DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Laboratory Services Division STATE BOARD OF HEALTH RULES PERTAINING TO TESTING FOR ALCOHOL AND OTHER DRUGS 5 CCR 1005-2 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] Part 1: General [Eff. 03/02/2009]

1.1 Purpose and Scope

This rule establishes minimum standards for certification and approval of entities and processes utilized for alcohol and drug testing. This rule is applicable to: samples taken while driving under the influence, driving while impaired, driving with excessive alcohol content; vehicular assaults and vehicular homicides involving an operator while under the influence of alcohol or one or more drugs or both; the testing of samples of blood or other bodily substances from the bodies of pilots in command, motorboat or sailboat operators in command, or drivers and pedestrians fifteen years of age or older who die within four hours after involvement in a crash involving a motor vehicle, a motorboat, a sailboat or an aircraft; and consumption of alcohol by underage persons and records related thereto.

1.2 Based on evidence gathered through testing and evaluation by the Colorado Department of Public Health and Environment and presented to the Board, the Department and the State Board of Health have determined that the results obtained from the certified EBAT instrument used to perform evidential breath alcohol testing is scientifically accurate, precise and reliable, when the certified EBAT instrument is properly operated as described in these rules and regulations.

1.3 Evidential Breath Alcohol Testing (EBAT) facilities will operate under Parts 2, 3, 4 and Appendix 2A of these rules and regulations. All EBAT facilities performing direct evidential breath alcohol tests must comply with Parts 2, 3, 4 and Appendix 2A of these rules and regulations.

1.4 Testing of blood alcohol, blood drug, urine drug and post mortem samples operate under Parts 6, 7, 8, 9 and Appendix 2C of these rules and regulations. All certified laboratories performing blood alcohol, blood drug, urine drug and post mortem testing must comply with Parts 6, 7, 8, 9 and Appendix 2C of these rules and regulations.

1.5 Definitions

“Alcohol Percent (%)” – grams of ethanol per 100 milliliters of blood or grams of ethanol per 210 liters of breath.

“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) have 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. “Certification” – the official approval by the Department of an Evidential Breath Alcohol Test (EBAT) instrument, instructor, operator, facility or laboratory to function under these rules and 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. The approved EBAT instrument for the state of Colorado is the Intoxilyzer 5000EN.

“Certified EBAT Instructor” – an employee of any approved 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 Laboratory” – a laboratory certified by the Department to perform analytical testing of bodily fluids for alcohol or other drugs.

“Certified EBAT Operator” – an employee of any approved 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.

“Department” – refers to The Colorado Department of Public Health and Environment, Laboratory Services Division.

“DUI Packet” – refers to the EBAT documentation provided by the law enforcement agency that must include, but is not limited to the following; a completed error-free EBAT and any error messages printed by the certified EBAT instrument, and all Appendix 2A checklists initiated by the certified EBAT operator or instructor.

“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.

“Facility” – any location that meets the requirements of these regulations and which is approved by the Department to perform evidential breath alcohol testing. “Laboratory Director” – the individual meeting the qualification requirements specified in Part 6 and Appendix 2C 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.

“Litigation Packet” – records requested for litigation purposes must include sufficient material to allow independent review by a qualified toxicologist. These records should include the request for analysis, chain of custody documents, all analytical data which supports identification, and if applicable, quantitation of the analyte(s) to include the limits of quantitation (LOQ). Where appropriate, it should include not just the raw data and reports, but worksheets, sequence tables, quality control data including target ranges. The material in the litigation packet should be complete and properly organized.

“Proficiency Testing” – The evaluation of unknown specimens supplied by a provider which determines target values for those unknown specimens.

“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.

“Standard Simulator Solution Logs” – the certified EBAT instrument printout containing all testing records for a period of 28 days or 96 tests, whichever comes first. “Supervisory Analyst” – the individual(s) that meet the qualification requirements specified in Part 6 and Appendix 2C of these rules and who is responsible for the day to day operation and reporting of results by the laboratory as delegated in writing by the laboratory director. “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. Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) [Eff. 03/02/2009] 2.1 Certification of Operators of EBAT Instruments to Determine Alcohol Concentration of Breath Specimens.

2.1.1 To initially be certified as an EBAT operator an individual must:

2.1.1.1 Be currently employed by a law enforcement agency or the Department;

2.1.1.2 Attend a minimum of eight (8) hours of instruction following the Department’s Operator Training Manual;

2.1.1.3 Score 80% or greater on a written exam; and

2.1.1.4 Complete a comprehensive practical exam as specified in the Department

1. Operator Training Manual.

2.1.1.5 Upon successful completion of the course requirements, a certificate shall be issued by the Department stating the operator’s name, the course instructor(s) and the initial date of certification.

2.1.2 To maintain certification an operator must:

2.1.2.1 Proficiently perform one error-free EBAT test following the procedure specified in Appendix 2A of this regulation in the presence of a certified instructor within a 180-day period.

2.1.2.2 The test performed must be a complete error-free EBAT test.

2.1.2.3 The printout obtained from the certification test shall be signed and dated by the certifying operator and the instructor.

2.1.2.4 The printout must be retained by the law enforcement agency as proof that the certification test was performed in accordance with this regulation.

2.1.3 An operator who fails to certify within the 180-day period must:

2.1.3.1 Be decertified by the instructor, and

2.1.3.2 Must repeat the 8-hour operator course.

2.1.4 Operators who return from active military service may renew their expired certification by completing the following procedure:

2.1.4.1 Document proof of active duty (period of absence must not exceed 2 years.);

2.1.4.2 Document proof of last operator certification prior to going on active duty;

2.1.4.3 Pass the current operator test with a score of 80% or better;

2.1.4.4 Proficiently perform without errors, one Evidential Breath Alcohol Test (EBAT) following the procedure specified in Appendix 2A in the presence of a certified instructor;

2.1.4.5 Documented proof of active duty, documented proof of last operator certification prior to going on active duty, operator test material and a copy of the error-free EBAT test must be sent to the Department’s Evidential Breath Alcohol Testing Program.

