A.R.S. tit. 36 ch. 4.1 — Arizona Revised Statutes Title 36 Chapter 4.1 — Clinical Laboratories

36-451. Definitions In this chapter, unless the context otherwise requires: 1. "Accredited laboratory" means a laboratory which has received accreditation from an accreditation program approved by the secretary of the United States department of health and human services to meet standards of the federal clinical laboratory improvement amendments of 1988 (P.L. 100-518). 2. "Approved proficiency testing program" means a proficiency testing program which is approved and conducted by an accredited body approved by the secretary of the United States department of health and human services to meet the standards of the federal clinical laboratory improvement amendments of 1988 (P.L. 100-518). 3. "Certified laboratory" means a laboratory certified by the United States department of health and human services. 4. "Clinical laboratory" or "laboratory" means any facility, agency, institution, medical office, health care institution, building, or place which provides through its ownership or operation facilities for the microbiological, serological, chemical, immunohematological, hematological, cytologic, histologic, radiobioassay, cytogenetic, histocompatibility, pathological, toxicological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of a disease or an impairment or the assessment of human health conditions or to determine the presence, absence or concentration of various substances in the body. Clinical laboratory does not include law enforcement crime laboratories. 5. "Department" means the department of health services. 6. "Director" means the director of the department of health services. 7. "Federally licensed laboratory" means a laboratory licensed pursuant to the United States clinical laboratory improvement amendments of 1988 (P.L. 100-518). 8. "Governing authority" means the individual, agency, group or corporation that is appointed, elected or otherwise designated and that has the ultimate responsibility and authority for the conduct of the health care institution. 9. "Health care institution" has the same meaning as prescribed in section 36-401. 10. "License" means a regular license, renewal license or provisional license issued by the department pursuant to this chapter. 11. "Person" means any individual, firm, partnership, association or corporation, whether or not organized for profit, or any other form of business enterprise. 36-452. Administration The provisions of this chapter shall be administered by the department of health services. 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 by the director by rule if the director determines that the exemptions will not adversely affect public health. 3. Laboratories operated and maintained solely for research or teaching purposes if the director provides for this exemption by rule and determines that the exemption will not adversely affect public health. 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 an applicant if the department determines that the applicant meets the requirements of this article and rules adopted pursuant to this article. B. The director may provide training and consultation to laboratory personnel to ensure compliance with the licensure requirements of this article. 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 accompanied by a license application fee prescribed by the director by rule pursuant to section 36-464. B. The application shall be on a form prescribed and furnished by the department. The application shall be under oath and shall contain: 1. The name and location of the clinical laboratory. 2. The name of the person owning the facility and the name of the person directing the facility. 3. A description of the services provided by the clinical laboratory. 4. Other information as the department determines necessary or expedient in carrying out its powers and duties under this article. C. The department may issue a provisional license to the applicant to operate a clinical laboratory to provide the services described in the application if the department is satisfied that the applicant substantially complies with the provisions of this article and the rules adopted pursuant to this article. D. A provisional license is valid for no more than six months and may not be renewed. E. If the owner of a clinical laboratory located outside of a licensed health care institution is not the director of that laboratory the director of the department of health services shall issue a joint license. The owner and the director of the laboratory are severally and jointly responsible to the department for the maintenance and conduct of the laboratory and for any violations of the provisions of this article and rules adopted pursuant to this article. A separate license shall be obtained for each clinical laboratory. A license is valid only for the persons to whom it is issued and shall not be sold or transferred. A license is not valid for any premises other than those for which it is issued. F. A person may apply for and shall be granted a new license without charge if the licensed laboratory is undergoing a change in location and the director or owner, prior to the actual change, proves to the satisfaction of the department that the change is in compliance with the provisions of this article and rules adopted pursuant to this article. The department must receive the application at least thirty days before the proposed change in location. G. A regular license is valid for two years and may be renewed on payment of an application for renewal fee prescribed by the director by rule pursuant to section 36-464 if the laboratory is in substantial compliance with this article and rules adopted pursuant to this article. H. A person who maintains, conducts or operates a clinical laboratory shall display in a prominent place in the clinical laboratory the license issued to him by the department. I. The department shall maintain a list of laboratories that meet the licensure requirements of this section. The department shall make this list available on request to licensed laboratories, physicians and the public. 