NAC: CHAPTER 652 - MEDICAL LABORATORIES

[Rev. 2/21/2018 3:37:14 PM]

[NAC-652 Revised Date: 3-18]

CHAPTER 652 - MEDICAL LABORATORIES

GENERAL PROVISIONS

652.010 Definitions.

652.020 “Accredited” defined.

652.025 “Approved course” defined.

652.033 “Board” defined.

652.060 “Committee” defined.

652.065 “Director” defined.

652.071 “Division” defined.

652.072 “Exempt laboratory” defined.

652.073 “Form” defined.

652.074 “HIV testing laboratory” defined.

652.075 “Laboratory” defined.

652.083 “Licensed laboratory” defined.

652.087 “National examination for certification” defined.

652.092 “Outpatient center of a laboratory” defined.

652.115 “Point-of-care test” defined.

652.125 “Point-of-care testing device” defined.

652.130 “Program for proficiency testing” defined.

652.133 “Quality control” defined.

652.135 “Registered laboratory” defined.

652.137 “Rural area” defined.

652.143 “Test” defined.

652.145 “Unapproved course” defined.

652.148 “Unit of continuing education” defined.

652.151 “Violation” defined.

652.155 Applicability; exemptions from compliance.

652.156 Exemption from provisions of chapter for director of HIV testing laboratory.

LICENSING AND REGISTRATION

652.157 Applications: Must include alternate method of contact; exemptions; requirement to notify Division of change to information; grounds for disciplinary action.

652.161 Conditions under which notice deemed sufficient.

652.170 Laboratory: Application for license or registration; action by Division on application; proof of identity of laboratory director to be provided with application.

652.175 Laboratory operated by licensed physician: Registration as exempt or nonexempt laboratory.

652.180 Laboratory operated by licensed physician: Issuance and renewal of certificate of registration.

652.195 Permit to operate laboratory at temporary location: Application; action on application; expiration.

652.200 Director’s license: Application.

652.210 Director’s license: Action on application.

652.220 Director’s license: Term.

652.230 Director’s license: Renewal.

652.240 Director’s license: Nontransferable; duplicates.

OPERATION AND PERSONNEL

652.280 Duties of director: Health and safety; physical premises and environmental conditions.

652.282 Duties of director: Testing procedures and results.

652.284 Duties of director: Program for proficiency testing.

652.286 Duties of director: Personnel.

652.291 Laboratory safety guidelines: Adoption; required procedures; manufacturer’s guidelines; training and evaluation of employees; notification to employees upon adoption.

652.300 Request or authorization for test; report of findings; required contents of request.

652.310 Record of accessions of specimens: Maintenance; content.

652.320 Inspections: Duties and authority of Division; submission of plan for correction of violations.

652.325 Violations: Severity levels.

652.340 Reports by laboratory: Contents; terminology; retention of copies.

652.342 Point-of-care testing device: Limitations on use.

652.344 Point-of-care testing device: Requirements for use.

652.346 Point-of-care testing device: Persons qualified to use.

652.348 Applicability of NAC 652.342, 652.344 and 652.346.

652.350 Personnel: General requirements.

652.370 Director: Availability and presence; prohibition against serving more than five laboratories; exception.

652.380 Director of licensed laboratory: Qualifications.

652.383 Director of licensed laboratory testing in oral pathology: Qualifications.

652.385 Director of licensed laboratory testing for pulmonary conditions: Qualifications.

652.395 Director of registered laboratory: Qualifications.

652.397 Director of exempt laboratory: Qualifications.

652.398 Director of HIV testing laboratory: Qualifications.

652.400 General supervisor of licensed laboratory: Duties.

652.410 General supervisor of licensed laboratory: Qualifications.

652.420 Clinical laboratory technologist: Activities and qualifications.

652.425 Cytotechnologist: Qualifications and activities.

652.433 Histotechnologist: Qualifications and activities.

652.437 Histologic technician: Qualifications and activities.

652.440 Medical technician: Activities and qualifications.

652.443 Blood-gas technologist: Qualifications and activities.

652.447 Blood-gas technician: Qualifications and activities.

652.450 Laboratory assistant; blood-gas assistant.

652.452 Pathologist’s assistant: Qualifications and activities.

652.453 Pathologist’s assistant: Responsibilities of supervising pathologist.

652.454 Point-of-care test analyst: Qualifications.

652.455 Continuing education: Prerequisites to renewal of license or certificate.

652.461 Continuing education: Prerequisites to reinstatement of inactive or delinquent license or certificate; exception.

652.465 Continuing education: Proof of completion.

652.470 Certification of personnel.

652.472 Minimal requirements for new employees.

652.474 Activities of certified personnel.

652.476 Renewal of certification.

652.478 Technologists: Specialties; activities.

652.480 Technologists: Certification in specialty for which national examination is given; application for certification; designation on certificate.

652.483 Technologists: Certification in specialty for which national examination is not given.

652.484 Technicians: Specialties; activities.

652.485 Technicians: Certification in specialty; designation on certificate.

652.4855 Laboratory assistants: Certification; qualifications.

652.486 Provisional certification.

MISCELLANEOUS PROVISIONS

652.488 Fees; assessed expenses.

652.491 Grounds for denial, suspension or revocation of certificate.

652.493 Appeal of denial, suspension or revocation of license or certificate.

652.496 Action by Board upon receipt of report of certain violations of laws relating to industrial insurance by holder of license or certificate; consideration by Division of report.

652.520 Computation of time relating to violations and monetary penalties.

652.530 Disciplinary action: Circumstances under which authorized without notice; subsequent notice by Division required.

652.540 Disciplinary action: Notice by Division required; contents of notice.

652.550 Violations: Monetary penalties.

652.560 Reduction of monetary penalties.

652.570 Payment of monetary penalties: Time limitations; interest; costs.

652.580 Failure to pay monetary penalties: Grounds for suspension of license of laboratory; notice of intent to suspend license.

652.590 Activities of certain licensed professional nurses working at community health nursing clinics established by Division.

652.600 Program of training for certification as technician.

GENERAL PROVISIONS

NAC 652.010 Definitions. (NRS 439.200, 652.123, 652.125, 652.130, 652.220, 652.260) As used in this chapter, unless the context otherwise requires, the words and terms defined in NAC 652.020 to 652.151, inclusive, have the meanings ascribed to them in those sections.

(Supplied in codification; A by Bd. of Health, 10-17-86; 1-4-88; 3-28-96; R177-97, 1-30-98; R057-99, 9-27-99; R135-99, 11-29-99; R104-13, 3-28-2014)

NAC 652.020 “Accredited” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Accredited” means an accreditation by a nationally recognized accrediting agency or other body accepted by the Board.

[Bd. of Health, Medical Laboratories Reg. § 1.2.10, eff. 8-5-74] — (NAC A 10-17-86)

NAC 652.025 “Approved course” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Approved course” means a course of study or training which is offered by any of the following:

1. The American Society of Clinical Pathologists.

2. The International Society of Clinical Laboratory Technologists.

3. The American Medical Association.

4. The American Medical Technologists.

5. National Certification Agency.

6. The State Board of Nursing.

7. The Center for Disease Control.

8. The Professional Acknowledgment for Continuing Education (P.A.C.E.) Program.

9. The Colorado Association for Continuing Medical Laboratory Education.

10. The College of American Pathologists.

11. The American Association for Respiratory Care.

12. Any other organization approved by the Committee.

13. An accredited college or university.

(Added to NAC by Bd. of Health, eff. 1-4-88; A 4-18-91)

NAC 652.033 “Board” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Board” has the meaning ascribed to it in NRS 652.030.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.060 “Committee” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Committee” means the Medical Laboratory Advisory Committee.

[Bd. of Health, Medical Laboratories Reg. § 1.2.4, eff. 8-5-74]

NAC 652.065 “Director” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Director” means a laboratory director as defined in NRS 652.050.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.071 “Division” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Division” has the meaning ascribed to it in NRS 652.035.

(Added to NAC by Bd. of Health, eff. 3-28-96)

NAC 652.072 “Exempt laboratory” defined. (NRS 439.200, 652.123, 652.125, 652.130)

1. Except as otherwise provided in this section and NAC 652.175, “exempt laboratory” means a laboratory in which each test performed is:

(a) Classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; or

(b) Categorized as a provider-performed microscopy procedure pursuant to 42 C.F.R. § 493.19.

2. The term does not include an HIV testing laboratory.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

NAC 652.073 “Form” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Form” includes, without limitation, a printed form, an electronic form or an online or interactive process provided via the Internet.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

NAC 652.074 “HIV testing laboratory” defined. (NRS 439.200, 652.123, 652.125, 652.130) “HIV testing laboratory” means a laboratory in which the only test performed is a test for the detection of the human immunodeficiency virus that is classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

NAC 652.075 “Laboratory” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Laboratory” means a medical laboratory as defined in NRS 652.060.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.083 “Licensed laboratory” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Licensed laboratory” means a laboratory that offers its services to the general medical profession.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.087 “National examination for certification” defined. (NRS 439.200, 652.123, 652.125, 652.130) “National examination for certification” means a written examination designed to measure professional competence.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.092 “Outpatient center of a laboratory” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Outpatient center of a laboratory” means a facility at a permanent location which is:

1. Operated by a licensed laboratory; and

2. Used to collect specimens or perform any test which is classified as a waived test pursuant to Subpart A of Part 493 of Title 42 of the Code of Federal Regulations, or both.

(Added to NAC by Bd. of Health by R135-99, eff. 11-29-99; A by R104-13, 3-28-2014)

NAC 652.115 “Point-of-care test” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Point-of-care test” means a test that is:

1. Performed by means of a point-of-care testing device; and

2. Classified as a waived test or a moderate complexity test pursuant to 42 C.F.R. Part 493, Subpart A.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.125 “Point-of-care testing device” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Point-of-care testing device” means a portable laboratory testing system, analytical instrument, kit or procedure that may be transported to the site of a patient in order to perform point-of-care tests.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.130 “Program for proficiency testing” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Program for proficiency testing” means a program approved pursuant to 42 C.F.R. §§ 493.901 to 493.959, inclusive.

[Bd. of Health, Medical Laboratories Reg. § 1.2.11, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93)

NAC 652.133 “Quality control” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Quality control” means a continuing program of testing samples of known content for the purposes of verification and assessment of accuracy, including the measurement of precision and the detection of error.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.135 “Registered laboratory” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Registered laboratory” means a laboratory which only performs tests on patients of a particular physician and the partner and associates of his or her private practice.

(Added to NAC by Bd. of Health, eff. 10-17-86)

NAC 652.137 “Rural area” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Rural area” means any area other than that included in Carson City, Henderson, Reno, Sparks, Las Vegas or North Las Vegas.

(Added to NAC by Bd. of Health, eff. 10-17-86; A by R078-04, 8-5-2004)

NAC 652.143 “Test” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Test” means a microbiological, serological, immunohematological (blood banking), cytological, histological, chemical, hematological, biophysical, toxicological or other method of examining the tissues, secretions or excretions of the human body.

