PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[ 28 PA. CODE CH. 27 ]
Complete Reporting of CD4 T-Lymphocyte, Viral Load and Genotyping Test Results Relating to HIV
[49 Pa.B. 2605]
[Saturday, May 25, 2019]The Department of Health (Department), with the approval of the State Advisory Health Board (Board) proposes to amend 28 Pa. Code §§ 27.21a, 27.22, 27.23, and 27.32a—27.32e. The proposed amendments are to read as set forth in Annex A.
(Editor's Note: Exhibits A through C and Exhibit E referenced in this preamble are attached to the Department's Regulatory Analysis Form (RAF) relating to this proposed rulemaking. The RAF may be obtained through the contact information listed as follows, or by searching the regulation number, 10-209, on the Independent Regulatory Review Commission's web site at www.IRRC.state.pa.us.)
A. Purpose of the Proposed Amendments
The Department added HIV infection, a virus that can lead to Acquired Immunodeficiency Syndrome (AIDS) if left untreated, to the list of reportable diseases and conditions in this Commonwealth in 2002. As part of those reporting requirements, the Department required the 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. The Department is now proposing to require the reporting of all CD4 T-lymphocyte cell counts and percentages relating to HIV infection, as well as all viral load test results, including detectable and undetectable viral loads and genotyping results.
The spread of HIV is a serious public health issue. By the end of 2016, 35,483 individuals were diagnosed and living with HIV infection in this Commonwealth. In the last 5 years, 6,168 new HIV cases were diagnosed (2012 to the end of 2016), accounting for 17.4% of all of those diagnosed and living with HIV infection by 2016. The estimated number of people living with HIV has increased each year on average by approximately 1,325 persons. With a growth curve following a very strong linear trend, projections indicate that, by 2020, there could be as many as 42,000 people in this Commonwealth living with HIV.
In order to stop the spread of HIV, prevent the emergence of new cases, and keep those living with HIV healthy, the National HIV/AIDS Strategy for the United States, updated for 2020, has, as its critical foci, widespread testing and linkage to care, broad support for people living with HIV to remain engaged in comprehensive care, universal viral suppression among persons living with HIV, and full access to Pre-Exposure Prophylaxis services to prevent the spread of disease. See National HIV/AIDS Strategy for the United States, updated for 2020 (July 2015), at Executive Summary 3, https://files.hiv.gov/s3fs-public/nhas-update.pdf. Accessed February 23, 2018, (hereinafter referred to as ''National HIV/AIDS Strategy''). In order to achieve these goals, the Federal Centers for Disease Control and Prevention (CDC) of the Department of Health and Human Services recommends, among other things, the reporting of all CD4 test results (counts and percentages) and all viral load results (undetectable and detectable specific values). See Letter from Kenneth G. Castro, MD, Assistant United States Surgeon General, United States Public Health Service and Amy Lansky, PhD, MPH, Deputy Director for Surveillance, Epidemiology and Laboratory Sciences, Division of HIV Prevention, CDC. See Exhibit A to the Department's Regulatory Analysis Form (RAF). A letter directly to the former Secretary of Health, Karen Murphy, from the Director of the Office for State, Tribal, Local and Territorial Support and Deputy Director of the CDC, reiterated this position to the Commonwealth, as one of six1 states that did not collect all CD4 test results. See Letter from Jose T. Montero, MD, MHCDS, Director, Office for State, Tribal, Local and Territorial Support and Deputy Director, CDC and Jonathan A. Mermin, MD, MPH, RADM and Assistant Surgeon General, United States Public Health Services, and Director, National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention to Secretary Karen Murphy, dated February 8, 2017 (''Letter to Secretary Murphy''). See Exhibit B to the RAF. The letter stated the following:
