POCQSE1: Organization
Title: Point of Care Testing Quality Management
Source: EP18-A
Adopted: 09-30-10
Document #: POCQSE1:02
Related Documents: POCQSE1:02a, Nursing Manual, POC training/competency forms (Section POCQSE 2:1
and 2:2)
Principal/Purpose: Advances in technology and the implementation of micro-techniques and portable
instruments have made it possible to move laboratory testing closer to the patient.
Point-of-care testing (POCT), also known as bedside testing or near patient testing, is
intended to provide more rapid test results than can be achieved in central or satellite
laboratory settings. This is particularly important in critical care areas such as the
intensive care unit, emergency rooms, emergency transport vehicles, and operating
rooms. POCT is used to expedite treatment decisions and provide convenience for the
patient. POCT testing is defined by the CAP as "those analytical test sites or services
within the institution which are operated or performed outside the physical facilities of
the clinical laboratories". This does not include satellite laboratories.
Scope: Palmetto Health Baptist, Point of Care testing (POCT) for bedside glucoses includes
Nursing Units, Intensive Care Units, Emergency Department, Nuclear Medicine,
Radiology Special Procedures, GI Lab, Cath Lab, OR and PACU. iSTAT testing is
performed in OR, NICU and NBN, CT, and PET SCAN. AmniSure ROM for fetal rupture
testing is performed on Labor and Delivery Units.
Responsibility: A. The Laboratory Pathologist with the designated service of Chemistry is the
Director of the Point of Care Testing Program. A Laboratory/Nursing Team
manages the Point of Care Testing Program.
B. The Laboratory POC department is responsible for the technical validation of
POCT instruments and test. The connectivity of instruments is the
responsibility of the Laboratory and IT department. The PHB Laboratory
provides the POCT testing equipment, evaluation, review, reporting of quality
control and proficiency testing, and Quality Improvement assessment, as well
as technical support. The POC Division is responsible for monitoring errors and
potential problems with preanalytical, analytical and postanalytical processes
of POC testing.
C. Nursing, Ancillary and Anesthesia staff performs the patient testing at the
point of care. The staff is responsible for performing quality control, keeping
the instruments clean, changing the batteries and notifying POC when there is
a problem with an instrument. Labeling and maintenance of quality control
solutions, monitoring of reagent expiration dates and storage conditions are
the responsibility of the staff performing the testing as well.
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Point of Care Testing Quality Management
D. Only trained personnel who demonstrate continued competence will perform
POC testing. An initial, six months and annual competency review will be
performed for all testing personnel. Nursing Support Services, Point of Care
(POC) staff and Clinical Nurse Specialists (CNS) will perform the skills training
and the six months competency check-off for the point of care testing
personnel. The POC Division and Nursing Support Services will be responsible
for monitoring competency compliance for all POCT personnel. Nursing
Support Services will notify the Unit Manager(s), before the expiration of the
employee’s competency, that skills review needs to be completed. The POC
Division will update operator’s POC competency in the database, upon
notification that the skills check-offs have been satisfactorily completed.
Employees not completing their six months competency skill assessments or
annual assessments by the expiration date in the POC databases will be locked
out of the testing system until their competency check-offs are complete.
Annual review will consist of the following quality essentials:
Quality control errors, patient ID errors, proficiency testing, and patient test
performance. Employees demonstrating 100% compliance in all quality
essentials of testing performance will be recertified for another year. Those
exhibiting errors or no performance of one or more of the quality essentials
will be required to attend a retraining class with Nursing Support Services or
the Laboratory POC Division.
E. Competency assessment tools:
1. Direct observations of routine patient test performance, patient
identification and preparation; and specimen collection, handling,
processing and testing
2. Monitoring the recording and reporting of test results, including, as
applicable, reporting critical results
3. Review of intermediate test results or worksheets, quality control records,
proficiency testing results, and preventive maintenance records
4. Direct observation of performance of instrument maintenance and
function checks, as applicable
5. Assessment of test performance through testing previously analyzed
specimens, internal blind testing samples or external proficiency testing
samples; and
6. Evaluation of problem-solving skills
F. Docking stations for test download to the LIS/HIS are placed on the units, in
locations designated by the Nurse Manager or Director of the unit. The
number of POC devices per unit will be determined by the patient care needs
of that area.