(Added to NAC by Bd. of Health by R177-97, eff. 1-30-98)

NAC 652.145 “Unapproved course” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Unapproved course” means a course of study or training or an activity related to medical technology which is not offered by any of the organizations set forth in NAC 652.025. The term includes:

1. The development and presentation of a seminar or workshop to persons who specialize in the area of health care;

2. Attendance at workshops offered at a person’s place of work or presented by manufacturers or vendors of medical technology;

3. The publication of a book or paper related to medical technology; and

4. The preparation of an exhibit for a medical journal or meeting.

(Added to NAC by Bd. of Health, eff. 1-4-88)

NAC 652.148 “Unit of continuing education” defined. (NRS 439.200, 652.123, 652.125, 652.130) “Unit of continuing education” means 10 hours of approved or unapproved courses.

(Added to NAC by Bd. of Health, eff. 1-4-88)

NAC 652.151 “Violation” defined. (NRS 439.200, 652.123, 652.130, 652.225, 652.260)

1. “Violation” means noncompliance with any provision of this chapter or chapter 652 of NRS.

2. The term includes, without limitation:

(a) Any incident where an action, practice or situation occurs that appears to be inconsistent with any provision of this chapter or chapter 652 of NRS concerning a laboratory where there are no extenuating circumstances or where the laboratory has responded inappropriately to a complaint; and

(b) The failure of a laboratory or the personnel of a laboratory to:

(1) Prevent such an incident from occurring, if the incident could have been avoided;

(2) Identify such an incident;

(3) Take action to correct such an incident before the identification of the incident by the Division; or

(4) Implement a contingency plan if permanent action to correct such an incident has not been undertaken.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.155 Applicability; exemptions from compliance. (NRS 439.200, 652.123, 652.125, 652.130)

1. Except as otherwise provided in this section and NRS 652.071, the provisions of this chapter:

(a) Apply to:

(1) A laboratory which is licensed pursuant to NRS 652.080 and which provides services to the public; and

(2) A nonexempt laboratory which is registered pursuant to NAC 652.175; and

(b) Do not apply to:

(1) An exempt laboratory which:

(I) Is licensed pursuant to chapter 652 of NRS; and

(II) Pays the applicable fees required by NAC 652.488;

(2) An HIV testing laboratory which:

(I) Is licensed pursuant to chapter 652 of NRS; and

(II) Pays the applicable fees required by NAC 652.488; or

(3) A laboratory which is registered as exempt pursuant to NAC 652.175.

2. Except as otherwise provided in subsection 3, a person who is employed by a laboratory that is licensed by or registered with the Division pursuant to chapter 652 of NRS may perform a test without complying with the provisions of this chapter if:

(a) The test has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; and

(b) The director, a designee of the director or a licensed physician at the laboratory at which the test is performed:

(1) Verifies that the person is competent to perform the test;

(2) Ensures that the test is performed in accordance with instructions of the manufacturer of the test; and

(3) Validates and verifies the manner in which the test is performed by using controls which ensure that the results of the test will be accurate and reliable.

3. Except as otherwise provided in subsection 4, the provisions of subsection 2 do not relieve a person who performs a test from the requirement to:

(a) Comply with the policies and procedures that the director of the laboratory at which the test is performed has established pursuant to NAC 652.280;

(b) Comply with the laboratory safety guidelines adopted by the laboratory pursuant to NAC 652.291; or

4. An advanced practice registered nurse as defined in NRS 632.012 or a physician assistant as defined in NRS 630.015 who is employed by a laboratory that is licensed by or registered with the Division pursuant to chapter 652 of NRS and who has not received certification pursuant to NAC 652.470 may perform a test without complying with the provisions of this chapter if the test:

(a) Has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; or

(b) Is a provider-performed microscopy procedure categorized pursuant to 42 C.F.R. § 493.19.

5. Except as otherwise provided in this subsection, a person may perform a test for the detection of the human immunodeficiency virus that is classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A, without complying with the provisions of this chapter if he or she complies with NRS 652.186. This subsection does not apply to a person who holds a license or certification issued pursuant to this chapter or a license or certification described in NRS 652.210.

6. As used in this section, “licensed physician” includes:

(a) A physician licensed as a doctor of medicine pursuant to chapter 630 of NRS;

(b) A physician licensed as a doctor of osteopathic medicine pursuant to chapter 633 of NRS;

(d) A podiatric physician licensed pursuant to chapter 635 of NRS.

(Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R177-97, 1-30-98; R078-04, 8-5-2004; R176-07, 1-30-2008; R149-15, 6-21-2017)

NAC 652.156 Exemption from provisions of chapter for director of HIV testing laboratory. (NRS 439.200, 652.123, 652.125, 652.130) Except as otherwise provided in NAC 652.398, the provisions of this chapter, including, without limitation, any requirement to perform duties other than those prescribed in NRS 652.180, do not apply to the director of an HIV testing laboratory.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

LICENSING AND REGISTRATION

NAC 652.157 Applications: Must include alternate method of contact; exemptions; requirement to notify Division of change to information; grounds for disciplinary action. (NRS 439.200, 652.090, 652.123, 652.125, 652.220, 652.260)

1. In addition to any applicable statutory or regulatory requirements, an application submitted pursuant to this chapter or chapter 652 of NRS must include a method by which the Division may communicate with the applicant other than by telephone or mail, which may include, without limitation, an electronic mail address or a telephone number that will accept electronic mail. The Division may exempt an applicant from the requirements of this subsection if the applicant attests that no additional methods of communication are feasible for the applicant and acknowledges that mail is the only means by which to communicate with the applicant.

2. A person who files an application for any license or certification as a laboratory director or laboratory personnel or who is licensed or certified as a laboratory director or laboratory personnel pursuant to NAC 652.380 to 652.486, inclusive, shall notify the Division of any change to the information contained in the application within 30 days after the change. Such notice may be provided in writing, by electronic mail or by any other method authorized by the Division. The failure of an applicant to comply with the requirements of this subsection constitutes grounds for disciplinary action that may include, without limitation:

(a) Denial of the application;

(b) Suspension or revocation of the applicant’s license or certificate;

(c) The imposition of a monetary penalty equal to the monetary penalty imposed for a violation of severity level two pursuant to NAC 652.550; and

(d) Any combination of the disciplinary actions described in paragraphs (a), (b) and (c).

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.161 Conditions under which notice deemed sufficient. (NRS 439.200, 652.130, 652.220, 652.225, 652.260) Any notice that is required to be provided to a licensee, certificate holder or applicant for a license or certificate pursuant to this chapter or chapter 652 of NRS shall be deemed sufficient if the notice is sent to the last address or electronic mail address that was provided to the Division by the licensee, certificate holder or applicant.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.170 Laboratory: Application for license or registration; action by Division on application; proof of identity of laboratory director to be provided with application. (NRS 439.200, 652.090, 652.130)

1. An application for a license or registration for a laboratory must be made on a form provided by the Division. Upon receipt of a completed application, the Division shall conduct an inspection of the facility which may include an examination of the policies and procedures of the laboratory to determine whether the laboratory is in substantial compliance with this chapter for the procedures for testing that the laboratory desires to provide.

2. The Division shall notify the applicant of the disposition of the application within 30 days after receipt of the application.

3. The laboratory director shall include at least one of the following forms of proof of identity with the application:

(a) An electronic signature;

(b) A notarized statement;

(c) A copy of a form of government-issued identification, which may include, without limitation, a driver’s license, passport, identification card issued by the Department of Motor Vehicles or other government-issued identification acceptable to the Division; or

(d) Other proof of identity acceptable to the Division.

4. As used in this section, “electronic signature” means a user name attached to or logically associated with a record and executed or adopted by an applicant with the intent to sign an electronic application or other document.

[Bd. of Health, Medical Laboratories Reg. §§ 2.1-2.1.5, eff. 8-5-74] — (NAC A 10-17-86; 1-4-88; 10-22-93; R078-04, 8-5-2004; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.175 Laboratory operated by licensed physician: Registration as exempt or nonexempt laboratory. (NRS 439.200, 652.123, 652.130)

1. A laboratory operated by a licensed physician pursuant to NRS 652.072 must register with the Division as an exempt laboratory or a nonexempt laboratory.

2. A laboratory operated by a licensed physician pursuant to NRS 652.072 may register with the Division as an exempt laboratory if:

(a) The operating physician submits an application for registration as an exempt laboratory on a form provided by the Division;

(b) The operating physician pays the applicable fees set forth in NAC 652.488;

(c) Each test performed by personnel other than the physician has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A; and

(d) Either:

(1) The operating physician performs tests on his or her own patients and makes his or her own readings of the results of the tests; or

(2) Any manipulation of a person for the collection of a specimen is made by an employee of the laboratory who is qualified pursuant to NRS 652.210.

3. A laboratory operated by a licensed physician pursuant to NRS 652.072 may register with the Division as a nonexempt laboratory if:

(a) The operating physician submits an application for registration as a nonexempt laboratory on a form provided by the Division;

(b) The operating physician is licensed as a director and pays the applicable fees set forth in NAC 652.488;

(c) At least some tests performed by personnel other than the physician have not been classified as waived tests pursuant to 42 C.F.R. Part 493, Subpart A; and

(d) Either:

(1) The operating physician or an employee of the laboratory performs tests on the patients of the physician and the physician or the employee of the laboratory makes his or her own readings of the results of the tests; or

(2) Any manipulation of a person for the collection of a specimen is made by an employee of the laboratory who is qualified pursuant to NRS 652.210.

4. As used in this section, “licensed physician” includes:

(a) A physician licensed as a doctor of medicine pursuant to chapter 630 of NRS;

(b) A physician licensed as a doctor of osteopathic medicine pursuant to chapter 633 of NRS;

(d) A podiatric physician licensed pursuant to chapter 635 of NRS.

(Added to NAC by Bd. of Health by R078-04, eff. 8-5-2004; A by R176-07, 1-30-2008; R104-13, 3-28-2014)

NAC 652.180 Laboratory operated by licensed physician: Issuance and renewal of certificate of registration. (NRS 439.200, 652.130)

1. Except as otherwise provided in subsection 2, the Division shall issue a certificate of registration to each laboratory which registers with the Division pursuant to NRS 652.072. A certificate of registration issued pursuant to this section is effective for 2 years after the date of issuance.

2. The Division may issue one certificate of registration for any number of laboratories which test specimens to protect the public health if each laboratory:

(a) Is supervised by the Division or a health district; and

(b) Performs at least 1 but not more than 15 tests which are classified pursuant to 42 C.F.R. Part 493, Subpart A, as moderate complexity tests or waived tests.

3. An application for renewal of a certificate must be on a form provided by the Division.

4. The failure to apply for renewal within 30 days after a certificate expires will result in termination of the laboratory’s authority to operate in this State.

