1. Alcohol Countermeasures Laboratory
Ed Conde
Surface Transportation Human Factors Division
The National Transportation Systems Center
U.S. Department of Transportation
Office of the Secretary of Transportation
John A. Volpe National Transportation Systems Center
Advancing transportation innovation for the public good

2. Who Are We? Federal Alcohol Countermeasures Laboratory
We are responsible for testing all of the breath alcohol measuring devices that are used by police and in workplace testing.
We fail most devices that we test.
Our mission is to ensure that all devices that we pass are precise and accurate.
We testify at many legal challenges to approved breath testers.

3. Why are we Important?
All devices used for workplace testing must be on NHTSA Conforming Products Lists (CPLs)
Screeners used for preliminary tests must be on the Conforming Products List for Alcohol Screening Devices
Evidential Breath Testers (EBTs) used for confirmation tests must be on the Conforming Products List for Evidential Breath Testers
Calibration devices used for accuracy checks must be on the Conforming Products List for Calibrating Devices

4. Laboratory Sponsor NHTSA Office of Research and Program Development
Impaired Driving Division - Maureen MacDonald
Behavioral Safety Research Division - DeCarlo Ciccel

5. Laboratory Personnel Ed Conde (Laboratory Director)
Employed at Volpe since 1986
With Alcohol Lab since 2001
Program Manager since January 2005
Art Flores
Program Manager
Contractor
Alan Kauffman
Chief Technician

6. Alcohol Program History
Development of NHTSA Model Specifications for evidential breath testers (EBTs)
Development of Breath Alcohol Sampling Simulator (BASS)
Testing of submitted EBTs
NHTSA Blood Alcohol Proficiency Program established
1980s:
Development of model specifications for calibrating devices (CUs)
Testing of submitted EBTs, CUs
1990s:
Develop Model Specifications for Preliminary Screening Devices (PBTs)
Testing of submitted PBTs, CUs, EBTs
2000s:
Updating of BASS device
Help develop worldwide alcohol device test standard (OIML)
Development of Model Specifications for Ignition Interlock Devices

7. Program Tasks
Model Specifications: Develop NHTSA model specifications and methods for evaluation of submitted police and workplace alcohol testing devices.
Device Testing: Evaluate domestic and international breath alcohol testers for precision and accuracy at a variety of operating conditions.
Blood Proficiency Program: Prepare blood alcohol proficiency samples and ship them to over domestic and international blood test laboratories.

8. Program Tasks (cont’d)
Court Testimony: Provide expert trial testimony regarding the validity of the police breath alcohol test as directed by NHTSA.
Develop International Recommendation for EBTs: Participate in the International Organization of Legal Metrology (OIML) working group to develop a draft international recommendation for the evaluation of EBTs.
Technical Support: Provide rapid response technical support to NHTSA on alcohol related issues as they arise.

9. How Breath Devices Are Tested
Most tests are performed using wet-bath Calibrating Devices which provide a sample of known alcohol concentration. The dynamic characteristics of test samples produced by these devices do not resemble those of an intoxicated human.
The Breath Sampling Efficiency Test for EBTs requires that the dynamic characteristics of the test sample closely resemble the breath of an intoxicated human. We use a special test apparatus called the BASS for this test.

10. Used for some Volpe testing.
Wet Bath Calibrator
Used for some Volpe testing.

11. BASS

12. Breath Alcohol Sample Simulator (BASS)
The BASS is a computer controlled breath alcohol sample generator designed at the Volpe Center.
The BASS was designed to mimic a drinking human’s breath.
The BASS can vary the strength and duration of the blow.
The BASS can vary the delivered alcohol concentration over time.
The BASS produces repeatable human-like breath samples without the difficulties associated with human drinking subjects.

