[32 Pa.B. 3597]
[Continued from previous Web Page] Section 27.21. Reserved.
This section has also changed from proposed to final rulemaking based upon the January 26, 2002, amendments to Chapter 27. The Department proposed in 31 Pa. B. 2126 to delete subsection (e), which required physicians to report cases of AIDS.
In the January 26, 2002, amendments to Chapter 27, however, the Department changed the title and substance of this section to deal solely with the reporting of AIDS by physicians and hospitals. The section had previously dealt with physician duties in reporting all reportable diseases. In this final rulemaking, the Department has consolidated all HIV and AIDS reporting requirements in § 27.32a(b) (relating to reporting AIDS, HIV, CD4-T lymphocyte counts and perinatal exposure of newborns to HIV). Therefore, the Department has deleted § 27.21 in its entirety.
Section 27.22. Reporting of cases by clinical laboratories.
The amendments to this section require laboratories to report the diseases, infections and conditions included in this rulemaking in a particular manner. The amendments to the section also require electronic reporting by laboratories.
The April 21, 2001 proposed amendments to this section were made obsolete by the January 26, 2002 amendments. Consequently, Annex A shows the current amendments to this regulation as the regulation read after January 26, 2002. Subsection (a) is amended to add the types of testing information that is reportable. This is language that was deleted from the regulations in the January 26, 2002, amendments. The word ''examination'' replaces the word ''test,'' as a more accurate term. Subsection (b) is amended to require the reporting of HIV test results and low CD4 T-lymphocyte counts.
However, this section does not contain comprehensive standards for those reports. Those standards are provided in new § 27.32a. For this reason, subsection (c) is amended to state that the reporting requirements of that subsection apply unless otherwise provided for in Subchapter A. Subsection (d) is amended to require that all laboratory results be reported to the Bureau of Epidemiology electronically in a manner specified by the Department, except for those diseases, infections and conditions which are contained in specific reporting requirements. These include HIV test results and CD4 T-lymphocyte test results.
Because part of the subject matter of proposed subsection (e) is deleted, and the remainder combined with subsection (d), the remaining subsections have been renumbered.
Since all of the comments received by the Department on this section were related to the proposed reporting requirements, the Department has chosen to discuss them under § 27.32a, rather than here.
Section 27.23. Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.
The Department has made a minor revision to this section to clarify that persons other than physicians and hospitals are not required to report cases of AIDS, and that only those individuals and entities required by § 27.32a are required to report CD4 T-lymphocyte test results as defined by § 27.21a, HIV test results or perinatal exposure of a newborn to HIV.
Section 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts, and perinatal exposure of newborns to HIV.
This section identifies those types of persons and entities required to report the four diseases, infections and conditions included in this rulemaking and specifies the manner by which the reporting is to be done. Section 27.32, which had been captioned ''Reporting AIDS,'' was repealed by the January 26, 2002 amendments. The subject matter that had been addressed in that section, as expanded to include the three other reportable items added by these amendments, is now addressed in this section.
Subsection (a). Reporting by clinical laboratories.
The Department has moved the proposed language relating to reporting by laboratories of HIV test results and CD4 T-lymphocyte counts from proposed § 27.22 (relating to reporting by clinical laboratories) to this subsection. The Department has added a reference to § 27.22(b) (relating to reporting of cases by clinical laboratories) to subsection (a) to clarify that laboratories are not required to report all CD4 T-lymphocite case results, but only those that meet the definition included in § 27.22(b).
Comment
If a patient has more than one specimen sent to a laboratory for successive HIV tests, will the laboratory have to report each time the test was positive?
Response
A laboratory is required to report each time a test that establishes the presence of HIV is positive. A laboratory is not required to report preliminary tests for HIV that are not approved by the FDA as establishing the presence of HIV.
Comment
If a patient changes insurance, a new laboratory may have to report the patient. The multiple reports may create problems with confidentiality.
Response
Each test result that meets the standards in paragraph (1) or (2) must be reported. The Department will review the test results, and develop a single case record, as it does with all other reportable diseases, infections and conditions. Rather than having reporters self-censor, leading to possible under-reporting, the Department prefers to follow the National standard for reporting, and require reporting by all reporters of all reportable results. If a report were not made, the Department would be unable to verify the case or respond appropriately. Confidentiality is not compromised by multiple reports of the same case. The steps that will be taken to safeguard confidentiality will be triggered by each report.
