USA Statutes : nevada
Title : Title 54 - PROFESSIONS, OCCUPATIONS AND BUSINESSES
Chapter : CHAPTER 652 - MEDICAL LABORATORIES
This chapter may be cited as the Medical
Laboratory Certification and Improvement Law.
(Added to NRS by 1967, 926)
As used in this chapter, unless the
context otherwise requires, the words and terms defined in NRS 652.030
to 652.060 , inclusive, have the meanings ascribed to them
in those sections.
(Added to NRS by 1967, 926; A 1991, 650)
“Board” means the State Board of
Health.
(Added to NRS by 1967, 926)
“Health Division” means
the Health Division of the Department of Health and Human Services.
(Added to NRS by 1995, 1590)
“Laboratory” means any medical
laboratory.
(Added to NRS by 1967, 926)
“Laboratory director”
means a person responsible for the administration of the technical and
scientific operation of a medical laboratory.
(Added to NRS by 1967, 926; A 1973, 660)
“Medical laboratory”
means any facility for microbiological, serological, immunohematological
(blood banking), cytological, histological, chemical, hematological,
biophysical, toxicological, or other methods of examination of tissues,
secretions or excretions of the human body. The term does not include a
forensic laboratory operated by a law enforcement agency.
(Added to NRS by 1967, 926; A 1983, 599; 1993, 499)
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;
(c) Performance standards for laboratories; and
(d) Requirements for the retention of the health care and other
regularly maintained records of laboratories.
(Added to NRS by 1967, 926; A 1997, 1123)
LICENSES
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 24 months and is renewable 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.
(Added to NRS by 1967, 926; A 1973, 660; 1975, 1162; 1995, 794,
1590; 1997, 1124)
An application for a license
must be made under oath on a form prescribed by the Health Division and
must contain the following information:
1. The name and location of the laboratory;
2. The name of the laboratory director;
3. The name of the owner or owners of the laboratory or, if a
corporation, the names of the officers, directors and beneficial owners
of 10 percent or more of its shares;
4. A description of the program and services provided by the
laboratory; and
5. Such other information as the Health Division may deem
necessary or expedient to carry out its powers and duties under this
chapter.
(Added to NRS by 1967, 927; A 1995, 1590)
Repealed. (See chapter 501, Statutes of Nevada 2005, at page
2818 .)
[Effective until the date of the repeal of the federal law
requiring each state to establish procedures for withholding, suspending
and restricting the professional, occupational and recreational licenses
for child support arrearages and for noncompliance with certain processes
relating to paternity or child support proceedings.]
1. In addition to any other requirements set forth in this chapter:
(a) An applicant for the issuance of a license or certificate
issued pursuant to NRS 652.125 shall
include the social security number of the applicant in the application
submitted to the Board.
(b) An applicant for the issuance or renewal of a license or
certificate issued pursuant to NRS 652.125 shall submit to the Board the statement
prescribed by the Division of Welfare and Supportive Services of the
Department of Health and Human Services pursuant to NRS 425.520 . The statement must be completed and signed by
the applicant.
2. The Board shall include the statement required pursuant to
subsection 1 in:
(a) The application or any other forms that must be submitted for
the issuance or renewal of the license or certificate; or
(b) A separate form prescribed by the Board.
3. A license or certificate may not be issued or renewed by the
Board pursuant to NRS 652.125 if the
applicant:
(a) Fails to submit the statement required pursuant to subsection
1; or
(b) Indicates on the statement submitted pursuant to subsection 1
that he is subject to a court order for the support of a child and is not
in compliance with the order or a plan approved by the district attorney
or other public agency enforcing the order for the repayment of the
amount owed pursuant to the order.
4. If an applicant indicates on the statement submitted pursuant
to subsection 1 that he is subject to a court order for the support of a
child and is not in compliance with the order or a plan approved by the
district attorney or other public agency enforcing the order for the
repayment of the amount owed pursuant to the order, the Board shall
advise the applicant to contact the district attorney or other public
agency enforcing the order to determine the actions that the applicant
may take to satisfy the arrearage.
(Added to NRS by 1997, 2180; A 2005, 2796 , 2807 )
[Effective on the date of the repeal of the federal law
requiring each state to establish procedures for withholding, suspending
and restricting the professional, occupational and recreational licenses
for child support arrearages and for noncompliance with certain processes
relating to paternity or child support proceedings and expires by
limitation 2 years after that date.]
