Md. Code Regs. 10.10.06.01

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

Section 10.10.06.01 - General

A. Primary Standards. To obtain or maintain a permit to operate a laboratory, a person or licensee shall ensure that the laboratory:

(1) Establishes and follows written policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total, that is, preanalytic, analytic, and postanalytic phases of the testing process;

(2) Maintains a quality assurance program that:

(a) Continually evaluates the effectiveness of the laboratory's policies and procedures,

(b) Routinely revises policies and procedures based on the results of on-going evaluation,

(c) Identifies and corrects problems,

(d) Assures accurate, reliable, and prompt reporting of test results,

(e) Assures adequate and competent personnel, and

(f) Documents all quality assurance activities; and

(3) Establishes and maintains a laboratory safety program.

B. Standards. A licensee shall ensure that the laboratory:

(1) Meets the applicable:

(a) Quality assurance standards set forth in this chapter and in 42 CFR §§ 493.1230- 493.1299; and

(b) Quality testing standards for facility administration set forth in this chapter and in 42 CFR §§ 493.1100 -493 . 1101;

(2) Establishes, maintains, and enforces a laboratory safety program that:

(a) Provides all personnel with access to a safety manual covering the following topics, when applicable:

(i) General personnel safety,

(ii) Fire prevention and control,

(iii) Biological hazards,

(iv) Chemical hazards,

(v) Radiological hazards,

(vi) Special medical waste disposal, and

(vii) The reporting of incidents and accidents; and

(b) Complies with the following applicable federal Occupational Safety and Health Administration standards:

(i) "Occupational Exposure to Hazardous Chemicals in Laboratories", contained in 29 CFR § 1910.1450, and

(ii) "Bloodborne Pathogens," contained in 29 CFR § 1910.1030; and

(3) Maintains a collection station:

(a) As part of and under the direction of the laboratory for which it collects specimens; and

(b) With equipment and staff appropriate for the collection, preservation, storage, and maintenance of specimens in a manner suitable for later examination.

Md. Code Regs. 10.10.06.01

Regulations .01, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859)
Regulations .01, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)
Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787)