Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 3. |
Subtitle 10. LABORATORIES |
Chapter 10.10.06. Medical Laboratories—Quality Assurance |
Sec. 10.10.06.05. Quality Control — General
Latest version.
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A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written quality control procedures for monitoring and evaluating the quality of the analytic phase of the testing process for each testing method and procedure to assure the accuracy and reliability of patient test results and reports.
B. Standard. A licensee shall ensure that the laboratory meets the applicable quality control standards as set forth in this chapter and in 42 CFR §§493.1200-493.1299.