1 Va. Admin. Code § 30-46-70

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

Section 1VAC30-46-70 - Process to apply and obtain accreditation

A. Duty to apply. All owners of (i) commercial environmental laboratories and (ii) TNI-accredited commercial environmental laboratories applying for secondary accreditation shall apply for accreditation as specified by the provisions of this section. Applications for accreditation must be obtained from DCLS program staff by email at Lab_Cert@dgs.virginia.gov.

B. Initial applications. Owners of commercial environmental laboratories applying for accreditation 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 accreditation annually for the accredited 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 1VAC30-46-210 B.

d. Pays the fee required by 1VAC30-46-150.

2. DCLS shall reassess the accredited environmental laboratory during an on-site assessment as required by 1VAC30-46-220.

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 accreditation.

3. While DCLS may notify 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 accreditation. An owner of an accredited environmental laboratory shall follow the process set out in 1VAC30-46-90 B to modify the laboratory's scope of accreditation.

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 technical 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., commercial, public wastewater system, mobile);

l. Laboratory hours of operation;

m. Fields of accreditation for which the laboratory is seeking accreditation;

n. The results of two successful unique TNI-compliant PT studies for each accreditation field of proficiency testing as required by 1VAC30-46-210 B (for primary accreditation only);

o. Quality assurance manual (for primary accreditation only);

p. Copy of the primary certificate of accreditation for secondary accreditation applications; and

q. 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 1VAC30-46-150.

3. Certification of compliance.

a. The application shall include a "Certification of Compliance" statement signed and dated by (i) the quality assurance officer, and (ii) the responsible official or the technical manager, or both.

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 accreditation program regulation (1VAC30 Chapter 46) and is subject to the provisions of 1VAC30-46-100 in the event of noncompliance. Specifically the applicant:

(1) Shall commit to fulfill continually the requirements for accreditation set by DCLS for the areas where accreditation is sought or granted.

(2) When requested, shall afford such accommodation and cooperation as is necessary to enable DCLS to verify fulfillment of requirements for accreditation. This applies to all premises where laboratory services take place.

(3) Shall provide access to information, documents, and records as necessary for the assessment and maintenance of the accreditation.

(4) Shall provide access to those documents that provide insight into the level of independence and impartiality of the laboratory from its related bodies, where applicable.

(5) Shall arrange the witnessing of laboratory services when requested by DCLS.

(6) Shall claim accreditation only with respect to the scope for which it has been granted accreditation.

(7) Shall pay fees as shall be determined by the accreditation body.

(8) Shall have access to a copy of the TNI standards incorporated by reference into this chapter.

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 or withdrawal of accreditation. I 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 the 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 accreditation pending final determination on application.

1. DCLS shall grant interim accreditation status to laboratories applying initially under the following conditions:

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

b. The laboratory has satisfied all the requirements for accreditation, 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 accreditation status shall have the same rights and status as a laboratory that has been granted accreditation by DCLS.

3. Interim accreditation status shall not exceed 12 months.

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 1VAC30-46-220 prior to issuance of a final determination on accreditation.

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

K. Grant of accreditation.

1. When a laboratory meets the requirements specified for receiving accreditation, DCLS shall issue a certificate to the laboratory. The certificate shall be sent to the technical manager, and the responsible official shall be notified.

2. The director of DCLS or his designee shall sign the certificate.

3. 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 accreditation (matrix, technology/method, and analyte) for which accreditation is granted;

g. Any addenda or attachments; and

h. Issuance date and expiration date.

4. TNI accreditation status.

a. Laboratories accredited under this chapter are accredited under the standards of TNI.

b. The certificate of accreditation shall contain the TNI insignia.

c. Accredited laboratories shall comply with the provisions of 1VAC30-46-130 with regard to the use of these certificates and their status as TNI-accredited laboratories.

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

6. Accreditation shall expire one year after the date on which accreditation is granted.

L. Denial of accreditation.

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

2. Denial of accreditation in total or in part.

a. DCLS may deny accreditation 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 1VAC30-46-210 A;

(3) Successfully analyze and report proficiency testing samples as required by 1VAC30-46-210 B;

(4) Submit a corrective action plan in accordance with 1VAC30-46-220 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 time frame specified by DCLS;

(6) Pass required on-site assessment as specified in 1VAC30-46-220; or

(7) Implement a quality system as defined in 1VAC30-46-210 C.

b. DCLS may deny accreditation to an environmental laboratory in total or in part if the laboratory's application is not determined to be complete within 90 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 accreditation 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 1VAC30-46-220 because a representative of the environmental laboratory denied the team entry during the laboratory's normal business hours that it specified in the laboratory application.

3. DCLS shall follow the process specified in 1VAC30-46-110 when denying accreditation to an environmental laboratory.

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

1 Va. Admin. Code § 30-46-70

Derived from Virginia Register Volume 25, Issue 7, eff. January 1, 2009; Amended, Virginia Register Volume 32, Issue 01, eff. 11/1/2015; Amended, Virginia Register Volume 38, Issue 12, eff. 4/1/2022.

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