1 Va. Admin. Code § 30-45-70

Current through Register Vol. 41, No. 8, December 2, 2024

Section 1VAC30-45-70 - Process to apply and obtain certification

A. Duty to apply. All owners of noncommercial environmental laboratories shall apply for certification as specified by the provisions of this section. Applications for certification must be obtained from DCLS program staff by email at Lab_Cert@dgs.virginia.gov.

B. Owners of noncommercial environmental laboratories applying for certification under this chapter for the first time shall submit an application to DCLS as specified under subsection F of this section.

C. Renewal and reassessment.

1. DCLS shall renew certification annually for the certified laboratory provided the laboratory does the following:

a. Maintains compliance with this chapter.

b. Attests to this compliance by signing the certificate of compliance provided under subdivision F 3 of this section.

c. Reports acceptable proficiency test values as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter.

d. Pays the fee required by 1VAC30-45-130.

2. DCLS shall reassess the certified environmental laboratory during an on-site assessment as required by Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter.

D. Responsibilities of the owner and operator when the laboratory is owned by one person and operated by another person.

1. When an environmental laboratory is owned by one person but is operated by another person, the operator may submit the application for the owner.

2. If the operator fails to submit the application, the owner is not relieved of his responsibility to apply for certification.

3. While DCLS may notify noncommercial environmental laboratories of the date their applications are due, failure of DCLS to notify does not relieve the owner of his obligation to apply under this chapter.

E. Submission of applications for modifications to certification. An owner of a certified noncommercial environmental laboratory shall follow the process set out in 1VAC30-45-90 B to modify the laboratory's scope of certification.

F. Contents of application.

1. Applications shall include but not be limited to the following information and documents:

a. Legal name of laboratory;

b. Name of owner of laboratory;

c. Name of operator of laboratory, if different than owner;

d. Street address and description of location of laboratory;

e. Mailing address of laboratory, if different from street address;

f. Address of owner, if different from laboratory address;

g. Name, address, telephone number, facsimile number and email, as applicable, of responsible official;

h. Name, address, telephone number, facsimile number and email, as applicable, of laboratory manager;

i. Name, address, telephone number, facsimile number and email, as applicable, of designated quality assurance officer;

j. Name and telephone number of laboratory contact person;

k. Laboratory type (e.g., public water system, public wastewater system or combination of the two, or industrial (with type of industry indicated));

l. Laboratory hours of operation;

m. Fields of certification (matrix, technology/method, and analyte) for which certification is sought;

n. The results of one successful unique PT study for each field of proficiency testing as required by Article 3 (1VAC30-45-500 et seq.) of Part II of this chapter;

o. Quality assurance manual; and

p. For mobile laboratories, a unique vehicle identification number, such as a manufacturer's vehicle identification number (VIN#), serial number, or license number.

2. Fee. The application shall include payment of the fee as specified in 1VAC30-45-130.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by the responsible official, by the quality control officer and by the laboratory manager.

b. The certification of compliance shall state: "The applicant understands and acknowledges that the laboratory is required to be continually in compliance with the Virginia environmental laboratory certification program regulation (1VAC30, Chapter 45) and is subject to the provisions of 1VAC30-45-100 in the event of noncompliance. I certify under penalty of law that this document and all attachments were prepared under my direction or supervision in accordance with a system designed to assure that qualified personnel properly gather and evaluate the information submitted. Based on my inquiry of the person or persons who manage the laboratory or those persons directly responsible for gathering and evaluating the information, the information submitted is, to the best of my knowledge and belief, true, accurate and complete. Submitting false information or data shall result in denial of certification or decertification. I hereby further certify that I am authorized to sign this application."

G. Completeness determination.

1. DCLS shall determine whether an application is complete and notify the laboratory of the result of such determination. DCLS shall provide this notice within 90 calendar days of its receipt of a laboratory's initial application.

2. An application shall be determined complete if it contains all the information required pursuant to subsection F of this section and is sufficient to evaluate the laboratory prior to the on-site assessment. Designating an application complete does not preclude DCLS from requesting or accepting additional information.