13. Breath Alcohol Profiles

14. Model Specifications
Model Specifications describe the tests and methods that are used to evaluate devices
Evidential Breath Testers (EBT)
Screening Devices (PBT)
Calibrating Units (CU)
Ignition Interlocks (BAIID)

15. Conforming Products Lists
Devices that conform to NHTSA’s Model Specifications are published to NHTSA’s Conforming Products Lists (CPLs)
The lists are updated periodically and published in the Federal Register
Workplace Rules require that Breath Alcohol Devices used must be listed on the CPLs
Also found on Volpe web site:

16. Volpe Website
Volpe Center Alcohol Countermeasures website can be found at: measuring-device
Alcohol Measuring Device Testing
NHTSA Evidential Breath Testers (EBT's) Model Specifications Test procedure and Requirements. (PDF, 171KB)
NHTSA EBT Conforming Products List Devices that conformed to the EBT Model Specifications. (PDF, 66KB) (updated 01/14/08)
NHTSA Alcohol Screening Devices (ASD's) Model Specifications Test procedure and Requirements. (PDF, 70KB)
NHTSA ASD Conforming Products List Devices that conformed to the ASD Model Specifications. (PDF, 55KB)
NHTSA Calibrating Units (CU's) Model Specifications and Conforming Products List Test procedure and Requirements; Devices that conformed to the CU Model Specifications. (PDF, 109KB)

17. Volpe Website – Workplace
Workplace Testing (testing done at transportation workplaces)
Rules (PDF)
Quality Assurance Plans (QAPs) for Alcohol Test Devices Used in Workplace Testing Programs
EBT QAP template (MS Word)
ASD QAP template (MS Word)
CU QAP templates:
Wet Bath Calibration (MS Word)
Dry Gas Calibration (MS Word

18. 49 CFR Part 40 U.S. Code TITLE 49: TRANSPORTATION
PART 40 - PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS
Subpart A - Administrative Provisions
§ 40.1 Who does this regulation cover?
§ 40.3 What do the terms used in this regulation mean?
§ 40.5 Who issues authoritative interpretations of this regulation?
§ 40.7 How can you get an exemption from a requirement in this regulation?

19. Quality Assurance Plans (QAP)
QAPs are special instructions for workplace testing personnel. They are available from the manufacturers.
All calibration devices, screening devices, and evidential breath testers used in workplace testing have QAPs
Every test site should have QAPs for all devices displayed where test personnel can see them
All test personnel should be very familiar with the QAPs and with the manufacturer’s instructions (manuals) for all devices

20. Calibration Devices
Compressed Gas Calibrator (alcohol in inert gas) Used to Calibrate EBTs and Screeners and for Accuracy Checks

21. Calibration Devices QAP
ILMO Specialty Gas Products
Quality Assurance Plan Breath Alcohol Calibration Standard
Test site requirements
Temperature: 30 degrees F to 115 degrees F
Humidity: Up to 99% relative humidity (non-condensing)
Other: Barometric Pressure or altitude correction should be made
Authorized valves: C-10
Event(s) which require Breath Alcohol Calibration Standard be taken out of service:
When cylinder is empty or does not have enough pressure to engage regulator’s first stage.
Cylinder is leaking.

22. Expiration Dates All Dry Gas calibration tanks have expiration dates
Do not use an expired tank.

23. Screening Devices
Used for Workplace Preliminary Testing

24. Screening Device QAP AK GlobalTech Corp Quality Assurance
Calibration Checks: Any device on the DOT’s Conforming Products List (CPL) may be used for calibration checks.
Calibration #1, Calibrator at BrAC 0.05: Revo should be within +/ agreement.
Calibration #2, Calibrator at BrAC 0.10: Revo should be within +/ agreement.
Interval between calibration checks: 30 days or 100 tests, whichever comes first.
Interval between maintenance (replacement of the sensor module*): 12 months or 1000 tests, whichever comes first.

25. Evidential Breath Testers (EBT)
Used for Workplace Testing confirmation tests

26. EBT Quality Assurance Plan (QAP)

27. EBT Quality Assurance Plan (QAP)

28. Lifeloc Phoenix QAP QAP Scope and Purposes:
To provide standard which ensure proper use and performance of the Phoenix portable Breath Analyzer in conformance with the provisions of the Omnibus Transportation Employee testing Act of 1991 and the procedure for conducting alcohol testing as set forth in 49 CFR part 40.

