South Carolina § 44-29-15 - Reporting requirements for laboratories testing for certain infectious or other diseases; civil penalty.

§ 44-29-15. Reporting requirements for laboratories testing for certain infectious or other diseases; civil penalty.

(A) A laboratory, within or outside the State, responsible for performing a test for any of the infectious or other diseases required by the Department of Health and Environmental Control to be reported pursuant to Section 44-29-10, shall report positive or reactive tests to the department. This includes, but is not limited to, all laboratories, within or outside the State, which collect specimens in South Carolina or which receive the initial order for testing from a practitioner, blood bank, plasmapheresis center, or other health care provider located in South Carolina. The department also may require that all results of certain, specifically identified laboratory tests be reported. All reports must be submitted within the time frame and in the form and manner designated by the department.

(B) Laboratories, within or outside the State, which perform tests as described in subsection (A) and which determine positive or reactive test results, shall, if required by the department, provide clinical specimens and isolates to the department or another laboratory designated by the department for further testing to determine incidence and other epidemiological information. These clinical specimens and isolates must be submitted within the time frame and in the form and manner designated by the department. The testing must be performed for epidemiological surveillance only; source consent is not required, and results are not required to be returned to the source patient or physician. The clinical specimens and isolates must be destroyed after tests are successfully completed, unless otherwise directed by the department.

(C) Persons and entities, which are required to report test results to the department pursuant to this section and which send clinical specimens and isolates out of state for testing, are responsible for ensuring that results are reported and clinical specimens and isolates are submitted to the department, or a laboratory designated by the department, as required under this section and related regulations.

(D) If a laboratory forwards clinical specimens and isolates out of state for testing, the originating laboratory retains the duty to comply with this section and related regulations, either by:

(1) reporting the results, providing the name and address of the testing laboratory, and submitting the clinical specimens and isolates to the department; or

(2) ensuring that the results are reported and that the clinical specimens and isolates are submitted to the department or another laboratory designated by the department.

(E) A person, laboratory, or other entity violating a provision of this section or related regulations is subject to a civil monetary penalty of not more than one thousand dollars for the first offense and not more than five thousand dollars for each subsequent offense. Each instance of noncompliance constitutes a separate violation and offense.

HISTORY: 2010 Act No. 166, SECTION 1, eff May 12, 2010.