FAQs for Medical Laboratories

1. Does my facility/laboratory/business require a State of Nevada laboratory license?

If yes to any of the questions below, you are required to apply and obtain a State of Nevada laboratory license before performing any laboratory tests or before providing any specimen collection in the State of Nevada.

  • Is your laboratory or business going to have personnel employed by you or contracted by your company to touch a person for the collection of a specimen in the State of Nevada? 
  • Is your laboratory or business going to perform any laboratory testing on human specimens (from a CLIA Waived test like a fingerstick glucose or urine dipstick to a High Complexity test like Toxicology confirmations using LCMS) where the testing will actually take place in the State of Nevada? 
  • Is your laboratory going to accept specimens from the State of Nevada for the purpose of Worker Compensation Drug Testing? 

If no to all of the above questions then you are not required to obtain a State of Nevada laboratory license.

Specimen collection, including phlebotomy services, requires the phlebotomy services to be performed under a State of Nevada laboratory license with a qualified laboratory director. Phlebotomists do not have an independent scope of practice to provide phlebotomy services in Nevada. All phlebotomists who are performing specimen collection in Nevada, are required to be employed by a laboratory that is licensed by the State of Nevada.

The State of Nevada regulations for Medical Laboratories can be found in the Nevada Administrative Code (NAC 652)  and the State of Nevada statutes for Medical Laboratories can be found in the Nevada Revised Statutes (NRS 652)

The State of Nevada does not recognize federal CLIA certificates that have been issued by other states. If your business/facility/laboratory wants to perform human laboratory specimen collection/testing in the State of Nevada, you are required to submit an application for a State of Nevada laboratory license and a federal CLIA certificate issued by Nevada.

The State laboratory license and federal CLIA certificate are required no matter what length of time that you want to perform specimen collection and/or laboratory testing.



2. Is the State of Nevada laboratory license and the federal CLIA certificate the same thing?

No. The State of Nevada laboratory license is issued by the State of Nevada. There are State of Nevada statutes and State regulations that are found in the Nevada Revised Statutes (NRS) Chapter 652 and the Nevada Administrative Code (NAC) also found in Chapter 652, respectively.

The federal CLIA certificate is issued by the federal government through our Medical Laboratory agency and is only issued to laboratories that are performing human specimen testing for the purpose of diagnosis, treatment or healthcare of an individual.

The fee for the State of Nevada laboratory license and the federal CLIA certificate are separate and must be paid to ensure that they remain in an active status.

3. How do I apply for a State of Nevada laboratory license and CLIA certificate?

The following are the instructions for submitting an application to perform laboratory specimen collection or laboratory testing in Nevada:

  1. You will need to go to our on-line application website at: https://nvdpbh.aithent.com/login.aspx
  2. On the left-hand side under “NEW APPLICANTS APPLY HERE”, you will choose the fifth line down that says, “TO APPLY FOR A NEW MEDICAL LABORATORY LICENSE OR CHANGE OF OWNERSHIP-CLICK HERE”.
  3. You will need to complete all of the required fields and pay the application fee.
  4. After the application is submitted, from your account home page, click on View Pending applications and upload:
    1. a driver’s license or passport picture of the person that has been identified as the Laboratory Director
    2. a copy of the director’s on-line verification of professional occupational license
    3. a completed CMS 116 form (5 pages)
    4. a completed Ownership and Disclosure form (2 pages).
     
  5. Once the application has been reviewed and is complete, the application will be forwarded on to a surveyor. The surveyor will contact your facility to schedule an inspection of your laboratory.
  6. Once the inspection has taken place, if there are no deficiencies found, the surveyor will complete the paperwork and submit the application for approval. If there are deficiencies found during the inspection, the deficiencies will need to be corrected and a Plan of Correction (POC) will need to be submitted.
  7. When the application is submitted for approval, the surveyor paperwork will be reviewed and approved.
  8. The CMS 116 form will be put into the Federal database to generate a CLIA certificate for your facility. You will receive a bill from CLIA for the CLIA certificate.
  9. When the application has been approved, the laboratory may begin performing laboratory testing. No human specimen collection and/or laboratory testing may be performed on anyone until the State of Nevada inspection has been performed and the submitted application approved.  