Comment
Requiring laboratories to report is burdensome and invasive of patients' privacy.
Response
The Department has not changed this regulation in response to this comment. This regulation has been developed to provide the Department with the most complete amount of relevant information available on a patient reportable under the regulation. This will help the Department identify every possible case of HIV, and act in a timely and effective manner when appropriate. To best ensure that a case is not missed, and that all important information is collected, the Department is requiring reporting from all possible reporters.
Further, the law directs the Department to require reporting for the protection of the public health. The General Assembly has already balanced the issue of total privacy of the individual against the public health and the health of the individual, and has determined that individual's complete privacy is subordinate to the Commonwealth's compelling need for protection of the public health through reporting of disease and condition information to the Department and the local health departments to facilitate epidemiological understanding and public health interventions. See the Disease Prevention and Control Law of 1955 (35 P. S. §§ 521.1--521.21) (act). The act prohibits the departments from releasing this information to any other person, except under very limited conditions.
Comment
Cases must be reported both to the State and to the local health departments. Both providers and laboratories are being required to report. The Department should either require such dual reporting be done only for new, previously unreported cases, or must financially support the increased reporting requirements.
Response
Providers report only to LMROs; laboratories report only to the Department. The Department will provide the laboratory results to the LMROs electronically. The reasons for requiring multiple reports by multiple reporters have already been fully discussed. Further, the Department does not require repeated reports of a case by a provider who has previously reported the case. Each test that results in a CD4 T-lymphocyte count reportable under these regulations must be reported, however, regardless of whether the case has been previously reported, and will be used to assist the Department in evaluating the progression of disease.
Comment
The Department should include language in proposed § 27.22 (c)(2) (adopted as § 27.32(a)) exempting laboratories located within Philadelphia from reporting the names and addresses, including city, county and zip code, to the State Health Department. Laboratories would still be required to report this information to the Philadelphia Department of Health.
Response
The Department has not changed its regulations based on this comment. The Department has already discussed its reasons for adopting reporting by name, rather than by unique identifier. The Department sees no reason to exempt laboratories within Philadelphia from this reporting requirement.
Comments
The Department should change the reference to name and address of the person from whom the specimen was obtained in proposed § 27.22(c)(1) (adopted as § 27.32a(a) (3)(i)) to the person's unique identifier.
The Department should change the reference to date of birth in proposed § 27.22(c)(2)(iii) (adopted as § 27.32(a)(3)(iii)) to year of birth.
Response
The Department has not changed this regulation in response to these comments. As has already been discussed, the Department has decided against the use of a unique identifier in favor of confidential name-based reporting.
Comment
The Department should delete proposed § 27.22(c) (2)(ix), which would specifically require reporting of CD4 T-lymphocyte test results with a count of less than 200 cells/µL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes. This subparagraph duplicates proposed § 27.22(c)(2)(viii), which would require reporting of test results.
Response
The Department agrees, and has not included the substance of proposed § 27.22(c)(2)(ix) in this section. Sections 27.21a (relating to reporting of cases by health care practitioners and health care facilities) and 27.22 (relating to reporting of cases by clinical laboratories) identify the CD4 T-lymphocyte results that are reportable.
Comment
Does the requirement that reports be made to the Department within 5 days of obtaining the test results, found in proposed § 27.22(d)(4) and (5) (adopted as § 27.32a(a)(1) and (2)) afford a laboratory sufficient time to report?
Response
The Department has not changed the regulation in response to this comment. Five days affords a laboratory sufficient time to report. The Department's current experience with laboratory reporting for other reportable diseases, infections and conditions shows that laboratories are capable of reporting within this time frame.
Comment
The Department should delete the word ''positive'' from proposed § 27.22(d)(5) (adopted as § 27.32a(a)(2)) in proposed § 27.2 (relating to reportable diseases) (now deleted) and in proposed § 27.32a(a)(2) (adopted as § 27.32a(b)(1)(ii)). Those regulations require reporting of ''the positive results of any test approved by the FDA to establish the presence of HIV including serologic, virologic, nucleic acid (RNA or DNA) or any other type of test . . . .'' This should be changed because many of these tests provide neither a positive nor a negative, but rather provide points on a continuum. An example of this is a CD4 assay.