29. Lifeloc Phoenix QAP (cont.)
General
For information regarding operation of the Phoenix and detailed calibration instructions, please refer to the Operations Manual supplied with each instrument.

30. Lifeloc Phoenix QAP (cont.)
Operating Environment
The Phoenix is designed to be used in the temperature range 0°C to 40°C
The Phoenix is capable of being used as either a stationary or mobile unit as defined by NHTSA

31. Lifeloc Phoenix QAP (cont.)
Calibration
Calibration must be performed by a certified operator utilizing dry gas or a wet bath simulator included on the NHTSA Conforming Products List of Calibrating Units.
The Phoenix must be calibrated every 12 months or when the instrument fails 2 consecutive calibration checks.
The Phoenix may be calibrated using a variety of standard values because the instrument instructs the operator to set the value. Please refer to the operations manual.

32. Lifeloc Phoenix QAP (cont.)
Verification (Calibration Check)
A verification must be performed by a certified operator utilizing dry gas or a wet bath simulator on the NHTSA CPL.
A verification must be conducted every thirty (30) days and as soon as circumstances permit after a positive alcohol test as defined by user policy and DOT regs.
A verification must also be conducted if the air blank procedure fails to show .000 after 2 consecutive attempts.
A verification must be performed if the unit has undergone repair.

33. Workplace Rules – Fatal Flaws
§ What problems always cause an alcohol test to be cancelled?
As an employer, a BAT, or an STT, you must cancel an alcohol test if any of the following problems occur. These are “fatal flaws.” You must inform the DER that the test was cancelled and must be treated as if the test never occurred. These problems are:
(b) In the case of a screening or confirmation test conducted on an EBT, the sequential test number or alcohol concentration displayed on the EBT is not the same as the sequential test number or alcohol concentration on the printed result
(c) In the case of a confirmation test:
(1) The BAT conducts the confirmation test before the end of the minimum 15-minute waiting period
(2) The BAT does not conduct an air blank before the confirmation test
(3) There is not a 0.00 result on the air blank conducted before the confirmation test
(4) The EBT does not print the result
(5) The next external calibration check of the EBT produces a result that differs by more than the tolerance stated in the QAP from the known value of the test standard. In this case, every result of 0.02 or above obtained on the EBT since the last valid external calibration check is cancelled

34. Fatal Flaws 1
(b) In the case of a screening or confirmation test conducted on an EBT, the sequential test number or alcohol concentration displayed on the EBT is not the same as the sequential test number or alcohol concentration on the printed result

35. Fatal Flaws 2 (c) In the case of a confirmation test:
(1) The BAT conducts the confirmation test before the end of the minimum 15-minute waiting period

36. Fatal Flaws 3 (c) In the case of a confirmation test:
(2) The BAT does not conduct an air blank before the confirmation test

37. Fatal Flaws 4 (c) In the case of a confirmation test:
(3) There is not a 0.00 result on the air blank conducted before the confirmation test

38. Fatal Flaws 5 (c) In the case of a confirmation test:
(4) The EBT does not print the result

39. Fatal Flaws 6 (c) In the case of a confirmation test:
(5) The next external calibration check of the EBT produces a result that differs by more than the tolerance stated in the QAP from the known value of the test standard. In this case, every result of 0.02 or above obtained on the EBT since the last valid external calibration check is cancelled

40. Workplace Rules – Use of EBTs
§ What are the requirements for proper use and care of EBTs?
c) As the user of the EBT), you must do the following:
(1) You must follow the manufacturer's instructions, including performance of external calibration checks at the intervals the instructions specify.
(2) In conducting external calibration checks, you must use only calibration devices appearing on NHTSA's CPL for “Calibrating Units for Breath Alcohol Tests.”
(3) If an EBT fails an external check of calibration, you must take the EBT out of service. You may not use the EBT again for DOT alcohol testing until it is repaired and passes an external calibration check.
(4) You must maintain records of the inspection, maintenance, and calibration of EBTs as provided in §40.333(a)(2) .
(5) You must ensure that inspection, maintenance, and calibration of the EBT are performed by its manufacturer or a maintenance representative certified either by the manufacturer or by a state health agency or other appropriate state agency.