The updated National HIV/AIDS Strategy for the United States identifies primary goals to guide our collective national fight against HIV. The success in advancing several of these goals, ensuring sustained viral suppression for person living with HIV and measuring progress towards HIV care, relies on laboratory reporting of HIV-related tests, including all CD4+ T-lymphocyte (CD4) and viral load test results, to local and national HIV surveillance systems. Complete laboratory data are critical to identifying cases, measuring care and treatment outcomes, and measuring the effectiveness of public health interventions. Specifically, these data are often used to monitor disease progression, determine the stage of HIV infection, monitor receipt of HIV care and treatment, and make decisions about public health interventions. Both viral load and CD4 data are used to assess whether patients are responding to treatment: when treatment is successful, CD4 counts rise and viral loads fall. Current HIV clinical management guidelines call for CD4 and viral load testing at the time of diagnosis and regularly thereafter. When CD4 and viral load results are reported, public health agencies can determine access to care and treatment outcomes. For these reasons, CDC recommends complete state reporting of all HIV test results.Letter to Secretary Karen Murphy, supra (emphasis added). At the present time, the Commonwealth is one of four states that do not collect all CD4 T-lymphocyte test results. See Email from Richard Selik (CDC/OID/NCHSTP) to Godwin Obiri, Epidemiology Supervisor, Bureau of Epidemiology, Pennsylvania Department of Health (9/11/2018 10:56 AM). See Exhibit C to the RAF. In addition, of the 50 states, only Pennsylvania and Idaho fail to require the reporting of all viral load test results. See Email from Dr. Richard Selik (CDC/OID/NCHSTP) to Dr. Godwin Obiri, Epidemiology Supervisor, Bureau of Epidemiology, Pennsylvania Department of Health (2/28/2018 12:24 PM). See Exhibit C to the RAF.
Persons tested for HIV have recorded CD4 and viral load test results, indicators of HIV progression within the body. Because the Department does not currently require the reporting of all CD4 and viral load test results, reporting within this Commonwealth is incomplete. This severely limits the Department's ability to comply with standards set by the CDC recommendations, accurately report on CDC-required core HIV indicators, and monitor and enhance patient outcomes across the continuum of HIV care services.
Ultimately, requiring the reporting of all CD4 T-lymphocyte and viral load test results will allow the Department to better track the epidemic in this Commonwealth, focus resources to meet the needs of the communities impacted and improve the health of the citizens of this Commonwealth. See National HIV/AIDS Strategy, at 46. In addition, the Department would be more able to ensure that those identified as infected living with HIV have access to care, are engaged in care and are virally suppressed. See, for example, National HIV/AIDS Strategy; see also Mahle Gray, et al., Enhanced Collection of Laboratory Data in HIV Surveillance Among 5 States with Confidential Name-Based HIV Infection Reporting, 2005-2006, The Open AIDS Journal, 2012, 6, (Suppl 1: M5) 90—97, 93-94, 96 (''Data collected through the national HIV surveillance system can be used to monitor the outcomes of the national strategy; however the validity of these measures is dependent upon the completeness and quality of the surveillance data''). See Exhibit E to the RAF.
At the present time, Pennsylvania is one of only four states in the nation that do not require the reporting of all CD4 test results and one of only two states that do not require the reporting of all viral load test results. See Exhibit C to the RAF. See also http://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-surveillance-supplemental-report-vol-21-4.pdf, at p. 63, accessed February 23, 2018. Goal 1 of the National HIV/AIDS Strategy, which calls for reducing new HIV infections, see National HIV/AIDS Strategy at 1, sets forth as a recommended action the allocation of public funding consistent with the geographic distribution of the epidemic. Id. at 19. The Strategy recommends a similar action with regard to Goal 4, achieving a more coordinated national response to the HIV epidemic. Id. at 43; see also 45 (''The Federal government should review the methods used to distribute Federal HIV funds and take steps to ensure that resources go to the States and localities with the greatest burden of disease.''). If, in the future, Federal funding is tied to disease burden, this Commonwealth would be at a disadvantage among other states with more complete data. See Exhibit B to the RAF.
