reglab/statecodes huggingface dataset:
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-80 - Maintaining certification

Current through Register Vol. 40, No. 24, July 15, 2024
A.
				  Certification remains in effect until withdrawn by DCLS, withdrawn voluntarily
				  at the written request of the certified laboratory, or until expiration of the
				  certification period. To maintain certification, the certified laboratory shall
				  comply with the elements listed in this section and in
				  1VAC30-45-90.
B. Quality systems. Laboratories seeking to
				  maintain certification under this chapter shall assure consistency and promote
				  the use of quality assurance and quality control procedures. Article 4
				  (1VAC30-45-600 et seq.) of Part II
				  of this chapter specifies the quality assurance and quality control
				  requirements that shall be met to maintain certification.
C. Proficiency tests. Laboratories seeking to
				  maintain certification under this chapter shall perform proficiency tests as
				  required under Article 3 (1VAC30-45-500 et seq.)
				  of Part II of this chapter.
D.
				  Recordkeeping and retention. All laboratory records associated with
				  certification parameters shall be kept as provided by the requirements for
				  records under Part II (1VAC30-45-200 et seq.)
				  of this chapter. These records shall be maintained for a minimum of three years
				  unless the records are required to be maintained for a longer period by another
				  section of this regulation or another regulation. All such records shall be
				  available to DCLS upon request.
Statutory Authority: § 2.2-1105 of the Code of
						Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-90 - Notifications and changes to certification elements and status

Current through Register Vol. 40, No. 24, July 15, 2024
A. Changes to key
				  certification criteria. The certified laboratory shall notify DCLS in writing
				  of any changes in key certification criteria within 30 calendar days of the
				  change. Key certification criteria are laboratory ownership, location, key
				  personnel, and major instrumentation.
B. Changes to scope of certification.
1. DCLS may approve a laboratory's
				  application to add a new matrix, technology, analyte, or test method to a
				  laboratory's scope of certification or to otherwise modify the laboratory's
				  scope of certification by performing a data review.
2. To apply, the owner of the certified
				  laboratory shall submit the following to DCLS:
a. A written request signed by the owner that
				  briefly summarizes the addition to be made to the laboratory's scope of
				  certification.
b. Pertinent
				  information demonstrating the laboratory's capability to perform the additional
				  matrix, technology/method, or analyte, such as proficiency testing performance
				  and quality control performance.
c.
				  A written standard operating procedure covering the new matrix,
				  technology/method, or analyte.
3. DCLS may approve a laboratory's
				  application for modification to its scope of certification by performing a
				  review of the application materials submitted, without an on-site assessment.
				  The addition of a technology or test method requiring the use of specific
				  equipment may require an on-site assessment. Other reviews of performance and
				  documentation may be carried out by DCLS depending on the modification for
				  which the laboratory applies.
4.
				  Within 90 calendar days of the receipt of the application from the certified
				  environmental laboratory, DCLS shall review and determine whether the proposed
				  modification may be approved.
5. If
				  the proposed modification to the laboratory's scope of certification is
				  approved, DCLS shall amend the laboratory's certificate of
				  certification.
6. DCLS shall not
				  send the amended certificate of certification to the laboratory until DCLS
				  receives the payment of the fee required under
				  1VAC30-45-130 F 1.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-95 - Suspension of certification

Current through Register Vol. 40, No. 24, July 15, 2024
A. DCLS
				  may suspend certification from an environmental laboratory in total or in part
				  to allow the laboratory time to correct the reason for which DCLS may withdraw
				  certification. Suspension is limited to the reasons listed in subsection B of
				  this section.
B. DCLS may suspend
				  certification from an environmental laboratory in part or in total when the
				  laboratory has failed to do any of the following:
1. Participate in the proficiency testing
				  program as required by Article 3 (1VAC30-45-500
				  et seq.) of Part II of this chapter.
2. Satisfactorily complete proficiency
				  testing studies as required by Article 3 (1VAC30-45-500
				  et seq.) of Part II of this chapter.
3. Submit an acceptable corrective action
				  plan after two opportunities as specified in
				  1VAC30-45-390.
4. Maintain a quality system as defined in
				  Article 4 (1VAC30-45-600 et
				  seq.) of Part II of this chapter.
5. Employ staff that meets the personnel
				  qualifications of Article 1 (1VAC30-45-200
				  et seq.) of Part II of this chapter.
6. Notify DCLS of any changes in key
				  certification criteria as set forth in
				  1VAC30-45-90.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-100 - Decertification

