5 CCR 1005-1
DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT Laboratory Services Division ENVIRONMENTAL LABORATORY ACCREDITATION 5 CCR 1005-1 [Editor’s Notes follow the text of the rules at the end of this CCR Document.] _________________________________________________________________________
1.1 Purpose and Scope.
The rules and regulations establish the minimum standards for environmental laboratories wishing accreditation to test samples under the Colorado Primary Drinking Water Regulations, and federal Safe Drinking Water Act (SDWA). Accreditation of laboratories is granted independently for each of the following: chemistry, microbiology, and radiochemistry. Under the Colorado Revised Statutes, Section 25- 1-107(l)(h), C.R.S. and Section 25-1-107(l)(x.5)(I), C.R.S., laboratory approval is delegated to the Department.
Through the rules and regulations, the Department affords laboratories accreditation for state requirements, federal requirements and interstate recognition (reciprocity) by adopting the SDWA standards in their entirety. The rules and regulations provide for reliable, accurate, and comparable laboratory data for public and environmental health monitoring and safety decisions.
1.2 Definitions.
“Accreditation” means official Department approval of a laboratory meeting SDWA standards. For the purposes of the rule and regulation “accreditation” is interchangeable with the term “certification”. Evidence of accreditation will be a document stating; the laboratory is accredited by the Department in one or more of the following: chemistry, microbiology, and/or radiochemistry. “Accrediting Authority” means the Territorial, State or Federal agency having responsibility and accountability for environmental laboratory accreditation. “Colorado Primary Drinking Water Regulations” means the Colorado Code of Regulations 5 CCR 1003-1 promulgated by the State Board of Health, pursuant to Part I of Title 25, Colorado Revised Statutes (C.R.S.), 1973.
“Department” means the Colorado Department of Public Health and Environment, Laboratory and Radiation Services Division.
“Laboratory Method” means a defined technical procedure for performing a test. “Primary accreditation” means approval of a laboratory based directly on Department accreditation authority and inspection processes.
“Proficiency testing” means the determination of laboratory performance by evaluation of analytical results on an interlaboratory comparison sample from an approved provider. “Reciprocity accreditation” means approval of a laboratory based on another accrediting authority's findings.
Code of Colorado Regulations 1 “Safe Drinking Water Act (SDWA)” means the enabling legislation under 42 U.S.C. 300f et seq. (Public Law 93-523) that requires EPA to protect the quality of drinking water by setting maximum allowable contaminant levels, monitor, and bring enforcement action for noncompliance. “United States Environmental Protection Agency (EPA)” means the federal agency with responsibility for the protection of public health and safeguarding and improving the natural environment upon which human life depends.
1.3 Accreditation of Environmental Laboratories
1.3.1 All environmental laboratories certified under the rules and regulations will meet:
1.3.2 Each laboratory wishing to obtain accreditation shall apply to the Department.
1.3.3 Application for accreditation shall be completed on forms furnished by the Department and shall contain all the information required by the form and any accompanying instructions.
1.3.4 Reapplications shall be submitted annually, at least 90 days before expiration of existing accreditation to assure continuous accreditation.
1.3.5 Laboratories holding letters or certificates of approval on the effective date of these regulations will remain certified until the expiration date of those approvals, unless voluntarily withdrawn, revoked, suspended or limited before that expiration date.
1.3.6 Laboratory accreditations will be issued annually based on submission of complete and acceptable application documents, and successful participation in proficiency test programs.
1.3.7 Laboratories may request primary or reciprocity accreditation.
1.4 Denial, Suspension. Limitation or Revocation of Accreditation.
The Department may deny, suspend, limit or revoke the accreditation of a laboratory based on: Code of Colorado Regulations 2
1.5 Notification of Violations, Hearings and Determinations.
All parties shall comply with the statutory requirements of the Administrative Procedures Act, Section 24- 4-105(7), C.R.S. Judicial review shall be in accordance with section 25-1-113, C.R.S. _________________________________________________________________________ Editor’s Notes History Code of Colorado Regulations 3