DAR File No. 41000

Health, Disease Control and Prevention, Laboratory Improvement

Rule R444-11

Rules for Approval to Perform Blood Alcohol Examinations

Notice of Proposed Rule

(Repeal)

DAR File No.: 41000
Filed: 11/15/2016 11:57:35 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rule was adopted in December 1969 and amended in 1981. Since that time, only grammatical and wording changes have been made. This rule was established in 1969 about the time there was a national movement to shape the quality of laboratory work. The Clinical Laboratory Improvement Act of 1967 was the national response to addressing quality issues with clinical testing. The Clinical Laboratory Improvement Act was updated in 1988 and is still in place today. Blood Alcohol testing is not an exact fit for clinical testing and this rule was to have been the state's response to improve the quality of testing in this forensic area. Over time, private sector labs have not sought approval status for this work citing various reasons with the most common being court appearance pulling their staff away from "productive work". Currently, no laboratories are registered under this rule. Forensic laboratories in the state of Utah that may do any testing for blood alcohol content are accredited by the American Board of Forensic Toxicology or American Society of Crime Laboratory Directors. The Division sees no need to maintain this rule.

Summary of the rule or change:

Over time, private sector labs have not sought approval status for this work citing various reasons with the most common being court appearance pulling their staff away from "productive work". Currently, no laboratories are registered under this rule. Forensic laboratories in the state of Utah that may do any testing for blood alcohol content are accredited by the American Board of Forensic Toxicology or American Society of Crime Laboratory Directors. The Division sees no need to maintain this rule. Therefore, this rule is repealed in its entirety.

Statutory or constitutional authorization for this rule:

• Subsection 26-1-30(15)

Anticipated cost or savings to:

the state budget:

None--This rule is outdated and has not been used for many years. There will be no costs or savings from the repeal.

local governments:

None--This rule is outdated and has not been used for many years. There will be no costs or savings from the repeal.

small businesses:

None--This rule is outdated and has not been used for many years. There will be no costs or savings from the repeal.

persons other than small businesses, businesses, or local governmental entities:

None--This rule is outdated and has not been used for many years. There will be no costs or savings from the repeal.

Compliance costs for affected persons:

None--This rule is outdated and has not been used for many years. There will be no costs from the repeal.

Comments by the department head on the fiscal impact the rule may have on businesses:

Over time, private sector labs have not sought approval status for this work citing various reasons with the most common being court appearance pulling their staff away from "productive work". Currently, no laboratories are registered under this rule. Forensic laboratories in the State of Utah that may do any testing for blood alcohol content are accredited by the American Board of Forensic Toxicology or American Society of Crime Laboratory Directors. The Division sees no need to maintain this rule. There is no fiscal impact on business because no labs are registered under this rule and none were expected.

Joseph Miner, MD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Disease Control and Prevention, Laboratory Improvement
CANNON HEALTH BLDG
288 N 1460 W
SALT LAKE CITY, UT 84116-3231

Direct questions regarding this rule to:

• Robyn Atkinson at the above address, by phone at 801-965-2424, by FAX at 801-969-3704, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

01/03/2017

This rule may become effective on:

01/10/2017

Authorized by:

Joseph Miner, Executive Director

R444. Health, Disease Control and Prevention, Laboratory Improvement.

[R444-11. Rules for Approval to Perform Blood Alcohol Examinations.

R444-11-1. Definitions.

A. "CHEMIST" means any person conducting the blood alcohol determinations and meeting the minimum qualification of this rule.

B. "DIRECTOR" means the Director of the Division of Epidemiology and Laboratory Services.

C. "DEPARTMENT" means the Department of Health.

D. "LABORATORY" means any place in which examinations for the determination of blood alcohol level are performed.

E. "REVIEW" means a visit to a laboratory by a reviewer for the purpose of determining compliance with R444-11.

F. "REVIEWER" means a representative of the Director authorized to conduct a review.

G. "SUPERVISOR" means a person responsible for the performance of blood alcohol determinations, who meets the personnel requirements of this rule.

 

R444-11-2. Authorization and Administration.

A. Department - Powers and Duties

The Department, under the powers and duties conferred upon it by Section 26-1-30(2)(m), upon being assured that a laboratory wishing to become approved or to maintain approval status has satisfied the requirements for approval, as detailed below, shall approve such a laboratory to conduct examinations for the determinations of blood alcohol levels.

B. Responsibilities - Department

It shall be the responsibility of the Department to assist any laboratory in the State which desires to obtain approval to conduct examinations for the determination of blood alcohol levels to gain and maintain approval. Toward this end, the Department will offer training, laboratory reviews, procedure evaluation studies, and reference materials to any laboratory requesting the services.

C. Requirements for Approval

Any laboratory desiring to be approved to provide blood alcohol determinations must have official approval of the Department.

1. Approval is conditional on meeting the herein specified minimum standards for personnel and facilities, as well as the herein specified minimum technical standards for the procedures used to examine specimens submitted to that laboratory for the presence or absence of alcohol in the blood. In addition the laboratory shall:

a. successfully participate in an acceptable proficiency testing program offered or authorized by the Department;

b. report agreement with reference laboratories using the same or similar procedures. Standard methods of evaluation will be used;

c. maintain an on-going quality control program; and

d. agree to a not less than biennial review of the laboratory.

2. A laboratory is approved under this rule if the laboratory is Medicare-approved or holds a Clinical Laboratory Improvement Act of 1967 (CLIA) certificate, under 42 CFR part 493, 1990 edition, which is incorporated by reference, for the specialty or subspecialty associated with the testing covered by this rule.

