Chapter 3701-53 | Alcohol Testing

Rule 3701-53-01 | Definitions and record retention periods.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) The purpose of Chapter 3701-53 of the Administrative Code is to clarify and implement the provisions of sections 1547.11 and 4511.19, of the Revised Code. As used in this chapter of the Administrative Code:

(1) "Director" means the director of the Ohio department of health and includes any authorized representative of the director.

(2) "Laboratory director" means a person who holds a valid laboratory director permit under rule 3701-53-10 of the Administrative Code.

(3) "Designated laboratory director" means the person responsible for activities outlined in paragraph (D) of rule 3701-53-07 of the Administrative Code.

(4) "Laboratory technician" means a person who holds a valid laboratory technician permit under rule 3701-53-10 of the Administrative Code.

(5) "Operator" means a person who holds a valid operator permit under rule 3701-53-10 of the Administrative Code.

(6) "Senior operator" means a person who holds a valid senior operator permit under rule 3701-53-10 of the Administrative Code.

(7) "Oral fluid" means a type of bodily substance collected from the mouth consisting of saliva and other oral secretions.

(8) "Deep lung breath" means breath collected or measured at the end of an exhalation (alveolar air).

(9) "In transit" means in the possession of an individual employed by a hospital, law enforcement agency, courier, or other delivery entity between the point of collection and a secure storage location or between secure storage location and a laboratory.

(10) "Procedure manual" means a document approved by the designated laboratory director that outlines laboratory procedures for techniques listed on the designated laboratory director's permit.

(11) "Traceable to NIST" means the standard was manufactured with equipment calibrated with NIST (national institute of standards and technology) weights or the standard was compared to a NIST traceable certified reference material or equivalent standard from a National Metrology Institute (N.M.I) with a reciprocal agreement with NIST. Traceability is documented by the certificate(s) of analysis provided by the manufacturer.

(12) "Controlled substance" means any controlled substance as defined in section 3719.01 of the Revised Code.

(13) "Drug of abuse" means any controlled substance as defined in section 3719.01 of the Revised Code, any harmful intoxicant as defined in section 2925.01 of the Revised Code, and any dangerous drug as defined in section 4729.01 of the Revised Code.

(14) "Impairing substance" means any substance that when taken into the human body can impair the ability of that person to operate a motor vehicle safely.

(B) Record retention periods.

(1) The results of the breath alcohol tests are to be retained for not less than three years from the test date.

(2) The results of laboratory tests are to be retained for not less than three years from the date the results are reported.

(3) The results of certifications and weekly checks for breath alcohol testing instruments are to be retained for not less than three years from the date performed.

(4) Records of repairs and maintenance for breath alcohol testing instruments and laboratory instruments are to be retained for not less than three years from the date of service or maintenance.

(5) Records may be maintained in electronic or paper format.

Last updated January 23, 2023 at 8:50 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 9/30/2002

Rule 3701-53-02 | Expression of results.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) Tests to determine the concentration of alcohol, drugs of abuse, a controlled substance or metabolite of a controlled substance may be applied to blood, breath, urine, or other bodily substances including oral fluid.

(B) Results are to be expressed as equivalent to:

(1) Grams by weight of alcohol per one hundred milliliters of whole blood, blood serum or plasma (grams per cent by weight);

(2) Grams by weight of alcohol per two hundred ten liters of breath;

(3) Grams by weight of alcohol per one hundred milliliters of urine (grams per cent by weight).

(4) Nanograms by weight of a drug of abuse, controlled substance or a metabolite of a controlled substance per milliliter of blood, urine, oral fluid or other bodily substance.

(5) Presence of a drug of abuse, controlled substance or other impairing substance in oral fluid with the cut off level expressed in nanograms per milliliter.

Last updated January 23, 2023 at 8:50 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 2/1/1976, 9/14/1995 (Emer.), 7/7/1997

Rule 3701-53-03 | Breath tests.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) The instruments listed in this paragraph are approved as evidential breath testing instruments for use in determining whether a person's breath contains a concentration of alcohol prohibited or defined by sections 4511.19, and/or 1547.11 of the Revised Code, or any other equivalent statute or local ordinance prescribing a defined or prohibited breath-alcohol concentration. The approved evidential breath testing instruments are:

(1) BAC DataMaster, BAC DataMaster K, BAC DataMaster cdm;

(2) Intoxilyzer model 5000 series 66, 68 and 68 EN;

(3) Intoxilyzer model 8000 (OH-5);

(4) Intox DMT (OH); and

(5) Intoxilyzer model 9000 (OH).