2.1.4.6 Upon successful completion of the requirements in Section 2.1.4 et seq. , a certificate shall be issued by the Department to be signed by the certified instructor indicating the operator name, the date of certification and “Reinstatement After Military Service.”

2.1.5 A facility must retain records showing each certified operator’s date of original certification and all subsequent dates of certification.

2.2 Certification of Instructors of Certified EBAT Instruments to Determine Alcohol Concentration of Breath Specimens

2.2.1 To initially be certified as an EBAT instructor an individual must:

2.2.1.1 Be currently employed by a law enforcement agency or the Department;

2.2.1.2 Be a currently certified EBAT operator;

2.2.1.3 Attend a minimum of sixteen (16) hours of instruction provided by the Department using the Instructor Training Manual;

2.2.1.4 Score 80% or greater on a written exam; and

2.2.1.5 Complete a comprehensive practical exam as specified in the Department

1. Instructor Training Manual.

2.2.2 Upon successful completion of the course requirements, a certificate shall be issued by the Department stating the instructor’s name, the Department’s course trainer(s) and the initial date of certification.

2.2.3 A certified instructor is also a certified operator and is authorized to train and certify operators of EBAT instruments.

2.2.4 To maintain certification an instructor must:

2.2.4.1 Participate in teaching one EBAT operator certification class, or

2.2.4.2 Pass a written instructor certification examination within a 365-day period.

2.2.5 An instructor who fails to certify in the 365-day period must be decertified by the Department and must repeat the 16-hour instructor course provided by the Department in order to be recertified as an instructor.

2.2.5.1 An instructor who fails to certify within the 365-day period may recertify as an operator after performing one error-free EBAT test in the presence of a certified instructor, following the procedure specified in Appendix 2A of this regulation prior to performing subject testing.

2.2.6 EBAT Instructors who return from active military service may renew their expired certification by completing the following procedure:

2.2.6.1 Document proof of active duty (period of absence must not exceed 2 years.);

2.2.6.2 Document proof of last instructor certification prior to going on active duty;

2.2.6.3 Pass the current instructor test with a score of 80% or better; and

2.2.6.4 Proficiently perform without errors, one EBAT test following the procedures specified in Appendix 2A in the presence of a certified instructor.

2.2.6.5 The documented proof of active duty, documented proof of last instructor certification prior to going on active duty, instructor test material and a copy of the error-free EBAT must be sent to the Department’s Evidential Breath Alcohol Testing Program.

2.2.7 Upon successful completion of the above requirements, a certificate shall be issued by the Department to be signed by the certified instructor or the Department’s program manager or designee, stating the instructor’s name, the date of certification and “Reinstatement After Military Service.”

2.2.8 A facility must retain records showing each certified instructor’s date of original certification and dates of all classes taught and written exams taken. Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities [Eff. 03/02/2009] 3.1 Standards for approved permanent, temporary and mobile Evidential Breath Alcohol Testing (EBAT) facilities 3.1.1 Evidential Breath Alcohol Test(s) must be conducted only in facilities that have been approved by the Department.

3.1.2 Department standards for all approved EBAT facilities are specified in these regulations.

3.1.3 All approved EBAT facilities must meet standards of performance as established by this section of these regulations.

3.1.4 Inspections of permanent, temporary and mobile facilities must be performed prior to initial approval and once in a calendar year thereafter by Department staff.

3.1.4.1 Facility inspection reports will be sent to the facility within 15 days of the inspection date.

3.1.4.2 When applicable, facilities must send a plan of correction to the Department for review and approval within 15 days of receipt of the facility inspection report.

3.1.5 Initial inspections of permanent and temporary EBAT facilities must be conducted by Department staff using sections 3.1.12.1 et seq. to 3.1.12.7 et seq. of these regulations.

3.1.6 Annual, complaint and follow-up inspections of permanent and temporary EBAT facilities must be conducted by Department staff using sections 3.1.12.2 et seq. to 3.1.12.8 et seq. of these regulations.

3.1.7 Initial inspections of mobile EBAT facilities must be conducted by Department staff using sections 3.1.12.1 et seq. ; 3.1.12.3 et seq. to 3.1.12.7 et seq. ; and 3.1.12.9 et seq. of these regulations.

3.1.8 Annual, complaint and follow-up inspections of mobile EBAT facilities must be conducted by Department staff using sections 3.1.12.3 et seq. to 3.1.12.9 et seq. of these regulations.

3.1.9 Mobile EBAT facilities, the certified EBAT instrument and its associated equipment must be brought to the Department each time a facility inspection is required.

3.1.10 A certified EBAT instrument that is used in an approved mobile EBAT facility must not be used at a permanent or temporary facility unless approved by the Department.

3.1.11 A certified EBAT instrument that is used in an approved permanent or temporary facility must not be used at a mobile facility unless approved by the Department 3.1.12 Department inspection procedure for permanent, temporary and mobile Evidential Breath Alcohol Test Facilities

3.1.12.1 Initial approval – permanent, temporary and mobile EBAT facilities

1. 3.1.12.1.1 Facilities must submit a written request to the Department for
   1. approval of an EBAT facility.
2. 3.1.12.1.2 After receipt of the written request for approval, the Department shall supply a copy of these regulations to the requesting facility.
3. 3.1.12.1.3 The facility’s certified instructor or DUI enforcement officer is
   1. responsible for monitoring the construction of the EBAT facility and verifying compliance with the requirements of this section.
4. 3.1.12.1.4 After the facility is constructed and ready for use, written verification of compliance with the requirement of this section must be sent to the Department by the facility. The written verification must include a letter from a certified electrician that the power line to the certified EBAT instrument is an isolated line.
5. 3.1.12.1.5 Department staff must perform an initial facility inspection to verify compliance with the requirements of this section. Subsequent facility inspections must be performed once in a calendar year by Department staff.
   1. 3.1.12.1.5.1 The certified EBAT instrument must not be moved from its
      1. approved location within the approved facility without authorization from the Department.