Failure to meet the minimum requirements, as determined by review or performance evaluation, shall be sufficient grounds for withdrawal of approval until the minimum standards can be met.

D. Initial Approval - Provisional Approval

A laboratory that has not been previously approved but that wishes to be considered for approval must request, in writing, a review of its facilities. The review will be to determine whether the laboratory and the affected personnel meet the minimum standards as established below. The reviewer shall report his findings to the Director and recommend action to be taken.

E. Full Approval - Period During Which Approval is Valid

After evaluation of the report of the reviewer, the Director may grant approval to the laboratory for one calendar year, subject to annual renewal, providing the laboratory continues to meet minimum standards as determined by procedural evaluation or on-site observations of both physical facilities and technical performance.

The approved laboratory shall notify the Director in writing when changes of personnel occur and shall submit a curriculum vitae on new personnel performing duties in the chemistry-toxicology laboratory. This notification shall be submitted within ten days of the status change.

F. Revocation of Approval

Approval of any laboratory may be revoked if:

1. the laboratory changes to a method other than that for which it has been approved without prior approval from the Department;

2. any person other than the person qualified to perform the testing is permitted to perform and report the results of blood alcohol determinations;

3. results of proficiency testing indicate a lack of ability to perform at satisfactory levels;

4. required minimum standards for performance of the examination are not maintained; or

5. safety standards are not maintained for personnel performing these examinations or personnel working in the surrounding laboratory environment.

G. Reinstatement of a Disapproved Laboratory

A laboratory that has lost approval because of a change in procedures or through the loss of qualified personnel may have approval reinstated by:

1. requesting a laboratory review during which processing of specimens and testing procedures will be observed by the reviewer;

2. providing all necessary information for the evaluating of credentials of new personnel assigned to the laboratory section in which blood alcohol determinations are made; and

3. continuing to participate, satisfactorily, in the proficiency testing program.

A laboratory that has lost approval through an unacceptable performance in proficiency testing may request a review to determine the reason for unacceptable performance.

Upon being assured by the reviewer that corrections leading to satisfactory and acceptable performance have been made, the Director may reinstate approval based on compliance with this rule.

H. Publishing Lists of Approved Laboratories - Reports

The Department shall publish at least annually a list of laboratories meeting the minimum standards established under this rule. Included on the list shall be the name and location of the laboratory, the name of the director, supervisor, and the chemist qualified to perform the examinations. This list shall be sent to all municipal, county, and state law enforcement agencies and laboratory directors in the state. The Department may publish semi-annual amendments to the list in a newsletter.

 

R444-11-3. Minimum Standards - Methods to be Employed.

The following minimum standards are as the basis for approval of a laboratory to conduct examinations for the determination of blood alcohol levels.

A. Personnel Qualifications

Minimum educational requirements for a person performing chemical examinations for the determination of blood alcohol levels shall be a recognized Bachelor of Arts or Bachelor of Science Degree or equivalent degree issued after a full course of resident instruction in one or more established and accredited institutions of higher education, with major work for a degree in one or more fields of chemistry, as shown by a transcript of credits. A Bachelor Degree in the biological sciences may be accepted where related work experience has been acquired, providing that the earned degree includes a minimum of 25 quarter hours of courses in chemistry. In addition to the bachelor degree or equivalent, the supervising chemist shall have demonstrated proficiency in blood alcohol determinations as gained by attendance at pertinent courses or the equivalent in practical clinical chemical laboratory training and experience.

Persons who have successfully completed a regular four year course in an established and accredited college or university, with major work leading to a degree in medical technology, providing the course shall have included not less than 25 quarter hours of chemistry, may also meet the minimum personnel requirements, provided subsequent training has been acquired in the field of clinical chemistry.

A person who is and who has been performing blood alcohol determinations for not less than two years, but who does not meet the above requirements, may also be qualified providing that, as determined by the Division of Epidemiology and Laboratory Services Advisory Committee, the person has completed not less than one year of pertinent education beyond the high school level, or has received training through a training program, providing the person is shown to be competent to perform these examinations as demonstrated by an examination and satisfactory participation in a proficiency testing program offered or authorized by the Department, and providing that the person is employed under the full-time supervision of a person meeting the qualifications presented in R444-11-3A.

Registration by nationally recognized certifying boards may be accepted by the Director, on recommendation of the Division of Epidemiology and Laboratory Services Advisory Committee, in lieu of the bachelor degree.

Technical personnel unable to meet these requirements may assist in the preparation and processing of specimens, but may not be responsible for any of the definitive analyses.

B. Required and Recommended Minimum Standards for Laboratory Facilities

The facilities provided for blood alcohol determinations shall meet reasonable standards for the procedure selected. There shall be sufficient space to process and examine the specimens commensurate with the workload of the laboratory. Facilities shall be clean, well-lighted, properly ventilated and with adequate temperature control to meet the requirements for the test performed in the laboratory. Adequate and proper storage facilities shall be available for the reagents used in the testing and shall be convenient to the area in which the tests are performed.

C. Laboratory Equipment and Supplies

All equipment, reagents, and glassware necessary for the satisfactory performance of blood alcohol determinations shall be on hand or readily available on the premises. Equipment shall be in good working order. Included in this equipment shall be all items specified for the procedure selected as recorded in techniques published in recognized professional publications.

 

KEY: medical laboratories

Date of Enactment or Last Substantive Amendment: 1992

Notice of Continuation: January 20, 2012

Authorizing, and Implemented or Interpreted Law: 26-1-30(2)(m)]