Md. Code Regs. 10.10.06.07

Current through Register Vol. 51, No. 26, December 27, 2024

Section 10.10.06.07 - Quality Control - Specialty and Subspecialty

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.

Md. Code Regs. 10.10.06.07

Regulations .07, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)
Regulation .07B amended effective June 1, 2009 (36:11 Md. R. 787)