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Effective Date: August 1, 2024

Program: Laboratory

Chapter: Waived Testing

Overview

A laboratory test is an activity that evaluates a substance(s) removed from a human body and translates that
evaluation into a result. A result can be stated as a number, presence or absence of a cell or reaction, or an
interpretation. Tests that produce a result measured as a discrete number are termed “quantitative.” Tests that
produce a negative or positive result, such as fecal occult blood and urine pregnancy screens, are termed
“qualitative.” A test that is more precise than a qualitative test (pos/neg), but less precise than a quantitative test
(numerical), is usually scored on a graded scale (1+, 2+, 3+) and is termed “semiquantitative.” Tests with analysis
steps that rely on the use of an instrument to produce a result are instrument-based tests. These can be qualitative,
semiquantitative, or quantitative.

Test results that are used to assess a patient’s condition or make a clinical decision about a patient are governed by
the federal regulations known as the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88). CLIA ’88
classifies testing into four complexity levels: high complexity, moderate complexity, provider-performed microscopy
(PPM) procedures (a subset of moderate complexity), and waived testing. The high, moderate, and PPM levels,
otherwise called nonwaived testing, have specific and detailed requirements regarding personnel qualifications,
quality assurance, quality control, and other systems. Waived testing, on the other hand, has few requirements and
is less stringent than the requirements for nonwaived testing.

The Joint Commission’s waived testing requirements are supported by the Morbidity and Mortality Weekly Report
article, “Good Laboratory Practices for Waived Testing Sites” from November 11, 2005. This report indicates quality
and safety concerns related to waived testing. Although by law waived tests should have insignificant risk of
erroneous results, these tests are not completely error proof; some waived tests have potential for serious health
impacts if performed incorrectly. This report draws attention to these pertinent risks:
- Lack of current manufacturers’ instructions, including manufacturers’ updates
- Failure to follow manufacturers’ instructions, including performing quality control
- Reporting of incorrect results
- Lack of adherence to expiration dates
- Inappropriate storage requirements
- Not performing test system function checks or calibration checks
- Lack of documentation, including quality control and tests performed
- Inadequate training
- Lack of understanding about good laboratory practices

These errors could cause inaccurate results that could lead to inaccurate diagnoses, inappropriate or unnecessary
medical treatment, and poor patient outcomes.

Waived testing is the most common regulated testing performed by caregivers at the patient bedside or point of care.
The current list of methods that are approved as waived is under constant revision, so it is advisable to check the US
Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), or Centers for Medicare &
Medicaid Services (CMS) websites, such as the following, for the most up-to-date information regarding test
categorization and complete CLIA ’88 requirements:
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/testswaived.cfm
- https://www.cdc.gov/labquality/waived-tests.html?
CDC_AA_refVal=https%3A%2F%2Ffanyv88.com%3A443%2Fhttps%2Fwww.cdc.gov%2Fclia%2Fwaived-tests.html
- https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html

About This Chapter

When a patient performs their own test (for example, whole blood glucose testing by a patient on their own meter
cleared by the FDA for home use), the action is not regulated. Only testing performed by staff on patients is
regulated by CLIA ’88. The Joint Commission standards apply to staff using instruments owned by staff, owned by
the organization, or owned by the patient in performing waived laboratory tests. If staff members are providing only
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instruction or cueing the patient, then these standards do not apply. This distinction is important when caring for
patients who monitor their own health care (for example, testing of glucose or prothrombin times with home devices).

Currently, The Joint Commission allows for an organization to use the patient’s results for treatment decisions. When
using a patient’s results from self-testing, health care staff do not have the same types of assurance about quality as
they would if they conducted the testing themselves. The following processes are not specific Joint Commission
requirements but are provided only as examples of how organizations have dealt with these concerns in practice:
- Verification of competency by either confirming that the patient has been previously trained or observing the patient
perform their first test
- Requiring the patient to perform quality control, if available for the meter, each day results are used
- Correlation of the patient’s first glucose result with testing by a main laboratory
- Confirmation of all critical and nonlinear instrument values with testing by the main laboratory
- Demonstration of proper equipment maintenance

Note: The Joint Commission requirements for laboratories or sites that perform nonwaived testing are located in the
“Quality System Assessment for Nonwaived Testing” (QSA) chapter.

