Section 10. Purpose

Section 20. Establishment of certification program

Section 30. Applicability

Section 40. Definitions

Section 50. Scope of certification

Section 60. General: certification requirements

Section 70. Process to apply and obtain certification

Section 80. Maintaining certification

Section 90. Notifications and changes to certification elements and status

Section 95. Suspension of certification

Section 100. Decertification

Section 110. Procedures to deny certification or decertify a laboratory; appeal procedures

Section 120. Exemptions

Section 130. Fees

Section 140. Petitioning for a variance

Section 150. (Reserved)

Section 160. (Reserved)

Section 170. (Reserved)

Section 180. (Reserved)

Section 190. (Reserved)

Section 200. Laboratory manager

Section 210. Quality assurance officer

Section 220. Laboratory personnel requirements and management responsibilities

Section 230. Absence of laboratory manager

Section 240. (Reserved)

Section 250. (Reserved)

Section 260. (Reserved)

Section 270. (Reserved)

Section 280. (Reserved)

Section 290. (Reserved)

Section 300. Frequency of on-site assessment

Section 310. Announced and unannounced on-site assessments

Section 320. Request for records

Section 330. Areas to be assessed

Section 340. National security considerations

Section 350. Arrival, admittance, and opening conference

Section 360. On-site laboratory records review and collection

Section 370. Observations of and interviews with laboratory personnel

Section 380. Closing conference

Section 390. Follow-up and reporting procedures.

Section 400. Documentation of on-site assessment

Section 410. (Reserved)

Section 420. (Reserved)

Section 430. (Reserved)

Section 440. (Reserved)

Section 450. (Reserved)

Section 460. (Reserved)

Section 470. (Reserved)

Section 480. (Reserved)

Section 490. (Reserved)

Section 500. Laboratory enrollment in proficiency testing program

Section 510. Requirements for laboratory testing of PT study samples

Section 520. PT criteria for laboratory certification

Section 530. [Repealed]

Section 540. (Reserved)

Section 550. (Reserved)

Section 560. (Reserved)

Section 570. (Reserved)

Section 580. (Reserved)

Section 590. (Reserved)

Section 600. Quality system

Section 610. Quality manual

Section 620. Organization

Section 630. Records

Section 640. Recordkeeping system and design

Section 650. Records management and storage

Section 660. Required records

Section 670. Audits

Section 680. Subcontracting analytical samples

Section 690. Outside support services and supplies

Section 700. Complaints

Section 710. Environment and work areas

Section 720. Equipment and reference materials

Section 730. Test methods and standard operating procedures

Section 740. Measurement traceability and calibration

Section 750. Quality assurance

Section 760. Quality control requirements

Section 770. Chemical testing: positive and negative controls

Section 771. Chemical testing: limit of detection and limit of quantitation

Section 772. Chemical testing: data reduction

Section 773. Chemical testing: quality of standards and reagents

Section 774. Chemical testing: selectivity

Section 775. Chemical testing: constant and consistent test conditions

Section 780. [Repealed]

Section 781. [Repealed]

Section 782. [Repealed]

Section 783. [Repealed]

Section 784. [Repealed]

Section 785. [Repealed]

Section 786. [Repealed]

Section 787. [Repealed]

Section 788. [Repealed]

Section 789. (Reserved)

Section 790. Microbiology testing: general

Section 791. Microbiology testing: sterility checks and blanks, positive and negative controls

Section 792. Microbiology testing: test variability and reproducibility

Section 793. Microbiology testing: method evaluation

Section 794. Microbiology testing: test performance

Section 795. Microbiology testing: data reduction

Section 796. Microbiology testing: quality of standards, reagents, and media

Section 797. Microbiology testing: selectivity

Section 798. Microbiology testing: constant and consistent test conditions

Section 800. [Repealed]

Section 801. [Repealed]

Section 802. [Repealed]

Section 803. [Repealed]

Section 804. [Repealed]

Section 805. [Repealed]

Section 806. [Repealed]

Section 807. [Repealed]

Section 808. [Repealed]

Section 809. (Reserved)

Section 810. Air testing: general

Section 811. Air testing: negative and positive controls

Section 812. Air testing: analytical variability/reproducibility

Section 813. Air testing: method evaluation

Section 814. Air testing: limit of detection

Section 815. Air testing: data reduction

Section 816. Air testing: quality of standards and reagents

Section 817. Air testing: selectivity

Section 818. Air testing: constant and consistent test conditions

Section 819. (Reserved)

Section 820. [Repealed]

Section 821. [Repealed]

Section 822. [Repealed]

Section 823. [Repealed]

Section 824. [Repealed]

Section 825. [Repealed]

Section 826. [Repealed]

Section 827. [Repealed]

Section 828. [Repealed]

Section 829. [Repealed]

Section 830. (Reserved)

Section 840. (Reserved)

Section 850. Sample handling, sample acceptance policy, and sample receipt

Section 860. Laboratory report format and contents

Appendix 9998. FORMS (1VAC30-45)

Appendix 9999. DOCUMENTS INCORPORATED BY REFERENCE (1VAC30-45)