5. Upon acceptance of an application for renewal, the Division shall provide the laboratory with a new certificate of registration.

[Bd. of Health, Medical Laboratories Reg. §§ 2.2-2.2.5, eff. 8-5-74] — (NAC A 10-17-86; 3-28-96; R133-96, 4-17-98; R042-98, 5-18-98; R104-13, 3-28-2014)

NAC 652.195 Permit to operate laboratory at temporary location: Application; action on application; expiration. (NRS 439.200, 652.090, 652.130)

1. A licensed laboratory that wishes to collect specimens or perform tests, or both, at a location other than the location set forth in its license must obtain a permit to operate a laboratory at a temporary location.

2. An application for a permit to operate a laboratory at a temporary location must be:

(a) Made on a form provided by the Division;

(b) Submitted to the Division in the manner set forth in NAC 652.170; and

3. The Division shall notify an applicant of the disposition of an application within 30 days after receipt of a completed application.

4. A permit to operate a laboratory at a temporary location issued pursuant to this section expires 90 days after the effective date of the permit.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

NAC 652.200 Director’s license: Application. (NRS 439.200, 652.090, 652.125, 652.130) An application for a license as a director must be on a form provided by the Division, giving complete information as indicated, including educational background, experience and the identity of the laboratory to be directed.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.1.2.1-5.1.1.2.1.2, eff. 8-5-74] — (NAC A 10-17-86; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.210 Director’s license: Action on application. (NRS 439.200, 652.125, 652.130) A license as a director may be issued by the Division on behalf of the Board for those applicants who qualify for licensure under NAC 652.380 to 652.395, inclusive. The Division shall notify the applicant of the status of the application within 30 days after receipt of a completed application.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.1.2.2.1 & 5.1.1.2.2.2, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.220 Director’s license: Term. (NRS 439.200, 652.125) A license as a director is effective for 2 years after the date of issuance.

[Bd. of Health, Medical Laboratories Reg. § 5.1.1.2.3, eff. 8-5-74] — (NAC A 10-17-86; 3-28-96; R042-98, 5-18-98)

NAC 652.230 Director’s license: Renewal. (NRS 439.200, 652.125)

1. An application for renewal of a license as a director must be:

(a) Made on a form provided by the Division; and

(b) Accompanied by the appropriate fee for renewal.

2. The failure to apply for renewal within 30 days after a license expires will result in termination of the licensee’s authority to act as a director in this State.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.1.2.4.1 & 5.1.1.2.4.2, eff. 8-5-74] — (NAC A 10-17-86; 3-28-96; R104-13, 3-28-2014)

NAC 652.240 Director’s license: Nontransferable; duplicates. (NRS 439.200, 652.125) A license as a director is not transferable. A duplicate of a license as a director may be obtained from the Division for each laboratory served.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.1.2.5.1 & 5.1.1.2.5.2, eff. 8-5-74] — (NAC A 10-17-86; R104-13, 3-28-2014)

OPERATION AND PERSONNEL

NAC 652.280 Duties of director: Health and safety; physical premises and environmental conditions. (NRS 439.200, 652.123, 652.130) A director shall ensure that:

1. Policies and procedures are established and enforced to ensure the health, welfare and safety of the personnel of the laboratory and visitors.

2. The physical premises and environmental conditions of the laboratory:

(a) Are appropriate for the testing performed; and

(b) Provide a safe environment in which employees are protected from biological, chemical and physical hazards.

3. The laboratory is adequately ventilated, with temperatures controlled within the requirements of the tests performed.

4. Showers and eyewashes are provided where necessary for safety.

[Bd. of Health, Medical Laboratories Reg. §§ 3.5-3.5.1.8, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93)

NAC 652.282 Duties of director: Testing procedures and results. (NRS 439.200, 652.123, 652.130, 652.135) A director shall ensure that:

1. The testing systems developed and used for each of the tests performed in the laboratory result in services of high quality for the analytic phase of each test and any activities conducted before and after that phase.

2. Acceptable levels of analytical performance are established and maintained for each testing system.

3. The methodology selected for each test yields results of a sufficient quality to provide for the care of patients.

4. The procedures used for the verification of testing methods are adequate to determine the accuracy, precision and other pertinent characteristics of performance for those methods.

5. Testing is performed in such a manner as required by federal and state statute and regulation, and any policies and protocols adopted by the laboratory.

6. The reports of testing results include the pertinent information required to interpret those results.

7. Programs of quality control and quality assurance are established and maintained to ensure the quality of the laboratory’s services and to identify any failure of quality when it occurs, and that records of such programs are maintained by the laboratory for at least 2 years.

8. Whenever there is a significant deviation from the laboratory’s established specifications for performance:

(a) Any necessary remedial action is taken and documented; and

(b) The results of patients’ tests are not reported until the deviation is corrected.

(Added to NAC by Bd. of Health, eff. 10-22-93; A by R177-97, 1-30-98)

NAC 652.284 Duties of director: Program for proficiency testing. (NRS 439.200, 652.123, 652.130, 652.260) A director shall ensure that:

1. The laboratory is enrolled in a program for proficiency testing regarding all the testing performed by the laboratory.

2. All procedures of the program are followed, including:

(a) The testing of samples as required; and

(b) The return of results within the required time.

3. Corrective action, which is approved by the Division, is performed if any results are found to be unacceptable or unsatisfactory.

4. The maintenance of documentation to verify that all reports received regarding the program are reviewed by appropriate members of the staff for evaluation of the performance of the laboratory and identification of any problems requiring corrective action.

5. If the laboratory fails to perform satisfactorily in two consecutive testing events or two out of three testing events for a procedure, and thereafter fails to perform that procedure satisfactorily in one or more subsequent testing events, the laboratory ceases to perform that procedure until it demonstrates to the satisfaction of the Division that the violations of the laboratory have been corrected in such a manner as to ensure that they will not recur.

(Added to NAC by Bd. of Health, eff. 10-22-93; A by R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.286 Duties of director: Personnel. (NRS 439.200, 652.123, 652.130) A director shall ensure that:

1. The laboratory employs a sufficient number of personnel, with the appropriate education and appropriate experience or training, to perform tests and report the results accurately.

2. Before the laboratory tests the specimen of any patient, all the personnel of the laboratory:

(a) Have the appropriate education and experience, and receive the appropriate training, for the type and complexity of services offered by the laboratory; and

(b) Demonstrate their abilities reliably to perform all testing procedures in such a manner as to obtain and report accurate results.

3. Policies and procedures are established for monitoring personnel who perform the analytic phase of each test, and any activities conducted before and after that phase, to:

(a) Ensure that they are competent, and maintain their competency, to process specimens, perform testing procedures, and report the results promptly and proficiently; and

(b) Identify any need for remedial training or continuing education to improve their skills.

4. A manual of the appropriate and current methods and procedures used in the laboratory, which is approved in writing by the director, is available to all personnel responsible for any aspect of the testing process.

5. The duties and responsibilities of:

(a) Every person who acts as a consultant to the laboratory; and

(b) Every person engaged in the performance of the analytic phase of each test and any activities conducted before and after that phase,

Ê are specified in writing.

6. Protocols specify the examinations and procedures each person is authorized to perform, and the supervision of the person required before the results of a patient’s test may be reported.

7. A qualified pathologist reviews all abnormal cytologic slides within 3 days after their initial screening.

(Added to NAC by Bd. of Health, eff. 10-22-93)

NAC 652.291 Laboratory safety guidelines: Adoption; required procedures; manufacturer’s guidelines; training and evaluation of employees; notification to employees upon adoption. (NRS 439.200, 652.090, 652.130)

1. A laboratory must adopt nationally recognized laboratory safety guidelines that must include, without limitation, infection control guidelines to be followed by employees of the laboratory. Acceptable guidelines include, without limitation, the Guidelines for Environmental Infection Control in Health-Care Facilities published by the Centers for Disease Control and Prevention of the United States Department of Health and Human Services, the Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories published by the Centers for Disease Control and Prevention of the United States Department of Health and Human Services and Laboratory Safety Guidance published by the Occupational Safety and Health Administration of the United States Department of Labor. The guidelines adopted pursuant to this section must prescribe procedures for safe operation of the laboratory, including, without limitation:

(a) Hand hygiene;

(b) The disposal of all waste that constitutes a biohazard, including, without limitation, needles, syringes, medical waste, microbial waste and specimens;

(d) The proper sterilization and disinfection of all reusable equipment, if such sterilization or disinfection is performed at the laboratory or by employees of the laboratory.

2. The director of the laboratory shall make a copy of the guidelines adopted by the laboratory available to all employees.

3. Each employee of a laboratory shall follow the manufacturer’s guidelines for the use and maintenance of equipment, devices and supplies. The director of a laboratory shall make the manufacturer’s guidelines available to each employee who uses or maintains the equipment, devices and supplies.

4. Each employee of a laboratory who has exposure to patients or patient specimens or participates in the disinfection or sterilization of equipment at the laboratory must receive training and must be evaluated by a supervisor on the employee’s knowledge and skills concerning the infection control guidelines adopted pursuant to subsection 1 within 10 working days after commencing employment and at least once each year thereafter.

5. If a laboratory that has adopted infection control guidelines pursuant to subsection 1 adopts new or additional guidelines, the laboratory must notify each employee of the laboratory who has exposure to patients or patient specimens or participates in the disinfection or sterilization of equipment at the laboratory of the change and provide instruction to each such employee concerning the new guidelines within 10 working days after adopting the new guidelines.

6. As used in this section, “employee” includes, without limitation, any person providing services pursuant to a contract.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.300 Request or authorization for test; report of findings; required contents of request. (NRS 439.200, 652.123, 652.130)

1. Except as otherwise provided in subsection 3, if a specimen is received by the laboratory, it must be accompanied by an authorized written request or a computerized authorization.

2. If the laboratory receives specimens referred from another laboratory, it shall report the results to the laboratory submitting the specimens.

3. Verbal requests from authorized persons may be accepted by the laboratory with proper verification. The laboratory shall obtain an authorized written request or a computerized authorization to supplement a verbal request within 30 days after the laboratory accepted the verbal request.

4. Each request must contain the following information:

(a) The full name of or a number which identifies the person from whom the specimen was taken.

(b) The name of the licensed physician, other authorized person or clinical laboratory that submitted the specimen.

(d) The type of test or specific test required.

[Bd. of Health, Medical Laboratories Reg. §§ 3.5.3-3.5.3.4, eff. 8-5-74] — (NAC A 10-17-86; R177-97, 1-30-98; R176-07, 1-30-2008)

NAC 652.310 Record of accessions of specimens: Maintenance; content. (NRS 439.200, 652.123, 652.130, 652.135)

1. A laboratory must maintain a daily record of accessions of specimens, each of which must be numbered or otherwise appropriately identified.

2. Daily records of accessions of specimens must:

(a) Be maintained in accordance with 42 C.F.R. Part 493; and

(b) Include the following information:

(1) A number that uniquely identifies each specimen, including, without limitation, an accession number or a number which identifies the person from whom the specimen was taken.

