Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 256 - MAINE MEDICAL LABORATORY RULES
Part TWO - PERMITS FOR HEALTH SCREENING LABORATORIES
Section 144-256-TWO-17 - HSL QUALITY CONTROL AND PROFICIENCY TESTING

Universal Citation: 10 ME Code Rules ยง 144-256-TWO-17

Current through 2024-38, September 18, 2024

17.1 Quality Control. Quality control must be practiced and documented as a routine part of the HSLs operation.

17.2 Laboratory instruments. Each HSL instrument must be calibrated for accuracy and linearity according to the manufacturer's instructions.

17.2.1 Each day (24 hour shift) of operation, each instrument must be checked for proper function according to the manufacturer's instructions.

17.2.2 Each day (24-hour shift), each instrument must be checked with two different levels of quality control material.

17.2.3 If available, standards and controls must be of the same matrix as client specimen, such as whole blood, serum, and similar specimen.

17.2.4 Acceptable ranges must be established for all aspects of the quality control program. Client test results must not be reported until causes for out of range quality control results have been resolved.

17.3 Repeat test. Client test results that meet the following criteria must be repeated at the same sitting:

17.3.1 Total cholesterol test results on clients that are above 300 mg/dL or below 100 mg/dL.

17.3.2 HDL cholesterol results above 100 mg/dl or below 15 mg/dl.

17.3.3 Triglyceride results above 400 mg/dl.

17.3.4 Glucose results above 350 mg/dl or below 50 mg/dl.

PROFICIENCY TESTING

17.4 Proficiency testing program. HSLs must be enrolled and successfully participate in a CLIA proficiency testing program for each test performed.

17.5 Documentation of enrollment. Documentation of enrollment in a CLIA proficiency testing program and records of the laboratory's performance must be provided upon request to the department.

17.6 Instrument performance records. HSL records must be maintained on the performance of each instrument.

Disclaimer: These regulations may not be the most recent version. Maine 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.
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