Current through Register Vol. 40, No. 24, July 15, 2024
A. DCLS shall
				  decertify an environmental laboratory in total if the laboratory is found to be
				  falsifying any data or providing false information to support
				  certification.
B. DCLS may
				  decertify an environmental laboratory in part or in total when the laboratory
				  has failed to do any of the following:
1.
				  Participate in the proficiency testing program as required by Article 3
				  (1VAC30-45-500
				  et seq.) of Part II of this chapter.
2. Satisfactorily complete proficiency
				  testing studies as required by Article 3 (1VAC30-45-500
				  et seq.) of Part II of this chapter.
3. Maintain a quality system as defined in
				  Article 4 (1VAC30-45-600 et
				  seq.) of Part II of this chapter.
4. Employ staff that meets the personnel
				  qualifications in Article 1 (1VAC30-45-200
				  et seq.) of Part II of this chapter.
5. Submit an acceptable corrective action
				  plan after two opportunities as specified in
				  1VAC30-45-390.
6. Implement corrective action specified in
				  the laboratory's corrective action plan as set out under
				  1VAC30-45-390.
7. Correct the causes of suspension within
				  the term of suspension.
8. Notify
				  DCLS of any changes in key certification criteria as set forth in
				  1VAC30-45-90.
9. Use accurate references to the
				  laboratory's certification status in the laboratory's documentation.
10. Allow a DCLS assessment team entry during
				  normal business hours to conduct an on-site assessment required by Article 2
				  (1VAC30-45-300
				  et seq.) of Part II of this chapter.
11. Pay the required fees specified in
				  1VAC30-45-130.
12. Meet the provisions regarding
				  communication with others in
				  1VAC30-45-510
				  C.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-110 - Procedures to deny certification or decertify a laboratory; appeal procedures

Current through Register Vol. 40, No. 24, July 15, 2024
A.
				  Notification.
1. If DCLS becomes aware of a
				  cause to deny certification or to decertify an environmental laboratory, DCLS
				  shall notify the environmental laboratory in writing of this information and
				  require a response from the responsible official. DCLS shall send this
				  notification by certified mail to the responsible official and provide a copy
				  to the manager of the environmental laboratory.
2. For a potential denial of certification,
				  the notice shall state that the laboratory has failed to meet the 1VAC30-45
				  standards and shall specify one or more of the reasons for denial of
				  certification under
				  1VAC30-45-70 L, providing a
				  detailed explanation of the basis for the denial of certification.
3. For a potential decertification, the
				  notice shall state that the laboratory has failed to meet the 1VAC30-45
				  standards and shall specify one or more of the reasons for decertification
				  under 1VAC30-45-100 A or B, providing a
				  detailed explanation of the basis for decertification.
4. In its notice, DCLS shall request the
				  laboratory to notify DCLS in writing if the laboratory believes the agency is
				  incorrect in its determination. Before rendering a decision on decertification
				  or denial of certification, DCLS shall provide the opportunity for the
				  laboratory to meet with DCLS in an informal fact-finding proceeding pursuant to
				  § 2.2-4019 of the Code of Virginia.
5. If the laboratory believes DCLS to be
				  incorrect in its determination, the laboratory shall provide DCLS with a
				  detailed written demonstration of why DCLS should not deny certification to or
				  decertify the laboratory. The laboratory shall include this demonstration in
				  the response required under subdivision 6 of this subsection.
6. The laboratory shall provide DCLS with a
				  written response within 30 calendar days of the date of notification from DCLS.
				  The laboratory shall indicate whether it disputes the DCLS determination
				  provided in the agency notice and whether the laboratory requests an informal
				  fact-finding proceeding. If the laboratory does not respond, DCLS shall render
				  its case decision.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-120 - Exemptions

