[Rev. 11/22/2013 10:18:10 AM--2013]

[NAC-652 Revised Date: 11-13]

CHAPTER 652 - MEDICAL LABORATORIES

GENERAL PROVISIONS

652.010            Definitions.

652.020            “Accredited” defined.

652.025            “Approved course” defined.

652.033            “Board” defined.

652.037            “Bureau” defined.

652.060            “Committee” defined.

652.065            “Director” defined.

652.071            “Division” 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.

652.155            Applicability; exemptions from compliance.

LICENSING AND REGISTRATION

652.170            Laboratory: Application for license or registration; action by Bureau on application; performance of tests at temporary location.

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.

652.200            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.

652.290            Sterilization of equipment and materials; disposal.

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 Bureau; submission of plan for correction of deficiencies.

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.

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

652.395            Director of registered 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.

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.

652.486            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            Consideration by Board of report of certain violations of laws relating to industrial insurance by holder of license or certificate.

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

652.510            Program of training for certification as technician.

 

 

GENERAL PROVISIONS

      NAC 652.010  Definitions. (NRS 439.200, 652.123, 652.125, 652.130)  As used in this chapter, unless the context otherwise requires, the words and terms defined in NAC 652.020 to 652.148, 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)

      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 652.037  “Bureau” defined. (NRS 439.200, 652.123, 652.125, 652.130)  “Bureau” means the Bureau of Licensure and Certification of the Division.

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

      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 652.075  “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 and 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.

     (Added to NAC by Bd. of Health by R135-99, eff. 11-29-99)

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

     1.  Except as otherwise provided in this section and NRS 652.230, 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 an exempt laboratory which is registered 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; or

     (b) Obtain certification pursuant to NAC 652.470 and pay the applicable fees as set forth in NAC 652.488.

     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 categorized pursuant to 42 C.F.R. § 493.19.

     5.  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;

     (c) A chiropractic physician licensed pursuant to chapter 634 of NRS; and

     (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)

LICENSING AND REGISTRATION

      NAC 652.170  Laboratory: Application for license or registration; action by Bureau on application; performance of tests at temporary location. (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 Bureau. Upon receipt of a completed application, the Bureau shall conduct a survey of the facility and examine 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 Bureau shall notify the applicant of the disposition of the application within 30 days after receipt of the application.

     3.  A laboratory seeking to perform tests at a temporary location must submit to the Bureau an application on the form provided by the Bureau and the fees required by NAC 652.488.

     [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)

      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 652.235 must register with the Division as an exempt laboratory or a nonexempt laboratory.

     2.  A laboratory operated by a licensed physician pursuant to NRS 652.235 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 Bureau;

     (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 652.235 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 Bureau;

     (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;

     (c) A chiropractic physician licensed pursuant to chapter 634 of NRS; and

     (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)

      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 Bureau shall issue a certificate of registration to each laboratory which registers with the Division pursuant to NRS 652.235. A certificate of registration issued pursuant to this section is effective for 2 years after the date of issuance.

     2.  The Bureau 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 Bureau.

     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 Bureau 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)

      NAC 652.200  Director’s license: Application. (NRS 439.200, 652.125, 652.130)  An application for a license as a director must be on a form provided by the Bureau, giving complete information as indicated, including educational background, experience and the identity of the laboratory to be directed. The fee for licensure is not refundable.

     [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)

      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 Bureau on behalf of the Board for those applicants who qualify for licensure under subsection 1 or 2 of NAC 652.380. If the Bureau cannot determine the qualifications of an applicant or if the applicant is applying for licensure under subsection 3 of NAC 652.380, the Bureau shall submit the application to the Committee for its recommendation and to the Board for its determination. The Bureau shall notify the applicant of the status of the application within 30 days after receipt of the 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)

      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 Bureau; 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)

      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 Bureau 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)

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)  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 Bureau, 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 out of any three testing events for a procedure, the laboratory ceases to perform that procedure until it demonstrates to the satisfaction of the Bureau that the deficiencies 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)

      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 652.290  Sterilization of equipment and materials; disposal. (NRS 439.200, 652.130)

     1.  Blood-letting devices such as syringes, needles and lancets must be sterile and not reused unless they are properly packaged and sterilized before each use and marked “sterilized.”

     2.  All microbial materials and blood and its products must be properly decontaminated or placed in two bags and marked “biohazard” before they are discarded in a public disposal service.

     3.  All disposable needles and syringes must be properly decontaminated and discarded in a container which cannot be punctured.

     [Bd. of Health, Medical Laboratories Reg. §§ 3.5.2-3.5.2.2.2, eff. 8-5-74]—(NAC A 10-17-86)

      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.