Although the recommendations are directed mainly towards complete laboratory reporting, the Department's proposed amendments would not merely revise the existing laboratory reporting section. The Department is proposing to make the same changes to reporting by health care practitioners and facilities and other persons or entities who diagnose AIDS or who receive or provide CD4 or HIV viral load test results. Those persons are currently required to report some of these test results, as are laboratories. In the interest of complete reporting, the Department is proposing to require complete reporting of these particular providers, as well as of laboratories. As the National HIV/AIDS Strategy notes:
HIV surveillance data are used extensively to target and evaluate HIV prevention and care programs. Therefore, comprehensive and timely data are critical, as are continued improvements in electronic laboratory reporting as timely receipt of laboratory data is critical. Surveillance necessitates a complex system of reporting from providers, laboratories, and State and local health departments to coordinate accurate, complete, and timely reporting.See National HIV/AIDS Strategy, at 46 (emphasis added). Reporting from all available sources is the best avenue to obtain all required information, and to work towards the vision that ''The United States will become a place where new HIV infections are rare, and when they do occur, every person, regardless of age, gender, race/ethnicity, sexual orientation, gender identity, or socio-economic circumstance, will have unfettered access to high quality, life-extending care, free from stigma and discrimination.'' National HIV/AIDS Strategy, VISION.
B. Requirements of the Proposed Amendments
Section 27.21a. Reporting of cases by health care practitioners and health care facilities.
This section requires health care practitioners and health care facilities to report the listed diseases, infections and conditions to the Department within a specified time frame. The Department is proposing to amend this section to require the reporting of all CD4 T-lymphocyte test results, not just results at or below a certain count or percentage. This would include counts and percentages of T-lymphocyte cells of all tests. In addition, the Department is proposing to require the reporting of all HIV viral load test results, even those that are undetectable, and all HIV genotype test results.
The availability of highly effective retroviral therapy makes it much more important to monitor all test results, including CD4 T-lymphocyte counts in individual patients, viral loads and HIV genotype test results, and to use that information to track population health improvements and quality of care among persons infected with HIV. Obtaining data on all test results would help to identify HIV cases, identify when persons with HIV infection enter treatment, determine the stage of disease, measure unmet health care needs among HIV infected persons, and evaluate HIV testing and screening activities. With this information, the Department should be able to offer to practitioners and their patients more effective tools to combat each individual's infection and would be itself better prepared to assign resources and recommend strategies for combatting the epidemic.
Section 27.22. Reporting of cases by clinical laboratories.
This section requires reporting of test results by clinical laboratories. The Department is proposing to amend this section to require the reporting of all CD4 T-lymphocyte counts and percentages, not just results at or below a certain count or percentage. In addition, the Department is proposing the reporting of all HIV viral load test results and all HIV genotype test results. The Department believes that this addition is necessary to track the spread of the disease across this Commonwealth and to more effectively target prevention and intervention efforts.
Section 27.23. Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.
This section requires the reporting of cases of reportable diseases and conditions by persons other than health care practitioners, health care providers and laboratories. The Department has made revisions to this section to reflect the additions and revisions to §§ 27.21a and 27.22, supra.
Section 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and nondetectable viral load results and genotype test results, and perinatal exposure of newborns to HIV.
This section currently requires reporting of AIDS, CD4 T-lymphocyte counts and percentages below a certain amount and perinatal exposure of newborns to HIV by both physicians and laboratories. The Department proposes to amend the title, and the remainder of the section, to reflect the proposed reporting of all CD4 T-lymphocyte counts and percentages, all viral load results and all genotype test results, as well as the required reporting of the other listed tests.
In subsection (a), relating to reporting by clinical laboratories, the Department has maintained the time frame for reporting for CD4 T-lymphocyte counts and percentages at 5 days, and has clarified that these would be work days, and not calendar days. The Department has proposed adding a time frame for viral load test results and HIV genotype test results, which would also be reportable within 5 days of the reporting entity obtaining those test results. See new subsection (a)(3). The Department also proposed revisions acknowledging that the Department's electronic disease surveillance system (NEDSS) is operational; it was not at the time the current regulations were promulgated. See proposed revisions to subsection (a)(1) and (2).