41. Workplace Rules – Use of EBTs
1) You must follow the manufacturer's instructions, including performance of external calibration checks at the intervals the instructions specify.
2) In conducting external calibration checks, you must use only calibration devices appearing on NHTSA's CPL for “Calibrating Units for Breath Alcohol Tests.”

42. Workplace Rules – Use of EBTs
3) If an EBT fails an external check of calibration, you must take the EBT out of service. You may not use the EBT again for DOT alcohol testing until it is repaired and passes an external calibration check.

43. Workplace Rules – Use of EBTs
(4) You must maintain records of the inspection, maintenance, and calibration of EBTs as provided in §40.333(a)(2) .
(5) You must ensure that inspection, maintenance, and calibration of the EBT are performed by its manufacturer or a maintenance representative certified either by the manufacturer or by a state health agency or other appropriate state agency.

44. Workplace Rules – Confirmation Tests
§ What are the procedures for conducting an alcohol confirmation test?
As the BAT conducting an alcohol confirmation test, you must follow these steps in order to complete the confirmation test process:
(a) In the presence of the employee, you must conduct an air blank on the EBT you are using before beginning the confirmation test and show the reading to the employee.
(1) If the reading is 0.00, the test may proceed. If the reading is greater than 0.00, you must conduct another air blank.
(2) If the reading on the second air blank is 0.00, the test may proceed. If the reading is greater than 0.00, you must take the EBT out of service.
(3) If you take an EBT out of service for this reason, no one may use it for testing until the EBT is found to be within tolerance limits on an external check of calibration.
(4) You must proceed with the test of the employee using another EBT, if one is available.

45. Workplace Rules – Confirmation Tests
As the BAT conducting an alcohol confirmation test, you must follow these steps in order to complete the confirmation test process:
In the presence of the employee, you must conduct an air blank on the EBT you are using before beginning the confirmation test and show the reading to the employee.

46. Workplace Rules – Confirmation Tests
(1) If the reading is 0.00, the test may proceed. If the reading is greater than 0.00, you must conduct another air blank.
(2) If the reading on the second air blank is 0.00, the test may proceed. If the reading is greater than 0.00, you must take the EBT out of service.
(3) If you take an EBT out of service for this reason, no one may use it for testing until the EBT is found to be within tolerance limits on an external check of calibration.
(4) You must proceed with the test of the employee using another EBT, if one is available.

47. Workplace Rules – Confirmation Tests
(b) You must open a new individually wrapped or sealed mouthpiece in view of the employee and insert it into the device in accordance with the manufacturer's instructions.
(c) You must ensure that you and the employee read the unique test number displayed on the EBT.
(d) You must instruct the employee to blow steadily and forcefully into the mouthpiece for at least six seconds or until the device indicates that an adequate amount of breath has been obtained.

48. Workplace Rules – Confirmation Tests
(e) You must show the employee the result displayed on the EBT.
(f) You must show the employee the result and unique test number that the EBT prints out either directly onto the ATF or onto a separate printout.
(g) If the EBT provides a separate printout of the result, you must attach the printout to the designated space on the ATF with tamper-evident tape, or use a self-adhesive label that is tamper-evident.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41954, Aug. 9, 2001]

49. Workplace Rules – First Steps
Subpart M - Alcohol Confirmation Tests
§ What are the first steps in an alcohol confirmation test?
As the BAT for an alcohol confirmation test, you must follow these steps to begin the confirmation test process:
(a) You must carry out a requirement for a waiting period before the confirmation test, by taking the following steps:
(1) You must ensure that the waiting period lasts at least 15 minutes, starting with the completion of the screening test. After the waiting period has elapsed, you should begin the confirmation test as soon as possible, but not more than 30 minutes after the completion of the screening test.
(i) If the confirmation test is taking place at a different location from the screening test (see §40.247(b)(3)) the time of transit between sites counts toward the waiting period if the STT or BAT who conducted the screening test provided the waiting period instructions.
(ii) If you cannot verify, through review of the ATF, that waiting period instructions were provided, then you must carry out the waiting period requirement.

