36C25618R0078-031.pdf

42 CFR Ch. IV (10–1–03 Edition)§ 493.15

§ 493.15 Laboratories performing waived tests.

(a) Requirement. Tests for certificate of waiver must meet the descriptive criteria specified in paragraph (b) of this section.

(b) Criteria. Test systems are simple laboratory examinations and proce-dures which—

(1) Are cleared by FDA for home use;

(2) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results neg-ligible; or

(3) Pose no reasonable risk of harm to the patient if the test is performed incorrectly.

(c) Certificate of waiver tests. A labora-tory may qualify for a certificate of waiver under section 353 of the PHS Act if it restricts the tests that it per-forms 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:

(1) Dipstick or Tablet Reagent Uri-nalysis (non-automated) for the fol-lowing:

(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;

(3) Ovulation tests—visual color com-parison 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 moni-toring devices cleared by the FDA spe-cifically for home use;

(8) Spun microhematocrit; and

(9) Hemoglobin by single analyte in-struments with self-contained or com-ponent features to perform specimen/ reagent interaction, providing direct measurement and readout.

(d) Revisions to criteria for test cat-egorization and the list of waived tests.

HHS will determine whether a labora-tory 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 com-ment.

(e) Laboratories eligible for a certifi-cate of waiver must—

(1) Follow manufacturers’ instruc-tions for performing the test; and

(2) Meet the requirements in subpart B, Certificate of Waiver, of this part.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]

§ 493.17 Test categorization.

(a) Categorization by criteria. Notices will be published in the FEDERAL REG- ISTER which list each specific test sys-tem, assay, and examination cat-egorized by complexity. Using the seven criteria specified in this para-graph for categorizing tests of mod-erate or high complexity, each specific laboratory test system, assay, and ex-amination will be graded for level of complexity by assigning scores of 1, 2, or 3 within each criteria. The score of ‘‘1’’ indicates the lowest level of com-plexity, and the score of ‘‘3’’ indicates the highest level. These scores will be totaled. Test systems, assays or exami-nations receiving scores of 12 or less will be categorized as moderate com-plexity, while those receiving scores above 12 will be categorized as high complexity.

NOTE: A score of ‘‘2’’ will be assigned to a criteria heading when the characteristics for a particular test are intermediate between the descriptions listed for scores of ‘‘1’’ and ‘‘3.’’

(1) Knowledge.

(i) Score 1. (A) Minimal scientific and technical knowledge is required to per-form the test; and

(B) Knowledge required to perform the test may be obtained through on-the-job instruction.

(ii) Score 3. Specialized scientific and technical knowledge is essential to per-form preanalytic, analytic or postanalytic phases of the testing.

(2) Training and experience.

VerDate jul<14>2003 13:27 Oct 14, 2003 Jkt 200174 PO 00000 Frm 00976 Fmt 8010 Sfmt 8010 Y:\SGML\200174T.XXX 200174T

Centers for Medicare & Medicaid Services, HHS § 493.17

(i) Score 1. (A) Minimal training is re-quired for preanalytic, analytic and postanalytic phases of the testing proc-ess; and

(B) Limited experience is required to perform the test.

(ii) Score 3. (A) Specialized training is essential to perform the preanalytic, analytic or postanalytic testing proc-ess; or

(B) Substantial experience may be necessary for analytic test perform-ance.

(3) Reagents and materials preparation.

(i) Score 1. (A) Reagents and mate-rials are generally stable and reliable;

and

(B) Reagents and materials are pre-packaged, or premeasured, or require no special handling, precautions or storage conditions.

(ii) Score 3. (A) Reagents and mate-rials may be labile and may require special handling to assure reliability;

or

(B) Reagents and materials prepara-tion may include manual steps such as gravimetric or volumetric measure-ments.

(4) Characteristics of operational steps.

(i) Score 1. Operational steps are either automatically executed (such as pipetting, temperature monitoring, or timing of steps), or are easily con-trolled.

(ii) Score 3. Operational steps in the testing process require close moni-toring or control, and may require spe-cial specimen preparation, precise tem-perature control or timing of proce-dural steps, accurate pipetting, or ex-tensive calculations.

(5) Calibration, quality control, and proficiency testing materials.

(i) Score 1. (A) Calibration materials are stable and readily available;

(B) Quality control materials are sta-ble and readily available; and

(C) External proficiency testing ma-terials, when available, are stable.

(ii) Score 3. (A) Calibration materials, if available, may be labile;

(B) Quality control materials may be labile, or not available; or

(C) External proficiency testing ma-terials, if available, may be labile.

(6) Test system troubleshooting and equipment maintenance.

(i) Score 1. (A) Test system trouble-shooting is automatic or self-cor-recting, or clearly described or requires minimal judgment; and

(B) Equipment maintenance is pro-vided by the manufacturer, is seldom needed, or can easily be performed.

(ii) Score 3. (A) Troubleshooting is not automatic and requires decision-making and direct intervention to re-solve most problems; or

(B) Maintenance requires special knowledge, skills, and abilities.