1. In addition to any other requirements set forth in this
chapter, an applicant for the issuance or renewal of a license or
certificate issued pursuant to NRS 652.125 shall submit to the Board the statement
prescribed by the Division of Welfare and Supportive Services of the
Department of Health and Human Services pursuant to NRS 425.520 . The statement must be completed and signed by
the applicant.
2. The Board shall include the statement required pursuant to
subsection 1 in:
(a) The application or any other forms that must be submitted for
the issuance or renewal of the license or certificate; or
(b) A separate form prescribed by the Board.
3. A license or certificate may not be issued or renewed by the
Board pursuant to NRS 652.125 if the
applicant:
(a) Fails to submit the statement required pursuant to subsection
1; or
(b) Indicates on the statement submitted pursuant to subsection 1
that he is subject to a court order for the support of a child and is not
in compliance with the order or a plan approved by the district attorney
or other public agency enforcing the order for the repayment of the
amount owed pursuant to the order.
4. If an applicant indicates on the statement submitted pursuant
to subsection 1 that he is subject to a court order for the support of a
child and is not in compliance with the order or a plan approved by the
district attorney or other public agency enforcing the order for the
repayment of the amount owed pursuant to the order, the Board shall
advise the applicant to contact the district attorney or other public
agency enforcing the order to determine the actions that the applicant
may take to satisfy the arrearage.
(Added to NRS by 1997, 2180; A 2005, 2796 , 2797 , 2807 , effective on the date of the repeal of
the federal law requiring each state to establish procedures for
withholding, suspending and restricting the professional, occupational
and recreational licenses for child support arrearages and for
noncompliance with certain processes relating to paternity or child
support proceedings)
1. All applications for a license or renewal thereof must be
accompanied by a reasonable fee in an amount prescribed by the Board. All
fees must be paid to the Health Division and must be deposited with the
State Treasurer for credit to the appropriate account of the State Board
of Health.
2. Claims for per diem and travel expenses and for other expenses
of administration of this chapter must be paid as other claims against
the State are paid.
(Added to NRS by 1967, 927; A 1975, 1163; 1983, 405; 1985, 446;
1995, 1590)
1. A license issued pursuant to the provisions of this chapter is
valid only for the laboratory premises for which it is issued and shall
be prominently displayed in such laboratory.
2. Any such license shall become void 30 days after a change of
laboratory directors or in the ownership or location of the laboratory.
(Added to NRS by 1967, 927)
POWERS AND DUTIES OF HEALTH DIVISION OF DEPARTMENT OF HEALTH AND HUMAN
SERVICES AND STATE BOARD OF HEALTH
The Health Division shall
enforce the provisions of this chapter.
(Added to NRS by 1967, 927; A 1995, 1590)
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.
(Added to NRS by 1997, 1123)
1. The Board shall adopt regulations for the certification and
licensure of laboratory directors and laboratory personnel who perform
technical duties other than the collection of blood.
2. The Health Division shall, as a prerequisite for the renewal of
a certificate or license, require the laboratory director and any
laboratory personnel certified by the Health Division pursuant to this
chapter to comply with the requirements for continuing education adopted
by the Board.
(Added to NRS by 1985, 549; A 1995, 1590)
To qualify for certification as an assistant in a medical
laboratory, a person must be a high school graduate or have a general
equivalency diploma and:
1. Must complete at least 6 months of training approved by the
Board and demonstrate an ability to perform laboratory procedures in the
medical laboratory where he receives the training; or
2. Must:
(a) Complete a course of instruction that qualifies him to take an
examination for certification in phlebotomy that is administered by:
(1) The American Medical Technologists;
(2) The American Society of Clinical Pathologists; or
(3) The National Certification Agency; and
(b) Pass an examination specified in paragraph (a).
(Added to NRS by 1999, 172 )
Except as otherwise provided in NRS 652.127 , the Board, with the advice of the Medical
Laboratory Advisory Committee, may prescribe and publish rules and
regulations relating to:
1. The education, training and experience qualifications of
laboratory directors and technical personnel.
2. The location and construction of laboratories, including
plumbing, heating, lighting, ventilation, electrical services and similar
conditions, to ensure the conduct and operation of the laboratory in a
manner which will protect the public health.
3. Sanitary conditions within the laboratory and its surroundings,
including the water supply, sewage, the handling of specimens and matters
of general hygiene, to ensure the protection of the public health.
4. The equipment essential to the proper conduct and operation of
a laboratory.
5. The determination of the accuracy of test results produced by a
laboratory and the establishment of minimum qualifications therefor.