3.1.12.2 Power requirements – permanent and temporary facilities

1. 3.1.12.2.1 AC line voltage of 120VAC ±10%, 60 HZ with a grounded 3-prong
   1. outlet(s) and a 20 ampere or less circuit breaker.
2. 3.1.12.2.2 The power line to the certified EBAT instrument must be an isolated
   1. line. Written verification of compliance with this requirement from a certified electrician must be provided to the Department.
3. 3.1.12.2.3 A surge protection device approved by the Department must be
   1. placed between the certified EBAT instrument and the isolated power outlet.
4. 3.1.12.2.4 Only the certified EBAT instrument and its associated equipment shall be connected to the surge protection device or the isolated power outlet.

3.1.12.3 Environment – permanent, temporary and mobile EBAT facilities

1. 3.1.12.3.1 The temperature of the approved facility must be maintained between
   1. 70 and 80 degrees Fahrenheit.
2. 3.1.12.3.2 The approved facility must have adequate lighting so the certified
   1. EBAT operator or instructor can see to safely conduct the evidential breath alcohol test and complete the required forms.
3. 3.1.12.3.3 The area around and under the certified EBAT instrument must be
   1. free of dust and dirt.
4. 3.1.12.3.4 The approved facility must be kept orderly.
5. 3.1.12.3.5 The certified EBAT instrument and breath alcohol simulator must be
   1. located on the organizer stand.
6. 3.1.12.3.6 The organizer stand must be placed on a sturdy and adequate work
   1. surface.
7. 3.1.12.3.7 The certified EBAT instrument must be in a smoke-free environment.
8. 3.1.12.3.8 The approved facility must have adequate ventilation to prevent vapor build-up around the certified EBAT instrument.
9. 3.1.12.3.9 The approved facility must not be used to store any cleaning
   1. compounds or volatile organics to include gasoline and petroleum products.
10. 3.1.12.3.10 The approved facility must be secure and not readily accessible to
    1. unauthorized individuals.
11. 3.1.12.3.11 Automobile emissions must not be allowed in the approved EBAT
    1. facility.

3.1.12.4 Documents – Permanent, temporary and mobile EBAT facilities

1. 3.1.12.4.1 The following documents must be maintained at the approved EBAT
   1. facility with the certified EBAT instrument.
   2. 3.1.12.4.1.1 Current, original certificate for the certified EBAT
      1. instrument.
   3. 3.1.12.4.1.2 Checklist, Appendix 2A
   4. 3.1.12.4.1.3 Error message sheet
   5. 3.1.12.4.1.4 Current list of certified operators and instructors from all
      1. agencies that regularly use this certified EBAT instrument to include original date of certification, date of last certification and date next certification is due.
   6. 3.1.12.4.1.5 Current Standard Simulator Solution Log Sheet.

3.1.12.5 Supplies – permanent, temporary and mobile EBAT facilities

1. 3.1.12.5.1 The following supplies must be maintained at the certified EBAT
   1. facility with the certified EBAT instrument.
   2. 3.1.12.5.1.1 Mouthpieces;
   3. 3.1.12.5.1.2 Standard simulator solution;
   4. 3.1.12.5.1.3 Printer paper

3.1.12.6 Certified Evidential Breath Alcohol Testing instrument functions – permanent, temporary and mobile EBAT facilities

1. 3.1.12.6.1 The certified EBAT instrument time and date must be correct, or
   1. synchronized with the facility dispatch clock when the facility dispatch clock is used instead of the certified EBAT instrument clock.
2. 3.1.12.6.2 The external breath tube must be heated.
3. 3.1.12.6.3 The simulator vapor tube must be heated.
4. 3.1.12.6.4 The certified EBAT instrument certification date on the printout must be the same as the certification date on the posted certification certificate – Permanent locations only.
5. 3.1.12.6.5 The certified EBAT instrument must be connected to an active analog
   1. telephone line at all times – Permanent locations only.

3.1.12.7 Simulator functions – Permanent, temporary and mobile EBAT facilities

1. 3.1.12.7.1 Active simulator
   1. 3.1.12.7.1.1 Record serial number
   2. 3.1.12.7.1.2 Display must read between 33.8°C and 34.2°C.
   3. 3.1.12.7.1.3 Simulator solution temperature must be between 33.8°C
      1. and 34.2°C measured by a calibrated, NIST-traceable, digital thermometer.
   4. 3.1.12.7.1.4 Simulator must be functioning properly.
2. 3.1.12.7.2 Backup simulator(s)
   1. 3.1.12.7.2.1 Record serial number(s).
   2. 3.1.12.7.2.2 Display(s) must read between 33.8°C and 34.2°C.
   3. 3.1.12.7.2.3 Simulator solution temperature must be between 33.8°C
      1. and 34.2°C measured by a calibrated, NIST-traceable, digital thermometer.
   4. 3.1.12.7.2.4 Simulator must be functioning properly.

3.1.12.8 Records review – Permanent, temporary and mobile EBAT facilities.

1. 3.1.12.8.1 Review of the Standard Simulator Solution Log Sheets must show
   1. precise standard results within ±10% of the target value.
2. 3.1.12.8.2 Review of the Standard Simulator Solution Log Sheet must not
   1. indicate an unacceptable number of error messages.
3. 3.1.12.8.3 A new Standard Simulator Solution Log Sheet must be created every
   1. 28 days or 96 tests, whichever comes first.
4. 3.1.12.8.4 Diagnostic checks must be performed every 28 days.
5. 3.1.12.8.5 Calibration checks must be performed with each new Standard
   1. Simulator Solution Log and every 7 days thereafter.
6. 3.1.12.8.6 A breath sample check must be performed every 28 days or 96 tests,
   1. whichever comes first.
7. 3.1.12.8.7 Effective April 1, 2009, all EBAT Standard Simulator Solution Logs,
   1. and solution records must be retained by the approved EBAT facility for a minimum of 5 years.