(7) Interpretation and judgment. (i) Score 1. (A) Minimal interpretation and judgment are required to perform preanalytic, analytic and postanalytic processes; and

(B) Resolution of problems requires limited independent interpretation and judgment; and

(ii) Score 3. (A) Extensive independent interpretation and judgment are re-quired to perform the preanalytic, ana-lytic or postanalytic processes; and

(B) Resolution of problems requires extensive interpretation and judgment.

(b) Revisions to the criteria for cat-egorization. The Clinical Laboratory Improvement Advisory Committee, as defined in subpart T of this part, will conduct reviews upon request of HHS and recommend to HHS revisions to the criteria for categorization of tests.

(c) Process for device/test categorization utilizing the scoring system under § 493.17(a). (1)(i) For new commercial test systems, assays, or examinations, the manufacturer, as part of its 510(k) and PMA application to FDA, will sub-mit supporting data for device/test cat-egorization. FDA will determine the complexity category, notify the manu-facturers directly, and will simulta-neously inform both CMS and CDC of the device/test category. FDA will con-sult with CDC concerning test cat-egorization in the following three situ-ations:

(A) When categorizing previously uncategorized new technology;

(B) When FDA determines it to be necessary in cases involving a request for a change in categorization; and

(C) If a manufacturer requests review of a categorization decision by FDA in accordance with 21 CFR 10.75.

VerDate jul<14>2003 13:27 Oct 14, 2003 Jkt 200174 PO 00000 Frm 00977 Fmt 8010 Sfmt 8010 Y:\SGML\200174T.XXX 200174T

42 CFR Ch. IV (10–1–03 Edition)§ 493.19

(ii) Test categorization will be effec-tive as of the notification to the appli-cant.

(2) For test systems, assays, or ex-aminations not commercially avail-able, a laboratory or professional group may submit a written request for cat-egorization to PHS. These requests will be forwarded to CDC for evaluation;

CDC will determine complexity cat-egory and notify the applicant, CMS, and FDA of the categorization deci-sion. In the case of request for a change of category or for previously uncategorized new technology, PHS will receive the request application and forward it to CDC for categorization.

(3) A request for recategorization will be accepted for review if it is based on new information not previously sub-mitted in a request for categorization or recategorization by the same appli-cant and will not be considered more frequently than once per year.

(4) If a laboratory test system, assay or examination does not appear on the lists of tests in the FEDERAL REGISTER notices, it is considered to be a test of high complexity until PHS, upon re-quest, reviews the matter and notifies the applicant of its decision. Test cat-egorization is effective as of the notifi-cation to the applicant.

(5) PHS will publish revisions peri-odically to the list of moderate and high complexity tests in the FEDERAL REGISTER in a notice with opportunity for comment.

[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]

§ 493.19 Provider-performed micros-copy (PPM) procedures.

(a) Requirement. To be categorized as a PPM procedure, the procedure must meet the criteria specified in para-graph (b) of this section.

(b) Criteria. Procedures must meet the following specifications:

(1) The examination must be person-ally performed by one of the following practitioners:

(i) A physician during the patient’s visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or an employee.

(ii) A midlevel practitioner, under the supervision of a physician or in independent practice only if authorized by the State, during the patient’s visit on a specimen obtained from his or her own patient or from a patient of a clin-ic, group medical practice, or other health care provider of which the mid-level practitioner is a member or an employee.

(iii) A dentist during the patient’s visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee.

(2) The procedure must be cat-egorized as moderately complex.

(3) The primary instrument for per-forming the test is the microscope, limited to bright-field or phase-con-trast microscopy.

(4) The specimen is labile or delay in performing the test could compromise the accuracy of the test result.

(5) Control materials are not avail-able to monitor the entire testing proc-ess.

(6) Limited specimen handling or processing is required.

(c) Provider-performed microscopy (PPM) examinations. A laboratory may qualify to perform tests under this sec-tion if it restricts PPM examinations to one or more of the following proce-dures (or additional procedures added to this list as provided under paragraph

(d) of this section), waived tests and no others:

(1) All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements.

(2) All potassium hydroxide (KOH) preparations.

(3) Pinworm examinations.

(4) Fern tests.

(5) Post-coital direct, qualitative ex-aminations of vaginal or cervical mu-cous.

(6) Urine sediment examinations.

(7) Nasal smears for granulocytes.

(8) Fecal leukocyte examinations.

(9) Qualitative semen analysis (lim-ited to the presence or absence of sperm and detection of motility).

(d) Revisions to criteria and the list of PPM procedures.

(1) The CLIAC conducts reviews upon HHS’ request and recommends to HHS revisions to the criteria for categoriza-tion of procedures.

VerDate jul<14>2003 13:27 Oct 14, 2003 Jkt 200174 PO 00000 Frm 00978 Fmt 8010 Sfmt 8010 Y:\SGML\200174T.XXX 200174T