaking relating to communicable and noncommunicable diseases will make who is to report AIDS unclear.
Response
The Department has not changed the regulations in response to this comment. There will be no discrepancy in Chapter 27 of the Department's regulations regarding who is to report AIDS. The Department had proposed to delete language from its regulations requiring hospitals to report cases of AIDS. See 30 Pa. B. 2715 (May 27, 2000). That deletion was inadvertent. The Department addressed that issue in its final rulemaking published at 32 Pa.B. 491. As discussed previously in this Preamble, the Department has taken steps to coordinate this rulemaking with the January 26, 2002, amendments to Chapter 27.
C. Affected Persons
These final-form regulations affect physicians, hospitals and other persons or entities providing HIV services who diagnose AIDS or who provide or receive HIV and CD4 T-lymphocyte test results. They are required to report diagnosed cases of AIDS, HIV test results, low CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV. The regulations also affect laboratories, which are required to report certain positive HIV test results and CD4 T-lymphocyte counts of a certain level.
The final-form regulations also affect local health departments that are involved in the reporting system, particularly the local health departments for Allegheny and Philadelphia Counties, which are currently considering or which have already implemented CD4 T-lymphocyte reporting. The regulations impact persons with AIDS, persons with HIV infection and at risk for contracting HIV, persons with low CD4 T-lymphocyte counts, and pregnant women at risk for HIV or who test positive for HIV, and their newborn children. Unless these individual choose to seek testing at an anonymous testing site (an option not available for pregnant women being tested during or immediately prior to labor because they are most likely in a hospital setting where anonymity is impossible), the names of those persons with these conditions or infected with HIV will be reported to the Department. The required reporting of these conditions and test results permits the Department to obtain more accurate information regarding the trends of the disease, and, therefore, to target funding to programs that would provide maximum benefit to these individuals. Further, reporting of cases to the Department enables public health professionals to provide counseling, testing and referral to infected persons, and with the individual's permission, to conduct contact tracing which can lead to early detection and treatment.
D. Cost And Paperwork Estimate
1. Cost
The final-form regulations have no measurable fiscal impact on local government, the private sector or the general public, because the disease reporting system already exists in this Commonwealth. There will be an increase in cost of $500,000 to the Commonwealth, since the Department anticipates spending that amount for additional positions in the ten local health departments for staff to carry out case management activities, including counseling, testing, referral, and partner notification. The Department anticipates this increase in personnel will be necessary because of the increase in the number of actual cases that should be reported once the reporting of the additional conditions imposed by this rulemaking goes into effect. The Department believes that this increase in cost to the Commonwealth will be outweighed by the savings from these final-form regulations, caused by reporting of information that will enable the Department to focus prevention efforts on the most at-risk populations. Over time, these activities will cause a reduction in the number of HIV cases in this Commonwealth. This will reduce health care costs.
No additional cost accrues from the Department's provision of software for electronic reporting, since the Department obtains that software for these purposes free-of-charge from the CDC. It is anticipated that any additional modification to the software necessary to suit the Department's purposes will be done either in-house or at no additional charge to the Department by current contractors.
2. Paperwork Estimates
Because the disease reporting system is already in place in this Commonwealth, the addition of other diseases and conditions to the list of reportable diseases and conditions creates no measurable increase in paperwork. Cases of HIV, low CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV will be reported and investigated in a similar manner to cases of currently listed diseases, infections, and conditions using National case definitions and a reporting format similar to that currently used to report AIDS. The Department is requiring electronic reporting but is offering the software, free of charge, to those persons required to report. The Department is willing to accept alternative forms of electronic reporting from those who do not have internet access, for example, by accepting reporting by diskette.
E. Statutory Authority
The Department obtains its authority to promulgate regulations relating to reporting of communicable and noncommunicable diseases from the act. The act provides the Board with the authority to issue rules and regulations on a variety of matters relating to communicable and noncommunicable diseases, including which diseases are to be reported, the methods of reporting diseases, the contents of reports and the health authorities to whom diseases are to be reported, what control measures are to be taken with respect to which diseases and any other matters the Board may deem advisable for the prevention and control of disease, and for carrying out the provisions and purposes of the act. See section 16(a) of the act. Section 16(b) of the act gives the Secretary the authority to review existing regulations and make recommendations to the Board for changes the Secretary considers to be desirable.