The Department has proposed the same revisions regarding time frames and its NEDSS system to revised subsection (b), relating to reporting by health care practitioners, hospitals, and other persons or entities, who diagnose AIDS or who receive or provide HIV test results, CD4 T-lymphocyte counts and percentages, or HIV viral load test results and HIV genotype test results. The Department also proposes to revise subsection (b) to clarify that clinicians, other than physicians, are required to report cases of AIDS, HIV, CD4 T-lymphocyte counts and percentages pertaining to HIV infection, HIV viral load test results and HIV genotype testing and perinatal exposure of newborns to HIV. The Department has, therefore, replaced the term, ''physician,'' with the more general term, ''health care practitioner.''
Finally, the Department has proposed eliminating the term, ''LMRO,'' or ''Local Morbidity Reporting Office,'' from the regulation. At the time HIV reporting was added to the Department's regulations relating to communicable and noncommunicable diseases, electronic reporting had not yet been introduced. Reporting was done on paper or by telephone and through the Department's 6 regional offices and 10 county/municipal health departments, known as its local morbidity reporting offices, or LMROs. Now that electronic reporting has become the norm, there is no need for this type of reporting structure. The Department, therefore, is proposing to replace the term, ''LMRO,'' with the term previously in use, ''local health department.'' See proposed revisions to subsection (b)(4).
Section 27.32b. Confidential and anonymous testing.
This section details the requirements for anonymous testing sites within this Commonwealth. The Department is proposing to amend the section to reflect the proposed additions and revisions to §§ 27.21a and 27.22, supra.
Section 27.32c. Partner services relating to HIV and AIDS.
This section would be significantly revised. The Department is proposing to revise this section to reflect proposed amendments to §§ 27.21a and 27.22 of these regulations, and changes to terminology relating to public health services offered to a patient being provided with an AIDS diagnosis, HIV test result, CD4 T-lymphocyte count or percentage, HIV viral load test result, including detectable and nondetectable viral load test results, or genotype test result. The regulations do not require a reference to the Confidentiality of HIV-Related Information Act (35 P.S. §§ 7601—7612), as amended, in order for the requirements of that act to be in place and followed. The Department has, however, added proposed subsection (b) to make it clear that a person providing that information must also inform his or her client that the Department or a local health department might be contacting the client to discuss the availability of partner services beneficial to that client and the client's partners.
Section 27.32d. Department authority to require complete reporting.
This section is not new; however, the Department is proposing to change the language to comport with revisions proposed to §§ 27.21a, 27.22 and 27.32a.
Section 27.32e. Record audits.
This section is not new; however, the Department is proposing to change the language to comport with revisions proposed to §§ 27.21a, 27.22 and 27.32a.
C. Affected Persons
This proposed rulemaking, which add reporting requirements, would impact all health care practitioners, health care facilities and other persons or entities providing HIV services who diagnose AIDS or who provide or receive HIV, CD4 T-lymphocyte counts or percentages, viral load test results or HIV genotype test results. They are required to report to the Department diagnosed cases of AIDS, HIV test results, all CD4 T-lymphocyte counts and percentages, all viral loads, both detectable and undetectable, and all HIV genotype test results. The proposed amendments would also affect laboratories, which are required to report to the Department HIV test results, all CD4 T-lymphocyte counts and percentages, all viral loads, both detectable and undetectable, and all HIV genotype test results.
This proposed rulemaking would also affect the 10 county/municipal health departments that are involved in the reporting system.
This proposed rulemaking would also impact all persons who have been given an HIV, CD4, viral load or HIV genotyping test. The required reporting of these test results permits the Department to obtain more accurate information regarding the trends of the disease, and, therefore, to better target funding to programs that would provide maximum benefit to these individuals. Obtaining data on all test results would help to identify HIV cases, identify when persons with HIV infection enter treatment, determine the stage of disease, measure unmet health care needs among HIV infected persons and evaluate HIV testing and screening activities.