Response
The Department has not changed the regulations in response to this comment. The use of the word ''positive'' is appropriate as it relates to the definitions for each condition. If the test result meets the definition for a condition, the test result is ''positive.''
Subsection (b). Reporting by physicians, hospitals, persons or entities, who diagnose AIDS within the scope of their practice or who receive or provide HIV and CD4 T-lymphocyte test results.
The proposed amendment of now repealed proposed § 27.32 is adopted in subsection (b). Subsection (b) contains direction as to where, how and when reports are to be submitted by 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. Subsection (b) requires that reports made by the individuals and entities referenced in the subsection are to be made to the LMRO where the case was tested or has been diagnosed. The comments relating to proposed § 27.32 are addressed under this subsection.
Comments
The Department should delineate who is required to report under this regulation. The section as proposed appears broad and vague. It does not appear to meet the intent of the preamble, which stated that the Department intended to capture entities that do not have physicians, but receive test results. Nothing in this section excludes laboratories, and persons within laboratories could be covered by it. The fact that there is no definition of ''HIV services'' adds to the confusion.
This regulation should address to whom data is to be transmitted. The proposal suggests that it go to the county health departments, when in most counties it would be transmitted to the regional district office of the Department.
Response
The Department does not agree that this subsection is overbroad or vague. The Department did intend to require reports from all entities that do not have physicians, but who receive or provide HIV and CD4 T-lymphocyte test results. This subsection only requires those entities and persons to file case reports if they also provide HIV services. The Department does agree, however, that a definition of ''HIV services'' would clarify this section further. The Department has added that definition to § 27.1 (relating to definitions). The definition encompasses prevention, treatment and case management services, to ensure that the widest reporting is available to the Department. This definition eliminates a laboratory's duty to report from this subsection. Subsection (a), which is specifically directed to laboratories, does not make a laboratory subject to the requirement that it also provide HIV services. The substance of subsection (a) does not differ from what the Department proposed in § 27.22(d).
With respect to the issue of where reports are to be made, the regulation clearly states that providers are to report to the LMRO where the case has been diagnosed or is located. An LMRO includes, by definition, the county and local health departments. There is no confusion about where laboratories are to report, since subsection (a) explains where, how and when laboratory reporting is to occur.
Comment
The regulations should specify who is responsible to report HIV for an entity that provides HIV services. Section 27.22 states that a person who is in charge of a laboratory is required to report. Similar language should be added here.
Response
The Department agrees, and has added to subsection (b)(1) ''person in charge'' language similar to that in § 27.22.
Comment
Dentists should not have an HIV or AIDS reporting responsibility since a dentist does not diagnose or treat HIV or AIDS. The information that a dentist may have relating to HIV or AIDS is provided by a physician, a laboratory or an infected patient.
Response
A dentist providing dental services to a client with HIV is no different than a dentist providing services to any other client with a communicable disease. A dentist operating in that capacity does not need to report HIV. Should the dentist have occasion to provide HIV services, as defined in the regulations, and receive or provide HIV test results, that dentist would be required to report.
Comment
Proposed amendments to § 27.32 (adopted as subsection (b) of this regulation) duplicate some of the reporting requirements in §§ 27.21 and 27.23--27.25 . The Department should amend those existing sections of the regulations, rather than adopt a new regulation, to include new reporting requirements applicable to entties with reporting responsibilities subject to the aforementioned regulations.
Response
The Department has not changed the regulations in response to this comment. The Department repealed §§ 27.24 and 27.25 when it amended its regulations on January 26, 2002. At that time, it also amended § 27.23. That section, which previously related to only school reports of communicable diseases, was amended to include reporting requirements for persons other than health care practitioners, facilities, laboratories or veterinarians. Because only certain persons are required to report HIV and AIDS, amending § 27.23 to require HIV or AIDS reporting would not be appropriate. Further, the Department, in keeping with the January 26, 2002 amendments, has placed specific requirements relating to HIV and AIDS reporting in that part of Chapter 27 that includes sections relating to diseases and conditions requiring special reporting. Section 27.21 is repealed by this rulemaking. The subject matter that had been addressed in § 27.21 is now included in this subsection.
Comments
The Department's requirement that entities receiving test results report to the Department means that entities that receive test results are required to make diagnoses. Only clinicians should be required to make a diagnosis. Laboratories should not be required to report without a diagnosis.