Current through Register Vol. 40, No. 24, July 15, 2024
A. DCLS may grant a
				  partial or full exemption from the requirements of this chapter based on
				  compliance and performance.
B. DCLS
				  may consider granting an exemption if a laboratory applies for an exemption and
				  has met all certification requirements for a period of four consecutive
				  years.
C. An environmental
				  laboratory may apply for an exemption by submitting a request. The request
				  shall include the following information:
1.
				  The scope of the requested exemption;
2. Whether the exemption should be partial or
				  total;
3. If partial, what form the
				  exemption will take; and
4. Why the
				  exemption is appropriate.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-130 - Fees

Current through Register Vol. 40, No. 24, July 15, 2024
A. General.
1. Environmental laboratories shall pay a fee
				  with all applications, including reapplications, for certification. DCLS shall
				  not designate an application as complete until it receives payment of the
				  fee.
2. Each certified
				  environmental laboratory shall pay an annual fee to maintain its certification.
				  DCLS shall send an invoice to the certified environmental laboratory.
3. Fees shall be nonrefundable.
4. DCLS, as part of its regular budgetary
				  review of the program, shall determine whether the fees charged under this
				  section offset the program costs as required under § 2.2-1105 of the Code of
				  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part I - General Provisions › Section 1VAC30-45-140 - Petitioning for a variance

Current through Register Vol. 40, No. 24, July 15, 2024
A. Any
				  person regulated by this chapter may petition the director to grant a variance
				  from any requirement of this chapter. Any person submitting a petition to the
				  director shall meet the provisions of this section. Any petition submitted to
				  the director is subject to the Virginia Administrative Process Act (§ 2.2-4000
				  et seq. of the Code of Virginia).
B. The petition shall be submitted to the
				  director by certified mail and shall include:
1. The petitioner's name and
				  address;
2. A statement of the
				  petitioner's interest in the proposed action;
3. A description of desired action and a
				  citation of the regulation from which a variance is requested;
4. A description of need and justification
				  for the proposed action, including impact of the proposed action on the
				  laboratory's operation;
5.
				  Information demonstrating that the requested variance will meet the purposes
				  and objectives of the relevant regulatory provision and of § 2.2-1105 of the
				  Code of Virginia (Environmental Laboratory Certification Program);
6. The duration of the variance, if
				  applicable;
7. The potential impact
				  of the variance on public health or the environment;
8. Other information believed by the
				  applicant to be pertinent; and
9.
				  The following statement signed by the petitioner or authorized representative:
				  "I certify that I have personally examined and am familiar with the information
				  submitted in this petition and all attached documents, and that, based on my
				  inquiry of those individuals immediately responsible for obtaining the
				  information, I believe that the submitted information is true, accurate, and
				  complete. I am aware that there are significant penalties for submitting false
				  information, including the possibility of fine and imprisonment."
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 1 - Personnel › Section 1VAC30-45-200 - Laboratory manager

Current through Register Vol. 40, No. 24, July 15, 2024
A. Laboratory
					 manager - general.
1. Each environmental
					 laboratory shall designate a person to be responsible for the general oversight
					 of the operation of the laboratory in accordance with this chapter, including
					 the day-to-day functioning and administration of the laboratory, the technical
					 operations, supervision of laboratory procedures, reporting of laboratory
					 results, and implementation of any corrective actions.
2. The title of this person may include but
					 is not limited to laboratory director, technical director, laboratory
					 supervisor or laboratory manager.
3. A laboratory may appoint one or more
					 technical directors for the appropriate fields of certification for which the
					 laboratory seeks certification.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 1 - Personnel › Section 1VAC30-45-210 - Quality assurance officer

