LABORATORY OF PATHOLOGY ONLINE POLICY MANUAL

PREANALYTIC SYSTEMS

Specimen Collection, Specimen Identification, Specimen Integrity, & Test Requisitions

The clinical sections have developed specimen collection and handling instructions that reflect the requirements of the diagnostic tests performed. The specific instructions for specimen collection are available on the Laboratory of Pathology Web page for all Clinical Center clinicians. Specific instructions for the proper patient preparation, specimen collection, specimen labeling (identification, specimen source), and handling of specimens are updated regularly and reviewed annually. These are available at:

Sections may receive specimens from outside the NIH. Entities or individuals wishing to send samples must contact the specific section for additional shipping instructions and documentation requirements (e.g., reason for consult, specific questions to be answered, referring pathologist working diagnosis, pertinent clinical information, etc).

Both paper and electronic requisitions, from authorized persons, are used to order test/exams in LP and must be in accord with CAP/CMS regulations. Examples of requisitions are found in Appendix D. Each clinical section must have a clearly defined and documented specimen receipt policy that ensures appropriate identification of specimens received and identifies inappropriate specimens. Specimens are analyzed only at the request of an authorized healthcare provider. Specimen receipt records are maintained in each laboratory.

The LP may accept oral requests for laboratory tests if it solicits a written or electronic authorization with 30 days of the oral request and maintains the authorization or documentation of its efforts to obtain the authorization. Any section accepting a verbal or phone order must read back the entire order to verify accuracy of transcription. Additionally, any written orders received that are unclear (e.g. orders using non-standard or non-specific terms), must be confirmed by a pathologist in consultation with the requesting clinician.

Each section has developed systems to positively identify all patient specimens, specimen types, and aliquots at all times. Each section must establish written policies for specimen storage and preservation, conditions for specimen transportation, and specimen integrity

Each section uses appropriate specimen containers to ensure that they do not contribute to analytic interference in assays performed. Evaluation of specimen containers can be done through some combination of direct testing, review of the clinical literature, and/or evaluation of information from manufacturers.

Refer to the NCI/CCR/LP Clinical Service Safety Manual for information regarding phlebotomy and safety of specimen handling, collection, and transportation.