The Department provides requested updates to the Statewide HIV Planning Group (HPG). The HPG is established by the Department under sections 301(a) and 317 of the Public Health Service Act (42 U.S.C.A. §§ 241(a) and 247b), and provides input on jurisdictional HIV prevention planning, a required activity of the Department's CDC grant for Comprehensive HIV Prevention Programs for Health Department. The HPG also fulfils the requirement under the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. Law 111-87), previously known as the Ryan White Comprehensive AIDS Resources Emergency Act of 1990 (42 U.S.C.A. §§ 300ff-21—300ff-38), that the Department engage in a public advisory planning process in developing a comprehensive plan. The HPG is in support of CD4 and viral load reporting. See Letter from HIV Planning Group, dated December 21, 2016.
D. Cost and Paperwork Estimate
1. Cost
The amendments would have no measurable fiscal impact on the Commonwealth, local government, the private sector or the general public because the disease reporting system already exists in the Commonwealth. The financial and economic impact of this proposed rulemaking outside of healthcare settings is very minimal. Healthcare practitioners, health care facilities and clinical laboratories currently are required to have systems in place to report some CD4 T-lymphocyte and HIV viral load test results into the electronic disease surveillance system (PA-NEDSS), so although this proposed rulemaking would result in reporting of all CD4 T-lymphocyte and HIV viral load results, they will not need to develop new systems. Currently, healthcare practitioners and clinical laboratories must separate out the CD4 T-lymphocyte and viral load test results required to be reported from those not required to be reported, and this process takes time and adds cost. The proposed change would allow reporters to report all the test results received and remove the need to separate the results into those reported and those not reported.
Healthcare practitioners and laboratories without the ability to send data electronically directly to PA-NEDSS would be required to keystroke enter these additional test results into PA-NEDSS. However, most CD4 and HIV viral load information is received from clinical laboratories with IT systems allowing direct electronic access. For these facilities, once their IT system is modified to capture the additional test results, the data would automatically be extracted and uploaded to PA-NEDSS. There would therefore be no ongoing cost associated with the additional reporting requirements, and the cost of the additional reports required as a result of the proposed changes to the regulation would be negligible.
The costs to both the Commonwealth and to local governments would not increase because of these amendments. The Commonwealth, through the Department, and local health departments, already have infrastructure in place to accept reporting of diseases and conditions, and to carry out, as required by law, disease prevention and control activities relating to HIV and AIDS, among other things. The additional work and cost relating to the reporting of more cases would be minimal and is outweighed by the benefit accruing from better understanding of the epidemic that allows for more targeted intervention and prevention strategies.
2. Paperwork
Because the electronic surveillance system that receives and stores reports of diseases and conditions is already in place in this Commonwealth, PA-NEDSS is expanding the list to include mandatory reports of all test results for an existing disease or condition and additional testing relating to that disease or condition would create no measurable increase in paperwork. Healthcare practitioners, health care facilities and clinical laboratories currently are required to have systems in place to report some CD4 T-lymphocyte and HIV viral load test results into PA-NEDSS, so although the amendments to the regulation would result in reporting of all CD4 T-lymphocyte and HIV viral load results, existing reporters should not need to develop new systems. Reporters without access to PA-NEDSS would still be able to send the report by mail; the number of reporters not using PA-NEDSS to report to the Department is very small.
The ongoing savings each year from more effective HIV disease control, prevention and timely treatment of individuals infected with HIV which would be expected to occur from this expanded reporting are immeasurable. All Pennsylvanians would benefit from these proposed amendments through the improved tracking of trends in HIV infection and treatment success, as well as assisting patients with linkage to care and treatment before those patients develop significant and expensive medical complications. When people living with HIV are in continuous medical care and have a suppressed viral load, the chances of those persons transmitting HIV to other people is tremendously reduced. These proposed amendments would help to protect Commonwealth citizens from exposure to HIV and subsequent hardship, disability or death. In addition, it would enable the Commonwealth to comply with the CDC's recommendations for effective HIV disease surveillance, control and patient management.