(2) The date and time each specimen was received by the laboratory.

(3) The condition and disposition of each specimen that does not meet the laboratory’s criteria for the acceptability of specimens.

(4) The date on which each specimen is tested.

(5) The identity of the person who performs each test.

[Bd. of Health, Medical Laboratories Reg. §§ 3.5.4-3.5.4.2.4, eff. 8-5-74] — (NAC A 10-17-86; R177-97, 1-30-98)

NAC 652.320 Inspections: Duties and authority of Division; submission of plan for correction of violations. (NRS 439.200, 652.123, 652.130, 652.220, 652.225, 652.260)

1. Except as otherwise provided in this subsection, the Division shall inspect periodically the premises and operation of each laboratory, including, without limitation, the premises of an outpatient center of the laboratory, if any. A laboratory that is subject to inspection by an accrediting organization approved by the Centers for Medicare and Medicaid Services of the United States Department of Health and Human Services pursuant to 42 C.F.R. §§ 493.551 to 493.575, inclusive, is not required to be inspected periodically by the Division if the reports of the inspections are available to the Division.

2. Upon receipt of a complaint against a laboratory or its personnel, except for a complaint concerning the cost of services, the Division may conduct an investigation into the premises, qualifications of personnel, methods of operation, policies, procedures and records of that laboratory or any other laboratory which may have information pertinent to the complaint.

3. The Division shall report violations noted at the time of each inspection by providing the director, or the director’s designee, with a statement of violations, which must include the severity level for the violation as determined by the Division, and a form for the director to submit a plan of correction. Any violation for which a severity level is not specified in the statement of violations is presumed to be a violation of severity level one. The director shall submit the plan of correction to the Division, containing thereon the plan of correction for each of the violations, within 14 days after receiving the form. The plan must indicate the date by which each violation will be corrected.

4. Failure to submit the plan of correction timely pursuant to subsection 3 to the Division constitutes a separate violation subject to monetary penalties with a severity level rated at the same level as the highest violation identified on the statement of violations.

[Bd. of Health, Medical Laboratories Reg. §§ 3.2-3.3, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R135-99, 11-29-99; R078-04, 8-5-2004; R176-07, 1-30-2008; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.325 Violations: Severity levels. (NRS 439.200, 652.123, 652.130, 652.260)

1. The severity scale set forth in this section must be used to assess the severity of a particular violation pertaining to the laboratory. The basis for the assessment must be the actual or potential harm to patients.

2. Violations of severity level one concern requirements promulgated primarily for administrative purposes. No harm is likely to occur to a patient. No negative patient impact has occurred or is likely to occur.

3. Violations of severity level two indirectly threaten the health, safety, rights, security, welfare or well-being of a patient. A potential for harm, as yet unrealized, exists. If continued over time, a negative impact on one or more patients or a violation of one or more patients’ rights would occur or would be likely to occur.

4. Violations of severity level three create a condition or incident in the operation or maintenance of a laboratory that directly or indirectly threatens the health, safety, rights, security, welfare or well-being of one or more patients. A negative impact on the health, safety, rights, security, welfare or well-being of one or more patients has occurred or can be predicted with substantial probability to occur.

5. Violations of severity level four create a condition or incident that has resulted in or can be predicted with substantial probability to result in death or serious harm to a patient. As used in this subsection, “serious harm” means serious mental harm, serious impairment of bodily functions, serious dysfunction of any bodily organ or part, life-threatening harm or death.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.340 Reports by laboratory: Contents; terminology; retention of copies. (NRS 439.200, 652.123, 652.130, 652.135)

1. A report by the laboratory to the source requesting the report must include, without limitation, the following:

(a) The full name of or a number which identifies the person from whom the specimen was taken.

(b) The name and address of the reporting laboratory.

(d) The condition of a specimen if considered unsatisfactory on receipt, for example, broken, leaked, hemolyzed or turbid.

(e) The type of test or specific test performed.

(f) The result of the test.

(g) The date of the test.

(h) If the specimen is sent to a reference laboratory for testing, the identity of the reference laboratory.

2. A report on tissue must be written using acceptable and standardized terminology.

3. Duplicate copies or a suitable record of all reports by a laboratory must be maintained by the laboratory in accordance with 42 C.F.R. Part 493 and in a manner which allows ready identification and accessibility.

[Bd. of Health, Medical Laboratories Reg. §§ 3.6-3.6.6, eff. 8-5-74] — (NAC A 10-17-86; R177-97, 1-30-98; R176-07, 1-30-2008)

NAC 652.342 Point-of-care testing device: Limitations on use. (NRS 439.200, 652.123, 652.130) A point-of-care testing device may be used only:

1. If the device:

(a) Performs tests on biological specimens that require no preparation after collection; and

(b) Provides testing results directly from the device without calculation or discretionary intervention by the testing personnel during the preanalytic and postanalytic phases of the test.

2. Within a medical facility that is licensed pursuant to chapter 449 of NRS and has a laboratory that is licensed pursuant to chapter 652 of NRS.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.344 Point-of-care testing device: Requirements for use. (NRS 439.200, 652.123, 652.130) A point-of-care testing device must be used:

1. In accordance with the testing management system and programs of quality control and quality assurance established by the laboratory performing the point-of-care test;

2. In accordance with the instructions of the manufacturer of the device; and

3. By qualified personnel under the supervision of a director.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.346 Point-of-care testing device: Persons qualified to use. (NRS 439.200, 652.123, 652.130) To be qualified to use a point-of-care testing device, a person must be licensed or certified as a:

1. Director;

2. General supervisor;

3. Clinical laboratory technologist;

4. Medical technician;

5. Blood-gas technologist;

6. Blood-gas technician;

7. Technologist;

8. Technician; or

9. Point-of-care test analyst.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.348 Applicability of NAC 652.342, 652.344 and 652.346. (NRS 439.200, 652.123, 652.130) The provisions of NAC 652.342, 652.344 and 652.346 do not apply to a licensed nurse or licensed or certified personnel of a laboratory performing a point-of-care test under the circumstances set forth in NRS 652.217.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.350 Personnel: General requirements. (NRS 439.200, 652.123, 652.125, 652.130)

1. A laboratory shall establish:

(a) Written policies and practices for personnel that encourage sound practice in a laboratory.

(b) A written program for the orientation of employees.

2. A laboratory shall maintain:

(a) Current records on each employee, which include documentation of each employee’s training, experience and continuing education.

(b) A health record for each employee, including the results of any physical examinations and tests performed by a laboratory which are required by the employer.

3. For each licensed laboratory other than a specialty laboratory, at least one member of the technical staff must have the qualifications set forth in NAC 652.420 for a clinical laboratory technologist. At least one such technologist must be certified, in accordance with NAC 652.410, as a general supervisor unless the director or a physician associated with the laboratory is so designated.

4. For each specialty laboratory, at least one member of the technical staff must be a technologist qualified in the appropriate specialty, except that a specialty laboratory in a rural area may, with the approval of the Division, instead employ a clinical laboratory technologist. At least one such technologist must be certified, in accordance with NAC 652.410, as a general supervisor unless the director or a physician associated with the laboratory is so designated.

5. As used in this section, “specialty laboratory” means a laboratory designated by the Division which specializes in histology, cytology, blood gases, nuclear medicine or another specialty.

[Bd. of Health, Medical Laboratories Reg. §§ 4.1-4.1.5.2, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R104-13, 3-28-2014)

NAC 652.370 Director: Availability and presence; prohibition against serving more than five laboratories; exception. (NRS 439.200, 652.123, 652.130)

1. A director shall be available to the personnel of a laboratory, in person or by telephone or other electronic means, for any necessary consultation.

2. The director must be on the premises of the laboratory at least once each month. If the director is absent from the laboratory for 1 month or more, the director shall provide a licensed substitute to serve in his or her place, unless the laboratory is in a rural area and the Division determines that a substitute is not necessary.

3. Except as otherwise provided in this subsection, a natural person shall not simultaneously serve as director of more than five laboratories. A natural person may simultaneously serve as director of more than five laboratories if the laboratories are registered under one certificate pursuant to subsection 2 of NAC 652.180.

[Bd. of Health, Medical Laboratories Reg. §§ 4.2-4.2.2.4, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R133-96, 4-17-98; R104-13, 3-28-2014)

NAC 652.380 Director of licensed laboratory: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130) Except as otherwise provided in NAC 652.383, to qualify for a license as a director of a licensed laboratory, a person must meet one of the following qualifications:

1. Be a physician who is licensed to practice medicine in this State and:

(a) Be certified in anatomical and clinical pathology, or in clinical pathology, by:

(1) The American Board of Pathology; or

(2) The American Osteopathic Board of Pathology;

(b) Possess qualifications which are equivalent to those required for certification by either of the institutions listed in paragraph (a);

(c) Within the 10 years immediately preceding application for a license, have successfully completed a 4-year program accredited by the National Accrediting Agency for Clinical Laboratory Sciences;

(d) Be certified, in accordance with NAC 652.410, as a general supervisor; or

(e) Have at least 4 years of experience as a technologist:

(1) In a licensed laboratory or a laboratory of a hospital, health department or university;

(2) As a full-time employee working at least 30 hours per week; and

(3) Under the supervision of a director who possesses a doctoral degree.

2. Hold an earned doctoral degree from an accredited institution, with a chemical, physical, biological or clinical laboratory science as the major, and:

(a) Be certified by:

(1) The American Board of Medical Microbiology;

(2) The American Board of Clinical Chemistry;

(3) The American Board of Bioanalysis;

(4) The American Board of Medical Laboratory Immunology;

(5) The American Board of Forensic Toxicology;

(6) The American Board of Medical Genetics and Genomics;

(7) The National Registry of Certified Chemists;

(8) The American Board of Histocompatibility and Immunogenetics; or

(9) Any other institution approved by the United States Department of Health and Human Services in accordance with 42 C.F.R. § 493.1443(b)(3); or

(b) Possess qualifications which are equivalent to those required for certification by any of the institutions listed in paragraph (a).

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.1-5.1.1.1.4, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R078-04, 8-5-2004; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.383 Director of licensed laboratory testing in oral pathology: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130) To qualify for a license as a director of a licensed laboratory in which the only tests performed are in the subspecialty of oral pathology, a person must be:

1. Certified by the American Board of Oral and Maxillofacial Pathology, the American Board of Pathology or the American Osteopathic Board of Pathology; and

2. A dentist licensed to practice dentistry in this State or a physician licensed to practice medicine in this State.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.385 Director of licensed laboratory testing for pulmonary conditions: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a license as a director of a licensed laboratory testing for pulmonary conditions, a person must:

(a) Be a physician certified in the subspecialty of pulmonary disease by the:

(1) American Board of Internal Medicine; or

(2) Any other nationally recognized board of internal medicine acceptable to the Division; or

(b) In a geographical area which does not have a person who meets the qualifications set forth in paragraph (a), be a physician licensed to practice in this State, whose experience is acceptable to the Division.

