UAMS DEPARTMENT OF PATHOLOGY AND LABORATORY SERVICES QUALITY PLAN
To ensure the highest quality of laboratory services, the
of Arkansas laboratories have developed the following plan to guide the
full range of quality assurance, quality control, and continuous quality
A. This plan provides for
implementation and execution of all pre-analytical
through post-analytical quality assurance activities. These include, but are
not limited to, such processes a positive sample handling and procedure
development as well as accurate results reporting and personnel
B. The quality plan includes
provision for the design and review of a
comprehensive quality control program, including procedure manuals,
calibration verification, review of control material results, active
instrument maintenance and temperature checks, calibration of pipettes
and other laboratory equipment.
C. Lastly, the plan sets the framework
for the implementation and
documentation of a continuous quality improvement program within
the laboratory, allowing the laboratory to continuously monitor and
improve its daily activities to provide the most efficient, highest quality
lab services possible.
II. Quality Assurance
A. Proficiency Testing
1. The University Hospital
of Arkansas laboratory is a CAP accredited
Laboratory and as such, participates in the CAP Inter-laboratory
Comparison proficiency testing program.
2. The labs are enrolled in
the appropriate CAP surveys available to
cover the scope of patient testing performed.
3. For analytes where
proficiency testing is not available, the
performance of the assay should be validated by another method
(i.e., assayed serum, regional pools, etc.) twice a year.
Methods of compliance are kept in the laboratory section where these tests are
4. Proficiency testing samples are integrated into the routine laboratory workload.
5. The laboratory
director, his designee or the supervisor of the lab section where
the testing was performed, reviews the proficiency or alternative method testing
6. When proficiency testing
or alternative performance assessment results are
unacceptable, the section supervisor will respond with the appropriate
investigation and corrective action which is reviewed by the Medical Director.
7. All proficiency testing results and corrective action are filed for review.
8. Inter-laboratory communication about proficiency tests samples is
submission of results to the proficiency test provider.
It is also prohibited to refer proficiency testing to an outside laboratory.
In the event a Proficiency test challenge was not graded due to lack
or our lab failed to submit results or method code, the section supervisor would
investigate the cause, document corrective action and assess the performance of
our results (if available) with the CAP final results. If we fail to receive the PT kit
or need to obtain another kit, CAP may be contacted to determine if extra PT kits are
available so that we may perform, evaluate and document results to assess performance.
Other methods used to assess performance might include those we use for tests for
which there are no external PT.
1. Each laboratory section
should develop procedures, which adhere
to and promote the quality and policies set by the Department of
Pathology & Laboratory Services. These procedures should define
goals for monitoring analytical performance, establish tolerance
limits for quality control, and establish corrective action steps and
2. Sectional procedures
should identify the delegation of
responsibilities for the process and review of the various activities
that occur within the section.
3. Quality assurance for
analytical processes may include the
following elements, as applicable:
Establishment of a system of periodic review of patient and
quality control results, maintenance records, temperature
Establishment of a system which ensures positive identification
of patients and their samples from collection through results
Establishment of procedures to ensure the integrity of the
reported results which includes positive sample identification
as well as maintaining the optimum integrity of the sample to
Establishment of a system designed to compare results of the
same test performed by different methodologies or at different
sites at least twice per year.
Establishment of a program of self-inspection to ensure the
efficiency and accuracy of procedures and results as well as
competency of personnel performing analytical testing.
Establishment of procedures to detect clerical errors and steps
to document corrective action appropriately.
g) Establishment of a system for laboratory records retention.
Records are kept for a minimum of two years.
4. The Laboratory
Information System provides the framework for all
a) Real-time functions
include order processing specimen identification
and result reporting.
b) The Laboratory
Information System provides retrospective quality
assurance reports which allow for review of patient results, detection
and correction of errors, and measurement of laboratory efficiency.
c) Usage of the Laboratory
Information System is incorporated into
the procedures developed by each laboratory section.
5. The Laboratory
Information System will develop and maintain procedures
which ensure the integrity, accuracy and security of the Laboratory Information
1. All laboratory sections
will develop and maintain a procedure manual in
compliance with the National Committee for Clinical Laboratory Standards
2. The Procedure manual must
be available in the work area and all personnel
performing testing must be familiar with the content of the procedure manual
relevant to the scope of the activities they perform. All testing personnel
will be apprised of any procedural changes.
