LabOratory | Waived vs Non-waived Testing

Note:  Recent LabOratory columns have examined the subject of waived testing in detail, including the Centers for Disease Control and Prevention’s (CDC) new “Ready? Set? Test!” waived test education program.   In this column, we provide a comparison of the requirements for waived versus non-waived tests.

Waived Testing

According to the Clinical Laboratory Improvement Amendments (CLIA), waived testing systems “are simple laboratory examinations and procedures which –

  1. Are cleared by FDA (Food and Drug Administration) for home use; or
  2. Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or
  3. Pose no reasonable risk of harm to the patient if the test is performed incorrectly.1

When the CLIA regulations were first published in 1988, only nine tests were classified as waived tests.  This number has grown to include more than 100 tests incorporated into thousands of test systems.  The number of laboratories that perform only waived testing has grown from 20% of CLIA-enrolled laboratories at the onset of the federal regulations to 67% of the more than 230,000 laboratories currently enrolled in the CLIA program.2

Since waived tests should be “simple and accurate” and “pose no reasonable risk of harm,” the only testing requirement is that manufacturer’s instructions must be followed.  Anyone can perform waived testing since there are no educational or experience requirements for testing personnel.

Non-waived Testing

Tests not categorized by the FDA as waived are considered “non-waived,” and are further classified as moderate complexity or high complexity.   Moderate complexity also includes a subcategory of “Provider Performed Microscopy” (PPM).  Each classification has different requirements under the CLIA regulations.

The FDA is also responsible for categorizing non-waived tests as moderate or high complexity.  The following criteria are scored, using a rating scale of 1 to 3:

  1. Knowledge – whether minimal or specialized technical knowledge is required to perform testing;
  2. Training and experience – whether minimal, limited, or substantial training is required to perform testing;
  3. Reagent and material preparation – whether reagents/materials are stable, reliable, and require no special handling or storage conditions; or are labile, require special handling, or manual preparation;
  4. Characteristics of operational steps – whether steps are automatic and/or easily controlled or require close monitoring, precise control, or extensive calculations;
  5. Calibration, quality control (QC), and proficiency testing (PT) materials – whether they are stable or labile, and whether or not they are readily available;
  6. Test system troubleshooting and equipment maintenance – whether troubleshooting is self-correcting/ automatic or requires direct intervention; whether maintenance is provided by the manufacturer, is seldom needed, or requires special knowledge, skills, or abilities;
  7. Interpretation and judgement -- whether minimal, limited or extensive independent interpretation and judgment is needed to perform testing.

Tests with a total score of 12 or less are classified as moderate complexity, and tests with a total score higher than 12 are considered high complexity.3

Provider Performed Microscopy

For a procedure to qualify as a PPM procedure, it must be classified as moderate complexity and be performed by a physician, a dentist, or a “midlevel practitioner,” which includes licensed nurse practitioners, nurse midwives, and physician assistants.  Other PPM criteria include:

  • “The primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy.
  • The specimen is labile or delay in performing the test could compromise the accuracy of the test result.
  • Control materials are not available to monitor the entire testing process.
  • Limited specimen handling or processing is required.”4

CLIA-designated PPM procedures include:

  • “All direct wet mount preparations for the presence or absence of bacteria, fungi, parasites, and human cellular elements;
  • All potassium hydroxide (KOH) preparations;
  • Pinworm examinations;
  • Fern Tests;
  • Post-coital direct, qualitative examinations of vaginal or cervical mucous;
  • Urine sediment examinations;
  • Nasal smears for granulocytes;
  • Fecal leukocyte examinations;
  • Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility).”5

Since these tests are classified as moderate complexity, the CLIA requirements for non-waived testing must be met.  However, some of the requirements may be modified.  For example, laboratories performing only PPM procedures do not undergo inspections, but competency assessment of providers (testing personnel) must be performed, adhering to the same requirements and timing as other non-waived tests.  Check with CMS or your accrediting agency for specific details.