The Department should clarify that only physicians can diagnose. As written, § 27.32(a) (adopted as subsection (b) of this regulation) links hospital, person, or entity providing HIV services to the words ''makes a diagnosis,'' and this causes confusion.
Response
The Department has not changed the regulation in response to these comments. The regulations do not require anyone to make a diagnosis of AIDS, nor do they require any practitioner to exceed the scope of the practitioner's practice. The regulations simply require that if a person makes a diagnosis of AIDS, that diagnosis must be reported. It is the Department's assumption that a person not authorized to diagnose within the scope of his practice will not do so. Further, the Department is not requiring entities or persons receiving the designated test results to make diagnoses, but is requiring them to report those test results. Test results are empirical data. That data can be reported without the person making a clinical decision or diagnosis.
Comment
Requiring reporting of case management agencies is burdensome and invasive of a patient's privacy.
Response
The Department has not changed this regulation in response to this comment. This regulation has been developed to provide the Department with the fullest amount of relevant information available on a patient reportable under the regulation. This will help the Department identify every possible case of HIV, and act in a timely and effective manner when appropriate. To best ensure that a case is not missed, and that all important information is collected, the Department is requiring reporting from all possible reporters.
Further, the law directs the Department to require reporting for the protection of the public health. The General Assembly has already balanced the issue of total privacy of the individual against the public health and the health of the individual, and has determined that an individual's complete privacy is subordinate to the Commonwealth's compelling need for protection of the public health through reporting of disease and condition information to the Department and the local health departments to facilitate epidemiological understanding and public health interventions. See the act (35 P. S. §§ 521.1--521.21). The act prohibits the departments from releasing this information to any other person, except under very limited conditions.
Comment
The Department should add the words ''or is diagnosed within'' to proposed § 27.32 (a), following the words ''when the individual who is a subject of the report is a resident.''
Response
The commentator misunderstood the proposal. The Department had proposed to repeal § 27.32(a) as it read at the time the proposals were made. The language referred to by the commentator is not included in § 27.32a(b).
Comment
Proposed § 27.32(a) (adopted as subsection (b)(1) of this section) would require that a report be made to the LMRO where the patient is diagnosed or tested. The Department is to be commended for including this language and changing its requirement that reports are to be made to the LMRO where the patient resides. The Department should make this change in all its disease regulations.
Response
The Department agrees that this should be the general reporting standard. In addition to retaining that language here, it has added similar language to its general regulations relating to communicable and noncommunicable disease reporting in § 27.4.
Comment
The Department should change the reference in proposed § 27.32(a)(4) (adopted as subsection (b)(4)(iv) of this section) from ''perinatal exposure'' to ''vertical transmission.''
Response
The Department has not changed the regulation in response to this comment, for the reasons cited in its response to comments on the definition of ''perinatal exposure of a newborn to HIV'' in § 27.1.
Comments
The Department should clarify what it means by ''perinatal reporting.'' Will all newborns be tested? How will confidentiality be assured throughout the follow-up process?
There is a possibility of testing pregnant women. How will this be managed, and will confidentiality be ensured throughout any follow-up process?
Response
The Department has not changed the regulation in response to these comments. The Department is not requiring testing of newborns or pregnant women. The regulation requires a report of the exposure of the newborn to HIV. The Department has recommended that pregnant women be tested, through dissemination of CDC guidelines for reducing perinatal exposure. The Department will work with the provider to ensure that the mother is properly counseled and has the opportunity to receive treatment that would reduce the risk of transmission. Again, the Department will only become involved with the case upon invitation by the provider, although the Department may contact a provider, advise of the services the Department can provide, and ask whether Department assistance is desired. The provider does not breach confidentiality or the patient-physician relationship by reporting in accordance with the regulations, since the reporting of patient information required by these regulations is a statutorily authorized exception to patient privacy.
Comment
Children exposed to HIV during pregnancy will be tracked by name, even if they are uninfected. There is no provision for removing from the database the names of those children who are shown not to be HIV positive by a negative confirmatory test. This should be included in the regulations.