The Department also finds general authority for the promulgation of its regulations in the Code. Section 2102(g) of the Code (71 P. S. § 532(g)) gives the Department this general authority. 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 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.
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 that certain actions relating to disease control and prevention 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 disease prevention and control measures in those facilities.
F. Effectiveness/Sunset Dates
The final-form regulations will become effective upon final publication in the Pennsylvania Bulletin, however, the reporting requirements for positive HIV tests, low CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV will not become effective until October 18, 2002. 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 April 10, 2001, the Department submitted a copy of notice of proposed rulemaking published at 31 Pa.B. 2126, 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(a)), the Department submitted a copy of the final-form regulations to IRRC and the Committees on May 15, 2002. 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 all comments received from IRRC, the Committees and the public.
These final-form regulations were deemed approved by the Committees on June 10, 2002. IRRC met on June 13, 2002 and approved the final-form regulations in accordance with section 5.1(e) of the Regulatory Review Act. The Attorney General approved the regulations on June 26, 2002.
H. Contact Person
Questions regarding this final-form rulemaking may be submitted to Joel H. Hersh, Director, Bureau of Epidemiology, Department of Health, P. O. Box 90, Harrisburg, PA 17108, (717) 783-4677. 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 Joel Hersh at the previously listed address or telephone numbers so that necessary arrangements may be made.
I. Findings
The Department, with the approval of the Board, finds 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 regulations in the manner provided by this order is necessary and appropriate for the administration of the authorizing statutes.
J. Order
The Department, with the approval of the Board, acting under the authorizing statutes, orders that:
(a) The regulations of the Department, 28 Pa. Code Chapter 27, are hereby amended by deleting § 27.21; by amending §§ 27.1, 27.21a, 27.22 and 27.23; and by adding §§ 27.32a, 27.32b, 27.32c, 27.32d and 27.32e, to read as set forth in Annex A with ellipses referring to the exiting text of the regulations.
(b) The Secretary 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 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 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.,
Secretary(Editor's Note: For the text of the order of the Independent Regulatory Review Commission, relating to this document, see 32 Pa.B. 3183 (June 29, 2002).)
Fiscal Note: Fiscal Note 10-166 remains valid for the final adoption of the subject regulations.
Annex A
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES
Subchapter A. GENERAL PROVISIONS § 27.1. Definitions.
The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:
* * * * * AIDS (Acquired Immune Deficiency Syndrome)--As defined by the CDC case definition published in the CDC Morbidity and Mortality Weekly Report (MMWR). (The Department will publish in the Pennsylvania Bulletin a reference to a CDC update of the case definition within 30 days of its publication in the MMWR).
Anonymous HIV Testing--HIV testing performed at a State-designated HIV testing site for an individual who chooses not to provide his name in giving consent for the testing.
CDC--Centers for Disease Control and Prevention.
* * * * * Confidential HIV testing--HIV testing performed for an individual who, in giving his consent for the testing, provides his name and other personal or demographic identifiers.
* * * * * FDA--Food and Drug Administration.
* * * * * HIV services--The range of services, including prevention, counseling, testing, treatment, case management, support and referral services, which are provided to persons infected with or affected by HIV or AIDS, and are intended to alleviate physical and psychosocial problems created by these diseases and conditions.
* * * * * Perinatal exposure of a newborn to HIV--The potential perinatal transmission of HIV to a newborn indicated by a positive HIV test result for the pregnant woman or mother of a newborn.
* * * * * State-designated anonymous HIV testing site--An HIV testing site supported by the Department either through direct funding or payment for testing, which provides anonymous and confidential testing and which agrees to adhere to the CDC's counseling and testing standards and guidelines issued by the Department.
* * * * *
Subchapter B. REPORTING OF DISEASES § 27.21. (Reserved).
§ 27.21a. Reporting of cases by health care practitioners and health care facilities.