(B) Approval for instruments listed under paragraphs (A)(1) and (A)(2) of this rule will expire two years from the effective date of this rule, unless an exemption is requested by a law enforcement agency and approved by the director.

(C) Breath samples of deep lung air will be analyzed for purposes of determining whether a person has a prohibited breath alcohol concentration with instruments approved under paragraph (A) of this rule.

(D) For instruments listed under paragraphs (A)(1) and (A)(2) of this rule:

(1) Breath samples are to be analyzed according to the operational checklist for the instrument being used; and

(2) Checklist forms prescribed by the director that record the results of subject tests are to be retained in accordance with paragraph (B) of rule 3701-53-01 of the Administrative Code.

(E) Breath samples using the instruments listed under paragraphs (A)(3), (A)(4) and (A)(5) of this rule are to be analyzed according to the instrument display for the instrument being used.

Last updated January 23, 2023 at 8:50 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 9/30/2002

Rule 3701-53-04 | Blood, urine, oral fluid and other bodily substance tests.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) Approved techniques for the analysis of alcohol in blood, urine, oral fluid and other bodily substances are:

(1) Gas chromatography;

(2) Enzyme assays; or

(3) Other techniques or methods, that have documented sensitivity, specificity, accuracy, precision, linearity and are based on procedures which have been published in a peer reviewed or juried scientific journal or thoroughly documented by the designated laboratory director may be approved by the director.

(B) Approved techniques for the analysis of controlled substances, metabolites of controlled substances, as defined in section 4511.19 of the Revised Code, impairing substances and drugs of abuse as defined in section 3719.011 of the Revised Code are:

(1) Immunoassay;

(2) Thin-layer chromatography;

(3) Gas chromatography;

(4) Mass spectrometry;

(5) High performance liquid chromatography;

(6) Spectroscopy;

(7) Liquid chromatography-mass spectrometry;

(8) Gas chromatography-mass spectrometry; or

(9) Other techniques or methods that have documented sensitivity, specificity, accuracy, precision, linearity and are based on procedures which have been published in a peer reviewed or juried scientific journal or thoroughly documented by the designated laboratory director may be approved by the director.

(C) All positive results of tests specified in paragraph (B) of this rule are to be confirmed by one or more approved analytical techniques or methods.

Last updated January 23, 2023 at 8:50 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 5/5/1990, 7/7/1997, 9/30/2002, 1/8/2009

Rule 3701-53-05 | Breath instrument checks, controls and certifications.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) For instruments listed under paragraphs (A)(1) and (A)(2) of rule 3701-53-03 of the Administrative Code:

(1) A senior operator shall perform an instrument check no less frequently than once every seven days in accordance with the appropriate instrument checklist for the instrument being used. The instrument check may be performed anytime up to one hundred ninety-two hours after the last instrument check.

(2) The instrument shall be checked to detect radio frequency interference (RFI) using a hand-held radio normally used by the law enforcement agency performing the instrument check. The RFI detector check is valid when the evidential breath testing instrument detects RFI or aborts a subject test. If the RFI detector check is not valid, the instrument shall not be used until the instrument is serviced.

(3) An instrument shall be checked using a solution containing ethyl alcohol approved by the director. An instrument check result is valid when the result of the instrument check is at or within five one-thousandths (0.005) grams per two hundred ten liters of the target value for that approved solution. Instruments with check results outside the range specified in this paragraph will require the issue to be identified, remediated and a successful check completed. If a second instrument check result is also out of range, the instrument shall not be used until the instrument is serviced or repaired.

(B) For the instrument listed under paragraph (A)(3) of rule 3701-53-03 of the Administrative Code:

(1) The instrument shall perform a dry gas control using a dry gas standard traceable to the national institute of standards and technology (NIST) before and after every subject test.

(2) A subject test shall include the collection of two breath samples. A dry gas control is not required between the two breath samples.

(3) Dry gas control results are valid when the results are at or within five one-thousandths (0.005) grams per two hundred ten liters of the alcohol concentration on the manufacturer's certificate of analysis for that dry gas standard.

(4) A dry gas control result which is outside the range specified in paragraph (B)(3) of this rule will abort the subject test or instrument certification in progress.

