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10.10.06.00.htm 10.10.06.00. Title 10 MARYLAND DEPARTMENT OF HEALTH Subtitle 10 LABORATORIES Chapter 06 Medical Laboratories ― Quality Assurance Authority: Health-General Article, §17-202, 17-202.1, 17-214, and 17-504, Annotated Code of Maryland
10.10.06.01.htm 10.10.06.01. 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:.
10.10.06.02.htm 10.10.06.02. 02 Authorization to Request Laboratory Tests.. A. Primary Standard. A laboratory may not perform a laboratory test, except under a health awareness permit or cholesterol permit, without obtaining written or electronic authorization from:1) A court of law;. 2) A doctor of medicine, osteopathy, podiatric medicine, or dentistry; or. 3) Another person authorized to order laboratory tests under the Annotated Code of Maryland..
10.10.06.03.htm 10.10.06.03. 03 Patient Test Management.. A. Primary Standard. A licensee shall ensure that the laboratory:. 1) Provides patient manipulation by qualified personnel; and. 2) Employs and maintains a quality assurance program that provides for:. a) Proper patient preparation;. b) Proper specimen:. i) Collection;. ii) Identification;. iii) Preservation;. iv) Transportation; and. v) Processing;. c) Record maintenance; and. d) Accurate reporting of results..
10.10.06.04.htm 10.10.06.04. 04 Reporting and Releasing Test Results.. A. Primary Standard. A laboratory shall report or release test results, except results of a health awareness test, only to an authorized person.B. Standards.. 1) For all test results except those from a health awareness test performed at a temporary laboratory or from a job-related alcohol or controlled dangerous substance test, a licensee shall ensure that the laboratory:a) Reports medical test results only to the physic
10.10.06.05.htm 10.10.06.05. 05 Quality Control ― General.. 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 standa
10.10.06.05-1.htm 10.10.06.05-1. 05-1 Quality Control ― Quality Control Program.. A. Primary Standard. A licensee shall develop, establish, implement, maintain, and follow quality control policies, procedures, and techniques that ensure accurate and reliable test results and patient test reports.B. Standard ― Quality Control Program. A licensee's quality control program shall:. 1) Cover all tests and related examinations and procedures performed by the laboratory; and.
10.10.06.06.htm 10.10.06.06. 06 Quality Control ― Single-Use Test Devices.. A. Primary Standard. This regulation applies to test systems that use single-use test devices as defined in COMAR 10.10.01.03B.1) General. A licensee shall ensure that the test system is validated on a continuing basis and that the ongoing validation includes:a) Calibration verification;. b) Parallel testing before or, when appropriate, instead of proficiency testing; and. c) Proficiency testing.. 2) Requirements of the Te
10.10.06.07.htm 10.10.06.07. 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 labor
10.10.06.08.htm 10.10.06.08. 08 Quality Control ― Job-Related Alcohol and Drug Testing.. A. Primary Standard. A licensee shall ensure that a laboratory has in place a quality assurance program designed to monitor and evaluate all phases of the testing process including but not limited to:1) Laboratory certification;. 2) Specimens, specimen collection, chain of custody, and transport;. 3) Security and controlled access;. 4) Storage and specimen retention;. 5) Analytical methods and procedures;.
10.10.06.09.htm 10.10.06.09. 09 Repealed..
10.10.06.10.htm 10.10.06.10. 10 Quality Control ― Cytology.. A. Primary Standard. A licensee of a laboratory offering to perform or performing tests in the subdiscipline of gynecologic cytology shall ensure that the laboratory:1) Limits the number of slides an individual may examine as set forth in 42 CFR §493.1274;. 2) Limits slide examination to the laboratory premises;. 3) Establishes a quality assurance program and follows written quality control procedures to monitor and evaluate the quality
10.10.06.11.htm 10.10.06.11. 11 Quality Control ― Dermatopathology.. A. Primary Standard. In addition to meeting the requirements of other applicable regulations of this subtitle, a licensee of a laboratory performing tests in the subdiscipline of dermatopathology shall ensure that the laboratory:1) Retains the services of either a:. a) Laboratory director who meets the qualifications in COMAR 10.10.07.04B(1) or. b) Technical supervisor who meets the qualifications in COMAR 10.10.07.05B(4).
10.10.06.12.htm 10.10.06.12. 12 Quality Control ― Temporary and Mobile Laboratories: General.. A. Primary Standard. The licensee shall ensure that a health awareness test or a job-related screening test for alcohol or controlled dangerous substances at a temporary or mobile laboratory is performed:1) Under effective supervision, quality control, and safety procedures;. 2) Using a previously evaluated analytical system; and. 3) For a job-related screening test for alcohol or controlled dangerous sub
10.10.06.13.htm 10.10.06.13. 13 Quality Control ― Temporary and Mobile Laboratories: Personnel Training.. A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee shall ensure that all laboratory personnel performing a health awareness test at a temporary or mobile laboratory are trained to perform all assigned duties.B. Standards.. 1) All Personnel. A licensee shall ensure that all personnel are trained to:. a) Keep examinees' health information confidential;.
10.10.06.14.htm 10.10.06.14. 14 Quality Control ― Temporary and Mobile Laboratories: Event Registration.. A. Primary Standard. In addition to meeting other applicable requirements set forth in this chapter, a licensee intending to perform a health awareness test at a temporary or mobile laboratory shall register the testing event with the Department before the testing event may occur.B. Standards.. 1) A licensee shall inform the OHCQ by phone or in writing of the date, time, location, and on-site
10.10.06.15.htm 10.10.06.15. 15 Quality Control ― Temporary and Mobile Laboratories: Cholesterol and Health Awareness.. A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee offering to perform or performing cholesterol or health awareness testing at a temporary or mobile laboratory shall ensure that the laboratory:1) Develops and maintains a written SOPM;. 2) Validates the analyzer initially and utilizes the manufacturer’s reference range for the quality
10.10.06.9999.htm 10.10.06.9999. Administrative History Effective date: November 18, 1985 (12:23 Md. R. 2217). Regulations .01―06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859) ―Regulations .01―28, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859)Regulation .03B amended effective September 16, 1991 (18:18 Md. R. 2005). Regulation .08C amended effective September 16, 1991 (18:18 Md. R. 2005).
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