3. If DCLS determines that an application is incomplete, the DCLS notification of such determination shall explain why the application is incomplete and specify the additional information needed to make the application complete.

4. If DCLS makes no determination within 90 calendar days of its receipt of either (i) the application or (ii) additional information, in the case of an application determined to be incomplete, the application shall be determined to be complete.

5. If the laboratory has not submitted the required additional information within 90 days of receiving a notice from DCLS requesting additional information, DCLS may inform the laboratory that the application cannot be processed. The laboratory may then submit a new application.

H. Grant of interim certification pending final determination on application.

1. DCLS shall grant a laboratory interim certification status under the following conditions:

a. The laboratory's application is determined to be complete;

b. The laboratory has satisfied all the requirements for certification, including all requests for additional information, with the exception of on-site assessment; and

c. DCLS is unable to schedule the on-site assessment within 120 days of its determination that the application is complete .

2. A laboratory with interim certification status shall have the same rights and status as a laboratory that has been granted certification by DCLS.

3. Interim certification expires when DCLS issues a final determination on certification.

I. On-site assessment. An on-site assessment shall be performed and the follow-up and reporting procedures for such assessments shall be completed in accordance with Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter prior to issuance of a final determination on certification.

J. Final determination on certification. Upon completion of the certification review process and corrective action, if any, DCLS shall grant certification in accordance with subsection K of this section or deny certification in accordance with subsection L of this section.

K. Grant of certification.

1. When a laboratory meets the requirements specified for receiving certification, DCLS shall issue a certificate to the laboratory. DCLS shall send the certificate to the laboratory manager and shall notify the responsible official .

2. The director of DCLS or his designee shall sign the certificate. The certificate shall include the following information:

a. Name of owner of laboratory;

b. Name of operator of laboratory, if different from owner;

c. Name of responsible official;

d. Address and location of laboratory;

e. Laboratory identification number;

f. Fields of certification (matrix, technology/method, and analyte) for which certification is granted;

g. Any addenda or attachments; and

h. Issuance date and expiration date.

3. The laboratory shall post the most recent certificate of certification and any addenda to the certificate issued by DCLS in a prominent place in the laboratory facility.

4. Certification shall expire one year after the date on which certification is granted.

L. Denial of certification.

1. DCLS shall deny certification to an environmental laboratory in total if the laboratory is found to be falsifying any data or providing false information to support certification.

2. Denial of certification in total or in part.

a. DCLS may deny certification to an environmental laboratory in total or in part if the laboratory fails to do any of the following:

(1) Pay the required fees.

(2) Employ laboratory staff to meet the personnel qualifications as required by Part II (1VAC30-45-200 et seq.) of this chapter.

(3) Successfully analyze and report proficiency testing samples as required by Part II of this chapter.

(4) Submit a corrective action plan in accordance with Part II of this chapter in response to a deficiency report from the on-site assessment team within the required 30 calendar days.

(5) Implement the corrective actions detailed in the corrective action plan within the timeframe specified by DCLS.

(6) Pass required on-site assessment as specified in Part II of this chapter.

(7) Implement a quality system as defined in Part II of this chapter.

b. DCLS may deny certification to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 calendar days following notification of incompleteness because the laboratory is delinquent in submitting information required by DCLS in accordance with this chapter.

c. DCLS may deny certification to an environmental laboratory in total or in part if the DCLS on-site assessment team is unable to carry out the on-site assessment pursuant to Article 2 (1VAC30-45-300 et seq.) of Part II of this chapter because a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in its application.

3. DCLS shall follow the process specified in 1VAC30-45-110 when denying certification to an environmental laboratory.

M. Reapplication following denial of certification. DCLS shall not waive application fees for a laboratory reapplying for certification.

1 Va. Admin. Code § 30-45-70

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; Amended, Virginia Register Volume 32, Issue 22, eff. 9/1/2016.

Statutory Authority: § 2.2-1105 of the Code of Virginia.