Chapter Outline
I. Policies and Procedures ( WT.01.01.01)
II. Identification of Staff Performing and Supervising Waived Testing ( WT.02.01.01)
III. Competency of Staff Performing Waived Testing ( WT.03.01.01)
IV. Performance of Quality Control Checks ( WT.04.01.01)
V. Recordkeeping ( WT.05.01.01)

Standard: WT.01.01.01
Policies and procedures for waived tests are established, current, approved, and readily
available.

Introduction: Not Applicable.

Rationale: Not Applicable.

Elements of Performance

1. The person from the organization whose name appears on the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) certificate approves a
consistent approach for when waived test results can be used for diagnosis and
treatment and when follow-up testing is required. (See also LD.04.01.01, EP 1)

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2. The person from the organization whose name appears on the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) certificate, or a
qualified designee, establishes written policies and procedures for waived testing
that address the following:
- Clinical usage and limitations of the test methodology
- Need for confirmatory testing (for example, recommendations made by the
manufacturer for rapid tests) and result follow-up recommendations (for example,

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a recommendation to repeat the test when results are higher or lower than the
reportable range of the test)
- Specimen type, collection, and identification, and required labeling
- Specimen preservation, if applicable
- Instrument maintenance and function checks, such as calibration
- Storage conditions for test components
- Reagent use, including not using a reagent after its expiration date
- Quality control (including frequency and type) and corrective action when
quality control is unacceptable
- Test performance
- Result reporting, including not reporting individual patient results unless quality
control is acceptable
- Equipment performance evaluation
Note 1: Policies and procedures for waived testing are made available to testing
personnel.
Note 2: The designee should be knowledgeable by virtue of training, experience,
and competence about the waived testing performed.

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3. If manufacturers’ manuals or package inserts are used as the policies or

procedures for each waived test, they are enhanced to include specific
operational policies (that is, detailed quality control protocols and any other
institution-specific procedures regarding the test or instrument).

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4. The person from the organization whose name appears on the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) certificate, or a
qualified designee, approves in writing policies and procedures for waived testing
at the following times:
- Before initial use of the test for patient testing
- Periodically thereafter, as defined by the person whose name appears on the
CLIA certificate but at least once every three years
- When changes in procedures occur (for example, when manufacturers' updates
to package inserts include procedural changes or when a different manufacturer
is used)

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5. Current and complete policies and procedures are available for use during testing
to the person performing the waived test.

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6. Written policies, procedures, and manufacturers' instructions for waived testing

are followed.
Note: Manufacturers' recommendations and suggestions are surveyed as
requirements. (See also WT.04.01.01, EPs 3, 4, 5)

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Standard: WT.02.01.01
The person from the organization whose name appears on the Clinical Laboratory
Improvement Amendments of 1988 (CLIA '88) certificate identifies the staff responsible for
performing and supervising waived testing.
Note 1: Responsible staff may be employees of the organization, contracted staff, or
employees of a contracted service.
Note 2: Responsible staff may be identified within job descriptions or by listing job titles or
individual names.

Introduction: Not Applicable.

Rationale: Not Applicable.

Elements of Performance
1. The person from the organization whose name appears on the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) certificate, or a
qualified designee, identifies in writing the staff responsible for performing and
supervising waived testing.

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2. The person from the organization whose name appears on the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) certificate, or a
qualified designee, identifies in writing the staff responsible for supervising
waived testing.

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Standard: WT.03.01.01
Staff performing waived tests are competent.

Introduction: Not Applicable.

Rationale: Not Applicable.

Elements of Performance
1. The person from the organization whose name appears on the Clinical
Laboratory Improvement Amendments of 1988 (CLIA '88) certificate, or a
qualified designee, provides orientation and training to and assesses the
competency of staff who perform waived testing.