2. As used in this section, “physician” means a physician licensed pursuant to chapter 630 or 633 of NRS.

(Added to NAC by Bd. of Health, eff. 10-17-86; A by R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.395 Director of registered laboratory: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130) To qualify for a license as a director of a registered laboratory, a person must:

1. Be a physician licensed to practice in this State and have:

(a) At least 1 year of experience directing or supervising laboratory testing in a laboratory which meets the requirements of NAC 652.170 to 652.600, inclusive;

(b) Credit for at least 20 hours of continuing medical education in laboratory practice regarding the responsibilities of a director; or

2. Hold an earned doctoral degree from an accredited institution, with a major in chemical, physical, biological or clinical laboratory science, and:

(a) Have at least 1 year of experience directing or supervising laboratory testing in a laboratory which meets the requirements of NAC 652.170 to 652.600, inclusive;

(b) Be certified by:

(1) The American Board of Medical Microbiology;

(2) The American Board of Bioanalysis;

(3) The American Board of Medical Laboratory Immunology;

(4) The American Board of Clinical Chemistry;

(5) The American Board of Forensic Toxicology;

(6) The American Board of Medical Genetics and Genomics;

(7) The National Registry of Certified Chemists;

(8) The American Board of Histocompatibility and Immunogenetics; or

(9) Any other institution approved by the United States Department of Health and Human Services in accordance with 42 C.F.R. § 493.1443(b)(3); or

(c) Possess qualifications which are equivalent to those required for certification by any of the institutions listed in paragraph (b).

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93; R078-04, 8-5-2004; R149-15, 6-21-2017)

NAC 652.397 Director of exempt laboratory: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130)

1. Except as otherwise provided in subsection 2 and NAC 652.395, to qualify to serve as a director of an exempt laboratory, a person must be:

(a) A licensed physician;

(b) Qualified for a license as a director of a licensed laboratory pursuant to NAC 652.380;

(d) An advanced practice registered nurse licensed pursuant to chapter 632 of NRS;

(e) A physician assistant licensed pursuant to chapter 630 or 633 of NRS;

(f) A general supervisor of a licensed laboratory certified in accordance with NAC 652.410; or

(g) A clinical laboratory technologist certified in accordance with NAC 652.420.

2. To qualify to serve as a director of an exempt laboratory in which the only tests performed are glucose tests that are classified as waived tests pursuant to 42 C.F.R. Part 493, Subpart A, a person must be:

(a) A person identified in subsection 1;

(b) A nurse licensed pursuant to chapter 632 of NRS;

(d) A person licensed or certified pursuant to chapter 652 of NRS, other than a certified blood-gas assistant, certified laboratory assistant or certified office laboratory assistant.

3. As used in this section, “licensed physician” includes:

(a) A physician licensed as a doctor of medicine pursuant to chapter 630 of NRS;

(b) A physician licensed as a doctor of osteopathic medicine pursuant to chapter 633 of NRS;

(d) A podiatric physician licensed pursuant to chapter 635 of NRS.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

NAC 652.398 Director of HIV testing laboratory: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130) To qualify to serve as a director of an HIV testing laboratory, a person must:

1. Possess the technical and managerial skills necessary to perform the duties of a laboratory director set forth in NRS 652.180; and

2. Satisfy the requirements set forth in NRS 652.186 to perform a test for the detection of the human immunodeficiency virus that is classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A.

(Added to NAC by Bd. of Health by R149-15, eff. 6-21-2017)

NAC 652.400 General supervisor of licensed laboratory: Duties. (NRS 439.200, 652.123)

1. The general supervisor of a licensed laboratory shall oversee the technical and administrative functions of the laboratory and may supervise other personnel, as assigned by the director.

2. The general supervisor shall be on the premises during all hours in which routine tests are being performed. The presence of the supervisor is not required during the performance of emergency testing procedures after scheduled work hours, but he or she shall review these procedures during his or her next period of duty.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.2.1-5.1.2.1.2.2, eff. 8-5-74] — (NAC A 10-17-86)

NAC 652.410 General supervisor of licensed laboratory: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a certificate as a general supervisor of a licensed laboratory, a person must, except as otherwise provided in this section, be:

(a) A qualified physician serving on behalf of the director; or

(b) A clinical laboratory technologist who has had at least 3 years of experience in a laboratory as a full-time employee working at least 30 hours per week, of which at least 2 years have been spent working:

(1) In a licensed laboratory or a laboratory of a hospital, university or health department; and

(2) Under the supervision of a director who possesses a doctoral degree.

2. A technologist certified by the Board in a specialty who has had at least 3 years of experience in a laboratory as a full-time employee working at least 30 hours per week, of which at least 2 years have been spent working:

(a) In a licensed laboratory or a laboratory of a hospital, university or health department; and

(b) Under the supervision of a director who possesses a doctoral degree,

Ê qualifies for a certificate as a general supervisor of a licensed laboratory if the tests performed in the laboratory are solely in his or her specialty.

3. A person who possesses a doctoral degree from an accredited institution with a major in chemical, physical or biological science and who has had at least 1 year of experience in a licensed laboratory or a laboratory of a hospital, university or health department as a full-time employee working for at least 30 hours per week under the supervision of a director who possesses a doctoral degree qualifies for a certificate as a general supervisor of a licensed laboratory.

4. A person who possesses a master’s degree from an accredited institution with a major in chemical, physical or biological science and who has had at least 2 years of experience in a licensed laboratory or a laboratory of a hospital, university or health department as a full-time employee working at least 30 hours per week under the supervision of a director who possesses a doctoral degree qualifies for a certificate as a general supervisor of a licensed laboratory.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.2.1.3-5.1.2.1.3.3, eff. 8-5-74] — (NAC A 10-17-86; 8-1-91; 10-22-93; R078-04, 8-5-2004; R176-07, 1-30-2008)

NAC 652.420 Clinical laboratory technologist: Activities and qualifications. (NRS 439.200, 652.123, 652.125, 652.130)

1. A clinical laboratory technologist may:

(a) Perform tests which require the exercise of independent judgment, under minimum supervision or review by the director or general supervisor, in those specialties for which the technologist has had adequate education, training and experience and in which he or she has demonstrated a proficiency; and

(b) Supervise, if necessary, the work of the medical technicians and laboratory assistants.

2. To qualify for a certificate as a clinical laboratory technologist, a person must:

(a) Successfully complete a full course of study which meets all academic requirements for a bachelor’s degree in medical technology from an accredited college or university, and pass a national examination for certification approved by the Board;

(b) Successfully complete a course of study for a bachelor’s degree in one of the chemical, physical or biological sciences at an accredited college or university, have at least 1 year of additional full-time experience or training in a licensed laboratory, or laboratory of a hospital, health department or university in the specialty or subspecialty in which the person performs tests, and pass a national examination for certification approved by the Board; or

(c) Pass the examination for clinical laboratory technologists given by the United States Department of Health and Human Services.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.2.2-5.1.2.2.2.4, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R078-04, 8-5-2004; R176-07, 1-30-2008; R149-15, 6-21-2017)

NAC 652.425 Cytotechnologist: Qualifications and activities. (NRS 652.123, 652.125, 652.130)

1. To qualify for a certificate as a cytotechnologist, a person must:

(a) Successfully complete 2 years in an accredited college or university with at least 12 semester hours in science, of which 8 hours are in biology, and at least 12 months of training in an accredited school of cytotechnology, and pass a national examination for certification approved by the Board;

(b) Successfully complete 6 months of formal training in an accredited school of cytotechnology and 6 months of full-time, supervised experience in cytotechnology in a laboratory whose director is a pathologist, and pass a national examination for certification approved by the Board; or

2. A cytotechnologist may perform tests only in cytology under the review of the director.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93)

NAC 652.433 Histotechnologist: Qualifications and activities. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a certificate as a histotechnologist, a person must have:

(a) A baccalaureate degree from an accredited college or university with at least 32 semester hours in science, of which 12 hours are in chemistry and 16 hours are in the areas of general biology, histology, zoology, anatomy and physiology, and 1 year of experience in a histopathology laboratory under the supervision of a pathologist certified by the American Board of Pathology and Anatomic Pathology or a pathologist eligible to be certified in anatomic pathology;

(b) A baccalaureate degree from an accredited college or university, including the semester hours required in paragraph (a), and successfully completed a program on histotechnology certified by the Committee on Allied Health Education and Accreditation; or

(c) National certification as a histotechnologist and 8 years of full-time experience before August 1980, in an approved histopathology laboratory.

2. A histotechnologist may perform only those procedures, under the minimal review of the director or general supervisor, for which he or she has adequate education, training and experience and in which he or she has demonstrated a proficiency. The histotechnologist may supervise the work of histologic technicians and assistants.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93)

NAC 652.437 Histologic technician: Qualifications and activities. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a certificate as a histologic technician, a person must:

(a) Successfully complete a program in histotechnology certified by the Commission on Accreditation of Allied Health Education Programs;

(b) Have an associate degree in chemistry, biology or a physical science or successfully complete at least 60 semester hours or the equivalent of academic credit from an accredited college or university with at least 12 semester hours in science, of which 6 hours are in chemistry and 6 hours are in biology, and have 1 year of full-time experience in histotechnology in a histology laboratory under the supervision of a pathologist certified in anatomic pathology by the American Board of Pathology Incorporated or a pathologist eligible for certification in anatomic pathology; or

(c) Be a high school graduate or the equivalent and have 2 years of full-time experience in histotechnology, within the preceding 5 years, in a histology laboratory under the supervision of a pathologist certified in anatomic pathology by the American Board of Pathology Incorporated or a pathologist eligible for certification in anatomic pathology.

2. A histologic technician may only perform histologic procedures under the supervision of a histotechnologist or the director and may only perform cytologic procedures under the direction of a cytotechnologist, a histotechnologist or the director.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93; R149-15, 6-21-2017)

NAC 652.440 Medical technician: Activities and qualifications. (NRS 439.200, 652.123, 652.125, 652.130)

1. A medical technician may perform a test only if the test is classified pursuant to 42 C.F.R. Part 493, Subpart A, as:

(a) A waived test;

(b) A moderate complexity test; or

(1) The results of the test are read directly from an instrument; and

(2) The test requires no interpretation and no intervention by the operator of the test during its analytic phase.