3. The procedure manual is
reviewed annually by the laboratory director of
designee. If revisions are made to a procedure, the revisions must be
documented and the procedure re-approved by the director or designee.
4. When a procedure is
discontinued, a copy of that procedure is maintained
for two years thereafter. All procedures should be dated with the following:
a) initial date put into service
b) revision dates
c) date of retirement
5. All procedures will be
reviewed and re-approved by the laboratory director
should there be a change in directorship.
1. Each laboratory section
will develop and maintain procedures that verify
sample identity and integrity. The procedures will include any special
handling required by various sample types, such as capillary samples,
aliquots, dilutions, etc.
2. The procedure should
outline each step of sample handling from receipt
of the sample through reporting of results.
3. Laboratory procedures
should include criteria for the rejection of
unacceptable samples as well as directives for documentation that the
sample has been rejected.
4. The procedure should list
condition under which sub-optimal samples
may be used for testing. The procedure should provide for the documentation
of the sub-optimal sample condition and how this may affect the interpretation
of the test results.
Specimen retention should be in compliance with accrediting and
agencies. Serum and body fluids should be retained for at least 48 hours,
urine specimens for 24 hours, blood films and permanently stained body fluid
slides and microbiology slides should be retained for at least 7 days.
1. Each test procedure,
where applicable, should be evaluated for the
following specifications prior to implementation:
c) analytic sensitivity
d) reportable range of patient test results
e) reference ranges for the population being tested
f) interferences which could affect results
2. The analytical
measurement range (AMR) is the range of analyte values
that a method can directly measure on the specimen without any dilution,
concentration, or other pretreatment not part of the usual assay process.
Each laboratory establishes the AMR that provides acceptable results for
the intended clinical use. This range can be established or verified using
appropriate reference materials; patient specimens, unaltered or altered
(i.e., diluted or concentrated) with known analyte concentrations; or
calibration materials. If the AMR exceeds the range of values of the
materials used for calibration or calibration verification, then the
laboratory must establish criteria for verifying the acceptability over time,
of the full AMR, and document compliance. The AMR can be
revalidated through the process of calibration verification every 6 months.
Apparent analyte concentrations that are
lower or higher than the AMR
do not routinely require repeat analysis if the result is reported as less than
the lower limit, or greater than the upper limit, respectively, and the
laboratory has evidence that the low result is not due to sampling/dilution
errors, immunologic "hook effects," etc.
3. The CRR
(Clinically Reportable Range)is the range of analyte values that
a method can measure, allowing for specimen dilution, concentration or
other pretreatment used to extend the direct analytical measurement range.
Each laboratory establishes the CRR that provides acceptable results for
the intended clinical use. Patient specimens, frequently obtained from
patients with disease conditions that produce very abnormal analyte
concentrations/activities, are typically used in a dilution or concentration
protocol to establish or verify the CRR. Analyte values less than or
greater than the CRR are usually reported as greater than or less than
some measurable value.
The CRR is usually a
characteristic of the assay technology and is
established at the time of initial validation of a method in a laboratory.
Once established, it does not need to be re-evaluated unless there are
instrumentation or methodology changes for the analyte. The CRR does
not need to be revalidated every 6 months.
4. The preceding evaluations should be documented.
a) Should there be a
significant change in analytic methodology,
the evaluations may need to be repeated.
b) If a revision of the
reference range is required, the laboratory
must notify its clients.
5. Laboratory procedures
should include any steps necessary to verify
results prior to their release, such as repeat of the test or dilution of the
sample if the test results exceed their reportable range.
6. The laboratory will have
a procedure for the immediate notification of
appropriate patient care personnel when results of certain tests are outside
“critical” limits. Critical values require a read back to confirm correct
communication. The critical limits should:
a) be established
b) be easily identified
c) have documentation of notification of the proper individual
7. The Delta Variance
function of the Laboratory Information System (LIS)
is designed to detect clinically significant changes in patient values for
specified tests. This function enables the technologist to detect possible
specimen handling errors, clerical errors, or analytical errors in a patient’s
results before the results are released to the patient’s chart.
The laboratory should have defined turnaround times for each test
and a procedure to notify clients, if necessary, in the case of delayed
9. All laboratory orders are
received through the Laboratory Information
System and all laboratory performed or reference test results are
reported through the Laboratory Information System. This allows for:
a) the results to be paired with the original order
b) any performance notes to be documented
c) the results to be reported appropriately
10. The laboratory will develop and
maintain procedures for the proper
handling, performance and reporting of test specimens received from
other laboratories and those referred to other laboratories.