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 application shall be under oath and shall contain the following: 1. The name and location of the health care institution. 2. A copy of the license of the health care institution. 3. The name of the governing authority. 4. A description of clinical laboratory services to be provided, including those to be provided in special function laboratories and ancillary test sites covered by the single license of the health care institution. 5. The name of the chief administrative officer directing the health care institution. 6. Other information required by the department. B. The application shall be signed by the owner of the health care institution. If the application is submitted by a partnership or a corporation it shall be signed by two of the partners or officers. If the application is submitted by a governmental unit it shall be signed by the head of the appropriate department. C. The department shall issue the license to the governing authority of the health care institution, and the license shall show the name of the chief administrative officer. The licensee is responsible for the maintenance and conduct of the laboratory and for violations of this article. The department shall issue a single license for all clinical laboratory services provided by the health care institution including those provided in special function laboratories and ancillary test sites covered by the single health care license. A license is valid only for the person to whom it is issued and may not be sold or transferred. D. The department may issue a provisional license if it is satisfied that the applicant substantially complies with the provisions of this article. A provisional license is valid for no more than six months and may not be renewed. E. A licensee may apply for and shall be granted a new license without charge if the licensed laboratory is undergoing a change in location and the administrator of the health care institution, prior to the actual change, proves to the satisfaction of the department that the change is in compliance with the provisions of this article and rules adopted pursuant to this article. The department must receive the application at least thirty days before the proposed change in location. F. A license is valid for two years and may be renewed on payment of a renewal fee prescribed by the director by rule pursuant to section 36-464 if the laboratory is in substantial compliance with this article and rules adopted pursuant to this article. G. The department shall maintain a list of laboratories that meet the licensure requirements of this section. The department shall make this list available on request to licensed laboratories, physicians and the public. 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. Inspections may be unannounced and shall take place during regular working hours. B. The department shall require a laboratory to enroll in an approved proficiency testing program. The department may also submit proficiency test specimens for examination by a laboratory to determine its compliance with the provisions of this chapter, if a laboratory has failed to meet the standards for proficiency testing, pursuant to this article. C. A laboratory is exempt from on-site inspection conducted pursuant to this article and on-site inspection fees if it is in substantial compliance with the licensure requirements of this article and is licensed or certified by the federal government, licensed or accredited by another state or accredited by a federally approved program. The laboratory shall submit to the department verified proof of this licensure, certification or accreditation along with the laboratory's evaluation report. A laboratory shall notify the department within twenty-four hours of its receipt of notice that its accreditation has been rescinded or modified. If the department determines that an accreditation program is no longer approved, it shall conduct on-site inspections pursuant to this section. D. If the director has reasonable cause to believe that a licensed or unlicensed laboratory or a laboratory requesting licensure is not in substantial compliance with the licensing requirements established pursuant to this article, the director may make announced or unannounced on-site inspections of the laboratory at any reasonable time to determine compliance. An application for licensure grants the department permission to conduct on-site inspections as prescribed pursuant to this section. E. If as a result of an inspection the director determines that a laboratory is not in substantial compliance with this article and rules adopted pursuant to this article, he may modify, suspend, revoke or deny renewal of the license. This action shall follow a hearing held pursuant to chapter 41, article 6. If the director believes that the immediate interests of the general public will be best served by allowing the laboratory an opportunity to correct the deficiency, he may issue a provisional license for not more than six months. The laboratory shall agree to carry out a plan approved by the department to correct the deficiencies. The laboratory may be relicensed only after the expiration of its provisional license and only if the department determines that the licensee 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 an application for a regular license, a provisional license and renewal of a license shall be based on the services that the laboratory is licensed to provide. B. Fees collected in accordance with the provisions of this article shall be deposited in the state general fund. 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 and enforce the provisions of this article. Committee members serve at the pleasure of the director. Committee members are not eligible to receive compensation but are eligible for reimbursement of expenses pursuant to title 38, chapter 4, article 2. B. After consultation with the advisory committee, the director shall adopt rules for clinical laboratories, relating to: 1. Classes and levels of laboratory practice and types and categories of laboratory examinations performed on material taken from the human body. 2. Minimum standards of proficiency testing to ensure valid and accurate laboratory testing. 