If someone other than a provider (physician, dentist, or midlevel practitioner) performs these procedures, they are considered moderate complexity and all associated requirements must be met without modifications.

Non-waived Requirements

There are several federally mandated requirements for non-waived testing and they are the same regardless of whether the testing is classified as moderate or high complexity.  These include requirements for Proficiency Testing (PT), facilities, and quality systems.  The quality systems regulations are divided into requirements for each phase of testing: pre-analytic, analytic, and post-analytic, as well as general laboratory systems.6

Personnel Requirements differ depending on whether the laboratory is performing moderate or high complexity testing.  CLIA defines several required positions, each with its own specific responsibilities and eligibility qualifications.  Eligibility qualifications are based on education and experience, and differ for each position.  One person can fill more than one position, as long as the individual meets the qualifications for each position.  The responsibilities and eligibility requirements for each required position are described in subpart M of the CLIA regulations.7

For moderate complexity testing, the required positions are:

  • Laboratory Director;
  • Clinical Consultant;
  • Technical Consultant;
  • Testing Personnel.

For high complexity testing, the required positions are:

  • Laboratory Director;
  • Clinical Consultant;
  • Technical Supervisor;
  • General Supervisor;
  • Testing Personnel.

For PPM testing, the required positions are Laboratory Director and testing personnel (often the same individual).  As stated earlier, the testing personnel must be licensed physicians, dentists, or midlevel practitioners.

Non-waived testing encompasses a huge array of tests that can be used for the diagnosis and treatment of disease.   Each level of testing has specific requirements that must be met to ensure compliance with federal regulations.  By achieving compliance, physicians ensure accurate and reliable test results are obtained ultimately leading to quality patient care.


 

1 Clinical Laboratory Improvement Amendments, subpart A, Sec. 493.15 Laboratories performing waived tests;http://wwwn.cdc.gov/clia/regs/subpart_a.aspx#493.15; last accessed February 2013

2 Cited statistics are from COLA’s live webinar:  CMS CLIA Update – Current and Future Events; presented on March 28, 2012 by Judith Yost, MA, MT(ASCP); Director, Division of Laboratory Services, Survey and Certification Group, Centers for Medicare and Medicaid Services (CMS).  The webinar also presents more information from studies performed by CMS and the Centers for Disease Control and Prevention (CDC).  To purchase the archived version of this webinar as a Webinar CEexpress course, go to http://www.labuniversity.org/?page_id=383; last accessed February 2013

3 Clinical Laboratory Improvement Amendments, subpart A, §493.17, Test categorization;http://wwwn.cdc.gov/clia/regs/subpart_a.aspx#493.17; last accessed February 2013

4 Clinical Laboratory Improvement Amendments, subpart A, §493.19, Provider-performed microscopy (PPM) procedures;  http://wwwn.cdc.gov/clia/regs/subpart_a.aspx#493.19; last accessed February 2013

5 For a complete list of PPM procedures included in the initial publication of the CLIA regulations, refer to the Clinical Laboratory Improvement Amendments, subpart A, §493.19(c), Provider-performed microscopy (PPM) examinations and §493.19(d), Revisions to criteria and the list of PPM procedures. http://wwwn.cdc.gov/clia/regs/subpart_a.aspx#493.19; last accessed February 2013

6 For a complete listing of the requirements, see Clinical Laboratory Improvement Amendments, subpart H, §§493.801 – 493.865, Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing;http://wwwn.cdc.gov/clia/regs/subpart_h.aspx;  subpart J, §§493.1100 – 493.1105, Facility Administration for Nonwaived Testing; http://wwwn.cdc.gov/clia/regs/subpart_j.aspx;  and subpart K, §§493.1200 – 493.1299, Quality Systems for Nonwaived Testing; http://wwwn.cdc.gov/clia/regs/subpart_k.aspx;  last accessed February 2013

7 Clinical Laboratory Improvements Amendments, subpart M, §§493.1351 – 1493.1495, Personnel for Nonwaived Testing; http://wwwn.cdc.gov/clia/regs/subpart_m.aspx; last accessed February 2013 

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