Clinical Laboratory Improvement Amendments

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U. S. through the Clinical Laboratory Improvement Amendments (CLIA). The objective of the CLIA program is to establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.

• DPHL CLIA Certification
• Email the completed CLIA Application to CLIA.delaware@delaware.gov or mail to DPH Laboratory.
• Visit the CLIA website for more information.
• Visit the CLIA FAQs page
• CLIA PT Requirements
• DPH Laboratory Procedure for Complaints
• DPH Laboratory Complaint Investigation Form

Environmental Protection Agency and Certification Program

The Environmental Protection Agency (EPA) regulates laboratories that analyze drinking water from public water systems. In protecting public health the EPA identifies contaminants regulated in drinking water. Public water systems provide water samples to be analyzed and the EPA sets regulatory limits for certain contaminants, including chemical and bacteriological. These contaminant standards are required by the Safe Drinking Water Act (SDWA). EPA works with states, tribes, and many other partners to implement these SDWA provisions. In order for the State of Delaware to maintain primacy with EPA as per the SDWA, the State of Delaware needs a laboratory certification program. One of the provisions of the laboratory certification program is that each certified drinking water laboratory must be inspected on a triennial basis. The personnel responsible for laboratory inspections are Laboratory Certification Officers (CO). In order to become certified as a CO, Environmental Laboratory staff must attend and pass the EPA Laboratory Certification Officers course provided by the EPA. To inspect a laboratory which analyzes drinking water for inorganic and/or organic chemistry and/or microbiology, a CO must be certified. Typically the CO performs inspections, writes reports, and makes recommendations regarding certification status of the laboratory to the Certifying Authority. All of the certification officers in Delaware function as full time employees within the laboratory. For laboratories operating in Delaware other than DPH, complaints may be directed to CLIA.delaware@delaware.gov.

• DPHL EPA Certification
• Visit the EPA website for more information.
• Learn About Drinking Water Laboratory Certification.
• Contact the Office of Drinking Water for Questions Regarding Laboratory Certification.
• EPA Certification of Laboratories that Analyze Drinking Water Samples to Ensure Compliance with Regulations.
• EPA Laboratory Certification Manual for Drinking Water.

Food and Drug Administration Milk Safety Program

The DPH Laboratory works with the Health Systems Protection’s Office of Food Protection, to ensure the public’s health by establishing minimum standards for those involved with the processing, transport and sale of milk and milk products in Delaware. To protect the health of Delawareans, the program conducts inspections, issues permits, and enforces the State of Delaware Milk Code.

The Food and Drug Administration (FDA) certified Laboratory Evaluation Officer (LEO) at DPHL performs annual evaluations of the dairy processing plants located in the state to ensure they meet the Drug Residue Testing responsibilities (Appendix N) of the current in use edition of the Grade "A" Pasteurized Milk Ordinance (PMO).

• Information regarding the FDA oversight of milk safety.
• Information regarding the DPH oversight of milk processing.

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