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Risk Area Human

Resources

2. Staff who perform waived testing have received orientation in accordance with
the organization’s specific services. The orientation for waived testing is
documented.

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Resources

3. Staff who perform waived testing have been trained for each test that they are
authorized to perform. The training for each waived test is documented.

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Resources

4. Staff who perform waived testing that requires the use of an instrument have
been trained on its use and operator maintenance. The training on the use and
operator maintenance of an instrument for waived testing is documented.

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Resources

5. Competency for waived testing is assessed using at least two of the following
methods per person per test:
- Performance of a test on a blind specimen
- Periodic observation of routine work by the supervisor or qualified designee
- Monitoring of each user's quality control performance
- Use of a written test specific to the test assessed

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Resources

6. Competence for waived testing is assessed according to organization policy at

defined intervals, but at least at the time of orientation and annually thereafter.
This competency is documented.
Note 1: When a physician or other licensed practitioner performs waived testing
that does not involve an instrument and the test falls within their specialty, the
organization may use the medical staff credentialing and privileging process to
document evidence of training and competency in lieu of annual competency
assessment. In this circumstance, individual privileges include the specific
waived tests appropriate to the scope of practice that they are authorized to
perform. At the discretion of the person from the organization whose name
appears on the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88)
certificate or according to organization policy, more stringent competency
requirements may be implemented.
Note 2: Provider-performed microscopy (PPM) procedures are not waived tests.
(See also HR.01.06.01, EP 18)

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Standard: WT.04.01.01
The organization performs quality control checks for waived testing on each procedure.
Note: Internal quality controls may include electronic, liquid, or control zone. External quality
controls may include electronic or liquid.

Introduction: Not Applicable.

Rationale: Not Applicable.

Elements of Performance

2. The documented quality control rationale for waived testing is based on the
following:
- How the test is used
- Reagent stability
- Manufacturers' recommendations
- The organization's experience with the test
- Currently accepted guidelines

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3. For non-instrument-based waived testing, quality control checks are performed at

the frequency and number of levels recommended by the manufacturer and as
defined by the organization’s policies.
Note: If these elements are not defined by the manufacturer, the organization
defines the frequency and number of levels for quality control. (See also
WT.01.01.01, EP 6)

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Risk Area Waived

Testing

4. For instrument-based waived testing, quality control checks are performed on

each instrument used for patient testing per manufacturers' instructions. (See
also WT.01.01.01, EP 6)

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Risk Area Waived

Testing

5. For instrument-based waived testing, quality control checks require two levels of
control, if commercially available. (See also WT.01.01.01, EP 6)

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Standard: WT.05.01.01
The organization maintains records for waived testing.

Introduction: Not Applicable.

Rationale: Not Applicable.

Elements of Performance
1. Quality control results, including internal and external controls for waived testing,
are documented.
Note 1: Internal quality controls may include electronic, liquid, or control zone.
External quality controls may include electronic or liquid.
Note 2: Quality control results may be located in the clinical record.

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§493.1256(g)

2. Test results for waived testing are documented in the patient's clinical record.

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3. Quantitative test result reports in the patient's clinical record for waived testing
are accompanied by reference intervals (normal values) specific to the test
method used and the population served.
Note 1: Semiquantitative results, such as urine macroscopic and urine dipsticks,
are not required to comply with this element of performance.
Note 2: If the reference intervals (normal values) are not documented on the
same page as and adjacent to the waived test result, they must be located
elsewhere within the patient's permanent clinical record. The result must have a
notation directing the reader to the location of the reference intervals (normal
values) in the patient's clinical record. (See also DC.02.03.01, EP 2)

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§493.1291(d)

4. Individual test results for waived testing are associated with quality control results
and instrument records.
Note: A formal log is not required, but a functional audit trail is maintained that
allows retrieval of individual test results and their association with quality control
and instrument records.

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5. Quality control result records, test result records, and instrument records for
waived testing are retained for at least two years.

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