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STATE BOARD OF HEALTH RULES PERTAINING TO TESTING FOR ALCOHOL AND OTHER DRUGS 5 STATE BOARD OF HEALTH RULES PERTAINING TO TESTING FOR ALCOHOL AND OTHER DRUGS 5 CCR 1005 -2 Rev 3. 09 Effective March 2, 2009 1

Table of Contents Part 1: General Part 2: Certification Requirements for Operators and Instructors Table of Contents Part 1: General Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures Part 5: Reserved Rev 3. 09 2

Table of Contents Part 6: Certification Requirements for Forensic Toxicology Laboratories Part 7: Blood Table of Contents Part 6: Certification Requirements for Forensic Toxicology Laboratories Part 7: Blood Forensic Toxicology – Collection and Testing Requirements Part 8: Urine Forensic Toxicology – Collection and Testing Requirements Part 9: Post Mortem Forensic Toxicology – Collection and Testing Requirements Part 10: Violations and Remedies Rev 3. 09 3

Appendices Appendix 1 A Reserved Appendix 2 A Approved Checklist for Performing Evidential Breath Appendices Appendix 1 A Reserved Appendix 2 A Approved Checklist for Performing Evidential Breath Alcohol Test(s) Appendix 2 B DUI and DUID Laboratory Certification Application Appendix 2 C DUI and DUID Laboratory Certification Onsite Evaluation Standards Rev 3. 09 4

Part 1 - General n Purpose and Scope – Establish minimum standards for certification Part 1 - General n Purpose and Scope – Establish minimum standards for certification and approval of entities and processes utilized for alcohol and drug testing. – Applies to DUI, DWAI, driving with excessive alcohol content, vehicular assault and homicide and consumption of alcohol by underage persons – Department has determined that the results obtained from the Certified EBAT Instrument are scientifically accurate, precise and reliable when operated as described in these rules. – The only instrument certified for use in Colorado is the Intoxilyzer 5000 EN. – EBAT facilities operate and must comply with Parts 2, 3, 4, and Appendix 2 A of these rules. – Laboratories performing blood alcohol, blood drug, urine drug and post mortem testing operate under Parts 6, 7, 8, 9, and Appendix 2 C of these rules. Rev 3. 09 5

Part 1 - General n Definitions – – – – Rev 3. 09 Alcohol Part 1 - General n Definitions – – – – Rev 3. 09 Alcohol Percent (%) Appropriate Clinical or Public Safety Facility Certification Certified EBAT Instrument Certified EBAT Instructor Certified Laboratory Certified EBAT Operator Department DUI Packet Evidential or Evidentiary Evidential Breath Alcohol Test (EBAT) Facility Laboratory Director Limit of Detection (LOD) Limit of Quantitation (LOQ) 6

Part 1 - General n Definitions – (continued) – Litigation Packet – Proficiency Testing Part 1 - General n Definitions – (continued) – Litigation Packet – Proficiency Testing – Representative of a Certified Laboratory – Standard Simulator Solution Logs – Supervisory Analyst – Tampering Rev 3. 09 7

Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) n Certification of EBAT Operators – Initial Certification » MUST be currently employed by a law enforcement agency or CDPHE » Attend a minimum of (8) eight hours of instruction following the Department’s Operator Training Manual » Score 80% or greater on written test; and » Complete a comprehensive practical exam as specified in the Department Operator Training Manual » Certificate with operator name, course instructor(s) and initial date of certification – Maintain Certification » Proficiently perform without errors one EBAT following Appendix 2 A in the presence of a certified instructor within 180 -day period » Both the Operator and Instructor sign printout » Agency retains printout Rev 3. 09 8

Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) n Certification of EBAT Operators – Failure to certify within the 180 -day period: » Decertified by the instructor, and » Repeat 8 -hour operator course – Certification after military service » Proof of active duty (not to exceed 2 years) » Proof of last operator certification prior to active duty » 80% or greater on current operator test » Proficiently perform without errors one EBAT following Appendix 2 A in the presence of a certified instructor » Send documentation to CDPHE » Certificate will indicate operator name, agency instructor, date of certification and “Reinstatement After Military Service” – Facility MUST retain records of operator’s original date of certification and all subsequent dates of certification Rev 3. 09 9

Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) n Certification of EBAT Instructors – Initial Certification » MUST be currently employed by a law enforcement agency or CDPHE » Currently certified as an EBAT operator » Attend the 16 -hour class Instructor course » Score 80% or greater on the written exam » Complete a comprehensive practical exam » Certificate with Instructor’s name, CDPHE course trainer(s) and initial date of certification – Maintain Certification » Teach one operator class within 365 days, or » Take a written instructor certification test within 365 days Rev 3. 09 10

Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) Part 2: Certification Requirements for Operators and Instructors Performing Evidential Breath Alcohol Testing (EBAT) n Certification of EBAT Instructors – Failure to maintain certification » Decertified and repeat 16 -hour instructor course » May recertify as an operator after performing one error-free EBAT in the presence of a certified instructor. – Certification after military service » Proof of active duty (not to exceed 2 years) » Proof of last instructor certification prior to active duty » 80% or greater on current instructor test » Proficiently perform without errors one EBAT following Appendix 2 A in the presence of a certified instructor » Send documentation to CDPHE » Certificate will indicate instructor name, agency name, Department Program Manager or designee, date of certification and “Reinstatement After Military Service” » Facility MUST retain records of instructor's original Rev 3. 09 11 date of certification and all subsequent dates of certification

Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards for Approved EBAT Facilities Ø EBAT must be conducted only in approved facilities Approved EBAT facilities must meet the standards of performance established by these rules Onsite inspections of EBAT facilities must be performed prior to testing and once a year thereafter Facility inspection reports will be sent within 15 days of the inspection date Facilities must send a plan of correction to the Department for review and approval within 15 days of receipt, when applicable Initial, annual, follow-up and complaint facility inspection to include permanent, temporary and mobile locations, must be conducted using Part 3 of these rules. A certified EBAT instrument must not be moved from its approved location within the approved facility without authorization from the Department Ø Ø Ø Rev 3. 09 12

Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards for Approved EBAT Facilities Ø Facility initial approval requirements are at 3. 1. 12. 1 Ø Instrument power requirements are at 3. 1. 12. 2 The Intoxilyzer 5000 EN must be use a surge protection device approved by the Department Ø Facility environmental requirements are at 3. 1. 12. 3 The temperature of the facility must be between 70° and 80° F and kept clean and orderly The organizer stand must be used and placed on a sturdy work surface The environment must be well ventilated and smoke-free. Cleaning compounds or volatiles must NOT be stored around the Intoxilyzer 5000 EN The facility must be secure with access only by authorized personnel. Automobile emissions must not be allowed in the approved facility Rev 3. 09 13

Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards for Approved EBAT Facilities Ø Documentation requirements for all facility types are at 3. 1. 12. 4 Current, original instrument certification certificate Current Appendix 2 A checklist Error message sheet Current list of certified operators and instructors Note: Must include original date of certification, date of last re-certification and date next re-certification is due. Current Standard Simulator Solution Log Sheet Ø Supply requirements for all facility types are at 3. 1. 12. 5 Mouthpieces Standard Simulator Solution Printer Paper Rev 3. 09 14

Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards for Approved EBAT Facilities Ø Certified EBAT Instrument function requirements for all facility types are at 3. 1. 12. 6 The certified instrument date and time must be correct The facility dispatch clock can be used as long as the instrument clock is synchronized with the dispatch clock The external breath tube must be heated The simulator vapor tube must be heated The certification date on the printout must be the same as the certification date on the certificate The instrument MUST be connected to an active, dedicated analog telephone line – Permanent locations only Rev 3. 09 15

Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards for Approved EBAT Facilities Ø Simulator function requirements for all facility types are at 3. 1. 12. 7 Active and Backup Simulator at each approved facility MUST record serial number MUST read between 33. 8 – 34. 2 degrees Centigrade Simulator Solution MUST be between 33. 8 – 34. 2 degrees Centigrade Ø Record requirements are at 3. 1. 12. 8 Calibration records MUST be within 10% of the 0. 100 value (0. 090 – 0. 110) on the Standard Simulator Solution Log The Standard Simulator Solution Log MUST not indicate an unacceptable number of error messages Rev 3. 09 16

Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards Part 3: Certification Requirements for Approved Evidential Breath Alcohol Testing (EBAT) Facilities n Standards for Approved EBAT Facilities Ø Record requirements are at 3. 1. 12. 8 (continued) A new Standard Simulator Solution Log MUST be created every 28 days or 96 tests, whichever comes first Diagnostic checks MUST be performed every 28 days Calibration checks MUST be performed with each new Standard Simulator Solution Log and every 7 days thereafter A breath sample check MUST be performed every 28 days or 96 tests, whichever comes first Standard Simulator Solution Logs and solution records MUST be retained for a minimum of 5 years Ø Additional mobile EBAT facility requirements are at 3. 1. 12. 9 Rev 3. 09 17

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Part Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Part 4 establishes MINIMUM standards for certification and approval of entities and processes used for EBAT testing Ø Evidential Breath Specimen Collection Must be tested on a certified EBAT instrument Must be tested by a certified instructor or operator Must be tested in an approved EBAT facility Must be tested using end-expiratory alveolar air Ø Subject advisement requirement at 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. Rev 3. 09 18

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis Ø Instructors and Operators MUST follow these procedures Ø Instructors and Operators MUST use Appendix 2 A with each test performed or initiated Appendix 2 A must not be changed in any way Appendix 2 A must be completed in the order listed A completed EBAT is one in which Appendix 2 A is followed and a printout without error messages is obtained Ø The certified Instructor or Operator MUST initial each step on Appendix 2 A to indicate that each step is performed properly Rev 3. 09 19

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT Steps 1 -7 Ø 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. ” Instrument must always be powered on Instrument will go into “Standby” mode after 120 minutes of inactivity Display is blank Simulator reads “Idle” Power Button red light is lit Instrument is ready when display is scrolling Rev 3. 09 20

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT Steps 1 -7 Ø 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. ” A new Appendix 2 A must be filled out each time Observation must be conducted at facility Observation time must be recorded from the instrument or the dispatch clock if the instrument clock is synchronized with the dispatch clock Rev 3. 09 21

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT Steps 1 -7 Ø Step 3 “Verify that the external breath tube and simulator vapor tube are both warm” Touch both tubes to ensure they are warm If they are cold, stop the test and notify a certified instructor Rev 3. 09 22

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT Steps 1 -7 Ø Step 4 “Observe the simulator temperature is between 33. 8 degrees Centigrade and 34. 2 degrees Centigrade. ” Allow the simulator to equilibrate for a minimum of ten (10) minutes after reaching the correct temperature when it has been in standby mode or is first turned on Rev 3. 09 23

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT Steps 1 -7 Ø Step 5 “Press the start test button. ” To initiate the automated test sequence Ø Step 6 “Follow the instructions and sequence of events as they appear on the certified EBAT instrument display. ” System blanks are used Rev 3. 09 24

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT Steps 1 -7 Ø Step 6 (continued) 0. 100 Standard Simulator Solution is used for the calibration checks and must be +/- 10% (0. 090 – 0. 110) A “No Calibration Correlation” error message will appear if not within the +/- 10% range The subject’s two breath samples must be within 0. 020 of each other A “No. 02 Agreement” error message will appear if the two breath samples are not within 0. 020 When a “No. 02 Agreement” error message occurs, the 20 -minute observation must be repeated using a new Appendix 2 A checklist Rev 3. 09 25

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT steps (1 -7) Ø Step 6 (continued) The Non-Compliance option must be used when belching, regurgitation or foreign material is detected in the mouth or nose from the start of the EBAT through the completion of the second breath sample. When the Non-Compliance option is chosen, the 20 minute observation period must be repeated using a new Appendix 2 A checklist Between the two-minute period between breath tests, the subject must be removed from close proximity to the instrument to prevent any tampering A clean mouthpiece will be used each time the subject blows into the instrument Rev 3. 09 26

Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods Part 4: Evidential Breath Alcohol Testing (EBAT) – Collection and Testing Procedures n Methods of Analysis EBAT steps (1 -7) Ø Step 7 “Retain all printouts generated by the certified EBAT instrument to include any error messages, and any checklist(s) initiated (Appendix 2 A) with the DUI packet. ” The certified instructor or operator performing the testing must sign any initiated checklist(s) and the completed EBAT Any checklist(s), error messages and the completed EBAT must be retained with the DUI packet All Standard Simulator Solution Logs and solution records must be retained by the facility for a minimum of 5 years Rev 3. 09 27

Part 5: Reserved n Rev 3. 09 Part 5 is reserved for future use Part 5: Reserved n Rev 3. 09 Part 5 is reserved for future use when rules are required for replacement instrumentation 28