3.1.12.9 Additional requirements for mobile EBAT facilities

1. 3.1.12.9.1 Power
   1. 3.1.12.9.1.1 Acceptable power sources are:
      1. 3.1.12.9.1.1.1 Square wave power inverter capable of
         1. generating an AC line voltage of 140 volts RMS± 10%.
      2. 3.1.12.9.1.1.2 Power inverter/sine wave converter combination
         1. that generates 120 volts AC ± 10% from 14 VOLTS DC.
      3. 3.1.12.9.1.1.3 Electric motor/generator combinations that use a
         1. 12 volt AC ± 10% 60 HZ generator.
      4. 3.1.12.9.1.1.4 The isolated power line to the certified EBAT
         1. instrument must be verified by Department staff.
      5. 3.1.12.9.1.1.5 A surge protection device approved by the
         1. Department must be placed between the certified EBAT instrument and the isolated power outlet.
      6. 3.1.12.9.1.1.6 Only the certified EBAT instrument and its
         1. associated equipment shall be connected to the surge protection device or the isolated power outlet.

Part 4: Evidential Breath Alcohol Testing (EBAT) - Collection and Testing Procedures [Eff. 03/02/2009]

4.1 Purpose and Scope

4.1.1 Part 4 establishes minimum standards for certification and approval of entities and processes used for breath alcohol testing using the certified EBAT instrument approved by the Department.

4.2 Evidential Specimen Collection

4.2.1 Breath

4.2.1.1 Evidential breath specimens must be analyzed using a certified EBAT instrument approved by the Department. Approval or disapproval of EBAT instruments will be based on scientific standards of performance established by the Department and approved by the Colorado Board of Health.

4.2.1.2 The Department must certify each EBAT instrument initially and annually

1. thereafter.

4.2.1.3 The Department must issue a certificate for each certified EBAT instrument after initial certification and after each annual certification. The certificate must reflect the approved facility name, the certified EBAT instrument serial number and the inclusive dates for the certification period. The certificate for EBAT instruments placed in approved mobile EBAT facilities must also include the vehicle identification number.

4.2.1.4 An evidential breath alcohol test specimen must only be collected and tested by certified EBAT operators or instructors using a certified EBAT instrument and following the steps outlined in these regulations.

4.2.1.5 Breath specimens consisting of end-expiratory alveolar air are analyzed to determine the ethyl alcohol concentration.

4.2.1.6 Unless otherwise provided by law, at the request of the subject, the subject must be given a choice of which type of evidential chemical test they wish to take to determine the alcohol concentration in their body (evidential breath alcohol test or evidential blood alcohol test) or they may refuse to take either evidential chemical test. Nothing in this regulation is intended to exempt or exonerate an individual from the penalties proscribed in Sections 42 42-4-1301.1 and 42-4- 1301.2, C.R.S, or any other relevant law, for the failure to submit to such test.

4.3 Methods of Analysis

4.3.1 Alcohol in Evidential Breath Specimens

4.3.1.1 The certified EBAT operator or instructor must follow the procedures specified in these regulations for evidential breath alcohol tests.

4.3.1.2 The certified EBAT operator or instructor must document compliance with these testing procedures by completion of the Department’s checklist form, which is available in Appendix 2A of these regulations or on the Department’s website.

1. 4.3.1.2.1 Information included in Steps 1 through 7 of Appendix 2A must not be
   1. changed in any way.
2. 4.3.1.2.2 Steps 1 through 7 must be performed in the order listed.
3. 4.3.1.2.3 A completed evidential breath alcohol test (EBAT) is one in which the
   1. checklist (Appendix 2A) is followed and a printout without error messages is obtained.

4.3.1.3 The certified operator or instructor conducting the EBAT must initial inside the parentheses to the left of each step (1 through 7). Initialing each step indicates that step is properly performed and completed.

4.3.1.4 Step 1. “Turn power button on or observe the power button has been activated. If the certified EBAT instrument is in the standby mode, press the start test button.”

1. 4.3.1.4.1 Certified EBAT instrument(s) at approved EBAT facilities must always
   1. be powered on. This is indicated by the small red light below the power button being illuminated.
2. 4.3.1.4.2 When the certified EBAT operator or instructor first enters the EBAT
   1. room he/she shall determine if the certified EBAT instrument is in the standby mode. The certified EBAT instrument is in the standby mode if the display is blank, the small red light under the power button is lit and the simulator display reads “idle.”
3. 4.3.1.4.3 If the certified EBAT instrument is in the standby mode, press the
   1. START TEST button.
4. 4.3.1.4.4 If the certified EBAT instrument is in the ready mode, (when the
   1. instrument display is scrolling or flashing and the simulator display is lit), proceed to Step 2.

4.3.1.5 Step 2. “The subject must remove foreign objects from the nose and mouth including removable dentures. The subject must be closely and continuously observed for 20 minutes prior to testing to ensure no belching, regurgitation or intake of any foreign material by nose or mouth has occurred. If such occurs, another 20 minutes of close and continuous observation must elapse under the same conditions.”

1. 4.3.1.5.1 Check the subject for foreign objects in the nose or mouth including
   1. dentures. There are two types of dentures, permanent and removable. Permanent dentures are typically anchored to the mouth and cannot be removed. Permanent dentures need not be removed. They will not interfere with the results obtained during the EBAT. Removable dentures are typically held in place by an adhesive and must be removed.
2. 4.3.1.5.2 During the 20-minute observation period the certified EBAT operator or instructor must be close enough to the subject to detect any belching, regurgitation or intake of foreign material.
3. 4.3.1.5.3 When belching, regurgitation or intake of foreign material is detected during the 20-minute observation period, the certified EBAT operator or instructor must start the observation period over again. A new checklist (Appendix 2A) must be filled out for this test.
4. 4.3.1.5.4 The observation period must be conducted at the approved EBAT
   1. facility by a certified EBAT operator or instructor .
5. 4.3.1.5.5 The observation period must not be conducted in the patrol car while
   1. driving to the approved EBAT facility.
6. 4.3.1.5.6 Start and stop times for the observation period must be recorded from
   1. the certified EBAT instrument clock or the facility dispatch clock, when the EBAT instrument has been synchronized with the facility dispatch clock.