Response
The Department has not changed the regulation in response to this comment. Children who are not HIVpositive will not be a part of the HIV database. The names of children perinatally exposed to HIV will be maintained as part of the perinatal exposure database. The Department's retention of the names of children not found to be HIV positive after birth is to allow the Department to perform follow-up for several reasons. Requiring reporting of the perinatal exposure of newborns to HIV will enable the Department and local health departments to follow up on children known to be exposed to HIV at birth and to ensure that the child and mother are linked to a provider, in case the child is infected with HIV. A child born to a mother infected with HIV will have antibodies to HIV, since the baby will have its mother's antibodies to the virus. However, not all babies born to infected mothers are actually infected with HIV. The departments will be able to follow the child to recommend additional testing to determine whether or not the child is HIV positive following delivery and to aid in the referral of that mother and child for treatment.
Further, maintaining a list of children potentially exposed but not actually HIV positive will allow the Department to track certain treatments used in attempting to prevent the transmission of the infection, as has already been discussed.
Comment
The regulations should require a report of counseling given regarding treatment/prophylaxis, mode of prophylaxis chosen or denied and why, mode of delivery, and other indicators of efforts made to prevent vertical transmission. This would be useful in ensuring that best practices are in place and are utilized, when in the judgment of the woman, treatment is in her interest and those of the unborn child.
Response
The Department agrees that the question in the case report form that elicits information on prevention and care service referrals should be expanded. This will enable the Department to collect more useful information. The Department is taking steps to make that change to the form but sees no need to revise subsection (b) to do so.
Comment
The Department should strike the language ''in a timely manner'' from § 27.32(b) and replace it with a period of time consistent with the period of time in which other providers are required to report.
Response
The commentator misunderstood the proposal. The Department had proposed to repeal § 27.32(b) as it read at the time the proposals were made. The language referred to by the commentator is not included in § 27.32a(b).
Comments
The Department should remove references to the name of the individual from proposed § 27.32(b) (adopted as subsection (b)(2)(i) of this section) and replace it with a unique identifier.
The Department should add language stating that Philadelphia County will substitute an identifier for the patient's name and street address as required in proposed § 27.32(b)(1) (adopted as subsection (b)(2)(i) of this section) for reports of positive HIV test results.
Response
The Department has not changed the regulation in response to these comments. The Department has decided to use a system of name-reporting for the reasons previously discussed in this preamble. This reporting system will work the best for the Commonwealth if it is used throughout the Commonwealth.
Comment
Proposed § 27.32(b)(8) and (9) duplicate the list of diseases in proposed § 27.32(a) (adopted as subsection (b) of this section) and should be deleted.
Response
The Department has deleted the language and replaced it with a requirement that the test results be reported. (See subsection (b)(2)(viii)).
Comments
The language ''probable mode of transmission'' in proposed § 27.32(b)(10) (adopted as subsection (b)(2)(ix) of this section) requires a subjective assessment. This opens the door for judgments about the individual. Providers should be instructed to use only those categories of risk delineated by the CDC.
Rather than use the term ''probable mode of transmission'' the Department should use the exact language requesting the information used by the CDC report form on which the Department plans to collect this data.
Response
For purposes of clarification, the Department has changed the language. Subsection (b)(2)(ix) requires the patient's history on probable modes of transmission. The Department's reporting form is the CDC form, and the information the Department is soliciting are those categories of risk delineated by the CDC. Patient history information that is entered on the case report is essentially factual information elicited through patient interviews and counseling on the likely modes of transmission. This is documented in the patient chart or the counselor's notes and is not based on subjective judgments. As reported cases may often have multiple risks or exposures, the CDC data management software objectively assigns the patient's risk index for most likely/most probable mode of transmission using a hierarchical risk assignment algorithm based on a scientifically established hierarchy of relative risks for the various modes of transmission listed on the CDC report form. The phrase ''patient history on probable modes of transmission'' is therefore more descriptive of the information the Department intends to capture.
Comment
Unless the Department can specifically list what other information it would deem to be relevant, proposed § 27.32(b)(14) (included as subsection (b)(2)(xiii) of this section) which requires reporting of any other relevant information required by the Department, should be deleted.
Response
The Department agrees with the comment, and has deleted subsection (b)(2)(xiii).
Comment
The time line given for reporters to report in proposed § 27.32(c) is too short, given the amount of information expected. This is especially true for physicians, unless the Department expects reporting to be done before the clients are given post-test counseling as required by law. This would mean reports would be required before patients could be notified personally.