(Added to NRS by 1967, 927; A 1999, 173 )
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.
(Added to NRS by 1997, 1123)
The Health
Division may:
1. Inspect the premises and operations of laboratories;
2. Conduct proficiency tests to determine the accuracy of the test
results of laboratories;
3. Require laboratories to submit reports to determine compliance
with the provisions of this chapter; and
4. Require that the reports submitted by a laboratory be:
(a) Made under oath;
(b) Signed by the laboratory director; or
(c) Made under oath and signed by the laboratory director.
(Added to NRS by 1967, 927; A 1995, 1591)
The Health Division shall maintain a registration list
of all laboratories meeting the minimum standards and qualifications of
this chapter.
(Added to NRS by 1967, 927; A 1995, 1591)
Notwithstanding the provisions of NRS 652.130 and 652.150 ,
and without requiring any examination or any other qualification than is
provided in this section, the Health Division shall, upon application and
the payment of any appropriate fee before January 1, 1972:
1. Issue a director’s license to any person who operated a
laboratory in this state for at least 3 years immediately preceding
January 1, 1967;
2. Issue a medical laboratory technologist’s certificate to any
person who was a medical laboratory technologist in this state for at
least 1 year immediately preceding January 1, 1967;
3. Issue a license to, and include in the registration list of
laboratories meeting the minimum standards and qualifications of this
chapter, any laboratory which was in operation in this state on January
1, 1967, which has a director meeting the qualifications provided in
subsection 1; and
4. Keep on inactive status any licensee under this section who
notifies the Health Division that he desires such a status and pays the
current fees.
(Added to NRS by 1971, 1315; A 1975, 1163; 1995, 1591)
MEDICAL LABORATORY ADVISORY COMMITTEE
A Medical Laboratory Advisory
Committee to advise the board on matters of policy concerning medical
laboratories, qualifications of laboratory directors and personnel and
other matters pursuant to the provisions of this chapter is hereby
created.
(Added to NRS by 1967, 928)
1. The Board shall appoint the members of the Medical Laboratory
Advisory Committee.
2. After the initial terms, members shall serve for 3-year terms.
3. A member may not serve for more than two consecutive terms.
Service of 2 or more years in filling an unexpired term constitutes a
term.
4. The Advisory Committee is composed of:
(a) Two pathologists, certified in clinical pathology by the
American Board of Pathology.
(b) Two medical technologists.
(c) One bioanalyst who is a laboratory director.
(d) One qualified biochemist from the Nevada System of Higher
Education.
(e) One licensed physician actively engaged in the practice of
clinical medicine in this State.
5. No member of the Advisory Committee may have any financial or
business arrangement with any other member which pertains to the business
of laboratory analysis.
6. The State Health Officer or his designated representative is an
ex officio member of the Advisory Committee.
7. Each member of the Advisory Committee is entitled to receive:
(a) A salary of not more than $60, as fixed by the Board, for each
day’s attendance at a meeting of the Committee; and
(b) A per diem allowance and travel expenses at a rate fixed by the
Board, while engaged in the business of the Committee. The rate must not
exceed the rate provided for state officers and employees generally.
8. While engaged in the business of the Committee, each employee
of the Committee is entitled to receive a per diem allowance and travel
expenses at a rate fixed by the Board. The rate must not exceed the rate
provided for state officers and employees generally.
(Added to NRS by 1967, 928; A 1973, 269; 1977, 1260; 1981, 1996;
1985, 446; 1989, 1706; 1993, 421)
REGULATION OF LABORATORIES AND LABORATORY DIRECTORS
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;
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 NRS 652.135 .
(Added to NRS by 1967, 927; A 1997, 1124)
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 , 442.325
and 652.193 , the laboratory may report
the results of the examination only to:
(a) The person requesting the test or procedure;
(b) A provider of health care who is treating or providing
assistance in the treatment of the patient;
(c) A provider of health care to whom the patient has been
referred; and
(d) The patient for whom the testing or procedure was performed.
3. The laboratory report must contain the name of the laboratory.
If a specimen is accepted by a laboratory and is referred to another
laboratory, the name and address of the other laboratory 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.
(Added to NRS by 1967, 928; A 1989, 59; 1993, 499; 1995, 1602;
1997, 1124; 1999, 3516 ; 2003, 1333 )
1. Except as otherwise provided in NRS 442.325 , a licensed laboratory may release the results
of tests performed at the laboratory regarding a patient of a rural
hospital only to:
(a) The patient;
(b) The physician who ordered the tests; and
(c) A provider of health care who is currently treating or
providing assistance in the treatment of the patient.