E. Statutory Authority
The Department's overarching authority to promulgate these regulations is found in the act. Section 16(a) of the Disease Prevention and Control Law of 1955 (the act) (35 P.S. § 521.16(a)) gives the Board the authority to issue rules and regulations on a variety of matters relating to communicable and noncommunicable diseases, including the following: the diseases that are to be reported; the methods of reporting diseases; the contents of reports; the health authorities to whom diseases are to be reported; the control measures that are to be taken with respect to different diseases; the enforcement of control measures; the immunization and vaccination of persons and animals; the prevention and control of disease in public and private schools; the treatment of sexually transmitted diseases, including patient counseling; and any other matters the Board may deem advisable to address for the prevention and control of disease and for carrying out the provisions and purposes of the act. Section 16(b) of the act (35 P.S. § 521.16(b)) gives the Secretary of Health (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 Administrative Code of 1929 (code) (71 P.S. §§ 51 et seq.) Section 2102(g) of the code (71 P.S. § 532(g)) gives the Department this general authority. Section 2111(b) of the code of 1949 (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.
Section 2111(b) of the code 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.
In addition, Section 803 of the Health Care Facilities Act (35 P.S. § 448.803) provides the Department with the authority to promulgate regulations relating to the licensure of health care facilities and allows the Department to require certain actions relating to disease control and prevention to occur within health care facilities.
F. Effectiveness/Sunset Dates
This proposed rulemaking will become effective upon final-form publication in the Pennsylvania Bulletin. No sunset date has been established. The Department will continually review and monitor the effectiveness of these regulations.
G. Regulatory Review
Under section 5(a) of the Regulatory Review Act, the act of June 30, 1989 (P.L. 73, No. 19) (71 P.S. §§ 745.1—745.15), the Department submitted a copy of this proposed rulemaking on May 15, 2019, to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Health Committee and the Senate Health and Human Services Committee. In addition to submitting this proposed rulemaking, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to this proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria that have not been met. The act specifies detailed procedures for review, prior to final publication of the regulation, by the Department, the General Assembly and the Governor of comments, recommendation or objections raised.
H. Contact Person
Interested persons are invited to submit written comments, suggestions or objections regarding this proposed rulemaking to Sharon Watkins, PhD, Director, Bureau of Epidemiology, Department of Health, 625 Forster Street, Room 933, Health and Welfare Building, Harrisburg, PA 17120, (717) 787-3350, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability who wish to submit comments, suggestions or objections regarding this proposed rulemaking may do so 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 Sharon Watkins so that necessary arrangements may be made.
RACHEL L. LEVINE, MD,
SecretaryFiscal Note: 10-209. No fiscal impact; (8) recommends adoption.
Annex A
TITLE 28. HEALTH AND SAFETY
PART III. PREVENTION OF DISEASES
CHAPTER 27. COMMUNICABLE AND NONCOMMUNICABLE DISEASES
Subchapter B. REPORTING OF DISEASES, INFECTIONS AND CONDITIONS
GENERAL § 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.
* * * * * (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:
* * * * * (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)] counts and percentages.
Campylobacteriosis.
* * * * * HIV (Human Immunodeficiency Virus) [(effective October 18, 2002)].
HIV viral load test results, including detectable and undetectable viral load results, and all genotyping results.
Hepatitis, viral, acute and chronic cases.
* * * * * § 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:
* * * * * 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)] counts and percentages.
* * * * * Granuloma inguinale.
HIV (Human Immunodeficiency Virus) [(effective October 18, 2002)].
HIV viral load results, including detectable and undetectable viral load results, and genotype test results.
Haemophilus influenzae infections—invasive from sterile sites.
* * * * * § 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] counts and percentages, HIV test results or perinatal exposure of a newborn to HIV, HIV viral load results, including detectable and undetectable viral load results, and genotype test results, 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 percentages, HIV viral load test results, including detectable and nondetectable viral load results and genotype test results, 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)] counts and percentages electronically to the [HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology,] Department through the Department's electronic disease surveillance system within 5 work 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,] Department through the Department's electronic disease surveillance system within 5 work days of obtaining the test results.
(3) A person in charge of a clinical laboratory shall report HIV viral load test results, including detectable and undetectable viral load results, and genotyping results, to the Department through the Department's electronic disease surveillance system, within 5 work days of obtaining the test results.
