|(a) Purpose. The Diabetes Mellitus Registry Pilot Program, Statute Chapter 262, uncodified (House Bill 1363), 81st Texas Legislature, 2009 requires the establishment of a pilot program for the reporting of glycosylated hemoglobin tests. (b) Definitions. The following words and terms when used in this subchapter shall have the following meanings unless the context clearly states otherwise. (1) Diabetes Mellitus--A syndrome characterized by disordered metabolism and abnormally high blood sugar (hyperglycemia) resulting from insufficient levels of the hormone insulin or reduced insulin sensitivity. (2) Glycosylated hemoglobin test--A measurement of a form of hemoglobin used primarily to identify the average plasma glucose concentration over prolonged periods of time. (c) Where to report. The pilot program is being conducted in the San Antonio Metropolitan Health District. This jurisdiction meets the requirements of the statute. A clinical laboratory located in the participating public health district shall submit to the district and the department the results of each glycosylated hemoglobin test that the laboratory performs for each patient that has not chosen to opt out of having their information included in the registry. (d) Reportable information requirements. (1) The physician who orders a glycosylated hemoglobin test on or after November 1, 2009 shall submit to the clinical laboratory the patient diagnosis codes along with the patient's sample. (2) A physician, who orders a glycosylated hemoglobin test for a patient, shall provide the patient with a form, developed by the department, that allows the patient to opt out of having the patient's information included in the registry. If the patient opts out by signing the form, the physician shall keep the form in the patient's medical records; and may not submit to the clinical laboratory the patient's diagnosis codes along with the patient's sample. (3) The test result information that shall be reported for each glycosylated hemoglobin test performed within the San Antonio Metropolitan Health District service area is as follows: glycosylated hemoglobin value; patient name, address, telephone number, age, date of birth, sex, race and ethnicity; date of test, location of test site, patient diagnosis codes; and physician name, address, and telephone number. (4) Additional information necessary to determine the trends and public health costs of diabetes control shall also be reported if requested. (5) Reports, records, and information are confidential and are not subject to disclosure under Government Code, Chapter 552, are not subject to subpoena, and may not otherwise be released. The reports, records, and information obtained are for the confidential use of the department and the persons or public or private entities that the department determines are necessary to carry out the intent of this pilot program. (e) When to report. Reporting shall begin on the effective date of this rule. Glycosylated hemoglobin test results shall be reported within 5 calendar days. (f) This rule expires September 1, 2011.