2. As used in this section:
(a) “Provider of health care” has the meaning ascribed to it in NRS
629.031 .
(b) “Rural hospital” has the meaning ascribed to it in NRS 449.0177
.
(Added to NRS by 1995, 1602; A 1999, 3516 )
1. A laboratory which performs a cytologic examination of
gynecologic specimens for a patient residing in this State shall submit
any bill for those services to:
(a) The patient directly;
(b) The responsible insurer or other third-party payor; or
(c) The hospital, public health clinic or nonprofit health clinic.
Ê Except as otherwise provided in subsection 3, the laboratory shall not
submit the bill for those services to the physician who directed the
examination.
2. Except as otherwise provided in subsection 3, it is unlawful
for a physician to charge, bill or otherwise solicit payment from a
person for cytologic services relating to the examination of gynecologic
specimens.
3. The provisions of this section do not apply to cytologic
services:
(a) Rendered by the physician himself or in a laboratory operated
solely in connection with the diagnosis or treatment of his own patients;
or
(b) Provided to an enrollee pursuant to a health care plan
authorized pursuant to chapter 695C of NRS.
(Added to NRS by 1991, 650)
No
interpretation of test results, diagnosis, prognosis or suggested
treatment may appear on the laboratory report form, unless the report is
made by a physician licensed to practice in this state.
(Added to NRS by 1967, 928)
No person other than a licensed
physician, a licensed optometrist, a licensed practical nurse, a
registered nurse, a licensed physician assistant, a certified osteopathic
physician’s assistant, a certified intermediate emergency medical
technician, a certified advanced emergency medical technician, a
practitioner of respiratory care licensed pursuant to chapter 630 of NRS or a licensed dentist may manipulate a person
for the collection of specimens, except that technical personnel of a
laboratory may collect blood, remove stomach contents, perform certain
diagnostic skin tests or field blood tests or collect material for smears
and cultures.
(Added to NRS by 1967, 928; A 1991, 375; 1993, 2842; 1997, 689;
1999, 1916 ; 2001, 776 ; 2005, 2517 )
A licensed professional nurse who
is employed by the Health Division to work in the field of community
health may perform specific laboratory procedures prescribed by the Board
under the supervision of the State Health Officer. The Board shall adopt
regulations governing the performance of these procedures.
(Added to NRS by 1983, 279; A 1995, 1591)
1. A 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 or a person he has designated:
(a) Verifies that the nurse is competent to perform the test;
(b) Ensures that the test is performed in accordance with any
manufacturer’s instructions; and
(c) Validates and verifies the manner in which the test is
performed through the use of controls which ensure accurate and reliable
results of the test.
2. Licensed or certified personnel of a laboratory licensed
pursuant to this chapter 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 on the premises of an outpatient
center of the laboratory or at a patient’s residence if the laboratory
director or a person he has designated:
(a) Verifies that the person is competent to perform the test;
(b) Ensures that the test is performed in accordance with any
manufacturer’s instructions;
(c) Validates and verifies the manner in which the test is
performed through the use of controls which ensure accurate and reliable
results of the test; and
(d) Ensures compliance with any requirements for safety adopted by
the Board.
(Added to NRS by 1995, 794; A 1997, 1125; 1999, 173 )
DISCIPLINARY PROCEEDINGS
A license may be denied, suspended or revoked if the
laboratory, laboratory director or any technical employee of the
laboratory:
1. Violates any provision of this chapter;
2. Makes any misrepresentation in obtaining a license;
3. Has been convicted of a felony relating to the position for
which the applicant has applied or the licensee has been licensed
pursuant to this chapter;
4. Has been convicted of violating any of the provisions of NRS
616D.200 , 616D.220 , 616D.240 or 616D.300 to 616D.440 , inclusive;
5. Is guilty of unprofessional conduct;
6. Knowingly permits the use of the name of a licensed laboratory
or its director by an unlicensed laboratory; or
7. Fails to meet the minimum standards prescribed by the Board.
(Added to NRS by 1967, 928; A 1993, 796; 2003, 2731 )
[Expires by limitation 2 years
after the date of the repeal of the federal law requiring each state to
establish procedures for withholding, suspending and restricting the
professional, occupational and recreational licenses for child support
arrearages and for noncompliance with certain processes relating to
paternity or child support proceedings.]