4.3.1.6 Step 3. “Verify that the external breath tube and simulator vapor tube are both warm.”

1. 4.3.1.6.1 Touch the external breath tube to ensure that it is warm.
2. 4.3.1.6.2 Touch the simulator vapor tube to ensure that it is warm.
3. 4.3.1.6.3 If either tube is cold to the touch, stop the test and call a certified EBAT instructor for assistance.

4.3.1.7 Step 4. “Observe the simulator temperature is between 33.8 degrees Centigrade and 34.2 degrees Centigrade.”

1. 4.3.1.7.1 Allow the simulator to equilibrate for a minimum of ten (10) minutes
   1. after reaching the correct temperature when it has been in standby mode or is first turned on.

4.3.1.8 Step 5. “Press the start test button.”

1. 4.3.1.8.1 Press the green start test button to initiate the automated test
   1. sequence.

4.3.1.9 Step 6. “Follow the instructions and sequence of events as they appear on the certified EBAT instrument display.”

1. 4.3.1.9.1 A system blank(s) analysis must be used during the test sequence of
   1. each evidential breath alcohol test.
2. 4.3.1.9.2 For each EBAT, Department-certified reference standard(s) of known
   1. ethanol concentration must be analyzed. The results of such analysis must agree with the reference standard(s) target value (s) of 0.100 grams of alcohol/210 liters of breath within ±10% (0.090 – 0.110 grams of alcohol/ 210 liters of breath).
3. 4.3.1.9.3 The results of analyzing more than one reference standard of the same
   1. value for each EBAT must agree with each other within ±10%.
4. 4.3.1.9.4 If the ±10% calibration correlation is not obtained, the instrument will abort the test and print a “No Calibration Correlation” error message.
5. 4.3.1.9.5 For each EBAT, the results of the two subject breath alcohol tests must agree with each other within 0.020 grams of alcohol/210 liters of breath.
   1. 4.3.1.9.5.1 If the 0.020 grams of alcohol/210 liters of breath correlation is
      1. not obtained, the instrument will abort the test and print a “NO . 02 Agreement” error message.
      2. 4.3.1.9.5.1.1 When a “NO .02 Agreement” error message is
         1. obtained, the certified EBAT operator or instructor must perform the EBAT test procedure over again after another 20-minute observation period. A new checklist (Appendix 2A) must be filled out for this test.
6. 4.3.1.9.6 The certified EBAT operator or instructor must be close enough to the
   1. subject to detect any belching, regurgitation or foreign material in the mouth or nose from the time the EBAT is started through the completion of the second breath sample.
   2. 4.3.1.9.6.1 Whenever belching, regurgitation or foreign material is
      1. detected in the mouth or nose from the start of the EBAT through completion of the second breath sample, the certified operator or instructor must choose the Non-Compliance option to abort the test. The certified EBAT operator or instructor must perform the test procedure over again after another 20-minute observation period. A new checklist (Appendix 2A) must be filled out for this test.
7. 4.3.1.9.7 In order to prevent tampering of the certified EBAT instrument during
   1. the testing procedure, the subject must be removed from the area in close proximity to the instrument during the two-minute period between subject breath tests.
8. 4.3.1.9.8 A clean mouthpiece will be used each time the subject blows into the
   1. certified EBAT instrument.

4.3.1.10 Step 7. Retain all printouts generated by the certified EBAT instrument to include any error messages, and any checklist(s) initiated (Appendix 2A) with the DUI packet.

1. 4.3.1.10.1 The certified EBAT operator or instructor conducting the EBAT must
   1. sign the checklist(s) and completed EBAT printout(s) and retain all initiated checklist(s) (Appendix 2A) with the DUI packet.
2. 4.3.1.10.2 All printouts generated by the certified EBAT instrument must be
   1. retained with the DUI packet, including error message printouts.
3. 4.3.1.10.3 Effective April 1, 2009, all certified EBAT instrument Standard
   1. Simulator Solution Logs and solution records must be retained by the facility for a minimum of 5 years.

Part 5: Reserved [Eff. 03/02/2009] Part 6: Certification Requirements for Forensic Toxicology Laboratories [Eff. 03/02/2009]

6.1 Laboratory Analysis of Blood, Urine and Post Mortem Specimens

6.1.1 Laboratories must be certified by the Department to provide analysis. Certification is based on successful on-site inspection, successful participation in proficiency testing and ongoing compliance.

6.1.2 Laboratories accredited by the American Board of Forensic Toxicology (ABFT) will be granted reciprocity on an annual basis.

6.1.3 Laboratories will be certified to perform tests for one or more of the following categories: blood alcohol, blood drugs, urine drugs and post mortem testing.

6.1.4 Laboratories must meet standards of performance as established by these regulations. Standards of performance will include personnel qualifications, standard operating procedure manual, analytical process, proficiency testing, quality control, laboratory security, chain of custody, specimen retention, space, records, and results reporting.

6.1.5 Laboratory inspections must be performed prior to initial certification and annually thereafter by Department staff as established by these regulations. A laboratory meeting the requirements of these regulations will be issued a certificate. Recertification shall be required each July 1.

6.2 Initial Application

6.2.1 Laboratory directors must submit to the Department a written request for certification of their laboratory.

6.2.2 The Department will acknowledge the request and provide a copy of the rules and regulations to the laboratory.

6.2.3 To be certified, laboratories shall meet all applicable requirements in Parts 6,7,8,9 and Appendix 2C of these rules and pass an on-site inspection.

