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Table 1. Recommended Report Content of A Patient

This document outlines the recommended content for a laboratory report of genetic testing results. The report should include patient identifiers, test results, an interpretation of the results, and comments providing context and recommendations. It should also specify the testing procedures, demographic information, and billing details. The goal is to concisely communicate all relevant clinical and analytic information to the ordering physician and patient.

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Ruchi Sharma
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36 views2 pages

Table 1. Recommended Report Content of A Patient

This document outlines the recommended content for a laboratory report of genetic testing results. The report should include patient identifiers, test results, an interpretation of the results, and comments providing context and recommendations. It should also specify the testing procedures, demographic information, and billing details. The goal is to concisely communicate all relevant clinical and analytic information to the ordering physician and patient.

Uploaded by

Ruchi Sharma
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Table 1.

Recommended Report Content of a patient

Laboratory/patient/sample identifiers

*Name and address of reporting laboratory (optional: phone, FAX, e-mail, Web site)
*Patient’s name (first and last with middle initial or middle name)*ID No. and/or date of
birth*Date of specimen collection (and time, if appropriate)

*Date of receipt or accession in laboratory, with accession number*Specimen source


(even if only 1 sample type is accepted) and how tissue was received (fresh is assumed
unless designated as frozen,

paraffin-embedded, etc) *Ordering physician

Results

*List results by test name; use standardized gene nomenclature and standard units of
measure *Reference range; or normal versus abnormal

Interpretation

Analytic and clinical interpretation of results: Analytic interpretation involves


synthesizing raw data to produce a reportable result. Clinical interpretation involves
synthesizing analytic and clinical information to describe what the result means for the
patient

Comments

Significance of the result in general or in relation to this patientCorrelate with prior test
resultsRecommend additional measures (eg, further testing, genetic counseling)Condition
of specimen that may limit adequacy of testing (eg, sample received thawed, partially
degraded DNA) Pertinent assay performance characteristics or interfering substances

Residual risk of disease (or carrier status) by Bayesian analysisControl test results, if
unusual or especially pertinentCite peer-reviewed medical literature or reliable Web sites
on the assay and its clinical utility (eg, educational materials on genetests.org) Document
intradepartmental consultationDocument to whom preliminary results, verbal results, or
critical values were reported and whenIncorporate information specifically requested on
the requisition (eg, ethnicity)Answer specific questions posed by the requesting clinician
(eg, rule out CML)Reason specimen rejected or not processed to completionDisposition
of residual sample (eg, sample repository)Chain of custody documentation, if needed*If
the report is an amended or addendum report, describe the changes or updates*Describe
discrepancies between preliminary and final reports*Name of testing laboratory, if
transmitting or summarizing a referral laboratory’s results

Procedure

*Type of procedure (eg, Southern blot, PCR, RT-PCR of RNA, Q-PCR, in situ
hybridization, gene dosage array, RNA expression array, protein expression array,
sequencing, protein truncation test)

*Defined target (ie, name of analyte tested such as gene, locus, or genetic defect; use
HUGO-approved gene nomenclature) Pertinent details of procedure, for example analyte-
specific reagent or kit version and manufacturer, instrument type Disclaimer on non-FDA
approved tests in which a commercial analyte-specific reagent was usedSignature and
printed name of reporting physician, for any test having a physician interpretation

Signature of lab director or designee when interpretation is performed (Reports may be


signed electronically.) *Date of report (and time, if appropriate)

Demographic information

Accession number, and specimen number from referring laboratory Genetic counselor,
when appropriateClinic/inpatient location; or name/address/phone of outside facility
Indications for testing (reason for referral)

Pertinent clinical history (clinical situation, ethnicity/race, pedigree diagram and/or


family history, previous molecular/genetic studies, and other relevant clinicopathologic
findings)

Billing informationICD-9 code (clinical indication for test)

CPT codes (laboratory procedures performed)

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