(a) Except as set forth in this section or as otherwise set forth in this chapter, a health care practitioner or health care facility is required to report a case of a disease, infection or condition in subsection (b) as specified in § 27.4 (relating to reporting cases), if the health care practitioner or health care facility treats or examines a person who is suffering from, or who the health care practitioner or health care facility suspects, because of symptoms or the appearance of the individual, of having a reportable disease, infection or condition:
(1) A health care practitioner or health care facility is not required to report a case if that health care practitioner or health care facility has reported the case previously.
(2) A health care practitioner or health care facility is not required to report a case of influenza unless the disease is confirmed by laboratory evidence of the causative agent.
(3) A health care practitioner or health care facility is not required to report a case of chlamydia trachomatis infection unless the disease is confirmed by laboratory evidence of the infectious agent.
(4) A health care practitioner or health care facility is not required to report a case of cancer unless the health care practitioner or health care facility provides screening, therapy or diagnostic services to cancer patients.
(5) Only physicians and hospitals are required to report cases of AIDS.
(b) The following diseases, infections and conditions in humans are reportable by health care practitioners and health care facilities within the specified time periods and as otherwise required by this chapter:
(1) The following diseases, infections and conditions are reportable within 24 hours after being identified by symptoms, appearance or diagnosis:
Animal bite.
Anthrax.
Arboviruses.
Botulism.
Cholera.
Diphtheria.
Enterohemorrhagic E. coli.
Food poisoning outbreak.
Haemophilus influenzae invasive disease.
Hantavirus pulmonary syndrome.
Hemorrhagic fever.
Lead poisoning.
Legionellosis.
Measles (rubeola).
Meningococcal invasive disease.
Plague.
Poliomyelitis.
Rabies.
Smallpox.
Typhoid fever.(2) The following diseases, infections and conditions are reportable within 5 work days after being identified by symptoms, appearance or diagnosis:
AIDS.
Amebiasis.
Brucellosis.
CD4 T-lymphocyte test result with a count of less than
200 cells/µL or a CD4 T-lymphocyte percentage of less
than 14% of total lymphocytes (effective October 18,
2002).
Campylobacteriosis.
Cancer.
Chancroid.
Chickenpox (varicella) (effective January 26, 2005).
Chlamydia trachomatis infections.
Congential adrenal hyperplasia (CAH) in children under 5 years of age.
Creutzfeldt-Jakob Disease.
Cryptosporidiosis.
Encephalitis.
Galactosemia in children under 5 years of age.
Giardiasis.
Gonococcal infections.
Granuloma inguinale.
Guillain-Barre syndrome.
HIV (Human Immunodeficiency Virus) (effective
October 18, 2002).
Hepatitis, viral, acute and chronic cases.
Histoplasmosis.
Influenza.
Leprosy (Hansen's disease).
Leptospirosis.
Listeriosis.
Lyme disease.
Lymphogranuloma venereum.
Malaria.
Maple syrup urine disease (MSUD) in children under 5
years of age.
Meningitis (All types not caused by invasive Haemophilus
influenza or Neis seria meningitis).
Mumps.
Perinatal exposure of a newborn to HIV (effective
October 18, 2002).
Pertussis (whooping cough).
Phenylketonuria (PKU) in children under 5 years of age.
Primary congenital hypothyroidism in children under 5
years of age.
Psittacosis (ornithosis).
Rickettsial diseases.
Rubella (German measles) and congenital rubella
syndrome.
Salmonellosis.
Shigellosis.
Sickle cell disease in children under 5 years
of age.
Staphylococcus aureus, Vancomycin-resistant (or
intermediate) invasive disease.
Streptococcal invasive disease (group A).
Streptococcus pneumoniae, drug-resistant invasive
disease.
Syphilis (all stages).
Tetanus.
Toxic shock syndrome.
Toxoplasmosis.
Trichinosis.
Tuberculosis, suspected or confirmed active disease
(all sites).
Tularemia.(c) A school nurse shall report to the LMRO any unusual increase in the number of absentees among school children. A caregiver at a child care group setting shall report to the LMRO any unusual increase in the number of absentees among children attending the child care group setting.
(d) A health care facility or health care practitioner providing screening, diagnostic or therapeutic services to patients with respect to cancer shall also report cases of cancer as specified in § 27.31 (relating to reporting cases of cancer).
