6 Colo. Code Regs. § 1009-1, reg. Regulation 3

Current through Register Vol. 47, No. 24, December 25, 2024

Regulation Regulation 3 - [Effective 1/14/2025] Laboratory Reporting

Where Reporter = 'L' in Appendix A, cases of diseases shall be reported with the information required in Regulation 1 by the laboratory, or by an outpatient clinic that performs laboratory testing on site, whether or not associated with a hospital. The following laboratories shall also report:

1) out-of-state laboratories that maintain an office or collection facility in Colorado or arrange for collection of specimens in Colorado; and

2) in-state laboratories that send specimens to out-of-state referral laboratories. The case shall be reported by a laboratory when a result diagnostic of or highly correlated with clinical illness is found. Laboratory assays which demonstrate only immunity should not be reported (for example, a single elevated rubella antibody titer obtained during routine prenatal screening should not be reported).

For organisms so noted in Appendix A, testing laboratories shall routinely submit bacterial culture isolates or patient clinical material that yields positive findings to the Department, State Public Health Laboratory. Clinical material is defined as:

(i) a culture isolate containing the infectious organism for which submission of material is required, or

(ii) if an isolate is not available, material containing the infectious organism for which submission of material is required, in the following order of preference:

(A) a patient specimen;

(B) nucleic acid; or

(C) other laboratory material.

All specimens shall be accompanied by a test order with the following information:

(a) Patient's name, date of birth, sex assigned at birth, race, ethnicity, phone number, physical address (including city and county), email address, and preferred language; pregnancy status shall be reported for cases of syphilis, HIV, hepatitis B and hepatitis C

(b) Name and address and phone number of responsible physician or other healthcare provider

(c) Name of disease or condition

(d) Laboratory information - test name, collection date, specimen accession number, and specimen type. Laboratories should make an effort to report all test results and patient information electronically, whenever possible, as specimen submission to the Department, State Public Health Laboratory does not constitute disease reporting.

6 CCR 1009-1, reg. Regulation 3

37 CR 18, September 25, 2014, effective 10/15/2014

38 CR 20, October 25, 2015, effective 11/14/2015

40 CR 08, April 25, 2017, effective 5/15/2017

41 CR 12, June 25, 2018, effective 7/15/2018

42 CR 10, May 25, 2019, effective 7/1/2019

44 CR 18, September 25, 2021, effective 10/15/2021

46 CR 06, March 25, 2023, effective 2/15/2023

46 CR 10, May 25, 2023, effective 6/14/2023

47 CR 24, December 25, 2024, effective 1/14/2025