     (c) The date and time the specimen was collected for testing.

     (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 Bureau; submission of plan for correction of deficiencies. (NRS 439.200, 652.123, 652.130)

     1.  Except as otherwise provided in this subsection, the Bureau 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 Bureau if the reports of the inspections are available to the Bureau.

     2.  Upon receipt of a complaint against a laboratory or its personnel, except for a complaint concerning the cost of services, the Bureau 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 Bureau shall report deficiencies noted at the time of each inspection by forwarding to the director a statement of deficiencies and a form for the director to submit a plan of correction. The director shall return the form to the Bureau, containing thereon the plan of correction for each of the deficiencies, within 10 working days after receiving the form. The plan must indicate the date by which each deficiency will be corrected.

     [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)

      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.

     (c) The date and time the specimen was received in the 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 Board, 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 Board 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)

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

     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.  If the laboratory provides:

     (a) Only routine services regarding hematology, urinalysis, chemistry, blood gas and microbiology, the director must be on the premises of the laboratory at least once every 30 consecutive days. If the director is absent from the laboratory for 30 consecutive days 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 Board determines that a substitute is not necessary.

     (b) Services regarding vaginal cytology, nonvaginal cytology, flow cytometry or histopathology, or toxicologic analysis involving high-pressure liquid chromatography or gas chromatography with mass spectroscopy, the director must be on the premises of the laboratory at least once every 10 consecutive days of testing. If the director is absent from the laboratory for 10 consecutive days or more of testing, the director shall provide for a licensed substitute to serve in his or her place.

     (c) Any services other than those set forth in paragraphs (a) and (b), the Bureau may establish the minimum frequency with which the director must be on the premises of the laboratory, which must be based upon the complexity of the testing performed by the laboratory and must not be less than once every 30 consecutive days.

     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)

      NAC 652.380  Director of licensed laboratory: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130)  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 or biological 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; or

          (6) The American Board of Medical Genetics; or

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

     3.  In a geographical area which does not have a person who meets the qualifications set forth in subsection 1 or 2, be a physician, licensed to practice in the State of Nevada, whose experience is acceptable to the Board.

     [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)

      NAC 652.385  Director of licensed laboratory testing for pulmonary conditions: Qualifications. (NRS 439.200, 652.123, 652.125, 652.130)  To qualify for a license as a director of a licensed laboratory testing for pulmonary conditions, a person must:

     1.  Be a physician certified by the American Board of Internal Medicine in the subspecialty of pulmonary disease; or

     2.  In a geographical area which does not have a person who meets the qualifications set forth in subsection 1, be a physician licensed to practice in this State, whose experience is acceptable to the Board.

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

      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 652.510, inclusive;

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

     (c) Laboratory training, obtained during medical residency, equivalent to the training required by paragraph (b); 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 652.510, 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; or

          (6) The American Board of Medical Genetics; 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)

      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 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)

      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

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

     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 Committee on Allied Health Education and Accreditation;

     (b) Have an associate degree 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)

      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

     (c) A high complexity test, and:

          (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 only those procedures requiring the degree of skill commensurate with his or her education, training and technical abilities. Except as otherwise provided in NRS 652.217 and NAC 652.155, a laboratory assistant may not independently perform laboratory procedures, 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)

      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;

     (c) Licensed practical nurse as defined in NRS 632.016;

     (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. (NRS 439.200, 652.123, 652.125, 652.130)

     1.  Except as otherwise provided in subsection 2, any person desiring to have an inactive or a delinquent license or certificate reinstated shall submit evidence to the Bureau 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.

     2.  An inactive or delinquent license or certificate may be conditionally reinstated without the evidence required by subsection 1 if the applicant completes one unit of continuing education within a period established by the Bureau. Any failure to complete the continuing education or satisfy any other condition established by the Bureau is a ground for revocation of the license or certificate.

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

      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;

     (c) A copy of a book or article published by the holder of a license or certificate issued pursuant to this chapter; or

     (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 Board 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)

      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 Bureau 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;

     (c) The form must indicate the level and title for which certification is desired; and

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

     2.  Temporary employment, for a period not exceeding 6 months, may be granted while the application is being processed, or when the applicant has been issued a provisional certificate.

     3.  The Bureau shall issue the appropriate certificate on behalf of the Board when it is determined that all requirements for certification are satisfied. Applications which are incomplete or require further review must be referred to the Committee for its recommendation.

     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 Bureau 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 Bureau 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 Bureau 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)

      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 Bureau a completed form for renewal. The Bureau 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)

      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;

     (c) In hematology;

     (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 Bureau 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 1 year of experience working 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 letter from the director of the laboratory in which the applicant obtained experience which verifies that the applicant has the experience required by subsection 1.