(5) A representative of the director will perform an instrument certification according to the instrument display using a solution containing ethyl alcohol approved by the director. A dry gas control using a dry gas standard traceable to the national institute of standards and technology (NIST) shall also be used when a certification is performed. An instrument in service shall be certified no less frequently than once every calendar year or when the dry gas standard on the instrument is replaced, whichever comes first. A calendar year means the period of twelve consecutive months, as indicated in section 1.44 of the Revised Code, beginning on the first day of January, and ending on the thirty-first day of December. Instrument certifications are valid when the certification results are at or within five one-thousandths (0.005) grams per two hundred ten liters of the target value for that approved solution. Instruments with certification results outside the range specified in this paragraph will require the issue to be remediated and a successful certification completed, or the instrument be removed from service until the instrument is serviced or repaired.

(C) For the instrument listed under paragraph (A)(4) of rule 3701-53-03 of the Administrative Code:

(1) The instrument shall perform a dry gas control using a dry gas standard traceable to the national institute of standards and technology (NIST) before and after every subject test.

(2) A subject test includes the collection of two breath samples. A dry gas control is not required between the two breath samples.

(3) Dry gas control results are valid when the results are at or within five one-thousandths (0.005) grams per two hundred ten liters of the target alcohol concentration on the manufacturer's certificate of analysis for that dry gas standard, adjusted for atmospheric pressure at the time of the test, as indicated on the subject test report.

(4) A dry gas control result which is outside the range specified on the test report will abort the subject test or instrument certification in progress.

(5) Senior operators shall perform an instrument certification according to the instrument display using a solution containing ethyl alcohol approved by the director. A dry gas control using a dry gas standard traceable to the national institute of standards and technology (NIST) shall also be used when a certification is performed. An instrument in service shall be certified no less frequently than once every three hundred sixty-five days or when the dry gas standard on the instrument is replaced, whichever comes first. Instrument certifications are valid when the certification results are at or within five one-thousandths (0.005) grams per two hundred ten liters of the target value for that approved solution. Instruments with certification results outside the range specified in this paragraph will require the issue to be remediated and a successful certification completed, or the instrument to be removed from service until the instrument is serviced or repaired.

(6) Instruments may be networked by law enforcement agencies if the software is purchased from the instrument manufacturer.

(D) For the instrument listed under paragraph (A)(5) of rule 3701-53-03 of the Administrative Code:

(1) The instrument shall perform a dry gas control using a dry gas standard traceable to the national institute of standards and technology (NIST) before and after every subject test

(2) A subject test includes the collection of two breath samples. A dry gas control is not required between the two breath samples.

(3) Dry gas control results are valid when the results are at or within five one-thousandths (0.005) grams per two hundred ten liters of the alcohol concentration on the manufacturer's certificate of analysis for that dry gas standard.

(4) A dry gas control result which is outside the range specified in paragraph (D)(3) of this rule will abort the subject test or instrument certification in progress.

(5) Senior operators shall perform an instrument certification according to the instrument display using a solution containing ethyl alcohol approved by the director. A dry gas control using a dry gas standard traceable to the national institute of standards and technology (NIST) shall also be used when a certification is performed. An instrument in service shall be certified no less frequently than once every three hundred sixty-five days or when the dry gas standard on the instrument is replaced, whichever comes first. Instrument certifications are valid when the certification results are at or within five one-thousandths (0.005) grams per two hundred ten liters of the target value for that approved solution. Instruments with certification results outside the range specified in this paragraph will require the issue to be remediated and a successful certification completed, or the instrument be removed from service until the instrument is serviced or repaired.

(6) Instruments may be networked by law enforcement agencies if the software is purchased from the instrument manufacturer.

(E) An instrument check or certification shall be made in accordance with this rule before a new evidential breath testing instrument is placed in service or before an instrument is placed into service following repairs.

(F) A bottle of solution containing ethyl alcohol approved by the director shall not be used more than three months after its date of first use, or after the manufacturer's expiration date on the approved solution certificate, whichever comes first. After first use, a bottle of approved solution shall be kept under refrigeration when not being used. The approved solution bottle shall be retained for reference until that bottle of approved solution is discarded.

(G) Representatives of the director, senior operators, or persons employed by law enforcement agencies who have successfully completed an instrument operation, calibration, maintenance, and repair course conducted by the manufacturer of an approved breath alcohol test instrument may perform such repairs, maintenance, and calibration as covered by the relevant training for that instrument. Records of calibration will be retained for not less than three years from the date performed. Other retention periods will be in accordance with paragraph (B) of rule 3701-53-01 of the Administrative Code.

