Department of Pathology
Hematology
Hematology QC Program SOP
Author: Department of Pathology.
Core Lab
Document Origin: Internal Procedure
Review by
Heidi Hanes
Document Number:
Effective (or Post) Date:
Company:
SMILE Approved by:
Review date
Pro50-14
09 Feb 2009
Johns Hopkins
Hospital.
Orlinda Maforo
1 April 2020
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s
specific processes and/or specific protocol requirements. Users are directed to countercheck facts when considering
their use in other applications. If you have any questions contact SMILE
Hematology Quality Control and Management Plan
HEA.1600 Version 1.0
Effective:___________
PURPOSE: To provide standards for quality control that are utilized in the Hematology!
Coagulation section of the CORE lab. Pre-analytic and post-analytic standards follow the
Laboratory Quality Management and Quality Control Plan. Specific pre-analytic or postanalytic requirements are documented in test procedures as needed. Per the the Laboratory
Quality Management plan, the department participates in Quality Improvement monitors as
defined.
Scope: Standards in this plan are pertinent to particular analyzer testing (GENS, HMX, MLA
1400C) and Manual testing (manual diff, Retic, ESR etc). The Quality Control program consists
of the following: analysis of quality control materials as specified in individual procedures,
documentation of quality control, investigation of quality control values and the use of
proficiency samples on a regular basis.
All solutions (Reagents, Control Materials and Calibrators) must be properly labeled:
1. Vendors usually supply content, quantity and concentration.
2. Storage requirements: vendor supplied but once opened or on board an
instrument, requirements that change must be added to the container.
3. Date prepared, opened or reconstituted must be on the container.
4. Expiration date: vendor supplied but once opened or on board an instrument
requirements may change and these must be added to the container.
Performance
The performance of the quality control material must be determined for each analyte it is used
for. For some testing this involves preparing several vials of controls for use over several days
and determining the concentrations of the desired analytes. Multiple technologists and shifts
should be involved to get a representative picture of the performance of the material of an
entire run.
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Generally, at least ten (10) and preferably twenty (20) determinations are required. The data
generated is used to calculate the arithmetic mean (average result) and standard deviation
(variance from the mean). Some pocket calculators and some computer programs can
perform these calculations.
Statistically, 68.2% of the results will be within  1 standard deviation from the mean, 95.5%
will be within  2 standard deviations from the mean, and 99.7% will be within  3 standard
deviations from the mean.
Multiple controls (2 or 3) with different mean values must be used. These may be low/high
levels or clinically normal/clinically abnormal levels. CLIA ’88 mandates the minimum level of
quality control to be, that which is recommended by the manufacturer of the analytical system.
The whole quality control system depends on stability. A number of factors will affect the
stability of the instrument/reagent analytical system. These include:
1. Environmental factors such as temperature and humidity
2. Quality of water used by the system, or for reconstitution of controls and
reagents
3. Recalibration of an existing lot of reagent
4. Change of reagent lot
5. Service to the analyzer
6. Deterioration of reagent or of control
7. Instrument mechanical wear or lamp problems
Any of the above may affect results of quality control specimens and patient samples and
could compromise patient care.
Some of the effects of these factors can be anticipated. A change in performance due to a
calibration or reagent lot change may be expected. Major service to an analyzer can also be
expected to change performance. In these cases, the analytical performance of a test around
the mean does not change; it is the mean that has changed. This is referred to as a “shift”. In
such cases the material must be re-assayed and a new mean assigned. A minimum of 5 – 10
patient results before and after should be examined to ensure changes in mean are not
associated with changes in patient values.
The other factors will cause drift away from the mean. This is referred to as a “trend”.
Deterioration of the reagent, the control, or the analyzer may result in values that start within
the acceptable control range and progressively move further away from the mean,
eventually exiting the range. The sooner a trend can be recognized, the sooner it can be
resolved.
In most situations trends are minor and not clinically significant. Attempts should be made to
determine the cause of a trend and institute corrective (remedial) action if it is indicated.
Quality Control must be performed, and the results must be acceptable, before any
patient result can be released.
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Quality control ranges for each analyte will be stored in those analyzers that support quality
control data storage.
