Clinical Laboratory Improvement
Amendments of 1988 ( CLIA ’ 88 )
 Federal regulations which govern test results that are
used to assess a patient’s condition or make a
clinical decision about the patient
 CLIA’ 88 classifies tests depending upon complexity
as: high, moderate, provider-performed microscopy,
or waived
 A CLIA Certificate of Waiver is required for labs
performing only waived testing
Waived Tests
Waived tests include test systems cleared
by the FDA for home use and those tests
approved for waiver under CLIA criteria. CLIA
requires that waived tests must be simple
and have a low risk for erroneous results.
This does not mean that waived tests are
completely error-proof. They should be
performed correctly
Testing Oversight
 CLIA does not specify requirements for
directors of laboratories with a Certificate of
Waiver ( some states require a physician )
 The person whose name appears on the
CLIA Certificate as the Medical Director is
responsible for testing oversight and decision
making .
Medical Director or Designee
Responsibilities
 Ensure appropriate preparation prior to
testing, i.e. patient ID, collection and handling
 Identify staff responsible for performing and
supervising testing.
 Ensure staff are trained in each test they
perform, aspects of safety, and QC prior to
reporting test results
 Ensure periodic evaluation of competency
Especially important since no specific degree or
certification is required and turnover rates are high
Medical Director or Designee
Responsibilities:
 Establish written policies and procedures for
waived testing
 Make decisions on how the test results are
used and when follow up testing is required
 Approve policies before a test is put in place
 Review and approve policies every 3 years or
more often if changes are made
Importance of Getting it Right!
Consider this:
 Waived tests are used to adjust medication
doses, i.e. anticoagulant therapy
 Pregnancy test prior to undergoing radiology
tests
 Glucose monitoring in diabetic patients
Importance of Preanalytical
Processes
 Preanalytical errors are the main cause of
laboratory errors
 Why?
Human factor
Difficult to detect and correct
Focus on Prevention!
 Standardize processes & understand
variables, i.e.:
Two patient identifiers
Use dedicated staff for collection
Correct order of draw
Methods to prevent hemolysis
Two Patient Identifiers
 Two patient identifiers are used when collecting blood
or other samples for clinical testing
 Two patient identifiers are used when providing other
treatments or procedures
 The patient’s physical location is not used as an
identifier    
 Containers used for blood and other specimens are
labeled in the presence of the patient
Ref: Joint Commission, camlab,2007
Methods to prevent hemolysis
 Appropriate needle bore
 Remove the tourniquet as soon as possible
 Allow alcohol to dry
 Avoid vigorous mixing or shaking
 Avoid prolonged contact of serum or plasma
with cells
Staff Training and Periodic
Competencies
 Staff identified by name or job description
 Staff trained for each test they are authorized
to perform including performance of quality
control
 Staff trained on the use of each instrument
operation, calibration and maintenance
Waived Policy Highlights
POLICY:
 Waivered laboratory procedures (as defined
by the Clinical Laboratory Improvement
Amendment of 1988) may be performed by
certified personnel with the guidance and
assistance of the Medical Director of the lab
or designee or may be performed by RMAs,
CMAs, Certified Phlebotomists who have
been authorized to perform the tests
Procedure Authorization
Staff Member Signature/Date ___________________
Trainer Signature/Date_________________________
Test /Instrument
Glucose Meter ( Accu-Chek )
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General Operation
Test Performance
Quality Control
Maintenance
Troubleshooting
Test/Instrument
PT/INR ( Coaguchek )
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General Operation
Test Performance
Quality Control
Maintenance
Troubleshooting
Assessing Competencies
Competency assessed using at least two of
the following:
 Direct observation of testing/or submit a blind
specimen
 Review of result reporting, track errors
 Review of maintenance and QC logs
 Use of a written exam
Competency should be assessed at least
at orientation and annually thereafter
Components of Policies and
Procedures for Waived Testing
 Confirmatory testing and result follow-up
 Specimen type, collection, ID, and labeling
 Specimen preservation
 Instrument maintenance and function checks
( calibration )
 Storage of reagents
Components, continued:
 Reagent use, expiration dates
 Quality control frequency and type ( including
corrective action when unacceptable )
 Test performance
 Reporting results ( do not report if quality
control is unacceptable )
 Equipment validation
Waived Policy Highlights
 PROCEDURES:
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A.
Bedside Glucose Accu-Chek Advantage
PURPOSE: This policy establishes guidelines for the
performance of accurate bedside glucose testing used in clinical
decision making such as the rapid evaluation of patients with
suspected hypo-or hyperglycemia, the determination of
appropriate insulin doses or infusion rates, and assessing the
effectiveness of treatment regimens. This method is not used
for the diagnosis of diabetes mellitus. These guidelines
follow recommendations defined by certain regulatory agencies
as dictated by principles of good laboratory practice.