2. To be certified as a medical technician, a person must pass a national examination for certification and must:

(a) Have an associate degree from an accredited institution as a medical technician or have successfully completed a program based on a course of study that includes chemistry, biology and a structural curriculum in techniques used in a laboratory;

(b) Have successfully completed 60 semester hours of academic credit, including chemistry, biology and a structured curriculum in techniques used in a laboratory, at an accredited institution;

(c) Be a high school graduate or the equivalent, have completed at least 1 year in a program for training technicians approved by the Board and have 3 years of experience in a laboratory within the preceding 5 years; or

(d) Be a high school graduate or the equivalent, have successfully completed an official 50-week course in procedures for a military laboratory and have been a medical laboratory specialist or laboratory technician in the military.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.2.4-5.1.2.4.2.3, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93)

NAC 652.443 Blood-gas technologist: Qualifications and activities. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a certificate as a blood-gas technologist, a person must:

(a) Have credentials from the National Board for Respiratory Care as a certified respiratory therapist; or

(b) Be certified by the National Board for Respiratory Care as a registered respiratory therapist.

2. A blood-gas technologist may only perform, under the minimal review of the director or general supervisor, those diagnostic and therapeutic procedures for which he or she has adequate education, training and experience and in which he or she has demonstrated a proficiency. The blood-gas technologist may supervise the work of blood-gas technicians and assistants.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93; R078-04, 8-5-2004)

NAC 652.447 Blood-gas technician: Qualifications and activities. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a certificate as a blood-gas technician, a person must:

(a) Be a graduate of a 1- or 2-year school of respiratory therapy or a school for cardiopulmonary technology accredited by the American Medical Association; or

(b) Successfully complete an equivalent course of training in the theory and practice of the determination of blood gases.

2. A blood-gas technician may only work under direct medical supervision and must be certified, in writing, by his or her medical supervisor as competent in drawing blood, including arterial puncture. The medical supervisor must be a blood-gas technologist or the director.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93)

NAC 652.450 Laboratory assistant; blood-gas assistant. (NRS 439.200, 652.123, 652.125, 652.130)

1. A laboratory assistant may perform any test that has been classified as a waived test pursuant to 42 C.F.R. Part 493, Subpart A, and may collect and process specimens. Except as otherwise provided in NRS 652.217 and NAC 652.155, a laboratory assistant may not independently perform a laboratory test which is classified as a test of moderate or high complexity pursuant to 42 C.F.R. Part 493, Subpart A, but may assist manually under direct supervision.

2. A blood-gas assistant may work only under the constant direct supervision of a blood-gas technologist or the director. To be certified as a blood-gas assistant, a person must be a high school graduate or the equivalent who is currently being trained in the determination of blood gases.

[Bd. of Health, Medical Laboratories Reg. §§ 5.1.2.5-5.1.2.6.3.3, eff. 8-5-74] — (NAC A 10-17-86; 10-22-93; R135-99, 11-29-99; R104-13, 3-28-2014)

NAC 652.452 Pathologist’s assistant: Qualifications and activities. (NRS 439.200, 652.123, 652.125, 652.130)

1. To qualify for a certificate as a pathologist’s assistant, a person:

(a) Must successfully complete a training program approved by the American Association of Pathologists’ Assistants; or

(b) Must:

(1) Possess a baccalaureate degree with a major or minor in a biological science or an allied health field; and

(2) Have at least 3 years of combined experience in surgical pathology and autopsy pathology.

2. A pathologist’s assistant may, under the supervision of a pathologist, assist in preparing for, performing and reporting:

(a) Postmortem examinations; and

(b) Surgical specimen dissection.

(Added to NAC by Bd. of Health, eff. 10-22-93)

NAC 652.453 Pathologist’s assistant: Responsibilities of supervising pathologist. (NRS 439.200, 652.123) A pathologist:

1. Is responsible for all of the activities relating to pathology performed by any pathologist’s assistant he or she is supervising.

2. Shall ensure that any pathologist’s assistant he or she is supervising performs only those activities relating to pathology which the pathologist’s assistant is qualified to perform.

(Added to NAC by Bd. of Health, eff. 10-22-93)

NAC 652.454 Point-of-care test analyst: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130) To qualify for a certificate as a point-of-care test analyst, a person must:

1. Be a:

(a) Registered nurse as defined in NRS 632.019;

(b) Advanced practice registered nurse as defined in NRS 632.012;

(d) Practitioner of respiratory care as defined in NRS 630.023;

(e) Physician assistant as defined in NRS 630.015;

(f) Registered pharmacist as defined in NRS 639.015 who has participated in the development of written guidelines and protocols as described in subsection 8 of NRS 639.0124; or

(g) Certified laboratory assistant who has successfully completed training approved by a director in performing point-of-care tests; and

2. Provide verification from a director that the person has successfully completed training approved by a director in performing the preanalytic, analytic and postanalytic phases of point-of-care tests.

(Added to NAC by Bd. of Health by R057-99, eff. 9-27-99)

NAC 652.455 Continuing education: Prerequisites to renewal of license or certificate. (NRS 439.200, 652.123, 652.125, 652.130)

1. Each director, general supervisor, technologist, technician, pathologist’s assistant and point-of-care test analyst licensed or certified pursuant to this chapter shall complete 2 units of continuing education within the 2 years immediately preceding the application for renewal of the license or certificate. At least half of the total units of continuing education required must be from approved courses.

2. Each laboratory assistant or blood-gas assistant shall complete 1 unit of continuing education within the 2 years immediately preceding the application for renewal of his or her certificate.

(Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R042-98, 5-18-98; R057-99, 9-27-99)

NAC 652.461 Continuing education: Prerequisites to reinstatement of inactive or delinquent license or certificate; exception. (NRS 439.200, 652.123, 652.125, 652.130)

1. Except as otherwise provided in subsection 2:

(a) Any person desiring to have an inactive or a delinquent license or certificate reinstated shall submit evidence to the Division that he or she has completed 1 unit of continuing education within the 2 years immediately preceding the application for reinstatement of the license or certificate.

(b) An inactive or delinquent license or certificate may be conditionally reinstated without the evidence required by paragraph (a) if the applicant completes one unit of continuing education within a period established by the Division. Any failure to complete the continuing education or satisfy any other condition established by the Division is a ground for revocation of the license or certificate.

2. This section does not apply to a person certified as an office laboratory assistant or to such a certificate.

(Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.465 Continuing education: Proof of completion. (NRS 439.200, 652.123, 652.125, 652.130)

1. Each person who is required to complete a program of continuing education shall retain proof of completion of the course of study or training for 4 years after the completion of the course or training.

2. Proof of completion of an approved course must be provided by a transcript, certificate of completion or other document furnished by the organization which offered the course.

3. Proof of completion of an unapproved course must be provided by:

(a) An explanation, by the employer of the holder of a license or certificate issued pursuant to this chapter, of a seminar or workshop developed and presented by the holder of that license or certificate;

(b) A record of attendance at a workshop offered at the place of employment of the holder of a license or certificate issued pursuant to this chapter, or presented by a manufacturer or vendor of medical technology;

(d) A description of an exhibit prepared for a medical journal or meeting, including the number of hours spent in preparation of the exhibit.

4. A copy of the proof must be submitted to the Division upon request to verify the completion of the course or training by the holder of a license or certificate issued pursuant to this chapter.

(Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R104-13, 3-28-2014)

NAC 652.470 Certification of personnel. (NRS 439.200, 652.123, 652.125, 652.130)

1. Before working in a laboratory at any technical level:

(a) An application for certification must be made on a form provided by the Division giving information on the applicant’s educational background;

(b) Substantiating documents such as college or other academic transcripts or copies of certificates of registration should accompany the application, but must be submitted within 6 months after the date of the application;

(d) The fee prescribed in NAC 652.488 must accompany the application.

2. Temporary employment may be granted:

(a) For a period not exceeding 12 months while the application is being processed; or

(b) If the applicant has been issued a provisional certificate, until the expiration of the provisional certificate.

3. The Division shall issue the appropriate certificate on behalf of the Board when it is determined that all requirements for certification are satisfied.

4. A person may upgrade his or her certificate after completing the appropriate additional experience, training or academic requirements, or any combination thereof, by applying to the Division pursuant to subsection 1.

5. A person whose certification has lapsed for more than 5 years may reapply for certification by submitting an original application to the Division accompanied by the fee prescribed in NAC 652.488.

6. A person whose certification has lapsed for 5 years or less may reapply for certification by submitting an application for reinstatement to the Division accompanied by the fee prescribed in NAC 652.488.

7. A certificate will be placed in an inactive status upon the approval of the Division and payment of the fee prescribed in NAC 652.488.

[Bd. of Health, Medical Laboratories Reg. §§ 5.3-5.3.4.4.4, eff. 8-5-74] — (NAC A 9-6-88; 9-6-88; R042-98, 5-18-98; R078-04, 8-5-2004; R176-07, 1-30-2008; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.472 Minimal requirements for new employees. (NRS 439.200, 652.123, 652.125, 652.130) Technical personnel newly employed in a private registered laboratory must be certified as at least an office laboratory assistant. If the person requires training to reach that level, the prospective assistant must apply as an office laboratory trainee and perform those duties for not more than 6 months. Upon the recommendation of the office operator, the trainee shall formally apply for certification as an office laboratory assistant.

(Added to NAC by Bd. of Health, eff. 9-6-88)

NAC 652.474 Activities of certified personnel. (NRS 439.200, 652.123) Technical personnel certified pursuant to NAC 652.470 may participate in the performance of such tests in a licensed or registered laboratory as are commensurate with their qualifications.

(Added to NAC by Bd. of Health, eff. 9-6-88)

NAC 652.476 Renewal of certification. (NRS 439.200, 652.123, 652.125)

1. A person certified pursuant to NAC 652.470 who wishes to renew the certification must submit to the Division a completed form for renewal. The Division shall, not less than 90 days before the expiration of the certificate, provide to the holder of the certificate the proper form for renewal.

2. The form for renewal must include a request for information regarding the current residence of the person holding the certificate.

3. The form for renewal must be accompanied by the fee for renewal.

4. A certificate issued pursuant to this section is effective for 2 years after the date of issuance. Failure to apply for renewal within 30 days after the certificate expires will result in the termination of the holder’s authority to work in a laboratory at a technical level.

(Added to NAC by Bd. of Health, eff. 9-6-88; A 3-28-96; R042-98, 5-18-98; R104-13, 3-28-2014)

NAC 652.478 Technologists: Specialties; activities. (NRS 439.200, 652.123, 652.125, 652.130) A technologist may:

1. Be certified:

(a) In chemistry;

(b) In microbiology;

(d) In immunology;

(e) In immunohematology;

(f) In nuclear medicine;

(g) In histocompatibility;

(h) In histology;

(i) In cytology;

(j) As a biotechnologist; or

(k) In more than one of the specialties set forth in this subsection.

2. Perform a test in a specialty only if certified in that specialty.

(Added to NAC by Bd. of Health, eff. 10-22-93)

NAC 652.480 Technologists: Certification in specialty for which national examination is given; application for certification; designation on certificate. (NRS 439.200, 652.123, 652.125, 652.130)

1. Except as otherwise provided in NAC 652.483, to be certified by the Division in a specialty, a technologist must pass a national examination for certification in the specialty and must have successfully completed a course of study for a bachelor’s degree in one of the chemical, physical or biological sciences at an accredited college or university, and have at least 1 year of additional full-time experience or training in a licensed laboratory, or a laboratory of a hospital, health department or university, in the chosen specialty under the supervision of a director who possesses a doctoral degree.