All major laboratory instruments are interfaced to the Laboratory Information System (LIS).
Quality control data from these instruments can be uploaded to LIS.
Quality control data for instruments that are not interfaced can be entered into the LIS
manually. At this time the following analyzers support on-board quality control but are not filed
in the LIS:
 .HMX
 GenS
All controls for quantitative tests must be within  2 SD of the assigned mean. Any value
outside of these ranges must be investigated and resolved before patient testing can be
continued.
Suggestions are:
1. Rerun the control. Pour a fresh sample.
2. If another vial of the control is available use that. Otherwise prepare a fresh
vial.
3. No more than 2 control reruns (same vial, new vial) should be made. If this
does not solve the problem begin troubleshooting. Do Not report patient
results use alternate instrument or kit.
4. Check analyzer maintenance, reagent, calibrations or kit for problems.
Has the reagent outdated, or been open longer than manufacturer’s
recommendations? Has calibration been performed? Does it need to be
performed? Has maintenance been performed? All instances of control
problems must be documented along with the corrective (remedial) action in
the department communications book.
Use of controls for kit forms of patient testing:
Controls are run on reagents or test kits each day of use or with each run depending
upon method, manufacturer instructions and compliance requirements. The manufacturer’s
instructions should be followed for the frequency of testing of external controls on test kits that
utilize Internal controls.
For external controls, at minimum, a positive and negative control should be run.
Reactive, weakly reactive, and nonreactive controls are used where results are reported in this
fashion. Semi-quantitative (titer) procedures include a positive control, run at two or more
levels, and a negative control. Whenever possible, patient samples are included in lot-to-lot
testing.
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Documentation of internal control must be included with the external controls whenever QC is
performed. If the internal control does not respond as expected, a re-run is to be performed
from same box. If second device fails internal control, the lot is to be removed from service; a
new lot QC’d and information left for the Section Manager and Materials Management.
Acceptable Control results for these types of reactions:
A “positive” control must be positive; a “negative” control must be negative.
Internal controls must react as described in the manufacturer’s instructions.
Semi-quantitative (titer) procedure control results should agree within ± 1 level.
Graded control results may be reported as +1, +2, etc or Small, Moderate, Large, or as defined
for the specific method by the manufacturer; and must come within the required range.
The laboratory will retain all quality control data and printouts for two years. Storage does not
need to be on-site.
Proficiency Testing:
Proficiency Testing is an integral part of Quality Control. Surveys will be performed for
every test performed in the clinical laboratory. This laboratory currently subscribes to the
College of American Pathologists Proficiency Testing Program. Other vendors may be added
to meet changing needs. Samples will be identified as Survey specimens and will be
integrated into the normal workflow with routine patient specimens.
Although there are no current tests performed without PT available there can be one instituted
at any time. For those tests that do not have a survey available, alternate PT methods will be
used. This can include split samples sent to a reference lab, split samples among techs or
comparison of manual method with analyzer method Proficiency testing will be done at least
two times a year per analyte. For in-house proficiency testing, the results will be documented
on the Alternate Proficiency Testing form; all supporting documents attached and then
submitted to the Manager for review. See ADM.0530, section D.
Survey samples may not be sent to a reference laboratory or another hospital laboratory.
Interlaboratory communication about proficiency testing samples prior to results submission is
prohibited.
Testing for each analyte will be done on the instrument routinely used for that analyte.
On automated instruments, results will be taken from the report generated from the Laboratory
Information System through the instrument interface. The first valid result obtained will be
entered on the PT result form. Tests will not be run in duplicate, triplicate, etc, unless this is
routinely done for patient specimens.
If the first result is beyond technical limits, an appropriate dilution will be prepared and the test
repeated until a valid result is obtained. Only approved dilution protocols for the individual
analyte will be used.
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If unusual results are obtained, which would normally prompt a request for review by a second
technologist or supervisor, or consultation from a Pathologist, it is appropriate to do so.
There will be no discussion of any survey with colleagues in other laboratories or re-runs of
material on alternate instruments, before results are submitted to the accredit ting agency.
