CMS SOM App. C, Tag D5203

The laboratory must establish and follow written policies and procedures that

ensure positive identification and optimum integrity of a patient’s specimen from

the time of collection or receipt of the specimen through completion of testing and

reporting of results.

Interpretive Guidelines §493.1232

The regulation provides laboratories the flexibility to establish a system that ensures

positive patient identification through specimen collection, labeling, accessioning,

processing, (e.g., aliquoting), storage, testing, and reporting of results. Review the

laboratory’s system (policy and practices) for ensuring positive patient identification

from specimen collection through reporting of results.

Optimum integrity of a patient’s specimen is determined according to the test

methodology utilized by the laboratory and the manufacturer’s instructions. Review the

manufacturer’s instructions for performance of each test method to ensure the specimen

is appropriate for the test system, is stored and preserved properly (e.g., maintained at

room temperature, kept on ice, separated and frozen or refrigerated), and analyzed within

the limitations of the test methodology. For specimen integrity problems in the

preanalytic system, see also D5311.

The laboratory must have a procedure to ensure that special handling of specimens is

maintained throughout the testing process when necessary (e.g., GC cultures and

GC/Chlamydia probes, blood gas specimens, and DNA probes).

Probes §493.1232

How does the laboratory ensure positive identification of patient specimens through all

phases of testing, especially when similar patient identification information (e.g., address,

sex, names, timed specimens, and birth dates) exists?

How does the laboratory ensure that special handling of specimens (as specified in the

laboratory’s procedure manual) is maintained throughout the testing process?

Does the laboratory process patient specimens using separate (distinct) or unique

identifiers in order to avoid mislabeling, specimen mix-ups, incorrect test request entry,

incorrect entry of test results in the Laboratory Information System (LIS), and incorrect

reporting of results?