Current through Register Vol. 40, No. 24, July 15, 2024
A.
					 The laboratory shall have a quality assurance officer who shall be responsible
					 for the quality system and its implementation. Where staffing is limited, the
					 quality assurance officer may also be the laboratory manager. The quality
					 assurance officer may be employed on a part-time basis or be a
					 consultant.
B. The quality
					 assurance officer shall have documented training or experience in quality
					 assurance and quality control procedures and be knowledgeable in the quality
					 system as defined in Article 4 (1VAC30-45-600 et seq.)
					 of Part II of this chapter. The quality assurance officer shall have a general
					 knowledge of the analytical test methods for which data review is
					 performed.
C. The responsibilities
					 of the quality assurance officer shall include, but not be limited to, the
					 implementation and oversight of the quality system, the implementation of new
					 quality assurance and control practices, periodic audits of the quality system
					 in place, periodic review of final data reports, and documentation of
					 laboratory quality system deficiencies.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 1 - Personnel › Section 1VAC30-45-220 - Laboratory personnel requirements and management responsibilities

Current through Register Vol. 40, No. 24, July 15, 2024
A. The laboratory
					 shall have sufficient personnel, having the necessary education, training,
					 technical knowledge and experience for their assigned functions.
B. The laboratory manager shall ensure that
					 the training of the laboratory personnel is kept up to date.
C. Laboratory personnel shall be responsible
					 for complying with all quality systems requirements set out in Article 4
					 (1VAC30-45-600 et seq.) of Part II
					 of this chapter that are pertinent to their assigned functions.
D. The laboratory manager shall ensure that
					 laboratory personnel have demonstrated initial and ongoing capability to
					 perform their assigned functions. See
					 1VAC30-45-730 E and F.
E. Records on the relevant qualifications,
					 training skills and experience of the laboratory personnel, including records
					 on demonstrated proficiency for each test method, shall be maintained by the
					 laboratory manager.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 1 - Personnel › Section 1VAC30-45-230 - Absence of laboratory manager

Current through Register Vol. 40, No. 24, July 15, 2024
When a laboratory manager will be absent for a period
						exceeding 15 consecutive calendar days, the laboratory shall designate a
						qualified replacement to perform the manager's function.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-300 - Frequency of on-site assessment

Current through Register Vol. 40, No. 24, July 15, 2024
A. Frequency.
1. A comprehensive on-site assessment shall
					 be conducted of each laboratory as a condition for granting certification
					 initially .
2. DCLS shall reassess
					 each certified laboratory at least once every three years starting from the
					 date of the previous assessment plus or minus six months.
3. DCLS may conduct an on-site assessment of
					 a laboratory every two years plus or minus six months under any of the
					 following circumstances:
a. When a laboratory
					 has received "not acceptable" PT results.
b. When a laboratory's corrective action
					 presented to VELAP for "not acceptable" PT studies does not identify and
					 correct the root cause of the PT study failure.
c. When DCLS has suspended certification for
					 a laboratory in full or in part.
d.
					 When on-site observations include nonconformances previously identified at an
					 on-site assessment, indicating the corrective action was not implemented or not
					 maintained.
e. When on-site
					 observations include failure to qualify nonconforming data to the data
					 user.
f. When on-site observations
					 indicate the laboratory's failure to monitor and maintain regulatory
					 conformance in documentation, traceability, or quality control requirements
					 such that data generated by the laboratory are of questionable quality or
					 defensibility.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-310 - Announced and unannounced on-site assessments

Current through Register Vol. 40, No. 24, July 15, 2024
A. DCLS may conduct, at its discretion,
					 either announced or unannounced on-site assessments.
B. Advance notice of an assessment shall not
					 be necessary.
C. To the maximum
					 extent practical, DCLS, when necessary, shall work with the owner of an
					 environmental laboratory to obtain government security clearances for
					 assessment personnel as far in advance as possible. The owner of the
					 environmental laboratory shall facilitate expeditious attainment of the
					 necessary clearances.
D. To the
					 maximum extent practical, assessment personnel shall minimize disruption of a
					 laboratory's operations and take into account competing demands on the time of
					 laboratory personnel.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-320 - Request for records

Current through Register Vol. 40, No. 24, July 15, 2024
Prior to the actual site visit, DCLS may request in
						writing from a laboratory those records required to be maintained by this
						chapter.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-330 - Areas to be assessed