G. The HL7 Interface, Data Repeater software and docking stations will be
maintained by Information Technology.
H. Bar-coded operator ID numbers will be distributed and maintained by Nursing
Support Services, the Laboratory POC Division, and Safety and Security.
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Point of Care Testing Quality Management
Certified Instructors: Laboratory and nursing staff who receive instruction on the operation of the Point of
Care equipment from the manufacturer’s representative or a certified trainer:
A. Demonstrate use of the system by performing satisfactory control testing.
B. Perform initial in-service, conduct performance reviews, and maintain records
pertaining to testing staff.
C. Perform quality assessment by reviewing results and assist in conducting
quarterly proficiency tests.
D. Serve as consultants within the facility for problem solving and remedial action
on shifts.
Employees RNs, LPNs, Nurse Technicians, Phlebotomists, and Medical Technologists, CRNAs,
Performing Point of Anesthesiologist, and Radiology Technologists who receive training in the performance
Care Tests: of POC Testing.
A. Satisfactorily pass the check-off exam, completing the checklist.
B. Describe location and use of the POC devices, appropriate procedure for
testing, and appropriate documentation of results.
C. Demonstrate use of the POC devices and perform Quality Control and or
Proficiency Tests accurately when prompted.
D. Identify quality control requirements for this facility.
E. Perform capillary sticks and blood draws proficiently.
F. Understand and follow proper patient identification procedures.
Security: The employee’s hospital identification number is assigned as the Point of Care testing
ID number for all point of care testing staff. The number will be used to track all testing
performed at the point of care. Employees trained to perform AmniSure testing will
use their initials and their 5 digit hospital ID number to document testing. Employees
are instructed at training to let no one use their ID number. Upon termination of
employment the operator’s ID number is removed from the active testing database.
The POC Interface Manager Program maintains a record of all transactions performed
under the operator’s barcoded number.
Auto backup of testing information assures retrieval of the patient information should
a problem occur with the PC. The POCT vendor also keeps a duplicate copy of the PHB
Interface Manager. The POC devices are password protected to prohibit anyone other
than specified Laboratory personnel from changing set parameters.
Competency Regulatory agencies require hospitals to assess the competency of every operator who
Assessment: performs point of care testing. Attachment F
A. Successful quality control testing is used as a mode of certification for
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Point of Care Testing Quality Management
continued competency. The operator’s competency documentation is a
function of the QCM software. A 100% pass rate for performing QUALITY
CONTROL and PROFICIENCY TESTING must be maintained by operators
performing testing in order to be auto certified annually. POC personnel will
be responsible for notifying the operator’s supervisor when deviation from
quality performance is noted. Depending upon the number and type of quality
issues the employee may have their testing ID number deactivated to prevent
patient testing until retraining is completed. The supervisor will be responsible
for making sure the operator is re-trained by a certified trainer from Nursing
Education or the POC Division. Nursing Education will notify the Laboratory
POC Division when retraining is completed. The POC Division will reactivate
the employee when notified that retraining and assessment is complete.
B. Changes to POC tests procedures are made in conjunction with Nursing
Support Services. Changes are approved by the Medical Director and the new
procedure placed on MyPal. Notification of the change will be sent to the
Nursing Unit Managers by POC staff, requesting that all staff performing POC
testing review the procedure changes.
C. Testing personnel on all three shifts will be expected to perform proficiency
samples when specimens are given to their assigned units.
Testing staff with results falling outside the acceptable range for performance
will be notified. An assessment will be performed to determine reasons for
the result discrepancy, and appropriate measures implemented for
improvement.
D. All quality control data, proficiency testing results, instrument error codes, and
operator information is documented in QCM. Quality Control lockout prevents
any patient testing from being performed when Quality Control has not been
done. Lockout also prevents testing if Quality Control is not within range. The
monitors are all set to give pass/fail answers for valid Quality Control. The POC
Division reviews Quality Control daily. The Medical Director reviews the
Quality Control summary monthly.
E. iSTAT performance records, and operator information is documented in the
QCM Data Manager. iSTAT operators are prevented from testing if the
electronic QC or any part of the test process fails by internal checks in the
iSTAT cartridge and iSTAT.