Last updated January 23, 2023 at 8:50 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 2/1/1976

Rule 3701-53-06 | Collection and handling of blood, urine and oral fluid specimens.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) All samples are to be collected in accordance with section 4511.19 or section 1547.11 of the Revised Code, as applicable.

(B) When collecting a blood sample, an aqueous solution of a non-volatile antiseptic will be used on the skin. No alcohols will be used as a skin antiseptic.

(C) Blood is to be drawn with a sterile dry needle into a vacuum container with an anticoagulant according to the laboratory protocol as written in the laboratory procedure manual based on the type of specimen being tested. Anticoagulant coated vacuum tubes include standard purple, blue, green, pink, tan, gray, yellow and white topped tubes.

(D) The collection of a urine specimen will be witnessed to assure that the sample can be authenticated. Urine is to be deposited into a clean glass or plastic screw top container and capped or collected according to the laboratory protocol as written in the laboratory procedure manual.

(E) The collection of an oral fluid specimen is to be done according to the sample collection device instructions.

(F) Blood, urine, and oral fluid containers are to be sealed in a manner such that tampering can be detected and have a label which contains at least the following information:

(1) Name of subject;

(2) Date and time of collection;

(3) Name or initials of person collecting the sample; and

(4) Name or initials of person sealing the sample.

(G) While not in transit or under examination, all blood, urine and oral fluid specimens will be refrigerated.

Last updated January 23, 2023 at 8:51 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 1/1/1987, 5/5/1990, 1/4/1996 (Emer.), 7/7/1997

Rule 3701-53-07 | Laboratory requirements.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) Chain of custody and the test results for evidential alcohol, controlled substances, metabolites of a controlled substance and drugs of abuse shall be identified and retained for not less than three years, after which time the documents may be discarded unless otherwise directed in writing from a court. All positive blood, urine, oral fluid and other bodily substances shall be retained according to the laboratory procedure manual for a period of not less than one year from the report date, after which time the specimens may be discarded unless otherwise directed in writing from a court or the submitting agency.

(B) The laboratory shall successfully complete a national proficiency testing program using the applicable techniques or methods for which the laboratory personnel seek a permit under rule 3701-53-10 of the Administrative Code. The designated laboratory director or designee will submit a copy of the proficiency test results to the director or their designee.

(C) The laboratory will have a written procedure manual of all analytical techniques or methods used for testing of alcohol or drugs of abuse in bodily substances. Textbooks and package inserts or operator manuals from the manufacturer may be used to supplement but may not be used in lieu of the laboratory's own procedure manual for testing specimens.

(D) The designated laboratory director will review, sign, and date the procedure manual to certify that the manual is in compliance with this rule. The designated laboratory director will ensure that:

(1) Any changes in a procedure be approved, signed, and dated by the designated laboratory director(s);

(2) The date the procedure was first used and the date the procedure was revised or discontinued is recorded;

(3) A procedure shall be retained for not less than three years after the procedure was revised or discontinued, or in accordance with a written order issued by any court to the laboratory to save a specimen that was analyzed under that procedure;

(4) Laboratory personnel are adequately trained and experienced to perform testing of blood, urine, oral fluid and other bodily substances for alcohol and drugs of abuse and shall ensure, maintain and document the competency of laboratory personnel. The designated laboratory director(s) shall also monitor the work performance and verify the skills of laboratory personnel;

(5) The procedure manual includes the criteria the laboratory shall use in developing standards, controls, and calibrations for the techniques or methods involved; and

(6) At least one copy of the current procedure manual specified in paragraph (C) of this rule for performing blood, urine, oral fluid, or other bodily substance tests shall be available in the area where the analytical tests are performed and followed by laboratory personnel.

(7) Each testing day, the analytical techniques or methods used in rule 3701-53-04 of the Administrative Code will be checked for proper calibration.

(E) Any time the designated laboratory director ceases to serve in that capacity the laboratory will notify the director and another permitted laboratory director or applicant will be designated and approved by the director. If the new designated laboratory director does not hold a valid permit, they will apply for a permit as outlined in rule 3701-53-10 of the Administrative Code.