Response
The Department has not changed the regulation in response to this comment. The Department is requiring in subsection (b)(1) that the report be made within 5 days after the person subject to subsection (b) makes the diagnosis or receives the test result. This provides ample time for the physician or counselor to discuss the matter with the patient. In any event, the Department will not be making any contact with a patient without a request from or referral by the provider. Therefore, the Department will have no contact with the patient unless the provider determines that contact would be useful for the patient. The only exception would be in the event of a public health emergency or outbreak, which would require that the Department act expeditiously to prevent and control the spread of disease, an unlikely scenario with respect to HIV or AIDS.
Comment
In proposed § 27.32(c) (adopted as subsection (b)(3) of this section) the Department is requiring providers to maintain information in the patient's file. The Department should clarify what is meant by ''the patient file.'' Is this to be electronic or on paper? Can the information be maintained in the disease report files, or must it be maintained in the patient's medical record?
Response
The Department has not changed the regulation in response to this comment. See subsection (b)(3). The Department intends the information to be maintained in the patient's medical record. The Department does not intend to specify the method by which that record is to be maintained.
Section 27.32b. Confidential and anonymous testing.
This section had been proposed as new § 27.32a. It is being renumbered for the reason previously discussed. It permits anonymous testing at certain sites designated by the Department as anonymous HIV testing sites and includes requirements for reporting by those sites. It also prohibits anonymous testing at any other site unless it is conducting blinded HIV testing authorized under section 5(f) of Act 148 (35 P. S. § 7605(f)).
Several commentators supported the Department's intention to continue to allow anonymous testing sites within the Commonwealth, since anonymous HIV testing provides a testing option for those who would otherwise refuse to be tested.
Comments
The mechanisms for State designation of anonymous testing sites are unclear.
The Department should explain how anonymous testing sites are to be chosen. Planned Parenthood has worked tirelessly to build relationships with its clients. If the Department does not permit these sites to continue as anonymous testing sites, the Department will lose this data, since name-based reporting is likely to deter persons who would have been tested at these sites from being tested. The regulations should allow for sites currently providing anonymous testing to continue to do so.
In Bucks County, five Planned Parenthood sites and the county health department are the only sites at which anonymous testing are occurring. The hours at the county health department are inconvenient to young persons who work or are in school. The Department should make provisions in the regulations for sites currently providing anonymous testing to continue to do so.
The Department should ensure adequate numbers of anonymous testing sites. It is advisable to have one or more test sites per county.
The regulation does not define ''State-designated,'' or indicate whether sites that are now providing anonymous testing will be ''State-designated.''
Response
To clarify the meaning and criteria applicable to anonymous and confidential testing and State-designated HIV testing sites, the Department has added definitions for these terms (see § 27.1) and has removed redundant language from this section. While the Department will not automatically accept any site currently performing anonymous HIV testing as a State-designated site, all Department-supported HIV counseling and testing sites will remain State-designated anonymous HIV testing sites. In addition, the Department may choose to designate and fund additional anonymous HIV testing sites if the Department finds, based on information reported to it under the Communicable Disease Regulations, that individuals are having problems accessing anonymous testing in a specific area. The Department may either ask a provider to provide anonymous testing or agree to a request from a provider where the same circumstances exist. A State-designated site must accept the Department's standards which are based on the CDC guidelines for the provision of HIV testing, counseling, referral and partner notification, and the Department may choose to grant that provider the funds to carry out the services. The CDC guidelines are available from the Department.
Anonymous HIV testing sites may also provide confidential testing.
The number of anonymous test sites is over 130, located throughout the Commonwealth. These include the Department's state health centers, local health departments, and sites operated by publicly funded providers. This number fluctuates because of the constant addition and deletion of sites due to changes in these agencies and the turnover of qualified counseling staff. The six county (Philadelphia, Allegheny, Bucks, Montgomery, Chester, and Erie) and four municipal (Allentown, Bethlehem, York, Wilkes-Barre) health departments were also asked by the Department to choose the number and location of sites to be designated as anonymous HIV testing sites in each of their health jurisdictions. The Department did not limit the number of anonymous sites each of the county and municipal health departments were permitted to choose.
Further, the Department's regulations do not prohibit persons who operate State-designated anonymous HIV testing sites from providing services in places where they have no physical facility. Once a site is designated by the Department, that site's operator can, and several do, send the site's workers into other communities where it has no physical facility to perform outreach and testing. The Department's regulations do not prohibit this type of outreach.
