Laboratory of Pathology - Staff

Test Result Management

Pathology Reports

Laboratory of Pathology and Surgical Pathology reports conform to standards recommended by the Association of Directors of Anatomic and Clinical Pathology, as published in the American journal of Surgical Pathology 16:84-86, 1992. Refer to Surgical Pathology Reporting for: elements included in the final report, critical value notification, and reporting of biomarkers. 

Reports for modified or laboratory-developed tests (LDTs) contain a disclaimer to identify that the test was developed or modified by the laboratory.

Disclaimers used in Laboratory of Pathology Reports

• Immunoperoxidase and in-situ hybridization tests performed here and used for diagnosis were developed and their performance characteristics determined by the Laboratory of Pathology, NCI. They have not been cleared or approved by the U.S. Food and Drug Administration.  The FDA has also determined that such clearance or approval is not necessary.  This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.  All controls related to the markers reported here reacted appropriately.

• These tests were developed and their performance characteristics determined by the Molecular Diagnostics Unit of the Laboratory of Pathology, NCI, in Bethesda, MD. They have not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. These tests are used for clinical purposes. They should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.
  
  

• Analyte specific reagents (ASR) are used in many laboratory tests necessary for standard medical care and generally do not require U.S. Food and Drug Administration (FDA) approval or clearance. This analysis is a supplement to the diagnosis of the requesting pathologist and does not represent final diagnosis. This test was developed and its performance characteristics were determined by the Chromosome Pathology Unit, Laboratory of pathology, CCR NCI. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.

Data Handling and Reporting of Test Results

Each clinical section must have a clearly defined and documented results reporting policy that ensures timely reporting of appropriate patient data in accordance with regulatory standards, such as those established by, The College of American of Pathologists (CAP), the Joint Commission, and Clinical Laboratory Improvement Amendments (CLIA-88). Surgical pathology reports are interpretative and therefore do not typically have reference intervals (normal values).

Clinical sections that have reference intervals, such as Chromosome Pathology, for interpretive ranges, the laboratory section validates or establishes reference intervals for each analyte and specimen source.  Methods that can be incorporated for verifying and establishing reference intervals include:

• Testing 20 healthy representative individuals for normal ranges, which is verified if no more than two results fall outside the proposed range.
• Tests with low occurrences or newly developed tests that do not have many cases available for validation can have a smaller set of reference material approved by the medical director or designee. 
• If a formal reference study is not possible or practical, evaluation of published data can be reviewed and documented.
• Literature references or manufacturers package inserts may be appropriate.
• Any combination of the above based on medical director approval
• Refer to the Clinical Laboratory Standards Institute (CLSI), EP28-A3C, available in the clinical managers office for further guidance on reference range validations.

Reference intervals or ranges must be verified:

• At the introduction of a new analyte or test
• If a change in analytic methodology
• If a change in patient population

Although there are no critical ranges, panic values, or alert values in LP, each section will immediately alert the health care provider (e.g., individual/entity requesting the test, individual responsible for using the test results) when any test result indicates an imminent life-threatening condition, unusual or unexpected abnormal results. If results must be communicated after-hours or on weekends, notify the Institute on-call physician, who is then responsible for notifying the attending physician and/or taking appropriate medical action. The pathologist will report positive test for tuberculosis to the Hospital Epidemiology Service at (301) 496-2209.

Upon request, the LP will make available to clients, a list of test methods employed by the laboratory and, as applicable, the performance specifications established or verified. LP will also make available, information that may affect the interpretation of test results (e.g., test interferences). Pertinent updates on testing information must be provided to clients whenever changes occur that affect the test results or interpretation of test results.

Test results must be released only to authorized persons and, if applicable, the individual responsible for issuing the test results and the laboratory that initially requested the test. See Patient Privacy Policy for more information.

When a section cannot report patient test results within its established timeframes, the section must determine, based on the urgency of the patient test(s) requested, the need to notify the appropriate individuals(s) of the delayed testing.

With the exception of frozen section consults and clinical cytogenetics testing, all reports are entered in the Laboratory Information System (LIS). Reports for frozen section consults and clinical cytogenetics are issued manually and copies are sent to the patient’s medical record. Each section maintains all test reports, or records of the information on the test reports, in a manner that permits ready identification and timely accessibility.

Supervisory Review of Results

Laboratory of Pathology reports are interpreted and signed out only by board-certified pathologists. Clinical Residents and Fellows in LP's ACGME-accredited training program do not sign out cases independently. Gross analysis are performed by qualified Pathologists' Assistants, but gross description is reviewed prior to sign out by the board-certified pathologists. Technical-level staff assist the pathologists by processing the case material necessary for pathologists' interpretation, but all diagnostic interpretation is performed by a board-certified pathologist.