Current through Register Vol. 40, No. 24, July 15, 2024
DCLS shall assess the laboratory against the personnel
						and quality control standards in Article 1 (1VAC30-45-200 et seq.) and Article
						4 (1VAC30-45-600 et seq.) of this
						part. The specific areas evaluated in an on-site assessment shall include but
						not be limited to:
1. Adequacy of the
					 laboratory facility.
2.
					 Organization and management of the laboratory.
3. Qualifications and experience of
					 laboratory personnel.
4. Receipt,
					 tracking and handling of samples.
5. Quantity, condition, and performance of
					 laboratory instrumentation and equipment.
6. Preparation and traceability of
					 calibration standards.
7. Test
					 methods (including the adequacy of the laboratory's standard operating
					 procedures as well as confirmation of the analyst's adherence to SOPs, and the
					 analyst's proficiency with the described task).
8. Data reduction procedures, including an
					 examination of raw data and confirmation that final reported results can be
					 traced to the raw data/original observations.
9. Quality assurance and quality control
					 procedures, including adherence to the laboratory's quality assurance plan and
					 adequacy of the plan.
10.
					 Recordkeeping.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-340 - National security considerations

Current through Register Vol. 40, No. 24, July 15, 2024
A. Assessments at facilities owned or
					 operated by federal agencies or contractors may require security clearances,
					 appropriate badging, or a security briefing before the assessment
					 begins.
B. The laboratory shall
					 notify DCLS in writing of any information that is controlled for national
					 security reasons and cannot be released to the public.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-350 - Arrival, admittance, and opening conference

Current through Register Vol. 40, No. 24, July 15, 2024
A. Arrival. Assessment personnel shall arrive
					 at the laboratory during established working hours. The laboratory manager (or,
					 if unavailable, the laboratory manager's designee) shall be located as soon as
					 possible after the assessment personnel arrive on the premises.
B. Admittance of assessment personnel.
1. A laboratory's refusal to admit the
					 assessment personnel for an on-site assessment shall result in an automatic
					 failure of the laboratory to receive certification or loss of an existing
					 certification by the laboratory, unless there are extenuating circumstances
					 that are accepted and documented by DCLS. The team leader for the assessment
					 personnel shall notify DCLS as soon as possible after refusal of
					 entry.
2. DCLS shall consider any
					 verbal or physical threat to the health and safety of its assessors or any
					 overt antagonism towards its assessors as a refusal to admit the assessors for
					 the purpose of on-site assessment. The assessors shall vacate the laboratory
					 and shall notify DCLS as soon as possible of the circumstances of this refusal
					 to admit. This refusal to admit shall result in an automatic failure of the
					 laboratory to receive certification or the automatic loss of an existing
					 certification by the laboratory.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-360 - On-site laboratory records review and collection

Current through Register Vol. 40, No. 24, July 15, 2024
A. Records shall be reviewed by assessment
					 personnel for accuracy, completeness and the use of proper methodology for each
					 analyte and test method to be evaluated.
B. Records required to be maintained pursuant
					 to this chapter shall be examined as part of an assessment for
					 certification.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-370 - Observations of and interviews with laboratory personnel

Current through Register Vol. 40, No. 24, July 15, 2024
A. As an element of the assessment process,
					 the assessment team shall evaluate an analysis regimen by requesting that the
					 analyst normally conducting the procedure give a step-by-step description of
					 exactly what is done and what equipment and supplies are needed to complete the
					 regimen. Any deficiencies shall be noted and discussed with the analyst. In
					 addition, the deficiencies shall be discussed in the closing
					 conference.
B. Assessment personnel
					 may conduct interviews with appropriate laboratory personnel.
C. Calculations, data transfers, calibration
					 procedures, quality control and quality assurance practices, adherence to test
					 methods, and report preparation shall be assessed for the complete scope of
					 certification with appropriate laboratory analysts.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-380 - Closing conference

Current through Register Vol. 40, No. 24, July 15, 2024
A.
					 Assessment personnel shall meet with representatives of the laboratory
					 following the assessment for a closing conference.
B. During the closing conference, assessment
					 personnel shall inform the laboratory of the preliminary findings and the basis
					 for such findings. The laboratory shall have an opportunity to provide further
					 explanation or clarification relevant to the preliminary findings. If the
					 laboratory objects to the preliminary findings during the closing conference,
					 all objections shall be documented by the assessment personnel and included in
					 the final report to DCLS.
C.
					 Additional problem areas may be identified in the final report.
D. Any potentially illegal activity that may
					 be the subject of further action shall not be discussed in the closing
					 conference.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-390 - Follow-up and reporting procedures