Results will be recorded on the PT result input form according to the PT Agency's instructions.
Since this is not a form routinely used for patient reports, it is appropriate for a second
technologist or supervisor to review the results for clerical error before submitting. Testing
personnel must sign the attestation statement
Results will be transmitted to the PT Agency by mail, FAX, on-line data entry or as otherwise
specified in the instructions. The QA coordinator will be notified of completion.
Once results are entered for the analytes on the Proficiency Samples, the samples may be run
on alternate instrument for correlated comparison upon receipt of Proficiency report. Results
from all methods and instruments are recorded and compared with results received later from
the PT agency. Such testing is necessary to insure that results from different instruments and
methods are comparable.
Survey evaluations are received an average of six weeks after submission. The Laboratory
Administrative Director and then the Laboratory Department Manager or other designee
reviews the evaluations. Problems, if any, will be researched and a discrepancy report
completed. The cause of the discrepancy will be determined and if possible corrective action
will be indicated. Pathologist will then review the evaluation. The Medical Director and
Administrative Director will respond to the CAP and Maryland State Department of Health and
Mental Hygiene as required for any deficiencies.
Survey evaluations and worksheets will be retained for two years. Storage need not be onsite.
Calculation of ranges:
Controls are available in two primary categories, assayed and unassayed. Ranges for both
categories must be developed in-house. Package insert ranges for assayed controls may be
used only for those procedures performed very infrequently. Developing in-house ranges is
not practical in this circumstance.
1. Use the package inserts to verify what constituents are present. Do not attempt to
develop a range for an analyte that is not listed.
2. Over the course of several days analyze the control for each desired analyte. This
should encompass several vials of control, multiple technologists, and all shifts. Run
in duplicate each time until a minimum of ten (10); preferably twenty (20) values have
been obtained. Retain all printouts.
3.
Using the data supplied by the vendor as a guideline, review the data obtained in the
laboratory to calculate the mean and  1 standard deviation (SD). Also calculate the
coefficient of variation (CV). Examine the data.
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4. Use the derived mean and SD to calculate 2 and 3 SDs and ranges for all the
parameters. Verify all calculations. Enter the appropriate numbers into each of the
analyzers that support QC. Post the means and ranges for analyzers not supporting
QC. Enter the appropriate numbers into LIS.
5. Monitor performance. Minor adjustments are sometimes needed.
I. Control Rules:
Controls should be run with initial patient run of the shift. The technologist must assure that
the displayed results upon data entry are within ± 2 SD of the assigned mean
Two Controls:
Acceptable:
both are within  2 SD.
Unacceptable:
one control is between 2-3 SD for two
consecutive runs, the second run is
not acceptable
one within  2 SD/one is between
one control is greater than  3 SD
2-3 SD
Three controls:
Acceptable:
Unacceptable:
three are within  2 SD.
one control is between 2-3 SD for two
consecutive runs, the second run is not
acceptable
two are within  2 SD/one is
between 2-3 SD
one control is greater than  3 SD
two or more results ± 2 - 3 SD
II. ACTION FOR OUT OF CONTROL RUN:
a) Set up another run using new controls and three patients from original run. If on re-run
the controls are in and patients still read their original results, all patients are okay to
release. Discard old controls. Make sure the unacceptable control value is entered along
with suitable modifier. If further action is taken, be sure to enter appropriate
documentation.
b) If both old and new controls are out, hold all patient results. Check: temperatures;
Reagents and Calibration dates. Run on alternate kit or instrument if available and within
control acceptability.
The following would indicate a shift is occurring; supervisory personnel must be notified.
Two consecutive results more than  2 SD from the mean on the same side.
All QC failures and variances must have corrective action documented in communications log.
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III. Corrective Actions:
Corrective actions include, but are not limited to, the following. In all cases the Supervisor
should be consulted.
1. Set up another run using new controls and three patients from original run. If on rerun the controls are in and patients still read their original results, all patients are okay
to release. Discard old controls. If controls still out, continue:
2. Check analyzer (or kit) for problems.
3. Is the control beyond the open vial expiration? If this is the case pour a fresh cup or
reconstitute a new vial as indicated. Run the new sample only once then proceed to
next level of troubleshooting.. Do Not continue to rerun controls until an incontrol result is obtained.
