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Add Methodology

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Adding a new methodology means adding usually a new analyzer to the lab. This is a relatively unusual event but is one of the the first procedures encountered when creating a new laboratory. It also occurs when the laboratory is expanding its services or when replacing an older methodology.

The process begins by selecting an appropriate analyzer. This is usually supplemented with a job cost analysis using estimated figures for the number of tests to be performed, the cost of reagents, disposable materials, control materials, calibration materials, the cost of the technician running the machine, and the estimated revenue from the number of tests multiplied by the projected reimbursement per test.

The machine is ordered along with appropriate reagents. On arrival the company providing the machine frequently will help set it up and provide initial training for the laboratory director and testing personnel.

The operation manual and procedures are recorded in the Laboratory Procedure Manual.

The date received and the serial number of the machine are recorded. If a Laboratory Information System (LIS) is available this is entered.

The date of receipt and lot numbers of reagents is recorded in the reagent log. (Name of reagent, date ordered, price per unit received, date received, expiration date). Most Laboratory Information Systems will track this information to make job cost analysis easy to perform on a per analyzer basis.

Turn on machine.

Verify correct function.

Run initial calibration.

Run initial controls.

Run a validation study. This is a study where duplicate patient test materials are analyzed by running specimens on the new analyzer and all patient test materials are run in a duplicate manner on a reference analyzer. Frequently these are run at a nearby hospital. Usually 20-50 patient samples are run in this duplicate fashion and make up the primary data of the correlation study.

The analyzer is put into service.

CLIA/CMS (and if involved COLA) are notified of the analyzer and methodology.

The analyzer is enrolled in a Proficiency Testing program.

In a physician office controls are performed usually on a daily basis for many methodologies but varies depending on the manufacturers recommendations. Inside the hospital or in an independent laboratory, controls are frequently run on a per shift basis. It is necessary to maintain and print a log of these controls on a monthly basis for review by the laboratory director.

The controls materials are statistically analyzed on a weekly basis. Levy-Jennings plots are generated and reviewed by the laboratory director.

Any maintenance is logged.

Calibration is performed per manufacturers recommendations and is logged.

If in the event the analyzer is moved, the correlation study must be repeated.