50. Workplace Rules – Waiting Period
As the BAT for an alcohol confirmation test, you must follow these steps to begin the confirmation test process:
 (a) You must carry out a requirement for a waiting period before the confirmation test, by taking the following steps:

51. Workplace Rules – Waiting Period
(1) You must ensure that the waiting period lasts at least 15 minutes, starting with the completion of the screening test. After the waiting period has elapsed, you should begin the confirmation test as soon as possible, but not more than 30 minutes after the completion of the screening test.

52. Workplace Rules – Waiting Period
(i) If the confirmation test is taking place at a different location from the screening test (see §40.247(b)(3)) the time of transit between sites counts toward the waiting period if the STT or BAT who conducted the screening test provided the waiting period instructions.
(ii) If you cannot verify, through review of the ATF, that waiting period instructions were provided, then you must carry out the waiting period requirement

53. Workplace Rules – Waiting Period
(iii) You or another BAT or STT, or an employer representative, must observe the employee during the waiting period.
(2) Concerning the waiting period, you must tell the employee:
(i) Not to eat, drink, put anything (e.g., cigarette, chewing gum) into his or her mouth, or belch;
(ii) The reason for the waiting period (i.e., to prevent an accumulation of mouth alcohol from leading to an artificially high reading);

54. Workplace Rules – Waiting Period
(iii) That following your instructions concerning the waiting period is to the employee's benefit; and
(iv) That the confirmation test will be conducted at the end of the waiting period, even if the instructions have not been followed.
(3) If you become aware that the employee has not followed the instructions, you must note this on the
“Remarks” line of the ATF.

55. Workplace Rules – Waiting Period
(b) If you did not conduct the screening test for the employee, you must require positive identification of
the employee, explain the confirmation procedures, and use a new ATF. You must note on the “Remarks” line of the ATF that a different BAT or STT conducted the screening test.
(c) Complete Step 1 of the ATF.

56. Workplace Rules – Waiting Period
(d) Direct the employee to complete Step 2 on the ATF and sign the certification. If the employee refuses to sign this certification, you must document this refusal on the “Remarks” line of the ATF and immediately notify the DER. This is a refusal to test.
(e) Even if more than 30 minutes have passed since the screening test result was obtained, you must begin the confirmation test procedures in §40.253, not another screening test.

57. Workplace Rules – Waiting Period
(f) You must note on the “Remarks” line of the ATF the time that elapsed between the two events, and if the confirmation test could not begin within 30 minutes of the screening test, the reason why.
(g) Beginning the confirmation test procedures after the 30 minutes have elapsed does not invalidate the
screening or confirmation tests, but it may constitute a regulatory violation subject to DOT agency sanction.

58. Workplace Rules – Problems
§ What is the effect of procedural problems that are not sufficient to cancel an alcohol test?
(a) As an STT, BAT, employer, or a service agent administering the testing process, you must document any errors in the testing process of which you become aware, even if they are not “fatal flaws” or “correctable flaws” listed in this subpart. Decisions about the ultimate impact of these errors will be determined by administrative or legal proceedings, subject to the limitation of paragraph (b) of this section.
(b) No person concerned with the testing process may declare a test cancelled based on a mistake in the process that does not have a significant adverse effect on the right of the employee to a fair and accurate test. For example, it is inconsistent with this part to cancel a test based on a minor administrative mistake (e.g., the omission of the employee's middle initial) or an error that does not affect employee protections under this part. Nor does the failure of an employee to sign in Step 4 of the ATF result in the cancellation of the test. Nor is a test to be cancelled on the basis of a claim by an employee that he or she was improperly selected for testing.
(c) As an employer, these errors, even though not sufficient to cancel an alcohol test result, may subject you to enforcement action under DOT agency regulations.