Current through Register Vol. 40, No. 24, July 15, 2024
A. DCLS shall present an assessment report to
					 the laboratory within 30 calendar days of the assessment.
B. If there are deficiencies identified in
					 the assessment report, the laboratory shall have 30 calendar days from the date
					 of its receipt of the assessment report to provide a response to DCLS. This
					 response shall be called a corrective action plan.
C. An exception to the deadlines specified in
					 subsections A and B of this section may occur in appropriate circumstances. Two
					 circumstances that may be considered appropriate by DCLS are where a possible
					 enforcement investigation or other action has been initiated or where the
					 laboratory shows good cause for an extension.
D. The corrective action plan shall include
					 the following:
1. Any objections that the
					 laboratory has with regard to the assessment report;
2. The action that the laboratory proposes to
					 implement to correct each deficiency identified in the assessment report;
					 and
3. The time period required to
					 accomplish the corrective action.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 2 - On-Site Assessment › Section 1VAC30-45-400 - Documentation of on-site assessment

Current through Register Vol. 40, No. 24, July 15, 2024
A. Checklists. The checklists used by
					 assessment personnel during the assessment shall become a part of DCLS's file
					 for the laboratory.
B. Assessment
					 report format.
1. The final assessment report
					 shall contain a narrative description of the adequacy of the laboratory as it
					 relates to the assessment standards specified in this chapter and in
					 1VAC30-45-330.
2. Assessment reports shall contain:
a. Name of owner of the laboratory (or
					 operator of the laboratory, if different from the owner);
b. Identification of the laboratory
					 assessed;
c. Date of the
					 assessment;
d. Identification and
					 affiliation of all assessment personnel;
e. Identification of participants in the
					 assessment process;
f.
					 Identification of analytes and test methods assessed;
g. Statement of the objective of the
					 assessment;
h. Summary;
i. Assessment observations, findings
					 (including any deficiencies), objections noted by the laboratory, and
					 requirements; and
j. Comments and
					 recommendations.
3. The
					 assessment findings and requirements shall be referenced to the standards in
					 Part II (1VAC30-45-200 et seq.) of this
					 chapter so that both the finding is understood and the specific requirement is
					 outlined. The assessor shall specify the laboratory records, documents,
					 equipment, procedures, or staff evaluated and the observations that contributed
					 to each identified deficiency. The assessment report shall support with
					 sufficient data all assessment findings and the overall evaluation of the
					 laboratory.
4. The comments and
					 recommendations section may be used to convey recommendations aimed at helping
					 the laboratory improve.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 3 - Proficiency Testing › Section 1VAC30-45-500 - Laboratory enrollment in proficiency testing program

Current through Register Vol. 40, No. 24, July 15, 2024
A. Required level of participation.
1. To be certified initially and to maintain
					 certification, a laboratory shall participate in PT studies as specified in
					 1VAC30-45-520 B for the fields of
					 certification (FoC) for which the laboratory seeks or wants to maintain
					 certification.
2. The applicant
					 laboratory shall obtain PT samples from a PT provider approved by TNI. If a PT
					 sample is not available from a TNI-approved provider, the laboratory shall
					 consult DCLS for an approved provider.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 3 - Proficiency Testing › Section 1VAC30-45-510 - Requirements for laboratory testing of PT study samples

