CMS SOM App. C, Tag D5300

Each laboratory that performs nonwaived testing must meet the applicable

preanalytic system(s) requirements in §§493.1241 and 493.1242, unless HHS

approves a procedure, specified in Appendix C of the State Operations Manual

(CMS Pub. 7), that provides equivalent quality testing. The laboratory must

monitor and evaluate the overall quality of the preanalytic systems and correct

identified problems as specified in §493.1249 for each specialty and subspecialty of

testing performed.

Interpretive Guidelines §493.1240

Preanalytic refers to all steps taken prior to the actual testing of a patient specimen from

the test request to the actual testing of the specimen. The preanalytic systems

requirements fall into three distinct standards: test requests; specimen submission,

handling, and referral; and preanalytic systems quality assessment.

Significant deficiencies cited under this condition may indicate deficiencies under

personnel responsibilities. Use D5300 when deficiencies are identified that have the

potential to, or are adversely affecting patient testing, or when they are systemic and

pervasive throughout the laboratory, and are not limited to any one specialty or

subspecialty.

To determine which tests are categorized as waived or nonwaived testing (i.e., moderate

and high complexity tests), refer to the following web link for the FDA categorization

database

(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm?sAN=0). Test

systems, assays and examinations not included in this listing (i.e., not yet categorized) are

considered high complexity.