59. Workplace Rules – Problems
(a) As an STT, BAT, employer, or a service agent administering the testing process, you must document any errors in the testing process of which you become aware, even if they are not “fatal flaws” or “correctable flaws” listed in this subpart. Decisions about the ultimate impact of these errors will be determined by administrative or legal proceedings, subject to the limitation of paragraph (b) of this section.

60. Workplace Rules – Problems
(b) No person concerned with the testing process may declare a test cancelled based on a mistake in the process that does not have a significant adverse effect on the right of the employee to a fair and accurate test. For example, it is inconsistent with this part to cancel a test based on a minor administrative mistake (e.g., the omission of the employee's middle initial) or an error that does not affect employee protections under this part. Nor does the failure of an employee to sign in Step 4 of the ATF result in the cancellation of the test. Nor is a test to be cancelled on the basis of a claim by an employee that he or she was improperly selected

61. Workplace Rules – Problems
(c) As an employer, these errors, even though not sufficient to cancel an alcohol test result, may subject you to enforcement action under DOT agency regulations.

62. Workplace Rules – Screening Tests
§ What devices are used to conduct alcohol screening tests?
EBTs and ASDs on the NHTSA conforming products lists (CPL) for evidential and non-evidential devices are the only devices you are allowed to use to conduct alcohol screening tests under this part. You may use an ASD that is on the NHTSA CPL for DOT alcohol tests only if there are instructions for its use in this part. An ASD can be used only for screening tests for alcohol, and may not be used for confirmation tests.

63. Workplace Rules – Screener Use
§ What are the requirements for proper use and care of ASDs?
(c) As the user of the ASD (e.g., employer, STT), you must follow the QAP instructions.
(d) You are not permitted to use an ASD that does not pass the specified quality control checks or that has passed its expiration date.
(e) As an employer, with respect to breath ASDs, you must also follow the device use and care requirements of §

64. Workplace Rules – Confirmation
§ What devices are used to conduct alcohol confirmation tests?
(a) EBTs on the NHTSA CPL for evidential devices that meet the requirements of paragraph (b) of this section are the only devices you may use to conduct alcohol confirmation tests under this part. Note that, among devices on the CPL for EBTs, only those devices listed without an asterisk (*) are authorized for use in confirmation testing in the DOT alcohol testing program.

65. Workplace Rules – Confirmation
(b) To conduct a confirmation test, you must use an EBT that has the following capabilities:
(1) Provides a printed triplicate result of each test;
(2) Assigns a unique number to each completed test, (3) Prints, on each copy of the result, the manufacturer's name for the device, its serial number, and the time of the test;
(4) Distinguishes alcohol from acetone at the 0.02
(5) Tests an air blank; and
(6) Performs an external calibration check.

66. Actual Case – My Letter
Thank you for sending hard copies of the ATF, the QAP, the letters, and the calibration logs for this Workplace case. The hard copies were much easier to read than the scans.
A Lifeloc Technologies, Inc. Phoenix Evidential Breath Tester (EBT), like the one used in this case, was tested at Volpe in June of 1998 and conformed to the Model Specifications for Evidential Breath Testers. It was subsequently added to NHTSA’s Conforming Products List of Evidential Breath Testers.

67. Actual Case – My Letter
This case has a number of troubling issues although none appear to be fatal flaws as described in §
In the subject’s letter, his point #1 stated that the BAT did not perform an air blank before the confirmation test. This would have been a fatal flaw, but the Alcohol Testing Form (ATF) indicates that an air blank was done before the confirmation test. Perhaps the BAT did not show the subject the results of this air blank as required by § , but this does not appear to be a fatal flaw.
The part of the ATF showing the air blank is shown in figure 1 below. § is appended below figure 1.

