(a) Methodology and instrumentation requirements.

1. (1) Analysis of blood, breath, urine, or other bodily substances to determine alcohol content in accordance with this part shall be by a method approved by the Office of Alcohol Testing (see subsection (b) of this section and 5 CAR § 20-502).
2. (2) All breath-testing instruments and accessories utilized in accordance with this part shall have the approval of the office (see subsection (c) of this section and 5 CAR § 20-503).
3. (3) The operation of approved breath-testing instruments will be according to manufacturer's recommendations unless otherwise approved in writing by the office (see subsection (f) of this section).

(c) Approval of types A and C testing devices and accessories.

1. (1) If application is made by the manufacturer for approval of a type A device not on the approved list (5 CAR § 20-503(a)), the office will examine and evaluate the device as soon as is practicable to determine if it meets the following criteria:

   1. (A) Breath specimens collected and presented for analysis shall be essentially alveolar (deep lung) in composition;
   2. (B)

(i) The device shall be capable of alcohol analysis which results in a concentration less than one hundredth gram per two hundred ten liters (0.01g/210L) breath on an alcohol-free sample.

1. (ii) It shall be capable of analyzing a suitable reference sample such as air equilibrated with a solution of known alcohol content at a constant temperature with accuracy of plus or minus one hundredth gram per two hundred ten liters (+/– 0.01g/210L) applied in accordance with the office’s current evaluation procedure;

   1. (C) The specificity of the procedure shall be adequate and appropriate for the analysis of breath specimens for the determination of alcohol concentration in traffic law enforcement;
   2. (D) The instrument shall be constructed and designed to be operated in a manner appropriate to the environment in which it will be used; and

   3. (E) Any breath-testing device submitted to the office for approval shall be accompanied by an application form supplied by the office and by all accessories and supplies necessary for the evaluation of the device and a detailed set of instructions which shall include information pertinent to:

      1. (i) Operation;
      2. (ii) Calibration;
      3. (iii) Maintenance; and
      4. (iv) Interpretation of results.

2. (2) If application is made by a manufacturer for approval of a calibration device not on the approved list (5 CAR § 20-503(b)), the office shall examine and evaluate the device to determine its:

   1. (A) Suitability;
   2. (B) Accuracy; and
   3. (C) Reliability.
3. (3) The office shall report the results of any evaluation to the manufacturer and shall have rights of publication of the results.
4. (4) The office shall not accept for evaluation any instrument or accessory for which the information, data, and documents submitted fail to support a judgment by the office that the instrument or accessory is in apparent compliance with the requirements of this part when operated according to the manufacturer's directions.

5. (5)

   1. (A) The office may, at any time, reevaluate an approved device or accessory to determine that compliance with the criteria in subsection (c) of this section is being maintained.
   2. (B) Failure to continue to meet the criteria may result in interdiction of usage of such equipment, suspension, or cancellation of approval.

   3. (C) Upon formal request from the manufacturer:

      1. (i) Further evaluation or investigation may be conducted; and
      2. (ii) The interdiction or suspension lifted.
   4. (D) A cancellation of approval will require an evaluation of the device or accessory.

6. (6) This office may remove from the approved list any testing device for which:

   1. (A) Adequate maintenance and repair are no longer available; or

   2. (B) The manufacturer's specifications no longer comply with the original specification.

      1. (d) Modified versions of approved instruments and accessories. The office may authorize modified versions of approved instruments and accessories when, in the judgment of the office, the modifications do not alter the abilities of such instruments or accessories to meet the standards of performance set forth in subsection (c) of this section in as much as the modified versions are equivalent in performance to the approved version.

(e) Approval of ampoules, dry-gas cylinders, or other prepackaged chemicals.

1. (1) Any prepackaged chemical to be used in conjunction with an approved testing device shall be approved by the office.
2. (2) The office shall examine and evaluate each lot or batch.
3. (3) Additional quantities may be required at the office’s discretion.

(f) Approval of chemical test procedures.

1. (1) Approved test procedures are supplied by the office on all approved instruments and may be updated periodically.
2. (2) For a test to be considered valid under the provisions of this part, the prescribed test procedure must be followed.
3. (3) The approved method may be characterized via computer programming which is provided and monitored by the office.