§ 27.22. Reporting of cases by clinical laboratories.
(a) A person who is in charge of a clinical laboratory in which a laboratory test of a specimen derived from a human body yields microscopical, cultural, immunological, serological, chemical, virologic, nucleic acid (DNA or RNA) or other evidence significant from a public health standpoint of the presence of a disease, infection or condition listed in subsection (b) shall promptly report the findings, no later than the next work day after the close of business on the day on which the test was completed, except as otherwise noted in this chapter.
(b) The diseases, infections and conditions to be reported include the following:
Amebiasis.
Anthrax.
An unusual cluster of isolates.
Arboviruses.
Botulism--all forms.
Brucellosis.
CD4 T-lymphocyte test result with a count of less than
200 cells/µL or less than 14% of total lymphocytes
(effective October 18, 2002).
Campylobacteriosis.
Cancer.
Chancroid.
Chickenpox (varicella).
Chlamydia trachomatis infections.
Cholera.
Congential adrenal hyperplasia (CAH) in children under 5 years of age.
Creutzfeldt-Jakob disease.
Cryptosporidiosis.
Diphtheria infections.
Enterohemorrhagic E. coli 0157 infections, or infections
caused by other subtypes producing shiga-like toxin.
Galactosemia in children under 5 years of age.
Giardiasis.
Gonococcal infections.
Granuloma inguinale.
HIV (Human Immunodeficiency Virus) (effective
October 18, 2002).
Haemophilus influenzae infections--invasive from sterile
sites.
Hantavirus.
Hepatitis, viral, acute and chronic cases.
Histoplasmosis.
Influenza.
Lead poisoning.
Legionellosis.
Leprosy (Hansen's disease).
Leptospirosis.
Listeriosis.
Lyme disease.
Lymphogranuloma venereum.
Malaria.
Maple syrup urine disease (MSUD) in children under 5
years of age.
Measles (rubeola).
Meningococcal infections--invasive from sterile sites.
Mumps.
Pertussis.
Phenylketonuria (PKU) in children under 5 years of age.
Primary congenital hypothyroidism in children under 5
years of age.
Plague.
Poliomyelitis.
Psittacosis (ornithosis).
Rabies.
Respiratory syncytial virus.
Rickettsial infections.
Rubella.
Salmonella.
Shigella.
Sickle cell disease in children under 5 years of age.
hemoglobinopathies in children under 5 years
of age.
Staphylococcus aureus Vancomycin-resistant (or
intermediate) invasive disease.
Streptococcus pneumoniae, drug-resistant invasive
disease.
Syphilis.
Tetanus.
Toxoplasmosis.
Trichinosis.
Tuberculosis, confirmation of positive smears or cultures,
including results of drug susceptibility testing.
Tularemia.
Typhoid.(c) The report shall include the following, except as provided in subsection (d):
(1) The name, age, address and telephone number of the person from whom the specimen was obtained.
(2) The date the specimen was collected.
(3) The source of the specimen (such as, serum, stool, CSF, wound).
(4) The name of the test or examination performed and the date it was performed.
(5) The results of the test.
(6) The range of normal values for the specific test performed.
(7) The name, address and telephone number of the physician for whom the examination or test was performed.
(8) Other information requested in case reports or formats specified by the Department.
(d) Laboratory test results shall be reported by the person in charge of a laboratory directly to the Department's Bureau of Epidemiology through secure electronic mechanisms in a manner specified by the Department, except for the following: Reports of CAH, galactosemia maple syrup urine disease, phenylketonuria, primary congenital hypothyroidism, sickle cell disease, cancer, CD4 T-lymphocyte test results with a count of less than 200 cells/µL or less than 14% of total lymphocytes, HIV (Human Immunodeficiency Virus), and lead poisoning shall be made in the manner and to the location specifically designated in this subchapter. See §§ 27.30, 27.31, 27.32a and 27.34.
(e) A clinical laboratory shall submit isolates of salmonella and shigella to the Department's Bureau of Laboratories for serotyping within 5 work days of isolation.
