IV.
POLICY STANDARDS
A. The intent of this policy is to provide
guidelines to ensure the reliability of testing
performed at the point of care and to meet
the regulatory standards.
B. University of Michigan Hospitals staff
who have demonstrated competency perform POCT
in accordance with accreditation standards
and, for nonwaived complexity testing, under
the supervision of the POCT Coordinator, Medical
Director, or other designated management staff.
C. All point of care tests at UMHHC are considered
definitive. A critical level, as defined in
the “Critical Value” table in
the current Pathology Laboratories Handbook,
or the on-line handbook, http://po.path.med.umich.edu/handbook/
must be confirmed by the laboratory.
D. POCT Approval Process
1. All tests performed under this policy are
reviewed and approved by the Director of Clinical
Pathology.
2. Approved point-of-care tests conforming
to this policy are included under the Department
of Pathology’s Laboratory Registration
Certificate for Waived testing CLIA ID# 23D0951143
or the Department of Pathology Certificate
of Accreditation CLIA ID# 23D0366712.
3. Activities of the Point of Care Test programs
must comply with current regulatory standards.
E. Training and Competency Assessment
1. Testing personnel are trained in the performance
of point-of-care tests.
a. The Department of Nursing orients and provides
specific training to nursing personnel that
perform point-of-care tests.
b. Pathology’s POCT Coordinator provides
specific training to non-nursing testing personnel
who perform point-of-care tests.
c. The POCT Coordinator provides training
to, or assists the Department of Nursing,
in training all testing personnel when a testing
procedure is changed or added to the test
menu.
2. Appropriate management staff documents
the training.
3. Staff is assessed at defined intervals
to show current competence in the specific
point-of-care tests they perform.
a. Competency assessment takes into consideration
the frequency that testing personnel perform
tests, their technical backgrounds, complexity
of the test methodology and the consequences
of an inaccurate result.
b. The following methods are approved to be
used to assess the competency of testing personnel:
• Participation in the proficiency testing
program – performing a test on an unknown
specimen
• Appropriate management staff periodically
observe the performance of point-of-care tests
during the normal work routine
• Monitor the quality control performance
4. Documentation of competency testing, and
any required remedial action, is maintained
on all testing personnel.
F. Pathology Responsibilities
1. Assures all regulatory standards are met
in the implementation of point of care testing.
2. The Laboratory Director of Clinical Pathology,
or designee, selects equipment and methods
used, and tests all aspects of their performance.
3. Maintains a list of approved tests and
instruments used for point of care testing.
4. The Laboratory Director and the POCT Coordinator
review and make recommendations for equipment,
methods and testing procedures.
5. The POCT Coordinator reviews quality control
for glucose tests performed at all testing
sites.
6. Development and maintenance of a Point
of Care Testing Procedure Manual. Please note:
the complete procedure manual is maintained
and available on-line at http://www.pathology.med.umich.edu/patient.html.
The manual is reviewed annually by the Director
of Clinical Pathology or designee. At a minimum
manufacturer’s instructions are followed
when performing these tests.
7. The POCT Coordinator performs the initial
quality control of new lot numbers of sequestered
reagents used for POCT testing. For waived
tests other than glucose meter testing, the
documented quality control rationale is based
on the following: how the test is used, reagent
stability, manufacturer’s recommendations,
the hospital’s experience with the test,
currently accepted guidelines.
8. The POCT Coordinator maintains a separate
inventory log of the sequestered POCT reagents
in use. Quality control documentation is maintained
for two years in the Department of Pathology.
9. Glucose testing results are transmitted
electronically from the patient unit to the
laboratory. The testing personnel dock the
glucose meter on the transmitting data port
and the test results, instrument number and
identification number of the testing personnel
transfers electronically to the laboratory.
The POCT coordinator reviews and maintains
the log of glucose testing results and provides
any necessary feedback to the nursing staff.
10. For POCT other than glucose, the results
of testing and the unique names of testing
personnel are recorded on the nursing flow
sheet, and/or paper requisition result form.
These results are sent to designated Department
of Pathology areas for entry into the laboratory
information system.
11. Normal ranges for test results are defined
by the laboratory and appear on the laboratory
report maintained in the CareWeb reporting
system.
12. The Department of Pathology maintains
the test result records.
G. Instruments and Equipment Calibration/Maintenance
1. All instruments used for POCT testing are
calibrated (standardized) by the testing personnel
according to procedure/manufacturer’s
instructions.
2. Maintenance varies with the complexity
of the instrument. The testing personnel perform
and document routine maintenance according
to the procedure/manufacturer’s directions.
More complex instrument maintenance is defined,
performed and documented by the Department
of Pathology.
H. Compliance
Failure to comply with this policy may result
in exclusion of an individual or a specific
patient care unit from performing point of
care tests.
|
|
|
|
|
|
|
|
|