Comment
The number and distribution of anonymous HIV testing sites may be inadequate, particularly in rural areas. The Department's regulations limit anonymous testing sites to those designated by the Department, limiting an already small number of sites. Although the Department has stated there are over 100 testing sites, most of these sites offer both confidential and anonymous testing. There are only 10 true anonymous testing sites available. Limiting anonymous testing sites will deter persons from being tested. The Department should make a commitment in the regulations to increase access to anonymous testing and expand the number of anonymous HIV testing sites.
Response
It is not the intention of the Department to limit access to anonymous HIV testing. It is also not correct that there are only 10 true anonymous testing sites available. The Department has approximately 126 anonymous testing sites. The number of anonymous sites will fluctuate because of the constant additions and deletions of sites due to changes in contracted agencies and turnover of qualified counseling staff. All State-designated sites will provide anonymous testing if requested.
Comment
The regulations should require confidential testing sites to provide an explanation to the client that anonymous testing is available.
Response
While anonymous HIV testing sites also provide confidential testing, the choice is up to the individual being tested. In the course of pretest counseling at State-designated anonymous HIV testing sites, the individual is advised that he may choose to be tested confidentially or anonymously at that site. The Department supports other providers making persons aware of the possibilities of both anonymous and confidential testing and referring them to anonymous HIV testing sites, but will not require it. The Department is concerned that if a provider was required to offer anonymous testing to a person coming to that provider for treatment or services other than HIV services, the provider could then find it necessary to refer the person to another site, and valuable treatment opportunities could be lost. For example, a person referred from an STD clinic to another site for anonymous HIV testing might assume that the anonymous testing site could treat all his problems. He could fail to obtain necessary STD services, since those anonymous HIV testing sites might not have the capability to treat STD.
Comment
The availability, location and hours of anonymous HIV testing sites should be clearly established and publicized prior to the institution of these regulations.
Response
The regulations will be effective 90 days after publication. The Department will post lists of State-designated anonymous HIV testing sites on its website, including the days and hour of operation of each during this 90-day period.
Comment
The regulations should make reference to periodic audits that will ensure anonymous testing is available to all Pennsylvania citizens throughout this Commonwealth.
Response
The Department has not changed the regulation in response to this comment. The Department will maintain quality control of the State-designated anonymous HIV testing sites in a manner that is consistent with the need to ensure the quality of patient care. The Department will also monitor the sites to ensure that anonymous HIV testing is actually available at those sites.
Comment
Anonymous testing should not be permitted at only State-designated sites. Anonymous testing should be the standard procedure throughout this Commonwealth.
Response
The Department has already discussed its reasons for choosing to promote confidential name reporting as its primary mechanism for receiving HIV case reports.
Comment
The Department should add the following language:
Anonymous testing for HIV in Philadelphia will be provided at those sites designated by the local health authority. Anonymous testing in Philadelphia is testing provided to an individual without collecting the name or any other information that could be used to ID an individual (street address, or algorithms based all or in part on the individual's name, social security number, date of birth). Confidential HIV testing in Philadelphia will require that the name of the individual tested be collected and reported to the local health authority upon receipt of reportable test results. Case reports on reportable HIV results obtained from all but anonymous test sites will be reported to the State substituting a UI for the name of the individual for whom a reportable HIV test result was obtained.The Department should add the following language:
Philadelphia will report anonymous HIV test results without identifiers, utilizing the case identification number to differentiate case reports.Response
The Department has not changed the regulation in response to this comment. The Department has decided to use a system of name reporting for reasons previously discussed in this preamble. This reporting system will work best for the Commonwealth if it is used throughout this Commonwealth.
Comment
The Department should delete the language from subsection (a) that states ''persons or entities 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.'' The language is confusing and seems to indicate that anonymous providers must report confidentially.
Response
The Department agrees that the section should be clarified, although it has not deleted the language in response to this comment. The Department has added, at the end of that sentence, the last sentence of subsection (a), the phrase ''unless it is a State-designated anonymous HIV testing site.'' This language reinforces the Department's requirement that only State-designated testing sites may perform anonymous testing.
Comments
The Department appears to be negating the intent of anonymous HIV testing by requiring the reporting of addresses and dates of birth. Unless two persons are twins and live together, this can hardly be considered to be anonymous HIV testing.
If anonymous testing sites report the information as the regulations require, how does the test remain anonymous? Does the Department intend to include certain categories of information from proposed § 27.32? Why is this information, date of birth, address, sex, race, required in an anonymous test?