Waived Policy Highlights
 Negative Result: Only one (1) pink colored
line appears in the control region. No
apparent pink colored line is visible in the test
region. A negative result indicated that there
is no Strep A antigen in the swab sample or
the Strep A antigen concentration is below
the detection level. A negative result should
be cultured to confirm the absence of
Strep A infection.
Waived Policy Highlights/Result
Follow up
Critical Values and Unusual Results:
 Any glucose value <40 mg/dL or >400 mg/dL should be
repeated. Repeat results exceeding these limits are designated
as Critical Values and should be reported as soon as practical to
the physician or physician extender
 If at any time results of bedside glucose testing, regardless of
whether they are critical values, are inconsistent with the
patient’s status, notify the physician or physician extender for
instructions.
Quality Control
 Quality Control checks are performed at the
frequency and number of levels
recommended by the manufacturer
 If the manufacturer doesn’t recommend the
frequency and number, the medical director,
designee or organization must define
Documentation of Quality Control
 Controls may be documented on a quality
control log or located in the patient’s clinical
record
 Often internal quality controls are
documented in the patient’s clinical record,
while external is documented on a log along
with reagent lot #s, open dates and expiration
dates
Waived Policy Highlights
Quality Control:
Accu-Chek Comfort Curve glucose controls, low and high levels
are used for quality control as follows:
Frequency: Run both levels of controls (low and high) with the
first run of the day. Also, both levels of controls should be run:
 Each time a new vial of test strips is opened.
 When a vial of test strips has been left opened.
 If the Advantage Meter has been dropped.
 Whenever the patient’s result contradicts the patient’s condition.
 When batteries are replaced.
Waived Policy Highlights
Validation of Controls:
 Log control results along with other required information on the Quality
Control Log. If control test results are not within expected limits, the
following steps are recommended:
 Confirm that the HemoCue Microcuvettes are within the expiration date
shown on the label.
 Retest with new controls.
 Log the invalid control results and the repeat results
on the Quality Control Log along with the corrective action used.
 Special Note: If these steps do not correct the problem,
call Northern Hospital Laboratory for assistance or contact
HemoCue Technical Services by calling 1-800-426-7256.
DO NOT REPORT PATIENT TEST RESULTS!
Instrument
Maintenance/Calibration
 Follow manufacturer’s instructions for
instrument maintenance and calibration
checks
 Instrument maintenance and calibration
checks must be documented
 Very important! Individual test results can be
associated with quality control, reagent lots,
instrument records, and calibration checks
Preventive Maintenance Schedule
C. HemoCue 201+-Hemoglobin System
 1. Daily a. Remove the cuvette holder from the photometer.
Clean the cuvette holder with 70% alcohol or mild soap solution.
Completely dry the cuvette holder before replacing in the
photometer. Wipe the surfaces with a commercially pre
moistened disinfecting cloth ( must be EPA registered
disinfectant ) SQUEEZING OFF THE EXCESS SOLUTION.
 2. Monthly a. Monthly inspection of workstation by designee.
 3. Annually a. Have NHSC Biomedical Engineering check for
proper electrical grounding.
REFERENCE: 1. HemoCue 201+ Blood Hemoglobin Operating Manual
Result Reporting
 Quantitative test result reports in the patient’s
clinical record for waived testing are
accompanied by reference limits ( normal
values ) specific to the test method used and
the population served
 Reference: Joint Commission Standards for Waived Testing
Hard Copy or EMR
 Result on a hard copy: Design the lab result
form with reference limits adjacent to the test
result
 Result in EMR: EMR page for entering lab
results may not be formatted to have
reference limits adjacent to the test result
 If not what? The reference limits must be
located elsewhere in the medical record and
the result must have a notation directing the
reader to that location
Documentation of Critical Values
 Very Important to document reporting of
critical values, i. e.,
Critical value reported to Dr. John Smith at 2:30
pm on April 15, 2012 by Mary Midkiff
Morbidity and Mortality Weekly
Report Indicates Risks
 Lack of current manufacturers’ instructions
including updates
 Failure to follow manufacturers’ instructions
including performing quality control
 Reporting of incorrect results
 Lack of adherence to expiration dates
 Inappropriate storage requirements
Reference: Morbidity and Mortality Weekly report, November 11, 2005
Morbidity and Mortality , conti.,
 Failure to perform 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
 Reference: Morbidity and Mortality Weekly Report, November 11,2005