11. Errors in reporting patient
results will be corrected as soon as possible
by notifying the nurse or physician and entering the corrected results in
the LIS with the previously reported results also displayed. Should a
major error in reporting multiple patient results be found, the lab will, in
consultation with the Pathology staff, develop and implement an
appropriate plan of notifying medical staff and correcting the results. The
underlying reasons for the error will be analyzed and steps will be taken
to prevent such problems in the future.
1. Laboratory procedures
should include the verification of assay
2. All reagents must be
properly labeled as appropriate with the
d) storage requirements
e) date prepared or reconstituted
f) expiration date
3. Components of reagent
kits must be used within the kit lot number
unless exceptions are noted by the manufacturer.
Each laboratory section should establish guidelines for calibration
and calibration verification of test procedures to ensure the continued
accuracy of the analytical methods. All calibrations and calibration
verifications should be documented.
Procedures should specify the proper calibrators or standards to be used
for calibration of each procedure. All calibrators/standards should be
properly labeled as to:
b) concentration or calibration values
c) date placed in service
d) expiration date
The above information should be recorded on the calibrator or readily
available. The calibrators should be of a compatible matrix with the
analytical system to be calibrated and have a known value appropriate
to the reportable range of the method.
Calibration procedures should include provisions for performance of
linearity on the system on initial set-up and guidelines for linearity
checks if an assay fails set criteria. Criteria for performing calibration
verification may include after major maintenance, as recommended by
manufacturer or at least every six months or at reagent lot changes if
accuracy of control data and patient results are affected.
The laboratory should define the reagent grade of water necessary for
each procedure and have documentation of the following:
a) definition of the nature
and frequency of water testing to
ensure the quality of water needed for laboratory procedures
b) evaluation of its source water for high concentration of silicate
c) specified checks and
corrective action taken if these checks do
not meet specified criteria
1. Each laboratory section
will establish and maintain written procedures
which direct the quality control program for testing performed in that
2. The quality control procedure must include the following elements:
a) definition of an
analytical run and performance frequency of
quality control for each test. For quantitative tests, controls
should be run at more than one concentration level each day
of testing. Coagulation test systems require testing with 2
levels of control during each 8 hour period of testing and
with each change of reagents.
b) identification and usage of the control materials
procedures used to establish the acceptable limits of un-assayed
and assayed control materials where applicable
d) inclusion of both a
positive and a negative control for applicable
e) organization and evaluation of the quality control data
f) procedures for corrective action, when applicable
g) verification of quality
control results before patient values are
Controls should be tested in the same manner and by the same personnel
as patient tests.
The quality control procedures should be under active surveillance by the
section supervisor or designee at least weekly with secondary review by
the pathologist, lab director or designee at least monthly. This review
should be documented to include the date of review and reviewer’s
Corrective action must be taken and properly documented prior to the
release of patient results.
Control specimens should be recorded in the Laboratory Information
System, where applicable, to approximate the same reporting mechanism
as patient results as well as to allow for long term results retrieval and
1. The laboratory will
purchase volumetric glassware of certified accuracy
whenever possible. If non-certified volumetric glassware is purchased,
all items must be checked for accuracy prior to use.
Volumetric pipettes should be stored segregated by size and type. Any
glassware which becomes damaged or unable to be read will be
Procedures for cleaning glassware should be developed to ensure
adequate washing and proper rinsing of reusable laboratory
Laboratory sections should develop procedures for the periodic checks
of the following laboratory equipment:
a) automatic pipettes
c) non-certified thermometers
d) temperature-dependent equipment
f) analytic balances
Procedures for checks of pipettes should provide for initial checks of
accuracy and precision before the device is placed into use. The
procedure should include:
a) the process to verify accuracy and precision
b) the defined interval for rechecks
c) explanation for documentation of checks
d) how to perform corrective action
The procedure for checking temperature dependent equipment may
be incorporated into other procedures or may be part of an instrument
The procedure should include:
a) definition of acceptable temperature ranges
b) steps to follow to record temperature
c) corrective action steps if acceptable limits are exceeded
Quality assurance procedures should provide for periodic checks and
cleaning of centrifuges as well as proper monitoring and servicing of
1. Each lab section which
employs automated equipment or systems
should develop and maintain procedures for the standard set-up and
operation of the system. Procedures should include:
a) evaluation of precision and accuracy
b) a schedule for, and
record of, function checks and periodic
c) a procedure for
calibration and performance of quality control
Each laboratory section employing automated systems should develop
procedures for recording and analyzing results of controls and other
function checks daily to detect instrument or process failure.