6.3 Application for Continued Certification

6.3.1 Annually the laboratory director must provide a completed application (Appendix 2B), no later than June 1, to the Department to be considered for continued certification.

6.3.2 Laboratories must be recertified every July 1, and certification will be for a period of 1 year.

6.3.3 Certified laboratories referring specimens to ABFT accredited laboratories must include documentation with the application (Appendix 2B) that the reference laboratory is ABFT accredited.

6.3.4 Laboratories must maintain a listing of all analytical methods used by the laboratory and all analytes tested and reported by the laboratory. The laboratory must provide this listing to the Department upon request.

6.3.5 To maintain certification, laboratories shall meet all applicable requirements in Parts 6,7,8,9, and Appendix 2C of these rules and pass an on-site inspection.

6.4 General Requirements

6.4.1 In addition to the laboratory’s application, the laboratory must provide the following information to the Department: written evidence concerning the education, scientific training, and experience of the laboratory director and personnel performing the testing.

6.4.2 Prior to independently analyzing samples, testing personnel must demonstrate acceptable performance on precision, accuracy, specificity, reportable ranges, blanks, and unknown challenge samples (proficiency samples or internally generated quality controls). The laboratory must have a system to evaluate and document employee competency as specified in Appendix 2C.

6.4.3 The laboratory must notify the Department in writing within thirty days of any changes pertaining to laboratory location or personnel.

6.4.4 The laboratory director is directly responsible for the accuracy of the tests performed, the accuracy of the reports issued, and adherence to these regulations.

6.4.5 The laboratory must have adequate space, equipment, materials, and controls available to perform the tests reported.

6.4.5.1 Samples which serve as test controls must be of such quality as could be determined “Certifiable” by National Institute of Standards and Technology (“NIST” ) standards, although such samples need not actually be NIST-Certified. Relevant documentation must be available for inspection.

6.4.6 The laboratory must document evidence of the utilization of a written method of analysis (Standard Operating Procedure (SOP)) to perform the tests reported. Critical elements that must be addressed in the SOP are in Appendix 2C, Section B5 (a-u).

6.4.7 The laboratory must demonstrate compliance with these regulations through a successful on-site inspection conducted by Department staff prior to certification. Certified laboratories will be inspected on an annual announced basis. Certified laboratories may be inspected on an unannounced basis to evaluate complaints.

6.4.8 Effective April 1, 2009, the laboratory must maintain all records related to analysis for a minimum of 5 years. Records to be maintained include instrument maintenance, quality control and quality assurance of all analyses performed, specimen processing, results and reports of analysis, dates of analysis and the identity of the person performing the analysis. Retained records must be open to inspection by Department personnel.

6.5 Proficiency Testing requirements for Blood, Urine and Post Mortem Samples

6.5.1 Proficiency Testing (PT) is the evaluation of unknown specimens supplied by a provider that determines target values for those unknown specimens. PT is required for each approved category.

6.5.2 Prior to initial certification, the laboratory must have successfully participated in one of the designated proficiency testing events in the category for which the laboratory seeks certification, within the past 12 months.

6.5.3 To maintain continued laboratory certification, a laboratory must participate in the designated PT program and maintain satisfactory performance as determined by the department.

6.5.4 PT samples shall be tested by the same procedure used for all samples, including, but not limited to, the same number of replicate analyses, the same standards, same testing personnel and equipment, and all other pertinent factors.

6.5.4.1 The laboratory must request that the proficiency testing provider mail a consultant copy of their PT survey results to:

1. Colorado Department of Public Health and Environment Laboratory Services Division Certification Program 8100 Lowry Boulevard Denver, CO 80230-6828

6.5.5 Blood Alcohol Testing

6.5.5.1 The Department will make arrangements to provide blood alcohol PT samples to the laboratories through a PT provider.

6.5.5.2 A laboratory must participate in PT testing through 3 events per year, consisting of 5 specimens each. The laboratory will submit results to the PT provider. The PT provider will evaluate the results and forward them to the laboratory as well as to the Department.

6.5.5.3 Other forensically significant volatiles, such as acetone, methanol and

1. isopropanol, may be included in one or more PT samples. The laboratory must be able to detect any volatile included in the PT samples and must retain documentation of this detection with the PT results.

6.5.5.4 Grading Criteria for Blood Alcohol Proficiency Testing

1. 6.5.5.4.1 Proficiency test results must be returned to the PT provider within the time specified by the PT provider. Results received after the due date will not be graded and will be considered an unsatisfactory performance resulting in a score of 0 for the testing event. The laboratory must contact the PT provider if extenuating circumstances prevent timely response to a PT event.
2. 6.5.5.4.2 The laboratory must investigate any score less than 100% and
   1. undertake corrective action as needed. The investigation outcome and corrective action must be submitted to the Department within 15 days of receipt of the results for approval.
3. 6.5.5.4.3 The PT provider will score each event as “satisfactory or
   1. “unsatisfactory” and the results will be reviewed by the Department to determine if successful PT performance has been achieved. If a laboratory has two consecutive “unsatisfactory” evaluations, or achieves an “unsatisfactory” score in 2 of any 3 consecutive PT events, the PT performance is deemed “unsuccessful” . The “unsuccessful” determination may result in a “directed plan of correction” specified by the Department, or suspension/ limitation of certification for the failed analyte.

6.5.6 Urine, Blood and Post Mortem Drug Testing

6.5.6.1 For blood drug, urine drug and post mortem screening and confirmation

1. certification, a laboratory must successfully participate in the appropriate College of American Pathologists (CAP) proficiency test programs.
2. 6.5.6.1.1 For blood-drug certification the required program is the Forensic
   1. Toxicology (Criminalistics) (FTC) survey.
3. 6.5.6.1.2 For urine-drug certification the required program is the Urine Toxicology
   1. (UT) survey.
4. 6.5.6.1.3 For laboratories performing only post mortem forensic toxicology
   1. testing the required programs are the Toxicology (T) and the Urine Toxicology (UT) surveys.
5. 6.5.6.1.4 Laboratories certified for both blood and urine drug testing are eligible to apply for post mortem certification without participating in the Toxicology (T) survey.