(F) Tests for alcohol in blood, urine, and other bodily substances shall be performed in a laboratory by a laboratory director or by a laboratory technician. Laboratory personnel shall not perform a technique or method of analysis that is not listed on the laboratory director's permit.

(G) Tests for drugs of abuse in blood, urine, oral fluid and other bodily substances shall be performed in a laboratory by a laboratory director or by a laboratory technician. Laboratory personnel shall not perform a technique or method of analysis that is not listed on the laboratory director's permit.

Last updated January 23, 2023 at 8:51 AM

Supplemental Information

Authorized By: 3701.143, 4511.19, 1547.11
Amplifies: 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 7/7/1997, 9/30/2002, 1/8/2009

Rule 3701-53-08 | Qualifications of personnel.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) For laboratory alcohol analysis:

(1) In order to qualify for a laboratory director permit, an individual will:

(a) Be employed by a laboratory that has successfully completed a proficiency examination administered by a national program for proficiency testing;

(b) Possess at least two academic years of college chemistry and at least two years of experience in a clinical or chemical laboratory; and

(c) Possess a bachelor's degree or higher degree.

(2) In order to qualify for a laboratory technician permit, an individual will:

(a) Be employed by a laboratory that has successfully completed a proficiency examination administered by a national program for proficiency testing; and

(b) Be certified by the designated laboratory director that he or she is competent to perform all procedures contained in the laboratory's procedure manual for testing specimens and meet one of the following conditions:

(i) Possess a bachelor's degree in laboratory sciences from an accredited institution and has six months experience in laboratory testing;

(ii) Possess an associate's degree in laboratory sciences from an accredited institution or has completed sixty semester hours of academic credit including six semester hours of chemistry and one-year experience in laboratory testing; or

(iii) Possess a high school diploma or equivalent and have successfully completed an official military laboratory procedures course of at least fifty weeks duration and has held the military enlisted occupational specialty of medical laboratory specialist (laboratory technician).

(B) For laboratory analysis of drugs of abuse, controlled substances or metabolites of controlled substances in blood, urine, oral fluid or other bodily substances:

(1) In order to qualify for a laboratory director permit, an individual will:

(a) Be employed by a laboratory that has successfully completed a proficiency examination administered by a national program for proficiency testing; and

(b) Possess at least two academic years of college chemistry and meet one of the following conditions:

(i) Possess a bachelor's degree or higher degree in laboratory sciences and has at least five years of experience in a clinical or chemical laboratory;

(ii) Possess a master's degree or higher degree and has at least three years of experience in a clinical or chemical laboratory; or

(iii) Possess an earned doctoral degree or higher degree and has at least two years of experience in a clinical or chemical laboratory.

(2) In order to qualify for a laboratory technician permit, an individual will:

(a) Be employed by a laboratory that has successfully completed a proficiency examination administered by a national program for proficiency testing; and

(b) Be certified by the designated laboratory director that he or she is competent to perform all procedures contained in the laboratory's procedure manual for testing specimens and meets one of the following conditions:

(i) Possess a bachelor's degree in laboratory sciences from an accredited institution and has one-year experience in laboratory testing;

(ii) Possess an associate's degree in laboratory sciences from an accredited institution or has completed sixty semester hours of academic credit including six semester hours of chemistry and two years of experience in laboratory testing; or

(iii) Possess a high school diploma or equivalent and have successfully completed an official military laboratory procedures course of at least fifty weeks duration and has held the military enlisted occupational specialty of medical laboratory specialist (laboratory technician) and two years of experience in laboratory testing.

(C) Breath tests used to determine whether a person's breath contains a concentration of alcohol prohibited or defined by sections 4511.19 or 1547.11 of the Revised Code, or any other equivalent statute or local ordinance prescribing a defined or prohibited breath alcohol concentration shall be performed by a senior operator or an operator.

(1) A senior operator shall be responsible for the care, maintenance and certification or instrument checks of the approved evidential breath testing instruments listed in paragraphs (A)(1), (A)(2), (A)(4) and (A)(5) of rule 3701-53-03 of the Administrative Code.

(2) Representatives of the director are responsible for the instrument certifications on approved evidential breath testing instruments listed under paragraph (A)(3) of rule 3701-53-03 of the Administrative Code.