Part 6: Certification Requirements for Forensic Toxicology Laboratories n Laboratories performing forensic toxicology testing Part 6: Certification Requirements for Forensic Toxicology Laboratories n Laboratories performing forensic toxicology testing must be certified by the Colorado Department of Health and Environment Certification Program n Laboratories must meet the requirements in these rules in order to be certified n Laboratories are certified to perform Ø Blood Alcohol Testing Ø Blood Drug Testing Ø Urine Drug Testing Ø Post Mortem Testing Rev 3. 09 29

Part 7: Blood Forensic Toxicology – Collection and Testing Requirements n Blood specimens must Part 7: Blood Forensic Toxicology – Collection and Testing Requirements n Blood specimens must be collected in the presence of the arresting officer or other responsible person who can authenticate the specimens n Can be collected by medical personnel trained to perform phlebotomy procedures n The venipuncture site must NOT be cleaned with alcohol or other phenolic solutions n Samples must be affixed with proper identification and evidence seal n After collection, samples must be refrigerated at less than 8 degrees Centigrade or frozen and must be shipped within 7 days of collection to a certified laboratory for testing Rev 3. 09 30

Part 8: Urine Forensic Toxicology Collection and Testing Requirements n Urine samples must be Part 8: Urine Forensic Toxicology Collection and Testing Requirements n Urine samples must be collected by personnel who can authenticate the specimen(s) n Urine samples must be collected in a clean, sterile container n Samples must be affixed with proper identification and evidence seal n After collection, samples must be refrigerated at less than 8 degrees Centigrade or frozen and must be shipped within 7 days of collection to a certified laboratory for testing Rev 3. 09 31

Part 9: Post Mortem Forensic Toxicology – Collection and Testing Requirements n Post mortem Part 9: Post Mortem Forensic Toxicology – Collection and Testing Requirements n Post mortem samples must be collected by personnel who’s training and normal duties include the collection of blood specimens from deceased persons, and these samples must be tested at a certified laboratory n 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 must be collected and tested at a certified laboratory Rev 3. 09 32

Part 10: Violations and Remedies n It is a violation to perform testing without Part 10: Violations and Remedies n It is a violation to perform testing without an appropriate certificate n Violation may result in denial, suspension or revocation of certification n Violation will not be cited if: – Unavoidable to prevent loss of life, personal injury, severe damage or there were no alternatives – Proper notification was given to CDPHE – Beyond control of facility or laboratory Rev 3. 09 33

Part 10: Violations and Remedies n Right to appeal the denial, suspension or revocation Part 10: Violations and Remedies n Right to appeal the denial, suspension or revocation of certification – Any facility, laboratory, operator or instructor whose certification is denied, suspended or revoked may seek appeal pursuant to section 24 -4 -105, C. R. S. (2006) Rev 3. 09 34

Part 10: Violations and Remedies n Denial, Suspension or Revocation of Certification – Falsification Part 10: Violations and Remedies n Denial, Suspension or Revocation of Certification – Falsification of data or other deceptive practices – False statements by omission or commission relevant to the certification process – Gross incompetence or negligent practice – Willful or repeated violation of any lawful rule, regulation or order of CDPHE or the Board of Health or its officers – Inadequate space, equipment or methods utilized for testing Rev 3. 09 35

Part 10: Violations and Remedies n n Denial, Suspension or Revocation of Certification (Continued) Part 10: Violations and Remedies n n Denial, Suspension or Revocation of Certification (Continued) – Submission of any test results of another person as those of the subject being evaluated – For a laboratory, failure to continuously participate in proficiency testing – For a laboratory, two consecutive “unsatisfactory” evaluations or failure in 2 of any three consecutive Proficiency Testing (PT) events – For a laboratory, contact with another laboratory concerning PT results prior to due date for those results Injunction – Department may seek an injunction for failure to comply with these rules and regulations Rev 3. 09 36

Web Sites • Internet address for the EBAT Program: http: //www. cdphe. state. co. Web Sites • Internet address for the EBAT Program: http: //www. cdphe. state. co. us/lr/Certification/EBAT. htm • Rules & Regulations: http: //www. cdphe. state. co. us/regulations/labregs/100502 alcohold rugtesting. pdf • For Latest Fact Sheet Data use: http: //www. nhtsa. dot. gov/people/ncsa/factshet. html Rev 3. 09 37

QUESTIONS? Rev 3. 09 38 QUESTIONS? Rev 3. 09 38