|Q&A: Laboratory-Initiated Electronic Reporting
The information below is for Clinical Laboratories and the electronic reporting procedures of HIV. Click on the links below to find answers to common questions about electronic reporting of HIV & CD4 Test Results in Pennsylvania. (Regulations Effective 10/18/2002)
Laboratory Initiated Electronic Case Reporting
Failure to Report
Specimen Submission to Laboratories with Required Data
- A person who is in charge of a laboratory conducting CD4 T-lymphocyte tests or Human Immunodeficiency Virus (HIV) tests [microscopical, cultural, immunological, serological, chemical, virologic, nucleic acid (DNA or RNA) or other evidence significant from a public health standpoint of the presence of HIV].
- These reporting regulations in Pennsylvania are applicable to all laboratories licensed by the State of Pennsylvania to perform HIV and/or CD4 tests on specimens from PA providers regardless of where the laboratory's testing facilities are located (i.e. including laboratories licensed in PA that may have testing facilities outside PA).
Designating a Staff Person to Make Reports on Behalf of the Legally Responsible Party (Electronic Lab Reporting, ELR Coordinator): The "legally responsible party" indicated above may designate specific staff person(s) to serve as Primary Contact(s) for Electronic Laboratory Reporting, to carry out the public health responsibility of making reports on behalf of the legally responsible person in charge of the laboratory.
Designating the Principal Laboratory Liaison for Public Health Reporting: In addition, the Department recommends that a senior manager responsible for the section of the laboratory that conducts the relevant tests should also be designated as the "Principal Laboratory Liaison for Public Health Reporting " for the relevant section of the laboratory. However, the responsible party in charge of the laboratory remains the party legally responsible for reporting.
- CD4 T-lymphocyte test results (<200 cells/µl or < 14%) , see case definition for low CD4 counts within the 1993 AIDS Case Definition [Attachment 1];
- Any Positive HIV test results [Attachment 2]; [Positive 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 types of tests the FDA approves to establish the presence of HIV)].
Required Data for Electronic Laboratory Reporting (and Required Data to be Submitted by Providers to Laboratories): There is a required list of data fields/variables for laboratory specimen submissions from providers which is in turn required to be forwarded along with test results by Laboratories to the State Department of Health as outlined in the regulations [ §27.32a (a) ] and clarified in the following documents which are available at the Department web page’s Quick Links:
- The detailed list of data fields/variables and their required formats are outlined in the layout of data/codebook for electronic laboratory reporting [Attachment 9] ;
- The recommended form to be used by providers for submission of specimens to laboratories [Attachment 10]; (this required information to be submitted by providers to laboratories is meant to enable the labs to in turn complete the lab report with the required information);
- The electronic database for capturing specimen submission data to be sent to laboratories AND for capturing test results [Attachment 11]; [Laboratories have the option of using their own compatible database or a free EpiInfo electronic laboratory database available through the Department of Health web page under Quick Links (the software and the database is public domain software from the Centers for Disease Control, CDC). The database must include all data elements required on the recommended specimen submission form].
- The reportable results of the laboratory test shall be reported within 5 days of obtaining the test result [§27.32a (a) (1)]
- The laboratory shall maintain the Lab report data required in a secure electronic database with all the required information.
- In addition to entering the data in an electronic database, the reporter shall transmit the encrypted data through secure electronic mechanisms as specified by the Department (see next section for "Where to Submit Reports" and next point for additional info on encryption) .
- Currently, PGP software is to be used for encrypting data files [Attachment 6]. A fully functional freeware version is available for non-commercial use or evaluation from: [http://web.mit.edu/network/pgp.html]. More detailed information on how to install and use PGP is available here [Attachment 7] at this Department web page.
- Laboratories shall report test results directly to the State Department of Health's Bureau of Epidemiology through secure electronic mechanisms in a manner specified by the Department, which is available at this Dept. web page [Attachment 8].
- E-mail with an attachment of the encrypted file must be sent to: firstname.lastname@example.org with the "state assigned laboratory number" only appearing in the subject line of the message.
Provider Responsibilities Related to Electronic Laboratory Reporting of HIV and CD4 test results:
The regulations require providers to send specific information along with specimens for HIV and CD4 testing to the Laboratory. This required information is meant to enable the Labs to complete and send the electronic lab reports with the required information. This information is exemplified in the Department-Recommended HIV and CD4 Specimen Submission Form [Attachment 10] and is listed under Information for Providers under "Required data for laboratory specimen submission", [§27.32a (a) (4)] with the exception of subparagraphs (vi)-- (ix). In addition to the information included above, 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.
What Happens if the Legally Responsible Parties Do Not Report Cases?
- To ensure complete, accurate and timely reporting, the regulations clarify that the Department reserves the right to conduct ongoing reporting audits (retrospectively to 1/2000) in a manner specified by the Department and access and review patient records of physicians, hospitals, and other persons and entities providing HIV services, who make diagnoses of AIDS or who receive or provide HIV and CD4 T-lymphocyte test results [Attachment 14].
- The Department may also levy a penalty when laboratories persistently fail to comply with Commonwealth Public Health laws and regulations.
For further information, write to:
Pennsylvania Department of Health
Bureau of Epidemiology-HAE
P.O. Box 90
Harrisburg, PA 17108