4. Has the reagent outdated, or been open longer than manufacturer’s
recommendations? Replace and rerun.
5. Has the elapsed time of calibration exceeded manufacturer’s recommendations?
Recalibrate.
6. Has a lot or vial of reagent been changed, with or without calibration? Calibrate.
7. Has there been maintenance to the analyzer or other equipment? May need
calibration and/or reassignment of control mean.
8. Has there been a recent calibration? May need to recalibrate.
9. Has there been a power interruption to the instrument?
NOTE: All instances of control problems must be documented along with the corrective
(remedial) action. Documentation must be on a written log, via coded comments in LIS and via
comments in the Hematology Communications Book. (see next page)
No patient results are to be reported until the out-of-control situation has been resolved.
If investigation shows that there is (was) a systems problem and previous run is questionable,
the assigned technologist is responsible for:
Repeating all patient testing since the last acceptable Quality Control was run .
Use of alternate method to process all samples.
Call for service/request service of hotline.
Documentation necessary in the Hematology Communications Book:
1. QC PROBLEMS
A. LEVEL and /or LOT NUMBER
B. PROBLEM OBSERVED
C. WHAT WAS DONE TO CHECK ISSUE?
i. ALTERNATE QC UTILIZED TO DEFINE PROBLEM?
ii. CAP MATERIAL USED?
iii. LINEARITY MATERIAL?
iv. PATIENT SAMPLES FROM PREVIOUS RUNS WHEN QC
ACCEPTABLE USED?
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D. WAS THERE IMPACT ON PATIENT RESULTS? What was done with patient
samples? How many?
E. RESOLUTION OF PROBLEM.
2. INSTRUMENT PROBLEMS
A. INSTRUMENT ID
B. TIME OF OCCURRENCE
C. PROBLEM OBSERVED AND/OR ENCOUNTERED
D. WERE PATIENT SAMPLES COMPROMISED? PRINT OUT ALL REPEATS,
ATTACH INITIAL RESULTS AND REPEATS FOR MANAGER REVIEW WITH
OCCURRENCE REPORT
E. WHAT WAS DONE?
i. INSTRUMENT TAKEN OFF LINE? TIME?
ii. LIST INTERNAL MAINTENANCE PERFORMED TO TRY TO RESOLVE
PROBLEM
iii. VENDOR HOTLINE CALLED – INCLUDE TIME CALL INITIATED AND
TIME OF RESPONSE.
iv. SOLUTION THROUGH HOTLINE?
v. RESOLUTION
vi. SERVICE NEEDED?
vii. TIME OF SERVICE ARRIVAL/ RESOLVED
viii. RESOLUTION
ix. TIME INSTRUMENT BACK IN USE
F. WAS THE ED OR OTHER ORIGINATING LOCATION(S) NOTIFIED OF
POSSIBLE DELAY? (ER CHARGE NURSE EXTENSION 9941)
Review of Quality Control:
Weekly review:
The Supervisor or Designee reviews all quality control weekly. This can be performed through
use of the computer system and reviewed on screen printed utilizing any accessible printer.
Correction of incorrectly entered data such as wrong level of control will be made. All
instances of out of range controls will be followed up to be sure there is adequate commenting
and, where necessary, corrective action. All actions will be documented. Tech ID is noted on
the results.
Weekly review of Communications book for Hematology will be performed by a Core Lab
Manager.
Monthly review:
The Section Manager, Supervisor or delegate, must print Quality Control charts monthly. A
Section Manager is then responsible to review for shifts, trends and bias. Documentation must
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be made on the charts after investigation of any of the above variances. Major shifts are to be
called to the attention of the Section Manager or Pathologist in charge of the section.
Statistics will be submitted monthly to Vendor for Interlaboratory comparison where applicable.
Internal review utilizing month-to-month statistical variation from computer printouts will be
used where no peer group is available. SDI’s of 1.0 are the goal, but are acceptable to 1.5.
Between 1.5 and 2.0 investigation and monitoring should occur. SDI > 2.0 requires immediate
investigation.