2. Each applicant for certification in a specialty must designate on the application the specialty in which he or she desires to be certified. The applicant must submit with the application:

(a) Verification of successful completion of the course of study required by subsection 1; and

(b) A signed and dated letter from the director of the laboratory in which the applicant obtained his or her experience, which verifies that the applicant has the experience required by subsection 1.

3. Each certificate will designate the holder by:

(a) The title of “Technologist” in a specialty; or

(b) An equivalent title and will show his or her area of specialty by a subtitle.

[Bd. of Health, Medical Laboratories Reg. §§ 9.1, 9.2, 9.4 & 9.5, eff. 2-28-80; § 9.3, eff. 2-28-80; A 2-5-82] — (NAC A 10-17-86; 1-4-88; 10-22-93; R176-07, 1-30-2008; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.483 Technologists: Certification in specialty for which national examination is not given. (NRS 439.200, 652.123, 652.125, 652.130) The Division shall certify a technologist in a specialty for which a national examination is not given if he or she:

1. Has education and experience in the specialty which is acceptable to the Division;

2. Obtains a written recommendation of the proposed certification from a director licensed in this State who holds a doctoral degree; and

3. Has successfully completed a course of study for a bachelor’s degree in one of the chemical, physical or biological sciences at an accredited college or university, and has 1 year of experience in a licensed laboratory, or a laboratory of a hospital, health department or university, in the chosen specialty under the supervision of a director who possesses a doctoral degree.

(Added to NAC by Bd. of Health, eff. 1-4-88; A 10-22-93; R176-07, 1-30-2008; R104-13, 3-28-2014)

NAC 652.484 Technicians: Specialties; activities. (NRS 439.200, 652.123, 652.125, 652.130) A technician may:

1. Be certified:

(a) In microbiology;

(b) In clinical chemistry;

(d) In immunology;

(e) In nuclear medicine;

(f) In histocompatibility;

(g) In histology;

(h) As an autopsy assistant;

(i) As a biotechnician; or

(j) In more than one of the specialties set forth in this subsection.

2. Perform a test in a specialty only if:

(a) The technician is certified in that specialty; and

(b) The test is classified pursuant to 42 C.F.R. Part 493, Subpart A, as:

(1) A waived test;

(2) A moderate complexity test; or

(3) A high complexity test and:

(I) The results of the test are read directly from an instrument; and

(II) The test requires no interpretation and no intervention by the operator of the test during its analytic phase.

(Added to NAC by Bd. of Health, eff. 10-22-93)

NAC 652.485 Technicians: Certification in specialty; designation on certificate. (NRS 439.200, 652.123, 652.125, 652.130)

1. To be certified in a specialty by the Division, a technician must:

(a) Pass a national examination for certification in the specialty, if such an examination is given;

(b) Be a high school graduate or the equivalent; and

(1) Completed at least 1 year of a formal program of training in the specialty, which is approved by the Division; or

(2) At least 2 consecutive years of experience working in the specialty, during the 5 years immediately preceding application for certification, in a laboratory under the supervision of a director who possesses a doctoral degree.

2. An applicant for certification in a specialty must designate on the application the specialty in which he or she desires to be certified. The applicant must submit with the application:

(a) Verification of successful completion of a program of training required by subparagraph (1) of paragraph (c) of subsection 1; or

(b) A letter from the director of the laboratory in which the applicant obtained experience which verifies that the applicant has the experience required by subparagraph (2) of paragraph (c) of subsection 1.

3. A certificate will designate the holder by:

(a) The title of “Technician” in a specialty; or

(b) An equivalent title and will show the area of specialty by a subtitle.

(Added to NAC by Bd. of Health, eff. 10-22-93; A by R104-13, 3-28-2014)

NAC 652.4855 Laboratory assistants: Certification; qualifications. (NRS 439.200, 652.123, 652.125, 652.127, 652.130) To qualify for certification as a laboratory assistant, an applicant must submit with the application proof that the applicant has a high school diploma or a general equivalency diploma and has:

1. Completed at least 6 months of training approved by the Division and demonstrated an ability to perform laboratory procedures in the laboratory where he or she has received such training;

2. Obtained a certification in phlebotomy from an organization approved by the Division, including, without limitation:

(a) The American Medical Technologists;

(b) The American Society for Clinical Pathology;

(d) The National Center for Competency Testing;

(e) The National Healthcareer Association; and

(f) The National Phlebotomy Association; or

3. Worked at least 30 hours per week for at least 3 years during the immediately preceding 5 years in a laboratory certified pursuant to the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, or a laboratory that is licensed by a federal or state governmental agency in any state or territory of the United States.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.486 Provisional certification. (NRS 439.200, 652.123, 652.125, 652.130)

1. The Division shall issue a provisional certificate to a technologist or technician who is otherwise qualified for a certificate if he or she has not yet:

(a) Passed a required national examination for certification, but has been accepted as a candidate for testing; or

(b) Accumulated the amount of experience or training required for certification.

2. A technologist or technician must apply for a provisional certificate on a form provided by the Division and pay the fee for initial certification of personnel set forth in NAC 652.488.

3. A provisional certificate issued pursuant to this section expires 18 months after the date of issue and is not renewable.

(Added to NAC by Bd. of Health, eff. 9-6-88; A 10-22-93; R104-13, 3-28-2014; R149-15, 6-21-2017)

MISCELLANEOUS PROVISIONS

NAC 652.488 Fees; assessed expenses. (NRS 439.150, 439.200, 652.100, 652.125)

1. Except as otherwise provided in this section, the following fees will be charged:

(a) Licensure of laboratory not described in paragraph (b) or (c)
Initial:
Annual test volume less than 25,000................................................................	$1,100
Annual test volume at least 25,000 but less than 100,000...............................	3,000
Annual test volume 100,000 or more...............................................................	4,000
Biennial renewal:
Annual test volume less than 25,000................................................................	800
Annual test volume at least 25,000 but less than 100,000...............................	2,500
Annual test volume 100,000 or more...............................................................	3,500
Reinstatement:
Annual test volume less than 25,000................................................................	1,100
Annual test volume at least 25,000 but less than 100,000...............................	3,000
Annual test volume 100,000 or more...............................................................	4,000
(b) Licensure of laboratory operated by health district, district board of health, county board of health or city or town board of health, or the State Public Health Laboratory
Initial:
Annual test volume less than 25,000................................................................	$550
Annual test volume at least 25,000 but less than 100,000...............................	800
Annual test volume 100,000 or more...............................................................	1,150
Biennial renewal:
Annual test volume less than 25,000................................................................	400
Annual test volume at least 25,000 but less than 100,000...............................	600
Annual test volume 100,000 or more...............................................................	800
Reinstatement:
Annual test volume less than 25,000................................................................	550
Annual test volume at least 25,000 but less than 100,000...............................	800
Annual test volume 100,000 or more...............................................................	1,150
(c) Licensure of HIV testing laboratory
Initial.....................................................................................................................	$150
Biennial renewal....................................................................................................	150
(d) Licensure of director pursuant to paragraph (b) of subsection 3 of NAC 652.175 or NAC 652.380 to 652.395, inclusive
Initial.....................................................................................................................	$500
Biennial renewal....................................................................................................	300
Reinstatement.......................................................................................................	500
(e) Registration of laboratory operated pursuant to NRS 652.072 which is nonexempt pursuant to NAC 652.155
Initial.....................................................................................................................	$1,500
Biennial renewal....................................................................................................	900
Reinstatement.......................................................................................................	1,500
(f) Registration of laboratory operated pursuant to NRS 652.072 which is exempt pursuant to NAC 652.155
Initial.....................................................................................................................	$500
Biennial renewal....................................................................................................	300
(g) Certification of personnel
Initial:
General supervisor............................................................................................	$225
Technologist.....................................................................................................	113
Technician........................................................................................................	113
Pathologist’s assistant......................................................................................	113
Point-of-care test analyst..................................................................................	75
Laboratory, blood-gas or office laboratory assistant........................................	60
Biennial renewal:
General supervisor............................................................................................	150
Technologist.....................................................................................................	75
Technician........................................................................................................	75
Pathologist’s assistant......................................................................................	75
Point-of-care test analyst..................................................................................	60
Laboratory, blood-gas or office laboratory assistant........................................	45
Reinstatement:
General supervisor............................................................................................	225
Technologist.....................................................................................................	113
Technician........................................................................................................	113
Pathologist’s assistant......................................................................................	113
Point-of-care test analyst..................................................................................	75
Laboratory, blood-gas or office laboratory assistant........................................	60
(h) Placement of license or certificate in inactive status................................................	$50
(i) Issuance of original duplicate license or certificate...................................................	$50
(j) Permit to operate laboratory at temporary location...................................................	$300
(k) Change of location of laboratory.............................................................................	$300
(l) Change of director of laboratory...............................................................................	$300
(m) Change of name of laboratory................................................................	$300
(n) Inspection following receipt of an application to perform additional tests at a laboratory (per application)............................................................	$300
(o) Inspection of an outpatient center of a laboratory (per site)
Initial inspection....................................................................................................	$300
Inspection at time of biennial renewal..................................................................	150

2. If the Division conducts an inspection of a laboratory that is located outside of this State, the Division shall assess the expenses that the Division incurs as a result of the inspection to the laboratory. The laboratory shall reimburse the Division for the expenses assessed pursuant to this subsection.

3. The Division shall not charge or collect a fee set forth in paragraph (k), (l) or (m) of subsection 1 to an HIV testing laboratory.

4. The holder of or an applicant for a license or certificate issued pursuant to chapter 652 of NRS, or an applicant for a permit to operate a laboratory at a temporary location issued pursuant to NAC 652.195, shall be deemed to have paid any fee otherwise required pursuant to subsection 1 if the holder or applicant:

(a) Is, or is employed by, a medical laboratory that is operated by a person, governmental entity or fire-fighting agency that holds a permit issued by a health authority pursuant to NRS 450B.200; and

(b) Has paid the fee for the permit established by a board pursuant to NRS 450B.200.

5. As used in this section:

(a) “Board” has the meaning ascribed to it in NRS 450B.060.

(b) “Health authority” has the meaning ascribed to it in NRS 450B.077.