Current through Register Vol. 40, No. 24, July 15, 2024
A. The laboratory shall report the analytical
					 results from its analysis of the PT study to the PT provider on or before the
					 closing date of the study using the reporting format specified by the PT
					 provider.
B. The laboratory's
					 management and all analysts shall ensure that all PT samples are managed,
					 analyzed, and reported in the same manner as real environmental samples
					 utilizing the same staff, methods as used for routine analysis of that analyte,
					 procedures, equipment, and facilities. When analyzing a PT sample, the
					 laboratory shall employ the same calibration, laboratory quality control and
					 acceptance criteria, sequence of analytical steps, number of replicates and
					 other procedures as used when analyzing routine samples.
C. Restrictions on exchanging information.
					 Laboratories shall comply with all of the following restrictions on the
					 transfer of PT samples and communication of PT sample results prior to the time
					 the results of the study are released. Laboratory management or staff shall
					 not:
1. Send any PT sample, or a portion of a
					 PT sample, to another laboratory for any analysis for which it seeks
					 certification or is certified.
2.
					 Knowingly receive any PT sample or portion of a PT sample from another
					 laboratory for any analysis for which the sending laboratory seeks
					 certification or is certified.
3.
					 Communicate with any individual at another laboratory (including intra-company
					 communication) concerning the PT sample.
4. Attempt to obtain the assigned value of
					 any PT sample from their PT provider.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 3 - Proficiency Testing › Section 1VAC30-45-520 - PT criteria for laboratory certification

Current through Register Vol. 40, No. 24, July 15, 2024
A. Result categories.
1. The criteria described in this section
					 apply individually to each FoPT, as defined by the laboratory seeking to obtain
					 or maintain certification in its certification request. These criteria apply
					 only to the PT portion of the overall certification standard.
2. There are two PT result categories:
					 "acceptable" and "not acceptable."
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 3 - Proficiency Testing › Section 1VAC30-45-530

Current through Register Vol. 40, No. 24, July 15, 2024
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-600 - Quality system

Current through Register Vol. 40, No. 24, July 15, 2024
A. This article
					 sets out the general requirements that an environmental laboratory has to
					 successfully demonstrate to be recognized as competent to carry out specific
					 environmental tests. The environmental laboratory shall establish, implement
					 and maintain a quality system based on the required elements contained in this
					 article.
B. The quality system
					 shall be appropriate to the type, range and volume of testing, analysis,
					 measurement or monitoring performed by the laboratory.
C. The quality system's documentation shall
					 be communicated to, understood by, available to, and implemented by the
					 appropriate personnel. All personnel concerned with testing and calibration
					 activities within the laboratory shall familiarize themselves with the quality
					 documentation and implement the policies and procedures in their
					 work.
D. If more stringent
					 standards or requirements are included in a mandated test method or by
					 regulation, the laboratory shall demonstrate that such requirements are met. If
					 it is not clear which standard or requirement is more stringent, the standard
					 or requirement from the method or regulation is to be followed.
E. Provisions pertaining to the management of
					 the quality system appear in
					 1VAC30-45-610 through
					 1VAC30-45-700. Provisions
					 pertaining to the technical requirements for the quality system appear in
					 1VAC30-45-710 through
					 1VAC30-45-770.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-610 - Quality manual

Current through Register Vol. 40, No. 24, July 15, 2024
A. General.
1. The laboratory shall document its quality
					 system in a quality manual. The quality manual shall reflect all quality
					 assurance and quality control practices and programs used by the laboratory.
					 The required elements of the quality system may be described in more than one
					 document.
2. The quality manual
					 shall be maintained current under the responsibility of the quality assurance
					 officer.
3. The quality manual and
					 any related documents shall be communicated to, understood by, available to,
					 and implemented by all laboratory personnel.
4. The quality manual shall include but not
					 be limited to the elements listed in subsections B and C of this
					 section.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-620 - Organization

Current through Register Vol. 40, No. 24, July 15, 2024
The laboratory shall specify and document the functional
						responsibility, level of authority, and interrelationship or lines of
						communication of all personnel who manage, perform or verify work affecting the
						quality of tests, analyses, measurements and monitoring. One person may cover
						more than one organizational function. Each manager and employee of the
						laboratory shall have a clear understanding of his or her duties and
						responsibilities and the relationship of those responsibilities to the overall
						work of the laboratory.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-630 - Records

Current through Register Vol. 40, No. 24, July 15, 2024
The laboratory shall maintain a record system to suit its
						particular circumstances and comply with any applicable regulations. This
						system shall produce unequivocal, accurate records that document all laboratory
						activities.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-640 - Recordkeeping system and design

