Sec. 10.10.06.15. 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 control with each new lot of quality control;

(3) Employs and maintains an in-field quality control program;

(4) Reports test results as set forth in §B(5) of this regulation; and

(5) Informs examinees of test limitations based on current nationally recognized standards for each test performed.

B. Standards.

(1) Supervisor. A supervisor knowledgeable in all aspects of health awareness testing shall oversee all cholesterol or health awareness testing conducted at a temporary or mobile laboratory.

(2) SOPM.

(a) A licensee shall develop and maintain a written SOPM covering all current procedures for:

(i) Training personnel;

(ii) Analytical system maintenance;

(iii) Testing participants and quality control;

(iv) Retesting;

(v) Documenting lot numbers and expiration dates of quality control materials and reagents (cassettes) used for participant testing;

(vi) Evaluation of quality controls on site and documentation of corrective actions when quality control results are unacceptable;

(vii) An every 6 month evaluation of all analyzers used in Maryland using the worksheet provided by the Department; and

(viii) Other aspects of the cholesterol and health awareness testing service's activities.

(b) The general supervisor or director shall initially approve and when changes are made review, sign, and date the SOPM.

(c) All personnel shall have routine access to a copy of the SOPM at each testing site throughout each testing event.

(3) Method Verification and Pre-Field Evaluation of an Analytical System. A licensee shall evaluate each analytical system by:

(a) Performing a method verification to demonstrate that the system produces test results within limits of accuracy and precision, as defined by either the licensee or the system's manufacturer, before the system may be used at a temporary or mobile laboratory; and

(b) Analyzing two levels of quality control materials.

(4) In-field Quality Control. At a temporary or mobile laboratory, a licensee shall maintain a continuous quality control program in which:

(a) Each person who performs tests at a screening event shall test both levels of quality control samples identified in §B(3)(b) of this regulation on one analyzer for each cholesterol and health awareness test performed at the screening event;

(b) Quality control testing shall be performed on at least one analyzer, if more than one analyzer at a screening event is used;

(c) Each testing person shall test two levels of quality control materials on another analyzer at the beginning of the cholesterol or health awareness event if more than one person is performing tests at an event; and

(d) The laboratory shall complete the comparison worksheet designated by the Department quarterly to ensure that all the analyzers used for reporting test results produce results within 15 percent to 20 percent of the other analyzers.

(5) Examinee results shall be reported above the established reportable range of the instrument, that is, analytic range, as greater than the highest reference point, with the analytic range being determined by pre-field testing.

(6) Reporting and Releasing Test Results.

(a) A licensee shall release cholesterol or health awareness test results only to the examinee or their physician in writing and in a manner to protect the confidentiality of the test results.

(b) A licensee shall include the following on its reports:

(i) The name, address, and phone number of the laboratory performing the test;

(ii) The date and location of the testing; and

(iii) The signature, initials, or electronic authentication of a laboratory employee.

(c) A laboratory shall provide to an examinee a written explanation of all cholesterol and health awareness test results and refer the examinee for medical care when indicated by the results.