[Bd. of Health, Medical Laboratories Reg. Appendix I, eff. 8-5-74] — (NAC A 10-17-86; 7-22-87; 10-22-93; 11-1-95; R177-97, 1-30-98; R042-98, 5-18-98; R057-99, 9-27-99; R135-99, 11-29-99; R078-04, 8-5-2004; R176-07, 1-30-2008; R104-13, 3-28-2014; R149-15, 6-21-2017)

NAC 652.491 Grounds for denial, suspension or revocation of certificate. (NRS 439.200, 652.125) A certificate may be denied, suspended or revoked if an applicant, a person who holds a certificate or any technical employee of the laboratory:

1. Violates any provision of this chapter or chapter 652 of NRS;

2. Makes any misrepresentation in obtaining a certificate;

3. Has been convicted of a crime listed in NRS 449.174 that is punishable as a felony;

4. Is guilty of unprofessional conduct; or

5. Fails to meet the minimum standards prescribed by the Board.

(Added to NAC by Bd. of Health by R078-04, eff. 8-5-2004; A by R104-13, 3-28-2014)

NAC 652.493 Appeal of denial, suspension or revocation of license or certificate. (NRS 439.200, 652.123, 652.125, 652.220, 652.225, 652.260)

1. If a person is aggrieved by a decision of the Division relating to the denial, suspension or revocation of a license or certificate based upon any of the grounds set forth in subsections 1 to 6, inclusive, of NRS 652.220 or NAC 652.461 or 652.491, or any disciplinary action imposed pursuant to NAC 652.157, 652.320, 652.530, 652.550 or 652.580, the aggrieved person may appeal the decision pursuant to the procedures set forth in NAC 439.300 to 439.395, inclusive.

2. Except as otherwise provided in subsection 1 of NAC 652.570 or in the case of an emergency or a summary suspension pursuant to NAC 652.530, the effective date of the disciplinary action is stayed upon receipt of an appeal until the hearing officer renders a decision regarding the appeal.

(Added to NAC by Bd. of Health by R036-97, eff. 10-30-97; A by R078-04, 8-5-2004; R104-13, 3-28-2014)

NAC 652.496 Action by Board upon receipt of report of certain violations of laws relating to industrial insurance by holder of license or certificate; consideration by Division of report. (NRS 439.200, 652.123, 652.225, 652.260)

1. If a report is received pursuant to subsection 5 of NRS 228.420, the Board will submit the report to the Division.

2. The Division shall consider the report and will determine whether to take disciplinary action.

(Added to NAC by Bd. of Health by R036-97, eff. 10-30-97; A by R104-13, 3-28-2014)

NAC 652.520 Computation of time relating to violations and monetary penalties. (NRS 439.200, 652.123, 652.130, 652.225, 652.260) For the purposes of any computation of time required pursuant to NAC 652.530, 652.540, 652.560, 652.570 and 652.580:

1. Any prescribed period of more than 5 days includes Saturdays, Sundays and holidays.

2. Any prescribed period of 5 days or less does not include Saturdays, Sundays or holidays.

3. If the date on which any action required to be performed falls on a Saturday, Sunday or holiday, the time is extended until the next day that is not a Saturday, Sunday or holiday.

4. The day of any act or event or on which notice is received is not included in the computation.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.530 Disciplinary action: Circumstances under which authorized without notice; subsequent notice by Division required. (NRS 439.200, 652.123, 652.130, 652.220, 652.225, 652.260)

1. If necessary to protect the public health and safety, the Division may impose such disciplinary action as it deems necessary without notice to the laboratory or with verbal notice to the laboratory.

2. The Division may suspend the license of a laboratory without notice or upon verbal notice if the Division finds a violation with a severity level of four where corrective action within 48 hours is necessary because the violation has caused, or if uncorrected is likely to cause, serious injury or harm or death to a patient.

3. Within 48 hours after the Division imposes disciplinary actions without written notice, the Division shall provide written notice in the manner set forth in NAC 439.345.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.540 Disciplinary action: Notice by Division required; contents of notice. (NRS 439.200, 652.123, 652.130, 652.225, 652.260)

1. Except as otherwise provided in NAC 652.530, the Division shall, in addition to providing the statement of violations required pursuant to NAC 652.320, give notice in the manner set forth in NAC 439.345 before taking disciplinary action.

2. If the Division imposes a monetary penalty pursuant to NAC 652.157 or 652.550, the notice provided to the laboratory pursuant to subsection 1 must state:

(a) The amount of each penalty;

(b) Whether the violation was a first, second, third or greater than third violation;

(d) A statement that the Division will reduce the total amount due by 25 percent if the laboratory meets the requirements set forth in NAC 652.560; and

(e) The total amount due for all penalties and the amount that would be due if each penalty were reduced pursuant to NAC 652.560.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.550 Violations: Monetary penalties. (NRS 439.200, 652.123, 652.130, 652.260)

1. In determining the amount of a monetary penalty, the Division:

(a) For a first violation with a severity level of four, shall impose a monetary penalty of $1,000 per violation.

(b) For a first violation with a severity level of three, shall impose a monetary penalty of $800 per violation.

(c) For a first violation with a severity level of two, may impose a monetary penalty of $100 per violation. The Division may suspend this penalty if the laboratory corrects the violations within the time specified in the plan of correction submitted to the Division pursuant to NAC 652.320.

(d) For a second violation with a severity level of four discovered during any subsequent inspection, shall impose a monetary penalty of $5,000 per violation.

(e) For a second violation with a severity level of three discovered during any subsequent inspection, shall impose a monetary penalty of $1,600 per violation.

(f) For a second violation with a severity level of two discovered during any subsequent inspection, may impose a monetary penalty of $200 regardless of whether a penalty was imposed for the first violation.

(g) For a third or subsequent violation with a severity level of four discovered during any subsequent inspection, shall impose a monetary penalty of $10,000 per violation.

(h) For a third or subsequent violation with a severity level of three discovered during any subsequent inspection, shall impose a monetary penalty of $3,200 per violation.

(i) For a third or subsequent violation with a severity level of two discovered during any subsequent inspection, may impose a monetary penalty of $400 per violation regardless of whether a first or second monetary penalty was imposed.

2. The Division shall not impose a monetary penalty for a violation with a severity level of one.

3. If the same violation that was discovered during the initial inspection is found during a subsequent inspection conducted to evaluate compliance with a plan of correction submitted to the Division pursuant to subsection 3 of NAC 652.320, there is a rebuttable presumption that the violation continued through the period between the inspection and the subsequent inspection. The Division may impose an additional monetary penalty for such a violation only if the subsequent inspection is made and the violation is found to be present after the laboratory has been notified of the violation and given an opportunity to correct the violation.

4. A laboratory may, upon approval by the Division, use a monetary penalty that would otherwise be imposed by the Division to correct the violation and to put measures in place to prevent the violation from reoccurring. In such a case, the laboratory must provide proof to the Division that the money was used to correct the violation. If the amount of the monetary penalty is greater than the cost to correct the violation, the laboratory must pay to the Division the portion of the monetary penalty that was not used to correct the violation.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.560 Reduction of monetary penalties. (NRS 439.200, 652.123, 652.130, 652.225, 652.260) The Division will reduce the total amount due for all penalties as determined pursuant to NAC 652.540 by 25 percent and no interest will be charged if the laboratory against which the penalties are imposed:

1. Waives the right to a hearing;

2. Corrects the violations that were the basis for the monetary penalty; and

3. Pays the monetary penalty within 15 days after receipt of the notice of the penalty.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.570 Payment of monetary penalties: Time limitations; interest; costs. (NRS 439.200, 652.123, 652.130, 652.225, 652.260)

1. Payments made to satisfy a monetary penalty imposed pursuant to NAC 652.157, 652.320 or 652.550 are due within 15 days after the date on which the notice of the penalty is provided pursuant to NAC 652.540 and must be paid irrespective of any administrative appeal.

2. If the laboratory has appealed a decision imposing a monetary penalty pursuant to NAC 652.493, the penalty is due and must be paid after the final administrative decision is rendered and within 15 days after the laboratory has been notified of the amount of the monetary penalty and any interest that may be due.

3. The total monetary penalty assessed against any laboratory bears interest at the rate of 10 percent per annum. Except as otherwise provided in subsection 4, interest will be assessed on the unpaid balance of the penalty, beginning on the date on which the penalty is due.

4. The payment of any interest that accrues while the laboratory has a hearing pending on the initial determination of violations leading to the imposition of a monetary penalty will be stayed pending the appeal.

5. Any costs, including, without limitation, attorney’s fees, incurred by the Division in the collection of any monetary penalty may be recovered from the laboratory.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.580 Failure to pay monetary penalties: Grounds for suspension of license of laboratory; notice of intent to suspend license. (NRS 439.200, 652.123, 652.130, 652.220, 652.260)

1. If the laboratory fails to pay a monetary penalty on or before the date on which the penalty is due, the Division may suspend the license of the laboratory.

2. If the Division determines to suspend the license of a laboratory pursuant to subsection 1, the Division must, in accordance with the requirements of NAC 439.345, provide notice of its intention to suspend the license of the laboratory.

3. If the laboratory fails to pay the monetary penalty, including any additional costs incurred in collection of the penalty, within 10 days after receipt of the notice described in subsection 2, the Division must suspend the license of the laboratory. The suspension must not be stayed during the pendency of any administrative appeal.

(Added to NAC by Bd. of Health by R104-13, eff. 3-28-2014)

NAC 652.590 Activities of certain licensed professional nurses working at community health nursing clinics established by Division. (NRS 439.200, 652.215)

1. A licensed professional nurse who is employed by the Division to work at a community health nursing clinic established by the Division may perform the following tests:

(a) Analysis of urine, by dipstick or tablet, for bilirubin, hemoglobin, leukocytes, specific gravity, protein, glucose, ketone, nitrite, Ph and urobilinogen.

(b) Testing of urine to determine pregnancy.

(d) Determination of hemoglobin.

(e) Spun microhematocrit.

(f) Fecal occult blood.

(g) Gram stain of urethral specimens.

(h) Direct wet preparation.

(i) Potassium hydroxide preparation.

(j) Blood glucose, using devices for monitoring approved by the Food and Drug Administration for use in the home.

2. Each such nurse shall participate in programs for proficiency testing which are appropriate for the services performed.

3. There must be a program for quality control established by the Division that ensures the proper performance of analytical procedures.

4. There must be a written program for the orientation of employees.

5. Assignments of work must be commensurate with the qualifications of the nurse and must not require the nurse to perform any tasks outside of his or her authority to practice professional nursing, as set forth in chapter 632 of NRS and chapter 632 of NAC.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93; R145-11, 5-30-2012) — (Substituted in revision for NAC 652.500)

NAC 652.600 Program of training for certification as technician. (NRS 439.200, 652.123, 652.125, 652.130)

1. Any program of training intended to prepare a person for certification as a technician must be approved by the Division. Application for approval must be submitted to the Division in the manner prescribed by the Division. The application must include:

(a) A description of the goals of the program;

(b) A description of the methods of instruction;

(d) A description of the qualifications of the instructors;

(e) A description of the methods of evaluating the performance of the trainee; and

(f) The name of the director who is responsible for the program.

2. The director shall certify in writing to the Division each trainee who has successfully completed the program.

(Added to NAC by Bd. of Health, eff. 10-17-86; A 10-22-93; R104-13, 3-28-2014; R149-15, 6-21-2017) — (Substituted in revision for NAC 652.510)