Response
The Department has revised subsection (b) to clarify that the Department is not requiring the reporting of addresses, social security numbers and other potentially identifying data on individuals for whom an anonymous test was conducted. The data collected will be the information listed in § 27.32a(b)(2), except for name and address, which is information useful for the public health purpose of assessing whether targeted high risk populations are being reached by counseling and testing. The Department has also changed the regulation to clarify that a preprinted number on the Department's HIV Counseling and Referral Form will be reported in lieu of the information required in § 27.32a(b)(2)(i), with the exception of the individual's county of residence. An algorithm will not be used.
Section 27.32c. Counseling, testing, referral and partner notification services.
This section had been proposed as new § 27.32b. It is being renumbered for the reason previously discussed. It states that counseling, testing, referral and partner notification must be done in accordance with Act 148. It also states that a person providing HIV test results to a patient may ask for the Department's assistance in doing so.
Comment
The language that states that persons may ask the Department's assistance if to do so would not violate Act 148 seems to suggest that the regulation supersedes the statute. This is not legally permissible.
Response
This section is included in the regulations so that the requirements of Act 148 would be considered by providers and acted upon. Act 148, however, provides that information may be released to the Department without consent as authorized by the act. Since the act gives the Department the authority to require reporting of HIV through the promulgation of regulations, as the Department has now done, information may be shared with the Department for purposes of posttest counseling without violating Act 148. Therefore, the language that states the Department's assistance may only be sought if Act 148 permits it is unnecessary, and the Department has deleted it.
Comments
The Department should clarify how follow-up of HIV infected persons will occur under a system of name reporting and how confidentiality will be affected or improved. How will partner notification be handled?
We are concerned about how confidentiality will be protected during follow-up. We have had success in convincing the client to bring partners in when there is a diagnosis of STD or a potential for HIV infection. Partner notification will be complicated by name reporting.
Response
The Department currently performs partner notification or, as it is now referred to, partner counseling and referral services (PCRS), and has done so for some time. PCRS has two goals: first, to provide counseling and testing services to sex and needle sharing partners of HIV infected persons so they can avoid infection or, if they are already infected, to prevent transmission to others; and second, to help partners gain earlier access to HIV counseling, testing, medical evaluation, treatment and other prevention services. These could include, for example, STD treatment, drug treatment, violence prevention, social support, family planning and housing.
The agreement to participate in the PCRS is voluntary on the part of the HIV infected person. In PCRS, the infected person is encouraged to voluntarily and confidentially disclose the identifying, locating and exposure information for each sex or needle-sharing partner that the Department or the infected person will attempt to inform. During the the the PCRS, information about the infected person is never revealed to the partner; this includes the person's name, sex, and physical description, or time, type, or frequency of exposure the partner may have had with the infected person.
During HIV prevention counseling, the rationale and options for the PCRS are explained by the counselor. The counselor assists the HIV infected person in understanding the person's responsibility for ensuring the person's partners are informed of their possible exposure and for referring those partners to HIV prevention counseling, testing and other support services. The prevention counselor counsels the person on if, how and when specific partners should be informed of their risk of exposure. The options for the PCRS are discussed and a plan for notifying each partner is developed. Options for the PCRS include: client referral, in which the HIV infected person informs the person's partners and refers them to HIV counseling and testing services; provider referral, in which the provider informs the person's partners and provides the HIV counseling and testing; or dual or combined referral, in which both the infected person and the provider together inform the person's partners.
PCRS personnel never reveal to the individual's friends, relatives or neighbors why they are trying to find a person. They never leave a note or message that mentions HIV exposure as the reason for attempting to make contact. No information is revealed that might lead others to learn the reason for the attempted contact or that might otherwise lead to disclosure of sensitive information or to a breach of confidentiality. When the Department is involved in the partner notification process, all partners are informed of their possible exposure to HIV privately and face-to-face. If the partner refuses to meet with the provider, a telephone call might become necessary, but only limited information is provided to the partner over the phone, with the ultimate goal of arranging a face-to-face meeting.
Name reporting should not have an impact on this system. Partners must agree to be tested, and the fact that they choose to meet with a provider does not mean that testing occurs. Once the anonymous and confidential HIV testing options are explained to them, in the Department's experience, most partners opt for confidential HIV testing.
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