6.5.6.2 A satisfactory event score is the identification of 80% of the target analytes present with no false positives. Any false positive will result in an unsatisfactory score for the PT event.

6.5.6.3 All analytes listed and reported by the laboratory to the Department must be tested for in the proficiency testing challenges when provided.

6.5.6.4 Whenever a laboratory has an unsatisfactory PT event, the laboratory must investigate and undertake corrective action as needed. The investigation outcome and corrective action documentation must be submitted to the Department within 15 calendar days of receipt of the results for approval.

6.5.6.5 Whenever a quantitative result reported by the laboratory in a PT challenge exceeds 20% from the target concentration, the laboratory must undertake and document corrective action. The corrective action documentation must be retained with the PT results.

6.5.6.6 A laboratory will be suspended from a category if two consecutive unsatisfactory PT events occur, or two out of three consecutive unsatisfactory PT events occur for unsuccessful PT performance. A laboratory may be reinstated to active status after successful participation in the next test event. Failure to successfully participate in the next test event will result in the revocation of the certificate and require two successful PT events before the laboratory may be eligible to reapply for certification. The laboratory may request the PT provider send, at the expense of the laboratory, one extra set of the designated PT samples when suspension status occurs.

6.6 On-Site Laboratory Inspection

6.6.1 On-site laboratory inspections must be performed prior to initial certification and annually thereafter by the Department.

6.6.2 The on-site inspection will include a review of the laboratory’s practices to assure compliance with these regulations. The requirements are in checklist format in Appendix 2C.

6.6.3 Laboratories will be contacted to arrange routine inspection dates approximately three weeks prior to a proposed date. A letter confirming the inspection date will be sent to the laboratory.

6.6.4 The on-site inspection’s checklist will be used systematically to evaluate and assess a laboratory’s compliance. Each item listed on the checklist will be answered by the department inspector as Yes (“Y” ), No (“N” ) or Not Applicable (“NA” ). Each item answered as “N” will be described in a report to include the noncompliant practice, the source of information and the scope and extent of the noncompliant practice.

6.6.5 Following the on-site inspection, a written report will be prepared and reviewed by a peer inspector or supervisor prior to mailing. The report should be sent to the laboratory within 15 days of inspection.

6.6.6 The laboratory must provide a written response to the report when noncompliant practices are identified. The laboratory must provide a written plan of correction within 15 days of receipt of the written inspection report for each noncompliant item cited as a result of items marked “N” on the inspection checklist. A response will not be required from the laboratory if all items on an inspection checklist are marked either “Y” or “NA” .

6.6.7 The written plan of correction will be reviewed by the inspector, and if acceptable, will be approved. Any items requiring clarification will be resolved by phone or written correspondence.

6.6.8 Documents must be provided to the Department by the laboratory within 90 days of the inspection for verification and proof of implementation of the corrections described in the written plan of correction. A subsequent on-site inspection will be conducted if the verification documents are not received, if compliance with corrective actions is difficult to verify by documentation, or if practices subject to correction have significant potential for direct impact on the quality of laboratory results.

6.6.9 Identification of noncompliant practices directly resulting in inaccurate laboratory reports, failure to provide a plan of correction or failure to adequately correct any noncompliant practice may result in inspector’s recommendation to deny initial certification or limit, deny, suspend or revoke the laboratory certificate. Such action shall be governed by section 24-4-105, C.R.S.

6.6.10 A certificate will be issued by the Department to the laboratory to show certification has been approved. The certificate will reflect the laboratory name, location, the analytical categories approved and the effective dates of the certification period. The certification period will not exceed twelve months.

6.6.11 The Department will annually publish a list of certified laboratories.

Part 7: Blood Forensic Toxicology – Collection and Testing Requirements [Eff. 03/02/2009]

7.1 Blood Specimen Collection

7.1.1 Blood Specimen(s) must be:

7.1.1.1 Collected in the presence of the arresting officer or other responsible person who can authenticate the specimens.

7.1.1.2 Collected by venipuncture by a physician, nurse, paramedic, emergency medical technician, medical technologist, or a person whose training and normal duties include collecting blood specimens under the supervision of a physician or nurse.

7.1.1.3 Collected only in an appropriate clinical or public safety facility (e.g., hospital, medical clinic, ambulance, police station, fire station or other approved facility). In no event will the collection of blood specimens interfere with the provision of essential medical care or the ready availability of emergency medical services to the public.

7.1.1.4 Collected using sterile equipment. The skin at the area of puncture must be thoroughly cleansed and disinfected with an aqueous solution of nonvolatile antiseptic. Alcohol or phenolic solutions must not be used as a skin antiseptic.

7.1.2 After Collection, Blood Specimens must be:

7.1.2.1 Dispensed or collected directly into two sterile tubes resulting in a sodium fluoride concentration greater than 0.90 percent weight.

7.1.2.2 Inverted several times to properly mix the blood with the sodium fluoride.

7.1.2.3 Affixed with an identification label and evidence seal.

7.1.2.4 The specimens must be placed in secured temporary refrigerated storage at less than 8 degrees Centigrade or frozen until shipped. Specimens must be shipped within 7 days of collection.

7.2 Blood Specimen Testing

7.2.1 One tube of blood must be analyzed for the State’s test(s). The State’s test(s) must be performed and completed in a reasonable period of time as not to affect the validity of the test(s). Specimens found to be positive on the initial test(s) must be confirmed prior to reporting the results.