3. The construction and operation of the laboratory, including plumbing, heating, lighting, ventilation, electrical services and similar conditions to assure that the operation of the laboratory is conducted in a manner which will protect the public health. A rule adopted pursuant to this paragraph shall require that laboratory facilities conform to all state and local building, safety and fire codes and ordinances. 4. The education, training, experience and responsibilities of laboratory directors, supervisors and personnel who perform laboratory examinations and procedures for collecting human specimens or blood. 5. All conditions within the laboratory related to infectious, hazardous and toxic materials. 6. Requirements to adequately assure the validity and reliability of the laboratory examinations and test results. 7. The proper collection, transportation and storage of specimens. 8. Reports, records, equipment and facilities necessary for the proper and effective operation of the laboratory. 9. Persons who may collect and submit human specimens for examination and receive examination results. 10. Additional grounds for denial, suspension and revocation of a license. 11. Exemptions from on-site inspections. 12. Criteria for determining substantial compliance with the provisions of this article and rules adopted pursuant to this article. C. The department may issue interpretive guidelines on subjects relating to rules adopted pursuant to this article. 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 who are licensed pursuant to title 32, chapter 13 or 17 and who are employed by a clinical laboratory as pathologists. The director shall appoint these members. 3. The director or the director's designee. B. The committee shall: 1. Annually select a chairperson and vice-chairperson from among its members. 2. Advise the department on the use and renewal of standing orders. 3. Conduct regular meetings at the call of the chairperson or a majority of the committee members. C. The department shall adopt rules based on the recommendations of the advisory committee. D. Committee members are not eligible to receive compensation or reimbursement of expenses. E. The department shall provide necessary staff services to the committee. F. The appointed committee members serve three-year terms. 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 signed by the owner and director of the laboratory and be available at all times at the laboratory. 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 access basis without a health care provider's request or written authorization. B. If a laboratory test of a person is conducted by or under the supervision of a person other than a health care provider and not at the request or with the written authorization of a health care provider, any report of the test results shall be provided by the person conducting the test to the person who was the subject of the test. The report shall state in bold type that it is the responsibility of the person who was tested to arrange with the person's health care provider for consultation and interpretation of the test results. C. A health care provider's duty of care to a patient does not include any responsibility to review or act on the laboratory test results of a patient if the health care provider did not request or authorize the laboratory test. A health care provider is not subject to liability or disciplinary actions for the failure to review or act on the results of a laboratory test of any patient if the health care provider did not request or authorize the laboratory test. D. A clinical laboratory may not submit a claim for reimbursement from a third-party payor for any laboratory test conducted without a health care provider's request or written authorization. E. This section does not require that a laboratory test be covered by a health insurance plan or product pursuant to title 20 or by any program administered by the Arizona health care cost containment system administration pursuant to chapter 29 of this title. F. For the purposes of this section, "health care provider" means a person who is licensed pursuant to title 32 and who is authorized to order laboratory testing. 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 6, article 10 to determine if a violation has occurred. B. The attorney general or the county attorney shall bring an action in the name of this state to enforce the collection of penalties assessed pursuant to this section. An action shall be brought in the justice court or the superior court in the county in which the violation occurs. C. Penalties assessed pursuant to this section are in addition to other penalties imposed pursuant to this chapter. D. The director shall deposit, pursuant to sections 35-146 and 35-147, penalties collected pursuant to this section in the state general fund. 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 medicine or surgery in another state or a person authorized by law or department rules. B. The result of a test shall be reported to the person who authorized it. A report of results issued from a clinical laboratory shall provide information required by the department by rule. A clinical interpretation, diagnosis or prognosis or suggested treatment other than normal values shall not appear on the laboratory report form, except that a report made by a physician licensed to practice medicine and surgery in this state or another state may include this information. C. The result of a test may be reported to a health care provider, as defined in section 12-2291, that has a treatment relationship with a patient, to a person or entity that provides services to the health care provider and with whom the health care provider or the clinical laboratory has a business associate