68. Actual Case – My Letter

69. Actual Case
§ What problems always cause an alcohol test to be cancelled?
As an employer, a BAT, or an STT, you must cancel an alcohol test if any of the following problems occur. These are “fatal flaws.” You must inform the DER that the test was cancelled and must be treated as if the test never occurred. These problems are:
(c) In the case of a confirmation test:
(2) The BAT does not conduct an air blank before the confirmation test (see §40.253(a));

70. Actual Case – My Letter
The subject stated in point #2 that “Two air blank procedures were attempted and failed to get a .000 but rather received a “excessive sensor noise reading instead. In the Quality Assurance Plan (QAP) for the Phoenix under verification: (3) a verification must also be conducted if the air blank procedure fails to show after 2 consecutive attempts.”
The QAP does indeed state “a verification must also be conducted if the air blank procedure fails to show .000 after 2 consecutive attempts.”

71. Lifeloc Phoenix QAP Verification (calibration check)
A verification must be performed by a certified operator utilizing dry gas or a wet bath simulator on the NHTSA CPL.
A verification must be conducted every thirty (30) days and as soon as circumstances permit after a positive alcohol test as defined by user policy and DOT regs.
A verification must also be conducted if the air blank procedure fails to show .000 after 2 consecutive attempts.
A verification must be performed if the unit has undergone repair.

72. Actual Case – My Letter
In the BAT’s statement she stated that she received “excessive sensor noise” error messages on the first 2 air blanks that she attempted before the subject test. According to the QAP, a calibration check (verification) should have been performed at this time, but was not. This is in violation of § (appended below).

73. Actual Case
§ What are the requirements for proper use and care of EBTs?
(c) As the user of the EBT (e.g., employer, service agent), you must do the following:
(1) You must follow the manufacturer's instructions (see paragraph (b) of this section), including performance of external calibration checks at the intervals the instructions specify.

74. Actual Case – My Letter
In addition, the list of Phoenix error codes (appended) states that an excessive sensor noise message indicates “external interference (such as RF interference) has been detected. Speaking to the manufacturer I learned that this could also be caused by an old failing fuel cell. This particular Phoenix (serial number xxxxx) was sold to the test facility in July of That means that the fuel cell sensor is over 10 years old which is old for a fuel cell.

75. Actual Case

76. Actual Case – My Letter
This Phoenix was sent to Lifeloc for a factory diagnostic check in February of 2007 and in November of The QAP recommends that the Phoenix be returned every 2 years for a complete evaluation. However, it was more than 2 years between the last diagnostic check and the positive results in this case. In addition, the 4 ½ year spread between factory diagnostic checks show that this 2 year recommendation is not being taken seriously.

77. Actual Case – My Letter
The subject stated in point #3 that “there were two failed calibration tests in a row two weeks before the March 3, 2014.” This is true according to the BAT’s calibration logs. The device underwent its yearly calibration on 2/5/14 as mandated by the QAP. The device failed 2 consecutive calibration checks 19 days later on 2/24/14 and had to be recalibrated. Good fuel cells normally hold calibration for at least 6 months so the fact that the device was out of calibration within 19 days is problematic.

78. Actual Case – My Letter
The subject stated in point #4 that “The difference between the first test and the confirmation test is .052 in 15 minutes which both Lifeloc and the George Washington University concede to be inhuman. Alcohol burns off at a precise rate of BAC per hour.” This statement is true. The fact that the screening test was and the confirmation test was .083 only 16 minutes later is a major problem. Given and average elimination rate of per hour, the confirmation test should have been approximately Most States allow a less than discrepancy for law enforcement cases.

79. Actual Case – My Letter
A difference of .052 is a big problem. Possible explanations include mouth alcohol or device malfunction. Do you know whether the BAT observed a waiting period before the initial screening test? I do not believe that this is required by part 40 (it should be). According to Lifeloc, manufacturer training and the operating manual require a minute waiting period before all tests. § (appended below) describes the need for this waiting period before confirmation tests

80. Actual Case Subpart M - Alcohol Confirmation Tests
§ What are the first steps in an alcohol confirmation test?
As the BAT for an alcohol confirmation test, you must follow these steps to begin the confirmation test process:
(a) You must carry out a requirement for a waiting period before the confirmation test, by taking the following steps:
(1) You must ensure that the waiting period lasts at least 15 minutes, starting with the completion of the screening test.