7.2.2 Any remaining blood specimens must be retained and stored by the certified laboratory at less than 8 degrees Centigrade or frozen for a period of not less than 12 months from the date of collection unless requested and receipted by a representative of another certified laboratory, acting on behalf of the defendant.

7.2.3 The second blood specimen must be analyzed by a certified laboratory designated by the defendant or defendant’s legal counsel. The test(s) must be performed and completed in a reasonable period of time as not to affect the validity of the test(s). Specimens found to be positive on the initial test(s) must be confirmed prior to reporting the results to a court of law.

Part 8: Urine Forensic Toxicology – Collection and Testing Requirements [Eff. 03/02/2009]

8.1 Urine Specimen Collection

8.1.1 Urine specimen(s) must be:

8.1.1.1 Collected in the presence of collection personnel who can authenticate the specimen(s).

8.1.1.2 Collected in a clean, sterile container.

8.1.1.3 Affixed with an identification label and evidence seal.

8.1.1.4 The specimens must be placed in secured temporary refrigerated storage at less than 8 degrees Centigrade or frozen until shipped. Specimens must be shipped within 7 days of collection.

8.2 Urine Specimen Testing

8.2.1 The State’s test(s) must be performed and completed in a reasonable period of time as not to affect the validity of the test(s). Specimens found to be positive on the initial test(s) must be confirmed prior to reporting the results.

8.2.2 Any remaining urine specimen(s) must be retained by the certified laboratory in frozen storage for a period of not less than 12 months unless requested and receipted for by a representative of another certified laboratory acting on behalf of the defendant.

8.2.3 Any remaining urine specimen(s) must be analyzed by a certified laboratory designated by the defendant or defendant’s legal counsel. The test(s) must be performed and completed in a reasonable period of time as not to affect the validity of the test(s). Specimens found to be positive on the initial test(s) must be confirmed prior to reporting the results to a court of law.

PART 9: Post Mortem Forensic Toxicology – Collection and Testing Requirements [Eff. 03/02/2009]

9.1 Post Mortem Specimen Collection

9.1.1 Collection of specimens from deceased persons is conducted as per Section 42-4-1304, C.R.S. by a person who’s training and normal duties include the collection of blood specimens from deceased persons.

9.1.2 The laboratory must develop and provide detailed guidelines and instructions for the collection of post mortem specimens.

9.1.3 Each specimen should be labeled with the name of the subject from whom the specimens were collected together with other appropriate identification; for example, the medical examiner’s case number and/or a unique identification number.

9.1.4 Whenever possible, the amount of specimen collected should be sufficient to allow for analysis of one or more analytes if needed at a later date.

9.2 Post Mortem Specimen Testing

9.2.1 Post mortem test(s) must be performed and completed within a reasonable period of time as to not affect the validity of the test(s). Specimens found to be positive on the initial test(s) must be confirmed prior to reporting the results.

9.2.2 Any remaining post mortem specimens must be retained by the certified laboratory for a period of not less than 12 months unless requested and receipted for by a representative of another certified laboratory acting on behalf of the defendant. PART 10: Violations and Remedies [Eff. 03/02/2009]

10.1 Violations

10.1.1 It is a violation of these rules and regulations to perform EBAT testing without the appropriate certification for the EBAT instrument, operator or instructor.

10.1.2 Violation of these rules and regulations may result in denial, suspension or revocation of certification as outlined in Part 8 of these rules and regulations.

10.1.3 Generally, a violation will not be cited if:

10.1.3.1 The violation was unavoidable to prevent loss of life, personal injury or severe property damage or there were no feasible alternatives, and provided that proper notification was given to the Department.

10.1.3.2 The violations resulted from matters beyond the control of the facility or laboratory, such as equipment failures that were unavoidable by reasonable quality assurance measures or management controls.

10.2 Complaints

10.2.1 Complaints received by the department will be investigated to determine if the claim is substantiated or unsubstantiated. Complaints received will be documented and an investigation may include and result in, but is not limited to, the following actions: desk review of documentation request by the Department from the laboratory, unannounced onsite survey, limitation, suspension, or revocation of the laboratory’s certification.

10.3 Right to appeal the denial, suspension or revocation of certification.

10.3.1 Any approved facility, certified laboratory, operator or instructor whose certification is denied, suspended or revoked under these regulations may seek appeal of that determination pursuant to section 24-4-105, C.R.S.

10.4 Denial, Suspension or Revocation of Certification:

10.4.1 The Department may deny, suspend or revoke the certification of EBAT instrument(s) located in an approved facility, the certification of an instructor, the certification of an operator or the certification of a laboratory for one or more of the following causes:

10.4.1.1 Falsification of data or other deceptive practices including false statements by omission or commission relevant to the certification process.

10.4.1.2 Refusing authorized department personnel access to the laboratory or facility, or failure to provide requested records to the Department for the purpose of determining compliance with these rules and regulations.

10.4.1.3 Gross incompetence or negligent practice.

10.4.1.4 Willful or repeated violation of any lawful rule, regulation or order of the Department or the Board of Health and its officers.

10.4.1.5 Inadequate space, equipment, or methods utilized for testing.

10.4.1.6 Submission of any test results of another person as those of the subject being evaluated.

10.4.1.7 For a laboratory, failure to successfully participate in proficiency testing.

10.4.1.8 For a laboratory, the receipt of two consecutive “unsatisfactory” evaluations, or achievement of an “unsatisfactory” score in 2 of any 3 consecutive proficiency testing events.

10.4.1.9 For a laboratory, contact with another laboratory concerning proficiency test results prior to the due date of those results.

10.5 Injunction

10.5.1 The Department may seek an injunction against any entity for failure to comply with these rules and regulations.

APPENDIX 1A Reserved [Eff. 03/02/2009] APPENDIX 2A [Eff. 03/02/2009] APPENDIX 2B [Eff. 03/02/2009] APPENDIX 2C [Eff. 03/02/2009] _____________________________________________________ Editor’s Notes History Entire Rule eff. 03/02/2009.