(D) In order to qualify as a senior operator, an individual shall:

(1) Possess a high school diploma or have passed the "General Education Development Test";

(2) Be a certified law enforcement officer sworn to enforce sections 4511.19 or 1547.11 of the Revised Code, or any other equivalent statute or local ordinance prescribing a defined or prohibited breath alcohol concentration, or a certified corrections officer; and

(3) Successfully complete the department of health senior operator training course for the type of approved evidential breath testing instrument for which he or she seeks a permit.

(E) In order to qualify as an operator, an individual shall:

(1) Possess a high school diploma or have passed the "General Education Development Test";

(2) Be a certified law enforcement officer sworn to enforce sections 4511.19 or 1547.11 of the Revised Code, or any other equivalent statute or local ordinance prescribing a defined or prohibited breath alcohol concentration, or a certified corrections officer; and

(3) Successfully complete the department of health operator training course for the type of approved evidential breath testing instrument for which he or she seeks a permit.

Last updated January 23, 2023 at 8:51 AM

Supplemental Information

Authorized By: 3701.143, ORC 4511.19, ORC 1547.11
Amplifies: ORC 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 1/8/2009

Rule 3701-53-09 | Surveys and proficiency examinations.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) Laboratory directors and laboratory technicians who apply for or are issued permits under paragraph (A) of rule 3701-53-10 of the Administrative Code are subject to surveys and proficiency examinations by representatives of the director. A survey or proficiency examination may be conducted at the director's discretion.

(1) A survey consists of a review of the permit holder's, applicant's or laboratory's compliance with the requirements of this chapter.

(2) A proficiency examination consists of an evaluation of the permit holder's, applicant's or laboratory's ability to test samples provided by a representative of the director or the successful completion of a proficiency examination administered by a national program for proficiency testing using the techniques or methods for which the permit is held or sought. Proficiency examination samples may be:

(a) Mailed to the facility where the permit holder or applicant uses or plans to use the permit; or

(b) Presented in person by a representative of the director at the facility where the permit holder or applicant uses or plans to use the permit.

(B) During proficiency examinations, laboratory directors, laboratory technicians and applicants will accept samples, perform tests, and report all test results to a representative of the director or the national program that administered the proficiency testing. During surveys and proficiency examinations, permit holders, applicants and laboratories will grant the director's representatives access to all portions of the facility where the permit is used or is intended to be used and to all records relevant to compliance with this chapter.

(C) Senior operators and operators who apply for or are issued permits under paragraph (B) of rule 3701-53-10 of the Administrative Code, are subject to surveys and proficiency examinations conducted at the director's discretion.

(1) A survey consists of a review of the permit holder's or applicant's compliance with this chapter.

(2) A proficiency examination consists of an evaluation of the permit holder's or applicant's ability to test samples using the evidential breath testing instrument for which the permit is held or sought.

(D) Operators who apply for or are issued an operator access card under paragraph (D) of rule 3701-53-10 of the Administrative Code, are subject to a proficiency examination at least once per calendar year conducted at the director's discretion. A calendar year means the period of twelve consecutive months, as indicated in section 1.44 of the Revised Code, beginning on the first day of January, and ending on the thirty-first day of December.

(E) During proficiency examinations senior operators, operators, and applicants accept samples or test their own breath or breath samples from a volunteer, perform tests and report all results to a representative of the director. Operators, senior operators, and law enforcement agencies will grant the director's representatives access to all portions of the facility where the permit is used or is intended to be used, and to all records relevant to compliance with this chapter.

Last updated January 23, 2023 at 8:51 AM

Supplemental Information

Authorized By: OAC 3701.143, ORC 4511.19, ORC 1547.11
Amplifies: ORC 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 9/30/2002, 1/8/2009

Rule 3701-53-10 | Permits.

• Effective: January 23, 2023
• Promulgated Under: 119.03

(A) To function as laboratory directors or laboratory technicians, individuals will apply to the director of health for permits on forms provided by the director. A separate application will be filed for a permit to perform tests to determine the amount of alcohol in a person's blood, urine or other bodily substance, and a separate permit application shall be filed to perform tests to determine the amount of drugs of abuse in a person's blood, urine, oral fluid or other bodily substance. A laboratory director's and laboratory technician's permit is only valid for the laboratory indicated on the permit.

(1) The director will approve or deny permits to perform tests to determine the amount of alcohol in a person's blood, urine or other bodily substance to individuals pursuant to rule 3701-53-08 of the Administrative Code. Laboratory personnel holding permits issued under this rule may only use those laboratory techniques or methods for which they have been issued a permit.