Current through Register Vol. 40, No. 24, July 15, 2024
A.
					 The laboratory shall have a recordkeeping system that allows historical
					 reconstruction of all laboratory activities that produced the analytical data.
					 The history of the sample shall be readily understood through the
					 documentation. This shall include inter-laboratory transfers of samples or
					 extracts or both.
B. The records
					 shall include the identity of personnel involved in sampling, sample
					 preservation, sample receipt, preparation, calibration or testing, all
					 documentation sent by the person transmitting the sample, including a chain of
					 custody record form, if utilized.
C. The laboratory shall document all
					 information relating to the laboratory facility's equipment, analytical test
					 methods, and related laboratory activities, such as sample receipt, sample
					 preparation, or data verification.
D. The laboratory shall have a recordkeeping
					 system that facilitates the retrieval of all working files and archived records
					 for inspection and verification purposes, e.g., set format for naming
					 electronic files.
E. Responsible
					 staff shall sign or initial all changes to records. The reason for the
					 signature or initials shall be clearly indicated in the records such as
					 "sampled by," "prepared by," or "reviewed by."
F. All generated data except those that are
					 generated by automated data collection systems, shall be recorded directly,
					 promptly and legibly in permanent ink.
G. Entries in records shall not be
					 obliterated by methods such as erasures, overwritten files or markings. All
					 corrections to recordkeeping errors shall be made by one line marked through
					 the error. The individual making the correction shall sign or initial and date
					 the correction. These criteria also shall apply to electronically maintained
					 records.
H. The laboratory shall
					 keep computer and electronic data records in accordance with the pertinent
					 provisions of this section,
					 1VAC30-45-650 C and E and
					 1VAC30-45-730 K.
Statutory Authority
§ 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-650 - Records management and storage

Current through Register Vol. 40, No. 24, July 15, 2024
A. The laboratory shall keep all records,
					 certificates, and reports as required by applicable state and federal
					 recordkeeping laws and regulations. The laboratory shall safely store these
					 records and hold them secure.
B.
					 The laboratory shall retain all records for a minimum of three years from
					 generation of the last entry in the records, or longer, if required by an
					 applicable regulatory program, whichever is greater. The laboratory shall
					 maintain all information necessary for the historical reconstruction of data,
					 including all original observations, calculations and derived data, calibration
					 records and a copy of the test report.
C. Records that are stored only on electronic
					 media shall be supported by the hardware and software necessary for their
					 retrieval. Records that are stored or generated by computers or personal
					 computers shall have hard copy or write-protected backup copies.
D. The laboratory shall establish a record
					 management system for control of laboratory notebooks, instrument logbooks,
					 standards logbooks, and records for data reduction, validation storage and
					 reporting.
E. The laboratory shall
					 protect these records against fire, theft, loss, environmental deterioration,
					 vermin and, in the case of electronic records, electronic or magnetic
					 sources.
F. The laboratory shall
					 have a plan to ensure that the records are maintained or transferred in the
					 event that a laboratory transfers ownership or goes out of business. In
					 addition, in cases of bankruptcy, the laboratory shall follow appropriate
					 regulatory and state legal requirements concerning laboratory
					 records.
Statutory Authority: § 2.2-1105 of the Code of
						  Virginia.
Virginia Administrative Code › Title 1 - ADMINISTRATION › Agency 30 - DEPARTMENT OF GENERAL SERVICES › Chapter 45 - CERTIFICATION FOR NONCOMMERCIAL ENVIRONMENTAL LABORATORIES › Part II - Standards › Article 4 - Proficiency Testing › Section 1VAC30-45-660 - Required records

Current through Register Vol. 40, No. 24, July 15, 2024
A. Sample
					 handling.
1. The laboratory shall maintain a
					 record of all procedures to which a sample is subjected while in the possession
					 of the laboratory. These shall include but are not limited to all records
					 pertaining to sample preservation, identification, receipt, acceptance or
					 rejection, log-in, storage and tracking. The laboratory shall also maintain
					 sampling information on each sample. This includes time and date of collection,
					 type of sample (grab or composite), type of container, sampling point and
					 preservation.
2. The laboratory
					 shall have documented procedures for the receipt and retention of samples,
					 including provisions necessary to protect the integrity of the
					 samples.