5 Colo. Code Regs. § 1005-2-1.5

Current through Register Vol. 47, No. 20, October 25, 2024
Section 5 CCR 1005-2-1.5 - [Effective until 11/14/2024] Definitions

"Analytical Non-Conformance" - refers to a result that has been reported by the certified laboratory that exceeds its established criteria of acceptability resulting in repeat analysis requiring amended reporting.

"Appropriate Clinical or Public Safety Facility" - provides for the health and safety of a person whose blood is collected (subject) and meets the following criteria:

1) provide for the washing or cleansing of hands of the blood collection personnel,
2) provide a comfortable chair for the subject with arm supports to assure the elbow remains straight and both arms are accessible to the blood collection personnel,
3) take precautions to assure the subject does not fall out of the chair,
4) provide for cot or other reclining surfaces for subjects who prefer to lie down or who have adverse response to the blood collection procedures,
5) provide for the adverse response to blood collection by providing procedures and equipment for subjects who become faint, nauseous, vomit, bleed excessively, or convulse including the provision of drinking water, and
6) provide for the cleaning and disinfection of the blood collection area.

"Approved Facility" - any location that meets the requirements of these regulations and which is approved by the Department to house the certified EBAT instrumentation.

"Certification" - the official approval by the Department of an Evidential Breath Alcohol Test (EBAT) instrument, instructor, operator, or forensic toxicology laboratory to function under these rules and regulations.

"Certified EBAT Instructor" - an employee of a law enforcement agency or the Colorado Department of Public Health and Environment who meets the requirements of Section 2.2 et seq. of these regulations.

"Certified EBAT Instrument" - the instrumentation approved for use by the Department for performing evidential breath alcohol testing in approved facilities by certified instructors and operators in order to determine the alcohol content in a subject's breath for evidentiary purposes as identified in Section 42-4-1301, C.R.S.

"Certified EBAT Operator" - an employee of law enforcement agency or the Colorado Department of Public Health and Environment who meets the requirements of Section 2.1 et seq. of these regulations.

"Certified Laboratory" - a forensic toxicology laboratory certified by the Department to perform analytical testing of bodily fluids for alcohol or other drugs in the categories of blood alcohol, blood drug, urine drug or postmortem testing.

"Department" - refers to The Colorado Department of Public Health and Environment, Laboratory Services Division.

"Discovery Packet" - refers to records requested for litigation purposes that include sufficient material to allow independent review by a qualified toxicologist. The records must include when applicable, but are not limited to; the request of analysis, chain of custody documents, test subject analytical data, calibration, standard, quality control data from the subject analytic run, limits of quantitation (LOQ), limits of detection (LOD), analyst curriculum vitae (CV), and the standard operating procedure used during the analysis.

"DUI" - refers to the term Driving Under the Influence of alcohol and/or other drugs as defined by Section 42-4-1301(1)(f), C.R.S.

"DUI Packet" - refers to the documentation produced by the certified EBAT instrument that must be included by the certified EBAT instructor or operator. This must include but is not limited to the following; the completed subject EBAT, and any Exception Messages which may have been encountered during the subject test attempts.

"DWAI" - refers to the term Driving While Ability Impaired by alcohol and/or other drugs as defined by Section 42-4-1301(1)(g), C.R.S.

"Evidential" or "Evidentiary" - refers to a sample which, when tested, gives rise to test results that are sufficiently reliable to be admissible as evidence in a court of law.

"Evidential Breath Alcohol Test (EBAT)" - is an evidentiary breath alcohol test performed using a certified evidential breath alcohol testing instrument approved by the Department as described by Section 42-4-1301, C.R.S.

"Exception Message" - is the term used for a report generated by the certified EBAT instrument whenever an Evidential Breath Alcohol Test (EBAT) is unable to be successfully completed.

"Internal Standard" - refers to a reference material that has similar chemical and physical properties to the analyte being measured and is added at a known concentration to a sample prior to testing.

"Key Management" - refers to personnel designated as top management and additional personnel who do not have laboratory wide authority but are "key" to the laboratory providing testing services which may include the laboratory director, technical personnel or any other designated qualified individual who has supervisory responsibilities for the scientific aspects of the laboratory.

"Laboratory Director" - the individual meeting the qualification requirements specified in Part 5 and Part 9 of these rules who is responsible for the overall operation and results reported by the laboratory.

"Limit of Detection (LOD)" - the lowest concentration or amount of an analyte that can be reliably shown to be present or measured under defined conditions and is derived by adding three standard deviations to the true value of the blank.

"Limit of Quantitation (LOQ)" - the concentration at which quantitative results can be reported with a high degree of confidence and is derived by adding ten standard deviations to the true value of the blank or administratively defined in terms of the lowest concentration of the lowest calibrator used in the analytic run.

"Proficiency Testing (PT)" - The evaluation of unknown specimens which determines target alcohol or drug values for those unknown specimens that is manufactured by a provider accredited to the International Standards Organization (ISO/IEC 17043). A single evaluation is commonly referred to as a PT event.

"Representative of a Certified Laboratory" - any employee of a certified laboratory or a courier employed by or contracted by the certified laboratory to transport specimens for the certified laboratory.

"Satisfactory PT Performance" - results scored from an individual PT event that meet or exceed the minimum score allowable to be considered passing.

"Successful PT Performance" - ongoing satisfactory PT performance in multiple PT events that meet or exceed the minimum score allowable to be considered passing.

"Tampering" - to meddle with the certified EBAT instrument especially for the purpose of altering test results, damaging or misusing the instrument either by intentional or unintentional means.

"Technical Personnel" - individuals who are engaged in any aspect of the testing of samples and reporting of results under the supervision of the laboratory director or the laboratory director's designee.

"Unsatisfactory PT Performance" - results scored from an individual PT event that are scored below the minimum allowable to be considered passing.

"Unsuccessful PT Performance" - two consecutive unsatisfactory individual PT events or 2 out of 3 unsatisfactory individual PT events that are scored below the minimum allowable to be considered passing.

5 CCR 1005-2-1.5

41 CR 04, February 25, 2018, effective 3/17/2018
42 CR 02, January 25, 2019, effective 2/14/2019