(2) The director will approve or deny permits to perform tests to determine the amount of drugs of abuse in a person's blood, urine, oral fluid or other bodily substances to individuals pursuant to rule 3701-53-08 of the Administrative Code. Laboratory personnel holding permits issued under this rule may use only those laboratory techniques or methods for which they have been issued permits.

(B) Applicants for senior operator or operator permits for instruments listed under paragraphs (A)(1), (A)(2), (A)(4) and (A)(5) of rule 3701-53-03 of the Administrative Code will apply to the director on forms prescribed and provided by the director of health. A separate application will be filed for each type of evidential breath testing instrument for which a permit is sought. The director of health will approve or deny permits to perform tests to determine the amount of alcohol in a person's breath to individuals pursuant to rule 3701-53-08 of the Administrative Code.

(C) Permits issued under paragraphs (A) and (B) of this rule expire one year from the effective date of the permit, unless revoked or voluntarily surrendered prior to the expiration date. An individual holding a permit may seek renewal of a permit issued under paragraphs (A) and (B) of this rule by filing an application with the director no sooner than six months before the expiration date of the current permit. The director will not renew the permit if the permit holder is in proceedings for revocation of his or her current permit under rule 3701-53-11 of the Administrative code.

(D) Applicants for operator permits for the instrument listed under paragraph (A)(3) of rule 3701-53-03 of the Administrative Code will apply to the director on forms prescribed and provided by the director of health. The director will approve or deny a permit to perform tests to determine the amount of alcohol in a person's breath to individuals pursuant to rule 3701-53-08 of the Administrative Code. The director will issue permits in the form of an operator access card to approved applicants.

(E) Permits issued under paragraph (D) of this rule do not expire unless the permit holder fails to successfully complete a proficiency examination as outlined in paragraph (D) of rule 3701-53-09 of the Administrative Code or the permit is revoked by the director under rule 3701-53-11 of the Administrative Code or if the permit is voluntarily surrendered. To retain a permit under paragraph (D) of this rule the individual will present evidence satisfactory to the director that he or she continues to meet the qualifications established by rules 3701-53-08 and 3701-53-09 of the Administrative Code for issuance of the permit sought.

(F) To qualify for renewal of a permit under paragraph (A) or (B) of this rule:

(1) A permit holder will present evidence satisfactory to the director that he or she continues to meet the qualifications established by the applicable provisions of rule 3701-53-07 of the Administrative Code for issuance of the type of permit sought.

(2) If the individual seeking a renewal permit currently holds a laboratory technician or laboratory director permit, the permit holder will meet the requirements of paragraph (A) of this rule.

(G) The director and representatives of the director are not required to obtain or retain permits while acting as representatives of the director.

(H) An individual may use any approved breath testing instruments for which the individual has been issued a permit.

Last updated January 23, 2023 at 8:51 AM

Supplemental Information

Authorized By: OAC 3701.143, ORC 4511.19, ORC 1547.11
Amplifies: ORC 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 12/12/1997, 1/8/2009

Rule 3701-53-11 | Revocation, suspension and denial of permits or operator access cards.

• Effective: January 23, 2023
• Promulgated Under: 119.03

The director may deny, suspend or revoke the permit or operator access card of any permit holder or individual who:

(A) Obtains or seeks to obtain a permit or operator access card falsely or deceitfully;

(B) Who fails to comply with any of the provisions of this chapter; or

(C) As a senior operator, fails to demonstrate that he or she can operate, maintain, and perform instrument checks or certifications of the breath testing instrument for which the permit is held;

(D) As an operator, fails to demonstrate that he or she can properly operate the breath testing instrument for which the permit is held;

(E) As a laboratory director or laboratory technician, fails to demonstrate that he or she can properly perform the techniques or methods of analysis for which the permit is held; or

(F) As the designated laboratory director, fails to comply with paragraph (D) of rule 3701-53-07 of the Administrative Code.

(G) The director may deny an application or suspend or revoke a permit in accordance with Chapter 119. of the Revised Code.

(H) The director may close an incomplete permit application after one hundred twenty days from the date of submission.

Last updated January 23, 2023 at 8:52 AM

Supplemental Information

Authorized By: OAC 3701.143, ORC 4511.19, ORC 1547.11
Amplifies: ORC 4511.19, 1547.11
Five Year Review Date: 1/23/2028
Prior Effective Dates: 5/5/1990, 7/7/1997, 9/30/2002