QUALITY ASSURANCE PROGRAM

JPH DIAGNOSTIC CENTER

I. Introduction:

To ensure the highest quality of laboratory services, the JPH Diagnostic Center
has developed the following plan to guide the full range of quality assurance, quality
control, and continuous quality improvement activities.

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 as positive sample handling and procedure development as well as
accurate results reporting and personnel competency documentation.
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 laboratory services possible.
II. Quality Assurance

A. Proficiency Testing

1. The JPH Diagnostic Center aims to be accredited by the Department of Health (DOH)
and as such, will participate in the DOH Inter-laboratory Comparison proficiency
testing program.
2. The laboratory will enroll in the appropriate DOH 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 counterchecked by another method and another laboratory. Methods of
compliance are kept in the laboratory section where these tests are performed.
4. Proficiency testing samples are integrated into the routine laboratory workload.
5. The head of the laboratory, or his designee or the supervisor of the lab section where
the testing was performed, reviews the proficiency or alternative method testing
results.
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 head of the laboratory.
7. All proficiency testing results and corrective action are filed for review.
8. Inter-laboratory communication about proficiency test samples is prohibited before
submission of results to the proficiency test provider. It is also prohibited to refer
proficiency testing to an outside laboratory.
9. In the event a Proficiency test challenge was not graded due to lack of consensus, 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 DOH final results. If we fail to receive the Proficiency
Testing kit or need to obtain another kit, DOH 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.

B. Analytical And Non-Analytical Quality Assurance System Design

1. Each laboratory section should develop procedures, which adhere to and promote the
quality and policies set by the JPH Diagnostic Center. These procedures should
define goals for monitoring analytical performance, establish tolerance limits for
quality control, and establish corrective action steps and documentation.
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 and non-analytical processes may include the
following elements, as applicable:

a) Establishment of a system of periodic review of patient and quality control

results, maintenance records, temperature checks, etc.
b) Establishment of a system which ensures positive identification of patients
and their samples from collection through results reporting.
c) 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 be tested.
d) 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.
e) 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.
f) 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.

C. Procedures

1. All laboratory sections will develop and maintain a procedure manual in compliance
with the DOH 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 head of the laboratory or his
designee. If revisions are made to a procedure, the revisions must be documented
and the procedure re-approved by the head or his 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.

D. Specimen Handling

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.

5. Specimen retention should be in compliance with accrediting and regulatory

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.

Results Reporting

1. Each test procedure, where applicable, should be evaluated for the following
specifications prior to implementation:
a) Accuracy
b) Precision
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 is 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 laboratory should have defined turnaround times for each test and a procedure
to notify clients, if necessary, in the case of delayed results.

8. 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.

9. Errors in reporting patient results will be corrected as soon as possible by notifying

the nurse or physician and submitting the corrected results with the previously
reported results also given. 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.
Assay Performance

1. Laboratory procedures should include the verification of assay

reagents.
2. All reagents must be properly labeled as appropriate with the following elements:
a) Content
b) Quantity
c) Concentration
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.

4. 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.

5. 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:

a) Content
b) Concentration or calibration values
c) Date placed in service
d) Expiration date

The above information should be recorded on the calibrator or should be 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.

6. Calibration procedures should include provisions for performance 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.

7. 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

Quality Control
 1. Each laboratory section will establish and maintain written procedures which direct
the quality control program for testing performed in that section.
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.
b. identification and usage of the control materials
c. procedures used to establish the acceptable limits of un-assayed and assayed
control materials when applicable
d. inclusion of both a positive and a negative control for applicable qualitative
tests
e. organization and evaluation of the quality control data procedures for
corrective action, when applicable
f. verification of quality control results before patient values are reported
g. Controls should be tested in the same manner and by the same personnel as
patient tests.
3. The quality control procedures should be under active surveillance by the section
supervisor or designee at least weekly with secondary review by the pathologist, at
least monthly. This review should be documented to include the date of review and
reviewer’s initials.

4. Corrective action must be taken and properly documented prior to the release of
patient results.

Instruments and Equipment

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.
2. Volumetric pipettes should be stored segregated by size and type. Any glassware
which becomes damaged or unable to be read will be appropriately discarded.
3. Procedures for cleaning glassware should be developed to ensure adequate washing
and proper rinsing of reusable laboratory glassware.
4. Laboratory sections should develop procedures for the periodic checks of the
following laboratory equipment:
a. non-mercurial thermometers
b. centrifuges
c. microscope
5. Quality assurance procedures should provide for periodic checks and calibration of
centrifuges as well as proper cleaning and servicing of microscope.

Instrument Maintenance

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.
2. Maintenance procedures should define tolerance limits for acceptable functions where
appropriate and should include:
a. stepwise instructions for performing maintenance and/or checks
 b. instructions for documentation of maintenance and/or checks

3. Procedures should include instructions for minor troubleshooting and instrument

repair, and may refer to manufacturer’s service manual.
4. 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 or near the instrument to detect
trends or malfunctions.

5. 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 Laboratory Manager must be notified in the
event that duplicate analyzers are out of service and lab work is being significantly
delayed.

III. Personnel

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 professional requirements.
C. Appropriate personnel files will be maintained for each employee.

Physical Facilities

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.
B. The available space should be efficiently utilized, and kept clean and well
maintained.
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 maintained.
D. The laboratory should establish procedures to ensure the integrity of temperature-
controlled reagents.

Laboratory Safety

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.
B. Safety policies and procedures should be posted and/or readily available to all
personnel.
C. Procedures should be developed to ensure that all occupational illnesses or injuries
are documented, treated, and evaluated.
D. Employees should receive training in use of firefighting equipment and drills, safe
handling of electrical equipment and hazard controls.
 E. 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
Hygiene Plan.
F. Safety procedures should define a method for the disposal of all hazardous wastes
and a program to reduce the volume of hazardous waste generated by the
laboratory.
G. Safety procedures should include programs for emergency preparedness, evacuation
plans, and procedures for biohazard control.
H. The laboratory’s safety program must include a documented policy for Universal
precautions in accordance with the OSHA Standard on “Occupational Exposure to
Blood borne Pathogens.”
I. The laboratory should provide for training of all applicable personnel in the proper
use of personal protective equipment (PPE), precautionary measures, and the
application of “universal precaution” to their work practices.
J. The laboratory should have in place a program for the follow-up procedure after
possible and known exposures to HIV, HBV, or HCV.
K. The laboratory should establish and periodically review procedures for safe work
practices.

Quality Improvement

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 Endorsement Logbook maintained by the person in charge
of the daily shift.
B. The laboratory’s continuous quality improvement program should provide for
each laboratory section to participate in problem identification and
resolution.
C. The program should provide for documentation of all problems and include steps
for investigation, monitoring and corrective action of problems.
D. 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 Head
2. Professional laboratory personnel
E. The continuous quality improvement program should be evaluated annually.