Action Protocol for Imprecision changes:
When the type of error cannot be easily identified and quantified from available control data, a
replication experiment is designed to estimate the contributions from several different
components. Duplicates may be analyzed within a run for several different runs. The data is
used to determine the components of within-run and between-run variation. This may help
identify the sources of random error. See NCCLS EP15-A, Fol.21, No.25, 5.1 on page 6 for
protocol.
Contact manufacturer if unable to resolve.
There will be a monthly review performed by the Manager or other appropriate supervisory
staff followed by additional review by the Pathologist, Medical Director and/or Laboratory
Administrative Director when appropriate. QC failure requiring corrections to patient results
already released must be documented on the Occurrence Report Form and the pathologist
notified immediately.
Daily review of QA report is performed by a Manager to include the following failures: Delta,
Technical and Verify (critical value). This process allows review of spurious patient failures
and any trends that may be occurring.
Reference Intervals:
The Reference Interval (or Reference Range) represents the range of results that includes
most healthy persons. This information comes from manufacturers as part of their method
documentation and similar data widely published in textbooks. The ranges are compared to
the population of patients that use laboratory services. Reference ranges are verified with the
introduction of new test; change of method/or change in patient population.
The Pathologist may consult with other physicians about the appropriateness of ranges as
well. Physicians will be educated about changes by mail, memo, posters/flyers and/or
comments on reports. If physicians have any concerns about specific reference ranges they
may refer the concerns to the Laboratory Director or the Pathologist for investigation.
Analyzer-Specific or Method-Specific Guidelines:
Note: All reconstitutions utilize Class-A volumetric pipettes or calibrated single-volume
mechanical pipets. Do not blow out the residual liquid from volumetric pipettes.
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In all references to water (Distilled, Reagent Grade or Type) there is only one source
water system utilized here at XXX for dilutions. This system produces Type I water. See
Lab General for specific system.
Control Materials:
A. Automated CBC Analyzers:
 Assayed: Beckman Coulter Tri-Ievel 5-C controls and 5C Retic
Chex controls. Normal, Abnormal Low and Abnormal High levels. Stored
refrigerated 2- 8 °C
 Tested two times in 24 hours. Night shift tests immediately after instrument
shutdown and restart. See chart for shifts and time of testing.
 Previously assayed materials as Quality Control: Blind Duplicate refers to two
specimens chosen on day shift and run mid-shift on evening and night shift. A
normal and abnormal patient sample is run in the primary and secondary modes.
Results are entered into the LIS and shifts are indicated on the Blind Duplicate
Log Form. Samples are repeated throughout the day as indicated on the QC
chart.
 Bull moving average (XB): Captured automatically by the analyzers. Ranges are
determined upon instrument setup. If more than 3 data points are at the + 5
range for any of the tests, the instrument must be investigated immediately,
beginning with running the quality controls. Troubleshoot until controls are within
range. All patient specimens that were part of the runs outside the range must be
repeated.
 Latron Primer: Supplier is Beckman Coulter. Simulated negative and positive
control are used to determine volume, conductivity and scatter functions of WBC
and differential mechanism.
Tests that flag must be repeated. Troubleshoot as needed.
When troubleshooting, a control can also be other materials such as calibrators, proficiency
materials, previously reported patient samples, etc. However, calibrators used for controls
may not be the same material that was used for the current calibration. Freshly diluted and/or
opened materials or that of a different lot must be utilized
B. Manual Retic
Quality Control:
 Assayed: Retic--Chek, Normal and Abnormal levels (Streck
Laboratories). Run 2 levels of QC when testing is performed. Store
refrigerated at 2-80 C.
 Frequency: Controls are run at least weekly if no manual tests
were required during the week.
 Recorded on Setup worksheet.
 Reviewed monthly by manager or designee.
 Values within + 2-3 SD must be repeated. If the control fails again, another tech
must read from the same sample preparation. Open fresh control if techs results
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are in agreement.
 New lot correlation: Retic- Chek controls are tested. Minimum of 3 patients tested
with old and new lot of dye. Recorded on New Lot Correlation form. Results must
agree within:!:: 1 SD of the control that is within the same range as the patient
value.