(f) A clinical laboratory shall submit isolates of Neisseria meningitidis obtained from a normally sterile site to the Department's Bureau of Laboratories for serogrouping within 5 work days of isolation.
(g) A clinical laboratory shall send isolates of enterohemorrhagic E. coli to the Department's Bureau of Laboratories for appropriate further testing within 5 work days of isolation.
(h) A clinical laboratory shall send isolates of Haemophilus influenzae obtained from a normally sterile site to the Department's Bureau of Laboratories for serotyping within 5 work days of isolation.
(i) The Department, upon publication of a notice in the Pennsylvania Bulletin, may authorize changes in the requirements for submission of isolates based upon medical or public health developments when such departure is determined by the Department to be necessary to protect the health of the people of this Commonwealth. The change will not remain in effect for more than 90 days after publication unless the Board acts to affirm the change within that 90-day period.
§ 27.23. Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.
Except with respect to reporting cancer, AIDS, CD4 T-lymphocyte test result with a count of less than 200 cells/µL or less than 14% of total lymphocytes, HIV test results or perinatal exposure of a newborn to HIV, individuals in charge of the following types of group facilities identifying a disease, infection or condition listed in § 27.21a (relating to reporting of cases by health care practitioners and health care facilities) by symptom, appearance or diagnosis shall make a report within the timeframes required in § 27.21a (relating to reporting of cases by health care practitioners and health care facilities):
(1) Institutions maintaining dormitories and living rooms.
(2) Orphanages.
(3) Child care group settings.
§ 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV.
(a) Reporting by clinical laboratories.
(1) A person in charge of a clinical laboratory shall report CD4 T-lymphocyte test results as defined in § 27.22(b) (relating to reporting of cases by clinical laboratories) electronically to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.
(2) A person in charge of a clinical laboratory shall report positive test results of any test approved by the FDA to establish the presence of HIV, including a serologic, virologic, nucleic acid (DNA or RNA) or any other type of test the FDA approves to establish the presence of HIV. The report shall be made to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.
(3) The report shall include the following information:
(i) The individual's name and the address, city, county, and zip code of the individual's residence.
(ii) The patient identifying number assigned to the individual by the physician or at the facility requesting the laboratory test.
(iii) The individual's date of birth (month, day, year).
(iv) The individual's sex.
(v) The individual's race/ethnicity.
(vi) The date of each test performed.
(vii) The type of tests performed.
(viii) The results of the tests.
(ix) The name of the person or entity submitting the specimen for testing.
(x) The address of the person or entity submitting the specimen for testing, including the zip code, physical address and telephone number of the submitter.
(4) To enable the laboratory to complete the report it is required to file with the Department, a person or entity that requests a laboratory test for HIV or a CD4 T-lymphocyte count shall provide to the laboratory the information in subsection (a)(3), with the exception of subparagraphs (vi)--(ix). In addition to the information included in subsection (a)(3), a person or entity that requests a laboratory test for HIV or a CD4 T-lymphocyte count shall provide to the laboratory the date each test was requested and the type of test or tests requested.
(b) Reporting by physicians, hospitals, persons or entities, who diagnose AIDS or who receive or provide HIV and CD4 T-lymphocyte test results.
(1) A physician, hospital, person providing HIV services or person in charge of an entity providing HIV services, who makes a diagnosis of AIDS or who receives HIV or CD4 T-lymphocyte test results or provides HIV or CD4 T-lymphocyte test results to patients, shall report the following to the LMRO responsible for the geographic area in which the person is tested or diagnosed within 5 business days of the diagnosis of AIDS or the receipt of the results of the test:
(i) A diagnosis of AIDS.
(ii) A positive result of any test approved by the FDA to establish the presence of HIV, including a serologic, virologic, nucleic acid (DNA or RNA) or any other type of test the FDA approves to establish the presence of HIV (effective October 18, 2002).
(iii) A CD4 T-lymphocyte test result with a count of less than 200 cells/µL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes (effective October 18, 2002).
(iv) A perinatal exposure of a newborn to HIV (effective October 18, 2002).
(2) A report of an HIV test result, CD4 T-lymphocyte count, AIDS case based on the CDC case definition, or perinatal exposure of a newborn to HIV shall include the following information:
(i) The individual's name and the address, city, county and zip code of the individual's residence.
