Title 36, Public Health and Safety

A. Except as otherwise provided pursuant to this article and rules adopted pursuant to this article, a person who desires to operate a clinical laboratory outside of a licensed health care institution shall file with the department an application accompanied by a license applicat…

A. A person who wishes to operate a laboratory in a health care institution which is covered by a single license issued pursuant to chapter 4 of this title shall submit an application for licensure on a form prescribed and furnished by the department. The application shall be und…

A. The department may inspect the premises and operations of a clinical laboratory subject to licensure pursuant to this article to study and evaluate the operation, supervision and procedures of that facility to determine if it is in substantial compliance with this article and …

A. The director shall establish by rule fees that do not exceed the cost to the department of conducting on-site inspections, evaluation and verification of information submitted with an application and other activities related to licensure of clinical laboratories pursuant to th…

A. The director shall appoint a clinical laboratory licensure advisory committee consisting of members representing a variety of persons affected by this article. The committee shall advise the director regarding the adoption of rules and shall make recommendations regarding inte…

A. The advisory committee on clinical laboratories is established consisting of the following members: 1. Four physicians who are licensed pursuant to title 32, chapter 13 or 17 and who are actively engaged in the practice of medicine. The director shall appoint these members. 2.…

A laboratory shall make available to the director on request all information that the laboratory is required by rule to keep including personnel records and information and data concerning its operation, quality assurance program, proficiency test program and laboratory procedure…

A. A person may obtain any laboratory test from a licensed clinical laboratory on a direct access basis without a health care provider's request or written authorization if the laboratory offers that laboratory test to the public on a direct access basis without a health care pro…

A. The department may assess a civil penalty in an amount of not more than three hundred dollars for each violation of this article or a rule adopted pursuant to this article. Each day a violation occurs constitutes a separate violation. The department shall hold a hearing pursua…

A. Except as otherwise provided, a clinical laboratory shall examine specimens at the authorization of any person licensed pursuant to title 32, chapter 7, 8, 13, 14, 17 or 29 or title 32, chapter 11, article 2, a person licensed to practice medicine or surgery in another state o…

A. Only a person authorized by law shall collect human bodily materials. Technical personnel of a laboratory may collect blood, remove stomach contents and collect material for smears and cultures or inject substances under the direction or on the written request of a licensed ph…

A. The owner or director of a laboratory shall not personally or through an agent, solicit the referral of specimens to his or any other laboratory in a manner which offers or implies an offer of rebates to persons submitting specimens or other fee-splitting inducements or partic…

A. A laboratory that provides anatomic pathology services shall not submit a bill to any person or entity other than the following: 1. The patient. 2. The responsible insurer or other third party payor. 3. The health care institution. 4. A referring laboratory, excluding the labo…

A. After a hearing held pursuant to title 41, chapter 6, article 10, the director may deny, suspend or revoke a license or deny the renewal of a license if he determines that a person has done any of the following: 1. Violated any of the provisions of this article or rules adopte…

A. The department may, upon its own initiative, and shall upon the verified complaint of any person setting forth facts which if proven would constitute grounds for action taken pursuant to section 36-473, investigate the applicant or licensee. B. The department shall notify the …

A. Upon the revocation of his license, a licensee shall be required to surrender his license to the department, and upon his failure or refusal to do so, the department shall have the right to seize the license. B. The department shall not be required to certify any record, file …

The operation or maintenance of an unlicensed clinical laboratory in violation of this article is declared a nuisance inimical to the public health, welfare and safety. The director, in the name of the people of the state, through the attorney general, may, in addition to other r…

A person is guilty of a class 3 misdemeanor if he: 1. Operates, maintains, directs or engages in the business of operating a clinical laboratory without a current license issued pursuant to this article. 2. Accepts blood or specimens for tests from and makes reports to persons wh…