     3.  In addition to the requirements of subsection 1, an applicant for certification as a biotechnologist must obtain the written recommendation of his or her certification from the Committee before the applicant is eligible for that certification.

     4.  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)

      NAC 652.483  Technologists: Certification in specialty for which national examination is not given. (NRS 439.200, 652.123, 652.125, 652.130)  The Bureau 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 Board;

     2.  Obtains a written recommendation of the proposed certification from:

     (a) A director licensed in this State who holds a doctoral degree; and

     (b) The Committee; 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)

      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;

     (c) In hematology;

     (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 Bureau, 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

     (c) Have:

          (1) Completed at least 1 year of a formal program of training in the specialty, which is approved by the Board; 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.  In addition to the requirements of subsection 1, an applicant for certification as a biotechnician must obtain the written recommendation of his or her certification from the Committee before becoming eligible for that certification.

     4.  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)

      NAC 652.486  Provisional certification. (NRS 439.200, 652.123, 652.125, 652.130)  The Bureau shall, upon request by a technologist or technician who is required to pass a national examination for certification and who has been accepted as a candidate for testing, issue him or her a provisional certificate. The provisional certificate expires 180 days after the date of issue and is not renewable. No technologist or technician may request more than three provisional certificates pursuant to this section. The fee for a provisional certificate is the same as the fee set forth in NAC 652.488 for the certification of personnel.

     (Added to NAC by Bd. of Health, eff. 9-6-88; A 10-22-93)

MISCELLANEOUS PROVISIONS

      NAC 652.488  Fees; assessed expenses. (NRS 439.150, 439.200, 652.100, 652.125)  The following nonrefundable fees will be charged:

     1.  Licensure of laboratory not described in subsection 2

 

               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

     2.  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

     3.  Licensure of director pursuant to paragraph (b) of subsection 3 of NAC 652.175, or NAC 652.380, 652.385 or 652.395

 

               Initial.....................................................................................................................

          $500

               Biennial renewal....................................................................................................

            300

               Reinstatement.......................................................................................................

            500

     4.  Registration of laboratory operated pursuant to NRS 652.235 which is nonexempt pursuant to NAC 652.155

 

               Initial.....................................................................................................................

       $1,500

               Biennial renewal....................................................................................................

            900

               Reinstatement.......................................................................................................

         1,500

     5.  Registration of laboratory operated pursuant to NRS 652.235 which is exempt pursuant to NAC 652.155

 

               Initial.....................................................................................................................

          $500

               Biennial renewal....................................................................................................

            300

     6.  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

     7.  Placement of license or certificate in inactive status...............................................

            $50

     8.  Issuance of original duplicate license or certificate.................................................

            $50

     9.  Permit to operate laboratory at temporary location.................................................

          $300

     10.  Change of location of laboratory...........................................................................

          $300

     11.  Change of director of laboratory...........................................................................

          $300

     12.  Change of name of laboratory...............................................................

          $300

     13.  Inspection for additional specialties and subspecialties in which tests will be performed at laboratory.............................................................

          $300

                                                                                                                   Plus $50 for each additional

                                                                                                                         specialty or subspecialty

     14.  Inspection of an outpatient center of a laboratory (per site)

 

               Initial inspection....................................................................................................

          $300

               Inspection at time of biennial renewal..................................................................

            150

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

     [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)

      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 felony relating to the position for which the applicant has applied or for which his or her certificate has been issued pursuant to chapter 652 of NRS;

     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)

      NAC 652.493  Appeal of denial, suspension or revocation of license or certificate. (NRS 439.200, 652.125)  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, the aggrieved person may appeal the decision pursuant to the procedures set forth in NAC 439.300 to 439.395, inclusive.

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

      NAC 652.496  Consideration by Board of report of certain violations of laws relating to industrial insurance by holder of license or certificate. (NRS 439.200, 652.225)

     1.  If a report is received pursuant to subsection 5 of NRS 228.420, the report must be placed on the agenda of the next regularly scheduled meeting of the Board or as soon thereafter as the schedule of the Board allows.

     2.  The Board will consider the report and will determine whether the report should be referred to the Bureau for possible disciplinary action.

     (Added to NAC by Bd. of Health by R036-97, eff. 10-30-97)

      NAC 652.500  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.

     (c) Collecting of samples for submission to a licensed laboratory.

     (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)

      NAC 652.510  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 Board. Application for approval must be submitted in writing to the Board. The application must include:

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

     (b) A description of the methods of instruction;

     (c) A description of the contents of the courses;

     (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 Bureau each trainee who has successfully completed the program.

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