F. Reports created by the POC Division and directed to Unit Managers for follow-
up and training include one or more of the following:
1. Patient ID Errors
2. Quality Control Errors
3. Quality Control Performance
4. Panic Value Notification
5. iSTAT operator error codes
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Point of Care Testing Quality Management
Unit managers are responsible for reviewing the variance report with the employee
and implementing corrective action if appropriate. The unit manager should return the
signed signature sheet to the POC division indicating their review of the quality report.
The signature sheet confirming the unit manager’s knowledge of the monthly reports
will be maintained in the POC Division. If corrective action is taken by the Unit
Manager, the action should be documented and remain on the unit in the employee’s
file.
Error Review: Ordering and resulting of the PxP glucose and iSTAT tests are handled by the interface
manager. All results must meet the rules for auto ordering before they are sent to the
HL7 interface for ordering and resulting. The interface manager will place the patient
tests that do not meet auto-verification requirements into a queue for POC personnel
review. The patient’s barcoded 10-digit account number is scanned by the operator
from the wristband and is a unique identification number for the PxP. The PxP monitor
also asked the operator to confirm the patient’s year of birth by entering the last two
digits of the birthdate after verifying the information from the wristband. Any
problems with the birthdate will stop the testing process until the correct data is
entered. Issues with the account number will result in the interface manager placing of
the results into an error queue. POC personnel review and reconcile errors.
Attachment A and B
Proficiency Testing: Palmetto Health Baptist Laboratory Point of Care department will participate in the
American Proficiency Test (API) Program for Whole Blood Glucose and API for iSTAT
testing. Proficiency testing (in the POC department will be integrated into quality
improvement program as required. Whenever possible the POC department will use
the information gained from investigation of unacceptable results to prevent similar
problems in the future. Review of results will incorporate monitoring data for trends
that could signal a developing problem.
The point of care staff will receive the API product and prepare the samples for
distribution among testing staff.
Proficiency test samples will be distributed to as many of staff as specimen quantity
allows. Specimens will be treated in the same manner as patient test samples.
Specimens will be rotated between testing personnel on all shifts.
Based on CLIA regulations, there will be no comparison or sharing of CLIA laboratory
proficiency test results with another related or non-related laboratory.
Linearity Test/ Linearity and precision testing will be performed on all POC instruments before they
Precision Testing: are placed into use. Instruments that fail linearity and/or precision testing will be sent
back to the manufacturer for replacement.
Calibration iSTAT cartridge calibration verification will be performed to verify the accuracy of the
Verification: results over the entire measurement range of a test. Each cartridge type used in the
PHB Point of Care department will be tested every six months, when quality control
fails to meet the established criteria, or after major maintenance or service.
Instruments that fail calibration verification will be sent back to the manufacturer for
replacement.
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Point of Care Testing Quality Management
Reagents: Glucose strips and controls will be maintained in the PYXIS on the units. Only lot
numbers verified and tested by the POC Division will work on the PxP monitors. When
a new lot number arrives in the warehouse, Materials Management will notify the POC
Division that a new lot number has arrived. Point of Care will obtain the new lot
number for parallel testing. Materials Management will be notified when the Point of
Care Division verifies the manufacturer’s established range of the new lot for use. The
tolerance ranges are obtained from the QCM data management system. The validation
report is printed, reviewed and filed by the POC staff. Once the range is verified,
Materials Management will be notified; and the strips can be placed in the PYXIS.
Attachment C
Quality control is performed on all iSTAT cartridges when they are received in the POC
Division. (Attachment E) Liquid quality control is performed by testing staff on lot
numbers in inventory every 30 days or whenever a question regarding storage and
stability occurs. If the liquid quality control fails a rerun of the control should be done.
If the second control is within limits, it is considered a random occurrence and no
ramifications on patient test results. If, however, the rerun control fails, this is an
external control failure, and the problem must be identified and corrected. Once
corrected a repeat of the Electronic Quality Control (EQC) validation must be done
before resuming testing.
Internal electronic simulator (EQC) is performed every 8 hours on H and H. Internal
electronic simulator (EQC) is performed every 12 hours on all other tests. If the
internal electronic (EQC) fails, the external simulator must be run. Failure of the
external simulator requires replacement of the iSTAT instrument.