81. Actual Case
The subject stated in point #5 that the BAT should have documented any errors in the testing process. This is true as mandated by § below.
§ What is the effect of procedural problems that are not sufficient to cancel an alcohol test?
(a) As an STT, BAT, employer, or a service agent administering the testing process, you must document any errors in the testing process of which you become aware, even if they are not “fatal flaws” or “correctable flaws” listed in this subpart. Decisions about the ultimate impact of these errors will be determined by administrative or legal proceedings, subject to the limitation of paragraph (b) of this section.

82. Actual Case – My Letter
In addition to the subject’s comments, I have some observations:
1) Where are the monthly calibration checks for November and January? The QAP requires calibration checks every 30 days and after a positive subject test.
2) Are the persons who performed the calibrations and the verifications on this Phoenix certified by Lifeloc as required in the QAP.

83. Actual Case – My Letter
3) What calibration device was used for the calibrations and the verifications? Is it on the CPL as mandated? If it is a dry gas calibration device, what is the expiration date? This information should be entered on all sheets in the appropriate section of the Verification/Calibration Logs, but is not. This is a major error. On the calibration log sheet dated 3/4/14, the gas manufacturer is listed as Lifeloc. While a Lifeloc sticker may be on the tank, Lifeloc does not manufacture dry gas and is not listed on the CPL. The actual tank manufacturer and device should be listed so that the user can verify its listing on the CPL.

84. Actual Case – My Letter
4) On the calibration log sheet dated 3/4/14, the BAT does not indicate whether this is a calibration or a calibration check (verification). This is important because this calibration/calibration check was done one day after the positive subject test for this case. The difference between a calibration and a calibration check (verification) in this case is vital. A calibration check should be done after a positive to ensure that the device was measuring properly during the positive test. If a calibration is done instead, then the device has been changed and you have no verification that the device was measuring accurately during the positive test.

85. Actual Case – My Letter
5) Why did the Phoenix fail 2 straight calibration checks on 2/24/14 only 19 days after it was calibrated on 2/5/14? To me, this sounds like a bad fuel cell and the device should have been sent in to Lifeloc for evaluation.
6) Why was there a drop in 16 minutes between the screening test and the confirmation test? With a good fuel cell, a drop like this would most likely mean that there was still residual alcohol in the subject’s mouth during the screening test. This should not be the case if the device was used according to Lifeloc instructions and a minute observation period was done before the screening test. The most likely alternative is that the fuel cell sensor was not performing properly.

86. Actual Case – My Letter
7) Why did the BAT need to use 3 different locations to get a zero air blank? Initially I thought that alcohol from the subject’s breath might be causing the non-zero air blanks. The manufacturer maintains that a non-zero air blank would give a “Air Blank Failure” error message not the “Excessive Sensor Noise” error message seen during this case. An “Excessive Sensor Noise” error message indicates Radio Frequency Interference (RFI) or a possible problem with the fuel cell. I asked whether RFI could account for the drop between the 2 tests and the manufacturer said no. The manufacturer maintains that RFI during the subject tests would have generated the same “Excessive Sensor Noise” error message seen in the failed air blanks.

87. Testing is only half the battle
An approved device is only as good as the testing program
Calibration tests should be done according to the manufacturer’s instructions in their Quality Assurance Plan (QAP). These tests ensure for the court that the breath tester is working properly
Calibration logs and calibration test logs should be carefully maintained. Failure to do so will cast doubt on the results
A 15 minute waiting period is essential to good results. Failing to observe the waiting period is a common cause for losing a case.

88. Testing is only half the battle
An approved device is only as good as the testing program
Do not alter an approved instrument
Check the expiration dates on all calibration alcohol solutions and on all dry gas calibration tanks.
Check the Conforming Products Lists to ensure that your Screening Devices, Evidential Testers, and Calibration Devices are on the lists. Occasionally, devices are removed.