agreement that requires the person or entity to protect the confidentiality of patient information as required by the health insurance portability and accountability act privacy standards, 45 Code of Federal Regulations part 164, subpart E or to the patient or the patient's health care decision maker. D. All specimens accepted by a laboratory for specified tests shall be tested on its premises, except that specimens, other than those for proficiency testing purposes, may be forwarded for examination to another laboratory licensed under this article or exempted by section 36-461, paragraph 1. E. When the laboratory performing the examination is other than the laboratory accepting the specimen, the report submitted shall include information required by the department by rule. F. Records involving laboratory services and copies of reports of laboratory tests shall be kept in a manner as prescribed by the department by rule. G. A person authorized to request clinical laboratory examinations pursuant to this section may direct that a clinical laboratory examine a person's specimens at that person's request if the authorization is given pursuant to department rules and specifies: 1. The name of the person authorized to request an examination and to receive the results of that examination. 2. The type of examinations to be performed by the laboratory. 3. The total number of examinations the authorized person may request. 4. The beginning and expiration dates of the authorization. 5. The identification of the person giving the authorization. H. The laboratory shall report test results ordered pursuant to subsection G of this section to the person who authorized the test and to the person who requested it. 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 examination by a licensed laboratory. B. Paramedics, advanced emergency medical technicians or personnel who have written approval of the director may collect blood and collect material for smears and cultures under the direction or on the written request of a licensed physician. 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 in any fee-splitting arrangement. This applies to contents of fee schedules, billing methods or personal solicitation. The contractual provision of laboratory services for a fixed fee independent of the number of specimens submitted for such services is declared to be a violation of this section. B. The bill to the patient shall specify the actual charge by the reference laboratory together with the reasonable specimen collection charge by the referring laboratory or physician. 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 professional who ordered the test. 5. A governmental agency or the agency's public or private agent, agency or organization that is acting on behalf of the recipient of the services. B. For the purposes of this section, "anatomic pathology services" includes cytology services, molecular pathology services, hematopathology, histopathology, surgical pathology, and blood banking services performed by a pathologist. Anatomic pathology services does not include the collection, packaging and transportation of the specimen. 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 provisions of this article or rules adopted pursuant to this article. 2. Violated any provision of title 32, chapter 13. 3. Advertised clinical laboratory procedures to the public in a form or manner not approved by the director. 4. Knowingly accepted a referral for laboratory tests or specimens from and submitted a report to persons not licensed or otherwise authorized by law to submit specimens and receive reports. 5. Referred a specimen for examination to a laboratory not licensed under this article or exempted by section 36-461 or as authorized by this article. 6. Submitted a report on clinical laboratory work actually performed in another clinical laboratory without designating the name of the director and the name and address of the laboratory in which the test was performed. 7. Been convicted of a felony or of any crime involving moral turpitude under the laws of any state or of the United States arising out of or in connection with the operation of a laboratory. The record of conviction or a certified copy is conclusive evidence of a conviction. 8. Failed to pay fees required by the department. B. If the director has reason to believe that a violation of this section is occurring that threatens the life or safety of patients he may order, on written notice to the licensee, the immediate termination of specific services, tests and use of equipment. 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 the date, time and place of the hearing which shall be heard not less than ten days after the notice is served or mailed. C. A hearing conducted pursuant to this section shall comply with the requirements of title 41, chapter 6, article 10. 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 answer or otherwise appear in any proceeding for judicial review unless the party filing the complaint deposits with the clerk of the court a reasonable and customary sum, as determined by the chief clerk of the department, to provide for the costs of such certification. Failure on the part of the plaintiff to make such deposit shall be grounds for dismissal of the action. 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 action for an injunction to restrain such violation or to enjoin the future operation or maintenance of any such clinical laboratory until compliance with the provisions of this article has been obtained. 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 law to submit, receive or use these reports or materials. This does not prohibit the transferral of blood or referral specimens from one clinical laboratory licensed under this article to another clinical laboratory licensed under this article if the report indicates clearly the laboratory performing the test and the name of the director of such clinical laboratory. 3. Knowingly violates any provision of this article or any rule adopted pursuant to this article.