4. Once I submit an application for a State of Nevada laboratory license and federal CLIA certificate, when can our laboratory begin testing?

When our agency receives an application from a facility to operate a laboratory, we must first process the application for the State of Nevada and also process the application for the federal government. Once the application has been found to be complete, the application is forwarded to an inspector. The inspector will schedule a date and time to perform an inspection of the laboratory. If the inspection finds no deficient practices, then the application will be approved and once the application has been approved, the laboratory may begin patient/client laboratory testing.
If the laboratory has been found to have cited deficiencies, then the laboratory must correct the deficiencies before patient/client testing may be performed. Once the cited deficiencies have been corrected, the laboratory may begin patient laboratory testing once the application has been approved.

5. What are the different types of laboratory licensure in the State of Nevada?

Exempt (NAC 652.072) – An authorized healthcare provider’s private practice, a home health agency, hospice, or other facility in which tests are collected or performed by an authorized healthcare provider, partner/associates, and qualified staff to perform Waived Tests or Provider Performed Microscopy.

Registered (NAC 652.135) – An authorized healthcare provider’s private practice or group practice in which tests are collected or performed by an authorized healthcare provider, partner/associates, and qualified staff to perform Waived and/or Non-Waived (moderate and/or high complexity) Laboratory tests.

Licensed (NAC 652.083)– A laboratory which serves the General Public such as a hospital laboratory or reference laboratory to perform Waived and/or Non-Waived (moderate and/or high complexity) laboratory tests by qualified laboratory personnel.

HIV (NAC 652.074) – A laboratory in which the only test performed is a waived test for the detection of the human immunodeficiency virus (HIV) by personnel with proof of successful training.

Collection Only (NAC 652.085) – A laboratory which serves the General Public for specimen collection only.  

6. How do I make changes to our laboratory director, laboratory location, laboratory name, or add additional tests?

A State of Nevada laboratory amendment application must be submitted when any of the following occurs:

  • A change of the location of the laboratory (when the laboratory has moved from one address to another. This includes a move to a different suite in the same building).
  • A change of laboratory director (every laboratory is required to have a laboratory director of record).
  • A change in the name of the laboratory.
  • The addition of a laboratory test in which the laboratory has not been previously approved.

To submit an amendment application, login to your online licensing account: https://nvdpbh.aithent.com/Login.aspx

After you login, you will want to select "Amendment" (under What Do You Want to Do), and then select the appropriate amendment type. You can use one amendment application to make one or more updates. After the application has been submitted, you will need to upload the required documents listed in the application checklist.



7. Once I submit an application for the addition of a laboratory test, when can we begin offering the new test to the patients/clients?

Once the application has been processed and there has been an inspection of the new laboratory test(s) with no deficiencies cited, the application will be approved, and the laboratory may then offer their patients/clients the new laboratory test.

8. If my State of Nevada laboratory license is due for renewal, does the fee cover an amendment to my laboratory license or is it separate?

Licenses are valid for two years from issue date and must be renewed biennially. If the State of Nevada laboratory license is due for renewal, this is a separate fee than an amendment for a change in the laboratory (test addition, change of director, etc.) and the renewal fee must be paid. A separate application for the amendment will need to be submitted and the separate fee for the amendment will be required to be paid.

An example would be if the laboratory license is due for renewal and the laboratory wants to add laboratory tests to their test menu, then the laboratory will need to pay for the renewal of the State of Nevada laboratory license, and then they will need to submit an amendment application for the addition of tests. The laboratory would need to pay the separate fee for the addition of the tests.

9. If the ownership of my laboratory has changed (a Change of Ownership), is the application process different than an amendment to my current State of Nevada laboratory license?

If it has been determined that the laboratory has incurred a Change of Ownership (a change in the laboratory tax ID, there are changes in the members of the ownership, or when the laboratory has been taken over by another business entity), then the laboratory would need to submit a Change of Ownership application.
A new state license number will be issued, but the CLIA certificate number will remain the same.

You will need to go to our on-line application website at: https://nvdpbh.aithent.com/login.aspx
On the left-hand side under “NEW APPLICANTS APPLY HERE”, you will choose the fifth line down that says, “TO APPLY FOR A NEW MEDICAL LABORATORY LICENSE OR CHANGE OF OWNERSHIP-CLICK HERE”.