(ii) The patient identifying number assigned to the individual by the physician or at the facility requesting the laboratory test.
(iii) The individual's date of birth.
(iv) The individual's sex.
(v) The individual's race or ethnicity.
(vi) The date of each test performed.
(vii) The type of tests performed.
(viii) The test results.
(ix) The patient's history on probable modes of transmission.
(x) The treatment provided.
(xi) The name, address and telephone number of the physician, hospital, or other person or entity that secured a specimen from the individual and submitted it for laboratory testing.
(xii) The name, address and telephone number of the entity in which the diagnosis was made or that received the HIV test result or CD4 T-lymphocyte count.
(3) In addition to reporting the AIDS diagnosis or the receipt of test results, the reporter shall maintain the data required in paragraph (2) in the patient file on the Department's HIV/AIDS report form.
(4) An LMRO receiving reports of diagnoses of AIDS, positive HIV test results, reportable CD4 T-lymphocyte counts, and perinatal exposures to HIV shall forward completed case reports containing the information included in paragraph (2) electronically to the Department's Bureau of Epidemiology through a secure electronic mechanism specified by the Department.
§ 27.32b. Confidential and anonymous testing.
(a) Anonymous testing for HIV, except for blinded HIV testing authorized under section 5(f) of the Confidentiality of HIV-Related Information Act (35 P. S. § 7605(f)), may only be provided at State-designated anonymous testing sites. All other HIV testing shall be conducted confidentially with the name of the tested individual collected, and the name of the individual reported when the result of the test is reportable. A person or entity reporting as required in this section shall offer all HIV and AIDS-related services confidentially and may not provide anonymous testing, or consider any test or its results to be anonymous, unless it is a State-designated anonymous HIV testing site.
(b) Anonymous test results shall be reported in accordance with § 27.32a(b)(2) (relating to reporting AIDS, HIV, CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV. In lieu of the information required in § 27.32a(b)(2)(i), the report of an anonymous test shall include an assigned number preprinted on the HIV counseling and testing report form. The report shall also include the individual's county of residence.
(c) The Department may create and fund an additional anonymous HIV-testing site in a particular area when it finds, based on demographic information reported to it under this chapter, that there is a lack of access to anonymous HIV testing in that particular area.
(1) The Department may begin the process of designating an anonymous HIV testing site either by contacting a provider or by responding to a request from a provider to increase the number of sites in the geographic area specified by the request.
(2) If a provider is designated as an anonymous HIV-testing site, the provider shall adhere to the CDC's Guidelines for Counseling, Testing, Referral and Partner Notification and to the terms set out by the Department in any grant agreement.
§ 27.32c. Counseling, testing, referral and partner notification services.
Counseling, testing, referral and partner notification services shall be performed in accordance with the Confidentiality of HIV-Related Information Act (35 P. S. §§ 7601--7612). A person providing HIV test results to a patient may ask for the Department's assistance with counseling if the person chooses to do so.
§ 27.32d. Department authority to require complete reporting.
The Department will have access to and may review the patient records of physicians, hospitals, persons providing HIV services and persons in charge of entities providing HIV services, who make diagnoses of AIDS, or who receive or provide HIV and CD4 T-lymphocyte test results. Access and review will enable the Department to conduct case investigations, to determine whether under-reporting is occurring, to investigate reporting delays and to investigate other reporting problems.
§ 27.32e. Record audits.
(a) The Department may conduct record audits of the records of physicians, hospitals, persons providing HIV services and persons in charge of entities providing HIV services who make diagnoses of AIDS or who receive or provide HIV test results for the purpose of obtaining information allowing the Department to complete HIV and CD4 T-lymphocyte case reports to aid it in tracking trends in disease and obtaining additional funding for prevention and treatment programs. The Department may audit records going back to January 1, 2000, for this purpose.
(b) The Department may require special reports of persons or entities required to report under this chapter to ensure compliance with this chapter.
[Pa.B. Doc. No. 02-1301. Filed for public inspection July 19, 2002, 9:00 a.m.]
[32 Pa.B. 3622]
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