If multiple instruments perform the same assay, a procedure should be
developed to check for calibration agreement and patient result
Current test methods including performance specifications, whether on
multiple test analyzers or independent tests, are available to clients upon
1. Each lab section should
develop and maintain a procedure and/or
schedule for instrument maintenance which verifies the critical
operating characteristics of all instruments or components in use.
Maintenance procedures should define tolerance limits for
acceptable functions where appropriate and should include:
a) stepwise instructions for
performing maintenance and/or
b) instructions for documentation of maintenance and/or checks
Procedures should include instructions for minor troubleshooting
and instrument repair, and may include or refer to manufacturer’s
Instrument maintenance and function checks should be documented
by the technical operator. Records of such checks, as well as service
calls and repairs, should be readily available to the technical
operating staff at or near the instrument to detect trends or
In order to minimize the possibility that duplicate analyzers are out of
service at the same time, appropriate measures will be taken by all lab
staff to assure that acceptable quality control is achieved on any
analyzer on which maintenance or repairs have been performed before
beginning any maintenance or repairs procedures on the second analyzer.
The Clinical Lab Medical Director and Lab Manager on call must be notified
in the event that duplicate analyzers are out of service and lab work is
being significantly delayed.
A. The laboratory should have an
organizational plan, personnel policies and job
description in accordance with Human Resources requirements.
B. The laboratory will be
staffed by appropriately trained and certified individuals in
accordance with state and federal requirements.
C. Appropriate personnel files
will be maintained for each employee.
A. The laboratory should have
adequate space for the overall workload so that the
quality of patient results, quality of control procedures, safety of personnel, and
patient care services are not compromised.
The available space should be efficiently utilized, and kept clean and well
C. The laboratory should have
adequate procedures and space for inventory, ordering
and storage of supplies and reagents. The storage areas should be well-organized and
D. The laboratory should establish
procedures to ensure the integrity of temperature-
A. The laboratory will develop and
maintain policies and procedures to ensure the
safety of laboratory personnel and patients. These policies and procedures
should also ensure compliance with regulatory agencies.
Safety policies and procedures should be posted and/or readily available to
Procedures should be developed to ensure that all occupational illnesses or
injuries are documented, treated, and evaluated.
Employees should receive training in use of fire fighting equipment and
safe handling of electrical equipment and hazard controls.
The laboratory must develop a Chemical Hygiene Plan which develops safety
procedures for all hazardous chemicals used in the laboratory. There must also
be annual review and evaluation of the effectiveness of the laboratory’s Chemical
Safety procedures should define a method for the disposal of all hazardous
and a program to reduce the volume of hazardous waste generated by the
Safety procedures should include programs for emergency preparedness,
plans, radiation safety and procedures for biohazard control.
The laboratory’s safety program must include a documented policy for
precautions in accordance with the OSHA Standard on “Occupational Exposure
To Bloodborne Pathogens.”
The laboratory should provide for training of all applicable personnel in
use of personal protective equipment (PPE), precautionary measures, and the
application of “universal precaution” to their work practices.
The laboratory should have in place a program for the follow-up procedure
possible and known exposures to HIV, HBV, or HCV.
The laboratory should establish and periodically review procedures for safe
A. The laboratory should establish
a systematic program for the monitoring and
evaluation of the quality and appropriateness of its contribution to patient care.
Communication regarding quality issues is reviewed daily at morning report and/or
recorded in the Red Communication Book maintained by the Tech in Charge for
the evening and night shift. Follow-up action, including variance and Patient
Safety Net reporting will be taken as necessary.
The laboratory’s continuous quality improvement program should provide for
each laboratory section to participate in problem identification and resolution.
The program should provide for documentation of all problems and include
for investigation, monitoring and corrective action of problems.
The quality improvement program should include provisions for reporting
problems to appropriate individuals and an established quality improvement
committee. The quality improvement committee should consist of:
1. The Laboratory Director
2. Professional laboratory personnel
E. The continuous quality improvement program should be evaluated annually.
**Policy review dates and signatures are available and on file in the laboratory.
(Original on file)
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