36-461. Exceptions to this article The provisions of this article apply to all clinical laboratories and directors of clinical laboratories but do not apply to the following: 1. Clinical laboratories operated, licensed or certified by the United States government. 2. Certain classes of clinical laboratories and types and categories of laboratory examinations exempted from licensure […]
36-462. License requirements; training and consultation A. No person shall establish, conduct or maintain a clinical laboratory in this state or engage in the business of providing clinical laboratory services to persons within the state unless that person applies for and obtains a license pursuant to this article. The department shall issue a license to […]
36-463. Licensure of laboratories located outside of a health care institution; application; issuance; display; expiration; renewal 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 […]
36-463.01. Licensure of laboratories located in a health care institution 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 […]
36-463.02. Inspections; exemptions; disciplinary action 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 rules adopted pursuant to this article. […]
36-464. Fees; deposit 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 this article and rules adopted pursuant to this article. Fees for […]
36-465. Clinical laboratory licensure advisory committee; department rules; interpretive guidelines 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 interpretive guidelines necessary to properly administer […]
36-466. Advisory committee on clinical laboratories; membership; duties 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. Two physicians […]
36-467. Reports by laboratories 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 procedures. The department may require that this information be under oath, be […]
36-468. Laboratory testing without health care provider’s order; results; report; duty of care; liability; definition 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 […]
36-469. Civil penalties 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 pursuant to title 41, chapter […]
36-470. Examination of specimens; written requests; reports of results; retention of test records 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 […]
36-471. Persons authorized to collect human specimens or blood 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 physician for […]
36-472. Rebates, fee-splitting and solicitation of referrals prohibited 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 participate […]
36-472.01. Billing for laboratory costs; definition 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 laboratory of the health […]
36-473. Grounds for denial, suspension or revocation of license 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 […]
36-474. Investigation of complaints; notice of hearing 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 applicant or licensee of […]
36-476. License surrender; certification 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 any […]
36-478. Injunction 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 remedies provided in this article, bring an […]
36-479. Violations; classification 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 who are not authorized by […]
