CMS SOM App. C, Tag D1000

A laboratory may qualify for a certificate of

waiver under section 353 of the PHS Act if it restricts the tests that it performs to

one or more of the following tests or examinations (or additional tests added to this

list as provided under paragraph (d) of this section) and no others:

Interpretive Guidelines §493.15(c)

Cite D1000 on the Form CMS-2567 and solicit a Plan of Correction when a laboratory

has failed to obtain a registration, accreditation or compliance certificate before

performing and reporting patient results for tests not categorized as waived. To

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

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

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

systems, assays, and examinations not yet classified are considered high complexity.

Test systems, assays and examinations that are waived, but are used in a manner that is

inconsistent with manufacturer’s instructions are also considered high complexity.

Significant deficiencies cited under this condition may also indicate deficiencies under

personnel responsibilities.

Notify CMS of a possible action by the OIG if the laboratory does not obtain the

appropriate certificate or cease nonwaived testing.

(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the following:

(i) Bilirubin;

(ii) Glucose;

(iii) Hemoglobin;

(iv) Ketone;

(v) Leukocytes;

(vi) Nitrite;

(vii) pH;

(viii) Protein;

(ix) Specific gravity; and

(x) Urobilinogen.

(2) Fecal occult blood - non-automated

(3) Ovulation tests -visual color comparison tests for human luteinizing

hormone;

(4) Urine pregnancy tests - visual color comparison tests;

(5) Erythrocyte sedimentation rate-non-automated;

(6) Hemoglobin-copper sulfate-non-automated;

(7) Blood glucose by glucose monitoring devices cleared by the FDA

specifically for home use;

(8) Spun microhematocrit; and

(9) Hemoglobin by single analyte instruments with self-contained or

component features to perform specimen/reagent interaction, providing

direct measurement and readout.

(d) Revisions to criteria for test categorization and the list of waived tests. HHS will

determine whether a laboratory test meets the criteria listed under paragraph (b) of

this section for a waived test. Revisions to the list of waived tests approved by HHS

will be published in the FEDERAL REGISTER in a notice with opportunity for

comment.