Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.06 - Medical Laboratories-Quality Assurance
Section 10.10.06.07 - Quality Control - Specialty and Subspecialty
Universal Citation: MD Code Reg 10.10.06.07
Current through Register Vol. 51, No. 19, September 20, 2024
A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written policies and procedures for a comprehensive quality control program that includes verification and assessment of accuracy, measurement of precision, and detection of error for all analyses and procedures performed by the laboratory.
B. Standards.
(1) General. A licensee shall ensure that the
laboratory meets the applicable quality control requirements for each specialty
and subspecialty under:
(a)42 CFR §§ 493.1200-
493.1299; and
(b) Regulations .07-.16 of this
chapter.
(2)
Cholesterol. A licensee or approved plan holder of a laboratory that performs
cholesterol tests shall ensure that the laboratory obtains and maintains
control samples at two levels, near or bracketing the 200 and 240
micrograms/deciliter decision levels.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
