Clinical Neurochemistry Laboratory

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

Clinical Neurochemistry Laboratory
Quality Assurance Plan

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PATIENT TEST MANAGEMENT

Testing is requested by referring physicians or through NIH patient recruitment. Two forms are sent to each clinician: (1) written instructions detailing interferences, blood collection, sample processing, and shipping; and (2) a Patient Information Sheet to be returned with each set of samples.

Different written instructions are provided to the physicians within and outside the NIH. The latter are required to send the collected plasma samples on dry ice, whereas within the NIH whole blood may be sent directly to the Laboratory, or the samples may be processed and the plasma delivered frozen, as for outside sources. The instructions detail requirements, policies, and preferences for blood sampling, volume of sample required, and preparation, storage, and transportation. All samples are labeled with a unique identifier for the patient and the date of collection.

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Test Requisition

The details supplied for test requisition by the ordering individual on the Patient Information Form must include several key items:

• Name of patient with identifier

• Birth date

• Gender

• Date and time of collection

• Name, address, telephone number and fax number of the individual requesting the test

• Test(s) requested

Some of the above information may be included by affixing an appropriate patient identification sticker at the designated place on the Patient Information Form. For delivery of whole blood samples, the above information must also include the time of collection and time of delivery.

Other information that is requested but which may or may not be immediately available or which may be supplied at the discretion of the clinician and patient includes several other items:

• Reason for test (e.g., high blood pressure, rule out dysautonomia, rule out pheo)

• Patient's vital signs at the time of sampling

• Results of other tests that might be relevant to the patient's diagnosis

• List of medications the patient has taken during the last week

• Checklist about conditions of sampling

All oral requests must be documented in writing before the plasma sample is analyzed.

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Specimen Accessioning

A test request (Patient Information Form) must accompany the specimen and include a unique identifier, name and address of ordering person, tests requested, and other pertinent information as outlined above. The Patient Information Form must be signed and dated by the receiving laboratory or secretarial personnel on delivery of the specimens to the NIH.

Plasma samples from outside the NIH must be received frozen on dry ice. From within the NIH, samples may be received as whole blood, but these must be delivered on ice within 4 hours of collection. Labeling of blood or plasma samples must include the patient's full name or unique sample identifier and the date the sample was drawn.

A specimen accession log is used to record receipt of specimens. The information in this log must include the patient's name or unique sample identifier, the date the sample was received, information about the patient's diagnosis or the condition of the sample, the storage location of the sample in the -70 oC freezer, and the initials of the person who took charge of delivery and storage. Other information to be recorded on the log includes the dates of the subsequent catechol or metanephrine assay and the initials of the person responsible for the assays. Receipt of unacceptable specimens or specimens that are not accompanied with the appropriately filled out Patient Information Form is recorded on the accession log. The details of the condition and disposition of the unacceptable specimen are recorded in a separate sample accession log for rejected samples or samples accompanied with incomplete patient information.

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Rejection Criteria

Specimens from outside the NIH are rejected if they arrive unfrozen in the laboratory. Specimens from within the NIH may be delivered on ice, but it must be documented on the Patient Information Form that the blood or plasma was delivered within 4 hours of collection. In situations where the ice has completely melted, a thermometer can be used to ascertain whether samples are below 10oC. Samples above 10oC should be rejected. Samples should also be rejected if they are unlabeled or improperly labeled so that the patient identifier and date the sample collection cannot be matched with the specific sample.

Specimens received without an accompanying Patient Information Form or with a form that has incomplete information are acceptable for storage; however, the samples should not be processed until the complete information is provided. If incomplete information is submitted, attempts made to receive the necessary information are documented in specimen log. If the specimen is unacceptable or inadequate for testing, the requesting physician is notified immediately that the particular sample was rejected, the reason for rejection is given, and a repeat specimen is requested when possible. If the test is performed and results are reported on a less than optimal specimen (e.g., the specimen is hemolyzed or clotted), the condition of the specimen is also recorded on the test report, for proper interpretation by the patient care provider. Problems involved with obtaining an appropriate specimen and corrective action taken are documented. Corrective actions taken to minimize communication breakdowns are evaluated for effectiveness.

Specific criteria for rejection of specimens therefore include the following:

• Plasma sample delivered from outside the NIH arrives thawed.

• Blood or plasma delivered from within the NIH is not on ice at the time of receipt by laboratory personnel and was above 10 oC.

• Blood or plasma sample is not labeled appropriately or erroneously.

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Test Recordkeeping

Chromatograms for each assay run are stored on disk in files that can be retrieved according to the date of assay. The laboratory test records include a results data sheet (Assay Data Sheet), which shows the data from processing the chromatograms. These data, which include patient test results, are recorded in an Excel spreadsheet that is also stored on disk and can be retrieved according to the date of assay. Zip/Jaz drive units and specified Zip/Jaz disks are utilized for long-term storage of electronic data. Hard copies of Assay Data Sheets are stored in laboratory notebooks, with information accessible by date of assay. These notebooks also contain Assay Data Sheets for non-CLIA samples (e.g., research only samples). All Assay Data Sheets are accompanied by the Sample Data Sheet, to justify the numbering of assay tubes/extraction columns against the specific patient samples. For CLIA assays, the Assay Data sheets detailing the laboratory test records are also accompanied by a separate form (Reagent Data Sheets) that details the reagent lot numbers, expiration dates, and information about the HPLC column and electrochemical cell and mobile phase used in the assay. Laboratory test records include the following information:

• Patient name or unique identifier

• Test name

• Test results

• Initial or name of individual performing the test

• Documentation of quality control

• Date test performed

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Test Report

All test results for CLIA-certified assays are reported for each individual in a separate report filed specifically for samples subjected to CLIA-certified assays (Patient Test Reports). The information in the Patient Test Reports includes the dates of the assay and of the report, the patient's name or unique sample identifier, the date the sample was collected, the requesting individual's name and fax number, the test results, the appropriate reference limits, and a comment that may provide interpretation of the results, recommendations for further testing or action, or problems with the sample. The Laboratory Director's name, with a contact address and fax and phone numbers of the Laboratory Director or testing personel, are also included for follow-up information. This report is filed along with the Patient Information Sheet that arrived with the sample. The original report is sent by fax or mail to the requesting person. Copies of reports are kept on file for a minimum of two years. Test results are confidential and are released only to authorized individuals.

The clinician is notified in the Instructions for Blood Sampling and Shipment of Samples about the expected turnaround time for the Patient Test Report. A turn-around time of 6 weeks is standardly given, but in emergency cases (e.g., diagnosis of Menkes disease) a quicker turnaround time may be made available.

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 Test Report Sample

e-mail: ge@box-g.nih.gov

Plasma metanephrines and catechols

Metanephrines — Free and total normetanephrine (NMN) and metanephrine (MN)

Catechols - Upper reference limts are all for samples taken supine)

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Comment

— For further information contact Graeme Eisenhofer at the above address. Copies of this report have been forwarded to Drs Karel Pacak. We will be happy to assist with further evaluations or screening tests for Ms Dunphy or any of her affected family members.

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