After the change of ownership application has been submitted, you will need to upload the required documents listed in the application checklist.

10. Our laboratory license has expired, how do I submit an application for reactivation?

The laboratory will need to go to our website at: https://nvdpbh.aithent.com/login.aspx

The laboratory will enter their login name and password and from their account home page click on Reactivation. The reactivation application will need to be submitted and all requested documents need to be uploaded prior to the application being processed.

11. If the laboratory license has expired, can the laboratory continue to perform patient testing?

No. Since the laboratory can only perform patient/client laboratory testing with an Active State of Nevada laboratory license, the laboratory would need to cease providing patient/client laboratory testing until the reactivation application has been submitted, the inspection of the laboratory has been completed with no deficiencies found, and the laboratory license has been reactivated.

12. How do I make changes when our laboratory is changing the complexity of the testing that we perform?

The following is the process for changing testing complexity- instructions for upgrading or downgrading licensure.

To upgrade or downgrade testing complexity on an existing license, you will need to complete an Initial application for a new license (see Instructions for submitting an application). When you submit your application, a new state license number will be issued but you will keep the same CLIA number.
If you are wishing to upgrade from an Exempt license to a Registered or Licensed lab, the laboratory director will need to be qualified and licensed through our department.

  • Registered laboratory director qualifications can be found in NAC 652.395
  • Licensed laboratory director qualifications can be found in NAC 652.380


13. Our business/facility wants to perform laboratory specimen collection and testing on our employees, do we need a State of Nevada laboratory license and a federal CLIA certificate?

A State of Nevada laboratory license is only required if the facility is going to touch a person (swab a person, fingerstick, or venipuncture) for the collection of the specimen or if there is laboratory testing being performed at the business/facility site. A federal CLIA certificate is required if the laboratory testing is for the purpose of diagnosis, treatment, or healthcare of the person whom the specimen has been acquired.

If a business/ facility is going to collect a urine specimen from a person and send the specimen to a CLIA certified laboratory for analysis, then there would be no requirement for a State of Nevada laboratory license or a federal CLIA certificate since the person is collecting their own specimen and because there is no testing being performed at the location of the business/facility.

If a business/facility wants to collect urine specimens from their employees to check for workplace drug testing and the testing will be performed at the location of the business/facility, then this would require a State of Nevada laboratory license, but a federal CLIA certificate would not be required since the laboratory testing is not for the diagnosis, treatment or healthcare of an individual.

If a business/facility wants to perform any laboratory testing (this includes all Waived and/or Non-Waived laboratory tests) to assess the healthcare of an individual, then this would require a State of Nevada laboratory license and a federal CLIA certificate.

14. Do I need to have a State of Nevada laboratory license and a federal CLIA certificate if I only want to perform specimen collection with no laboratory testing?

NRS 652.210 explains who may manipulate a person for the collection of a specimen. Persons listed in NRS 652.210(1) may perform specimen collection under their professional license.

In the State of Nevada, a phlebotomist does not have an independent scope of practice. A phlebotomist is required to work for a laboratory and under the direction of a laboratory director. In addition, a phlebotomist in the State of Nevada, is required to be certified by the Division of Public and Behavioral Health as a Laboratory Assistant.

A phlebotomist/Laboratory Assistant can create their own business to collect specimens, but they would need to submit an application for a Licensed Laboratory for Collection Only. They would need to identify a person to be the laboratory director that met the qualifications listed in NAC 652.397(1)(a-g). Once the laboratory application has been submitted, the application will be processed and forwarded to an inspector to schedule an onsite inspection of the laboratory/facility. Once the application has been completed, the phlebotomist could begin specimen collection.

15. We paid for our CLIA certificate renewal, why haven’t we received it?

CMS releases the new certificate approximately one month prior to the certificate’s expiration date. Review the expiration date of your CLIA certificate to see if it is within a month of its expiration.

The federal CLIA Program recently started posted CLIA certificates to the QCOR website here: https://qcor.cms.gov/main.jsp

16. Contact

Please reach out to us at pbhclialab@health.nv.gov if you have any further questions.