Senate Bill No. 448

Senate Bill No. 448-Senator Rawson (By Request)

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AN ACT relating to medical laboratories; making various changes relating to the records of and reports made by medical laboratories; requiring the state board of health to adopt certain regulations relating to medical laboratories; revising provisions governing the licensure of medical laboratories; revising the conditions for performance of certain laboratory tests by licensed nurses; and providing other matters properly relating thereto.

[Approved July 5, 1997]

THE PEOPLE OF THE STATE OF NEVADA, REPRESENTED IN SENATE AND ASSEMBLY, DO ENACT AS FOLLOWS:

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Section 1. NRS 629.051 is hereby amended to read as follows:
629.051 [Each] Except as otherwise provided in regulations adopted by the state board of health pursuant to section 3 of this act with regard to the records of a medical laboratory, each provider of health care shall retain the health care records of his patients as part of his regularly maintained records for 5 years after their receipt or production. Health care records may be retained in written form, or by microfilm or any other recognized form of size reduction, including, without limitation, microfiche, computer disc, magnetic tape and optical disc, which does not adversely affect their use for the purposes of NRS 629.061. Health care records may be created, authenticated and stored in a computer system which limits access to those records.
Sec. 2. Chapter 652 of NRS is hereby amended by adding thereto the provisions set forth as sections 3 and 4 of this act.
Sec. 3. The board shall adopt regulations establishing the length of time that the health care and other regularly maintained records of a medical laboratory must be retained. The regulations must be consistent with the provisions of Part 493 of Title 42 of the Code of Federal Regulations.
Sec. 4. Regulations adopted by the board pursuant to this chapter may not be more stringent than the provisions of Part 493 of Title 42 of the Code of Federal Regulations, except that the board may adopt regulations which are more stringent relating to:
1. Any laboratory test classified as a waived test pursuant to the provisions of Part 493 of Title 42 of the Code of Federal Regulations; and
2. The qualifications and duties of the personnel of a medical laboratory.
Sec. 5. NRS 652.070 is hereby amended to read as follows:
652.070 The legislature declares that:
1. The proper operation of medical laboratories within the state is a matter of vital concern affecting the public health, safety and welfare.
2. The purpose of this chapter is to promote public health, safety and welfare by developing, establishing and enforcing:
(a) Minimum standards for the licensing of medical laboratories;
(b) Minimum qualifications for laboratory directors and the certification of laboratory personnel; [and]
(c) Performance standards for laboratories [.] ; and
(d) Requirements for the retention of the health care and other regularly maintained records of laboratories.
Sec. 6. NRS 652.080 is hereby amended to read as follows:
652.080 1. Except as otherwise provided in NRS 652.217 and 652.235, no person may operate, conduct, issue a report from or maintain a medical laboratory without first obtaining a license to do so issued by the health division pursuant to the provisions of this chapter.
2. A license issued pursuant to the provisions of subsection 1 is valid for [12] 24 months and is renewable [annually] biennially on or before the date of its expiration.
3. No license may be issued to a laboratory which does not have a laboratory director.
4. A license may be placed in an inactive status upon the approval of the health division and the payment of current fees.
5. The health division may require a laboratory that is located outside of this state to be licensed in accordance with the provisions of this chapter before the laboratory may examine any specimens collected within this state if the health division determines that the licensure is necessary to protect the public health, safety and welfare of the residents of this state.
Sec. 7. NRS 652.180 is hereby amended to read as follows:
652.180 A laboratory director shall:
1. Select and supervise all laboratory procedures;
2. Report the findings or results of laboratory tests;
3. Actively participate in the operation of the laboratory to the extent necessary to assure compliance with the provisions of this chapter; [and]
4. Be responsible for the proper performance of all work in the laboratory and of all subordinates [.] ; and
5. Retain the health care and other regularly maintained records of the laboratory in accordance with regulations adopted by the board pursuant to section 3 of this act.
Sec. 8. NRS 652.190 is hereby amended to read as follows:
652.190 1. A laboratory may examine specimens only at the request of:
(a) A licensed physician;
(b) Any other person authorized by law to use the findings of laboratory tests and examinations; or
(c) If the examination can be made with a testing device or kit which is approved by the Food and Drug Administration for use in the home and which is available to the public without a prescription, any person.
2. Except as otherwise provided in NRS 441A.150 and 652.193, the laboratory may report the results of the examination only to the person requesting the test or procedure and to the patient for whom the testing or procedure was performed. The laboratory report must contain the name of the laboratory . [and of the laboratory director.]
3. If a specimen is accepted by a laboratory and is referred to another laboratory, the name and address of the other laboratory [and its director] must be clearly shown by the referring laboratory on the report to the person requesting the test or procedure.
4. Whenever an examination is made pursuant to paragraph (c) of subsection 1, the laboratory report must contain a provision which recommends that the results of the examination be reviewed and interpreted by a physician or other licensed provider of health care.
Sec. 9. NRS 652.217 is hereby amended to read as follows:
652.217A licensed nurse who is employed by a medical facility which is licensed pursuant to chapter 449 of NRS may perform any laboratory test which is classified as a waived test pursuant to Subpart A of Part 493 of Title 42 of the Code of Federal Regulations if the laboratory director [of the medical laboratory in which the test is conducted] or a person he has designated:
1. Verifies that the nurse is competent to perform the test;
2. Ensures that the test is performed in accordance with any manufacturer's instructions; and
3. Validates and verifies the manner in which the test is performed through the use of controls which assure accurate and reliable results of the test.
Sec. 10. The amendatory provisions of section 6 of this act that extend the period of validity of licenses issued to medical laboratories apply only to licenses that are issued or renewed on or after October 1, 1997.
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