1. If the Board receives a copy of a court order issued pursuant
to NRS 425.540 that provides for the
suspension of all professional, occupational and recreational licenses,
certificates and permits issued to a person who is the holder of a
license or certificate issued pursuant to NRS 652.125 , the Board shall deem the license or
certificate issued to that person to be suspended at the end of the 30th
day after the date on which the court order was issued unless the Board
receives a letter issued to the holder of the license or certificate by
the district attorney or other public agency pursuant to NRS 425.550
stating that the holder of the license
or certificate has complied with the subpoena or warrant or has satisfied
the arrearage pursuant to NRS 425.560 .
2. The Board shall reinstate a license or certificate issued
pursuant to NRS 652.125 that has been
suspended by a district court pursuant to NRS 425.540 if the Board receives a letter issued by the
district attorney or other public agency pursuant to NRS 425.550 to the person whose license or certificate was
suspended stating that the person whose license or certificate was
suspended has complied with the subpoena or warrant or has satisfied the
arrearage pursuant to NRS 425.560 .
(Added to NRS by 1997, 2180; A 2005, 2807 )
If the Board receives a report pursuant to subsection 5 of
NRS 228.420 , a hearing must be held
pursuant to regulations adopted by the Board to consider the contents of
the report. The Board shall adopt such regulations as are necessary to
carry out the provisions of this section.
(Added to NRS by 1993, 796; A 1995, 1591)
1. Except as otherwise provided in this section, a complaint filed
with the Board, all documents and other information filed with the
complaint and all documents and other information compiled as a result of
an investigation conducted to determine whether to initiate disciplinary
action are confidential.
2. The complaint or other document filed by the Board to initiate
disciplinary action and all documents and information considered by the
Board when determining whether to impose discipline are public records.
3. An order that imposes discipline and the findings of fact and
conclusions of law supporting that order are public records.
(Added to NRS by 2003, 3476 )
APPLICABILITY OF CHAPTER
The provisions of this chapter apply to all public and
private medical laboratories except:
1. A laboratory of any college, university or school which is
conducted for the training of its students, actively engaged in research
and approved by the State Department of Education.
2. Laboratories operated by the Federal Government.
3. Laboratories operated by the State Department of Agriculture.
(Added to NRS by 1967, 926; A 1967, 1206; 1973, 660; 1993, 1894;
1999, 3740 )
1. A licensed physician may operate a medical laboratory solely in
connection with the diagnosis or treatment of his own patients if the
medical laboratory complies with the provisions of this section.
2. Each such medical laboratory shall:
(a) Register with the Health Division.
(b) Comply with the rules and regulations adopted by the Board
pursuant to NRS 652.130 .
(c) Submit to the inspections and tests provided for in subsections
1 and 2 of NRS 652.140 .
(Added to NRS by 1973, 661, 1406; A 1989, 1115; 1993, 2598; 1995,
1592)
1. A laboratory which was in operation in this state on January 1,
1967, is not required to be licensed pursuant to this chapter before
January 1, 1972, but may apply for a license before that date. Unless
such a laboratory is so licensed, the Health Division shall not include
it in the registration list of laboratories meeting the minimum standards
and qualifications of this chapter.
2. A person who was operating a laboratory in this state on
January 1, 1967, may continue to do so or may be employed in a laboratory
before, on or after July 1, 1972, without qualifying as a laboratory
director or pursuant to any rules pertaining to technical personnel. A
person who was employed in a laboratory in this state on January 1, 1967,
may be employed in a laboratory before, on or after January 1, 1972,
without qualifying pursuant to any rules pertaining to technical
personnel.
(Added to NRS by 1967, 929; A 1995, 1592; 1997, 1622)
The provisions of this chapter do not apply to any
test or examination conducted by a law enforcement officer or agency.
(Added to NRS by 1993, 499)
UNLAWFUL ACTS; PENALTIES
The operation or
maintenance of a laboratory in violation of this chapter is declared to
be a public nuisance, and the Board may, in addition to other remedies,
initiate an action to enjoin such violations or to enjoin the future
operation of the laboratory until compliance with the provisions of this
chapter is obtained.
(Added to NRS by 1967, 929)
Any person or laboratory violating any of
the provisions of this chapter shall be punished by a fine of not more
than $250 for the first offense and not more than $500 for any subsequent
offense. Each act in violation of this chapter constitutes a separate
offense.
(Added to NRS by 1967, 929; A 1979, 1491)
