Clinical Neurochemistry Laboratory

CLIA # 21D0955652 LAB DIRECTOR: Graeme Eisenhofer, Ph.D.

Clinical Neurochemistry Laboratory
Quality Assurance Plan

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OVERVIEW OF PLAN

The Clinical Neurochemistry Laboratory of the Clinical Neurochemistry Section, NINDS, NIH, carries out assays of levels of catechols and metanephrines in clinical plasma samples, as part of intramural and collaborative patient-oriented research. A mission of the Laboratory is to provide results from two separate assay procedures, for purposes of diagnosis in several pathological conditions, including pheochromocytoma, dysautonomias, and neurogenetic diseases.

The two assay procedures are measurements of plasma concentrations of catechols and measurements plasma concentrations of metanephrines. Each procedure includes measurements of 2 or more analytes as detailed below:

1. Plasma concentrations of catechols

• norepinephrine (NE)

• epinephrine (EPI)

• dopamine (DA)

• 3,4-dihydroxyphenylglycol (DHPG)

• 3,4-dihydroxyphenylalanine (DOPA)

• 3,4-dihydroxyphenylacetic acid (DOPAC)

2. Plasma concentrations of metanephrines

• normetanephrine (NMN)

• metanephrine (MN)

This quality assurance (QA) program monitors and evaluates the quality of the services provided. The laboratory director, Dr. Eisenhofer, oversees the implementation of the QA plan for measurements of plasma metanephrines. Ms. Courtney Holmes is responsible for overseeing the implementation of the QA plan for measurements of plasma catechols. Dr. Eisenhofer and Ms. Holmes are also responsible for identifying and correcting any problems with the respective procedures as they occur. The QA plan is periodically reviewed to minimize the possibility of recurrence of problems. Areas for improvement to the QA plan will be implemented where applicable.

The QA program is designed to:

• Evaluate the effectiveness of the Laboratory's policies and procedures

• Identify and correct problems

• Ensure accurate, reliable, and prompt reporting of test results

• Ensure the adequacy and competency of the Laboratory staff

• Meet all regulatory requirements as they apply to the services offered

Techniques are constantly being refined, tested against controls, and documented, so that other scientists and testing personnel with the appropriate background can duplicate the results. Quality Assurance is maintained through detailed and thorough discussion of techniques. Results and problems are shared regularly in laboratory meetings, individual meetings, and on a wider scale through peer-reviewed publications in scientific journals. Problems identified through these processes and corrective actions are documented. The documentation of problems and corrective actions is reviewed to assess whether the action taken has prevented recurrences.

Test results that appear inconsistent with patient history, symptoms, diagnosis, or pertinent clinical data are evaluated for clerical and technical error. The same specimen or an additional specimen of the same type may be obtained for retesting when possible. In addition, if no clerical errors are identified, there will be a review of the patient test management process, the testing system, and the reporting system. Findings will be documented and, if necessary, revisions will be made in test criteria for patient preparation, collection, labeling, preservation, transportation, or specimen rejection.

New testing personnel must show initial competency prior to reporting results and again at six months for newly hired personnel and annually thereafter. Each investigator, physician and all testing personnel are encouraged to communicate problems or concerns in a timely manner. All complaints will be investigated, and the resolution of the complaint will be documented. All quality assurance records include the problems identified and corrective action taken and are maintained for a minimum of two years.

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