In POLs, this might be a physician or
someone in a senior management
position who has the appropriate
background and knowledge to make
decisions about laboratory testing.
B. Anticipating and Addressing
Personnel Needs
Personnel competency and turnover are
important factors affecting the quality
and reliability of waived testing results.
While there are no CLIA requirements
for personnel performing waived testing,
all applicable state or local personnel
regulations must be met.
Personnel issues to consider include
assessment of present staffing levels and
training, to ascertain whether employees
have sufficient time and skills to reliably
perform all activities needed for testing.
1. Personnel Training
Personnel should be trained and
competent in each test they will perform
before reporting patient results. It is the
responsibility of the laboratory director
or other supervisory staff to ensure that
this training has occurred, along with
proper documentation of these efforts.
2. Competency Assessment
To ensure testing procedures are
performed consistently and accurately,
periodic evaluation of competency is
recommended, with retraining, as
needed, on the basis of results of the
competency assessment.
C. Development and Maintenance
of Procedure Manuals
It is good laboratory practice to develop
written policies and procedures so that
responsibilities and testing instructions are
clearly described for the testing personnel.
Written test procedures also form the basis
of training and evaluation of testing
personnel. These procedures should be
derived from the manufacturer's
instructions, and include directions for
specimen collection and handling, quality
control, test and reagent preparation, and
instructions for test performance,
interpretation, and reporting.
New testing procedures should be
reviewed, signed, and dated by the
laboratory director before incorporating
them into the procedure manual. The
“ Good laboratory practices
can be expanded to include
activities to evaluate and
improve the quality of
waived site testing, utilizing
both internal and external
quality assessment
activities. Results from
these assessment activities
should be documented and
evaluated, noting any
irregularities and the
actions taken to resolve
problems or improve
processes or procedures.”
Irwin Z. Rothenberg
manual should be updated as tests or
other aspects of the testing service
change and should be reviewed by the
director whenever changes are made.
When procedures are no longer used, the
date of discontinuance should be noted,
and they should be removed from the
manual. The manual should always be
readily available to all testing personnel.
II. Follow Best Practices During
Testing
A. The Pre-analytic phase
1. Test orders
Confirm that the written test order is
correct. If there is a question, check with
the ordering clinician before proceeding.
2. Patient identification
Use two unique identifiers to ensure
D. Maintenance of Complete and
accurate identification of the patient
Accurate Documents and Records before the specimen is collected. Names
Proper documentation is necessary for
can be similar and lead to confusion,
monitoring and assessing test performance, therefore use birth dates, middle initials,
identifying and resolving problems that
patient identification numbers or other
could affect patient testing, retrieving and
means to ensure correctness.
verifying information, and maintaining
3. Pretest instructions and information
adequate patient and personnel records.
Some tests require special preparation on the
Log books or electronic systems can be
patient’s part (e.g. fasting), or that the patient
used for maintaining and tracking
collect the specimen (e.g. urine or stool).
information. In some cases, records might
Provide the patient with pretest instructions
be part of the patient's medical chart.
when appropriate, and verify that patients
have received and understood the instructions
E. Performance of Quality
before collecting or accepting the specimen
Assessment
4. Specimen collection and handling
Good laboratory practices can be expanded The product insert provides details on
to include activities to evaluate and improve proper collection, handling and storage
the quality of waived site testing, utilizing
of patient specimens. Specimens need to
both internal and external quality
be adequately labeled to prevent mix-up.
assessment activities. Results from these
Always label specimens as soon as they
assessment activities should be documented are collected with pertinent patient
and evaluated, noting any irregularities and information. Labeling should also include
the actions taken to resolve problems or
the date and time of collection and
improve processes or procedures.
identification of the collector.
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