Duties of Laboratories

PURPOSE: This rule establishes the responsibility of laboratories to report to the Missouri Department of Health and Senior Services specified results of tests and to submit isolates/specimens for certain diseases and conditions. (1) The director, person in charge of any laboratory, or designee of the director or person in charge of any laboratory shall report to the local health authority or the Missouri Department of Health and Senior Services the result of any test that is positive for, or suggestive of, any disease or condition listed in 19 CSR 20-20.020. These reports shall be made according to the time and manner specified for each disease or condition following completion of the test and shall designate the test performed, all results of the test, including numeric results, if applicable, units of measure of the results, and reference ranges for normal and abnormal results, the name and address of the attending physician, the name of the disease or condition diagnosed or suspected, the date the test results were obtained, the name and home address (with zip code) of the patient and the patient’s age, date of birth, sex, race, and ethnicity. (2) In reporting findings for diseases or conditions listed in 19 CSR 20-20.020, laboratories shall report— Arsenic—results of all biological specimens including time frame of urine specimen collection, if applicable; Cadmium—results of all biological specimens including time frame of urine specimen collection, if applicable; Carboxyhemoglobin proportion—all results; Chemical/pesticide (blood or serum)—all results, including if none detected; Lead level—results of all biological specimens; Mercury—results of all biological specimens including time frame of urine specimen collection, if applicable; and Methemoglobin proportion—all results. (3) Isolates or specimens positive for the following reportable diseases or conditions must be submitted to the State Public Health Laboratory for epidemiological or confirmation purposes: Anthrax (Bacillus anthracis) Cholera (Vibrio cholerae) Diphtheria (Corynebacterium diphtheriae) Escherichia coli O157:H7 Glanders (Burkholderia mallei) Haemophilus influenzae, invasive disease Influenza Virus-associated mortality Listeriosis Malaria (Plasmodium species) Measles (rubeola) Melioidosis (Burkholderia pseudomallei) Mycobacterium tuberculosis Neisseria meningitidis, invasive disease Orthopoxvirus (smallpox/cowpox-vaccinia/monkeypox) Other Shiga Toxin positive organisms Pertussis (Bordetella pertussis) Plague (Yersinia pestis) Salmonella species Severe Acute Respiratory Syndrome-associated Coronavirus (SARS-CoV) disease Shigella species Tularemia (Francisella tularensis) Potential Vancomycin Resistant Staphylococcus aureus (VRSA), with MIC greater than or equal to eight (> 8) (4) Every laboratory performing culture and sensitivity testing on human specimens in Missouri for health care facilities shall annually report these results to the Missouri Department of Health and Senior Services (MDHSS) for each facility provided this service. The data submitted should be in the format of antibiograms as defined by the Clinical and Laboratory Standards Institute (CLSI), M39-A2, Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. Only data from the first unique isolate from each patient should be included. Duplicate cultures must be excluded when compiling these antibiograms. The antibiograms for the preceding year are to be sent to MDHSS by July 1 of the following year (ex: 2006 data, January 1, 2006–December 31, 2006, will be due on July 1, 2007). AUTHORITY: section 192.006, RSMo 2000, and sections 192.020 and 192.131, RSMo Supp. 2013.* This rule was previously filed as 13 CSR 50-101.090. Original rule filed July 15, 1948, effective Sept. 13, 1948. Amended: Filed Aug. 4, 1986, effective Oct. 11, 1986. Amended: Filed Aug. 14, 1992, effective April 8, 1993. Amended: Filed Sept. 15, 1995, effective April 30, 1996. Emergency rule filed June 1, 2000, effective June 15, 2000, expired Dec. 11, 2000. Emergency rescission filed June 2, 2000, effective June 15, 2000, expired Dec. 11, 2000. Previous version of rule rescinded filed June 1, 2000, effective Jan. 30, 2001. Readopted: Filed June 1, 2000, effective Nov. 30, 2000. Amended: March 14, 2003, effective Sept. 30, 2003. Amended: Filed March 14, 2003, effective Sept. 30, 2003. Amended: Filed April 15, 2005, effective Oct. 30, 2005. Amended: Filed Feb. 15, 2006, effective Sept. 30, 2006. Amended: Filed Nov. 15, 2007, effective May 30, 2008. Amended: Filed Nov. 10, 2015, effective April 30, 2016. *Original authority: 192.006, RSMo 1993, amended 1995; 192.020, RSMo 1939, amended 1945, 1951, 2004; and 192.131, RSMo 2004.