 Proficiency material: College of American Pathologists - survey RET.
C. Manual Differential
 Instrument differentials were compared to manual differentials upon initial setup
of the analyzers.
 Instrument flags were established based on review by the Medical Director or
Pathologist designee. Some differential review is required based on specific
patient populations such as pediatrics.
 Daily, the technologists are comparing the function of the analyzer while reading
manual differentials.
 The LIS has keyboards and guidelines are available in the SOP for grading
(trace, small, moderate, large) cell or other morphological descriptions.
 Proficiency testinq is used to ensure uniformity of result reporting. The PT
material is assigned to one tech. After data is submitted, material is available for
all technologists to perform competency testing.
 Proficiency material: College of American Pathologists - FH6 (KP transparencies)
and CM.
D. Body Fluid Cell Counts:





All body fluid cell counts are performed using manual counts on the
hemacytometer.
Qualitv Control: Cell-Chex ( Streck Laboratories).
Controls are refrigerated at 2-80 C.
a. One level is run each shift when a body fluid cell count is performed.
b. Levels are alternated. Values are entered on the Patient Log and into
the LIS.
c. Counts on each side of the hemacytometer must agree within 10%
or the dilutions must be repeated.
Proficiency testinq is used to ensure uniformity of result reporting. PT material is
assigned to one tech. After data is submitted, material is available for all
technologists to perform competency testing.
Proficiency material: College of American Pathologists - HFC, FLD
and CM.
E. Sickle Cell Screen:
 Qualitv Control: Sickle-Trol (Dade) Positive/ Negative Hgb S controls.
Stored at 2 - 80 C.
a. Frequency: When test is performed.
b. Recorded in LIS and on Setup Worksheet. Reviewed monthly
by manager or designee.
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Proficiency material: College of American Pathologists - SCS
F. ESR (Erythrocyte Sedimentation Rate)
 Qualitv Control- Sed-chek 2 (Polymedco) Normal & Abnormal controls. Stored at
2 - 80 C.
 Frequency: Daily on day shift. Used on alternate shifts if there is a concern
about environmental temperature or balance of the holding rack. Recorded in
LIS and on Daily Quality Patient Log.
 New tube lots are checked by running 2 patients (preferably one normal and one
abnormal) along with the daily quality controls and recording on the Lot
correlation form.
 Proficiency material: College of American Pathologists - ESR
G. Phase Platelet
 Quality Control - Each test is compared to analyzer results.
 Result Frequency: When test is performed. Count on slide and analyzer platelet
count should compare within 10%.
 Proficiency material: Internal blind testing at least every six months. Two samples
previously performed on the hematology analyzer and manually tested by one or
two techs as unknowns. Internal Proficiency Testing Form used. Reviewed by the
pathologist.
H. Sperm Presence:
 XXX Laboratory does not classify sperm as to shape nor do we
perform sperm counts on semen. Reporting indicates only presence
or absence of sperm.
 Proficiency testing is used to ensure uniformity of result reporting. The PT
material is assigned to one tech. After data is submitted, material is available for
all technologists to perform competency testing.
 Proficiency material: College of American Pathologists surveys SEM and CM.
Data Entry
Resulting:
For detection of abnormal patient results, the LIS has alerts programmed to flag for
abnormal and critical values. Specific tests are programmed for delta checking in order to
detect possible sample errors or change in the patient status.
Manual tests are recorded on log sheets along with the resulting tech's initials. These
logsheets are retained should there ever be a question about the result.
All techs within the department have been CLIA approved for review of moderate and high
complexity testing.
Weekly a manual log sheet is randomly reviewed and the results verified within the LIS.
Errors are documented on the Occurrence Report and corrective action performed. Review
is documented on the Clerical QA Error log.
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REFERENCES:
1. James.O Westgard, Ph.D Basic QC Practices, 2nd Edition, Westgard QC,
Inc., 2002.
2. NCClS. Statistical Quality Control for Quantitative Measurements: Principles
and Definitions; Approved Guideline - 2nd edition. NCClS Document C24 A2.
Approval Signature: ___________________________
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