Approval of Laboratories for the Performance of Serologic Tests for Hepatitis B on Prenatal Blood

PURPOSE: This rule establishes uniform requirements for all laboratory approvals relating serologic tests for Hepatitis B prenatal blood. (1) For a laboratory to be approved by the Missouri Department of Health to perform serologic tests for Hepatitis B on prenatal blood specimens, the laboratory shall have a current valid registration certificate showing compliance with the Clinical Laboratory Improvement Amendment of 1988 (CLIA 88). AUTHORITY: sections 192.006.1., 192.020 and 210.030, RSMo (1994).* This rule originally filed as 19 CSR 20-35.010. Original rule filed Sept. 15, 1994, effective March 30, 1995. Changed to 19 CSR 25-35.010 Jan. 1, 1995. *Original authority: 192.006.1., RSMo (1993); 192.020, RSMo (1939), amended 1945, 1951; and 210.030, RSMo (1941), amended 1986, 1993.