[(3)] (4) 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.
* * * * * [(4)] (5) 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 or percentage, or HIV viral load test results, including detectable or nondetectable test results, and genotype test results shall provide to the laboratory the information in subsection [(a)(3)] (a)(4), with the exception of subparagraphs (vi)—(ix). In addition to the information included in subsection [(a)(3)] (a)(4), a person or entity that requests a laboratory test for HIV [or], a CD4 T-lymphocyte count or percentage, an HIV viral load test result, including detectable or nondetectable test results, and genotype test results shall provide to the laboratory the date each test was requested and the type of test or tests requested.
(b) Reporting by [physicians] health care practitioners, hospitals, and other persons or entities, who diagnose AIDS or who receive or provide HIV [and] test results, CD4 T-lymphocyte [test results] counts and percentages, or HIV viral load test results, including detectable and nondetectable results, and genotype test results.
(1) A [physician] health care practitioner, 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] test results, CD4 T-lymphocyte [test results] counts and percentages, HIV viral load test results, including detectable and nondetectable results, or genotype test results, or who provides an AIDS diagnosis, HIV [or] test results, CD4 T-lymphocyte [test results] counts and percentages, HIV viral load test results, including detectable and nondetectable test results, and genotype test results to patients, shall report the following to the [LMRO responsible for the geographic area in which the person is tested or diagnosed] Department through the Department's electronic disease surveillance system within 5 [business] work 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)] counts and percentages.
(iv) A perinatal exposure of a newborn to HIV [(effective October 18, 2002)].
(v) HIV viral load results, including detectable and undetectable viral load results, and genotype test results.
(2) A report of an HIV test result, CD4 T-lymphocyte count and percentage, HIV viral load test result, including detectable and nondetectable test results, and genotype test result, AIDS case based on the CDC case definition, or perinatal exposure of a newborn to HIV shall include the following information:
* * * * * (xi) The name, address and telephone number of the [physician] health care practitioner, 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 AIDS diagnosis was made or that received the HIV test result [or], CD4 T-lymphocyte count and percentage, HIV viral load test results, including detectable and nondetectable test results, or genotype test results.
* * * * * (4) [An LMRO] A local health department receiving reports of diagnoses of AIDS, positive HIV test results, [reportable] CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and nondetectable test results, and genotype test results, 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 medium specified by the] Department through the Department's electronic disease surveillance system.
§ 27.32b. Confidential and anonymous testing.
* * * * * (b) Anonymous test results shall be reported in accordance with § 27.32a(b)(2) (relating to reporting AIDS, HIV, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and nondetectable test results, and genotype test results 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.
* * * * * § 27.32c. [Counseling, testing, referral and partner notification services] Partner services relating to HIV and AIDS.
[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) A person providing an AIDS diagnosis, HIV test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results including detectable and nondetectable viral load test results, or genotype test results to a patient may ask for the Department's assistance with counseling if the person chooses to do so.
(b) A person who provides an AIDS diagnosis, HIV test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and nondetectable viral load test results, or genotype test results to an individual shall inform the individual that the Department or a local health department may contact the patient for a voluntary confidential interview to discuss partner services, including counseling, testing, referral and partner notification.
§ 27.32d. Department authority to require complete reporting.
The Department will have access to and may review the patient records of [physicians] health care practitioners, 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] test results, CD4 T-lymphocyte [test results] counts or percentages, HIV viral load test results including detectable and nondetectable test results, or genotype 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] health care practitioners, 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, CD4 T-lymphocyte counts and percentages, HIV viral load test results including detectable and nondetectable test results, or genotype test results for the purpose of obtaining information allowing the Department to complete HIV [and], CD4 T-lymphocyte case reports, and viral load and genotyping 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. 19-781. Filed for public inspection May 24, 2019, 9:00 a.m.] _______
1 At the time the letter was sent, the Commonwealth was one of six states that did not collect all CD4 test results. That number has since fallen to four. See Preamble at 3.
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