Quality control and concurrent testing is performed on AmniSure reagents by the
testing staff when they are received in the POC Division and if questions regarding
storage or performance occur. Attachment D
Reagent Handling When reagents are received into the department the following steps will be taken:
Verify reagents temperature requirements have been maintained.
Label the reagent containers with the received date.
Store the reagents per manufacturers’ recommendations.
Place reagents needing validation on the appropriate shelf labeled “Do not
use.”
Glucose calibrators and controls should be labeled when opened with the open
date and the new expiration date.
iSTAT cartridges must be labeled with the new date of expiration when
removed for more than 5 minutes for individual cartridges and 1 hour for a box
of cartridges. (Each cartridge must be labeled not the box.)
All reagents must be used within their indicated expiration date.
Instrument The POC Division will perform bi-annual testing of the iSTAT instrument comparability
Comparability: by:
Take 5 of each type iSTAT cartridges in use out to warm
Collect two or three green lithium heparin tubes from 5 normal patients
Label the tubes with the downtime stickers from Chemistry
Have hematology run the H&H on each patient
Spin the green tube down and give to Chemistry to run a full BMP
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Point of Care Testing Quality Management
POC will run the EG7+ and Chem 8+ on a separate tube on the reference iSTAT
for each patient.
For each patient and cartridge type the results will be entered into the Excel
spreadsheet and calculated. The results will be compared to the criteria set by
CLIA 88 for allowed variance from target value.
Quality Improvement An ongoing review of the essential elements in the process for performing POC tests
Assessment: will be performed by the POC Division staff: The essential elements in the testing
process are as follows:
A. Preanalytical Essentials
B. Analytical Essentials
C. Postanalytical Essentials
The POC Division will distribute quality information to unit managers as applicable.
Process changes will be implemented when deemed necessary in order to improve
quality of patient care. An audit of the testing process will be performed periodically
to check compliance with regulatory requirements. POC quality will be integrated with
the PHB Laboratory Quality System.
POC Test Daily A. QCM database will be monitored by the POC staff daily for problems. The
Review: review will consist of, but is not limited to, the following:
1. Patient Identification Errors
2. Expired/Terminated Operators
3. Quality Control Issues
4. Emergency Barcode Numbers
5. Instrument Error Codes
6. Pending Logs
7. Panic Results
B. Database for iSTATs will be monitored by the POC staff daily for problems. The
review will consist of, but is not limited to, the following:
1. Patient Identification Errors
2. Expired/Terminated Operators
3. Quality Control Issues
4. Instrument Error Codes
5. Pending Logs
6. Panic Results
POC Quality Control: Quality control is performed on all POCT tests according to CLIA, CAP, JCAHO and
manufacturer’s guidelines. PxP and iSTAT monitors use operator lockout functions
when Quality Control is due. Operators are notified by instrument messaging Quality
Control is due. No testing can occur until the Quality Control is performed. POC
DEVICES WILL NOT OPERATE IF QUALITY CONTROL IS NOT ACCEPTABLE. Quality
Control data is downloaded to the POC division when the POC devices are downloaded.
Quality Control download records contain the date, time of performance, and
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Point of Care Testing Quality Management
operators identification number. Quality Control review is performed by the POC
Technologist, POC Coordinator, and POCT Director at specified times. The data
management devices keep up to date records of all reagent lot numbers and expiration
dates. Attachment G and H
External quality control for AmniSure ROM is performed parallel with new and old lot
numbers, monthly or when there is suspicion that the product performance is
compromised.
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Procedure: Point of Care Quality Management
Document #: POCQSE1:02
Supersedes Document #: Not applicable
Originally Adopted Date: 09-30-10
Original Author(s): Eileen Postles, Supervisor
Accepted by: __________
(Date) M. D.
Pathologist
Reviewed Revised Accepted Date Signature
QSE6: Documents and Records
Title: Document History
Form Adopted: 02-04-10
Form Document #: QSE6:04
History Document Title: Point of Care Quality Management
History Document #: POCQSE1:02
Date Revision Completed Typist
Date Document Retired
Superceding Document Title
Superceding Document #